30-day Major Adverse Limb Events Research Articles

Endovascular treatment of femoro‐popliteal occlusions with retrograde tibial access after failure of the antegrade approach

Despite the development in endovascular technologies and the introduction of new tools in clinical practice, the endovascular crossing of femoropopliteal occlusions is not always possible with the antegrade approach, with a failure rate that can be up to 20%. This study aims to assess the feasibility, safety, and efficacy in terms of acute outcome of the endovascular retrograde crossing of femoro-popliteal occlusions with tibial access. This study is a single-centre, retrospective analysis of prospectively collected data of 152 consecutive patients, who had undergone, from September 2015 to September 2022, endovascular treatment of femoro-popliteal arterial occlusions with retrograde tibial access after the failure of the antegrade approach. The median lesion length was 25 cm and 66 patients (43.4%) had a calcium grading according to the peripheral arterial calcium scoring system of 4. Angiographically, 44.7% of the lesions were TASC II category D. In all cases, successful cannulation and sheath introduction were performed with an average cannulation time of 150.4 s. Femoropopliteal occlusions were successfully crossed with the retrograde route in 94.1% of cases; the intimal approach was performed in 114 patients (79.7%). The mean time from puncture to retrograde crossing was 20.5 min. Acute vascular access-site complications were noted in 7 (4.6%) patients. Thirty-day major adverse cardiovascular events rate and 30-day major adverse limb events rate of 3.3% and 2%, respectively, were observed. The results of our study indicate that retrograde crossing of femoro-popliteal occlusions with tibial access is a feasible, effective, and safe approach in case of failed antegrade approach. The results presented represent one of the largest investigations ever published on tibial retrograde access and contribute to the small body of literature present on this topic to date.

Racial and ethnic disparities in 3-year outcomes following infrainguinal bypass for chronic limb-threatening ischemia.

Black and Hispanic patients have had higher rates of chronic limb-threatening ischemia (CLTI) and experienced worse perioperative outcomes after lower extremity bypass compared with White patients. The underlying reasons for these disparities have remained unclear, and data on 3-year outcomes are limited. Therefore, we examined the differences in 3-year outcomes after open infrainguinal bypass for CLTI stratified by race/ethnicity and explored the potential factors contributing to these differences. We identified all CLTI patients who had undergone primary open infrainguinal bypass in the Vascular Quality Initiative registry from 2003 to 2017 with linkage to Medicare claims through 2018 for the 3-year outcomes. Our primary outcomes were the 3-year rates of major amputation, reintervention, and mortality. We also recorded the 30-day major adverse limb events (MALE) defined as major amputation or reintervention. We used Kaplan-Meier estimation methods and multivariable Cox regression analyses to evaluate the outcomes stratified by race/ethnicity and identify contributing factors. Of the 7108 patients with CLTI, 5599 (79%) were non-Hispanic White, 1053 (15%) were Black, 48 (1%) were Asian, and 408 (6%) were Hispanic patients. Compared with White patients, Black patients had higher rates of 3-year major amputation (Black vs White, 32% vs 19%; hazard ratio [HR], 1.9; 95% confidence interval [CI], 1.7-2.2), reintervention (Black vs White, 61% vs 57%; HR, 1.2; 95% CI, 1.1-1.3), and 30-day MALE (Black vs White, 8.1% vs 4.9%; HR, 1.3; 95% CI, 1.2-1.4) but lower mortality (Black vs White, 38% vs 42%; HR, 0.9; 95% CI, 0.8-0.99). Hispanic patients also experienced higher rates of amputation (Hispanic vs White, 27% vs 19%; HR, 1.6; 95% CI, 1.3-2.0), reintervention (Hispanic vs White, 70% vs 57%; HR, 1.4; 95% CI, 1.2-1.6), and MALE (Hispanic vs White, 8.7% vs 4.9%; HR, 1.5; 95% CI, 1.3-1.7. However, mortality was similar between the two groups (Hispanic vs White, 38% vs 42%; HR, 0.88; 95% CI, 0.76-1.0). The low number of Asian patients prevented a meaningful assessment of amputation (Asian vs White, 20% vs 19%; HR, 0.93; 95% CI, 0.44-2.0), reintervention (Asian vs White, 55% vs 57%; HR, 0.79; 95% CI, 0.51-1.2), MALE (Asian vs White, 8.5% vs 4.9%; HR, 0.71; 95% CI, 0.46-1.1), or mortality (Asian vs White, 36% vs 42%; HR, 0.83; 95% CI, 0.52-1.3). In the adjusted analyses, the association of Black race and Hispanic ethnicity with amputation and reintervention was explained by differences in the demographic characteristics (ie, age, sex) and baseline comorbidities (ie, tobacco use, diabetes, renal disease). Compared with White patients, Black and Hispanic patients had higher 3-year major amputation and reintervention rates. However, mortality was lower for Black patients than for the White patients and similar between Hispanic and White patients. Disparities in amputation and reintervention were partly attributable to differences in demographic characteristics and the higher prevalence of comorbidities in Black and Hispanic patients with CLTI. Future work is necessary to determine whether interventions to improve access to care and reduce the burden of comorbidities in these populations will confer limb salvage benefits.

