A new research letter shows a decrease in the use of embolic protection devices with transcatheter aortic valve replacement (TAVR) post-PROTECTED TAVR trial results. These data were reported by Marwan Saad, MD, PhD, from the Brown University Cardiovascular Institute, Providence, and colleagues, in a manuscript published Wednesday online in JACC: Cardiovascular Interventions. Research on the use of embolic protection devices (EPD) to capture debris during TAVR for the treatment of aortic stenosis (AS) is limited. PROTECTED TAVR (Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement) was a multicenter, international study where a total of 3,000 patients were randomized to either cerebral embolic protection (CEP, n=1,501) or no CEP (control, n=1,499). The results were originally published in the New England Journal of Medicine by Samir R. Kapadia, MD, of the Cleveland Clinic, and colleagues, in September 2022. The primary endpoint, stroke within 72 hours after TAVR or before discharge in the intent-to-treat population, was not met. The investigators in this present study utilized the Vizient Clinical Database to identify readmission data from over 1,000 US academic medical centers and affiliated hospitals that used EPD with percutaneous TAVR from October 2021 to September 2022. Four categories separated hospitals in this analysis by the percentage of cases using EPD: <25%, 20%-50%, 50%-75% and >75%. The change in hospital EPD use in the year post-publication of the PROTECTED TAVR trial (November 2022 – October 2023) was the primary endpoint of this study. A total of 88,158 TAVRs performed across 321 hospitals included in this study, and 11.9% of these cases utilized EPD. The categories were as follows: 85.1% (<25%), 6.9% (25%-50%), 6.2% (50%-75%) and 1.9% (>75%). In year two, there was an overall decrease in EPD use, hospitals with <25% had 98.2% of patients remain in the same category, 45.5% of patients in the 25%-50% category dropped down to the <25% category, 65% of patients in the 50%-75% category dropped to one of the lower categories and 50% of patients in the >75% category dropped to one of the lower categories. Of the 321 hospitals in this study, 17 also participated in the PROTECTED TAVR trial, which did not meet its primary endpoint. The authors of this present study noticed a decline in the use of EPD, and they estimated this may be partially due to the decline in the number of hospitals that routinely use EPD. Roughly 1 in 10 TAVR procedures in the US uses EPD. The authors of this study also noted that enrollment in the British Heart Foundation (BHF) PROTECT-TAVI study on this subject was terminated, after an analysis of 7,490 randomized patients, due to futility and inability to rule out the potential for harm. Results from the BHF study will be presented later in 2025. Overall, the investigators in this study recommended further research on the use of EPD during TAVR, and this present study showed a modest decline in the use of EPD in the US after the PROTECTED TAVR trial. Sources: Saad M, Has P, Elkaryoni A, et al. Embolic protection device use with transcatheter aortic valve replacement after PROTECTED TAVR trial. JACC Cardiovasc Interv. 2025 March 19 (Article in Press). Kapadia SR, Makkar R, Leon M, et al. Cerebral embolic protection during transcatheter aortic-valve replacement. N Engl J Med. 2022;387(14):1253– 1263. https://doi.org/10.1056/NEJMoa2204961 Image Credit: Kadmy – stock.adobe.com