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

Objectives: The 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).
Background: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI.
Methods: This 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.
Results: New 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).
Conclusions: New 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.
Competing Interests: Funding Support and Author Disclosures Dr Pagnesi has received personal fees from Abbott, AstraZeneca, Boehringer Ingelheim, and Vifor Pharma. Dr Kim is a proctor for Boston Scientific and Abbott Vascular; and has received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic and Meril outside the submitted work. Dr Barbanti has served as a consultant for Edwards Lifesciences. Dr De Marco has served as a proctor for Boston Scientific and Kardia. Dr Adamo has received speaker fees from Abbott Vascular and Medtronic. Dr Estévez-Loureiro has served as a consultant for Abbott Vascular and Boston Scientific; and is a proctor for Lifetech Scientific. Dr Conradi has served as an advisory board member for Abbott, Medtronic, JenaValve, and Neovasc; and has received personal fees from Edwards Lifesciences, Boston Scientific, and MicroInterventions. Dr Toggweiler is a proctor for Abbott Vascular, Boston Scientific, Medtronic, and Biosensors/NVT; and is a consultant for Boston Scientific, Medtronic, Biosensors/NVT, Medira, Shockwave, Teleflex, AtHeart, VeoSource, and Equity in Hi-D Imaging. Dr Mylotte is a proctor for Medtronic and Microport. Dr Veulemans has received lecture fees and travel support from Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic and SMT. Dr Wolf is a proctor for Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Pilgrim has received institutional research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received personal fees from Boston Scientific, Biotronik, Abbott, Medtronic, and HighLifeSAS outside the submitted work. Dr Montorfano serves as a proctor for Edwards Lifesciences, Abbott Vascular, and Kardia. Dr Hildick-Smith has served as an adviser or proctor for Edwards Lifesciences, Boston Scientific, and Medtronic. Dr Taramasso is a consultant for Boston Scientific, Abbott Vascular, 4Tech, and CoreMedic; and has received speaker fees from Edwards Lifesciences. Dr Sinning is a proctor for Medtronic and Boston Scientific; has received speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received research grants from Boston Scientific, Edwards Lifesciences, and Medtronic outside the submitted work. Dr Van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi Sankyo; and has received advisory fees from Abbott Vascular, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi Sankyo. Dr Khogali is a proctor for Medtronic and Boston Scientific. Dr Wood has received grant support from Boston Scientific; and is a consultant for Medtronic. Dr MacCarthy is a proctor for Edwards Lifesciences. Dr Hamm has served on advisory boards for Medtronic. Dr Schäfer is a proctor for Boston Scientific and Medtronic; and has received lecture fees and travel support from both companies. Dr Zeus is a proctor for Medtronic; and has received speaker fees and financial scientific support from Medtronic and Edwards Lifesciences. Dr Naber has received lecture fees from Boston Scientific, Medtronic, and Abbott Vascular; and has served on advisory boards for Boston Scientific and Abbott Vascular. Dr Windecker has received institutional research and educational grants from Abbott Vascular, Amgen, AstraZeneca, Bristol Myers Squibb, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi, Sinomed, Terumo, and V-Wave. Dr Siqueira is a proctor for Medtronic and Edwards Lifesciences. Dr Sedaghat has received travel grants and support from Medtronic. Dr Metra has received personal fees from Amgen, Vifor Pharma, AstraZeneca, Abbott Vascular, Bayer, Servier, Edwards Therapeutics, Actelion, LivaNova, and Windtree Therapeutics. Dr Latib has served on advisory boards or as a consultant for Medtronic, Boston Scientific, Philips, Edwards Lifesciences. and Abbott Vascular. Dr Mangieri has received an institutional research grant from Boston Scientific; has served on a medical advisory board for Boston Scientific; and has received speaker honoraria from Concept Medical and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)