Cerebral embolic protection during TAVI: the game is not over.
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ABSTRACT:
SUBMITTER: Bagur R
PROVIDER: S-EPMC9707453 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
Publications
Cerebral embolic protection during TAVI: the game is not over.
Bagur Rodrigo R Sposato Luciano A LA
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20210201 14
Similar Datasets
Project description:AimsThe aim of this study was to investigate the total amount, size and heterogeneity of debris captured among different transcatheter valve types and while repositioning.Methods and resultsA total of 328 patients who underwent transcatheter aortic valve implantation (TAVI) with the SENTINEL cerebral embolic protection (CEP) at our centre were eligible. Histopathological and semiquantitative analysis of captured debris was performed and data were entered into our prospective database. TAVI was performed with either the Evolut R/PRO (N=123), SAPIEN 3 (N=113) or Lotus valve (N=92). Capture of debris occurred in 98% of patients. Lotus TAVI resulted in more frequent foreign body material (62% vs 40% vs 47%, p=0.006), endothelium (49% vs 30% vs 16%, p<0.0005), calcified material (33% vs 12% vs 24%, p=0.001) and myocardial tissue (19% vs 11% vs 2%, p<0.0005) compared to SAPIEN 3 or Evolut R/PRO. Native (functional) bicuspid valves (OR 2.91, 95% CI: 1.20-7.03, p=0.02) and Lotus (OR 2.44, 95% CI: 1.14-5.24, p=0.02) were associated with the highest risk for dislodging particles ≥1,000 um. Valve repositioning was independently associated with larger amounts of debris (OR 2.96, 95% CI: 1.42-6.16, p=0.004).ConclusionsAll THV platforms had similar amounts of captured debris. THV repositioning seemed to be associated with a higher risk for dislodging greater amounts of debris to the brain.
| S-EPMC9724925 | biostudies-literature
Project description:The presence of a left ventricular (LV) thrombus is considered an absolute contraindication to transcatheter aortic valve implantation (TAVI) because of the very high embolic risk. We report a case of TAVI under complete protection of the cerebral arteries in a patient with a large LV thrombus, severely impaired LV function, and no surgical options. (Level of Difficulty: Beginner.).
| S-EPMC8311951 | biostudies-literature
Project description:Diagnostic biopsy of a left atrial mass is technically feasible but has the risk of tumor embolization causing stroke or seeding. In this case report, we highlight the technical steps for left atrial mass biopsy under transesophageal echocardiography guidance by using cerebral embolic protection. Pathologic examination disclosed low-grade B-cell lymphoma. (Level of Difficulty: Advanced.).
| S-EPMC9350902 | biostudies-literature
Project description: Not available
| S-EPMC11198681 | biostudies-literature
Project description:Transcatheter aortic valve replacement is the therapy of choice for patients with severe aortic stenosis who have prohibitive or high surgical risk. However, the benefit of TAVR is attenuated by the occurrence of major disabling stroke which is associated with increased mortality and early-reduced quality of life. Despite advances in TAVR technology, stroke remains a serious complication that is associated with significant negative outcomes. The majority of these occur in the acute phase following TAVR where cerebral embolic events are frequent. Cerebral embolic protection devices (CEPD) have been developed to minimize the risk of peri-procedural ischemic stroke during TAVR. CEPD have the potential to reduce intraprocedural burden of new silent ischemic injury. In this review we outline the etiology and incidence of stroke in TAVR population, and systematically review current evidence for cerebral embolic protection devices.
| S-EPMC6205957 | biostudies-literature
Project description:Cerebrovascular events following transcatheter aortic valve implantation (TAVI) is one of the most devastating complications. Several studies with magnetic resonance or cerebral filters have demonstrated the universal brain embolization after TAVI, in the majority of patients clinically silent. Embolic protection devices (EPD) have been developed as a mechanical barrier to prevent these emboli to reach cerebral vasculature and potentially reduce neurological events. We review the current evidence about EPD in relation to histopathological and cerebral imaging findings and neurological events.
| S-EPMC6242920 | biostudies-literature
Project description:One of the most feared complications of transcatheter aortic valve implantation (TAVI) is stroke, with increased mortality and disability observed in patients suffering a stroke after TAVI. There has been no significant decline in stroke rates seen over the last 5 years; attention has therefore been given to strategies for cerebral embolic protection. With the emergence of new randomized trial data, we sought to perform an updated systematic review and meta-analysis to examine the effect of cerebral embolic protection during TAVI both on clinical outcomes and on neuroimaging parameters. We performed a random-effects meta-analysis of randomized clinical trials of cerebral embolic protection during TAVI. The primary end point was the risk of stroke. The risk of stroke was not significantly different with the use of cerebral embolic protection: relative risk (RR) 0.88, 95% confidence interval (CI) 0.57 to 1.36, p = 0.566. Nor was there a significant reduction in the risk of disabling stroke, non-disabling stroke or death. There was no significant difference in total lesion volume on MRI with cerebral embolic protection: mean difference -74.94, 95% CI -174.31 to 24.4, p = 0.139. There was also not a significant difference in the number of new ischemic lesions on MRI: mean difference -2.15, 95% -5.25 to 0.96, p = 0.176, although there was significant heterogeneity for the neuroimaging outcomes. In conclusion, cerebral embolic protection during TAVI is safe but there is no evidence of a statistically significant benefit on clinical outcomes or neuroimaging parameters.
