Transcatheter Release of a Stuck Mechanical Valve in Aortic Position With Cerebral Embolic Protection.
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ABSTRACT:
SUBMITTER: Nandhakumar V
PROVIDER: S-EPMC11308309 | biostudies-literature | 2022 Nov-Dec
REPOSITORIES: biostudies-literature
Publications
Transcatheter Release of a Stuck Mechanical Valve in Aortic Position With Cerebral Embolic Protection.
Nandhakumar Vasu V Kalidoss Latchumanadhas L Ajit Mullasari S MS
Journal of the Society for Cardiovascular Angiography & Interventions 20220924 6
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Project description: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.
| S-EPMC10356028 | biostudies-literature
Project description:BackgroundThe cerebral embolic protection (CEP) device captures embolic debris during transcatheter aortic valve replacement (TAVR). However, the impact of CEP on stroke severity following TAVR remains unclear. Therefore, we aimed to examine whether CEP was associated with reduced severity of stroke following TAVR.MethodsThis was a retrospective cohort study of 2839 consecutive patients (mean age: 79.2 ± 9.5 years, females: 41.5%) who underwent transfemoral TAVR at our institution between 2013 and 2020. We categorized patients into Sentinel CEP users and nonusers. Neuroimaging data were reviewed and the final diagnosis of a cerebrovascular event was adjudicated by a neurologist blinded to the CEP use or nonuse. We compared the incidence and severity (assessed by the National Institutes of Health Stroke Scale [NIHSS]) of stroke through 72 h post-TAVR or discharge between the two groups using stabilized inverse probability of treatment weighting (IPTW) of propensity scores.ResultsOf the eligible patients, 1802 (63.5%) received CEP during TAVR and 1037 (36.5%) did not. After adjustment for patient characteristics by stabilized IPTW, the rate of overall stroke was numerically lower in CEP users than in CEP nonusers, but the difference did not reach statistical significance (0.49% vs. 1.18%, p = 0.064). However, CEP users had significantly lower rates of moderate-or-severe stroke (NIHSS ≥ 6: 0.11% vs. 0.69%, p = 0.013) and severe stroke (NIHSS ≥ 15: 0% vs. 0.29%, p = 0.046). Stroke following CEP use (n = 8), compared with stroke following CEP nonuse (n = 15), tended to carry a lower NIHSS (median [IQR], 4.0 [2.0-7.0] vs. 7.0 [4.5-19.0], p = 0.087). Four (26.7%) out of 15 patients with stroke following CEP nonuse died within 30 days, with no death after stroke following CEP use.ConclusionsCEP use may be associated with attenuated severity of stroke despite no significant difference in overall stroke incidence compared with CEP nonuse. This finding is considered hypothesis-generating and needs to be confirmed in large prospective studies.
| S-EPMC9805232 | 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:BackgroundStroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), which has persisted despite refinements in technique and increased operator experience. While cerebral embolic protection devices (EPDs) have been developed to mitigate this risk, data regarding their impact on stroke and other outcomes after TAVR are limited.MethodsWe performed an observational study using data from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients were included if they underwent elective or urgent transfemoral TAVR between January 2018 and December 2019. The primary outcome was in-hospital stroke. To adjust for confounding, the association between EPD use and clinical outcomes was evaluated using instrumental variable analysis, a technique designed to support causal inference from observational data, with site-level preference for EPD use within the same quarter of the procedure as the instrument. We also performed a propensity score-based secondary analysis using overlap weights.ResultsOur analytic sample included 123 186 patients from 599 sites. The use of EPD during TAVR increased over time, reaching 28% of sites and 13% of TAVR procedures by December 2019. There was wide variation in EPD use across hospitals, with 8% of sites performing >50% of TAVR procedures with an EPD and 72% performing no procedures with an EPD in the last quarter of 2019. In our primary analysis using the instrumental variable model, there was no association between EPD use and in-hospital stroke (adjusted relative risk, 0.90 [95% CI, 0.68-1.13]; absolute risk difference, -0.15% [95% CI, -0.49 to 0.20]). However, in our secondary analysis using the propensity score-based model, EPD use was associated with 18% lower odds of in-hospital stroke (adjusted odds ratio, 0.82 [95% CI, 0.69-0.97]; absolute risk difference, -0.28% [95% CI, -0.52 to -0.03]). Results were generally consistent across the secondary end points, as well as subgroup analyses.ConclusionsIn this nationally representative observational study, we did not find an association between EPD use for TAVR and in-hospital stroke in our primary instrumental variable analysis, and found only a modestly lower risk of in-hospital stroke in our secondary propensity-weighted analysis. These findings provide a strong basis for large-scale randomized, controlled trials to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR.
