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

ultrasound-activated microbubbles, heart attack, pig model, NIBIB, human clinical trials

An ultrasound-stimulated microbubble burrows through a fibrin clot (green) allowing penetration of the surrounding fluid into the clot (yellow). Image courtesy of Christopher Acconci and David Goertz, University of Toronto.

News | Ultrasound Imaging| February 11, 2016
Researchers funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) used ultrasound-activated...
Fred Hoiberg, Chicago Bulls coach, On-X aortic heart valve, education campaign

Fred Hoiberg, head coach of the NBA Chicago Bulls, is launching a new campaign to help people with heart valve problems on www.heartvalvesurgery.com. Coach Hoiberg, pictured here with his family, wanted a single, life-long solution to his aortic heart valve problem, and received an On-X aortic mechanical valve from On-X Life Technologies Inc. in April 2015.

News | Heart Valve Repair| February 10, 2016
February 10, 2016 — Fred Hoiberg, head coach of the National Basketball Assocation’s (NBA) Chicago Bulls, is launchin
CeloNova, COBRA REDUCE trial, first patient enrolled, Cobra PzF coronary stent
News | Stents| February 10, 2016
CeloNova BioSciences Inc. announced this week that the first patient has been enrolled in its COBRA REDUCE trial. The...
HeartWare, terminated acquisition, Valtech Cardio
News | Structural Heart| February 10, 2016
February 10, 2016 — HeartWare International Inc. and Valtech Cardio Ltd.
new study, titin protein, blood pumping, heart failure
News | Heart Failure| February 10, 2016
In a finding that could lead to new drugs to treat heart failure, researchers have uncovered the molecular mechanism...
Valtech Cardioband, reimbursement, Germany, mitral regurgitation in heart failure
News | Heart Valve Repair| February 09, 2016
Valtech Cardio Ltd. announced that it has received German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 1...
Mount Sinai Heart, TANSNIP-PESA study, worksite lifestyle intervention, cardiovascular risk
News | Cardiac Diagnostics| February 09, 2016
Mount Sinai Heart is undertaking a three-year study to determine whether a workplace-based lifestyle intervention,...
cardiomyocytes, electrical stimulation, human stem cells, Columbia Engineering

Electrically conditioned human cardiomyocytes. Striated ultrastructure containing troponin ( stained in green) forms around cell nuclei (stained in blue.) Image courtesy of Benjamin Lee, Columbia Engineering

News | Stem Cell Therapies| February 09, 2016
Columbia Engineering researchers have shown, for the first time, that electrical stimulation of human heart muscle...
ACC late breakers
News | ACC| February 09, 2016
February 9, 2016 — The late-breaking clinical trial presentations have been announced for the 2016 American College o
transcatheter repair of a mitral valve paravalvular leak

Transcatheter repair of a surgical mitral replacement paravalvular leak with an Amplatzer Vascular Plug II.

Feature | Heart Valve Repair| February 08, 2016 | Dave Fornell
Off-label use of the St.
Overlay Init