Archive for the ‘Pacemaker / AICDs’ Category
Share Our Mission to Heal
Holy Cross Hospital is seeking studio audience members for A Mission to Heal, a new show all about the heart.
Needed: 75 audience members for each show; Mix of demographics. No children under 18; Community groups are encouraged to have representation in the audience, as well as community leaders.
Where
A studio in Davie, FL. Details will be provided to audience members upon selection.
When
September 30, 2010; Refreshments will be served.
The show is not “live” but it is being recorded “live” so it will be edited and shown at a later date. Audience members should dress comfortably for long periods of sitting. No white blouses, shirts, hats or sweaters.
Please email info@holy-cross.com and put A Mission to Heal in the subject field OR call 954-776-3244 if you are interested in being part of the studio audience.
Please provide your full name, phone number, e-mail address, age range (20s, 30s, 40s, 50+) and race/ethnicity. Someone will be in touch to let you know if you have been selected and provide additional information.
New Toys for the Electricians
Electrophysiology is the subspecialty of cardiology that deals with the electrical problems of the heart. At times the heart develops rhythms that break down into the fast rhythms, the slow rhythms and the lethal rhythms. I have blogged in the past about the development of ICDs or implantable defibrillators and now we are seeing the next generation of these devices.
This paper was published online at the NEJM website and presented at the Heart Rhythm Society Meeting in May. It was presented by Dr. Bardy who is the founder of the company as well as one of the inventers of the device. Dr. Bardy works at the Cleveland Clinic in Cleveland Ohio.
A conventional ICD is implanted by placing a wire into the right top chamber of the heart known as the atrium and a “shocking catheter” into the right lower chamber of the heart known as the ventricle. There are other ways to do this but the descriptions are outside the scope of this blog. To do this, the wires are in contact with the blood of the body and special equipment and x-ray is need. This new device uses a generator that is implanted in the top part of the chest underneath the skin as in a standard ICD. The new part is an array shocking catheter which is placed under the skin near the heart alongside the sternum. It is not in actual contact with the heart and is not in the blood stream.
The procedure requires no x-ray and can be done in any suitable surgical location. This device requires much more energy to work, almost twice as much, and the device is capable of delivering an astounding 80 joules of energy. Most ICDs deliver shocks in the range of 18 joules.
The study encompassed 55 patients followed for a short 10 months. One hundren and thirty seven bouts of induced rhythm were terminated. Twelve episodes of spontaneous rhythms were successfully treated by the device. For one patient the device would not successfully work in the lab and the patient received a standard ICD. One patient died of renal failure unrelated to the study.
This is an exciting advance but not ready for prime time. The device lacks many of the standard features of ICDs; perhaps the most important one is that of tiered therapy. What is meant by that is that the device delivers therapy in many ways and often terminates the rhythm without delivering a full shock. In addition the ICDs often function as backup pacemakers for patients.
Not quite ready, but an exciting advance and I applaud the thought leaders here.
Next: A new device for atrial fibrillation…
One year and continuing
It has been one year and 104 blogs since I started this dialogue with you and I hope you are enjoying it. I have learned a great deal and I look forward to continuing it this year.
I would like to thank the people behind the scenes Christine Moncrieffe and Lidia Amoretti who edit and post them for me and allow the administrative functions of the blog to work.
If there are topics you would like to me to blog on please send them on. I appreciate the support and the growth of our readers.
And now for year Two… Not a good week for cardiology. Congress adjourned without changing the payment cuts, so on June 1st every physician got a 20% pay cut. This is on top of the 41% pay cut that cardiologists received January 1st for ancillary testing i.e. stress tests and echoes.
Further, two studies were published recently stating that overtime work leads to heart attacks. Since I have no overtime I have to work until I finish I guess it doesn’t apply to me. Honestly, it doesn’t apply to me since I have never for one day considered what I do work. Also, this week brought news that cardiology is responsible for much of this health care crisis anyway. Let me explain.
