Jochen Wöhrle (Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany) and his team report in JACC: Cardiovascular Interventions that, in an all-comer population, patients who underwent transcatheter aortic valve implantation (TAVI) with the Sentinel embolic protection device (Claret Medical) had a significantly higher rate of stroke-free survival at seven days than did patients who underwent TAVI without the device.
The SENTINEL trial previously indicated that the Sentinel was safe and reduced new lesion volume (when results were adjusted for TAVI device type) while a meta-analysis, published after the SENTINEL trial, found the device to significantly reduce the risk of stroke and death. The aim of the present study was to evaluate the safety and efficacy of Sentinel in an all-comers population. Wöhrle et al comment: “The primary composite endpoint was all-cause mortality or all strokes according to VARC-2 criteria within seven days. The secondary endpoint was technical success of the device, defined as successful insertion and deployment of both filters at intended position.”
Of 802 consecutive patients enrolled in the study, 280 underwent TAVI with the Sentinel device and 522 underwent TAVI without the device. In a propensity matched analysis, the primary endpoint occurred significantly less frequently in the Sentinel device group: 2.1% vs. 6.8% for the unprotected group (p=0.01). According to the authors, based on this result, the device is associated with an absolute risk reduction of stroke or death of 4.7% and a number need to treat of 21.
Additionally, with the device, the rate of disabling and non-disabling stroke was significantly reduced from 4.6% to 1.4% (p=0.03) compared with when the device was not used. Wöhrle et al state: “This represents an absolute risk reduction of 3.2%, which is similar to the 2.9% absolute risk reduction in DEFLECT III using the Triguard system and an absolute 3.6% reduction of stroke (p=0.057) in the SENTINEL trial”.
In a multivariate analysis, the Society of Thoracic Surgeons (STS) score for mortality and TAVI procedure without use of embolic protection were the only independent predictors for the occurrence of death or stroke. Lack of use of the Sentinel device was also an independent predictor of stroke at seven days (but not STS score). “In addition, stroke was significantly lower with use of the protection device compared with unprotected procedures within 48 hours (3.6% vs. 1.1%; p=0.03),” the authors report.
They conclude: “In patients undergoing TAVI, use of a cerebral embolic protection device demonstrated a significantly higher rate of stroke-free survival compared with unprotected TAVI.”
Wöhrle told Cardiovascular News: “Since there are no independent predictors of stroke except for STS score and use of the protection device, all patients should undergo TAVI with embolic cerebral protection.”