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Published on: June 3, 2018
Safety and efficacy of cerebral embolic protection devices for patients undergoing transcatheter aortic valve
Dhan Bahadur Shrestha1, Jurgen Shtembari1, Sandesh Lamichhane2
1Department of Internal Medicine Mount Sinai Hospital Chicago Illinois USA.
Insights
Cerebral embolic protection (CEP) devices may reduce mortality and stroke risk during transcatheter aortic valve replacement (TAVR). While the Sentinel device showed benefits, further research is needed to identify high-risk patients for optimal CEP use.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Neurosurgery
Background:
- Cerebral embolic protection (CEP) devices aim to mitigate stroke risk during transcatheter aortic valve replacement (TAVR) by capturing embolic debris.
- Existing evidence on the safety and efficacy of CEP devices during TAVR is inconclusive.
- This meta-analysis sought to consolidate current data on CEP device utilization in TAVR procedures.
Purpose of the Study:
- To systematically evaluate the safety and effectiveness of cerebral embolic protection (CEP) devices in patients undergoing transcatheter aortic valve replacement (TAVR).
- To compare outcomes between TAVR procedures with and without CEP device use.
- To identify potential differences in efficacy among various CEP devices.
Main Methods:
- A comprehensive literature search was conducted across major electronic databases (PubMed, Scopus, Cochrane Library, Embase).
- Data from 20 relevant studies, including eight randomized controlled trials (RCTs), were extracted and analyzed.
- Statistical analysis utilized Odds Ratios (OR) with 95% Confidence Intervals (CI) to assess outcomes.
Main Results:
- The meta-analysis of 210,871 patients indicated that CEP device use was associated with a significant reduction in 30-day mortality (OR: 0.61) and stroke (OR: 0.69).
- The Sentinel device demonstrated a benefit in reducing mortality and stroke, unlike other devices evaluated.
- No significant differences were found in rates of acute kidney injury, major bleeding, or vascular complications between CEP and non-CEP groups. Subgroup analysis of RCTs showed no significant outcome differences.
Conclusions:
- The overall evidence suggests a net benefit for cerebral embolic protection (CEP) use in TAVR, particularly when employing the Sentinel device.
- However, the lack of significant findings in the RCT subanalysis highlights the need for further research.
- Additional studies are required to pinpoint patient populations most susceptible to stroke, thereby optimizing the clinical decision-making process for CEP utilization.
Background And Aims:
Cerebral embolic protection (CEP) devices are employed to capture embolic debris and reduce the risk of stroke during transcatheter aortic valve replacement (TAVR). Evidence is mixed regarding the safety and efficacy of CEP. We aimed to summarize the safety and effectiveness of CEP use during TAVR.
Methods:
Electronic databases, including PubMed, PubMed Central, Scopus, Cochrane Library, and Embase, were searched using relevant search terms for articles relating to CEP. All relevant data from 20 studies were extracted into a standardized form. Statistical analyses were performed using Revman 5.4. Odds ratio (OR) or mean differences (MDs) were used to estimate the desired outcome with a 95% confidence interval (CI).
Results:
Twenty studies (eight randomized controlled trials [RCTs]) involving 210,871 patients (19,261 in the CEP group and 191,610 in TAVR without the CEP group) were included. The use of CEP was associated with a lower odds of 30-day mortality by 39% (OR: 0.61, 95% CI: 0.53-0.70) and stroke by 31% (OR: 0.69, 95% CI: 0.52-0.92). Comparing devices, benefit in terms of mortality and stroke was observed with the use of the Sentinel device (Boston Scientific), but not among other devices. No differences were observed in the outcomes of acute kidney injury, major or life-threatening bleeding events, or major vascular complications between groups. When only RCTs were included, there were no observed differences in the primary or secondary outcomes for CEP versus no CEP use during TAVR.
Conclusions:
The totality of evidence suggests a net benefit for the use of CEP, weighted by studies in which the Sentinal device was used. However, given the RCT subanalysis, additional evidence is needed to identify patients at the highest risk of stroke for optimal decision-making.
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