Clinical Implications of Physical Function and Resilience in Patients Undergoing Transcatheter Aortic Valve Replacement

Abstract

Background Gait speed is a reliable measure of physical function and frailty in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). Slow gait speed pre-TAVR predicts worse clinical outcomes post-TAVR. The consequences of improved versus worsened physical function post-TAVR are unknown. Methods and Results The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Randomized Clinical Evaluation) trial randomized high/extreme risk patients to receive a mechanically-expanded or self-expanding transcatheter heart valve. Of 874 patients who underwent TAVR, 576 with complete data at baseline and 1 year were included in this analysis. Slow gait speed in the 5-m walk test was defined as <0.83 m/s. A clinically meaningful improvement (≥0.1 m/s) in gait speed 1 year after TAVR occurred in 39% of patients, 35% exhibited no change, and 26% declined (≥0.1 m/s). Among groups defined by baseline/1-year post-TAVR gait speeds, 1- to 2-year mortality or hospitalization rates were as follows: 6.6% (normal/normal), 8.0% (slow/normal), 20.9% (normal/slow), and 21.5% (slow/slow). After adjustment, slow gait speed at 1 year (regardless of baseline speed) was associated with a 3.5-fold increase in death/hospitalization between 1 and 2 years compared with those with normal baseline/1-year gait speed. Patients whose slow gait speed normalized at 1 year had no increased risk. One-year, but not baseline, gait speed was associated with death or hospitalization between 1 and 2 years (adjusted hazard ratio, 0.83 per 0.1 m/s faster gait; 95% CI, 0.74-0.93, P=0.001). Conclusions Marked heterogeneity exists in the trajectory of physical function after TAVR and this, more than baseline function, has clinical consequences. Identifying and optimizing factors associated with physical resilience after TAVR may improve outcomes. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02202434.

Keywords: aortic valve stenosis; frailty; gait speed; outcomes; physical function; transcatheter aortic valve replacement.

Conflict of interest statement

Dr Barker is on the medical advisory board for Boston Scientific. Dr Rajagopal is on the scientific advisory board for Boston Scientific and is a speaker/proctor for Medtronic, Edwards, and Abbott vascular; Dr Makkar receives research grants from Boston Scientific and Medtronic. Dr Bajwa is a consultant for Medtronic. Dr Kleiman provides educational services for Medtronic. Dr Linke has received speaker honoraria or served as a consultant for the following companies: Medtronic Inc., St. Jude Medical Inc., Claret Medical Inc., Boston Scientific, Edwards Lifesciences, Symetis as well as Bard, and owns stock option from Claret Medical Inc and receives grants and consultant fees from Medtronic, Edwards, Boston Scientific, and Abbott. Dr Kereiakes is a consultant and is on the Scientific Advisory Board, Boston Scientific, Inc and receives research grants from Edwards Lifesciences. Dr Waksman receives grant/research support or consulting fees/honoraria from Boston Scientific, Biotronik Biosensors, Medtronic Vascular, Abbott Vascular, Symetis, Med Alliance, LifeTech, Amgen, and Volcano/Philips. Dr Allocco is a full‐time employee and shareholder of Boston Scientific. Dr Reardon receives research grants from Boston Scientific and Medtronic. Dr Lindman has served on the scientific advisory board for Roche Diagnostics, has received research grants from Edwards Lifesciences and Roche Diagnostics, and has consulted for Medtronic. The remaining authors have no disclosures to report.

Figures

Figure 1. Patient selection flowchart for the current study.

ITT indicates intent‐to‐treat; and TAVR, transcatheter aortic valve replacement.

Figure 2. Gait speed at baseline and 1 year and changes in between those time points.

Gait speeds at baseline and 1 year for the whole population are shown (whiskers at 2.5 and 97.5 percentiles and box from 25th to 75th percentiles with line at median) (A). The magnitude and direction of change in gait speed from baseline to 1 year is shown for the whole population and then according to whether baseline gait speed was slow or normal (B).

Figure 3. Clinical outcomes between 1 and 2 years based on gait speed at baseline and 1 year.

Kaplan–Meier curves are shown based on slow vs normal gait speed at baseline and 1 year for 1‐ to 2‐year death or hospitalization (A), death (B), and hospitalization (C).