I another bizarre corporate twist: I was held hostage at Mease Countryside Hospital in Clearwater, Florida a couple months ago. After checking into the Sleep Disorders Center, a technician noticed something "funky" in my EKG just after the testing began. I was rushed a few hundred feet away to the Emergency Room where I underwent several hours of blood tests, X-rays, and EKG's. THose did not show anything wrong. But the doctor on duty did not want to release me, until after my Guidant ICD could be interrogated.

Guess what? That did not happen for three (3!) days - so I sat there for half a week taking up a bed in CICU as my insurance company shelled out thousands of dollars for me to read and watch television! Turns out Bay Care, the megamedical company that operates seven hospitals in this part of Florida has signed an exclusivity deal with Medtronic - shutting out Guidant and other device makers. Medtronic is supposed to be on call to handle things such as in-hospital interrogations of non-Medtronic units as well and turning those devices off before surgery and back on after we come out of the recovery room.

I called Guidant, and pleaded for help. But because there is no longer a demand for their products around here... they had to lay off many of their field technicians and had no one they could send. And apparently no Medtronic techs were on duty or even on call in this area, so I waited and waited and waited until Guidant had a tech drive from Fort Myers to Clearwater to test my device - showing it, too, was just fine. The funky EKG that caused all the concern? Probably due to a loose sensor wire.

After that episode, a Guidant executive I've known for ten years called and chatted. He says a Bay Care Vice President and an Electrophysiologist in Clearwater ramrodded the excusivity deal through the approval process - after which both got six figure "consultation fees." There's a hell of a story here, but sadly it's only one of a zillions reasons our health care costs are running out of control.

~~~~~~~~~~HrtZapL~~~~~~~~~~~

Needless to say, when my EP told me he wanted me to undergo one of the dreaded NIPS Tests... having it done at Mease Countryside was not an option. It meant driving an hour north to have the procedure done at the HCA Bayonet Point Medical Center in Hudson. That was done two weeks ago today. It was a flawless exercise and the hospital folks up there are among the most professional I have encountered in the dozen years since my heart attack.

A friend of mine, a producer at the NBC TV station in Tampa, went along to take pictures of the whole thing. He shot it using my HD videocam and got some great stuff. The worse part of the process was having my chest shaved for the external defibrillator adhesive pads. I did not like that at all. That's on tape. Also recorded: Me chanting (while unconscious) a tune sung by monks in a Tibetan monastery! I hope to get the tape edited into a mini-documentary next week and turn it into a video podcast that can be downloaded here. I will likely offer it for free, but hope people who download it will make a small donation

~~~~~~~~~~HrtZapL~~~~~~~~~~~

In the distant past, Zapper readers were often paralyzed by fearwhen told they were to undergo a NIPS test. But, when we recently asked, "What scares you THE MOST about having an ICD?" in a Zapper BBS poll... the NIPS test was only mentioned once! Of the 73 people who actually voted...

1.
GETTING ZAPPED remains the top fear, earning 54% of the tallies.
2.
DEVICE FAILURE came in second with 27%
3.
OTHER was the third with 15% of the votes..
4.
NIPS test tied for fourth with ALTERING MY LIFESTYLE

Comments by OTHER voters provides some interesting insights. Those choosing that option mentioned magnests, driving, kids getting implanted, passing out while doing something needing a high level of attention and hurting someone, and getting zapped in public. Thanks to ALL who took the time to take part in the unscientific survey. With more than 1400 reading the postings... I hope more folks will come back and vote.

Defibrillator Lead Report Misleads
It didn't take long for the media to chew up this week's report on the high failure rate of old defibrillator leads published in Circulation from a single center registry from Germany today. What's better than to scare the heck out of patients? I mean, fear sells, doesn't it?

For those of you who haven't seen it yet, doctors from Germany decided to look back at their last 990 consecutive defibrillator lead implants between 1992 and 2005. They found 148 (15%) of defibrillator leads failed during follow-up and required replacement. They found that annual failure rates increased over time, peaking at 20% in 10-year-old leads.

But before you go out an insist that your defibrillator be removed, let's look at a few facts from the very same article:


* 15% of the leads had problems, 85% of them did just fine.

* No patent died as a result of ICD lead failure

* Older lead materials that have since been show to have high failure rates are no longer used, but included in this report

* The authors performed 95% of their implants using a subclavian approach, an approach they freely admit is prone to an unusually high level of lead "crush" as the lead passes between the first rib and clavicle. Like a coat-hanger repetitively bent, leads implanted by this approach are subject to a higher failure rate.

But the authors do make several valuable points: (1) defibrillators and their leads need constant monitoring, even after they are implanted and (2) in patients implanted for "primary prevention" of a cardiac arrhythmia (that is, they've never had an arrhythmia before the device is implanted), consideration of device failure over the lifetime of the patient should be considered when recommending a device for implantation.

It is important to note that the Heart Rhythm Society has been aware that these devices can be subject to malfunction on occasion. As such they have recommended that implantable cardiac defibrillators (ICDs) be evaluated every three months by a qualified physician. Further, most of the ICD manufacturers are developing wireless telemetry systems that can check these devices even as often as daily to assure their reliability. Furthermore, companies have migrated away from the form of polyurethane that can degrade when exposed to metal oxides (as occurred in leads manufactured before 1997). The fact that these older leads were included in the analysis serves to make the data more sensational and press-ready.

I would suggest that people evaluate the performance data maintained by each of the companies and published on-line. Boston Scientific's (formerly Guidant) performance data on their devices can be found here, Medtronic's here, St. Jude's here and Biotronik's can be found here. These data suggest current failure rates for most ICD's is approximately 10% after 10 years, fully one-half of that described by the authors in the above article. Certainly, this number is not perfect, but helps keep a reasonable perspective on defibrillator lead reliability, and reflects the world-wide experience of patient's with a particular lead or device system, and may be a more accurate reflection of lead trends across multiple centers and operators.