A little electrical boost may help many heart failure patients

November 11, 2003

Orlando, Fla., Nov. 11 - An electrical device that can strengthen the heart's pumping power shows promise as a new treatment for heart failure - a disease that affects some 4.9 million Americans, researchers reported today at the American Heart Association's Scientific Sessions 2003.

Heart failure generally results from a weakening of the heart muscle so that the heart can no longer pump enough blood to supply the body's needs. The disease be caused by a heart attack, high blood pressure or it can be inherited. Often, the cause is unknown.

The OPTIMIZER II is an implantable device, similar in size and shape to an artificial heart pacemaker, but that's where the similarity ends. An artificial pacemaker makes sure the heartbeat doesn't go too slow by initiating contractions when there's a missed beat. In contrast, the OPTIMIZER II senses when a beat has already started, then sends an electrical signal to strengthen the heart's contraction.

Last year, the U.S. Food and Drug Administration approved devices that deliver a different form of heart failure treatment called "cardiac resychronization therapy," or CRT, for treating a subgroup of patients with heart failure, said Daniel Burkhoff, M.D., Ph.D., a co-author of the report and a consultant to the maker of OPTIMIZER II.

"CRT appears to be useful in about 20 percent to 30 percent of people with heart failure who also have an abnormality in the timing heart chamber contractractions," said Burkhoff, an associate professor of medicine at Columbia University's College of Physicians and Surgeons in New York City.

"Our goal is to develop a treatment for the greater number of heart failure patients who don't necessarily have a problem with synchrony," he said.

The researchers enrolled 25 patients with moderately severe heart failure from medical centers in Austria, Germany and Italy. Their average age was 62 years, and 23 were men. To be eligible for the study, patients had to have a heart ejection fraction of less than 35 percent. Ejection fraction is the percentage of blood the heart expels during contractions. A normal ejection fraction is 60 percent, Burkhoff said.

Also, the patients had poor exercise tolerance; they could only walk short distances before becoming fatigued.

During the implantation procedure, which is similar to implanting a pacemaker, physicians tested the device to ensure that the patient's heart responded to the special signals the device delivered. Two patients did not respond, so the device was not implanted.

In the other 23 patients, the device was activated three hours a day for eight weeks. The patients returned periodically for tests.

At the end of the follow-up period, the patients' ejection fraction increased from an average of 22 percent to 28 percent, a statistically significant improvement.

"This improvement is comparable to those seen in prior studies of CRT. This encouraged us that the ultimate impact on patients' quality of life would also be similar to that achieved with CRT, with the hope that this treatment will be applicable to a larger percentage of the heart-failure population," Burkhoff said.

Indeed, the average distance patients could walk in six minutes increased from 411 meters to 465 meters (1,348 to 1,526 feet), also a statistically significant improvement. And participants reported that they had a better quality of life.

All the patients received appropriate medical treatment prior to enrolling in the trial, including beta-blockers, and continued to get treatment during the study, he said.

"The adverse events observed thus far seem to be similar to those encountered in patients with advanced heart failure and from normal pacemaker procedures," Burkhoff said.

"This is a very small study designed primarily to obtain some basic safety data, and in this regard the results are very encouraging. We are also encouraged by the efficacy findings, but we emphasize that this is merely a pilot study, and that patients knew they had gotten the device. Therefore, the efficacy findings could be influenced by a placebo effect," he said.

The team is now preparing a much larger trial of the device. Burkhoff and his colleagues have proposed that a large-scale patient trial be conducted primarily in the United States.

Some 550,000 new cases of heart failure are diagnosed each year and 51,500 people die from it annually, according to the American Heart Association.

"It is a very complex and long path to develop treatments for heart failure," said Burkhoff.
Co-authors are Guenter Stix, M.D.; Michael Wolzt, M.D.; Gabriele Vicedomini, M.D.; Salvatore Rosanio, M.D.; Martin Borggrefe, M.D.; Christian Wolpert, M.D.; Gerhard Hindricks, M.D.; Hans Kottkamp, M.D.; Dieter Horstkottre, M.D.; Barbara Lamp, M.D.; Dirk Böcker, M.D.; Thomas Wichter, M.D.; Yuval Mika, M.D.; Shlomo Ben-Haim, M.D. and Herwig Schmidinger, M.D.

NR03-1151 (SS03/Burkhoff)

Abstract# P2551

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.