Doctors lobby wins again

".........From The estimated $30 billion deal also includes $4 billion to prevent doctors from having their reimbursement rates slashed by Medicare.


http://www.huffingtonpost.com/2011/12/16/payroll-tax-cut-deal-to-include-keystone_n_1154888.html

it's not time that heals all wounds - it's REM sleep

Not all sleep is REM sleep.  It is the dreaming phase of sleep which you go in and out of depending on other physiologic variable.  


The other consequences of too little sleep (from WebMD):

• Impaired memory and thought processes.
• Depression.
• Decreased immune response.

Sleep deprivation also magnifies alcohols effects on the body, so a fatigued person who drinks will become much more impaired than someone who is well-rested. Sleep deprivation also increases pain perception on pain simulation testing. Caffeine and other stimulants can temporarily overcome the effects of severe sleep deprivation, but cannot do so for extended periods of time.

Natural pain remedies from your kitchen

Good to know.

http://www.ivillage.com/natural-pain-remedies-your-kitchen/4-b-334141

A new benefit from medical marijuana?

Whatever your stance on medical marijuana this is exciting.  Anything that can prevent or reduce Alzheimer's disease should be studied carefully. Hopefully a peer reviewed study will prove this benefit.

http://www.ncbi.nlm.nih.gov/pubmed/17140265

Are we what we eat? Scientific American says yes.

www.scientificamerican.com/article.cfm%253Fid%253Dvitamins-minerals-and-microrna

“You are what you eat.” The old adage has for decades weighed on the minds of consumers who fret over responsible food choices. Yet what if it was literally true? What if material from our food actually made its way into the innermost control centers of our cells, taking charge of fundamental gene expression?

That is in fact what happens, according to a recent study of plant-animal micro­RNA transfer led by Chen-Yu Zhang of Nanjing University in China. MicroRNAs are short sequences of nucleotides—the building blocks of genetic material. Although microRNAs do not code for proteins, they prevent specific genes from giving rise to the proteins they encode. Blood samples from 21 volunteers were tested for the presence of microRNAs from crop plants, such as rice, wheat, potatoes and cabbage.

The results, published in the journal Cell Research, showed that the subjects’ bloodstream contained approximately 30 different microRNAs from commonly eaten plants. It appears that they can also alter cell function: a specific rice microRNA was shown to bind to and inhibit the activity of receptors controlling the removal of LDL—“bad” cholesterol—from the bloodstream. Like vitamins and minerals, microRNA may represent a previously unrecognized type of functional molecule obtained from food.

The revelation that plant microRNAs play a role in controlling human physiology highlights the fact that our bodies are highly integrated ecosystems. Zhang says the findings may also illuminate our understanding of co-evolution, a process in which genetic changes in one species trigger changes in another. For example, our ability to digest the lactose in milk after infancy arose after we domesticated cattle. Could the plants we cultivated have altered us as well? Zhang’s study is another reminder that nothing in nature exists in isolation.

job opp in Europe

Very interesting technology.  Can't wait to see some clinical data.

http://www.miracormedical.com/p-58875.html

OCT news

Acouple of nice articles on the ever evolving applications of OCT imaging technology.

http://www.ajnr.org/content/early/2011/11/03/ajnr.A2740.abstract


http://onlinelibrary.wiley.com/doi/10.1002/ccd.23385/abstract?systemMessage=Wiley+Online+Library+will+be+disrupted+5+Nov+from+10-12+GMT+for+monthly+maintenance

Exciting new, and not so new, diagnostic tools

http://www.octnews.org/articles/3208854/renowned-interventional-cardiologists-discuss-pote/

The image is of Dr. Gus Pichard, of the Washington Hospital Center.  I assisted him during his first experience with the C7-XR OCT imaging device, which then was the development of LightLab Imaging Inc.  Now part of St. Jude Medical.

The current list of drug shortages

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

Serious medication shortages spreading

"...And because most of these drugs have been off-patent for years, some drug companies don’t want to spend the money to upgrade lines to produce drugs with slim profit margins. 


