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. 2023 Jun 26;7(6):100202.
doi: 10.1016/j.shj.2023.100202. eCollection 2023 Nov.

Site Variability in Cerebral Embolic Protection for Transcatheter Aortic Valve Implantation and Association With Outcomes

Aamer Ubaid  1 , Kevin F Kennedy  2 , Adnan K Chhatriwalla  1   2 , John T Saxon  2 , Anthony Hart  2 , Keith B Allen  3 , Corinne Aberle  3 , Islam Shatla  4 , Abdelrhman Abumoawad  5 , Satya Preetham Gunta  1 , David Skolnick  2 , Chetan P Huded  2
Affiliations

Site Variability in Cerebral Embolic Protection for Transcatheter Aortic Valve Implantation and Association With Outcomes

Aamer Ubaid et al. Struct Heart. .

Abstract

Background: The 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.

Methods: Patients 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.

Results: Of 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.

Conclusions: Two-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.

Keywords: CEPD; Stroke; TAVI.

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Conflict of interest statement

J. T. Saxon is a proctor for Edwards Lifesciences and Medtronic Inc and is on the speaker Bbreau for Abbott Vascular, Medtronic Inc, and Edwards Lifesciences. Dr A. K. Chhatriwalla has a grant from Boston Scientific, is a proctor for Edwards Lifesciences and Medtronic Inc, and is on the speaker bureau for Abbott Vascular, Edwards Lifesciences, and Medtronic Inc. Dr K. B. Allen is an institutional research supporter for Abbott, Medtronic, Edwards, and Boston Scientific and is a proctor and on speaker bureau for Abbott, Medtronic, and Edwards with all payments to the institution and none to him personally. Dr C. P Huded has consulting fees from Boston Scientific and a grant from Abbott Vascular.

Figures

Figure 1
Figure 1
Study Population. Abbreviations: CEPD, cerebral embolic protection device; TAVI, transcatheter aortic valve implantation.
Figure 2
Figure 2
Histogram of Hospital Level CEPD Use for TAVI. Individual hospitals are plotted on the X axis with each hospital’s % of CEPD use during TAVI in 2019 plotted on the Y axis. Among 392 total hospitals, there were 258 CEPD non-user hospitals (65.8%) and 134 CEPD user hospitals (34.2%). Among the CEPD user hospitals there was considerable variability in CEPD use with some hospitals using CEPD in <10% of procedures and others using CEPD in >50% of procedures. Abbreviations: CEPD, cerebral embolic protection device; TAVI, transcatheter aortic valve implantation.
Figure 3
Figure 3
Risk-Adjusted TAVI Outcomes by Hospital Level CEPD Use. All models were risk adjusted for the following variables: age, sex, diabetes mellitus, hypertension, peripheral vascular disease, prior myocardial infarction, home oxygen, dialysis, tricuspid insufficiency, heart failure with reduced ejection fraction, prior stroke, atrial fibrillation, atrial flutter, hospital size, hospital control/ownership, hospital location, and hospital teaching status. Abbreviations: CEPD, cerebral embolic protection device; TAVI, transcatheter aortic valve implantation; TIA, transient ischemic attack.
Figure 4
Figure 4
Cost for Index TAVI Admission by Hospital Level CEPD Use. Values are mean US dollars with error bar indicating standard deviation. Abbreviations: CEPD, cerebral embolic protection device; TAVI, transcatheter aortic valve implantation; US, United States.
Figure 5
Figure 5
Pattern of CEPD Use for TAVI in US Hospitals in 2019. Abbreviations: CEPD, cerebral embolic protection device; TAVI, transcatheter aortic valve implantation; US, United States.
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