Vibrational Angioplasty in the Treatment of Chronic Femoropopliteal Arterial Occlusions: Preliminary Experience

Michalis, Lampros K.; Tsetis, Dimitrios; Katsamouris, Asterios; Rees, Michael R.; Sideris, Dimitris A.; Gourtsoyiannis, Nicholas

doi:10.1177/152660280100800615

Cited by 7 publications

(9 citation statements)

References 20 publications

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“…In cases where CTO crossing with standard guidewires was unsuccessful after 5 min of continuous attempt, patients were then enrolled in the trial and treated with the Wingman catheter (Reflow Medical, San Clemente, CA) prior to endovascular revascularization. The time period for attempted crossing with a standard guidewire was based off of precedent set by previous crossing catheter trials (usually 3 min in previous trials) 4,5,9‐17 ) . The Wingman catheter is an over‐the‐wire crossing catheter available in 0.014‐, 0.018‐, and 0.035‐in.…”

Section: Methodsmentioning

confidence: 99%

“…The primary endpoints of the trial were statistically compared to performance goals that were calculated based on results from other CTO crossing catheters 4,5,9‐17 . Study success required the lower one‐sided 95% confidence limit of the primary efficacy endpoint to exceed 70.7%, which was derived assuming an 83.2% crossing rate and a 12.5% margin.…”

Section: Methodsmentioning

confidence: 99%

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Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short‐term results from the international Wing‐It trial

Laird

Mathews

Brodmann

et al. 2020

Cathet Cardio Intervent

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Objectives To determine the safety and effectiveness of a peripheral artery chronic total occlusion (CTO) crossing catheter following failed crossing attempts with standard guidewires. Background CTO crossing remains a challenge during peripheral artery interventions. Methods In this prospective, international, single‐arm study, patients with a peripheral artery CTO that was uncrossable with standard guidewires were treated with a crossing catheter (Wingman, Reflow Medical). The primary efficacy endpoint of CTO crossing success was compared to a performance goal of 70.7%. The primary composite safety endpoint (major adverse event [MAE], clinically significant perforation or embolization, or grade C or greater dissection) was assessed over a 30‐day follow‐up period and compared to a performance goal of 13.0%. Results A total of 85 patients were treated using the Wingman catheter for peripheral artery CTO crossing. Key patient characteristics were mean age of 71±9 years, 66% male, and mean lesion length of 188±94 mm in the superficial femoral artery (71%), popliteal artery (15%), or infrapopliteal arteries (14%). Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%). Over 30 days of follow‐up, Rutherford score decreased by at least 2 categories in 74% patients; the percentage of patients with normal hemodynamics assessed with the ankle‐brachial index increased from 1% to 51%. Conclusions Among patients with a CTO that was unable to be crossed with a standard guidewire, the Wingman catheter was able to cross 90% of occlusions with a favorable safety profile.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short‐term results from the international Wing‐It trial

Laird

Mathews

Brodmann

et al. 2020

Cathet Cardio Intervent

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“…To facilitate intraluminal crossing of chronic total occlusions, we also used vibrational angioplasty in a subcohort of our patients (18). This is a method that uses a specially designed hand-held motorized device that produces vibrational motion to a 0.014 or 0.018 guide wire (19–21). Once the lesions were successfully crossed, our treatment strategy consisted of direct stenting of lesions prone to peripheral embolization, such as occlusions or complex stenoses in the aortoiliac axis and acute occlusions in the femoropopliteal region and primary balloon angioplasty of below-the-knee lesions (17,18,22).…”

Section: Methodsmentioning

confidence: 99%

Feasibility of ischemic leg ulcer healing using percutaneous techniques: a real-life study

et al. 2019

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Background Percutaneous transluminal angioplasty is established as the first-line vascular procedure in patients with lower extremity artery disease. Purpose We aimed to evaluate the technical and clinical effectiveness of percutaneous transluminal angioplasty in the management of ischemic foot ulcers. Material and Methods All consecutive patients presenting with a foot ulcer at the outpatient vascular surgery clinic of our hospital between June 2009 and June 2015 were evaluated using foot pulse assessment, ankle-brachial index, and duplex scanning. If non-invasive parameters suggested lower extremity artery disease, CT angiography and/or digital subtraction angiography were performed and a percutaneous transluminal angioplasty was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short- and long-term clinical success was evaluated based on ulcer size and appearance. Patients with worsening ulcers after percutaneous transluminal angioplasty underwent bypass grafting or amputation. Results Percutaneous transluminal angioplasty was performed in 161 patients (100%) with stenoses > 50%, including cases lesions > 10 cm and/or multiple/calcified lesions, 144 of which completed the study. In 88 (61.2%) patients, percutaneous transluminal angioplasty was performed in the suprapopliteal axis exclusively, in 10 (6.8%) patients in the infrapopliteal axis only, and in 46 (31.9%) in both levels. Percutaneous transluminal angioplasty was technically successful in 141 (98%) patients. After 3.1 years, the rate of healing was 68%, limb salvage 88%, overall survival 69.5%, and amputation-free survival 64%. Conclusion Our data suggest that percutaneous transluminal angioplasty for ischemic foot ulceration treatment is in the majority of patients feasible, effective, and safe with high rates of healing and limb salvage.

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“…The thermal laser angioplasty has been proved to be effective, with successful recanalization of the superficial femoral artery in 80% of cases and a primary patency rate of 50% at 1 year 32 . It has also been suggested that vibrational angioplasty, using coronary equipment, improves the recanalization rate in long chronic femoral occlusions with a 100% technical success rate and acceptable patency at 9 months 33 . Moreover, an interesting and promising technique seems to be cryoplasty; the angioplasty balloon is inflated with pressurized liquid nitrous oxide which cools to a temperature of −10°, freezing the plaque and inducing apoptosis.…”

Section: Chronic Critical Arterial Ischemiamentioning

confidence: 99%

Endovascular Therapies for Noncoronary Atherosclerosis in the Elderly: Aortoiliac and Femorotibial Lesions

Rigatelli¹,

Zanchetta²

2005

American J Geri Cardiology

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Many interventional cardiologists are becoming interested in the interventional treatment of noncoronary atherosclerotic disease. The elderly may be especially benefited by the application of many new techniques for the treatment of lower limb atherosclerosis, such as protection and thromboaspiration devices, new atherectomy devices, and cryoplasty. In this review the authors offer geriatric cardiologists an overview and an update of the most recent advances in techniques and results in the field of interventional treatment of aortoiliac and femorotibial artery atherosclerosis in the elderly.

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Vibrational Angioplasty in the Treatment of Chronic Femoropopliteal Arterial Occlusions: Preliminary Experience

Abstract: Vibrational angioplasty using coronary guidewires seems to be a promising ancillary technique in the management of chronic femoropopliteal arterial occlusions.

Cited by 7 publications

References 20 publications

Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short‐term results from the international Wing‐It trial

Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short‐term results from the international Wing‐It trial

Feasibility of ischemic leg ulcer healing using percutaneous techniques: a real-life study

Endovascular Therapies for Noncoronary Atherosclerosis in the Elderly: Aortoiliac and Femorotibial Lesions

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