At the forefront of innovative research, Baptist Health’s structural heart team is bringing the latest treatment options to Jacksonville
Clinical trials for the Amulet™ device, Lotus Edge™ device and the WatchTAVR procedure provide access to cutting-edge treatment option for patients with structural heart disease.
March 15, 2019 | Jacksonville, Florida
Advancing research in a unique branch of cardiovascular medicine that focuses on the valves and structures within the heart, Baptist Health is at the forefront of innovation with multiple clinical trials for new devices and procedures helping patients with structural heart disease extend and improve the quality of their lives.
Many of these treatments wouldn’t otherwise be available in North Florida.
Ruby Satpathy, MD, FACC, FSCAI, a nationally recognized interventional cardiologist with Baptist Heart Specialists and medical director of the Baptist Structural Heart Program, recently completed one of the final Amulet™ device procedures in the clinical trial stage and the device will now be reviewed by the FDA for approval. Using a minimally invasive technique that doesn’t require surgery, the Amulet device is strategically placed in the left atrial appendage within the top chamber of the heart to help prevent blood clots from entering the bloodstream, reducing a patient’s risk of stroke.
As the No. 1 enroller in Florida for the Amulet clinical trial, Baptist Health had a significant impact in moving the device to the next stage of approval. Because this is smaller than other similar devices in the market and allows patients to stop taking blood thinners, there are many eligible patients who are candidates to receive the device.
In addition to the Amulet clinical trial, Baptist Health has been selected for many other clinical trials to advance structural heart treatment. The clinical trials provide unique access in Northeast Florida to the nation’s latest in structural heart technologies and techniques. Among the numerous ongoing trials, these are the most recent:
- WatchTAVR: This clinical trial combines two minimally invasive procedures into one to help expedite the recovery of patients undergoing transcatheter aortic valve replacement (TAVR). First, a TAVR device replaces the aortic valve in the heart, restoring blood flow for patients with a narrowing of the aortic valve opening. Next, a WATCHMAN™ device is implanted into the left atrial appendage in the heart, helping patients avoid the need for long-term blood thinners.
- AMPLATZER™: This device repairs holes in the wall between the left and right upper chambers of the heart, using a catheter-based procedure known as PFO closure. Baptist Health was selected to be part of the national registry for this device and is currently the No. 1 enroller in the state of Florida and No. 4 in the nation.
- “Next-generation” TAVR: Today, patients with severe aortic stenosis who are high or intermediate-risk for open-heart surgery are approved to receive TAVR because of its superior performance compared to surgical aortic valve replacement. Dr. Satpathy was a part of the PARTNER (Edwards) and SURTAVI (Medtronic) studies that led to the approval of these devices. With TAVR volumes in the top 5th percentile in the country and outcomes above the national median, Baptist Health now has access to the LOTUS Edge™ Valve System, the next-generation TAVR, which is being considered for use in patients with aortic stenosis who are at lower risk for open-heart surgery.
- “Next-generation” MitraClip: After being approved in 2013 for patients with degenerative mitral valves and severe mitral regurgitation, MitraClip® was approved in 2018 for treatment of heart failure patients based on the impressive results of a clinical trial named COAPT, in which Dr. Satpathy participated. Baptist Health was the first in Jacksonville to offer MitraClip therapy and continues to lead in volume and outcomes.
“Not long ago, open-heart surgery was the only solution for structural heart diseases,” said Dr. Satpathy. “And quite often, patients who needed these procedures were too high-risk to receive the care they needed. Now we can ‘treat the untreatable’ using these minimally invasive procedures, and our patients can start feeling better right away.”
Because structural heart is a relatively new and highly specialized area of cardiovascular medicine, clinical trials are key in advancing the field by improving survival and quality of life for patients. “Baptist Health has been selected for these prestigious national and international research trials, so we are among the few sites which are helping to create the future technology for structural heart,” said Dr. Satpathy. “The comprehensiveness of our program allows us to offer treatments and techniques that may not otherwise be available in this area.”
The Structural Heart Program at Baptist Health has become one of the top programs in the country in just three years, with higher volumes and better outcomes than national medians. The team completed nearly 350 life-changing procedures in 2018 alone, more than any other program in Jacksonville.
One of the keys to improving patient outcomes is expediting patient recovery, and experience can make a significant difference. For years, Dr. Satpathy has used the “magic stitch,” a catheter-based, minimally invasive technique to close the artery or vein that avoids any incision in the groin. This approach enables the use of twilight sleep for surgery instead of general anesthesia, and allows patients to walk a few hours after surgery. Often, they can go home the day after the procedure.
“We are passionate about providing personalized care,” said Dr. Satpathy. “Our heart team at Baptist consists of talented physicians of many different disciplines who are dedicated to taking the best possible care of our patients. We want our patients to have access to every available treatment option. At the same time, we do what’s right for each patient, just as we would do for our own family member.”