title: Deep sedation versus general anesthesia in percutaneous edge-to-edge mitral valve reconstruction using the MitraClip system.
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.
authors.affiliation: 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.|German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Luebeck, Lübeck, Germany. s-dw@gmx.net.
authors.forename: Suzanne
authors.initials: S
authors.lastname: de Waha
authors.affiliation: Department of Cardiac Surgery, Heart Center, University of Leipzig, Leipzig, Germany.
authors.forename: Joerg
authors.initials: J
authors.lastname: Seeburger
authors.affiliation: Department of Anesthesiology, Heart Center, University of Leipzig, Leipzig, Germany.
authors.forename: Joerg
authors.initials: J
authors.lastname: Ender
authors.affiliation: 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.|German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Luebeck, Lübeck, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Desch
authors.affiliation: 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.|German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Luebeck, Lübeck, Germany.
authors.forename: Ingo
authors.initials: I
authors.lastname: Eitel
authors.affiliation: 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.|German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Luebeck, Lübeck, Germany.
authors.forename: Adrian
authors.initials: A
authors.lastname: Reinhardt
authors.affiliation: 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.|German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Luebeck, Lübeck, Germany.
authors.forename: Janine
authors.initials: J
authors.lastname: Pöss
authors.affiliation: 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.|German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Luebeck, Lübeck, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Fuernau
authors.affiliation: Department of Cardiac Surgery, Heart Center, University of Leipzig, Leipzig, Germany.
authors.forename: Thilo
authors.initials: T
authors.lastname: Noack
authors.affiliation: Department of Cardiac Surgery, Heart Center, University of Leipzig, Leipzig, Germany.
authors.forename: Denis Rouven
authors.initials: DR
authors.lastname: Merk
authors.affiliation: Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.affiliation: Department of Cardiac and Thoracic Vascular Surgery, University Heart Center Luebeck, University Hospital Schleswig-Holstein, Lübeck, Germany.
authors.forename: Hans-Hinrich
authors.initials: HH
authors.lastname: Sievers
authors.affiliation: Department of Cardiac Surgery, Heart Center, University of Leipzig, Leipzig, Germany.
authors.forename: Friedrich-Wilhelm
authors.initials: FW
authors.lastname: Mohr
authors.affiliation: 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.|German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Luebeck, Lübeck, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000768:Anesthesia, General / Q000009:adverse effects; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D054810:Deep Sedation / Q000009:adverse effects; D004867:Equipment Design; D005260:Female; D005858:Germany; D006801:Humans; D007362:Intensive Care Units; D007902:Length of Stay; D008297:Male; D008944:Mitral Valve Insufficiency / Q000175:diagnosis / Q000628:therapy*; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
keywords: Deep sedation; General anesthesia; Mitral regurgitation; Percutaneous edge-to-edge mitral valve reconstruction