World Toilet Summit

Laugh if you will, but after visiting the outer reaches of India and China in the not-so-distant past, I can vouch for the importance of such a "conference" for these developing countries.

"It is as important an issue as anything," says Bindeshwar Pathak of Sulabh International, an NGO that promotes the use of low-cost toilets in India and is joint organiser of the summit.

"It is mostly the Asian, African and Latin American countries that lack basic sanitation. So that's what we will be discussing at the summit," he adds.

Funny how we take such conveniences for granted here in the US. I wonder if they offer CME?

-Wes

Another 3 Seconds of Fame

Heh. It looks like our diabetes shirts might be popular with the Byetta folks just a little longer.

-Wes

Hauntings

Some haunting things doctors hear:

"Doctor, why is Mr. Smith's blood pressure so low?"

"Doctor, your patient hasn't had a bowel movement in three weeks. Could you disimpact him?"

In the patient with insulin-dependent diabetes: "Blood sugar? Why do I need to check his blood sugar?"

As you find your patient with severe chronic obstructive pulmonary disease moribund on rounds: "It was just a little sleeping pill."

"Doctor, what are those little bugs in his hair?"

"Doctor, I saw a sad face next to your name on RateMD.com."

"I know you guys have been incredibly productive lately, but we're sorry guys, we have to cut your pay 10% next year."

Happy Halloween!

-Wes

Image credit.

Defibrillator Lead Recalls: Industry and Clinical Implications

Medtronic’s most recent defibrillator lead recall will have profound implications (Wall Street Journal: subscription required) for the medical device industry as a whole:

"The events surrounding the Medtronic recall expose a hole in the U.S.’s medical safety system: Medical devices are regulated under different standards from those applied to prescription drugs. The Food and Drug Administration requires that almost all new medications be tested in human trials before they go on the market. But some devices, like the Sprint Fidelis leads, are subject to lighter guidelines because they are considered modifications of earlier products. The FDA, in most cases, also doesn't mandate major studies of medical devices after they've hit the market.

As a result, both the federal agency and the company were handicapped in evaluating whether a widespread public health threat was emerging.”

The broad market penetration of a these life-saving devices and the minimal safety data required for their approval, the FDA’s entire 510(k) device exemption and GMP (Good Manufacturing Practices) product development processes are now being reviewed. Even the smallest widget being developed that might be implanted in a patient and is sterilized (so-called Class II devices), be it cardiovascular, orthopedic, or otherwise, will be coming under ever-increasing scrutiny. This, in turn, will inevitably slow development and raise costs. What is clear now is that efforts to improve patient safety, already underway, will not be allowed to maintain the status quo.

But for those of us in this field, the defibrillator lead recall has even more far-reaching implications clinically. The recommendation of defibrillators for “primary prevention” of sudden arrhythmic death in those felt to be at high risk and whom have not yet had such an arrhythmia needs to be reviewed in light of these recent developments. (ed. comment: For lay readers, "Primary prevention" refers to patients who have not yet had an incidence or episode of a particular medical condition – in this case an abnormally rapid heart rhythm known as ventricular tachycardia (VT) or ventricular fibrillation (VF), often leading to sudden cardiac arrest (SCA) or sudden cardiac death (SCD). "Secondary prevention" refers to patients who have survived these conditions, and receive a particular therapy in response to the episode. Secondary prevention trials, such as AVID, CASH and CIDS, have shown a significant mortality benefit for patients who receive ICDs over those who receive just drug therapy.)

While there are excellent prospective, randomized data extolling the virtues of implanting implantable cardiac defibrillators (ICDs) in patients with markedly reduced ejection fractions (see the MADIT-II and SCD-HeFT data), these data were obtained with older device systems. (ed comment: Again, for the lay reader, the "ejection fraction" is the percentage of blood ejected from the heart with each beat - normal is over 50%) We are now left to wonder: should we be using older technology for our patients when recommending defibrillator implantation? After all, this is where we have the clinical data. Or do the newer advances of the more sophisticated devices (that might still be subject to later recalls but contain newer advanced features that we assume will provide better device oversight) warrant abandoning more conservative, evidenced-based medicine in the presumed interest of patient safety? Should new, expensive clinical trials be developed for these newer devices as well?

It is helpful to remember the raw data from the SCD-HeFT trial: there were 829 patients implanted with ICDs. Of those patients, 259 (31%) were shocked for ANY cause, and 177 (68% of those shocked) were shock appropriately for ventricular tachycardia or ventricular fibrillation. Therefore, the annual rate of shocks was 7.5% and the annual rate of appropriate shocks in these patients was 5.1%. Further, the number of deaths in the three arms studied were as follows: placebo (no therapy) 244 deaths, Amiodarone (medical therapy only) 240 deaths, ICD therapy 182 deaths. Would a faulty lead have changed the frequency of shock data? Certainly. Would it have changed the mortality data? Even if we added 5 deaths (as was potentially seen with the Sprint Fidelis lead) to the ICD arm of SCD-HeFT, it seems unlikely.

Nonetheless, given the recent recall, I suspect that we will see increased resistance by referring physicians to recommend these devices for primary prevention of arrhythmias. This is an inevitable outcome of such a massive recall, much like the later revelation of the propensity of stent thrombosis in drug-eluting stents. But like that scenario, there will still be appropriate patients in whom devices are warranted for primary prevention like those with markedly reduced left ventricular ejection fractions less than 25%. It’s just that the benefit for patients with higher ejection fractions in the 30-35% range may now be viewed more skeptically.

-Wes

Doctors vs. Lawyers - Update

After seeing the article in the New York Times this morning about which party is being supported by the healthcare sector, I thought it would be interesting to update a prior post and see how the campaign finances are shaping up between lawyers and doctors. (You can check out your favorite donors, too, at the Chicago Tribune's Campaign Presidential Campaign Contributions site.)

Here's the standings:

Under the occupations of "Attorney" or "Lawyer:"
Attorney - 34,306 contributions totalling $32,392,344.51
Lawyer - 2,682 contributions totalling $2,443,718.47
TOTAL: 36,988 contribution totalling $34,836,062.98

Under the occupations of "Physician" or "Doctor:"
Physician - 6,384 contributions totalling $4,204,323.07
Doctor - 440 contributions totalling 407,580.84
TOTAL: 6824 contributions totalling $4,611,903.91

Physicians are losing at a ratio of 7.5 to 1! Common guys, let's get on it!

-Wes

Where's Your Germiest Place?

Sorry, I have to take issue with Health Magazine's "germiest places." I'd suggest the following:

Your mouth
Your nose (staph organism LOVE this location - so don't pick!)
Your colon (er, I'll stay away from this one...)
Your hands (they touch all KINDS of nasty places - like just about every one of the places described by Health Magazine!)
Your skin (largest organ in the body).

Therefore, remove your mouth, nose, colon, hands and skin and hey, you might be dead, but at least you'll be clean.

Now, how can I raise more MRSA hysteria?????

-Wes

h/t: Clinical Cases and Images blog

Public Broadcasting - Service?

Roy Poses, MD discusses potential conflicts of interest at PBS with the "Mysterious Human Heart" series over at Health Care Renewal.

-Wes

Priorities

This graphic was brought to my attention during our most recent cath conference regarding door-to-balloon (DTB) times. It demonstrates that if we could somehow shave a few minutes off of time to opening a coronary artery, we'd save lives. It all looks so perfect.

