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AHN Specialists Perform Region’s First Procedure with Next-Generation Heart Valve Replacement Device

Wednesday, August 19, 2015

In their continued efforts to provide the region’s most innovative cardiovascular care, Allegheny Health Network cardiac specialists recently implanted the newest generation of a Transcatheter Aortic Valve Replacement (TAVR) device in a patient with aortic valve stenosis. Allegheny General Hospital (AGH) is the first medical center in western Pennsylvania to perform the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) procedure, which provides an alternative treatment for patients with aortic valve stenosis who are unable to undergo open heart surgery.

In June, the U.S. Food and Drug Administration (FDA) approved the third generation of the SAPIEN THV, which the FDA originally approved in 2011. Allegheny Health Network has performed more than 350 of the potentially life-saving TAVR procedures at AGH and Saint Vincent Hospital.

Stephen Bailey, MD, Director of Cardiac Surgery at AGH, and David Lasorda, DO, Director of Interventional Cardiology at AGH, implanted the valve through the patient’s femoral artery. “The SAPIEN 3 THV features a major design change to minimize leakage around the valve,” said Dr. Lasorda. “A skirt has been added to the base of the valve to minimize leakage, and the delivery system has been miniaturized, which fosters better outcomes for these patients.”

Aortic stenosis – a severe narrowing of the aortic valve of the heart – forces the heart to work harder to push blood through the damaged aortic valve, eventually weakening the heart muscle. Aortic stenosis can cause fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias) and cardiac arrest. 
In the clinical trial, patients with SAPIEN 3 had a significantly lower rate of leakage around the valve (3.0 percent at 30 days) compared to patients treated with the previous generation of SAPIEN (14.3 percent at 30 days). The FDA approved the SAPIEN 3 THV after that clinical study of nearly 600 patients with aortic stenosis who were at high risk for open heart surgery. 

“The SAPIEN 3 was also found to have very low rates of stroke and vascular complications,” said Dr. Bailey. “This new transcatheter valve provides a wonderful alternative for patients whose medical comorbidities put them at high risk for open heart surgery.”  

TAVR is a less invasive treatment for heart valve disease that involves replacing the damaged aortic valve with a new one while the heart continues to beat on its own. AGH’s multidisciplinary team does a comprehensive evaluation of patients to identify the optimal procedure for each individual patient. That team includes cardiac surgeon Robert Moraca, MD, and interventional cardiologist Ramzi Khalil, MD, as well as cardiac imaging specialists and cardiac anesthesiologists.

“TAVR is just one of several leading-edge procedures Allegheny Health Network has started performing in recent years in order to provide the best possible care for patients with diseased or damaged heart valves,” said Srinivas Murali, MD, Director of Allegheny Health Network's Cardiovascular Institute. 

For example, AGH is among a select group of medical centers nationwide to perform a robotically assisted mitral valve repair surgery, which reduces trauma to tissue and muscles by accessing the valve with a few small incisions on the side of the chest. AGH also began offering MitraClip therapy in 2014, a novel, catheter-based approach that allows interventional cardiologists to use fluoroscopic guidance to insert a clip through the groin to the impacted area along the mitral valve.
“By providing our patients a variety of minimally invasive procedures to treat heart valve problems,” Dr. Murali added, “Allegheny Health Network continues to lead the way in cardiovascular care in western Pennsylvania.”