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Posts Tagged ‘medical news’

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Free pdf:

Mexicali! a mini-gem guide to surgery in Baja, California

The pdf has been uploaded to Google books, and several other sites.

Low-cost e-format:  I managed to work out a kindle format, but Amazon.com won’t allow independent publishers to offer our books for free (except as part of a limited trial on KDP select.)  However, I have received several emails specifically asking for the Mexicali book to be placed on Amazon.com – so I am reluctantly doing so.  Please note that this e-format version is priced at the minimum – of 99 cents with a free download trial period.  (In case you are wondering, Amazon.com collects 65% of that.)

Update:

Paperback book:  The paperback version of the Mexicali book is now available!  I had hoped to offer a color version (for fans of medical photography) but for small-run books, it was going to be 28.00 a book, which seems excessive to me.  I’ve priced it at just above the cost to produce and offer it on Amazon channels for less than 7.00.

 

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It’s a busy Sunday in Mexicali – presidential elections are today, so I am going to try to get some pictures of the nearest polling station later.. In the meantime, I am spending the day catching up on my writing..

a polling station in Mexicali

Lots to write about – just haven’t had the time..  Friday morning was the intern graduation which marks the end of their intern year – as they advance in their residencies.. Didn’t get a lot of pictures since I was at the back of the room, and frankly, unwilling to butt ahead of proud parents to get good pics.. This was their day, not mine and I was pleased that I was invited.

I did get a couple of good pictures of my ‘hermanito’ Lalo and Gloria after the event.  (I’ve adopted Lalo as my ‘kid’ brother.. Not sure how he feels about – but he’s pretty easy-going so he probably just thinks it’s a silly gringa thing, and probably it is..)

Dr. ‘Lalo” Gutierrez with his parents

Lalo’s parents were sitting in the row ahead of me, so of course, I introduced myself and said hello.. (They were probably a little bewildered by this middle-aged gringa talking about their son in atrocious Spanish) but I figured they might be curious about the same gringa that posts pictures of Lalo on the internet.. I also feel that it’s important to take time and tell people the ‘good things’ in life.  (Like what a great person their son has turned out to be..)

Same thing for Gloria.. She is such a hard-worker, and yet, always willing to help out.. “Gloria can you help me walk this patient?”  It’s not even her patient, (and a lot of people would say – it’s not our jobs to walk patients) but the patient needs to get out of bed – I am here, and I need some help (with IV poles, pleurovacs, etc.)  and Gloria never hesitates.. that to me – is the hallmark of an excellent provider, that the patient comes first .. She still has several years to go, but I have confidence in her.

She throws herself into her rotations.. When she was on thoracics, she wanted to learn.. and she didn’t mind learning from a nurse (which is HUGE here, in my experience.)

Dr. Gloria Ayala (right) and her mother

She wasn’t sure that her mom would be able to be there – (she works long hours as a cook for a baseball team) but luckily she made it!

Met a pediatric cardiologist and his wife, a pediatrician.. Amazing because the first thing they said is, “We want nurse practitioners in our NICU,” so maybe NPs in Mexico will become a reality.. Heard there is an NP from San Francisco over at Hospital Hispano Americano but haven’t had the pleasure of meeting her.  (I’d love to exchange notes with her.)

I spent the remainder of the day in the operating room of Dr. Ernesto Romero Fonseca, an orthopedic surgeon specializing in trauma.  I don’t know what it is about Orthopedics, but the docs are always so “laid back”, and just so darn pleasant to be around.  Dr. Romero and his resident are no exception.

[“Laid back” is probably the wrong term – there is nothing casual about his approach to surgery but I haven’t had my second cup of coffee yet, so my vocabulary is a bit limited.. ]  Once I finish editing ‘patient bits’ I’ll post a photo..

Then it was off to clinic with the Professor.

Saturday, I spent the day in the operating room with Dr. Vasquez at Hospital de la Familia. He teased me about the colors of the surgical drapes,(green at Hospital de la Familia), so I guess he liked my article about the impact of color on medical photography.  (Though, truthfully, I take photos of surgeons, not operations..)

Since the NYT article* came out a few days ago – things have changed here in Mexicali.  People don’t seem to think the book is such a far-fetched idea anymore.  I’m hopeful this means I’ll get more response from some of the doctors.  (Right now, for every 15 I contact – I might get two replies, and one interview..)

Planning for my last day with the Professor  – makes me sad because I’ve had such a great time, (and learned a tremendous amount) but it has been wonderful.  Besides, I will be starting classes soon – and will be moving to my next location (and another great professor.)

