title: A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement.
abstract: BACKGROUND
  Minimally invasive surgical procedures (MIS) may offer several advantages over conventional full sternotomy (FS) aortic valve replacement (AVR). A novel class of aortic valve prostheses has been developed for rapid-deployment AVR (RDAVR). We report a randomized, multicenter trial comparing the outcomes for MIS-RDAVR with those of conventional FS-AVR.
  
  
  METHODS
  A total of 100 patients with aortic stenosis were enrolled in a prospective, multicenter, randomized comparison trial (CADENCE-MIS). Exclusion criteria included ejection fraction below 25%, AVR requiring concomitant procedures, and recent myocardial infarction or stroke. Patients were randomized to undergo MIS-RDAVR through an upper hemisternotomy (n = 51) or AVR by FS with a conventional stented bioprosthesis (n = 49). Three patients were excluded before the procedure, and 3 more patients who were randomized to undergo RDAVR were excluded because of their anatomy. Procedural, early clinical outcomes, and functional outcomes were assessed for the remaining 94 patients. Hemodynamic performance was assessed by an echocardiography core laboratory.
  
  
  RESULTS
  Implanted valve sizes were similar between groups (22.9 ± 2.1 vs 23.0 ± 2.1 mm, p = 0.9). MIS-RDAVR was associated with significantly reduced aortic cross-clamp times compared with FS-AVR (41.3 ± 20.3 vs 54.0 ± 20.3 minutes, p < 0.001), although cardiopulmonary bypass times were similar (68.8 ± 29.0 vs 74.4 ± 28.4 minutes, p = 0.21). Early clinical outcomes were similar between the two groups, including quality of life measures. The RDAVR patients had a significantly lower mean transvalvular gradient (8.5 vs 10.3 mm Hg, p = 0.044) and a lower prevalence of patient-prosthesis mismatch (0% vs 15.0%, p = 0.013) 3 months postoperatively compared with the FS-AVR patients.
  
  
  CONCLUSIONS
  RDAVR by the MIS approach is associated with significantly reduced myocardial ischemic time and better valvular hemodynamic function than FS-AVR with a conventional stented bioprosthesis. Rapid deployment valves may facilitate the performance of MIS-AVR.
authors.affiliation: University of Leipzig, Leipzig, Germany. Electronic address: mb3851@cumc.columbia.edu.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Borger
authors.affiliation: University Hospital of the Ruhr University of Bochum, North Rhine-Westphalia, Germany.
authors.forename: Vadim
authors.initials: V
authors.lastname: Moustafine
authors.affiliation: University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Lenard
authors.initials: L
authors.lastname: Conradi
authors.affiliation: German Heart Institute Berlin, Berlin, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Knosalla
authors.affiliation: Jena University Hospital, Jena, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Richter
authors.affiliation: University of Leipzig, Leipzig, Germany.
authors.forename: Denis R
authors.initials: DR
authors.lastname: Merk
authors.affiliation: Jena University Hospital, Jena, Germany.
authors.forename: Torsten
authors.initials: T
authors.lastname: Doenst
authors.affiliation: German Heart Institute Berlin, Berlin, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Hammerschmidt
authors.affiliation: University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.affiliation: University of Leipzig, Leipzig, Germany.
authors.forename: Pascal
authors.initials: P
authors.lastname: Dohmen
authors.affiliation: University Hospital of the Ruhr University of Bochum, North Rhine-Westphalia, Germany.
authors.forename: Justus T
authors.initials: JT
authors.lastname: Strauch
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures; D011446:Prospective Studies; D015607:Stents; D056346:Sternotomy