Monday, December 27, 2010

Time in a Bottle

If I could save time in a bottle
The first thing that I'd like to do
Is to save every day 'til eternity passes away
Just to spend them with you.

From: "Time in a Bottle", by Jim Croce

Was it a day with you at Wrigley?
Or an extra day at the beach?
A chance to see a few more recitals?
A tack, a turn, or broad reach?

What will we miss, I wonder?
What should we have done?
Sorry, Superman was busy.
Sorry there was so little fun.

You see I used to save time in a bottle,
Time I’d supposedly earned.
But you can’t see time, now can you?
So, the rules were easily turned.

What comes now, I wonder.
When the grains of sand are lost?
What did we lose together?
What has it really cost?

There’s one sure thing going forward,
One particular thing I know.
Time stands still for no one.
So the bottle has to go.


Wednesday, December 22, 2010

EKG Du Jour #21 - The Post-op Heart

Sometimes a case comes along that reminds you why this job is so much fun. Maybe it's the fact that not a lot of thinking is involved, or maybe it's just that you realize that, as a heart rhythm specialist, you think differently than others do. Whatever it is, I still find that human physiology remains remarkably interesting.

Take the following case:
A nice guy gets bypassed and is recovering in the Intensive Care Unit. Everything has gone as planned and his post-operative course has been completely uneventful. He is extubated post-op day one and is sore, but breathing fairly well, has a good blood pressure and urine output, and (most importantly) the ICU nurses are happy.

Until the following morning. Suddenly, he starts "throwing PVC's" and then, BLAMMO, this happens:

Click image to enlarge

The ICU nurse recognizes the rhythm and shocks the patient back to normal rhythm, the ICU intern starts Amiodarone and calls the cardiologist. The cardiologist recommends to pace the patient faster and call the EP to see what can be done to prevent this from happening.
You recognize the simple problem that took place and fix the problem.

What did you see and do?


Monday, December 20, 2010

Non-Screen Time

Lately, like several times before, I have found it challenging to keep up with the demands of time this blog requires. In the hyper-speed world of electronic communication and the world's insatiable quest for new entertainment content, I find I need more non-screen time this time of year, especially now that the kids are home from school.

And yet, even though my hours in front of the screen have declined, time in front of patients has not. Call and work demands, staff and co-worker vacations, the end-of-the-year push for procedures as annual deductibles are paid in full, and the winter birds whose travel plans demand they get seen before heading South, continue to pull me from the kids. I guess it's the nature of what we do: the 90-year's pacemaker yesterday preempted my attendance at the annual Christmas pageant at church. I guess you could say we had our own pageant as we wheeled our nice lady into our lab. We prepped, we timed-out, we performed, we smiled, we bowed and went on our ways.

But we did it with our work families rather than our own.

By now, my kids have grown to understand this. They tell their friends why their Dad's not there, and the story still plays well amongst their peers: "Dang, your Dad does pacemakers?!?"

But I know quietly they had other thoughts: maybe hot chocolate or a Sunday breakfast after church? Or maybe a little more sleep would be nice. What do you mean clean up my room?

Thankfully, they did find time later to debrief me about the two lost black sheep amongst the sea of two- and three-year old white ones that were ushered down the aisle.


Friday, December 17, 2010

St. Jude Withdraws Riata Defibrillator Leads

St. Jude Medical announced they are withdrawing a portion of their thinner 7Fr Riata defibrillator lead line despite earlier glowing company reports because of a higher degree of insulation failures in the earlier design of the leads made with silicone insulation material:
The Riata and Riata ST family of silicone defibrillation leads have exhibited an insulation abrasion rate of 0.47% over 9 years of use. Silicone rubber, while representing the industry’s most commonly used defibrillation lead insulation material over the past 20 years, has been observed to be vulnerable to abrasion. Abrasion of silicone defibrillation leads is acknowledged within the clinical community as a well known clinical risk and is well documented in the literature as the number one cause of lead failure across the industry with reported failure rates ranging from 3 to 10 %. Lead insulation damage and its possible effects are also described as a potential adverse event in all silicone defibrillation lead user’s manuals, including Riata User’s manuals.
Later St. Jude lead designs with their newer "Optim" polymer insulation appear to not be affected by this action. St. Jude had hoped their Riata line of defibrillator leads could replace the niche left by Medtronic's earlier withdrawl of their downsized Sprint Fidelis defibrillator leads after Medtronic's line of 7Fr defibrillator leads experienced higher-than-expected fracture rates.