But if we look closely at this graph, we are struck by the right-hand scale of relative risk reduction and the remarkable linearity of the graph and wonder, is anything that linear in medicine? The graph is a compilation of retrospectively acquired, self-reported, chart-review data of "door-to-balloon times" taken from medical records of patients undergoing emergent angioplasty during the throws of an acute heart attack. It appeared in the New England Journal of Medicine on the 18th October, 2007, in a “review” article regarding the benefits of reducing time to coronary revascularization. Now I think the data are pretty clear that "time is heart muscle" when it comes to coronary revascularization. Just like time is brain, too. And certainly, there is nothing wrong with raising awareness regarding this relationship. But could we be spending an enormous amount of our limited medical resources creating such a relatively small reduction of relative risk (from 1.7 to 1.2) in the name of self-promotion of our medical centers and to assure Medicare reimbursement? Might our precious health care resources be better spent tackling more pressing issues to cardiovascular health like the obesity epidemic? And how do we reconcile that others from the Netherlands have failed to find a relationship between door-to-balloon time and mortality when the issue was studied in the clinical setting? (In their study using multivariate analysis, only a symptom-onset-to-balloon time over 4 hours was identified as an independent predictor of one-year mortality.)

Unfortunately, I already see the first vestiges of manipulation of the data by medical centers (sanctioned, of course, by regulators) because of the challenges of applying this measure in the real clinical world. But there is such a high expectation to massage this data to improve referrals as hospitals as they are compared online to other medical centers that it has become a National Medical Priority. The addition of Medicare reimbursements being tied to this "performance measure" makes things even more pressing for medical centers. But the truth be told, there remains a remarkable amount of subjectivity by centers deciding who should be included in the DTB calculation. For instance, "He had multi-vessel disease? Good, we can exclude him!" or "Oh, and what was that? Another patient hit the door at the same time? That’s OK, the lab was full, we can exclude this guy, too!"

The exclusion list goes on and on.

It seems few care about the costs inherent to such an oversight system at a time when millions of patients are left reeling from high health care costs. A team of individuals are required to compile the data, review the charts, and produce the reports regarding door-to-balloon times. Lots and lots of people. And lets not forget the legions of auditors sent throughout the land in the interest of assuring conformity. They even have “how-to” articles that look anything but simple to me. So the monitoring has now become a fact of life for hospitals. And so we are spending a remarkable amount for relative statitistical minutia.

I have already commented from the staff and patient's perspective on this issue. Others have noted other potential pitfalls to this measure as well. I especially like these comments from the editorial by Drs. Brodie, Grines and Stone of Greensboro, North Carolina:

"We believe that an excessive emphasis on minimizing DBT as the overriding quality-of-care measure by hospitals, insurers, and regulators (and guidelines committees) may at times detract from optimal patient care. Rushing to perform primary PCI before stabilizing unstable patients may lead to laboratory complications and worse clinical outcomes. Indiscriminant treatment with fibrinolytic therapy of ST-segment elevation myocardial infarction patients presenting at noninterventional hospitals, rather than transferring appropriate patients for primary PCI, deprives these patients of the benefits of higher rates of reperfusion, less reinfarction, less intracranial hemorrhage, and in many cases lower mortality. A recent meta-analysis of randomized trials with primary PCI versus fibrinolysis has shown primary PCI reduced mortality even with treatment delays up to 2 h. Decisions regarding triage of patients for primary angioplasty should thus be based on an assessment of time and risk, and should utilize common sense. High-risk patients presenting early after the onset of symptoms with long delays to primary PCI are probably best treated with fibrinolytic therapy. Most other patients are best treated with transfer for primary PCI despite longer treatment delays."

And people are doing other dumb things, all in the name of “door-to-balloon time.” For instance, a person is rushed to the lab and a coronary angiogram is performed. A critically-narrowed left anterior descending coronary artery is seen, but the vessel is open with good distal blood flow. Thrombus is noted. Now many interventionalists might like to keep the person on high-dose antithrombotic agents and come back another day when things have stabilized. But that would not satisfy the door-to-BALLOON requirement. So a wire is passed, a balloon placed over the guidewire, and a sham inflation performed at one atmosphere for one second. There. Now the BALLOON has been inflated – stop the clock!

Is this good medicine? Hardly. It is wasteful medicine: that balloon was expensive. But we turn a blind eye to this since insurers will never see what really happens – it is seen as a “necessary” expense and so they reimburse the cost of the balloon.

And your insurance premiums rise.

Meanwhile, more and more and more rotund, well-meaning patients make appointments to see me wondering why their cholesterol and blood pressure are elevated, their blood sugar out of control, and they have atrial fibrillation.

Might we be chasing the wrong goal?

-Wes

References:

Brahmajee K. Nallamothu, M.D., M.P.H., Elizabeth H. Bradley, Ph.D., and Harlan M. Krumholz, M.D., S.M. "Time to Treatment in Primary Percutaneous Coronary Intervention." N Engl J Med 18 Oct 2007; 357 (16): 1631-1638.

Bruce R. Brodie, MD, Cindy L. Grines, MD and Gregg W. Stone, MD. Effect of Door-to-Balloon Time on Patient Mortality (editorial) J Am Coll Cardiol, 2006; 48:2600, doi:10.1016/j.jacc.2006.09.023 (Published online 21 November 2006).

Giuseppe De Luca, MD, Harry Suryapranata, MD, PhD, Felix Zijlstra, MD, PhD, FACC, Arnoud W. J. van't Hof, MD, PhD, Jan C. A. Hoorntje, MD, PhD, A. T. Marcel Gosselink, MD, PhD, Jan-Henk Dambrink, MD, PhD, Menko-Jan de Boer, MD, PhD, FACC ZWOLLE Myocardial Infarction Study Group. "Symptom-onset-to-balloon time and mortality in patients with acute myocardial infarction treated by primary angioplasty." J Am Coll Cardiol 2003; 42: 991-997.

A New Adventure

Today I'll be starting to contribute to MedPageToday's new physicians' blog from time to time. The blog kicks off today. There's a number of us physician bloggers contributing to this endeavor, so stop by and check it out.

Today's topic: my perspectives on the new heart attack definition.

-Wes

Behind the Scenes at TCT 2007

Although the Transcatheter Cardiovascular Therapeutics Conference in Washington DC just ended, I though it would be cool to show some of the behind-the-scenes action at our hospital as we transmitted four live cases on the 22nd of October via satellite to the conference. A tremendous effort was made by all, and gratefully, the three PFO closures and one mitral valvuloplasty cases went without a hitch. For patients who have never seen a cath lab before, here ya go!

Thanks to Jon Hillenbrand from the Media Department at Evanston Northwestern Healthcare for these great shots:


The audiovisional setup: "Hello, Houston, we have a signal."

Reviewing the case under way from the AV room.

Video switcher to cut between different views

The control room just outside the procedure room where vital signs are monitored.

The camera crew.

The crowd in the procedure room.

Drs. Ted Feldman (left) and Mike Salinger study the fluoroscopy images to determine the proper size of the foramen ovale closure device.

The monitors that Drs. Feldman (right) and Salinger were viewing in the previous picture.
A view of the next room with the next case standing by ready to go.

Dr. Tim Sanborn has prepped the patient for the next case and stands by.

The happy crew after everything went well.

Not bad for a bunch of "plumbers." Nice job, guys!

-Wes

Man Down

Boy! This has been quite a week. One of my colleagues has been gone for a bit (those damn honeymoons get in the way) and I've been remarkably busy, which has encroached significantly into blog time. I'm having...

