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Safety and efficacy of cerebral protection devices in transcatheter aortic valve replacement: A clinical end-points

Divyanshu Mohananey1, Kesavan Sankaramangalam1, Arnav Kumar2

  • 1Department of Cardiovascular Medicine, Cleveland Clinic, OH, United States.

Cardiovascular Revascularization Medicine : Including Molecular Interventions
|March 19, 2018
PubMed

Insights

Cerebral protection devices (CPD) show a reduced risk of stroke within one week after transcatheter aortic valve replacement (TAVR). However, these devices do not significantly impact the primary composite outcome of stroke and mortality at 30 days.

Area of Science:

  • Cardiology
  • Neurology
  • Medical Devices

Background:

  • Stroke is a significant complication of transcatheter aortic valve replacement (TAVR), occurring in 4-11% of patients.
  • Cerebral protection devices (CPD) are designed to mitigate cerebrovascular events during TAVR.
  • While imaging studies suggest CPD reduce lesion volume, their clinical benefit remains unclear.

Purpose of the Study:

  • To evaluate the clinical safety and efficacy of cerebral protection devices (CPD) in transcatheter aortic valve replacement (TAVR).
  • To synthesize data from prospective randomized and non-randomized studies using meta-analysis techniques.

Main Methods:

  • Meta-analysis of prospective randomized and non-randomized studies.
  • Data summarized using Mantel-Haenszel relative risk (RR) and 95% confidence intervals (CI).
  • Heterogeneity assessed using Higgins' I² statistic.

Main Results:

  • No significant difference in the primary composite outcome of stroke and mortality at 30 days between CPD and no-CPD groups (RR 0.70; 95% CI 0.40-1.21).
  • Comparable rates for peri-procedural strokes, 30-day stroke, mortality, AKI, major bleeding, life-threatening bleeding, and major vascular complications.
  • A statistically significant reduction in the risk of strokes within the first week post-TAVR was observed in the CPD group (RR 0.56; 95% CI 0.33-0.96).

Conclusions:

  • Cerebral protection devices (CPD) are associated with a decreased incidence of strokes within one week following TAVR.
  • CPD do not increase the risk of other peri-procedural adverse events.
  • The clinical utility of CPD in TAVR warrants further investigation despite the observed reduction in early stroke risk.
Abstract

Keywords:
Cerebral embolic protectionSafety and efficacyStrokeTAVR

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