Just as with the Medtronic Sprint Fidelis defibrillator lead withdrawl, St. Jude does not recommend the affected leads be extracted. I would suspect that doctors will weigh the risks vs. benefits of placing a new defibrillator lead at the time of device battery changes.

In November 2007, the Riata line of defibrillator leads were plagued by concerns of a higher-than-average rate cardiac perforation, but these were quickly disputed by the company.


Tuesday, December 14, 2010

My Top Ten Blog Posts of 2010

It's always fun to look back and review the blog posts from the preceding year and pick a few that stood out for me. Clearly, not all are literary brillance, but they stood out nonetheless. From 2010:
(10) Swiss Call Girls Offer Full Cardiovascular Services

(9) 'Twas the Week Before School Starts

(8) Accountable Care Organizations: So Sad, It's Funny
Patient Care
(7) Preconceptions

(6) When the Doctor's Always In

(5) Twice Shocked

(4) Al Fine
Health Care Reform
(3) Our Health Care Happy Meal

(2) Our Health Care Reform Illusion
(1) Top Ten Reasons to Be A Doctor
Enjoy! (again)


Grand Rounds Are Up!

Over at Dr. John M(androla)'s place:
Welcome to another edition of Grand Rounds, a collection of writings from medical bloggers, the world-wide.

Here are this week's posts, collated into four chapters, with just a little commentary and a few selected images.


Who Do They Think They Are?

Who do they think they are, those pesky judges who rule that those piddling, nagging, annoying rights of the individual matter? Who do they think they are getting in the way of grand sweeping visions?

But who they are is Americans. This is what makes America unique: the profound belief that the individual and their rights matter above the interests of the government. As messy and maddening as that may seem, it is, and has been, our strength as a nation.

I wonder if such a suit would have happened in any other country in the world.

Russia? France? England? Germany? Cuba?


Only in America the beautiful.


Monday, December 13, 2010

Get $5 Off Medical T-Shirts Today

.... over at Cafepress's marketplace. (In fact, ALL shirts are $5 off today only) Just use code LRTXY99 at checkout. Offer good 'til midnight tonight.


So You Want to Be a Clinical Investigator

Young doctors raised in the sheltered environment of hospital systems are finding the foray into a private practice setting increasingly anxiety-provoking thanks to the economic uncertainty of such a practice due to the recent health care reform legislation. Consequently, many are turning to clinical research as an alternative career path. But what does it take to become a productive clinical researcher?

