September 17th, 2009 by DrRich in Better Health Network, Opinion
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When DrRich left his medical practice nearly a decade ago, he spent much of the next few years as a consultant to certain companies that make implantable defibrillators.
Most of his work was in research and development, and had next to nothing to do with defibrillators themselves, or any aspect of treating cardiac arrhythmias. Rather, DrRich was interested in developing physiologic sensors that could be deployed in implantable devices, and the algorithms that could use these sensors to predict and detect various developing medical conditions (so as to enable early intervention, and potentially prevent said medical conditions from becoming manifest). DrRich considered this work a) interesting, and b) representative of a business model that could potentially flourish within a healthcare system whose chief concern is reducing costs.
And whenever the captains of industry who signed his checks would ask him something about implantable defibrillators, usually seeking his opinion on a proposed subtle variation in some unbelievably complicated programming feature, DrRich’s reply was likely to be something like this: “Sir (or Madam) – I will be happy to study the question you pose to me, as I am working on your dime. But it greatly saddens me to see all this time, energy and talent wasted on adding yet more irrelevant features to a mature technology, in pursuit of a business model that is fundamentally broken.”
To which they would smile indulgently, hand DrRich the document describing the proposed changes, and schedule a meeting to discuss them.
The indulgent smile was in recognition of the fact that DrRich never made a secret of his disdain for the business model embraced by implantable defibrillator companies. The fact that these captains of industry put up with DrRich’s disapproval was a clear indicator that they considered it to be “quaint,” and apparently not worth taking seriously, and that the value DrRich provided in other arenas at least counterbalanced the annoyance of having him criticize their core business every chance he got.
DrRich’s disdain for the implantable defibrillator business model was based on two factors.
First, their business model relies on the artificially high prices the system will pay for their devices. DrRich has discussed this before. While these high prices are not directly the fault of the companies themselves (rather, they are fundamentally the fault of Medicare processes that distort and destroy natural market forces), these companies have now come to rely entirely on this artificial price structure, and have established all their business practices around this high-margin enterprise. The problem is that this high-price model absolutely precludes any reasonable penetration of this life-saving technology into the vast population of patients who might benefit from it. Also, because the price structure is not only artificial but arbitrary, a few simple changes in Medicare processes could abruptly destroy their business overnight.
Second, nobody is really interested in preventing sudden death. It’s difficult to sell any product when there’s no demand for that product, and there is no demand for sudden death prevention. In contrast, most other medical problems have a built-in constituency Read more »
*This blog post was originally published at The Covert Rationing Blog*
September 7th, 2009 by Toni Brayer, M.D. in Better Health Network, News
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Finally, a study that many women can like. The British Medical Journal published a study out of Denmark that looked at the association between thigh circumference and the incident of cardiovascular disease and mortality. Why anyone would even think of thigh circumference being of importance is beyond me, but the Danes seem to think it was important. They found people with thin thighs had more risk of developing heart disease or premature death.
The study looked at 1436 men and 1380 women and examined them for height, weight, hip, thigh and waist circumference. The results showed that small thigh circumference (below 60cm or 23 inches) was associated with more cardiovascular disease and mortality. They did not find the same association with waist size and the findings were independent of percentage body fat mass or obesity. Small thighs were a disadvantage to health and survival for both sexes.
Twenty three inches is not a very small thigh, and in fact, more than half of the men and women aged 35-65 have thigh circumferences below that size. Maybe it has to do with muscle mass (less exercise, less mass). I can’t imagine any other reason this strange finding should occur.
I think this study will probably not hold up to analysis and further investigation. There are just too many variables and I don’t think people with large thighs should feel they are immune to heart disease.
But the idea that, for once…the skinny models and actresses don’t have the advantage is kind of heart warming.
*This blog post was originally published at EverythingHealth*
August 23rd, 2009 by scanman in Better Health Network, True Stories
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…in four parts, from Paul Levy’s blog.
