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.
RCT Entities:
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.
Authors: Jakob Ledwoch; Predrag Matić; Jennifer Franke; Sameer Gafoor; Stefan Bertog; Markus Reinartz; Laura Vaskelyte; Ilona Hofmann; Horst Sievert Journal: Clin Res Cardiol Date: 2015-09-16 Impact factor: 5.460
Authors: Johannes Patzelt; Miriam Ulrich; Harry Magunia; Reinhard Sauter; Michal Droppa; Rezo Jorbenadze; Annika S Becker; Tobias Walker; Ralph Stephan von Bardeleben; Christian Grasshoff; Peter Rosenberger; Meinrad Gawaz; Peter Seizer; Harald F Langer Journal: J Am Heart Assoc Date: 2017-12-02 Impact factor: 5.501