First US Multi-center Study Finds Unprotected TAVR Procedures Produce New Brain Lesions in Nearly All Cases

SAN FRANCISCO, October 13, 2015 /PRNewswire/ --

Keystone Heart, a medical device company and the developer of CE marked TriGuard™ Cerebral Protection Device, announced that it will be sharing additional findings from the multicenter Neuro-TAVR study with the clinical community at the Trans-Catheter Therapeutics (TCT) meeting in San Francisco this week.

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The Neuro-TAVR study was initially presented last month at PCR London Valves conference by Professor Alexandra Lansky, MD., Yale University School of Medicine. In the first study of its kind in the US, the vast majority of patients undergoing Transcatheter Aortic Valve Replacement (TAVR) were found to have new brain lesions on post-procedure MRI. This multicenter study, led by Yale Cardiovascular Research Group ("YCRG"), was designed to investigate the occurrence of new brain lesion formation following unprotected TAVR procedures, using US approved Edwards Lifesciences and Medtronic valves, in high volume US centers, and to compare those results to prior European studies investigating the same phenomenon. Enrolling centers included: Yale New Haven Hospital, The Heart Hospital Baylor, Plano, St. Francis Medical Center, Roslyn, NY, Baptist Hospital Miami and Columbia University Medical Center, NY.

The primary findings of the study were consistent with prior studies, with 94% of US patients undergoing TAVR having at least one new brain lesion immediately post-procedure. Neuro-TAVR was also the first US study to examine MRI lesion formation together with neurocognitive findings immediately post TAVR procedure and at 30 days.  The neurocognitive findings showed stroke rate (VARC-2) of 6.8% at discharge and 7.3% at 30-days. Stroke rates as defined by AHA/ASA where considerably higher, with 22.6% at discharge and 14.8 at 30-days. MoCA and other neurocognitive tests showed that over 40% of patients had worsening in all tests at 30 days when compared to pre TAVR scores.

Professor Alexandra Lansky, MD, Yale Cardiovascular Research Group, stated:  "We recognized the need to confirm that the US incidence of cerebral infarction during TAVR were similar to the rates reported in multiple European trials. We were also interested in trying to correlate brain MRI lesions with neurocognitive assessments following the procedures. The Neuro-TAVR trial, supported by Keystone Heart, is the first US registry to comprehensively evaluate neurologic outcomes after TAVR since its US commercialization. Our goal was to establish a true baseline for present day unprotected TAVR with state of the art techniques and devices used at top US centers. We think the results speak for themselves; all enrolling centers had patients with new brain lesions post TAVR, 80% of lesions having volumes larger than 50 mm3, with 22% of patients having some measurable neurologic deficit and 40% having cognitive decline. Our results underscore the need to evaluate methods to reduce the risk of embolic brain infarction and clinical stroke and optimize the outcomes of patients undergoing TAVR".

Dr. Michael Mack, of The Heart Hospital Baylor Plano, commented "TAVR is a great advance for our patients and offers lower morbidity and maybe mortality to our sickest patients. Recent studies also suggest benefits to younger and less acute patients, but we need to ensure that the catheter based procedure is as safe as possible.  In this study and data from similar studies on TAVR, we see 94% new brain lesion rates following TAVR, higher than we see from many other cardiovascular procedures. The history of innovation in medicine and interventions is all about continuous improvements in terms of safety and efficacy - and this study should help guide our priorities going forward."

The rise in recognition of brain damage in cardiovascular procedures is clearly evident at TCT 2015 this week in San Francisco, with a range of industry and clinical community workshops and sessions. These include sessions on new TAVR related technologies and embolic protection devices.

Keystone Heart is exhibiting (booth 1744) and has consultation presence at TCT. In addition to presentation of data from Neuro-TAVR and Keystone Heart's other clinical studies, TriGuard™ product demonstrations and tutorials will be available, to highlight recent enhancements to the Company's product and delivery system, and conduct procedural training. The CE approved TriGuard™ Cerebral Protection Device is available in Europe, but not yet commercially available in the USA.

About Keystone Heart
Keystone Heart Ltd. is a medical device company developing and manufacturing cerebral protection devices to reduce the risk of stroke, neurocognitive decline and dementia caused by brain emboli associated with cardiovascular procedures.

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. The novel TriGuard™ product pipeline is designed to help interventional cardiologists, electrophysiologists and cardiac surgeons to preserve brain reserve while performing these procedures.

Headquartered in Israel, 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.

Contact:
Mr. Shuki Porath, President and CEO  
[email protected]
Tel:  +972-4-615 8000
http://www.keystoneheart.com

SOURCE Keystone Heart