It is, says Paul, “From a friend of a friend,” and it starts thus…
My son is sleeping right now…had a rough weekend – his blood pressure dropped, his blood count was decreasing, and he had chest and neck pain. The clinical team adjusted his meds, gave him a unit of blood, and are now trying to figure out what to do next. He is scared and worried and wants so desperately to be “normal” again. He is scheduled for leg surgery this afternoon and then we wait to see what the next steps will be.
While I have a few quiet moments, I thought I’d document the story of how he made it this far….it is a story of extraordinary luck and a fair amount of clinical heroism.
My son was born 17 years ago with transposition of the great arteries (his heart had over-rotated and was pumping in a way that didn’t allow oxygenated blood to move from the lungs to the body and back again) so he had a 9 hour operation at a week old to reconstruct his heart.
…read the rest of part one
…and parts two, three & four.
Here, in my opinion, is the best passage from the entire saga…
My son is receiving absolute top-notch care from the only place in the area that could have saved him, but was by luck, not by any “consumerism” on our part – we didn’t Google “teenage arterial switch survivor with heart attack” or pull up HealthGrades to find the best hospital or doctors to treat him….we have benefited from the kindness and skill of a community of health care providers affiliated with a hospital that was uniquely situated to help him, but the only choice we had in this was what hospital to drive him to.
…
In part 2, we learn the reason for the young man’s sudden collapse…
We learned much later that the problem that caused the heart attack was due to his reconstructive surgery when he was a baby…as he grew and became more active, one of the reimplanted coronary arteries became pinched between the rebuilt pulmonary artery and the aorta….this was an inevitable result of the surgery that saved his life 17 years ago and would have happened at some point – while swimming, riding his bike, walking in the neighborhood, playing lacrosse, or running by himself in the neighborhood as he trained for cross country….so the fourth link – he happened to have his attack while at a school with trainers equipped with an AED, with coaches and parents and teammates right there ready and able to help him. He wasn’t alone….and he was in the best possible place to have his attack (even though he complicated things a bit by having it in the woods and falling down a steep bank)
…
Congenital cardiovascular abnormalities, especially anomalous coronary arteries, are amongst the commonest of causes of sudden cardiac death in athletes.1 Ramona had posted about a young man who collapsed and died during the Little Rock Marathon in 2008. That unfortunate young athlete had a rare disease of the coronary arteries.
Coronary artery anomalies constitute 1–3% of all congenital malformations of the heart. In approximately 0.46–1% of the normal population, anomalies of the coronary arteries are found incidentally during catheter angiography or autopsy. The etiology of coronary artery anomalies is still uncertain. Maternal transmission of some types has been suggested, particularly when only a single coronary artery is involved. Familial clustering is also reported for one of the most common anomalies, in which the left circumflex coronary artery (CX) originates from the right sinus of Valsalva. Anomalies of the coronary arteries may also be associated with Klinefelter’s syndrome and trisomy 18 (i.e., Edwards syndrome). Cardiac causes for early and sudden infant death include anomalies of the coronary arteries; the Bland-White-Garland-Syndrome may be one relevant cause. Anomalies of the coronary arteries found in children may be associated with other congenital anomalies of the heart like Fallot’s syndrome, transposition of the great arteries, Taussig-Bing heart (double-outlet right ventricle), or common arterial trunk.2
Normal Coronary Arterial Anatomy
Common variants are anomalies with origin from the contralateral side of the aortic bulb. These include an origin of the LMA or the LAD from the RSV or the proximal RCA and an origin of the RCA from the LSV or the LMA. There are four possible pathways for these aberrant vessels to cross over to their regular peripheral locations: (1) “anterior course” ventral to the pulmonary trunk or the right ventricular outflow tract, (2) “interarterial course” between the pulmonary artery and aorta, (3) “septal course” through the interventricular septum, and (4)”retro-aortic course”. Clinically, course anomalies of the coronary arteries are subdivided into “malignant” and “non-malignant” forms. Malignant forms are associated with an increased risk of myocardial ischemia or sudden death and mostly show a course between the pulmonary artery and aorta (i.e., “interarterial”). The most common case is an origin of the RCA from the LSV that courses between the aortic bulb and the pulmonary artery. Anomalies of the LMA or the LAD arising from the RSV with a similar course are associated with higher cardiac risk, too. It is suggested that myocardial ischemia and sudden death result from transient occlusion of the aberrant coronary artery, due to an increase of blood flow through the aorta and pulmonary artery during exercise or stress. The reason is either a kink at the sharp leftward or rightward bend at the vessel’s ostium or a pinch-cock mechanism between the aorta and pulmonary artery. Up to 30% of such patients are at risk for sudden death.2
…
The young man in this story probably had something like this after the surgical correction (Arterial Switch Operation) for TGA…
“Malignant” course of LAD
…a classical malignant course of the LAD between the Aorta and Pulmonary artery.
