Outcomes after endovascular aneurysm repair conversion and primary aortic repair for urgent and emergency indications in the Society for Vascular Surgery Vascular Quality Initiative.

OBJECTIVE: Open conversion after endovascular aortic aneurysm repair (EVAR-c) is performed nonelectively in up to 60% of cases. EVAR-c has been reported to have significantly greater risk of postoperative morbidity and mortality than primary aortic repair, but few data exist on outcomes for symptomatic or ruptured presentations. This study determined outcomes and identified predictors of postoperative major adverse cardiac events (MACEs) and mortality for patients undergoing nonelective EVAR-c compared with nonelective primary aortic repair (PAR) in the Vascular Quality Initiative (VQI). METHODS: All VQI patients undergoing urgent/emergency EVAR-c or urgent/emergency PAR from 2002 to 2014 were reviewed. Urgent presentation was defined by repair ≤24 hours of a nonelective admission, and emergency operations had clinical or radiographic evidence, or both, of rupture. End points included in-hospital MACE (myocardial infarction, dysrhythmia, congestive heart failure) and 30-day mortality. Possible covariates identified on univariate analysis (P < .2) were entered into a multivariable model, and stepwise elimination identified the best subset of predictors. Generalized estimating equations logistic regression analysis was used to determine the relative effect of EVAR-c compared with PAR on outcomes. RESULTS: During the study interval, we identified 277 EVAR-c, and 118 (43%) underwent urgent/emergency repair. nonelective PAR was performed in 1388 of 6152 total (23%). EVAR-c patients were older (75 ± 9 vs 71 ± 10 years; P < .0001), more likely to be male (84% vs 74%; P = .02), and had a higher prevalence of hypertension (88% vs 79%; P = .02) and coronary artery disease (38% vs 27%; P = .01). No differences in MACE (EVAR-c, 31% [n = 34] vs PAR, 30% [n = 398]) or any major postoperative complication (EVAR-c, 57% [n = 63] vs PAR, 55% [n = 740]; P = .8) were found; however, 30-day mortality was significantly greater in EVAR-c (37% [n = 41]) than in (PAR, 24% [n = 291]; P = .003), with an odds ratio (OR) of 2.2 (95% confidence interval [CI], 1.04-4.77; P = .04) for EVAR-c. Predictors of any MACE included age (OR, × 1.03 for each additional year; 95% CI, 1.01-1.03; P = .0002), male gender (OR, 1.3; 95% CI, 1.03-1.67; P = .03), body mass index ≤20 kg/m2 (OR, 1.8; 95% CI, 1.13-2.87; P = .01), chronic obstructive pulmonary disease (OR, 1.2; 95% CI, 0.86-1.80; P = .25), congestive heart failure (OR, 1.5; 95% CI, 0.98-2.34; P = .06), preoperative chronic ß-blocker use (OR, 1.3; 95% CI, 0.97-1.63; P = .09), and emergency presentation (OR, 2.3; 95% CI, 1.8-3.01; area under the curve, 0.70; P < .0001). Significant predictors for 30-day mortality were age (OR × 1.07 for each additional year; 95% CI, 1.05-1.09; P < .0001), female gender (OR, 1.6; 95% CI, 1.01-2.46; P = .04), preoperative creatinine >1.8 mg/dL (OR, 1.6; 95% CI, 1.04-2.35; P = .03), an emergency presentation (OR, 4.8; 95% CI, 2.93-7.93; P < .0001), and renal/visceral ischemia (OR, × 1.1 for each unit increase log (time-minutes); 95% CI, 1.02-1.22; area under the curve, 0.84; P = .01). CONCLUSIONS: Nonelective EVAR-c patients are older and have higher prevalence of cardiovascular risk factors than PAR patients. Similar rates of postoperative complications occur; however, urgent/emergency EVAR-c has a significantly higher risk of 30-day mortality than nonelective PAR. Several variables are identified that predict outcomes after these repairs and may help risk stratify patients to further inform clinical decision making when patients present nonelectively with EVAR failure.

Clinical consequence of bare metal stent and stent graft failure in femoropopliteal occlusive disease.

