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Cerebral Protection Devices for TAVR Patients
Quick Takes
- Cerebral embolic devices are rarely used in TAVR procedures and outcomes are not beneficial with respect to stroke and delirium.
- Based on available data, the routine use of cerebral protection device cannot be recommended without further randomized controlled trials.
- Additional studies are indicated to define specific patient groups that might benefit from cerebral protection devices.
Study Questions:
What is the impact of cerebral protection devices on outcomes during transfemoral transcatheter aortic valve replacement (TAVR) in real-world clinical practice?
Methods:
The investigators extracted data on a total of 41,654 isolated transfemoral TAVR procedures with or without cerebral protection devices conducted between 2015 and 2017 for this analysis. In-hospital mortality was the primary endpoint of the study. Secondary endpoints were acute kidney injury, permanent pacemaker implantation, mechanical ventilation >48 hours, length of hospital stay, postprocedural delirium, stroke, and total reimbursement. Because patients were not randomized to the two treatment options (transfemoral TAVR with or without cerebral protection devices), analyses using the propensity score method were applied to verify the impact of cerebral protection devices.
Results:
A total of 41,654 TAVR procedures performed between 2015 and 2017 were analyzed. The overall share of procedures incorporating cerebral protection devices was 3.8%. Patients receiving cerebral protection devices were at increased operative risk (European System for Cardiac Operative Risk Evaluation score 13.8 vs. 14.7; p < 0.001) but of lower age (81.1 vs. 80.6 years; p = 0.001). To compare outcomes that may be related to the use of cerebral protection devices, a propensity score comparison was performed. The use of a cerebral protection device did not reduce the risk for stroke (adjusted risk difference [aRD], +0.88%; 95% confidence interval [CI], -0.07% to 1.83%; p = 0.069) or the risk for developing delirium (aRD, +1.31%; 95% CI, -0.28% to 2.89%; p = 0.106) as a sign of acute brain failure. Although brain damage could not be prevented, in-hospital mortality was lower in the group receiving a cerebral protection device (aRD, -0.76%; 95% CI, -1.46% to -0.06%; p = 0.034).
Conclusions:
The authors concluded that cerebral embolic protection devices were associated with lower mortality but not a reduction in stroke or delirium.
Perspective:
This analysis of a nationwide dataset shows that cerebral embolic devices are rarely used in TAVR procedures and that outcomes are not beneficial with respect to stroke and delirium. Although brain damage could not be prevented, in-hospital mortality was lower in the group receiving cerebral protection devices. Based on these data and previous studies, the routine use of cerebral protection devices cannot be recommended without further randomized controlled trials. Additional studies are also recommended to define specific patient groups that might benefit from cerebral protection devices.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Interventions and Vascular Medicine
Keywords: Acute Kidney Injury, Brain Damage, Chronic, Delirium, Embolic Protection Devices, Heart Valve Diseases, Hospital Mortality, Intracranial Embolism, Length of Stay, Pacemaker, Artificial, Primary Prevention, Respiration, Artificial, Stroke, Transcatheter Aortic Valve Replacement, Vascular Diseases
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