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Objectives: To assess 24-month outcome differences based on sex in symptomatic femoro-popliteal arterial disease of patients treated with drug-coated balloon (DCB). Background: Peripheral artery disease affects over 12 million people in the United States. Drug-coated balloons have shown to be effective in treating patients with symptomatic femoropopliteal arterial occlusive disease. Debate remains regarding its safety and efficacy in female gender. We investigated the differential treatment effect between genders. Methods: Patients (93 females and 102 males) with symptomatic femoropopliteal arterial disease treated with DCB from November 2014 to November 2015 were included in this retrospective study. We compared the resting ankle-brachial indices (ABIs) and peak systolic velocities (PSVs) by arterial duplex between the male and female patients at 6, 12, and 24 months postintervention. Results: Females had significantly smaller vessels (4.70 ± 0.9, P =.02) and higher body mass index (BMI; 30.0 ± 3.7, P =.002) than males. Females had significantly decreased ABI and PSV at the 6-month (ABI: 0.90 ± 0.15, P =.05 and PSV: 188.30 ± 103.1, P =.02), 12-month (ABI: 0.86 ± 0.15, P <.0001 and PSV: 219.10 ± 100.10, P =.001), and at 24-month (ABI: 0.84 ± 0.2, P =.0001 and PSV: 251.0 ± 135.9, P <.0001) intervals when compared to males. Females had increased clinically driven target lesion revascularization (TLR) at 6 months (females = 8 vs males = 4, P =.22), 12 months (females = 12 vs males = 4, P =.02), and 24 months (females = 14 vs males = 6, P =.03). In simple logistic regression analysis, BMI, age, reference vessel diameter (RVD), and gender were strongly associated with target lesion restenosis. The final model included the above and it produced the following odds ratios (ORs): BMI (OR = 1.07, 95% confidence interval [CI]: 0.98-1.2), age (OR: 1.0, CI: 0.96-1.03), RVD (OR: 1.6, CI: 1.02-2.4), and gender (OR: 3.5, CI: 1.6-7.8). Conclusion: Females treated with DCBs have significantly decreased ABI, PSVs, and an increased rate of TLR than their male counterparts. [ABSTRACT FROM AUTHOR]

Introduction: Patients with critical limb ischemia (CLI), who are unsuitable for intervention, face the consequence of primary amputation. Sequential compression biomechanical device (SCBD) therapy provides a limb salvage option for these patients. Objectives: To assess the outcome of SCBD in patients with severe CLI who are unsuitable for revascularization. Primary end points were limb salvage and 30-day mortality. Methods: From 2005 to 2012, 189 patients with severe CLI were not suitable for revascularization. In all, 171 joined the SCBD program. We match controlled 75 primary amputations. Results: All patients were Rutherford category 4 or higher. Sustained clinical improvement was 68% at 1 year. Mean toe pressure increased from 19.9 to 35.42 mm Hg, P < .0001. Mean popliteal flow increased from 35.44 to 55.91 cm/sec, P < .0001. The 30-day mortality was 0.6%. Limb salvage was 94% at 5 years. Freedom from major adverse clinical events was 62.5%. All-cause survival was 69%. Median cost of managing a primary amputation patient is €29 815 compared to €3985 for SCBD. We treated 171 patients with artassist at a cost of €681 965. However, primary amputation for 75 patients cost €2 236 125. Conclusion: The SCBD therapy is a cost-effective and clinically effective solution in patients with CLI having no option of revascularization. It provides adequate limb salvage while providing relief of rest pain without any intervention. [ABSTRACT FROM AUTHOR]

