Baptist Memorial Hospital-Memphis was approved to participate in the Summit trial for Tendyne, a catheterized replacement for the heart’s complicated mitral valve. To conclude in 2022, the study sponsor Abbott Vascular is accumulating years of research, pre-and post-procedure on an estimated 950 patients nationwide with mitral valve disease.
The Summit Trial
The Summit trial is a prospective, controlled, multicenter clinical investigation with three trial cohorts including 1) randomized, 2) non-randomized and 3) mitral annual calcification (MAC). Participants in the randomized cohort will be randomized in a 1:1 ration to the trial device or to the MitraClip system. Participants in the non-randomized and MAC cohorts will receive the trial device. The study commenced in July 2018 and the estimated primary completion date is June 2022.
Baptist Memorial Hospital-Memphis Participation
As reported in the Daily Memphian, the Baptist-Memphis regional cardiology center was approved to participate in the Summit trial for Tendzyne (Abbott) for a catheterized replacement for the heart’s complicated mitral valve. One of 29 U.S medical centers participating in the Summit trial, the only other Tennessee center is St. Thomas Health in Nashville according to the local press.
The center hopes to do 10 to 12 of the procedures in the next 12 months. The medical investigators, including Dr. Basil Paulus, report the patients are thrilled to have a possible solution despite being investigational. Prior to this point “if you were not strong enough to undergo open-heart surgery, we told them you are probably going to die from this.” A tough conversation for any doctor to have with a patient and their family. As far as exclusion and inclusion criteria only those patients with absolutely no other choice—including open-heart surgery—can participate in the Summit trial. These are the sickest and oldest patients. However some have been younger—one even in his 30s.
Conducted in a hybrid operating room at Baptist-Memphis, which offers a suite of functions (space included) supporting the cardiologists and surgeons to undertake endovascular operations (small or no incisions) or more traditional surgeries in the same operating room. Upon an emergency, teams of the appropriate professionals (nurses, physicians, surgeons, and radiologists) quickly convert the room for open-heart surgery.
In the Summit trial, the investigators insert a Tendyne valve rather than opening up a rib cage for open-heart surgery—the surgeons make an incision two or three inches long between the ribs and insert and move the catheter through the heart where the mitral valve lies reports the Daily Memphian.
The Sponsor and Product
Tendyne was acquired by Abbott Vascular in 2015 for $250 million. The Daily Memphian reports that about 10% of patients over 75 have moderate to a severe loss of mitral valve function as reported by Dr. John Craig, a cardiovascular surgeon at Baptist. Once the condition is in place the risk of irregular heartbeat and stroke increase and if it goes untreated (and this can be seen potentially at higher rates in the southern United States) the risk of heart failure and death is dangerously high. Residents of the American South may be at higher risks due to diet, lifestyle and other socioeconomic and demographic factors.
This year the FDA approved the use of the MitroClip for people with mitral valve regurgitation—a condition where the valve leaks blood back into the left ventricle. The MitroClip is the only approved regurgitation remedy for those that are not able to undergo open-heart surgery.
A video clip of the MitroClip procedure is included in the link here. Inserted through the femoral vein in the leg, it is guided to the heart’s left ventricle. The cardiologist helps the surgeon maneuver it into place while the entire care team monitors the progress on X-ray screens in the hybrid operating room. Once in place, both sides of the valve are attached.
Baptist Memorial Hospital Memphis
Baptist Memorial Hospital Memphis and it’s East Memphis campus include their flagship hospital which is one of Tennessee’s highest volume medical centers. The 80-acre campus is also home to Baptist Memorial Hospital for Women, the Spence, and Becky Wilson Baptists Children’s Hospital, Baptist Memorial Restorative Care Hospital, Baptist Heart Institute, Baptist Women’s Health Center and five physician’s office buildings.
Clinical Research at Baptist Memorial
Baptist Memorial Hospital-Memphis Clinical Research Institute (BCRI) opened in 1989 and has a reputation, according to its website, for high-quality standards in research. BCRI conducts inpatient and outpatient phase I through IV clinical trials to assist in the development of innovative medical care patients. BCRI staff collaborates with physicians, pharmaceutical sponsors, the National Institutes of Health (NIH), the Gynecologic Oncology Group and other research organizations to test original ideas, new medical equipment, and technology as well as investigational medications. Margie DeBon, Ph.D. is the Executive Director of the Clinical Research Institute.
Lead Research/Investigators for Baptist Memorial-Memphis
Call to Action: If you or a loved one has a diagnosis that includes a mitral valve disease it is important to keep updated on new methods, products, and FDA approvals.