...oh, my, God!....

...withdrawl!

I've got to get back at this blogging thing.

But there's one benefit, though....

at least my writer's cramp is improving.

-Wes

Another Artistic Diversion

Here's some cool art by British artist Chris Gilmour made from nothing but cardboard.

I wonder if he could make a heart?

-Wes

So Much for COURAGE

If a feel-good PR piece for interventional cardiologists, Adolph Bachman, the first angioplasty recipient, was introduced at the Transcatheter Therapeutics Conference (TCT) and told his story about insisting he get another stent, despite what the COURAGE trial suggested:

X-rays showed a new blockage near the site that had been cleared in 1977. Dr. Meier said he told Mr. Bachman it was not serious enough to warrant even a low-risk procedure like angioplasty.

After Mr. Bachman continued to complain, Dr. Meier inserted a catheter into the artery to perform a diagnostic test that showed strong blood flow through the narrowing. The test is one that some doctors think should be more widely used to avoid unnecessary stenting, but Dr. Meier is among the majority who believe it is generally not worth the additional time and cost.

Despite the results, Mr. Bachman insisted on not only getting the angioplasty but on getting a stent inserted. Two months later, he was back at the hospital in need of a procedure to clear a new blockage in the bare-metal stent.

Now we see who's driving the stenting bus...

-Wes

Silent MI's Fair Game for Vioxx Suits?

If you never felt your MI but took Vioxx, could you sue Merck anyway and get free medical monitoring anyway? Well, maybe:

Traditionally, New Jersey law has covered medical monitoring for people exposed to toxic chemicals. But lawyers point out that monitoring also has been allowed in some pharmaceutical cases, such as one several years ago involving the diet drug combo Fen-Phen.

“It makes logical sense that you should have the ability for medical monitoring,” says E. Drew Britcher, a past president of the American Trial Lawyers Association-New Jersey, which filed a “friend of the court” brief. “The question is whether or not you get a heart condition from a medication as opposed to getting cancer from a chemical. It’s still the same concept. … This should be a remedy available.”

Pharmalot has the story.

-Wes

An EKG Axis Pearl

"Pearls" are simple, easy-to-understand gems that medical students and residents love to acquire in training because they can quickly simplify a tough concept in medicine, and likewise can be easily shared with colleagues, making them look really intelligent to their colleagues who haven't heard the "pearl" yet. Here's an example:

Recently, a conversation with an internal medical resident went like this on rounds as we reviewed the patient's EKG:

"What the main QRS axis of this patient's EKG?" I asked.

"Well, if the QRS is positive in lead I and negative in lead aVF, it must be left axis."

"Not necessarily. Sounds like you learned EKG axis from Dubin's text, eh."

"Yeah. We have always been told to look at lead I and aVF."

"Well, you should really look at leads I and II."

When I was in medical school, I learned EKG reading from the classic book by Dale Dubin, MD, called "Rapid Interpretation of EKG’s". Now in its 6th edition, the book serves as a cornerstone for the interpretation of EKG’s for most medical students. Even though Dr. Dubin is frowned upon as a textbook for EKG's by some because of his past transgressions, his classic textbook has withstood the test of time and has undoubtedly taught more physicians how to read an EKG than any other textbook.

But it contains some errors, too, and anyone wanting to become an avid EKG reader should be aware of the text's shortcomings. EKG axis determination is one of the most glaring examples.

Perhaps the most challenging concept for most medical students to grasp is that of EKG Axis, that is, the general direction of the heart's depolarization wavefront (or mean electrical vector) in the frontal plane in which the the ventricles electrically activate.

Dubin simplifies axis determination by dividing the frontal plane into four equally-divided major quadrants: normal quadrant (0-+90 degrees), left axis quadrant(-1 to –90 degrees), right axis quadrant (+91 to +180 degrees)and extreme right axis quadrant(-91 to –180 degrees). To identify an EKG with a “normal” axis, then, Dubin suggests students use leads I and aVF to determine the main QRS axis. According to his algorithm, if the main QRS deflection in I and aVL are positive, then the axis should be considered “normal.”

But Dubin’s method fails to acknowledge that QRS axes between 0 and -29 degrees are also considered normal (physiologic). Only at –30 degrees and less, is left axis deviation considered. So Dubin's algorithm is flawed.

So is there a simple way to quickly determine if an EKG has a frontal plane QRS normal axis? Sure! Just look at leads I and II instead of leads I and aVF.

If leads I and II both have a QRS deflection that is mostly positive, then the QRS axis of the EKG is normal. If the QRS in lead I is positive and II is negative, then the QRS axis is defined as left axis deviation. If lead I is negative and II is positive, then the QRS axis is defined as right axis deviation, and if both leads I and II QRS deflections are mainly negative, then the EKG is axis is considered to be extreme right axis deviation. Wikipedia has a nice graphic (but would have been better is they excluded the bottom row, Lead III, and just focused on Leads I and II):



So just by looking at the main QRS deflection in leads I and II on the EKG, rather than leads I and avF, you can always quickly determine whether an EKG has a normal axis, left axis, right axis, or extreme right axis deviation.

Here ends the EKG axis pearl-of-the-day.

-Wes

Office Heroics

To the heroic office staff all over the world who have worked hard to notify patients about the Medtronic's Sprint Fidelis lead recall this week, I offer this short video by Zack Lipovsky:



-Wes

Heart Surgeon Quits at 102

Simply amazing.

-Wes

Kick 'em When They're Down

The hallmark of junk science reporting is quoting statistics out of context.

“Heart Wires May Pose More Risk for the Young” was the title of the article (subscription) in the Wall Street Journal this morning. The article noted the work of a fellow Northwestern University pediatric cardiologist, Wayne H. Franklin, MD who found preliminary data of higher than expected lead fracture rates in children with congenital heart disease under the age of 21. Dr. Franklin pooled data from 32 institutions who specialize in treating pediatric patients had noted a fracture rate of 6.7% of 569 patients with Medtronic’s Sprint Fidelis lead compared to Medtronic’s quoted 2.3% failure rate in the overall defibrillator population.

But what the article failed to mention was that failure rates of all types of transvenous pacing and defibrillator leads are always higher in children than in adults:

Current practice suggests that transvenous pacing leads routinely can be placed in children weighing more than 10 kg. This figure is likely to continue to decrease as pacing technology continues to reduce lead body diameter. Because of continued growth and vigorous activity, however, pediatric patients have lead fracture and failure rates distinctly higher than adults. Actual survival comparisons have been performed for transvenous pacing leads in children. These comparisons show progressive lead failure over time from fracture, insulation discontinuities, adapter/header failures, or pacing exit block.

While I have no argument with the findings of Dr. Franklin, journalists using these specialists’ data to produce sensationalist headlines for business interests which serve to panic pediatric patients and families already in a difficult and fragile situation is irresponsible. I mean, is there another dog we can kick?

-Wes

Challenges with a Lead Recall

Not surprisingly, the inevitable investigations and litigation regarding the Sprint Fidelis lead situation has started:

(WSJ) In early signs of the pressure likely to come for Medtronic and the FDA, (Senator) Mr. (Chuck) Grassley, a Republican, last night sent letters to the company and the agency asking for more information about the leads. Separately, consumer group Public Citizen argued in a letter that the company and agency should have taken action sooner.

