New way to fix leaking mitral heart valves safe in initial testing

June 23, 2009

A new nonsurgical technique to repair leaking mitral valves in heart failure patients was safe in a study reported in Circulation: Cardiovascular Interventions.

In a small study that focused on feasibility and safety, researchers observed improvements in mitral regurgitation in patients successfully treated with a reversible implant called the Percutaneous Transvenous Mitral Annuloplasty (PTMA®) system.

"Heart failure prevalence is worsening, and we know that the outcome of congestive heart failure is worse when mitral regurgitation is present," said Stefan Sack, M.D., Ph.D., lead author of the study and chief of cardiology, pneumology and intensive care at Schwabing Hospital in Munich, Germany.

The mitral valve controls the flow of blood from the heart's upper left chamber (left atrium) into the lower left chamber (left ventricle). If the mitral valve leaks, a condition known as mitral regurgitation occurs where small to large quantities of blood flow back into the left atrium rather than to the aorta and subsequently on to the rest of the body. This common condition can lead to congestive heart failure or worsen existing heart failure. Prior studies have clearly demonstrated the relationship of mitral regurgitation with illness and death in heart failure patients.

The PTMA® system consists of a repair device contained inside a catheter. The catheter is threaded through a vein into the coronary sinus, which rests at the back of the heart and collects most of the blood returning from the heart. The catheter is pushed up to the mitral annulus, a fibrous ring encircling the mitral valve, and anchors the device in place.

Tiny, shaped metal rods made of a nickel-titanium alloy are inserted into the catheter. The combination changes the shape of the mitral annulus and allows the valve's two leaflets to close more tightly and prevent blood leakage.

In the study, Sack and colleagues at one Canadian and four European centers evaluated 27 patients divided into four groups between April 2006 and November 2007. The patients' average age was 70. Researchers made device improvements and refined their diagnostic and implantation techniques between each successive group.

Nine patients received PTMA® implants, but researchers removed four devices -- one due to fracture and three because they had shifted position.

No deaths, heart attacks, strokes or emergency surgeries occurred among the 27 patients. Four patients suffered at least one major adverse event -- including pneumonia, temporary kidney dysfunction or an abnormal accumulation of fluid around the heart.

If proven effective, the PTMA® system could significantly reduce risks associated with surgical repair of the mitral valve. Today, the operation requires opening the chest and putting the patient on a heart-lung machine, which carries some risk of heart attack and stroke during surgery, and infection, lung problems and irregular heart beats afterward.

However, the study showed that the PTMA® system does not work with all patients due to a variety of anatomic and disease specific causes.

Researchers said it's too soon to gauge the clinical impact of the device.

The international research team is engaged in Ptolemy-2, a larger follow-up trial assessing the PTMA® system's efficacy and further confirming its safety.

Heart failure is a condition in which the heart can't pump enough blood to meet the body's needs. It caused or contributed to more than 292,000 deaths in the United States in 2005, according to the American Heart Association. At age 40, men and women have a 20 percent lifetime risk of developing heart failure. The risk doubles for those with a blood pressure of 160/90 milligrams of mercury (mm Hg) or higher.
-end-
Co-authors are Philipp Kahlert, M.D.; Luc Bilodeau, M.D.; Luc A. Pierard, M.D.; Patrizio, Lancellotti, M.D.; Victor Legrand, M.D.; Jozef Bartunek, M.D., Ph.D.; Marc Vanderheyden, M.D.; Rainer Hoffmann, M.D.; Patrick Schauerte, M.D.; Takahiro Shiota, M.D.; David S. Marks, M.D.; Raimund Erbel, M.D.; and Stephen G. Ellis, M.D. Individual author disclosures can be found on the manuscript.

PTMA®-maker Viacor, Inc. funded the study.

Statements and conclusions of study authors published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association's policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.americanheart.org/corporatefunding.

American Heart Association

Related Heart Failure Articles from Brightsurf:

Top Science Tip Sheet on heart failure, heart muscle cells, heart attack and atrial fibrillation results
Newly discovered pathway may have potential for treating heart failure - New research model helps predict heart muscle cells' impact on heart function after injury - New mass spectrometry approach generates libraries of glycans in human heart tissue - Understanding heart damage after heart attack and treatment may provide clues for prevention - Understanding atrial fibrillation's effects on heart cells may help find treatments - New research may lead to therapy for heart failure caused by ICI cancer medication

Machining the heart: New predictor for helping to beat chronic heart failure
Researchers from Kanazawa University have used machine learning to predict which classes of chronic heart failure patients are most likely to experience heart failure death, and which are most likely to develop an arrhythmic death or sudden cardiac death.

Heart attacks, heart failure, stroke: COVID-19's dangerous cardiovascular complications
A new guide from emergency medicine doctors details the potentially deadly cardiovascular complications COVID-19 can cause.

Autoimmunity-associated heart dilation tied to heart-failure risk in type 1 diabetes
In people with type 1 diabetes without known cardiovascular disease, the presence of autoantibodies against heart muscle proteins was associated with cardiac magnetic resonance (CMR) imaging evidence of increased volume of the left ventricle (the heart's main pumping chamber), increased muscle mass, and reduced pumping function (ejection fraction), features that are associated with higher risk of failure in the general population

Transcendental Meditation prevents abnormal enlargement of the heart, reduces chronic heart failure
A randomized controlled study recently published in the Hypertension issue of Ethnicity & Disease found the Transcendental Meditation (TM) technique helps prevent abnormal enlargement of the heart compared to health education (HE) controls.

Beta blocker use identified as hospitalization risk factor in 'stiff heart' heart failure
A new study links the use of beta-blockers to heart failure hospitalizations among those with the common 'stiff heart' heart failure subtype.

Type 2 diabetes may affect heart structure and increase complications and death among heart failure patients of Asian ethnicity
The combination of heart failure and Type 2 diabetes can lead to structural changes in the heart, poorer quality of life and increased risk of death, according to a multi-country study in Asia.

Preventive drug therapy may increase right-sided heart failure risk in patients who receive heart devices
Patients treated preemptively with drugs to reduce the risk of right-sided heart failure after heart device implantation may experience the opposite effect and develop heart failure and post-operative bleeding more often than patients not receiving the drugs.

How the enzyme lipoxygenase drives heart failure after heart attacks
Heart failure after a heart attack is a global epidemic leading to heart failure pathology.

Novel heart pump shows superior outcomes in advanced heart failure
Severely ill patients with advanced heart failure who received a novel heart pump -- the HeartMate 3 left ventricular assist device (LVAD) -- suffered significantly fewer strokes, pump-related blood clots and bleeding episodes after two years, compared with similar patients who received an older, more established pump, according to research presented at the American College of Cardiology's 68th Annual Scientific Session.

Read More: Heart Failure News and Heart Failure Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.