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TriGuard Cerebral Embolic Protection Device in TAVI (REFLECT I)
Quick Takes
- This is a prospective, multicenter, single-blind, randomized controlled trial comparing use of the TriGuard HDH cerebral embolic protection device (covering the ostia of the arch branch vessels) to no cerebral protection in transfemoral TAVI.
- TriGuard cerebral protection during TAVI was safe, but did not meet the primary effectiveness endpoint compared to unprotected TAVI.
Study Questions:
What is the safety and efficacy of the TriGuard HDH cerebral embolic protection (CEP) device in patients undergoing transcatheter aortic valve implantation (TAVI)?
Methods:
REFLECT I is a prospective, multicenter, single-blind, randomized controlled trial investigating the safety and efficacy of the TriGuard HDH (TG) CEP device during transfemoral TAVI in patients with severe symptomatic aortic stenosis. Patients with recent (<72 hours) myocardial infarction, recent (<6 months) stroke or transient ischemic attack, cardiogenic shock, impaired renal function, history of bleeding/coagulopathy, contraindication to antiplatelet therapy, prior prosthetic aortic valve, inadequate iliofemoral vascular access, or severely atheromatous aortic arch were excluded. Both balloon-expanding and self-expanding TAVI valves were implanted. The primary combined safety endpoint was defined according to the Valve Academic Research Consortium 2 (VARC-2) and was compared to a performance goal of 34.4% (taken from the literature).
The primary efficacy endpoint was a composite of all-cause mortality or any stroke at 30 days, National Institutes of Health Stroke Scale worsening at 2-4 days or Montreal Cognitive Assessment worsening at 30 days, and total volume of cerebral ischemic lesions detected by diffusion-weighted magnetic resonance imaging (DW-MRI) at 2-5 days. Neurologic assessments were performed by a neurologist blinded to treatment allocation and DW-MRI findings. Analysis was in the as-treated population, defined as patients with established arterial access for intended TG use.
Results:
From June 2016 to July 2017, 258 patients were enrolled in REFLECT I at 20 US and six European centers. After 2:1 block randomization, there were 141 patients in the TG group, of which 135 underwent TAVI, and 63 patients in the control group, of which 62 patients underwent TAVI. Groups were similar aside from more patients with porcelain aorta and insulin-dependent diabetes in the control group. The study population was overall at intermediate surgical risk (mean Society of Thoracic Surgeons risk score for mortality 4.6 ± 2.8 in TG group, 4.8 ± 3.1 in control group). The TG device was successfully deployed prior to TAVI in 93.4% of cases. In 8.8% of cases, the TAVI system interfered with the TG device. TG device success was achieved in 57.3% (i.e., core laboratory confirmed angiographic complete coverage of all three arch vessels). There were no problems with device removal.
The primary safety endpoint was met. The primary efficacy endpoint was not significantly different between groups, with mean score (higher being better) of -5.3 ± 99.8 for TG and 11.8 ± 96.4 for controls (p = 0.341); therefore, the primary efficacy endpoint was not met. Exploratory analysis of secondary efficacy endpoints showed no significant difference. At 90 days, there was no significant difference in the composite or individual safety or efficacy endpoints, though efficacy comparisons were limited by small sample size, imbalanced randomization, patient withdrawal from the study, and some loss to clinical and DW-MRI follow-up.
Conclusions:
TG cerebral protection during TAVI was safe, but did not meet the primary effectiveness endpoint compared to unprotected TAVI.
Perspective:
Cerebral protection during TAVI is usually obtained using the Sentinel (Boston Scientific) CEP device. Via 6 Fr right radial artery access, filters are placed in the innominate and left carotid arteries, trapping debris that may embolize to the right vertebral, right carotid, and left carotid arteries during TAVI. The left vertebral artery is not protected. The TG device is different in that access is transfemoral (9 Fr to accommodate the CEP device and a pigtail catheter) and is deployed in the arch, covering the ostia of the arch branch vessels. Potential benefits of this design would be additional embolic protection of the left vertebral artery and potential deflection of the TAVI delivery system, keeping it from interfacing with atherosclerotic or calcific disease along the greater curve of the arch or at the ostia of the arch branch vessels. The 9 Fr femoral vascular access may be a drawback. Interestingly, the device was only successfully deployed in 57% of cases, and interference with the TAVI delivery system occurred in 9% of cases. It was safe to use but did not offer benefit in terms of reducing death, stroke, objective neurologic assessment, or cerebral lesion volume by DW-MRI in this study.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Magnetic Resonance Imaging
Keywords: Aorta, Thoracic, Aortic Valve Stenosis, Cardiac Surgical Procedures, Carotid Arteries, Device Removal, Diabetes Mellitus, Diffusion Magnetic Resonance Imaging, Embolic Protection Devices, Heart Valve Diseases, Insulins, Ischemic Attack, Transient, Magnetic Resonance Imaging, Myocardial Infarction, Platelet Aggregation Inhibitors, Risk Factors, Shock, Cardiogenic, Stroke, Transcatheter Aortic Valve Replacement
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