Cardiac Health: Implantable Cardiac Devices – number of procedures on the rise, but is the technology really there to handle this boom?

It is reported that an estimated 650,000 people in the United States currently have implanted cardiac devices (ICD’s) designed for defibrillation (cardiac electro-shock therapy) or combination defibrillation and heart pacing.  For you  Baby Boomers rounding (or having passed) the 60’s bend, these numbers are expected to grow exponentially.  Cardiovascular Business posted an article on April 20 advising that hospital admissions for implantation of ICD’s increased ten-fold from 1990 to 2005.

This same article was quite alarming in its lack of scientific data on factors that determine the best results.  While it may be comforting to know that several large patient-studies have recently shown that centers performing the greatest numbers of procedures have the lowest rates of procedural complications, it is important to also note that authorities in this area of medicine warn that more data and study are needed on individual operator volume, specialty identification, training, performance and outcomes.

Cardiovascular Business News released a feature on April 20, 2010, citing an article published in 2009 by the Journal of the American Medical Association.  The data suggest that your odds of having procedural complications were greater if the device was implanted by a non-electrophysiologist. In short, does this mean you have better odds with an electrophysiology cardiologist? What about a general cardiologist? Or a thoracic surgeon? The study data apparently did not adjust for underlying health conditions or patients who are more ill. Why not? Are we to assume the latter groups of patients may have merely been more prone to complications? Or do the non-electrophysiologists just have less experience and training in implanting ICD devices? As of this time, Boomers, the medical profession has not published answers to these questions.

Perhaps we should be encouraged that Medicare is requiring implant and performance outcome data. As of June 2009, the agency had collected information on more then 380,000 implants.  Yet almost a year later, with many more procedures entered into that same database, the medical specialty communities are still unable to let us know which are the safest specialists and hospitals performing ICD implant procedures.  Physicians say longer term outcomes are needed.

In the meantime, are Medicare and other payors paying for all procedures regardless of the quality of practitioner or hospital performance?

More alarming, on May 17, 2010, Dr. Westby G. Fisher, a cardiologist at North Shore University Hospital Health System wrote in medcitynews.com that the medical system currently can no longer sustain the volume to maintain the implanted devices safely. He complains that physicians are unable to re-program ICD devices remotely.  Is this true? Due to the growing volume of implanted devices now occurring, technicians with no medical degree are programing patient devices from remote locations with sometimes no documentation or notification to the patient’s physician. Physicians are supposed to be overseeing the process according to Dr. Foster. However, he is of the opinion that due to the high maintenance these devices require, along with the growing number of patients, managing the technology will be of great concern to the boomer population and their physicians.  Once again, how are the pressing issues of quality, safety, and cost going to be timely addressed in this burgeoning aspect of our healthcare?

Finally, perhaps we can be comforted by the recent news release from the Heart Rhythm Society. Apparently, the medical profession had never previously determined parameters on how and when to stop these devices at the end of one’s life.  The study cited a dying patient whose defibrillator went-off  greater than 12 times, causing the patient needless suffering. Several groups of medical societies have now have published a consensus statement outlining ethical and legal issues, a decision-making algorithm for withdrawing/deactivating the device(s), and rights/responsibilities for those physicians who have ethical conflicts. The Heart Rhythm Society is encouraging and educating physicians and patients on what needs to happen in this algorithm for ending ICD-sustained life.

One can only hope that a physician is not placed into a remote call-waiting voicetree for dying boomers when the time comes to deactivate. It’s bad enough that we don’t yet know how to choose the best physician and/or hospital to have these devices implanted. Now there is growing concern that simple but critical issues of maintenance, remote re-programming and the like will get out-of-hand due to the ever increasing volume of these devices being implanted.

Contributor: Sharon M. Stabile