Decreasing pacemaker implantation rates with Evolut supra-annular transcatheter aortic valves in a large real-world registry

James E Harvey; Rishi Puri; Kendra J Grubb; Steven J Yakubov; Paul D Mahoney; Hemal Gada; Megan Coylewright; Marie-France Poulin; Stanley J Chetcuti; Paul Sorajja; Joshua D Rovin; Ruth Eisenberg; Michael J Reardon

doi:10.1016/j.carrev.2024.05.024

Decreasing pacemaker implantation rates with Evolut supra-annular transcatheter aortic valves in a large real-world registry

Cardiovasc Revasc Med. 2024 May 20:S1553-8389(24)00493-7. doi: 10.1016/j.carrev.2024.05.024. Online ahead of print.

Authors

Affiliations

¹ WellSpan York Hospital, 1001 S George Street, York, PA 17403, USA. Electronic address: jharvey3@wellspan.org.
² Cleveland Clinic, 2049 East 100(th) Street, Cleveland, OH 44195, USA. Electronic address: purir@ccf.org.
³ Emory University, 100 Woodruff Circle, Atlanta, GA 30322, USA. Electronic address: kendra.janel.grubb@emory.edu.
⁴ Riverside Methodist-Ohio Health, 3535 Olentangy River Road, Columbus, OH 43214, USA.
⁵ Sentara Healthcare, 600 Gresham Drive, Suite 8630A, Norfolk, VA 23507, USA.
⁶ University of Pittsburgh-Pinnacle, 1000 N Front Street, Wormleysburg, PA 17043, USA.
⁷ Erlanger Heart and Lung Institute, 979 E 3rd Street, C-520, Chattanooga, TN 37403, USA. Electronic address: megan.coylewright@erlanger.org.
⁸ Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA 02215, USA. Electronic address: mpoulin@bidmc.harvard.edu.
⁹ University of Michigan, 1500 E Medical Center Drive, Ann Arbor, MI 48109, USA. Electronic address: chetcuti@med.umich.edu.
¹⁰ Minneapolis Heart Institute-Abbott-Northwestern Hospital, 920 E 28th Street, Suite 100, Minneapolis, MN 55404, USA. Electronic address: paul.sorajja@allina.com.
¹¹ Morton Plant Hospital, 55 Pinellas St #320, Clearwater, FL 33756, USA. Electronic address: joshua.rovin@baycare.org.
¹² Medtronic, 8200 Coral Sea Street, Mounds View, MN 55112, USA. Electronic address: ruth.e.eisenberg@medtronic.com.
¹³ Houston Methodist DeBakey Heart and Vascular Center, 6550 Fannin St #1401, Houston, TX, USA. Electronic address: mreardon@houstonmethodist.org.

PMID: 38871537
DOI: 10.1016/j.carrev.2024.05.024

Abstract

Background: Permanent pacemaker implantation (PPI) rates following transcatheter aortic valve replacement (TAVR) remain a concern. We assessed the PPI rates over time in patients implanted with an Evolut supra-annular, self-expanding transcatheter valve from the US STS/ACC TVT Registry.

Methods: Patients who underwent TAVR with an Evolut R, Evolut PRO or Evolut PRO+ valve between July 2018 (Q3) and June 2021 (Q2) were included. PPI rates were reported by calendar quarter. In-hospital PPI rates were reported as proportions and 30-day rates as Kaplan-Meier estimates. A Cox regression model was used to determine potential predictors of a new PPI within 30 days of the TAVR procedure.

Results: From July 2018 to June 2021, 54,014 TAVR procedures were performed using Evolut valves. Mean age was 79.3 ± 8.8 years and 49.2 % were male. The 30-day PPI rate was 16.6 % in 2018 (Q3) and 10.8 % in 2021 (Q2, 34.9 % decrease, p < 0.001 for trend across all quarters). The in-hospital PPI rate decreased by 40.1 %; from 14.7 % in 2018 (Q3) to 8.8 % in 2021 (Q2) (p < 0.001 for trend across all quarters). Significant predictors of a new PPI within 30 days included a baseline conduction defect, history of atrial fibrillation, home oxygen, and diabetes mellitus.

Conclusion: From 2018 to 2021, TAVR with an Evolut transcatheter heart valve in over 50,000 patients showed a significant decreasing trend in the rates of in-hospital and 30-day PPI, representing the lowest rate of PPI in any large real-world registry of Evolut. During the same evaluated period, high device success and shorter length of stay was also observed.

Keywords: Length of stay; Permanent pacemaker; Self-expanding; Supra-annular; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement.