title: Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial.
abstract: OBJECTIVE
  Transcatheter aortic valve replacement (TAVR) is an effective treatment option for high-risk patients with severe aortic stenosis. Different from surgery, transcatheter deployment of valves requires either a balloon-expandable or self-expandable system. A randomized comparison of these 2 systems has not been performed.
  
  
  OBJECTIVE
  To determine whether the balloon-expandable device is associated with a better success rate than the self-expandable device.
  
  
  METHODS
  The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure. One hundred twenty-one patients were randomly assigned to receive a balloon-expandable valve (Edwards Sapien XT) and 120 were assigned to receive a self-expandable valve (Medtronic CoreValve). Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany.
  
  
  METHODS
  Transfemoral TAVR with a balloon-expandable or self-expandable device.
  
  
  METHODS
  The primary end point was device success, which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system, correct position of the device, intended performance of the heart valve without moderate or severe regurgitation, and only 1 valve implanted in the proper anatomical location. Secondary end points included cardiovascular mortality, bleeding and vascular complications, postprocedural pacemaker placement, and a combined safety end point at 30 days, including all-cause mortality, major stroke, and other serious complications.
  
  
  RESULTS
  Device success occurred in 116 of 121 patients (95.9%) in the balloon-expandable valve group and 93 of 120 patients (77.5%) in the self-expandable valve group (relative risk [RR], 1.24, 95% CI, 1.12-1.37, P < .001). This was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation (4.1% vs 18.3%; RR, 0.23; 95% CI, 0.09-0.58; P < .001) and the less frequent need for implanting more than 1 valve (0.8% vs 5.8%, P = .03) in the balloon-expandable valve group. Cardiovascular mortality at 30 days was 4.1% in the balloon-expandable valve group and 4.3% in the self-expandable valve group (RR, 0.97; 95% CI, 0.29-3.25; P = .99). Bleeding and vascular complications were not significantly different, and the combined safety end point occurred in 18.2% of those in the balloon-expandable valve group and 23.1% of the self-expandable valve group (RR, 0.79; 95% CI, 0.48-1.30; P = .42). Placement of a new permanent pacemaker was less frequent in the balloon-expandable valve group (17.3% vs 37.6%, P = .001).
  
  
  CONCLUSIONS
  Among patients with high-risk aortic stenosis undergoing TAVR, the use of a balloon-expandable valve resulted in a greater rate of device success than use of a self-expandable valve.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01645202.
authors.affiliation: Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Wahab
authors.affiliation: Munich University Clinic, Munich, Germany.
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.affiliation: Cardiology Department, Asklepios Clinic St Georg, Hamburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Frerker
authors.affiliation: University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.affiliation: Cardiology Department, Lübeck University Hospital, Lübeck, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Kurz
authors.affiliation: Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Tölg
authors.affiliation: Radiology Department, Segeberger Kliniken, Bad Segeberg, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Zachow
authors.affiliation: Intracoronary Stenting and Antithrombosis Research Center, Munich, Germany.
authors.forename: Elena
authors.initials: E
authors.lastname: Guerra
authors.affiliation: Munich University Clinic, Munich, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Massberg
authors.affiliation: Cardiology Department, Asklepios Clinic St Georg, Hamburg, Germany8Cardiology Department, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schäfer
authors.affiliation: Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.
authors.forename: Mohamed
authors.initials: M
authors.lastname: El-Mawardy
authors.affiliation: Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000033:anatomy & histology / Q000473:pathology; D001024:Aortic Valve Stenosis / Q000628:therapy*; D006328:Cardiac Catheterization; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006470:Hemorrhage; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012306:Risk; D015996:Survival Rate; D016896:Treatment Outcome