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

New Guidelines for Endocarditis Prevention Published

Infective endocarditis (IE) is a devastating infection of the structures of the heart caused by blood-borne bacteria or fungi. These organisms can enter the blood stream during dental procedures involving infected tissues of the mouth. New guidelines were published before print today online in Circulation by the American Heart Association and the American Dental Association. The guidelines limit antibiotic prophylaxis to only those at highest risk of contracting endocarditis which are outlined below:

Cardiac Conditions Associated With the Highest Risk of Adverse Outcome From Endocarditis for Which Prophylaxis With Dental Procedures Is Recommended:

• Prosthetic cardiac valve


• Previous IE


• Congenital heart disease (CHD)*


• Unrepaired cyanotic CHD, including palliative shunts and conduits


• Completely repaired congenital heart defect with prosthetic material or device, whether placed by surgery or by catheter intervention, during the first 6 months after the procedure†


• Repaired CHD with residual defects at the site or adjacent to the site of a prosthetic patch or prosthetic device (which inhibit endothelialization)


• Cardiac transplantation recipients who develop cardiac valve abnormalities

- - -
*Except for the conditions listed above, antibiotic prophylaxis is no longer recommended for any other form of CHD.

†Prophylaxis is recommended because endothelialization of prosthetic material occurs within 6 months after the procedure.

Likewise, the antibiotic regimen has remained simplified, requiring only a single pre-procedure dose 30 to 60 minutes before dental work, with Ampicillin 2 grams orally (kids 50mg/kg) being the main antibiotic and Clindamycin (600 mg; kids 20 mg/kg) or Azithromycin or Clarithromycin (500 mg; kids 15 mg/kg) being suitable alternatives. Remarkably, gastrointestinal (GI) and genitourinary (GU) procedures no longer require antibiotic prophylaxis:

The administration of prophylactic antibiotics solely to prevent endocarditis is not recommended for patients who undergo GU or GI tract procedures, including diagnostic esophagogastroduodenoscopy or colonoscopy (Class III, Level of Evidence B). This is in contrast to previous AHA guidelines that listed GI or GU tract procedures for which infective endocarditis prophylaxis was recommended and those for which prophylaxis was not recommended.

You can find a full pdf file of the recommendations here.

-Wes

Pericardial Robotics

Robotics may facilitate pericardial procedures on the outside of the heart:

Since medieval times the leech has been used to cure everything from fever to possession by evil spirits.

Now doctors have brought it into the 21st century with a robotic version that can repair damaged hearts.
The tiny device slides across the surface of the still-beating heart, (and stabilizes itself on the surface of the heart using suction while potentially) delivering treatment without the need for open heart surgery.

Once inside the body, the Heart-Lander can inject drugs, attach pacemaker leads and may even be able to destroy damaged tissue.

This might be tough on patients with a prior history of heart surgery due to the presence of adhesions, but the concept is intriguing.

-Wes

Reference: Percutaneous Subxiphoid Access to the Epicardium Using a Miniature Crawling Robotic Device T. Ota, N. Patronik, C. Riviere, and M.A. Zenati Innovations, Vol. 1, No. 5, October, 2006, pp. 227-231.

Art and Cataracts

Could cataracts have affected some great artists' works?

Degas and Monet were both founders of the Impressionist era, and the style of both painters was well-formed before their eye disease affected their vision. But their paintings grew significantly more abstract in later life as, coincidentally, their eye problems increased.

Be sure to click on the slide show at the above link.

-Wes

The Last Opus

This is a remarkable photo series by Renee C. Byer of the Sacramento Bee with a family during the child's last days with terminal cancer - it richly deserved the Pulitzer prize it received.

-Wes

Hat Tip: Clinical Cases Blog

Drug Approvals: Who's Using Whom?

Only one word for Dr. Jerry Avorn's perspective piece in this week's New England Journal of Medicine: Amen!

-Wes

Who Moved the Cheese?

“After much consideration, I have decided to change the nature of my practice effective immediately.

I will be limiting my practice to no more than 600 patients in order to provide a level of individualized service and care that is not possible in the current medical environment. This reduction in practice size will afford me the time to focus of proactive, preventive care….”

So begins a letter I received from one of my referring physicians today. He’s a good guy, but he must have wanted to make a change. As I read his letter, I noticed it was printed on some fancy stationary emblazoned with a fancy “MDVIP” logo. MDVIP, I learned, is a company “focusing beyond concierge healthcare.” So I wondered how this company marketed this to my referring doctor.

