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.

-Wes

Pros and Cons of MRSA Screening

This morning’s Chicago Tribune announced that Illinois is reviewing a bill (see SB233 and HB378) to require hospitals to perform tests for methicillin-resistant staphylococcus aureus (MRSA) in all intensive care and “at risk” patients, such as those transferred from nursing homes.

The program requires "active surveillance" for MRSA using a rapid polymerase chain reaction (PCR) assay specific for the super-bug. If positive, strict contact isolation measures are employed, including the use of plastic gowns and gloves and plastic stethoscopes.

Evanston Northwestern Healthcare has taken a very pro-active approach at MRSA screening, spearheaded by Dr. Lance Peterson. Every patient admitted to our hospitals has a nasal swab performed and patients who test positive are placed in contact isolation. According to the Tribune this morning:

Evanston Northwestern went from 1200 cases of patient-to-patient MRSA transmission in 2003 to 80 cases in 2006, and the $600,000-a-year program saved twice as much as it cost by reducing infections, Peterson said.

But this surveillance program is not without its critics.

Active surveillance for MRSA is "an important tool I want to be able to use, but I don't want to be told where and when I have to use it," said Dr. Stephen Weber, an infectious disease specialist at the University of Chicago Medical Center.

Instead, Weber argued, hospitals should be free to direct resources toward the most compelling concerns in their institutions. For instance, the University of Chicago is focusing on reducing infections at surgical sites, which will help control MRSA as well as other drug-resistant bacteria, Weber said.

"It's probably not a good idea to legislate a one-size-fits-all approach, because hospitals have different problems," said Dr. Gary Noskin, associate chief medical officer at Northwestern Memorial Hospital. "The best approach is to rely on each institution's expertise."

Since the bill is supported by the Illinois Hospital Association, a strong push for this initiative seem inevitable.

But from the patient's perspective, contact isolation is no picnic. In my anecdotal experience, I believe patients placed in contact isolation have less contact with health care providers of all types when "isolated." Putting on the gown and gloves and using poor-fidelity plastic stethoscopes has its limitations for the patient, especially in the noisy ICU setting. Medical students and residents rarely visit these patients out of concerns of spreading germs. Teaching rounds are almost never conducted on these patients for similar reasons.

The polymerase chain reaction test used to screen these patients has some limitations as well, including a 1% false positive rate for MRSA. This means that 1% of patients that test positive for MRSA, actually do not have the bug (there is cross reactivity with methicillin sensitive staphylococcus aureus I am told in a small percentage of cases). In these cases, some patients (admittedly few) will be relegated to contact isolation, even though they have a more benign form of staphylococcus aureus in their nose.

So is this legislation the answer? I don't know. But it is sure to have significant implications - both good and bad - for our patients.

-Wes

Medical School Prerequisites

I was sitting at the computer Friday, and a bright resident noticed my fairly rapid hunt-and-peck typing method. I commented to her that I should have had typing as a prerequisite to medical school and it got me thinking...

My required medical school prerequisites looked something like this:

Chemistry with lab
Biology with lab
Organic Chemistry with lab
Algebra I, II, Trigonometry, Geometry, Calculus I
Physics
English

And as I look back on these prerequisites for medical school many years later, I realize that I can't remember a single organic chemistry formula, nor integral derivation from Calculus. Oh, I knew them at one time. But after medical school and the time required to cram countless anatomic relationships, diseases, microbes, and pharmaceutical names in your brain, the prior effort is lost forever. Sad, really.

Perhaps it would be better to take prerequisites that would come in handy throughout medical school and beyond. So for this, I am proposing a new prerequisite list to supercede the old:

Typing 101 and Speed Typing
Absolute must-haves for the Medicine of Today: Electronic Medical Record, Electronic Billing, yada, yada, yada. You want to get home before midnight? These courses are a must.

Psychology
Chemistry is so passé and so useless in medical school (did I ever use this?). Psychology, my friends, is much more practical, especially in the context of repetitive handwashing. (Obsessive Compulsives can comp out of this course).

Astrology
Critical to know in the era of Alternative Medicine. The importance of knowing which "house" you're in at various times of the lunar cycle, especially for ER physicians, is always valuable.

Socialism 101 and perhaps Maoism 203
- only for the providers in the health care sector.

Collective Bargaining and Labor Law
How many hours do you work?

Economics (Macro and Micro)
Never taught, but should be.

