Brajesh K Lal1, James F Meschia2, Gary S Roubin3, Brian Jankowitz4, Donald Heck5, Tudor Jovin6, Christopher J White7, Kenneth Rosenfield8, Barry Katzen9, Guilherme Dabus10, William Gray11, Jon Matsumura12, L Nelson Hopkins13, Sothear Luke2, Jashank Sharma14, Jenifer H Voeks15, George Howard16, Thomas G Brott2. 1. Department of Surgery, University of Maryland, Baltimore, Md. Electronic address: blal@som.umaryland.edu. 2. Department of Neurology, Mayo Clinic, Jacksonville, Fla. 3. Department of Cardiology, Cardiovascular Associates of the Southeast/Brookwood, Baptist Medical Center, Birmingham, Ala. 4. Department of Neurosurgery, UPMC Presbyterian University Hospital, Pittsburgh, Pa. 5. Department of Radiology, Novant Health Clinical Research, Winston-Salem, NC. 6. Department of Neurology, UPMC Presbyterian University Hospital, Pittsburgh, Pa. 7. Department of Cardiology, Ochsner Health System, New Orleans, La. 8. Department of Cardiology, Massachusetts General Hospital, Boston, Mass. 9. Department of Interventional Radiology, Miami Cardiac and Vascular Institute at Baptist Hospital of Miami, Miami, Fla. 10. Department of Interventional Neuroradiology, Miami Cardiac and Vascular Institute at Baptist Hospital of Miami, Miami, Fla. 11. Department of Cardiology, Lankenau Medical Center, Wynnewood, Pa. 12. Department of Surgery, University of Wisconsin Hospital and Clinics, Madison, Wisc. 13. Department of Neurosurgery, SUNY Buffalo, Buffalo, NY. 14. Department of Surgery, University of Maryland, Baltimore, Md. 15. Department of Neurology, Medical University of South Carolina, Charleston, SC. 16. Department of Biostatistics, University of Alabama at Birmingham, Birmingham, Ala.
Abstract
BACKGROUND: The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) is a pair of randomized trials assessing the relative efficacy of carotid revascularization in the setting of intensive medical management (IMM) in patients with asymptomatic high-grade atherosclerotic stenosis. One of the trials assesses IMM with or without carotid artery stenting (CAS). Given the low risk of stroke in nonrevascularized patients receiving IMM, it is essential that there be low periprocedural risk of stroke for CAS if it is to show incremental benefit. Thus, credentialing of interventionists to ensure excellence is vital. This analysis describes the protocol-driven approach to credentialing of CAS interventionists for CREST-2 and its outcomes. METHODS: To be eligible to perform stenting in CREST-2, interventionists needed to be credentialed on the basis of a detailed Interventional Management Committee (IMC) review of data from their last 25 consecutive cases during the past 24 months along with self-reported lifetime experience case numbers. When necessary, additional prospective cases performed in a companion registry were requested after webinar training. Here we review the IMC experience from the first formal meeting on March 21, 2014 through October 14, 2017. RESULTS: The IMC had 102 meetings, and 8311 cases submitted by 334 interventionists were evaluated. Most were either cardiologists or vascular surgeons, although no single specialty made up the majority of applicants. The median total experience was 130 cases (interquartile range [IQR], 75-266; range, 25-2500). Only 9% (30/334) of interventionists were approved at initial review; approval increased to 46% (153/334) after submission of new cases with added training and re-review. The median self-reported lifetime case experience for those approved was 211.5 (IQR, 100-350), and the median number of cases submitted for review was 30 (IQR, 27-35). The number of CAS procedures performed per month (case rate) was the only factor associated with approval during the initial cycle of review (P < .00001). CONCLUSIONS: Identification of interventionists who were deemed sufficiently skilled for CREST-2 has required substantial oversight and a controlled system to judge current skill level that controls for specialty-based practice variability, procedural experience, and periprocedural outcomes. High-volume interventionists, particularly those with more recent experience, were more likely to be approved to participate in CREST-2. Primary approval was not affected by operator specialty.