This approach to internal medicine cannot be offered in most traditional primary care practices. A physician in a typical practice of 2,500 patients could not provide a comprehensive annual physical examination to all patients, as to do so would require approximately 2,500 hours, or one year. In that case, a physician would have no time available to deliver any care to patients other than the physical examination. By limiting their practice size MDVIP physicians have time to provide both extensive preventive and wellness care and treatment of acute and chronic illness.

I found impressive statistics on their website demonstrating how such a practice can provide reduced hospital admissions:

Reductions in hospitalizations are up to 65% for Medicare beneficiaries and up to a staggering 80% for those with commercial insurance. The results are scientific, not anecdotal and are because MDVIP physicians have the time to have much closer relationships with their patients.

And then I noticed that you can refer patients to other like-minded “MDVIP” physicians via their network in other cities. Even global rescue exists.

Wow. Our two-tiered health care system is here now, isn’t it? The cheese was moved long ago. And some business-minded primary care doctors have been smart enough to skim the walking well with insurance off the top early.

-Wes

The Eight-Dollar Ultrasound

Flood a market with ultrasound machines, and see what happens:

(WSJ) General Electric Co. and other companies have sold so many ultrasound machines in India that tests are now available in small towns like this one (Indergarh, India). There's no drinking water here, electricity is infrequent and roads turn to mud after a March rain shower. A scan typically costs $8, or a week's wages.

GE has waded into India's market as the country grapples with a difficult social issue: the abortion of female fetuses by families who want boys. Campaigners against the practice and some government officials are linking the country's widely reported skewed sex ratio with the spread of ultrasound machines. That's putting GE, the market leader in India, under the spotlight. It faces legal hurdles, government scrutiny and thorny business problems in one of the world's fastest-growing economies.

But their business practice model was simple:

The company also teamed with banks to help doctors finance the purchase of their machines. GE now sells about 15 different models, ranging from machines costing $100,000 that offer sophisticated color images to basic black-and-white scanners that retail for about $7,500.

To boost sales, GE has targeted small-town doctors. The company has kept prices down by refurbishing old equipment and marketed laptop machines to doctors who traveled frequently, including to rural areas. GE also offered discounts to buyers inclined to boast about their new gadgets, according to a former GE employee.

"Strategically, we focused on those customers who had big mouths," said Manish Vora, who until 2006 sold ultrasounds in the western Indian state of Gujarat for the Wipro-GE joint venture.

Don't think these "big mouth" sales practices are limited to India. I just wonder what will happen when the U.S. market becomes saturated with low-cost imaging devices. Maybe the analogy does not stop there: should CT scans of the heart be performed in healthy 40 year-old men without risk factors for coronary disease? Should ultrasounds be performed on healthy women with normal pregancies just to determine the child's gender? And what will happen when these techniques are used in other male-dominated societies, like China?

I wonder...

-Wes

Medical Specialization

Funny. But there might be some truth in there...

-Wes

Hat tip: Clinical Cases Blog

Health Care Quality Rankings Be Damned

Today pharmacy rankings produced by J.D. Power were posted on the Wall Street Journal Health Blog. It seems that even pharmacies are not immune to such rankings. The J.D. Powers’ ranking system is different that those created by individuals close to a particular industry and offers a glimpse into the minds of health care consumers. Issues like convenience, communication, economy and responsiveness to the consumer’s needs are paramount.

But remarkably I don’t use any of the pharmacies listed. I use my local pharmacist who lets me have a credit account, will deliver the drugs to my door (and those of many seniors in our area), and knows me (and my family members) by name. My needs must be different than those of the J.D. Powers survey respondents.

Not to be dissuaded, I decided to perused other rankings by J.D. Powers, particularly their Distinguished Hospitals ranking. It was interesting to note the dramatic difference in J.D. Powers “Distinguished Hospitals” for service excellence compared it the US News and World Report’s list of Best Hospitals. How remarkably different they are! Not a single university hospital exists on the J.D. Power list, but many university hospitals are on the US News and World Report’s list.

So which is better? Where should you receive your care?

It depends, doesn’t it? When we or a loved one is sick and hospitalized, we want the “best” care possible. But the best might be very different from one patient to another. For the young patient suddenly afflicted with a serious cancer, “best” might be the hospital center with the widest experience treating that form of tumor. For the aging senior who has been in and out of hospitals repetitively, “best” might be the center that makes accessibility and attentiveness to their daily needs most important (its amazing what free valet parking to do for a local center’s rankings).

