Acute Outcomes With a Novel Plaque Modification System in Real-World Femoropopliteal Lesions
| Autor: | Louis Lopez, John P. Pigott, Thomas Zeller |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Drug coated balloon Databases Factual medicine.medical_treatment Lumen (anatomy) Scoring balloon Constriction Pathologic Peripheral Arterial Disease Coated Materials Biocompatible medicine.artery Angioplasty medicine Humans Popliteal Artery Radiology Nuclear Medicine and imaging Vascular Patency Aged Retrospective Studies Aged 80 and over Superficial femoral artery business.industry Stent Equipment Design Middle Aged Plaque Atherosclerotic United States Popliteal artery Europe Femoral Artery Treatment Outcome Feasibility Studies Female Stents Surgery Radiology Cardiology and Cardiovascular Medicine business Angioplasty Balloon Vascular Access Devices |
| Zdroj: | Journal of Endovascular Therapy. 26:333-341 |
| ISSN: | 1545-1550 1526-6028 |
| Popis: | Purpose: To report outcomes of a multicenter feasibility study using the FLEX Vessel Prep (VP) System, a novel technology that facilitates plaque incision and lumen gain in stenosed or occluded femoropopliteal arteries prior to balloon angioplasty. Materials and Methods: Two hundred fifty-five patients (mean age 71.8±9.1 years) were treated with the FLEX VP System at 38 centers between December 2015 and November 2017. Average lesion length was 133±88 mm. Average baseline stenosis was 92%±11%; 112 (44.3%) of 253 patients presented with a chronic total occlusion. Conventional or drug-coated balloon (DCB) angioplasty was performed in all patients after vessel preparation. Vessel measurements were derived from angiograms acquired at baseline, after FLEX passage, and after subsequent ancillary procedures. Logistic regression analyses were performed to identify baseline or procedure variables that predicted the need for provisional stenting. Results: Average percent reduction in vessel stenosis following treatment with the FLEX VP System was 27%±17%. No flow-limiting dissection, vessel perforation, or embolization was observed; 15 (5.9%) patients had minor (type A or B) dissections. Provisional stenting was performed in 49 (19.2%) patients. Average stenosis following angioplasty ± stenting was 9.1%±7.4%; 9 (3.6%) patients had significant residual stenosis ≥30%. Logistic regression analyses found that patients with dissections, longer lesions, and those receiving conventional balloon dilation alone were most likely to undergo stenting. Conclusion: In a real-world patient population with long, complex femoropopliteal lesions, use of the FLEX VP System as vessel preparation for angioplasty improved acute outcomes compared to historical controls. The rate of provisional stenting was low, and no serious vessel complications were observed. |
| Databáze: | OpenAIRE |
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