In addition, a group of plaintiffs attorneys, which has been a leader in major heart-device lawsuits, filed suits against Medtronic related to the Sprint Fidelis leads in federal court in Minneapolis and Puerto Rico, according to Hunter Shkolnik, one of the lawyers.

The investigations are likely to again focus attention on the FDA's oversight of medical devices, which are regulated under different standards than drugs. For instance, the Sprint Fidelis leads, which went on the U.S. market in 2004, weren't required to be tested in humans before they won FDA approval. Previous versions were tested in humans, but the Sprint Fidelis models weren't different enough from those earlier iterations to require human trials, the FDA said.

Now, looking back, things seem so obvious, don't they? It's all so easy, to detect these trends of lead fracture, isn't it? Well, maybe.

Then again, maybe not.

I thought it would be informative to check the FDA's MAUDE database for Medtronic's "safe" Sprint Quattro leads, and check on the number of deaths with that lead since 1/2005. And you know what? There are four deaths not related to infection. Hmm. 4 of 126,400 implants of Quattro leads (1 in 31,600) verses five of 268,000 implants of the "faulty" Sprint Fidelis (1 in 53,600). These data seem to support the Sprint Fidelis as less lethal than the Quattro. Could this be true? Admittedly, the FDA's MAUDE database is not the best place to evaluate such occurrences, but the point remains: verifying if the cause of death in an individual patient was actually caused by the lead itself is difficult - the circumstances of each death must be carefully evaluated and sometimes data are not available to ascertain the actual circumstances that caused death. How much time should a company get to do such an investigation before informing the public?

It does seem there are more fractures with the Sprint Fidelis than the earlier Sprint Quattro leads. But, according to Medtronic's 2007 Product Performance Report, the Quattro lead was also subject to fractures on occasion. So what number of lead fractures is tolerable? Zero of 126,400? One in 126,400? Twenty in 126,400? Two hundred in 126,400? When should the public be notified?

And if the leads fracture, don't we want to know why? What component was failing? What action is needed to correct the problem? Was the engineering of the lead responsible for the defect or the implant physician's technique? Does it matter? How long should a company be permitted to attempt to identify the root cause for a defect before the public is notified - 24 hours? A week? A month? 6 months? Should Medtronic have notified physician's first or the patients? Should Medtronic have notified the doctors before having an action plan established and a website developed to accompany the calls and questions?

These are all difficult questions to answer.

The Heart Rhythm Society has developed guidelines which begin to address and underscore the importance of many of these issues. Many of the actions taken with this recall have been in line with the initial draft of these proposals. Certainly, the information provided immediately to patients and physicians is much better with this recall than that we experienced in 2005 with earlier defibrillator recalls, but the challenges regarding patient notification and dealing with the clinical issues at hand remain.

I believe that the investigations ongoing and questions being asked are appropriate and worthwhile. The legal actions, too, may serve as an impetus for improvement of ICD systems. But in all of these dealings it is helpful to realize the complexity of the issues being discussed, and that in the end, it's the patients' interests that should matter most. After all, they're the ones dealing with the fallout.

-Wes

If It Ain't Broke, Don't Fix It

Reiterating most electrophysiologists' recommendations regarding Medtronic's Sprint Fidelis recall from the market, Tom Burton from the Wall Street Journal reports this morning:

Perhaps most important, Medtronic isn't recommending that the leads be taken out unless they are actually fractured. And cardiologists overwhelmingly agree with that advice. Surgical removal of a lead is potentially deadly itself. The lead sits in the patient's vein. Scar tissue forms there and at the point in the heart where the lead attaches. So extracting it can trigger bleeding, which can be lethal.

If a lead is found to be fractured, patients may have a choice of intervention. Doctors differ as to whether lead extraction or adding a new lead threaded through the same vein is a better approach. But many patients will have to have it extracted because there isn't room for a new lead in the vein.

What most agree, again, is that if a patient does not have an actual fracture, that leaving the lead alone is probably the most prudent advice and to continue close monitoring. Every time a device pocket is opened to revise the system, there is also a small but real risk of infecting the defibrillator system.

Should a lead become fractured and the defibrillator system require revision, however, one other option exists that was not mentioned in the WSJ article: a new lead (or even a new system), could be implanted from the contralateral (opposite) arm. In some cases of lead fracture, this might be the safest route to take.

-Wes

More on Medtronic's Sprint Fidelis Advisory

With the issuance of the Medtronic's Sprint Fidelis lead advisory (on defibrillator lead models 6930, 6931, 6948, 6949) issued today, our office has already received over 50 calls with excellent questions. Understandably, people are concerned, so I thought I would take a moment to review the issues of the recall and answer a few of the more common questions.

Why would Medtronic have tried to design a thinner (6.6 Fr) lead, when their larger lead already had a fairly good track record for performance?

With the advent of biventricular defibrillators, that require three leads (one for the atrium, one for the right ventricle and one for the left ventricle), there is limited space in the subclavian and axillary vein. With the additional lead requirement of biventricular pacing, it was hoped that the smaller lead size would permit fewer vascular complications.

Why did Medtronic decide to voluntarily withdraw the Sprint Fidelis leads from the market?

There had already been a recognition my Medtronic and others that the lead may have a higher failure rate than prior lead models. An article in the journal Heart Rhythm also noted a higher-than-expected early fracture rate for this lead, but initial failures appeared clustered in certain centers. Hence, it was uncertain whether the failures were from implant technical issues or the lead design itself. Upon review of Medtronic’s ongoing quality review at their 30-month assessment, they felt the 2.3% failure rate sufficiently exceeded the complication rate of former leads (<1% failure rate) and decided to withdraw the lead, even though the fracture rate had not yet reached statistical significance. The trend, it seemed, suggested it would eventually reach significance.

What kind of problems can arise as a result of a lead malfunction?

The Sprint Fidelis lead contains four wires. Two of these wires are used for the rate sensing and pacing function of the lead, while the other two high-voltage wires are used for the shock-delivery function of the defibrillator system. If a fracture of one of the pacing/sensing leads were to fracture, typically noise is detected by the device as the wires rub together, and this might be interpreted by the device as an abnormal heart rhythm which, if it occurs long enough, could cause the device to deliver an inappropriate shock. Alternatively, a fractured pace/sense lead could lead to failure of the device to effectively pace the heart. If a shocking coil were fractured, while it might not effect the pacing or sensing feature of the device, it could lead to ineffective shock delivery during rapid heart rhythms, leading to ineffective termination of the arrhythmia.

Have deaths occurred from the lead malfunction?

Five deaths have been reported on the FDA's Maude database that are not related to infection of the device and may have been attributable to lead malfunction. Several instances of device undersensing of arrhythmias have been reported to the FDA database, and at least one episode of recurent shocks that may have contributed to death, but the details of these deaths have been limited.

I have a Sprint Fidelis lead. Should I have it replaced?

It is important to remember that a very small number of complications of this lead have occurred. The total complication rate with this lead was been 2.3% of the implanted devices to date. 97.7% of the leads implanted are performing correctly at this time. Because removal of the lead has a relatively high 1.4-7.3% mortality risk associated with their removal, it is generally not recommended these leads be removed at this time. If a lead fracture should occur, then placement of a new lead adjacent to the existing lead and leaving the old lead in place is usually recommended rather than extraction of the old lead with new lead implantation. Certainly, there may be circumstances where lead extraction is required, but these should be reviewed with your doctor.

