cardiovascular-agents and Graft-Occlusion--Vascular

To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis.. PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where. In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.

Topics: Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Graft Occlusion, Vascular; Humans; Randomized Controlled Trials as Topic; Renal Dialysis; Time Factors; Treatment Outcome; Vascular Patency

Arteriovenous fistula (AVF) stenosis is a common problem leading to dialysis access dysfunction. The conventional balloon (CB) is the most commonly used device during angioplasty but suffers from poor durability of results due to neointimal hyperplasia-mediated recurrence. The drug-coated balloon (DCB) is an adjunct to balloon angioplasty that reduces neointimal hyperplasia, thereby improving post-angioplasty patency. Despite the heterogeneity of DCB clinical trials to date, the evidence suggests that DCBs of different brands are not necessarily equal, and that patient selection, adequate lesion preparation and proper DCB procedural technique are important to realize the benefit of DCB angioplasty.

Topics: Angioplasty, Balloon; Arteriovenous Fistula; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Graft Occlusion, Vascular; Humans; Hyperplasia; Paclitaxel; Renal Dialysis; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To perform an individual patient data level meta-analysis of randomised controlled trials comparing drug coated balloon angioplasty (DCB) against conventional percutaneous transluminal angioplasty (PTA) in the treatment of dysfunctional haemodialysis venous access.. A search was conducted from inception to 13 November 2020. Kaplan-Meier curves comparing DCB with PTA by target lesion primary patency (TLPP) and access circuit primary patency (ACPP) were graphically reconstructed to retrieve patient level data. One stage meta-analyses with Cox models with random effects shared frailties were conducted to determine hazard ratios (HRs). Dynamic restricted mean survival times (RMST) were conducted in view of violation of the proportional hazards assumption. Conventional two stage meta-analyses and network meta-analyses under random effects Frequentist models were conducted to determine overall and comparative outcomes of paclitaxel concentrations used. Where outliers were consistently detected through outlier and influence analyses, sensitivity analyses excluding those studies were conducted.. Among 10 RCTs (1 207 patients), HRs across all models favoured DCB (one stage shared frailty HR 0.62, 95% CI 0.53 - 0.73, p < .001; two stage random effects HR 0.60, 95% CI 0.42 - 0.86, p = .018, I. Overall evidence suggests that DCB is favoured over PTA in TLPP and ACPP.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Randomized Controlled Trials as Topic; Renal Dialysis; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

A systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to determine the effectiveness and safety of drug coated balloon (DCB) angioplasty compared with uncoated plain balloon (PB) angioplasty in treating arteriovenous access stenosis.. MEDLINE, Embase, Scopus, and the Cochrane Central Register of Controlled Trials were searched for RCTs comparing paclitaxel coated DCB and PB angioplasty for arteriovenous access stenosis. The last date of the literature search was 31 December 2020. Risk of bias of the retrieved studies was assessed with the Cochrane Collaboration tool for assessing risk of bias (RoB 2.0). The random effects model was used to estimate the risk of loss of target lesion patency (six and 12 months) and circuit patency (six and 12 months). Procedure related adverse events and mortality rate were also compared. Patency results were pooled using the time to event meta-analytical method and the quality of evidence was assessed according to the GRADE approach.. Sixteen eligible trials, including 1 682 lesions, were included in the quantitative analysis for the efficacy and safety of paclitaxel coated DCBs. DCBs were associated with a lower risk of loss of target lesion patency at six months (HR 0.53, 95% CI 0.42 - 0.66) and 12 months (HR 0.60, 95% CI 0.47 - 0.76), and were also associated with improved six and 12 month circuit patency. Overall quality of evidence was moderate to low. Procedural complications were rare, and the risk of death up to 12 months was similar between the two groups (OR 1.03, 95% CI 0.68 - 1.56).. Paclitaxel coated DCBs reduced the risk of loss of target lesion patency and circuit patency in arteriovenous access stenosis compared with PBs. Considering the heterogeneity of the included trials, there is a need to investigate optimal treatment regimens regarding drug dose and agent of the DCB and the treatment procedure.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Randomized Controlled Trials as Topic; Renal Dialysis; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Arteriovenous fistula is the most preferred form of vascular access, but stenosis treated by balloon angioplasty is prone to restenosis. Multiple trials have been published with regard to the use of paclitaxel-coated balloon to prolong lesion patency compared to conventional balloon. Although paclitaxel-coated balloon has theoretical appeal, its use has not been widespread nationwide due to cost and lack of large-scale multicenter studies. We performed this meta-analysis to evaluate whether paclitaxel-coated balloon outperforms conventional balloon to prolong target lesion patency.. PubMed/Medline, Clinical Trials.gov, EMBASE, Scopus, Web of Science, and Cochrane Central were searched from inception through April 2019 for studies that investigated the use of paclitaxel-coated balloon in arteriovenous fistula.. Ten studies were included in the final meta-analysis: six studies were randomized controlled trials and four studies were cohort studies. There were 911 participants with a mean age of 64.78 (±5.96) years, and 61.89% were male. Outcome of interest was target lesion primary patency, recorded at 1, 3, 6, 7, 12, and 24 months. Meta-analysis of randomized controlled trials shows that paclitaxel-coated balloons did not statistically improve target lesion primary patency compared to conventional balloons at months 1 (odds ratio = 1.54, p = 0.6373), 3 (odds ratio = 0.57, p = 0.0575), 6 (odds ratio = 0.65, p = 0.3644), 7 (odds ratio = 0.63, p = 0.0582), 12 (odds ratio = 0.64, p = 0.0612), and 24 (odds ratio = 0.43, p = 0.3452). Effect of paclitaxel-coated balloons was statistically significant for cohort studies at months 6 (odds ratio = 0.26, p = 0.0007), 12 (odds ratio = 0.21, p = 0.0001), and 24 (odds ratio = 0.23, p = 0.01).. Paclitaxel-coated balloon showed no statistically significant improvement over conventional balloons in decreasing fistula stenosis in randomized controlled trial but were significant for cohort studies.

Topics: Aged; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Observational Studies as Topic; Paclitaxel; Randomized Controlled Trials as Topic; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

Hemodialysis access dysfunction is the major cause of hospitalization for patients undergoing hemodialysis due to stenosis at the anastomotic site. Our purpose is to perform a meta-analysis comparing target lesion primary patency rates at 6 months and one year, and major procedure-associated complications between drug-eluting balloon (DEB) and plain balloon angioplasty (PBA) for the treatment of arteriovenous fistula (AVF) or synthetic arteriovenous graft (AVG) stenosis.. PubMed, Embase, and MEDLINE databases were screened up to December 2018 to compare target lesion primary patency and complications between DEB and PBA. Two independent reviewers identified studies fulfilling our inclusion/exclusion criteria, extracted relevant data, and assessed quality. Fixed- or random-effects models were used to calculate overall effect estimates.. Our literature search identified 10 articles eligible for inclusion in the review and analysis. DEB provided significantly higher target lesion primary patency rates for failing hemodialysis access than did PBA at 6 months [70% vs. 54%; odds ratio (OR), 2.71, 95% confidence interval (CI), 1.51 to 4.85; P < 0.01] and one year (59% vs. 37%; OR, 3.12, 95% CI, 2.14 to 4.55; P < 0.01). No major procedure-associated complications were observed in the 2 groups.. DEB is an effective and safe technology that can significantly prolong 6-month and one-year target lesion primary patency for failing hemodialysis access when compared to PBA.

Topics: Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Graft Occlusion, Vascular; Humans; Renal Dialysis; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Comparative Effectiveness Research; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Renal Dialysis; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Restenosis remains a significant problem in endovascular therapy for hemodialysis vascular access. Drug-coated balloon (DCB) angioplasty decreases restenosis in peripheral and coronary artery diseases. The aim of this systematic review and meta-analysis is to assess the patency outcomes following DCB angioplasty, as compared to conventional balloon (CB) angioplasty for the stenosis of hemodialysis vascular access.. A comprehensive search in the MEDLINE, EMBASE, and CENTRAL databases was conducted in order to identify eligible randomized controlled trials evaluating DCB angioplasty for hemodialysis vascular access dysfunction. The primary endpoint was the 6-month target lesion primary patency and the secondary endpoints were 12-month target lesion primary patency and procedure-related complications. Risk ratios (RR) were pooled and relevant subgroups were analyzed separately.. Eleven randomized controlled trials comprised of 487 patients treated with DCB angioplasty and 489 patients treated with CB angioplasty were included. There were no significant differences in the target lesion primary patency at 6 months [RR, 0.75; 95% confidence interval (CI), 0.56, 1.01; p = 0.06] and at 12 months (RR 0.89; 95% CI, 0.79, 1.00; p = 0.06). The absence of benefit for the DCB group remained, even in the arteriovenous fistula subgroup or the subgroup of studies excluding central vein stenosis. The risk of procedure-related complication did not differ between the two groups (RR 1.00; 95% CI 0.98, 1.02; p = 0.95).. DCB angioplasty did not demonstrate significant patency benefit for the treatment of hemodialysis vascular access dysfunction. Wide variations in patency outcomes across studies were noted. Further studies focusing on specific types of access or lesions are warranted to clarify the value of DCB for hemodialysis vascular access. (PROSPERO Number CRD42019119938).

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Fistula; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Renal Dialysis; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The comparison between paclitaxel-coated balloon (PCB) angioplasty and plain balloon angioplasty (PBA) for hemodialysis (HD) access stenosis or occlusion has not been well investigated. The objectives of this systematic review and meta-analysis were to compare all-cause mortality, HD access primary patency, and circuit primary patency after endovascular maintenance procedures using PCB angioplasty vs PBA.. MEDLINE, Embase, and Cochrane Databases were systematically searched to identify all the relevant studies on paclitaxel-coated devices for stenosis or thrombosis of HD access. A random effects model was applied to pool the effect measures. Dichotomous data were presented using an odds ratio (OR). Effect data were presented using pooled hazard ratio (HR) with 95% confidence interval (CI).. A total of 16 studies were included in this meta-analysis, 12 randomized controlled trials and 4 cohort studies involving 1086 patients who underwent endovascular treatment for HD access stenosis or occlusion. All-cause mortality rates at 6, 12, and 24 months after intervention were similar between the PCB and PBA groups (6 months: OR, 1.06 [95% CI, 0.38-2.96; P = .907; I. This systematic review and meta-analysis demonstrated that PCB angioplasty is associated with significantly improved primary patency of arteriovenous fistula and central venous stenosis for HD access maintenance, with no evidence of increasing all-cause mortality based on short-term and midterm follow-up. Further large cohort study is needed to investigate long-term mortality.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Recurrence; Renal Dialysis; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Reactive oxygen species (ROS) are natural byproducts of oxygen metabolism in the cell. At physiological levels, they play a vital role in cell signaling. However, high ROS levels cause oxidative stress, which is implicated in cardiovascular diseases (CVD) such as atherosclerosis, hypertension, and restenosis after angioplasty. Despite the great amount of research conducted to identify the role of ROS in CVD, the image is still far from being complete. A common event in CVD pathophysiology is the switch of vascular smooth muscle cells (VSMCs) from a contractile to a synthetic phenotype. Interestingly, oxidative stress is a major contributor to this phenotypic switch. In this review, we focus on the effect of ROS on the hallmarks of VSMC phenotypic switch, particularly proliferation and migration. In addition, we speculate on the underlying molecular mechanisms of these cellular events. Along these lines, the impact of ROS on the expression of contractile markers of VSMCs is discussed in depth. We conclude by commenting on the efficiency of antioxidants as CVD therapies.

Topics: Angiotensin II; Antioxidants; Atherosclerosis; Biomarkers; Cardiovascular Agents; Cell Cycle Proteins; Cell Movement; Cell Proliferation; Fibroblast Growth Factors; Gene Expression Regulation; Graft Occlusion, Vascular; Humans; Hypertension; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; NADPH Oxidases; Oxidative Stress; Phenotype; Reactive Oxygen Species; Signal Transduction

Arteriovenous fistulas for patients undergoing hemodialysis (HD) are at high risk of stenosis. Despite conventional balloon angioplasty (CBA), restenosis rates are high. The use of a drug-coated balloon (DCB) may offer an alternative to reduce restenosis.. This study has been performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. An electronic search on MEDLINE, Embase, and the Cochrane Library was performed to identify articles evaluating DCB angioplasty for patients with HD access stenosis. Risk ratios (RRs) of primary patency were pooled, and relevant subgroup and sensitivity analyses were conducted.. There were 17 studies (8 randomized controlled trials [RCTs], 9 cohort studies) included, comprising a total of 1113 stenotic dialysis accesses, of which 54.7% underwent DCB angioplasty and 45.3% underwent CBA. There was a significantly superior 6-month (RR, 0.57; 95% confidence interval [CI], 0.44-0.74; P < .00001; I. DCB angioplasty appears to be a better and safe alternative to CBA in treating patients with HD stenosis in terms of 6- and 12-month primary patency. However, a larger trial is warranted to establish these findings.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Renal Dialysis; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Renal Dialysis; Risk Assessment; Risk Factors; Time Factors; Treatment Failure; Vascular Access Devices

To perform a systematic review and meta-analysis assessing patency outcomes following drug-coated balloon angioplasty (DCBA) in hemodialysis circuits.. MEDLINE and EMBASE systematic searches were performed from inception to November 2018 to identify comparative studies assessing DCBA vs plain old balloon angioplasty (POBA) in hemodialysis circuits. Abstract selection, data extraction, and quality assessment were performed by 2 independent reviewers. Primary outcome was loss of target lesion patency at 3, 6, 12, and 24 months for autogenous arteriovenous fistula (AVF), prosthetic arteriovenous graft (AVG), and hemodialysis-related central venous stenosis.. Twelve studies comprising 908 patients were included. There was a significant improvement in patency among AVF after DCBA vs POBA at 3, 6, 12, and 24 months (odds ratio 0.58 [95% confidence interval, 0.36-0.94]; odds ratio 0.40 [95% confidence interval 0.23-0.70]; odds ratio 0.39 [95% confidence interval, 0.25-0.61]; and odds ratio 0.20 [95% confidence interval, 0.07-0.62]). This benefit persisted on subgroup analysis of randomized controlled trials (RCTs) only. Meta-analysis of results specific to AVG could not be performed, as only 1 RCT was identified that favored DCBA. Hemodialysis-associated central vein stenosis did not demonstrate a significant difference in patency rates between DCBA and POBA on meta-analysis. Twelve-month mortality and same-day complication rates did not differ between arms.. Significant improvement in patency was identified with DCBA in AVF at 3, 6, 12, and 24 months. A single comparative study identified benefit of DCBA use in the AVG group. No significant benefit was identified with DCBA for central stenosis.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Recurrence; Renal Dialysis; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The arteriovenous fistula is currently the best permanent access for the hemodialysis patient. Unfortunately, stenosis impairs maturation, long-term survival, and function of the arteriovenous fistula. Angioplasty currently is the best procedure for the treatment of immature and dysfunctional arteriovenous fistulas. In this review, the authors discuss the optimum time to evaluate arteriovenous fistulas for maturity, methods of evaluation for maturity, and the role of angioplasty in salvaging immature arteriovenous fistulas. The review also discusses the effect of stenosis on dysfunction in mature arteriovenous fistulas and the role of angioplasty to treat this complication. Finally, the impact of cutting balloons and drug-eluting balloons in the treatment of resistant and recurrent stenosis, respectively, is also discussed.

