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

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