Traveling Heart Road Shows

Does anybody ever go to these things? Seems like alot of money to hit very few people, and with the exposure in only three cities... seems like a limited focus. And why these cities? Are people in these cities special when it comes to heart health?

Perhaps spreading the word via blogs might be better.... :)

--Wes

Free the Electronic Medical Record

I find this news interesting about New York providing funds for installation of Electronic Medical Records, when the Veteran Administration's Vista System will be offered for free.

--Wes

Heart Rhythm Society: ICD Recall, er, Safety Alert Guidelines

The Heart Rhythm Society released their "Draft" recommendations regarding the Device (a.k.a., pacemaker and defibrillator) Performance Policies and Guideline recommendations after this year's device failure and reporting fiasco. One of these recommendations is to remove the word "recall" from the FDA's lexicon, and instead use the term "Advisory Alert" or "Safety Alert." You can see the full report here (pdf file, 787K). They did a great job. It has recommendations for the FDA, industry, physicians, and Congress, and the Center for Medicare and Medicaid Services (CMS).

One suggestion I'd make: Make a Class I Safety Alert the least concerning, while Class III Safety Alert would be the most concerning.... this would be in line with other schema in medicine (Class A vs Class D cancer, Class I vs Class IV heart failure)... Just a thought.

On a (much) less serious note, since "recall" was thought by the committee to be to troublesome to the public, a few other terms that could be used instead of "Safety Alert" were passed around in our lab today. They included: "glitch," "hiccup," "boo-boo," and the best: "faux pas."

--Wes

Still Have a Recalled Defibrillator? Good.

A series of important articles are published today in JAMA (Journal of the American Medical Association) about the risks of following a recalled defibrillator versus replacing the device. Bottom line: ALWAYS discuss risks with you doctor: it might be better to take your chances rather than replacing the device. This from a Canadian survey by the Canadian Heart Rhythm Society Working Group on Device Advisories:

At the 17 surveyed centers, 2915 patients had recall devices, including 533
(18.3%) who had advisory ICDs replaced a mean (SD) of 26.5 (11.5) months after
their initial implant. Of these patients, 66% had a secondary prevention ICD,
and 45% had received a previous appropriate shock. During a mean (SD) of 2.7
(2.8) months' follow-up after ICD generator replacement, complications occurred
in 43 patients (8.1%). Major complications attributable to advisory device
replacement requiring reoperation occurred in 31 patients (5.8%), with death in
2 patients after extraction for pocket infection. Minor complications occurred
in 12 patients (2.3%). There were 3 (0.1%) advisory-related device malfunctions
reported, without clinical consequences.

Remember, every person's circumstance and device indication is different. These data help with the decisions you and your doctor can discuss.

--Wes

New Heart Valve Has Promise

Interesting read on newer prosthetic heart valve design still under investigation by the FDA (but approved in Europe) described today in the Chicago Tribune. The valve is made by Shelhigh Inc., Union, NJ. The valve is a "valve conduit" bioprosthetic design that incorporates bovine (cow) pericardium and a porcine (pig) aortic valve that is treated in a patented technique to resist the build-up of calcium on the leaflets long-term. The longest follow-up with this valve is 9 years (in Europe), and while the follow-up is not as long as conventionally-available metal valves (that require the blood thinner, warfarin, and have over a 20-year clinical track record), it is promising that it might be less reactive than conventionally-prepared porcine valves. While this might be great, remember that this valve still requires open heart surgery. Percutaneously-implanted valves (one requiring no open-heart surgery and placed through a leg artery) are under development now, but remain much farther from clinical approval in the US.

--Wes

American Heart Association Breaks Hearts

In the world of rubber-chicken dinners and self-congratulatory fundraisers, the American Heart Association has always had a moment of sincerity with it's Coeur d' Or, "heart of gold" award - given in years past to dedicated clinical researchers and physicians. The Coeur d' Or turned into the Coeur d'Green last night, as the local AHA chapter, without a hint of irony or embarassment, gave the award to the President and CEO of the presenting sponsor organization underwriting the event, Advocate Healthcare. I had to suspend my disbelief and check the program. That's right, the same guy chairing the selection committee and authorizing the checks for the gala was the same guy being feted on the dais.

