title: Sapien 3 Transcatheter Aortic Valve Implantation With Moderate or Without Predilation.
abstract: OBJECTIVE
  Aortic valve preparation with balloon aortic valvuloplasty (BAV) has been previously considered mandatory during transcatheter aortic valve implantation (TAVI) procedures. BAV-inherent risks including stroke, conduction abnormalities, and reduced device profile size established the rationale for safe valve deployment without the need for aggressive valve preparation. We investigate the feasibility and safety of performing Sapien 3 (S3; Edwards Lifesciences) balloon-expandable TAVI with moderate or without predilation (PD).
  
  
  METHODS
  We examined consecutive patients with severe aortic stenosis who underwent S3-TAVI at our institution. Overall, 119 patients underwent TAVI without PD and 126 with moderate PD (mean valvuloplasty balloon diameter, 15.3 ± 2.1 mm). TAVI endpoints and adverse events were considered according to the Valve Academic Research Consortium (VARC)-2 definitions.
  
  
  RESULTS
  Device success for the entire cohort was 98.8%. PD rates were similar between groups. Total fluoroscopy time and amount of contrast used were lower in the no PD group (13 min vs 16.2 min [P<.001] and 71.3 mL vs 81 mL [P=.03], respectively). All-cause mortality up to 30 days was 0% (0/119) in the no PD group vs 1.6% (2/126) in the moderate PD group (P=.49). VARC-2 defined complication rates at 30 days including cerebrovascular accident were similar between groups. Overall, there was no significant difference in survival rate between both groups (hazard ratio, 3.6; 95% confidence interval, 0.80-16.2; P=.09).
  
  
  CONCLUSIONS
  Balloon-expandable TAVI using the S3 device with moderate or without balloon PD is feasible and safe. Omission of PD in appropriate cases was associated with reduced fluoroscopy time and total contrast used without affecting procedural success.
authors.affiliation: Heart Institute, Cedars-Sinai Medical Center, 127 S. San Vicente Boulevard, AHSP, Suite A3600, Los Angeles, CA 90048 USA. yigalab@yahoo.com.
authors.forename: Yigal
authors.initials: Y
authors.lastname: Abramowitz
authors.forename: Hasan
authors.initials: H
authors.lastname: Jilaihawi
authors.forename: Tarun
authors.initials: T
authors.lastname: Chakravarty
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Maeno
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kawamori
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Kazuno
authors.forename: Geeteshwar
authors.initials: G
authors.lastname: Mangat
authors.forename: Tanya
authors.initials: T
authors.lastname: Rami
authors.forename: Zev
authors.initials: Z
authors.lastname: Allison
authors.forename: David
authors.initials: D
authors.lastname: Anderson
authors.forename: Larry
authors.initials: L
authors.lastname: Chan
authors.forename: Wen
authors.initials: W
authors.lastname: Cheng
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery; D063126:Balloon Valvuloplasty / Q000379:methods; D006328:Cardiac Catheterization / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D005471:Fluoroscopy / Q000379:methods; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D010043:Outcome and Process Assessment, Health Care; D011183:Postoperative Complications / Q000175:diagnosis / Q000209:etiology / Q000401:mortality; D011474:Prosthesis Design; D012189:Retrospective Studies; D012720:Severity of Illness Index; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D014481:United States / Q000453:epidemiology