Success of experimental technique may open new route for transcatheter valve replacement

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 15 Aug 2013 - 1:00 PDT Current ratings for:
Success of experimental technique may open new route for transcatheter valve replacement

Doctors at Henry Ford Hospital have created a new route to the heart to implant an artificial heart valve by temporarily connecting major blood vessels that do not normally intersect.

In a July 3 operation on 79-year-old Viola Waller of Charlevoix, physicians performed a world-first cardiac procedure when it became evident that other means would not work.

"I knew of an experimental technique that had not yet been done in humans, and I had a patient with no other options who was failing rapidly," says William O'Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital.

The new approach, called transcaval, involves threading a guide wire through a vein in a leg, and passing it from the main vein in the body into the main artery, the abdominal aorta. Then, by gradual dilation, the openings of the vein and artery are widened to the point of allowing a catheter to connect them, continue to the heart, and implant the new artificial heart valve.

As the catheter is removed, plugs are inserted in the artery and the vein to close the holes made for the temporary connection of the two major blood vessels.

Approximately 5 million people in the U.S. are diagnosed with heart valve disease each year. With an aging population that is often too frail for open-heart surgery, more than 20,000 Americans die of the disease each year, according to the American Heart Association.

Dr. O'Neill estimates that this new procedure could help 25,000 - 50,000 patients a year in the U.S.

Waller was transferred from northern Michigan to Detroit by medical helicopter in critical condition. Her aortic valve, a previous implant done through open-heart surgery many years ago, was failing.

The preferred access for transcatheter aortic valve replacement (TAVR) is through the leg arteries. However, Ms. Waller's arteries were too small in diameter for the catheter due to prior plaque buildup and stents that had been previously placed in them. Cardiologists made an attempt to reach her heart through a minimally invasive chest incision, but fatty deposits near the patient's heart could not support the necessary structure for a catheter.

"Since all traditional options were not feasible our multi-specialty team felt the new technique could be the answer for this patient," says Adam Greenbaum, M.D., director of the Cardiac Catheterization Lab at Henry Ford Hospital and leader of the team. "She could not have open-heart surgery, and her condition was deteriorating daily."

Robert Lederman, M.D., an interventional cardiologist and senior investigator at the National Institutes of Health who developed the technique in pigs, came to Detroit to observe the procedure and share his insights.

Waller is making a remarkable recovery, and has returned to her home in northern Michigan.

"The success of this new procedure may open a new route for transcatheter valve replacement," adds Dr. O'Neill.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Earlier surgical correction of heart valve disorder associated with greater long-term survival, lower risk of heart failure risk

Main Category: Cardiovascular / Cardiology
Article Date: 13 Aug 2013 - 13:00 PDT Current ratings for:
Earlier surgical correction of heart valve disorder associated with greater long-term survival, lower risk of heart failure risk

In a study that included patients with mitral valve regurgitation due to a condition known as flail mitral valve leaflets, performance of early surgical correction compared with initial medical management was associated with greater long-term survival and lower risk of heart failure, according to a study in the August 14 issue of JAMA.

"Degenerative mitral regurgitation [backflow of blood from the left ventricle to the left atrium due to mitral valve insufficiency] is common and can be surgically repaired in the vast majority of patients, improving symptoms and restoring normal life expectancy. Despite the safety and efficacy of contemporary surgical correction, an ongoing international debate persists regarding the need for early intervention in patients without American College of Cardiology (ACC)/American Heart Association (AHA) guideline class I triggers (no or minimal symptoms and absence of left ventricular dysfunction). This is in part propagated by discordant views of the prognostic consequences of uncorrected severe mitral regurgitation; considered as benign by those supporting medical watchful waiting (nonsurgical observation until a distinct event is encountered) vs. conveying excess mortality and morbidity (including heart failure and atrial fibrillation) by those advocating early surgical intervention," according to background information in the article.

