title: Safety and efficacy of deep sedation as compared to general anaesthesia in percutaneous mitral valve repair using the MitraClip system.
abstract: 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.
  
  
  CONCLUSIONS
  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.affiliation: Medical Faculty, Department of Medicine, Division of Cardiology, Pulmonology, and Vascular Medicine, University Hospital Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany.
authors.forename: Tienush
authors.initials: T
authors.lastname: Rassaf
authors.forename: Jan
authors.initials: J
authors.lastname: Balzer
authors.forename: Tobias
authors.initials: T
authors.lastname: Zeus
authors.forename: Christos
authors.initials: C
authors.lastname: Rammos
authors.forename: Sascha
authors.initials: S
authors.lastname: Shayganfar
authors.forename: Silke V
authors.initials: SV
authors.lastname: Hall
authors.forename: Rabea
authors.initials: R
authors.lastname: Wagstaff
authors.forename: Malte
authors.initials: M
authors.lastname: Kelm
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000768:Anesthesia, General / Q000009:adverse effects; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation; D054810:Deep Sedation / Q000009:adverse effects; D005858:Germany; D007902:Length of Stay; D008943:Mitral Valve / Q000503:physiopathology; D008944:Mitral Valve Insufficiency / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
keywords: local anaesthesia; mitral regurgitation; percutaneous repair