…
References:
- Sudden Death in Young Athletes: Screening for the Needle in a Haystack – Free full text article in American Family Physician.
- Text about congenital coronary artery anomalies and the two figures are from this textbook – Multi-slice and Dual-source CT in Cardiac Imaging.
Start Slide Show with PicLens Lite 
*This blog post was originally published at scan man's notes*
July 27th, 2009 by DrWes in Better Health Network, Health Policy, News
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Yesterday in our cath conference, we discussed the substudy from the prospective randomized trial called PREVENT-IV just published in the New England Journal of Medicine. That study evaluated the major adverse cardiac event rates of minimally invasive vein harvesting compared to open vein harvesting prior to coronary bypass surgery.
I was surprised to see that minimally-invasive vein harvesting had a higher combined complication rate of death, myocardial infarction (heart attack) and need for revascularization in the patients who received vein grafts harvested by the minimally-invasive technique. Following the presentation of the data, our surgeons were asked why this might be the case. While none knew for sure, they postulated that the art of harvesting vein-conduits using endovascular techniques might play a role (it’s more difficult), or the effects of the thrombolytic state induced by on-pump bypass vs. off-pump bypass might create the discrepency in post-surgery vein survival, since patients are less likely to develop clinical thromboses in the post-open chest bypass population.
So this morning, I was surprised that President Obama toured Cleveland Clinic yesterday and had such an up-front experience with minimally-invasive robotic surgical techniques for mitral valve repair that hardly represents mainstream American health care. While the marvels of the technology cannot be disputed, like the endovascular vein harvesting study above, might we find that robotics could be as deleterious to patients compared to open chest techniques? After all, these techniques have yet to be compared in multi-center trials to more conventional open techniques for mitral valve repair. But more concerning as we move forward is this question: will academic centers be granted more funds to test comparative effectiveness research for robotics at the expense of front-line American health care? Surely, this won’t be, will it?
Probably.
But when I see pieces like this I wonder why the article does not question the cost and risks of this technique compared to conventional open-chest procedures, especially in this era of touting the need for health care cost containment. How much is this piece about the marketing of this technique to the community (for financial gain) or to the President (for obtaining grants or political favors)?
Perhaps we should ask ourselves how many of the physicians and surgeons at Cleveland Clinic stand to earn a seat on the proposed MEDPAC board that will determine if Congress will approve payment for robotic techniques even when few data exist to show their superiority over conventional techniques.
Now that might make for some really interesting reading.
*This blog post was originally published at Dr. Wes*
July 14th, 2009 by Harriet Hall, M.D. in Better Health Network, Quackery Exposed
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A study published in Alternative Therapies in Health and Medicine is being cited as evidence for the efficacy of healing touch (HT). It enrolled 237 subjects who were scheduled for coronary bypass, randomized them to receive HT, a visitor, or no treatment; and found that HT was associated with a greater decrease in anxiety and shorter hospital stays.
This study is a good example of what I have called “Tooth Fairy Science.” You can study how much money the Tooth Fairy leaves in different situations (first vs. last tooth, age of child, tooth in baggie vs. tooth wrapped in Kleenex, etc.), and your results can be replicable and statistically significant, and you can think you have learned something about the Tooth Fairy; but your results don’t mean what you think they do because you didn’t stop to find out whether the Tooth Fairy was real or whether some more mundane explanation (parents) might account for the phenomenon.
