nitinol and Coronary-Artery-Disease

The first stent implanted in the human coronary circulation was a self-expandable (SE) stent and was introduced almost simultaneously with the first balloon-expandable (BE) stents in the late 1980s. Nowadays, the majority of the available stents are delivered by balloon expansion. While BE stents reach their final size at the time of implantation, the SE stent continues to enlarge days to weeks after implantation. Potential advantages of the self-expandable and self-apposing properties of nitinol stents, a super-elastic metallic alloy of nickel and titanium, could be reduction of acute and late acquired stent malapposition with a subsequently decreased risk of target vessel restenosis. Several nitinol stents have been developed and clinically evaluated and are now in use in daily clinical practice. However, it is important to further improve and optimize the SE stent design and apply newer strategies to the development of next generation SE stents. The present review will provide an overview of the development of these devices and the currently available clinical evidence of the contemporary SE stents.

Topics: Alloys; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Stents; Time Factors

The aim of this study was to evaluate the Sparrow sirolimus-eluting stent (Sparrow-SES) against the Sparrow bare-metal stent (Sparrow-BMS) and conventional balloon-expandable bare-metal stent (BMS: Driver/Micro-Driver stent, Medtronic Vascular, Santa Rosa, CA).. The Sparrow stent (Biosensors International, Singapore) consists of a guide wire-based, self-expandable, ultra-thin nitinol stent. The performance of this device with sirolimus in a fully biodegradable polymer has not been determined.. A total of 74 patients were included in this intravascular ultrasound (IVUS) sub-study of the CARE II trial, which was a prospective, randomized, multicenter trial in the treatment of single de novo native coronary artery lesions in vessels ranging from 2.0 mm to 2.75 mm in diameter (Sparrow-SES: n = 31, Sparrow-BMS: n = 22, BMS: n = 21).. Stent volume index (VI) was significantly increased 8-month later in Sparrow-SES and Sparrow-BMS, but not in BMS (4.0 ± 1.0 to 4.6 ± 1.0 mm(3) /mm, p<0.0001, 4.0 ± 0.6 to 4.4 ± 0.8 mm(3) /mm, p<0.05, and 5.2 ± 1.0 to 5.1 ± 0.9 mm(3) /mm, p=0.421, respectively). % neointimal obstruction in Sparrow-SES was significantly smaller than those in Sparrow-BMS and BMS at follow-up (17.6 ± 9.4 vs. 36.2 ± 13.8 and 39.9 ± 11.1%, p<0.001). Sparrow-SES showed a mean 15% stent expansion and good suppression of neointimal proliferation, resulting in a significantly lower percentage of change in lumen VI during follow-up period (Sparrow-SES: -6.2 ± 16.2%, Sparrow-BMS: -30.4 ± 11.6%, BMS: -40.4 ± 10.0%, p<0.001).. The self-expanding Sparrow-SES demonstrated chronic stent expansion, good suppression of neointimal proliferation and resulted in a more preserved lumen in stented small vessels compared with the Sparrow-BMS and conventional balloon expandable BMS.

Topics: Aged; Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The aim of the pilot SECRITT trial was to evaluate the safety and feasibility of sealing the high risk IVUS and optical coherence tomography-derived thin cap fibroatheroma (TCFA), with a dedicated nitinol self-expanding vShield device.. After screening with angiography, fractional flow reserve (FFR), intravascular ultrasound virtual histology (IVUS-VH) and optical coherence tomography (OCT), 23 patients met enrolment criteria (presence of non-obstructive VH-derived TCFA lesion with thin cap on OCT) and were randomised to vShield (n=13) versus medical therapy (n=10). In the shielded group, baseline percent diameter stenosis was 33.2±13.5%, FFR was 0.93±0.06. At six-month follow-up in shielded patients percent diameter stenosis further decreased to 18.7±16.9% and FFR remained the same 0.93±0.05. Average late loss was 0.24±0.13 mm. Average baseline fibrous cap thickness was 48±12 µm. After shield placement at six-month follow-up neo-cap formation was observed with average cap thickness of 201±168 µm. There were no dissections after shield placement and no plaque ruptures. In addition, mean stent area of 8.76±2.16 mm2 increased to 9.45±2.30 mm2, that is by 9% at six-month follow-up. The number of malapposed struts decreased from 10.7% to 7.6% and the number of uncovered struts at six months was 8.1%. There were no device-related major adverse cardiovascular events (MACE) events at six-month follow-up.. High risk plaque passivation and sealing with a vShield self-expanding nitinol device appears feasible and safe. A long-term larger randomised study with streamlined screening criteria is needed to evaluate the efficacy of this approach over medical therapy.

