Theraphy Enhanced Defibrillators Saves Lives

RAFT RESULTS PRESENATION was held Wednesday November 24th/2010 at London Health Sciences Centre, University Hospital, London:

From the desk of Ted Misselbrook:

On December 19th/2007 Doctors at LHSC, University Hospital, installed a ICD in my chest and connected it to my heart. The Implantable Cardioverter Defibrillator contains an internal defibrillator and pacemaker. The defibrillator acts as an automatic "watch dog" and is designed to shock my heart in the event of  cardiac arrest. The shocks pass through to the heart, stop the erratic electrical activity, and allow the heart to return to a more regular rhythm. The pacemaker delivers therapies to treat my heart rhythm disorders.

Earlier in the interview process with my cardio doctor, I was given the opportunity to join a clinical trial and would randomly be assigned either an ICD or and ICD plus a CRT at the time of implant surgery. I agreed and entered the clinical trial program.

The CRT is similar to an ICD but it uses small shocks to coordinate the pumping action for both sides of the heart, which in turn improves the circulation of the blood through the body.  The physicians found the combination of the ICD and CRT reduced deaths by 25% and significantly reduced heart failure related hospital stays. 

I participated in the study for 40 months not knowing which unit was implanted until Wednesday, November 24th/2010. I'm inclined to compare this "gala presentation" to a night at the OSCARS, were the more that 100 patients attending were given a sealed envelope and at an appropriate moment asked to open and discover their fate.

My letter told me that I was one of 50% who DID NOT RECEIVE the next generation, combination CRT/ICD. That being said, I have been promised the opportunity to upgrade to the new generator, at a time and stage that will maximize benefits and results.

It is important to note in the here and now, that it has been a privilege to be one of 1798 patients enrolled in RAFT Clincial Studies.  Twenty-four centres were established in Canada, 8 centres in Europe and Turkey, and 2 centres in Australia. The results of the study are impressive and will enhance the lives of Heart Failure patients now and in the years to come.

       Ted Misselbrook was one of 1798 patients engaged in the RAFT Clinical Trial detailed here. LHSC had the second highest enrollment in the Resynchronization/ defibrillation for Ambulatory Heart-Failure Trial (RAFT) study with 140 patients.


 Original Article

Cardiac-Resynchronization Therapy for Mild-to-Moderate Heart Failure

Anthony S.L. Tang, M.D., George A. Wells, Ph.D., Mario Talajic, M.D., Malcolm O. Arnold, M.D., Robert Sheldon, M.D., Stuart Connolly, M.D., Stefan H. Hohnloser, M.D., Graham Nichol, M.D., David H. Birnie, M.D., John L. Sapp, M.D., Raymond Yee, M.D., Jeffrey S. Healey, M.D., and Jean L. Rouleau, M.D. for the Resynchronization–Defibrillation for Ambulatory Heart Failure Trial (RAFT) Investigators

November 14, 2010 (10.1056/NEJMoa1009540)


Article
References

 

 

Results

We followed 1798 patients for a mean of 40 months. The primary outcome occurred in 297 of 894 patients (33.2%) in the ICD–CRT group and 364 of 904 patients (40.3%) in the ICD group (hazard ratio in the ICD–CRT group, 0.75; 95% confidence interval [CI], 0.64 to 0.87; P<0.001). In the ICD–CRT group, 186 patients died, as compared with 236 in the ICD group (hazard ratio, 0.75; 95% CI, 0.62 to 0.91; P=0.003), and 174 patients were hospitalized for heart failure, as compared with 236 in the ICD group (hazard ratio, 0.68; 95% CI, 0.56 to 0.83; P<0.001). However, at 30 days after device implantation, adverse events had occurred in 124 patients in the ICD-CRT group, as compared with 58 in the ICD group (P<0.001).

Conclusions

Among patients with NYHA class II or III heart failure, a wide QRS complex, and left ventricular systolic dysfunction, the addition of CRT to an ICD reduced rates of death and hospitalization for heart failure. This improvement was accompanied by more adverse events. (Funded by the Canadian Institutes of Health Research and Medtronic of Canada; ClinicalTrials.gov number, NCT00251251.)

