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Gray, WA; Cardenas, JA; Brodmann, M; Werner, M; Bernardo, NI; George, JC; Lansky, A.
Treating Post-Angioplasty Dissection in the Femoropopliteal Arteries Using the Tack Endovascular System: 12-Month Results From the TOBA II Study.
JACC Cardiovasc Interv. 2019; 12(23):2375-2384
Doi: 10.1016/j.jcin.2019.08.005
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- Co-authors Med Uni Graz
- Brodmann Marianne
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- Abstract:
- The aim of this study was to evaluate the Tack Endovascular System (Intact Vascular, Wayne, Pennsylvania) for treating dissections following angioplasty in the superficial femoral artery and/or proximal popliteal artery. Dissection after angioplasty of femoropopliteal arteries with either a plain balloon or a drug-coated balloon (DCB) can negatively affect both short- and long-term outcomes. TOBA (Tack Optimized Balloon Angioplasty) II is a prospective, single-arm, multicenter study enrolling 213 patients, all with dissection following angioplasty. Eligibility included Rutherford classification 2 to 4 with a de novo or nonstented restenotic lesion in the superficial femoral artery or proximal popliteal artery undergoing plain balloon or DCB angioplasty. Following dilation, lesions with <30% residual stenosis and presence of ≥1 dissection were enrolled. The 12-month efficacy endpoint was primary patency (freedom from duplex-derived binary restenosis and clinically driven target lesion revascularization. Patients' mean age was 68 ± 9 years, and 43.2% had diabetes. Twenty-three percent of lesions were chronic total occlusions, and ∼60% had moderate to severe calcium. The mean lesion length was 74.3 ± 40.6 mm. Severe dissection (grade ≥C) was present in 69.4%. By operator choice, 57.7% of patients underwent DCB angioplasty. Most (92.1%) dissections resolved completely, and only 1 bailout stent was required. There were no 30-day major adverse events. The 12-month efficacy endpoint was met, with Kaplan-Meier primary patency and freedom from clinically driven target lesion revascularization of 79.3% and 86.5%, respectively. At 12 months, there were no device fractures or clinically significant migrations, and significant improvements were noted in Rutherford category, ankle-brachial index, and quality of life. TOBA II demonstrated the safety and efficacy of the Tack Endovascular System for focal dissection repair following standard and DCB angioplasty. Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Angioplasty, Balloon - adverse effects
- Angioplasty, Balloon - instrumentation
- Blood Vessel Prosthesis -
- Blood Vessel Prosthesis Implantation - adverse effects
- Blood Vessel Prosthesis Implantation - instrumentation
- Blood Vessel Prosthesis Implantation -
- Female -
- Femoral Artery - diagnostic imaging
- Femoral Artery - injuries
- Femoral Artery - physiopathology
- Femoral Artery - surgery
- Humans -
- Male -
- Middle Aged -
- Peripheral Arterial Disease - diagnostic imaging
- Peripheral Arterial Disease - physiopathology
- Peripheral Arterial Disease - therapy
- Popliteal Artery - diagnostic imaging
- Popliteal Artery - injuries
- Popliteal Artery - physiopathology
- Popliteal Artery - surgery
- Prospective Studies -
- Prosthesis Design -
- Risk Factors -
- Stents -
- Time Factors -
- Treatment Outcome -
- Treatment Outcome -
- Vascular Access Devices -
- Vascular Patency -
- Vascular System Injuries - diagnostic imaging
- Vascular System Injuries - etiology
- Vascular System Injuries - physiopathology
- Vascular System Injuries - therapy
- Find related publications in this database (Keywords)
- angioplasty
- dissection
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