Outcomes of open and endovascular lower extremity revascularization in active smokers with advanced peripheral arterial disease.

Concern over perioperative and long-term durability of lower extremity revascularizations among active smokers is a frequent deterrent for vascular surgeons to perform elective lower extremity revascularization. In this study, we examined perioperative outcomes of lower extremity endovascular (LEE) revascularization and open lower extremity bypass (LEB) in active smokers with intermittent claudication (IC) and critical limb ischemia (CLI). Active smokers undergoing LEE or LEB from 2011 to 2014 were identified in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) targeted vascular data set. Patient demographics, comorbidities, anatomic features, and perioperative outcomes were compared between LEE and LEB procedures. Subgroup analysis was performed for patients undergoing revascularization for IC and CLI independently. From 2011 to 2014, 4706 lower extremity revascularizations were performed in active smokers (37% of all revascularizations). In this group, 1497 were LEE (55.6% for CLI, 13.4% for below-knee pathology) and 3209 were LEB (68.9% CLI, 34.7% below-knee). Patients undergoing LEE had higher rates of female gender, hypertension, end-stage renal disease, and diabetes (all P ≤ .02). LEE patients also had a higher frequency of prior percutaneous interventions (22.7% vs 17.2%; P < .01) and preoperative antiplatelet therapy (82.3% vs 78.7%; P = .02). On risk-adjusted multivariate analysis, LEE patients had higher need for reintervention on the treated arterial segment than LEB (5.1% vs 5.2%; odds ratio [OR], 1.52; 95% confidence interval [CI], 1.08-2.13; P = .02) but had lower wound complications (3.1% vs 13.2%; OR, 0.32; 95% CI, 0.23-0.45; P < .01) and no statistically significant difference in 30-day mortality (0.6% vs 0.9%), myocardial infarction or stroke (1.1% vs 2.6%), or major amputation (3.2% vs 2.1%) in the overall cohort of active smokers. In the IC subgroup, myocardial infarction or stroke was significantly higher in the LEB group (1.9% vs 0.6%; OR, 1.83; 95% CI, 1.17-1.97; P = .03), although no difference was found in the CLI subgroup (2.8% vs 1.4%; OR, 0.75; 95% CI, 0.37-1.52; P = .42,). Also in IC group, there was a trend for lower major amputation rates ≤30 days in the LEE group, whereas in the CLI group, LEE had a trend toward higher risk of early amputation compared with LEB. In active smokers, LEB for IC and CLI requires fewer reinterventions but is associated with a higher rate of postoperative wound complications compared with LEE revascularization. However, the risk for limb amputation is higher in actively smoking patients when treated by LEE compared with LEB for CLI. Importantly, cardiovascular complications are significantly higher in actively smoking patients with IC undergoing LEB compared with LEE. This additional cardiovascular risk should be carefully weighed when proposing LEB for actively smoking patients with nonlimb-threatening IC.

Chen SL ，Whealon MD ，Kabutey NK ，Kuo IJ ，Sgroi MD ，Fujitani RM ... -  《-》

Comparison of open and endovascular treatment of patients with critical limb ischemia in the Vascular Quality Initiative.

There is significant controversy in the management of critical limb ischemia (CLI) arising from infrainguinal peripheral arterial disease. We sought to compare practice patterns and perioperative and long-term outcomes for patients undergoing lower extremity bypass (LEB) and percutaneous vascular interventions (PVIs) for CLI in the Vascular Quality Initiative (VQI). The prospectively collected VQI (2010-2013) LEB and PVI databases were retrospectively queried. Demographics, comorbidities, and perioperative outcomes were recorded. We evaluated all patients (cohort 1), those without comorbidities known to increase surgical risk (cohort 2) to control for patient factors, and patients with treatment anatomically limited to the superficial femoral artery (cohort 3) to control for anatomic factors. Multivariable analyses were performed to identify predictors of outcomes. There were 7897 patients with CLI and infrainguinal peripheral arterial disease, 4838 treated with PVI and 3059 with LEB. PVI patients had more comorbidities across all cohorts, whereas those undergoing LEB were more likely to have had a previous revascularization procedure. Follow-up at 1 year was 45.8% for PVI and 53.5% for LEB. After adjustment for comorbidities, cohort 1 patients treated with PVI vs LEB had lower odds of in-hospital or 30-day mortality (odds ratio [OR], 0.59; 95% confidence interval [CI], 0.43-0.81; P = .001). This difference was not seen for the lower risk (cohort 2) patients (OR, 0.66; 95% CI, 0.39-1.14; P = .134) or the superficial femoral artery-only (cohort 3) patients (OR, 1.25; 95% CI, 0.53-2.96; P = .604). The 3-year mortality was higher with PVI in cohort 1 (HR, 1.23; 95% CI, 1.07-1.42; P = .003) and cohort 2 (HR, 1.63; 95% CI, 1.32-2.02; P < .001) but not cohort 3 (HR, 1.18; 95% CI, 0.82-1.71; P = .368). Amputation or death at 1 year was similar for PVI vs LEB in cohort 1 (HR, 0.98; 95% CI, 0.82-1.16; P = .816), cohort 2 (HR, 0.89; 95% CI, 0.7-1.15; P = .37), and cohort 3 (HR, 1.67; 95% CI, 0.86-3.2; P = .13). Major adverse limb event or death was lower for PVI at 1 year in cohort 1 (HR, 0.81; 95% CI, 0.72-0.91; P < .001) and cohort 2 (HR, 0.83; 95% CI, 0.71-0.97; P = .02) but not in cohort 3 (HR, 1.25; 95% CI, 0.85-1.84; P = .259). Length of stay for PVI was lower in all cohorts. In the VQI, PVI was more frequently offered to patients who were older and had more comorbidities, and LEB patients were more likely to have a history of previous interventions. Patients treated with PVI had lower perioperative mortality overall, although this benefit was not seen when treating patients with fewer comorbidities or less advanced disease. However, PVI patients had higher adjusted 3-year mortality in the overall sample and in lower-risk patients. Limitations to this study, especially the follow-up, hamper meaningful interpretation of reinterventions and further reinforce the need for large, randomized, clinical studies with better long-term follow-up.

