Friday Chuckle

Most of us are familiar with On-Star, the electronic road-side assistance service available on many GM cars. Although it's been out a while, it seems there is a special version for blondes, called BlondeStar.

-Wes

Still Smoking? Look at This

From England, this picture is one of many to appear on cigarette packs to make people think twice about smoking:

However, this particular package slogan might be considered misleading given the proximity of the turmor to this man's airway and carotid arteries: his death might not be so slow after all...

-Wes

21:00 - And if this is not enough, comes this report today suggesting that gene expression changes brought on by heavy smoking may persist long after the smoker has kicked the habit.

Blue Cross Illinois to Permit Reimbursement for CTA

Effective 1 September 2007, Blue Cross/Blue Shield of Illinois will permit reimbursement for CT Angiography for the following conditions:

Computed Tomography (CT) Angiography (CTA), with or without contrast enhancement or media, utilizing 64-slice or greater multi-detector row CT (MDCT) scanner, as an adjunct to other testing may be considered medically necessary for any of the following indications:

A. Detection of coronary artery disease (CAD) in:

Symptomatic individuals (such as, chest pain syndrome as described by the American College of Cardiology [ACC]) who:
Have intermediate pre-test probability of CAD (as identified by the ACC guidelines); AND
Had a non-diagnostic stress electrocardiograph (ECG or EKG) (as defined by the ACC guidelines); AND
Have a contraindication to an exercise stress test or for whom the results are equivocal or suspected to be inaccurate, OR
Symptomatic individuals with unexplained chest pain or anginal equivalent symptoms (as described by the ACC) who:
Have intermediate pre-test probability of CAD (as identified by the ACC guidelines); AND
Had no ECG changes suggestive of ischemia or infarction; AND
Had negative cardiac enzymes and cardiac marker results; AND
Have a contraindication to an exercise stress test or for whom the results are equivocal or suspected to be inaccurate.

B. Evaluation of cardiac structure and function:

To assess complex congenital heart disease, including anomalies of coronary circulation, great vessels, and cardiac chambers and valves; OR
To assess coronary arteries in individuals with new onset heart failure when ischemia is the suspected etiology and cardiac catheterization and nuclear stress test are not planned; OR
To assess a cardiac mass (suspected tumor or thrombus) in individuals with technically limited images from echocardiography, magnetic resonance imaging (MRI), or transesophageal echocardiography (TEE); OR
To assess a pericardial condition (such as, pericardial mass, constrictive pericarditis, or complications of cardiac surgery in patients) with technically limited images from echocardiography, MRI, or TEE; OR
For non-invasive coronary vein mapping prior to placement of a biventricular pacemaker; OR
For non-invasive coronary arterial mapping, including internal mammary artery prior to repeat cardiac surgical revascularization; OR
For evaluation of pulmonary vein anatomy prior to invasive radiofrequency ablation for atrial fibrillation; OR
To assess coronary arteries in asymptomatic patients scheduled for open heart surgery for valvular heart disease in lieu of invasive coronary arteriography.
Note: Refer to the Rationale in this medical policy for guidelines issued by the ACC.

MDCT with less than 64-slice scanner is considered experimental, investigational and unproven.

CTA, using MDCT, to screen asymptomatic individuals for CAD or to evaluate individuals with cardiac risk factors in lieu of cardiac evaluation and standard non-invasive cardiac testing is considered experimental, investigational and unproven.

CTA, using MDCT, for any other indication not listed above is considered experimental, investigational and unproven.

Note: For any other Electron Beam Computed Tomography (EBCT) Technology applications, such as Whole Body Scanning or Imaging for screening, see policy RAD604.006; for CT for Calcium Scoring, see policy RAD604.009.

It's a whole new world...

-Wes

Reference: Blue Cross/Blue Shield Illinois' website.

Hunting Season

With fall comes a new season: recruiting new physicians.

For cardiology groups nationwide there is a vigorous push to recruit the best and brightest of our medical school fellowship candidates to join groups of specialists and subspecialists.

But inevitably when I interview candidates, I find the same debate circulating in the young cardiologists’ minds: private practice or academics?

Most cardiology candidates come from an academic background: that is, lots of support staff, collegial interaction daily, work hour restrictions, a familiar turf, a call-night hierarchy that filters the less important nurses’ calls to the resident and in-house physicians before the call to the attending.

In contrast, there is the siren song of the "mega-bucks" private practice setting. While initially appealing, this appeal is quickly tempered the realization that higher wages come at significant personal cost. Aggressive business practices of today's successful private practice groups demand more from their young cardiologists: seeing more patients in less time, no work hour restrictions (work until the work is done), being directly responsible for a patient’s care, understanding the complexities of billing and diagnosis codes, and often working alone late at night to accomplish these business goals. How many graduating fellows are prepared for this? I dare say, none of them.

So they sit in my office for their first interview for the big wide world and squirm. Appropriately. These are tough decisions.

Sure, there are practices that have tried to balance the transition from fellowship to an attending by developing mentor programs or lightening the load in the clinic for a few weeks. But there is no substitute for experience – irrespective of the practice environment encountered. Having come from a military practice setting, then private practice, now back to a somewhat hybrid practice situation, I felt it might be helpful to share a few the thoughts about what attendings-to-be should consider during this transition period:

(1) It is helpful to remember that about 50% of all first-year physicians change jobs. Don’t over-commit to a large fancy home, huge mortgage, and don the "golden handcuffs.”

(2) Look at the practice environment you are entering. Is the hospital fiscally sound? Do people in the community want to bring their families there, or to the competing hospital across town? Is the group well-respected in the community? Are most of them older and due to retire soon?

(3) Probably the most important question to understand as you enter a new practice environment: Who’s the competition? Irrespective of practice setting today, everyone is in competition for patients and the almighty health care dollar. If you’re walking into a practice with rose-colored glasses, take them off and get real. Research your environment.

(4) Ask to call someone who just left the practice. Why did they leave?

(5) Know the community. Take time to be sure it is safe, conducive to raising a family (if that is your goal) and has an acceptable cost of living, schools, etc. Realize that tough-to-recruit places generally have higher starting salaries: if you’re offered $400,000 your first year, you'd better know why.

(6) Learn how to bill. If you have no clue what a CPT or ICD-9 code is and how they interact, you'd better learn. Like it our not, this is how you will be paid. I can honestly say that I left hundreds of thousands of dollars on the table early in my career because I had no clue how to bill.

(7) Does the practice have a business manager, or are you and your physician-colleagues expected to perform this function yourself? Who will make sure you are billing correctly, hire and fire staff as needed, be sure human resources standards are kept, manage billing processes? Having been in a private practice without a capable business manager at the start of my career, I'd never do this again.

(8) Understand compensation arrangements. Is the practice a socialist "even-split" model or a productivity "eat-what-you-kill" model. Is it a balance of the two? Most practices will support your salary initially, but after the one- to three-year grace period, how will you be paid? Is there a buy-in to the group? If so, how it it handled?

