Impact of routine use of a cerebral protection device on the TAVR procedure and its short-term outcomes: a single-centre experience

Kemp, Marnix J. von; Floré, Vincent; Lau, Chirik Wah; Sutter, Johan De; Provenier, Frank; Cornelis, Kristoff

doi:10.1080/00015385.2022.2111128

Cited by 5 publications

(1 citation statement)

References 19 publications

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“…Finally, 26 studies including 540.247 patients were available for meta‐analysis. Of these, eight were randomized trials and 18 observational studies (Table 2), published from 2014 to 2023 14–39 …”

Section: Resultsmentioning

confidence: 99%

Clinical impact of cerebral protection during transcatheter aortic valve implantation

Boccuto,

Carabetta,

Cacia

et al. 2024

Eur J Clin Investigation

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BackgroundEmbolization of debris can complicate transcatheter aortic valve implantation (TAVI) causing stroke. Cerebral embolism protection (CEP) devices can divert or trap debris.PurposeTo evaluate the efficacy of CEP during TAVI vs the standard procedure.Data SourcesPubMed, SCOPUS and DOAJ 1/01/2014–04/12/2023.Study SelectionRandomized and observational studies comparing CEP versus standard TAVI, according to PRISMA. Primary outcome: stroke. Secondary outcomes: death, bleeding, vascular access complications, acute kidney injury and infarct area.Data ExtractionTwo investigators independently assessed study quality and extracted data.Data SynthesisTwenty‐six articles were included (540.247 patients). The primary endpoint was significantly lower (RR = 0.800 95%CI:0.682–0.940; p = 0.007) with CEP. Similarly, death rates were significantly lower with CEP (RR = 0.610 95%CI:0.482–0.771; p < 0.001). No difference was found for bleeding (RR = 1.053 95%CI:0.793–1.398; p = 0.721), vascular complications (RR = 0.937 95%CI:0.820–1.070; p = 0.334) or AKI (RR = 0.982 95%CI:0.754–1.279; p = 0.891).ConclusionsUse of CEP during TAVI is associated with improved outcomes. Future studies will identify patients who benefit most from CEP.

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Section: Resultsmentioning

confidence: 99%

Clinical impact of cerebral protection during transcatheter aortic valve implantation

Boccuto,

Carabetta,

Cacia

et al. 2024

Eur J Clin Investigation

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Safety and efficacy of cerebral embolic protection devices for patients undergoing transcatheter aortic valve replacement: An updated meta‐analysis

Shrestha

Shtembari

Lamichhane

et al. 2023

Health Science Reports

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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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Focus on valvular heart disease

et al. 2022

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Impact of routine use of a cerebral protection device on the TAVR procedure and its short-term outcomes: a single-centre experience

Cited by 5 publications

References 19 publications

Clinical impact of cerebral protection during transcatheter aortic valve implantation

Clinical impact of cerebral protection during transcatheter aortic valve implantation

Safety and efficacy of cerebral embolic protection devices for patients undergoing transcatheter aortic valve replacement: An updated meta‐analysis

Focus on valvular heart disease

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