Additional surveillance will be required to see how the remaining leads perform in the future. For now, most of us are recommending that the Patient Alert features on a patient’s defibrillator system be programmed to make them more sensitive to changes in lead impedance (a resistance measurement that might precede lead failure). Patients should make the appointments with their device clinic. The urgency of this reprogramming is generally up to the patient, but should probably be performed within the next 30-60 days.

Additional physician information, including parameters for programming the patient alert features can be found at http://www.medtronic.com/fidelis/physician-letter.html.

Information from Medtronic Regarding the Fidelis Advisory can be found at http://www.medtronic.com/fidelis.

-Wes

New York Times article on the lead advisory.

Medtronic to Pull Its Most Popular Defibrillator Lead

Tomorrow, Medtronic will begin notifying patients and doctors that they will be voluntarily stop selling their most popular thin defibrillator lead, the Sprint Fidelis (Models 6949, 6930, 6931, 6948), because of a higher-than expected failure rate from lead fractures.

According to Medtronic, over 268,000 of these leads have been implanted worldwide. The Sprint Fidelis lead has had a 97.7% reliability rate, but this has fallen well-below the 99.1% reliability rate of their thicker Sprint Quattro lead. Consequently, they will be withdrawing the Sprint Fidelis defibrillator lead from the market.

For patients already implanted with the lead, it is not expected that leads will require explantation, but Medtronic will be advising careful follow-up of the lead, including changing some warning parameters (so called "Patient Alerts") on their devices in hope of detecting lead fractures earlier. It seems higher-than expected impedances were identified just before lead failure in the rate sensing or defibrillator coil wires from the lead. When a lead fractures, noise is detected by the defibrillator due to intermittent "make-break" connections in the wire(s) of the lead, occassionally leading to shocks delivered at inappropriate times. Should patients experience recurrent unexpected shocks, they should seek evaluation by their implanting physicians immediately. For patients who do not receive such shocks, ongoing monitoring of the lead should occur at regular intervals, and if an impedance change or evidence of noise is detected on the lead, Medtronic is recommending a new lead be inserted.

Since the "Dear Doctor" letter will be issued tomorrow, we'll stand by to see the official recommendations from Medtronic.

-Wes

Update: Wall Street Journal (subscription required).

Press release.

Follow-up recommendations also added. -Wes

Where the Money Goes

We visited Harry and Louise (not their real names), both in their 80's, here in California and what follows is a small excerpt of our conversation:

“You know, I had an examination by a physician here in Calistoga, California, and he has never removed my clothes. It is so interesting, he just stands me on a scale and has me grip these two side bars, and then he gets this big print-out on me. I think I’ve seen him five times and he’s yet to completely examine me. But boy, do I have a lot of bills from the lab company. He gets blood work on me every three months.”

"Could I see the information that he gets on you?"

“Sure. Here it is.”

I looked and it contained her weight and body fat measurement, calculated from an impedance measurement taken from each arm.

“Who pays for these evaluations?”

“Blue Cross and Blue Shield."

“Really?”

“Yeah. They pay for all of these checkups. They call it their “wellness” examinations. And my doctor, well, he specializes in Preventative Medicine.”

“And Blue Cross pays him for these evaluations?” I asked.

“Yep. I have a great policy.”

"Louise, have you ever thought of getting a general internist or family practice physician?"

Great indeed. That is until Louise gets sick. Then the insurer won’t be able to find the money to pay for her care once she gets sick.

Why?

Because they’ve spent too much money reimbursing unproven technologies called impedance measurements that have little data to support their effectiveness. Will a change in bioimpedance discover a growing skin cancer or the breast mass? Is it really proper to reimburse physicains who never examine a patient?

In an era where precious healthcare dollars are not available for millions of uninsured, I was appalled to learn of this practice of reimbursing such technologies in California, all in the interest of “wellness,” a medical misnomer unto itself.

-Wes

Just "OK"

It is difficult to describe the beauty of Big Sur, California. Our friends that we visited there wanted me to be sure that I described it as "just OK" in hopes of keeping the area just as uncrowded and undeveloped as it stands now. So, in the interest of not overindulging the obvious, here's a few pictures:




Yep, just "ok," indeed.

-Wes

Blog Break

I'll be on a blog break for a bit beginning today: headin' to Big Sur, California, then up to Napa Valley for some much needed R&R. I'll be taking my camera, so perhaps a few photos will follow.

Back soon.

-Wes


Photo credit. (No that's not me in the photo above. But soon, very soon...)

By the way, Don't forget to check out this week's blogging Grand Rounds over at Nurse Rached's.

The Heart of the Matter

It was heartwarming, indeed, to read the attempts of a man with a heart of gold to demonstrate how arteries and arterioles have been so coldheartedly rejected by the literary world. Although he clearly followed his heart, his attempt was somewhat half-hearted, as he neglected the heart and soul of literary prose.

But we need not have a broken heart, or heart of lead, since in times of heartache, the heart is the only broken instrument that works.

-Wes

PS: Don't be heartless: any bleeding hearts want to add more?

Image credit.

Bioengineered Blood Vessels

The New York Times reports on a correspondence published today in the New England Journal of Medicine which describes the development of bioengineered blood vessels made from a patient's own skin cells.

This might have huge implications for patients with severe peripheral vascular disease or those with poor vein harvesting sites for coronary bypass surgery.

Very cool.

-Wes

Image credit: The New York Times.

Blaming It All on Mitral Valve Prolapse

Chicago is still reeling from the aftermath of the Chicago Marathon as they struggle to ascertain why Chad Schieber, an otherwise healthy 35 year old police officer, could die during the event. Certainly, everyone’s heart goes out to the grieving family, and at times like this, we all search for “the cause” – why should an otherwise fit individual die?

The coroner’s report that described “mitral valve prolapse” as the cause. But for those of us in the cardiac field, we wonder, how the heck can the presence of mitral valve prolapse cause death?

Mitral valve prolapse is caused by a redundancy of the mitral valve that causes the mitral valve (which separates the left atrium from the main pumping chamber of the heart, the left ventricle) to bow, or prolapse, into the left atrium. The leaflets are prevented from bowing too far back into the left atrium during systole by strong strands of tissue (called chordae) that act to tether the leaflets to the left ventricular chamber (think of the lines attached to a parachute that serve to hold air inside the parachute). Some patients have some leakage of the valve from the left ventricle backward into the left atrium caused by the bowing leaflets. Tons of folks live just fine with a minor leakage. But if the leakage gets too severe, or if one of the chordae ruptures, the flow of blood backward into the lungs can be so severe that the lungs fill abruptly with fluid, and respiratory collapse and perhaps death, occurs.

We are given limited information in the coroner’s report if a chordal rupture occurred in Mr. Stokes, only that he had “mitral valve prolapse.” So if he did NOT have chordal rupture, then we are left to wonder, would the mitral valve prolapse in and of itself, have killed him? Likely not. So if not, what other causes might explain his untimely demise?

First, let me say, I doubt we will ever know. But much more common in marathoners running on a hot day is the presence of heat stroke and electrolyte abnormalities. Given the hype about the need for water and the experience of this runner, it’s hard to imagine that heat stroke would be the most likely cause here, but it can’t be excluded. Electrolyte abnormalities, on the other hand, may have played a significant role.

There are two main “electrolytes of life,” as I like to call them: sodium and potassium. Sodium is the major electrolyte outside of cells, and potassium is the main electrolyte inside of cells. Sweat is important cooling mechanism for the body, since evaporative heat loss is a very effective way to lose heat. But with sweat goes sodium and a small amount of potassium, too. And so the marathoner drinks water – lots of water – but often, does not replace any of the sodium lost with sweating.

