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
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
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