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Clinical Predictors for Procedural Stroke and Implications for Embolic Protection Devices during TAVR: Results from the Multicenter Transcatheter Aortic Valve Replacement In-Hospital Stroke (TASK) Study.

ABSTRACT: Background: Data to support the routine use of embolic protection devices for stroke prevention during transcatheter aortic valve replacement (TAVR) are controversial. Identifying patients at high risk for peri-procedural cerebrovascular events may facilitate effective patient selection for embolic protection devices during TAVR. Aim: To generate a risk score model for stratifying TAVR patients according to peri-procedural cerebrovascular events risk. Methods and results: A total of 8779 TAVR patients from 12 centers worldwide were included. Peri-procedural cerebrovascular events were defined as an ischemic stroke or a transient ischemic attack occurring ≤24 h from TAVR. The peri-procedural cerebrovascular events rate was 1.4% (n = 127), which was independently associated with 1-year mortality (hazards ratio (HR) 1.78, 95% confidence interval (CI) 1.06-2.98, p < 0.028). The TASK risk score parameters were history of stroke, use of a non-balloon expandable valve, chronic kidney disease, and peripheral vascular disease, and each parameter was assigned one point. Each one-point increment was associated with a significant increase in peri-procedural cerebrovascular events risk (OR 1.96, 95% CI 1.56-2.45, p < 0.001). The TASK score was dichotomized into very-low, low, intermediate, and high (0, 1, 2, 3-4 points, respectively). The high-risk TASK score group (OR 5.4, 95% CI 2.06-14.16, p = 0.001) was associated with a significantly higher risk of peri-procedural cerebrovascular events compared with the low TASK score group. Conclusions: The proposed novel TASK risk score may assist in the pre-procedural risk stratification of TAVR patients for peri-procedural cerebrovascular events.

SUBMITTER: Berkovitch A

PROVIDER: S-EPMC9316224 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Transcatheter mitral valve replacement (TMVR) is currently being investigated as a procedural alternative to surgical mitral valve repair or replacement (SMVR). Early data from first-in-man trials with current devices suggest that TMVR is technically feasible but carries a high mortality. This is substantially different from the early success transcatheter aortic valve replacement (TAVR) has seen and is related to complexities of the mitral valve anatomy, differences in pathology that require mitral valve replacement as well as the impact that mitral valve replacement has on physiology and cardiac function, irrespective of the modality by which the mitral valve is replaced. Importantly, in the case of TAVR, a less invasive method is offered to accomplish the same as the traditional surgical intervention. On the other hand, valve replacement is not the recommended treatment option for the majority of mitral valve disease, and in fact is avoided whenever possible during surgery given the shortened life expectancy and increased morbidity with mitral valve replacement. Another distinction between TAVR and TMVR is the etiology and natural progression of the underlying disease and driving factors for intervention that are vastly different between aortic and mitral valve disease. The primary aortic disease treated has been aortic stenosis, which has several etiologic factors that cause a similar physiologic dysfunction and risk. Aortic valve replacement leads to improved survival and quality of life. The primary mitral valve disease targeted is regurgitation, which occurs as a primary valve defect and as a secondary consequence of ventricular dysfunction. Primary mitral regurgitation is treated by valve repair with excellent long-term outcomes. Secondary regurgitation has poor long-term outcomes with current commonly used repair techniques and limited data exists showing that correction of the regurgitation improves survival. Adoption of TMVR will require overcoming the anatomic challenges as well as generating data that supports improved survival and/or quality of life.

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.

Dataset Information

Clinical Predictors for Procedural Stroke and Implications for Embolic Protection Devices during TAVR: Results from the Multicenter Transcatheter Aortic Valve Replacement In-Hospital Stroke (TASK) Study.

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