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Background: Chronic total occlusions (CTOs) are reported in up to 40% of patients with symptomatic peripheral arterial disease. The Viance Crossing catheter (Covidien) and the CrossBoss catheter (Boston Scientific) are novel devices that facilitate either true lumen or subintimal navigation across CTOs. The purpose of this study was to examine the acute procedural success of these devices for popliteal and below-the-knee (BTK) CTOs., Methods: Clinical and procedural outcome data between Sept 2010 and October 2013 were analyzed from the ongoing multicenter XLPAD registry. Technical success was defined as true lumen passage of the catheter, while procedural success was defined as successful vessel revascularization inclusive of subintimal passage and reentry., Results: Twenty-nine patients underwent 31 procedures, in which 37 lesions were treated with the Viance and CrossBoss catheters. Mean age of the group was 69.1 ± 10.7 years and 26 patients were male (90%). All patients (100%) had hypertension, 62% were diabetic, and 48% were active smokers. Critical limb ischemia was the indication for the procedure in 58% of cases; mean Rutherford class was 4.2 ± 1.2 for the entire cohort. Target CTOs included 14 anterior tibial, 9 posterior tibial, 5 peroneal, 1 tibio-peroneal trunk, and 8 popliteal artery lesions. Mean lesion length was 81 ± 64 mm; 15 lesions (41%) were severely calcified. True lumen passage was obtained in 24 lesions (65% technical success). Subintimal entry was achieved in 5 lesions (14%). Procedural success was achieved in 26 lesions (70%). Procedural failure was related to longer lesion length (P<.001), and mean length of failed lesions was 136 ± 65 mm., Conclusion: Viance and CrossBoss catheters were associated with an overall 70% procedural success with predominantly true lumen crossing in a BTK-CTO cohort. CTO length remains an important determinant of device success.

Background: There are limited data regarding contemporary use of stent and non-stent based treatment strategies of infrainguinal peripheral artery disease (PAD)., Methods: We analyzed data from the ongoing multicenter XLPAD registry between July 2005 and October 2013 to report on the use of non-stent (atherectomy ± balloon angioplasty) and stent-based treatment of superficial femoral artery (SFA), popliteal, and below-the-knee (BTK) vessels in contemporary clinical practice., Results: A total of 584 interventions (SFA, 82.5%; popliteal, 7.2%; BTK, 9.9%) were performed in 372 patients (mean age, 63.2 years; diabetes mellitus, 57.7%; Rutherford category 1-3, 73.5%; Rutherford category 4-6, 20.1%). Stents were deployed in 389 lesions (66.6%; SFA, 90.5%; popliteal, 5.1%; BTK, 4.1%) and non-stent strategy (atherectomy, 49%) in 195 lesions (33.4%; SFA, 66.7%; popliteal, 11.3%; BTK, 21.5%). In the stent and non-stent groups, mean lesion lengths were 133.9 mm and 86.0 mm (P<.001), chronic total occlusions (CTOs) constituted 63.0% and 49.7% (P<.01), and restenotic lesions were 12.6% and 32.3% (P<.001), respectively. At a mean follow-up of 260 ± 130 days, in the stent and non-stent treated patients, all-cause mortality was 4.3% and 3.5% (P=.65), clinically indicated repeat revascularization was 17.5% and 14.9% (P=.42), and amputation was 4.6% and 9.2% (P<.01), respectively. SFA lesion location, long lesion length, and CTO were associated with the use of stents. Advanced Rutherford class was associated with a non-stent treatment strategy., Conclusion: The majority of endovascular peripheral arterial interventions are performed in the SFA; most include a CTO and in patients with diabetes mellitus. Operators use stents to primarily treat complex SFA lesions with overall similar outcomes, except for fewer amputations compared to a non-stent strategy.