(9) Have an exit strategy. Although no one wants to consider this initially (call it the "rose-colored glasses" phenomenon), this might be one of the more important considerations. For instance, if you decide to leave a practice, will you be responsible for a "tail" of malpractice insurance? If there a restrictive covenant? If so, is there another practice outside the covenent where you could work at to prevent having to move your family, or would you have to move to a new town if the practice opportunity falls through?

(10) Consider your experience and expertise when negotiating salaries and benefits. New attendings have little negotiating ability in this regard, but people who have been out in the world a while bring real-world experience to the table and might be able to demand a higher starting salary. That being said, be sure to inquire about the growth potential both professionally and financially should things work out.

In the end, the decisions are still tough. Certainly not all areas are covered here (I'd welcome other suggestions), but careful consideration of these ideas are sure to help smooth the transition from trainee to attending physician.

Best of luck.

-Wes

Should Defibrillators Be In Schools?

Just in time for the back-to-school season comes this report on the epidemiology of cardiac arrest in our schools.

The report adds much to our knowledge of the epidemiology of sudden death in schools from two large counties near Seattle, WA, USA. Of 3773 episodes of cardiac arrest in a public domain over 16 years, 97 arrests occurred in 671 schools but only 12 of these occurred in children.

The incidence of sudden death among (adult) school staff was 25-fold greater than that among students. Given the additional contribution of other adults not employed by the school, greater than 90% of cardiac arrests in schools occurred among adults. The finding supports the assertion that school-based CPR and AED programs would benefit faculty and staff members, as well as visitors to the school who, because of their age, are at greater risk of cardiac arrest than the students.

And while some doctors are in favor of expanding CPR and AED distribution, others are not:

"It is estimated that over 350,000 individuals die of sudden cardiac arrest in the U.S. each year," said Dr. Gregg C. Fonarow, a professor of cardiology at the University of California, Los Angeles. "Improved cardiac arrest recognition and emergency activation, early CPR, and early defibrillation, including the use of AEDs, can significantly increase the chances of surviving sudden cardiac arrest."
This study provides important community-based data on the incidence, circumstances and outcome of cardiac arrest in the school setting, Fonarow said. "This study found that half of the student cardiac arrests were not associated with physical exertion or sports participation, and student risk was similar for elementary school, middle school, high school and college," he said.

The majority of cardiac arrests in schools occurred among adults, Fonarow noted. "The finding supports the assertion that school-based CPR and AED programs would benefit not only students, but faculty, staff members, as well as school visitors, and provides important data for considering increasing CPR training and the availability of AEDs in the school setting," he said.

Another expert disagrees. The very rarity of cardiac arrests at schools makes having AEDs available unnecessary, he said.

"Any cardiac arrest in a student, especially if it occurs on school grounds, gets a lot of media attention," said Dr. Byron Lee, an associate professor of cardiology at the University of California, San Francisco. "This has led some to call for AED in every school."

However, because cardiac arrest at schools is extremely rare, and only a minority of cardiac arrests occurs in the students, "it seems unlikely that putting an AED in every school would be cost-effective," Lee said.

But what was remarkable in this study was the unusually high success rates of public access defibrillation by lay rescuers. From the study:

Seven of the school-based cardiac arrests received lay-rescuer defibrillation. Survival to hospital discharge among cardiac arrests was 39% in school settings (46% for initial rhythm of ventricular fibrillation) compared with 27% in other public locations.

These data, in my view, make a compelling case for the wide availability of public access defibrillation. It is survival to discharge from a hospital that matters, and there is nothing that will improve survival in that setting better than a beating heart. The chest thumping of CPR, while helpful temporarily, only mildly improves the chance of survival following cardiac arrest until the coordinated contraction of the heart can be restored with defibrillation.

-Wes


Reference: Katayoun Lotfi BS, Lindsay White MPH*, Tom Rea MD, MPH, Leonard Cobb MD, Michael Copass MD, Lihua Yin MBA, Linda Becker MA, and Mickey Eisenberg MD, PhD. "Cardiac Arrest in Schools," Circulation 2007 doi:10.1161/CIRCULATIONAHA.107.698282

Image credit.

Sermo and the AMA

Peter Turner over at Opensource.Association has some interesting thoughts on Sermo and its relationships with the American Medical Association.

My point is why does the AMA need them to create an environment where “people come together, have their voices heard, and send messages out?” In fact, advocacy is not the main purpose of Sermo which is to sell aggregated information to institutional clients of Sermo....
Would you trust this model?

Doctors are paid for posting and even given Amazon gift cards to join. One student doctor said he was getting between $40-100 per month as a result of his postings. Clients (those in the lower half of the Sermo business model diagram below) pay a subscription fee and in return can post questions to the Sermo community. If doctors vote on one of these postings, they may be financially rewarded for “your astute observations.”

And I especially like the part that explains that full access to JAMA and the Archives journals are free on Sermo, but AMA members must pay for them.

-Wes

Line of the Week - No.2

From a 90 year-old:

"If my computer gets a virus, could it infect my pacemaker?"

Impressive question from one so young.

-Wes

The Best Chest Pain Case

As a cardiologist, we all have one: our best “chest pain” case.

I thought I had the best… until last night. That’s when one of my colleagues, a very skilled cardiologist, told me his. I’m afraid his took the prize, hands down.

You see, he has two daughters who grew up during his residency and fellowship years in cardiology. They heard the millions of calls he received to return to the hospital for a heart attack victim. These daughters were about ages 3 to 5: you know, those years where his daughters really didn’t want to go to bed when they were told to. But he and his wife were bound and determined to have the girls get to sleep, so one night they jointly vowed not to respond to the girls’ requests at bedtime:

“Mommy, can you bring me a glass of water.”

They held fast.

“Moooommmmmmyyy, can you turn on the light in my closet?”

They laid quietly together, and gently whispered, “Get to bed girls.”

“Mommy, I’m hungry.”

They stood fast and failed to reply.

Finally, the room fell silent. They felt victorious. But the victory was short-lived. Before long they heard:

“Daddy..... I have chest pain.”

-Wes

Food for Thought

I recently ate dinner and paid my tab at a local restaurant.

I looked at the amount: $53.61

Tell me, was it a good meal?

What, you’re having trouble telling what the quality of the meal was from how much I paid? What's that you asked? Oh, you want to know how many people were dining? Why that's not important! Just tell me: was it a quality meal?

Impossible to tell, right?

Now imagine your "Checkbook" just won the jackpot and got its hands on a database of 4 billion or so Medicare payment amounts and the names of the doctors that received them.

Tell me, which of these doctors are the good, er, quality, doctors?

Come on, people. You have the DATA! What the heck's wrong with you? There it is, black and white. Surely you'd send your wife or child to the doctor with the most receivables from Medicare, right?

Oh, no? What's the matter? Having trouble making the connection between Medicare payments received and the quality of a physician?

