Implantation depth of balloon-expandable transcatheter heart valves and risks for permanent pacemaker implantation and midterm adverse events.

TAVI implantation depth mortality pacemaker implantation

Journal

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139

Informations de publication

Date de publication:
Dec 2023
Historique:
revised: 05 09 2023
received: 09 06 2023
accepted: 05 10 2023
pubmed: 25 10 2023
medline: 25 10 2023
entrez: 25 10 2023
Statut: ppublish

Résumé

Permanent pacemaker implantation (PPI) remains a relevant complication after transcatheter aortic valve implantation (TAVI) and its impact on outcome remains controversial. This study aimed to analyze the effects of implantation depth on PPI at 30 days and assess its impact on outcome with the balloon-expandable Sapien 3 (S3) prosthesis. Between 2014 and 2018, 849 patients without previous pacemaker undergoing transfemoral TAVI with the S3 were included. Prosthesis implantation depth was measured and divided into Quintiles. An ordinal logistic regression was used to assess its association with PPI, while a multivariate logistic regression was performed to identify predictors of PPI. Survival analyses were performed with the Kaplan-Meier method and a multivariable Cox regression was performed to ascertain the impact of PPI on mortality. Overall, incidence of PPI at 30 days was 9.7%. Implantation depth decreased consistently from a median of 6.7 mm [5.55-8.00] in 2014 to 2.7 mm [2.30-3.50] in 2018 (p < 0.001). When considering Quintiles of implantation depth, incidence of PPI was significantly higher in upper Quintiles and risk for PPI was significantly lower for the 1. Quintile compared to the 5. Quintile (OR: 0.34, 95% CI: [0.16-0.73]; p = 0.003). In the adjusted multivariable logistic regression implantation depth persisted ad independent predictor of PPI at 30 days. Patients requiring PPI at 30 days displayed significantly higher mortality at 4 years compared to patients without PPI (49.5% vs. 40.0%; log-rank = 0.022). In a multivariate analysis, increased logistic EuroScore, diabetes mellitus, and history of atrial fibrillation, were independent predictors of all-cause mortality at 2 years. Higher prosthesis implantation relative to the virtual aortic annulus was significantly associated with reduced risk for PPI at 30 days. Patients with PPI at 30 days exhibited higher mortality during follow-up, however, only logistic EuroScore, diabetes mellitus, and history of atrial fibrillation were identified as independent predictors of mortality at 2 years.

Sections du résumé

BACKGROUND BACKGROUND
Permanent pacemaker implantation (PPI) remains a relevant complication after transcatheter aortic valve implantation (TAVI) and its impact on outcome remains controversial.
AIMS OBJECTIVE
This study aimed to analyze the effects of implantation depth on PPI at 30 days and assess its impact on outcome with the balloon-expandable Sapien 3 (S3) prosthesis.
METHODS METHODS
Between 2014 and 2018, 849 patients without previous pacemaker undergoing transfemoral TAVI with the S3 were included. Prosthesis implantation depth was measured and divided into Quintiles. An ordinal logistic regression was used to assess its association with PPI, while a multivariate logistic regression was performed to identify predictors of PPI. Survival analyses were performed with the Kaplan-Meier method and a multivariable Cox regression was performed to ascertain the impact of PPI on mortality.
RESULTS RESULTS
Overall, incidence of PPI at 30 days was 9.7%. Implantation depth decreased consistently from a median of 6.7 mm [5.55-8.00] in 2014 to 2.7 mm [2.30-3.50] in 2018 (p < 0.001). When considering Quintiles of implantation depth, incidence of PPI was significantly higher in upper Quintiles and risk for PPI was significantly lower for the 1. Quintile compared to the 5. Quintile (OR: 0.34, 95% CI: [0.16-0.73]; p = 0.003). In the adjusted multivariable logistic regression implantation depth persisted ad independent predictor of PPI at 30 days. Patients requiring PPI at 30 days displayed significantly higher mortality at 4 years compared to patients without PPI (49.5% vs. 40.0%; log-rank = 0.022). In a multivariate analysis, increased logistic EuroScore, diabetes mellitus, and history of atrial fibrillation, were independent predictors of all-cause mortality at 2 years.
CONCLUSIONS CONCLUSIONS
Higher prosthesis implantation relative to the virtual aortic annulus was significantly associated with reduced risk for PPI at 30 days. Patients with PPI at 30 days exhibited higher mortality during follow-up, however, only logistic EuroScore, diabetes mellitus, and history of atrial fibrillation were identified as independent predictors of mortality at 2 years.

