Low-volume operators linked to worse outcomes after TAVR, M-TEER
Low operator volume is associated with significantly worse 30-day outcomes after transcatheter aortic valve replacement (TAVR) and mitral edge-to-edge repair (M-TEER), according to new findings published in JAMA Cardiology.[1] This trend was identified in both low- and high-volume facilities.
The study’s authors focused on data from more than 400,000 patients who underwent TAVR or M-TEER from 2020 to 2023 in the United States. This included more than 350,000 TAVR patients with a median age of 79 years old and more than 51,000 M-TEER patients with a median age of 79 years old. Women made up 42.4% of TAVR patients and 45.5% of M-TEER patients. All data came from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies (STS/ACC TVT) registry.
Exploring registry data on more than 350,000 TAVR patients
TAVR operators—which can be interventional cardiologists or cardiac surgeons—were categorized based on how many TAVRs they performed on an annual basis. Low-volume operators perform fewer than 15 TAVR procedures per year, medium-volume operators perform 15 to 37 TAVR procedures per year, and high-volume operators perform 38 TAVR procedures or more.
Overall, the composite outcome that included death, stroke, major bleeding events, acute kidney injury or moderate-to-severe paravalvular leak was seen in 3.7% of patients treated by a low-volume operator and 3.2% of patients treated by a high-volume operator. Low-volume operators were also associated with a higher 30-day mortality rate (2.4% vs. 2%), higher in-hospital complications rate (7.1% vs. 6.4%) and longer median procedure lengths (70 minutes vs. 60 minutes).
In addition, low-volume operators were less likely to perform valve-in-valve TAVR or a TAVR that involved alternative access. Lengths of stay, meanwhile, were the same for all groups.
Exploring registry data on more than 50,000 M-TEER patients
The same three volume-based categories were then built for M-TEER patients. Low-volume operators perform fewer than 8 M-TEER procedures per year, medium-volume operators perform 8 to 16 M-TEER procedures per year and high-volume operators perform more than 16 M-TEER procedures per year.
Overall, the composite outcome that included death, stroke, heart failure hospitalization or residual mitral regurgitation of 2 or higher was seen in 39.7% of patients treated by a low-volume operator and 35.3% of patients treated with a high-volume operator. While 30-day mortality was not different for the two groups, the in-hospital complication rate was higher for patients treated by a low-volume operator (4% vs. 3.2%).
Again, low-volume operators were linked to significantly longer procedures, but no change in length of stay.
“An inverse association was observed between annual operator volumes and the risk of the composite endpoint and complications after adjusting for differences in patient characteristics,” wrote first author Dharam J. Kumbhani, MD, SM , an interventional cardiologist with UT Southwestern Medical Center in Dallas, and colleagues. “Further, important process differences related to procedural efficiency and efficacy were noted between low- and high-volume operators for both procedures. The observed associations between operator volumes and outcomes was not modified by hospital volume. In other words, low-volume operators at both low- and high-volume hospitals had comparably worse outcomes than high-volume operators, regardless of hospital setting.”
Kumbhani et al. also emphasized the many reasons why this is such a critical topic to explore.
“Our analysis may help inform future policy documents for these procedures,” they wrote. “It also highlights the potential challenges associated with further expansion of TAVR and M-TEER to sites that do not currently meet volume requirements to initiate these programs, as this would lead to a further increase in low-volume operators and hospitals performing these procedures. To further inform these policies, long-term studies on transcatheter volumes and outcomes will be important to pursue.”
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Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.