Topics: Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Graft Occlusion, Vascular; Humans; Renal Dialysis; Risk Factors; Salvage Therapy; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Current Renal Association guidelines recommend the creation of an arteriovenous fistula as the first choice for hemodialysis access, with artificial grafts kept in reserve. However, maintaining working access comes with significant difficulties, as well as an estimated annual cost to the National Health Service of greater than £84 million. Multiple methods of improving the successful creation of hemodialysis access, improving access maintenance and preventing access dysfunction therefore exist. The aim was to review these methods, including surgical, radiological, and pharmacological techniques.. The literature was reviewed up to March 2016 for reports of surgical, radiological, and pharmacology approaches to improve maturation, maintain function, and prevent dysfunction of arteriovenous fistulas and artificial access grafts.. Access function has been related to fistula and graft configuration and anastomotic technique. Novel surgical approaches include the use of early-cannulation grafts and biological grafts. Preoperative radiological vessel mapping and access surveillance have both been studied, and once stenosis or thrombosis has occurred, endovascular management techniques for thrombolysis and thrombectomy, along with angioplasty and stenting, are common. Pharmacological trials include the use of antiplatelets, ACE inhibitors, statins, along with perivascular therapies, and other more novel drug targets.. The evidence for the strategies that can be used to maintain access function is highly variable, with many small, observational, and retrospective studies. In the future, the more widespread use of early cannulation grafts, hybrid surgical and endovascular procedures, and the further pursuit of both biological grafts and biological perivascular therapies may yield improvements in vascular access function.

Topics: Arteriovenous Shunt, Surgical; Bioprosthesis; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Endovascular Procedures; Graft Occlusion, Vascular; Humans; Prosthesis Design; Regional Blood Flow; Renal Dialysis; Renal Insufficiency, Chronic; Risk Factors; Treatment Outcome; Vascular Patency

Topics: Acute Coronary Syndrome; Aged; Aged, 80 and over; Basophils; Biomarkers; Cardiovascular Agents; Computed Tomography Angiography; Coronary Angiography; Early Diagnosis; Eosinophils; Female; Graft Occlusion, Vascular; Humans; Male; Myocardial Revascularization; Risk Assessment; Ventricular Remodeling

Vascular access maintenance is vital for hemodialysis patients. Conventional balloon angioplasty is the gold standard of treatment in endovascular therapy according to published guidelines, accompanied by bare metal stents as a bail-out method. Several devices have been used so far with a view to improve patency outcomes, but only covered stents have been proposed as a valid alternative and only for venous juxta-anastomotic stenosis of arteriovenous grafts. Paclitaxel-coated balloons (PCBs) have been extensively investigated in the last few years in pilot studies with small numbers of patients in dialysis access. Results from these studies have been promising so far; however, a larger number of subjects is needed to prove outcomes. Aim of this analysis is to discuss current available studies and explore some critical aspects of PCB use in dialysis access treatment.

Topics: Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Graft Occlusion, Vascular; Humans; Models, Cardiovascular; Paclitaxel; Prosthesis Design; Recurrence; Renal Dialysis; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Maintaining vascular access patency represents a tremendous challenge in hemodialysis patients. Although "native" arteriovenous fistula (AVF) is currently recommended as primary vascular access, neointimal hyperplasia stenoses frequently develop, with a risk for AVF thrombosis and vascular access loss. For years, first-line treatment of AVFs stenoses has been percutaneous transluminal angioplasty, generally with high-pressure or cutting uncoated balloons. However, restenosis and reintervention rates remain incredibly high and occur, according to recent studies, in up to 60% and 70% of patients at 6 and 12 months, respectively. Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia and drug-coated balloons, therefore, it represents an attractive option for AVF stenoses. Because data are scarce, the aim of this paper was to review the concepts and current results of drug-coated balloons in AVF stenosis management.

Topics: Angioplasty, Balloon; Animals; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Graft Occlusion, Vascular; Humans; Renal Dialysis; Renal Insufficiency, Chronic; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Vascular access dysfunction, due to venous stenosis at the vein-artery anastomosis in arteriovenous fistulas and vein-graft anastomosis in synthetic arteriovenous grafts, is a major cause of morbidity and mortality in dialysis patients. The two overarching approaches to prevent and treat vascular access dysfunction are from systemic or local (including endovascular and perivascular) routes. However, there are currently very few effective therapies to treat vascular access dysfunction. This article will review major studies evaluating systemic, endovascular, and perivascular therapies for vascular access dysfunction. Ongoing research to evaluate novel innovations to prevent and/or manage vascular access dysfunction appears promising.

Topics: Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Endovascular Procedures; Graft Occlusion, Vascular; Humans; Renal Dialysis; Treatment Outcome; Vascular Patency

Cardiac allograft vasculopathy (CAV) is a common complication following heart transplantation (HT), resulting in diminished graft survival. The preferred strategy for preventing CAV is optimal medical management; however, for patients who develop CAV, delaying disease progression through effective medication management is equally important. A review of the literature regarding medication management of CAV was conducted via a search of the MEDLINE database. Studies were included if they were published in English, conducted in humans ≥ 18 years of age or older, and used noninvestigational medications. Immunosuppressive medications such as the antiproliferative mycophenolate, the calcineurin inhibitor tacrolimus, and the proliferation signal inhibitors sirolimus and everolimus have been shown to prevent the development of CAV. Certain cardiovascular medications, such as HMG-CoA reductase inhibitors (statins), gemfibrozil, calcium channel blockers, and angiotensin-converting enzyme inhibitors, have also demonstrated efficacy in preventing this disease process. Prevention of CAV has also been observed with prophylaxis against cytomegalovirus infection and antioxidant medications. Despite being commonly used in HT patients, neither antiplatelet agents nor glycemic control have proved effective at preventing CAV. Only sirolimus has been shown to arrest the progress of existing CAV.

Topics: Allografts; Antioxidants; Calcineurin Inhibitors; Cardiovascular Agents; Cytomegalovirus Infections; Everolimus; Graft Occlusion, Vascular; Graft Rejection; Graft Survival; Heart Transplantation; Humans; Immunosuppressive Agents; Mycophenolic Acid; Postoperative Complications; Sirolimus; Tacrolimus

Coronary artery bypass graft surgery remains one of the most widely performed surgical procedures in North America and aortocoronary saphenous vein grafts (SVG) are the most frequently used surgical conduits. SVG disease (SVGD) remains the leading cause of symptomatic coronary artery disease postcoronary artery bypass graft. When optimal medical therapy is ineffective, repeat surgery is associated with higher mortality combined with less favorable clinical and angiographic results, thus percutaneous revascularization on SVG is currently the standard of care for the revascularization of SVGD. Balloon angioplasty, bare metal stents, polytetrafluoroethylene-covered stents, and drug-eluting stents have been extensively investigated for SVG interventions. Multiple recent randomized trials and meta-analyses have confirmed the pathophysiologic and clinical differences between SVGD and coronary artery disease. Decisions such as patient selection, premedication, stent, and protection device characteristics should be carefully considered to achieve optimal procedural and clinical results. Acute coronary syndromes due to SVG involvement, chronic total occlusions, retrograde approaches, and SVG perforation management are newer fields requesting additional research.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Constriction, Pathologic; Coronary Angiography; Coronary Artery Bypass; Embolic Protection Devices; Graft Occlusion, Vascular; Humans; Patient Selection; Prosthesis Design; Reoperation; Risk Factors; Saphenous Vein; Stents; Treatment Outcome

We report the case of a 27-year-old woman with a rare presentation of right ventricular failure secondary to isolated right ventricular myocardial infarction, 3 weeks after an uncommon surgical procedure, the modified Cabrol operation. Her medical history also included a Ross procedure at the age of 12 years. On the basis of her subacute presentation and a consultation with cardiac surgeons, we decided on medical management. Follow-up echocardiography at 6 months revealed that the right ventricular systolic function remained severely impaired, but the patient was asymptomatic with excellent functional capacity.We review the surgical techniques of aortic graft replacement and their respective complications. We also discuss the impact of conservative and reperfusion strategies on prognosis and long-term outcomes in the setting of right ventricular infarction.

Topics: Adult; Aorta; Aortic Valve; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Echocardiography; Female; Graft Occlusion, Vascular; Heart Failure; Heart Valve Prosthesis Implantation; Humans; Myocardial Infarction; Recovery of Function; Thrombosis; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ventricular Dysfunction, Right; Ventricular Function, Right

More than 1 in 1,000 patients in the U.S. has end-stage renal disease, and most patients who require renal-replacement therapy undergo hemodialysis. By the year 2020, more than 750,000 patients are expected to have end-stage renal disease, and over 500,000 will require hemodialysis. The greatest limitation of hemodialysis is the finite durability of hemodialysis accesses, which on average remain patent for <3 years but are the lifeline for hemodialysis patients. Catheter-based interventions are successful in restoring flow in more than 80% of hemodialysis accesses that undergo thrombosis and have replaced surgical revision as the treatment of choice for failing or thrombosed accesses. Catheter-based interventions have improved the quality of life for hemodialysis patients by reducing the need for temporary hemodialysis catheters and have prolonged total survival time by preserving existing access sites and by saving venous segments for future access creation. This review discusses the pathophysiology of dialysis access failure, presents the success rates of catheter-based treatments, and illustrates the interventional approaches for treating failing and thrombosed fistulas and grafts.

Topics: Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Graft Occlusion, Vascular; Humans; Kidney Failure, Chronic; Phlebography; Quality of Life; Radiography, Interventional; Renal Dialysis; Thrombectomy; Thrombosis; Time Factors; Treatment Outcome; Upper Extremity; Vascular Patency

The introduction of stents to clinical practice was the major breakthrough in the field of percutaneous coronary intervention. The introduction of stents was associated with two serious complications, the first was increase in subacute thrombosis within the first 30 days of stent implantation later controlled with the use of high pressure inflation and dual antiplatelet therapy, the second was the phenomenon of in-stent restenosis that was primarily caused by smooth muscle proliferation. While coronary stenting eliminates elastic recoil, it is unable to inhibit excessive neointimal formation. Stents were associated with an increase of neointimal formation compared to balloon angioplasty as a result of excessive injury to the vessel wall and the inflammatory process from interaction of metal with vessel wall. Local delivery of the potential agents for inhibition of neointimal formation to the site of the lesion was considered the desired approach. Several compounds have been tested for stent coating, primarily with the aim of the inhibition of SMC proliferation. Recently, new stents have emerged which are loaded with anti-inflammatory, anti-migratory, anti-proliferative or pro-healing drugs. In this review article the results of clinical studies investigating drug-eluting stents are discussed from pharmacological and clinical points of view, reviewing the current literature and the future prospective.

Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Agents; Biocompatible Materials; Cardiovascular Agents; Clinical Trials as Topic; Coronary Disease; Graft Occlusion, Vascular; Humans; Immunologic Factors; Polymers; Protease Inhibitors; Stents

This review analyzes important facets of contemporary percutaneous coronary interventions. The optimal strategy of acute myocardial infarction and shock is addressed, as is the role of angioplasty in multivessel coronary disease. Vascular Brachytherapy is essentially the sole available treatment modality for in-stent restenosis. The WRIST trials have provided the foundation for clinical experience and are discussed in detail. Finally, drug-eluting stents may become the next revolution in interventional cardiology and offer the hope of a "cure" for restenosis.

Topics: Angioplasty, Balloon; Animals; Brachytherapy; Cardiovascular Agents; Clinical Trials as Topic; Coronary Disease; Graft Occlusion, Vascular; Humans; Myocardial Infarction; Myocardial Revascularization; Shock, Cardiogenic; Stents

Restenosis is a complicated disease. Neointima formation and unfavorable remodeling seem to contribute to the development of restenosis after angioplasty. Remodeling, a relatively new hypothesis, might be more crucial than neointima formation, although the two could well be inter-related. Stenting prevents unfavorable remodeling to some extent and lowers restenosis rates as compared to conventional balloon angioplasty. However, restenosis still occurs at too high a rate with stent angioplasty. A great many drugs have been tested in humans for the prevention of restenosis and failed, as most addressed the neointima formation problem only. Future drug design for restenosis should address both remodeling and neointima formation and some antioxidants, such as probucol, have shown promising results in this respect.

Topics: Animals; Anticholesteremic Agents; Anticoagulants; Cardiovascular Agents; Graft Occlusion, Vascular; Heparin; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Muscle, Smooth, Vascular; Platelet Aggregation Inhibitors; Probucol

Recent clinical trials have demonstrated beyond doubt that statins are effective in the prevention of acute coronary events. Critical analysis of these studies suggests that the benefits of statin therapy cannot be fully explained on the basis of reductions in plasma cholesterol levels. Accumulating knowledge of the actions of these drugs shows that they may prevent several processes that eventually lead to plaque rupture and the development of occlusive thrombosis, the basis of acute coronary events. Hence, statins may correct endothelial dysfunction (thus protecting against ischaemic injury), stabilise existing plaques and modify the coagulation pathway, thereby reducing the likelihood of a sudden vascular event. At a cellular level, these drugs inhibit the synthesis not just of cholesterol, but of other compounds important in cell proliferation. Antiproliferative effects have been demonstrated in vitro and may broaden the applications of statins to the treatment of noncardiovascular diseases. Finally, preliminary clinical studies indicate that as a result of immunosuppressive actions, statins may reduce the incidence of rejection following organ transplantation.

Topics: Animals; Antineoplastic Agents; Cardiovascular Agents; Enzyme Inhibitors; Graft Occlusion, Vascular; Humans; Hypolipidemic Agents; Immunosuppressive Agents; Kidney Diseases; Naphthalenes; Pravastatin

The processes that take place following damage to the vessel wall are well understood. Endovascular manipulation by its very nature induces such damage and the repair process can lead to a recurrence of symptoms. There have been many clinical trials of drugs chosen for their known impact on preventing excess vessel wall response. With one or two exceptions none of these trials has shown any benefit, partly because only low doses could be given systemically to avoid side effects. Local drug delivery allows high doses to be given where needed, at the site of the process, without inducing systemic complications. There are various drugs and agents that have been shown to be effective in models of vessel wall damage, including heparin, nitric oxide, inhibitors of platelet function and the antisense oligonucleotides. Some of these agents are now being tested in clinical trials. Methods of delivering the agent include devices that bathe the luminal layer, deliver the agent to the media or inject it into the adventitia where a reservoir can form. Stents improve the outcome after angioplasty, but can also induce a proliferative vessel wall response. To overcome this, stents have recently been considered as local delivery devices with radiation being delivered and polymer coated stents, loaded with agents, being developed. While local drug delivery provides great promise as a way of reducing the adverse effect of response of the vessel wall to damage, the results of clinical trials in humans are awaited.

Topics: Animals; Arteries; Cardiovascular Agents; Clinical Trials as Topic; Drug Delivery Systems; Graft Occlusion, Vascular; Humans; Muscle, Smooth, Vascular; Stents; Vascular Surgical Procedures

Plain balloon angioplasty is regarded as the mainstay of treatment for failing vascular access with high success rate, but the poor treatment durability creates significant workload and increases patient morbidity. The study aims to compare target lesion primary patency rate at 12 months between paclitaxel-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for treatment of dysfunctional vascular access.. This nonsponsored-randomized trial enrolled 40 patients with dysfunctional dialysis access at a single center. Patients were randomized into In.Pact Admiral Paclitaxel DCB or POBA after lesion crossing regardless of lesion type. Patients are followed up under surveillance protocol. Patients, hemodialysis staff, and sonographer are blinded to the treatment arms. Twelve-month primary patency rate in both arms are evaluated.. 40 patients were recruited since June 2016 and were allocated to the DCB or POBA group. The mean age is 58 and 57 years with comparable demographic parameters. The locations of target lesion were comparable in both groups (juxta and arteriovenous anastomosis, cannulation site, and fistula/graft), with similar mean target lesion stenosis 69.8 +/- 15.8% for DCB and 69.5 +/- 13.6% for POBA (P = 0.95), and the lesion length for DCB is 45.8 +/- 38.4 mm and 50.2 +/- 33.5 mm for POBA (P = 0.70). Patients in DCB performed significantly better in terms of primary patency at 6 months 85% versus 55% (P = 0.007). The superiority in primary patency in DCB group exists at 12 months 65% versus 30% (P = 0.007).. Paclitaxel balloon angioplasty approach provides significant better primary patency in dysfunctional arteriovenous access at 12 months in our nonsponsored-randomized trial.

