Lifestyle-limiting Claudication Research Articles

The natural history of isolated common femoral endarterectomy for chronic limb-threatening ischemia

ObjectiveOcclusive disease of the common femoral artery can generate profound lower extremity ischemia as the normal collateral pathways from the profunda to the superficial femoral artery cannot adequately develop. In patients with lifestyle-limiting claudication, isolated common femoral endarterectomy (CFE) is highly effective. Because CFE does not provide direct, in-line flow to the plantar arch, it has been felt to provide inadequate revascularization to patients with chronic limb-threatening ischemia (CLTI). The purpose of this retrospective clinical study was to report and assess the natural history of selected patients with CLTI treated with isolated CFE (without concomitant infrainguinal revascularization). MethodsConsecutive CFEs performed in a large, urban hospital for CLTI between 2014 and 2021 were reviewed. Patient characteristics, limb, and anatomical stages using the Wound, Ischemia, foot Infection (WIfI) and Global Limb Anatomic Staging System were tabulated. Limb-specific and survival-related end points were analyzed. ResultsFifty-eight patients presenting with CLTI underwent isolated CFE (mean age, 74 ± 10 years; 62% male, 90% current or prior smoker). Comorbidities included diabetes (52%), coronary artery disease (55%), congestive heart failure (22%), and end-stage renal failure on hemodialysis (5%). Patients presented with either rest pain (36%) or tissue loss (64%); the latter group exhibited advanced limb threat (68% in WIfI stage 3 or 4). The majority of patients had associated severe infrainguinal disease (50% Global Limb Anatomic Staging Systems 3). After a median follow-up of 17 months (range, 10-29 months), vascular reintervention was required in 7 patients (12%). One patient (2%) required major limb amputation after presentation in WIfI stage 4 (W3I3fI0). Indeed, WIfI stage 4 was a significant univariate predictor of the need for subsequent infrainguinal bypass (P = .034). ConclusionsIsolated CFE as primary therapy in highly selected patients with CLTI was safe and effective. Index limb stage is predictive of the need for associated infrainguinal revascularization in this complex population.

Predictors of Revascularization in Lower-Extremity Peripheral Artery Disease: Insights From the PORTRAIT Study.

Peripheral artery disease (PAD) guidelines recommend revascularization only for patients with lifestyle-limiting claudication that is refractory to goal-directed medical therapy (class IIA, level of evidence A). However, real-world invasive treatment patterns and predictors of revascularization in patients with symptomatic lower-extremity PAD are still largely unknown. We aimed to examine rates, patient-level predictors, and site variability of early revascularization in patients with new or worsening PAD symptoms. Among patients with new-onset or recent exacerbation of PAD in the 10-center Patient-centered Outcomes Related to TReatment practices in peripheral Arterial disease: Investigating Trajectories (PORTRAIT) study enrolled between June 2011 and September 2015, we classified early revascularization (endovascular or surgical) as procedures being performed within 3 months of presentation. Hierarchical logistic regression was used to identify patient characteristics associated with early revascularization. Variability across sites was estimated using the median odds ratio (OR). Among 797 participants, early revascularization procedures were performed in 224 (28.1%). Rutherford class 3 (vs Rutherford class 1; OR=1.86, 95% confidence interval [CI] 1.04-3.33) and having lesions in both iliofemoral and below-the-knee arterial segments (vs below the knee only; OR=1.75, 95% CI: 1.15-2.67) were associated with a higher odds of revascularization. Longer PAD duration >12 months (vs 1-6 months; OR=0.50, 95% CI: 0.32-0.77), higher ankle-brachial index scores (per 0.1 unit increase; OR=0.86, 95% CI: 0.78-0.96), and higher Peripheral Artery Questionnaire Summary scores (per 10 unit increase; OR=0.89, 95% CI: 0.80-0.99) were associated with a lower odds of revascularization. The raw rates for revascularization in different sites ranged from 6.25% to 66.28%, and the median OR was 1.88, 95% CI: 1.38-3.57. About 1 in 3 patients with symptomatic PAD received early revascularization. A more extensive disease and symptom burden were the main predictors of receiving early revascularization in PAD. There was significant site variability in revascularization patterns, and further studies will better understand the source of this variability and optimal selection criteria for early revascularization. Real world patterns and predictors of early revascularization in peripheral artery disease are not well understood. In this retrospective analysis of the POTRAIT study, about 1 out of 3 patients with PAD symptoms received early revascularization, with significant site variability. A more extensive disease and symptom burden were the main predictors of receiving early revascularization in PAD.

