Key result
Deep sedation for MitraClip implantation was as safe as general anesthesia for the primary combined safety endpoint, requiring intraprocedural conversion to general anesthesia in only 2% of patients.
Why the study?
Does deep sedation improve safety and procedural efficiency compared to general anesthesia in patients undergoing MitraClip implantation for severe mitral regurgitation?
Cohort (n=232)
Does deep sedation improve safety and procedural efficiency compared to general anesthesia in patients undergoing MitraClip implantation for severe mitral regurgitation?
Deep sedation is a safe and effective alternative to general anesthesia for MitraClip implantation, offering shorter preparation times and ICU stays without compromising safety.
Supports deep sedation feasibility for MitraClip; hypothesis-generating for efficiency gains pending randomized trials.
Objectives To investigate in a series of 232 patients whether the MitraClip® procedure can be performed safely using deep sedation (DS) without general anesthesia (GA). Background Transcatheter mitral valve repair using the MitraClip® system is a safe and effective therapy for severe mitral regurgitation (MR) in patients who are at high operative risk or are unsuitable for surgery. For these patients, avoidance of GA might be beneficial. Methods Between 2011 and 2015, we performed 232 MitraClip® procedures for the treatment of severe MR. Of those, 76 procedures were performed using GA, while the remaining 156 procedures were performed using DS. Results Age, logistic EuroScore, severity of MR, left and right ventricular function, and renal function did not differ between the groups. The primary combined safety endpoint, which was defined as the occurrence of major adverse cardiac and cerebrovascular events, conversion to surgery, major vascular complications or pneumonia, did not differ between MitraClip® procedures performed using GA and MitraClip® procedures performed using DS. Intraprocedural conversion to GA was required in 2% of the patients in the DS group. There were no differences in procedural success or clinical outcome between the groups at the 3‐month follow‐up. Preparation time in the catheterization laboratory and intensive care unit (ICU) stay were shorter in the DS group compared to the GA group. Conclusion The MitraClip® implantation performed using DS is as safe and effective as MitraClip® implantation performed using GA.
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Horn et al. (2017) conducted a cohort in Severe mitral regurgitation (n=232). Deep sedation vs. General anesthesia was evaluated on Occurrence of major adverse cardiac and cerebrovascular events, conversion to surgery, major vascular complications or pneumonia. Deep sedation for MitraClip implantation was as safe as general anesthesia for the primary combined safety endpoint, requiring intraprocedural conversion to general anesthesia in only 2% of patients.
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