Topics: Aged; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Graft Occlusion, Vascular; Hong Kong; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Renal Dialysis; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To assess whether angioplasty of hemodialysis access (HA) stenosis with a drug-coated balloon (DCB) would prevent restenosis in comparison with plain-balloon percutaneous transluminal angioplasty (PTA).. This prospective randomized clinical trial enrolled 120 patients with dysfunctional arteriovenous fistulae (n = 109) and grafts (n = 11), due to a ≥50% stenosis between March 2014 and April 2018. All patients underwent high-pressure balloon angioplasty and were then randomized to either DCB (n = 60) or PTA (n = 60). Patients were followed-up for 1 year, and angiography was performed 6 months after angioplasty. The primary endpoint was the late lumen loss (LLL) at 6 months. Secondary endpoints included other angiographic parameters at 6 months and HA failures, adverse event, and mortality at 12 months. Continuous variables were compared with a Student t-test, and Kaplan-Meier curves were used for freedom from HA failure and for mortality.. LLL in the DCB and in the PTA group were 0.64 mm ± 1.20 and 1.13 mm ± 1.51, respectively (P = .082, adjusted P = .0498). DCB was associated with lower percentage stenosis (54.2% ± 19.3 vs 61.7% ± 18.2; P = .047) and binary restenosis ≥50% (56.5% vs 81.1%; P = .009) than PTA. The number of HA failures after 12 months was lower for DCB than for PTA (45% vs 66.7%; P = .017). Mortality at 12 months was 10% and 8.3% in the DCB and PTA groups, respectively (P = .75).. Despite LLL improvement that failed to reach statistical significance, this study demonstrated decreased incidence and severity of restenosis with DCB compared with PTA to treat dysfunctional HA.

Topics: Aged; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Quebec; Recurrence; Renal Dialysis; Risk Factors; Single-Blind Method; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Paclitaxel-coated balloons are used to reduce neointimal hyperplasia in native arteriovenous (AV) fistulas. However, no study specifically evaluated their effect on venous anastomotic stenosis of dialysis grafts. We aimed to compare the efficacy of angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs) for venous anastomotic stenosis in dysfunctional AV grafts.. In this investigator-initiated, single-center, single-blinded, prospective randomized controlled trial, we randomly assigned 44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n = 22) or CBs (n = 22) from July 2015 to August 2018. Access function was observed per the hemodialysis center's protocols; ancillary angiographic follow-up was performed every 2 months for 1 year after the interventions. The primary end point was target lesion primary patency at 6 months. Secondary outcomes included anatomic and clinical success after angioplasty, circuit primary patency at 6 months and 1 year, and target lesion primary patency at 1 year.. At 6 months, target lesion primary patency in the DCB group was significantly greater than that in the CB group (41% vs 9%; hazard ratio [HR], 0.393; 95% confidence interval [CI], 0.194-0.795; P = .006), as was the primary patency of the entire access circuit (36% vs 9%; HR, 0.436; 95% CI, 0.218-0.870; P = .013). At 1 year, the target lesion primary patency in the DCB group remained greater than that in the CB group (23% vs 9%; HR, 0.477; 95% CI, 0.243-0.933; P = .019) but not the primary patency of the access circuit (14% vs 9%; HR, 0.552; 95% CI, 0.288-1.059; P = .056). No difference in anatomic or clinical success was observed; no major complications were noted.. Angioplasty with DCBs showed a modest improvement in primary patency of venous anastomotic stenosis and all dialysis AV grafts at 6 months. The short-term benefit was not durable to 1 year, and reinterventions were eventually needed.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Renal Dialysis; Single-Blind Method; Taiwan; Time Factors; Treatment Outcome; Vascular Patency

To present final, 2-year results of a randomized trial comparing paclitaxel-coated vs uncoated balloon angioplasty following vessel preparation with ultra-high-pressure percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistulae (AVFs).. Twenty-three sites enrolled 285 subjects with dysfunctional AVFs located in the arm. Before 1:1 randomization, successful vessel preparation was achieved (full waist effacement, < 30% residual stenosis). Follow-up was clinically driven except for a 6-month office visit.. Ninety-six of 141 subjects in the drug-coated balloon (DCB) arm and 111 of 144 in the control arm completed the study. Target lesion primary patency (TLPP) rates for the DCB and control groups were 58% ± 4 vs 46% ± 4 (P = .02) at 9 months, 44% ± 5 vs 36% ± 4 (P = .04) at 12 months, 34% ± 5 vs 28% ± 4 (P = .06) at 18 months, and 27% ± 4 vs 24% ± 4 (P = .09) at 24 months, respectively. Mean time to TLPP event for subjects with an event was longer for DCBs (322 vs 207 d; P < .0001). Fewer interventions were needed to maintain target lesion patency in the DCB group at 9 months (P = .02) but not at 12 (P = .08), 18 (P = .13), or 24 months (P = .19). The noninferiority safety target was met at all intervals (P < .01). Mortality did not differ between groups (P = .27). Post hoc analyses showed equivalent DCB effect in all subgroups.. Two-year results demonstrate long-term safety and variable efficacy of DCB angioplasty in AVFs.

Topics: Aged; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Renal Dialysis; Time Factors; Treatment Outcome; United States; Vascular Patency

Stenosis is a known complication in bypass vein grafts for peripheral arterial disease. The aim of this study was to evaluate the effect of drug-coated balloons (DCBs) in the treatment of vein graft stenoses. DCBs may prevent restenosis in arterial lesions. One small prospective and larger retrospective and registry studies have failed to show benefit from DCBs in vein grafts. Prospective data are scarce.. Sixty patients treated for primary or recurrent stenosis in venous bypass grafts were randomized to DCB (n = 30) or standard balloon angioplasty (BA) (n = 30). Follow-up was 1 year. The primary outcome measure was target lesion revascularization (TLR). Secondary outcome measures were assisted primary patency and secondary patency and graft occlusion.. Fifty-seven patients were analyzed. Three patients were excluded due to primary technical failure (2 DCB, 1 BA). Overall TLR rate was 34.5% and 46.4% in the DCB and BA groups, respectively (P = 0.33). Five (8.8%) grafts occluded during follow-up (1 DCB, 4 BA). Assisted primary patency was 93.1% (DCB) versus 85.7% (BA) (P = 0.362) and secondary patency was 100% (DCB) versus 89.3% (BA) (P = 0.076). Subgroup analysis showed a significant benefit from DCB in the treatment of primary stenosis (TLR rate 15.0% vs. 18.9%, P = 0.03).. There was no significant benefit from DCBs for treatment of vein graft stenosis compared to BA, although a trend in favor of DCBs could be seen.. ClinicalTrials.govNCT03023098.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Finland; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Peripheral Arterial Disease; Saphenous Vein; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Grafting; Vascular Patency

Endovascular treatment of autogenous arteriovenous haemodialysis fistula stenosis has high reintervention rates. We investigate the effect of drug-eluting balloons in the treatment of recurrent haemodialysis fistula stenosis.. This is a randomised, controlled, investigator-initiated and run, prospective, blinded, multicentre trial. Patients with recurrent autogenous arteriovenous haemodialysis fistula stenosis received standard endovascular treatment plus drug-eluting balloon or standard endovascular treatment plus uncoated balloon (Sham). Primary endpoint was late lumen loss in trial area on ultrasound at 6 weeks, 3, 6 and 12 months. Secondary endpoints were freedom from reintervention to the Index Trial Area and decline in fistula flow (Qa). Interim analysis was performed at 6 months (unblinded due to timeliness).. Patients with 132 recurrent stenoses (48% in bare Nitinol stents) were randomised with 70 receiving drug-eluting balloon and 62 Sham. At 6 months, decline in late lumen loss was 0.23 ± 0.03 mm/month for Sham and 0.045 ± 0.03 mm/month for drug-eluting balloon arm, a significant difference (0.18 mm, p = 0.0002). At 12 months, this difference persisted at 0.12 mm (p = 0.0003). At 6 months, significant difference in late lumen loss for instent restenoses (p = 0.0004) was observed, with non-significant difference for unstented restenoses (p = 0.065). Mean time for freedom from reintervention was 10.14 months for Sham versus 42.39 months for drug-eluting balloon (p = 0.001). The same was shown for instent (p = 0.014) and unstented (p = 0.029) restenoses. Qa decline rate at 6 months was 36.89 mL/min/month (Sham) and 0.41 mL/min (drug-eluting balloon). The difference was significant (36.48 mL/min; p = 0.02) and persisted to 12 months (p = 0.44).. Paclitaxel drug-eluting balloon significantly delays restenosis after angioplasty for recurrent autogenous arteriovenous haemodialysis fistula stenosis, persisting to 12 months. Drug-eluting balloon significantly increases freedom from reintervention at 12 months with these effects true in stented and unstented fistulas.

Topics: Aged; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; New South Wales; Paclitaxel; Recurrence; Renal Dialysis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Access Devices; Vascular Patency

Chronic obstructive pulmonary disease (COPD) is associated with long-term all-cause death after percutaneous coronary intervention with bare-metal stents. Regarding other outcomes, previous studies have shown conflicting results and the impact of drug-eluting stent (DES) in this population is not well known. We analyzed 4,605 patients who underwent percutaneous coronary intervention with bare-metal stents (33.1%) or DES (66.9%) from the Basel Stent Kosten-Effektivitats Trial-Prospective Validation Examination trials I and II. COPD patients (n = 283, 6.1%), were older and had more frequently a smoking or cardiovascular event history. At 2-year follow-up, cumulative event rates for patients with versus without COPD were the following: major adverse cardiac events (MACE: composite of cardiac death, nonfatal myocardial infarction, and target vessel revascularization): 15.2% versus 8.1% (p <0.001); all-cause death: 11.7% versus 2.4% (p <0.001); cardiac death: 5.7% versus 1.2% (p <0.001); myocardial infarction: 3.5% versus 1.9% (p = 0.045); definite/probable/possible stent thrombosis: 2.5% versus 0.9% (p = 0.01); and major bleeding: 4.2% versus 2.1% (p = 0.014). After adjusting for confounders including smoking status, COPD remained an independent predictor for MACE (hazard ratio [HR] 1.80, 95% confidence interval [CI] 1.31 to 2.49), all-cause death (HR 3.62, 95% CI 2.41 to 5.45), cardiac death (HR 3.12, 95% CI 1.74 to 5.60), and stent thrombosis (HR 2.39, 95% CI 1.03 to 5.54). We did not find evidence of an interaction between COPD and DES implantation (p for interaction = 0.29) for MACE. In conclusion, COPD is associated with increased 2-year rates of all-cause death, cardiac death, and stent thrombosis after stent implantation. DES use appears to be beneficial also in patients with COPD.

Topics: Aged; Cardiovascular Agents; Coronary Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Pulmonary Disease, Chronic Obstructive; Risk Factors; Stents; Treatment Outcome

The initial therapy for a stenosis in an arteriovenous fistula used for haemodialysis is radiological balloon dilatation or angioplasty. The benefit of angioplasty is often short-lived, intervention-free survival is reported to be 40-50 % at 1 year. Previous small studies and observational data suggest that paclitaxel-coated balloons may be of benefit in improving outcomes after fistuloplasty of stenotic arteriovenous fistulae.. We have designed a multicentre, double-blind randomised controlled trial to test the superiority of paclitaxel-coated balloons for preventing restenosis after fistuloplasty in patients with a native arteriovenous fistula. Two hundred and eleven patients will be followed up for a minimum of 1 year. Inclusion criteria include a clinical indication for a fistuloplasty, an access circuit that is free of synthetic graft material or stents, and a residual stenosis of 30 % or less after plain balloon fistuloplasty. Exclusion criteria include a synchronous venous lesion in the same access circuit, location of the stenosis central to the thoracic inlet or a thrombosed access circuit at the time of treatment. The primary endpoint is time to end of target lesion primary patency. This is defined as a clinically-driven radiological or surgical re-intervention at the treatment segment, thrombosis that includes the treatment segment, or abandonment of the access circuit due to an inability to re-treat the treatment segment. Secondary endpoints include angiographic late lumen loss, time to end of access circuit cumulative patency, the total number of interventions, and quality of life. The trial is funded by the National Institute for Health Research.. We anticipate that this trial will provide rigorous data that will determine the efficacy of additional paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis.. ISRCTN14284759 . Registered on 28 October 2015.

Topics: Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Clinical Protocols; Coated Materials, Biocompatible; Double-Blind Method; Graft Occlusion, Vascular; Humans; Paclitaxel; Renal Dialysis; Research Design; Time Factors; Treatment Outcome; United Kingdom; Vascular Access Devices; Vascular Patency

The objective of this study was to assess the efficacy of sealing intermediate nonobstructive coronary saphenous vein graft (SVG) lesions with drug-eluting stents (DES; paclitaxel- or everolimus-eluting stents) for reducing major adverse cardiac events (MACE).. This was a randomized controlled multicenter clinical trial that enrolled patients with a previous coronary artery bypass graft who had developed at least 1 intermediate nonobstructive SVG lesion (30%-60% diameter stenosis by visual estimation). Patients were randomized (1:1) to DES implantation (SVG-DES) or medical treatment (SVG-MT) of the target SVG lesion. The primary efficacy outcome was the first occurrence of MACE defined as the composite of cardiac death, myocardial infarction, or coronary revascularization related to the target SVG during the duration of follow-up (minimum of 2 years). Secondary efficacy outcomes included MACE related to the target SVG lesion and overall MACE. A total of 125 patients (mean age 70±9 years, 87% men) were included, with a mean time from coronary artery bypass graft of 12±5 years. Sixty and 65 patients were allocated to the SVG-DES and SVG-MT groups, respectively. There were no events related to the target SVG at 30 days. After a median follow-up of 3.4 (interquartile range: 2.8-3.9) years, the MACE rate related to the target SVG was not significantly different in the 2 groups (SVG-DES: 15.0%, SVG-MT: 20.0%; hazard ratio, 0.65; 95% confidence interval, 0.23-1.53; P=0.33). There were no significant differences between groups in MACE related to the target SVG lesion (SVG-DES: 10.0%, SVG-MT: 16.9%; hazard ratio, 0.53; 95% confidence interval, 0.20-1.43; P=0.21) or global MACE (SVG-DES: 36.7%, SVG-MT: 44.6%; hazard ratio, 0.73; 95% confidence interval, 0.42-1.27; P=0.26).. Sealing intermediate nonobstructive SVG lesions with DES was safe but was not associated with a significant reduction of cardiac events at 3-year follow-up.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01223443.

Topics: Aged; Canada; Cardiovascular Agents; Constriction, Pathologic; Coronary Angiography; Coronary Artery Bypass; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Saphenous Vein; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

To determine whether the use of a paclitaxel-coated balloon (PCB) improves patency in patients undergoing percutaneous transluminal angioplasty (PTA) for recurrent juxtaanastomotic stenosis of radiocephalic arteriovenous fistulas (RCAVFs).. This prospective study recruited hemodialysis patients with two short (< 2 cm) and separated inflow RCAVF lesions. After dilation of lesions using a 4-mm plain balloon (PB), half of the lesions were randomly selected for treatment with PTA using PCB (size, 4 mm; length, 2 cm) and PB (size, 5-mm or 6-mm) (group 1), and the other half were treated with PTA using PB alone (group 2). After the index PTA, dysfunction-driven angiography was performed to confirm target lesion restenosis (TLR). TLR and lesion patency were compared in the two groups by χ(2) test, t test, and Kaplan-Meier analysis.. The analysis of 20 lesions in 10 patients revealed that the TLR-free duration in group 1 was significantly longer than the TLR-free duration in group 2 (251.2 d vs 103.2 d; P < .01). The patency rate of the target lesion was significantly higher in group 1 than in group 2 at 6 months (70% vs 0%; P < .01) but not at 12 months (20% vs 0%; P > .05).. This early study suggests that, for improving short-term patency, PTA with PCB and PB is more effective than PTA with PB alone, warranting further study.