Safety and efficacy outcomes of the Pioneer Plus catheter in endovascular revascularization of lower extremity chronic total occlusions

ObjectiveOur aim was to evaluate the efficacy and safety outcomes of the Pioneer Plus catheter (Philips, San Diego, Calif) and report the in-hospital and 30-day outcomes of lower extremity chronic total occlusion (CTO) interventions assisted by the Pioneer Plus catheter. In addition, we explored the factors associated with procedural success. MethodsWe conducted a retrospective review of 135 consecutive procedures in 116 patients from July 2011 to September 2018 performed by eight operators with various levels of experience at a high-volume center where the Pioneer Plus catheter was used for lower extremity CTO. The patient demographics, preprocedural symptoms, preprocedural testing results, procedural setting, and angiography findings were abstracted. The outcomes were divided into device-related and procedure-related outcomes. Device-related efficacy outcome included procedural success. Device-related safety outcomes included device-related complications. Procedure-related outcomes included procedure-related complications, 30-day major adverse cardiovascular events, and 30-day major adverse limb events. We conducted univariate comparisons of the provider, patient, and procedural characteristics stratified by procedural success. ResultsProcedural success was observed in 118 procedures overall (87.4%), and success rates ≤95.8% were observed for operators with an experience level of >25 devices deployed. No device-related complications, such as pseudoaneurysm formation, vessel perforation, or arteriovenous fistula formation, were observed. The Pioneer Plus catheter was mostly often used for CTO in the superficial femoral and popliteal arteries. Overall, the procedure-related complications included access site hematoma (5.2%), major bleeding (0.7%), pseudoaneurysm formation (0.7%), distal embolization (1.5%), and acute arterial thrombosis (1.5%). The 30-day major adverse limb events included index limb unplanned amputation (0.7%), index limb reintervention (4.4%), and index limb acute limb ischemia (0.7%) and occurred in 5.9% of the procedures. The only factor associated with procedural success was operator experience (P < .0001). ConclusionsThe results from the present study have shown that Pioneer Plus catheter use is safe and effective when used to cross lower extremity CTO. However, further investigation is needed to identify patient- and provider-level factors to optimize patient outcomes.

Drug-Coated Balloon for the Treatment of Femoropopliteal Tosaka Class III In-stent Restenosis Lesions.

Background: To date, there have been few studies examining the efficacy and safety of drug-coated balloon (DCB) angioplasty in the treatment of Tosaka class III in-stent restenosis (ISR) lesions in the clinical setting. Therefore, this study aimed to investigate the clinical efficacy and safety of DCBs in patients with Tosaka class III ISR femoropopliteal lesions.Methods: This single-center study enrolled 28 femoropopliteal ISR Tosaka III patients who were treated by DCB angioplasty from September 2016 to September 2018. The patency, the freedom from target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints were analyzed during a 14-month follow-up period.Results: Out of the 28 patients, 32.1% presented with critical limb ischemia. The mean lesion length was 250.4 ± 93.9 mm. Technical success was achieved in all lesions (100%). Debulking devices were used in 50% of lesions, and bailout stents were performed in 3.6% of patients. Kaplan Meier estimates that the 14-month primary patency was 79.2% (95% CI 60.6–97.8%), whereas the freedom from TLR rate was 91.5% (95% CI 80.1–100%). Clinical symptoms improved by at least 1 Rutherford category in 82.1% of limbs. The ankle-brachial index (ABI) values improved from 0.51 ± 0.30 to 1.05 ± 0.22 at the final follow-up (P < 0.001). The rate of freedom from 30-day major adverse limb events (MALEs) was 100%. The mortality rate was 7.1%.Conclusion: These results suggested that the use of DCBs is safe and effective in treating femoropopliteal Tosaka class III ISR lesions.

Extent of heel ulceration influences the outcomes in patients with isolated infrapopliteal limb threatening critical ischemia

BackgroundThe aim of the present study was to assess the effects of the extent of heel ulceration on the outcomes of limb threatening critical ischemia due to isolated infrapopliteal disease. MethodsA retrospective review identified 989 patients with isolated infrapopliteal disease and heel ulceration treated from 2001 to 2018. The heel was defined as the back of the foot, extending from the Achilles tendon to around the plantar surface and covering the apex of the calcaneum bone. Heel ulceration was categorized into three groups by area: <5 cm2, 5 to 10 cm2, and >10 cm2. The interventions were endovascular, open bypass, major amputation, and wound care. An intention-to-treat analysis by patient group was performed. The 30-day outcomes and amputation-free survival (AFS; survival without a major amputation) were evaluated. ResultsOf the 989 patients, 384 (58% male; average age, 65 years; n = 768 vessels) had undergone isolated endovascular tibial intervention, 124 (45% male; average age, 59 years) had undergone popliteal tibial vein bypass for limb threatening critical ischemia, 219 (52% male; average age, 67 years) had undergone major amputation, and 242 (49% male; average age, 66 years) had received wound care. No difference was found in the 30-day major adverse cardiac events in the endovascular and open bypass groups, with significantly more events in the major amputation group (P = .03). The 30-day major adverse limb events and 30-day amputation rates were equivalent between the open bypass and endovascular groups. The 5-year AFS rate was superior in the open bypass group (37% ± 8%; mean ± standard error of the mean) compared with the endovascular group (27% ± 9%; P = .04). The wound care group had a 5-year AFS rate of 20% ± 9%, which was not significantly different from that of the endovascular group. Patients with heel ulcers of <5 cm2 had better AFS (47% ± 8%) than those with 5- to 10- cm2 heel ulceration (24% ± 9%). Heel ulcers >10 cm2 were associated with markedly worse 5-year AFS outcomes (0% ± 0%). The presence of end-stage renal disease, osteomyelitis, uncontrolled diabetes (hemoglobin A1c >10%), and/or frailty combined with a heel ulcer >10 cm2 were predictive of poor AFS. ConclusionsAn increasing heel ulcer area combined with osteomyelitis and systemic comorbidities was associated with worsening 30-day outcomes and 5-year AFS, irrespective of the therapy chosen.