Topics: Aged; Aged, 80 and over; Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Feasibility Studies; Female; Fractional Flow Reserve, Myocardial; Humans; Longitudinal Studies; Male; Middle Aged; Percutaneous Coronary Intervention; Pilot Projects; Plaque, Atherosclerotic; Stents; Tomography, Optical Coherence; Ultrasonography, Interventional

Saphenous vein graft patency is frequently limited by degeneration. Experimental studies have indicated that rigid external support of venous grafts by a flexible, tubular nitinol mesh may improve graft patency. The study presented was part of a prospective, randomized, multicenter first-in-man trial investigating the safety and effectiveness of nitinol-supported venous grafts in coronary artery bypass graft (CABG) surgery. From our clinic, 25 subjects with multivessel coronary artery disease requiring saphenous vein graft CABG of the right coronary artery (RCA) and the circumflex artery were entered into the trial. Subjects were randomized to receive a mesh-supported graft on one of these arteries; the other vessel received an untreated vein graft. Graft patency was assessed by coronary angiography nine months after surgery. The implantation of mesh grafts was simple and safe. In 10 cases, a nitinol mesh-supported venous graft was anastomosed to the circumflex artery and in 15 cases to the RCA. All patients survived the observation period. A total of 72% of the patients underwent control coronary angiography. The patency rate of mesh-supported grafts was 27.8% nine months postoperatively. Conventional vein grafts showed an 85.7% patency, and arterial grafts had a 100% patency. No complications directly related to the implantation of mesh-supported grafts were observed. The promising experimental results of mesh-supported venous grafts could not be reproduced in the study presented. A critical item seems to be correct selection of nitinol mesh diameter, the anastomotic method and fixation of the mesh tube to the venous graft.

Topics: Aged; Alloys; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Equipment Design; Female; Germany; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Prospective Studies; Saphenous Vein; Surgical Mesh; Time Factors; Treatment Outcome; Vascular Patency

Earlier generation self-expanding stents (SExS) showed high restenosis rates and long-term stent over-expansion. A novel SExS with reduced outward expansive force has been developed to overcome these limitations. This first-in-human study aimed to evaluate the safety and feasibility of the low pressure self-expanding nitinol-based vProtect™ luminal shield (LS) in the treatment of intermediate coronary lesions.. A total of 29 patients with clinical evidence of myocardial ischaemia and intermediate de novo coronary lesions were included. The LS was deployed after low-pressure balloon pre-dilatation. Acute procedural and device success was achieved in all patients. Angiographic follow-up at nine months showed an in-stent lumen loss of 0.50±0.30 mm and a binary restenosis rate of 10.3%. There were no cases of late LS over-expansion or acute/late malapposition as evaluated by intravascular ultrasound (IVUS). The cumulative major adverse cardiac events (MACE) rate at nine months was 10.3%, consisting of three target lesion revascularisations, with no cases of death, myocardial infarction or stent thrombosis.. Implantation of the LS in non-complex coronary lesions of intermediate severity was feasible, safe, and resulted in low rates of late loss and restenosis. IVUS analysis at nine months showed favourable mechanical properties of the LS without evidence of late device over-expansion.