To understand the comparative effectiveness of early surgery vs. initial medical management strategies, Rakesh M. Suri, M.D., D.Phil., of the Mayo Clinic College of Medicine, Rochester, Minn., and colleagues conducted a study to ascertain the comparative effectiveness of initial medical management (nonsurgical observation) vs. early mitral valve surgery following the diagnosis of mitral regurgitation due to flail leaflets (an abnormality of the mitral valve in which a portion of the valve has lost its normal support). For the study, the researchers used data from the Mitral Regurgitation International Database (MIDA) registry, which includes 2,097 patients with flail mitral valve regurgitation (1980-2004) receiving routine cardiac care from 6 tertiary centers (France, Italy, Belgium, and the United States). Of 1,021 patients with mitral regurgitation without ACC and AHA guideline class I triggers, 575 patients were initially medically managed and 446 underwent mitral valve surgery within 3 months following detection.

Within 3 months following diagnosis, 8 patients died, 5 (1.1 percent) after early surgery vs. 3 (0.5 percent) during initial medical management; 9 patients developed heart failure, 4 (0.9 percent) after early surgery vs. 5 (0.9 percent) during initial medical management; and 30 patients developed new-onset atrial fibrillation, 6.2 percent after early surgery vs. 1.2 percent during initial medical management.

Ninety-eight percent of patients were followed up from diagnosis until death or at least 5 years. A total of 319 deaths were observed during an average follow-up time of 10.3 years. "Survival among the entire unmatched cohort for early surgery was 95 percent at 5 years, 86 percent at 10 years, 63 percent at 20 years vs. 84 percent at 5 years, 69 percent at 10 years, and 41 percent at 20 years for initial medical management, favoring early surgery," the authors write. Early surgical correction of mitral valve regurgitation was associated with a 5-year reduction in mortality of 53 percent.

With class II triggers (atrial fibrillation or pulmonary hypertension), survival was again better with early surgery, both overall and in the matched cohort at 10 years.

During follow-up, 167 patients incurred at least 1 incident episode of heart failure representing a rate of 16 percent at 10 years and 27 percent at 20 years. In the overall cohort, heart failure was less frequent after early surgery (7 percent for early surgery vs. 23 percent for initial medical management at 10 years and 10 percent for early surgery vs. 35 percent for initial medical management at 20 years), with a heart failure risk reduction of approximately 60 percent.

Reduction in late-onset atrial fibrillation was not observed.

"These findings emanate from institutions that together provide a very high rate of mitral valve repair (>90 percent) with low operative mortality, emphasizing that such results might also be achieved in routine practice at many advanced repair centers," the authors write. "The advantages associated with early surgical correction of mitral valve regurgitation were confirmed in both unmatched and matched populations, using multiple statistical methods."

In an accompanying editorial, Catherine M. Otto, M.D., of the University of Washington School of Medicine, Seattle, comments on how the findings of this study may influence patient care.

"The study group is atypical compared with most patients with chronic severe mitral regurgitation seen in clinical practice who are referred for surgical intervention at symptom onset or when serial imaging shows early left ventricular (LV) dysfunction. In patients with severe mitral regurgitation due to mitral valve prolapse, early surgery is reasonable if surgical risk is low and the likelihood of successful valve repair is high, which is often the case for patients with a flail leaflet; the new data support this recommendation."

"However, if surgical risk is high or if the likelihood of valve repair is low, it remains uncertain whether early surgical intervention is appropriate in the asymptomatic patient with severe mitral regurgitation due to a flail leaflet when LV size and systolic function are normal. Although the majority of these patients will develop clear indications for valve surgery within 2 years, it may be reasonable to postpone the risks of having an intervention and having a prosthetic valve as long as possible."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cardiovascular / cardiology section for the latest news on this subject.

Article - JAMA. 2013;310(6):609-616

Editorial - JAMA. 2013;310(6):587-588

JAMA

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14 Aug. 2013. APA

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'Earlier surgical correction of heart valve disorder associated with greater long-term survival, lower risk of heart failure risk'

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