Gambling 307
Know when to walk away, know when to run.

Litigation 537 + Lab
(a graduate level course, to be sure)

... and last, but not least:

Dilbert Linguistics


-Wes

Friday Chuckle

Dr. Bob wins this week's laugh with his new franchise opportunity...

-Wes

Feeling Guilty

I lied today.

I feel guilty.

But it was good.

I feel a bit like Robin Hood: stealing from the wealthy and giving to the poor.

So in order to clear my consciousness, I'll confess to my transgression...

... I am not authorized to practice medicine in the state of California, yet clicked on a webscreen button intended only for California physicians.

It seems California doctors are special, at least in the eyes of Kaiser Permanente, when it comes to making helpful suggestions about managing heart disease.

We have designed our website to help everyone in our communities have the healthiest heart possible. Our clinical experts understand the critical role that individual clinicians play in helping their patients lead heart-healthy lives. We want to provide a resource to California practitioners in their efforts to help their California patients make healthy heart choices about their lives. If you are a California clinician, we hope that the Kaiser Permanente tools and resources we are offering on our website will be useful for you in your practice. Over time, we are planning to add more resources as we develop them. This information is not intended to provide medical advice or services to any individual.

But you know what? Their recommendations aren't bad. Their flow charts and data seem sound, and they might just help doctors of the front lines of health care around the world remember a simple approach to evidence-based management of common cardiovascular ailments.

But there's just one catch...

... if you don't practice medicine in California, you'll have to lie to use them.

-Wes

Patient Blogs Make HIPAA Unenforceable

HIPAA, the Health Insurance Portability and Accountability Act of 1996, contains privacy provisions that provide "protection" of patient's health care information to assure that health care providers, health plans, and health care clearinghouses don't leak such sensitive information in a public forum. You see, our legislature felt that doctors and health care providers might use such information to the detriment of our patients, so they made this law to allow government to reassure others that Big Brother could do a better job at protecting your privacy.

But now comes another realization: patient's family members might leak the informaton instead.

Patient blogs are now the rage at local hospitals here in Chicago, detailing play-by-play accounts of health care delivery and histories on patients themselves. You see, patients aren't covered by HIPAA. They can say what ever they want about themselves. But sometimes the patient isn't the one posting on the patient's blog, family members were, dutifully updating the daily progress of their loved one to the world.

"Many people have been inquiring about him so I would like to share some information with everyone," said the first in a series of near-daily updates posted by Nequin's wife, Dawn.

She described in detail how her husband had slipped on ice March 6 while walking the family dog, hit his head on the sidewalk and, nearly three hours later, asked to be taken to the hospital, complaining of a headache and weakness in his leg.

"Within minutes he was having a CAT scan, and in a few more minutes we knew he had a brain bleed," she wrote.

And companies providing these patient weblogs and message boards are springing up like 17-year cicadas:

TLContact Inc., the Northwest Side company that oversees CarePages, has created more than 50,000 such pages, according to a spokeswoman. CaringBridge, a competing service based near Minneapolis, and theStatus.com, a third major competitor based in Anchorage, claim roughly the same numbers of pages, most of them generated in the last few years as word has spread about their availability.

"Most people don't find out about them until a friend goes into the hospital and starts one," said theStatus founder Mark Pierson.

Such sites have been around nearly 10 years, are free, easy to use and fairly secure -- families can control access to them via passwords and invitation lists. Though the companies contract with hospitals for branding and promotional purposes, any patient anywhere can sign up and use any of the services.

They relieve family members and patients of the tedious job of telling the same story over and over, while the accompanying message areas become a forum for encouragement and prayers.

They offer an advantage for health-care professionals as well. Having the family post updates online allows them to skirt the awkwardness and even legal peril that newly stringent medical privacy regulations have added to such simple questions as "How's he doing?"

So in the future, if doctors or insurers get accused of violating the HIPAA provisions, they'll just look stupid and say, "Hey, I just read what I know about him on his patient blog!"

-Wes

How to Impress Your Doctor

Come in with one of these.

-Wes

Hat tip: Echodoc

On Today's Hospital Ratings

Another highly scientific survey sampling 25-30% of patients regarding their care in hospitals was published today:

Hospitals averaged a rating of 84.2 on a 100-point scale, up 1.2 points from five years ago, according to Press Ganey Associates, a health-care quality measurement specialist that conducted the survey.

