Ascension's Via Christi Hospital St. Francis is the first in the United States to participate in a pivotal clinical study of a minimally invasive, first-of-its-kind treatment device developed by Abbott to allow doctors to replace patients' damaged mitral heart valves without open-heart surgery.
Abbott announced today that it had launched an investigational device study — the SUMMIT U.S. pivotal trial — evaluating the safety and efficacy of its revolutionary Tendyne Transcatheter Mitral Valve Replacement, or TMVR, system. Abbott is a global device manufacturer whose minimally invasive MitraClip device has been a leading therapy for repairing patients’ leaky mitral valves since 2008.
This comes on the heels of what Abbott called promising early results from a separate global study at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions in May.
“Abbott's Tendyne system is an exciting development for patients living with mitral valve regurgitation and for those of us who provide their care,” said structural heart specialist Bassem Chehab, MD, medical director for Via Christi Structural Heart program, noting that currently there are no federally approved minimally invasive therapies for replacing the mitral valve.
"MitraClip and Transcatheter Aortic Valve Replacement, or TAVR, were the two biggest breakthroughs in the rapidly evolving area of minimally invasive cardiac therapy during the past decade," said Dr. Chehab. "TMVR is poised to be the biggest breakthrough for the next decade and it is being rolled out first here in Wichita at Via Christi."
On July 9, Dr. Chehab, together with cardio-thoracic surgeon Brett Grizzell, MD, and cardiologist Richard Steckley, MD, successfully treated two patients using the minimally invasive device at St. Francis as part of the SUMMIT trial. Both patients were discharged from the hospital in a week or less with marked symptom improvement. Abbott's investigational Tendyne system is the first and only transcatheter mitral valve replacement device that can be repositioned and fully retrieved. It is designed to provide a minimally invasive treatment option for patients with mitral regurgitation, or MR.
MR is a debilitating, progressive and life-threatening disease in which the heart's mitral valve does not close completely, causing blood to flow backward and leak into the left atrium of the heart. The condition can raise the risk of irregular heartbeats and stroke, and if left untreated, could ultimately lead to heart failure and death. Nearly one in 10 people over the age of 75 have moderate to severe mitral regurgitation.
According to Abbott, up to 1,010 patients at 80 international sites in the U.S., Europe and Canada will be enrolled in the SUMMIT study. Wichita, which in addition to having been the site where the first TMVR procedure was performed as part of the trial, is one of only eight sites in the Midwest and the only one in Kansas.
Via Christi’s Structural Heart program began as a conversation in 2012 among hospital leadership and community physicians about the need to bring transcatheter aortic valve replacement procedures and other emerging, life-saving structural heart procedures to south-central Kansas.
Dr. Chehab was recruited to serve as the program’s medical director and Via Christi began developing the area’s only technologically advanced hybrid OR. Less than a year later, St. Francis’ hybrid OR was ready for use and the first TAVR was performed at St. Francis.
“Today, we’re a comprehensive program — one that offers a vast spectrum of therapies to match patients’ needs and desire to receive leading-edge treatment close to home and family,” said Dr. Chehab, of Cardiovascular Consultants of Kansas, who works closely with a multidisciplinary team that includes Dr. Grizzell, of Wichita Surgical Specialists; Dr. Steckley, of Cardiovascular Consultants of Kansas; and physician assistant Richard Allenbach, director of the Via Christi Heart Valve Clinic.
The now-mature program has gone far beyond initial introduction of TAVR, a procedure that since October 2013 has benefited nearly 700 Via Christi patients with severe aortic stenosis. It expanded to include MitraClip — which to date has benefitted nearly 200 Via Christi patients with mitral valve regurgitation — and a growing list of other less-invasive structural heart procedures. That, in turn, has led to the program being selected as a site for numerous domestic and international pivotal clinical trials.
"Being chosen as the launch site for this trial validates our position as a national leader in advancing future therapies and cardiac care,” said Dr. Grizzell. “We do excellent work as evidenced by our consistently successful patient outcomes."
Said Dr. Chehab: “It’s amazing how in just five years Via Christi’s footprint has expanded from being the local and regional leader in structural heart to national and even international prominence.”
Kevin Strecker, St. Francis hospital president, agreed, noting, “Our multidisciplinary structural heart team is helping keep Wichita and Ascension on the leading edge of heart care, while at the same time helping break new ground in minimally invasive treatment options for patients worldwide. That’s something in which we can all take pride.”