| S-EPMC8082278 | biostudies-literature
Project description:BackgroundThe Sentinel cerebral embolic protection device (CEP) aims to reduce the risk of stroke during transcatheter aortic valve replacement (TAVR). We performed a systematic review and meta-analysis of propensity score matched (PSM) and randomized controlled trials (RCT) investigating the effect of the Sentinel CEP to prevent strokes during TAVR.MethodsEligible trials were searched through PubMed, ISI Web of science databases, Cochrane database, and proceedings of major congresses. Primary outcome was stroke. Secondary outcomes included all-cause mortality, major or life-threatening bleeding, major vascular complications and acute kidney injury at discharge. Fixed and random effect models were used to calculate the pooled risk ratio (RR) with 95% confidence intervals (CI) and absolute risk difference (ARD).ResultsA total of 4066 patients from 4 RCTs (3'506 patients) and 1 PSM study (560 patients) were included. Use of Sentinel CEP was successful in 92% of patients and was associated with a significantly lower risk of stroke (RR: 0.67, 95% CI: 0.48-0.95, p = 0.02. ARD: -1.3%, 95% CI: -2.3 - -0.2, p = 0.02, number needed to treat (NNT) = 77), and a reduced risk of disabling stroke (RR: 0.33, 95% CI: 0.17-0.65. ARD: -0.9%, 95% CI: -1.5 - -0.3, p = 0.004, NNT = 111). Use of Sentinel CEP was associated with a lower risk of major or life-threatening bleeding (RR: 0.37, 95% CI: 0.16-0.87, p = 0.02). Risk for nondisabling stroke (RR: 0.93, 95% CI: 0.62-1.40, p = 0.73), all-cause mortality (RR: 0.70, 95% CI: 0.35-1.40, p = 0.31), major vascular complications (RR: 0.74, 95% CI: 0.33-1.67, p = 0.47) and acute kidney injury (RR: 0.74, 95% CI: 0.37-1.50, p = 0.40) were similar.ConclusionsThe use of CEP during TAVR was associated with lower risks of any stroke and disabling stroke with an NNT of 77 and 111, respectively.
| S-EPMC10276451 | biostudies-literature
Project description:BackgroundLimited studies are available which aim to identify patient populations that would potentially benefit from the use of cerebral embolic protection devices (CPDs) during transcatheter aortic valve replacement (TAVR). We aimed to analyze the impact of CPD use during TAVR among patients with atrial fibrillation (AF).MethodsData on adult TAVR patients with a concomitant diagnosis of AF was obtained from the 2017-2020 National Readmissions Database. Stroke, major stroke, in-hospital mortality, and 30-day readmission rates were compared between the CPD and no-CPD cohorts in a propensity score matched analysis. Association of CPD use with adverse events was analyzed using multivariable logistic regression models.ResultsOf 100,928 eligible TAVR patients with AF, CPD was used in 6.9% of patients with a mean age of 80 years. CPD use was independently associated with lower overall stroke (1.7% vs. 2.2%; odds ratio [OR] 0.81 [95% CI 0.68-0.98]; p = 0.032), major stroke (1.2% vs. 1.8%; OR 0.69 [0.55-0.86]; p = 0.001), in-hospital mortality (0.9 vs. 1.5%; OR 0.56 [0.43-0.72]; p < 0.001), and lower 30-day readmission rates (12.7% vs. 14.7%; OR 0.87 [0.81-0.94]; p < 0.001). Reduction in adverse events with CPD was noted in high-volume but not in low-volume TAVR centers.ConclusionsThe present point towards clear benefits of CPD use among patients with AF undergoing TAVR. In anatomically eligible patients, the potential benefit of debris capture may be considered especially as younger and lower risk patients become eligible for TAVR. Data from future trials and registries are required to further corroborate our findings.
| S-EPMC11864126 | biostudies-literature
Project description:BackgroundStroke is a feared complication of transcatheter aortic valve replacement (TAVR), which embolic protection devices (EPDs) may mitigate. This systematic review and meta-analysis synthesized randomized controlled trials (RCTs) to evaluate the effect of EPDs in TAVR.MethodsAll RCTs comparing EPDs with control during TAVR were systematically identified. Prespecified primary end points were all stroke, disabling stroke, nondisabling stroke, and all-cause mortality. Safety and neuroimaging parameters were assessed. Sensitivity analyses were stratified by EPD type. Study registration was a priori (CRD42022377939).ResultsEight trials randomizing 4043 patients were included. There was no significant difference between EPDs and control for all stroke (relative risk [RR], 0.88; 95% CI, 0.65-1.18; P = .39; I2 = 0%), disabling stroke (RR, 0.67; 95% CI, 0.31-1.46; P = .32; I2 = 8.6%), nondisabling stroke (RR, 0.99; 95% CI, 0.71-1.40; P = .97; I2 = 0%), or all-cause mortality (RR, 0.87; 95% CI, 0.43-1.78; P = .71; I2 = 2.3%). There were no differences in safety end points of bleeding, vascular complications, or acute kidney injury. EPDs did not result in differences in total lesion volume or the number of new lesions. The Sentinel EPD significantly reduced the risk of disabling stroke (RR, 0.42; 95% CI, 0.20-0.88; P = .022; I2 = 0%) but did not affect all stroke, nondisabling stroke, or all-cause mortality.ConclusionsThe totality of randomized data for EPDs during TAVR demonstrated no safety concerns or significant differences in clinical or neuroimaging end points. Analyses restricted to the Sentinel EPD demonstrated large, clinically meaningful reductions in disabling stroke. Ongoing RCTs may help validate these results.
| S-EPMC10533415 | biostudies-literature