Impact of the Timing of Foot Tissue Resection on Outcomes in Patients Undergoing Revascularization for Chronic Limb-Threatening Ischemia.

The objective of this study is to describe utilization of revascularization and tissue resection in patients with chronic limb-threatening ischemia (CLTI) and determine whether the timing of resection impacts outcomes. Revascularizations for CLTI were queried (ACS-NSQIP 2011-2015). Outcomes included 30-day major adverse limb events (MALE), major adverse cardiac events (MACE), length of stay (LOS), operative time, 30-day readmissions, and wound infections. Groups included revascularization alone, revascularization/tissue resection during the same procedure (concurrent), or revascularization/delayed tissue resection (delayed). Resections were debridement or transmetatarsal amputations. Multivariate logistic regression determined risk-adjusted effects of tissue resection on outcomes. There was no difference in overall 30-day MACE or MALE between groups (P = .70 and P = .35, respectively). Length of stay (6.1 days revascularization alone vs 7.8 days concurrent vs 8.7 days delayed, P < .0001) was longer in patients who underwent any tissue resection. Highest 30-day readmission and operative time was the concurrent group (P = .02 and P < .0001, respectively). Wound infection was highest in the delayed group (1.4% revascularization alone vs 1.3% concurrent vs 6.2% delayed, P < .0001). After risk adjustment, timing of resection did not impact LOS for concurrent and delayed groups compared to revascularization alone (both P < .0001). Debridement and minor amputations can be done concurrently in patients undergoing revascularization for CLTI.

Outcomes after Open Lower Extremity Revascularization in Patients with Critical Limb Ischemia

For decades, open intervention was the treatment of choice in patients requiring lower extremity revascularization. In the endovascular era, however, open and endovascular revascularization are options. The implications of prior revascularization on the outcomes for subsequent revascularization are not known. In the present study, we evaluated 30-day outcomes after open lower extremity revascularization for critical limb ischemia (CLI) in those who had previous interventions. The 2012-2017 open lower extremity bypass Participant User Data Files from the National Surgical Quality Improvement Program were used to identify a cohort of patients with CLI. Patients whose operation was considered emergent were excluded from the analysis. Patients were stratified on whether they had a previous open or endovascular intervention or undergoing a primary revascularization. The primary outcome measure was 30-day major adverse limb events (MALEs). Secondary outcomes included major adverse cardiac events (MACEs) and wound complications. A total of 12,668 patients met study criteria with 59.6% (n=7,549) undergoing a primary open revascularization, 22.4% (n=2,839) having a prior endovascular intervention, and 18.0% (n=2,280) having a prior open revascularization. There were notable differences in the baseline characteristics between the 3 groups. In addition, there were differences in the reason for intervention (rest pain versus tissue loss), type of revascularization, and type of conduit used between the 3 groups. After adjustment, a prior open revascularization was significantly associated with 30-day MALE when compared with a primary revascularization (adjusted odds ratio, 1.69; 95% confidence interval, 1.47-1.94; P<0.001) and prior endovascular intervention (adjusted odds ratio, 1.76; 95% confidence interval, 1.46-2.12; P<0.001). There were no differences in outcomes between primary revascularization and prior endovascular patients. There were no differences between MACEs or wound complications between the 3 groups. A prior endovascular intervention does not seem to accrue any additional short-term risk when compared with primary revascularization, suggesting an endovascular-first approach may be a safe strategy in patients with CLI. However, a prior open intervention is significantly associated with 30-day MALE in patients undergoing redo open revascularization, which may be related to the rapid decline in patients once they have exhausted their best open revascularization option.

Percutaneous Deep Venous Arterialization for Severe Critical Limb Ischemia in Patients With No Option of Revascularization: Early Experience From Two European Centers.

To report our initial experience of fully percutaneous deep venous arterialization (pDVA) for the treatment of chronic critical limb ischemia (cCLI) after failed distal angioplasty. pDVA was performed in five consecutive patients by creating an arteriovenous fistula (AVF) between a below the knee artery and its satellite deep vein. In this early experience, only patients with failed prior interventional attempts at establishing flow with no distal targets for an arterial bypass were selected. Early technical success was defined as successful AVF creation and retrograde venous perfusion of the wound site. Patient demographics, procedural details, morbidity/mortality and wound healing outcomes were assessed prospectively. Patients were followed up in wound care centers, and graft patency was documented on duplex ultrasound. All five consecutive patients (mean age 58years) underwent successful pDVA without any procedural complications. There were neither 30-day major adverse limb events nor major cardiovascular complications. Three out of the five patients (60%) had clinical improvement as observed by resolution of rest pain and complete wound healing. At the 1-month FU, one patient died and one patient received a major amputation. The median wound healing time was 39weeks. pDVA is a safe and feasible vascularization alternative in patients with end-stage/no-option CLI. The early experience highlights the need for a multidisciplinary approach including a dedicated wound care service.

