title: Early clinical outcomes of a novel self-expanding transapical transcatheter aortic valve bioprosthesis.
abstract: Coronary obstruction remains a challenging complication of transcatheter aortic valve replacement; however, a new self-expanding transapical prosthesis may reduce this risk. The purpose of this study was to evaluate the early 1-year outcomes of patients with low coronary heights who received the Acurate TA bioprosthesis (Symetis, Ecublens, Switzerland).
  
  
  
  Between May 2014 and April 2015, 30 consecutive patients (aged 85 ± 6 years, 63% were female, Society of Thoracic Surgeons score 8.4 ± 6.0) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the Acurate TA bioprosthesis. Relevant patient characteristics included reoperation in 47% (n = 14), peripheral vascular disease in 43% (n = 13), and porcelain aorta in 30% (n = 9). The mean left and right coronary heights were 10.8 ± 1.5 mm and 16.4 ± 4.1 mm, respectively, with a sinus of Valsalva : annular ratio of 1.3 ± 0.8.
  
  
  
  All 30 device implants were successful. The 30-day in-hospital mortality was 3.3% (n = 1), and no patients had coronary obstruction or stroke. One patient (3.3%) had apical rupture requiring cardiopulmonary bypass for repair, 1 patient (3.3%) had a localized femoral artery dissection, and 1 patient (3.7%) required a new pacemaker. There were no other complications. Mean and peak transaortic valve gradients decreased from 59 ± 17 and 84 ± 31 mm Hg to 14 ± 7 and 28 ± 12 mm Hg, respectively (P < .0005). No patients had more than mild paravalvular aortic insufficiency. At 30 days, there were no further complications and 96.7% (n = 29) were in New York Heart Association class I/II. Survival at 30 days and 1 year was 97% and 89%, respectively.
  
  
  
  The Symetis Acurate TA device demonstrates high procedural success and excellent acute and 1-year patient outcomes. The device allows safe implantation in patients at higher risk for coronary artery obstruction.
authors.affiliation: Division of Cardiac Surgery, Department of Surgery, Western University, Lawson Health Research Institute, London, Ontario, Canada. Electronic address: Michael.Chu@lhsc.on.ca.
authors.forename: Michael W A
authors.initials: MW
authors.lastname: Chu
authors.affiliation: Division of Cardiology, Department of Medicine, Western University, Lawson Health Research Institute, London, Ontario, Canada.
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Bagur
authors.affiliation: Division of Cardiac Surgery, Department of Surgery, Western University, Lawson Health Research Institute, London, Ontario, Canada.
authors.forename: Katie L
authors.initials: KL
authors.lastname: Losenno
authors.affiliation: Department of Anesthesia & Perioperative Medicine, Western University, Lawson Health Research Institute, London, Ontario, Canada; Department of Epidemiology & Biostatistics, Western University, Lawson Health Research Institute, London, Ontario, Canada.
authors.forename: Philip M
authors.initials: PM
authors.lastname: Jones
authors.affiliation: Division of Cardiology, Department of Medicine, Western University, Lawson Health Research Institute, London, Ontario, Canada.
authors.forename: Pantelis
authors.initials: P
authors.lastname: Diamantouros
authors.affiliation: Division of Cardiology, Department of Medicine, Western University, Lawson Health Research Institute, London, Ontario, Canada.
authors.forename: Patrick
authors.initials: P
authors.lastname: Teefy
authors.affiliation: Division of Cardiac Surgery, Department of Surgery, Western University, Lawson Health Research Institute, London, Ontario, Canada.
authors.forename: Jill J
authors.initials: JJ
authors.lastname: Gelinas
authors.affiliation: Division of Cardiac Surgery, Department of Surgery, Western University, Lawson Health Research Institute, London, Ontario, Canada.
authors.forename: Bob
authors.initials: B
authors.lastname: Kiaii
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D063126:Balloon Valvuloplasty / Q000009:adverse effects / Q000401:mortality; D001705:Bioprosthesis; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000601:surgery; D011474:Prosthesis Design; D020127:Recovery of Function; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016896:Treatment Outcome
keywords: aortic valve; coronary obstruction; transapical; transcatheter aortic valve implantation; transcatheter aortic valve replacement