Topics: Aged; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Pilot Projects; Prospective Studies; Radial Artery; Radiography; Recurrence; Renal Dialysis; Time Factors; Treatment Outcome; Upper Extremity; Vascular Access Devices; Vascular Patency

To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG).. The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1 ± 14.3 years) were randomized to undergo either PCB dilation (n = 20) or standard BA (n = 20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures).. Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006).. PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.

Topics: Aged; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Catheters; Constriction, Pathologic; Drug Delivery Systems; Equipment Design; Female; Graft Occlusion, Vascular; Greece; Humans; Kaplan-Meier Estimate; Kidney Failure, Chronic; Male; Middle Aged; Paclitaxel; Proportional Hazards Models; Prospective Studies; Radiography; Renal Dialysis; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

This study sought to report the long-term outcomes after drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions in the SOS (Stenting of Saphenous Vein Grafts) trial.. The long-term outcomes after DES implantation in SVGs are poorly studied. Apart from the SOS trial, the only other randomized trial comparing DES with bare-metal stents (BMS) in SVGs reported higher mortality in the DES group at 32 months.. In the SOS trial, 80 patients with 112 lesions in 88 SVGs were randomized to a BMS or paclitaxel-eluting stent (PES) and demonstrated improved short-term angiographic and clinical outcomes with PES. Extended clinical follow-up was subsequently obtained.. Mean age was 67 ± 9 years, and all patients were men. The indications for stenting included acute coronary syndrome in 60% and stable angina in 31% of patients. The mean SVG age was 12 ± 6 years. The baseline characteristics of the patients in the 2 study groups were similar. Procedural success was achieved in 77 patients (96%). During a median follow-up of 35 months, compared with patients randomized to BMS, those receiving PES had a lower incidence of myocardial infarction (hazard ratio [HR]: 0.32, p = 0.01), target lesion revascularization (HR: 0.20, p = 0.004), target vessel revascularization (HR: 0.41, p = 0.03), and target vessel failure (HR: 0.34, p = 0.001) as well as a trend toward less definite or probable stent thrombosis (HR: 0.15, p = 0.08). All-cause mortality (HR: 2.04, p = 0.19) and cardiac mortality (HR: 0.62, p = 0.51) did not differ between groups.. During long-term follow-up, use of PES was associated with significantly better clinical outcomes than BMS in SVG lesions. (Stenting of Saphenous Vein Grafts Trial [SOS]; NCT00247208).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Saphenous Vein; Single-Blind Method; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

The SYNTAX-LE MANS substudy prospectively evaluated 15-month angiographic and clinical outcomes in patients with treated left main (LM) disease.. In the SYNTAX trial, 1,800 patients with three-vessel and/or LM disease were randomised to either CABG or PCI; of these, 271 LM patients were prospectively assigned to receive a 15-month angiogram. The primary endpoint for the CABG arm was the ratio of ≥50% to <100% obstructed/occluded grafts bypassing LM lesions to the number placed. The primary endpoint for the PCI arm was the proportion of patients with ≤50% diameter stenosis ('patent' stents) of treated LM lesions. Per protocol, no formal comparison between CABG and PCI arms was intended based on the differing primary endpoints. Available 15-month angiograms were analysed for 114 CABG and 149 PCI patients. At 15 months, 9.9% (26/263) of CABG grafts were 100% occluded and an additional 5.7% (15/263) were ≥50% to <100% occluded. Overall, 27.2% (31/114) of patients had ≥1 obstructed/occluded graft. The 15-month CABG MACCE rate was 8.8% (10/114) and MACCE at 15 months was not significantly associated with graft obstruction/occlusion (p=0.85). In the PCI arm, 92.4% (134/145) of patients had ≤50% diameter LM stenosis at 15 months (89.7% [87/97] distal LM lesions and 97.9% [47/48] non-distal LM lesions). The 15-month PCI MACCE rate was 12.8% (20/156) and this was significantly associated with lack of stent patency at 15 months (p<0.001), mainly due to repeat revascularisation.. At 15 months, 15.6% (41/263) of grafts were at least 50% obstructed but this was not significantly associated with MACCE; 92.4% (134/145) of patients had stents that remained patent at 15 months, and stent restenosis was significantly associated with MACCE, predominantly due to revascularisation.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Regression Analysis; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; United States; Vascular Patency

To assess the long-term benefit-risk ratio of drug-eluting (DES) vs. bare-metal stents (BMS) relative to stent size.. All 826 consecutive BASKET (BAsel Stent Kosten-Effektivitäts Trial) patients randomized 2:1 to DES vs. BMS were followed after 3 years. Data were analysed separately for patients with small stents (<3.0 mm vessel/<4.0 mm bypass grafts, n = 268) vs. only large stents (> or =3.0 mm native vessels, n = 558). Clinical events were related to stent thrombosis. Three-year clinical target-vessel revascularization rates remained borderline reduced after DES [9.9 vs. 13.9% (BMS), P = 0.07], particularly in patients with small stents (10.7 vs. 19.8%, P = 0.03; large stents: 9.5 vs. 11.5%, P = 0.44). Cardiac death/myocardial infarction (MI) rates (12.7 vs. 10.0%, P = 0.30) were similar, however, death/MI beyond 6 months was higher after DES [9.1 vs. 3.8% (BMS), P = 0.009], mainly due to increased late death/MI in patients with large stents (9.7 vs. 3.1%, P = 0.006). The results paralleled findings for stent thrombosis.. The clinical benefit of DES was maintained at no overall increased risk of death or death/MI up to 3 years. However, death/MI rates were increased in DES vs. BMS patients beyond 6 months, particularly in patients with large stents, paralleling findings for stent thrombosis. Thus, stent size seems to influence the 3-year benefit-risk ratio after DES implantation.

Topics: Aged; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Equipment Design; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Proportional Hazards Models; Risk Assessment; Stents; Time Factors; Treatment Outcome

Angiographic parameters (such as late luminal loss) are common endpoints in drug-eluting stent trials, but their correlation with the neointimal process and their reliability in predicting restenosis are debated.. Using quantitative coronary angiography (QCA) data (49 bare metal stent and 44 sirolimus-eluting stent lesions) and intravascular ultrasound (IVUS) data (39 bare metal stent and 34 sirolimus-eluting stent lesions) from the randomised Reduction of Restenosis In Saphenous vein grafts with Cypher stent (RRISC) trial, we analysed the "relocation phenomenon" of QCA-based in-stent minimal luminal diameter (MLD) between post-procedure and follow-up and we correlated QCA-based and IVUS-based restenotic parameters in stented saphenous vein grafts. We expected the presence of MLD relocation for low late loss values, as MLD can "migrate" along the stent if minimal re-narrowing occurs, while we anticipated follow-up MLD to be located close to post-procedural MLD position for higher late loss. QCA-based MLD relocation occurred frequently: the site of MLD shifted from post-procedure to follow-up an "absolute" distance of 5.8 mm [2.5-10.2] and a "relative" value of 29% [10-46]. MLD relocation failed to correlate with in-stent late loss (rho = 0.14 for "absolute" MLD relocation [p = 0.17], and rho=0.03 for "relative" relocation [p = 0.811). Follow-up QCA-based and IVUS-based MLD values well correlated in the overall population (rho = 0.76, p < 0.001), but QCA underestimated MLD on average 0.55 +/- 0.49 mm, and this was mainly evident for lower MLD values. Conversely, the location of QCA-based MLD failed to correlate with the location of IVUS-based MLD (rho = 0.01 for "absolute" values--in mm [p = 0.911, rho = 0.19 for "relative" values--in % [p = 0.111). Overall, the ability of late loss to "predict" IVUS parameters of restenosis (maximum neointimal hyperplasia diameter, neointimal hyperplasia index and maximum neointimal hyperplasia area) was moderate (rho between 0.46 and 0.54 for the 3 IVUS parameters).. These findings suggest the need for a critical re-evaluation of angiographic parameters (such as late loss) as endpoints for drug-eluting stent trials and the use of more precise techniques to describe accurately and properly the restenotic process.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Double-Blind Method; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Metals; Predictive Value of Tests; Prosthesis Design; Reproducibility of Results; Saphenous Vein; Sirolimus; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

We sought to compare the clinical presentation and angiographic patterns of saphenous vein graft (SVG) failure after stenting with a paclitaxel-eluting stent (PES) versus a similar bare-metal stent (BMS).. The mode of SVG failure after stenting has been poorly characterized.. The SOS (Stenting Of Saphenous Vein Grafts) trial enrolled 80 patients with 112 lesions in 88 SVGs who were randomized to a BMS or PES. Angiographic follow-up at 12 months was available in 83% of the patients.. Binary angiographic restenosis occurred in 51% (24 of 47) of BMS-treated lesions versus 9% (4 of 43) of PES-treated lesions (p < 0.0001). Graft occlusion occurred in 9 of the 21 SVGs (43%) that failed in the BMS group and in 2 of 4 SVGs (50%) that failed in the PES group. SVG failure after stenting presented as an acute coronary syndrome in 10 of the 24 patients (42%) (7 of those 10 patients presented with non-ST-segment elevation acute myocardial infarction), stable angina in 9 (37%) patients, and without symptoms in 5 (21%) patients. Of the 19 patients (with 20 grafts) who developed symptomatic graft failure, repeat SVG revascularization was successfully performed in all 13 (100%) subtotally obstructed SVGs but was attempted (and successful) in only 1 of 7 (14%) occluded SVGs. Revascularization of a native coronary artery was performed in an additional 4 of 7 (57%) symptomatic patients with an occluded SVG.. SVG failure after stenting often presents as acute myocardial infarction and with SVG occlusion. Compared with BMS, PES reduce SVG failure.

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Drug-Eluting Stents; Graft Occlusion, Vascular; Greece; Humans; Metals; Myocardial Infarction; Paclitaxel; Prosthesis Design; Recurrence; Saphenous Vein; Single-Blind Method; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

Data supporting the utility of percutaneous treatment to maintain vein graft patency have been limited to a collection of single-institution, retrospective analyses. Using the prospective, multi-institutional PREVENT III database, we sought to define the outcomes for endovascular vs surgical vein bypass graft revision and to define predictors for the success or failure of these interventions.. A nested cohort study of 1404 patients in the PREVENT III trial who underwent infrainguinal vein bypass grafting for critical limb ischemia was performed to identify those patients who underwent either open surgical or endovascular graft revision. All patients in PREVENT III were followed up for 1 year from the initial bypass operation. The following were modeled as end points from the time of the initial open surgical or endovascular revision: freedom from graft reintervention, occlusion, amputation, and death.. A total of 156 open surgical and 134 endovascular reinterventions were performed, with a mean follow-up after revision of 193 and 151 days, respectively. Although the demographics for each group were similar, the choice of repair was influenced by the interval between the index graft placement and the initial revision, with a high percentage of the early graft revisions treated with an open surgical procedure (0-1 months: 84% open surgical vs 16% endovascular; P < .001). The primary end point (ie, failure resulting in repeat graft revision, graft occlusion, or major amputation) was reached in 30.2% of the endovascular and 26.2% of the open surgical individuals, with significant improvements in the durability of graft revisions noted in the open surgical group (12-month amputation-/revision-free survival of 75% for the open surgical and 56% for the endovascular group; hazard ratio, 2.2; 95% confidence interval, 0.92-5.26; P = .043). Furthermore, subgroup analysis revealed this benefit to be most profound within the subset of thrombosed grafts undergoing salvage (P = .006). For revisions performed to treat graft stenosis, early outcomes were similar, with a trend favoring the open surgical group developing beyond 6 months. Although 80% of open surgical and 64% of endovascular-revised grafts required no further intervention, endovascular revisions necessitated significantly more reinterventions to maintain patency. The mean hospital lengths of stay (open surgical, 2.1 days; endovascular, 1.7 days) and quality of life at completion of the study (VascuQoL: open surgical, 4.72; endovascular, 4.76) were similar between the groups.. Open surgical revision of infrainguinal vein grafts provides an increased freedom from further reinterventions or major amputation, but early success rates for endovascular procedures were similar, particularly for nonoccluded grafts. With time, endovascular revisions necessitate an increasing number of reinterventions and manifest higher rates of failure.

Topics: Aged; Amputation, Surgical; Angioplasty; Cardiovascular Agents; Critical Illness; Double-Blind Method; Extremities; Female; Graft Occlusion, Vascular; Humans; Ischemia; Length of Stay; Male; North America; Oligonucleotides; Patient Selection; Prospective Studies; Quality of Life; Reoperation; Risk Assessment; Risk Factors; Secondary Prevention; Time Factors; Treatment Failure; Ultrasonography, Doppler, Duplex; Vascular Patency; Vascular Surgical Procedures; Veins

The influence of operator-dependent variables on the outcomes of lower extremity bypass (LEB) surgery have primarily been reported in single-institution, retrospective studies. We utilized data from a prospective, multicenter trial to identify technical variables that were significantly associated with early and midterm results of autogenous LEB for limb salvage.. The PREVENT III trial database includes 1404 North American patients with critical limb ischemia (CLI) who underwent LEB using excised autogenous vein. The study protocol excluded claudicants and in situ reconstructions. Technical factors analyzed included vein diameter, conduit type, graft length, vein orientation, location of proximal and distal anastomoses, and performance of completion imaging. Univariate analysis was used to determine the effect of these factors on 30 day and 1-year outcomes. Multivariate Cox regression models evaluated the influence of these factors while adjusting for age, sex, race, tobacco, diabetes, dialysis-dependency, previous index limb bypass, and study drug (edifoligide) administration. The primary outcomes were primary patency (PP), primary assisted patency (PAP), and secondary patency (SP) assessed by Kaplan-Meier method.. Univariate analysis revealed that vein diameter <3.5 mm and composite graft type were significantly associated with early (30 day) graft failure. At 1 year, multivariate analysis revealed that patency rates were negatively associated with diameter <3.5 mm (PP, PAP, SP), non-great saphenous vein (GSV) type (PP, SP), and graft lengths >50 cm (PP only). Limb salvage and survival at 1 year were not significantly impacted by technical variables. Employing a prespecified trial definition of high-risk conduits (diameter <3mm or nonsingle segment GSV; 24% of entire cohort) revealed that use of such conduits was associated with a 2.1-fold increased risk of 30 day graft failure (P < .05), as well as reduced PP, PAP, and SP at 1 year. Use of a high-risk conduit was also associated with an increased index length of stay (mean 9.37 vs 8.71 days, P = .03) and a greater number of reinterventions (mean 0.67 vs 0.42, P < .0001) over the ensuing year.. In this large, multicenter cohort of patients undergoing LEB for CLI, vein diameter and conduit type were the dominant technical determinants of early and late graft failure. High-risk conduits and longer grafts may benefit from aggressive postoperative graft surveillance.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Double-Blind Method; Extremities; Female; Graft Occlusion, Vascular; Humans; Ischemia; Length of Stay; Limb Salvage; Male; Middle Aged; North America; Oligonucleotides; Proportional Hazards Models; Prospective Studies; Risk Assessment; Risk Factors; Time Factors; Transplantation, Autologous; Treatment Failure; Ultrasonography; Vascular Patency; Vascular Surgical Procedures; Veins

Aneurysmal degeneration after peripheral angioplasty is a potentially serious complication. In this case, the patient underwent repeated angioplasty of a prior vein bypass graft utilizing a paclitaxel-coated balloon. He subsequently developed a progressive aneurysmal degeneration, threatening his bypass, which ultimately required an urgent exclusion with a covered stent. This case represents a rare complication of peripheral bypass graft related to percutaneous intervention as well as paclitaxel-coated devices and warns other practitioners of the increased scrutiny and caution one should exercise in the use of such interventions.

