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

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

doi:10.1016/j.jcin.2023.05.020

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

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

Medicine

Research output: Contribution to journal › Article › peer-review

6 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	2004-2017
Number of pages	14
Journal	JACC: Cardiovascular Interventions
Volume	16
Issue number	16
DOIs	https://doi.org/10.1016/j.jcin.2023.05.020
State	Published - Aug 28 2023

Keywords

Acurate neo
Evolut PRO
mortality
pacemaker
self-expanding
transcatheter aortic valve replacement

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jcin.2023.05.020

Cite this

Pagnesi, M., Kim, W. K., Baggio, S., Scotti, A., Barbanti, M., De Marco, F., Adamo, M., Eitan, A., Estévez-Loureiro, R., Conradi, L., Toggweiler, S., Mylotte, D., Veulemans, V., Søndergaard, L., Wolf, A., Giannini, F., Maffeo, D., Pilgrim, T., Montorfano, M., ... Mangieri, A. (2023). Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves. JACC: Cardiovascular Interventions, 16(16), 2004-2017. https://doi.org/10.1016/j.jcin.2023.05.020

Pagnesi, M, Kim, WK, Baggio, S, Scotti, A, Barbanti, M, De Marco, F, Adamo, M, Eitan, A, Estévez-Loureiro, R, Conradi, L, Toggweiler, S, Mylotte, D, Veulemans, V, Søndergaard, L, Wolf, A, Giannini, F, Maffeo, D, Pilgrim, T, Montorfano, M, Zweiker, D, Ferlini, M, Kornowski, R, Hildick-Smith, D, Taramasso, M, Abizaid, A, Schofer, J, Sinning, JM, Van Mieghem, NM, Wöhrle, J, Khogali, S, Van der Heyden, JAS, Wood, DA, Ielasi, A, MacCarthy, P, Brugaletta, S, Hamm, CW, Costa, G, Testa, L, Massussi, M, Alarcón, R, Schäfer, U, Brunner, S, Reimers, B, Lunardi, M, Zeus, T, Vanhaverbeke, M, Naber, CK, Di Ienno, L, Buono, A, Windecker, S, Schmidt, A, Lanzillo, G, Vaknin-Assa, H, Arunothayaraj, S, Saccocci, M, Siqueira, D, Brinkmann, C, Sedaghat, A, Ziviello, F, Seeger, J, Rottbauer, W, Brouwer, J, Buysschaert, I, Jelisejevas, J, Bharucha, A, Regueiro, A, Metra, M, Colombo, A, Latib, A & Mangieri, A 2023, 'Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves', JACC: Cardiovascular Interventions, vol. 16, no. 16, pp. 2004-2017. https://doi.org/10.1016/j.jcin.2023.05.020

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

abstract = "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.",

keywords = "Acurate neo, Evolut PRO, mortality, pacemaker, self-expanding, transcatheter aortic valve replacement",

author = "Matteo Pagnesi and Kim, {Won Keun} and Sara Baggio and Andrea Scotti and Marco Barbanti and {De Marco}, Federico and Marianna Adamo and Amnon Eitan and Rodrigo Est{\'e}vez-Loureiro and Lenard Conradi and Stefan Toggweiler and Darren Mylotte and Verena Veulemans and Lars S{\o}ndergaard and Alexander Wolf and Francesco Giannini and Diego Maffeo and Thomas Pilgrim and Matteo Montorfano and David Zweiker and Marco Ferlini and Ran Kornowski and David Hildick-Smith and Maurizio Taramasso and Alexandre Abizaid and Joachim Schofer and Sinning, {Jan Malte} and {Van Mieghem}, {Nicolas M.} and Jochen W{\"o}hrle and Saib Khogali and {Van der Heyden}, {Jan A.S.} and Wood, {David A.} and Alfonso Ielasi and Philip MacCarthy and Salvatore Brugaletta and Hamm, {Christian W.} and Giuliano Costa and Luca Testa and Mauro Massussi and Robert Alarc{\'o}n and Ulrich Sch{\"a}fer and Stephanie Brunner and Bernhard Reimers and Mattia Lunardi and Tobias Zeus and Maarten Vanhaverbeke and Naber, {Christoph K.} and {Di Ienno}, Luca and Andrea Buono and Stephan Windecker and Albrecht Schmidt and Giuseppe Lanzillo and Hana Vaknin-Assa and Sandeep Arunothayaraj and Matteo Saccocci and Dimytri Siqueira and Christina Brinkmann and Alexander Sedaghat and Francesca Ziviello and Julia Seeger and Wolfgang Rottbauer and Jorn Brouwer and Ian Buysschaert and Julius Jelisejevas and Apurva Bharucha and Ander Regueiro and Marco Metra and Antonio Colombo and Azeem Latib and Antonio Mangieri",

