New Minimally Invasive Transcatheter Heart Valve Procedure Superior to Open-Heart Surgery for High Risk Patients
Mount Sinai's David H. Adams, MD, reports CoreValve U.S. Pivotal Trial results in Late-Breaking Clinical Trial Session at American College of Cardiology 2014 Scientific Session.
David H. Adams, MD, national co-principal investigator for the CoreValve U.S. Pivotal Trial, presented study results showing minimally invasive transcatheter aortic valve replacement (TAVR) with the CoreValve System is superior to surgical aortic valve replacement (SAVR) at one year in patients with severe aortic stenosis who are considered high risk for surgery.
Dr. Adams presented the findings at a late-breaking clinical trial session at the 63rd Annual Scientific Session of the American College of Cardiology (ACC), and also published simultaneously in the New England Journal of Medicine (NEJM).
The CoreValve High Risk Study is the first prospective, randomized study to show any transcatheter aortic valve to be superior to surgery. The CoreValve System was approved by the U.S. Food and Drug Administration (FDA) in January 2014 for patients considered extreme risk for surgery; the device is not currently approved in the U.S. for use with patients at high risk.
The head-to-head study met its primary endpoint with a low one year, all-cause mortality rate of only 14.2 percent in patients receiving the CoreValve System, compared to 19.1 percent in patients receiving SAVR at one year (non-inferiority p-value<0.001; superiority p-value=0.04).
"The extremely low mortality rates in both arms of the trial confirm that our heart teams were outstanding, particularly considering they had no prior experience with transcatheter aortic valve therapy," said David H. Adams, MD, chair of the Department of Cardiothoracic Surgery at The Mount Sinai Hospital, who is national co-principal investigator of the CoreValve U. S. Pivotal Trial and presenter of the data at ACC. "Our key finding that TAVR with CoreValve was associated with a significantly higher rate of survival at one year in patients at increased risk has significant and broad implications."
Stroke rates in patients with the CoreValve System were low and not statistically different than in SAVR patients; this finding is especially important because stroke is one of the complications most concerning to physicians and patients because it increases mortality and affects quality of life. As determined by detailed neurological assessments before and after each procedure, major stroke rates in patients who received the CoreValve System were 3.9 percent at 30 days and 5.8 percent at one year, while those same rates for patients with surgery were 3.1 percent (30 days) and 7.0 percent (one year).
Patients also saw significant improvements in their quality of life (QoL). QoL scores improved 19.0 points for CoreValve patients and 3.7 points for surgical patients at 30 days (p=<0.0001); at one year both patient groups improved significantly with CoreValve patients improving 23.2 points and surgical patients improving 21.9 points (as measured by KCCQ 100-point scale, where five points is considered important, and 20 points is considered a very large improvement).
While there was no statistical difference between CoreValve System and surgery in MACCE (major adverse cardiovascular or cerebral events) rates at 30 days (p=0.1), at one year the MACCE rate was significantly better for CoreValve patients (p=0.03). The frequency of death or major stroke at one year was also lower with CoreValve (p=0.03). Overall hemodynamic (blood flow) performance in CoreValve patients was better than SAVR across all time points (p=<0.02 at discharge, 30 days and one year). In addition, rates of moderate or severe paravalvular leak (PVL) for TAVR were acceptably low with 7.8 percent at discharge and 6.1 percent at one year. Consistent with the Extreme Risk Study, PVL in most patients improved over time. As with previous studies on self-expanding technology, the permanent pacemaker rate was 19.8 percent at one month and, importantly, for these patients a difference in mortality was not observed.
To participate in the High Risk study, the 747 patients were estimated to have a predicted risk of operative mortality of 15 percent or higher at 30 days, assessed by two clinical site surgeons and confirmed by at least two surgeons on a National Screening Committee. The average age of patients in the study was 83.2 years old, and the study enrolled a nearly equal number of men and women. In addition to the STS Predicted Risk of Mortality estimate of 7.4, these patients had documented co-morbidities, frailty and disability that placed them at increased risk for surgery. The majority of patients (56 percent) had a Charlson co-morbidity score of 5 or greater (on a scale of 6, where 5 or greater represents severe co-morbidity). Ten percent of patients did not live independently.
The CoreValve System was approved by the FDA in January 2014 for patients considered extreme risk for surgery. Since receiving CE (Conformité Européenne) Mark in 2007, the CoreValve System has been implanted in more than 50,000 patients in more than 60 countries.
Upon reviewing the CoreValve Trial's results for high risk patients, the FDA has determined it has sufficient information to evaluate the safety and efficacy of the Medtronic CoreValve System for this patient group without the need for an external expert panel.
The CoreValve System was designed specifically to overcome the challenges of a broad range of TAVR patients. The device has a small 18Fr profile for all valve sizes, which minimizes trauma at implant, and allows physicians to treat patients with small or calcified vasculature. Its Nitinol frame is designed to prevent unwanted leakage and optimize blood flow. In addition, the CoreValve System is available in the broadest range of sizes available, so patients who have smaller, larger or in-between sizes can be accommodated.
About the Mount Sinai Health System
The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services—from community-based facilities to tertiary and quaternary care.
The System includes approximately 7,100 primary and specialty care physicians; 12 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. Physicians are affiliated with the renowned Icahn School of Medicine at Mount Sinai, which is ranked among the highest in the nation in National Institutes of Health funding per investigator. The Mount Sinai Hospital is in the "Honor Roll" of best hospitals in America, ranked No. 15 nationally in the 2016-2017 "Best Hospitals" issue of U.S. News & World Report. The Mount Sinai Hospital is also ranked as one of the nation's top 20 hospitals in Geriatrics, Gastroenterology/GI Surgery, Cardiology/Heart Surgery, Diabetes/Endocrinology, Nephrology, Neurology/Neurosurgery, and Ear, Nose & Throat, and is in the top 50 in four other specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 10 nationally for Ophthalmology, while Mount Sinai Beth Israel, Mount Sinai St. Luke's, and Mount Sinai West are ranked regionally. Mount Sinai's Kravis Children's Hospital is ranked in seven out of ten pediatric specialties by U.S. News & World Report in "Best Children's Hospitals."