Machine Learning Model Predicts Open Bypass Outcomes in VQI Claudicants

Peripheral artery disease (PAD) studies have largely focused on patients with acute or critical limb ischemia, although one in five patients with PAD are claudicants. New endovascular technology has fallen into favor for use in patients with claudication. However, there is debate surrounding the longevity of these interventions that may ultimately still result in a patient requiring an open bypass that could possible last a patient's lifetime. The aim of this prospective study was to leverage existing data in the Vascular Quality Initiative (VQI) database and preoperatively risk stratify patients with lifestyle-limiting claudication who may be eligible for an open bypass. The VQI was queried for all patients who underwent infrainguinal lower extremity bypass between December 2004 and December 2017. Of the 71,561 procedures, 15,633 of these procedures were initial open procedures performed for patients with lifestyle-limiting claudication. Our outcomes of interest included 30-day survival, major adverse limb events (MALE), and major cardiac events (MCE). The machine learning algorithm Random Forrest was used to identify univariate significant predictors after multiple testing correction. Generalized liner models with all significant predictors were then trained on 80% of the existing data set and tested on 20% of the dataset for accuracy of predicting outcomes. Eleven percent of patients survived after 30 days, 3.2% had an MALE, and 14% had an MCE. The best performing prediction model created was for 30-day survival, where we included the following predictors identified on univariate analysis in addition to age, race, and gender: utilizing a conduit other than great saphenous vein (GSV) (odds ratio [OR], 0.79; 95% confidence interval [CI], 0.72-0.88; P corrected = .05), uncontrolled hypertension (OR, 0.50; 95% CI, 0.42-0.60; P corrected = 8.96 × 10−11), preoperative ambulation with assistance (OR, 1.75; 95% CI, 1.53-2.01; P corrected = 8.39 × 10−12), quitting smoking before the surgery (OR, 0.72; 95% CI, 0.61-0.85; P corrected = .05), and having a preoperative computed tomography angiography available (OR, 1.28; 95% CI, 1.16-1.43; P corrected = .02). Model characteristics for each of the three outcome are listed in Table I. The model for 30-day readmission had an area under the curve of 0.79 (95% CI, 0.74-0.82) (Fig). We developed a model to predict 30-day survival in claudicants undergoing infrainguenal bypass using clinical characteristics commonly available to physicians. This computational machine learning model was developed using real world VQI data and can possibly be used in a general clinic setting for preoperative risk stratification.TableModel characteristics used to predict 30-day survival, major adverse limb event (MALE) created from a composite of any limb amputation and any return to the operating room for revision, and major cardiac event (MCE) created from a composite of stroke, myocardial infarction, or death30-day survivalMALEMCEAUC (95% CI)0.79 (0.74-0.82)0.68 (0.57-0.72)0.71 (0.69-0.74)TPR (IQR)0.79 (0.66-0.91)0.55 (0.27-0.83)0.76 (0.50-0.90)FPR (IQR)0.46 (0.20-0.73)0.39 (0.10-0.69)0.47 (0.22-0.73)Cutoff0.10.030.1Sensitivity0.810.680.65Specificity0.640.510.65AUC, Area under the curve; CI, confidence interval; FPR, false positive rate; IQR, interquartile range; TPR, true positive rate. Open table in a new tab

Outcomes of Femoropopliteal Bypass for Lifestyle-Limiting Claudication in the Endovascular Era