Me, too.

-Wes

A Decorating Idea With Heart

Now here's something to pass some time, and to decorate your local cath lab or EP lab.

Yes, I tried it and it was pretty easy and hangs next to our computer terminal in our EP lab.

-Wes

St. Jude Pacemakers Enter Trade War

SeekingAlpha reports an interesting tidbit regarding presumed "voltage variation" problem with some of St. Jude's pacemakers sent to China and how the return might have represented a trade relatiation move.

Although five devices were found defective, the entire shipment of 272 devices was returned. The shipment had a value of $236,294, a small amount for a company like St. Jude. But safety issues have significant commercial ramifications, which the heart device companies like Medtronic (NYSE: MDT), Boston Scientific (NYSE: BSX), and Johnson & Johnson (NYSE: JNJ) have discovered over the past two years. As have the Chinese, though for other products.

The most important takeaway from this story is the implication of retaliation. So far this year, the Chinese have been battered by charges of a variety of safety issues – toothpaste, dog food, cold medication, and most recently lead paint on toys. At first, they denied that a real problem existed. Then they issued a number of press releases that detailed how the government would increase surveillance to ensure that Chinese exports would be safe.

Although St. Jude scoffed at the accusations, I wonder what voltage variations we should tolerate, since lower voltages imply shorter device longevity?

-Wes

Some Big Storms

Some big storms rolling though Chicago right now...here's one of many huge trees felled by the storm with 60-80 MPH winds:





Yeee haaaah....

-Wes

19:37 Addendum: After the next front went through. we went past 7 inches of rain so far this month. Here's some pics of our streets right now. Fortunately, the basement's still dry...




Wow - this is more rain than most of us have ever seen around here. Many, it seems, are not as lucky as we've been. Here's some info where people can donote to the American Red Cross to help with disaster relief efforts.

-Wes

Blaming It All on Red Bull

In case you haven't seen it, there's been a report of aborted sudden death circulating about in the press and blog-o-sphere about a guy who drank too many Red Bulls, and had a cardiac arrest.

Everyone wants to blame Red Bull.

But was Red Bull to blame?

Here's how the press painted the episode:

Mr Penbross, a concreter, regularly had four Red Bull drinks a day.

"With the work I do I don't have a lot of time to eat," he said. "I have a couple of Red Bulls in the morning and it carries me through."

Last Sunday he was competing in a motocross event near Port Macquarie when he consumed eight Red Bulls over five hours.

"It was to get a bit of a buzz and keep down my reaction time," he said. "You have got to get off [the mark] and around the first corner first."

After his event, Mr Penbross, from Bonny Hills, noticed his heart racing. He collapsed soon after.

He was taken to Port Macquarie Hospital before being flown to Newcastle.

For the record, Redbull contains the about same amount of caffeine as a cup of coffee:

A 7 oz cup of coffee has the following caffeine (mg) amounts, according to Bunker and McWilliams in J. Am. Diet. 74:28-32, 1979:

Drip 115-175
Espresso 100mg of caffeine
1 serving (1.5-2oz)

Brewed 80-135
Instant 65-100

Sure, too much caffeine can cause the heart to race. And some studies have suggested it raises blood pressure, but at least one long term study did not substantiate this effect. And over five hours, about half of his caffeine had metabolized, provided he had a normal liver. Most reported deaths from caffeine overdose (usually from pills) have occurred with 50-100 times the amount of caffeine as this man ingested.

So was caffeine really the CAUSE? Of was it a mere bystander? We will probably never know.

But I was also intrigued by the part of the article that mentioned what his cardiologist had said:

He said Mr Penbross had no other risk factors apart from smoking and had told him he previously experienced chest pain at times when his intake of the drinks was high.

Now I never saw this dude, but given this story, one wonders about previously undiagnosed coronary disease as the cause of his cardiac arrest. Oh, sure, the Red Bull might have increased the heart's requirement for oxygen if his rate or blood pressure increased, but the lack of delivery of oxygen around an area of fixed obstruction from a plaque is more likely what made a young man's heart fibrillate and develop full cardiac arrest.

I wonder: did anyone suggest this man stop smoking?

-Wes

A Medical Blog-o-sphere First

Meet Dr. Richard Keller from Lake County, IL. He's probably the first blogging coroner.

-Wes

Now I've Heard it All: Noise Can Affect Your Heart?

It seems the World Health Organization (WHO) thinks so:

Thousands of people in Britain and around the world are dying prematurely from heart disease triggered by long-term exposure to excessive noise, according to research by the World Health Organisation. Coronary heart disease caused 101,000 deaths in the UK in 2006, and the study suggests that 3,030 of these are caused by chronic noise exposure, including to daytime traffic.

But what's amazing is how they came to this conclusion:

The WHO came to its figures by comparing households with abnormally high exposure to noise with those in quieter homes. It also studied people with problems such as coronary heart disease and tried to work out if high noise levels had been a factor in developing the condition. This data was then combined with maps showing the noisiest European cities.

Man, this is worse than smoking, or hypertension, or hypercholesterolemia! Imagine all those poor new mothers with crying babies at risk of sudden death! Or worse still, construction workers should have prophylactic defibrillators implanted before using that jackhammer! Quick everyone, don your ear plugs. It might just save your life!

And if it doesn't, well at least you won't have to listen to this report...

But to be fair, there have been reports of sudden death in patients with Long QT syndrome who are startled by a sudden loud noise such as an alarm clock. And noise does increase adrenaline levels. But is noise alone the CAUSE of all of these cardiovascular deaths in Britain when NO other confounding variables have been controlled?

What gets into these guys?

-Wes

References:

New Scientist's "Special Report".

World Health Organization's Noise Web Page.

Huge Facial Tumor Partially Removed

Remarkable video of the young Chinese man who underwent removal of a portion of a huge 23 kilogram facial tumor... and the poor guy's still got more to go...

-Wes

h/t: Healthbolt

HeartSurgeons.com Bidding Update

Well the bidding has ended. It seems $17,350 failed to reach the "Reserve" price to purchase the domain name "HeartSurgeons.com." I wonder what they purchased it for originally?

Still, it was an impressive showing.

-Wes

Remote Magnetic Catheter Ablation of Atrial Fibrillation Stumbles

This week, Dr. Luigi Di Biase and his colleagues from the Cleveland Clinic reported in the Journal of the American College of Cardiology their early results of magnetic navigation to aid catheter ablation of atrial fibrillation in 45 patients during pulmonary vein isolation procedures. The results were poor at best, especially for the near $2 million dollar price of the technology.

Marketed by Stereotaxis as a safe and effective means for performing atrial fibrillation procedures, magnetic navigation was able to negotiate catheters to appropriate locations, but the technology, with its current generation of specially-designed floppy magnetic ablation catheters, failed to adequately electrically isolate the pulmonary veins (except in one patient) and had a significant 33% incidence of char formation on the conventional temperature-controlled (non-irrigated) ablation catheter tip.

