Thousands Of Cardiac Patients Could Avoid Open Heart Surgery

Tens of thousands of heart patients may not need open-heart surgery

Expandable Heart Valves Could Mean Fewer Surgeries

The patient underwent bypass surgery in 2004 and had undergone cancer treatment in 2009.

"This is our last frontier" to make these devices a standard of care, said Dr. Joseph Cleveland, a University of Colorado heart surgeon with no role in the studies or ties to the companies that sponsored them.

Across 71 centers in the United States, the researchers recruited 1,000 patients who have severe aortic stenosis, a condition in which the heart valve narrows and prevents normal blood flow. TAVR's initial success led the FDA to commercially approve TAVR in high-risk patients in 2012 and allow studies to proceed in medium- and low-risk patients. Comparatively, Bloomberg's Cortez observes, 15.1 percent of surgery patients experienced these same consequences during the first year post-procedure. If heart valve is not replaced or repaired, 50% of the valvular heart disease patients would not survive. Although mechanical valves last for decades, they require the lifelong use of blood thinners and, of course, carry the physical toll exacted by invasive surgery.

A month after the procedure, the TAVR group saw fewer occurrences of stroke and new-onset atrial fibrillation than the surgery group. TAVR patients also had significantly better quality of life and hemodynamics (a measure of how well the aortic stenosis is relieved) at 30 days, which are important factors, especially in younger, more active patients. The four major valves in the heart are two atrioventricular valves known as bicuspid valve and tricuspid valve and two semilunar valves known as aortic valve and pulmonary valve. TAVR had lower rates of all-cause mortality (2.4 vs 3 percent), but it was not statistically significant. Results from earlier clinical trials on high- and intermediate-risk TAVR patients show positive outcomes that are comparable to, or in some cases, better than open-heart surgery.

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"At one year, patients with TAVR were more likely than surgery patients to be alive, without a disabling stroke and without a hospital admission for heart failure", Reardon said. By one year, both TAVR and surgery had similar improvements in quality of life, 22.2 and 20.9, respectively. The TAVR group also had major vascular injury, including dissection, cardiac perforation or access site injury.

Transcatheter heart valve is used in transcatheter aortic valve replacement procedure for valvular heart disease patients who are unable to sustain open-heart surgery and it poses life threatening risks to the patient. A patient at low risk can say "I want a non-surgical approach with good confidence".

"It's a great thing" for patients to be able to avoid major surgery, he said. The recovery period after insertion of transcatheter heart valve is seven to eight days which is less than other surgical procedures.

The researchers, however, warned that the study has its limitations.

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Cleveland and other experts also said long-term studies are needed to determine if expandable valves are as durable as surgical valves, the AP reported.

The study received funding from Medtronic.

This study was simultaneously published online in the New England Journal of Medicine at the time of presentation. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The agency only offers TAVR reimbursements to about 600 hospitals nationwide, according to The Wall Street Journal.

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