Factors influencing credentialing of interventionists in the CREST-2 trial

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 rereview. 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)(28)(29)(30)(31)(32)(33)(34)(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.

Safety of the transradial approach to carotid stenting

“…Li and colleagues reported a transfemoral access complication rate of 9.02% and a transradial access complication rate of 3.73%. The major difference between our results and the results published by Li and colleagues is that C2R interventionists are a highly selected and skilled group that has undergone rigorous credentialing and quality assurance 11,12 . Therefore, our observed low complication rates may not be representative of the general community's experience.…”

“…The major difference between our results and the results published by Li and colleagues is that C2R interventionists are a highly selected and skilled group that has undergone rigorous credentialing and quality assurance. 11,12 Therefore, our observed low complication rates may not be representative of the general community's experience. In addition, although this is one of the largest series of collective experience with transradial CAS, the low event rates mean that small differences in access site complications or stroke or death between the two approaches could be missed.…”

“…Our aim is to compare the periprocedural risks of CAS performed transradially relative to CAS performed transfemorally in C2R (clinicaltrial.gov identifier: NCT02240862), a study which has the advantage of procedural oversight and quality assurance provided by the Registry Management Committee. 11,12 2 | METHODS…”

“…The CREST‐2 Registry (C2R) was initiated as a companion to the trial to help maintain, enhance, and ensure requisite expertise in CAS and ensure the conduct of a rigorous comparison of high‐quality carotid stenting to IMM. Our aim is to compare the periprocedural risks of CAS performed transradially relative to CAS performed transfemorally in C2R (http://clinicaltrial.gov identifier: NCT02240862), a study which has the advantage of procedural oversight and quality assurance provided by the Registry Management Committee 11,12 …”

Vascular Surgery and Neurosurgery

“…CREST-2 also reported on factors influencing trial credentialing 6 and on implementation of intensive risk factor treatment. 7 Early symptomatic stenting versus surgery trials reported variable stroke risks, and some interventionists had little CAS experience.…”