Patients with severe aortic stenosis can now be considered for the less-invasive procedure with the new device known as the Sapien transcatheter aortic valve replacement (TAVR), manufactured by Edwards Lifesciences in Irvine, CA. These patients are generally older with multiple medical conditions which can put people at very high risk if traditional surgical procedures were performed.
“TAVR is a breakthrough because it offers some patients who could not withstand the conventional surgery due to age or serious medical conditions a viable treatment option,” said S. Jacob Scheinerman, MD, vice chair of cardiothoracic surgery at LIJ. The US Federal Drug Administration (FDA) approved TAVR in November. The procedure is only being done in the top seven percent of heart programs in the country.
Approximately 250,000 Americans suffer from severe aortic stenosis, often developing debilitating symptoms that can affect normal day-to-day activities such as walking short distances or climbing stairs. Generally, the condition affects people over 70. Aortic stenosis occurs when the aortic valve does not properly open and close, usually due to a build-up of calcium. The calcium build-up restricts blood flow from the heart to the rest of the body. This increases pressure within the heart, causing heart muscles to weaken. All of these events increase the risk of heart failure. Symptoms of the disease can include extreme fatigue, dizziness, chest pain or pressure, shortness of breath during activity, rapid or irregular heart beat and fainting.
“Patients who do not receive an aortic valve replacement have no effective, long-term treatment option to prevent or delay the progression of severe aortic stenosis and eventual death,” said Dr. Scheinerman, noting that approximately 50 percent of patients who are in their 80s and have symptoms of congestive heart failure with critical aortic stenosis will die in six months to a year without treatment. “For patients who were previously inoperable, the new TAVR gives hope for extending the lives of these patients with improved quality of life.”
On January 23, Dr. Scheinerman, Barry Kaplan, MD, vice chair of cardiology at LIJ and North Shore University Hospital and an interventional cardiologist, Rajiv Jauhar, MD, chief of cardiology and director of the cardiac catheterization laboratory at LIJ, and Robert Palazzo, MD, a cardiothoracic surgeon, joined the multidisciplinary team of specialists in performing the procedure on an elderly woman suffering from severe aortic stenosis for about a year. The procedure was performed in the new state-of-the art hybrid operating room built at LIJ. The $5 million surgical suite combines the latest surgical and cardiac catheterization, robotic technology and three-dimensional radiologic imaging capabilities with real-time patient monitoring.
“Having all the equipment and members of the cardiac team in one OR saves time and eliminates the need for a patient to be moved from one room to another,” said Dr. Kaplan. “Interventional cardiologists and cardiac surgeons are able to collaborate closely during the procedure. Working in our new hybrid surgical suite allows us to be ready for any situation or potential emergency.”
Similar to a technique to implant cardiac stents into clogged arteries, the TAVR procedure involves the physician guiding a catheter, or thin tube, attached to the Sapien valve, through the patient’s femoral artery in the thigh. The cardiac team uses transesophageal echo (TEE) and fluoroscopic imaging guidance for proper placement. The Sapien valve is expanded by a balloon in the delivery system (about the diameter of a quarter), pushing away the calcium to enlarge the opening of the valve. Once it is placed at the opening of the valve it is anchored inside the aorta and blood flow is restored.
Ann Pszybylski, an 84 year-old grand-and-great grandmother of eight from Hauppauge, was the first patient at LIJ to receive the TAVR. Her symptoms increased to the point that she had shortness of breath while doing any type of activity that required movement, even walking. Due to her Parkinson’s disease and frail condition, Ms. Pszybylski was not a candidate for the conventional heart valve procedure.
“After the TAVR procedure, Ms Pszybylski did remarkably well,” said Dr. Scheinerman. “Within 24 hours after the procedure, she was up and walking around the intensive care unit and breathing was easier.” Ms. Pszyblyski, who spent three days in the hospital, said she used to “huff and puff” to keep up with her daughters or residents of the assisted living facility where she lives.
Ms. Pszyblyski added, “I’d like to travel to see my nephew in Georgia and daughter in North Carolina, but mostly I’m looking forward to just living longer.”
Also on January 23, Elliott Gaberman, 78, of Oakland Gardens, Queens, received the TAVR procedure at LIJ. He also suffered from severe aortic stenosis and TAVR was used to replace his failing heart valve. Over the last year, Mr. Gaberman, a retired safety quality assurance specialist, struggled with shortness of breath and extreme fatigue while walking and climbing stairs. As his symptoms increased, Mr. Gaberman sought relief from his condition. He was not a candidate for surgical valve replacement because he had a triple heart bypass in 2007 and he had other medical conditions that closed the door on surgery. “With the TAVR, Mr. Gaberman is breathing easier, walking more comfortably and physically more energetic,” said Dr. Kaplan.
Mr. Gaberman is looking forward to recuperating at home and resuming his volunteer work at St. Albans VA Hospital, where he has transported patients every week for the last eight years. “I’m thankful I was able to receive this new treatment close to my home as opposed to getting the procedure in Manhattan…it’s much easier, especially with pre-surgical testing and follow up visits.”
At LIJ, interventional cardiologists, cardiothoracic surgeons and cardiac anesthesiologists evaluate patients for the TAVR procedure. The hospital’s heart team works together to ensure optimal patient outcomes. Specialists include cardiac surgeons, interventional cardiologists, cardiologists, anesthesiologists, echocardiographers, physician assistants, nurses, OR staff and other professionals.
The TAVR was studied extensively in the United States and has been used in Europe since 2002.
For more information about the Transcatheter Aortic Valve Replacement, please call LIJ’s Department of Cardiac Services at (718) 470-7460.
Media Contact: Betty Olt