Room conditions, food quality and the discharge process continued to draw complaints from patients. More than half of patients' comments about room conditions were negative, while more than a third of comments about meals and discharge from hospitals were negative.

Gloating over a 1.2 percentage point difference would make most statisticians cringe - especially when Press Ganey, the survey firm, puts the margin of error for the survey at about 1%.

Let's not fool ourselves thinking that patients' rooms and even the food make that much difference in the patient experience in our hospitals. These are immaterial to improving care. What matters is the nurse to patient ratio.

I bet any one of us would eat dog food in a hospital if we had a caring attentive nurse help us through our toughest hours; one who called the doctor about a medication error, helped us to the bathroom when we needed it, and took the time to explain our discharge instructions and follow-up care as we leave.

Too many hospitals have increased nursing-to-patient ratios to save money and counteract the decline in nurses available nation-wide. And patients have gotten little as a result for their health care dollar. Geez. 1.2% return on our health care dollar investment?

Hey guys and gals, it's the people that matter, not buildings and surveys. Give the patients more contact and watch your surveys climb. Problem is, are hospital administrators willing to pay?

-Wes

We Spend Too Much Time Hiding Illness

So says Robert Ebert in today's Chicago Sun Times. For those who may not know Mr. Ebert, he is a famous film critic here in the U.S. that became an icon to the film industry. He organized the Overlooked Film Festival in University of Illinois in Urbana, IL and has attended it every year to the delight of his fans.

But there was a twist to his attendance this year:

"What happened was, cancer of the salivary gland spread to my right lower jaw. A segment of the mandible was removed. Two operations to replace the missing segment were unsuccessful, both leading to unanticipated bleeding.

A tracheostomy was necessary so, for the time being, I cannot speak. I make do with written notes and a lot of hand waving and eye-rolling. The doctors now plan an approach that does not involve the risk of unplanned bleeding. If all goes well, my speech will be restored.

So when I turn up in Urbana, I will be wearing a gauze bandage around my neck, and my mouth will be seen to droop. So it goes.

I was told photos of me in this condition would attract the gossip papers. So what? I have been very sick, am getting better and this is how it looks. I still have my brain and my typing fingers."

Remarkably, there were those who encouraged him not to attend because of his appearance - people might make fun of him, or the paparazzi might take unflattering pictures of him - but to that he says:

We spend too much time hiding illness. There is an assumption that I must always look the same.

What a cool guy, huh? He beat the critics and paparazzi at their own game - published pictures of himself and all before they could. And even gave a caption for the pictures of him in his La-Z-Boy watching the movies: "La-Z-Critic."

Brilliant.

-Wes

The Best of the Medical Blogging Universe

...literally (or should it be literarily?) ... is up over at Med Valley High.

-Wes

EPIC Capacity Concerns Aired

EPIC Systems of Wisconsin runs many of the hospital information systems here in the Chicago area, and recent "upgrades" to software have demonstrated noticeable slowing and occassional "hanging" of the system from time to time. While there are always issues with new software releases that need "fixing," these glitches are placed in a new light after reading concerns of a former employee at Kaiser Permanente, Juten Deal, who e-mailed concerns about the selection of EPIC as Kaiser Permanente's medical record system to his fellow employees. These issues included those of significant costs, conflicts of interest, and capacity concerns. While Kaiser responded to his e-mail after a "thorough investigation" and described his claims "an unfortunate combination of partial facts, old data, incomplete data, 'conspiracy' thinking, and naiveté" concluding that "It raised alarms that were extremely inaccurate."

I have a feeling this will not be the last we hear of this incident.

-Wes

References:
Justen Deal's website fixkp.org.
Wall Street Journal article (subscription) with links to the E-mail and Kaiser Permanente's response.
Kaiser Permanente's response.

Post Virginia Tech: HIPAA Implications

Walter Olson reviews the implications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) following the Virginia Tech massacre:

Under HIPAA’s terms, doctors and other covered persons who improperly release information about identifiable persons’ health care are subject to fines and even prison terms of up to ten years. That a disclosure is well-meaning rather than malicious is no defence: disclosures to patients’ own parents or roommates, as well as disclosures to other medical or custodial institutions, can very much trigger liability; and the exact scope of what is deemed proper disclosure is by no means precisely defined.