Sometimes it is sort supply of raw material, sometime they have to shut down for quality reasons.  But letting people die because there is no profit in saving them?  I get it, but it the government is partly at fault because of the big pharma lobby getting their way potentially shutting down smaller companies who could develop an alternative

Read more: http://www.foxnews.com/health/2011/10/13/hospital-drug-shortages-threaten-patient-health-prove-costly/#ixzz1ahSCQEDe..."

http://www.foxnews.com/health/2011/10/13/hospital-drug-shortages-threaten-patient-health-prove-costly/

Patient safety versus costs

This study is really misleading.  They looked at a huge population and still didn't get statistical significance.  This is a pure money versus patient safety play.  The comment that a randomized trial is needed before they can draw any conclusions is right on.


http://www.medpagetoday.com/Cardiology/PCI/28877?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&eun=g409551d0r&userid=409551&email=ctklex@yahoo.com 

From Cardiobrief: A new vascular repair tool

This is a very cool new product.  If it works as advertised it could be a real breakthrough in vascular repair.


http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm274372.htm?utm_source=twitterfeed&utm_medium=twitter

ACC; Shame on you!

The ACC recommends three completely self-serving limitations regarding the proposed cuts to Medicare/Medicaid:

• Permanent reform of the Medicare physician payment system (The current Sustainable Growth Rate  (SGR) formula calls for massive cuts of 29.5 percent on Jan. 1, 2012.).
• Inclusion of medical liability reforms in any final committee recommendations.
• Avoidance of further medical imaging payment cuts as an offset in any final recommendations.

The single biggest  group expense in the Medicaid budget is?  Physician salaries.  What a surprise.  And the single biggest line-item expense?  the incredibly over-prescribed use of Imaging!  (CT, MRI, etc).  One of the highest paid subgroups of physicians?  What a coincidence, it is cardiologists.

This is the type of self-serving lobbying that is killing our economy.  I HATE the very existence of lobbyists.  I wish the Super Committee would propose a complete phase-out plan for the entire sector!

Having said all this I do agree in the proposed liability tort reform issue.  But expecting lawyers (did you know that 100% of congress have law degrees?) to limit litigation opportunities (can you say cha-ching) is akin to expecting the Cubs to win another world series.

EKG noise. Not all artifact after all.

EKG "noise" has several causes; poor lead placement, patient shivering, 60 hz interference, etc.  The MIT/Partners (Brigham and Women's in this case) collaboration has once again born fruit.  This newly published study shows that there are at least three statistically significant biomarkers hidden in the low amplitude "noise" in EKG's.

This impressive and important because it helps identify those with high risk of death, hopefully leading to a modified, and more successful, preventative strategy.

Although was only studied in association with NSTEMI ACS there is hope that the three identified markers, or some other markers, will have relevance in diagnosing other conditions.

http://www.medpagetoday.com/Cardiology/AcuteCoronarySyndrome/28839

Interesting evidence that emotions effect your physiology

"...A surge in inflammatory and prothrombotic factors following the death of a loved one may help explain the elevated cardiovascular risk present at this most stressful of times, a prospective study suggested..."


http://www.medpagetoday.com/Cardiology/Prevention/28515


Why not?  If stress can effect your cardiac health, and it can, why not the powerful emotion of grief?

Check out this cool app for improved teaching and communicating with your patients and colleagues.

http://www.drawmd.com/

Informative web site and nice article on OCT

http://www.hindawi.com/journals/crp/2011/312978/

Comments on the Ozaki study

Typical Japanese study.  Single center, non-randomized.  I have great respect for Professor Akasaka and his team.  I believe they are the most experienced OCT (Optical Coherence Tomography) team in the world.

No surprise that presence TCFA ( thin-cap fibroatheroma) is related to higher observation of MVO (microvascular obstruction).   I think OCT will change the management of coronary disease due to data like these.  Would love to see the NIH fund a outcome driven study with OCT.