At the recent American Heart Association meeting in Washington, DC that I have blogged about recently a study was presented regarding the “Increasing use of cardiovascular devices and rising health care costs.” This study presented by Dr. Peter Groeneveld of the VA Medical Center Philadelphia found that stents and ICDs, implantable cardioverter defibrillators, represented 29% of the total increase in the cost of taking care of those two patient populations.
The study found that from 2003 to 2006 the cost of caring for coronary artery disease increased from $13,558 to $14,215. For every 1% increase in drug-eluting stents, the cost increase was $394. On the heart failure side, the costs rose from $18,930 to $20,235. For every 1% increase in ICD implants an extra $627 was added to the bill. During the years 2003 and 2006 Medicare spent $4.97 billion on drug eluting stents. This accounted for 89% of the total costs for coronary artery patients. On the heart failure side The ICD cost was $893 million or 29% of the total cost.
That is a considerable amount of money but not a complete analysis in that it is not matched by outcome data. These are the types of discussions that were not heard during the recent health care legislation discussion. We are going to have to make choices as we cannot afford this type of expense indefinitely. I have no answers but I know that the answers can not be imposed from above. We are all going to need to become active in the debate before it is to late.
Already Being Used Devices
Last week I blogged about a unique example of common sense, the re-use of pacemakers and defibrillators that were explanted because of infection. Instead of throwing the devices away, the devices were donated, cleaned and implanted in patients who needed them but could not acquire them. This is a serious problem. There are people who die without a pacemaker or are subjected to a life of sickness.
Now a poster presentation was performed at the American Heart Association meeting called the 10th Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke. This poster reviewed the situation from a different perspective. The devices that were obtained came from patients that had died.
Before you go “that’s icky,” let me ask you what is the difference between getting someone’s heart or getting someone’s pacemaker. Seriously you are going to die without either and both donors have unfortunately succumbed. As our population ages and needs these devices, does an 89 year old patient need a pacer with a 10 year battery life? What do you do after they die from other causes after one year? After one month? I have a friend in this industry and patients are actually beginning to ask her “why do I need a device that lasts so long?”
Trust me, this isn’t going to fly in this country. The industry will never go for it, but what about just cleaning them and giving them to countries that can’t afford them. The poster showed that 4 trials with a total of 603 patients proved that compared to new devices, the reused devices were not associated with a significant risk of overall complication, infections or device malfunction. There were no device related deaths.
I believe this maybe an idea whose time has come. It just needs organization and some cooperation. I’m going to work on it.
Anyone Want a Used Pacemaker?
In our land of plenty, one could spend a considerable amount of time bemoaning the waste that goes on in medicine. One of the areas where this is least apparent is that of devices and what their “shelf life” is. We all know that milk expires and generally doesn’t taste good. Meat spoils and lettuce wilts, but what about a stent or a pacemaker?
When the original drug coated stents arrived, they were in short supply. This problem was worsened by a decision that was originally made that had nothing to do with science. That decision was how long the shelf life should be, and this was determined by the testing of the drug by the FDA at a point in time. The time chosen was 6 months. So a stent was deemed good and could be implanted for up to six months after manufacture and if not used, it had to be destroyed. This had nothing to do with the actual time that it could have stayed on the shelf, perhaps up to a year or more. The same issue occurs with any sterile device. After their expiration date, they must be destroyed. I can not tell you the amount of money that is wasted by the manufacture and destruction of devices but I am sure it is an astounding amount.
What about a pacemaker or defibrillator that has just been implanted and two weeks later must be removed and replaced? What do we do with it? Well, in the United States it is generally thrown out. Does it need to be?
At the recent Heart Rhythm Society meeting in Denver, a paper was presented about this issue. I applaud these Investigators as they have done a great service for many patients. In brief they explanted 17 devices had them cleaned, yes it is possible, just not allowed in the United States, and then they were implanted in patients who need them in Managua, Nicaragua.
Holy Cross sponsor’s medical missions in Nicaragua under the Sponsorship of the Sisters of Mercy and Dr. Ed Coppersmith have led many of these missions. I have been on two and many of the physicians at Holy Cross have participated, so I am familiar with the circumstances of medical care there. Neither Holy Cross nor any of its physicians have participated in this project that I am reporting.