IntroductionOutcomes after femoropopliteal bypass for intermittent claudication (IC) remain unclear in the endovascular era. MethodsA multi-institutional database was retrospectively queried for all femoropopliteal bypass procedures performed between 1995 and 2020. Demographics, operative details, and outcomes were documented. A statistical analysis included Kaplan–Meier curves and Cox proportional hazards ratios (HR). ResultsA total of 282 patients underwent femoropopliteal bypass surgery for IC. Median age was 68 y (interquartile range, 61-73 y). Bypass conduits included great saphenous vein (GSV) (48.2%), prosthetic grafts (48.9%), and non-GSV autogenous grafts (2.8%). Distal bypass target was above-knee in 62.1% and below-knee in 37.9% of patients. The most common postoperative complications were wound infections (14.2%) followed by unplanned 30-d hospital readmissions (12.4%). Mortality rates were low at 0.4% (30 d) and 3.2% (1 y). Five-year primary patency rates trended highest for claudicants undergoing above-knee bypass with GSV conduit (log-rank P = 0.065). Five-year amputation-free survival rates were highest using GSV conduit regardless of distal bypass target (log-rank P = 0.017). On a multivariable analysis, age (HR 1.02 [1.00-1.04], P = 0.023) and active smoking (HR 1.48 [1.06-2.06], P = 0.021) were identified as risk factors for diminished primary graft patency. Risk factors for amputation-free survival included age (HR 1.03 [1.01-1.05], P < 0.001) and GSV conduit type (HR 0.65 [0.46-0.90], P = 0.011). ConclusionsFemoropopliteal bypass among claudicants is associated with high rates of wound infection and hospital readmission. Active smoking portends worse outcomes in this population. These data may inform clinical decision-making regarding surgical intervention for claudication in the endovascular era.

A-40 | 12-Month Primary Patency Rates of Contemporary Endovascular Device Therapy for SFA Occlusive Disease

Superficial femoral artery (SFA) disease is the most common cause of symptomatic PAD which may progress to lifestyle-limiting claudication, critical limb ischemia or limb amputation. In this study, we attempted to investigate the 12—month primary patency rates of various endovascular therapies in patients with SFA PAD using published registries, case reports, and trials.

Acute limb ischemia in a cancer patient has high morbidity, high mortality, and atypical presentation: a tertiary cancer center\u2019s retrospective study

BackgroundAcute Limb Ischemia (ALI) carries a high morbidity and mortality rate that is compounded in the cancer patient. Though it is a relatively uncommon event, it is of extremely high adverse impact and carries poor awareness among clinicians.MethodsRetrospective review of electronic medical records was performed of cancer patients presenting with acute limb ischemia (ALI) to the tertiary cancer center’s urgent care center or as inpatient between January 1, 2014 and January 1, 2020.ResultsOut of the 29 cancer patients with ALI, 12 (41%) died within 3 month and 9 (31%) patients died within 1 months of ALI diagnosis. 65% had long term adverse outcome after ALI – 31% with death in 1 month, 2 (7%) with an amputation, 5 (17%) with lifestyle-limiting claudication, and 3 (10%) with subsequent wound ulceration or gangrene. Patients not eligible for standard of care (12 patients, 41%) (RR 2.33 95% CI [1.27–4.27], p < 0.01) and heparin administration ≥6 h from presentation (19 patients, 65%) (RR 2.81 [1.07–7.38], p = 0.04) were at increased risk of adverse outcome. Atypical/confounded presentation of ALI (13 patients, 45%) (RR 1.84 95% CI [1.03–3.29], p = 0.04), pulse exam not documented (12 patients, 41.4%) (RR 1.95 [95% CI [1.14–3.32], p = 0.01), and patients with services other than a vascular specialist initially consulted (8 patients, 27.6%) (RR 1.91 95% CI [1.27–2.87], p < 0.01) were significant risk factors for heparin administered ≥6 h from presentation.ConclusionsALI is devastating in cancer patients, with a high number presenting with atypical/confounded signs and symptoms which delays treatment. Heparin administered ≥6 h from presentation is associated with adverse outcome.

One-Year Clinical Outcome and Risk Factor Analysis of Directional Atherectomy Followed With Drug-Coated Balloon for Femoropopliteal Artery Disease

