Stroke is still a major complication of transcatheter aortic valve replacement (TAVR), with a 30-day mortality of 16.7%. Even in the absence of symptoms, most patients (68-93%) have some type of diffusion imaging defect after TAVR implantation.
The Sentinel cerebral protection device (CPD) (Boston Scientific) received FDA approval for the capture of emboligenic material that may be generated during TAVR implantation, with the aim of reducing the risk of periprocedural neuronal damage. In the pivotal study conducted, it was effective in capturing debris in 99% of the cases, which did not mean a reduction in the volume of neurological lesion quantified by imaging.
PROTECTED TAVR was a prospective, multicenter, randomized study with the aim of investigating whether the use of the Sentinel DPC device could reduce the risk of periprocedural stroke in patients with severe aortic stenosis treated using transfemoral access. Patients with 70% or more stenotic disease in the left common carotid or brachiocephalic artery were excluded.
The primary endpoint (PEP) was the presence of clinical stroke within 72 hours after TAVR or prior to hospital discharge. Neuroimaging in search of asymptomatic cerebral infarction was not routinely performed. Other endpoints analyzed were all-cause mortality, a composite of stroke, transient ischemic attack, or delirium, and acute kidney injury.
Data were obtained from 3000 patients in 51 centers. Successful CPD implantation was performed in 94.4% of cases. Mean patient age was 78.9 years and mean STS risk was 3.4±2.7%.
There was no significant difference in the incidence for the PEP between the CPD group and the control group (2.3% vs. 2.9%, difference 0.6%; 95% confidence interval [CI]: -1.7% to 0.5%; p = 0.30). When analyzing all-cause mortality and the composite of stroke, transient ischemic attack, or delirium, there were no significant differences. There was a very low rate of vascular access site complications (0.1%).
In the multivariate analysis, there was a higher rate of stroke in female patients (odds ratio [OR]: 1.93, 95% CI 1.20-3.12), while the use of balloon-expandable valves was inversely associated with vascular events (OR: 0.46, 95% CI: 0.28-0.76).
Evidence shows that cerebral protection devices have a high implantation success rate. However, both in the analysis of neuroimaging outcomes in the randomized pivot study and in this study with a clinical impact event, stroke, their benefit for the population included in the study was not demonstrated.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Font: Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement: The
PROTECTED TAVR Study, presentado por Samir R. Kapadia, MD en TCT Congress, Boston, EE.
UU. 17 septiembre de 2022.
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