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Cerebral Embolic Protection for TAVR: TVT Registry Results
Quick Takes
- This registry study did not find an association between embolic protection device (EPD) use and in-hospital stroke (or any secondary endpoint).
- The results of the secondary propensity-weighted analysis and the confidence interval for the primary analysis suggest a possible modest reduction in risk of stroke.
- Pending definitive data from randomized trials powered to detect differences in clinically important endpoints with EPDs, it is hard to justify their routine use in TAVR.
Study Questions:
What is the relationship between embolic protection device (EPD) use during transcatheter aortic valve replacement (TAVR) and clinical outcomes?
Methods:
The investigators performed an observational study using data from the Society of Thoracic Surgeons/American College of Cardiology-Transcatheter Valve Therapy (STS/ACC-TVT) 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 (IV) 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. The authors also performed a propensity score-based secondary analysis using overlap weights.
Results:
The 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 zero procedures with an EPD in the last quarter of 2019. In the primary analysis using the IV model, there was no association between EPD use and in-hospital stroke (adjusted relative risk, 0.90; 95% confidence interval [CI], 0.68, 1.13; absolute risk difference, -0.15%; 95% CI, -0.49, 0.20). However, in the 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, -0.03). Results were generally consistent across the secondary endpoints as well as subgroup analyses.
Conclusions:
The authors concluded that they did not find an association between EPD use for TAVR and in-hospital stroke in their primary IV analysis, and found only a modestly lower risk of in-hospital stroke in the secondary propensity-weighted analysis.
Perspective:
This registry study did not find an association between EPD use and in-hospital stroke (or any secondary endpoint). However, the results of the secondary propensity-weighted analysis and the CI for the primary analysis suggest a possible modest reduction in risk of stroke. These findings imply a need for large-scale randomized trials to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR. Pending such definitive data from randomized trials powered to detect differences in clinically important endpoints, it is hard to justify routine use of EPDs in TAVR.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Interventions and Vascular Medicine
Keywords: Cardiac Surgical Procedures, Embolic Protection Devices, Geriatrics, Heart Valve Diseases, Intracranial Embolism, Risk, Secondary Prevention, Stroke, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement
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