Diastolic Function and Clinical Outcomes After Transcatheter Aortic Valve Replacement: PARTNER 2 SAPIEN 3 Registry

Abstract

Background: Few studies have evaluated if diastolic function could predict outcomes in patients with aortic stenosis.

Objectives: The authors aimed to assess the association between diastolic dysfunction (DD) and outcomes in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR).

Methods: Baseline, 30-day, and 1- and 2-year transthoracic echocardiograms from the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registry were analyzed by a consortium of core laboratories and divided into the American Society of Echocardiography DD groups.

Results: Among the 1,750 included, 682 (54.4%) had grade 1 DD, 352 (28.1%) had grade 2 DD, 168 (13.4%) had grade 3 DD, and 51 (4.1%) had indeterminate DD grade. Incremental baseline grades of DD were associated with an increase in combined 1- and 2-year cardiovascular (CV) death/rehospitalization (all p < 0.002) and all-cause death at 2 years (p = 0.01) but not at 1 year. Improvement in DD grade/grade 1 DD at 30 days post-TAVR was seen in 70.8% patients. Patients with improvement in ≥1 grade of DD/grade 1 DD had reduced 1-year CV death/rehospitalization (p < 0.001) and increased 2-year survival (p = 0.01). Baseline grade 3 DD was a predictor of 1-year CV death/rehospitalization (hazard ratio: 2.73; 95% confidence interval: 1.07 to 6.98; p = 0.04). Improvement in DD grade/grade 1 DD at 30 days was protective for 1-year CV death/rehospitalizations (hazard ratio: 0.39; 95% confidence interval: 0.19 to 0.83; p = 0.01).

Conclusions: In the PARTNER 2 SAPIEN 3 registry, baseline DD was a predictor of up to 2 years clinical outcomes in patients who underwent TAVR. Improvement in DD grade at 30 days was associated with improvement in short-term clinical outcomes. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128; PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7 [PII S3HR/NR7]; NCT03222141).

Keywords: aortic stenosis; diastolic dysfunction; transcatheter aortic valve replacement.

Conflict of interest statement

Author Disclosures The PARTNER 2 trial was funded by Edwards Lifesciences. Drs. Pibarot, Weissman, Jaber, Douglas, and Hahn have echocardiographic core laboratory contracts with Edwards Lifesciences (no direct financial compensation). Dr. Makkar has received grant funding from Edwards Lifesciences and St. Jude Medical; and has received consulting fees/honoraria from Abbott Vascular, Cordis Corporation, and Medtronic. Dr. Kodali has received consulting fees/honoraria from Abbott Vascular, Merrill Lifesciences, and Claret Medical; and has served on the Scientific Advisory Boards of Thubrikar Aortic Valve Inc., Dura Biotech, and Biotrace Medical. Dr. Thourani serves on Advisory Boards for Edwards Lifesciences, Abbott Vascular, Gore Vascular, Bard Medical, JenaValve, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.