Association of Transcatheter Aortic Valve Replacement Reimbursement, New Technology Add-on Payment, and Procedure Volumes With Embolic Protection Device Use

Lowenstern, Angela; Hung, Anna; Manandhar, Pratik; Wegermann, Zachary K.; Kapadia, Samir; Lindman, Brian R.; Goel, Kashish; Levack, Melissa M.; Barker, Colin M.; Reed, Shelby D.; Cohen, David J.; Vemulapalli, Sreekanth

doi:10.1001/jamacardio.2022.2608

Cited by 4 publications

(2 citation statements)

References 14 publications

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“…Despite the above, its use during TAVR remains infrequent. The SENTINEL device was used in 7.1% of TAVR procedures across 551 sites in the USA between 2018 and 2019 22 . Although multiple patient and hospital characteristics have been associated with CEPD use, TAVR case volume seems to be the predominant factor associated with its use in the USA, rather than its eligibility for the Centers for Medicare & Medicaid Services (CMS) TAVR reimbursement or the CMS new technology add-on payment.…”

Section: Cerebral Embolic Protection Devicesmentioning

confidence: 99%

Cerebral embolic protection during transcatheter heart interventions

Jimenez Diaz,

Kapadia,

Linke

et al. 2023

EuroIntervention

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Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), with the incidence of clinically apparent stroke seemingly fixed at around 3% despite TAVR's significant evolution during the past decade. Embolic showers of debris (calcium, atheroma, valve material, foreign material) are captured in the majority of patients who have TAVR using a filter-based cerebral embolic protection device (CEPD). Additionally, in systematic brain imaging studies, the majority of patients receiving TAVR exhibit new cerebral lesions. Mechanistic studies have shown reductions in the volume of new cerebral lesions using CEPDs, yet the first randomised trial powered for periprocedural stroke within 72 hours of a transfemoral TAVR failed to meet its primary endpoint of showing superiority of the SENTINEL CEPD. The present review summarises the clinicopathological rationale for the development of CEPDs, the evidence behind these devices to date and the emerging recognition of cerebral embolisation in many non-TAVR transcatheter procedures. Given the uniqueness of each of the various CEPDs under development, specific trials tailored to their designs will need to be undertaken to broaden the CEPD field, in addition to evaluating the role of CEPD in non-TAVR transcatheter heart interventions. Importantly, the cost-effectiveness of these devices will require assessment to broaden the adoption of CEPDs globally. KEYWORDS • aortic stenosis • cerebral protection • mitral valve repair • other • stroke • TAVR AS aortic stenosis CEPD cerebral embolic protection device DW-MRI diffusion-weighted magnetic resonance imaging SAVR surgical aortic valve replacement TAVR transcatheter aortic valve replacement TCD transcranial Doppler

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Section: Cerebral Embolic Protection Devicesmentioning

confidence: 99%

Cerebral embolic protection during transcatheter heart interventions

Jimenez Diaz,

Kapadia,

Linke

et al. 2023

EuroIntervention

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“…Therefore, perhaps not surprisingly, uptake of the device has been relatively modest, with wide variation across hospitals. 7 In this issue of JAMA Cardiology, Lowenstern et al 8 describe EPD use rates and examine the association of EPD use with overall TAVR reimbursement and the availability of NTAPs across 551 sites in the United States between January 2018 and September 2019 using the Society of Thoracic Surgeons/ American College of Cardiology Transcatheter Valve Therapy Registry. During the study period, an EPD was used in 7.1% of TAVR procedures, with a history of stroke being the strongest predictor of use.…”

mentioning

confidence: 99%