Here are some points to consider:
  1. First, think like a medical device company. By and large, companies are usually the ones funding the research. They want to save costs since many companies have limitations to their research budgets. Every step in clinical research, from the design of the trial to the support documentation and prototype patient consent form(s) should be carefully assembled to reduce delays in approval from an hospital's investigastional review board (IRB). Months of delays with IRB's can occur without this documentation and remember, time is money. An acceptable number of patients with the studied ailment must also be seen at your institution. For instance, if the trial requires congenital heart disease patients and your clinic only sees ten of these patients a quarter, you will probably find the trial will be completed before your center has an opportunity to enroll even a single patient. In return, you get nothing more than the enjoyment of completing tons of paperwork.
  2. Make sure your center can afford the trial. All research centers require budgets. Most require an itemization of direct costs and then an overhead fee for "indirect costs" (think lights, heating, facilities charges, etc). These costs cut both ways: centers that have "indirect costs" that are excessive will never be approached by companies for research work (unless they are suicidal) and likewise, companies that don't offer some amount for these real-life expenses to conduct the work, shouldn't be performed at your center. Working out the budget needs BEFORE the research is submitted to the IRB will save countless hours of work in the end.
  3. Learn to write. Most doctors are great at math and science, but far fewer are skilled at writing. The most productive researchers I have met are not only good doctors, but great writers as well. They can construct an organized research paper complete with a thorough literature review on their first pass. Learn this skill and you will be a highly sought-after researcher.
  4. Be a cheerleader. Patients have to believe in the work and so do your referring doctors. If you can't articulate the importance of the trial to these folks, you'll never be successful. Also, since trials take time, keeping your trial at the forefront of your collegue's minds will be one of the toughest challenges that any young researcher will encounter. Other doctors will not have the passion or commitment for your work, so frequent reminders about your trial (along with follow-up on patients that are enrolled) will go a long way to improve trial enrollment. Again, time is money.
  5. Be prepared to work after hours. The days of sheltered research time have long since passed. In today's clinical environment, you'll still need to see your usual cauldron of clinic and procedural patients, lest your clincal productivity (and maybe your salary) suffer. While some clinical trials can increase your clinic volume as patients are referred for evaluation in trials, this is usually not the norm.
  6. Be timely at returning e-mails and phone calls.
  7. Believe it or not, corporate time is just as important as yours.
  8. Be transparent. In today's world, it is not okay to keep your relationships with a device company private. Tell everyone what you're doing and how much you make doing it (they'll find out anyway). If a speaking or consulting junket sounds too good to be true, avoid it. Sticking to this advice will help keep your clinical research career not only viable, but fruitful, for years to come.
  9. Get help.
  10. In today's regulatory environment, the number and scope of rules for research are greater than ever. Many centers have people that can help young investigators stay out of trouble. Find out who these people are and use them. Often.

Sunday, December 12, 2010

"This Is The Way It's Done"

Stephen L Snyder, attorney for Dr. Mark Midei, comments on the US Senate's Finance Committee's staff report (4.4 MB pdf file) of stent usage at St. Joseph Medical Center in Towson, Maryland:


Thursday, December 09, 2010

Defibrillators Make Top Ten Technology Hazards List

In a desperate attempt to reach an even number is seems, hospital defibrillators were added to's top ten health technology hazards list of devices that threaten to kill or maim patients:
The Top 10 Health Technology Hazards list is updated each year based upon the prevalence and severity of incidents reported to ECRI Institute by healthcare facilities nationwide; information found in the Institute’s medical device problem reporting databases; and the judgment, analysis, and expertise of the organization’s multidisciplinary staff. Many of the items on this year’s list are well-recognized hazards with numerous reported incidents over the years.
If one honestly looks at the number of saves versus the number of deaths from defibrillators, I wonder how many of this highly esteemed group of "multidisciplinary staff" of the ECRI might reconsider.

Clearly, most of them have never been in a code situation.


h/t: Wall Street Journal Health Blog

How to Catch a Perp

... thank him for saving someone's life:
"He administered CPR until paramedics arrived and then left. We just want to identify him and thank him. It's nice to know that people are there to help."

Police released a photo of the man in the store.

But Wright said the man "also committed a crime at this convenience store, but we . . are not releasing any of this information at this time."
Gee, I wonder if he'll step forward...


Wednesday, December 08, 2010


One more to see after cases were completed. It had been a long day, and I was finding it challenging to summon the effort for one more case. I reviewed the chart. Her past medical history in the Electronic Medical Record read much like a Rorschach blot: ninety-one, uterine cancer, hysterectomy, colostomy, breast cancer, mastectomy, a digit had been amputated, hypertension, hyperlipidemia, recent stent. The medication list was complicated, but not incomprehensible - at least most of the drugs were familiar. I noticed that anti-platelet agents, but not anticoagulants, were part of the mix. "Fall risk," I thought. I braced myself for another hour's work, realizing the inevitable. What room was she in again?