From the article: Char found on the ablation catheter tip after an ablation lesion.

Whether the system will be able to perform better with irrigated-tip ablation catheters under development with Biosense-Webster remains to be seen. For now, based on this report, the use of conventional temperature-controlled catheter ablation with the magnetic navigation system appears to add no benefit to the more conventional atrial fibrillation ablation procedures.

-Wes

Reference: Di Biasi L, et. al., "Remote Magnetic Navigation, Human Experience in Pulmonary Vein Ablation," J Am Coll Cardiol 2007; 50:868-874.

This Week's Grand Rounds

... is up over at MedSource.

Defibrillators in Athletes?

The new ICD registry might help us understand the risks of these devices in this patient population.

-Wes

The Challenges of Measuring Outcomes with Guidelines

In Circulation’s published-before-print edition this week, results of the CRUSADE trial (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines) were published.

This trial compared the care received by patientswas with acute coronary syndromes (unstable angina, non-Q wave myocardial infarctions) admitted to a specialty cardiology service versus a general medical service. Patient characteristics, the use of American College of Cardiology/American Heart Association guidelines class I recommendations, and in-hospital outcomes by the specialty of the primary in-patient service (cardiology versus noncardiology) in patients from 301 tertiary care hospitals were compared. A total of 35 374 patients (63.2%) were primarily cared for by a cardiology service, and these patients had lower-risk clinical characteristics, but they more commonly received acute (<24 hours) medications, invasive cardiac procedures, and discharge medications and lifestyle interventions.

Their findings? While non–ST-segment elevation acute coronary syndrome patients primarily cared for by a cardiology inpatient service more commonly received evidence-based treatments and had a lower risk of mortality, these patients had lower-risk clinical characteristics (healthier patients did better).

This, then, leads to the question, were the improved outcomes an effect of application of guideline-based therapies, or just selection bias (healthier patients were referred to cardiology because they had fewer co-morbidities)? It was impossible to tell by the data collected.

So why is this study important?

Because performance measures (as determined by application of Class I guideline recommendations for the management of acute coronary syndromes), while measurable, were still unable to determine if improved outcomes were from the application of guideline recommendations, or just a matter of the healthier population to whom these guidelines could be applied.

This throws in to doubt the legitimacy of CMS’s pay for performance initiatives using the application of lock-step guidelines to measure outcomes, since these guidelines are applied disproportionately to healthier patients.

-Wes

Image credit.

Pacemaker Leads: Is Ping the Thing?

Imagine having no pacemaker wire between the pacemaker pulse generator and the heart. It seems it has happened:

(theheart.org) A remote ultrasound energy source may one day replace implanted pacing leads in permanent pacemakers, results from a pilot study suggest [1]. Dr Kathy L Lee (University of Hong Kong, China) and colleagues used an ultrasound transducer on the chest wall to transmit energy to a receiver electrode on the tip of a transvenously placed electrophysiology catheter in 24 patients, reporting their results in the August 28, 2007 issue of the Journal of the American College of Cardiology.

The system, says Lee, "works by transfer of energy in different forms: ultrasound energy is transmitted through the chest wall to a receiver in the heart, and the energy is transferred back into electrical energy for direct myocardial stimulation or pacing. Conventionally, the electrical impulse is delivered via a pacing lead; with transfer of ultrasound energy, no pacing lead is required. . . . When this technique is mature enough for clinical use, it should be less burdensome, as less hardware is implanted."

...

The authors tested their ultrasound transducer and receiver electrode during or immediately following clinical electrophysiology procedures in 24 patients, testing a total of 80 pacing sites in the right atrium, right ventricle, and left ventricle; two additional sites were excluded from testing because ultrasound energy could not be consistently "captured" by the receiver electrode. Ultrasound energy from the transducer was amplitude-adjusted and transmitted at levels ranging from 313 kHz to 385 kHz. The receiver electrode, containing circuitry to convert the ultrasound energy to electrical energy, was positioned on the tip of a steerable bipolar electrophysiology catheter. Lee et al report that pacing was successfully achieved at all 80 test sites and consistently achieved at 77 sites, with no adverse events and no patient discomfort. Mean distance between the transducer and receiver was 11.3 cm but ranged from 5.3 to 22.5 cm."

It seems the frequencies used might have interference issues with conventional cell phone technologies in its present form, but this report demonstrates an important "proof of concept" of the application and has exciting ramifications for future pacemaker technologies.

-Wes


Reference: Lee KL, Lau CP, Tse HF, et al. First human demonstration of cardiac stimulation with transcutaneous ultrasound energy delivery: Implications for wireless pacing with implantable devices. J Am Coll Cardiol 2007; 50:877-883.

Guidelines: Not for Doctors Anymore

My printer nearly burned up printing the nearly 160-page guidelines of the American College of Cardiology for management of unstable angina and non-Q wave myocardial infarctions (heart attacks).

While these "guidelines" are helpful and contain the latest in evidence-based research to justify the recommendations, they now exceed the length of chapters of our classic textbooks of medicine for their specific problem. It was interesting to note that these guidelines dwarf the classic chapter in Braunwald's Heart Disease (7th ed.) with its chapter on the same information that spans just 30 pages.

These guidelines are now being written more for regulators, I'm afraid, than doctors.

-Wes

References: Cannon CP and Braunwald E. "Chapter 49, Unstable Angina and Non-ST Elevation Myocardial Infarction" in Zipes DP, Libby P, Bonow RO, Bruanwald E (eds.), Braunwald's Heart Disease - A Textbook of Cardiovascular Medicine, 7th ed., pp 1243-1273.

Speeders' Wee Weenies

A new ad campaign remainds speeders in Australia that this activity results in, er, shrinkage.

Brilliant.

-Wes

Survival in Diabetes

..it's all about the heart:

The key to saving lives is to reduce levels of LDL cholesterol to below 100 and also control other risk factors like blood pressure and smoking. The cholesterol reduction alone can reduce the very high risk of heart attacks and death from cardiovascular disease in people with diabetes by 30 percent to 40 percent, Dr. Cleeman said. And clinical trials have found that LDL levels of 70 to 80 are even better for people with diabetes who already have overt heart disease.

-Wes

A New Commercial Cause of Sudden Death

And to think these babies are available to the public...

A good shot to the chest, and bammo: stunned maybe, but possibly dead, too. The implications are discussed over at Dr. Helen ...

h/t: Instapundit.com

Another Cause of Financial Death

We're gonna be seeing more of this...

From the article's side bar:

Here are the line-item charges from Santa Barbara Hematology and Oncology for Kathleen Aldrich's final round of chemotherapy over two days in the spring of 2005. Carboplatin and Docotaxel are the main anti-cancer drugs; Neulasta is given to help boost white blood cells destroyed by chemo.

