Objectives: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women. Background: Data on pacemaker insertion complicating TAVR in women are scarce. Methods: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints. Results: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85–7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30–0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9–16] days in PPI vs. 9 [7–14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups (adjHR 0.95, 95% CI 0.60–1.52, p = 0.84 and adjHR 1.22, 95% CI 0.83–1.79, p = 0.31, respectively). Conclusion: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.
|Journal||Catheterization and Cardiovascular Interventions|
|Publication status||Published - 15 Nov 2021|
Bibliographical noteFunding Information:
Dr. Usman Baber received institutional research grant from AstraZeneca; personal fees from Amgen, AstraZeneca, and Boston Scientific. Dr. Anna Sonia Petronio received consultancy fees from Medtronic, Abbott, Boston and funds by Boston and Abbott. Dr. Julinda Mehilli received institutional grants from Boston Scientific and lecture fees from AstraZeneca, Bristol‐Myers Squibb, Boston Scientific and Edwards Lifescience. Dr. Thierry Lefèvre proctors for Edwards, Boston and Abbott. Dr. Gennaro Sardella received sponsorships from Medtronic in terms of technical training courses and congress assistance. Dr. Nicolas M Van Mieghem received research grant support and advisory fees from Abbott, Boston Scientific, and Medtronic and research grant support from Edwards Lifesciences. Dr. Nicolas Dumonteil received proctoring and consultancy fees from Abbott Vascular, BostonScientific, Edwards LifeSciences, Medtronic. Dr. Ghada W Mikhail is the Director of Imperial Valve and Cardiovascular Course (IVCC) which is supported by a number of device and pharmaceutical companies; has received educational grant from Abbott for an Interventional Fellowship. Dr. Maria‐Cruz Ferrer‐Gracia received sponsorships from Medtronic and Edwards companies in terms of: Technical training courses and congress assistance. Dr. Samin K. Sharma served on the Speakers Bureau of Abbott Vascular, Boston Scientific, and Cardiovascular Systems, Inc. Dr. Marie‐Claude Morice is CEO and shareholder of CERC, a CRO based in Massy that had no role in WINTAVI. Dr. George D. Dangas received consulting fees from GE HealthCare, Janssen Pharmaceuticals, Inc., and Medtronic, Inc.; <1% equity with Claret Medical and Elixir Medical; delivered industry sponsored lectures for The Medicines Company; and is on Scientific Advisory Board of AstraZeneca. Dr. Alaide Chieffo received speaker/consultant fees from Abiomed, Abbott vascular, Biosensor, Cardinal Health, GADA, Magenta Medical. Dr. Roxana Mehran reports institutional research grants from Abbott Laboratories, Abiomed, Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich; consultant fees from Abbott Laboratories, Boston Scientific, Janssen Scientific Affairs, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences, Sanofi, Siemens Medical Solutions; consultant fees paid to the institution from Abbott Laboratories, Bristol‐Myers Squibb; advisory board, funding paid to the institution from Spectranetics/Philips/Volcano Corp; consultant (spouse) from Abiomed, The Medicines Company, Merck; Equity <1% from Claret Medical, Elixir Medical; DSMB Membership fees paid to the institution from Watermark Research Partners; consulting (no fee) from Idorsia Pharmaceuticals Ltd., Regeneron Pharmaceuticals. Associate Editor for ACC, AMA.
© 2021 Wiley Periodicals LLC.