Siracuse JJ ，Menard MT ，Eslami MH ，Kalish JA ，Robinson WP ，Eberhardt RT ，Hamburg NM ，Farber A ，Vascular Quality Initiative ... -  《-》

Major adverse limb events and major adverse cardiac events after contemporary lower extremity bypass and infrainguinal endovascular intervention in patients with claudication.

Major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs) at 30 days provide standardized metrics for comparison and have been adopted by the Society for Vascular Surgery's objective performance goals for critical limb ischemia. However, MALEs and MACEs have not been widely adopted within the claudication population, and the comparative outcomes after lower extremity bypass (LEB) and infrainguinal endovascular intervention (IEI) remain unclear. The purpose of this study was to compare MALEs and MACEs after LEB and IEI in a contemporary national cohort and to determine predictors of MALEs and MACEs after revascularization for claudication. A national data set of LEB and IEI performed for claudication was obtained using National Surgical Quality Improvement Program vascular targeted Participant Use Data Files from 2011 to 2014. Patients were stratified by LEB vs IEI and compared by appropriate univariate analysis. The primary outcomes were MALE (defined as untreated loss of patency, reintervention on the index arterial segment, or amputation of the index limb) and MACE (defined as stroke, myocardial infarction, or death). Multivariable logistic regression was used to identify predictors of MALEs and MACEs. A total of 3925 infrainguinal revascularization procedures (2155 LEB and 1770 IEI) were performed for claudication. There was no difference in 30-day MALEs between LEB and IEI (4.0% vs 3.2%; P = .17). On multivariable logistic regression, predictors of 30-day MALEs included tibial revascularization (odds ratio [OR], 2.2; P < .0001) and prior LEB on the same arterial segment (OR, 1.8; P = .004). LEB had significantly higher 30-day MACEs (2.0% vs 1.0%; P = .01) but similar mortality (0.5% vs 0.4%; P = .6). Predictors of MACEs included LEB vs IEI (OR, 2.1; P = .01), chronic obstructive pulmonary disease (OR, 2.2; P = .01), dialysis dependence (OR, 4.4; P = .003), and diabetes (OR, 1.9; P = .02). In this large national cohort, LEB and IEI for claudication are associated with similar 30-day MALEs. Tibial revascularization and revascularization after prior failed bypass predict MALEs in claudicants and should therefore be undertaken with caution. LEB was associated with more 30-day MACEs but comparable 30-day mortality compared with IEI. Patients with end-stage renal disease, chronic obstructive pulmonary disease, and diabetes are at high risk for MACEs. The risk of 30-day MACEs after LEB should be weighed against the longer term outcomes of LEB vs IEI and conservative management, particularly in these higher risk patients. This analysis helps define contemporary 30-day outcomes after infrainguinal revascularization performed for claudication and serves as a baseline with which the short-term outcomes of future treatments can be compared.

Fashandi AZ ，Mehaffey JH ，Hawkins RB ，Kron IL ，Upchurch GR Jr ，Robinson WP ... -  《-》

Comparison of open and endovascular procedures in patients with critical limb ischemia on dialysis.

