Let’s see how effective CRT is in Heart Failure
If you read the information below it is a real positive step towards the options now becoming available for the treatment of Heart Failure. Often patients feel as though Heart Failure meets a dead end but this is not always the case. Pumping Marvellous has a real focus around educating and giving options around what all the various treatments mean before they become an option. Forewarned is forearmed. It is also really very comforting to the millions that suffer with this condition see that great technical steps are being taken all the time from drug therapy with Serviers Ivabradine, Medtronics development in CRT and VAD’s (ventricular assist devices).
So familiarise yourself with CRT’s below. You don’t need to be an expert to understand their value.
Medtronic the US implantable device manufacturer announced the first patient enrollment in MIRACLE EF, which is a global clinical trial that will evaluate the effectiveness of cardiac resynchronization therapy-pacemakers (CRT) in delaying the progression of heart failure in symptomatic patients with mildly reduced heart pumping function. This large study will be the first to evaluate CRT in a widely under served patient group – those who have a slightly reduced left ventricular ejection fraction (LVEF) in the range of 36 to 50%, which means that their hearts work somewhat more efficiently than heart failure patients who are currently indicated for implanted device therapy because of their lower LVEF.
The CRT-P devices used in MIRACLE EF are not approved by the US FDA for the patient population being studied. Edward Schloss, M.D., FACC, performed the first implant at The Christ Hospital’s Lindner Research Center in Cincinnati; primary investigator for the site is Greg Egnaczyk, M.D., Ph.D., FACC.
“Previous studies have proven the real-world therapeutic benefits of CRT in treating mildly to severely symptomatic heart failure patients with moderately to severely reduced cardiac pumping capacity and electrical dyssynchrony,” said Professor Cecilia Linde, M.D., Ph.D., of Karolinska University Hospital in Stockholm, and worldwide principal investigator in the trial. “Through this large global study we hope to further our research on the overall effectiveness of CRT-P by showing its benefit in treating patients with mild-to-moderate heart failure symptoms, but with milder impairment of heart pumping capacity than previously studied.”
Approximately 275 centers throughout the world, in regions including the United States, Canada, Europe, Japan and developing markets, will enroll up to 2,300 patients in this double blind, randomized controlled trial. Patients will be followed for at least two years or until close of the study. Medtronic anticipates the trial will take four to five years to complete. The effectiveness of CRT-P in this patient population will be assessed using a composite endpoint of time to first event, defined as all-cause mortality or heart failure hospitalisation.
Heart Failure Conference “Cardiac Centre To Community”
Pumping Marvellous, The East Lancshire Hospital Trust, Medtronic and Servier put on a clinician led Heart Failure conference for GP’s to talk through the innovative options and solutions to Heart Failure Care in patients. Guest speaker is Dr David Fox, Consultant Electrophysiologist from the Northwest Cardiac Centre in Wythenshawe. Invites available from Pumping Marvellous.
June 12th 2012 was the day we staged our very succesfull heart failure charity patient conference. We had guest speakers from -
Talking about cardiomyopathy – Cardiomyopathy Association – CEO Robert Hall
Devices and what do they do – Medtronic – Emma Nardo
What is Tai Chi – Jason Hacking
Heart failure update – East Lancashire Hospital Trust – Angela Graves
Pumping Marvellous update – Nick Hartshorne-Evans
We received some positive feedback and some developmental feedback from the conference so for the next conference which will be Winter 2012 it has already been decided that technical content will be limited to a minimum.
Here are some pictures of the event -
Medtronic Device for Heart Failure gets approval in the US
Medical device maker Medtronic said on Tuesday that the U.S. Food and Drug Administration had approved its implantable heart defibrillator with resynchronization therapy for a wider group of patients.
The FDA approved the device, known as CRT-D, for heart failure patients with mild symptoms. This treatment potentially can improve survival, reduce hospitalisations and prevent the disease from getting worse, Medtronic said. The latest approval could increase the number of patients eligible to get the device by 620,000 worldwide, including nearly 200,000 in the United States, the company said.
Heart failure affects more than 22 million people worldwide, including around 1 million in the UK and more than 5.8 million in the United States. Previously the defibrillators, which help the heart’s lower chambers beat in a more synchronized way, were only approved by the FDA to treat certain patients with moderate-to-severe heart failure.