Lower extremity bypass and endovascular intervention for critical limb ischemia fail to meet Society for Vascular Surgery's objective performance goals for limb-related outcomes in a contemporary national cohort

ObjectiveIn 2009, the Society for Vascular Surgery (SVS) developed objective performance goals (OPGs) to define the therapeutic benchmarks in critical limb ischemia (CLI) based on outcomes from randomized trials of lower extremity bypass (LEB). Current performance relative to these benchmarks in both LEB and infrainguinal endovascular intervention (IEI) remains unknown. The objective of this study was to determine whether LEB and IEI performed for CLI in a contemporary national cohort met OPG 30-day safety thresholds. MethodsSVS OPG criteria were applied to 11,043 revascularizations for CLI performed from 2011 to 2015 in the National Surgical Quality Improvement Program (NSQIP) vascular targeted modules. Primary 30-day safety OPGs including major adverse cardiovascular events (MACEs), major adverse limb events (MALEs), and amputation were calculated for the NSQIP LEB (n = 3833) and IEI (n = 3526) cohorts as well as for subgroups at “high anatomic risk” (infrapopliteal revascularization) and “high clinical risk” (age >80 years and tissue loss). These were compared with SVS OPG benchmarks using χ2 comparisons. ResultsCompared with the SVS OPG cohort, both the NSQIP LEB and IEI cohorts had fewer patients at high anatomic risk (LEB, 51%; IEI, 27%; SVS OPG, 60%; both P < .0001). The LEB cohort had fewer patients with high clinical risk than the SVS OPG cohort (LEB, 11%; SVS OPG, 16%; P < .0001). The 30-day MALE was significantly higher in the NSQIP LEB (9.0% [8.7%-9.2%]) and IEI (9.7% [9.4%-10.0%]) cohorts compared with the SVS OPG cohort (6.1% [4.7%-9.0%]; both P ≤ .007), including significantly higher rates of amputation. MACE was significantly lower in the NSQIP LEB (4.2% [4.1%-4.3%]) and IEI (3.1% [3.0%-3.2%]) cohorts compared with the SVS OPG cohort (6.1% [4.7%-8.1%]; both P ≤ .013). Among patients at high anatomic risk, 30-day MALE was significantly higher after LEB (9.5% [9.1%-9.8%]) and IEI (11.1% [10.4-11.8%]) compared with the SVS OPG cohort (6.1% [4.2%-8.6%]; P ≤ .002). Among patients with high clinical risk, IEI was associated with lower MACE compared with the SVS OPG cohort, with similar limb-related outcomes. ConclusionsIn contemporary real-world practice, LEB and IEI for CLI failed to meet SVS OPG limb-related 30-day safety benchmarks for the entire CLI cohort as well as for the patients at high anatomic risk. Additional investigation using SVS OPGs as consistent end points is required to determine why limb-related outcomes after revascularization for CLI remain suboptimal. LEB and IEI surpassed OPG benchmarks for 30-day cardiovascular morbidity and mortality. OPGs for cardiovascular morbidity in patients undergoing revascularization for CLI deserve re-evaluation using contemporary data.

Adventitial Drug Delivery of Dexamethasone to Improve Primary Patency in the Treatment of Superficial Femoral and Popliteal Artery Disease: 12-Month Results From the DANCE Clinical Trial

ObjectivesThis study was designed to evaluate outcomes of adventitial dexamethasone delivery adjunctive to standard endovascular revascularization in femoropopliteal peripheral artery disease. BackgroundDrug-coated balloons and drug-eluting stents improve patency of endovascular interventions with passive diffusion of antiproliferative drugs. Adventitial dexamethasone delivery targets the initial triggers of the inflammatory reaction to injury, thus potentially providing a potent antirestenotic strategy. MethodsThe single-arm DANCE (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization) trial enrolled 262 subjects (283 limbs) with symptomatic peripheral artery disease (Rutherford category 2 to 4) receiving percutaneous transluminal angioplasty (PTA) (n = 124) or atherectomy (ATX) (n = 159) in femoropopliteal lesions ≤15 cm in length. A mixture of dexamethasone/contrast medium (80%/20%) was delivered to the adventitia and perivascular tissues surrounding target lesions in all subjects. Thirty-day assessments included major adverse limb events (MALE) and post-operative death. Twelve-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), Rutherford scoring, and walking impairment questionnaire. ResultsAt 12 months, primary patency rates in DANCE-ATX and -PTA per-protocol populations were 78.4% (74.8% intent-to-treat [ITT]) and 75.5% (74.3% ITT), respectively. Rates of CD-TLR in DANCE-ATX and -PTA subjects were 10.0% (13.1% ITT) and 11.0% (13.7% ITT), respectively. There were no 30-day MALE + post-operative death events nor 12-month device- or drug-related deaths or MALE. ConclusionsDirect adventitial delivery of dexamethasone appears to be an effective and safe therapy to prevent restenosis. Randomized studies are needed to further test this possibility. (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization [DANCE]; NCT01983449)

Regional variation in racial disparities among patients with peripheral artery disease