note = "Publisher Copyright: {\textcopyright} 2023 American College of Cardiology Foundation",

year = "2023",

month = aug,

day = "28",

doi = "10.1016/j.jcin.2023.05.020",

language = "English (US)",

volume = "16",

pages = "2004--2017",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "16",

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TY - JOUR

T1 - Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves

AU - Pagnesi, Matteo

AU - Kim, Won Keun

AU - Baggio, Sara

AU - Scotti, Andrea

AU - Barbanti, Marco

AU - De Marco, Federico

AU - Adamo, Marianna

AU - Eitan, Amnon

AU - Estévez-Loureiro, Rodrigo

AU - Conradi, Lenard

AU - Toggweiler, Stefan

AU - Mylotte, Darren

AU - Veulemans, Verena

AU - Søndergaard, Lars

AU - Wolf, Alexander

AU - Giannini, Francesco

AU - Maffeo, Diego

AU - Pilgrim, Thomas

AU - Montorfano, Matteo

AU - Zweiker, David

AU - Ferlini, Marco

AU - Kornowski, Ran

AU - Hildick-Smith, David

AU - Taramasso, Maurizio

AU - Abizaid, Alexandre

AU - Schofer, Joachim

AU - Sinning, Jan Malte

AU - Van Mieghem, Nicolas M.

AU - Wöhrle, Jochen

AU - Khogali, Saib

AU - Van der Heyden, Jan A.S.

AU - Wood, David A.

AU - Ielasi, Alfonso

AU - MacCarthy, Philip

AU - Brugaletta, Salvatore

AU - Hamm, Christian W.

AU - Costa, Giuliano

AU - Testa, Luca

AU - Massussi, Mauro

AU - Alarcón, Robert

AU - Schäfer, Ulrich

AU - Brunner, Stephanie

AU - Reimers, Bernhard

AU - Lunardi, Mattia

AU - Zeus, Tobias

AU - Vanhaverbeke, Maarten

AU - Naber, Christoph K.

AU - Di Ienno, Luca

AU - Buono, Andrea

AU - Windecker, Stephan

AU - Schmidt, Albrecht

AU - Lanzillo, Giuseppe

AU - Vaknin-Assa, Hana

AU - Arunothayaraj, Sandeep

AU - Saccocci, Matteo

AU - Siqueira, Dimytri

AU - Brinkmann, Christina

AU - Sedaghat, Alexander

AU - Ziviello, Francesca

AU - Seeger, Julia

AU - Rottbauer, Wolfgang

AU - Brouwer, Jorn

AU - Buysschaert, Ian

AU - Jelisejevas, Julius

AU - Bharucha, Apurva

AU - Regueiro, Ander

AU - Metra, Marco

AU - Colombo, Antonio

AU - Latib, Azeem

AU - Mangieri, Antonio

PY - 2023/8/28

Y1 - 2023/8/28

N2 - 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.

AB - 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.

KW - Acurate neo

KW - Evolut PRO

KW - mortality

KW - pacemaker

KW - self-expanding

KW - transcatheter aortic valve replacement

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UR - http://www.scopus.com/inward/citedby.url?scp=85168329282&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2023.05.020

DO - 10.1016/j.jcin.2023.05.020

M3 - Article

C2 - 37480891

AN - SCOPUS:85168329282

SN - 1936-8798

VL - 16

SP - 2004

EP - 2017

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 16

ER -

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

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