Introduction to TAVI and Its Complications
Transcatheter Aortic Valve Implantation (TAVI) has gained widespread acceptance due to its favorable risk-benefit profile, particularly among elderly patients. However, like any medical procedure, TAVI is not without its risks. One of the most concerning complications is the peri-procedural stroke, which occurs when tissue debris migrates to the cerebral circulation. This complication affects approximately 2% to 4% of patients during or shortly after the procedure, often resulting in permanent disability in half of the cases.
The Sentinel Device: A Proposed Solution
To mitigate the risk of peri-procedural strokes, the Sentinel cerebral protection device was developed by Boston Scientific. This device aims to prevent embolic events during TAVI procedures. Despite the ambiguous results from the PROTECTED TAVR trial published in 2022 in the New England Journal of Medicine, the use of the Sentinel device has been on the rise in some Western countries. This increase in usage necessitated a reevaluation of the device’s effectiveness and utility.
The BHF PROTECT-TAVI Trial
The British BHF PROTECT-TAVI trial was designed to assess the efficacy of the Sentinel device in preventing strokes during TAVI procedures. This multicenter, randomized, open-label trial included a blinded evaluation of outcomes. Conducted between 2020 and 2024, the trial recruited 7,635 patients with an average age of 81 years across 33 specialized centers. All participants had aortic stenosis warranting TAVI. In one of the randomized groups, TAVI was performed with the addition of the Sentinel device (n = 3,795). The primary endpoint was the occurrence of a stroke within 72 hours post-procedure or before hospital discharge.
Key Findings of the Trial
The results of the BHF PROTECT-TAVI trial were clear: there was no significant difference between the groups in terms of the incidence of strokes of all clinical forms (2.1% versus 2.2%; not significant). Similarly, there was no difference in the incidence of disabling strokes (1.2% versus 1.4%) or severe strokes (0.5% in both groups), nor in mortality rates (0.8% versus 0.7%). Subgroup analyses based on age, sex, bicuspid aortic valve, calcifications, and valve type yielded consistent results. Notably, the deployment of the filter between the innominate artery and the left carotid artery was deemed complete in over 80% of cases (81%).
Implications for Clinical Practice
The robust statistical power of this British multicenter randomized trial leads to unequivocal conclusions: for patients eligible for TAVI, the routine use of the Sentinel device does not reduce the incidence of strokes, including the most disabling ones, within 72 hours following the procedure. Consequently, the systematic use of such a device cannot be justified in routine medical practice. However, its use may still be considered in cases of high embolic risk, such as significant aortic atheroma, a history of stroke (especially in the absence of a cardio-embolic etiology), or unfavorable anatomical factors. The risk-benefit ratio of this procedure may need reevaluation in these specific or other yet-to-be-defined indications.
This article was originally published on JIM.fr, a member of the Medscape network.
Further Reading and Resources
– Aortic Stenosis with Bicuspid Valve: Twice the Mortality After TAVI
– Reinterventions After TAVI Are Rare and Predicted by Certain Factors
For more information, visit the original article on Medscape: [https://francais.medscape.com/s/voirarticle/3613153](https://francais.medscape.com/s/voirarticle/3613153)
🔗 **Fuente:** https://francais.medscape.com/s/voirarticle/3613153