Unintended consequences soon blossomed, in large quantity. Frantic family members dialed emergency rooms in vain seeking confirmation that their unconscious loved ones were there. Preferring to play it safe, some hospitals removed patients’ names from doors. Clergy were ordered not to drop in on ill parishioners unless on specific request. Wider areas within clinics were closed off to unescorted visitors; Santa Claus could drop by only with a proper release form on hand for each ailing child.

Infringement of medical privacy is a lamentable thing, but experience soon suggested that other things can be even worse. After a Washington, D. C. pedestrian was fatally struck by a car, his family learned nothing of it for two weeks until a $17,000 hospital bill arrived in the mail. In rural Colorado, where ambulance dispatchers had been casually accustomed to naming the family whose home needed a run (get over to the Wilson ranch, Vern is having chest pains) it was thought advisable to rely on unfamiliar street addresses instead, leaving drivers to fumble.

In my experience, if a referring clinic knows me they will send a patient's records without requiring written authorization for release of records from the patient. Are they breaking the law by releasing this information to me without a "consent form" being signed?

Technically, I suppose they are.

Yet here we are, forced to comply with a mandate that isn't enforced, has significant limitations, and in many ways limits the quality of health care delivery.

-Wes

Yeltsin Dies of Heart Failure

Boris Yeltsin, former Russian President, died today at the age of 76 from heart failure.

-Wes

Tough Recruiting New Cardiologists?

Be sure you have a good airport:

Chuck Redwing, administrator of Orthopedic Associates, said the problems vary from a lack of private schools and shopping to an airport with unreliable service.

"Airport service kills us every time. Three hops is a tough, tough sell. We have lost more good candidates because of that than any other factor," Redwing said.

-Wes

Free AED? Check the Serial Number

I hope this church that received this "free" automatic external defibrillator from an anonymous donor in Cincinnati checks the serial number on the device.

-Wes

Could A "Heart Healthy" Logo Backfire?

It seems some New Zealander's think it might contribute to obesity:

The Heart Foundation's campaign includes about 1000 food products that are low in total fat, saturated fat, sugar and sodium, and sometimes higher in fibre. Companies pay thousands to have their product go through the evaluation process before being able to wear the tick (logo).

The Obesity Action Coalition says many people who see the tick wrongly believe it means they can eat as much of the product as they want. Chairperson Bronwyn King says some smaller companies cannot afford to put their potentially healthier products through the assessment process.

Anyone know what the American Heart Association charges for their "heart healthy" logo to be used on package labeling here in the US?

Oh, you mean it's not free?

-Wes

Bicycling and ED

I've never liked bicycle seats, and now my worst fears have been confirmed:

When urologist Dr. Irwin Goldstein declared in 1997: "There are only two kinds of male cyclists -- those who are impotent and those who will be impotent," many bike riders scoffed. Saying the equipment housed in their spandex shorts worked just fine, they optimistically kept riding. Several prominent urologists dismissed Goldstein's claims, saying that they were based on a small sample of riders and that the cardiovascular benefits of cycling outweighed any risk of impotence.

Ten years later, more than two dozen published studies, including several by Goldstein, have confirmed the connection between cycling and sexual dysfunction. Problems can range from impotence -- the complete inability to penetrate -- to an erection that doesn't last as long as desired.

The data seem slight, but then, any harm to "Mr. Microphone" might be significant:

Not all male riders, or even the majority of male bicyclists, are likely to experience erectile dysfunction. A study presented to the American Urological Association in 1997 found that 4.2 percent of cyclists had moderate to complete ED, compared with 1.1 percent of runners. That study compared 738 male riders from a Boston cycling club with an age-matched control group of runners. A second study, presented to the association the following year comparing cyclists and swimmers, found that 4 percent of cyclists had ED compared with 2 percent of swimmers.

Older bicyclists and those riding long distances tend to have an increased risk. And yet another study, published in the International Journal of Impotence Research in 2001, found that men who rode for less than three hours a week decreased their risk of ED, compared with non-cyclists, possibly because of the benefits to the cardiovascular system. But the same research found that cycling more than three hours a week nearly doubled the risk of ED, compared with non-cyclists.

How to fix this? Seems a seat without a nose might be best:

Dr. Roger Minkow, a specialist in ergonomics, said that a properly designed and fitted bike seat with a nose can work as well as noseless saddles in avoiding erectile problems without sacrificing control and safety on the bike. Minkow, who has developed pilot seats for United Airlines and training equipment for the U.S. Olympic gymnastics team, was hired in 1997 by Specialized Bicycle Components to design a new line of bicycle seats.

