Objective: To characterize the safety and efficacy of deep sedation (DS) as compared to general anaesthesia (GA) in percutaneous mitral valve repair (PMVR) using the MitraClip system.
Background: PMVR with the MitraClip system has emerged as a therapeutic alternative to surgical valve repair in high-risk patients. The PMVR procedure is typically performed under GA. Due to their high surgical risk, avoidance of GA in many of those patients would be desirable.
Methods: In an open-label observational study 21 patients with severe mitral regurgitation were randomized to either GA or DS using propofol. Primary endpoints of this comparison were related to safety with rate of conversion from DS to GA, bleeding, aspiration, and pneumonia. Secondary endpoints were related to efficacy with procedural, in-hospital, and mid-term outcome at 1 month.
Results: All clips have been implanted successfully in both groups. No conversion from DS to GA was necessary. Four patients undergoing GA suffered from upper respiratory tract infections and two from peripheral vascular complications during placement of central venous catheter for GA. Short- and mid-term efficacy were comparable in both groups with a reduced hospital stay in the DS group.
Conclusion: PVMR in high-risk patients performed under DS is as safe and effective as with GA, preventing complications related to GA and shortening hospital stay.
Trial registration: ClinicalTrials.gov NCT02023762.
Keywords: local anaesthesia; mitral regurgitation; percutaneous repair.
© 2014 Wiley Periodicals, Inc.