Sunday, April 24, 2016

Keeping an Open Heart – Literally

PinnacleHealth in Harrisburg, Pennsylvania became the first institution to work in a nationwide medical clinical trial.

The trial is set to test transcatheter aortic valve replacement (TAVR) treatment. Also known as transcatheter aortic valve implantation (TAVI), TAVR is slated to be a less invasive and longer lasting treatment for cardiac conditions.

The trial has currently gathered 1,200 patients. Each patient was diagnosed with aortic stenosis and considered moderately low-risk. Half will randomly receive the TAVR treatment, while the other half will receive standard open-heart surgery.

Aortic stenosis is a condition in which a valve fails to open, restricting blood flow from the heart. A potentially fatal condition, aortic stenosis can cause damage to the heart, lungs, nerves, and kidneys, as well as paralysis or stroke.

“Aortic stenosis is a real insidious disease,” said Dr. Hemal Gada, PinnacleHealth’s medical director of structural heart. “It’s a process that robs your quality of life slowly but surely, so you’ll start developing symptoms like shortness of breath, chest discomfort, lightheadedness, episodes of passing out. These are all very worrisome signs that indicate that it’s time to get your valve replaced.”

Current treatments for the condition include medication and a balloon aortic valvuloplasty (BAV). Using the BAV method, surgeons insert a catheter through either the groin or arm. The catheter has a balloon attached at the end which, when inserted into the valve, opens it and allows improved blood flow.

Each of these treatments are not without faults, though. Most treatments are temporary or fail to completely resolve the condition.

The alternative, longer-lasting treatment is to replace the damaged valve through surgical aortic valve replacement (SAVR), known informally and more commonly as open-heart surgery. As the name implies, this requires opening the patient’s chest cavity and replacing the damaged valve with a mechanical one. The procedure entails a sternotomy, in which surgeons break open the sternum to make the replacement possible.

Nearly 1.5 million people in the United States come down with aortic stenosis, according to John Muir Health. Of this group, most affected patients are older than 65 and considered too high-risk for open-heart surgery.

TAVR is envisioned to be both longer lasting and substantially less invasive.

Here, surgeons run a catheter – inserted through either a slit in the chest or femoral artery – and into the affected valve. A balloon attached to the catheter helps open the narrowed valve, allowing a replacement to be positioned by a thin wire frame called a stent. Once the balloon deflates, the catheter is removed and the replacement valve can begin functioning.

Dr. Gada sees the less invasive nature of the procedure as a key benefit. “Getting a valve in a less invasive fashion is something we are really enthusiastic about,” he said in an abc27 News article.

The procedure was developed in Europe and first implemented in France in 2002. The trial across the United States is scheduled to be the first to test the procedure in low-risk cardiac patients.

TAVR has been available to Central Pennsylvania through PinnacleHealth since 2011. Harrisburg Hospital was selected to be the first American hospital to perform the procedure as part of the trial.
Dr. Gada and Dr. Mubashir Mumtaz, PinnacleHealth’s chief of cardiothoracic surgery, oversaw and performed the operation in the last days of March. The patient was a yet-to-be-named 72-year-old woman.

“Our team of cardiologists and cardiovascular surgeons is pleased to be involved in this next phase of clinical investigation,” said Dr. Mumtaz on PinnacleHealth’s involvement. “It is invigorating to be on the national forefront of care and to help heart teams understand the potential benefits of TAVR in a broader patient population.”

Once the trial is complete, the results of the TAVR patients will be compared to results of the open-heart surgery patients after a two-year period. “If the two groups did the same, the TAVR will still win because it will be less invasive,” said Dr. Mumtaz.


Sources & References


Posted by at
Labels: , , ,

No comments:

Post a Comment

Subscribe to: Post Comments (Atom)