While certain mildly-symptomatic heart failure patients could already receive an implantable defibrillator to protect them from sudden cardiac arrest, they are still vulnerable to a further weakening of their heart. CRT-D therapy works by sending electrical impulses to the heart muscles, improving the blood-pumping capability
As you may or may not know one of the goals of Pumping Marvellous is to get Heart Failure patients to the specialists in cardio care they deserve. See our main site for our goals pumpingmarvellous.org.
In December 2010 the National Heart Failure audit indicated at least 5,000 sufferers in the UK die needlessly each year because they are treated on the wrong hospital wards, while others are prescribed too little medication to be effective.
The June edition of the American Heart Journal reported nearly 70,000 Americans die each year because they do not receive optimal therapy as called for in guidelines promoted by national health authorities, researchers said Monday. Physicians have been slow to implement many of the procedures called for in the guidelines, according to the first national study of adherence to the treatment goals, the team reported in the June edition of the American Heart Journal.
Dr. Gregg D. Fonarow of UCLA’s Geffen School of Medicine and his colleagues studied six evidence-based therapies for heart failure, using data from clinical trials, in-patient and out-patient registries for heart failure patients, quality-of-care studies and other published sources.The six treatments are highly recommended for heart failure patients by the American College of Cardiology and the American Heart Association. The researchers found that 2,644,800 heart failure patients were eligible for the therapies, but did not receive them. The total number of potential deaths that could be prevented each year with optimal implementation of all six therapies is 67,996, they reported.
The therapies included four different families of drugs, cardiac resynchronization therapy (which helps coordinate heart contractions and arrythimias) and implantable cardioverter-defibrillators (which shock hearts beating erratically back into a normal rhythm). The estimated number of lives that could be saved by wide implementation of each therapy, they estimated, are:
– Aldosterone antagonists, 21,407.
– Beta blockers, 12,922.
– Hydralazine/isosorbide dinitrate, 6,655.
– Cardiac resynchronization therapy, 8,317.
– Implantable cardioverter-debrillators, 12,179.
The findings “have significant clinical and public health implications” because tens of thousands of lives could be saved with optimal implementation of the therapies, Fonarow said in a statement. Pointing out which therapies are not sufficiently used, he added, will push clinicians toward a more careful examination of their treatment strategies.
Is there another way of treating Heart Failure?
People with mild or moderate heart failure got good news yesterday: Studies show a Pfizer drug and a device from Medtronic can boost survival rates and cut trips to the hospital by those who have trouble breathing. But another drug, Johnson & Johnson’s Natrecor, did little to help those with severe heart failure. “It’s hard to tell now which patients should get the pricey medicine, said Dr. Alfred Bove, past president of the American College of Cardiology. All three studies, presented at an American Heart Association conference, are expected to have an immediate effect on care.
Inspra, made by Pfizer is already used for advanced heart failure. In a study of more than 2,700 people with milder symptoms, it cut the risk of death or hospitalization by 37 percent. After nearly two years, fewer than 13 percent of those on Inspra had died of heart problems, versus fewer than 16 percent of those given dummy pills.
“This has the potential of changing the guidelines,’’ said Dr. Mariell Jessup, who heads the heart failure program at the University of Pennsylvania.
Many doctors saw an alternative: wider use of an older relative of Inspra, spironolactone, a generic medicine that costs less than 20 cents a day, versus about $133 a month for Inspra.
The other good news came from a test of an implanted heart device made by Medtronic Inc. Many people with severe heart failure have defibrillators to zap their hearts if they suffer a rhythm problem. Newer combination devices also control how blood moves through the heart. Defibrillators cost $20,000 to $25,000; the combinations are $5,000 to $7,000 more.
The study tested them in 1,800 Canadian patients with mild to moderate heart failure. More than three years later, 40 percent of those with simple defibrillators had died or been hospitalized for heart failure, versus 33 percent of those with combo devices.
The bad news came from a test of Natrecor for shortness of breath. One of six people hospitalized with heart failure were given Natrecor until 2005, when studies suggested it raised the risk of kidney problems. In tests involving more than 7,000 patients, Natrecor, made by Scios Inc., made no difference in rates of hospitalization or death in the following month and only modestly relieved shortness of breath within 6 hours of its infusion.