Identifiants

pubmed: 37877190
doi: 10.1002/ccd.30870
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1301-1310

Informations de copyright

© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Références

Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. Circulation. 2021;143(5):e72-e227.
Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J. 2021;43:561. doi:10.1093/eurheartj/ehab395
Rodés-Cabau J, Ellenbogen KA, Krahn AD, et al. Management of conduction disturbances associated with transcatheter aortic valve replacement. J Am Coll Cardiol. 2019;74(8):1086-1106.
Faroux L, Chen S, Muntané-Carol G, et al. Clinical impact of conduction disturbances in transcatheter aortic valve replacement recipients: a systematic review and meta-analysis. Eur Heart J. 2020;41(29):2771-2781.
Nazif TM, Chen S, George I, et al. New-onset left bundle branch block after transcatheter aortic valve replacement is associated with adverse long-term clinical outcomes in intermediate-risk patients: an analysis from the PARTNER II trial. Eur Heart J. 2019;40(27):2218-2227.
Regueiro A, Abdul-Jawad Altisent O, Del Trigo M, et al. Impact of new-onset left bundle branch block and periprocedural permanent pacemaker implantation on clinical outcomes in patients undergoing transcatheter aortic valve replacement. Circulation: Cardiovasc Interve. 2016;9(5):e003635.
Siontis GCM, Jüni P, Pilgrim T, et al. Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR. J Am Coll Cardiol. 2014;64(2):129-140.
Sammour Y, Krishnaswamy A, Kumar A, et al. Incidence, predictors, and implications of permanent pacemaker requirement after transcatheter aortic valve replacement. JACC: Cardiovasc Interve. 2021;14(2):115-134.
Costa G, Zappulla P, Barbanti M, et al. Pacemaker dependency after transcatheter aortic valve implantation: incidence, predictors and long-term outcomes. EuroIntervention. 2019;15:875-883. doi:10.4244/EIJ-D-18-01060
Naveh S, Perlman GY, Elitsur Y, et al. Electrocardiographic predictors of long-term cardiac pacing dependency following transcatheter aortic valve implantation. J Cardiovasc Electrophysiol. 2017;28(2):216-223.
Nai Fovino L, Cipriani A, Fabris T, et al. Anatomical predictors of pacemaker dependency after transcatheter aortic valve replacement. Circulation: Arrhythmia Electrophysiol. 2021;14(1):e009028.
Husser O, Pellegrini C, Kessler T, et al. Predictors of permanent pacemaker implantations and new-onset conduction abnormalities with the SAPIEN 3 balloon-expandable transcatheter heart valve. JACC: Cardiovasc Interve. 2016;9(3):244-254.
VARC-3 Writing Committee, Généreux P, Piazza N, Alu MC, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021;42(19):1825-1857.
Mar PL, Angus CR, Kabra R, et al. Perioperative predictors of permanent pacing and long-term dependence following tricuspid valve surgery: a multicentre analysis. EP Europace. 2017;19(12):1988-1993.
Yoshida K, Bartel A, Chipman JJ, et al. Package “tableone” for R. Accessed February 3, 2023. https://cran.r-project.org/web/packages/tableone/tableone.pdf
Therneau TM, Lumley T, Elizabeth A, Cynthia C. Package “survival” for R. Accessed February 3, 2023. https://cran.r-project.org/web/packages/survival/survival.pdf
Kassambara A, Kosinski M, Biecek P, Fabian S. Package “survminer” for R. Accessed February 3, 2023. https://cran.r-project.org/web/packages/survminer/survminer.pdf
Mauri V, Reimann A, Stern D, et al. Predictors of permanent pacemaker implantation after transcatheter aortic valve replacement with the SAPIEN 3. JACC: Cardiovasc Interve. 2016;9(21):2200-2209.
Tarantini G, Mojoli M, Purita P, et al. Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve. EuroIntervention. 2015;11(3):343-350.
De Torres-Alba F, Kaleschke G, Diller GP, et al. Changes in the pacemaker rate after transition from edwards SAPIEN XT to SAPIEN 3 transcatheter aortic valve implantation. JACC: Cardiovasc Interve. 2016;9(8):805-813.
Sammour Y, Banerjee K, Kumar A, et al. Systematic approach to high implantation of SAPIEN-3 valve achieves a lower rate of conduction abnormalities including pacemaker implantation. Circulation: Cardiovasc Interve. 2021;14(1):e009407.
Alperi A, Muntané-Carol G, Freitas-Ferraz AB, et al. Overcoming the transcatheter aortic valve replacement Achilles heel: conduction abnormalities-a systematic review. Ann Cardiothorac Surg. 2020;9(6):429-441.
Pellegrini C, Garot P, Morice M-C, et al. Permanent pacemaker implantation and left bundle branch block with self-expanding valves-a SCOPE 2 subanalysis. EuroIntervention. 2022;18:e1077. doi:10.4244/EIJ-D-22-00558
Fadahunsi OO, Olowoyeye A, Ukaigwe A, et al. Incidence, predictors, and outcomes of permanent pacemaker implantation following transcatheter aortic valve replacement. JACC: Cardiovasc Interve. 2016;9(21):2189-2199.
Fujita B, Schmidt T, Bleiziffer S, et al. Impact of new pacemaker implantation following surgical and transcatheter aortic valve replacement on 1-year outcome. Eur J Cardiothorac Surg. 2020;57(1):151-159.

Auteurs

Costanza Pellegrini (C)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.

Markus Freißmuth (M)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.

Tobias Rheude (T)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.

David Graas (D)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.

N Patrick Mayr (NP)

Institut für Anästhesiologie, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.

Finn Syryca (F)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.

Hector A Alvarez-Covarrubias (HA)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
Hospital de Cardiología, Centro Médico Nacional Siglo XXI, IMSS, Mexico City, México.

Andrei Fetcu (A)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.

Judith Hübner (J)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.

Carsten Lennerz (C)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.

Heribert Schunkert (H)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.

Adnan Kastrati (A)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.

Erion Xhepa (E)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.

Michael Joner (M)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.

Classifications MeSH