Theoretical underpinnings
According to the study’s introduction:
Healing touch is a biofield- or energy-based therapy that arose out of nursing in the early 1980s…HT aids relaxation and supports the body’s natural healing process, i.e., one’s ability to self-balance and self-heal.” This noninvasive technique involves (1) intention (such as the practitioner centering with the deep, gentle, conscious breath) and (2) placement of hands in specific patterns or sequences either on the body or above it. At its core, the theoretical basis of the work is that a human being is a multi-dimensional energy system (including consciousness) that can be affected by another to promote well-being.
They cite a number of references to theorists who support these ideas. They cite Ochsman; he wrote a book Energy Medicine: The Scientific Basis which I reviewed, showing that despite the book’s title, there is no credible scientific basis and the “evidence” he presents cannot be taken seriously.
They cite Candace Pert, who said in the foreword to Ochsman’s book that Dr. Oschman “pulled” some energy away from her “stagnant” liver. She said the body is “a liquid crystal under tension capable of vibrating at a number of frequencies, some in the range of visible light,” with “different emotional states, each with a predominant peptide ligand-induced ‘tone’ as an energetic pattern which propagates throughout the bodymind.” Does this even mean anything?
They even cite the PEAR study, suggesting that it is still ongoing (it isn’t) and claiming it shows that “actions in one system can potentially influence actions of another on a quantum energetic level.” (It didn’t.)
This is nothing but imaginative speculation based on a misunderstanding of quantum physics and of what physicists mean by “energy.” It is a truism that electromagnetic phenomena are widespread in the human body, but there is a giant gap between that and the idea that a nurse with intention and hand movements can influence electrical, magnetic, or any other physical processes in the body to promote healing. There is no evidence for the alleged “human biofield.”
Previous Research
They cite several randomized controlled studies of HT over the last few years. One showed “better health-related quality of life” in cancer patients. One, the Post-White study, showed no difference between HT and massage. One small study by Ziembroski et al. that I couldn’t find in PubMed apparently showed no significant difference between HT and standard care for hospice patients. One study showed that HT raised secretory IgA concentrations, lowered stress perceptions and relieved pain, and results were greater with more experienced practitioners; but it only compared HT to no treatment and didn’t use any placebo treatment.
A pilot study compared 4 noetic therapies-stress relaxation, imagery, touch therapy, and prayer, and found no difference.
A larger study showed that neither touch therapy nor masked prayer significantly improved clinical outcome after elective catheterisation or percutaneous coronary intervention.
They cite a review of healing touch studies by Wardell and Weymouth It concluded “Over 30 studies have been conducted with healing touch as the independent variable. Although no generalizable results were found, a foundation exists for further research to test its benefits.” Wardell noted that “the question has been raised whether the field of energy research readily lends itself to traditional scientific analysis due to coexisting paradoxical findings.” This is a common excuse of true believers who find that science is not cooperative in validating their beliefs.
Study Design
237 patients undergoing first-time elective coronary artery bypass surgery were randomly assigned to one of 3 groups: an HT group, a visitor group, and a standard care group. All received the same standard care from the hospital. The HT group received preoperative HT education and 3 HT interventions. Practitioners established a relationship with their patients, assessed their energy fields, and performed a variety of HT techniques based on their assessment, including techniques that involved light touch and those that involved no touch (practitioners’ hands held above body). Sessions lasted 20 to 90 minutes; each patient had the same practitioner throughout the study. The “visitor” group patients were visited by a nurse on the same schedule. The visits consisted of general conversation or the visitor remaining quietly in the room with the patient. They mentioned that some visits were shortened at the patient’s request.
Results of the Study
The six outcome measures were postoperative length of stay, incidence of postoperative atrial fibrillation, use of anti-emetic medication, amount of narcotic pain medication, functional status, and anxiety. HT had no effect on atrial fibrillation, anti-emetics, narcotics, or functional status. The only significant differences were for anxiety scores and length of stay. The length of stay for the HT group was 6.9 days, for the visitor group 7.7 days, and for the routine care group 7.2 days, suggesting that the simple presence of a visitor made things worse(!?). Curiously, for the subgroup of inpatients, the length of stay was HT 7.4 days, visitor 7.7 days and routine care 6.8 days, which was non-significant at p=0.26 and suggested that both HT and visitor made things worse.