Topics: Aged; Alloys; Angioplasty, Balloon, Coronary; Colombia; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Feasibility Studies; Female; Humans; Male; Middle Aged; Prospective Studies; Prosthesis Design; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional

To compare the effectiveness and safety of self-expandable, sirolimus-eluting Stentys stents (SES) and second-generation drug-eluting stents (DES-II) for the treatment of the unprotected left main (ULM).. SES may provide a valuable option to treat distal ULM, particularly when significant caliber gaps with side branches are observed.. Patients from the multicenter SPARTA (clinicaltrials.gov: NCT02784405) and FAILS2 registries were included. Propensity-score with matching was performed to account for the lack of randomization. Primary end-point was the rate of major adverse cardiovascular events (MACE, a composite of all cause death, myocardial infarction, target lesion revascularization [TLR], unstable angina and definite stent thrombosis [ST]). Single components of MACE were the secondary end-points.. Overall, 151 patients treated with SES and 1270 with DES-II were included; no differences in MACE rate at 250 days were observed (9.8% vs. 11.5%, P = 0.54). After propensity score with matching, 129 patients treated with SES and 258 with DES-II, of which about a third of female gender, were compared. After a follow-up of 250 days, MACE rate did not differ between the two groups (9.9% vs. 8.5%, P = 0.66), as well as the rate of ULM TLR (1.6% vs. 3.1%, P = 0.36) and definite ST (0.8% vs. 1.2%, P = 0.78). These results were consistent also when controlling for the treatment with provisional vs. 2-stents strategies for the ULM bifurcation.. SES use for ULM treatment was associated with a similar MACE rate compared to DES-II at an intermediate-term follow-up. SES might represent a potential option in this setting.

Topics: Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Comparative Effectiveness Research; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Self Expandable Metallic Stents; Sirolimus; Time Factors; Treatment Outcome

The objective of the study was to retrospectively evaluate the long-term clinical outcome after implantation of the self-expandable (SE) STENTYS stent in a large multicenter cohort.. Incomplete stent apposition is known to cause higher rates of myocardial infarction (MI) and stent thrombosis. Because of its self-expanding features, the SE STENTYS stent adapts to the vessel wall and is therefore expected to minimize malapposition and therefore the rates of MI and stent thrombosis.. Treatment with a total of 351 SE coronary stents was attempted in 314 patients of a cohort from three German institutions between 2011 and 2015. Technical success was achieved with 331/351 (94%) stents. Patients treated successfully with SE stents (n=298) were followed up using the primary outcome measure of target lesion failure (TLF), a combined endpoint of cardiac mortality, recurrent target vessel MI, acute stent thrombosis, and clinically driven target lesion revascularization. Follow-up was complete in 268/298 (90%) patients with a median follow-up period of 2.5 (interquartile range: 1.4-3.3) years.. TLF occurred in 54/298 (18%) patients. Event rates were 7.5% for cardiac mortality, 11.6% for target vessel MI, and 5.2% for clinically driven target lesion revascularization. Acute stent thrombosis occurred in 2/298 (0.7%). Overall, stent thrombosis had an incidence of 2.6% within the follow-up period. ST-elevation MI at baseline (P=0.02) and a dual antiplatelet therapy with clopidogrel for only 6 months (P=0.04) were the only clinical factors linked to the absence of TLF.. Technical success of SE coronary stent implantation in an all-comer cohort of patients was high, although the rate of TLF and stent thrombosis during long-term follow-up was also relatively high.

