Abstract TP119: Credentialing of Interventionists in a Large Randomized Trial
Introduction: Outcomes from endovascular procedures are highly dependent on the experience and skill of the operating physician. The multi-disciplinary CREST-2 Interventional Management Committee (IMC) was charged with credentialing a cohort of skilled interventionists with adequate contemporary case volumes.
Methods: Applicants were required to submit 25 consecutive cases completed within 5 years as primary operator out of a required total experience of ≥ 50 cases (≥ 20 for operators completing training). Interventionists not approved on initial review were asked to submit additional cases (with procedural angiograms), the number depending on quality and recent-quantity of the cases.
Results: The IMC has had 102 meetings, and 283 interventionists have been evaluated: 104 (37%) interventionists were cardiologists, 64 (23%) vascular surgeons, 42 (15%) neurosurgeons, 32 (11%) neuroradiologists, 26 (9%) neurologists, 9 (3%) interventional radiologists, and 6 (2%) other. The mean total experience among the 226 interventionists with available information was 220±263 carotid stent cases (median 135; range 10-2500). A total of 7037 cases have been reviewed by the IMC, dating from August 2001 to April 2016, with 3366 symptomatic, 3541 asymptomatic and 130 undetermined. The range of cases reviewed per interventionist was 5 to 50. Of the 251 interventionists with sufficient periprocedural follow-up data, no stroke events were reported by 152 (60.5%), and at least one or more stroke events were reported by 99 (39.5%). The IMC has approved 115 interventionists, 29 at the first review and 86 subsequently, based upon submission and review of 631 additional contemporary cases (mean=7 cases per interventionist); 122 have approval pending submission of additional cases; 33 have been denied; 8 have been deferred; 4 have been approved for the CREST-2 Companion Registry only; and 1 is pending decision.
Discussion: Rigorous evaluation and credentialing of carotid stenters in CREST-2 has been demanding, for the candidates and for the evaluators. Yet the cohort of interventionists so selected should be able to provide the high-quality stenting outcomes necessary for acceptance of the trial results.
Author Disclosures: G.S. Roubin: Honoraria; Modest; Royalty from Cook, Inc.. Ownership Interest; Modest; Essential Medical, Inc. D.V. Heck: Consultant/Advisory Board; Modest; Consultant for Stryker. C.J. White: None. K. Rosenfield: Research Grant; Modest; Abbott Vascular; Atrium; Lutonix-BARD; National Institutes of Health. Consultant/Advisory Board; Modest; Abbott Vascular, Cardinal Health, Surmodics, Vocalno-Philips, Cook. Other; Modest; Board of Directors: VIVA – 501c3 corporation; Consulting and/or personal investment: PQ Bypass; Primacea; Capture Vascular; VORTEX; MD Insider; Micell; shockwave; Cruzar Systems; Endospan; Eximo; Valc. G. Dabus: Consultant/Advisory Board; Modest; Consultant for Medtronic Neurovascular and Microvention/Terumo. T.G. Jovin: None. B.T. Jankowitz: None. B.T. Katzen: Consultant/Advisory Board; Modest; Scientific Advisory Board for WL Gore. W.A. Gray: Consultant/Advisory Board; Modest; Scientific Advisory Board for Medtronic and WL Gore. J.S. Matsumura: Research Grant; Modest; Abott, Cook, Medtronic, Endologix, Gore. L.N. Hopkins: Other Research Support; Modest; Toshiba. Honoraria; Modest; Memorial Healthcare System, Complete Conf. Management, Covidien. Consultant/Advisory Board; Modest; Consultant for Boston Scientific, Cordis, Abbott, Covidien, Medtronic; Board, Trustee, or Office Position for Claret Medical, Inc.. Other; Modest; Financial Interest: Boston Scientific, Valor Medical, Claret Medical, Inc., Augmenix, Endomation, Silk Road, Ostial, Apama, StimSox, Photolitec, ValenTx, Ellipse, Axtria, NextPlain, Ocular, The Stroke. D.M. Gamble: None. J.H. Voeks: None. S.M. Luke: None. B.K. Lal: None. J.F. Meschia: None. T.G. Brott: None.
- © 2017 by American Heart Association, Inc.