But despite all of these rankings used as powerful marketing aides, the one thing that never waivers is this: the quality of the health care providers - the doctors, nurses, and technical staff (yes, even pharmacists) - is what really matters. Doctors that are not afraid to refer to others with more expertise, encourage second opinions, and look you in the eye as they speak are critical to me. Sure, the physical plant and information technology help, but if you can’t see your doctor quickly, talk to a real human being, and get the answers to your questions and support for your concerns in a timely and professional manner, you’ll take your health care business elsewhere - rankings be damned.

And you know what?

That’s the way it should be.

-Wes

Medical Grand Rounds - Vol 3, No. 30

Almost forgot. This week's medical blogging Grand Rounds is up over at Fat Doctor.

Enjoy!

-Wes

Shelhigh Company's Products Pulled

The FDA has seized all implantable medical devices, including pediatric heart valves, vascular conduits, and dural patches made by Shelhigh, Inc of Union, NJ due to concerns over sterility issues.

U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals today seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies in the company's manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.

The products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.

See the entire FDA alert here. So much for their No-React® Tissue Detoxification process.

Maybe this explains these failures with their valves.

-Wes

When the Heart Skips, Flips, Flops or Flies

Oh, I've got rhythm, I've got music,
I got my girl, who could ask for anything more?
I've got rhythm, I've got rhythm ...

- George Gershwin

So your heart does not have perfect rhythm? You're not alone. It seems I’ve been seeing lots of folks recently with the unpleasant sensations of a racing, irregular or forceful beating of the heart in their chest, commonly called palpitations.

The diagnosis of palpitations can be perplexing if they occur very infrequently. It seems many doctors I work with almost always initially order a HOLTER MONITOR to evaluate an irregular or rapid heart rhythm. A Holter monitor records every heartbeat over (usually) a 24-hour period. The newer Holter monitors record the electrocardiogram signal digitally and are less prone to artifact caused by variations in tape speed seen with older monitors that recorded the electrocardiogram signals to recording tape. Patients are asked to record the time of any symptoms they experience on a diary to include with the recording. Unfortunately, if you do not have symptoms the day the Holter is connected, a diagnosis for your symptoms is unlikely to be identified.

More often, I have found that an EVENT RECORDER (this example: Del Mar Reynolds Medical) is more reliable at capturing the cause of intermittent palpitations. This device is about the size of a pager and continuously records your electrocardiogram from two small electrodes attached to your chest in a continuous loop-like fashion. Your heart rhythm activity is recorded in a memory buffer that continuously refreshes new heart rhythm information over old information, thereby always haveing the last minute of heart rhythm in its memory. When a symptom strikes, you can push a button on the top of the device to lock the preceding minute of the heart rhythm in the memory of the device while it records an additional minute of the electrocardiogram. Later, at a time that is convenient, the signal can be transmitted via any phone line to a reading site. The nice thing about event recorders is they ae usually issued for a month at a time, making them especially useful for intermittent rhythms. Some newer companies have event recorders that are even disposable, eliminating the administrative overhead of retrieving the devices and reducing the number of trips the patient needs to make to the office.

HEART CARDS (First Call Medical), a small credit-card sized device with four electrodes on the back of it, are not my favorite recording device. While its advantages are that it is small, it only records what the heart is doing at the time the device is held to the skin over the chest. Women are not likely to use this device for obvious reasons. While patients complain to be that this can be embarrassing to use in a public space since the device emits a tone as it records, their problems are offset, to some extent, by their simplicity.

If these devices are ineffective and the diagnosis remains elusive, a rarely used device can often succeed where other devices fail: an IMPLANTABLE LOOP RECORDER (Medtronic, Inc.). This device is surgically implanted beneath the skin in a minor same-day surgical procedure under local anesthesia. Like the event recorder, it continuously records the electrocardiogram from two small electrodes on the device. If the patient feels a rhythm, they can place a small “actuator” over the device and lock the rhythm occurring before and after the symptom within the device’s computer memory. Perhaps the best feature of this device is that it can be set to “auto-trigger” for heart rhythms above or below a set cut-off value, making the need for a patient to have to capture the rhythm unnecessary. This is particularly useful for older patients. One drawback to this device is that monthly visits to your doctor should be performed to check the memory of the device to see if there is was a rhythm stored within its memory that was not perceived. Since the device only holds the last 5 episodes in its memory, heart rhythm abnormalities not perceived by the patient might be missed otherwise. Battery life of the device typically lasts 14 months and most people opt to have the device surgically removed after that time.