BACKGROUND: The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) is a pair of randomized trials assessing the relative efficacy of carotid revascularization in the setting of intensive medical management (IMM) in patients with asymptomatic high-grade atherosclerotic stenosis. One of the trials assesses IMM with or without carotid artery stenting (CAS). Given the low risk of stroke in nonrevascularized patients receiving IMM, it is essential that there be low periprocedural risk of stroke for CAS if it is to show incremental benefit. Thus, credentialing of interventionists to ensure excellence is vital. This analysis describes the protocol-driven approach to credentialing of CAS interventionists for CREST-2 and its outcomes. METHODS: To be eligible to perform stenting in CREST-2, interventionists needed to be credentialed on the basis of a detailed Interventional Management Committee (IMC) review of data from their last 25 consecutive cases during the past 24 months along with self-reported lifetime experience case numbers. When necessary, additional prospective cases performed in a companion registry were requested after webinar training. Here we review the IMC experience from the first formal meeting on March 21, 2014 through October 14, 2017. RESULTS: The IMC had 102 meetings, and 8311 cases submitted by 334 interventionists were evaluated. Most were either cardiologists or vascular surgeons, although no single specialty made up the majority of applicants. The median total experience was 130 cases (interquartile range [IQR], 75-266; range, 25-2500). Only 9% (30/334) of interventionists were approved at initial review; approval increased to 46% (153/334) after submission of new cases with added training and re-review. The median self-reported lifetime case experience for those approved was 211.5 (IQR, 100-350), and the median number of cases submitted for review was 30 (IQR, 27-35). The number of CAS procedures performed per month (case rate) was the only factor associated with approval during the initial cycle of review (P < .00001). CONCLUSIONS: Identification of interventionists who were deemed sufficiently skilled for CREST-2 has required substantial oversight and a controlled system to judge current skill level that controls for specialty-based practice variability, procedural experience, and periprocedural outcomes. High-volume interventionists, particularly those with more recent experience, were more likely to be approved to participate in CREST-2. Primary approval was not affected by operator specialty.
Authors: Herbert D Aronow; Tyrone J Collins; William A Gray; Michael R Jaff; Bryan W Kluck; Rajan A G Patel; Kenneth A Rosenfield; Robert D Safian; Piotr S Sobieszczyk; Siddharth A Wayangankar; Christopher J White Journal: Catheter Cardiovasc Interv Date: 2015-11-25 Impact factor: 2.692
Authors: Greg D Sacks; Aaron J Dawes; Susan L Ettner; Robert H Brook; Craig R Fox; Melinda Maggard-Gibbons; Clifford Y Ko; Marcia M Russell Journal: Ann Surg Date: 2016-12 Impact factor: 12.969
Authors: L Nelson Hopkins; Gary S Roubin; Elie Y Chakhtoura; William A Gray; Robert D Ferguson; Barry T Katzen; Kenneth Rosenfield; Jonathan Goldstein; Donald E Cutlip; William Morrish; Brajesh K Lal; Alice J Sheffet; MeeLee Tom; Susan Hughes; Jenifer Voeks; Krishna Kathir; James F Meschia; Robert W Hobson; Thomas G Brott Journal: J Stroke Cerebrovasc Dis Date: 2010-03 Impact factor: 2.136
Authors: Frank L Silver; Ariane Mackey; Wayne M Clark; William Brooks; Carlos H Timaran; David Chiu; Larry B Goldstein; James F Meschia; Robert D Ferguson; Wesley S Moore; George Howard; Thomas G Brott Journal: Stroke Date: 2011-02-09 Impact factor: 7.914
Authors: Kenneth Rosenfield; Jon S Matsumura; Seemant Chaturvedi; Tom Riles; Gary M Ansel; D Chris Metzger; Lawrence Wechsler; Michael R Jaff; William Gray Journal: N Engl J Med Date: 2016-02-17 Impact factor: 91.245
Authors: Young Erben; James F Meschia; Donald V Heck; Fayaz A Shawl; Minerva Mayorga-Carlin; George Howard; Kenneth Rosenfield; John D Sorkin; Thomas G Brott; Brajesh K Lal Journal: Catheter Cardiovasc Interv Date: 2021-08-13 Impact factor: 2.585