Beyond the five-year horizon: long-term outcome of high-risk and inoperable patients undergoing TAVR with first-generation devices

EuroIntervention. 2018 May 20;14(1):41-49. doi: 10.4244/EIJ-D-17-00603.


Aims: We sought to determine the long-term outcome of high-risk patients who underwent transcatheter aortic valve replacement (TAVR) with first-generation devices with a focus on the identification of predictors for mortality and valve durability.

Methods and results: Consecutive patients in our prospective single-centre registry undergoing TAVR with first-generation devices (n=214 CoreValve; n=86 SAPIEN) between 06/2007 and 07/2009 were retrospectively analysed (n=300, mean age 81.43±6.55 years, mean STS score 6.5±4.5%). Kaplan-Meier estimates of survival and the Cox proportional hazards model were used to identify independent predictors of all-cause-mortality. At 1, 5, and 7 years, estimated survival rates were 76.0%, 40.2%, and 23.2%, respectively. Age-adjusted baseline predictors of mortality included atrial fibrillation, impaired kidney function, peripheral artery disease, and mitral regurgitation (≥moderate). Baseline risk-adjusted procedure-related predictors for all-cause mortality included acute kidney injury, neurological events, major vascular complications, and major/life-threatening bleeding. At both five and six years, 78.2% of surviving patients were in NYHA Class I or II. PVL was ≤mild in the majority of patients at discharge and throughout follow-up. At seven years, the overall crude cumulative incidence of structural valve deterioration according to the 2017 EAPCI/ESC/EACTS definition was 14.9% (CoreValve 11.8% vs. SAPIEN 22.6%; p=0.01).

Conclusions: Seven years after TAVR, 23.2% of high-risk patients were still alive. Independent predictors of all-cause mortality included both patient- and procedure-related factors. With a cumulative incidence of 14.9% at seven years, there is some suggestion that SVD post TAVR may become increasingly relevant during longer-term follow-up.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / surgery
  • Atrial Fibrillation / surgery
  • Female
  • Heart Valve Prosthesis* / adverse effects
  • Humans
  • Male
  • Prospective Studies
  • Registries
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Transcatheter Aortic Valve Replacement / adverse effects
  • Transcatheter Aortic Valve Replacement / instrumentation*
  • Treatment Outcome*