To be accepted the devices had to have > 70% of the battery power left. They were checked at discharge, four weeks later and every six months there after. The mean follow up was 68 months. These devices performed as if they were new. No patient who was asked to donate a device refused. No infections were found.
The organ donation campaign uses the slogan “don’t send your organs to heaven.” Maybe we as cardiologists should start are own campaign “don’t throw your devices away.”
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More on Implantable Defribrillators
Despite all odds, no financial backing or grants, the three men mentioned in my previous blog developed the implantable defibrillator in Baltimore. After animal testing, the first device was implanted in a patient at Johns Hopkins Hospital by Dr. Levi Watkins, Jr. in February 1980. A patent was issued on May 13, 1980 entitled “Method and Apparatus for Monitoring Heart Activity, Detecting Abnormalities, and Cardioverting a Malfunctioning Heart.” The FDA approved the device in 1985 and it was commercialized in the late 1980s. Dr. Mirowski died in March 1990 at the age of 65 of multiple myeloma. He lived to see the device accepted with nearly 10,000 implants by then. He would not be surprised to find out that from 1990 to 2002 more than 416,000 implants were performed.
These devices have been the subject of numerous studies in an attempt to find the optimal patient selection and to avoid the burden that these devices do impose on patients. We are looking for the “sweet spot” — making sure that the right people get the devices and will benefit the most from them.
The early devices were shock only. Since then, all ICDs as they are now called provide pacing as well and the devices can provide various types of therapy in an attempt to terminate the rhythm and only shock as a last resort. Many patients can have their arrhythmias terminated by pacing or small shocks and these changes in therapy allow for longer battery life. These devices cost upwards of $50,000 and have other features’ that will be discussed in other blogs.
Dr. Luceri of this institution who sits on our Clinical Advisory Committee participated in the seminal trial documenting these devices value. The Sudden Cardiac Death in Heart Failure Trial also known as SCD-HeFT was published in the NEJM January 2005. Twenty-five years after the first ICD was implanted, this study proved once and for all that ICDs were superior to medical management and saved lives.
Dr. Mirowski’s insight and determination has saved hundred’s of thousands of patients. One person can make an enormous difference.
The Genesis of Implantable Cardiac Defibrillators
The vast majority of people who die from sudden cardiac death are not being monitored in a coronary care unit. Two individuals in particular are responsible for saving the lives of millions of people. One in particular has a truly inspiring story.
Michel Mirowski was born Mordechai Frydman in Warsaw, Poland, in 1924. This was not the time or place to be born Jewish. His father changed his name to Mieczyskaw Mirowski and he blended into the Polish population. He escaped with other Poles to the Ukraine and fought alongside them in the Polish Army. After the war, he returned to Poland, but his family had all been murdered and all his possessions lost. He, like many others, was displaced and he was able to go to Israel. He wanted to become a doctor and as there was no training in Israel, he went to Lyon, France, and entered medical school. He knew neither French nor English but learned both. He was taught in French and studied medical books in English. He married a French women and she called him Michel.
He then studied cardiology in Mexico City, teaching himself Spanish and then went on to Johns Hopkins, where he studied with the great Helen Taussig. When he completed this journey, he went back to Tel Aviv and was the only cardiologist in the hospital. He had a great mentor and teacher in another physician in the hospital. About five years after Mirowski returned, this individual became ill with ventricular tachycardia. Although he was urged to remain in the hospital under observation, he elected to go home and two weeks later he died suddenly during dinner with his family.
Heartbroken, Mirowski began to conceptualize a device that would be implanted in a person to monitor and treat these fatal rhythms. As with most new ideas, everyone said it couldn’t be done. He soon realized that it was not possible to do in Israel and again arrived back in America at Sinai Hospital in Baltimore, Maryland. Here he met Dr. Morton Mower who was the head of the cardiac care unit. Along with Alois Langer, an expert in electrocardiographic signal analysis, these three men went on to develop a device that could be implanted in a patient which would monitor the heartbeat continuously and, if needed, provide life-saving therapy.
Next…why this is so important.
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