Aortic regurgitation after transcatheter aortic valve implantation with balloon- and self-expandable prostheses: a pooled analysis from a 2-center experience

JACC Cardiovasc Interv. 2014 Mar;7(3):284-92. doi: 10.1016/j.jcin.2013.11.011.

Abstract

Objectives: This study sought to assess aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) with the self-expandable Medtronic CoreValve (MCV) (Medtronic Inc., Minneapolis, Minnesota) versus balloon-expandable Edwards Sapien XT valve (ESV) (Edwards Lifesciences, Irvine, California).

Background: AR after TAVI has been associated with poor survival, but limited data exist comparing MCV with ESV.

Methods: We pooled the prospective TAVI databases of 2 German centers. The primary endpoint was more-than-mild post-TAVI AR assessed by echocardiography. We also assessed device success and survival within 1 year. Endpoints were adjudicated according to the Valve Academic Research Consortium criteria and analyzed by unadjusted and propensity-score-adjusted models.

Results: A total of 394 patients were included, 276 treated with MCV and 118 with ESV. More-than-mild AR was significantly higher with MCV than with ESV (12.7% vs. 2.6%, p = 0.002). This difference remained significant after propensity adjustment (adjusted odds ratio [OR]: 4.59, 95% confidence interval [CI]: 1.03 to 20.44). The occurrence of any degree of AR was also higher with MCV (71.6% vs. 56.9%, p = 0.004). Device success was mainly influenced by the occurrence of AR and was consequently higher with ESV (95.8% vs. 86.6%, p = 0.007), but this was not significant after propensity adjustment (adjusted OR: 0.34, 95% CI: 0.11 to 1.03, p = 0.06). At 1 year, survival was comparable between both valve types (83.8% MCV vs. 88.2% ESV, p = 0.42), but was significantly worse in patients with more-than-mild AR (69.8% vs. 87.4%, p = 0.004) and in those with device failure (65.6% vs. 87.4%, p < 0.001).

Conclusions: More-than-mild AR after TAVI was more frequent with MCV than with ESV. This finding deserves consideration, as more-than-mild AR was associated with higher mortality at 1 year.

Keywords: aortic regurgitation; device success; outcome; transcatheter aortic valve implantation.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged, 80 and over
  • Angiography
  • Aortic Valve Insufficiency / diagnosis
  • Aortic Valve Insufficiency / epidemiology
  • Aortic Valve Insufficiency / etiology*
  • Confidence Intervals
  • Echocardiography, Transesophageal
  • Female
  • Follow-Up Studies
  • Gated Blood-Pool Imaging
  • Germany / epidemiology
  • Heart Valve Prosthesis*
  • Humans
  • Incidence
  • Male
  • Odds Ratio
  • Postoperative Complications
  • Propensity Score
  • Prospective Studies
  • Prosthesis Design
  • Registries*
  • Risk Assessment / methods
  • Risk Factors
  • Severity of Illness Index
  • Survival Rate / trends
  • Tomography, X-Ray Computed
  • Transcatheter Aortic Valve Replacement / adverse effects*
  • Transcatheter Aortic Valve Replacement / methods
  • Treatment Outcome