The hall was bustling with activity as family members stood outside rooms discussing their loved ones, nurses skittered from room to room answering call lights and bed alarms. Patient transportation personnel were lifting the last patients of the day on to their neatly pressed bed linens, as they promised a rapid response from the dietary staff.

Her door was closed while most others were open. Why do a procedure on someone so limited? I entered and looked for the quick-wipe alcohol foam dispenser and squirted the foam in my hand, turning to see her. Startled, there was not one person there, but around the small intervening wall her husband could be found, too.

This was not a dismal, dreary place I had foreshadowed. Quite the contrary. I had interrupted the fiery proclamation emanating from the tiny frame lying in bed as she challenged her husband's desire for her to stay another night. "We'll discuss this later," she said, "the doctor's here now." She turned to me, smiling, "Yes?"

I introduced myself and explained the purpose of my visit. "Yes, yes," she said, fully comprehending the circumstances, challenges, potential reasons for her six readmissions in the last three months. She was sharp, engaging, a remarkably accurate historian - not at all what her Rorschach had predicted. She rifled through her own history, explained her symptoms concisely, and looked at me willingly: "Now, how soon can we get going?"

My Rorschach had spoken.

She was a simply a delight - a firestorm of personality and drive that even the most ardent supporters of the electronic medical record could never have predicted. It was then that I realized its stony information lacked her vision, her wit, her charm. Suddenly, her procedure made sense.

And so we proceeded.

And so did she, right out the door, just as soon as her 93-year-old husband would let her.


Monday, December 06, 2010

Our Health Care Reform Illusion

The greatest minds are assembled to discern the answer in health care reform. Powerful interest groups are aligned to design solutions to protect their turf. Rubrics, formulas, slogans and taglines get designed, spun, pitched and thrown out. The burden of finding alignment, an answer, a plan that suits everyone seems insurmountable.

Unless we don’t.

The idea of a fit for all is an illusion. Justice and equity are seen differently. We imagine some public consensus at our own peril. But honesty has been in short supply. To paraphrase Oprah: what do we know for sure?

Some people want a relationship with a trusted doctor who knows them well. They want to pick the doctor, the neighborhood and the hospital they attend. Others want immediate access and have little trust or interest in a personal relationship with a doctor.

Some people want interchangeable access to medical care in the most convenient venue – they care little if it occurs at Walgreens, Doc in a box, by a nurse practitioner or by a newly minted resident – it is about access that fits their lifestyle – which may be at a late hour, and may be chosen by shortest waiting time at an ER. To others, this type of medical care is anathema.

Some people do not trust the medical field – they want oversight, monitoring, zero errors, and do not want to rely of a doctor’s judgment. They prefer rubrics, computer generated solutions and objective control. Others live in fear of losing the right to confer with their doctor as to his best judgment,, with freedom to choose treatment, medication and plans made between doctor and patient.

Some people expect to pay nothing for their health care – they want health care provided as a right, an entitlement, a government administered program that can never disappear. They do not want to have health savings accounts, worry about saving for care, or plan for medical expenses. Others are prepared to pay for the type of health care they want and when they want it. These people would rather have choice and control over the security of someone else being in charge.

Some people see health care as a chance to exercise equity and redistribution – the chance to level the playing field in health care delivery trumps the issues of rationing, waits, doctor availability or any other front line problem. Others do not support redistribution or using health care as a method of forcing equity in a country that has thus far been thought of as a meritocracy.

We will not find agreement. If there is one thing we can agree on – it is that.

What to do then?

Most obviously, a forced solution shoved onto an unwilling public is wrong. A government that takes a position to advocate for either side of the preferences and needs listed above is on dangerous territory. Can both types of health care exist? What would that look like? Or do we kill one in the race to get to the other?