If the AHA or Advocate had experienced even a frisson of conscience, one would have at least expected the award to go to an Advocate system heart specialist. Is this for the lack of any heroic, tireless clinicians deserving such an award this year? On the contrary, the ballroom was filled with dismayed physicians and bedside clinicians, excellent professionals who devote countless hours to forward research, who run in at 11pm when a defibrillator is shocking someone every five minutes, who stands, legs swollen, at the operating table long past the point of reason trying to stitch up a dissected aorta. But here is what the physicians did NOT do: they did not head up a hospital group that made a major financial contribution. The age of unapologetic cynicism in health-care has arrived.

But why dissemble? If this wasn't bad enough, the clinicians attending were treated to a promo video about the Advocate Healthcare system - a system certainly under scrutiny recently.

Who cares if the AHA wants to pat the back of one of its' chief funders? It only matters to the little guy if AHA similarly tilts its' public policy toward the interests of its corporate supporters. Are we now to look without cynicism at the treatment recommendations the AHA makes to the public? The medical device recommendations? The dietary? Should we be asking for a financial disclosure statement? Are rewards granted to sponsors in direct violation of the AHA's of conflict of interest policy?

The AHA opens itself to this scrutiny in its' breathless endorsement of its' own funders last night - and it's abandonment of the front-line for the deep pockets. It would be interesting to know if the national organization endorses this new orientation.

-Wes

Near death experiences...

Every day in America, patients have their heart fibrillated and rhythm restored during testing of automatic defibrillators - about as close to a "near death" experience as I know. I still have NEVER heard of a "near death" experience like seeing a white light, etc. during these moments. Could it be the sedation? Does this jolt happen so quickly that no such experience occurs? I'm just fascinated that researchers found so many such subjects like those studied in the April 11th issue of Neurology and reported on the the LA Times.

--Wes

Another Needless Death...

I saw this story on CNN.com about a 57 year-old defense lawyer with known heart disease who died suddenly while trying a case in a county courtroom. He probably died of a rapid heart rhythm that comes on suddenly and unexpectedly in some people with heart problems. A shock to his heart using an automatic external defibrillator (AED) likely could have helped revive him. But no defibrillators were on site. Presumably, no first responders, like police, had them either. And the saddest thing: this happens about 450,000 times per year.

Communities would be wise to consider placing defibrillators in the back of police squad cars, since there are typically many more police officers than paramedics or firemen on the publics' payrolls. Often, they respond before paramedics to similar incidences and on occassion (as in cases like this), have the ONLY defibrillator available. Illinois offered a grant in 2001 to MANY communities in our state (tho' we could still use more), but the need is still great throughout other communities in America. And remember, about 20% of sudden death survivors are under 18 years of age! (This is not just for "old" people!! For instance...'Commodio cordis' a rare but real cause of sudden death due to blunt trauma to the chest, seen most often in baseball players.)

--Wes

Shock Docs Help FDA

According to the New York Times, a panel of physicians from the Heart Rhythm Society will help the Food and Drug Administration (FDA) decide proper notification practices during medical device (especially pacemaker and defibrillator) recalls. Defibrillators are used to prevent sudden cardiac arrest in heart patients susceptable to the development of rapid heart rhythms by delivering a powerful shock automatically to the heart to restore normal rhythm. Last fall, despite evidence they were aware of a rare incidence of short-circuiting of one model of their defibrillator, Guidant Corporation (soon to be acquired by Boston Scientific) initially failed to issue a recall until physicians threatened to go public, citing statistics suggesting the defect was rare. The Heart Rhythm Society subsequently convened a panel to study better ways to notify patients and work with physicians when medical issues with these devices surface. Their report is due May 2, 2006. This will mark the first time an outside panel will advise members of the FDA. Recommendations will be made for physicians, too, to assure more timely reporting of device-related complications.

