SENTINEL - SENTINEL
Contribution To Literature:
The SENTINEL trial showed that routine use of the Sentinel TCEP does not result in a reduction in new lesion volume on MRI or strokes within 30 days compared with usual management.
The goal of the trial was to compare the safety and efficacy of the Sentinel transcatheter cerebral embolic protection (TCEP) device in reducing cerebral embolization among patients undergoing transcatheter aortic valve replacement (TAVR).
Patients were randomized in a 2:1 fashion to either Sentinel TCEP (n = 244) or control (n = 119).
- Total number of enrollees: 363
- Duration of follow-up: 30 days
- Mean patient age: 83.4 years
- Percentage female: 52%
- High-risk patients undergoing TAVR for severe symptomatic aortic stenosis
- Computed tomography showing eligibility for Sentinel use
- Known contraindications for right radial or brachial artery access
- Patients unable to undergo magnetic resonance imaging (MRI) evaluation of their brain for any reason
Other salient features/characteristics:
- Median Society of Thoracic Surgeons Predicted Risk of Operative Mortality (STS PROM) score: 6%
- Previous stroke: 5.8%
- Previous transient ischemic attack (TIA): 7.4%
- Lesion volume at baseline: 7848 mm3
- Sentinel use: radial, 93.2%; both filters deployed, 94.4%
- Devices used: Sapien S3, 52.4%; Sapien XT, 17.8%; CoreValve Evolut R, 25.9%
The primary efficacy outcome, median total new lesion volume in protected territories at day 2-7 post-TAVR, for Sentinel vs. control (n = 240), was 102.8 vs. 178.0 mm3, p = 0.33.
The primary safety outcome, any major adverse cardiac and cerebral events (MACCE) (includes death [any cause], stroke [any], acute kidney injury [Stage 3] at 30 days), for Sentinel vs. control, was 7.3% vs. 9.9%, p = 0.4.
- All-cause mortality: 1.3% vs. 1.8%, p = 0.65
- All strokes: 5.6% vs. 9.1%, p = 0.25
Secondary outcomes for Sentinel vs. control:
- Total new lesion volume: 294 vs. 309.8 mm3, p = 0.81
- Disabling stroke: 0.9% vs. 0.9%, p = 1.0
- Major vascular complication: 8.6% vs. 5.9%, p = 0.53
- No differences in neurocognitive testing
- Significant interaction of primary efficacy endpoint by device type in a post hoc analysis: lowest efficacy with Sapien S3
The results of this trial indicate that routine use of the Sentinel TCEP does not result in a significant reduction in new lesion volume on MRI and nondisabling strokes within 30 days. It adds to the total procedure and fluoroscopic times with a slight increase in vascular complication rates (deployed via the right radial or brachial arteries).
Atherothrombotic debris is common following TAVR and was noted in 99% of patients in this trial. This included acute thrombus with tissue elements, artery wall, calcification, valve tissue, and foreign materials. The efficacy appeared to be lowest in patients receiving the Sapien S3 valve. This is hypothesis generating and could possibly be due to lower rates of embolization with this device due to smaller sheath sizes and lack of routine predilation. Long-term neurocognitive effects of the MRI differences noted in this trial would be informative, particularly as this technology transitions to lower risk populations. It is also unclear if certain subsets would benefit with their use, such as those with prior strokes/TIA or unrevascularized cerebrovascular disease.
Kapadia SR, Kodali S, Makkar R, et al. Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2016;Nov 1:[Epub ahead of print].
Presented by Dr. Susheel Kodali at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2016), Washington, DC, November 1, 2016.
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