ObjectivePrior studies identified significant racial disparities as well as regional variation in outcomes of patients with peripheral artery disease (PAD). We aimed to determine whether regional variation contributes to these racial disparities. MethodsWe identified all white or black patients who underwent infrainguinal revascularization or amputation in 15 deidentified regions of the Vascular Quality Initiative between 2003 and 2017. We excluded three regions with <100 procedures. We used multivariable linear regression, allowing clustering at the hospital level to calculate the marginal effects of race and region on adjusted 30-day mortality, major adverse limb events (MALEs), and amputation. We compared long-term outcomes between black and white patients within each region and within patients of each race treated in different regions using multivariable Cox regression. ResultsWe identified 90,418 patients, 15,527 (17%) of whom were black. Patients underwent 31,263 bypasses, 52,462 endovascular interventions, and 6693 amputations. Black patients were younger and less likely to smoke, to have coronary artery disease, or to have chronic obstructive pulmonary disease, but they were more likely to have diabetes, limb-threatening ischemia, dialysis dependence, and hypertension and to be self-insured or on Medicaid (all P < .05). Adjusted 30-day mortality ranged from 1.2% to 2.1% across regions for white patients and 0% to 3.0% for black patients; adjusted 30-day MALE varied from 4.0% to 8.3% for white patients and 2.4% to 8.1% for black patients; and adjusted 30-day amputation rates varied from 0.3% to 1.2% for white patients and 0% to 2.1% for black patients. Black patients experienced significantly different (both higher and lower) adjusted rates of 30-day mortality and amputation than white patients did in several regions (P < .05) but not MALEs. In addition, within each racial group, we found significant variation in the adjusted rates of all outcomes between regions (all P < .01). In adjusted analyses, compared with white patients, black patients experienced consistently lower long-term mortality (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.73-0.88; P < .001) and higher rates of MALEs (HR, 1.15; 95% CI, 1.06-1.25; P < .001) and amputation (HR, 1.33; 95% CI, 1.18-1.51; P < .001), with no statistically significant variation across the regions. However, rates of all long-term outcomes varied within both racial groups across regions. ConclusionsSignificant racial disparities exist in outcomes after lower extremity procedures in patients with PAD, with regional variation contributing to perioperative but not long-term outcome disparities. Underperforming regions should use these data to generate quality improvement projects, as understanding the etiology of these disparities is critical to improving the care of all patients with PAD.

National Utilization and Outcomes of Redo Lower Extremity Bypass versus Endovascular Intervention after a Previous Failed Bypass

Redo lower extremity bypass (LEB) and infrainguinal endovascular intervention (IEI) are options to treat critical limb ischemia after a failed prior LEB, but the utilization and outcomes of each are poorly described. The purpose of this study was to compare 30-day major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs) after LEB and IEI in patients with a failed prior ipsilateral LEB and determine risk factors for each composite outcome. Patients with prior failed ipsilateral LEB who underwent LEB or IEI involving the same arterial segment for critical limb ischemia were identified in the National Surgical Quality Improvement Program (NSQIP) Vascular Targeted File (2011-2014). LEB with single-segment saphenous vein was compared to LEB with alternative conduit (prosthetic/spliced vein/composite) and IEI. Primary outcomes were MALE (untreated loss of patency, reintervention, or amputation) and MACE (stroke, myocardial infarction, or death). Multivariate analysis was utilized to identify independent predictors of MALE and MACE. Among 8,066 revascularizations performed for critical limb ischemia (CLI), 1,606 (461 [28.7%] IEI, 518 [32.3%] LEB saphenous, and 627 [39.0%] LEB alternative) were performed after failed ipsilateral LEB involving the same arterial segment. LEB with saphenous had lower MALE than LEB with alternate conduit and IEI (15.8% IEI, 10.8% saphenous, and 15.5% alternative, P=0.03). Higher MALE was driven by higher 30-day amputation in IEI (7.8% IEI, 3.7% saphenous, and 5.3% alternative, P=0.02). Independent predictors of MALE include transfer status (odds ratio [OR] = 1.7, P=0.01), tobacco use (OR = 1.5, P=0.02), infrageniculate revascularization (OR = 1.6, P=0.004), and saphenous conduit (OR = 0.5, P=0.002). MACE was also different between groups (3.9% IEI, 7% saphenous, and 5.6% alternative, P=0.049), with no difference in 30-day mortality (P=0.53). Independent predictors of MACE included congestive heart failure (OR = 3.0, P=0.01) and dialysis dependence (OR = 2.5, P=0.02). In this large national sample representing routine vascular care of patients with CLI after failed ipsilateral LEB of the same arterial segment, IEI is common and represents 30% of revascularizations in this data set. Redo LEB with saphenous is associated with superior limb-related outcomes, but IEI offers an acceptable potential alternative to bypass in patients who would require alternative conduit. Finally, perioperative care is critical as we demonstrate that patient comorbidities, not the method of revascularization, predicted MACE.

Lower extremity bypass for critical limb ischemia decreases major adverse limb events with equivalent cardiac risk compared with endovascular intervention

ObjectiveLower extremity bypass (LEB) has traditionally been the “gold standard” in the treatment of critical limb ischemia (CLI). Infrainguinal endovascular intervention (IEI) has become more commonly performed than LEB, but comparative outcomes are limited. We sought to compare rates of major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs) after LEB and IEI in a propensity score-matched, national cohort of patients with CLI. MethodsThe National Surgical Quality Improvement Program (NSQIP) vascular targeted files (2011-2014) for LEB and IEI were merged. CLI patients were identified by ischemic rest pain or tissue loss. Patients were matched on a 1:1 basis for propensity to undergo LEB or IEI. Primary outcomes were 30-day MALEs and MACEs. Within the propensity-matched cohort, multivariate logistic regression was used to identify independent predictors of MALEs and MACEs. ResultsA total of 13,294 LEBs and IEIs were identified, with 8066 cases performed for CLI. Propensity matching identified 3848 cases (1924 per group). There were no differences in preoperative variables between the propensity-matched LEB and IEI groups (all P > .05). At 30 days, rates of MALEs were significantly lower in the LEB group (9.2% LEB vs IEI 12.2%; P = .003). On multivariate logistic regression, bypass with single-segment saphenous vein vs IEI (odds ratio [OR], 0.7; 95% confidence interval [CI], 0.54-0.92; P = .01), bypass with alternative conduit (prosthetic, spliced vein, or composite) vs IEI (OR, 0.7; 95% CI, 0.56-0.98; P = .04), antiplatelet therapy (OR, 0.8; 95% CI, 0.58-1.00; P = .049), and statin therapy (OR, 0.8; 95% CI, 0.62-0.99; P = .04) were protective against MALEs, whereas infrageniculate intervention (OR, 1.4; 95% CI, 1.09-1.72; P = .01) and a history of prior bypass of the same arterial segment (OR, 1.8; 95% CI, 1.41-2.41; P <. 0001) were predictive. Rates of 30-day MACEs were not significantly different (4.9% LEB vs 3.7% IEI; P = .07) between the groups. Independent predictors of MACEs included age (OR, 1.02; 95% CI, 1.01-1.04; P = .01), steroid use (OR, 1.8; 95% CI, 1.08-2.99; P = .03), congestive heart failure (OR, 1.7; 95% CI, 1.00-1.96; P = .02), beta blocker use (OR, 1.6; 95% CI, 1.09-1.43; P = .01), dialysis (OR, 2.3; 95% CI, 1.55-3.45; P < .0001), totally dependent functional status (OR, 3.1; 95% CI, 1.25-7.58; P = .02), and suboptimal conduit for LEB compared with IEI (OR, 1.6; 95% CI, 1.08-2.36; P = .02). ConclusionsWithin this large, propensity-matched, national cohort, LEB predicted lower risk-adjusted 30-day MALE rate compared with IEI. Furthermore, there was no difference in 30-day MACE rate between the groups despite higher inherent risk with open surgical procedures. Therefore, this study supports the effectiveness and primacy of LEB for revascularization in CLI.

