Meta-analysis of the Safety and Efficacy of the Sentinel Cerebral Protection System in Transcatheter Aortic Valve Implantation

Radwan, Yasser; Al-abcha, Abdullah; Salam, Mohammad Fahad; Khor, Si Yuan; Prasad, Rohan; Elshafie, Ahmed; Abela, George S.

doi:10.1016/j.amjcard.2021.04.006

Cited by 7 publications

(9 citation statements)

References 2 publications

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“…A recent large real-world study showed significantly lower mortality (0.5% vs. 1.3%, p < 0.01) and lower ischemic stroke (1.4% vs. 2.2%, p < 0.01) with cerebral EPD vs. no cerebral EPD, respectively [55]. Similar results were reported in a meta-analysis including three RCTs and four observational studies, in which patients undergoing TAVR with the Sentinel EPD experienced a lower rate of stroke, 30-day mortality and bleeding compared with patients without EPD [56]. In contrast with these results, two meta-analysis showed a reduction of early stroke with cerebral EPD during TAVR but without impact on in-hospital mortality [57,58].…”

Section: What Is the Current Place Of Cerebral Embolic Protecting Dev...supporting

confidence: 67%

Antithrombotic Therapy Following Transcatheter Aortic Valve Replacement

Guedeney

Collet

2022

JCM

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Due to a large technical improvement in the past decade, transcatheter aortic valve replacement (TAVR) has expanded to lower-surgical-risk patients with symptomatic and severe aortic stenosis. While mortality rates related to TAVR are decreasing, the prognosis of patients is still impacted by ischemic and bleeding complications, and defining the optimal antithrombotic regimen remains a priority. Recent randomized control trials reported lower bleeding rates with an equivalent risk in ischemic outcomes with single antiplatelet therapy (SAPT) when compared to dual antiplatelet therapy (DAPT) in patients without an underlying indication for anticoagulation. In patients requiring lifelong oral anticoagulation (OAC), the association of OAC plus antiplatelet therapy leads to a higher risk of bleeding events with no advantages on mortality or ischemic outcomes. Considering these data, guidelines have recently been updated and now recommend SAPT and OAC alone for TAVR patients without and with a long-term indication for anticoagulation. Whether a direct oral anticoagulant or vitamin K antagonist provides better outcomes in patients in need of anticoagulation remains uncertain, as recent trials showed a similar impact on ischemic and bleeding outcomes with apixaban but higher gastrointestinal bleeding with edoxaban. This review aims to summarize the most recently published data in the field, as well as describe unresolved issues.

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Section: What Is the Current Place Of Cerebral Embolic Protecting Dev...supporting

confidence: 67%

Antithrombotic Therapy Following Transcatheter Aortic Valve Replacement

Guedeney

Collet

2022

JCM

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“… 4 Considering the low incidence of stroke, early RCTs evaluating the efficiency of CEP were small and underpowered to demonstrate significant protection from brain injury. 9 , 20 , 21 The MISTRAL‐C (MRI Investigation in TAVI With Claret) trial equally randomized a total of 65 patients with aortic stenosis to transfemoral TAVR with versus without CEP; however, in the CEP group only a numerically lower incidence of disabling stroke was found (0/32 versus 2/33; 7%). 21 The sample size of the Cerebral Protection in Transcatheter Aortic Valve Replacement (SENTINEL trial), which enrolled 363 patients, was comparatively large, but it also failed to demonstrate a significant reduction in cerebrovascular accidents.…”

Section: Discussionmentioning

confidence: 99%

Outcomes of Cerebral Embolic Protection for Bicuspid Aortic Valve Stenosis Undergoing Transcatheter Aortic Valve Replacement