Much of our current conundrum is a failure of courage. We know what we secretly believe but we are unwilling to say it. If we publicly endorse health care for all as a right, while privately planning on paying for our own special needs at a future date – we hamper any honest resolution. We need to be honest about what kind of a society we live in and how we see health care fitting in. Guilt, shaming, intimidation and fear are poor policy planners. How do we explicitly acknowledge the differing needs and plan for them without denial of either group?

We will not solve the issue of trust. We will not solve the issue of lifestyle, cost, access, convenience, or fear of fairness. We will not make all patients compliant, responsible for their own treatment, or responsible for their own expenses. We will not change human nature so that all follow medical plans religiously, or stop chaotic lifestyles or master self-destructive behavior. So we must acknowledge this directly as we design solutions – multiple solutions.

Our society in unique in honoring individualism, freedom and plurality. Can our solutions for health care tomorrow reflect this?

We are not there yet.

Diane Fisher, PhD
Wes Fisher, MD

Friday, December 03, 2010

Should Doctors Join Social Media?

The pros and cons of social media for physicians are nicely reviewed by a number of prominent medbloggers (including yours truly) by Bonnie Ellerin in her recent white paper (pdf).


h/t: @hjlucks on Twitter via Smartblog On Social Media.

More on Biotronik's Exploding ('Venting'?) ICD

According to MedPageToday, it appears an earlier case report that was mysteriously withdrawn from the peer-reviewed journal Europace will soon be republished:
A controversial article about problems with an implanted cardiac device -- published by and then withdrawn from the journal Europace -- has been resubmitted and is under review, according to the journal's editor.

"I expect that a decision on publication will be made very shortly," John Camm, MD, of St. George's University of London, told MedPage Today in an e-mail.
Hopefully, the journal will explain why they failed to notify their readers about the withdrawl as well. To withdraw an article of such signficance to their readership without explanation should not be tolerated by the scientific community.

Several other issues:
  1. Perhaps even more concerning this whole ordeal has been the FDA's management of the device report made to them in May. It seems public reporting of Biotronik's filing did not appear on the MAUDE database until after my blog post was published in October.

    If this is their policy to withhold reports in patients that are injured for this length of time irrespective of "cause," there are bigger concerns with the government's policies that should be immediately addressed.
  2. I should also explain my rationale for my "defensive blogging" earlier, too.

    The Fair Use Act of US Copyright law has been a favorite place for malicious lawyers to attack bloggers who republish content in their blogs. Irrespective of whether or not one could defend their actions in the court of law on the consitutional basis of "free speech."

    But when challenged, as soon as a lawyer gets involved, thanks to the large costs involved, you've "lost" your case even before going to trial. I did not need that expense at the time, so I caved and withdrew the pictures I had published (note: they have since been republished on the blog, courtesy of Google cache, but have included a pdf of my copy of the entire case report in this blog post).

Specialists' New Game: Musical Chairs

The consolidation of physician specialty practices in to larger corporate health care systems in urban areas is creating a new challenge for today's doctors when the music stops: there might not be a chair available.

There are simply many fewer hospital systems in large urban areas than there are specialy practices, so the number of specialist positions a large health care system is willing to absorb might be limited. As doctors and hospital systems coalesce into as-yet-to-be-clearly-defined "Accountable Care Organizations," the cost of too many specialists in an organization is being carefully weighed.

This is playing out in our area as more and more cardiology groups join forces with hospital systems. The concern in some circles is what will happen to laggard practices in similar geographic locales. Will they be able to go it alone and refuse government payments for services? Will they have to align themselves with an alternate hospital system that might not be there first choice? Or might they just simply fade away as the specialists in these practices retire?

It's hard to know where this might sift out, but the construct developing suggests that certain specialty services might be even harder for patients to obtain in the years ahead.

But then again, that's probably been the plan of our new health care reformers all along.


Thursday, December 02, 2010

Co-Opting the History and Physical Examination

This week, new "performance" guidelines were published for adults with peripheral artery disease (or as one drug company brands it, "PAD.")