Applicability of the Society for Vascular Surgery's Objective Performance Goals for Critical Limb Ischemia to Current Practice of Lower-Extremity Bypass

In 2009, the Society for Vascular Surgery (SVS) established objective performance goals (OPGs) for critical limb ischemia (CLI) based on data from previous, randomized, controlled trials of lower-extremity bypass (LEB). These OPG sought to establish a benchmark of outcomes to which one could compare future endovascular therapy. However, the cohort used to develop the OPG excluded all patients who required prosthetic conduit and those with end-stage renal disease (ESRD), possibly limiting the generalizability of these results and the subsequent guidelines. The goal of this study was to determine if the SVS OPG are applicable to the current population of patients undergoing LEB. All patients who underwent infrainguinal LEB for CLI from January 2010 to December 2013 were identified in a prospectively maintained database. Patients were stratified into OPG eligible and ineligible (non-OPG) groups based on their demographic and operative characteristics. OPG eligible patients were further stratified into high risk and average risk. Outcomes included 30-day major adverse limb events (MALEs), 30-day major adverse cardiovascular events (MACE), 1-year survival, and 1-year freedom from amputation. A total of 89 individual patients were identified. Only 43 (48%) patients met OPG inclusion criteria and 46 (52%) were not OPG eligible (non-OPG). The 30-day MALE was 8.7% (13.0% non-OPG vs. 7.0% OPG, P = 0.34). The 30-day MACE was 11.2% (13.0% non-OPG vs. 9.3% OPG, P = 0.58). One-year survival was 80.3% ± 4.5% (71.2% non-OPG vs. 90.0% OPG, P = 0.21). One-year freedom from amputation was 71.7% ± 5.5% (58.8% non-OPG vs. 84.0% OPG, P = 0.03). The SVS OPG for LEB are likely not generalizable to current practice as 51% of patients would have been excluded from the SVS cohort because of ESRD and prosthetic conduit. Most SVS OPG (30-day MALE, 1-year survival, and 1-year limb salvage) were attainable in patients who met SVS OPG inclusion criteria; but for the patients who are not OPG eligible, new benchmarks are needed.

Outcomes of Isolated Tibial Endovascular Interventions for Tissue Loss in CLI Patients on Hemodialysis

Purpose: To compare the objective performance goals (OPGs) and patient-centered outcomes of isolated tibial interventions in patients with tissue loss who were on hemodialysis (HD) to patients with tissue loss who were not on HD. Methods: Interrogation of a prospectively maintained database identified 242 critical limb ischemia (CLI) patients who underwent isolated tibial interventions for tissue loss in a single limb between 2007 and 2012. The 78 patients (mean age 66±12 years; 44 men) on HD were compared with 164 patients (mean age 50±13 years; 82 men) who were not on HD. There was an equal distribution of the tibial vessels treated; 152 (63%) patients had more than one treated tibial vessel. Patient-centered outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and no major amputation), amputation-free survival (AFS), and freedom from major adverse limb events (MALE) were evaluated. The Society for Vascular Surgery OPGs were defined at 30 days and 1 year. Results: The 30-day major adverse cardiac events was significantly higher (p=0.004) in the HD group (5, 5%) compared with the no-HD group (0%), but both remained under the stated OPG of ≤10%. The 30-day MALE rates were significantly higher than the stated ≤9% OPG at 13% and 18% for the no-HD and HD groups, respectively. At 1 year, the rates for AFS, freedom from MALE, limb salvage, and survival did not achieve the stated Society for Vascular Surgery OPGs in the HD group. Clinical efficacy was 61% and 25% at 3 years for the no-HD and HD groups, respectively (p<0.01). Overall, AFS was 54% and 22% and freedom from MALE was 56% and 27% at 3 years for the no-HD and HD groups, respectively (both p<0.01). Conclusion: Tibial intervention for tissue loss in patients on HD is a valid treatment option but is associated with a high MALE rate. Three-year outcomes remain relatively poor, with <25% success in terms of clinical efficacy and AFS.

