Muhammad Zia Khan1, Salman Zahid2, Muhammad U Khan3, Asim Kichloo4, Waqas Ullah5, Yasar Sattar6, Muhammad Bilal Munir7, Atul Singla8, Andrew M Goldsweig9, Sudarshan Balla3. 1. Department of Medicine, West Virginia University, Morgantown, West Virginia, USA. 2. Department of Medicine, Rochester General Hospital, Rochester, New York, USA. 3. Division of Cardiovascular Medicine, West Virginia University Heart & Vascular Institute, Morgantown, West Virginia, USA. 4. Division of medicine, St. Mary's of Saginaw Hospital, Saginaw, Michigan, USA. 5. Division of medicine, Abington Jefferson Health, Abington, Pennsylvania, USA. 6. Division of medicine, Icahn school of Medicine at Mount Sinai Elmhurst Hospital, New York, New York, USA. 7. Division of Cardiovascular Medicine, University of California San Diego, La Jolla, California, USA. 8. Division of Cardiology/Department. of Medicine, Tulane University School of Medicine, New Orleans, Louisiana, USA. 9. Division of Cardiovascular Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA.
Abstract
BACKGROUND: Outcomes data on the use of cerebral embolic protection devices (CPDs) with transcatheter aortic valve replacement (TAVR) remain limited. Previous randomized trials were underpowered for primary outcomes of stroke prevention and mortality. METHODS: The National Inpatient Sample and Nationwide Readmissions Database were queried from 2017 to 2018 to study utilization and inpatient mortality, neurological complications (ischemic stroke, hemorrhagic stroke, and transient ischemic attack), procedural complications, resource utilization, and 30-day readmissions with and without use of CPD. A 1:3 ratio propensity score matched model was created. RESULTS: Among 108,315 weighted encounters, CPD was used in 4380 patients (4.0%). Adjusted mortality was lower in patients undergoing TAVR with CPD (1.3% vs. 0.5%, p < 0.01). Neurological complications (2.5% vs. 1.7%, p < 0.01), hemorrhagic stroke (0.2% vs. 0%, p < 0.01) and ischemic stroke (2.2% vs. 1.4%, p < 0.01) were also lower in TAVR with CPD. Multiple logistic regression showed CPD use was associated with lower adjusted mortality (odds ratio (OR], 0.34 [95% confidence interval [CI], 0.22-0.52), p < 0.01) and lower adjusted neurological complications (OR, 0.68 (95% CI, 0.54-0.85], p < 0.01). On adjusted analysis, 30-day all-cause readmissions (Hazard ratio, HR 0.839, [95% CI, 0.773-0.911], p < 0.01) and stroke (HR, 0.727 [95% CI, 0.554-0.955), p = 0.02) were less likely in TAVR with CPD. CONCLUSION: We report real-world data on utilization and in-hospital outcomes of CPD use in TAVR. CPD use is associated with lower inpatient mortality, neurological, and clinical complications as compared to TAVR without CPD.
BACKGROUND: Outcomes data on the use of cerebral embolic protection devices (CPDs) with transcatheter aortic valve replacement (TAVR) remain limited. Previous randomized trials were underpowered for primary outcomes of stroke prevention and mortality. METHODS: The National Inpatient Sample and Nationwide Readmissions Database were queried from 2017 to 2018 to study utilization and inpatient mortality, neurological complications (ischemic stroke, hemorrhagic stroke, and transient ischemic attack), procedural complications, resource utilization, and 30-day readmissions with and without use of CPD. A 1:3 ratio propensity score matched model was created. RESULTS: Among 108,315 weighted encounters, CPD was used in 4380 patients (4.0%). Adjusted mortality was lower in patients undergoing TAVR with CPD (1.3% vs. 0.5%, p < 0.01). Neurological complications (2.5% vs. 1.7%, p < 0.01), hemorrhagic stroke (0.2% vs. 0%, p < 0.01) and ischemic stroke (2.2% vs. 1.4%, p < 0.01) were also lower in TAVR with CPD. Multiple logistic regression showed CPD use was associated with lower adjusted mortality (odds ratio (OR], 0.34 [95% confidence interval [CI], 0.22-0.52), p < 0.01) and lower adjusted neurological complications (OR, 0.68 (95% CI, 0.54-0.85], p < 0.01). On adjusted analysis, 30-day all-cause readmissions (Hazard ratio, HR 0.839, [95% CI, 0.773-0.911], p < 0.01) and stroke (HR, 0.727 [95% CI, 0.554-0.955), p = 0.02) were less likely in TAVR with CPD. CONCLUSION: We report real-world data on utilization and in-hospital outcomes of CPD use in TAVR. CPD use is associated with lower inpatient mortality, neurological, and clinical complications as compared to TAVR without CPD.
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