Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.
EuroIntervention
; 11(1): 75-84, 2015 May.
Article
in En
| MEDLINE
| ID: mdl-25868876
ABSTRACT
AIMS:
This study aimed to evaluate the safety and performance of the TriGuard™ Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery take-offs to deflect emboli away from the cerebral circulation, in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS ANDRESULTS:
The prospective, multicentre DEFLECT I study (NCT01448421) enrolled 37 consecutive subjects undergoing TAVR with the TriGuard EDD. Subjects underwent clinical and cognitive follow-up to 30 days; cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed pre-procedure and at 4±2 days post procedure. The device performed as intended with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of subjects (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischaemic lesions on post-procedure DW-MRI (n=28) was similar to historical controls (82% vs. 76%, p=NS). However, an exploratory analysis found that per-patient total lesion volume was 34% lower than reported historical data (0.2 vs. 0.3 cm3), and 89% lower in patients with complete (n=17) versus incomplete (n=10) cerebral vessel coverage (0.05 vs. 0.45 cm3, p=0.016).CONCLUSIONS:
Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Aortic Valve
/
Aortic Valve Stenosis
/
Heart Valve Prosthesis
/
Cardiac Catheterization
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Heart Valve Prosthesis Implantation
/
Intracranial Embolism
/
Embolic Protection Devices
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
Limits:
Aged80
Country/Region as subject:
America do sul
/
Brasil
/
Europa
Language:
En
Journal:
EuroIntervention
Journal subject:
ANGIOLOGIA
/
CARDIOLOGIA
/
TERAPEUTICA
Year:
2015
Type:
Article
Affiliation country:
United kingdom