Meta-Analysis of Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement

Nazir, Salik; Zafrullah, Fnu; Virk, Hafeez Ul Hassan; Sandhu, Charnjeet; Ameen, Muhammad; Ahuja, Keerat Rai

doi:10.1016/j.amjcard.2020.10.038

Cited by 6 publications

(4 citation statements)

References 7 publications

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“…In two reviews and metaanalyses [66,67] reporting results from randomized controlled trials (RCTs) and observational studies, the use of EPDs was effectively associated to fewer short-term stroke events. In contrast, other ones [68][69][70] (predominantly based on RCTs) did not show any difference on clinical outcomes or neuroimaging parameters. One of the most recent and updated summaries of evidence by Baloch et al [71] comprehended 128,471 patients from RCTs and observational studies and highlighted the benefit of CEPD in reducing incidence of 30 day disabling stroke in patients undergoing TAVR; the majority of studies was based on TriGUARD and Sentinel devices.…”

Section: Summary Of Evidencementioning

confidence: 62%

Stroke Risk during TAVR: Is Prevention Better than Cure?

Di Pietro,

Riccardo,

Tocci

et al. 2024

Cardiology and Cardiovascular Medicine

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Periprocedural stroke is an uncommon but feared complication in patients undergoing transcatheter aortic valve replacement (TAVR). Typically embolic, it occurs more frequent in the first days (within seven days) after the procedure and it is secondary to procedural factors. It has a wide clinical spectrum and it is associated with increased mortality and a controversial worse impact on cognitive functions. Capture of the debris by different cerebral embolic protection devices (CEPDs) during the TAVR were thought to be a safe and effective preventive strategy to reduce the risk of stroke. A lot of trials were conducted to demonstrate a benefit of CEPDs, but the current evidence is not conclusive on their impact on periprocedural strokes.

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Section: Summary Of Evidencementioning

confidence: 62%

Stroke Risk during TAVR: Is Prevention Better than Cure?

Di Pietro,

Riccardo,

Tocci

et al. 2024

Cardiology and Cardiovascular Medicine

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“…Lacking statistical power secondary to small sample sizes and a low incidence of post-TAVR CVA, none of these trials were able to use CVA as a primary endpoint [ 29 , 32 , 38 ]. Several meta- and propensity matched-analyses have also tried to examine Sentinel CPS efficacy [ 29 ], with available meta-analyses yielding similar results (due to significant study overlap) and failing to demonstrate device efficacy [ 14 , 39 , 40 ]. Propensity matched analyses using data from multiple large registries have also been unable to consistently demonstrate significant reductions in stroke with Sentinel CPS use [ 36 , 37 , 41 , 42 ].…”

Section: Discussionmentioning

confidence: 99%

Patient Characteristics and Outcomes Associated with Sentinel Protection Device Use in Patients with Aortic Valve Disease Undergoing TAVR in a “Real-World” Setting

Jabagi,

Shaw,

Gharibeh

et al. 2024

Rev. Cardiovasc. Med.