| S-EPMC8184596 | 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: Not available
| S-EPMC10241296 | biostudies-literature
Project description:BackgroundThe effectiveness of cerebral embolic protection devices (CEPD) in mitigating stroke after transcatheter aortic valve implantation (TAVI) remains uncertain, and therefore CEPD may be utilized differently across US hospitals. This study aims to characterize the hospital-level pattern of CEPD use during TAVI in the US and its association with outcomes.MethodsPatients treated with nontransapical TAVI in the 2019 Nationwide Readmissions Database were included. Hospitals were categorized as CEPD non-users and CEPD users. The following outcomes were compared: the composite of in-hospital stroke or transient ischemic attack (TIA), in-hospital ischemic stroke, death, and cost of hospitalization. Logistic regression models were used for risk adjustment of clinical outcomes.ResultsOf 41,822 TAVI encounters, CEPD was used in 10.6% (n = 4422). Out of 392 hospitals, 65.8% were CEPD non-user hospitals and 34.2% were CEPD users. No difference was observed between CEPD non-users and CEPD users in the risk of in-hospital stroke or TIA (adjusted odds ratio (OR) = 0.99 [0.86-1.15]), ischemic stroke (adjusted OR = 1.00 [0.85-1.18]), or in-hospital death (adjusted OR = 0.86 [0.71-1.03]). The cost of hospitalization was lower in CEPD non-users.ConclusionsTwo-thirds of hospitals in the US do not use CEPD for TAVI, and no significant difference was observed in neurologic outcomes among patients treated at CEPD non-user and CEPD user hospitals.
| S-EPMC10692348 | biostudies-literature
Project description: Not available
| S-EPMC10900717 | biostudies-literature
Project description:BackgroundOutcomes data on the use of cerebral embolic protection devices (CPDs) with transcatheter aortic valve replacement (TAVR) remain limited. Previous randomized trials were underpowered for primary outcomes of stroke prevention and mortality.MethodsThe National Inpatient Sample and Nationwide Readmissions Database were queried from 2017 to 2018 to study utilization and inpatient mortality, neurological complications (ischemic stroke, hemorrhagic stroke, and transient ischemic attack), procedural complications, resource utilization, and 30-day readmissions with and without use of CPD. A 1:3 ratio propensity score matched model was created.ResultsAmong 108,315 weighted encounters, CPD was used in 4380 patients (4.0%). Adjusted mortality was lower in patients undergoing TAVR with CPD (1.3% vs. 0.5%, p < 0.01). Neurological complications (2.5% vs. 1.7%, p < 0.01), hemorrhagic stroke (0.2% vs. 0%, p < 0.01) and ischemic stroke (2.2% vs. 1.4%, p < 0.01) were also lower in TAVR with CPD. Multiple logistic regression showed CPD use was associated with lower adjusted mortality (odds ratio (OR], 0.34 [95% confidence interval [CI], 0.22-0.52), p < 0.01) and lower adjusted neurological complications (OR, 0.68 (95% CI, 0.54-0.85], p < 0.01). On adjusted analysis, 30-day all-cause readmissions (Hazard ratio, HR 0.839, [95% CI, 0.773-0.911], p < 0.01) and stroke (HR, 0.727 [95% CI, 0.554-0.955), p = 0.02) were less likely in TAVR with CPD.ConclusionWe report real-world data on utilization and in-hospital outcomes of CPD use in TAVR. CPD use is associated with lower inpatient mortality, neurological, and clinical complications as compared to TAVR without CPD.
| S-EPMC8578314 | biostudies-literature