title: Outcomes with post-dilation following transcatheter aortic valve replacement: the PARTNER I trial (placement of aortic transcatheter valve).
abstract: OBJECTIVE
  This study sought to characterize the patients receiving post-implantation balloon dilation (PD) following transcatheter aortic valve replacement (TAVR) and evaluate procedural outcomes in the PARTNER (Placement of Aortic Transcatheter Valve) I trial.
  
  
  BACKGROUND
  Following TAVR, PD has been used to treat paravalvular regurgitation.
  
  
  METHODS
  The PARTNER I trial cohort A (n = 304) and cohort B (n = 194) patients randomized to TAVR and the nonrandomized continued access TAVR (n = 1,637) patients were included in the analysis. PD was performed at the discretion of the operator. Clinical events and echocardiographic variables were collected prospectively out to 1 year.
  
  
  RESULTS
  The overall incidence of PD was 12.4%. PD patients had significantly less prosthesis-patient mismatch (p < 0.001) and larger effective orifice areas (p < 0.001) throughout the follow-up period. There were significantly more subacute strokes (occurring <7 days: 4.9% vs. 2.6%; p = 0.04) in PD patients but no difference in late stroke, either at 7 to 30 days (0.0% vs. 0.8%; p = 0.16) or >30 days (1.9 vs. 1.7%; p = 0.75). Although there was no significant increase in early mortality with PD, at 1 year, there was a trend for higher all-cause mortality (p = 0.054) and a significant difference in death or stroke (p = 0.04). When the subgroup of patients with none/trace paravalvular regurgitation were evaluated, there was no significant association of PD with mortality (p = 0.61) and death or stroke (p = 0.96). Multivariable analysis failed to show a relationship between PD and mortality.
  
  
  CONCLUSIONS
  PD is associated with reduced rates of moderate or severe prosthesis-patient mismatch with no evidence for short-term structural deterioration of the balloon-expandable transcatheter valve. Although PD is associated with a greater incidence of early stroke, there is no significant association between PD and stroke beyond 7 days. Multivariable analysis shows no significant association between PD and mortality.
authors: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York. Electronic address: rth2@columbia.edu.
authors: Rebecca T
authors: RT
authors: Hahn
authors: Department of Medicine, Laval University, Quebec, Canada.
authors: Philippe
authors: P
authors: Pibarot
authors: University of British Columbia and St. Paul's Hospital, Vancouver, Canada.
authors: John
authors: J
authors: Webb
authors: Department of Medicine, Laval University, Quebec, Canada.
authors: Josep
authors: J
authors: Rodes-Cabau
authors: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
authors: Howard C
authors: HC
authors: Herrmann
authors: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors: Mathew
authors: M
authors: Williams
authors: Cedars-Sinai Medical Center, Los Angeles, California.
authors: Raj
authors: R
authors: Makkar
authors: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
authors: Wilson Y
authors: WY
authors: Szeto
authors: Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
authors: Michael L
authors: ML
authors: Main
authors: Emory University School of Medicine, Atlanta, Georgia.
authors: Vinod H
authors: VH
authors: Thourani
authors: Cleveland Clinic Foundation, Cleveland, Ohio.
authors: E Murat
authors: EM
authors: Tuzcu
authors: Cleveland Clinic Foundation, Cleveland, Ohio.
authors: Samir
authors: S
authors: Kapadia
authors: Edwards Lifesciences, Irvine, California.
authors: Jodi
authors: J
authors: Akin
authors: Cardiovascular Research Foundation, New York, New York.
authors: Thomas
authors: T
authors: McAndrew
authors: Cardiovascular Research Foundation, New York, New York.
authors: Ke
authors: K
authors: Xu
authors: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors: Martin B
authors: MB
authors: Leon
authors: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors: Susheel K
authors: SK
authors: Kodali
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D063126:Balloon Valvuloplasty / Q000009:adverse effects / Q000401:mortality; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation / Q000401:mortality; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography
keywords: aortic stenosis; paravalvular regurgitation; post-dilation; prosthesis-patient mismatch; reballooning; transcatheter aortic valve replacement