Study compares heart valve systems

March 30, 2014

Among patients undergoing aortic valve replacement using a catheter tube, a comparison of two types of heart valve technologies, balloon-expandable or self-expandable valve systems, found a greater rate of device success with the balloon-expandable valve, according to a JAMA study released online to coincide with presentation at the 2014 American College of Cardiology Scientific Sessions.

Transcatheter (TAVR) has emerged as a new option for with severe narrowing of the and as an effective alternative treatment method to surgical aortic valve replacement in selected high-risk patients. Different from surgery, transcatheter placement (via the patient's groin) of aortic valve prostheses requires either a self-expandable or balloon-expandable system. A direct comparison of these 2 systems has not been previously performed, according to background information in the article.

Mohamed Abdel-Wahab, M.D., of the Segeberger Kliniken, Bad Segeberg, Germany, and colleagues with the CHOICE trial, randomly assigned patients with (narrowing) who met other criteria to receive either a balloon-expandable valve (n = 121) or self-expandable valve (n = 120). Device success was defined by several measures, including successful vascular access and deployment of the device and retrieval of the delivery system, correct position of the device, and performance of the heart valve without moderate or severe regurgitation (backflow of blood through the valve).

The researchers found that device success occurred in 116 of 121 patients (95.9 percent) in the balloon-expandable group and 93 of 120 patients (77.5 percent) of patients in the self-expandable group. This difference was attributed to a lower frequency of more-than-mild aortic regurgitation (4.1 percent vs 18.3 percent) and the less frequent need for implanting more than 1 valve (0.8 percent vs 5.8 percent) in the balloon-expandable valve group.

Bleeding and vascular complications were not significantly different between groups. Cardiovascular mortality at 30 days was 4.1 percent in the balloon-expandable valve group and 4.3 percent in the self-expandable valve group. Need for placement of a new permanent pacemaker was less frequent in the balloon-expandable valve group.

"With an accumulating body of evidence linking more-than-mild aortic regurgitation and consequently device failure with a worse clinical outcome after transcatheter aortic valve replacement, the findings of the CHOICE trial may have important clinical implications. Notably, at short-term follow-up, improvement of heart failure symptoms was more frequently observed with the balloon-expandable valve, whereas minor stroke rates were numerically higher. Nevertheless, long-term follow-up of the CHOICE population should be awaited to determine whether the observed differences in device success will translate into a clinically relevant overall benefit for the balloon-expandable valve," the authors write.

Further investigation is needed to determine which valve examined in this study will provide better long-term survival rate and better quality of life, write E. Murat Tuzcu, M.D., and Samir R. Kapadia, M.D., of the Cleveland Clinic, in an accompanying editorial.

"Continued efforts at understanding the risks and benefits of TAVR particularly in relation to patient characteristics, and long term outcomes are imperative for continued progress and refinement of these revolutionary devices. Additional rigorous randomized trials, like the CHOICE trial, will provide the quality of evidence necessary to ensure optimal use and optimal patient outcomes from TAVR."

Explore further: Repeat sternotomy for aortic valve replacement safe option for octogenarian patients

More information: DOI: 10.1001/jama.2014.3316
DOI: 10.1001/jama.2014.3317

Related Stories

Repeat sternotomy for aortic valve replacement safe option for octogenarian patients

March 26, 2014
Surgical aortic valve replacement generally improves patients' symptoms and prolongs survival. However, the perceived risk of surgical aortic valve replacement in patients over 80 may result in surgery being denied or a recommendation ...

Results of the REPRISE II trial reported

November 1, 2013
In a clinical trial, a second-generation transcatheter aortic valve demonstrated low rates of complications that are sometimes seen in transcatheter aortic valve replacement (TAVR), including challenges with positioning, ...

Approval expanded for sapien artificial heart valve

October 22, 2012
(HealthDay)—U.S. Food and Drug Administration approval for the Sapien Transcatheter Heart Valve has been expanded to include additional people with aortic valve stenosis, the medical term for a narrowing of the aortic valve ...

Availability of transcatheter repair of aortic stenosis benefits patients

January 30, 2014
The introduction of minimally invasive transcatheter aortic valve replacement (TAVR) for treatment of aortic stenos not only has increased the number of patients eligible for aortic valve replacement (AVR), but also has led ...

Study confirms benefits of transcatheter aortic valve replacement over 3 years

October 24, 2012
A study found that transcatheter aortic valve replacement (TAVR) yielded lower mortality rates after three years compared with medical therapy in patients deemed to be ineligible for conventional aortic valve surgery. Results ...

Researchers study new heart valve that doesn't require open-heart surgery

October 9, 2013
Northwestern's Bluhm Cardiovascular Institute has enrolled its first participant in SALUS, a clinical trial studying the effectiveness of a prosthetic aortic heart valve that can be placed without open-heart surgery. The ...

Recommended for you

How Gata4 helps mend a broken heart

August 15, 2017
During a heart attack, blood stops flowing into the heart; starved for oxygen, part of the heart muscle dies. The heart muscle does not regenerate; instead it replaces dead tissue with scars made of cells called fibroblasts ...

Injectable tissue patch could help repair damaged organs

August 14, 2017
A team of U of T Engineering researchers is mending broken hearts with an expanding tissue bandage a little smaller than a postage stamp.

Air pollution linked to cardiovascular disease; air purifiers may lessen impact

August 14, 2017
Exposure to high levels of air pollution increased stress hormone levels and negative metabolic changes in otherwise healthy, young adults in a recent study conducted in China. Air purifiers appeared to lessen the negative ...

Study hints at experimental therapy for heart fibrosis

August 14, 2017
Researchers report encouraging preclinical results as they pursue elusive therapeutic strategies to repair scarred and poorly functioning heart tissues after cardiac injury—describing an experimental molecular treatment ...

Scientists identify mutations in venous valve disease

August 14, 2017
A team of scientists has discovered that mutations in the genes FOXC2 and GJC2 are associated with defects in venous valves, flaps within veins that help maintain proper blood flow.

Mechanism behind sudden cardiac deaths in sports uncovered

August 10, 2017
Researchers have worked out the mechanism behind sudden cardiac deaths that follow a hard blow to the chest.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.