title: Transapical aortic valve replacement for severe aortic stenosis: results from the nonrandomized continued access cohort of the PARTNER trial.
abstract: BACKGROUND
  Transapical (TA) aortic valve replacement was an integral part of the Placement of Transcatheter Aortic Valves (PARTNER) trial. Enrollment during the randomized trial included 104 transapical (premarket approval TA [PMA-TA]) and 92 surgical aortic valve replacements (SAVR) within the TA cohort. On completion of the trial, enrollment continued in a nonrandomized continued access (NRCA) program. We compared the outcomes of NRCA-TA procedures with those of PMA-TA and SAVR.
  
  
  METHODS
  In 22 centers, 975 patients underwent TA aortic valve replacement as part of the NRCA registry. Inclusion and exclusion criteria were unchanged from the previously reported PARTNER trial. All patients were followed up for at least 1 year.
  
  
  RESULTS
  Thirty-day or in-hospital mortality was 8.8% for the NRCA-TA cohort, compared with 10.6% and 12.0% for the PMA-TA and SAVR patients, respectively (p = 0.54). One-year mortality in the NRCA-TA cohort was 22.1%, not significantly lower than the mortality in PMA-TA and SAVR patients at 29.0% and 25.3%, respectively (p = 0.27). Thirty-day or in-hospital stroke was 2.2% among NRCA-TA patients in contrast to the 6.7% stroke rate observed in the PMA-TA group and 5.4% in SAVR patients (p = 0.008). Lower rates of neurologic adverse events in the NRCA-TA group persisted at 1 year compared with the PMA-TA and SAVR patients.
  
  
  CONCLUSIONS
  Among the 975 patients in the NRCA-TA cohort, rates of major outcomes including death and stroke compared favorably with outcomes of PMA-TA and SAVR patients enrolled in the PARTNER trial. This trend toward improved outcomes may be attributed to improved patient selection, individual centers surmounting the procedural learning curve, and refinements in surgical technique.
authors: Medical City Dallas Hospital, Dallas, Texas. Electronic address: todd.dewey@hcahealthcare.com.
authors: Todd M
authors: TM
authors: Dewey
authors: Bruce
authors: B
authors: Bowers
authors: Vinod H
authors: VH
authors: Thourani
authors: Vasilis
authors: V
authors: Babaliaros
authors: Craig R
authors: CR
authors: Smith
authors: Martin B
authors: MB
authors: Leon
authors: Lars G
authors: LG
authors: Svensson
authors: E Murat
authors: EM
authors: Tuzcu
authors: D Craig
authors: DC
authors: Miller
authors: Paul S
authors: PS
authors: Teirstein
authors: Jeffrey
authors: J
authors: Tyner
authors: David L
authors: DL
authors: Brown
authors: Gregory P
authors: GP
authors: Fontana
authors: Raj R
authors: RR
authors: Makkar
authors: Mathew R
authors: MR
authors: Williams
authors: Isaac
authors: I
authors: George
authors: Ajay J
authors: AJ
authors: Kirtane
authors: Joseph E
authors: JE
authors: Bavaria
authors: Michael J
authors: MJ
authors: Mack
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D006328:Cardiac Catheterization; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology; D012189:Retrospective Studies; D012720:Severity of Illness Index; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
keywords: 28; 35; NRCA; PARTNER Trial; PMA; Placement of Aortic Transcatheter Valve Trial; SAVR; STS; TA; TAVR; The Society of Thoracic Surgeons; nonrandomized continued access; premarket approval; surgical aortic valve replacement; transapical; transcatheter aortic valve replacement