Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry

Johny Nicolas; Paul Guedeney; Bimmer E. Claessen; Julinda Mehilli; Anna Sonia Petronio; Samantha Sartori; Thierry Lefèvre; Patrizia Presbitero; Piera Capranzano; Alessandro Iadanza; Davide Cao; Mauro Chiarito; Ridhima Goel; Anastasios Roumeliotis; Rishi Chandiramani; Siyan Chen; Gennaro Sardella; Nicolas M. Van Mieghem; Sabato Sorrentino; Emanuele Meliga; Didier Tchétché; Nicolas Dumonteil; Chiara Fraccaro; Daniela Trabattoni; Ghada W. Mikhail; Maria Cruz Ferrer-Gracia; Christoph Naber; Peter C. Kievit; Usman Baber; Samin K. Sharma; Marie Claude Morice; George D. Dangas; Jaya Chandrasekhar; Alaide Chieffo; Roxana Mehran

doi:10.1002/ccd.29807

Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry

Johny Nicolas, Paul Guedeney, Bimmer E. Claessen, Julinda Mehilli, Anna Sonia Petronio, Samantha Sartori, Thierry Lefèvre, Patrizia Presbitero, Piera Capranzano, Alessandro Iadanza, Davide Cao, Mauro Chiarito, Ridhima Goel, Anastasios Roumeliotis, Rishi Chandiramani, Siyan Chen, Gennaro Sardella, Nicolas M. Van Mieghem, Sabato Sorrentino, Emanuele MeligaDidier Tchétché, Nicolas Dumonteil, Chiara Fraccaro, Daniela Trabattoni, Ghada W. Mikhail, Maria Cruz Ferrer-Gracia, Christoph Naber, Peter C. Kievit, Usman Baber, Samin K. Sharma, Marie Claude Morice, George D. Dangas, Jaya Chandrasekhar, Alaide Chieffo, Roxana Mehran^*

^*Corresponding author for this work

Cardiology

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

3 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	E908-E917
Journal	Catheterization and Cardiovascular Interventions
Volume	98
Issue number	6
DOIs	https://doi.org/10.1002/ccd.29807
Publication status	Published - 15 Nov 2021

Bibliographical note

Funding 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.

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© 2021 Wiley Periodicals LLC.

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Nicolas, J., Guedeney, P., Claessen, B. E., Mehilli, J., Petronio, A. S., Sartori, S., Lefèvre, T., Presbitero, P., Capranzano, P., Iadanza, A., Cao, D., Chiarito, M., Goel, R., Roumeliotis, A., Chandiramani, R., Chen, S., Sardella, G., Van Mieghem, N. M., Sorrentino, S., ... Mehran, R. (2021). Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry. Catheterization and Cardiovascular Interventions, 98(6), E908-E917. https://doi.org/10.1002/ccd.29807

@article{7ddd362cd5c94f8886c774552249ac1f,

title = "Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry",

abstract = "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.",

author = "Johny Nicolas and Paul Guedeney and Claessen, {Bimmer E.} and Julinda Mehilli and Petronio, {Anna Sonia} and Samantha Sartori and Thierry Lef{\`e}vre and Patrizia Presbitero and Piera Capranzano and Alessandro Iadanza and Davide Cao and Mauro Chiarito and Ridhima Goel and Anastasios Roumeliotis and Rishi Chandiramani and Siyan Chen and Gennaro Sardella and {Van Mieghem}, {Nicolas M.} and Sabato Sorrentino and Emanuele Meliga and Didier Tch{\'e}tch{\'e} and Nicolas Dumonteil and Chiara Fraccaro and Daniela Trabattoni and Mikhail, {Ghada W.} and Ferrer-Gracia, {Maria Cruz} and Christoph Naber and Kievit, {Peter C.} and Usman Baber and Sharma, {Samin K.} and Morice, {Marie Claude} and Dangas, {George D.} and Jaya Chandrasekhar and Alaide Chieffo and Roxana Mehran",

note = "Funding 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 Lef{\`e}vre 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. Publisher Copyright: {\textcopyright} 2021 Wiley Periodicals LLC.",

year = "2021",

month = nov,

day = "15",

doi = "10.1002/ccd.29807",

language = "English",

volume = "98",

pages = "E908--E917",

journal = "Catheterization and Cardiovascular Interventions",

issn = "1522-1946",

publisher = "Wiley-Liss Inc.",

number = "6",

}

Nicolas, J, Guedeney, P, Claessen, BE, Mehilli, J, Petronio, AS, Sartori, S, Lefèvre, T, Presbitero, P, Capranzano, P, Iadanza, A, Cao, D, Chiarito, M, Goel, R, Roumeliotis, A, Chandiramani, R, Chen, S, Sardella, G, Van Mieghem, NM, Sorrentino, S, Meliga, E, Tchétché, D, Dumonteil, N, Fraccaro, C, Trabattoni, D, Mikhail, GW, Ferrer-Gracia, MC, Naber, C, Kievit, PC, Baber, U, Sharma, SK, Morice, MC, Dangas, GD, Chandrasekhar, J, Chieffo, A & Mehran, R 2021, 'Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry', Catheterization and Cardiovascular Interventions, vol. 98, no. 6, pp. E908-E917. https://doi.org/10.1002/ccd.29807

Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation : Insights from a prospective multinational registry. / Nicolas, Johny; Guedeney, Paul; Claessen, Bimmer E. et al.

In: Catheterization and Cardiovascular Interventions, Vol. 98, No. 6, 15.11.2021, p. E908-E917.

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

TY - JOUR

T1 - Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation

T2 - Insights from a prospective multinational registry

AU - Nicolas, Johny

AU - Guedeney, Paul

AU - Claessen, Bimmer E.

AU - Mehilli, Julinda

AU - Petronio, Anna Sonia

AU - Sartori, Samantha

AU - Lefèvre, Thierry

AU - Presbitero, Patrizia

AU - Capranzano, Piera

AU - Iadanza, Alessandro

AU - Cao, Davide

AU - Chiarito, Mauro

AU - Goel, Ridhima

AU - Roumeliotis, Anastasios

AU - Chandiramani, Rishi

AU - Chen, Siyan

AU - Sardella, Gennaro

AU - Van Mieghem, Nicolas M.

AU - Sorrentino, Sabato

AU - Meliga, Emanuele

AU - Tchétché, Didier

AU - Dumonteil, Nicolas

AU - Fraccaro, Chiara

AU - Trabattoni, Daniela

AU - Mikhail, Ghada W.

AU - Ferrer-Gracia, Maria Cruz

AU - Naber, Christoph

AU - Kievit, Peter C.

AU - Baber, Usman

AU - Sharma, Samin K.

AU - Morice, Marie Claude

AU - Dangas, George D.

AU - Chandrasekhar, Jaya

AU - Chieffo, Alaide

AU - Mehran, Roxana

N1 - Funding 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. Publisher Copyright: © 2021 Wiley Periodicals LLC.

PY - 2021/11/15

Y1 - 2021/11/15

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85107824467&partnerID=8YFLogxK

U2 - 10.1002/ccd.29807

DO - 10.1002/ccd.29807

M3 - Article

C2 - 34117817

AN - SCOPUS:85107824467

SN - 1522-1946

VL - 98

SP - E908-E917

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

IS - 6

ER -

Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry

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