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Background: Transcatheter aortic valve replacement (TAVR) has become the dominant treatment for aortic valve disease. While TAVR safety has improved over time, concern remains over the occurrence of cerebrovascular accidents (CVA) secondary to device placement, which is associated with increased morbidity and mortality. The Sentinel Cerebral Protection System (CPS) was developed to reduce the risk of embolic strokes associated with debris produced during TAVR. Studies evaluating Sentinel CPS efficacy have produced conflicting results, and there is little understanding of which patients are selected for device placement in “real-world” settings. With no existing guidelines on device use, the purpose of this study was to describe and compare the characteristics of patients who receive CPS with those who do not in a “real-world” setting of consecutive TAVR patients and evaluate its impact on postoperative complications, namely stroke. Methods: This was a single-center, retrospective study of all patients undergoing TAVR between July 1, 2019, and December 31, 2020. Patient demographics, baseline, and perioperative characteristics were collected prospectively using the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry and our institution’s TAVR database for analysis. Postoperative outcomes were assessed using primary endpoints of in-hospital/30-day stroke and the composite of death, stroke, and bleeding/vascular events at one-year. To adjust for baseline differences, a propensity score was developed including all factors that were different between groups, and Multivariate Cox Regression analysis was used to control for these differences. Patient follow-up was 97% complete at 12 months with 100% echocardiographic follow-up. Results: A total of 242 consecutive patients (57.9% male) were analyzed, with a mean age of 79.9 9 years. Of these patients, 134 (55.4%) received the Sentinel CPS and 108 (44.6%) did not. Sentinel CPS patients were more likely to be male, not on dialysis, without prior CVA or pacemaker, had less severe chronic lung disease, and were lower operative risk compared to concurrent non-CPS patients. CPS patients were also found to have higher hemoglobin and albumin levels, lower creatinine, and were less likely to be on immunosuppressant therapy. The incidence of in-hospital/30-day stroke after TAVR did not differ between CPS and non-CPS patients (0.0% vs. 1.9%; p = 0.198). Unadjusted analyses at one-year showed a lower occurrence of the composite endpoint in CPS patients compared non-CPS patients (8.3% vs. 17.0%; p = 0.034). After adjustment, the hazard ratio (Adj HR) for the CPS group was no longer significantly associated with a lower composite endpoint (Adj HR = 0.609, 95% CI 0.244–1.523; p = 0.289). Both unadjusted ( ...

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“…[6][7][8] Published randomized controlled trials (RCTs) and retrospective cohort studies were insu cient to demonstrate that CEPD avoids or reduces stroke, death and other complications in patients after TAVI. Not only that, the published meta-analysis may not draw rm conclusions due to insu cient sample size and short follow-up time [4,5,9,10] .…”

Section: Introductionmentioning

confidence: 98%

Efficacy of Cerebral Embolic Protection Device During Transcatheter Aortic Valve Implantation: An Updated Meta-Analysis

Wang

Han

et al. 2023

Preprint

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Aims: Perioperative stroke remains a devastating complication after transcatheter aortic valve implantation (TAVI), using cerebral embolic protection device (CEPD) during TAVI may reduce stroke rate according to some studies. Therefore, we conducted this meta-analysis and may suggest whether CPED should be routinely used during TAVI. Methods and results: Studies were included which compared the outcome of stroke when with or without CEPD during TAVI, random controlled trials (RCTs) only, and followed up for at least 30 days. The primary end point was stroke. The risk of stroke at 30-days was no significantly difference in using CEPD during TAVI compared with control: RR 0.84, 95% CI 0.63 to 1.12, p = 0.23, I2=9%. Subgroup analysis was conducted according to the type of CEPD. There were no significantly differences neither using I&LCCA type nor TMCA type compared with control: RR 0.69, 95% CI 0.47 to 1.00, p = 0.05, I2=25%; RR 1.16, 95% CI 0.74 to 1.83, p = 0.51, I2=0%. Conclusions: In this meta-analysis, there was no significant evidence indicated CEPD can reduce the risk of stroke risk during TAVI. However, subgroup analysis of I&LCCA type group P=0.05, according to the basis of the 95% CI around this outcome, it is hard to rule out the efficacy of CEPD during TAVI. Maybe with large sample size, one valve type only, one outcome definition only, multicenter studies and extend the retention time of CEPD, the efficacy of CEPD would be proofed.

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Meta-Analysis of Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement

Cited by 6 publications

References 7 publications

Stroke Risk during TAVR: Is Prevention Better than Cure?

Stroke Risk during TAVR: Is Prevention Better than Cure?

Patient Characteristics and Outcomes Associated with Sentinel Protection Device Use in Patients with Aortic Valve Disease Undergoing TAVR in a “Real-World” Setting

Efficacy of Cerebral Embolic Protection Device During Transcatheter Aortic Valve Implantation: An Updated Meta-Analysis

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