April 28
Office visit: $166.56
Chemo infusion: $446.72
Chemo infusion: $104.96
Carboplatin: $3,867.50
Docotaxel: $5,726.56
Infusion: $240.56
Dexamethanose: $40.00
Kytril: $320.00
Benadryl: $4.83
Saline: $60.00

April 29
Office visit: $43.44
Injection: $50.00
Neulasta: $5,700.00

Total: $16,771.73

Source: Santa Barbara Hematology's account statement as filed in Santa Barbara County Superior Court.

When I read this, I wondered, who's a "fault" here? The doctor's office? The insurer? The patient?

But I could not help to note the prices of a single dose of the drugs administered to this patient...

-Wes

Warfarin's Labeling Fiasco

As practicing cardiac electrophysiologist, I have great respect for the blood thinning medication, warfarin (Coumadin®). You see, a good portion of my patients with atrial fibrillation take this drug to reduce their risk of stroke.

Warfarin has a complicated pharmacology: the dose you take today isn’t likely to affect you blood thinning level for about three days; and it has a complicated, yet very specific effect, blocking the production of Vitamin K in one’s liver. It blocks Vitamin K by “competitive inhibition:”

Warfarin inhibits epoxide reductase (specifically the VKORC1 subunit), thereby diminishing available vitamin K and vitamin K hydroquinone in the tissues, which inhibits the carboxylation activity of the glutamyl carboxylase. When this occurs, the coagulation factors are no longer carboxylated at certain glutamic acid residues, and are incapable of binding to the endothelial surface of blood vessels, and are thus biologically inactive. As the body stores of previously-produced active factors degrade (over several days) and are replaced by inactive factors, the anticoagulation effect becomes apparent. The coagulation factors are produced, but have decreased functionality due to undercarboxylation; they are collectively referred to as PIVKAs (proteins induced [by] vitamin K absence/antagonism). Hence, the effect of warfarin is to diminish blood clotting in the patient.

But Vitamin K is not just made in the liver. Vitamin K is also made by bacteria that reside in the gut.

This is why blood thinning levels sky-rocket when people take antibiotics – not because they necessarily affect the production of Vitamin K in the liver, but rather that the antibiotic kills the gut bacteria that provide an important amount of Vitamin K to the blood stream. Genetic testing tests humans, not the bacteria that reside in human’s gut. And the number of other confounding drug interactions reads like a Who’s Who of pharmacology.

So it is interesting that today’s Wall Street Journal discusses that the FDA is going to add a labeling change to warfarin that says that the initial lower warfarin dose “should be considered for patients with certain genetic variations.”

Never mind that the testing is not covered by all insurers.

Never mind that this testing adds significant costs.

Never mind that the testing takes about 10 days to return, is performed at only one lab in North Carolina, and returns only AFTER the initial dosing is performed in the first place.

Never mind that there have been no prospective, multi-center, randomized real-world clinical trials demonstrating that the application of these tests effects outcomes or reduces the incidence of bleeding in patients – especially patients carefully monitored in specialized “coumadin clinics.”

Never mind that it exposes doctors to significant claims of negligence if the tests are not used.

Never mind the conflict of interest that exists within the FDA’s fee-for-review structure that makes this labeling change sound like a boon for the genetic testing companies and a kick-back to the FDA.

And what if a patient refuses warfarin because they were found to be positive for a genetic defect, citing their risk of bleeding might be too high without really knowing the risks?

Will the FDA want to talk to my patient after their stroke?

-Wes

18:24 - Addendum: Links fixed.
19:30 - The FDA's News Release and the Package Insert (pdf) - Genetic recommendations are on page 25.

A Quiet Hero

Yesterday, at my father’s funeral, I hugged a quiet hero.

He was a quiet, humble, gentle man.

He had only known my father for one year, exactly.

This hero took the time to get to know him,

One who flew below the radar.

He was a man my father knew as “the quarterback,” and the consummate optimist, especially when he needed it most,

A man who told it like it was, always,

A man my father trusted with all his soul.

He was a man who helped my mother, held her hand, gave her strength, and still does, even now.

He was a man who took the time, even when there was no time.

And there he was, at the back of the church.

He entered quietly, without me knowing.

But when he left, we shed a tear, and hugged.

My hero,

Dad’s doctor.

-Wes

Eeny, Meeny, Miny, Moe

The take-over rumors are rumbling on Boston Scientific's drop in share price. But if I were Johnson and Johnson (JNJ), who would I want, a stock that has been pummeled and continues w/massive debt, or a company with about the the same market cap that has had a steady record of growth over the past year?

Decisions, decisions.

-Wes

Heart Surgeons: Now's Your Chance

It seems that the HeartSurgeons.com domain name is up for sale. Either a clever entrepreneur is offering this for your acquisition, or Mid-Atlantic Surgical Associates has fallen on tough times. They seem intrigued that Cardiology.com reportedly went for $550,000, but I've seen this amount proported by two different purchasers over the last three months. Seeing as Cardiology.com has internet dating and music downloads associated with it, I'm not sure it's such a good deal. Gee, could HeartSurgery.com want to go the same way?

Given the declining surgeries heart surgeons are seeing this days, though, it might be a declining asset and go for cheap.

Right now, the bid is $102.50 on e-Bay.

-Wes

Addendum: 16 Aug 2007 @ 1830: Wow, bidding's up to $8,600!

Cardiology as Cards

Fun art by physician-turned-artist Don Stewart, MD appears this morning in the Birmingham News.

-Wes

The Basics of Cardiac Bypass

Courtesy of DoctorsHangout.com:



-Wes

h/t: Dr. Subrahmanyam Karuturi.

McCardiac Arrest

McDonald's answer to Hardee's Monster Burger in Australia:

Some of the fast-food chains sell super-sized Quarter Pounders, which contain about 220g of fat and 11,500kJ each, on request.

The "double pounder" is the equivalent of more than three days' worth of fat for a grown man - or almost five Pizza Hut deep-pan Hawaiian pizzas or 45 Tim Tams.

"Have it Your Way" takes on new meaning. And for $0.99 more, they'll throw in a defibrillator, too.

-Wes

ADDENDUM: In this related article, it seems the Australian Medical Association wants to take McDonalds $330,000 for use of their heart-healthy logo, but then turns around and claims to the media "Sheesh. These things are really BAD for you!"

Looks like they got their hand caught in the cookie jar, just like our AMA across the pond...

The X-Ray Tech Pointillist

Neo-impressionists used it, so why not an xray technician? Stunning works by a talented artist. You can see how he created his works on video if you scroll down on this webpage.

-Wes

The Sea Change

In My Humble Opinion nicely articulates how the changes in the health care system have affected physician attitudes toward their profession.

-Wes

Doctors vs. Lawyers - Part II

This is interesting. The Chicago Tribune has a site to check on campaign contribitions to the 2007 Presidential Campaign.

I typed in "Doctor" under the Occupation field and got:

254 contributions totaling $255,011.71.

Then I typed in "Lawyer" in the Occupation field and got:

1,489 contribtions totaling $1,653,421.35.