And the results for the heart can be catastrophic. An important study was recently reported in the New England Journal of Medicine regarding hyponatremia (low sodium levels) in marathon runners in the Boston Marathon. This weekend, I had a chance to see this first-hand on Sunday when a marathon runner presented to our ER with hyperventilation, confusion and muscle fasciculations (diffuse fine twitching) and positive cardiac markers. Here were his lab studies:

Sodium 125 (ref: 133-145 meq/L)
Potassium 3.4 (ref: 3.5-5.3meq/L)
Chloride: 90 (ref:98-108 meq/L)
CO2 17 (ref: 23-32 meq/L)

Myoglobin: 1453 (ref: 21-98)
CK-MB 62.5 (ref:0.6-6.3)
Troponin-I 0.31 (ref: 0.0-0.06)

His EKG was normal.

What was striking were his confusion and muscle fasciculations. If effect, his sodium was so low that it was affecting all of the excitable tissues: his neurons and muscles. Fortunately for this individual, he did not have any skipped heart beats.

But throw a few extra heart beats into a heart exposed to that low sodium (which certainly could happen in the setting of mitral valve prolapse) and fatal cardiac arrhythmias can occur abruptly and irreversibly, resulting in sudden death.

So could this have been the real cause of death for this young man? Perhaps. Perhaps not. But blaming it all on mitral valve prolapse sends the wrong message to the thousands of patients living with this common heart valve anomaly.

-Wes

CT Screening for Lung Cancer

“If you order a test, you’d better know what you’re going to do if it’s positive or if it’s negative.”

Truer words were never spoken by my chief resident in medical school.

So it was interesting to read this morning’s Wall Street Journal article criticizing a doctor’s perspective that CT scanning to detect early lung cancer might be dangerous when applied to the general population of at-risk smokers. People are aghast that this UCLA doctor took monies from the tobacco industry to testify in a court case about the pitfalls of such testing and applied those funds to an “educational fund” at UCLA.

In a dispute with broad implications for cancer treatment, patient advocates and congressional overseers are raising questions about the objectivity of a massive federal study that is supposed to determine whether annual CT scans of smokers' lungs can save lives.

The nine-year study, called the National Lung Screening Trial, is tracking 50,000 smokers at a cost of $200 million, and is funded by the National Cancer Institute, or NCI. Due to be finished in 2009, the study is expected to have a major impact on whether regular CT scans for smokers will become a standard of care -- and whether tobacco companies could be forced to pay for them. The 90 million current and former smokers in the U.S. are all potential candidates for such screening.

Since late last year, the Lung Cancer Alliance, a Washington, D.C., nonprofit that supports screening, has asserted in letters to the NCI and its parent, the National Institutes of Health, that two of the study's key researchers have conflicts of interest because they have accepted money from tobacco companies to be expert defense witnesses in lawsuits. The suits sought to force the companies to pay for annual CT screening.

The Alliance, which is funded by individual donations and corporate grants, including $100,000 from General Electric Co., a maker of CT scanners, also charged the study has design flaws that could bias its outcome against screening.

There are two powerful corporate interests in this debate. On one side, there is Big Tobacco, who doesn’t want to have to pay for all of these screening CT scans in smokers, and has paid a few influential doctors who understand the downside of screening tests to argue their case. On the other side, is Big Imaging Companies, backed by hospital and physician (mainly radiologists, but others too), who stand to gain handsomely with the zillions of tests soon to be performed if CT scans are better at detecting lung masses than conventional plain-film chest x-rays.

In the middle, are the patients themselves, concerned that they might get cancer because of their genetic history or social predilection to smoke. It is the patients who will receive the seemingly innocuous scans and the invasive follow-up tests required if their scan is “positive.” What we don’t know is, does it matter to the patient’s longevity?

Now I think most doctors inherently feel that CT scans can detect smaller lung nodules compared to plain chest films.

But therein lays the problem. Once a small nodule is found, what happens? People have to know: do I have cancer? And the only definitive way to determine if they have cancer is tissue. “When tumor’s the rumor, tissue’s the issue, and cancer’s the answer – sometimes.” Certainly, positron-emission-CT scans (PET scans) can be helpful, but they are not conclusive. Tissue remains the issue.

And so, a slippery slope of additional surgical interventions (needle biopsies, bronchoscopies, mediastinoscopies, or even open thoracotomies) is required to establish if a nodule is benign or malignant. Each of these procedures has risks to the patient – some of those risks include death.

So when a sensitive, but non-specific test like a CT scan is applied to a broader population of patients, we’d better accept that, in some cases, there are untoward consequences as well as beneficial ones, and it’s the patients that deserve a controlled trial with appropriate follow-up to determine which screening test is in their best interest, irrespective of the corporate forces at play.

-Wes

Update: More on the conflicts of interest on both sides of the debate can be found at the Wall Street Journal's Health Blog.

Echocardiogram Contrast Agents to Get Black Box Warning

It seems the FDA is about to issue a block box warning on echocardiographic contrast agents:

A spokeswoman for the agency told the Health Blog that it “has been investigating reports of deaths and serious cardiopulmonary reactions.” The FDA will alert health-care professionals about the “serious risks” and “provide guidance regarding the safe use” of the drugs, she said. The warning could come later this week.

The contrast agents are used in a small fraction of echocardiograms, the FDA said. Doctors often turn to the drugs when ultrasound without them is inconclusive.

The principal drug at issue is Definity, made by Bristol-Myers Squibb. A second drug called Optison, from General Electric, is also expected to get the same labeling treatment. The drugs contain microscopic gas-filled spheres and are injected into the veins of patients to punch up the contrast of images for tough cases. After a few minutes the gas leaves the body.

The agency has asked the manufacturers to update their product labeling, which they’ve agreed to do, the FDA spokeswoman said. So look for some new black boxes, the sternest warnings available, that would tell doctors not to use the medicines in patients with unstable angina, acute heart attacks and unstable cardiopulmonary disease, according to people familiar with the matter.

It’s also expected that the labels would instruct doctors to monitor patients’ heartbeats for trouble with an electrocardiogram, or ECG, for a half-hour after the ultrasound exam is finished.

It seems that these agents have been associated with some extention of the EKG's QT interval slightly and there are concerns they may be proarrhythmic. These agents already have a warning regarding their use in patient's with suspected cardiac shunts because the phospholipid-encapsulated microspheres can bypass the lung's natural filtering mechanism and potentially cause microsphere trapping in small arterioles under 15 mm in size, especially at branch points. it is interesting to note that deaths have been reported late after the use of these agents:

Among the 1716 activated DEFINITY® patients, 19 (1.1%) suffered serious cardiopulmonary adverse events including eight deaths. The deaths occurred several days after activated DEFINITY® administration and appear to be related to the course of underlying disease. Of the 11 other serious adverse events, which appeared within days of the drug administration (2-15 days), all appeared to be a progression underlying cardiac and non-cardiac disease.

These imaging agents can really help evaluate the heart function of our increasingly obese population undergoing echocardiography, but the logistical nightmare required to monitor these patients after their echo might significantly limit their use.

I'll update this post when the FDA's statement is issued.

-Wes

Reference: Image of microspheres from Kenneth S. Suslick, University of Illinois, Urbana-Champaign.

