Holy Cow!

Pharmalot shows how much money some orthopedists got from the medical device industry:

Zimmer notched 21 payments greater than $1 million and DePuy made the biggest - more than $6.7 million to $6.75 million to Thomas Thornhill, who chairs the department of orthopedic surgery at Brigham and Women’s hospital in Boston.

It's more than I ever imagined.

He adds links to the companies' disclosures as well.

-Wes

The First Angioplasty

Today's post over at MedPage Today.

-Wes

Amish Ingenuity

The Amish are a regilious demonination here in the United States that live the simple life, often without electricity in their home. But they do avail themselves of medical technology on occassion, and to this end, here's a case where technology permitted follow-up of one Amish patient's implantable defibrillator from the countryside, using a telephonic follow-up service from Boston Scientific, called Latitude. (ed. note: Thanks to our local rep, Greg Roth, for providing these images. Please feel free to click them to enlarge).

The patient was a 73 year old Amish man who was implanted in 2003 with a Guidant Ventak Prism II implantable cardiac defibrillator. He traveled 30 miles for his checks from rural Pennsylvania, and then applied his own version of remote follow-up using Boston Scientific's Latitude system:


A view of the countryside.


A view of the countryside from the other angle.
Note the outhouse-style shed.


But is it an outhouse?


A closer look reveals the answer.


Not only is the shed beautifully constructed, using a voltage inverter connected to a car battery, the patient has rigged the Latitude system to a phone line for remote follow-up of his defibrillator. Doctors review the information provided to assure proper functioning of his defibrillator from their office.
Ingenious, indeed.

-Wes

Another Rare Use of A Pacemaker

Gastroparesis.

-Wes

Brugada Gene Identified

It might be fair game for next year's EP board certification exam: the Brugada Syndrome gene:

Using positional cloning and gene sequencing on a family affected with Brugada syndrome, Dr. London and colleagues identified a mutation in a previously unstudied gene, GPD1-L, on chromosome 3p24. This mutation impairs the heart’s natural electrical ability to beat in a coordinated manner and maintain a stable rhythm. To date, only ion channel genes had been shown to cause Brugada syndrome.

-Wes

Calling Dr. Pappone

Alexis Madrigal seems to want to get Carlo Pappone, MD to respond to his post on Wired magazine's blog regarding Hansen's robot-assisted atrial fibrillation ablation device.

Will he respond? Or was the demo nothing more than ill-conceived marketing hype?

-Wes

5 Nov 2007 @ 1930: Mr. Madrigal's update.

Strange Bedfellows

I've got to rant.

From a recent press release by the AMA:

"On behalf of the American Medical Association, I would like to commend New York Attorney General Cuomo for his groundbreaking agreement with CIGNA. Physicians greatly appreciate your leadership and your commitment to our shared goal of enhancing the quality of care and ensuring patients are provided with reliable information that is meaningful to them.

"The AMA also commends CIGNA for leading the industry by renouncing physician evaluations and rankings based solely on economic factors, and agreeing to a balanced approach that acknowledges physician ratings have a risk of error and should not be the sole basis for selecting a physician."

I feel so reassured when our physician political leadership is in bed with the insurance industry in the interest of "enhancing quality of care and ensuring patients are provided with reliable information that is meaningful to them."

What a bunch of double-speak. What really should have been said by the AMA to Mr. Cuomo was this:

"Physicians who still are members of the AMA greatly appreciate your leadership and your commitment to siding with the insurance industry's efforts to rank physicians. We at the AMA share your vision of disempowering physicians so they become better providers of healthcare as measured by industry- and government-mandated milestones which, to date, have had little to no proof of being effective."

Now THAT, my friends, would have been the truth.

Instead, in the push to belly-up to the corporate interests, Mr. Cuomo has negotiated a system that works best for the his government and the insurers, and does little to nothing to reduce the ultimate cost of healthcare and healthcare outcomes for our patients, now dubbed "healthcare consumers." Can we honestly think that the bureaucracy developed by these interests really will save costs for our health care system? You know it's bad when other press releases describe such terms as "actionable information:"

"'Our program is focused on providing actionable and meaningful information and is founded on clinical integrity to ensure comparisons are fair,' (Jeffrey) Kang (chief medical officer of Cigna) said today at a news conference in New York."