Zhang

Tian

et al. 2023

JAHA

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Background There was limited high‐quality evidence that illuminated the efficiency of cerebral embolic protection (CEP) use during transcatheter aortic valve replacement (TAVR) for bicuspid aortic valve (BAV) stenosis. Methods and Results In this retrospective cohort study, patients with BAV stenosis undergoing TAVR with or without CEP were identified by querying the National Inpatient Sample database. The primary end point was any stroke during the hospitalization. The composite safety end point included any in‐hospital death and stroke. We applied propensity score–matched analysis to minimize standardized mean differences of baseline variables and compare in‐hospital outcomes. From July 2017 to December 2020, 4610 weighted hospitalizations with BAV stenosis undergoing TAVR were identified, of which 795 were treated with CEP. There was a significant increase in the CEP use rate for BAV stenosis ( P ‐trend <0.001). A total of 795 discharges with CEP use were propensity score matched to 1590 comparable discharges but without CEP. CEP use was associated with a lower incidence of in‐hospital stroke (1.3% versus 3.8%; P <0.001), which in multivariable regression was also independently associated with the primary outcome (adjusted odds ratio=0.38 [95% CI, 0.18–0.71]; P =0.005) and the safety end point (adjusted odds ratio=0.41 [95% CI, 0.22–0.68] P =0.001). Meanwhile, no significant difference was found in the cost of hospitalization ($46 629 versus $45 147; P =0.18) or the risk of vascular complications (1.9% versus 2.5%; P =0.41). Conclusions This observational study supported CEP use for BAV stenosis, which was independently associated with less in‐hospital stroke without burdening the patients with a high hospitalization cost.

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“…This reduction in stroke rate has been corroborated in several meta-analyses on the topic. Radwan et al 24 showed a reduction in stroke (OR 0.82, 95% CI: 0.71-0.94; p=0.004) with use of the SENTINEL device. Similarly, Ndunda et al 14 showed significant reductions in all stroke (OR 0.51, 95% CI: 0.29-0.90; p=0.02) at 30 days.…”

Section: Efficacymentioning

confidence: 99%

Safety and efficacy of cerebral embolic protection in transcatheter aortic valve implantation: an updated meta-analysis

Tan,

Fei,

Rizwan Amanullah

et al. 2024

AsiaIntervention

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Background: The use of cerebral embolic protection devices during transcatheter aortic valve implantation (TAVI) reveals conflicting data.Aims: This updated meta-analysis aims to evaluate the efficacy and safety of the SENTINEL Cerebral Protection System.Methods: A literature search for relevant studies up to September 2022 was performed. Study outcomes were divided based on time period -overall (up to 30 days) and short (≤7 days). The outcomes studied include stroke (disabling, non-disabling), mortality, neuroimaging findings, transient ischaemic attack, acute kidney injury and major vascular and bleeding complications.Results: A total of 15 studies involving 294,134 patients were included. Regarding overall outcomes, significant reductions were noted for mortality (odds ratio [OR] 0.60, 95% confidence interval [CI]: 0.41-0.88; p=0.008), all stroke (OR 0.64, 95% CI: 0.46-0.88; p=0.006) and disabling stroke (OR 0.42, 95% CI: 0.23-0.74; p=0.003) using the SENTINEL device. No significant differences were noted for other outcomes. There was significant heterogeneity across the studies for mortality (p=0.013) and all stroke (p=0.003). Including only randomised data (n=4), there was only significant reduction in the incidence of disabling stroke (OR 0.39, 95% CI: 0.17-0.89; p=0.026) in the SENTINEL group. In studies reporting ≤7-day outcomes (n=8), use of the SENTINEL device demonstrated significantly lower rates of all stroke (p<0.001), disabling stroke (p<0.001) and major bleeding complications (p=0.02). No differences in neuroimaging outcomes were noted. Conclusions:In this updated meta-analysis, use of the SENTINEL Cerebral Protection System was associated with lower rates of mortality, all stroke and disabling stroke, although significant heterogeneity was noted for mortality and all stroke. Including exclusively randomised data, there was only significant reduction in the incidence of disabling stroke. No significant adverse outcomes with device use were noted.

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Meta-analysis of the Safety and Efficacy of the Sentinel Cerebral Protection System in Transcatheter Aortic Valve Implantation

Cited by 7 publications

References 2 publications

Antithrombotic Therapy Following Transcatheter Aortic Valve Replacement

Antithrombotic Therapy Following Transcatheter Aortic Valve Replacement

Outcomes of Cerebral Embolic Protection for Bicuspid Aortic Valve Stenosis Undergoing Transcatheter Aortic Valve Replacement

Safety and efficacy of cerebral embolic protection in transcatheter aortic valve implantation: an updated meta-analysis

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