FDA Approves new Valve Replacement Procedure for Some Cancer Patients

Malignant primary cardiac tumors are extremely rare. Most heart tumors are benign; however, atypical cancerous heart tumors generally originate in the soft tissues of the body. Melanomas, lymphomas and sarcomas sometimes spread to the heart. Cancer of the heart may affect heart valves; result in obstruction of blood flow or cardiac fibrosis. Chemotherapy and hormones produced by some tumors may lead to damage of heart valves.

Some cancer patients are not considered candidates for traditional open heart valve replacement methods. A new heart valve replacement therapy gives hope to many patients that previously had run out of options. The mortality rate for untreated heart valve disease is extremely high. If left untreated, most patients die within 18 to 24 months of developing symptoms.

The Transcather Aortic Valve Replacement Procedure (TAVR) was developed by Professor Alain Cribier in France in 2002 utilizing an angioplasty balloon. The TAVR procedure received FDA approval in the United States in 2011 for patients that were previously inoperable. The FDA approved the new procedure for patients at high surgical risk the following year. The procedure is currently approved in over 50 countries.

During the TAVR procedure, a catheter is threaded through an artery. A replacement valve is crimped onto a balloon device. A surgeon positions the balloon device into the space for the damaged valve and inflates the balloon. The surgeon drops the new valve into place and retracts the catheter. The new valve is operational as soon as the catheter is retracted.

The patient realizes increased blood flow instantaneously. The patient experiences immediate relief from symptoms such as shortness of breath, fatigue, dizziness, heart palpitations and chest pains. Recovery time is reduced from two months or more with the traditional open heart surgery method to one week with the TAVR procedure. Open heart aortic valve replacement surgery is still the preferred method for most valve replacement candidates. However, the TAVR procedure is now a viable option for previously inoperable or high risk patients.


*Photo courtesy of Angioplasty Balloon by Denise Chan at Flickr’s Creative Commons.



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