Outcomes with post-dilation following transcatheter aortic valve replacement: the PARTNER I trial (placement of aortic transcatheter valve)

JACC Cardiovasc Interv. 2014 Jul;7(7):781-9. doi: 10.1016/j.jcin.2014.02.013.

Abstract

Objectives: 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.

Keywords: aortic stenosis; paravalvular regurgitation; post-dilation; prosthesis-patient mismatch; reballooning; transcatheter aortic valve replacement.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Insufficiency / diagnosis
  • Aortic Valve Insufficiency / etiology
  • Aortic Valve Insufficiency / mortality
  • Aortic Valve Insufficiency / physiopathology
  • Aortic Valve Insufficiency / therapy*
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / therapy*
  • Aortic Valve* / diagnostic imaging
  • Aortic Valve* / physiopathology
  • Balloon Valvuloplasty* / adverse effects
  • Balloon Valvuloplasty* / mortality
  • Cardiac Catheterization / adverse effects*
  • Cardiac Catheterization / instrumentation
  • Cardiac Catheterization / mortality
  • Female
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation / adverse effects*
  • Heart Valve Prosthesis Implantation / instrumentation
  • Heart Valve Prosthesis Implantation / methods
  • Heart Valve Prosthesis Implantation / mortality
  • Hemodynamics
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Multivariate Analysis
  • Proportional Hazards Models
  • Prosthesis Design
  • Randomized Controlled Trials as Topic
  • Retrospective Studies
  • Risk Factors
  • Severity of Illness Index
  • Stroke / etiology
  • Stroke / mortality
  • Time Factors
  • Treatment Outcome
  • Ultrasonography