Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Feb 12;17(3):391-401.
doi: 10.1016/j.jcin.2023.12.005.

National Variability in Pacemaker Implantation Rate Following TAVR: Insights From the STS/ACC TVT Registry

Amit N Vora  1 , Hemal Gada  2 , Pratik Manandhar  3 , Andrezej Kosinski  3 , Ajay Kirtane  4 , Tamim Nazif  4 , Michael Reardon  5 , Susheel Kodali  4 , David J Cohen  6 , Vinod Thourani  7 , Matthew Sherwood  8 , Howard Julien  9 , Sreekanth Vemulapalli  3
Affiliations

National Variability in Pacemaker Implantation Rate Following TAVR: Insights From the STS/ACC TVT Registry

Amit N Vora et al. JACC Cardiovasc Interv. .

Abstract

Background: Although permanent pacemaker (PPM) implantation is a common complication of transcatheter aortic valve replacement (TAVR), hospital variation and change in PPM implantation rates are ill defined.

Objectives: The aim of this study was to determine hospital-level variation and temporal trends in the rate of PPM implantation following TAVR.

Methods: Using the American College of Cardiology/Society of Thoracic Surgeons TVT (Transcatheter Valve Therapy) Registry, temporal changes in variation of in-hospital and 30-day PPM implantation were determined among 184,452 TAVR procedures across 653 sites performed from 2016 to 2020. The variation in PPM implantation adjusted for valve type by annualized TAVR volume was determined, and characteristics of sites below, within, and above the 95% boundary were identified. A series of stepwise multivariable hierarchical models were then fit, and the median OR was used to measure variation in pacemaker rates among sites.

Results: From 2016 to 2020, the overall rate of PPM implantation was 11.3%, with wide variation across sites (range: 0%-36.4%); rates trended lower over time. Adjusted for annualized volume, there were 34 sites with PPM implantation rates above the 95th percentile CI and 28 with rates below, with wide variation among the remaining sites. After adjusting for patient-level covariates, there was variation among sites in the probability of PPM implantation (median OR: 1.39; 95% CI: 1.35-1.43, P < 0.001); although some of the variation was explained by the addition of valve type, residual variation in PPM implantation rates persisted in additional models incorporating site-level covariates (annualized volume, region, teaching status, hospital beds, etc).

Conclusions: Although PPM implantation rates have decreased over time, substantial site-level variation remains even after accounting for observed patient characteristics and site-level factors. As there are numerous outlier sites both above and below the 95% confidence limit, dissemination of best practices from high-performing sites to low-performing sites and guideline-based education may be important quality improvement initiatives to reduce rates of this common complication.

Keywords: TAVR; hospital-level variation; pacemaker.

PubMed Disclaimer

Conflict of interest statement

Funding Support and Author Disclosures This research was supported by the ACC Foundation’s National Cardiovascular Data Registry. The analytic work for this investigator-initiated study was performed by the Duke Clinical Research Institute, with financial support from the ACC. The STS/ACC TVT Registry is an initiative of the STS and the ACC. The views expressed in this report represent those of the authors and do not necessarily represent the official views of the National Cardiovascular Data Registry or its associated professional societies, identified at https://cvquality.acc.org/NCDR-Home. The manuscript was reviewed by the National Cardiovascular Data Registry for compliance with registry description and representation, but the sponsor had no role in the design and conduct of the study, analysis and interpretation of the data, preparation of the manuscript, or decision to submit the manuscript for publication. Dr Vora is a consultant for Medtronic. Dr Gada is a consultant for Medtronic, Abbott, PiCardia, GHX, and Boston Scientific; and has conducted research for Medtronic, Abbott, PiCardia, GHX, Boston Scientific, and Edwards Lifesciences. Dr Kirtane has received institutional funding to Columbia University and/or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, Cardiovascular Systems, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, Shockwave Medical, and Merck (in addition to research grants, institutional funding includes fees paid to Columbia University and/or the Cardiovascular Research Foundation for consulting and/or speaking engagements for which Dr Kirtane controlled the content); is a consultant for IMDS; and has received reimbursement of travel expenses and meals from Amgen, Medtronic, Biotronik, Boston Scientific, Abbott Vascular, CathWorks, Edwards, Cardiovascular Systems, Novartis, Philips, Abiomed, Merck, ReCor Medical, Chiesi, Zoll, Shockwave Medical, and Regeneron. Dr Nazif is a consultant for Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Reardon is a consultant for Medtronic, Boston Scientific, Abbott Medical, and Gore Medical. Dr Cohen has received research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; and has received consulting income from Edwards Lifesciences and Medtronic. Dr Thourani is a consultant for and has received research support from Abbott Vascular, Artivion, AtriCure, Boston Scientific, Edwards Lifesciences, Dasi simulations, JenaValve, and Medtronic. Dr Sherwood has received research support from Abbott; and has received consulting fees from Medtronic and Boston Scientific. Dr Julien holds equity in Johnson & Johnson and Shockwave Medical. Dr Vemulapalli has grants or contracts with the STS, the ACC, the National Institutes of Health (R01 and UG3), Cytokinetics, Abbott Vascular, and Boston Scientific; and is a consultant for Medtronic, Edwards Lifesciences, the American College of Physicians, Total CME, and Veralox Therapeutics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Comment in

References

Publication types

MeSH terms

LinkOut - more resources