--Wes

Giving of ourselves to help others

This is an incredible story of one soldier helping another child. Unfortunately, he lost his life before being thanked. We should all donate medical equipment to the less fortunate in our wills or when it's no longer needed.

--Wes

Oil painting...

My first oil on canvas:

"Paper," Oil on Canvas 12"x15"

Worked on this for hours and I felt blood pressure drop 10 points every time I came back to it....

--Wes

UnitedHealth's McGuire: Hand caught in the cookie jar...

"I've never made it a practice of looking for money," says Dr. William McGuire, CEO of UnitedHealth Group in response to the page 1 story in the Wall Street Journal today. Yet the timing of his twelve stock option grants that netted over $450 million suggest otherwise....

-Wes

What a medically-fragile child can teach us...

When you've lost hope in the medical system, read this.

--Wes

Stay-at-home ICD Followup

The internet will provide more and more options for continued health care follow-up for implantable cardiac defibrillator patients. All three big manufacturers have options, most of which work with their latest models, but might not work with earlier models. (Pacemakers might come soon if Medicare approves reimbursement).

Guidant
Medtronic
St.Jude

See if these can be used for your device.

--Wes

Insurance Vendors Fleece Healthcare

Congratulations to UnitedHealth’s CEO, William McGuire. As reported in the Wall Street Journal today, since 2000, he has cashed out some $488 million in options, has an $8 million dollar annual salary, use of a private jet, private perks of a $139,000 annual travel allowance, $69,100 in financial planning fees, and worst of all, 1.6 billion in unexercised options. All at a time with an expanding number of uninsured in America grows and reimbursements plummet to the folks who really provide care: the docs and hospitals. Now to be fair, they do process paperwork and fill pill bottles as middlemen while purporting to “restrain costs” in health care delivery (“huh?”). Though it might qualify as the WSJ’s “Rewarding Career,” this compensation travesty can’t really help our health care system. I only wish there were a way to really fix this abomination.

--Wes

Can I have some of your blood?

The New York Times Magazine had a provocative piece this morning regarding the biotech industry and its use of tissue samples by Rebecca Skloot (who, ironically, stands to make handsome profits from her soon-to-be-published book on the topic called The Immortal Life of Henrietta Lacks) :

"When you go to the doctor for a routine blood test or mole removal, when you
have an appendectomy or any other type of –ectomy, the stuff you leave behind
does not get thrown out. Doctors, hospitals, and laboratories keep them. ….
Scientists use these products to develop everything from flu vaccines to tissue
penis enlargement products. … Without these tissues, we would have no tests for
diseases like hepatitis and H.I.V.; no vaccines for polio, smallpox, measles;
none of the new promising drugs for leukemia, breast cancer, colon cancer. And
without these tissues, the developers of these products would be out millions of
dollars."

The article describes a case regarding John Moore, a man who had hairy cell leukemia and required splenectomy. His spleen supplied valuable proteins and carried a rare virus that might lead to treatments for H.I.V., and the doctor who removed that spleen filed a patent on Mr. Moore’s cell line, the "Mo" cell line, standing to make $3.5 million in potential royalties.

Here's an idea: why don't hospitals and industry just stop this practice because we're so upset that our polyp is over at University of Massachusetts! Or at least make sure every shaved basal cell comes with a travel itinerary!

First of all, the "payday" like this is unusual: the article describes cells of 178 million people's tissues or blood on file somewhere (duh, can you say DNA for the FDA's crime lab?). The dollars and intellectual property to develop such tests and treatments is as extraordinary. How many tests, hours of research, and teams of researchers had to be made (and paid) to find one such tissue sample?

Simple question: should doctors and researchers request your consent to use your discarded tissues to conduct research that could potentially be profitable?

Insulin Pumps on Pacemakers or Defibrillators is Just a Matter of Time...

