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Published on: June 3, 2018
Cerebral embolic protection for stroke prevention during transcatheter aortic valve replacement
Jawad Basit1, Mushood Ahmed1, George Kidess2
1Department of Medicine, Rawalpindi Medical University, Rawalpindi, Pakistan.
Insights
Cerebral embolic protection devices (CEPD) significantly reduce stroke during TAVR procedures. While CEPD use lowered overall stroke incidence, it did not impact disabling stroke, mortality, or other complications in this meta-analysis.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Transcatheter Aortic Valve Replacement (TAVR) is a common procedure for aortic stenosis.
- Embolic events, particularly stroke, are a significant concern during TAVR.
- Cerebral Embolic Protection Devices (CEPD) are designed to mitigate embolic risks.
Purpose of the Study:
- To systematically evaluate the statistical evidence on the effectiveness and safety of CEPD during TAVR.
- To re-calibrate existing data in light of recent pivotal trials and cohort studies.
Main Methods:
- A systematic literature search was performed across multiple databases up to February 2023.
- Data from 17 studies (7 RCTs, 10 cohorts, n=155,829) were included.
- Dichotomous outcomes were pooled using Odds Ratios (OR) and continuous outcomes using Standardized Mean Differences (SMD), with 95% CIs.
Main Results:
- CEPD use was associated with a significant reduction in the odds of all strokes (OR=0.60, 95% CI=0.43-0.85, p=0.003).
- No significant differences were observed in disabling stroke, non-disabling stroke, or 30-day mortality.
- There were no significant differences in DW-MRI findings, acute kidney injury, pacemaker implantation, bleeding events, or vascular complications.
Conclusions:
- CEPD use during TAVR effectively reduces the overall incidence of stroke.
- Despite reducing all strokes, CEPD did not show significant benefits for disabling strokes, mortality, or other assessed complications.
- Further research may be warranted to fully elucidate the comprehensive impact of CEPD in TAVR.
Introduction:
Cerebral Embolic Protection Device (CEPD) captures emboli during Transcatheter Aortic Valve Replacement (TAVR). With recently published pivotal trials and multiple cohort studies reporting new data, there is a need to re-calibrate available statistical evidence.
Methods:
A systematic literature search was conducted across databases from inception till February 2023. Dichotomous outcomes were pooled using Odds Ratio (OR), while continuous outcomes were pooled using Standardized Mean Difference (SMD) along with 95% corresponding intervals (95% CIs).
Results:
Data was included from 17 studies (7 RCTs, 10 cohorts, n = 155,829). Use of CEPD was associated with significantly reduced odds of stroke (OR = 0.60, 95% CI = 0.43-0.85, p = 0.003). There was no significant difference in disabling stroke (p = 0.25), non-disabling stroke (p = 0.72), and 30-day mortality (p = 0.10) between the two groups. There were no significant differences between the two groups for Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) findings, acute kidney injury, risk of pacemaker implantation life-threatening bleed, major bleed, minor bleed, worsening National Institute of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and vascular complications (p > 0.05).
Conclusions:
The use of CEPD during TAVR reduced the incidence of all-stroke (p = 0.003); however, there were no significant differences in any of the other pooled outcomes (p > 0.05).
Registration:
The protocol of this meta-analysis was registered with the Open Science framework [https://doi.org/10.17605/OSF.IO/7W564] before data acquisition was started.
