ABSTRACT
Objective With the recent expansion of the Centers for Medicare and Medicaid Services (CMS) coverage, transfemoral carotid artery stenting (tfCAS) is expected to play a larger role in the management of carotid disease. Existing research on the tfCAS learning curve, primarily conducted over a decade ago, may not adequately describe the current effect of physician experience on outcomes. This study evaluates the tfCAS learning curve using VQI data.
Methods We analyzed tfCAS patient data from 2005-2023. Each physician’s procedures were chronologically grouped into 12 categories, from procedure counts 1-25 to 351+. Primary outcome was in-hospital stroke/death rate; secondary outcomes were in-hospital stroke/death/MI, 30-day mortality, and in-hospital stroke/TIA. The relationship between outcomes and procedure counts was analyzed using Cochran Armitage test and a generalized linear model with restricted cubic splines, validated using generalized estimating equations.
Results We analyzed 43,147 procedures by 2,476 physicians. In symptomatic patients, there was a decrease in rates of in-hospital stroke/death (procedure counts 1-25 to 351+: 5.2% to 1.7%), in-hospital stroke/death/MI (5.8% to 1.7%), 30-day mortality (4.6% to 2.8%), in-hospital stroke/TIA (5.0% to 1.1%) (all p-values<0.05). The in-hospital stroke/death rate remained above 4% until 235 procedures. Similarly, in asymptomatic patients, there was a decrease in rates of in-hospital stroke/death (2.1% to 1.6%), in-hospital stroke/death/MI (2.6% to 1.6%), 30-day mortality (1.7% to 0.4%), and in-hospital stroke/TIA (2.8% to 1.6%) with increasing physician experience (all p-values<0.05). The in-hospital stroke/death rate remained above 2% until 13 procedures.
Conclusions In-hospital stroke/death and 30-day mortality rates post-tfCAS decreased with increasing physician experience, showing a lengthy learning curve consistent with previous reports. Given that physicians’ early cases may not be included in the VQI, the learning curve was likely underestimated. With the recent CMS coverage expansion for tfCAS, a significant number of physicians would enter the early stage of the learning curve, potentially leading to increased post-operative complications.
Type of Research Retrospective analysis of prospectively collected Vascular Quality Initiative registry data.
Key Findings In patients undergoing tfCAS in VQI, in-hospital stroke/death, in-hospital stroke/death/MI, 30-day mortality and in-hospital stroke/TIA decreased with increasing physician experience in both symptomatic and asymptomatic patients. In symptomatic patients, in-hospital stroke/death rate did not drop below 4% until after 235 procedures, and it remained above 2% until 13 procedures in asymptomatic patients.
Take home Message This study showed a decrease in post-operative in-hospital stroke/death with a substantially high risk in an operator’s first 25 procedures in VQI. The recent expansion of the Center for Medicare and Medicare Services coverage of tfCAS warrants caution since a rise in early-phase physicians could lead to increased post-operative complication rates in transfemoral carotid artery stent patients.
Table of Contents Summary In this retrospective analysis of the tfCAS learning curve, in-hospital stroke/death, in-hospital stroke/death/MI, 30-day mortality, and in-hospital stroke/TIA rates decreased significantly with increased physician experience. With the recent CMS coverage expansion for tfCAS, more physicians would enter the early stage of the learning curve, potentially leading to increased post-operative complications.
Competing Interest Statement
The authors have declared no competing interest.
Funding Statement
Grant support: - This work in part was funded by NIH 5T35HL110843 fellowship award to ?Strauss, S.? - AS is supported by the Harvard-Longwood Research Training in Vascular Surgery NIH T32 Grant #5T32HL007734-29 -This work was conducted with support from Harvard Catalyst (NIH grant #UL1 TR002541)
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
This study was approved by the Beth Israel Deaconess Medical Center institutional IRB, informed consent for participation was waived due to the deidentified retrospective nature of the data.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data Availability
Data are available upon request for all VQI centers. R codes for data analysis are available upon request.