Source Information

From the Island Medical Program, University of British Columbia, Vancouver (A.S.L.T.); the University of Ottawa Heart Institute, Ottawa (A.S.L.T., G.A.W., D.H.B.); Montreal Heart Institute and Université de Montréal, Montreal (M.T., J.L.R.); London Health Science Centre, London, ON (M.O.A., R.Y.); the University of Calgary, Libin Cardiovascular Institute of Alberta, Calgary (R.S.); Hamilton Health Science Centre, Hamilton, ON (S.C., J.S.H.); and Queen Elizabeth II Health Sciences Center, Halifax, NS (J.L.S.) — all in Canada; J.W. Goethe Universität, Frankfurt, Germany (S.H.H.); and the University of Washington Harborview Medical Center, Seattle (G.N.).

Address reprint requests to Dr. Tang at 335-1900 Richmond Ave., Victoria, BC V8R 4R2, Canada, or at .

Media in This Article

Figure 1Kaplan–Meier Estimates of Death or Hospitalization for Heart Failure (Composite Primary Outcome) and Death from Any Cause.Figure 2Kaplan–Meier Estimates of Death or Hospitalization for Heart Failure (Composite Primary Outcome) and Death from Any Cause among Patients with New York Heart Association (NYHA) Class II Heart Failure at Baseline and among Those with Class III Heart Failure.Figure 3Subgroup Analyses of Death or Hospitalization for Heart Failure (Composite Primary Outcome).

The use of implantable cardioverter–defibrillators (ICDs) improves survival among patients who have New York Heart Association (NYHA) class II or III heart failure with left ventricular systolic dysfunction despite optimal medical therapy.1 Cardiac-resynchronization therapy (CRT) improves symptoms of heart failure, quality of life, exercise capacity,2-6 and left ventricular function7 when used in patients with NYHA functional class III or ambulatory class IV heart failure with a wide QRS complex. CRT has also been shown to reduce mortality among patients not receiving an ICD.8 However, studies have not shown a survival benefit of CRT in patients with NYHA class II or III heart failure, left ventricular dysfunction, and a wide QRS complex who have been treated with optimal medical therapy and an ICD. Recent studies have shown that the use of CRT improves heart function in patients with mild (NYHA class I or II) heart failure and reduces the rate of hospitalization (or medical encounters) for heart failure.9,10 It is reasonable to hypothesize that CRT may slow the progression of heart failure and reduce mortality and morbidity among such patients.

We conducted a multicenter, double-blind, randomized, controlled study, called the Resynchronization–Defibrillation for Ambulatory Heart Failure Trial (RAFT), to determine whether the addition of CRT to an ICD and optimal medical therapy would reduce mortality and the rate of hospitalization for heart failure, as compared with an ICD and optimal medical therapy alone, among patients with NYHA class II or III symptoms, left ventricular systolic dysfunction, and a wide QRS complex.11

For more information please follow the link shown below.
http://www.nejm.org/doi/full/10.1056/NEJMoa1009540#t=articleDiscussion 

ICD/CRT-Defibrillator, Pacemaker and Resynchronization Therapy Device

December 19th, 2007 my first ICD was installed in my chest and connected to my heart at University Hospital in London.

January 15th/2013 my second surgery took place at UH to install a new 

ICD/CRT (defibrillator,

 pacemaker and resynchronization therapy device.


February 6th/2013 my third surgery took place at UH to install a St. Jude model heart device (pictured on the far right) to replace the Medtronic ICD implanted in January of the same year. 

After meeting with technical staff and doctors, it was determined that the third lead which connects the CRT component had failed to secure itself inside the chosen heart vein and as a result would need to be replaced with a St. Jude ICD. 


April 27/2018 my fourth surgery took place to install a new generation ICD, (Medtronic My Care Link) replacing the St Jude model over concerns that in some cases this particular model was known to have a defective battery. 

Dr. Peter Pflugfelder Cardiologist/Retired

I owe my life to this brilliant cardiologist and compassionate human. My first visit to his London office was in 2006 and the diagnosis wasn't good. "You have congestive heart failure" noted Dr. Pflugfelder and we will need to start a course of treatment immediately. Later I learned that 40% of newly diagnosed patients die within 5 years, while  80% percent die in 8 years.  Despite those grim numbers Dr. Pflugfelder guided me through the process that included extensive testing, a trusted medicine regime, and later the recommendation that I enter a blind study and have an implantable cardio device wired to my heart.   I followed every suggestion he made and 11 years later I can still count myself among the living. 
In 2015 he announced his retirement. I wish him well for whatever comes next. A long, happy and exciting life should be his, for this man has certainty earned it. 

