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

Journal of Endovascular Therapy - Tập 24 Số 3 - Trang 355-366 - 2017
Arne Schwindt1, Johannes Bennett2, William H. Crowder2, Suhail Dohad3, Sean Janzer4, Jon C. George5, Barry Tedder6, Thomas P. Davis7, Ian Cawich8, Roger Gammon9, Patrick Muck10, John P. Pigott11, Dwight A. Dishmon12, Lou A. Lopez13, Jaafer Golzar14, Jack Chamberlin15, Michael J. Moulton16, Ramzan M. Zakir17, Amir K. Kaki18, Gary J. Fishbein19, Huey B. McDaniel20, Ayala Hezi‐Yamit21, John B. Simpson21,22, Arjun Desai21,23
1Department of Vascular Surgery, St. Franziskus-Hospital, Münster, Germany
2St Dominic-Jackson Memorial Hospital, Jackson, MI, USA
3Cedars Sinai Medical Center, West Hollywood, CA, USA
4Einstein Medical Center, Philadelphia, PA, USA
5Deborah Heart and Lung Center, Brown Mills, NJ, USA
6St Bernards Medical Center, Jonesboro, AR, USA
7St John Hospital and Medical Center, Detroit, MI, USA
8Arkansas Heart Hospital, Little Rock, AR, USA
9Heart Hospital of Austin, TX, USA
10Good Samaritan Hospital, Cincinnati, OH, USA
11Jobst Vascular Institute Promedica Toledo Hospital, Toledo, OH, USA
12Methodist South Hospital, Memphis, TN, USA
13St Joseph's Hospital, Fort Wayne, IN, USA
14Advocate Christ Hospital and Medical Center, Oak Lawn, IL, USA
15Alexian Brothers Medical Center, Elk Grove Village, IL, USA
16University of Nebraska Medical Center, Omaha, NE, USA
17St Peters University Hospital, New Brunswick, NJ, USA
18DMC Cardiovascular Institute Harper-Hutzel Hospital, Detroit, MI, USA
19Good Samaritan Hospital, Dayton, OH. USA
20Coastal Vascular and Interventional, Pensacola, FL, USA
21Avinger Inc, Redwood City, CA, USA
22Sequoia Hospital, Redwood City, CA, USA
23Stanford University Medical Center, Stanford, CA, USA

Tóm tắt

Purpose: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)–guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. Methods: 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. Results: 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. Conclusion: 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.

Từ khóa


Tài liệu tham khảo

10.1161/CIRCULATIONAHA.111.033878

10.1161/CIRCOUTCOMES.108.775247

10.1016/S0140-6736(13)61249-0

10.1016/j.ccl.2014.09.008

10.3400/avd.ra.13-00124

Jones WS, Schmit KM, Vemulapalli S, et al. Treatment strategies for patients with peripheral artery disease [Internet]. Rockville, MD: Agency for Healthcare Research and Quality; May 2013. http://www.ncbi.nlm.nih.gov/books/NBK148574/.

10.1002/ccd.26349

10.1111/ans.12897.

10.1177/1526602815597683

10.1583/12-4091.1

Terashima M, 2009, J Invasive Cardiol, 21, 602

10.1016/j.atherosclerosis.2015.08.014

10.1007/s00270-010-0092-8

10.1177/1526602816657392

10.1053/j.tvir.2009.10.006

Korabathina R, 2010, Vasc Dis Manage, 7, E110

10.1007/s11886-015-0643-3

10.1583/05-1780MR.1

10.1016/j.jcin.2014.05.006

George JC., Paper presented at: LINC 2016

10.1016/j.jcin.2014.10.016

10.1177/1538574415607361

Virmani R., Paper presented at: LINC 2015

Tepe G., Paper presented at: LINC 2015

10.1177/1526602816683933

10.1016/j.jcmg.2012.01.007

10.1016/j.jcin.2009.06.019

10.1177/2048004016658142

Thông tin
Thông tin xuất bản

Journal of Endovascular Therapy

Tập 24 Số 3

355-366

Thông tin tác giả