So next time you feel your heart doesn't have rhythm, you can always "ask for anything more."

Like one of the devices above.

-Wes

Pharmaceutical Dragnet

Ladies and gentlemen: the story you are about to hear is true. Only the names have been changed to protect the innocent.

“Doctor, I think I saw that lady who just went out to the waiting room stuff a bunch of samples in her coat!”

“Really?”

“What’d she take?”

“Boxes of those Coreg CR pills just dropped off by the drug rep.”

“Why did he leave them there? * sigh *”

Tuesday, February 12. It was cold in Chicago. We were working the day watch out of the pacemaker division. My partner's Ben Romero. The boss is Ed Backstram, chief of detectives. My name's Friday. Doctor Joe Friday.
(Doctor Friday enters waiting room to confront suspect.)

“Ma’am. We have reason to believe that you might have been the perp in a recent drug heist here in our office.”

“Who me?”

“Yes ma’am.”

“But I was just waiting for my husband who’s having his defibrillator checked.”

“Yes ma'am. But did you pass in the proximity of the front counter?"

"I did."

"And might you have taken a few boxes of the Coreg CR on our counter?”

“No.”

“You do realize that the new Coreg CR pills do not have the same bioavailability as regular Coreg, and that these are once a day pills, not twice a day, don’t you?"

“They are?”

“Yes ma’am. We wouldn’t want any of our patients overdosed, you know.”

Suspect reconsiders. “Well, I might have taken one. Here you go. I’m sorry.”

Doctor Joe Friday returns to office area, feeling victorious. Secretary confronts said doctor.

“I know she has many more boxes, did you frisk her?”

“No.” Doctor Joe Friday returns to waiting room.

“Ma’am? Did you or did you not return all boxes of Coreg CR? We have reason to believe that there may be others. You wouldn’t be holding others, would you?”

Patient feels guilt. Eyes of fellow suspects fall upon her. She then produces 8 more boxes of Coreg CR from her purse and overcoat.

“Any others?”

“No. Really.”

“Thank you, ma’am.”

In the end, another criminal brought to justice.

“But we don’t even try to prove that crime doesn’t pay ... sometimes it does.”

- Jack Webb

-Wes

Dear Patient: P4P is Here

Dear Mr. and Ms. Patient,

I regret to inform you that I will be spending less time focusing on your heart problem because I have decided to focus on the heart and medical problems that Medicare deems important to assure I get paid. They call this initiative "Pay for Performance (P4P)."

You see they published a list of 74 criteria that will be measured to see if I give good care, so I will get paid appropriately. Fortunatelty for cardiologists, we only have to do four things:

The ACC (American College of Cardiology) is asking cardiologists to report on these Physician Consortium for Performance Improvement (PCPI), National Quality Forum (NQF)-endorsed measures, which include at this time:
• ACE or ARB therapy for heart failure patients with LVSD (left ventricular systolic dysfunction)
• Antiplatelet therapy prescribed for CAD (coronary artery disease) patients
• Beta-blocker therapy prescribed for CAD patients with prior MI (myocardial infarction or heart attack)
• Beta-blocker therapy prescribed for heart failure patients with LVSD

And the specifications for how we should do this providing and documenting good care can be found here (Caution, this pdf file is 181 pages long!).

So, dear patient, I'm sorry if you have pericarditis or heart block. I'm gonna need to focus on my heart attack and heart failure patients a bit more to make sure my office staff can still return your calls.

I hope you understand.

Sincerely,

-Wes

Blazing Bidets

Blazing bidets and the "Tornado Wash:" where's Medgadget when I need 'em?

-Wes

Governmental Efficiency

Amazing that the FDA will soon charge medical device companies 65% more for their device reviews, yet promise only a 9% reduction in their device review time:

(Wall Street Journal) The agency said Monday it will ask the industry for a 31% increase in fees in 2008 compared to fiscal 2007, with an additional 8.5% raise in each of the four subsequent years. Fees are charged for a variety of things including a fee for companies that file for premarket approval applications for medical devices.

...

