Neurological Events Following Transcatheter Aortic Valve Replacement and Their Predictors: A Report From the CoreValve Trials

Circ Cardiovasc Interv. 2016 Sep;9(9):e003551. doi: 10.1161/CIRCINTERVENTIONS.115.003551.

Abstract

Background: The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread.

Methods and results: Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis. The 1-year stroke rate after TAVR was 8.4%. Analysis of the stroke hazard rate identified an early phase (0-10 days; 4.1% of strokes) and a late phase (11-365 days; 4.3% of strokes). Baseline predictors of early stroke included National Institutes of Health stroke scale score >0, prior stroke, prior transient ischemic attack, peripheral vascular disease, absence of prior coronary artery bypass surgery, angina, low body mass index (<21 kg/m(2)), and falls within the past 6 months. Significant procedural predictors were total time in the catheterization laboratory or operating room, delivery catheter in the body time, rapid pacing used during valvuloplasty, and repositioning of the prosthesis. Predictors of stroke between 11 and 365 days were small body surface area, severe aortic calcification, and falls within the past 6 months. There were no significant imaging predictors of early or late stroke.

Conclusions: Predictors of early stroke after TAVR included clinical and procedural factors; predictors of later stroke were limited to patient but not anatomic characteristics. These findings indicate that further refinement of imaging to identify anatomic factors predisposing to embolization may help improve stroke prediction in patients undergoing TAVR.

Clinical trial registrations: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01240902, NCT01531374.

Keywords: CoreValve; aortic valve stenosis; stroke; transcatheter aortic valve implantation; transient ischemic attack.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / pathology*
  • Aortic Valve / physiopathology
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / surgery*
  • Balloon Valvuloplasty / adverse effects
  • Bioprosthesis
  • Calcinosis / diagnostic imaging
  • Calcinosis / mortality
  • Calcinosis / physiopathology
  • Calcinosis / surgery*
  • Cardiac Pacing, Artificial / adverse effects
  • Clinical Trials as Topic
  • Female
  • Heart Valve Prosthesis
  • Humans
  • Incidence
  • Intracranial Embolism / diagnosis
  • Intracranial Embolism / epidemiology*
  • Intracranial Embolism / mortality
  • Kaplan-Meier Estimate
  • Male
  • Proportional Hazards Models
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index
  • Stroke / diagnosis
  • Stroke / epidemiology*
  • Stroke / mortality
  • Time Factors
  • Transcatheter Aortic Valve Replacement / adverse effects*
  • Transcatheter Aortic Valve Replacement / instrumentation
  • Transcatheter Aortic Valve Replacement / mortality
  • Treatment Outcome

Supplementary concepts

  • Aortic Valve, Calcification of

Associated data

  • ClinicalTrials.gov/NCT01240902
  • ClinicalTrials.gov/NCT01531374