Dr. Malcom Arnold, Lead Investigator RAFT Clinical Trial, LHSC, University Hospital

Ted Misselbrook Upgrades to ICD-CRT Hardware System, January,15th/2013 at University Hospital, London.

THERAPY ENHANCED
DEFIBRILLATORS SAVE LIVES

Clinical trial studies have showed a significant reduction in deaths and heart failure hospitalization when cardiac-resynchronization therapy (CRT) was added to implantable cardioverter defibrillators (ICD) and best medical therapy.

Surgical Replacement-Upgrade of Implatible Cardio Device system includes pacemaker, defibrillator with a resynchronization therapy component  

The photo above is representative of the new device, a three lead hardware system that is surgically connected to my heart. This procedure took place on Tuesday, January 15th/2013 at University Hospital with Doctor Peter Leong-Sit in charge of the surgical procedure.

The CRT is similar to an ICD but it uses small shocks to coordinate the pumping action for both sides of the heart, which in turn improves the circulation of the blood through the body.  The physicians found the combination of the ICD and CRT reduced deaths by 25% and significantly reduced heart failure related hospital stays. 

Editor's Note:
One week after having the new ICD/CRT (defibrillator, pacemaker and resynchronization therapy device installed, I reported to the ICD Clinic at University Hospital as scheduled to have a check-up and inspection.  

After meeting with technical staff and doctors, it was determined that the third lead which connects the CRT component had failed to secure itself inside the chosen heart vein.

As a result, a "do-over" has been scheduled for Wednesday, Feb. 6th/2013.

To view a YOU TUBE Video that shows in antimated format the installation of a
ICD/CRT device to the heart. The same procedure that Doctors at UH did with me.
Here's the link
http://www.misselbrook.net/10667520



 

Media Release----November 24, 2010

 

THERAPY ENHANCED
DEFIBRILLATORS SAVE LIVES

Study results will change the way doctors treat heart failure

LONDON, Ontario – In what is being considered a landmark study, physician-researchers from London Health Sciences Centre (LHSC) and Lawson Health Research Institute (Lawson) recently co-presented their findings in Chicago that showed a significant reduction in deaths and heart failure hospitalization when cardio-resynchronization therapy (CRT) was added to implantable cardioverter defibrillators (ICD) and best medical therapies.

An ICD is a small electronic device that is surgically implanted into the chest and connected to the heart. Its purpose is to help maintain the heart’s rhythm by sending a small shock when the rhythm becomes irregular and life threatening. The CRT is similar to an ICD but it uses small shocks to coordinate the pumping action for both sides of the heart, which in turn improves the circulation of blood throughout the body. The physicians found the combination of the ICD and CRT reduced deaths by 25% and significantly reduced heart failure related hospitals stays that were longer than 24 hours.

LHSC had the second highest enrollment in the Resynchronization/ defibrillation for Ambulatory Heart-Failure Trial (RAFT) study with 140 patients. Close to 1,800 patients from 34 sites worldwide with mild-to-moderate heart failure symptoms were enrolled in the randomized study, in which they received either an ICD or an ICD equipped to provide cardiac-resynchronization therapy (CRT). Both patient groups also received standard heart failure medicine.

“This study will change the way physicians treat patients who have heart dysfunction with mild to moderate heart failure symptoms. The trial clearly showed additional benefit to prolong life and reduce hospitalizations. These specialized devices offer further hope of improved quality of life and will play an important role in managing many patients with heart failure,” says RAFT Executive Committee member Dr. Malcolm Arnold, a Cardiologist at LHSC and Scientist at Lawson.

According to the Heart and Stroke Foundation of Canada, it is estimated that 500,000 Canadians are living with heart failure and 50,000 new patients are diagnosed each year. In addition, up to 40-50% of people with congestive heart failure die within five years of diagnosis. “The results of RAFT prove that we can reduce hospitalization, suffering and dying,” concludes Dr. Raymond Yee, RAFT co-investigator and Cardiologist working at LHSC and Lawson.

About Lawson Health Research Institute

As the research institute of London Health Sciences Centre and St. Joseph's Health Care, London, and working in partnership with The University of Western Ontario, Lawson Health Research Institute is committed to furthering scientific knowledge to advance health care around the world.

University Hospital RAFT Clinical Trial team members, Kathy Blacker and Julie Smith

And perhaps the most important team member in my Heart Failure Journey, Pat Misselbrook