Pumping Marvellous

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.

The world’s first wireless heart pacemaker was unveiled Monday. The device dramatically reduces surgical time so reducing cost and the chances of infection.

Andrew Diston, Head of Global Medical Technology at Cambridge Consultants which collaborated with start-up company EBR Systems to develop the system said the device, Wireless Cardiac Stimulation system (WiCS), solves two problems.

“Conventional pacemakers have to have a wire threaded through into the ventricle. That is very hard to place. And secondly we can place the electrode in a much better place and so get better results.” Pacemakers are in two parts, a pulse generator, with its associated power
supply, and an electrode that stimulates the cardiac muscle that is placed in  the heart. Such devices require three leads into the heart, one of which involves painstakingly threading a lead through a difficult and complex route running from the right atrium of the heart, out of the heart and into the coronary sinus, a vasculature structure on the outside surface of the heart to the left ventricle.

Chance of lead failure and infection

A pacemaker/defibrillator device is connected to the leads which are used to sense heart activity and to deliver electrical stimulation through electrodes at the end of the leads. The electrical stimulation applied to the right and to the left ventricles synchronizes the heart’s contraction in a way that improves overall cardiac function in heart failure patients. However, added to the difficulty of the procedure itself is the chance of
lead failure and infection. WiCS uses a lead-less electrode to convert mechanical energy, wirelessly transmitted from an ultrasonic pulse generator, into electrical energy which is used to pace the heart’s left ventricle.

“It is the same technology as was found in an old stylus. We beam the energy using ultrasound. That is picked up in the electrode and using piezo technology, the ultrasound is converted into an electrical signal,” said Mr. Diston.

Hope to get approval in 2012

“Provided you focus the energy onto the electrode it is very efficient.” “The device is currently in clinical trials in a number of places across
Europe,” said Mr. Diston. “They will carry on through 2012. We hope to get approval in 2012 for a European launch, and then will take the technology to America.” This, first generation device, is used to pace the heart as part of Cardiac Resynchronization Therapy. WiCS works in conjunction with a conventional pacemaker/defibrillator, sensing the electrical pacing pulse of the pacemaker from the right ventricle.

Mr. Diston said that future devices would be able to work without a conventional pacemaker being present.

Image via Wikipedia

Frightening Similarities

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.

– Angiotensin-converting enzyme (ACE) inhibitors, 6,516.

– 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.