Peripheral artery disease is a common comorbidity in patients with end-stage renal disease (ESRD), but there is a paucity of data comparing outcomes of different interventions in this group of patients. In this study, we examined perioperative outcomes of lower extremity endovascular revascularization (ER) and open revascularization (OR) in dialysis patients with critical limb ischemia (CLI). Patients on dialysis and undergoing ER and OR for CLI from 2011 to 2015 were identified in the American College of Surgeons National Surgical Quality Improvement Program dataset. Patient demographics, comorbidities, anatomic features, and perioperative outcomes were compared between ER and OR procedures. From 2011 to 2015, 1021 lower extremity revascularizations were performed in dialysis patients with CLI. In this group, 535 were ER (53%) and 486 were OR (47%) procedures. Although demographic characteristics such as age and gender were similar between the two groups, there was a higher proportion of Caucasians and African Americans in the OR group. Patients undergoing open and endovascular procedures had similar rates of hypertension, congestive heart failure, diabetes, chronic obstructive pulmonary disease, and bleeding disorders. A minority of procedures (4%) were emergencies, which were distributed equally between the two groups. Preoperative aspirin usage was higher in the ER group (84% vs 78%; P = .024), beta-blocker use was higher in the OR group (79% vs 74%; P = .08), and statin use was similar between the two groups (72% in OR and 70% in ER; P = .54). On risk-adjusted multivariate analysis, OR was associated with a lower rate of major amputation (5.97% vs 11.78%; odds ratio, 0.48; 95% confidence interval [CI], 0.26-0.85), but a higher rate of postoperative bleeding (29.6% vs 8.97%; odds ratio, 2.86; 95% CI, 1.8-4.35) and wound complications (15% vs 3%; odds ratio, 4.5; 95% CI, 2.38-8.3). The 30-day mortality and cardiovascular morbidity were similar between the two groups. In patients with ESRD with CLI, OR is associated with a lower risk of major limb amputation but a higher rate of postoperative wound complications and bleeding, compared with ER. Cardiovascular complications, 30-day mortality, reinterventions and readmissions were similar between the two groups. In patients with ESRD with CLI, OR should be considered as an option for limb salvage if feasible. Long-term outcomes comparing the two types of procedures are needed.

Ramanan B ，Jeon-Slaughter H ，Chen X ，Modrall JG ，Tsai S ... -  《-》

Clinical outcomes of bypass-first versus endovascular-first strategy in patients with chronic limb-threatening ischemia due to infrageniculate arterial disease.

Chronic limb-threatening ischemia (CLTI), defined as ischemic rest pain or tissue loss secondary to arterial insufficiency, is caused by multilevel arterial disease with frequent, severe infrageniculate disease. The rise in CLTI is in part the result of increasing worldwide prevalence of diabetes, renal insufficiency, and advanced aging of the population. The aim of this study was to compare a bypass-first with an endovascular-first revascularization strategy in patients with CLTI due to infrageniculate arterial disease. We reviewed the American College of Surgeons National Surgical Quality Improvement Program targeted lower extremity revascularization database from 2012 to 2015 to identify patients with CLTI and isolated infrageniculate arterial disease who underwent primary infrageniculate bypass or endovascular intervention. We excluded patients with a history of ipsilateral revascularization and proximal interventions. The end points were major adverse limb event (MALE), major adverse cardiovascular event (MACE), amputation at 30 days, reintervention, patency, and mortality. Multivariable logistic regression was used to determine the association of a bypass-first or an endovascular-first intervention with outcomes. There were 1355 CLTI patients undergoing first-time revascularization to the infrageniculate arteries (821 endovascular-first revascularizations and 534 bypass-first revascularizations) identified. There was no significant difference in adjusted rate of 30-day MALE in the bypass-first vs endovascular-first revascularization cohort (9% vs 11.2%; odds ratio [OR], 0.73; 95% confidence interval [CI], 0.50-1.08). However, the incidence of transtibial or proximal amputation was lower in the bypass-first cohort (4.3% vs 7.4%; OR, 0.60; CI, 0.36-0.98). Patients with bypass-first revascularization had higher wound complication rates (9.7% vs 3.7%; OR, 2.75; CI, 1.71-4.42) compared with patients in the endovascular-first cohort. Compared with the endovascular-first cohort, the incidence of 30-day MACE was significantly higher in bypass-first patients (6.9% vs 2.6%; adjusted OR, 3.88; CI, 2.18-6.88), and 30-day mortality rates were 3.23% vs 1.8% (adjusted OR, 2.77; CI, 1.26-6.11). There was no difference in 30-day untreated loss of patency, reintervention of treated arterial segment, readmissions, and reoperations between the two cohorts. In subgroup analysis after exclusion of dialysis patients, there was also no significant difference in MALE or amputation between the bypass-first and endovascular-first cohorts. CLTI patients with isolated infrageniculate arterial disease treated by a bypass-first approach have a significantly lower 30-day amputation. However, this benefit was not observed when dialysis patients were excluded. The bypass-first cohort had a higher incidence of MACE compared with an endovascular-first strategy. These results reaffirm the need for randomized controlled trials, such as the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL-2) trial and Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI), to provide level 1 evidence for the role of endovascular-first vs bypass-first revascularization strategies in the treatment of this population of challenging patients.

Dayama A ，Tsilimparis N ，Kolakowski S ，Matolo NM ，Humphries MD ... -  《-》