In exchange for the additional fees that would be charged to companies, the agency has slightly accelerated its timetables for completing application reviews. For example, the agency has set a goal of reviewing 90% of applications for new medical devices within 295 days rather then a current goal of 320 days.

But AvaMed, a conglomerate "trade group" (a.k.a., lobby) of Big Business interests is behind the move, it seems.

I wonder why? Is it really on the basis of improving safety for the patients they serve?

Or might this be an alternate means to cooerce the judges while providing funds to other elected officials?

“We look forward to working with policy makers to move this important agreement through the Congress,” said (Stephen J.) Ubl.

Once enacted, it'll be hard for Congress to ask device companies to lower prices, won't it?

-Wes

Mr. Stephen J. Ubl is president and CEO of AvaMed.

Reference: The FDA Announcement

Boston Scientific Dumps One Boat Anchor

Finally, Boston Scientific received notice from the FDA that their manufacturing process can again begin releasing new products, removing a significant boat anchor to the stock's valuation. Patients should benefit, too, from new product releases and better quality assurance in the production process.

The removal of the sanctions allowed the FDA today to approve four software upgrades to existing implantable devices and authorize a new supplier for a manufacturing component, Boston Scientific spokesman Paul Donovan said in an interview.

But this slow-down was not without cost, as the device-maker has lost significant defibrillator and pacemaker product share to Medtronic and St. Jude Medical over the past twelve months.

Now the other 1,175 boat anchors in the form of lawsuits filed over Guidant's defibrillators remain.

-Wes

Ima Fake, MD, PhD

P = M.D.

That was the most important formula in medical school. If you passed your course work and clerkships, did it satisfactorily, and made the grade, you’d get to place those initials after your name.

But the path was not easy: countless hours of study, testing, ward rounds, sleepless nights and call. The day a student of medicine graduates from medical school is one of the proudest days of their lives: it culminates years of disciplined study and hard work.

A PhD designation after one’s name is equally (and some would argue even more) arduous, requiring years of study, a long dissertation, oral examination, and peer review process that is daunting.

But for those who want to put the initials "MD" or "PhD" (or both) after their name, there’s an easier way: push-ups, sit-ups, and payment of a $5000 “fee” to the Illinois Department of Professional Regulation:

(NYT) Dr. (Ronald M.) Klatz and Dr. (Robert M.) Goldman are not afraid to take on their critics. In the last few years, they have been embroiled in legal disputes — with the State of Illinois, over offshore medical degrees they received in the late 1990s, and with professional critics whom they sued for giving them a “silver fleece” award in 2004 for promotion of questionable anti-aging products. (That suit was settled last November; its terms are confidential.)

…

Through his lawyer, Dr. Goldman said that he had received two doctoral degrees from “distance learning programs,” which he said had required “work with a mentor, textbook reading and testing.” A fitness buff, he says in a biography posted on www.worldhealth.net that he has held world records for one-armed push-ups (321) and consecutive sit-ups (13,500).

Both men received medical degrees in 1998 from the Central American Health Sciences University in Belize, without, they acknowledged, ever having studied in the country. Dr. Klatz and Dr. Goldman say through their lawyer that they earned their medical degrees with transfer credit from previous academic work and a year in clinical rotations in Mexican hospitals.
Licensing authorities in Illinois did not recognize the Belize degrees, and in 2000 fined the doctors $5,000 each for adding M.D. after their names. They agreed to a cease-and-desist order with an exception: books already printed or being reprinted with the contractual requirement that they be identified as M.D.’s. They were also allowed to continue using the M.D. designation on their résumés.

It seems Dr. Goldman gets to use the PhD designation, too.

I’m so glad the medical licensing body in Illinois is so careful to protect our medical profession – never mind the patients subjected to the questionable practices of Drs. Goldman and Klatz in the use of human growth hormone injections as a fountain of youth.

But then I better not say anything else. I might get beat up.

-Wes

Drs Klatz and Goldman are licensed doctors of osteopathy (DO) in the State of Illinois.

2016 Olympics in Chicago?

Great logo. Great city. And now they've been picked as the US representative to compete against the rest of the world to host the 2016 Olympics.

Congrats, Chicago.

-Wes

How to Ruin a Good Cocktail Hour

... just learned about this olive recall that could kill you due to botulism.

Sheesh.