Purpose: This study investigated the 1-year clinical outcomes of directional atherectomy combined with drug-coated balloon (DA + DCB) in femoropopliteal artery disease (FPAD) from real-world experience. Materials and Methods: A retrospective study was conducted of patients treated between July 2016 and June 2019 using DA + DCB for FPAD. Patients’ demographics, comorbidities, clinical characteristics and outcomes, and angiography and duplex ultrasound findings were analyzed. The 6-month and 1-year primary patency, primary assisted patency, secondary patency, and freedom from clinically-driven target lesion revascularization (CD-TLR) were evaluated. Univariate and multivariate analyses were performed to identify risk factors of primary patency loss or CD-TLR. Results: Seventy-nine consecutive patients (83 lesions, mean age 70.9 years, 52 men) were included. Twenty-seven limbs had lifestyle-limiting claudication and 56 limbs had critical limb ischemia. There were 73 and 10 limbs with de novo lesion and in-stent restenosis, respectively. The mean lesion length of all the patients was 22.1 cm. The mean length of chronic total occlusions (CTOs) was 8.3 cm. Severe calcification was found in 32.5% cases. The 1-year primary patency rate was 80.8% and freedom from CD-TLR was 92.2%. The bailout stenting rate was 2.4%. Patients with CTO >10 cm had significantly lower 1-year primary patency rate and freedom from CD-TLR than did patients with CTO ≤10 cm. Total length of CTO (stratified as ≤5 cm, 5–10 cm, >10 cm) was identified as an independent risk factor of 1-year primary patency loss and CD-TLR. Conclusion: DA + DCB appears to be a safe and effective endovascular therapy to treat FPAD in real-world clinical practice, with a promising 1-year patency rate with a low rate of bailout stenting.

Early outcomes of novel Temren atherectomy device combined with drug-coated balloon angioplasty for treatment of femoropopliteal lesions.

In this study, perioperative properties and early outcomes of patients who underwent combined Temren rotational atherectomy (RA) and drug-coated balloon (DCB) angioplasty treatment for complex femoropopliteal lesions in a single center were reported. Between June 2019 and February 2020, 40 patients who underwent combined Temren RA and DCB treatment due to critical lower limb ischemia or claudication-limiting daily living activities were retrospectively evaluated. The mean age of patients was 73.2 ± 7.8 years and the majority of the patients were male (65%). Of the patients, 17 had critical limb ischemia and 23 had lifestyle-limiting claudication. Pathologies were total occlusion in 33 limbs and critical stenosis in seven limbs. Nine patients previously underwent endovascular intervention or surgery. The mean total occlusion length was 140.9 ± 100.9 (range, 20-360) mm in patients with chronic total occlusion. There was an additional iliac artery pathology in 5 and below the knee pathology in 8 patients. Rotational atherectomy was possible in all cases. Flow-limiting dissection was seen in six patients (15%). Provisional stent was performed to these patients. Following Temren RA, all patients underwent DCB. Adequate vascular lumen (less than 30% stenosis) was provided in all patients and the symptoms regressed. No distal embolization was encountered. Access site complications (17.5%) were small hematoma in four patients, ecchymosis in two patients, and pseudoaneurysm of the femoral artery in one patient. The mean follow-up was 13.55 ± 4.2 (range, 1-18) months. Re-occlusion was seen in three patients (7.5%) (n = 2 at 2months and n = 1 at 4months). Of these patients, two had required open revascularization via femoropopliteal bypass graft with common, superficial femoral, and popliteal artery endarterectomy and one had required femoro-posterior tibial artery bypass. Four minor toe amputations (10%) were performed to reach complete wound healing in the critical limb ischemia patients. A below-knee amputation was performed in a 94-year-old patient with long segment stenosis at the end of a 1-month follow-up period. There was no mortality after follow-ups. The Kaplan-Meier estimator estimated the rate of freedom from target lesion revascularization (TLR) which was 92.3%. The decrease in the Rutherford levels after the procedure was found to be statistically significant in 36 patients (p < 0.001). The increase in the ankle-brachial index after the procedure was found to be statistically significant in 36 patients (p < 0.001). Combined use of Temren RA with adjunctive DCB is safe and effective method with high rates of primary patency and freedom from TLR and low rates of complication in the treatment of femoropopliteal lesions.

2-Year Outcomes of the Eluvia Drug-Eluting Stent for the Treatment of Complex Femoropopliteal Lesions.

The aim of this study was to evaluate the 2-year performance of a polymer-based drug-eluting stent (DES) for the treatment of complex femoropopliteal lesions. Despite the promising early outcomes of the Eluvia DES, the long-term safety and efficacy of the device in a real-world scenario remain unclear. Between March 2016 and December 2018, 130 patients (137 lesions) with symptomatic femoropopliteal disease were included in this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization, freedom from surgical conversion, and overall mortality and morbidity were additionally analyzed. The majority of patients presented with lifestyle-limiting claudication (n=90 [69%]). The mean lesion length was 194 ± 108mm, 74% of the lesions (n=101) were chronic total occlusions, and 72% (n=99) were calcified. Moderate to severe calcification (Peripheral Arterial Calcium Scoring Scale score 3 or 4) was observed in 48% of the treated vessels (n=67). At 24months, the Kaplan-Meier estimate of primary patency was 71%, whereas both the secondary patency rate and freedom from target lesion revascularization were 80%. Overall survival amounted to 85%. Freedom from major amputation was 98%, while freedom from surgical conversion was 89%. Degeneration of the vessel wall was observed in 27 lesions (20%). In this study, use of the Eluvia polymer-based DES for the treatment of complex femoropopliteal disease showed promising 2-year results. Nonetheless, a relatively high rate of vessel wall degeneration was observed after DES deployment.

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial

Purpose: To evaluate the 36-month technical and clinical outcome after implantation of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface in TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral and proximal popliteal arteries. Materials and Methods: This prospective, multicenter, single-arm trial (ClinicalTrials.gov; identifier NCT01263665) enrolled 71 patients (mean age 66.7±8.3 years; 50 men) with lifestyle-limiting claudication or rest pain (Rutherford category 2–4) and long (>20-cm) lesions of the superficial femoral and proximal popliteal arteries. Primary endpoint was primary patency at 36 months. Secondary endpoints included primary assisted patency; secondary patency; freedom from target lesion revascularization (TLR); freedom from a composite of death, target vessel revascularization (TVR), and amputation; clinical success; and freedom from device fracture. Results: Primary patency estimated by Kaplan-Meier analysis was 40.6% at 36 months. Primary assisted patency and secondary patency estimates were 53.0% and 96.9%, respectively. Within 36 months, 27 patients had to undergo a TLR. Twenty-five patients (35.2%) had a TVR. Freedom from the composite of death, TVR, and amputation endpoint was 44.5%. The estimate of the sustained clinical success with stable or improved Rutherford category was 58.5%. No stent fracture was detected during follow-up. Conclusion: The primary patency rate without reintervention after treatment of long femoropopliteal lesions is low. However, secondary patency after implantation of a Viabahn endoprosthesis is high and seems to be superior to the use of other revascularization techniques, resulting in persistent clinical improvement.

Hybrid-based iliofemoral endarterectomy for severe and complete iliofemoral occlusive disease

ObjectivePrimary endovascular approaches are now the dominant modality for the treatment of iliac occlusive disease. However, stenting of the external iliac artery is plagued with high in-stent restenosis rates. This hybrid approach with fluoroscopic, retrograde iliofemoral endarterectomy combined with stenting was previously demonstrated to be both a safe and effective alternative to bypass and primary stenting alone for TransAtlantic Inter-Society Consensus (TASC) II C and D lesions. In this study, early outcomes and hemodynamic improvements of this hybrid approach are evaluated with an expanded patient population. MethodsThis was a single-institution, retrospective review of all hybrid-based retrograde iliofemoral endarterectomies from the common femoral artery extending to the proximal external iliac artery from January 1, 2010, to November 15, 2017. Data were collected from the electronic medical record and analyzed using standard quantitative statistical techniques. All preprocedure and postprocedure imaging was independently reviewed by two vascular surgeons. Variables included patient demographics, degree of ischemia, and stent characteristics. The primary outcomes were mortality and freedom from amputation, with secondary outcomes including changes in the ankle-brachial index and toe pressure. ResultsThe procedure was performed on 63 limbs in 51 total patients. In 33 limbs, the indication was critical limb ischemia (tissue loss/gangrene = 17, rest pain = 16) and 30 for lifestyle-limiting claudication. The cohort consisted of 84% TASC D and 16% TASC C. External iliac stenting was required in 68% (modal diameter, 10 mm) and ipsilateral common iliac stenting was completed in 75% (modal diameter, 9 mm). The ankle-brachial index significantly improved from 0.42 ± 0.25 to 0.73 ± 0.27 (P < .001) as did toe pressure from 29 ± 27 mm Hg to 59 ± 34 mm Hg (P < .001). Thirteen limbs ultimately required an infrainguinal procedure. One patient experienced an intraoperative iliac perforation that resolved with stenting. One death occurred within 90 days. Ninety-five percent of patients remained free from amputation. ConclusionsExtensive hybrid-based, retrograde iliofemoral endarterectomy with stenting is a safe and efficacious approach to severe iliac arterial occlusive disease, with excellent early outcomes. This series promulgates the hypothesis that extensive endarterectomy with selective iliac stenting yields superior results to external iliac stenting alone. Given the superb hemodynamic improvements in a larger patient population, this hybrid-based, extensive iliofemoral endarterectomy should be recommended as a minimally invasive, first-line treatment for severe iliac occlusive disease.