The Call Mantra

"Keep 'em alive until 8:05"

Thirty-five patients. 07:05 AM Saturday

"Keep 'em alive until 8:05"

Eight new consults.

"Keep 'em alive until 8:05"

Six patients in the ICU.

"Keep 'em alive until 8:05"

Two acute infarctions.

"Keep 'em alive until 8:05"

Four stress echos.

"Keep 'em alive until 8:05"

Three adenosine thalliums.

"Keep 'em alive 'til 8:05"

Seven discharges. "Dr. Fisher, When are you going to discharge Mr. Smith?"

"Keep 'em alive 'til 8:05"

A hundred pages.

"Keep 'em alive 'til 8:05"

No deaths. 08:05 AM Sunday.

(Why do I hate my life right now?)

-Wes

Posers

Are you a morally upstanding individual? Do see cardiology patients once in a while? Do you have $300? Can you fill out this simple application?

If you do, it seems you can be "boarded" by the American Academy of Cardiology and wear the prestigious initials "F.A.A.C" behind your name, since you're now considered an "fellow" in the American Academy of Cardiology.

Don't worry if you're not a cardiologist, it doesn't matter. You'll look cool.

You see, it seems the American Academy of Cardiology and the American Board of Cardiology have noting to do with cardiology, the practice of cardiology, medical board certification, or the American College of Cardiology or the American Heart Association - rather, it's they're a "ministry" run by the questionable Rev. A Lasko, MD (as it says on the application). Or is it the questionable Rev. K. Lasko, MD? (as it says on the website?) Gee, I'm not sure. It probably doesn't matter since I could not find any such person to substantiate their existence. It seems his ministry is to spread cardiology to noncardiologists:

The American Academy of Cardiology under the new policy of expanding the specialty of Cardiology to the Internist-Cardiologist, considers that since it is the Internist who actually sees and manages the vast majority of cardiac patients, and under the belief of the new Director that Cardiology is not just the domain of the catheterists, the number of appointments of newly certified Diplomates of the American Academy of Cardiology needs to be expanded, to gain influence in American Medicine and to advance our mission to emphasize and to promote honor, ethics, and humanitarianism in Medicine, and emphasis on the kindness invoked in true religious values and true family values, for the benefit of the public and the advancement of the medical profession.

Just what we need. Someone nice enough to take our money to show the world we can feel good about ourselves as humanitarian souls.

Now if this "group" or individual wanted to promote honor, ethics, and humanitarianism, how about coming clean on this scam?

But it seems it doesn't stop there.

Not interested in cardiology? Want different initials after your name? How about F.A.C.G.S.? That's even longer! It stands for the "Fellow of the American College of Geriatrics Specialists." Here's the College of Geriatric's website with mailing address in Berkley, CA that issues this Board of Geriatrics "certification" and looks about as reputable as the American Academy of Cardiology and is issued by the same K. Lasko, MD. There's only one problem, though: for this extra letter it seems the "organization" (who, by the way, boasts 30 people on their "board" but I could not find their names) wants to set you back $500 rather than $300.

Now I tried to find out who the venerable Rev A. Lasko, MD D. Divinity (Hon), F.A.B.H.P., M.A.B.H.P., F.A.C.G.S., M.A.C.G.S., F.A.A.C. was behind the application. Guess what? I couldn't find this person anywhere on the internet, except these websites. There was only one "Lasko" in Nevada and one in Massachusetts, and neither appeared to be reverends.

But at least I found out what the M.A.B.H.P. stands for here.

-Wes

Hat tip: Gruntdoc.

Losing Control

"Doctor, your patient's blood pressure really low, it's 60/40!"

"Wha....??? What happened?"

"I don't know doctor. I know he had that catheter ablation yesterday where you poked holes in the patient's legs and thread catheters to all kinds of chambers in his heart to ablate his atrial fibrillation, and he was doing so well..."

"So what the hell happened?"

"Nothing."

"What do you mean, 'Nothing?'"

"Well, I guess I gave him that flu shot."

"What flu shot?"

"That one that you ordered."

"I didn't order a flu shot!"

"The computer says you did."

"What the hell are you talking about?"

"Our computer says that all patients will get a flu shot if they are over 50 and a pneumovax vaccine if they're over 65 as part of the quality assurance initiative, so they added it to your orders. And I went ahead and gave it, because the patient didn't refuse, and I have to take off all of the orders, you know."

"Please give him 500cc saline bolus, hydrocortisone 100 mg IVPB and benadryl 50 mg IVP right away. I'll be right in."

* * *
How many other orders will be added on my behalf without my knowledge in the interest of "quality healthcare?"


-Wes

Drivers to Healthcare

Today, I learned, Microsoft introduced their version of a health maintenance web sites called Healthvault, a snazzy, little feel-good webpage that really makes me want to enter my health information online.

But I found myself asking, why on earth would Microsoft want to foray into the health care arena? I mean, for what Grand Purpose does Microsoft need or want my health information? Are they really concerned about my health? Gosh, I never knew their little Redmonian nerds really cared that much. I mean, the thought of them facilitating my care in my older years when I can no longer see the screen on my computer or feel the keyboard on my desk felt so, so…well, confusing. I mean aren’t they really all about computer software?

Well, yes.

Here’s the news flash. Microsoft could care less about your health. What Microsoft cares most about are software and “drivers.”

You see, software is the little computer instructions that tell a computer how to behave. Telling a bunch of zero’s and one’s how to move about in just the right fashion to do anything constructive is complicated business. It is the software instructions that tell the computer what to do. Software, once designed, is usually pretty nifty, but it’s maintenance, with upgrades and all, can be quite a drag. I mean, look at all those security patches that Microsoft has to upload to their computers all the time to “patch” new holes in the virus protection to their operating systems. Do you think those are fun to code? But people need those instructions to make their computer work, so they sometimes pay for new software. And so there is economic demand.

But the other interest by Microsoft are drivers: drivers that permit a device to interact with computers, drivers that permit nice advertising revenue, and drivers for growth.

Software drivers are the little bits of software code that allow a gadget or gizmo to interact with a computer, especially a computer that uses the Microsoft operating system. And there are tons of little devices out there that would love to interact with your home computer: pulse rate monitors, blood pressure monitors, temperature monitors, glucose monitors, etc. But those are the little guys. The Big Guys are pacemakers, and defibrillators, and event recorders, and the stuff that doctors put inside patients. The guys that make these devices need someone to manage all of the information, and changes to operating systems, and software enhancements that come with the internet and computer terrain – and Microsoft is well-suited to manage this information and the software needs for plenty of other Fortune-500 health care companies. Just look to Medtronic – struggling to supply their Carelink software across Microsoft and Apple's MAC platforms and having to devote more and more manpower to managing this data and the upgrades to technology that are inherent to our computer world. You see housing data on their server causes one nasty problem: if they want to upgrade their software, they have to figure out a way to distribute updates to all of their data entry sites. It is this interaction that Microsoft can help these Big Guys.

And if they can squeeze in a little advertising revenue to boot to compete against Google?

Well, all the better.

-Wes

High Security

Funny. I was at a hospital to which I rarely travel, and had to get changed in the male locker room. I had no idea what the combination was on the lock of the door, but glanced, and figured it out pretty quickly.


If one assumes the buttons to be pressed on the lock are numbered consecutively from the top to bottom as 1, 2, 3, 4, and 5, what's the combination?

-Wes

My New Halloween Shoes

Saw these on Play Blogger and felt I needed these for the EP lab on Halloween! (from this guy's blog in Malasia).