The Society for Vascular Surgery's objective performance goals for lower extremity revascularization are not generalizable to many open surgical bypass patients encountered in contemporary surgical practice

In 2009, the Society for Vascular Surgery (SVS) established objective performance goals (OPG) for lower extremity bypass (LEB) in patients with critical limb ischemia (CLI) based on pooled data from previously performed prospective studies in an effort to provide a benchmark and historical control for future trials. However, patients with a prosthetic conduit and end-stage renal disease were excluded from this cohort. In contemporary practice, many patients do not meet the criteria for SVS OPG inclusion, making generalization of the SVS OPG difficult. The goal of this study was to establish safety and efficacy measures for patients who were excluded from the original SVS OPG analysis. All patients who underwent LEB for CLI in the Vascular Study Group of New England (VSGNE) from 2003 to 2013 were identified. Patients were stratified into OPG-eligible and non-OPG-eligible cohorts. Outcomes included 30-day major adverse limb events, 30-day major adverse cardiovascular events, 1-year survival, and 1-year freedom from amputation. The SVS OPG methodology was used to create new performance goals for the non-OPG-eligible patients. We identified 3609 patients: 2360 OPG (65%) vs 1249 non-OPG (35%), and overall results were stratified as a function of OPG status. The 30-day major adverse limb event rate was 5.0% (5.5% non-OPG vs 4.4% OPG; P = .34), and the 30-day major adverse cardiovascular event rate was 7.3% (9.2% non-OPG vs 6.2% OPG; P = .001). At 1 year, survival was 84% (75.9% non-OPG vs 88.3% OPG; P < .001), and freedom from amputation was 86.9% (80.9% non-OPG vs 90.1% OPG; P < .001). The SVS OPG were attainable in New England for the population of patients who would have met SVS OPG study cohort inclusion criteria. However, 35% of the patients who underwent LEB for CLI in the last 10 years fell outside of these criteria by having end-stage renal disease or requiring a prosthetic conduit. We therefore suggest new benchmarks for these high-risk populations.

PC70. Acute Limb Ischemia After Cardiothoracic Surgery Is Associated With High Rates of Amputation and Mortality

Objectives: Failure of a femoropopliteal bypass often necessitates redo lower extremity surgery and is associated with increased mortality and morbidity. An alternative strategy is to perform endovascular revascularization of the superficial femoral artery (SFA) and avoid catheter-directed lysis or open surgery. The purpose of this retrospective study was to examine the outcomes of native SFA chronic total occlusion (CTO) recanalization compared with bypass after failed femoropopliteal bypass. Methods: Patients presenting with a symptomatic failed femoropopliteal bypass who underwent attempted CTO recannulization of the native SFA or a redo femoropopliteal bypass from2000 to 2014were included. Patients undergoing catheter-directed thrombolysis were excluded. Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Factor analyses were performedusing aCoxproportional hazardmodel for time-dependentvariables. Results: A total of 104 patients (69% male, average age 65 years) underwent nativeCTO recannulization (n1⁄4 40) or redobypass (n1⁄4 64) after presentation with symptomatic occlusion of a previous femoropopliteal bypass graft (rest pain in 84% and life style-limiting claudication in 16%, 79% to the aboveknee popliteal), 81% of the lesions being TASC-II category D and 19% TASC-II category C. Tibial runoff was one tibial vessel in most patients (79%) and two-vessel runoff in the remainder. Lesions treated endovascularly underwent primary stenting with a median of three stents used. Sixty-nine percent of the bypasses were to the below-knee popliteal and remainder to the proximal tibials (68% of the patients has venous conduit). Overall, 30-day major adverse cardiac eventswere 5.6%andall-causemorbiditywas6.3%. 30-daymajor adverse limbevents was 17% and30-day amputation ratewas 8% (Table).Overall amputation-free survival was 43%6 9% and freedom frommajor adverse limb events was28%6 7%at3years (Table).Critical ischemia,TASC-II lesion (D), andonevessel tibial runoff were significant predictors of failure.

Retrograde Transpopliteal Access Is Safe and Effective—It Should Be Added to the Vascular Surgeon's Portfolio

The aim of the study was to review the outcomes of superficial femoral artery (SFA) interventions using a retrograde transpopliteal access approach after failed antegrade recanalization. A database of patients undergoing endovascular treatment of the SFA between 2008 and 2011 was retrospectively queried, and those cases with transpopliteal artery retrograde access were analyzed. Time-dependent outcomes were determined by Kaplan-Meier survival analyses. A total of 16 patients (75% men; mean age 61 ± 9 years) underwent retrograde popliteal access after failed antegrade attempts. Patients had multiple cardiovascular comorbidities with a mean modified cardiac index score of 3.1 ± 1.8. The reason for intervention was lifestyle-limiting claudication in 67% of cases and critical ischemia in the remainder. Most of the lesions were Trans-Atlantic Inter-Society Consensus II C and D. Retrograde ultrasound-guided puncture of the popliteal artery was successful in all cases and there were no local site complications. Intervention was successful in 94% of cases. One uncomplicated perforation (7%) was encountered during attempted recanalization of the SFA in the thigh. There was no perioperative morbidity or 30-day mortality. The 30-day major adverse cardiovascular events rate was 6% but both 30-day major adverse limb events and the 30-day major amputation rate were 0%. There was a 40% increase in actual ankle-brachial index (ABI); 93% of patients achieved an ABI rise >0.15. On longer term follow-up, 2 patients developed restenosis and 1 an asymptomatic occlusion. Both restenosis patients required re-angioplasty. Two patients required expected toe amputations as a result of their presenting symptoms. The primary patency was 66 ± 9%, assisted patency 81 ± 9%, and secondary patency 87 ± 8% at 2 years. Limb salvage was 100%. Clinical efficacy was 63 ± 9% at 2 years. Ultrasound-guided retrograde transpopliteal access is a safe and successful technique, which extends the ability to perform endovascular interventions after failed antegrade approaches.

PS160. Applicability of the Society for Vascular Surgery's Objective Performance Goals for Critical Limb Ischemia to Current Practice of Lower Extremity Bypass

Background: In 2009, the Society for Vascular Surgery (SVS) established objective performance goals (OPGs) for critical limb ischemia (CLI) based on data from previous, randomized, controlled trials of lower-extremity bypass (LEB). These OPG sought to establish a benchmark of outcomes to which one could compare future endovascular therapy. However, the cohort used to develop the OPG excluded all patients who required prosthetic conduit and those with end-stage renal disease (ESRD), possibly limiting the generalizability of these results and the subsequent guidelines. The goal of this study was to determine if the SVS OPG are applicable to the current population of patients undergoing LEB. Methods: All patients who underwent infrainguinal LEB for CLI from January 2010 to December 2013 were identified in a prospectively maintained database. Patients were stratified into OPG eligible and ineligible (non-OPG) groups based on their demographic and operative characteristics. OPG eligible patients were further stratified into high risk and average risk. Outcomes included 30-day major adverse limb events (MALEs), 30-day major adverse cardiovascular events (MACE), 1-year survival, and 1-year freedom from amputation. Results: A total of 89 individual patients were identified. Only 43 (48%) patients met OPG inclusion criteria and 46 (52%) were not OPG eligible (non-OPG). The 30-day MALE was 8.7% (13.0% non-OPG vs. 7.0% OPG, P 1⁄4 0.34). The 30-day MACE was 11.2% (13.0% non-OPG vs. 9.3% OPG, P 1⁄4 0.58). One-year survival was 80.3% ± 4.5% (71.2% non-OPG vs. 90.0% OPG, P 1⁄4 0.21). One-year freedom from amputation was 71.7% ± 5.5% (58.8% non-OPG vs. 84.0% OPG, P 1⁄4 0.03). Conclusions: The SVS OPG for LEB are likely not generalizable to current practice as 51% of patients would have been excluded from the SVS cohort because of ESRD and prosthetic conduit. Most SVS OPG (30-day MALE, 1-year survival, and 1-year limb salvage) were attainable in patients who met SVS OPG inclusion criteria; but for the patients who are not OPG eligible, new benchmarks are needed.

21.5 Assessment of crural vessels using duplex prior to distal grafting

Lower extremity bypass (LEB) has traditionally been the “gold standard” in the treatment of critical limb ischemia (CLI). Infrainguinal endovascular intervention (IEI) has become more commonly performed than LEB, but comparative outcomes are limited. We sought to compare rates of major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs) after LEB and IEI in a propensity score-matched, national cohort of patients with CLI.The National Surgical Quality Improvement Program (NSQIP) vascular targeted files (2011-2014) for LEB and IEI were merged. CLI patients were identified by ischemic rest pain or tissue loss. Patients were matched on a 1:1 basis for propensity to undergo LEB or IEI. Primary outcomes were 30-day MALEs and MACEs. Within the propensity-matched cohort, multivariate logistic regression was used to identify independent predictors of MALEs and MACEs.A total of 13,294 LEBs and IEIs were identified, with 8066 cases performed for CLI. Propensity matching identified 3848 cases (1924 per group). There were no differences in preoperative variables between the propensity-matched LEB and IEI groups (all P > .05). At 30 days, rates of MALEs were significantly lower in the LEB group (9.2% LEB vs IEI 12.2%; P = .003). On multivariate logistic regression, bypass with single-segment saphenous vein vs IEI (odds ratio [OR], 0.7; 95% confidence interval [CI], 0.54-0.92; P = .01), bypass with alternative conduit (prosthetic, spliced vein, or composite) vs IEI (OR, 0.7; 95% CI, 0.56-0.98; P = .04), antiplatelet therapy (OR, 0.8; 95% CI, 0.58-1.00; P = .049), and statin therapy (OR, 0.8; 95% CI, 0.62-0.99; P = .04) were protective against MALEs, whereas infrageniculate intervention (OR, 1.4; 95% CI, 1.09-1.72; P = .01) and a history of prior bypass of the same arterial segment (OR, 1.8; 95% CI, 1.41-2.41; P <. 0001) were predictive. Rates of 30-day MACEs were not significantly different (4.9% LEB vs 3.7% IEI; P = .07) between the groups. Independent predictors of MACEs included age (OR, 1.02; 95% CI, 1.01-1.04; P = .01), steroid use (OR, 1.8; 95% CI, 1.08-2.99; P = .03), congestive heart failure (OR, 1.7; 95% CI, 1.00-1.96; P = .02), beta blocker use (OR, 1.6; 95% CI, 1.09-1.43; P = .01), dialysis (OR, 2.3; 95% CI, 1.55-3.45; P < .0001), totally dependent functional status (OR, 3.1; 95% CI, 1.25-7.58; P = .02), and suboptimal conduit for LEB compared with IEI (OR, 1.6; 95% CI, 1.08-2.36; P = .02).Within this large, propensity-matched, national cohort, LEB predicted lower risk-adjusted 30-day MALE rate compared with IEI. Furthermore, there was no difference in 30-day MACE rate between the groups despite higher inherent risk with open surgical procedures. Therefore, this study supports the effectiveness and primacy of LEB for revascularization in CLI.