Applicability of Transcatheter Aortic Valve Replacement Trials to Real-World Clinical Practice

Background: In some patients, the alternative access route for transcatheter aortic valve replacement (TAVR) is utilized because the conventional transfemoral approach is not felt to be either feasible or optimal. However, accurate prognostication of patient risks is not well established. This study examines the associations between peripheral (transsubclavian/transaxillary, and transcarotid) versus central access (transapical and transaortic) in alternative access TAVR and 30-day and 1-year end points of mortality and stroke for all valve platforms. Methods: Using data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry with linkage to Medicare claims, patients who underwent alternative access TAVR from June 1, 2015 to June 30, 2018 were identified. Adjusted and unadjusted Cox proportional hazards modeling were performed to determine the association between alternate access TAVR site and 30-day and 1-year end points of mortality and stroke. Results: Of 7187 alternative access TAVR patients, 3725 (52%) had peripheral access and 3462 (48%) had central access. All-cause mortality was significantly lower in peripheral access versus central access group at in-hospital and 1 year (2.9% versus 6.3% and 20.3% versus 26.6%, respectively), but stroke rates were higher (5.0% versus 2.8% and 7.3% versus 5.5%, respectively; all P <0.001). These results persisted after 1-year adjustment (death adjusted hazard ratio, 0.72 [95% CI, 0.62–0.85] and stroke adjusted hazard ratio, 2.92 [95% CI, 2.21–3.85]). When broken down by individual subtypes, compared with transaxillary/subclavian access patients, transapical, and transaortic access patients had higher all-cause mortality but less stroke ( P <0.05). Conclusions: In this real-world, contemporary, nationally representative benchmarking study of alternate access TAVR sites, peripheral access was associated with favorable mortality and morbidity outcomes compared with central access, at the expense of higher stroke. These findings may allow for accurate prognostication of risk for patient counseling and decision-making for the heart team with regard to alternative access TAVR.

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“…Nonetheless, CMS data has been shown to align reliably with clinical trial data, to improve clinical decision-making. 33…”

Section: Discussionmentioning

confidence: 99%

Association Between Peripheral Versus Central Access for Alternative Access Transcatheter Aortic Valve Replacement and Mortality and Stroke: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry

Kaneko

Hirji

Yazdchi

et al. 2022

Circ: Cardiovascular Interventions

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Transporting Results of TAVR Trials to the Real World

Shahim¹,

Cohen²

2021

JACC: Cardiovascular Interventions

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Enriching the American Heart Association COVID‐19 Cardiovascular Disease Registry Through Linkage With External Data Sources: Rationale and Design

Oseran

Sun

Wadhera

et al. 2022

JAHA

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Background The AHA Registry (American Heart Association COVID‐19 Cardiovascular Disease Registry) captures detailed information on hospitalized patients with COVID‐19. The registry, however, does not capture information on social determinants of health or long‐term outcomes. Here we describe the linkage of the AHA Registry with external data sources, including fee‐for‐service (FFS) Medicare claims, to fill these gaps and assess the representativeness of linked registry patients to the broader Medicare FFS population hospitalized with COVID‐19. Methods and Results We linked AHA Registry records of adults ≥65 years from March 2020 to September 2021 with Medicare FFS claims using a deterministic linkage algorithm and with the American Hospital Association Annual Survey, Rural Urban Commuting Area codes, and the Social Vulnerability Index using hospital and geographic identifiers. We compared linked individuals with unlinked FFS beneficiaries hospitalized with COVID‐19 to assess the representativeness of the AHA Registry. A total of 10 010 (47.0%) records in the AHA Registry were successfully linked to FFS Medicare claims. Linked and unlinked FFS beneficiaries were similar with respect to mean age (78.1 versus 77.9, absolute standardized difference [ASD] 0.03); female sex (48.3% versus 50.2%, ASD 0.04); Black race (15.1% versus 12.0%, ASD 0.09); dual‐eligibility status (26.1% versus 23.2%, ASD 0.07); and comorbidity burden. Linked patients were more likely to live in the northeastern United States (35.7% versus 18.2%, ASD 0.40) and urban/metropolitan areas (83.9% versus 76.8%, ASD 0.18). There were also differences in hospital‐level characteristics between cohorts. However, in‐hospital outcomes were similar (mortality, 23.3% versus 20.1%, ASD 0.08; home discharge, 45.5% versus 50.7%, ASD 0.10; skilled nursing facility discharge, 24.4% versus 22.2%, ASD 0.05). Conclusions Linkage of the AHA Registry with external data sources such as Medicare FFS claims creates a unique and generalizable resource to evaluate long‐term health outcomes after COVID‐19 hospitalization.

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Applicability of Transcatheter Aortic Valve Replacement Trials to Real-World Clinical Practice

Cited by 3 publications

References 37 publications

Association Between Peripheral Versus Central Access for Alternative Access Transcatheter Aortic Valve Replacement and Mortality and Stroke: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry

Association Between Peripheral Versus Central Access for Alternative Access Transcatheter Aortic Valve Replacement and Mortality and Stroke: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry

Transporting Results of TAVR Trials to the Real World

Enriching the American Heart Association COVID‐19 Cardiovascular Disease Registry Through Linkage With External Data Sources: Rationale and Design

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