OBJECTIVE: The optimal role for bare metal stents (BMS) or stent grafts (SG) in femoropopliteal occlusive disease (FPOD) is as of yet undefined. Understanding the clinical consequences of failure can help guide initial treatment decisions. The goal of this study was to define the nature, frequency, and risk factors for adverse clinical events related to BMS and SG failure in FPOD. METHODS: This is a single-institution retrospective review of primary endovascular interventions for FPOD using either a BMS or SG, from September 2007 through October 2011. Patients were excluded if they had any previous lower extremity interventions. Patient demographics, indications for intervention, anatomic characteristics, procedural details, clinical outcomes, and reintervention details were reviewed. Clinical outcomes included the composite end point of any reintervention, amputation, or stenosis, acute limb ischemia (ALI), and the composite end point of major adverse limb events, which included a need for bypass, thrombolysis, or major amputation. RESULTS: Seventy-one limbs were treated with BMS and 63 with SG. Although patient demographics were largely similar between cohorts, key differences included indication for intervention (percent claudication BMS vs SG, 34/71 (48%) vs 42/63 (67%); P < .05) and the TransAtlantic Inter-Society Consensus II classification of lesions in the claudicant subgroup (TransAtlantic Inter-Society Consensus D BMS vs SG, 4/34 (12%) vs 17/42 (40%); P < .01). Freedom from reintervention at 1 year was better in the SG group (75% vs 64%; hazard ratio, 0.46; 95% confidence interval, 0.25-0.78; P < .01). Freedom from major adverse limb events was not different between groups; however, SG thrombosis resulted in a more frequent need for thrombolysis. On multivariate analysis, treating with a BMS vs SG was a significant predictor for freedom from thrombolysis (hazard ratio, 0.53; confidence interval, 0.37-0.76; P < .01). ALI during follow-up was seen only in the SG group (nine vs zero events, log- rank; P < .02). CONCLUSIONS: Failure modes of BMS and SG used to treat FPOD differ, and the clinical consequences may not be benign. Claudicants may not revert back to claudication with treatment failure. Although the overall reintervention rate at 1 year is lower for SG compared to BMS, we observed a higher rate of ALI and need for thrombolysis with SG failure. In light of these differential risks of treatment failure, we believe that the use of SG as initial therapy for FPOD should be carefully deliberated and mandates close postoperative surveillance.

Risk factors for clinical failure after stent graft treatment for femoropopliteal occlusive disease.

OBJECTIVE: Optimal selection of a revascularization strategy in femoropopliteal occlusive disease (FPOD) remains controversial. Among endovascular treatment options for FPOD, covered stent placement has become increasingly used. We sought to examine the influence of clinical, anatomic, and device-related characteristics on the clinical performance of these devices. METHODS: This was a retrospective, single-center study of consecutively treated limbs that underwent Viabahn (W. L. Gore, Flagstaff, Ariz) stent graft placement for FPOD from 2005 to 2010. Clinical, anatomic, and device-related characteristics were obtained from review of medical records and angiograms. End points were occurrence of any reintervention, major adverse limb event (eg, major amputation, thrombolysis/thrombectomy, or open bypass surgery), or thrombolysis/thrombectomy treatment alone. Univariate predictors were calculated and multivariate models constructed for each clinical end point using Cox proportional hazards models. RESULTS: The study cohort included 87 limbs in 77 unique patients, with a median follow-up time of 382 days. The indication for intervention was claudication in 56%. In 25 cases (29%), the index procedure was a secondary intervention for FPOD, including treatment of in-stent restenosis in 22 cases (25%). Lesions treated included 45% TransAtlantic Inter-Society Consensus (TASC) II D and 58% chronic total occlusions. The observed Kaplan-Meier 1-year event rates for reintervention, major adverse limb event (MALE), and thrombolysis were 43%, 28%, and 17%, respectively. MALE occurred in 18 patients, nine of whom presented with acute limb ischemia; no patient underwent major amputation. Univariate predictors of negative outcomes included lack of dual-antiplatelet usage, advanced TASC II classification, smaller implant diameter, increased number of devices used, longer total implant length, and coverage of a patent distal collateral vessel. Multivariate analysis demonstrated that the presence of dual-antiplatelet usage was protective against all three outcomes, 5-mm device diameter was a risk factor for both reintervention and MALE, and the use of multiple devices and distal collateral coverage were significant risk factors for thrombolysis events. CONCLUSIONS: Reintervention is common in the first year after Viabahn placement for FPOD, with more than half of the events being a MALE. Procedural factors such as antiplatelet therapy, stent graft diameter, implant length/number, and distal collateral coverage are strongly associated with adverse clinical outcomes. These factors should be carefully considered to optimize patient selection and intraoperative decision making for this procedure.

Management of infrapopliteal peripheral arterial occlusive disease.

OPINION STATEMENT: The management of infrapopliteal peripheral arterial occlusive disease (PAD) is challenging. For patients with asymptomatic disease or claudication, exercise and optimal medical management, including antiplatelet agents, blood pressure control, statin therapy and tight glucose control for patients with diabetes mellitus, are the mainstays of therapy. However, patients with isolated tibial artery occlusive disease often have diabetes mellitus or renal insufficiency and present with critical limb ischemia (CLI). CLI is advanced occlusive disease marked by the development of rest pain, ischemic ulceration, or gangrene and is associated with a high mortality rate. Limb salvage requires an intervention in cases of CLI, but careful operative planning is required as patients often have multilevel disease and limited options for revascularization. A surgical bypass with a vein graft remains the best treatment for infrapopliteal PAD, especially in patients with a life expectancy of over 2 years. Balloon angioplasty can play an important role in limb salvage, especially for patients lacking adequate vein for bypass, at high operative risk, or with a life expectancy of less than 2 years. However, a lack of rigorous trials has left unanswered questions as to the efficacy of infrapopliteal angioplasty with or without stents compared to bypass surgery. As such, endovascular therapy is currently not a proven treatment for intermittent claudication. Patients who are unable to undergo a revascularization procedure for infrapopliteal CLI have few options besides amputation or palliation. New therapies, such as drug-eluting stents, drug-coated balloons, and stem cell therapy are under development, but their efficacy and effectiveness remain unproven.