CINCINNATI (Oct. 18, 2016) – The Christ Hospital and The University of Kentucky Gill Heart Institute are the first healthcare providers in the region to offer an innovative procedure to patients with congenital heart disease.
The Compassion Trial, led by principal investigator, Dean Kereiakes, MD, medical director of The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education, in collaboration with Andrew Leventhal, MD, co-principal investigator from University of Kentucky, is transforming healthcare options for those born with congenital heart disease.
“This study offers a revolutionary new treatment for patients with adult congenital heart disease who would otherwise be facing at least a second surgical procedure,” said Dr. Kereiakes. “The Compassion Trial offers the leading edge technology currently available for catheter-based aortic valve replacement to patients with surgically repaired congenital heart disease who need pulmonary valve replacement”.
Ian Sarembock, M.D., cardiovascular service line executive medical director, is co-principal investigator for the trial at The Christ Hospital.
“These patients are facing yet another open heart surgical procedure. Furthermore, we believe that the Sapien 3 valve will be a significant improvement over the only catheter-based treatment currently approved for use in these patients,” said Dr. Sarembock.
“UK HealthCare is one of the few U.S. centers to offer a multidisciplinary program dedicated to Adult Congenital Heart Disease. This new specialty is for patients who were successfully treated by pediatric cardiologists and surgeons, and as a result have grown to adulthood. These patients now require specialized follow-up care,” said Dr. Leventhal. “My challenge is to bridge the gaps between pediatric cardiology, adult cardiology, and surgery. The Compassion Trial is an excellent example of new technology that will help my patients who need pulmonic valve replacement. This trial will utilize the skills of my adult cardiology colleagues who are highly experienced with transcatheter aortic valve replacement and it will give my patients access to the most up-to-date valve replacement available. I am extremely happy that Drs. Kereiakes, Sarembock and Gurley will be supporting our Adult Congenital program through participation in this clinical trial.”
Physicians at The Christ Hospital Lindner Research Center inserted the second Sapien 3 valve used in the U.S. and ranked among the top ten performing centers in the clinical trial that led to approval of this device by the U.S. FDA. Sapien 3 is now the leading catheter-based device for treatment of aortic valve stenosis and is now being evaluated for pulmonary valve replacement. The same minimally invasive techniques for valve replacement will be used in the COMPASSION Trial and include conscious sedation as well as no surgical incisions. In COMPASSION, the Sapien 3 valve will be inserted via the femoral vein in the leg to the right side of the heart and into the pulmonary valve position. Sapien 3 was developed by Edwards Lifesciences of Irvine, CA, and is designed to provide a simpler, easier procedure with fewer post procedural complications and a faster recovery.
“The potential advantages of Sapien 3 over the currently available valve for this purpose include being much thinner, more flexible and steerable as well as having a proprietary sealing cuff around the valve to prevent leaks” said Dr. Kereiakes. “The hole we put in the vein is significantly smaller.”
The Christ Hospital is partnering with UK HealthCare, the clinical enterprise at the University of Kentucky in Lexington, to enroll patients into the Compassion trial, providing exceptional leading edge care not available elsewhere in the region.
“This is a perfect partnership of pediatric and adult congenital heart disease expertise with technical proficiency and experience with the Sapien 3 valve.” said Dr. Sarembock. “We are fortunate to have such a collaborative partnership between The Christ Hospital and UK HealthCare physicians which will be to the benefit of all patients in our multi-state region.”
“I am thrilled to be working with Drs. Kereiakes and Sarembock on this project,” said John Gurley, MD, adult interventional cardiologist at UK Healthcare. “What we are doing is special. We are combining two of the strongest medical centers and most experienced operators in the field in order to bring state-of-the-art heart valve technology to our community. Our individual programs have been nationally recognized for some time. Now, by sharing our capabilities and our experience we can move to an elite level. This collaboration will succeed because Dr. Kereiakes and I share a great confidence in our programs and great respect for each other. We hope that COMPASSION is just the beginning of a partnership that will bring additional advanced valve therapies.”
Patients enrolled into the trial will undergo their procedure at The Christ Hospital under the care of physicians from both The Christ Hospital and UK Healthcare.
To learn more about advanced heart care at The Christ Hospital’s Lindner Research Center, call 513-585-1777 or visit TheChristHospital.com/heart. To learn more about UK’s Gill Heart Institute, call 859-257-1000 or toll free 1-800-333-8874 or visit http://ukhealthcare.uky.edu/gill/.