Predictors, Incidence, and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation Complicated by Stroke

Circ Cardiovasc Interv. 2019 Mar;12(3):e007546. doi: 10.1161/CIRCINTERVENTIONS.118.007546.

Abstract

Background: Stroke remains one of the most devastating complications of transcatheter aortic valve implantation (TAVI). The aim of this study was to identify the incidence, timing, temporal trends, and predictors of stroke after TAVI and evaluate the outcomes of patients with stroke.

Methods and results: The CENTER-Collaboration is an international collaboration consisting of 3 national registries and 7 local registries or prospective clinical trials, selected through a systematic review. Accordingly, a total of 10 982 patients undergoing transfemoral TAVI between 2007 and 2018 were included in the current patient-level pooled analyses. A total of 261 patients (2.4%) experienced stroke during the first month after TAVI. The median time between TAVI and stroke was 1 day (interquartile range, 0-6 days). The stroke rate was comparable in procedures performed in the early years of TAVI (2007-2012) to those in the more recent years of TAVI (2013-2018; both 2.4%; P=1.0). Independent predictors of stroke at 30 days were a history of cerebrovascular events (odds ratio, 2.2; 95% CI, 1.4-3.6; P=0.0012) and a glomerular filtration rate of <30 mL/min per 1.73 m2 (odds ratio, 1.7; 95% CI, 1.0-2.8; P=0.05). Stroke occurring within the first 30 days after TAVI was associated with a 6-fold increase of 30-day mortality (odds ratio, 6.0; 95% CI, 4.4-8.1; P<0.001). Moreover, patients with stroke more frequently had documented new-onset atrial fibrillation (16% versus 3%; P<0.001) and major or life-threatening bleedings (12% versus 7%; P=0.002) at 30-day follow-up.

Conclusions: In this large, global, patient-level analysis, the incidence of stroke after transfemoral TAVI was 2.4%. Prior cerebrovascular events and a low glomerular filtration rate independently predicted the occurrence of stroke after TAVI. The occurrence of stroke after TAVI was associated with a strikingly 6-fold increase of 30-day mortality; additionally, there was a 5-fold higher rate of new-onset atrial fibrillation in patients with stroke.

Clinical trial registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03588247.

Keywords: follow-up studies; humans; incidence; stroke; transcatheter aortic valve replacement.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / surgery*
  • Catheterization, Peripheral / adverse effects*
  • Catheterization, Peripheral / mortality
  • Clinical Trials as Topic
  • Female
  • Femoral Artery*
  • Humans
  • Incidence
  • Male
  • Punctures
  • Registries
  • Risk Assessment
  • Risk Factors
  • Stroke / diagnosis
  • Stroke / epidemiology*
  • Stroke / mortality
  • Time Factors
  • Transcatheter Aortic Valve Replacement / adverse effects*
  • Transcatheter Aortic Valve Replacement / mortality
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT03588247