Helping Mind the Gap on Cardiovascular Diseases
Lifesavers appear in big sizes and small. For patient Adam Livingstone, rescue was a dime-sized clip that restored his heart’s normal rhythm and size. For months, Livingstone had been experiencing shortness of breath, chest pain and fatigue. Diagnosed with mitral valve regurgitation, a minimally invasive procedure to repair the valve was performed at Sutter Medical Center, Sacramento—one of Sutter’s sites where researchers evaluate new devices for treating damaged or diseased heart valves.
The Heart’s Finely Orchestrated Blood Flow
Like a musical conductor, the heart oversees rhythm and flow, circulating blood to each of its chambers in a coordinated, unidirectional symphony.
THE MITRAL VALVE
Mitral regurgitation, the most common type of heart valve disorder, occurs when blood leaks backward through the mitral valve when the left ventricle closes.
Some patients undergo non-surgical heart valve repair with transcatheter mitral valve repair (TMVR) with MitraClip®.2 During the procedure, doctors thread a catheter into a large leg vein reaching the heart. Then a dime-sized clip clamps the improperly working valve, allowing it to close more tightly with less backward blood flow.
“Some research participants recover faster and resume normal activities within a week of the procedure, and may not require lifelong anticoagulant medications, repeat surgeries, or re-hospitalization,” says David Roberts, M.D., FACC, FSCAI, medical director of cardiovascular services at Sutter in the Valley Area.
A new clinical trial at Sutter called PASCAL CLASP IID/IIF will test the safety and effectiveness of TMVR with the PASCAL Transcatheter Valve Repair System® compared with MitraClip® in patients with mitral regurgitation.3
For patients with severe mitral regurgitation, Sutter’s CPMC seeks to enroll patients in a clinical trial called SM3, which assesses the safety and efficacy of the SAPIEN M3 System™.4
“In this study, we are evaluating a new type of mitral valve that may provide a minimally invasive alternative to surgery for high-risk patients with severe mitral valve disease,” says David Daniels, M.D., co-director of Sutter’s Structural Heart Program in the Bay Area, and principal investigator of the SM3 clinical trial at Sutter.
Some patients develop mitral valve disease when calcium deposits accumulate on the fibrous ring attached to the mitral valve leaflets. For these patients with mitral annular calcification (MAC), Sutter will begin offering enrollment in the Summit clinical trial, which will test the safety and effectiveness of the Tendyne™ transcatheter mitral valve.5
“Previous approaches to treat patients with MAC have mainly involved the off-label use of transcatheter aortic valves,” says Dr. Roberts. “But this strategy may lead to residual mitral regurgitation and the need for open-heart surgery. Sutter’s participation in Summit may lead to novel ways to care for this hard-to-treat subset of patients.”
THE TRICUSPID AND AORTIC VALVES
Although a skilled conductor, sometimes the heart needs help to maintain proper blood flow for musical perfection. To the rescue: Sutter researchers test interventional devices designed to treat patients with diseased or damaged tricuspid and aortic valves.
In one new clinical trial, Sutter researchers will collect information about treatment for severe aortic regurgitation, a condition typically treated with aortic valve replacement surgery.
This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve™ Pericardial TAVR System, designed to help treat patients with severe aortic regurgitation or severe aortic stenosis.6
“Until now, all commercially available TAVR valves have focused on aortic stenosis, or a restricted valve,” says Dr. Daniels, co-principal investigator of the TAVR with JenaValve™ clinical trial at Sutter. “The JenaValve™ may allow researchers to treat patients with a leaky valve in the absence of any calcium. Currently these patients are only candidates for open-heart surgery.”
Additionally, Sutter researchers at CPMC and Sutter Medical Center are seeking to enroll patients who have tricuspid regurgitation in a clinical trial called TRILUMINATE.
The TRILUMINATE study will evaluate the safety and effectiveness of the Tricuspid Valve Repair System™ (TVRS) for treating moderate or severe tricuspid regurgitation in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.7
- Learn more about Sutter cardiovascular diseases research and clinical trials.
- If you are suffering from mitral or tricuspid valve regurgitation, aortic valve stenosis or other heart valve disorder, talk to your cardiologist to see if research participation and/or valve replacement or repair is right for you.
- American Heart Association.
- MitraClip™ is manufactured by Abbott Medical Devices.
- The PASCAL clinical trial is sponsored by Edwards Life Sciences, makers of the Transcatheter Valve Repair System®.
- The S3 clinical trial is sponsored by Edwards Life Sciences, makers of the SAPIEN M3 System™.
- The Summit clinical trial is sponsored by Abbott Medical Devices, makers of the Tendyne System™.
- The JenaValve™ clinical trial is sponsored by JenaValve Technology, Inc., makers of the Pericardial Transcatheter Aortic Valve Replacement (TAVR) System.
- The TRILUMINATE clinical trial is sponsored by Abbott Medical Devices, makers of the Tricuspid Valve Repair System™.