Treating Post-Angioplasty Dissection in the Femoropopliteal Arteries Using the Tack Endovascular System: 12-Month Results From the TOBA II Study.

MedStar author(s):
Citation: Jacc: Cardiovascular Interventions. 12(23):2375-2384, 2019 12 09.PMID: 31806218Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Angioplasty, Balloon/ae [Adverse Effects] | *Blood Vessel Prosthesis | *Blood Vessel Prosthesis Implantation/is [Instrumentation] | *Femoral Artery/su [Surgery] | *Peripheral Arterial Disease/th [Therapy] | *Popliteal Artery/su [Surgery] | *Vascular System Injuries/th [Therapy] | Aged | Angioplasty, Balloon/is [Instrumentation] | Blood Vessel Prosthesis Implantation/ae [Adverse Effects] | Europe | Female | Femoral Artery/dg [Diagnostic Imaging] | Femoral Artery/in [Injuries] | Femoral Artery/pp [Physiopathology] | Humans | Male | Middle Aged | Peripheral Arterial Disease/dg [Diagnostic Imaging] | Peripheral Arterial Disease/pp [Physiopathology] | Popliteal Artery/dg [Diagnostic Imaging] | Popliteal Artery/in [Injuries] | Popliteal Artery/pp [Physiopathology] | Prospective Studies | Prosthesis Design | Risk Factors | Stents | Time Factors | Treatment Outcome | United States | Vascular Access Devices | Vascular Patency | Vascular System Injuries/dg [Diagnostic Imaging] | Vascular System Injuries/et [Etiology] | Vascular System Injuries/pp [Physiopathology]Year: 2019Local holdings: Available online through MWHC library: 2008 - presentISSN:
  • 1936-8798
Name of journal: JACC. Cardiovascular interventionsAbstract: BACKGROUND: 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.CONCLUSIONS: TOBA II demonstrated the safety and efficacy of the Tack Endovascular System for focal dissection repair following standard and DCB angioplasty. Copyright (c) 2019 The Authors. Published by Elsevier Inc. All rights reserved.METHODS: 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.OBJECTIVES: 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.RESULTS: 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.All authors: Bernardo NI, Brodmann M, Cardenas JA, George JC, Gray WA, Lansky A, Werner MOriginally published: Jacc: Cardiovascular Interventions. 12(23):2375-2384, 2019 Dec 09.Fiscal year: FY2020Digital Object Identifier: Date added to catalog: 2020-01-03
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 31806218 Available 31806218

Available online through MWHC library: 2008 - present

BACKGROUND: 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.

CONCLUSIONS: TOBA II demonstrated the safety and efficacy of the Tack Endovascular System for focal dissection repair following standard and DCB angioplasty. Copyright (c) 2019 The Authors. Published by Elsevier Inc. All rights reserved.

METHODS: 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.

OBJECTIVES: 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.

RESULTS: 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.

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