Topics: Aged; Aneurysm; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Graft Occlusion, Vascular; Humans; Male; Paclitaxel; Peripheral Arterial Disease; Treatment Outcome; Vascular Access Devices; Vascular Grafting

To investigate the use of a sirolimus drug-coated balloon (DCB) in the management of a thrombosed arteriovenous graft (AVG).. A single-center prospective pilot study was conducted between October 2018 and October 2019. Twenty patients (age = 67.0 years ± 10; male = 35%; mean time on dialysis = 31 months) with thrombosed upper limb AVG were enrolled. After successful pharmacomechanical thrombectomy and adequate treatment of the graft vein junction, sirolimus DCB angioplasty was performed at the graft vein junction. The patients were followed-up for 6 months, and all adverse events occurring during the study period were recorded.. The primary circuit patency rates at 3 and 6 months were 76% and 65%, respectively, while the assisted-primary circuit patency rates at 3 and 6 months were 82% and 65%, respectively. The 3- and 6-month secondary circuit patency rates were 88% and 76%, respectively. Using Kaplan-Meier analyses, the estimated mean primary, assisted-primary, and secondary patencies were 285 days (95% confidence interval (CI) = 194-376 days), 319 days (95% CI = 221-416 days), and 409 days (95% CI = 333-485 days). No adverse event directly related to sirolimus DCB use was observed.. The results of this pilot study suggest that the application of sirolimus DCB at the graft vein junction after the successful thrombectomy of AVG may be a feasible option to improve patency outcomes.

Topics: Aged; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Pilot Projects; Prospective Studies; Recurrence; Renal Dialysis; Risk Factors; Sirolimus; Thrombectomy; Thrombosis; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Zilver PTX polymer-free, paclitaxel-coated stents and Viabahn stent grafts are effective for the treatment of femoropopliteal lesions. The aim of this study was to compare clinical outcomes between the two devices in patients with symptomatic peripheral arterial disease in real-world settings.. This multicenter, retrospective study concerned a clinical database of 445 patients with symptomatic peripheral arterial disease (Rutherford categories 1-6) who underwent either Zilver PTX or Viabahn implantation for a femoropopliteal lesion of 10 cm or longer with reference vessel diameters of 4.0 to 7.5 mm between 2012 and 2018 at five hospitals in Japan. Outcome measures were primary patency, freedom from stent thrombosis, freedom from any target lesion reintervention, limb salvage, and overall survival. After propensity score matching, these clinical outcomes were compared between patients treated with the Zilver PTX and those treated with the Viabahn. Also assessed were the interaction effects of baseline characteristics on the association of the Zilver PTX and Viabahn with restenosis and stent thrombosis.. In total, 271 patients were treated with the Zilver PTX, and 174 patients were treated with the Viabahn. Propensity score matching extracted 133 patient pairs with no major intergroup differences in baseline characteristics. The Zilver PTX group had a lower rate of 3-year primary patency (59.5%; [95% confidence interval (CI), 53.0%-66.2%] vs 69.6% [95% CI, 59.3%-79.4%]; P = .005), but a higher rate of 3-year freedom from stent thrombosis (93.6% [95% CI, 90.0%-96.3%] vs 82.4% [95% CI, 74.5%-89.0%], P = .038). There was no significant difference in overall survival, limb salvage, or freedom from reintervention (all P > .05). An interaction analysis showed that the restenosis risk of the Zilver PTX was significantly higher vs the Viabahn in patients with no or one below-the-knee runoff vessel and in those with intravascular ultrasound use than in patients with two or three below-the-knee runoff vessels and in those without intravascular ultrasound use, respectively (P for interaction = .046 and .010, respectively), whereas the stent thrombosis risk of the Zilver PTX was significantly smaller vs the Viabahn in patients not on dialysis than in those on dialysis (P for interaction = .034).. Compared with Viabahn stent grafts, Zilver PTX stents have a lower rate of primary patency but a higher rate of freedom from stent thrombosis.

Topics: Aged, 80 and over; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Databases, Factual; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Japan; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Reoperation; Retrospective Studies; Risk Assessment; Risk Factors; Thrombosis; Time Factors; Treatment Outcome; Vascular Patency

To assess the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional arteriovenous fistulae (AVF) and grafts (AVG) in a heterogenous real-world population.. This multicenter, prospective study enrolled 320 subjects from 12 countries in 25 sites across Europe and Asia. A total of 392 lesions were treated with the Lutonix 035 DCB catheter. Lesions were de novo and restenotic, located in every part of the circuit from the cannulation zone to central venous outflow. In-stent restenotic lesions also were treated. The primary safety endpoint was freedom from serious adverse events involving the access circuit through 30 days. The primary effectiveness endpoint was target lesion primary patency (TLPP) through 6 months. Secondary endpoints included access circuit primary patency (ACPP) at 6 months and the investigation of factors that would independently influence the primary endpoints.. The primary safety endpoint was 95.5%, while TLPP was 73.9% at 6 months, per Kaplan-Meier survival analysis. ACPP was 71% at 6 months. TLPP for stenosis of AVFs was 78.1%. Subgroup analysis showed significantly improved TLPP when DCB was dilated for ≥120 seconds (P = .007). TLPP was significantly better when predilation occurred compared with cases where only DCB angioplasty was performed (77% vs 48.6%, P = .0005).. The Lutonix AV Global Registry confirms that the Lutonix DCB is a safe and effective treatment option in real-world patients with dysfunctional AVF or AVG. Procedural details had a significant role in TLPP. No significant difference in TLPP was observed among different treatment areas.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Asia; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Europe; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Recurrence; Registries; Renal Dialysis; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

We present here a case of an uncommon cutaneous manifestation after paclitaxel-coated balloon angioplasty. In this case, the patient underwent drug-coated balloon angioplasty for stenosis of a prior vein bypass graft. The patient subsequently developed extensive cutaneous lesions not confined to a single arterial distribution. This case represents a rare complication related to paclitaxel-eluting balloons and provides a cautionary tale as well as clinical acumen for providers in using such devices in their practice.

Topics: Analgesics; Angioplasty, Balloon; Cardiovascular Agents; Embolism; Graft Occlusion, Vascular; Humans; Lower Extremity; Male; Middle Aged; Paclitaxel; Treatment Outcome; Vascular Access Devices

The aim of our study is to report the results of two types (type A, type B) paclitaxel drug-coated balloon compared with standard percutaneous transluminal angioplasty in the treatment of juxta-anastomotic stenoses of mature but failing distal radiocephalic hemodialysis arteriovenous fistulas. Two groups of 26 and 44 patients treated with two different drug-coated balloon are compared with a control group of 86 treated with standard percutaneous transluminal angioplasty. A color Doppler ultrasound was performed to evaluate stenosis and for treatment planning. We assess primary patency, defined as the absence of dysfunction of the arteriovenous fistulas, patent lesion or residual stenosis < 30% and no need for further reintervention of target lesion. Primary patency and secondary patency are evaluated after 12 months with color Doppler ultrasound for the whole arteriovenous fistulas, defined as absolute (absolute primary patency, absolute secondary patency) and target lesion. Postprocedural technical and clinical success was 100%. After 12 months, absolute primary patency is 81.8% for type A, 84.1% type B, and 54.7% for standard percutaneous transluminal angioplasty; target lesion primary patency is 92% type A, 86.4% type B, and 62.8% standard percutaneous transluminal angioplasty; absolute secondary patency is 95.4% type A, 95.5% type B, and 80.7% standard percutaneous transluminal angioplasty; target lesion secondary patency is 100% type A, 97.7% type B, and 80.7% standard percutaneous transluminal angioplasty. All the patients treated with drug-coated balloon (type A + type B) have an absolute primary patency of 83.3%, a target lesion primary patency of 87.9%, an absolute secondary patency of 95.5%, and a target lesion secondary patency of 98.4%. Our study confirms that the use of drug-coated balloon, indiscriminately among different brands, improves primary patency with statistically significant difference in comparison with standard percutaneous transluminal angioplasty and decreases reintervention of target lesion in juxta-anastomotic stenoses of failing distal arteriovenous fistulas maintaining the radiocephalic fistula as long as possible.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Radial Artery; Renal Dialysis; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Upper Extremity; Vascular Access Devices; Vascular Patency

Poly (propylene carbonate, PPC) is a new member of the aliphatic polyester family. An outstanding feature of PPC is that it produces mainly water and carbon dioxide when degraded in vivo, causing minimal side effects. This unique property together with excellent biocompatibility and biodegradability makes PPC a promising material for drug delivery. In this study, we explored the effect of the sirolimus (an inhibitor of cell growth)-eluting PPC mesh on graft stenosis and its possible mechanisms in a rat arteriovenous grafting model. The PPC mesh was prepared by electrospinning. A jugular vein to abdominal aortic autograft transplantation model was established in rats. The graft was then treated by wrapping with the drug mesh or the drug-free mesh or left untreated. Four weeks posttransplantation, neointima was measured with hematoxylin and eosin staining, matrix metalloproteinase-2 (MMP-2), and MMP-9, and proliferating cell nuclear antigen (PCNA) in the grafts were assayed by Western blotting and immunohistochemistry, respectively. In vitro rat aortic adventitial fibroblast cell (RAAFC) migration was assessed using the Boyden chamber assay, and phospho-mammalian target of rapamycin (mTOR) levels in RAAFCs were determined by Western blotting. Animals with the drug mesh had an intimal area index of 4.87% ± 0.98%, significantly lower than that of the blank group (14.21% ± 2.56%) or the PPC group (15.03% ± 2.35%, both P < .05). The sirolimus mesh markedly suppressed MMP-2 and MMP-9 expression, decreased PCNA-positive cell numbers, inhibited RAAFC migration, and reduced phospho-mTOR levels. Our data suggest that the sirolimus-eluting PPC mesh might be potentially applied for the management of grafting stenosis.

Topics: Animals; Aorta, Abdominal; Autografts; Cardiovascular Agents; Cell Movement; Coated Materials, Biocompatible; Equipment Design; Fibroblasts; Graft Occlusion, Vascular; Jugular Veins; Male; Matrix Metalloproteinase 2; Matrix Metalloproteinase 9; Phosphorylation; Proliferating Cell Nuclear Antigen; Propane; Rats, Wistar; Sirolimus; Surgical Mesh; TOR Serine-Threonine Kinases; Vascular Grafting; Vascular Patency

A retrospective longitudinal analysis was performed to evaluate the outcome of consecutive treatments with drug-coated balloons (DCBs) in dysfunctional arteriovenous (AV) dialysis access (fistulae and grafts).. From January 2015 to December 2017, 339 DCBs were used in 257 procedures in 165 patients with dysfunctional accesses. Of these, 38 patients had ≥ 2 procedures and were included in the analysis. A total of 112 procedures were performed with 133 devices (22 patients treated twice, 4 treated 3 times, 7 treated 4 times, 2 treated 5 times, and 3 treated 6 times). Mean balloon diameter was 8.13 mm (min-max range, 3-12 mm) and length was 63.16 mm (min-max range, 40-150 mm). Primary outcome measures were safety and effectiveness based on the noninferiority hypothesis that the second treatment would be as effective as the first regarding postintervention primary patency (PIPP). Secondary outcome measures included independent factors that may influence outcomes.. Mean lesion follow-up was 617 d (range, 175-1,100 d). Median PIPP durations were 216.5 d for the first intervention and 280 d for the second (P = .37; hazard ratio, 1.271; 95% confidence interval, 0.75-2.16). There was a significant difference in PIPP in favor of the second intervention when patients with only 2 interventions (22 of 38; 57.9%) were included (first intervention, 269 d; second intervention, 520 d; P = .03; hazard ratio, 2.354; 95% confidence interval, 1.087-5.098).. There was no significant difference in PIPP between the first and second DCB procedures. Results suggest consistency in PIPP with the use of DCBs regardless of aging AV access.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Longitudinal Studies; Male; Middle Aged; Renal Dialysis; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

We evaluated the safety and technical and clinical outcomes of angioplasty with a drug-coated balloon for the management of venous stenosis in arteriovenous grafts and arteriovenous fistulas in patients undergoing haemodialysis.. Data were obtained from an ongoing prospective, non-randomised registry conducted at three Italian centres. Patients were treated with a drug-coated balloon according to standard procedures in each participating centre. Evaluation was by colour Doppler imaging every 3 months. The primary end-point was primary assisted patency. The secondary end-point was the rate of assisted patency of the vascular access.. A total of 311 angioplasty procedures in 200 patients, (60.4% male), were analysed. The procedural success rate was 100%. A total of 192 treatments of restenosis were necessary in 81 patients during average 21 ± 8 months follow-up. Kaplan-Meier estimates indicated that 88.0%, 64.2% and 40.6% of treated lesions were free from restenosis at 6, 12 and 24 months, respectively. Including multiple angioplasty, circuit patency rates were 99.2%, 92.5% and 84.8% at 6, 12 and 24 months, respectively. Primary patency rates were highest in shunts treated de novo with drug-coated balloons. Risk of restenosis was associated with circuit age (p = 0.017), history of treatment with conventional angioplasty (p < 0.001) and the kind of balloon used during pre-dilation (p = 0.001).. The results suggest that favourable long-term patency rates can be achieved with the drug-coated balloon in a varied population of patients with failing haemodialysis arteriovenous shunts treated under conditions of actual care.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Italy; Male; Middle Aged; Prospective Studies; Recurrence; Registries; Renal Dialysis; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Endovascular treatment of a significant stenosis in an infrainguinal autologous bypass prevents bypass occlusion and improves bypass patency. Drug-eluting balloons (DEBs) have been proven to possess antirestenotic features in the treatment of femoropopliteal stenoses and occlusions. This study evaluated the effects of DEB angioplasty vs uncoated balloon (UCB) angioplasty to rescue infrainguinal autologous bypass grafts at risk (BAR).. The study included all consecutive patients treated endovascularly for BAR from December 1, 2012, to July 31, 2015. As of April 1, 2014, the primary treatment of BAR was changed from UCBs to DEBs. Patients treated with DEBs were prospectively recorded in a database and retrospectively analyzed. Patients treated with UCBs were retrospectively collected from a historical cohort with a similar inclusion period length as the DEB cohort. The follow-up scheme did not differ between the two groups. The primary end point was the combined end point of freedom from recurrent stenosis or bypass occlusion. Secondary end points were primary assisted patency, secondary patency, technical success, major amputation, and mortality.. Twenty-one patients were treated in the DEB group and 18 were treated in the UCB group. The two groups were evenly distributed in demographics, bypass, treatment, and lesion characteristics. No statistically significant differences were found in the combined end point of freedom from recurrent stenosis and the occlusion rate after 1 year between the UCB group (77.8%) and the DEB group (80.0%; P = .76). After 1 year, the primary assisted patency rate was 88.2% in the UCB group vs 95.2% in the DEB group (P = .47), and the secondary patency rate was 94.1% in the UCB group vs 95.2% in the DEB group (P = .91). During follow-up, restenosis developed in four patients (22.2%) in the UCB group and in four patients (19.0%) in the DEB group (P = .80). One bypass (5.6%) in the UCB group and one bypass (4.8%) in the DEB group occluded during follow-up (P = .884).. DEBs and UCBs perform equally in the treatment of significant stenosis in infrainguinal autologous bypasses with regard to freedom from restenosis or bypass occlusion, primary assisted patency, and secondary patency at 1 year. We suggest using a less expensive UCB in the treatment of BAR.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Databases, Factual; Disease-Free Survival; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Recurrence; Retrospective Studies; Risk Factors; Time Factors; Transplantation, Autologous; Treatment Outcome; Vascular Access Devices; Vascular Grafting; Vascular Patency

A 59-year-old man with critical claudication underwent left femoro-anterior bypass grafting, which was uneventful. The graft was tunneled medially across the knee, then anterior to the tibia. His symptoms recurred 1 year later and he was found to have critical stenosis of the vein graft just proximal to the anterior tibial arterial anastomosis. This was treated with scaffolded balloon angioplasty and implantation of a coronary, zotarolimus-eluting balloon-expandable stent, which was also uneventful. However, his claudication again recurred 1 year later. Diagnostic angiography revealed crush, deformation and restenosis of the balloon-expandable stent requiring surgical revision of the bypass graft.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Computed Tomography Angiography; Critical Illness; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Intermittent Claudication; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Recurrence; Reoperation; Saphenous Vein; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Grafting; Vascular Patency