So I wonder whose interests will be attended to first in the political health care debate?

-Wes

Lawyer Jokes

Three general surgeons are in the locker room after a long day's work. Two were younger, energetic types; the other, more senior. One of the younger surgeons asked:

"Hey, what's your favorite patient to work on?"

"Oh, hell, that's easy," said the youngest surgeon. "I like engineers. You open them up and all of the parts are labelled numerically. To put them back together you just connect the parts labeled '1' to the other part labeled '1', '2' to '2', and so forth."

The other younger surgeon piped in, "I like artists for the same reason. They're all color-coded. You connect the red pieces, the yellow pieces, the green pieces and so forth."

The crusty old surgeon had heard enough. As he was straightening his tie, he said, "You're all full of shi*. Everyone knows that the best patients to work on are lawyers. Hell, the only have two parts, a mouth and an a**hole, and they're both interchangeable."

I heard this joke years ago. Chuckled, and moved on. No doubt there's plenty of similar jokes about doctors.

But in an interview with the director of media and public relations with the Allegheny County Bar Association, they asked, "What are you going to do about lawyer jokes?"

Seriously.

It seems the Allegheny Bar Association is concerned about this survey:

In a 2002 survey by the American Bar Association, only 19 percent of 450 individuals polled said they had extreme or high confidence in the legal profession. Lawyers ranked second-lowest in the study, just above the media, which garnered a vote of confidence from only 16 percent of those surveyed.

Some of the reasons lawyers aren't respected, according to the survey: They "are more interested in winning than seeing justice served;" "spend too much time finding technicalities to get criminals released;" and are "more interested in making money than in serving their clients."

Most of my neighbors are lawyers. They are very nice people. Really. But lawyers can bill for their time, right down to the minute. The rest of the world gets paid by the hour, but lawyers get paid by the minute. Lawyers are smart and have an inside edge to the legal system here in America, and know how to sue. And they sue sometimes for ridiculously big sums.

But now it's spreading to the Pennsylvania Bar Association, too:

The Pennsylvania Bar Association is also tackling the image issue. It has retained a Philadelphia media consultant to create a three-commercial campaign that will air beginning in April on CBS television affiliates in Pittsburgh and Philadelphia, an ABC affiliate in Erie, and on cable stations in central parts of the state.

...

The state bar -- with about $400,000 to spend on its campaign -- also plans radio spots and an improved Web site to get its message out.

So does a marketing campaign by the Allegheny and Pennsylvania Bar Associations that serves to add additional expense to the already high minute-by-minute wages for lawyers and might be considered a "frivolous" concern serve to help or hurt their profession?

-Wes

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Thanks, Kevin for the legal help.

And hat tip to Overlawyered.com.

Medtronic Purchases MRI Patents

Medtronic made a necessary purchase of Biophan's intellectual property for its newly-introduced MRI-safe pacemaker product line. They got off pretty cheap: $11 million, and avoided later legal challenges that were sure to arise if they had not made the purchase. The next question is, since Biophan was best-known for their work in this space, will they have enough intellectual property left to survive?

-Wes

Mini-Motors For Your Heart

For patients with severe congestive heart failure, new innovative technologies seem to be developing rapidly, perhaps because heart failure represents a very common end-stage cardiac ailment and transplant donors are just too rare.

Recently, there have been a slew of new miniature pumps being developed for heart failure patients. One such device, recently implanted in the first human in Europe, is Synergy, a new left ventricular assist device from Circulite, Inc. The first patient was enrolled in their European Bridge To Transplant Feasibility Trial in June, 2007 with the first implant announced in a press release yesterday.

The technology is interesting on several fronts. First, the pump is of a remarkably small size and is designed to withdraw blood from the left atrium via the fossa ovalis, and pump blood into a subclavian artery.


This may permit an eventual percutaneous approach to implantation. Unfortuantely, it seems a portion of the device still resides outside the patient, making the potential for long-term use due to infection risks limited.


Nonetheless, the pump may offer an interesting left ventricular assist capability for patients with the most severe forms of heart failure.

My only criticism is on such early technologies is the marketing they do when a new gizmo is under development. Take, for instance, Circulite's video (downloadable here) that demonstrates the mechanism that the pump facilitates the heart. In the end, we see a moderately overweight smiling fellow looking like a terrorist bomber with the batteries strapped to his chest, throwing on his sport coat and jaunting off happily. Given that most of these sick pre-transplant heart patients can't even walk from their bed to the bathroom, could they please spare the feel-good shenanigans?

-Wes

Hat tip: MedLauches.com

Recycling Defibrillators and Pacemakers

"So, does your husband have any devices that might damage the crematory?"

"He has two artifical hips," she said.

"No, I mean like pacemakers or defibrillators that might explode when incinerated."

"No," she said.

And the conversation continued today. I could have done without it, but was fascinated by the fact that our funeral home asked this question. So I had to ask:

"So you remove them?"

"Yep, and now the manufacturers want them sent back to them, but a patient brought an article describing how some of these are recycled for poor countries. It was in the Sun Times."

"Do you have that article?"

"Sure. Here it is."

I looked and saw my colleague at University of Chicago, Brad Knight, MD who researched the fact that most people would want their loved one's device donated, if it could be, and realized this is in opposition to the new Heart Rhythm Society's mandate to return all defibrillators to the manufacturer for "analysis" to assure "quality" devices are manufactured. This new mandate must make it tough for groups like Heart to Heart, a nonprofit group in Billings, Montana that collects pacemakers and defibrillators from funeral homes and families to gives them to Solidarity Bridge and other groups for use in Third World countries.

If it were me, I'd want to donate my Dad's, too, if he had had one.

These are remarkably expensive devices, costing between $20,000 and $35,000. Sadly, some of them are used for a remarkably short time. Should we just dispose of a device with the potential to save someone else?

Somehow, the "official" take by Medtronic in the article fell flat to me:

But Medtronic, a leading manufacturer, opposes reusing the devices in people. A spokeswoman said the company cannot ensure recycled devices are as safe and reliable as new devices. The complex devices might be hard to sterilize, and cleaning and reprocessing could have a "debilitating effect on the durability of the materials."

What if Medtronic could be absolved of the liability, in such a case? There's a lawyer somewhere who could make that happen, isn't there? Also, consider that re-sterilization could use a variant of a cleansing agent and water, followed by exposure to ethylene oxide, the same technique used to sterilize the original device. Perhaps Medtronic could add this to their philanthropic efforts already under way?

They should.

But in the meantime, here's the flier with the address if you want to donate your loved one's device.

And Brad and company? Sorry I didn't about know this sooner. Keep up the good work.