Skip to main page content

• Original Article

Thin-Cap Fibroatheroma as High Risk Plaque for Microvascular Obstruction in Patients With Acute Coronary Syndrome

1. Yuichi Ozaki, 
2. Atsushi Tanaka*, 
3. Takashi Tanimoto, 
4. Hironori Kitabata,
5. Manabu Kashiwagi, 
6. Takashi Kubo, 
7. Shigeho Takarada, 
8. Kohei Ishibashi,
9. Kenichi Komukai, 
10. Yasushi Ino, 
11. Kumiko Hirata, 
12. Masato Mizukoshi,
13. Toshio Imanishi and 
14. Takashi Akasaka

+Author Affiliations

1. Wakayama Medical University, Japan

1. ↵* Corresponding author; email: a-tanaka@wakayama-med.ac.jp

Abstract

Background—Plaque contents can cause microvascular impairment, which is an important determinant of clinical outcomes in patients with acute coronary syndrome (ACS). We hypothesized that percutaneous coronary intervention (PCI) for thin-cap fibroatheroma (TCFA) could easily disrupt the fibrous cap and expose the contents of plaque to coronary flow, possibly resulting in microvascular obstruction (MVO). The purpose of this study was to investigate whether TCFA was associated with MVO following PCI in patients with ACS.

Methods and Results—We enrolled 115 patients with ACS who were successfully recanalized with PCI. The patients were divided into a ruptured plaque group (n=59), a non-rupture with TCFA group (n=21), and a non-rupture and non-TCFA group (n=35) according to optical coherence tomography findings of the culprit lesion. Using contrast-enhanced magnetic resonance imaging, we assessed MVO. There were no statistically significant differences in patient's characteristics. The non-rupture with TCFA group more frequently presented MVO (ruptured plaque 27% vs. non-rupture with TCFA 43% vs. non-TCFA and non-rupture 9%, P=0.012). The prevalence of MVO increases as cap thickness decreases.

Conclusions—TCFA is more frequently associated with MVO following PCI. TCFA is a high-risk plaque for MVO following PCI in patients with ACS.

Healthcare reimbursement penalizes the have-not's

Boston Medical Center, like most city hospitals, serves a poor sector of the population.  75% of it's patients live below the poverty line.  They lost $25M last year, in part due to reduced federal and state support and low reimbursement rates.

On the flip side are institutions like Massachusetts General Hospital and its sister site, Brigham and Women's.  These more renowned (and profitable) hospitals get preferential treatment from insurers and get the highest reimbursement rates in the greater-Boston area.

Hey, I have a good idea!  Let's slash Medicare and Medicaid to the bone.  Then all those poor people will just die and stop costing all us other folks so much money.  What a messed up system.  We do need healthcare reform but not the kinds that are bandied about by our politicos. 

Commercial Intravascular Optical Coherence Tomography Imaging Systems – Who’s Next, What's at Stake, and What’s Taking So Long?

I really admire Eric Swanson, one of the founders of LightLab Imaging and the author and webmaster at www.octnews.org.  I have one bone to pick regarding this article because it is a personal thing about my profession.   

I quote from his article:  

"To take over 6 years to develop a medical device product and spend ~$100M and still not be shipping when a competitor is would make most investors cringe and for engineering and product management to miss a product release date by over 4 years and counting is hard to imagine in most industries."

Now just one minute there.  I was Director of Marketing at LightLab Imaging from 2007 until they were acquired by SJM in mid 2010 , and I was the de facto product manager for the C7-XR FD-OCT platform.  The definition of "product manager" varies by industry.  In US automotive companies, and many large medical device hardware companies, the product manager is in charge of everything to do with the product and the whole team reports to him/her.

Not so, in most of the positions I have held in medical devices.  The product manager can be extremely influential in the right team environment, and quite limited in others.

So, Eric, please reconsider the ability of product management to play a role in a four year project delay.

Just sayin'

IABP not shown to reduce infarct size

This surprised me a bit.  Having cared for 300+ IABP patients during my career in healthcare I have seen first-hand what the device is capable of.  I really need to read the whole study to see how it was designed. In my personal experience it provides more benefit than just limiting infarct size.  Other benefits include, stabilizing patients in cardiac shock, a bridge to bypass surgery or PCI, cardiac output improvement to get off cardiopulmonary perfusion during cardiac surgery to name some.

Yes it is invasive, and not clinically benign, but it does save lives.

Intra-aortic Balloon Counterpulsation and Infarct Size in Patients with Acute Anterior MI Without Shock

Researching the treatment of Peripheral Vascular Disease and raising awareness

A recent study performed in Germany, named the PACIFIER trial compared a drug-coated balloon to a standard balloon for treatment of lesions in femoral-popliteal anatomy.