I wonder if I can get these close to home...

-Wes

ICD's: Playing the Sexism Card

Two important trials (one free to see, one not) from Duke University School of Medicine, Durham, North Carolina appear in JAMA this week that review lots of diagnosis codes from Medicare databases to reveal some pretty eye-opening data: men get implantable cardiac defibrillators about three times as often as women.

The first "free" report was conducted by examining US Centers for Medicare & Medicaid Services (CMS) coding files from 1999 to 2005 (before the big ICD recalls). Patients records included were 65 years or older with Medicare fee-for-service coverage and diagnosed with acute myocardial infarction and either heart failure or cardiomyopathy (based on Medicare diagnosis codes) but no prior cardiac arrest or ventricular tachycardia (ie, the primary prevention cohort [n = 65,917 men and 70,504 women]), or with cardiac arrest or ventricular tachycardia (ie, the secondary prevention cohort [n = 52,252 men and 47,411 women]). This trial was limited by the lack of clinical data (no measures like ejection fraction or confirmation of arrhythmias occured - only diagnosis codes were used) and so was limited at the outset. But despite its limitations, no mater how it wsa cut in multivariate analyses, men were more likely than women to receive ICD therapy (hazard ratio [HR], 3.15; 95% confidence interval [CI], 2.86-3.47).

The second trial, conducted by the same Duke researchers, examined actual clinical data from a voluntary "Get with the Guidelines" heart failure quality improvement initiative called OPTIMIZE-HF and supported by GlaxoSmithKline (makers of a major heart failure drug, cardevilol, marketed as Coreg® and Coreg CR®) and the American Heart Association. It occurred more recently (2005-2007: after the defibrillator recall period). In this study, left ventricular ejection fraction data, paired with diagnosis codes, were studied. It too, demonstrated that women were 40% less likely than men to receive an ICD.

So why the difference?

Well, it's tough to say for sure. One item discussed in the papers was the increased likelihood for women to have a form of "impaired relaxation" heart failure (rather than from systolic dysfunction), but the second trial used only people with ejection fractions (the amount of blood squeezed from the heart with each heartbeat which is normally greater than 50%) that were less than 30%. It seems ICDs were still more common in men than women.

Another reason might be because of confounding factors, like women may have more co-morbidities, especially since they usually get older than men. After all, controlling for everything in these observational studies is difficult. But the first trial still revealed a propensity for men to receive an ICD in both the under-75 crowd or the over-75 crowd.

Perhaps (and I say this reluctantly) it is because doctors are sexist. Especially male doctors. Could it as simple as that? Probably not. But men still outnumber women in cardiovascular subspecialties and we might just not be thinking that women get heart disease. Also, most of the major ICD trials had more men than women, so doctors might have a bias against referring a female rather than a male.

These findings raise all kinds of questions. It would be interesting to see if others out there in the blog-o-sphere have some other ideas.

But one thing is for sure, you can bet Medtronic (also tacitly a research contributor to these studies) and the other ICD manufacturers will have an e-mail in my inbox tomorrow with these findings.

-Wes


References:

Lesley H. Curtis, PhD; Sana M. Al-Khatib, MD, MHS; Alisa M. Shea, MPH; Bradley G. Hammill, MS; Adrian F. Hernandez, MD, MHS; Kevin A. Schulman, MD. "Sex Differences in the Use of Implantable Cardioverter-Defibrillators for Primary and Secondary Prevention of Sudden Cardiac Death." J Am Med Assoc 2007;298:1517-1524.

Adrian F. Hernandez, MD, MHS; Gregg C. Fonarow, MD; Li Liang, PhD; Sana M. Al-Khatib, MD, MHS; Lesley H. Curtis, PhD; Kenneth A. LaBresh, MD; Clyde W. Yancy, MD; Nancy M. Albert, PhD; Eric D. Peterson, MD, MPH. "Sex and Racial Differences in the Use of Implantable Cardioverter-Defibrillators Among Patients Hospitalized With Heart Failure" J Am Med Assoc 2007;298:1525-1532.

2 Oct 2007 1930PM CST Addendum: An accompanying editorial in JAMA looks at the gender issue as a glass half full rather than half empty:

(HeartWire) Dr Rita Redberg (University of California, San Francisco), who wrote an accompanying editorial, told heartwire: "They've definitely established that white men are more likely to get ICDs, but we all know that defibrillators are not the only thing that white men are more likely to get." In her editorial, she says, "The results are troubling, but not for the expected reasons. In other words, the bad news may not be for women and minorities, but for white men who are undergoing a procedure that, for primary prevention, has not been shown to extend their lives. By reporting the first outcomes data for ICDs in the Medicare population, the study by Curtis et al should stimulate national dialogue on this crucial question."

Her issue was with the primary prevention cohort, she had no issue with the secondary prevention cohort.

-Wes

Grand Rounds - Dr. Seuss Style

'Tis Rounds that abounds, for your eyes to feast,
Dr. Rob does a job, that'll be sure hard to beat.

-Wes

SCHIP: It's Not About the Kids

The State Children's Health Insurance Program (SCHIP): it seems it's really about adults:

The bitter battle over children's health care in Washington is threatening to punch a hole in the state's budget and calling into question medical coverage for 130,000 Illinois adults.

Late last week, Congress forwarded legislation reauthorizing the State Children's Health Insurance Program to the White House. But President Bush has vowed to veto the bill -- a move that could come any day.

Illinois has a lot at stake, as 170,000 children and 130,000 adult residents currently get health insurance through SCHIP. Last year, the federal government paid more than $400 million to the state for those services.

No wonder there's likely to be a veto.

-Wes

The Effect of International Healthcare Competition

David Williams over at the Health Business Blog interviews Maggie Ann Grace, author of State of the Heart: A Medical Tourist’s True Story of Lifesaving Surgery in India. As the wife of the first US citizen to have a heart valve replacement in India, their experience demonstates the remarkable international pressure building for marketing of global health services:

David: Now you mention in the book that you think that people were going to be asking you about how much the two days with the Heparin in the U.S. was compared to the whole trip to India. So I have to ask, what was the comparison of the U.S. cost versus the whole surgery and trip to India?

Maggi: Well, I wish I knew the answer because the last time we addressed this issue, Durham Regional was negotiating this price, and what happened coming back was when we got into the hospital was, Dr. Hinckey who is Dr. Engel in the book tried very hard when she put Howard, — she knew how devastating it was for him to get put in the hospital when she saw him again after the return from India, and she said I’m going to do everything in my power to make this just a Heparin drip stay and not a procedure, not anything that’s going to cost like what a surgery would cost, and I think she coded him in as a special research patient, or I don’t know what she did, but she kept the cost down that way, and then I think because of all the publicity the hospital bent over backwards to keep the cost down. So if I can put this in some relation to something else, a friend told us right when we got back from India that he had been put in the same hospital in Durham overnight for a drip of antibiotics because he had an abscessed tooth. So he was in overnight because the only way to get the antibiotics working fast enough was through the I.V. He got out the next morning and his bill was $7500, which was more than our entire three-week stay…

David: Right.

Maggi: And two surgeries in India. Howard’s bill for the Heparin drip two-day stay when we got back was nothing like that. As I recall it was in the couple thousand range. But that’s because everyone was bending over backwards. I know that. And they were bending over backwards in India as well…

David: Yeah.

Great interview and worth a read.

The times, they are a changin'.

-Wes