The aim of this study was to compare the clinical and hemodynamic outcomes of plain vs paclitaxel-coated percutaneous transluminal angioplasty (PTA) in patients with infrainguinal vein bypass stenosis.. A single-center retrospective analysis was conducted of consecutive patients treated by infrainguinal bypass PTA. Primary study end points were primary and assisted primary patency. Secondary end points were clinical and hemodynamic improvement, limb salvage, and survival. Society for Vascular Surgery reporting standards were applied.. From April 2008 to November 2014, 83 infrainguinal vein bypasses were treated for graft stenosis by plain (group A, n = 41) or by paclitaxel-coated PTA (group B, n = 42). The groups did not differ significantly in mean age (71.9 years for both groups; P = .99), hypertension (P = 1.0), hyperlipidemia (P = .5), diabetes (P = .6), coronary artery disease (P = 1.0), smoking (P = 1.0), preoperative ankle-brachial index (P = .08), or bypass characteristics (below-knee, P = .82). Technical success rate was 100% for both groups. Mean follow-up was 2.9 years for group A patients and 2.2 years for group B patients (P = .08). No patient was lost to follow-up. Primary patency rates were 88% vs 87% and 73% vs 75% (P = .19) and assisted primary patency rates were 88% vs 90% and 77% vs 84% (P = .76) for group A and B patients at 1 and 2 years, respectively. Repeat target lesion revascularization rates were 22% vs 14% (P = .17). At the last follow-up, there were eight vs seven bypass occlusions (P = .74) for group A and B patients, respectively. In univariate analysis, proximal in-graft stenosis (Cox F, P = .041), bypass failure <6 months after bypass surgery (Cox F, P = .013), more than one bypass stenosis per graft (Cox F, P = .047), and redo bypass procedure (Cox F, P = .0001) were significantly related to assisted primary bypass patency. Immediate hemodynamic and sustained clinical improvement rates were 88% vs 86% and 70% vs 73% for group A and B patients, respectively. There were three vs one major amputations (P = .36) and eight vs seven deaths (P = .78) in group A and B patients, respectively.. Paclitaxel-coated and plain angioplasty of significant infrainguinal vein bypass stenoses performed equally well in clinical and hemodynamic improvement and in primary and assisted primary bypass patency rates.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Austria; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Proportional Hazards Models; Reoperation; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency; Veins

The internal mammary artery (IMA) is the preferred conduit for bypassing the left anterior descending (LAD) artery in patients undergoing coronary artery bypass grafting. Systematic evaluation of the frequency and predictors of IMA failure and long-term outcomes is lacking.. The Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV trial participants who underwent IMA-LAD revascularization and had 12- to 18-month angiographic follow-up (n=1539) were included. Logistic regression with fast false selection rate methods was used to identify characteristics associated with IMA failure (≥75% stenosis). The relationship between IMA failure and long-term outcomes, including death, myocardial infarction, and repeat revascularization, was assessed with Cox regression. IMA failure occurred in 132 participants (8.6%). Predictors of IMA graft failure were LAD stenosis <75% (odds ratio, 1.76; 95% confidence interval, 1.19-2.59), additional bypass graft to diagonal branch (odds ratio, 1.92; 95% confidence interval, 1.33-2.76), and not having diabetes mellitus (odds ratio, 1.82; 95% confidence interval, 1.20-2.78). LAD stenosis and additional diagonal graft remained predictive of IMA failure in an alternative model that included angiographic failure or death before angiography as the outcome. IMA failure was associated with a significantly higher incidence of subsequent acute (<14 days of angiography) clinical events, mostly as a result of a higher rate of repeat revascularization.. IMA failure was common and associated with higher rates of repeat revascularization, and patients with intermediate LAD stenosis or with an additional bypass graft to the diagonal branch had increased risk for IMA failure. These findings raise concerns about competitive flow and the benefit of coronary artery bypass grafting in intermediate LAD stenosis without functional evidence of ischemia.. URL: http:/www.clinicaltrials.gov. Unique identifier: NCT00042081.

Topics: Aged; Cardiac Catheterization; Cardiovascular Agents; Combined Modality Therapy; Comorbidity; Coronary Angiography; Coronary Disease; Coronary Restenosis; Diabetes Complications; Double-Blind Method; Female; Graft Occlusion, Vascular; Humans; Internal Mammary-Coronary Artery Anastomosis; Kaplan-Meier Estimate; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Postoperative Complications; Proportional Hazards Models; Randomized Controlled Trials as Topic; Reoperation; Treatment Failure

The objective of this study was to use instrumental variable (IV) analyses to evaluate the clinical effectiveness of percutaneous stent revascularization versus bypass surgery in the treatment of peripheral artery disease (PAD) among type 2 diabetic patients. Type 2 diabetic patients who received peripheral artery bypass surgery (n = 5,652) or stent revascularization (n = 659) for lower extremity arterial stenosis between 2000 and 2007 were identified from the Taiwan National Health Insurance claims database. Patients were followed from the date of index hospitalization for 2 years for lower-extremity amputation, revascularization, and hospitalization for medical treatment. Analysis using treatment year, patients' monthly income level, and regional difference as IVs were conducted to reduce unobserved treatment selection bias. The crude analysis showed a statistically significant risk reduction in favor of stent placement in lower extremity amputation and in the composite endpoint of amputation, revascularization, or hospitalization for medical treatment. However, peripheral artery stent revascularization and bypass surgery had similar risk of lower limb amputation and composite endpoints in the analyses using calendar year or patients' monthly income level as IVs. These two treatment modalities had similar risk of lower limb amputation among DM patients with PAD.

Topics: Age Distribution; Aged; Amputation, Surgical; Cardiovascular Agents; Comorbidity; Databases, Factual; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Diabetic Nephropathies; Endovascular Procedures; Female; Graft Occlusion, Vascular; Hospitalization; Humans; Hypoglycemic Agents; Leg; Limb Salvage; Lung Diseases; Male; Middle Aged; Minimally Invasive Surgical Procedures; Peripheral Arterial Disease; Risk Reduction Behavior; Stents; Taiwan; Treatment Outcome; Vascular Grafting

The local delivery of paclitaxel onto a graft has been reported to prevent neointimal hyperplasia. Because more than half of vascular stenoses occur within 3 cm of the venous anastomosis, this study tested the effectiveness of a paclitaxel coating restricted to both ends of the expanded polytetrafluoroethylene (ePTFE) graft to reduce the amount of drug delivered.. Both ends of ePTFE grafts were coated with paclitaxel at a dose of 0.58 μg/mm(2); the total amount of paclitaxel per graft was 0.66 mg. Paclitaxel-coated hemodialysis grafts 15 cm in length were surgically implanted between the common carotid artery and external jugular vein in female Landrace pigs. The animals were sacrificed 6 weeks after graft placement. Cross sections of the anastomosis sites were analyzed histomorphometrically to measure the ratio of neointimal hyperplasia to the graft area (H/G ratio) and the percentage of luminal stenosis. The experimental results were compared between grafts coated with paclitaxel at the ends only (n = 8), grafts coated over the entire length (n = 6), and uncoated control grafts (n = 6).. The mean ± standard error values of the H/G ratios for the arterial anastomosis were 0.82 ± 0.13 (control), 0.41 ± 0.09 (terminal coating), and 0.21 ± 0.04 (whole coating). The values for the venous anastomosis were 0.82 ± 0.12 (control), 0.39 ± 0.11 (terminal coating), and 0.12 ± 0.03 (whole coating). Compared with the uncoated grafts, neointimal hyperplasia was suppressed effectively in the vascular grafts coated terminally with paclitaxel (artery, P = 050; vein, P < .001). However, the suppressive effect was less than that of grafts coated with paclitaxel over the entire length. The percentages of luminal stenosis showed similar tendency to the H/G ratios.. Despite a reduced amount of the drug, paclitaxel coating applied to both ends of the ePTFE hemodialysis grafts effectively suppressed neointimal hyperplasia at the sites of anastomosis.

Topics: Animals; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Carotid Artery, Common; Coated Materials, Biocompatible; Constriction, Pathologic; Disease Models, Animal; Female; Graft Occlusion, Vascular; Hyperplasia; Jugular Veins; Neointima; Paclitaxel; Polytetrafluoroethylene; Prosthesis Design; Renal Dialysis; Swine; Time Factors

Newer-generation everolimus-eluting stents (EES) have been shown to improve clinical outcomes compared with early-generation sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) in patients undergoing percutaneous coronary intervention (PCI). Whether this benefit is maintained among patients with saphenous vein graft (SVG) disease remains controversial.. We assessed cumulative incidence rates (CIR) per 100 patient years after inverse probability of treatment weighting to compare clinical outcomes. The pre-specified primary endpoint was the composite of cardiac death, myocardial infarction (MI), and target vessel revascularisation (TVR). Out of 12,339 consecutively treated patients, 288 patients (5.7%) underwent PCI of at least one SVG lesion with EES (n=127), SES (n=103) or PES (n=58). Up to four years, CIR of the primary endpoint were 58.7 for EES, 45.2 for SES and 45.6 for PES with similar adjusted risks between groups (EES vs. SES; HR 0.94, 95% CI: 0.55-1.60, EES vs. PES; HR 1.07, 95% CI: 0.60-1.91). Adjusted risks showed no significant differences between stent types for cardiac death, MI and TVR.. Among patients undergoing PCI for SVG lesions, newer-generation EES have similar safety and efficacy to early-generation SES and PES during long-term follow-up to four years.

Topics: Aged; Cardiovascular Agents; Coronary Artery Bypass; Drug-Eluting Stents; Everolimus; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Myocardial Infarction; Netherlands; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Risk Factors; Saphenous Vein; Sirolimus; Switzerland; Time Factors; Treatment Outcome

To evaluate the safety and feasibility of using drug-eluting balloons (DEBs) in the treatment of infrainguinal bypass graft stenoses.. A nonrandomized prospective study evaluated the feasibility of DEB treatment for intragraft/anastomotic stenoses arising >1 month after infrainguinal bypass grafting; stenoses due to graft/technical problems (e.g., vein torsion) were excluded, as were failed grafts that could not be successfully recanalized with catheter-directed thrombolysis. Between February 2010 and February 2012, 41 patients (35 men; mean age 71 years, range 46-87) were treated with DEBs for 63 anastomotic/intragraft stenoses in vein or prosthetic grafts. Follow-up was performed with duplex ultrasonography. The primary endpoint at 12 months was graft occlusion or >50% restenosis at the DEB treatment site.. DEB treatment was technically successful in 61 (96.8%) of the 63 lesions with no complications other than one instance of vasospasm; one totally occluded segment and one restenosis were treated surgically. The mean follow-up was 16.7 months (range 3-24). The estimated cumulative target site primary and secondary patency rates at 6 months were 91% and 96%, respectively, and 70% and 90%, respectively, at both 12 and 18 months (no restenoses after 12 months). The estimated mean durations of primary and secondary treatment site patency were 20.3 and 22.7 months, respectively (p=0.033). At 6 and 12/18 months, the cumulative rates were 96% and 90%, respectively, for graft patency and 98% and 93% for freedom from amputation.. DEBs proved to be a feasible, safe, and effective treatment for vein and prosthetic bypass graft stenoses, with excellent technical success and acceptable short and midterm patency.

Topics: Aged; Aged, 80 and over; Angiography, Digital Subtraction; Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Feasibility Studies; Female; Graft Occlusion, Vascular; Humans; Lower Extremity; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Salvage Therapy; Saphenous Vein; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Topics: Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Graft Occlusion, Vascular; Humans; Lower Extremity; Male; Paclitaxel; Peripheral Arterial Disease; Salvage Therapy; Saphenous Vein; Vascular Access Devices

Aim of the present study was to report the imaging and clinical outcomes of a prospective single-center study investigating paclitaxel-coated balloons (PCB) for the treatment of failing peripheral bypass grafts (BYPACS study).. In total, 32 patients had their failing peripheral native or synthetic bypass graft treated with PCB angioplasty (Group PCB). Basic inclusion criteria were any significant proximal or distal anastomotic stenosis confirmed by Duplex ultrasound (DUS; PSVR>2.5) associated with significantly reduced in-graft velocities (<45 cm/s) putting the graft at risk of thrombosis. Results were compared with a similar historical control group of 24 patients who had their failing peripheral bypass treated with plain uncoated balloon angioplasty (Group PTA). Primary endpoint was binary lesion restenosis defined as >50% stenosis of the treated lesion on DUS. Secondary endpoints included freedom from target lesion revascularization (TLR) defined as a patent peripheral bypass graft regardless of restenosis but without any repeat intervention (driven by reduced in-graft velocities <45 cm/s), major amputations and graft thrombosis. Multivariable Cox proportional hazards regression analysis was applied to adjust for confounding factors of heterogeneity. Results are reported as Cox-adjusted hazard ratios (HR and 95% CI).. Baseline variables were equally distributed between the two groups. Median follow-up was 7 months in group PCB and 8 months in group PTA. Rates of binary restenosis were similar between the 2 groups (HR=1.08, 95% CI=0.49-2.40; P=0.84). Freedom from TLR was also similar (HR=0.97, 95% CI=0.36-2.66; P=0.88). One amputation occurred in the PCB group and 2 in the PTA (P=0.58). Four events of bypass thrombosis occurred in each group (P=0.71).. PCB does not significantly inhibit restenosis or improve freedom from repeat angioplasty after treatment of failing peripheral arterial vein or synthetic bypass grafts.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angiography, Digital Subtraction; Angioplasty, Balloon; Blood Flow Velocity; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Constriction, Pathologic; Drug Carriers; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Limb Salvage; London; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Peripheral Arterial Disease; Proportional Hazards Models; Prospective Studies; Prosthesis Failure; Regional Blood Flow; Reoperation; Risk Factors; Time Factors; Treatment Failure; Ultrasonography, Doppler, Duplex; Vascular Access Devices; Veins

In this case report, we provide the first detailed description of an intermittent mechanical kink of a right internal thoracic artery (ITA) graft to the left anterior descending coronary artery secondary to respiratory movements, and its assessment by pressure wire derived fractional flow reserve (FFR). The patient presented with recurrent unstable angina and documented anterior/anterolateral ischemia. Persistent symptoms were attributed to the ITA kink and stenting was planned on clinical grounds. However, the lesion proved not physiologically significant when FFR was assessed after intermittency related to respiratory movements was documented. Complex stenting was therefore avoided and medical therapy was prescribed for distal diagonal disease. We therefore propose that intermittency should be actively investigated when a kink is documented in a coronary bypass graft by conventional angiography (using dedicated angiographic evaluation in maximal inspiration and expiration). Furthermore, when this type of lesion is encountered, we suggest that it should be assessed physiologically using pressure wire derived FFR before potentially complex interventions are considered.