Testing showed that the modified saddles allowed blood flow up to about 70 percent of normal in an upright position and 60 percent in a forward position. Some other saddles tested had flows less than 2 percent of normal. Minkow said that flows of more than 50 percent should be enough to prevent ED problems.

So guys, ride carefully out there, and have a great Summer!

-Wes

Living (Not Dying) With Heart Failure

I’m on call this weekend. Too much to do and too little time.

But I thought I’d share this video with you. The story that accompanies the video speaks to the human condition, and since I manage lots of folks with heart failure, I thought this might inspire others:

This is from a documentary shown on Channel 4 in the UK called 'Young@Heart'; the name of the New England octogenarian chorus line. The performer here is Fred Knittle, who suffers from congestive heart failure. This song was intended to be a duet between Fred and another chorus member, Bob Salvini. Sadly, Bob died of a heart attack and it was left to Fred to carry the song on his own. If I'm correct, the people you see crying at 01:13 are Bob's family. The lady you occasionally see mouthing the lyrics in the audience is Fred's wife.

Although moving, the real story is what he's chosen to do with his disability. And yes, the man has a set of pipes, even on oxygen!



Enjoy!

-Wes

Martin Leon, MD the Scapegoat

Poor Marty Leon, MD. Dissed by the New England Journal of Medicine.

I never understand this stuff. Why pick on just him? Oh sure, this was a big "no, no" to leak embargoed trial results early, but others hinted at tidbits from this big trial, too. This is not the first time scientific meetings have had to deal with leaks in the age of the internet. Why single him out? What about this from the Wall Street Journal Health Blog at 25 Mar 2007 @ 11:38 PM:

Interventional cardiologists the Health Blog spoke with – including Leon’s colleague Gregg Stone of Columbia University, who ran major Boston Scientific and Abbott Labs stent studies; Donald S. Baim, the chief scientist at Boston Scientific, and Barry F. Uretsky, who co-chairs part of the confab here – echoed this analysis. Hip replacements don’t decrease deaths either, Stone pointed out, but they’re still worth doing in many patients to improve quality of life.

Note that these comments were also made before the COURAGE trial was released. Not that I really care. But should they be reprimanded, too? They were big dogs in this trial, weren't they? Or was the reprimand less about Marty Leon and more about the New England Journal of Medicine?

Maybe the real reason Martin Leon, MD was singled out was another reason: the Journal's impact factor.

Dr. Leon is well known in Cardiology circles. Dr. Leon knows people and industry. He is likeable. When Dr. Leon speaks, people listen. And people write articles. And articles that reference the New England Journal of Medicine are what are needed to increase the Journal's impact factor.

(British Medical Journal - 3/07) The impact factor has become the global currency for a journal's scientific standing and, by implication, of the papers it publishes. Available at the click of a mouse (http://scientific.thomson.com/isi/) from the Institute of Scientific Information and updated every year, the impact factor has three decimal place precision and an impressive range from close to zero to over 30. Some journals delight in flaunting their impact factors, and when the big names such as Nature do this you could be forgiven for believing that the impact factor is both credible and important.

Sadly, this is not the case. Even superficial scratching beneath the hype shows this currency to be so seriously debased that only the naive could attach any value to it. A journal's impact factor is derived as the total number of citations of all its eligible articles (full papers and reviews) published during the previous two years, divided by the total number of eligible articles. The basic assumption that this ratio reflects the journal's scientific quality has been challenged on many counts, including the heavy citation of reviews, self citation, and period of measurement. It doesn't even matter if a paper turns out to be rubbish—or even if the only reason for citing it is to point this out—because all citations count and contribute equally to the journal's impact factor.

And the worst point of all of this, is that the impact factor can be manipulated during a rebuttal process sanctioned by the ISI:

This system of negotiations—or, as (the Institute of Scientific Information) ISI's Ms McVeigh prefers it "discussions or clarifications"—has made journals far more cognisant of how editorial decisions can affect impact factors. As well as monitoring cases in which ISI gets it wrong, editors are using this knowledge to their advantage. By keeping the numbers of scholarly articles as small as possible, journals can maximise their ranking. "Every time you get a number you get people working out how to make it work to their advantage", admits Dr (George)Lundberg (editor of JAMA). Several artefacts can influence a publication's ranking in journal lists. Review articles or letters are generally cited more than research papers, so boosting review content can make journals perform better in the ranking. Inclusion of news articles, editorials, and media reviews that are among articles considered "non-source" by ISI can win a journal citations without increasing the denominator. And journals can, of course, deliberately try to inflate self citations by asking authors to reference papers in their journal.

