LATE ALL-CAUSE MORTALITY AND REHOSPITALIZATIONS FOLLOWING IMPLANTATION OF A NOVEL PERICARDIAL TISSUE VALVE (CCC-151)

Friday, October 27, 2023

15:50 – 16:00 EST

Location: Palais, 520DEF

Target Audience: Valvular Interventions, Surgery

Corresponding Author(s)

VR

Vivek Rao, MD, PhD

Senior Scientist, Toronto General Hospital Research Institute (TGHRI) Professor, Department of Surge
University of Toronto
CSCS

First Author(s)

VR

Vivek Rao, MD, PhD

Senior Scientist, Toronto General Hospital Research Institute (TGHRI) Professor, Department of Surge
University of Toronto
CSCS

Presenting Author(s)

VR

Vivek Rao, MD, PhD

Senior Scientist, Toronto General Hospital Research Institute (TGHRI) Professor, Department of Surge
University of Toronto
CSCS

Co-Author(s)

MR

Michael J. Reardon, MD
MC

Michael W.A. Chu, MD

Associate Professor of Surgery
MM

Michael G. Moront, MD
FD

Francois Dagenais, MD

cardiac surgeon
TW

Thorsten Wahlers, MD
RS

Robert J. Steffen, MD
FL

Fang Liu, MD, MS
RK

Robert JM Klautz, MD, PhD
JS

Joseph F. Sabik, III, MD

Surgeon-In-Chief, University Hospitals

Senior Author(s)

JS

Joseph F. Sabik, III, MD

Surgeon-In-Chief, University Hospitals

Submitter(s)

VR

Vivek Rao, MD, PhD

Senior Scientist, Toronto General Hospital Research Institute (TGHRI) Professor, Department of Surge
University of Toronto
CSCS

Disclosure(s):

Vivek Rao, MD, PhD: Abbott: Consultant/Advisory Board (Ongoing), Speaker/Honoraria (Ongoing); Gore: Consultant/Advisory Board (Ongoing); Medtronic: Consultant/Advisory Board (Ongoing), Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing), Speaker/Honoraria (Ongoing)

Background: Aortic valve replacement (AVR) is lifesaving for patients with a dysfunctional aortic valve. Newer bioprosthetic valves are intended to improve long-term durability and reduce periprocedural morbidity compared to percutaneous technology, but data are limited. We sought to identify characteristics and complications predisposing patients to late death or cardiac rehospitalization.

METHODS AND RESULTS: Patients with moderate/greater aortic stenosis or regurgitation with an indication for surgical AVR were enrolled in a study of a novel stented pericardial aortic valve. The study was conducted at 38 centers in North America and Europe. Standardized follow-up was prescribed through 5 years. Kaplan-Meier (KM) analysis was performed to determine freedom from late all-cause mortality and from late cardiac rehospitalization. Late was defined as 31 d to 5 y postimplant. The rate of permanent pacemaker implantation (PPI) at 30 d and 5 y also was evaluated. Multivariable analysis using stepwise selection was performed to determine predictors of late all-cause mortality, late cardiac rehospitalization, and a composite of these endpoints. Patients with a baseline pacemaker were excluded, as were patients with missing data for any covariates in the model. p=0.20 was required for model entry; p=0.15 was required for remaining. A total of 1288 patients were enrolled; 1118 patients received the study valve. Median follow-up was 4.9 years. At baseline, mean age was 70.2±9.0 y; 840 patients (75.1%) were male. Mean STS predicted risk of mortality was 2.0±1.4%; 124 patients (11.1%) had comorbid atrial fibrillation (AF). The KM rate of freedom from late all-cause mortality was 88.9% (86.7-90.7%); for freedom from late cardiac rehospitalization, the rate was 86.2% (83.8-88.2%). Freedom from the combined endpoint was 78.1% (75.3-80.6%). The KM rate of permanent pacemaker implantation was 3.9% (2.9-5.2%) at 30 d and 7.2% (5.7-9.0%) at 5 y. Multivariable analysis showed age at implant, bleeding within 30 days, and baseline AF were associated with late mortality (Table). Baseline New York Heart Association (NYHA) class, AF, hypertension, and coronary artery disease were associated with late cardiac rehospitalization. Age, NYHA class, AF, hypertension, coronary artery disease, and total bypass time were associated with the composite endpoint.

Conclusion: The KM rates of freedom from late all-cause mortality and from late cardiac rehospitalization through 5 y of follow-up were excellent, and the KM rate of permanent pacemaker implantation was low. These outcomes after SAVR with this novel pericardial valve should serve as a benchmark for comparison with transcatheter AVR in low-risk patients.