-Wes

Thief Helps Victim With Apparent Heart Attack

A funny story, complete with video:

It started when the masked robber walked into the Kangaroo Express and demanded the cashier open the safe. When she told him she didn't have the keys, he ordered her to empty whatever cash was in the register into a bag.

That's when 60-year-old Mary Parker faltered and told the stranger she was having chest pains.

He allowed her to sit on a stool and explain he was forced to turn to robbery because no one would hire him. Security video captured the bizarre conversation that took place next.

"I have heart trouble. Help me," she pleaded.

"I'm sorry, ma'am," was the reply.

"I have heart trouble," she repeated.

"Ma'am, it's going to be all right," the gunman reassured.

"I'm probably going to have a heart attack," she continued.

"Oh my, ma'am, please do not have a heart attack. Please do not have a heart attack. Please don't, ma'am," he responded, starting to panic. "I'm sorry, I'm sorry."

"I'm having a heart attack, honey," she continues. "I'm having a heart attack."

And then he let her call 911, even allowing her to use her own cell phone when the one at the store stopped working.

Be sure to see the whole story - it gets better...

-Wes

Welcome to My World - Part 2

For those who might have missed the earlier Part I of this post regarding a rapid wide complex arrhythmia in a young man, and want to give this case a try, click on the link. Otherwise, the answers to this mystery will be disclosed below.

This is a case of a wide complex, regular and very rapid rhythm in a young (remarkably minimally symptomatic) man. There are several possible causes of an arrhythmia this fast in the young patient.

Little was known about this young man when he presented to the Emergency Room – which was just as the ER doctors saw him. There was a rush to treat him - to do something, but careful reasoning can help in the decision making process with such a case. It is helpful, therefore, to review the differential diagnoses. Possible causes of such a wide comlpex arrhythmia include:

• Ventricular tachycardia (VT) - Certainly, in the elderly patient with such a wide complex, regular tachycardia the most likely diagnosis would be ventricular tachycardia. But ventricular tachycardia can occur in the young patient with prior structural or congenital heart disease. So called “normal heart ventricular tachycardias” of the right ventricular outflow tract variety (manifest my a left bundle branch, inferior axis ventricular tachycardia) or idiopathic left septal ventricular tachycardia (manifest by a right bundle superiorly directed axis) can also present like this patient.



• Supraventricular tachycardia (SVT) with aberrancy – at this rate and with this regular rhythm, atrial flutter with 1:1 conduction would be the most common diagnosis, although some focal atrial tachycardias could also occur at this rate. Certainly, athletic, healthy individuals can occassionally conduct one-to-one down the normal conduction system (AV node), but often one of the distal bundle branches cannot support this rate, leading to aberrant conduction. Note that the morphology of lead V1 is not that of a characteristic right bundle branch block (no rSR' morphology is seen) and it is not characteristic of a left bundle branch block (no QS morphology either). Much more likely, however, is 1:1 conduction of atrial flutter across an accessory pathway. The presence of a large RS complex in lead V1 would suggest anterograde conduction accross a left-sided accessory pathway - but left ventricular ventricular tachycardia remains in the differential here as well.



• Finally, antidromic atrioventricular reentrant tachycardia (down an accessory pathway to the ventricle and retrograde up the AV node or a second accessory pathway to the atrium) is a much rarer, but possible cause for the arrhythmia seen. (For review, recall that "ortho-" means "straight." Since orthodromic atrioventricular reentrant tachycardia proceeds down the AV node to the ventricle and retrograde back up the accessory pathway to the atrium, it creates a narrow-complex supraventricular tachycardia (SVT). This is NOT what was seen in this case.)

So What Should You Do?

While there are no absolute correct answers, there are a few caveats that can be shared. First, electricity (synchronized cardioversion, typically after sedation) is a very acceptable option. When such a patient presents to the Emergency Room, one cannot be sure whether the rhythm is an SVT or VT, but cardioversion would correct either arrhythmia.

Alternatively, some might attempt treating this patient with a medication since he appeared fairly stable on presentation. But not any medication will do. First of all, Adenosine could be attempted, but here’s one scenario that could play out: if he has atrial flutter that then converts to atrial fibrillation, his atrial rate might go even faster and conduct across the accessory pathway, fibrillating the patient. (oops!). Verapamil is also contraindicated in this situation since it changes the fibrillatory threshold of the ventricle and may facilitate conduction over the accessory pathway, leading to ventricular fibrillation (oops!). A beta blocker might drop the blood pressure precipitously but would not slow and accessory pathway’s conduction (if indeed this is what the patient had). Amiodarone slows conduction in both the AV node and accessory pathway, and could treat ventricular tachycardia, but it takes too long before a measurable clinical effect can be identified. As such, it is not the best drug in this situation.

Perhaps the best drug to use in this circumstance due to its ability to be rapidly administered and its ability to slow conduction in both the AV node and accessory pathway while also being effective for ventricular tachycardia, is procainamide (Pronestyl).

So What Happened?

Well, the doctors weren’t sure what was happening, but they had extensive experience giving Amiodarone IV for ventricular tachycardia in the ER, so they started this medication. Unfortunately, the diluent in IV Amiodarone can cause blood pressure to drop if the drug is given too quickly – and that’s what happened. He became hypotensive and uncomfortable, so the doctors did the right thing and sedated him. Unfortunately, they only used 50 Joules of energy, and the following EKG was noted after the cardioversion:


Now there is an irregular rhythm that is mostly wide. Note that after very rapidly-coupled beats, there is a gap and a single narrow beat noted – this is where the atrial fibrillation rate actually exceeds the refractory period of this patient’s accessory pathway, and so one beat is narrow, before aberrant conduction across the accessory pathway resumes. Unfortunately, the doctors were still confused, but called for help.

Procainamide (1 gram over 20-30 minutes) was administered, and the rhythm spontaneously converted to sinus rhythm after approximately 30 minutes. The EKG then looked like:


Note the characteristic delta waves, perhaps most easily seen in lead I. What was also interesting was the “pseudo-Q” waves in II, III, and aVF caused by a “negative” delta wave. Such a finding localizes the pathway on the posterior aspect of the heart. With continued slowing, these “pseudo-Q” waves in II, III, and aVF became more prominent:


Final diagnosis: Atrial flutter and atrial fibrillation with evidence of a manifest left posterior accessory pathway (Wolff-Parkinson-White Syndrome).

Epilogue: The patient was taken to the Electrophysiology Laboratory and a left posterior mitral annular accessory pathway was successfully ablated. During the electrophysiology study, both atrial fibrillation and atrial flutter were demonstrated but did not persist. Here is the EKG after ablation:


Note the new inverted T waves in II, III, aVL. This finding is fondly called “T-wave memory" in electrophysiology parlance following catheter ablation. It is thought that the abnormal depolarization over an accessory pathway results in abnormal repolarization, and following ablation of an accessory pathway, the cells near the prior accessory pathway have persistent abnormal repolarization for a period of time. This finding usually resolves in a week or two. This is NOT due to myocardial ischemia (lack of oxygen).

Hope this was informative. Thanks to all the brave souls out there who risked it all to play along! Have a great weekend.

-Wes

On Doctors Saying They're Sorry

"If you cut, you bleed."

So said a sage surgical colleague of mine. He was referring, of course, to the fact that unfortunate outcomes are part of what we do as doctors. No one is perfect. No invasive procedure without risks and no two cases are alike or medical co-morbidities the same. Doctors who "cut" usually spend significant time explaining the procedure, its inherent risks, and possible outcomes - hopefully good, but sometimes, not so good. Even in the best of hands, unfortunate outcomes do occur.

But as hard as it may be for many to realize, a bad outcome does not always mean that malpractice occurred during the course of a procedure. When unfortunate outcomes occur, I still believe it is appropriate to say you're sorry. Doctors are humans too, after all, and most care deeply about their patients.

Risk managers seem to welcome doctors speaking with patients after a mishap and saying they're sorry.

The wave of "I'm sorry" laws is part of a movement in the medical industry to encourage doctors to promptly and fully inform patients of errors and, when warranted, to apologize. Some hospitals say apologies help defuse patient anger and stave off lawsuits.

A law in Vermont exempts only oral statements of regret or apology, not written ones. Illinois gives doctors a 72-hour window to safely apologize after they learn about the cause of a medical mishap.

But malpractice insurers are not thrilled with the risks inherent to this procedure:

Boston-based ProMutual Group, which insures 18,000 doctors, dentists and health care facilities in the Northeast, warns its clients against apologies that admit guilt -- even in states that have laws protecting doctors who say they are sorry.

It distributes a tip sheet cautioning doctors against uttering the words "error," "mistake," "fault" or "negligence."

