Safety and Patient Experience With Early Mobilization After Transcatheter Aortic Valve Implantation: A Randomized Trial.

Background: Immobilization after transcatheter aortic valve replacement (TAVR) is the standard treatment for preventing access-related complications. However, the length of bed rest varies, and possible complications and patient experience remain unexplored.

Objective: In this pilot study, our aim was to investigate safety and efficacy after bed rest after TAVR.

Methods: This single-center randomized trial included 298 patients. Patients were randomized to standard 6 hours (n = 149) or 3 hours (n = 149) of bed rest after TAVR. The primary safety endpoint was a composite of access-related bleeding (Bleeding Academic Research Consortium type ≥ 2), hematoma (>5 cm), pseudoaneurysm, and vascular complications requiring intervention. The primary efficacy endpoint was patient-reported back pain, rated ≥6 on a numeric rating scale 24 hours post procedure. The secondary endpoints were the individual components of the primary safety endpoint, patient-reported pain, urination problems, and comfort.

Results: The primary safety endpoint occurred in 14 (9.4%) and 12 (8.1%) patients in the 6-hour and 3-hour immobilization groups, respectively (risk ratio, 0.86 [95% confidence interval, 0.41-1.79]; P = .68). There were no significant differences in individual bleeding or vascular complication endpoints. Patients with 3 hours of bed rest reported less back pain (P < .001), fewer urination problems (P < .001), and better comfort (P < .001) than patients with 6 hours of bed rest.

Conclusions: Mobilization as early as 3 hours after TAVR was shown to be safe, not resulting in a higher rate of bleeding or vascular complications as compared with 6 hours of bed rest. However, there was a difference in patient-reported back pain, urination problems, and comfort, favoring early mobilization.