Treatment of an external iliac artery chronic total occlusion using alternate access sites

BackgroundWith the advent of endovascular techniques, alternate sites such as the pedal and radial arteries can now be accessed when treating peripheral arterial disease to reduce procedural complications, shorten recovery time, and improve patient comfort. However, a paucity of literature exists on the availability of support devices that can be utilized during challenging cases.Case presentationA 70 year-old female patient presented for evaluation of severe lifestyle-limiting left-sided claudication refractory to maximal medical therapy. Angiography revealed a chronic total occlusion of the left external iliac artery, which was treated successfully by percutaneous intervention via a primary transpedal approach and with the assistance of the Outback® Elite re-entry device. The patient was discharged 2 h after the procedure and reported significant symptom improvement at follow-up.ConclusionThis case highlights a newly adopted endovascular approach through an alternate access site and illustrates how the Outback® Elite device can be used as an adjunctive tool in the treatment of complex lower-extremity vascular lesions.

IP001. Aortoiliac Endarterectomy: A Modern Series

Aortoiliac endarterectomy (AIE) was historically the treatment of choice for aortoiliac occlusive disease. The advent of prosthetic grafts and endovascular interventions has lead to a dramatic decrease in the number of AIE being performed. Our goal was to analyze a modern series to determine the safety and efficacy of AIE in select patients. A retrospective review of all patients that underwent AIE from 2006 to 2018 was performed at our institution. Our primary end point was functional patency rate at last follow-up. Secondary end points included 30-day mortality, 30-day complication rates, late postoperative complications, and long-term survival. Summary statistics and survival rates were calculate using the frequency, means and lifetest procedures with the SAS/STAT software version 9.4 (SAS Institute Inc., Cary, NC). A total of 12 AIE procedures were identified. The indications were lifestyle-limiting claudication (75%, 9/12) and critical limb ischemia (25%, 3/12). The majority of patients (75%) were female. Mean age was 51.5 years and average body mass index was 26.7 kg/m2. Ten patients (83%) were active smokers. Preoperative studies included interventional angiography (58%) and computed tomography angiogram (42%). The extent of aortoiliac occlusive disease reached the left external iliac artery in one patient, and it was limited to the infrarenal aorta and common iliacs in the remainder. Two patients had existing infrainguinal disease. Mean follow-up was 49 months (range, 3-139 months). Over the follow-up period, functional primary patency rate was 11 of 12 (92%). One patient was noted to have unilateral common iliac artery thrombosis at 8 months; patency was restored with thrombolysis. Postoperative 30-day survival was 100%. One intraoperative complication of distal embolization occurred that required an immediate embolectomy for revascularization. Other complications included one subarachnoid hemorrhage and one pulmonary embolism. One patient presented with progression of distal lower extremity arterial disease 9 months later requiring secondary intervention. It was noted that the three patients who suffered subsequent lower extremity ischemic events had been acute presentations initially and were active smokers. Existing infrainguinal disease was present in only one of the three patients who had lower extremity ischemic complications. Limb salvage rate was 100% and overall survival rate was 11 of 12 (92%) over the 49-month mean follow-up period. Our results indicate that AIE continues to be a successful and durable option for revascularization in select patients. AIE performed in an acute setting is associated with more complications, but overall survival is not affected.

