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Published on: June 3, 2018
Cerebral embolic protection devices in transcatheter aortic valve implantation: An updated meta-analysis of
Ensieh Sadat Mansouri1, Flavia Queiroga2, Mohammadhasan Ghasemi3
1Department of Internal Medicine, Ziaeian Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Insights
Cerebral embolic protection devices (CEPD) do not significantly reduce stroke or mortality in transcatheter aortic valve replacement (TAVR) patients. This meta-analysis of eight RCTs found no benefit for CEPD in preventing strokes during TAVR procedures.
Area of Science:
- Cardiovascular Medicine
- Neurosurgery
- Medical Devices
Background:
- Cerebral embolic protection devices (CEPD) aim to prevent brain emboli during transcatheter aortic valve replacement (TAVR).
- The effectiveness and safety of CEPD for stroke prevention in TAVR patients remain unclear.
Purpose of the Study:
- To evaluate the efficacy and safety of CEPD in reducing stroke incidence and all-cause mortality in patients undergoing TAVR.
Main Methods:
- A systematic meta-analysis of randomized controlled trials (RCTs) was conducted.
- Searches included PubMed, Embase, and Cochrane Library for RCTs comparing CEPD versus control in TAVR patients.
- Pooled risk ratios (RR) with 95% confidence intervals (CI) were calculated using a random-effects model.
Main Results:
- Eight RCTs comprising 11,596 patients were included; 51% were assigned to the CEPD group.
- No significant difference in stroke incidence was observed between the CEPD and control groups (3.51% vs. 3.64%; RR 0.91; 95% CI 0.75-1.1).
- CEPD did not significantly reduce all-cause mortality compared to control (0.82% vs. 0.67%; RR 1.13; 95% CI 0.74-1.74).
Conclusions:
- Cerebral embolic protection devices do not significantly decrease stroke incidence in patients undergoing TAVR.
- CEPD also showed no significant benefit in reducing all-cause mortality among TAVR patients.
Background:
Cerebral embolic protection devices (CEPD) have been designed to prevent embolization to the cerebral circulation during transcatheter aortic valve replacement (TAVR). However, the efficacy and safety of CEPD in stroke prevention in TAVR remains uncertain.
Methods:
PubMed, Embase, and Cochrane Library were searched for randomized controlled trials (RCTs) comparing CEPD vs. control for patients undergoing TAVR. Risk ratios (RR) with 95 % confidence intervals (CI) were pooled with a random-effects model.
Results:
Our meta-analysis included eight RCTs with 11,596 patients, of whom 5946 (51 %) were randomized to the CEPD group. There was no significant difference in the incidence of any stroke (3.51 % vs. 3.64 %; RR 0.91; 95 % CI 0.75-1.1; p = 0.33; I2 = 0 %) between groups. Similarly, CEPD did not significantly reduce the incidence of all-cause mortality (0.82 % vs. 0.67 %; RR 1.13; 95 % CI 0.74-1.74; p = 0.57; I2 = 0 %) CONCLUSIONS: Among patients undergoing TAVR, CEPD did not significantly reduce stroke incidence or all-cause mortality.
