• TAVR Outcomes May Be Impacted by Center’s Valve Preference: Registry Data

    Overall preference of balloon-expandable valves (BEVs) or self-expanding valves (SEVs) at a center has a significant effect on transcatheter aortic valve replacement (TAVR) outcomes when stratified to valve type, according to a new analysis of registry data.

    The study, published online Monday and in the June 27 issue of JACC: Cardiovascular Interventions, compared outcomes of TAVR procedures using third-generation BEVs and SEVs stratified by center valve preference – finding that periprocedural outcomes, aortic regurgitation (AR) greater than mild, and 2-year mortality are worse when TAVR is performed using SEVs at BEV-dominant centers.

    However, outcomes were found to be similar regardless of valve type at SEV-dominant centers, said the authors, led by Guy Witberg, MD, MPH, from Rabin Medical Center and Tel-Aviv University, Israel.

    “Data comparing TAVR outcomes using BEVs and SEVs are scarce,” said the authors. “Research on the interaction between center valve preference and BEV and SEV outcomes is even more limited.”

    “Our data suggest that center valve preference has a significant effect on TAVR outcomes when stratified to valve type,” they said. “Although BEV outcomes are similar regardless of valve preference, using SEVs at BEV-dominant centers is associated with increased mid-term mortality and higher risk for several periprocedural complications.”

    Study setup

    Witberg and colleagues analyzed data from a multi-center registry, including 17 centers and a total of 7,528 TAVR procedures (3,854 with SEVs and 3,674 with BEVs). A total of 13 centers were found to exhibit valve preference for either BEV or SEV – defined as a single valve type accounting for between 66.6% and 90% of the total procedural volume. Eight centers were classified as SEV-dominant and the remaining five as BEV-dominant.

    Patient and procedural characteristics, as well as periprocedural and intermediate term (2-year) outcomes, were compared between TAVR procedures performed using BEVs and SEVs, stratified by center dominance (BEV- or SEV-dominant center).

    At baseline, patients undergoing TAVR procedures were an average age of 81.0 years and had a mean Society of Thoracic Surgeons (STS) score of 5.2%. Femoral access was used in 94.9% of procedures, noted the research team, adding that patients treated with BEVs were more often men, and balloon pre-dilatation was used more frequently with SEVs. All other characteristics were similar between BEVs and SEVs, they said.

    The primary endpoint was 2-year mortality, while secondary endpoints included in-hospital complications (defined according to the Valve Academic Research Consortium 2 definitions) and pre-discharge valve hemodynamic status.

    Key findings

    The research team reported a significant interaction between center valve preference and mortality with SEVs vs. BEVs. Two-year mortality was higher with SEVs at BEV-dominant centers, but not at SEV-dominant centers (21.9% vs 16.9% [P = 0.021] and 16.8% vs 16.5% [P = 0.642], respectively; hazard ratio [HR]: 1.20; P for interaction = 0.032).

    Furthermore, Witberg and colleagues noted that AR greater than mild was more frequent with SEVs at BEV-dominant centers and similar with BEVs regardless of center dominance (5.2% vs 2.8% [P < 0.001] and 3.4% vs 3.7% [P = 0.504], respectively).

    Need for pacemaker implantation was higher with SEVs at BEV- and SEV-dominant centers (17.8% vs 9.3% [P < 0.001] and 12.7% vs 10.0% [P = 0.036], respectively; HR: 1.51; P for interaction = 0.021), while risk for cerebrovascular accident was higher with SEVs at BEV-dominant but not SEV-dominant centers (3.6% vs 1.1% [P < 0.001] and 2.2% vs 1.4% [P = 0.162]; HR: 2.08; P for interaction < 0.01).

    All other periprocedural complications were similar between BEVs and SEVs regardless of center valve preference, said the team.

    Focus on patient characteristics

    Writing in an accompanying editorial, Sachin S. Goel, MD, from Houston Methodist DeBakey Heart & Vascular Center, and Firas Zahr, MD, from Oregon Health and Science University, Portland, noted that the choice of BEV or SEV for individual patients continues to be a subject of ongoing debate – adding that to date, only two randomized head-to-head trials have compared BEVs and SEVs: the CHOICE trial and the SOLVE TAVI trial.

    “Studying the association of mortality with valve type and center or operator preference is extremely challenging and nuanced, if not impossible,” commented the editorialists.

    “Based on the 2-existing head-to-head RCTs comparing TAVR with BEV and SEV, it is reassuring that in patients with suitable anatomic features for both types of valves, the outcomes are similar,” they said.

    The expert commentators noted that for specific anatomic features that are undesirable for a specific valve platform, centers need to have the skill and experience in the use of both BEV and SEV platforms.

    “We need long-term data regarding durability of both types of THV, robust simulation models to predict feasibility of redo TAVR based on baseline root anatomy, and continued innovation in existing valve technology as well as newer platforms to achieve coronary alignment, ease of coronary access, and low pacemaker rates, and facilitate repeat transcatheter valve interventions,” they said.

    “Rather than just studying what valve is superior, focus should be on what patient characteristics are best suited for specific BEV or SEV platforms.”

    Sources:

    Witberg G, Landes U, Talmor-Barkan Y, et al. Center Valve Preference and Outcomes of Transcatheter Aortic Valve Replacement: Insights From the AMTRAC Registry. JACC Cardiovasc Interv 2022;15:1266-1274.

    Goel SS, Zahr F. Center Valve Preference and TAVR Outcomes: Is it Really the Valve? JACC Cardiovasc Interv 2022;15:1275-1277.

    Image Credit: iushakovsky – stock.adobe.com

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