David Geffen School of Medicine at UCLA Los Angeles, California, United States
Disclosure(s):
Joanna Curry, BA: No financial relationships to disclose
Purpose: Stroke is a serious complication of transcatheter aortic valve replacement (TAVR), occurring in approximately 2% of patients [1]. With mixed data regarding the efficacy of Cerebral Protection Systems (CPS) against stroke, a large scale evaluation of their association with clinical and financial endpoints is warranted [2,3]. Methods: The 2018-2019 National Readmission Database was used to identify all adult elective hospitalizations for isolated TAVR. International Classification of Disease Tenth Revision codes for CPS were used to ascertain use of the device. Patients were included for analysis if they received their TAVR at a center that used CPS. Patients receiving a TAVR with CPS comprised the CPS cohort, while others were considered as the non-CPS cohort. High volume hospitals (HVH) were defined as those in the top quartile of CPS utilization.
The primary outcome of interest was stroke during the index admission for TAVR. In-hospital mortality, length of stay (LOS), and hospitalization costs were secondarily evaluated.
Linear and logistic regression models were developed to determine the association of CPS, patient characteristics, and hospital volume with outcomes of interest. Results: Of an estimated 55,752 patients who underwent TAVR, 10,231 (18.4%) comprised CPS. The incidence of CPS and the number of CPS capable centers increased over the study period (16.0% to 19.6%, p< 0.001; 66 to 130 centers). HVH utilized CPS in 18% and 35% of all TAVRs in 2018 and 2019 respectively. CPS had a similar distribution of age (78.7 vs. 79.0 years, p=0.23), but were less commonly female (40.1 vs 45.2 %, p< 0.001), and had a lower burden of comorbid disease as measured by the Elixhauser index (5 [4 - 7] vs. 6 [4 - 7], p< 0.001) (Table).
After adjustment, CPS conferred similar odds of stroke following TAVR (Adjusted Odds Ratio [AOR] 0.91, 95% Confidence Interval [CI] 0.70-1.18), with others as reference. Age (AOR 1.03/year, 95%CI 1.02-1.04), Elixhauser index (AOR 1.85 per, 95%CI 1.74-1.96), and history of prior stroke (AOR 1.41, 95%CI 1.24-1.78) were associated with increased odds of stroke. Notably, hospital CPS volume did not significantly impact stroke risk (Figure). CPS did not alter the odds of in-hospital mortality (AOR 0.73, 95%CI 0.52-1.01). Despite decreased LOS (β -.57 days, 95%CI [-0.93, -0.24]), CPS was associated with comparable costs (β+$400, 95%CI [-4,200, +5,000]). Conclusion: In this large nationwide retrospective study, we found CPS use during TAVR was not associated with reduced odds of stroke or differences in resource utilization. Future large-scale randomized control trials are needed to further elucidate the clinical relevance of this technology and identify patients who may benefit from its use.
Identify the source of the funding for this research project: There is no funding to report.