Topics: Aged; Angina, Unstable; Blood Pressure; Cardiovascular Agents; Coronary Angiography; Fractional Flow Reserve, Myocardial; Graft Occlusion, Vascular; Humans; Internal Mammary-Coronary Artery Anastomosis; Male; Mammary Arteries; Predictive Value of Tests; Recurrence; Respiration; Risk Factors; Time Factors

This study was designed to investigate the immediate and one-year outcomes of polymer-free paclitaxel coated drug-eluting stent (DES) implantation in a consecutive series of patients presenting with stenosis of infrainguinal bypass grafts.. Between January 2011 and January 2012, 11 patients with failing infrainguinal bypass grafts were treated in two institutions. Clinical status and Duplex scan parameters were recorded at baseline and over a follow-up period of one year.. DES implantation was successfully performed in all patients. Ten patients received a single stent and one patient received two stents. At one year, one patient showed total bypass graft occlusion (9%). In all the remaining patients, Duplex scan examination documented patency of the treated grafts.. DES implantation in failing infrainguinal bypass grafts can be safely performed and provides satisfactory clinical outcomes. The patency rate of 91% favourably compares with those obtained with other endovascular treatments such as plain balloon or cutting balloon angioplasty.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Constriction, Pathologic; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Italy; Lower Extremity; Male; Middle Aged; Paclitaxel; Prosthesis Design; Prosthesis Failure; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The aim was to investigate the 7-year clinical outcomes of patients treated with either drug-eluting stents (DES) or bare-metal stents (BMS) for saphenous vein graft disease (SVG).. Atherosclerotic disease in SVG has several peculiarities which make it difficult to extrapolate outcomes of the use of DES as compared to BMS, from outcomes observed in native coronary arteries. To date no long-term safety and efficacy results for DES in SVG have been published.. Between January, 2000 and December, 2005 a total of 250 consecutive patients with saphenous vein graft disease were sequentially treated with DES (either sirolimus- or paclitaxel-eluting stents) or with BMS. Yearly follow-up was performed.. At 87 months (7.25 years), a total of 101 patients died (58 [46%] in the BMS group and 43 [42%] in the DES group, P-value= 0.4). There was no significant difference in the combined endpoint mortality or myocardial infarction. Cumulative target vessel revascularisation (TVR) was higher in the BMS group compared to the DES group (41% vs. 29%, respectively; adjusted hazard ratio [HR] 0.63, 95% confidence interval [CI]: 0.39-1.0). The cumulative incidence of major adverse cardiac events was 73% vs. 68% in the BMS and DES groups, respectively (adjusted HR 0.93, 95% CI: 0.67-1.3).. In the present study, the unrestricted use of DES for SVG lesions appeared safe and effective up to 7.25 years- and the use of DES resulted in a clinically relevant lower rate of TVR.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Constriction, Pathologic; Coronary Angiography; Coronary Artery Bypass; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Netherlands; Paclitaxel; Predictive Value of Tests; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Saphenous Vein; Sirolimus; Stents; Time Factors; Treatment Outcome

Paclitaxel coating of hemodialysis grafts is effective in suppressing neointimal hyperplasia in the graft and vascular anastomosis sites. However, paclitaxel can have unwanted effects on the surrounding tissues. To reduce such problems, we developed a method to coat the drug only on the luminal surface of the graft, with little loading on the outer surface.. A peristaltic pump and a double-solvent (water and acetone) system were used to achieve an inner coating of paclitaxel. At the ratio of 90% acetone, paclitaxel was homogeneously coated only on the luminal surface of the graft without changing the physical properties. To determine its effect, grafts were implanted between the common carotid artery and the external jugular vein in pigs using uncoated control grafts (n = 6) and low-dose (n = 6, 0.22 μg/mm(2)) and high-dose (n = 6, 0.69 μg/mm(2)) paclitaxel inner-coated grafts. Cross-sections of graft-venous anastomoses were analyzed histomorphometrically 6 weeks after placement to measure the patency rate, percentage of luminal stenosis, and neointimal area.. No signs of infection or bacterial contamination were observed in the paclitaxel inner-coated groups. Only one of the six control grafts was patent, but all of the paclitaxel-coated grafts were patent, with little neointima. The mean ± standard error values of percentage luminal stenosis were 75.7% ± 12.7% (control), 17.5% ± 3.1% (low dose), and 19.7% ± 3.0% (high dose). The values for the neointimal area (in mm(2)) were 8.77 ± 1.66 (control), 3.53 ± 0.73 (lose dose), and 4.24 ± 0.99 (high dose). Compared with the control group, paclitaxel inner-coated vascular grafts significantly suppressed neointimal hyperplasia (low dose, P = .001; high dose, P = .002). Myofibroblast proliferation and migration into the graft interstices confirmed the firm attachment of the implanted graft to the surrounding tissue.. Paclitaxel coating on the inner luminal surface of vascular grafts was effective in suppressing neointimal hyperplasia, with little inhibition of myofibroblast infiltration within the graft wall.

Topics: Animals; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Carotid Artery, Common; Cell Movement; Cell Proliferation; Coated Materials, Biocompatible; Drug Carriers; Female; Graft Occlusion, Vascular; Hyperplasia; Jugular Veins; Myofibroblasts; Paclitaxel; Prosthesis Design; Renal Dialysis; Solubility; Swine; Time Factors; Tunica Intima; Vascular Patency

Despite rapid progress in surgical techniques, there is still a significant lack of surgery-supportive pharmacological treatments. The aim of this study was to test the hypothesis that ursolic acid (UA) may prevent intimal hyperplasia of venous bypass grafts.. The hypothesis was tested by means of primary cell isolation and culture followed by real-time polymerase chain reaction, western blotting, fluorescence microscopy and fluorescence-activated cell sorting analyses, as well as an in vivo rat model for intimal hyperplasia of venous bypass grafts and immunohistochemistry and histochemistry.. The local application of UA significantly inhibited intimal hyperplasia in vivo (intimal thickness control: 25 µm, UA group: 18 µM-8 weeks after surgery). The UA treatment of grafts significantly resulted in reduced endothelial vascular cell adhesion molecule-1 (VCAM-1) expression, reduced infiltration of the grafts vessel wall by CD45-positive cells and increased smooth muscle cell (SMC) death. In in vitro condition, it could be shown that UA inhibits VCAM-1 expression downstream of NFκB and is likely to interfere with VCAM-1 protein synthesis in endothelial cells. Quantification of cell death in vascular smooth muscle cells treated with UA indicated that UA is a potent inducer of SMC apoptosis.. Our results suggest that UA-mediated inhibition of endothelial VCAM-1 expression reduces the infiltration of venous bypass grafts by CD45-positive cells and inhibits intimal hyperplasia. Apoptosis induction in SMCs may be another method in which UA reduces intimal thickening. UA may constitute a surgery-supportive pharmacon that reduces intimal hyperplasia of vein grafts.

Topics: Animals; Apoptosis; Biomarkers; Blotting, Western; Cardiovascular Agents; Cell Survival; Flow Cytometry; Graft Occlusion, Vascular; Hyperplasia; Jugular Veins; Leukocyte Common Antigens; Male; Microscopy, Fluorescence; Rats; Rats, Wistar; Real-Time Polymerase Chain Reaction; Treatment Outcome; Triterpenes; Tunica Intima; Ursolic Acid; Vascular Cell Adhesion Molecule-1; Vascular Grafting

Autologous vein grafts are often used for treating damaged vessels, e.g. arteriovenous fistulas or arterial bypass conduits. Veins have a different histological structure from arteries, which often leads to intimal hyperplasia and graft restenosis. The aim of this study was to develop a perivascular sirolimus-delivery system that would release the antiproliferative drug sirolimus in a controlled manner. Polyester Mesh I was coated with purasorb, i.e. a copolymer of L-lactide and ɛ-caprolactone, with dissolved sirolimus; Mesh II was coated with two copolymer layers; the layer with dissolved sirolimus was overlaid with pure purasorb. This arrangement allowed sirolimus to be released for 6 and 4 weeks, for Mesh I and Mesh II, respectively. Mesh II released sirolimus more homogeneously, without the initial burst effect during the first week. However, the cumulative release curve was steeper at later time points than the curve for Mesh I. Both meshes inhibited proliferation of rat vascular smooth muscle cells during 14-day culture in vitro and preserved excellent cell viability. Newly developed sirolimus-releasing perivascular meshes are promising devices for preventing autologous graft restenosis.

Topics: Animals; Cardiovascular Agents; Cell Proliferation; Cells, Cultured; Chemistry, Pharmaceutical; Chromatography, High Pressure Liquid; Coated Materials, Biocompatible; Delayed-Action Preparations; Drug Carriers; Drug Compounding; Drug Stability; Graft Occlusion, Vascular; Kinetics; Male; Microscopy, Electron, Scanning; Molecular Weight; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; Polyesters; Rats; Rats, Wistar; Sirolimus; Solubility; Surface Properties; Technology, Pharmaceutical

Percutaneous intervention carries a higher risk of distal embolization and poorer outcome in saphenous vein grafts (SVG) than in native coronary vessels. Embolic protection devices (EPD) have demonstrated value in decreasing the risk of embolization and post-procedural enzymes elevation after SVG intervention. Although there is ample evidence to support the routine use of EPD for SVG interventions, frequently those devices are not utilized or cannot be used because of technical reasons. As we previously reported, the "undersized stenting" approach seems to be an attractive strategy when EPD cannot be used. We present a case with severe SVG degeneration that illustrates the feasibility of this strategy.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Drug-Eluting Stents; Embolism; Everolimus; Graft Occlusion, Vascular; Humans; Male; Prosthesis Design; Saphenous Vein; Sirolimus; Thrombosis; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Autologous vein grafts used as aortocoronary bypasses are often prone to intimal hyperplasia, which results in stenosis and occlusion of the vein. The aim of this study was to prevent intimal hyperplasia using a newly developed perivascular system with sustained release of sirolimus. This system of controlled drug release consists of a polyester mesh coated with a copolymer of L-lactic acid and epsilon-caprolactone that releases sirolimus. The mesh is intended for wrapping around the vein graft during surgery. The mesh releasing sirolimus was implanted in periadventitial position onto arteria carotis communis of rabbits, and neointimal hyperplasia was then assessed. We found that implanted sirolimus-releasing meshes reduced intima thickness by 47+/-10 % compared to a vein graft after 3 weeks. The pure polyester mesh decreased vein intima thickness by 35+/-9 %. Thus, our periadventitial system for controlled release of sirolimus prevented the development of intimal hyperplasia in autologous vein grafts in vivo in rabbits. A perivascularly applied mesh releasing sirolimus is a promising device for preventing stenosis of autologous vein grafts.

Topics: Animals; Cardiovascular Agents; Cell Proliferation; Drug Carriers; Graft Occlusion, Vascular; Hyperplasia; Jugular Veins; Polyesters; Rabbits; Sirolimus; Tunica Intima

The aim of this study was to assess the angiographic results of the radial artery as a coronary bypass conduit at long term (>5 years).. Radial artery grafts were controlled in 202 patients at 10.1 years by conventional angiography (n = 79) and computed tomography (n = 123). Clinical or paraclinical evidence of ischemia was noted in 81 patients, whereas 121 patients were asymptomatic. Some 520 conduits were controlled: radial artery (n = 230), left internal thoracic artery (n = 190), right internal thoracic artery (n = 30), and veins (n = 70). Radial arteries were anastomosed to the right coronary (24%), marginal (58%), diagonal (16%), and left anterior descending (<1%) arteries, whereas left internal thoracic arteries were primarily anastomosed to the left anterior descending artery (95%). The mean number of antithrombotic and anti-anginal medications was 1.2 and 1.9 per patient, respectively.. The ejection fraction was slightly decreased compared with its preoperative value (54% +/- 11% vs 57% +/- 9%; P = .009). Nine reoperations were required at 10.5 years for valve replacement (n = 8) and isolated bypass (n = 1). Percutaneous intervention was performed in 48 patients (24%) at 7.6 years on a graft (28%) or a native coronary artery (72%). The 10-year patency of radial artery grafts was 83%, which was lower than the patency of left internal thoracic arteries (95%, P < .001) and similar to the patency of right internal thoracic arteries (87%, P = .66) and veins (81%, P = .50). No medication seemed to influence radial artery graft patency (aspirin: P = .26; calcium blockers: P = .36). All graft patency was lower when clinical or paraclinical evidence of ischemia was present than in asymptomatic cases (83% vs 90% P = .02). The patency of left anterior descending grafts was higher than that of non-left anterior descending grafts (96% vs 82% P < .001).. The radial artery-to-coronary bypass conduit provided a low coronary reoperation rate with an excellent patency (83%) up to 20 years postoperatively.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Graft Occlusion, Vascular; Humans; Internal Mammary-Coronary Artery Anastomosis; Middle Aged; Radial Artery; Reoperation; Stroke Volume; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Vascular Patency

Percutaneous treatment of old, degenerated saphenous vein grafts (SVG) is associated with a high likelihood of major adverse cardiac events. When an acute coronary syndrome (ACS) develops in a patient with old SVG, fresh thrombus may superimpose on an old, degenerative atheroma: a sudden increase in the athero-thrombotic burden ensues with consequent, frequent total occlusion of the lumen. In this scenario, transluminal recanalization of the graft is usually associated with the highest chance of distal embolization and no-reflow and positioning of an embolic protection device (EPD) is almost mandatory. However, distal EPD are difficult to place when the vessel is totally occluded and do not completely avoid distal embolization. We report two cases of totally occluded SVG in patients admitted for ACS that were recanalized with the aid of a proximal EPD system with angiographic and clinical success.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Drug-Eluting Stents; Embolism; Equipment Design; Everolimus; Female; Filtration; Graft Occlusion, Vascular; Humans; Male; Metals; Middle Aged; Prosthesis Design; Saphenous Vein; Sirolimus; Stents; Thrombectomy; Thrombosis; Treatment Outcome; Vascular Patency

The aim of this study was to examine the incidence of clinical events after implantation of the TAXUS Express (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent in saphenous vein graft (SVG) lesions in an unselected patient population.. Saphenous vein grafts have 1-year occlusion rates of 12% to 20%, with >50% failure by 7 to 10 years. Many diseased SVGs are treated by percutaneous coronary intervention to avoid higher-risk reoperation, but bare-metal stents have 35% to 40% historical SVG restenosis rates by 18 months. Reported outcomes of drug-eluting stents in SVG lesions are limited and mainly retrospective.. The ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program compiled data on 7,492 patients receiving > or =1 TAXUS Express (Boston Scientific) stent, including 474 patients with SVG. All cardiac events were monitored with independent adjudication of end points. Patients enrolled at procedure start with no mandated inclusion/exclusion criteria.. The ARRIVE SVG patient 2-year follow-up was 96% complete (457 of 474). The SVG patients had significantly more baseline comorbidities/complex disease than simple-use patients (n = 2,698) undergoing native coronary intervention or other expanded-use patients (n = 4,320 without SVG patients). They had higher 2-year rates of mortality (10.9% vs. 4.2%, p < 0.001), myocardial infarction (5.3% vs. 2.2%, p < 0.001), and Academic Research Consortium definite/probable stent thrombosis (4.7% vs. 1.4%, p < 0.001) than the simple-use group. They also had higher 2-year adverse event rates, including significantly more mortality (10.9% vs. 7.5%, p = 0.008) than other expanded-use patients.. The ARRIVE SVG patients have significantly different baseline risk and higher clinical risk through 2 years than simple-use and other expanded-use patients. Nonetheless, compared with historical SVG revascularization rates, treatment with paclitaxel-eluting stent seems to offer a reasonable therapeutic option in this high-risk group. (TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance Program; NCT00569491) and (TAXUS ARRIVE 2: A Multicenter Safety Surveillance Program; NCT00569751).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Bypass; Coronary Restenosis; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Saphenous Vein; Thrombosis; Time Factors; Treatment Outcome; United States

Intimal hyperplasia is a major cause of restenosis after the interventional or surgical treatment of occlusive arterial disease. We investigated the effects of clopidogrel, calcium dobesilate, nebivolol, and atorvastatin on the development of intimal hyperplasia in rabbits after carotid venous bypass surgery. We divided 40 male New Zealand rabbits into 4 study groups and 1 control group. After occluding the carotid arteries of the rabbits, we constructed jugular venous grafts between the proximal and the distal segments of the occluded artery. Thereafter, group 1 (control) received no medication. We administered daily oral doses of clopidogrel to group 2, calcium dobesilate to group 3, nebivolol to group 4, and atorvastatin to group 5. The rabbits were killed 28 days postoperatively. The arterialized jugular venous grafts were extracted for histopathologic examination. Intimal thicknesses were 42.87 +/- 6.95 microm (group 2), 46.5 +/- 9.02 microm (group 3), 34.12 +/- 5.64 microm (group 4), and 48.37 +/- 6.16 microm (group 5), all significantly less than the 95.12 +/- 9.93 microm in group 1 (all P < 0.001). Medial thicknesses were 94 +/- 6 microm (group 2), 101.5 +/- 13.52 microm (group 3), 90.5 +/- 9.69 microm (group 4), and 101.37 +/- 7.99 microm (group 5), all significantly thinner than the 126.62 +/- 13.53 microm in group 1 (all P < 0.001). In our experimental model of carotid venous bypass grafting in rabbits, clopidogrel, calcium dobesilate, nebivolol, and atorvastatin each effectively reduced the development of intimal hyperplasia. Herein, we discuss our findings and review the medical literature.