"We encourage physicians to apologize about the outcome, not necessarily for any error that may have occurred," ProMutual spokeswoman Nina Akerley said. "Apology is not about confession."

But the real reason risk managers are eager for doctors to fess up early is not to show our altruistic side, I've learned. It's actually about legal statute of limitations.

(Chicago Tribune) On average, the states took 15 to 24 months before a medical injury was reported to insurance carriers. For Illinois and Nevada, it took 67 months on average to close after injury.

"Several factors influence the decision concerning when to file a medical malpractice claim, including statute of limitations restrictions and the need to ascertain various medical, work-related, and pain and suffering expenses," the authors said.

In Illinois, the minute a doctor acknowledges that there was a problem, a hidden clock starts that lasts three years. You see defense attorneys know about the bungled system of justice here in the US, and once an admission of responsibility about an injury occurs, plaintiffs have three years to have the case tried. And given my experience with how long it took a civil suit to wind its way to the courthouse, I can see why there's a push by risk managers to have doctors disclose.

-Wes

Reference: US Department of Justice Bureau of Justice Statistics: Medical Malpractice Insurance Claims in Seven States, 2000-2004.

Welcome to My World - Part 1

A 20 year old presents to the Emergency Room because his palpitations changed and felt more “severe.” He is awake, conversant, and his pulse is thready and tachycardic – the nurse thinks it was “fast.” His initial blood pressure: 80/60. His initial EKG, clocking in at 285 beats/min, is shown:


“Yikes!” says the resident.

“Yikes!” says the ER attending.

So what do you say?

Remember the first rule of ER medicine: Take your own pulse first. Then, what could this be and what therapy would you recommend?

-Wes

Realism versus Optimism

This morning, a realist spoke in the editorial section of the Chicago Tribune and it was refreshing. Frederick R. Lynch, a government professor at Claremont McKenna College, wrote:

Americans historically have been a death-denying people, but the aging of Baby Boomers may change all that. Actor-politician Fred Thompson, a potential GOP presidential nominee, has just announced that he is in remission from lymphoma and that he will "not be affected in any way by it." His full-speed-ahead reaction was an echo of Tony Snow's and Elizabeth Edwards' responses to cancer recurrences that continue to attract public attention and discussion -- a signal that the forever young will not go quietly into that good night.

This is in sharp contrast to the optimistic (and in my view bordering on ridiculous) ‘Chasing Life’ campaign being promulgated over at CNN by Dr. Sanjay Gupta where 'Living to be a 100’ by just changing a few lifestyle habits exemplifies the problems when personal gain and media hype trump reality. As Dr. Lynch states:

Besides testing bedrock beliefs in work and success, Boomers' lifelong faith in scientific salvation is also fading. Older Boomers are recognizing that much-anticipated magic bullets may not arrive in time. Heart and circulatory death rates have been reduced through bypass surgery, statins and behavioral change; early detection and prevention have proved effective against diabetes and some cancers; but aggressive cancers and some other lethal illnesses remain stubborn foes.

Absent scientific breakthroughs, highly educated, driven Boomers facing serious health issues are falling back upon their related faith in "management" and take-charge "empowerment." In "The Year of Magical Thinking," author Joan Didion was struck by her successful friends' confidence in their ability to control their own lives -- even life-threatening illness. "Their initial instinct was that this event could be managed. In order to manage it they needed only information ... They believed absolutely in the power of the telephone numbers they had at their fingertips, the right doctor, the major donor, and the person who could facilitate a favor." Indeed, in discussing the Edwards and Snow cases, several talk-show hosts and experts assured audiences that cancer increasingly is a "manageable disease" like other chronic conditions such as diabetes. (Contrarian Boomers invoke their generation's dictum to "get real." The late Texas political columnist Molly Ivins bluntly summarized four years of breast-cancer treatment: "First they mutilate you; then they poison you; then they burn you.")

While optimists certainly have their place, to suspect that we have perfected the formula of life misleads and misinforms patients. But then, Dr. Gupta is trying to sell his book, isn’t he? I mean, sweepstakes?

-Wes

The Hand-Carried Cardiac Ultrasound

Perhaps a useful tool in the evaluation of murmurs and heart muscle function in the cardiology and medical clinic settings, the hand-carried cardiac ultrasound device might reduce the need for conventional echocardiography. But given that cardiologists earn significant income from performing and interpreting standard echocardiograms, would they ever use this device?

-Wes