Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves

Matteo Pagnesi ,Albrecht Schmidt,Hana Vaknin Assa ,Verena Veulemans ,Giuseppe Lanzillo ,Amnon Eitan ,Joachim Schöfer ,Saib Khogali ,Nicolás M Van Mieghem ,Alfonso Ielasi ,Maurizio Taramasso ,Maarten Vanhaverbeke ,Antonio Colombo ,Ulrich Schäfer ,Alexander Wolf ,Robert Alarcón ,Lenard Conradi ,Mauro Massussi ,Christoph Naber ,Alexandre Abizaid ,Stephan Windecker ,Matteo Montorfano ,Jan A.s Van Der Heyden ,Stephanie Brunner ,Francesca Ziviello ,Francesco Giannini ,Julia Seeger ,Matteo Saccocci ,Christian W Hamm ,Won Keun Kim ,Jorn Brouwer ,Dimytri Siqueira ,Andrea Scotti ,Sara Baggio ,Philip Maccarthy ,Marco Metra ,Azeem Latib ,Jan‐Malte Sinning ,Giuliano Costa ,Mattia Lunardi ,Luca Testa ,Jochen Wöhrle ,Ran Kornowski ,Thomas Pilgrim ,Ian Buysschaert ,Andrea Buono ,Stefan Toggweiler ,Rodrigo Estévez‐Loureiro ,Apurva Bharucha ,Diego Maffeo ,Ander Regueiro ,Tobias Zeus ,David Wood ,Wolfgang Rottbauer ,Luca Di Ienno ,Alexander Sedaghat ,Christina Brinkmann ,Salvatore Brugaletta ,Marianna Adamo ,Marco Barbanti ,Darren Mylotte ,Bernhard Reimers ,Julius Jelisejevas ,David Zweiker ,Federico De Marco ,Marco Ferlini ,Lars Søndergaard ,Sandeep Arunothayaraj ,David Hildick‐Smith ,Antonio Mangieri

doi:10.1016/j.jcin.2023.05.020

Abstract

ObjectivesThe authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BackgroundNeed for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. MethodsThis study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. ResultsNew PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). ConclusionsNew PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

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