Topics: Administration, Oral; Animals; Atorvastatin; Benzopyrans; Calcium Dobesilate; Cardiovascular Agents; Carotid Stenosis; Clopidogrel; Disease Models, Animal; Ethanolamines; Graft Occlusion, Vascular; Heptanoic Acids; Hyperplasia; Jugular Veins; Male; Nebivolol; Pyrroles; Rabbits; Ticlopidine; Tunica Intima; Vascular Surgical Procedures

A 69 year old man was admitted with unstable angina (Class IIB). He had a history of chronic renal impairment, diabetes mellitus, hypertension and coronary bypass surgery in 1997 (LIMA graft to the LAD anf diagonal branch, saphenous vein grafts to the RCA and first marginal branch of LCx.. Coronary angiography.. Unstable angina (Class IIB). Occlusion of the LCx and RCA. Functionally occluded LIMA on the LAD and diagonal branch. Diffuse disease of the LAD with two significant lesions at the LAD-first diagonal and mid-distal LAD.. Revascularisation.

Topics: Aged; Angina, Unstable; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Diabetes Complications; Drug-Eluting Stents; Everolimus; Graft Occlusion, Vascular; Hemodynamics; Humans; Hypertension; Kidney Diseases; Male; Sirolimus; Treatment Outcome

To evaluate the long-term clinical outcomes of patients undergoing percutaneous coronary intervention for saphenous vein graft (SVG) disease. Specifically, we compared clinical endpoints of patients who received sirolimus-eluting stents (SES) versus bare-metal stents (BMS) for SVG disease.. A recent small randomized-controlled trial (RCT) reported increased mortality with the use of SES in SVG disease.. We retrospectively identified patients who underwent SES placement for a SVG lesion(s) at our institutions over a 4-year period. The procedural and medical records were reviewed to identify predetermined clinical outcomes.. 318 patients who underwent SES placement for a SVG lesion were identified. 7 patients were lost to follow-up. 141/311 patients (45%) received SES, while 170/311 (55%) received BMS. At a mean follow-up of 34 months, there was a reduction in target lesion revascularization (TLR) (7% vs. 14%, P = 0.07) without an increased risk of mortality (6% vs. 12%, P = 0.06) in patients who received SES compared to patients who received BMS. When compared to the recent RCT's SES patients at long-term follow-up, our SES patients had significantly less mortality; rates of myocardial infarction, TLR, target vessel revascularization, and major adverse cardiac events; and were more likely to be taking dual antiplatelet and statin medications.. Our results support that SES used in SVG lesions result in a reduction in TLR without an increased risk of mortality, and therefore may be an equally safe and feasible technique for revascularization with excellent long-term clinical outcomes. These patients may benefit from prolonged dual antiplatelet and statin medication regimens.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Restenosis; Drug-Eluting Stents; Feasibility Studies; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Kaplan-Meier Estimate; Male; Metals; Patient Selection; Platelet Aggregation Inhibitors; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Saphenous Vein; Sirolimus; Stents; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Restenosis; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Metals; Patient Selection; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Assessment; Saphenous Vein; Sirolimus; Stents; Time Factors; Treatment Outcome

Retrieval of intravascular objects can be accomplished through snare retrieval. We report a case in which a patient presented with symptomatic in-stent restenosis caused by a fractured aorto-ostial sirolimus-eluting stent in a saphenous vein graft. Because of the inability to selectively engage the stent ostium with the guide catheter, the fractured stent was removed with an endovascular snare in order to permit successful revascularization. With the proximal portion of the stent retrieved by the snare, a new stent was implanted without complication.

Topics: Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Device Removal; Graft Occlusion, Vascular; Humans; Male; Prosthesis Design; Prosthesis Failure; Radiography, Interventional; Saphenous Vein; Sirolimus; Stents

The frequent use of the internal mammary artery as a bypass graft has brought about an increasing need for angioplasty to treat stenotic arterial grafts. Percutaneous interventions of internal mammary artery grafts by balloon angioplasty or stenting with bare-metal stents have been described in the past. However, implantation of bare-metal stents was associated with high rates of restenosis. The introduction of drug-eluting stents for the treatment of diseased native coronary vessels has been associated with a reduced need for repeat intervention compared with bare-metal stents for both low-risk lesions and high-risk, complex lesions, including the 'long lesion' subset. We describe a case of long drug-eluting stent implantation for a diffusely diseased right internal mammary artery.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Female; Graft Occlusion, Vascular; Humans; Mammary Arteries; Prosthesis Design; Saphenous Vein; Stents; Treatment Outcome

This study evaluated the effect of a bioabsorbable mesh containing paclitaxel on neointimal hyperplasia in a sheep model of dialysis access failure.. Forty neutered male sheep were randomized to one of five parallel groups: no mesh; or a 3-cm x 6-cm mesh with 0.0, 0.3, 0.7, or 1.2 microg/mm(2) of paclitaxel for a total dose of 0.0, 0.6, 1.3, or 2.2 mg, respectively. Commercially available 6-mm internal diameter expanded polytetrafluoroethylene grafts were surgically placed between the left common carotid artery and the right external jugular vein. For those animals randomized to one of the mesh groups, the mesh was placed around the distal end of the graft and venous anastomosis. Patency was assessed at weekly intervals throughout the study. Animals were euthanized 8 weeks after implantation, and grafts and veins were harvested. After histologic processing, six cross sections were cut at the venous end of the graft and vessel. The primary and secondary efficacy outcome measures, respectively, were the area and capillary density of the neointima at the graft-vein anastomosis. Histologic analyses were also performed to investigate the effects of the paclitaxel-eluting mesh on the anastomotic site.. Grafts occluded before the scheduled sacrifice in five animals, and they were excluded from the study and not replaced. Control animals developed significant neointimal hyperplasia at the cross section taken perpendicular to the graft at its most distal end: the neointimal area measured 10.5 +/- 6.8 mm(2) in the no mesh group and 6.4 +/- 3.2 mm(2) in the zero-dose mesh group (P = .28). In contrast, neointimal area was significantly reduced in the paclitaxel mesh groups: 0.9 +/- 1.4 mm(2) in the 0.3 microg/mm(2) group (P = .008 vs zero-dose mesh), 1.3 +/- 1.5 mm(2) in the 0.7 microg/mm(2) group (P = .004 vs zero-dose mesh), and 1.2 +/- 1.4 mm(2) in the 1.2 microg/mm(2) group (P = .008 vs zero-dose mesh). Capillary density in the neointima at the graft-vein anastomosis decreased with paclitaxel and was significantly reduced in the paclitaxel mesh groups with 0.3 and 1.2 mug/mm(2) compared with the zero-dose mesh control (3.6 +/- 2.9 vs 8.9 +/- 5.6 per mm(2) [P = .022] and 1.1 +/- 1.7 vs 8.9 +/- 5.6 per mm(2) [P = .001] respectively). The paclitaxel mesh had no significant effect on healing of the anastomosis or on the thickness of the adjacent vein.. In this model, the paclitaxel-eluting mesh significantly reduced neointimal hyperplasia and neointimal capillary density without apparent toxicity to the adjacent vein.

Topics: Anastomosis, Surgical; Animals; Arteriovenous Shunt, Surgical; Cardiovascular Agents; Drug Delivery Systems; Graft Occlusion, Vascular; Hyperplasia; Male; Models, Animal; Paclitaxel; Prostheses and Implants; Random Allocation; Surgical Mesh; Treatment Failure; Tunica Intima; Vascular Patency

To compare the postprocedural and long-term clinical outcomes of two groups of patients, all presenting with chronic saphenous vein graft (SVG) occlusion, who underwent either SVG or native vessel reopening.. Chronic total occlusions (CTO) treatment in patients who underwent previous surgical revascularization is a dilemma and the choice of performing native vessel or SVG recanalization is not always easy.. Between July 2002 and October 2004, a total of 260 patients were successfully treated for a CTO. Of them, we selected all patients (n = 24) who had previous bypass surgery with graft occlusion. Of this final group, 13 patients underwent a percutaneous graft recanalization while 11 underwent native vessel reopening.. Primary end points were in-hospital and 3-year rates of death, myocardial infarction, target lesion revascularization, and target vessel revascularization. No events occurred in either group during the in-hospital period. Cumulative 3-year event-free survival in the native vessel and SVG group was 81.8% and 83.9% respectively (P = NS). One death and one TVR occurred in each group.. In selected cases, SVG reopening instead of the native vessel is feasible. In such a high-risk population, drug-eluting stent implantation in both SVG and native CTO lesions is associated with good long-term outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Artery Bypass; Coronary Disease; Feasibility Studies; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Retrospective Studies; Saphenous Vein; Stents; Time Factors; Treatment Outcome

Infrainguinal bypass (IB) surgery is an effective means of improving arterial circulation to the lower extremity for patients with critical limb ischemia (CLI). However, wound complications (WC) of the surgical incision following IB can impart significant morbidity.. A retrospective analysis of WC from the 1404 patients enrolled in a multicenter clinical trial of vein bypass grafting for CLI was performed. Univariate and multivariable regression models were used to determine WC predictors and associated outcomes, including graft patency, limb salvage, quality of life (QoL), resource utilization (RU), and mortality.. A total of 543 (39%) patients developed a reported WC within 30 days of surgery, with infections (284, 52%) and hematoma/hemorrhage (121, 22%) being the most common type. Postoperative anticoagulation (odds ratio [OR], 1.554; 95% confidence interval [CI] 1.202 to 2.009; P = .0008) and female gender (OR, 1.376; 95% CI, 1.076 to 1.757; P = .0108) were independent factors associated with WC. Primary, primary-assisted, and secondary graft patency rates were not influenced by the presence of WC; though, patients with WC were at increased risk for limb loss (hazard ratio [HR], 1.511; 95% CI 1.096 to 2.079; P = .0116) and higher mortality (HR, 1.449; 95% CI 1.098 to 1.912; P = .0089). WC was not significantly associated with lower QoL at 3 months (4.67 vs 4.79, P = .1947) and 12 months (5.02 vs 5.13, P = .2806). However, the subset of patients with serious WC (SWC) demonstrated significantly lower QoL at 3 months compared with patients without WC, (4.43 vs 4.79, respectively, P = .0166), though this difference was not seen at 12 months (4.94 vs 5.13, P = .2411). Patients with WC had higher RU than patients who did not have WC. Mean index length of hospital stay (LOS) was 2.3 days longer, mean cumulative 1-year LOS was 8.1 days longer, and mean number of hospitalizations was 0.5 occurrences greater for patients with WC compared with patients without WC (all P < .0001).. WC is a frequent complication of IB for CLI, associated with increased risk for major amputation, mortality, and greater RU. Further detailed investigation into the link between female gender and oral anticoagulation use with WC may help identify causes of WC and perhaps prevent or lessen their occurrence.

Topics: Administration, Oral; Aged; Aged, 80 and over; Anticoagulants; Cardiovascular Agents; Extremities; Female; Graft Occlusion, Vascular; Health Care Costs; Health Resources; Hematoma; Humans; Incidence; Ischemia; Limb Salvage; Male; Middle Aged; North America; Odds Ratio; Oligonucleotides; Postoperative Hemorrhage; Quality of Life; Retrospective Studies; Risk Assessment; Risk Factors; Sex Factors; Surgical Wound Infection; Transplantation, Autologous; Treatment Outcome; Vascular Patency; Vascular Surgical Procedures; Veins

Dopamine is an endogenous inotropic agent commonly used during coronary artery surgery and in the medical therapy of a revascularized patient. In this study the responses of intimal hyperplastic vein grafts to dopamine are examined.. The in vitro isometric tension responses to dopamine of common carotid jugular vein bypass grafts in New Zealand White rabbits were determined. The responses were compared to those obtained in the jugular vein and in the common carotid artery. Both endothelialized and denuded vessels were precontracted with prostaglandin F(2alpha) and the responses to dopamine were assessed. The contributions of nitric oxide and prostanoids to the response were also determined.. Each vessel showed a biphasic dose response to dopamine with relaxation at low concentrations followed by contraction at high concentrations. Dopamine relaxation in the jugular vein was endothelial independent while in the carotid artery it was endothelial dependent and decreased. The sensitivity of both vessels was significantly greater than the vein graft (6.62 +/- 0.12; P < 0. 05); however, after endothelial denudation, the sensitivity of dopamine-mediated relaxation of the vein graft (8.91 +/- 0.09) was significantly enhanced. Preincubation with L-NMMA (to block NO synthesis) inhibited vein graft relaxation to dopamine and preincubation with indomethacin (to block cyclooxygenase activity) inhibited carotid artery relaxation to dopamine. Addition of phenoxybenzamine, a broad alpha-adrenergic antagonist, enhanced dopamine relaxation in the jugular vein and depressed the relaxation in the carotid artery. There was no effect on the dopamine response in the vein graft. Jugular vein and carotid artery responded to dopamine with cholera toxin-sensitive (Galpha(s)) responses. In contrast, dopamine relaxation in the vein graft was enhanced by inhibition of Galpha(s).. Dopamine relaxation in vein grafts is mediated in part by NO but not by either prostanoids or alpha-adrenergic receptor activation. It is diminished compared to native vessels due to an endothelium-dependent, Galpha(s)-mediated pathway.

Topics: Adjuvants, Immunologic; Adrenergic alpha-Antagonists; Animals; Cardiotonic Agents; Cardiovascular Agents; Carotid Artery, Common; Cholera Toxin; Dopamine; Dose-Response Relationship, Drug; Endothelium, Vascular; Enzyme Inhibitors; Graft Occlusion, Vascular; GTP-Binding Proteins; Hyperplasia; Indomethacin; Jugular Veins; Male; Nitric Oxide; omega-N-Methylarginine; Phenoxybenzamine; Prostaglandins; Rabbits; Receptors, Adrenergic, alpha; Receptors, Dopamine; Tunica Intima; Vasodilation

Topics: Animals; Cardiovascular Agents; Cricetinae; Dipeptides; Dogs; Graft Occlusion, Vascular; Guinea Pigs; Humans; In Vitro Techniques; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Thrombosis

It has been well documented that the use of the internal thoracic artery yields better long-term patency rates than saphenous vein grafts for coronary artery bypass grafting. This knowledge has prompted surgeons to use other arterial conduits such as the radial artery.. Between April 1994 and January 1996, radial artery grafts were used in 83 patients (mean age, 54.6 years) undergoing myocardial revascularization. All patients received diltiazem, 80 mg orally three times daily. Angiographic studies were performed in the early post-operative period in 61 patients, and 6 to 19 months later in 12 patients.. There were four hospital deaths (4.8%), none of them due to cardiac causes. Perioperative myocardial infarction was observed in 3 patients, 1 related to a radial artery graft occlusion. Of 61 grafts studied early, 59 were patent (96.7%), but two grafts showed diffuse spasm. Twelve patients had a second angiogram after a mean interval of 8.7 months, and all grafts were patent. One patient who had a diffuse spasm at the early study had recurrent symptoms, and repeat angiogram showed further narrowing of the graft (string sign).. Our results suggest that with proper care, the radial artery may be used for coronary artery bypass grafting with good early results. Long-term follow-up and angiography studies will be needed to establish the merit of the radial artery as a graft for coronary artery operations.

Topics: Administration, Oral; Adult; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Vasospasm; Diltiazem; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Myocardial Infarction; Postoperative Complications; Radial Artery; Recurrence; Survival Rate; Vascular Patency; Vasoconstriction; Vasodilator Agents