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Winchester Medical Center offers groundbreaking clinical trial for low-risk heart valve patients

Winchester Medical Center offers groundbreaking clinical trial for low-risk heart valve patients

Innovative, minimally invasive valve replacement procedure expands to benefit even more patients.

Low-risk patients needing heart valve replacement now have access to a life-changing procedure. Valley Health’s Heart & Vascular Center announced its participation in a new clinical trial using transcatheter aortic valve replacement (TAVR) for low-risk patients with heart valve disease. The Medtronic Evolut Low Risk Trial will assess the safety and efficacy of TAVR in patients at low risk for surgical aortic valve replacement (SAVR).

“This trial is a game changer for low-risk heart valve disease patients,” said Basel Ramlawi, M.D., cardiothoracic surgeon and chairman of Valley Health’s Heart & Vascular Center and director of the Advanced Valve & Aortic Center at Winchester Medical Center in Winchester. “Now more patients will have access to the TAVR procedure, which means shorter hospital stays, less pain and a quicker recovery for many patients.”

Traditionally, open-heart surgery has been the common treatment to repair heart and aortic valve disease. TAVR uses a minimally invasive technique and gives patients an alternative to open-heart surgery. The procedure allows for an implant to be placed in the diseased aortic valve with significantly less distress to the patient. While TAVR has been successful in patients who are not good candidates for the surgical approach, the procedure has not been an option for low-risk patients. The Evolut Low Risk Trial will open that door, expanding TAVR access to almost every patient presenting with aortic valve stenosis.

The trial will enroll up to 1,256 patients ranging in age mostly from 50-85 at 80 hospitals within the United States, Europe, Canada, Australia and New Zealand. Dr. Ramlawi is one of the most experienced TAVR surgeons in the country and is leading the trial at Valley Health as principal investigator. He has taught the TAVR procedure for years, previously directing the aortic program and assisting with thoracic surgery education at Houston Methodist DeBakey Heart & Vascular Center. A team of experienced specialists and clinical staff is assisting Dr. Ramlawi with the study at Winchester Medical Center. Omar Ali, MD, interventional cardiologist and TAVR specialist and co-director of the Advanced Valve & Aortic Center, is serving as sub-investigator. Jeffrey Skiles, MD, cardiologist and cardiac imaging expert, is also serving as a sub-investigator.

Benefits of the transcatheter valve procedure vs. open-heart surgery include: reduced procedure time (one to three hours vs. two to four), use of local anesthesia, reduced hospital stay (three to five days vs. five to 10), quicker recovery time (one week vs. six to eight weeks) and less pain during healing.

The preliminary outcomes of TAVR trials for high-risk patients have been favorable, paving the way for this low-risk trial. And with low-risk cases on the rise, there is a need for extending TAVR into this new population. On average, there are three times as many medium- and low-risk heart valve disease cases as high-risk cases.

Currently, Valley Health is one of only 48 medical centers in the country offering this low-risk clinical trial and in a short period of time has become the leading site in the region for the number of enrolled patients. This makes Valley Health a part of the one percent of medical centers performing the procedure for patients with all risk levels through the Evolut Low Risk Trial.

“At Valley Health, we pride ourselves on providing the most advanced and comprehensive cardiovascular care and being able to tailor procedures to each individual patient,” said Dr. Ramlawi. “With the addition of this low-risk trial for TAVR, we now have even more procedural offerings to best suit our patients’ needs.”

The primary objective of the Evolut Low Risk Trial is to compare open-heart surgical aortic valve replacement and Evolut TAVR in patients with severe aortic stenosis (AS) at a low surgical risk. Patients who receive SAVR will undergo open-heart surgery and have their aortic valve surgery through a traditional or minimally invasive approach. In the Evolut TAVR procedure, a catheter is used to place the new aortic heart valve, which is made of natural tissue obtained from the heart of a pig.

“There are rare moments in medicine that represent a paradigm shift in how we approach a problem or pathology. The advent of TAVR represents one of those moments,” said Dr. Skiles. “Now we are privileged to be part of the continued evolution of this technique in an important patient population (the low risk patient).”

Patients and providers interested in knowing more about the clinical trial may call the Advanced Valve & Aortic Center at 540-536-4000, or email AVAC@valleyhealthlink.com.