Interestingly, in explaining the rationale for these performance measures, these guidelines state:
Despite the overwhelming evidence that patients with PAD are at a markedly increased risk of myocardial infarction, stroke, and death, these patients are often undertreated, in that they do not receive antiplatelet therapy or statins with the same frequency as do patients with coronary artery disease (19).

Thus, these PAD performance measures are directed at strategies to improve diagnosis and treatment of patients with PAD with an overall goal of improving patients' walking distance and speed, improving their quality of life, and decreasing cardiovascular event rates.
And we should add, giving them appropriate pharmachologic and interventional therapy.

Fair enough.

But the guidelines push for the performance of an ankle brachial index, or ABI (a part of a thorough cardiovascular physical examination), in all patients determined on the basis of a questionnaire to be at risk for peripheral vascular disease. And they push hard, with statements simultaneously published the the Journal of the American College of Cardiology, Circulation, and reportedly also later in the Journal of Vascular Nursing, the Journal of Vascular Surgery and the Vascular Medicine Journal. The ABI is nothing more than a calculated ratio of blood pressures of the lower extremety systolic pressure divided by the upper extremity systolic blood pressure. A ratio of 0.9 or less is thought to suggest significant "PAD." To speed measurement of both arms and legs simultaneously, fancy new machines have been developed and costs about $75-110 to have performed by ancillary personnel.

Now don't get me wrong, I do think we can do a better job of detecting and treating peripheral vascular disease, but I have to ask several questions:

First, if "8 million persons in the United States are afflicted with PAD" and "the prevalence of PAD is approximately 12% of the adult population, with men being affected slightly more than women," how much will these screenings cost? Cost and the issues of dealing with false positive findings were part of the reason why screening EKG's were not recommended for all high school athletes in the American Heart Association's earlier guidelines. Should we not have a similar discussion for ABI screening?

Secondly, since when did we allow portions of the history and physical examination to be co-opted into billable procedures by professional organizations interested in promoting "quality care?"

How about a few more minutes in the exam room instead?

This is not just a rhetorical question any longer. Doctors are constantly being pushed by more and more "performance measures" to focus on things that might not have anything to do with the patient's chief complaint. Like bugs to a light, we are re-directed by these performance measures, soon-to-be mandated by Medicare, to direct our thinking away from patients toward the bureaucrats in the name of professional organizations' turf preservation.

Every screening measure amplified by millions of people has the potential to raise costs, not reduce them. And this era of a real need to significantly reduce costs of health care delivery, maybe we should have an honest discussion of the costs of these "performance measures."


Wednesday, December 01, 2010

The Need for Doctors' Right To Investigative Free Speech

Imagine having a medical device that is being tested in multiple centers, but one doctor thinks the device has problems. He says so at a national conference despite glowing reviews by others. Should the company sue the doctor for liable and remove him from their investigative panel?

Today, it seems that might not be such a good idea.

This is, in fact, what NMT Medical did regarding comments made by Peter Wilmshurst, MD regarding NMT's patent foramen ovale (PFO) closure device called Starflex:
NMT sued Dr Wilmshurst for libel after he criticized its research at a US cardiology conference in 2007. The doctor vowed to take the case to trial in order to defend scientists' rights to free academic debate.

The company threatened Dr Wilmshurst with libel a second time for subsequent comments he made about the case on BBC Radio Four's Today programme.

"During the last three years, enormous pressure has been placed on my family and me from time wasted dealing with the case, money laid out for legal costs and interference with my ability to work and other activities," Dr Wilmshurst said.

"I'm concerned my case will have a chilling effect because other scientists and doctors will realize the enormous financial and time costs of speaking out about products and the risk of being sued by manufacturers."
For medical device companies that pay doctors as consultants, they have to be willing to have the knife cut both ways during clinical testing of their devices, regardless of the implications to their investors. Releasing an ineffective or defective product would be far more damaging to the company (and patients) in the long run. When concerns arise regarding the performance of a device, companies would be best served by providing additional data or additional independent reviews to support their claims rather than suing their own investigators.