Endovascular intervention has become a well-recognized treatment modality for peripheral artery disease; however, mid- and long-term outcomes have been plagued by limited durability. Plain balloon angioplasty and bare-metal stents have historically suffered from high restenosis rates leading to the need for frequent repeat revascularization procedures. The innovation of locally administered, drug-delivering balloons and stents has been a direct result of technological innovations directed toward prevention and treatment of this limitation. Over the last 5 years, numerous clinical trials investigating the use of drug-coated stents and drug-coated balloons indicate a significant improvement in endovascular treatment durability and outcomes. This review provides an up-to-date assessment of the current evidence for the use of drug-coated stents and drug-coated balloons in the treatment of femoropopliteal and infrapopliteal peripheral artery disease. Additionally, it provides an overview of the development of this technology, highlights landmark ongoing and completed clinical trials, examines evidence to support the use of drug-coated technologies in combination with other modalities, and examines promising new technological developments. Last, it summarizes the challenges and safety concerns that have delayed U.S. Food and Drug Administration approval of these devices., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: Crossing of lower-extremity arterial chronic total occlusion (CTO) can be challenging. Use of the Viance peripheral CTO crossing device (Covidien) in the superficial femoral (SFA), popliteal, and below-the knee (BTK) arterial locations has received limited study., Methods: Fifty-eight patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) were treated between April 2010 and November 2013 with the Viance device. The procedural and 30-day clinical outcomes were collected., Results: Mean age was 65.5 ± 8.7 years and 55.1% had diabetes mellitus. Most lesions (n = 58) were TASC classification type C (n = 16; 27.6%) and D (n = 16; 27.6%), with mean lesion length 140.0 ± 71.0 mm; 93.1% of lesions were de novo and 81.0% were severely calcified. Technical success (crossing without the use of a reentry device) was achieved in 87.9% of cases and procedural success was obtained in 86.2%; 51.7% of lesions received stents, with the remaining treated with balloon angioplasty and/or atherectomy. Average fluoroscopy time was 39.1 ± 21.2 min, with 187.8 ± 72.0 mL of contrast and 210.0 ± 212.0 Gy cm² radiation dose-area product. There was 1 periprocedural complication (access-site hematoma treated conservatively without blood transfusion). At 30 days post procedure, there was significant improvement in ankle-brachial index (0.72 ± 0.30 to 0.84 ± 0.16; P=.01) and Rutherford class (3.33 ± 0.81 to 1.54 ± 1.47; P<.001). Clinically-indicated target vessel revascularization, surgical intervention or amputation at 30 days was 5.2%., Conclusion: Use of Viance to cross infrainguinal arterial CTO was associated with high success, low complication rates, and significant symptom improvement.

Purpose: To report experience with a recently approved peripheral chronic total occlusion (CTO) crossing device in the superficial femoral (SFA), popliteal, and below-the-knee (BTK) arteries. Methods: Thirteen patients (all men; mean age 68.6±7.9 years) from the XLPAD registry (ClinicalTrials.gov identifier NCT01904851) were treated between April 2012 and August 2013 with the TruePath device after an unsuccessful guidewire crossing attempt. More than half of the patients had diabetes mellitus. Most lesions were TASC classification type C (n=5) or D (n=6), with mean lesion length 169.8±83.3 mm; 12 lesions were de novo and severely calcified. Procedure success was defined as successful revascularization of the CTO. Technical success was placement of a guidewire beyond the distal CTO cap into the true lumen without the need for a re-entry device. Results: All CTOs were successfully crossed using the TruePath, but 3 subintimal recanalizations required the use of a re-entry device (77% technical success). Eight lesions were stented, while the remaining were treated with balloon angioplasty and/or atherectomy. Average fluoroscopy time was 41.1 ±18.3 minutes, during which a mean 200.0±46.2 mL of iodinated contrast were used (radiation dose area product 211.2±202.6 Gy*cm2). There were no periprocedural complications. Significant improvement was seen in the 6-month ankle-brachial index (p=0.018) and Rutherford class (p=0.019). The 6-month clinically indicated target vessel revascularization rate was 8%. Conclusion: TruePath facilitated successful crossing of infrainguinal CTOs following an unsuccessful guidewire recanalization, with significant improvement in symptoms and no complications. [ABSTRACT FROM AUTHOR]

Purpose:To present a systematic safety evaluation of the CrossBoss blunt microdissection catheter for crossing peripheral chronic total occlusions (CTOs). Methods: Between July 2010 and July 2011, 15 patients (all men; mean age 60.7±9.1 years) underwent endovascular treatment of 17 infrainguinal CTOs that were resistant to guidewire passage, so the blunt microdissection catheter was employed to recanalize the artery. Fourteen lesions were de novo and 3 were ¡n-stent restenoses. Sixteen lesions were in the superficial femoral artery; 8 of 17 CTOs were TASC II type D. Extensive calcification was present in 12 lesions. Mean lesion length was 182.9±66.2 mm (range 57-296). Results: Procedural success was 100% and successful crossing without the use of a re-entry device (technical success) was achieved in 15 cases. Twelve lesions were stented. Average fluoroscopy time was 36.5±21.2 minutes (143.8±76.9 Gy*cm² radiaton dose area product), during which a mean 172.1 ±62.2 mL of iodinated contrast were used. Two patients had access site hematomas that were treated conservatively, and there was no perforation, distal embolization, amputation, or need for urgent revascularization. During the mean follow-up of 11.4±0.1 months, 1 patient died, and none required an amputation or surgical revascularization. There was a significant improvement in ankle-brachial index (0.6±0.1 to 0.8±0.2, p=0.001) and symptoms as assessed by Rutherford class at 1 year. Four of 17 limbs required secondary revascularization procedures within 1 year. Conclusion: The CrossBoss blunt microdissection catheter facilitated successful crossing of CTOs in patients with infrainguinal lesions following unsuccessful guidewire crossing, with an acceptably low rate of periprocedural complications and significant improvement in symptoms. [ABSTRACT FROM AUTHOR]