While the results were good, and the study was well designed, it bore the hallmark of most PVD studies:

• Small cohort.  Most PVD studies are underpowered and shouldn't be making statistical significance claims.  The reasons for this are important to note.  
• Most studies are financed by industry
• Device and pharma companies make research planning decisions based on ROI
• PVD is a relatively small market when compared to coronary disease

Unfortunately, both the industry, healthcare providers and insurance entities have unwittingly collaborated to make this so.

• PVD was/is under-served with low reimbursement rates
• Interventional Radiologists traditionally have lagged surgeons in patient referrals and now Interventional Cardiologists as well in some countries.
• PVD varies greatly in its presentation and etiology depending on the location in the vascular tree. This limits the ability extrapolate data beyond the subject anatomy.  
• I postulate that the combination of limited competitiveness, smaller interventional budgets, the willingness of smaller companies to lowball prices for market share, and the lack of peer reviewed proof of outcome improvements have kept the PVD therapeutic market the minor market segment it still is.

However, the primary co-morbidities of PVD; smoking, obesity and diabetes, make this a problem of enormous magnitude in the US especially.

IMHO the government (NIH, CDC) must step up and address this issue.  All the years of treating the problem and it is still being addressed with trickle-down products from the coronary disease market.  The result is poorly targeted tools and a dearth of solid data on the complex underlying disease state.

Anybody with these co-morbidities and any kind of symptoms; calf pain, trouble walking as far as you used too, skin lesions, etc. should seek medical consultation as early as possible.  I urge you, your friends and family to help raise awareness of this growing problem by any means possible.  

TCTMD.com

http://www.tctmd.com/show.aspx?id=107192

The link to the NG article on virus-fighting shark bits

http://news.nationalgeographic.com/news/2011/09/110919-sharks-drugs-medicine-viruses-science-health-squalamine/?source=link_fb20110919news-sharksviruskiller

Virus fighting shark bits. From National Geographic

A cholesterol-like compound found in dogfish sharks' tissue has been shown to combat several viruses that cause hard-to-treat human diseases, such as dengue fever and hepatitis, a new study says. 

Called squalamine, the compound is already in human clinical trials for cancer and eye disorders, and several hundred people have been exposed without major side effects.

The new study revealed that squalamine can also disrupt a virus's life cycle and prevent it from replicating in both tissue cultures and live animals.

Though there are plenty of drugs to treat bacterial infections, there are few pharmaceuticals that are effective against viruses. Current antiviral drugs are highly specific—each targeting just one strain of a virus—but strains can easily mutate and become resistant to the medication.

New hope for start-up's

Having trouble raising funds for your start-up?  Follow the example of GI Dynamics Inc., who went public in Australia where they have already achieved regulatory approval.  An early investor in the company was quoted as saying; "When companies launch a product in a country, investors there hear buzz.....Secondly he added, Australian investors have more of a buy-and-hold mentality that US investors...".

Their product, named "Endobarrier", is intended to change the very invasive and risky GI bypass surgery into an endoscopic procedure.   

New efficiencies in healthcare

Good article in the Boston Globe today describing a new system being trialed at the Dana Farber Institute in Boston. They are asking employees and patients (showing first names only) to wear badges to show name, location, how long they have been waiting, status of rooms (empty or in use) and several other functions to increase efficiencies. Since time really does equal money in healthcare this new application of existing technology is a great example of starting a company based on a simple, but creative concept.  The developing company is Versus Technology.

Introduction

I am new at this so advice is welcome.  Postings here will include data, links and opinions about the healthcare industry in general, and vascular diseases in particular.  I am not an MD but I worked in cardiac cath lab's, cardiac surgery and general surgery at Massachusetts General Hospital and the Hospital of the Good Samaritan in L.A.

After 10 years or so I transitioned to the medical device industry, and held numerous positions in Clinical, Marketing, Product Development and Sales.  Predominantly, Strategic Marketing both upstream and downstream.

I hope you enjoy my site and welcome your opinion(s) both positive and negative.
Craig T. Kelley
Craig.Kelley@gmail.com