Feature | April 07, 2014

Head-to-Head Study Favors Balloon-Expandable Over Self-Expanding Transcatheter Heart Valves

Trial shows significant advantages over self-expanding valves for treating aortic stenosis

April 7, 2014 — A first-ever randomized head-to-head comparison of two devices commonly used to treat aortic stenosis finds balloon-expandable transcatheter valves (such as the Edwards Sapien) result in more successful procedures and relieve symptoms more frequently than self-expanding valves (e.g., Medtronic CoreValve), according to research presented at the American College of Cardiology’s (ACC) 63rd annual scientific session and published online in the Journal of the American Medical Association (JAMA).

Aortic stenosis is a condition in which a crucial valve in the heart ceases to function properly. The only cure is to replace the valve, either through open-heart surgery or through transcatheter aortic valve replacement (TAVR), a less invasive option in which a replacement valve is threaded into the heart through an artery in the patient’s leg.

“We know in general that the transcatheter approach works and that patients benefit from it,” said Mohamed Abdel-Wahab, M.D., head of the cardiac catheterization laboratory at Segeberger Kliniken, Bad Segeberg, Germany, and senior author of the study. “But we have two main types of valves available for this procedure, and until now, there was no conclusive data about their relative effectiveness. This study is important because it’s the first randomized comparison of these two technologies.”

The researchers tracked 241 TAVR procedures in five major hospitals in Germany. Half of the patients received a balloon-expandable valve, which is implanted by inflating a balloon that forces the valve into place. The other half received a self-expanding valve, which automatically expands when its sheath is removed.

The results show the balloon-expandable valve results in more successful procedures (the study’s primary endpoint) and improved patient symptoms (one of the study’s secondary endpoints). There was no significant difference between the groups for cardiovascular mortality at 30 days, bleeding and vascular complications or stroke. Successful procedures were those in which the valve was implanted in the correct position and provided a tight enough seal to prevent blood from leaking across the valve. Procedures using a balloon-expandable valve had a success rate of 95.9 percent as compared to 77.5 percent for the self-expanding valve.

Patients receiving the balloon-expandable valve also reported improvements in symptoms 30 days after the procedure at a rate of 94.3 percent compared to 86.7 percent in patients receiving a self-expanding valve. Common symptoms for aortic stenosis include breathlessness, chest pain, dizziness and palpitations. “Symptoms improved for a majority of patients overall, but the improvements were more common in the patients who received a balloon-expandable valve,” Abdel-Wahab said.

Abdel-Wahab speculated that the mechanics of the two valves may explain why the balloon-expandable option was generally more successful. The balloon-expandable valve may be better able to provide the amount of force needed to achieve a tight seal and prevent leakage. The average age of patients in the study was 80.

TAVR has been used routinely in Europe since 2007 and in the United States since 2011. In the absence of conclusive studies comparing the balloon-expandable and self-expanding valves, operators have typically selected valves based on availability and the operator’s own level of comfort with the technology.

“This is a very dynamic field,” Abdel-Wahab said. “We now have new valves coming out that will probably be even better, but we do not have enough data about them yet. These results can help to inform the design of future devices.”

The researchers will continue to monitor the patients for five years to compare long-term health outcomes in the two patient groups.

For more information: https://jama.jamanetwork.com/article.aspx?articleid=1854355

Related Content

Body Weight Fluctuations Linked to More Deaths in People with Coronary Artery Disease
News | Cardiac Diagnostics| April 25, 2017
Repeated cycles of weight loss and gain may be linked to higher risk for stroke, heart attack and death in people with...
Clinical Study Validates Efficiencies of Stereotaxis Niobe ES System Over Niobe II System
News | Robotic Systems| April 24, 2017
A recent study conducted at Centre Hospitalier Universitaire (CHU) of Saint-Étienne, France validated the advantages of...
Alabama Medical Center First in Southeast to Offer CoreValve Evolut Pro TAVR Device
News | Heart Valve Technology| April 20, 2017
The Structural Heart Program at Princeton Baptist Medical Center, (Birmingham, Ala.) recently became the first center...
Updated AATS Guidelines Help Cardiovascular Surgeons Navigate Challenges of Managing Ischemic Mitral Regurgitation
News | Heart Valve Technology| April 20, 2017
April 20, 2017 — Mitral regurgitation can occur in up to 50 percent of patients with ischemic heart disease and even
USC Study Finds Potassium-Rich Diet Can Lower Blood Pressure
News | Hypertension| April 19, 2017
Eating potassium-rich foods like sweet potatoes, avocados, spinach, beans, bananas and even coffee could be key to...
3-D-printed Model of Stenotic Intracranial Artery Enables Vessel-Wall MRI Standardization
News | 3-D Printing| April 18, 2017
A collaboration between stroke neurologists at the Medical University of South Carolina (MUSC) and bioengineers at the...
3-D Printed Patch Can Help Mend a ‘Broken’ Heart

This photo shows the 3D-bioprinted cell patch in comparison to a mouse heart. When the patch was placed on a live mouse following a simulated heart attack, the researchers saw significant increase in functional capacity after just four weeks. Image courtesy of Patrick O’Leary, University of Minnesota.

News | Stem Cell Therapies| April 18, 2017
April 18, 2017 — A team of biomedical engineering researchers, led by the University of Minnesota, has created a revo
University of California Study Searches for Consistent CT Dose Best Practices
News | Radiation Dose Management| April 17, 2017
A new study led by UC San Francisco has found that radiation doses can be safely and effectively reduced – and more...
Study Finds Significant Variability in Doctors Angioplasty Death Rates
News | Cath Lab| April 17, 2017
Some doctors have higher or lower than expected death rates from coronary angioplasty procedures, also known as...
Grey Hair Linked With Increased Heart Disease Risk in Men
News | Cardiac Diagnostics| April 14, 2017
Grey hair has been linked with an increased risk of heart disease in men, in research presented recently at EuroPrevent...
Overlay Init