The need for inflating impact factors in journals that report clinical research cannot be overstated:

There has been a haemorrhage of clinical academic staff from universities during the past 10 years—mirroring the existence of the research assessment exercise—and wide ranging cuts in specialist teaching available in medical schools, with some subjects now completely absent. Professor Rees says 1000 members of staff have been lost from medical schools, most of them clinical researchers. He attributes this damaging decline to the fact that papers reporting laboratory based research get published in journals with generally higher impact factors than their clinical counterparts, so universities selectively return those sorts of papers for departmental evaluations in the research assessment exercise and funding for clinical investigation decreases as a result.

What is clear is that in the age of the internet, print journals, like newspapers, are losing readership. The internet is fast becoming doctors' source for information. So journals are eager to keep up their relevance in such a wired world.

And nothing sells news like bad news - and drives up an impact factor - like the reprimand of one of their own.

-Wes

23 Apr 2007 - Update: It seems others realize that Wall Street always seems to know the results of these trials before they're released:

But Dr. Kaul said doctors talking about the New Orleans incident were more concerned about whether medical companies or Wall Street analysts had been alerted to the medical study’s results well before Dr. Leon’s reported lapse. “It’s very common,” Dr. Kaul said, “to hear rumors that companies are in the know about trial results.”

-Wes

Oral Communication in the Wireless Era

I was shooting hoops with my son behind our garage, the other day. He demonstrated how ridiculous and old man can look next to an adolescent with spring-loaded knees and an eagle eye for the basket. It was humbling to say the least.

Our basketball setup is one of those portable units, set up right next to the garage. We were deeply involved in a game of “HORSE” when suddenly, just as I was planning a perfect “swish” from the corner, the electric garage door opened behind me. The sudden unexpected nature of this event startled me and I watched my perfect “swish” transition into an “air ball.” After the brief adrenaline rush subsided, my wife drove up and asked, “How’s it going?” with a big smile on her face – not realizing that her wireless transmission to the garage door mechanics had precipitated, at least in part, my basketball demise at the hands of my son.

It dawned on me that a similar event probably occurs daily in operating rooms and electrophysiology labs around the country with the advent of wireless implantable defibrillators. You see, both Medtronic and Boston Scientific have defibrillators that can communicate wirelessly with their respective programming computers. It’s a handy feature, in many respects.

But today, as I was replacing an older defibrillator with a new wireless model, a subtle, yet significant event occurred.

First, let me say that no one perished as a result of what happened. No one was initially aware that anything had even occurred. But I suddenly realized it.

At first, I became aware of a subtle background sound across the room: * tap * * tap * * tap * * tap *. I kept working and had just replaced an old defibrillator with a new wireless model. * tap * * tap * * tap * * tap * *tap *. And then I looked up at the monitor. Much to my surprise a dramatic change in the EKG characteristic was there. I hadn’t expected that. It seems the person controlling the wireless programmer was testing different parameters on the device quietly in the background and this person was pacing only one lead rather than both leads as part of the device checking process. This programming change dramatically changed how the EKG appeared to this startled surgeon.

Checking these parameters, by the way, is perfectly appropriate. Every device has a series of tests that are performed on the device to assure that it is receiving signals from the leads within the heart correctly, that no lead was damaged during the device change, etc. No, this was not my gripe. That’s what you WANT people doing.

What bothered me was the lack of verbal communication between the person performing those tests and the operating physician. You see, the doctor performing the surgery should know when a programming change is being made to their patient’s device, just in case something is NOT done correctly or if there was a problem discovered. It avoids that startled rush of adrenaline that occurs when the garage door suddenly activates without your knowledge. Doctors don’t like it when things happen they don’t know about while their operating on a patient. Trust me on this.

So if you are a device representative or nurse in a lab or operating room responsible for performing programming of any wireless device, let the doctor know what you’re about to do before you do it. Tell him something like “I’m going to test the threshold of the right ventricular lead now, OK?” and wait for the doctor to acknowledge he is aware that changes are being made. Always, always, always keep the oral communication going when wirelessly communicating with these new medical devices.

Doctors will appreciate it, and patients will certainly benefit.

-Wes