Sutter Health a Leading Site Enrolling Patients to the PARTNER 3 Trial for Treatment of Aortic Value Stenosis
SAN FRANCISCO – Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure done without open-heart surgery to replace a narrowed aortic valve. The procedure is one of several research breakthroughs and interventional cardiology advances being pioneered at Sutter Health through the research of David Daniels, MD, an interventional cardiologist at Mills-Peninsula Medical Center and California Pacific Medical Center who directs Sutter’s Structural Heart Program, and collaborators across Sutter.
Interventional cardiologist David Daniels, MD, and collaborators at Sutter leading research to advance the treatment of cardiovascular illnesses
For people with aortic valve stenosis, which occurs when the heart’s aortic valve narrows, surgical treatment options may be limited. This is especially true in patients at high risk of complications from valve replacement, in older patients, and in those with lung or kidney disease.
The obstruction of blood flow resulting from aortic stenosis can cause chest pain, fainting, fatigue, leg swelling and shortness of breath. It may also lead to heart failure and sudden cardiac death.
A non-surgical solution: Groundbreaking research
pioneered at Sutter Health
Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure done without open-heart surgery to replace a narrowed aortic valve. The procedure is one of several research breakthroughs and interventional cardiology advances being pioneered at Sutter Health through the research of David Daniels, MD,* an interventional cardiologist at Mills-Peninsula Medical Center and California Pacific Medical Center who directs Sutter’s Structural Heart Program, and collaborators across Sutter.
During TAVR, surgeons place a thin, flexible tube called a catheter through a small cut into a large blood vessel in the patient’s groin or chest, and insert a large catheter to access the heart. A guide-wire fed through the catheter goes up to the heart and through the diseased aortic valve. Another catheter with a balloon on the end is fed over the guide-wire. The balloon inflates inside the damaged valve to expand and make room for the new bio-prosthetic valve.
The catheter delivers the replacement valve via the guide-wire. When deployed, the new valve deflects the leaflets of the old valve, and begins working immediately. Throughout the procedure the doctor views images of patient’s heart by X-ray.
Foundational research progression
Placement of Aortic Transcatheter Valves (PARTNER): An interventional clinical trial launched in 2007 that led the American College of Cardiology (ACC) and American Heart Association to recognize the success of TAVR by incorporating it as a feasible option in high-risk patients, and recommending it as the standard of care for patients at prohibitive risk of surgery.
PARTNER 2: Further safety and efficacy data on TAVR was assessed in the PARTNER 2 cohort study, a randomized trial conducted in 2016 in which intermediate-risk patients were randomized 1:1 to undergo either TAVR or surgical aortic valve replacement (conventional open-heart surgery). Patients who received TAVR experienced greater opening of the aortic value and had a lower incidence of acute kidney injury, bleeding events, and atrial fibrillation, compared with patients treated with conventional open-heart surgery. However some patients who received TAVR had a higher incidence of vascular complications. Overall, the risk of stroke and mortality was lower with TAVR (with an S3 valve) compared to surgery.
New! PARTNER 3:* Follow-up data on the study will be released next month at the ACC’s annual meeting, at which PARTNER3 investigators will present research findings of low surgery-risk patients who received TAVR to treat their aortic stenosis.
Because there is a gap between the end of the PARTNER 3 study and when the FDA may issue its decision, Sutter Health sites at Alta Bates Medical Center, CPMC and Mills Peninsula Medical Center have qualified to continue providing TAVR to low-risk aortic stenosis Medicare patients through inclusion in a continued access protocol. The goal is to ensure TAVR procedures are available for low-risk Northern California patients aged 65 and older. These Sutter sites are currently the only Northern California hospitals participating in this continued access protocol.
“Among patients with severe aortic stenosis, TAVR is an increasingly popular option, and patients are so happy when they find out they qualify,” says Russell Stanten, MD, a cardiothoracic surgeon at Alta Bates Medical Center who has been performing TAVR procedures since 2014.
“This study will help provide more data on TAVR in low-risk patients, as well as provide continued access to this procedure while it is still investigational,” said Dr. Daniels.
expertise and coordinated clinical trial efforts at Sutter Health
Sutter Health was among the top 10 sites nationally to enroll patients to the PARTNER 3 trial.
“Sutter Health’s cardiovascular services and our research efforts bring comprise a multidisciplinary approach that provides the full continuum of cardiovascular care for our patients.”
Dr. Daniels notes other, new interventional cardiology advances on the horizon including non-surgical options to replace the heart’s mitral valve in patients with diseased or damaged valves. “Earlier this month we conducted the first surgery in California to implant a new mitral valve in a patient with a diseased mitral valve,” said Dr. Daniels.
About Sutter Health Research
Sutter’s world-class research institutes are home to hundreds of clinical trials to investigate underlying causes of diseases and discover effective new ways to predict, prevent and treat them. Through research, we adopt new technologies to help our patients achieve their best health.
*The PARTNER trials were sponsored by makers of TAVR valves, Edwards Lifesciences of Irvine, Calif., and Medtronic, headquartered in Dublin. Dr. Daniels is a consultant for Edwards Lifesciences.
- TAVR is commonly referred to as “valve-in-valve” replacement, and the procedure is safe in most cases. Yet 10 to 15 years after TAVR patients may need a second replacement valve, and that repeat surgery – using the TAVR method – has added risk because the existing valve’s leaflets may obstruct the new valve, effectively blocking the coronary artery.
- TAVR is a minimally invasive surgery that prevents a patient from needing open-heart surgery, which comes with many days in the hospital and weeks of recovery.
Transformative care: These types of new advances at Sutter reduce hospital stays, lower the risk of infection, yield shorter recovery times, and improve overall symptoms, quality of life and life expectancy.
Innovation: Sutter Health sites are among the only centers across the U.S. using these interventional cardiology approaches to replace heart valves. These represent creative research solutions to help solve some of health care’s most pressing challenges.