Study Shows Unprotected TAVR Procedures Produce New Brain Lesions in Nearly All Cases

October 19, 2015—Keystone Heart Ltd. recently announced that findings from the company-sponsored multicenter Neuro-TAVR study were presented at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium, held October 11–15 in San Francisco, California.

According to the company, the Neuro-TAVR study showed that the vast majority of patients undergoing transcatheter aortic valve replacement (TAVR) were found to have new brain lesions on postprocedure magnetic resonance imaging (MRI). Keystone Heart manufactures the TriGuard cerebral protection device, which received CE Mark approval in September 2013 and is commercially available in Europe. The TriGuard is not yet commercially available in the United States.

Professor Alexandra Lansky, MD, initially presented the Neuro-TAVR study data at the 2015 PCR London Valves conference, held September 20–22 in Berlin, Germany. Prof. Lansky is from the Yale Cardiovascular Research Group and Yale University School of Medicine in New Haven, Connecticut.  

This multicenter study, led by the Yale Cardiovascular Research Group, was designed to investigate the occurrence of new brain lesion formation after unprotected TAVR procedures, using the US Food and Drug Administration-approved TAVR devices from Edwards Lifesciences and Medtronic plc in high-volume centers in the United States. The study then compared those results to previous European studies investigating the same phenomenon. Enrolling centers included: Yale New Haven Hospital in New Haven, Connecticut; The Heart Hospital Baylor in Plano, Texas; St. Francis Medical Center in Roslyn, New York; Baptist Hospital Miami in Miami, Florida; and Columbia University Medical Center in New York, New York.

Keystone Heart reported that the primary findings of the study were consistent with previous studies, with 94% of United States patients undergoing TAVR having at least one new brain lesion immediately postprocedure. Neuro-TAVR also examined MRI lesion formation together with neurocognitive findings in TAVR immediately postprocedure and at 30 days.

The neurocognitive findings showed a stroke rate (Valve Academic Research Consortium, VARC-2) of 6.8% at discharge and 7.3% at 30 days. Stroke rates, as defined by American Heart Association/American Stroke Association, where considerably higher, with 22.6% at discharge and 14.8% at 30 days. Montreal Cognitive Assessment and other neurocognitive tests showed that more than 40% of patients had worsening results in all tests at 30 days when compared to pre-TAVR scores.

In the company’s press release, Prof. Lansky commented, "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 United States registry to comprehensively evaluate neurologic outcomes after TAVR since its United States 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 United States 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.”

Michael Mack, MD, of The Heart Hospital Baylor Plano, stated, “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.”