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- Title
Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study.
- Authors
Schwindt, Arne G.; Bennett, J. Gray; Crowder, William H.; Dohad, Suhail; Janzer, Sean F.; George, Jon C.; Tedder, Barry; Davis, Thomas P.; Cawich, Ian M.; Gammon, Roger S.; Muck, Patrick E.; Pigott, John P.; Dishmon, Dwight A.; Lopez, Lou A.; Golzar, Jaafer A.; Chamberlin, Jack R.; Moulton, Michael J.; Zakir, Ramzan M.; Kaki, Amir K.; Fishbein, Gary J.
- Abstract
<bold>Purpose: </bold>To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease.<bold>Methods: </bold>The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance.<bold>Results: </bold>The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy.<bold>Conclusion: </bold>OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.
- Subjects
GERMANY; UNITED States; PERIPHERAL vascular disease treatment; ANGIOPLASTY; BLOOD vessels; CLINICAL competence; COMPARATIVE studies; ENDARTERECTOMY; FEMORAL artery; LEARNING; LEG; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; MEDICAL equipment; PERIPHERAL vascular diseases; RESEARCH; SURGICAL stents; TIME; PRODUCT design; EVALUATION research; STENOSIS; OPTICAL coherence tomography; TREATMENT effectiveness; PREDICTIVE tests; POPLITEAL artery; EQUIPMENT &; supplies
- Publication
Journal of Endovascular Therapy, 2017, Vol 24, Issue 3, p355
- ISSN
1526-6028
- Publication type
journal article
- DOI
10.1177/1526602817701720