Topics: Acute Coronary Syndrome; Aged; Alloys; Coronary Artery Disease; Coronary Thrombosis; Female; Germany; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Quality of Life; Recurrence; Retrospective Studies; Risk Factors; Self Expandable Metallic Stents; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

To analyse the patency rates of femoro-popliteal stenting with different self-expandable Nitinol stent-designs.. Two hundred and twenty-two patients (142 (64%) male; age 72.4 ± 11.6 years) with symptomatic femoro-popliteal peripheral arterial occlusive disease (PAOD) underwent percutaneous transluminal angioplasty (PTA) and stenting with three different Nitinol stents (interwoven IW: n = 70; closed-cell CC: n = 85; open-cell OC: n = 67). One-year post-procedural target lesion revascularization (TLR_12M) rates were investigated with regard to co-morbidities: diabetes (DBM), hyperlipidaemia (HLP), hypertension (RR), coronary artery disease (CAD) and degree of calcification.. Twelve-month follow-up data were available for 60, 69 and 50 patients in the IW, OC and CC groups (179 patients in total). The cumulative patency (IW: 52 (86.7%); OC: 50 (72.5%); CC: 23 (46.0%); P < 0.001) and the TLR_12M rates (IW: 8 (13.3%); OC: 19 (27.5%); CC: 27 (54.0%); P < 0.001) differed significantly, as did the subgroup analyses (DBM: P = 0.05; RR: P = 0.003; HLP: P = 0.005; CAD: P = 0.02; localization: P < 0.001; calcification: P < 0.001), with the best patency for the IW stent and the highest TLR_12M for the CC stent.. The interwoven stent-design was superior to the standard open- and closed-cell stent-designs in endovascular treatment of femoro-popliteal PAOD in a follow-up period of 12 months.. • Results of femoro-popliteal stenting are still unsatisfactory. • Comparative studies for currently available different Nitinol stent-designs are lacking. • This is a first comparative study on long-term patency of different Nitinol stent-designs. • Interwoven stent-design leads to improved long-term patency. • Interwoven stent-design leads to lower TLR than other stent-designs.

Topics: Aged; Alloys; Angioplasty; Angioplasty, Balloon; Arterial Occlusive Diseases; Coronary Artery Disease; Female; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Reperfusion; Stents; Treatment Outcome; Vascular Patency

Saphenous vein conduits are still used in a large proportion of coronary artery bypass graft (CABG) operations. A recently commercialized nitinol mesh seems to improve venous graft patency. The aim of this study was to control nitinol mesh vein graft patency in a series of isolated CABG patients by computed tomographic (CT) scan.. In 25 patients (mean age: 61.0 ± 9.65 years), operated for isolated CABG, the eSVS nitinol mesh (Kips Bay Medical Inc., Minneapolis, Minnesota, United States) was used to wrap one vein graft in each patient. Nitinol mesh vein graft was used to revascularize the right coronary (4 patients; 16%), the posterior descending (18 patients; 72%), and the obtuse marginal (3 patients; 12%) arteries. CT scans were performed at 1, 6, and 12 months postoperatively.. The procedure was uneventful in all patients. CT controls showed an overall patency rate of 86.9, 42.7, and 34.1% at 1, 6, and 12 months, respectively. The 4 mm mesh had a significantly higher patency rate at 12 months (83.33%) than the 3.5 mm one which showed quite unsatisfactory results (20%) (p = 0.02). Patients with graft occlusion underwent stress testing which was mildly positive in two cases. One of them underwent a percutaneous revascularization.. Despite promising early results, use of nitinol mesh for saphenous veins was disappointing in our experience. Further refinements are probably needed.

Topics: Aged; Alloys; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Risk Factors; Saphenous Vein; Surgical Mesh; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Vascular Patency

We sought to assess the efficiency of two different sternal closure techniques in preventing sternal wound instability in high-risk patients.. Between January 2009 and February 2012, 2068 consecutive cardiac patients were prospectively collected in our database. The 561 patients in whom the thermoreactive nitilium clips (Flexigrip) have been used (group A) were matched 1 : 1 with 561 patients who received a standard parasternal wiring technique (group B) on 10 available risk factors known to affect sternal wound healing (age, age >75 years, sex, diabetes mellitus, cardiac procedure, obesity, re-intervention, cross-clamp, and total operative times). The study was completed with a cost analysis.. The two groups were well matched, although different for bilateral internal thoracic harvesting, chronic obstructive pulmonary disease, renal insufficiency, and congestive heart failure, which were significantly more frequent in group A. At 30 days of follow-up, the association of wound complication and sternal instability was significantly less frequent in group A versus group B (0.2 versus 1.6%) (P = 0.04). Overall incidence of sternal wound complication was lower in group A (2 versus 3.5%) (P = 0.28). In the presence of wound infection, a sternal wound instability was never observed in group A (P = 0.06). Overall costs were €8,701,854 and €9,243,702 in groups A and B, respectively; thus the Flexigrip closure technique offered a €541,848 cost saving.. Flexigrip use in high-risk patients showed a lower incidence of sternal wound instability with no need for sternal re-wiring in any case, even in the presence of wound infection.

