cardiovascular-agents and edifoligide

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

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