Active Tobacco Use in Patients with Claudication Does Not Affect Outcomes after Endovascular Interventions

With the advent of endovascular procedures, the indications for intervention in claudicants have become less strict. Many interventionalists, however, will not intervene in patients with lifestyle-limiting claudication unless they have discontinued tobacco use. Many patients are unable to comply with this goal, and there is little published evidence to suggest that continued tobacco use results in poorer outcomes. We sought to determine if it is justified to deny this group of patients endovascular, potentially lifestyle-improving, procedures based on their outcomes. A retrospective chart review was performed between 2007 and 2011 at a midsize community teaching hospital. Patients included had documented lifestyle-limiting claudication, underwent endovascular therapy, and had no previous vascular intervention. Patients were divided into 2 groups: active smokers (AS) and nonsmokers (NS) including former and never smokers. The primary outcome was the need for reintervention and the secondary outcomes were the need for surgical revascularization, limb loss, myocardial infarction (MI), stroke, and death. One hundred thirty-eight patients met inclusion criteria with 89 being male (64.5%). Forty-seven (34%) were active smokers versus 91 (66%) who were nonsmokers. Mean age at initial intervention for all 138 subjects was 66.34years (standard deviation 10.7) and was not statistically different between the AS and NS groups. Mean follow-up was 3.6years and was not significantly different between the two groups. Between the two groups (AS vs NS), there was no statistically significant difference between the rate of reintervention, surgical bypass, and limb loss. We also did not observe any significant difference in the rate of MI, stroke, or death during our follow-up period. Although tobacco use has been shown to negatively impact bypass patency, our data show that it does not appear to increase the need for reintervention, conversion to open surgical revascularization, limb loss, or other morbidities in patients undergoing endovascular interventions for claudication. We continue to strongly recommend all our patients who smoke to discontinue tobacco use. Our results, however, do not support the notion that those patients who are unable to quit should be denied the potential benefit of an endovascular intervention. The most important limitation of our study is the small numbers of patients available for review. Larger studies will be necessary to confirm our findings.

External Iliac Artery to Tibial Arteries Vein Graft for Inaccessible Femoral Artery

An endovascular-first approach to limb salvage and relief from lifestyle-limiting claudication is widely accepted. Stenosis or short occlusion of common, superficial femoral, and popliteal arteries can be corrected with percutaneous transluminal angioplasty (PTA) with stent positioning. Patency rates of these procedures are limited. We report our experience with external iliac artery to the infrapopliteal vessels vein grafts when the endovascular treatment fails. Between January 2013 and January 2019, 16 patients (16 limbs) were operated on for limb-threatening ischemia after the occlusion of PTA with stent positioning of the common, superficial femoral, and popliteal arteries. Three patients were treated at our hospital by interventional radiologists; the remaining were operated on elsewhere. An external iliac artery to the infrapopliteal vessels vein bypass graft was anatomically interposed to restore blood flow. End points of the study were death-related events, vein graft failure, and major (above- or below-knee amputation) or minor (foot or toe amputation) limb loss. There were 12 men and 4 women. Mean age of patients was 68years. Indication for the initial PTA with stent positioning of the common and superficial femoral artery was according to the Rutherford classification Grade I: Category 1, 11 patients (69%) and Category 2, 5 (31%) patients (Stage IIa and IIb according to Fontaine classification, respectively). Great saphenous vein was used in 14 (87%) cases and in 2 (13%) cases a composite graft with a segment of cephalic vein was required. The distal anastomoses were performed on the posterior tibial artery in 6 (37%) cases, anterior tibial artery in 4 (26%), and peroneal artery in 6 (37%). Four-year survival and primary patency rates were 71% (standard error [SE]=0.15) and 73% (SE=0.14), respectively. One graft occlusion required an above-knee amputation. Four-year limb salvage rate was 86% (SE=0.13). We recommend the external iliac artery as source of inflow in patients in whom the vein bypass cannot originate from the common femoral or from a more distal inflow source because of previous PTA with stent positioning or it is deemed hazardous.

Higher Inpatient Mortality for Women after Intervention for Lifestyle Limiting Claudication