-Wes

09:12 AM CST Update: This from Solidarity Bridge's website:

One of the most serious medical issues facing Bolivia today is Chagas, a parasitic heart disease, which affects 1.8 million Bolivians, mostly those who live in poverty or rural areas. In 2004, Solidarity Bridge forged a partnership with the Medtronic Corporation who committed to donating hundreds of thousands of dollars worth of pacemakers and other related heart surgical supplies to save the lives of poor Bolivians afflicted with Chagas. These devices cost upwards of $8,000. The average wage in Bolivia is between $50 and $100 a month, making it impossible for the poor to receive the medical aid they need without our help. Since 2001, we have sent 685 pacemakers to Bolivia. This program functions in three cities: La Paz, Cochabamba and Santa Cruz and draws on patients from the entire country.

It is my understanding that these are "expired devices" that Medtronic has donated - not used devices.

Imagine: Physical Exam Can Save Lives

Embarassingly, a study in the British Medical Journal Online First reveals a window into the "non-touch," paint-by-numbers world of health care today: it seems that if doctors actually checked a pulse, they might be able to reduce the risk of stroke by detecting atrial fibrillation.

Who knew?

What will our government-run health care systems think of next?

-Wes

Touching Down

Dad had the perfect glideslope and touched down at 5:07 PM CST tonight - on Peace Day.

-Wes

The Paper Cranes

Sadako Sasaki was two years old when the bomb was dropped on her home city of Hiroshima on August 6, 1945. Saduko seemed to escape any ill effects after her exposure to the bomb, until, ten years later, she developed leukemia, "the atom bomb disease."

While she was in the hospital, her friend Chizuko brought her a folded paper crane and told her the story about it. According to Japanese legend, the crane lives for a thousand years, and a sick person who folds a thousand cranes will become well again.

Sadako folded cranes throughout her illness. The flock hung above her bed on strings. When she died at the age of twelve, Sadako had folded six hundred forty-four cranes. Classmates folded the remaining three hundred and fifty-six cranes, so that one thousand were buried with Sadako.

In 1958, with contributions from school children, a statue was erected on Hiroshima Peace Park, dedicated to Sadako and all the children who were killed by the atomic bomb.

Each year, on August 6, Peace Day, thousands of paper cranes are placed beneath Sadako's statue by people who wish to remember Hiroshima and express their hopes for a peaceful world. Their prayer is engraved on the base of the statue:

This is our cry, this is our prayer; peace in the world.

My mother, a former school teacher, read this tonight at my father's side as I held my his fasciculating hand. She had saved this story with a million other papers that she found poignant. I know she did not realize the date. I'm convinced God wanted it read.

Peace in the world. May you find peace, too, Dad.

-Wes

Reference "Sadako and the Thousand Paper Cranes," by Eleanor Coerr.

The Sadaku Statue.

Close Encounter

Disclaimer: My spousal consultant, in the interest of retaining my current place of employment, has insisted that I take a moment to note that this case occurred at a previous location, that will go unnamed, although I suspect it has happened elsewhere.

It was a case like every other Friday afternoon - a lady in her 80's who needed a permanent pacemaker after falling at home and arriving to the Emergency Room with a heart rate of 30.

After a careful evaluation of her situation and agreeing that a pacemaker made sense, I discussed the risks, benefits and alternatives to a permanent pacemaker implantation with her, and she agreed.

She was brought to the pre-operative holding area and her left upper chest was prepped with an antiseptic solution for 5 minutes. She was pre-medicated with an antibiotic to avoid infection, and after wheeling her into the electrophysiology laboratory, her chest area was prepped twice more with antiseptic solution.

Great care was used to drape her first in sterile towels, then this was covered with an antiseptic-impregnated plastic film that was draped over the surgical site. Next the sterile final drape was carefully exposed over the operative field to shield all other contaminated areas from affecting the surgical site. A plastic cover was placed over the image intensifier of the x-ray tube, and finally, her face exposed to the nurses on the other side of the bed.

A local anesthetic was infiltrated beneath the skin:

"You'll going to feel a pinch and a bit of burning as we numb up the area here, Mrs. Smith."

She jerked slightly, but soon tolerated the anesthetic. After all, this was the necessary step to avoid the discomfort of the pacemaker implantation. She tolerated the anesthetic administration remarkably well.

A bright light shown from my forehead, an operative light strapped there to permit the light to move where my visual field traveled. It illuminated the surgical area remarkably well, causing the patient to question, "What it that light I see flashing?" she asked.

"Oh, it's just a bright light I use to see into the surgical area, Mrs. Smith." She silenced as the sedation took effect.

A small silver scalpel blade was then pressed against the skin and passed to the subcutaneous tissue in one smooth stroke. Bleeding was managed with gentle pressure and a cauterization unit stopped the flow of significant bleeding.

Suddenly, a small flurry of activity occurred in the back of the laboratory. I was unaware at first. It was just a minor scuffle. But soon one of my technicians could be seen standing on a chair waving a towel.

"What the...? Can I help you guys?"

"No, thanks. Just keep working."

"How the hell can I keep working when you guys are dancing on chairs around the EP lab?"

"Well, it just... well... this...."

"Whaaaaatttt???"

"... this... this... fly."

"What the hell are you talking about? You mean we have a fly in here?"

"Yes, sir."

"Turn off my headlight, guys! I don't want that sucker over here!"

The light was dimmed. We stood motionless, waiting for any hint of motion from the little tiny black contaminated object.

Nothing.

We waited.

My technicians had a vague idea where they had seen it last. They approached one corner of the operating suite. Suddenly, like a Komikaze pilot aiming for the sterile surgical drape, the fly turned perilously close to the surgical field but veered off at the last moment toward the room light above. My technician, armed with a medium sided towel, hurled himself toward the critter, but as he turned to address the flying foreign body, his head collided with the xray monitors dropping him to the ground like a giant sequoia. He rose quickly, determined to capture the maggot with wings, blood dripping from his brow. The fly, impervious to the damage below, circled above. I stood scrubbed, helpless.

By now, the nurses, too, had joined the chase. The fly had become Public Enemy Number One. Nothing could proceed until we were assured of its demise. The contol room technician and industry rep, too, helped identify the location and trajectory of the defiled detritus with wings.

"In-coming," I said as the fly approached the surgical field.

A maze of hands attached to towels swooped in to prevent the flying refuse residue from entering our "no-fly" zone. But his velocity exceeded their swipes. As he approached the surical field, they withdrew. The fly made a close pass, but hurried past to the corner of the operating room. There, it made one critical error: it landed briefly.

By now, my blood-stained technician, fire burning from his eyes, descended on the critter with such might, it looked like a scene from Apocalypse Now, and the fly was flattened. He raised his hands, victorious.

We all breathed a collective sigh of relief but stood stunned at what had just transpired. Soon, my headlight was illuminated once more.

"Well alrighty then... Anybody got some valium for the doctor?"

-Wes

Photo credit.

Specialization

So my wife goes to see her opthalmologist for minor surgery to remove a growth on her eyelid. She doesn't take kindly to needles and becomes vagal - nearly passing out as she tries to rise from the examining chair.

Her ophthalmologist, not blinking an eye, states: "Don't you dare fall. I have no idea how to bill for the care you'll receive if you do."