Pardon me, but what the hell is "actionable and meaningful information?" Actionable by whom - the insurance industry? Government agencies? Web-site developers? Healthcare "consumers?" Or do we really mean 82-year old patients who have never used a computer in their life and will never pick up a computer mouse because they can't even see the computer screen?

Who the hell are we kidding?

I must admit, I initially felt a bit warm and fuzzy when the good Mr. Cuomo threatened Cigna, Aetna and UnitedHealth with lawsuits from the State of New York. I thought he got it:

He warned the companies that the ratings are confusing and potentially deceptive, in part because insurers don't disclose how prone to error their rankings are. The move follows rankings lawsuits by doctors accusing insurers of libel, unfair business practices and breach of contract in other states.

So why the change of heart? Could it be that the Great State of New York wanted its cut of the monies that the insurance companies can bring to bear in the rush to tap the Almighty Healthcare Dollar? Where, exactly, will the oversight 501(3c) organization, funded in part to a tune of $100,000 seed monies from Cigna, be based? Could it be in New York? Would they have to pay property taxes on their building to the State of New York? What about the employee's state taxes contributed by all of the little gnomes working for this newly-formed organization? Will they have to pay New York state income tax? Ah, the potential for revenue streams for the Great State of New York are endless! And if "this will be a rating system that will serve as a model for the nation," as Mr. Cuomo hopes, then it really WILL be an economic engine for New York, won't it?

But that is not enough. Seizing on a potentially lucrative opportunity, our "own" AMA has quickly joined in the congratulatory praise. But wasn't it recently that they were found to have sold our prescribing information to the pharmaceutical companies behind our backs for revenue to their organization? Could the AMA now be on board with Mr. Cuomo because they can provide similar information to an even bigger deep-pocket: the insurance companies? Hot damn! Jackpot indeed! What's that you say? That'll never happen because of an independent organization? We wonder: which measures will the oversight organization (paid, of course by Cigna's grant and dubbed the "Select Few") be tasked to review - those published overtly or those covertly performed? Will they be privy to the backroom dealings of the AMA with the insurance corporations? Unlikely.

It is no secret that drug companies carefully track the effectiveness of their doctor "lunch" meetings by noting a rise in prescriptions filled by a physician's name. To achieve this analysis, pharmacies and the AMA sell the information on prescriptions actually filled by the patient back to the drug companies. The drug companies then have specially-hired marketing firms scruitinize the data to decide where best to invest in their next marketing efforts. Transparent? Hardly. So what's to stop the AMA from doing similar shenanigans with the insurance industry?

Meanwhile, patients continue to be restricted from purchasing insurance across state lines, are forced to buy pre-arranged medical care plans decided for them by their employer (in concert with the insurers) and have no method of measuring the "quality" of the insurer. Claim denials and payment delays to physicians and patients alike continue, and the AMA stands "happy" with these measures "negotiated" by New York Attorney General Cuomo.

I've got a headache.

-Wes

References:
Rachel M. Werner, MD, PhD; Eric T. Bradlow, PhD. "Relationship Between Medicare’s Hospital Compare Performance Measures and Mortality Rates" JAMA. 2006;296:2694-2702. (ed. note: This report concluded: "Hospital performance measures predict small differences in hospital risk-adjusted mortality rates. Efforts should be made to develop performance measures that are tightly linked to patient outcomes.")

Bruce E. Landon, MD, MBA; Ira B. Wilson, MD, MSc; Keith McInnes, MS; Mary Beth Landrum, PhD; Lisa Hirschhorn, MD, MPH; Peter V. Marsden, PhD; David Gustafson, PhD; and Paul D. Cleary, PhD. "Effects of a Quality Improvement Collaborative on the Outcome of Care of Patients with HIV Infection: The EQHIV Study." Ann Intern Med. 2004;140:887-896.

The Death of Moonlighting

For resident and fellow housestaff, there has been another sequela from the hospitalist movement that was brought to my attention today: they are no longer employed as moonlighters to provide night coverage at many hospitals.

Residents now find themselves looking for other avenues of additional spending revenue during school, since they are often paid poorly. Like the "starving actor" stereotype, will we see them as waiters and waitresses soon?

-Wes

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