Suzanne de Waha1,2, Joerg Seeburger3, Joerg Ender4, Steffen Desch5,6, Ingo Eitel5,6, Adrian Reinhardt5,6, Janine Pöss5,6, Georg Fuernau5,6, Thilo Noack3, Denis Rouven Merk3, Gerhard Schuler7, Hans-Hinrich Sievers8, Friedrich-Wilhelm Mohr3, Holger Thiele5,6. 1. Department of Cardiology, Angiology and Intensive Care Medicine, Medical Clinic II (Cardiology/Angiology/Intensive Care Medicine), University Heart Center Luebeck, University Hospital Schleswig-Holstein, Ratzeburger Allee 160, 23538, Lübeck, Germany. s-dw@gmx.net. 2. German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Luebeck, Lübeck, Germany. s-dw@gmx.net. 3. Department of Cardiac Surgery, Heart Center, University of Leipzig, Leipzig, Germany. 4. Department of Anesthesiology, Heart Center, University of Leipzig, Leipzig, Germany. 5. Department of Cardiology, Angiology and Intensive Care Medicine, Medical Clinic II (Cardiology/Angiology/Intensive Care Medicine), University Heart Center Luebeck, University Hospital Schleswig-Holstein, Ratzeburger Allee 160, 23538, Lübeck, Germany. 6. German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Luebeck, Lübeck, Germany. 7. Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany. 8. Department of Cardiac and Thoracic Vascular Surgery, University Heart Center Luebeck, University Hospital Schleswig-Holstein, Lübeck, Germany.
Abstract
BACKGROUND: Percutaneous edge-to-edge mitral valve reconstruction (PMVR) has emerged as a treatment option in patients with severe mitral regurgitation not considered suitable candidates for surgery. The majority of PMVR procedures are performed under general anesthesia (GA), although deep sedation (DS) appears to be an attractive alternative. We thus sought to assess the impact on intensive care unit (ICU) length of stay, efficacy, and safety of DS in comparison to GA in patients undergoing PMVR using the MitraClip(®) system. METHODS: Sixty consecutive patients underwent PMVR procedures at two centers. The first 30 patients were treated by GA followed by 30 patients undergoing DS under different settings. The primary clinical endpoint was ICU length of stay. The primary efficacy endpoint included procedural success and procedural duration. The safety endpoint was defined as a composite of death, stroke, cardiogenic shock, moderate and severe bleeding as well as pneumonia. RESULTS: The ICU length of stay was significantly shorter in the DS group in comparison to GA patients (p = 0.001). The hospital length of stay did not differ following DS in comparison to GA (p = 0.96). Procedural success was high in both groups (100 versus 96.7 %, p = 0.34) at similar procedural duration time (p = 0.60). No difference between GA and DS was observed with respect to the occurrence of the combined safety endpoint (p = 0.47). CONCLUSIONS: In comparison to GA, DS reduces the ICU length of stay in PMVR without negative effects on safety and efficacy. Prospective randomized trials are needed to confirm these findings.
BACKGROUND: Percutaneous edge-to-edge mitral valve reconstruction (PMVR) has emerged as a treatment option in patients with severe mitral regurgitation not considered suitable candidates for surgery. The majority of PMVR procedures are performed under general anesthesia (GA), although deep sedation (DS) appears to be an attractive alternative. We thus sought to assess the impact on intensive care unit (ICU) length of stay, efficacy, and safety of DS in comparison to GA in patients undergoing PMVR using the MitraClip(®) system. METHODS: Sixty consecutive patients underwent PMVR procedures at two centers. The first 30 patients were treated by GA followed by 30 patients undergoing DS under different settings. The primary clinical endpoint was ICU length of stay. The primary efficacy endpoint included procedural success and procedural duration. The safety endpoint was defined as a composite of death, stroke, cardiogenic shock, moderate and severe bleeding as well as pneumonia. RESULTS: The ICU length of stay was significantly shorter in the DS group in comparison to GA patients (p = 0.001). The hospital length of stay did not differ following DS in comparison to GA (p = 0.96). Procedural success was high in both groups (100 versus 96.7 %, p = 0.34) at similar procedural duration time (p = 0.60). No difference between GA and DS was observed with respect to the occurrence of the combined safety endpoint (p = 0.47). CONCLUSIONS: In comparison to GA, DS reduces the ICU length of stay in PMVR without negative effects on safety and efficacy. Prospective randomized trials are needed to confirm these findings.
Entities:
Keywords:
Deep sedation; General anesthesia; Mitral regurgitation; Percutaneous edge-to-edge mitral valve reconstruction
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