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 Sondergaard; 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 Sondergaard, 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^*

^*Corresponding author af dette arbejde

Afdeling for Hjertesygdomme

18 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	JACC. Cardiovascular interventions
Vol/bind	16
Udgave nummer	16
Sider (fra-til)	2004-2017
Antal sider	14
ISSN	1936-8798
DOI	https://doi.org/10.1016/j.jcin.2023.05.020
Status	Udgivet - 28 aug. 2023

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10.1016/j.jcin.2023.05.020

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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., Sondergaard, 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, 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, Sondergaard, 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, J-M, 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, bind 16, nr. 16, s. 2004-2017. https://doi.org/10.1016/j.jcin.2023.05.020

@article{f3fd563342dd424fa319c0c4972a8ecd,

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 = "Bundle-Branch Block, Humans, Incidence, Pacemaker, Artificial, Prognosis, Transcatheter Aortic Valve Replacement/adverse effects, Treatment Outcome, pacemaker, Evolut PRO, self-expanding, mortality, transcatheter aortic valve replacement, Acurate neo",

author = "Matteo Pagnesi and Won-Keun Kim 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 Sondergaard 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 Jan-Malte Sinning 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",

year = "2023",

month = aug,

day = "28",

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

language = "English",

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 - Sondergaard, 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 - Bundle-Branch Block

KW - Humans

KW - Incidence

KW - Pacemaker, Artificial

KW - Prognosis

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Treatment Outcome

KW - pacemaker

KW - Evolut PRO

KW - self-expanding

KW - mortality

KW - transcatheter aortic valve replacement

KW - Acurate neo

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

U2 - 10.1016/j.jcin.2023.05.020

DO - 10.1016/j.jcin.2023.05.020

M3 - Journal article

C2 - 37480891

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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