BAYHEALTH FIRST HOSPITAL IN DELAWARE TO IMPLANT INTUITY HEART VALVE

As another step forward in the growth of Bayhealth’s cardiac surgery program, the team led by Chief Cardiothoracic Surgeon Gary Szydlowski, MD and Cardiothoracic Surgeon Daniel Marelli, MD have successfully performed implantation of the EDWARDS INTUITY heart valve in several patients for the treatment of aortic stenosis. This condition is a hardening or narrowing of the aortic valve opening. It affects millions of older adults worldwide and typically worsens with age. Bayhealth became the first hospital in Delaware to use the next generation device after it received Food and Drug Administration (FDA) approval.

Bayhealth introduced its heart surgery program 15 years ago to offer to the community the same expertise and care as large medical centers, but close to home. The program has been advancing ever since. Since 2003, a partnership with Penn Medicine, ranked #6 in the nation for cardiology and heart surgery, has provided elite training and resources for Bayhealth doctors and staff. This has been valuable in the evolution of Bayhealth’s program, which offers comprehensive surgical and interventional cardiac services on par with the best in the region. Advancements have included aortic stenting and the Transcatheter Aortic Valve Replacement (TAVR) procedure, which replaces the aortic valve without the need for open heart surgery. Since 2016, Bayhealth’s cardiac surgery team has performed the TAVR procedure. It was originally designed for patients with severe aortic stenosis considered too ill or weak for surgery, and in August 2019, the FDA expanded its use to those with lower risk of complications. Edwards Lifesciences introduced its EDWARDS INTUITY Elite valve system as a competing treatment option, available to a wider group of patients suffering from aortic stenosis.

The Journal of Geriatric Cardiology reports that aortic valve disease affects over 25% of individuals over the age of 65. About 2%–5% show signs of significant aortic stenosis. Common symptoms may include chest pain, shortness of breath, lightheadedness or feeling dizzy, or inability to exercise. Experts agree that patients with strong symptoms of this condition have a poor prognosis without intervention, such as aortic valve replacement.

Drs. Szydlowski and Marelli answered questions related to this new device for aortic valve replacement and its use at Bayhealth. This adds to the growing number of options to help their patients with cardiovascular conditions improve their function and quality of life.

THE BENEFITS ARE A QUICKER OPERATION, THE FACT THAT IT CAN ENABLE A MINIMALLY INVASIVE APPROACH WITH A SMALLER INCISION, AND THERE IS EVIDENCE THAT THIS NEW DEVICE MAY RELIEVE THE OBSTRUCTION BETTER THAN TRADITIONAL SUTURED VALVES.

Q. PLEASE EXPLAIN HOW THIS DEVICE AND THE IMPLANTATION PROCEDURE ARE UNIQUE.

This is a bovine pericardial valve much like the type we’ve been implanting for years. When patients have aortic stenosis, their valve does not open properly. This means the heart must work harder to pump blood through it and results in reduced blood flow to the body and a weakened heart muscle. It may lead to heart failure if left untreated. The difference with this new heart valve is that it’s sutureless. Not to be confused with TAVR, implantation of this device still requires full cardiac surgery, or open heart surgery, but an advantage is that it can facilitate a less invasive approach. Unlike other valves which require 12 to 15 reinforced sutures to secure the valve, this new valve is balloon dilated into place using the EDWARDS INTUITY Elite valve system.

Q. WHAT ARE THE BENEFITS AND RISKS OF THIS PROCEDURE?

A. The benefits are a quicker operation, the fact that it can enable a minimally invasive approach with a smaller incision, and there is evidence that this new device may relieve the obstruction better than traditional sutured valves. Because it takes up less space on the wall of the aorta, there is less resistance which creates superior results. There are standard risks to any open heart surgery and this would be no different. Pacemakers are a possibility after any cardiac procedure, especially aortic valve replacement, and the chance is slightly higher in these procedures. With any tissue valve like this, patients typically avoid the need for long-term blood thinners. Clinical studies show that this procedure may mean shorter hospital stays and faster healing times for patients.

Q. WHAT ARE THE FUTURE PLANS FOR USE OF THIS PROCEDURE?

A. At Bayhealth we strive to stay on the cutting edge with advances in medicine. This is another option in the toolbox for aortic valve replacement. As with any treatment, however, this may not be for everyone. We consider the unique conditions of each of our patients and work with them to determine a course of action. A disadvantage of this device is that it is expensive, and we want to be fiscally responsible and use it appropriately. Over the years we have been moving forward with less invasive options and we’ll continue to see how this procedure fits in among our other cardiac services.