-Wes

Feeding the Beast

I want to be the first to go on record and say that a 90-minute door-to-balloon time for the treatment of an Acute Coronary Syndrome is not good enough.

After all, there are two important studies that appeared in Circulation this week (here and here) that have demonstrated that maybe half of the patients can achieve the 90-minute goal if we just devote enough resources! The Wall Street Journal even noted how cleaning staff can be diverted to help transport patients in smaller, outlying health care facilities:

When a Level 1 heart case is declared, everyone has a specific job to do. One rural hospital assigns its cleaning lady to help push the stretcher to the helicopter. "Level 1 is all you have to say," says David Larson, an emergency-room doctor at Ridgeview Medical Center who helped develop the protocol. "You're all on the same page right off the bat."

I still think we can do better. I think we should have, say, 30-minute door-to-balloon times! We could save many, many more lives if we just focus, people!

Here’s how it will work:

When Charlie gets chest pain at 3AM, we’re gonna set up a system whereby he’ll just lift his cell phone, punch and hold “5” on the keypad (it’s the central number, and dialing just one number will save 30 seconds!), and activate the Emergency Chest Pain System (ECPS).

The ECPS will be a well-coordinated team of specialized health care professionals devoted to saving lives 24/7/365. State-of-the-art telecommunications will permit live, continuous monitoring of transport operations from Emergency Rooms of each of the designated Centralized Chest Pain Centers (CCPC). Even Charlie’s cell phone will transmit his continuous EKG on a Specialized Medical Frequency (SMF) to the CCPC in real-time. The ECPS will have a Centralized Coordination Center (CCC) that will help determine which resources we should bring to bear to save Charlie’s life. The CCC will have at its disposal decision-support software that will have live feeds from GPS, weather, and ground transportation monitoring systems specially-developed to streamline patient flow from the street to the Emergency Room.

Should there be a tie-up of traffic on I-94, then the CCC will determine the location where Charlie’s cell phone originates from and re-route the response team from the ground to the air. A specially designed Sikorsky jet helicopter that we have designated for this purpose equipped with the latest medical technology and defibrillators. Never mind that you can't hear a blood pressure on the helo. It's time that matters! The Sikorsky will also permit twice the range as conventional medical helicopters because it is equipped with jet engine technology. Charlie can just walk out his door and the Sikorsky will come to him! (Time saved – 45 minutes!). Oh, and don’t worry if there might be inclement weather, our team of crack professionals will have specially-designed helo’s equipped with the latest infrared and night vision systems to tackle any weather!

Next, we’ll need to clear the airspace. Once the ECPS is activated, the government air-traffic control system will be notified by the CCC to clear the airspace to provide the most direct flight path between Charlie and the CCPC. Time saved (10 minutes).

Once Charlie arrives at the CCPC, specially-designed transport tubes will ascend from the CCPC to meet the Sikrorsky hovering overhead, and apply high, continuous suction to expedite Charlie’s transport into the Angiography Suite at the CCPC. Money will be saved here because people will no longer be needed to transport Charlie from the aircraft to the catheterization laboratory. (Time saved - 10 minutes)

There, our well-trained and ever-attentive gnomes doctors who will now be living at the facility around the clock (time saved - 30 minutes) to support the expedited care, will perform the necessary catheterization procedure to open Charlie’s artery.

What did you say? His EKG only showed T wave inversion? Well, we’ll cath him anyway, just to be sure!

After all, the Beast is hungry.

-Wes

Medtronic's Most Popular Defibrillator Lead Faulty?

Could Medtronic's very popular downsized defibrillator lead, the Sprint Fidelis Model 6949, have problems? We were notified a while ago about a "clustering" of fractures with this lead design, but it was thought that the problem occurred if the distal tip became acutely bent during the implant process or the lead was secured improperly at the chest area in a "Dear Doctor" letter. We've been following this lead carefully.

In reviewing our database of implants, as of today, we have 264 patients have implanted and follow with the Sprint Fidelis lead (Model 6949) since 2005. We have three different implanting physicians at our institution. Number of fractures, insulation breaks, deaths or other
problems? Zero.

But now, according to this news article from the Star Tribune, a death in a patient with this lead is being investigated. This was confirmed in a separate piece from theheart.org:

According to reporter Janet Moore, 169 000 Sprint Fidelis leads have been used since the US Food and Drug Administration approved them in September 2004. Doctors, she writes, prefer it because it is thin and nimble, and the company says the overall fracture rate is "extremely low." Although Medtronic informed the FDA about the lead fractures, the letter was not considered an official advisory, nor has the FDA recalled the leads.

"Unlike its February 2005 defibrillator recall, Medtronic did not issue a news release, and a product performance report on its website lists no advisories associated with Sprint Fidelis leads," writes Moore. "Patients would likely hear of potential problems through their doctors."

...

Ms Moore noted that a study published in the journal Heart Rhythm by Dr Robert Hauser (Minnesota Heart Institute Foundation, Minneapolis, MN) found that six Sprint Fidelis leads failed of the 592 implanted at his institution between September 2004 and February 2007. An additional analysis of FDA data revealed 679 reports for the leads during a 30-month period, and that Medtronic found 77 of 125 returned leads defective, mainly with tears. Of seven deaths, one was attributed to shocks, but no details on the patient were provided, reports the Star Tribune.

Based on these data, Hauser concluded "that the Sprint Fidelis leads appear prone to early failure, probably because they are thinner, and perhaps less robust," writes Moore. He did, however, praise Medtronic, noting that the company was candid and forthcoming with all requests for information.

But what Ms. Moore failed to mention was the excellent accompanying editorial by Dr. Bruce L Wilkoff, MD from the Cleveland Clinic and Case Western Reserve University (Heart Rhythm, Vol 4, No. 7, July 2007) which raises the question about the role that the implanting physician might have in creating an elevated complication rate. Certainly this has been called into qeustion with drug eluting stent failures as well (inadeuquate stent deployment). Teasing out the problems with leads caused by implant technique versus the lead itself, or even patient variables (size, anatomic variationsm etc.), is a significant challenge for device makers.

To paraphrase Dr. Wilkoff, once a decision is made to communicate with the physician and public about lead failure findings, great care care must be exercised to define the problem. Scarey terms like "lead tears" as in Ms. Moore's article should be avoided, since even those in the field are confused by her interpretation of the issues. Secondly, data should be actively collected regarding failures and implants, so that real deviations from norms can be quickly identified and the magnitude of the problem defined. Finally, there should be active resistence to lump failure types together and jump to conclusions. There are three different failures noted in the analysis discussed in Dr. Hauser's article, and Dr. Wilcoff wisely questions if these failure mechanisms are related. To exclude any one of the failure mechanisms (lead design, operator technique, and patient variables) as a potential cause might lead the lay press to jump to conclusions - after all, it makes good reading.

-Wes

Disclosure: I am on the speakers bureau for Medtronic and Boston Scientific.