The mean decreases in anxiety scores were HT 6.3, visitor 5.8, and control 1.8. They said this was significant at the p=0.01 level. But the tables for results broken down by inpatient and outpatient show no significant differences (p=0.32 for outpatients and p=0.10 for inpatients). If it was not significantly different for either subgroup, how could it be significant for the combined group?
These discrepancies are confusing. They suggest that the significant differences found were due to chance rather than to any real effect of HT..
Problems with this Study
Four out of the six outcomes were negative: there was no change in the use of pain medication, anti-emetic medication, incidence of atrial fibrillation, or functional status. The only two outcomes that were significant were hospital stay and anxiety, and these results are problematic and might have other explanations.
It is impossible to interpret what the difference in length of stay means, because they did not record the reasons for delaying discharge. As far as we can tell from the paper, the doctors deciding when to discharge a patient were not blinded as to which study group the patient was in. It’s interesting that the visitor group length of stay was intermediate in the outpatient subgroup, but higher than control for the combined inpatient/outpatient group. They offer no explanation for this. I was puzzled by the bar graph showing these numbers, because the numbers on the graph don’t seem to match the numbers in the text. The numbers were manipulated: they did a logarithm transformation for length of stay “to handle the skewness of the raw data.” I don’t understand that and can’t comment. The range of hospital days is such that the confidence intervals largely overlap. In all, these data are not very robust or convincing and they raise questions.
They interpret the anxiety reduction scores (HT 6.3, visitor 5.8, and control 1.8) as showing a significant efficacy of HT, but it seems more compatible with a placebo response and a slightly better response for the more elaborate placebo.
There were fewer patients (63) in the visitor group than in the HT and control groups (87 each). This was not explained. The comparison of groups appears to show that the control group had significantly higher pre-op anxiety scores than either of the other groups, which would tend to skew the results
They didn’t use a credible control group. A visitor sitting in the room can’t be compared to a charismatic touchy-feely hand-waving practitioner. Other studies have used mock HT where the hand movements were not accompanied by healing thoughts. These researchers rejected that approach because they didn’t think it would be ethical to offer a sham procedure where the practitioner only “pretended” to help. Hmm… One could argue that they have provided no evidence that HT practitioners are ever doing anything more than pretending to help.
They don’t comment on how practitioners were able to “assess the energy fields” of their patients. Emily Rosa’s landmark study showed that practitioners who claimed to be able to sense those fields couldn’t.
The authors consist of 3 RNs (2 of them listed as healing touch therapists and presumably the ones who provided treatment in the study), a statistician with an MS, and two “directors of research” for whom no degrees are listed. The authors are clearly prejudiced in favor of HT.
They interpret this study as supporting the efficacy of HT. I don’t think it does that. I think the results are entirely compatible with a placebo response. With any made-up intervention presented with strong suggestion, one could expect to find one or two statistically significant differences when multiple endpoints are evaluated. And the magnitude of the improvement here is far from robust. This is the kind of result that tends to diminish in magnitude or vanish when better controls are used. I think the study is Tooth Fairy science, purporting to study the effects of a non-existent phenomenon, but actually only demonstrating a placebo response.
I wonder if better results might be obtained by having a patient advocate stay with the patient and offer reassurance, explanations, massage and other comfort measures – something like the doulas who have been shown to improve childbirth outcomes.
The frightening thing is that during the course of this study, patients increasingly bought into the HT belief system and refused to sign up for the study because they wanted HT and didn’t want to risk being assigned to a control group. And hospital staff bought into the belief system, were treated themselves, and became proponents of offering it to patients for other indications.
The paper ends with a rather incoherent statement one would not expect to find in a scientific medical journal: “At the very heart of this study is the movement toward recognizing that the metaphoric and physical heart are both very real, if we allow them to be.”
*This blog post was originally published at Science-Based Medicine*