With the announcement of the FDA approval of Medtronic's Paradigm closed-loop insulin pump paired with the soon-to-be-released IS-4 pacemaker generator-to-lead connector standard (which permits four wire connection points in the connection block of a defibrillator or pacemaker for each wire placed into a patient instead of just two connection points as on the currently-available IS-1 standard), we are now a step closer to a fully-implantable insulin infusion device that can also monitor blood glucose levels. Other sensors will soon follow. My job's secure at least another week....

--Wes

Show Me the Money

I’ve been thinking a lot about the difficulties with the costs of healthcare today, the growing number of uninsured, and how downright impotent us doctors feel to effect change with the system. I guess our impotence is derived in part from the lofty expectation of the Hippocratic Oath. We are patient’s advocate after all, with little real understanding of the political and business jet streams above our heads that move policy across the landscape of the healthcare arena. Unfortunately, these business and political interests are often contrary to our patients’ best interests. How do we influence these jet streams for our patient’s benefit?

I feel a major problem in our misunderstanding of controlling costs of healthcare lies in a superficially simple (but realistically exceedingly complex) observation – people don’t have to pay for the services rendered when they get sick – insurance does. In ways, this encourages people not to ignore their health care if they become ill since the monetary disincentive does not exist. Doctors don’t have to worry about the cost of procedures or tests for their patients. They order tons of blood tests, EKG’s, x-rays, fancy scans, and the like because the patient needn’t worry about the bill. No test is too frivolous or too repetitive. Computers make daily (or even hourly) laboratory blood test ordering easy. But are such daily tests necessary? Liability concerns help counter the guilt regarding the expense. Protect theyself, o’ physician, lest ye be sued! (And believe me, this is no small issue.)

But what if costs were disclosed? What if costs were available online or during the ordering process on the Electronic Medical Record for physicians to make judgments about how many tests they REALLY need? Might it affect care negatively? I doubt it. Would it change outcomes? Probably not. Reduce cost? Absolutely. Is it difficult to implement? No.

And taking that concept one further, what if the patient could see the costs of expensive technologies? What if the costs of implantable defibrillators were available online? (For instance, it’s easier to find what a defibrillator weighs, than what it costs…. I checked Google, the big three ICD manufacturers websites [Guidant, Medtronic, St. Jude] and could find none.) Stents? Would patients always want the “expensive version” of technology or would they settle for a lesser model if it saved them or the system a few bucks? I don’t know. But to shield the ultimate consumers (the patient and their doctors) from these costs is counter-productive and serves to permit price increases to occur without public awareness and limits free-market competition. Transparency in healthcare costs is just as important as transparency on corporate financial statements. Maybe more. And this won’t just help the doctors and patients.

More and more doctors help hospital administrators bid on bulk purchases of expensive technologies. You see, these administrators really don’t know what’s “in” and “cutting edge” in a particular field, but they know to ask an experienced doctor for guidance (after all the doctors have to agree to use the purchased technology). Wouldn’t it be nice for the hospitals to know the retail price for equipment across provider lines and thereby make more informed decisions in concert with these physicians?

Anyone who has read The Tipping Point by Malcolm Gladwell knows that big epidemic changes can occur through the action of small, summative, incremental actions. Price transparency might be one of these actions. I say, show me the money.

--Wes

Weighing in on Insurance for All...

If you haven't seen this yet from the Chicago Tribune, it's a great look at early opinion both pro and con about the proposed Massachusetts Health Insurance mandate. Take a minute and read this. It's worth it.

--Wes

Dark Chocolate for your heart?

If you read this today and are ready to buy tons on chocolate to help your heart, beware:

"Collectively, for the most part, clinical trials have failed to demonstrate a
beneficial effect of antioxidant supplements on CVD morbidity and mortality.
With regard to the meta-analysis, the lack of efficacy was demonstrated
consistently for different doses of various antioxidants in diverse population
groups."

-- AHA Consensus Statement, 2004

--Wes