Objective: We conducted a retrospective study to compare short- and mid-term patencies of Viabahn with surgical above-knee prosthetic bypass (pAKB). Methods: The records of 52 patients with either pAKB (n ¼ 25) or Viabahn (n ¼ 27) were reviewed. The majority had Rutherford clinical grade 3. Patients were followed after 3, 6, and 12 months and yearly thereafter. Results: For Viabahn, the short-term (1-16 months) primary patency rate was 60% with a secondary patency rate of 90%, and mid-term (1-68 months) patencies of 47% and 83.3%, respectively. In pAKB, the short-term results revealed a primary patency rate of 78% with a secondary patency of 91% and mid-term results of 65% and 90%, respectively. No statistical difference was found concerning short-term patencies. Mid-term primary patency was lower for Viabahn (P < .05) and secondary patency proved no significant difference. Conclusion: Viabahn revealed similar short-term primary and secondary patencies but lower mid-term primary patency. It provides a good alternative therapy to pAKB. [ABSTRACT FROM AUTHOR]

We aim to compare cool excimer laser-assisted angioplasty (CELA) versus tibial balloon angioplasty (TBA) in patients with critical limb ischemia (CLI) with tibial artery occlusive disease. The primary end point is sustained clinical improvement (SCI) and amputation-free survival (AFS). The secondary end points are binary restenosis, target extremity revascularization (TER), and cost-effectiveness. From June 2005 to October 2010, 1506 patients were referred with peripheral vascular disease and 572 with CLI. A total of 80 patients underwent 89 endovascular revascularizations (EVRs) for tibial occlusions, 47 using TBA and 42 using CELA. All patients were Rutherford category 4 to 6. Three-year SCI was enhanced with CELA (81%) compared to TBA (63.8%; P = .013). Three-year AFS significantly improved with CELA (95.2%) versus TBA (89.4%; P = .0165). Three-year freedom from TER was significantly improved with CELA (92.9%) versus 78.7% TBA (P = .026). Three-year freedom from MACE was comparable in both the groups (P = .455). Patients with CELA had significantly improved quality time without symptoms of disease or toxicity of treatment (Q-TWiST) at 3 years (10.5 months; P = .048) with incremental cost of €2073.19 per quality-adjusted life year gained. Tibial EVR provides exceptional outcome in CLI. The CELA has superior SCI, AFS, and freedom from TER, with improved Q-TWiST and cost-effectiveness. [ABSTRACT FROM PUBLISHER]

We aimed to determine the long-term results after infrapopliteal PTA (primary patency, limb salvage, survival) and examine for association with risk factors (e.g. diabetes, infection, etc). We studied 268 patients with 282 critically ischemic limbs treated with PTA of at least one crural artery during a six-year period. Data included TASC II morphological classification of lesions and risk factors. Technical success rate was 97.2%, and overall mortality 0.7%. Patients with milder TASC lesions preserved primary patency longer than patients with more severe lesions. Similar results were obtained for limb salvage and survival. Fontaine stage, TASC class and postoperative infection of operated limb increased the risk for loss of primary patency and major amputation. Concomitant carotid stenosis was associated with loss of primary patency. Diabetes mellitus, preoperative ulcer or gangrene were associated with need of major amputation. PTA was a safe and effective treatment for CLI due to lesions of infrapopliteal vessels. [ABSTRACT FROM PUBLISHER]

Short- to mid-term results of a prospective study evaluating dual intramuscular and intra-arterial autologous bone-marrow mononuclear cell (BM-MNC) implantation for the treatment of patients with severe peripheral arterial occlusive disease (PAD) in whom amputation was considered the only viable treatment option are presented. Ankle-brachial indices (ABIs), rest pain, and ulcer healing were assessed at 3 months. Success was defined as improvement in ABI measurements; absence of rest pain; absence of ulcers; and absence of major limb amputations. Twenty patients (21 limbs) have been enrolled. Three-month follow-up evaluation accounting included 18 patients (19 limbs). Four (22.2%) major and 2 (11.1%) minor amputations were performed within 3 months postoperatively. With 17 (94.4%) of 18 limbs demonstrating at least one criterion for success and major amputation avoided in 14 (77.8%) of 18 limbs at the 3-month evaluation, this specific BM-MNC implantation technique is an effective limb salvage strategy for patients with severe PAD. [ABSTRACT FROM PUBLISHER]

