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Florida Hospital Orlando brings latest in incisionless heart valve surgery to high risk patients

Edwards Lifesciences has teamed up with Florida Hospital Orlando to roll out a newly FDA-approved heart surgery device that cardiologists and cardiac surgeons are heralding as a game-changer for repairing calcified heart valves in high risk patients who are not surgical candidates.
The Edwards-manufactured transcatheter aortic valve replacement (TAVR) device, which gained FDA approval on Nov. 2, allows a multi-disciplinary cardiac team of doctors to replace a heart valve by inserting it through a catheter into the heart. The Florida Hospital Orlando team will begin their official training later this month.
Until this innovative solution came on the market in the United States, a heart valve replacement required an open incision into the chest to repair or replace the malfunctioning valve. But now, patients who are too ill for surgery may be candidates to have their heart valve repaired with this transcatheter procedure.  
“This clearly has the potential to be a major development in how cardiac valve surgery is performed,” said Kevin Accola, MD, medical director of valve surgery for the Florida Hospital Cardiovascular Institute. “The data from the clinical trials are showing us this TAVR device could help many patients who are too ill or are at high risk to undergo more traditional heart valve surgery.”

Specifically Speaking
Aortic valve stenosis, Accola reminded, occurs when the valve on the left side of the heart becomes calcified.
“The heart has to work harder and harder to get the same amount of blood to go through an opening that should be the size of a quarter, but is instead the size of a lima bean,” he said. “Conventional surgery involves opening the chest. Now we’re actually doing less invasive procedures with small incisions and opening just a portion of the sternum. But still, we have to remove the valve and the calcification and sew in another valve in its place to function as a normal heart valve would.”
The TAVR device is inserted through the femoral artery in the groin, much in the same way an angioplasty or stent procedure is done, Accola said.
“The TAVR device is an option for high risk patients to have a new valve,” said Accola, cautioning that risks exist for this procedure. “For now, the FDA has approved this device only for patients for whom traditional cardiac surgery is not an option.” (The European Association of Cardio-Thoracic Surgery and European Society of Cardiology conceded that questions linger concerning its safety and long-term durability.)  

Ahead of the Curve
Last year, Florida Hospital Orlando developed a multi-disciplinary team to learn about and eventually implement the TAVR technology in Central Florida. Even though there was only one clinical trial site in south Florida for the TAVR device in the entire state, the Florida Hospital Orlando cardiology team prepared for FDA approval yearlong.
 “The hospital has been on board, giving us a tremendous amount of support,” said Accola. “Our task force anticipated FDA approval of this device and began preparing ahead of time. High risk patients will get better with this device. That’s why we’re all excited. This is innovative technology that we really believe is important now and in the future.”
The Florida Hospital Cardiovascular Institute is dedicated to remaining in the forefront of new technology, and being ready for this important approval is part of that commitment, noted Andrew Taussig, MD, medical director of the Florida Hospital Cardiovascular Institute.
“The members of our multi-disciplinary team have been traveling to medical institutions in Texas, Pennsylvania and Georgia that have been testing this technology to learn from their teams on how to best implement it here in the Central Florida region,” he said.  

Reaping Benefits
Even though it remains unclear how quickly this device will be available for use in the Central Florida region, cardiologists are enthusiastic about the potential it offers to add quality years to the lives of the elderly and patients who are too ill to undergo traditional heart valve surgery yet suffer from the effects of calcified heart valves.
“To be able to be more active and get back to doing what they like to do without shortness of breath and other symptoms, it’s truly a new innovation that we’re happy to be participating in for the hospital,” said Accola.  
 
 

Tags:

Dr. Andrew Taussig, Dr. Chin Kim, Dr. Jorge Suarez-Cavelier, Dr. Kevin Accola, Edwards Lifesciences, Florida Hospital Orlando, TAVR device.

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