title: Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial.
abstract: OBJECTIVE
  Aortic valve replacement (AVR) via minimally invasive surgery (MIS) may provide clinical benefits in patients with aortic valve disease. A new class of bioprosthetic valves that enable rapid deployment AVR (RDAVR) may facilitate MIS. We here report the 1-year results of a randomized, multicentre trial comparing the outcomes for MIS-RDAVR with those for conventional AVR via full sternotomy (FS) with a commercially available stented aortic bioprosthesis.
  
  
  METHODS
  A total of 100 patients with aortic stenosis were enrolled in a prospective, multicentre, randomized comparison trial (CADENCE-MIS). Key exclusion criteria included AVR requiring concomitant procedures, ejection fraction of <25% and recent myocardial infarction or stroke. Patients were randomized to undergo MIS-RDAVR via upper hemisternotomy (EDWARDS INTUITY) or AVR via FS with a commercially available stented valve. Procedural, early and late clinical outcomes were assessed for both groups. Haemodynamic performance was evaluated by an echocardiography CoreLaboratory.
  
  
  RESULTS
  Technical success was achieved in 94% of MIS-RDAVR patients. MIS-RDAVR was associated with significantly reduced cross-clamp times compared with FS (41.3 ± 20.3 vs 54.0 ± 20.3 min, P < 0.001). Clinical and functional outcomes were similar at 30 days and 1 year postoperatively for both groups. While both groups received a similarly sized implanted valve (22.9 ± 2.1 mm MIS-RDAVR vs 23.0 ± 2.1 mm FS-AVR; P = 0.91), MIS-RDAVR patients had significantly lower peak gradients 1 year postoperatively (16.9 ± 5.3 vs 21.9 ± 8.6 mmHg; P = 0.033) and a trend towards lower mean gradients (9.1 ± 2.9 vs 11.5 ± 4.3 mmHg; P = 0.082). In addition, MIS-RDAVR patients had a significantly larger effective orifice area 1 year postoperatively (1.9 ± 0.5 vs 1.7 ± 0.4 cm2; P = 0.047). Paravalvular leaks, however, were significantly more common in the MIS-RDAVR group (P = 0.027).
  
  
  CONCLUSIONS
  MIS-RDAVR is associated with a significantly reduced cross-clamp time and better valvular haemodynamic function than FS-AVR. However, paravalvular leak rates are higher with MIS-RDAVR.
authors.affiliation: Columbia University Medical Center, New York, NY, USA mb3851@cumc.columbia.edu.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Borger
authors.affiliation: Leipzig Heart Center, Leipzig, Germany.
authors.forename: Pascal M
authors.initials: PM
authors.lastname: Dohmen
authors.affiliation: German Heart Institute Berlin, Berlin, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Knosalla
authors.affiliation: German Heart Institute Berlin, Berlin, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Hammerschmidt
authors.affiliation: Leipzig Heart Center, Leipzig, Germany.
authors.forename: Denis R
authors.initials: DR
authors.lastname: Merk
authors.affiliation: Jena University Hospital, Jena, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Richter
authors.affiliation: Jena University Hospital, Jena, Germany.
authors.forename: Torsten
authors.initials: T
authors.lastname: Doenst
authors.affiliation: University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Lenard
authors.initials: L
authors.lastname: Conradi
authors.affiliation: University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.affiliation: University Hospitals of the Ruhr University of Bochum, Bochum, Germany.
authors.forename: Vadim
authors.initials: V
authors.lastname: Moustafine
authors.affiliation: Leipzig Heart Center, Leipzig, Germany.
authors.forename: David M
authors.initials: DM
authors.lastname: Holzhey
authors.affiliation: Edwards Lifesciences LLC, Irvine, CA, USA.
authors.forename: Francis
authors.initials: F
authors.lastname: Duhay
authors.affiliation: University Hospitals of the Ruhr University of Bochum, Bochum, Germany.
authors.forename: Justus
authors.initials: J
authors.lastname: Strauch
mesh_terms: D000368:Aged; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods; D006439:Hemodynamics; D006801:Humans; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D011446:Prospective Studies
keywords: Aortic valve replacement; Haemodynamics; Heart valve, Bioprosthesis; Minimally invasive