Objectives: Many investigators including TransAtlantic Inter-Society Consensus (TASC) recommend against primary endovascular treatment for severe (TASC C and D) superficial femoral artery (SFA) disease. Vein bypass is preferable but may not be appropriate due to comorbidities or lack of suitable vein. This study reviews our results with Viabahn stent graft-assisted subintimal recanalization (VASIR) for TASC C and D SFA atherosclerosis. Methods: In all, 13 males and 14 females, mean age 72 ± 11 years underwent 28 VASIR for severe (TASC C 8 of 28, TASC D 20 of 28, and 5 of 28 no continuous infrapopliteal runoff artery) SFA disease. Indications were claudication (14 of 28 limbs), ischemic rest pain (6 of 28), and tissue loss (8 of 28). Viabahn stent graft-assisted subintimal recanalization was chosen instead of bypass due to comorbidities or lack of vein. Patients received aspirin and, if not already taking warfarin, they also received clopidogrel. Patients were examined with Ankle-brachial Index (ABI) and duplex scan at 1 month, then every 3 months after VASIR. Results Viabahn stent graft-assisted subintimal recanalization was technically successful in all. Ankle-brachial Index averaged 0.47 ± 0.17 preprocedure, 0.89 ± 0.20 postprocedure, and increased by 0.15 or more in every case. Median follow-up is 20 months. There were 3 perioperative (<30 days) and 7 later failures including revision prior to any thrombosis. One patient required amputation. Four have died, 2 with patent grafts, none from causes related to VASIR, all more than 30 days post-VASIR. Estimated 1-year primary and secondary patency were 70% ± 11% and 73% ± 10%. Failure was not significantly associated with indications, comorbidities, or runoff status. There was a clear distinction between patients with early failure and the rest of the patients. None of the 8 patients with failure in the first 8 months after surgery has a patent graft. However, of 17 grafts primarily patent at 8 months, only 2 have failed (1 thrombosed and 1 required preemptive balloon angioplasty). There was a strong trend toward better patency with 6 and 7 mm diameter compared to 5 mm diameter stent grafts. Furthermore, although warfarin was not prescribed as part of the protocol, no patient taking warfarin before and who resumed warfarin after VASIR (n = 4) suffered failure. Conclusions: Despite significant early failures, we found VASIR to be durable in those who did not have early failure. Viabahn stent graft-assisted subintimal recanalization is an acceptable alternative to vein bypass in selected patients with severe SFA disease. Smaller arterial or stent graft diameter may be associated with poorer results. Warfarin may be valuable to reduce the risk of failure after VASIR. [ABSTRACT FROM PUBLISHER]

Revascularization of patients with intermittent claudication (IC) is recommended only for selected patients who have chronic pain or disabling disease. However, improvement in the quality of life (QoL) could justify more widespread use.Objectives: To determine the effect of conservative treatment and revascularization on the QoL and physical performance of selected patients with IC.Patients and Methods: This nonrandomized, parallel group, follow-up study included 83 patients with IC at Fontaine stage II. On the basis of interventional opportunities and the risks and benefits, combined with the preference of the patient, 47 patients were treated conservatively and 41 were revascularized. The patients were examined at inclusion and 3 months later. The evaluations included the QoL measure Short Form 36 (SF-36), the Walking Impairment Questionnaire (WIQ), pain-free and maximal walking distance (treadmill at 3 km/h, no incline), maximal isometric knee-extension strength and endurance, and ankle—brachial blood pressure index (ABI).Results: At baseline, the SF-36 and WIQ scores and the ABI were significantly lower in the patients selected for revascularization. After revascularization, all dimensions of QoL and functional status increased significantly in the patients who underwent revascularisation compared with the patients treated conservatively. The difference in the change in the physical component summary of SF-36 was 29.4% (P < .001), in the total WIQ 63.6% (P = .0002), and in the pain-free and maximal walking distances 313% (P < .001) and 135% (P < .001), respectively. After adjustment for age, smoking, ABI, body mass index (BMI), and baseline values, the differences remained statistically significant.Conclusion: Revascularization above the knee increased QoL, functional status, and walking distance significantly in patients with moderate IC. [ABSTRACT FROM PUBLISHER]