Sex-related differences in outcomes have been identified in patients with peripheral artery disease (PAD). We hypothesized that women with PAD would have equivalent inpatient mortality with men after vascular intervention. Patients with a primary diagnosis of critical limb ischemia (CLI) or lifestyle-limiting claudication (LLC) receiving endovascular (EV) or open surgical repair from 2003-2012 were identified from the Nationwide Inpatient Sample. Demographics, comorbidities, and inpatient mortality were analyzed by chi-squared tests of independence and independent-samples t-tests. Logistic regression analysis was performed to identify predictors of inpatient mortality. SPSS 24 software was used with P<0.05 considered statistically significant. We identified 139,435 (59,432 women and 80,003 men) individuals meeting the aforementioned criteria. Women were older than men (71.5years vs. 68.2, P<0.001). There were no differences in racial distribution but women had lower rates of diabetes (38.6% vs. 39.7%, P<0.001), chronic obstructive pulmonary disease (17.9% vs. 19.5%, P<0.001), and coronary artery disease (38.6% vs. 47.4%, P<0.001), while having a higher rate of hypertension (60.0% vs. 56.1%, P<0.001). There was no sex-related difference in the rate of chronic renal failure. Women had higher inpatient mortality than men after vascular intervention (1.3% vs. 1.1%, P<0.001). When stratified by surgical technique, women also had higher inpatient mortality after EV repair (1.0% vs. 0.8%, P<0.05) and open repair (1.9% vs 1.3%, P<0.001). When separated by admitting diagnosis, women with CLI had higher inpatient mortality than men after open surgery (2.3% vs. 1.9%, P<0.05) but not after EV intervention. Women with LLC had higher inpatient mortality after both open (0.6% vs. 0.3%, P<0.05) and EV surgery (0.3% vs. 0.1%, P<0.05). Regression analysis revealed female sex as an independent predictor of inpatient mortality in patients with LLC (OR, 1.74; 95% CI 1.30-2.32, P<0.001) but not CLI. Women had higher inpatient mortality than men after vascular intervention for PAD. Women were also older and more likely to have EV intervention than men. Subgroup analysis suggests that these sex-related differences in inpatient mortality are more pronounced in patients with LLC than with CLI. Furthermore, regression analysis shows that sex is a significant predictor for patients diagnosed with LLC but not with CLI. Treatment guidelines should include consideration of sex in their indications for revascularization, particularly for patients diagnosed with LLC.

Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study

ObjectivesThe IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. BackgroundRandomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. MethodsThe IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. ResultsMean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. ConclusionsThis real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296)

Long-term outcomes of supervised exercise in peripheral artery disease: Impact of differing modes of exercise 1–4 years after intervention

The prevalence and debilitating nature of peripheral artery disease (PAD) mandate the development and aggressive implementation of the most efficacious treatment strategies available. Research has clearly demonstrated that supervised exercise in individuals with PAD and lifestyle-limiting claudication leads to improved outcomes in the short term. An important factor in determining the relative value of exercise training in PAD rehabilitation is the extent to which the benefits are sustained over time. The aim of this study was to examine the long-term outcome status of participants in the EXercise Training to Reduce Claudication: Arm ERgometry versus Treadmill Walking (EXERT) trial. Twenty-two participants agreed to attend a single data collection visit 1-4years after their completion of the EXERT study. Objective and subjective measures of health status and physical function and a measure of quality of life were obtained and compared to performance at the end of the EXERT trial. Although analyses indicate that changes in health status and objective measures of physical function occurred in the long-term follow-up period, between-group differences were minimal and were limited to a statistically significant difference in the distance covered during the 6-minute walk test. Subjects' perceptions on change in physical function and quality of life were similarly stable over time although a statistically significant decrease in participant's confidence in managing their disease/symptoms was evident, suggesting the importance of ongoing support and symptom management strategies. This has significant implications for vascular nurses.

Endovascular management of aortic endograft occlusion

Endovascular aortic repair is becoming the standard of care for abdominal aortic aneurysm. Despite aorta being a high flow system, there is still a definite risk of endograft occlusion. Management of occluded aortic endograft is highly controversial. Successful endovascular relining in aortic endograft occlusion is a technically demanding and forthcoming secondary intervention, not been studied extensively. We are reporting a case of aortic endograft thrombosis in a morbidly obese, 64-year-old gentleman with multiple comorbidities presenting with lifestyle-limiting claudication. The patient had a history of abdominal aortic aneurysm repair with aorto-uni-iliac device and femorofemoral bypass. The patient was managed by relining of aortic endograft with graft thrombectomy and snorkeling of the left renal artery. Postoperative course was uneventful. After 1 year of follow-up, the patient is free of symptoms with patent endograft. More empirical evidence is yet required to make the standard guidelines for the management of aortic endograft occlusion.

Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Common Femoral Artery Atherosclerotic Disease

Purpose: To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions. Methods: A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR). Results: Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02). Conclusion: Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory.