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Cerebral Embolic Protection Devices in Transcatheter Aortic Valve Implantation: Meta-Analysis With Trial Sequential
Nav Warraich1,2, Michel Pompeu Sá3, Xander Jacquemyn4
1Division of Cardiac Surgery, Department of Cardiothoracic Surgery University of Pittsburgh Pittsburgh PA USA.
Insights
Cerebral embolic protection devices during transcatheter aortic valve implantation show no significant benefit for stroke or mortality. Current randomized controlled trial data is insufficient to draw definitive conclusions on stroke outcomes.
Area of Science:
- Cardiovascular Interventions
- Neurology
- Medical Device Technology
Background:
- Transcatheter aortic valve implantation (TAVI) is a growing procedure.
- Cerebral embolic protection devices (CEPDs) aim to reduce stroke risk during TAVI.
- Evidence on CEPD efficacy remains debated.
Purpose of the Study:
- To reevaluate randomized controlled trial (RCT) data on CEPD use during TAVI.
- To assess the impact of CEPDs on stroke and mortality outcomes.
- To evaluate the strength of current evidence using meta-analysis and trial sequential analysis.
Main Methods:
- Systematic search of RCTs evaluating CEPD use in TAVI.
- Conventional meta-analysis using random-effects modeling.
- Trial sequential analysis (TSA) to assess evidence robustness, futility, and required information size.
Main Results:
- Seven RCTs with 4031 patients (2171 CEPD, 1860 no CEPD) were included.
- No significant difference in all stroke (RR 0.85) or disabling stroke (RR 0.59) with CEPD use.
- TSA indicated absence of evidence for all stroke and disabling stroke, and futility for all-cause mortality.
Conclusions:
- Insufficient RCT data exists to provide conclusive meta-analytic findings on CEPD use for stroke outcomes in TAVI.
- Further high-quality trials are needed to definitively establish the benefit of CEPDs.
Background:
We aimed to reevaluate randomized controlled trial data on outcomes of cerebral embolic protection device use during transcatheter aortic valve implantation. A conventional meta-analysis followed by trial sequential analysis was conducted to evaluate the strength of the current evidence.
Methods And Results:
Databases were searched for randomized controlled trials. Primary outcomes included all stroke, disabling stroke, and all-cause mortality. Conventional study-level meta-analysis was performed using random-effects modeling. Trial sequential analysis was conducted to generate adjusted significance boundaries, futility boundaries, and the required information size considering a type I error of 5% and a power of 90%. Seven trials were included with a total of 4031 patients, of whom 2171 were treated with a device and 1860 were not. Conventional meta-analysis showed no significant difference in all stroke (relative risk [RR], 0.85 [95% CI, 0.61-1.18]; P=0.339) and disabling stroke (RR, 0.59 [95% CI, 0.30-1.13]; P=0.113) with device use. The trial sequential analysis determined an absence of evidence for all stroke (required information size of 71 650 [5.6%]) and disabling stroke (required information size of 337 256 [1.2%]). Conventional meta-analysis determined no significant difference in all-cause mortality (RR, 1.03 [95% CI, 0.49-2.17]; P=0.928) with device use. The trial sequential analysis determined that the futility boundary was reached (required information size of 5772 [69.3%]).
Conclusions:
There are insufficient randomized controlled trial data on cerebral embolic protection device use to provide conclusive meta-analytic findings for stroke outcomes.
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