CAESAREA, Israel and TAMPA, Fla., Oct. 3, 2016 /PRNewswire/ -- Keystone Heart Ltd., an emerging medical device company focused on developing cerebral protection devices for patients undergoing cardiovascular procedures, announces data recently published in the American Journal of Cardiology demonstrating new brain lesions in 94% of patients undergoing transcatheter aortic valve replacement (TAVR) by diffusion weighted magnetic resonance imaging (DWI-MRI) (n=34) prior to hospital discharge.
"These data show the realities of stroke risk among patients undergoing TAVR, and underscore the need for physicians to mitigate the peri procedural brain injury," said Jeffrey W. Moses, MD. Professor of Medicine Columbia University Medical Center
Neuro-TAVR, a prospective, observational study conducted in 5 centres in the U.S., evaluated 44 consecutive patients who had undergone TAVR and findings demonstrated:
- An average of at least 10.4 new lesions per patient with a mean of 295 mm3 (71.6 to 799.6 mm3) total lesion volume was seen among the 34 patients evaluated with DWI-MRI post-TAVR
- 7.3% of these patients (n=34) experienced an ischemic stroke, as defined by Valve Academic Research Consortium (VARC) 2 definitions at 30 days post-TAVR
- Neurologic impairment, based on a worsening National Institutes of Health Stroke Scale (NIHSS), accompanied by DWI-MRI-documented cerebral infarction, was detected in 22.6% of patients undergoing DW-MRI (n=34) at discharge and in 14.8% at 30 days.
- Systematic use of serial NIHSS evaluation in all patients undergoing DW-MRI uncovered additional neurologic deficits in 16% of patients before discharge.
- 59.4% of patients had worsening of scores when evaluated by National Institutes of Health Stroke Scale (NIHSS) or Montreal Cognitive Assessment (MoCA) prior to discharge, and 40.7% of patients at 30 days
- 33% of all patients (n=44) had a worsening MoCA score from baseline to discharge and a 41% worsening to 30 days.
- A consistent decrease in cognitive measures was found in 20% to 56% of all patients (n=44) at 30 days compared to pre-TAVR baseline, based on paper and pencil neuropsychological testing
Importantly, the results likely underestimate the true degree of cognitive decline because subjects with larger cerebral infarctions were less likely to complete subsequent cognitive assessments, according to study authors.
"These data underscore the wide spectrum of neurologic injury after TAVR and emphasize the critical need for meaningful standardized assessment methods and definitions - that incorporate neurology expertise - in reporting neurologic outcomes in clinical trials," says lead author Alexandra Lansky, MD, Professor of Medicine, Yale University School of Medicine.
The trial was conducted at Yale University School of Medicine, New Haven, Connecticut; The Heart Hospital, Baylor University, Plano, Texas; Baptist Hospital of Miami, Miami, Florida; St. Francis Hospital, Roslyn, New York; and College of Physicians and Surgeons, Columbia University, New York, New York.
While this study is the first of its kind in the United States, numerous other studies conducted in Europe have shown similar results demonstrating that 58% to 100% of patients have new brain damage by imaging following TAVR.
Additionally, other published and presented data have supported the safety and benefits of brain protection for patients undergoing TAVR using Keystone Heart TriGuard device. Recently, data presented as part of PCR London Valves 2016, demonstrated the safety and efficacy of covering all three cerebral branches with the TriGuard™ Cerebral Embolic Protection device reducing significantly both clinical symptoms and new brain lesions post TAVR (Lansky et al, London Valves 2016).
About The TriGuard™ Cerebral Protection Device
Keystone Heart's TriGuard™ is the only cerebral protection device designed to provide full coverage to all brain territories to minimize the risk of cerebral damage during TAVR and other cardiovascular procedures. The CE marked TriGuard™ device is shaped to accommodate anatomic variations of the aortic arch. Formed to withstand potential interface with the TAVR delivery system and other procedure related accessories, it uses a Nitinol® frame and mesh — flexible and atraumatic, yet robust and sturdy.
The TriGuard Cerebral Protection Device is placed via one of two femoral artery access ports typically used in TAVR, thereby eliminating the need for a third puncture site. It deploys rapidly, and self-positions through a small 9F catheter. It provides stable, atraumatic protection, with simple retrieval.
The TriGuard Cerebral Protection Device has been granted the CE Mark in the European. In the United States, the device is currently available for investigational use only.
About Keystone Heart
Keystone Heart Ltd. is a medical device company developing and manufacturing cerebral protection devices. The company is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, surgical valve replacement, atrial fibrillation ablation and other cardiovascular procedures.
Headquartered in Israel with US operations in Tampa, FL, Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research. The Company's management has extensive experience in the fields of interventional cardiology and medical devices. For additional information, please contact us.
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SOURCE Keystone Heart Ltd.