Topics: Aged; Aged, 80 and over; Alloys; Bone Wires; Coronary Artery Disease; Equipment Design; Female; Health Care Costs; Humans; Male; Middle Aged; Prospective Studies; Sternum; Surgical Wound Dehiscence; Surgical Wound Infection; Treatment Outcome; Wound Closure Techniques

Vessel tapering represents an important limitation of the balloon-expandable drug-eluting stent (DES) in the treatment of distal unprotected left main coronary artery (ULMCA) lesions. In this study, we assessed the suitability of the STENTYS DES((P)) , a self-apposing nitinol paclitaxel-eluting stent, for use in the treatment of distal ULMCA lesions.. From February 2012 to September 2013, 75 consecutive patients with tapered (that is a >1 mm difference in the diameter from the proximal to the distal main vessel) distal ULMCA lesions were treated with the STENTYS DES((P)) (STENTYS-DES group) at the Clinica Mediterranea (Naples, Italy). A matched-group of 75 patients treated with second-generation DES in the same period (Control group) was selected from the database of New Tokyo Hospital (Chiba, Japan). The result was assessed by both quantitative coronary angiography and intravascular ultrasound (IVUS). Although the final balloon diameter was larger in the Control group (4.51 ± 0.51 vs. 3.62 ± 0.49 mm; P < 0.001), the IVUS analysis showed a larger final minimal lumen area in the STENTYS-DES group than in the Control group (left main: 17.45 ± 3.45 vs. 14.84 ± 3.45 mm(2) ; P < 0.001; polygon of confluence: 15.74 ± 3.28 vs. 12.55 ± 5.45 mm(2) ; P < 0.002; ostial left anterior descending artery: 11.73 ± 1.97 vs. 8.56 ± 1.80 mm(2) ; P < 0.001). At 12 ± 5 months, major adverse cardiac events (including death, myocardial infarction, and repeat revascularization) occurred in seven patients in both groups.. This pilot study suggests that the self-apposing properties of the STENTYS DES((P)) offer a valid alternative for the treatment of the distal ULMCA lesions.

Topics: Aged; Alloys; Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Italy; Japan; Male; Paclitaxel; Percutaneous Coronary Intervention; Pilot Projects; Treatment Outcome

Coronary bypass grafting remains the best option for patients suffering from multivessel coronary artery disease, and the saphenous vein is used as an additional conduit for multiple complete revascularizations. However, the long-term vein graft durability is poor, with almost 75% of occluded grafts after 10 years. To improve the durability, the concept of an external supportive structure was successfully developed during the last years: the eSVS Mesh device (Kips Bay Medical) is an external support for vein graft made of weft-knitted nitinol wire into a tubular form with an approximate length of 24 cm and available in three diameters (3.5, 4.0 and 4.5 mm). The device is placed over the outer wall of the vein and carefully deployed to cover the full length of the graft. The mesh is flexible for full adaptability to the heart anatomy and is intended to prevent kinking and dilatation of the vein in addition to suppressing the intima hyperplasia induced by the systemic blood pressure. The device is designed to reduce the vein diameter of about 15-20% at most to prevent the vein radial expansion induced by the arterial blood pressure, and the intima hyperplasia leading to the graft failure. We describe the surgical technique for preparing the vein graft with the external saphenous vein graft support (eSVS Mesh) and we share our preliminary clinical results.

Topics: Aged; Alloys; Anastomosis, Surgical; Coronary Artery Bypass; Coronary Artery Disease; Equipment Design; Female; Humans; Male; Middle Aged; Retrospective Studies; Saphenous Vein; Stents; Surgical Mesh; Treatment Outcome; Vascular Patency

We sought to evaluate the pathologic findings of the percutaneous Parachute device implanted in patients with severe heart failure (HF).. Currently, most treatments of HF rest on optimal medical therapy with adjunctive interventional or surgical palliative treatments. One such treatment is the Parachute device, which partitions the left ventricle excluding the scarred myocardium from functioning myocardium, and has shown promise in clinical studies.. We have examined histopathologically seven cases [six males (age range 43–74 years; mean 56 years) and one female (55 years)] of Parachute device that were either retrieved at autopsy (n = 4) or during transplantation (n = 3); implant duration, 15-1,533 days.. Three patients died of cardiac causes and none died from complications. Histologic early changes (<30 days, n = 1) included adherent thrombus, with focal neutrophil infiltration and degenerating inflammatory cells. Over time (31–300 days, n = 4), there was organized thrombus and development of neoendocardial thickening especially at the free-edge of the device and its contact with the adjacent endocardium while the base of the device showed varying degrees of fibrin thrombus. The greatest organization of thrombus was observed in devices removed at >300 days (680 and 1533 days); both had fractures of the foot along with strut fracture and one had tearing of the expanded polytetrafluoroethylene.. The percutaneous Parachute device appears as a promising adjunctive treatment for patients suffering from severe HF. The pathologic changes are those of organizing thrombus with and without inflammation with minor complications of foot and strut fracture.

Topics: Adult; Aged; Alloys; Autopsy; Coronary Artery Disease; Device Removal; Equipment Design; Female; Heart Failure; Heart Transplantation; Heart-Assist Devices; Humans; Male; Middle Aged; Myocarditis; Myocardium; Severity of Illness Index; Thrombosis; Time Factors; Wound Healing

Although durable clinical outcomes have been reported, arterial repair after paclitaxel-coated nitinol drug-eluting stent (Zilver PTX) implantation in the superficial femoral artery (SFA) remains unclear.. Angioscopic evaluation was performed in SFA intra-stent surfaces 80±29 (range, 49-135) days or 84±18 (range, 52-112) days following Zilver PTX (20 stents in 10 patients; mean age, 72±8 years; 40% men) or bare metal stent (BMS; 14 stents in 9 patients; mean age, 70±7 years; 67% men) implantation, respectively. Neointimal coverage (NIC) was graded as 0, stent struts exposed; grade 1, struts bulging into the lumen, but still transparently visible although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous when the NIC grade variation was ≥1. Presence of yellow plaque and thrombus were investigated. Dominant NIC was significantly different between Zilver PTX (grade 0, 35%; grade 1, 20%; grade 2, 25%; grade 3, 20%) and BMS (grade 0, 7%; grade 1, 0%; grade 2, 14%; grade 3, 79%; P=0.001). NIC heterogeneity was less frequently observed in Zilver PTX (40% vs. 86%, P=0.009). Prevalence of yellow plaque or thrombus (75% vs. 79%, P=0.57) or thrombus (75% vs. 79%, P=0.57) were similar between Zilver PTX and BMS.. Early phase arterial repair was different between Zilver PTX and BMS.

Topics: Aged; Aged, 80 and over; Alloys; Angioscopy; Antineoplastic Agents, Phytogenic; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Retrospective Studies

Topics: Aged, 80 and over; Alloys; Coronary Artery Disease; Humans; Male; Prosthesis Design; Stents

Topics: Alloys; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Female; Graft Occlusion, Vascular; Humans; Male; Saphenous Vein; Surgical Mesh

The aim of this study was to evaluate the novel CardioMind Sparrow (CMS) stent (CardioMind, Inc., Sunnyvale, California) against the Multi-Link Pixel (MLP) stent (Guidant Corp., Santa Clara, California) for small vessel percutaneous coronary intervention (PCI).. The CMS consists of a guidewire-based, self-expandable, ultra-thin nitinol stent with smaller profile and improved flexibility and deliverability. The performance of this novel device against a standard balloon-expandable stent for small vessel PCI has not been determined.. Twenty-one patients were treated with the CMS and compared with 30 patients treated with MLP. Only single de novo lesions <14 mm in length, in native vessels of 2.0 to 2.5 mm were included. The primary goal was the comparison of quantitative coronary angiography lumen loss and intravascular ultrasound intimal hyperplasia (IH) formation between groups at 6 months.. Clinical characteristics were similar between groups. The CMS cohort had smaller vessels (2.20 +/- 0.20 mm vs. 2.43 +/- 0.16 mm, p < 0.0001) and shorter lesions (10.86 +/- 3.19 mm vs. 13.12 +/- 2.79 mm, p = 0.0091). Six-month late loss was significantly lower among CMS cohort (0.73 +/- 0.57 mm vs. 1.11 +/- 0.72 mm, p = 0.038). By intravascular ultrasound, 6-month IH volume was similar between groups (1.45 +/- 0.46 mm(3)/mm vs. 1.65 +/- 1.02 mm(3)/mm, p = 0.50). However, CMS presented a mean 13.39% expansion of its volumes, resulting in a significantly lower percentage of IH volumetric obstruction (31.94 +/- 8.19% vs. 39.90 +/- 4.72%, p = 0.0005).. Despite producing similar amounts of IH volume, the self-expanding CMS stent presented chronic expansion of its volumes, better accommodating the neoformed tissue and resulting in significantly lower late loss and percent of IH volumetric obstruction in comparison with the MLP stent.

Topics: Alloys; Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Registries; Stents; Ultrasonography, Interventional

Topics: Aged; Alloys; Angina Pectoris; Coronary Angiography; Coronary Artery Disease; Female; Humans; Internal Mammary-Coronary Artery Anastomosis; Saphenous Vein; Surgical Instruments; Tomography, X-Ray Computed

Distal embolization of plaque particulate liberated during stenting may cause periprocedural complications. The number, size, and volume of debris released during stenting, however, have not been quantified, rendering embolic protection approaches empiric. We used a novel method of microparticle size assessment to measure volume and characterize individual sizes of particles captured by the PercuSurge GuardWire balloon or a vascular filter during saphenous vein graft stenting.. Braided nitinol filters (average distal pore size 100 microns) were used in 47 saphenous vein grafts in 44 patients. The PercuSurge GuardWire was used in 17 saphenous vein grafts in 16 patients. Particulate debris was subjected to microparticle size analysis (RapidVue, Beckman Coulter). All samples contained particulate debris. For both filter and GuardWire populations, most particles were <100 microm in longest dimension (87% and 90% of particles, respectively), and the distribution of particle sizes was identical. Total embolic load per lesion for both filters and GuardWire aspirates was also similar: median embolic load per filter was 16 mm3 (range 2 to 84 mm3). Median embolic load per GuardWire was also 16 mm3 (range 7 to 42 mm3). Histopathologic analysis demonstrated that most samples contained plaque elements and platelet-rich thrombus.. During saphenous vein graft interventions, particulate retrieved with a vascular filtering device or an occlusion balloon was similar in amount and character. This supports the notion that unless soluble mediators play an important role in adverse acute clinical events after stenting, the clinical efficacy of filtering devices may be equal to that of occlusion devices.

Topics: Alloys; Calibration; Catheterization; Coronary Artery Bypass; Coronary Artery Disease; Embolism; Equipment Design; Filtration; Foam Cells; Humans; Intraoperative Complications; Microspheres; Particle Size; Randomized Controlled Trials as Topic; Saphenous Vein; Stents; Suction; Thrombosis