Professor Ochoa and Dr. Vasquez

But I do have to say – that he has been a great professor, and I think, a good friend.  He let me steer my education at times (hey – can I learn more about X..) but always kept me studying, reading and writing.  He took time away from his regular life, and his other duties as a professor of other students (residents, interns etc.) to read my assignments, make suggestions and corrections when necessary.    and lastly, he tolerated a lot with good grace and humor.  Atrocious Spanish, (probably) some outlandish ideas and attitudes about patient care (I am a nurse, after all), a lot of chatter (one of my patient care things), endless questions…  especially, “donde estas?” when I was lost – again.

So as I wrap up my studies to spend the last few weeks concentrating on the book, and getting the last interviews, I want to thank Dr. Carlos Ochoa for his endless patience, and for giving me this opportunity.  I also want to thank all the interns (now residents) for welcoming me on rounds, the great doctors at Hospital General..  Thanks to Dr. Ivan for always welcoming me to the ER, and Dr. Joanna for welcoming me to her hospital.  All these people didn’t have to be so nice – but they were, and I appreciate it.

* Not my article [ I wish it were – since I have a lot to say on the topic].

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Thanks again to ‘Lapeyre’, who as it turns out is Dr. Didier Lapeyre, a renowned, French cardiothoracic surgeon credited with the development of the first mechanical valves.

Dr. Didier Lapeyre was gracious enough to send some additional literature to add to our ongoing discussions regarding severe aortic stenosis and TAVI/ TAVR therapies.  He also commented that the best way to avoid these ‘high risk situations’ is by earlier intervention with conventional surgery – something we discussed before in the article entitled, “More patients need surgery.”

He also points out that ‘elderly’ patients actually do quite well with aortic valve replacement and offers a recently published meta-analysis of 48 studies on patients aged 80 or older.

As readers know, on June 13, 2012 – the FDA ruled in favor of expanding the eligibility criteria for this therapy.  Previously, this treatment modality, due to its experimental nature and high rate of complications including stroke and serious bleeding, has been limited in the United States to patients deemed ineligible for aortic valve replacement surgery.

Now on the heels of the Partner A trial, in which researchers reported favorable results for patients receiving the Sapien device, the FDA has voted to approve expanding criteria to include patients deemed to be high risk candidates for surgery.  As we have discussed on previous occasions, this opens the door to the potential for widespread abuse, misapplication of this therapy and potential patient harm.

In the accompanying 114 page article, “Transcatheter aortic valve implantation (TAVI): a health technology assessment update,” Belgian researchers (Mattias, Van Brabandt, Van de Sande & Deviese, 2011) looking at transcatheter valve procedures have found exactly that in their examination of the use of TAVI worldwide.

Most notably, is the evidence of widespread abuse in Germany (page 49 of report), which has become well-known for their early adoption of this technology, and now uses TAVI for an estimated 25 – 40% of valve procedures*.  Closer examination of the practices in this country show poor data reporting with incomplete information in the national registry as well as a reported mortality rate of 7.7%, which is more than double that of conventional surgery.  Unsurprisingly, in Germany, TAVI is reimbursed at double the amount compared to conventional surgery**, providing sufficient incentive for hospitals and cardiologists to use TAVI even in low risk patients. (and yes, german cardiologists are often citing “patient refused surgery” as their reason, particularly when using TAVI on younger, healthy, low risk patients.)

In their examination of the data itself, Mattias et al. (2011) found significant researcher bias within the study design and interpretation of results.  More alarmingly, Mattias found that one of the principle researchers in the Partner A study, Dr. Martin Leon had major financial incentives for reporting successful results.  He had recently received a 6.9 million dollar payment from Edward Lifesciences, the creators of the Sapien valve for purchase of his own transcatheter valve company.   He also received 1.5 million dollar bonus if the Partner A trial reached specific milestones.  This fact alone, in my mind, calls into question the integrity of the entire study.

[Please note that this is just a tiny summary of the exhaustive report.]

Thank you, Dr. Lapeyre for offering your expertise for the benefit of our readers!

* Estimates on the implantation of TAVI in Germany vary widely due to a lack of consistent reporting.

** At the time of the report, TAVI was reimbursed at 36,000 euros (45,500 dollars) versus 17,500 euros (22,000 dollars) for aortic valve replacement.

For more posts on TAVI and aortic stenosis, see our TAVI archive.

References

Mattias, N., Van Brabandt, H., Van de Sande, S. & Deviese, S. (2011).  Transcatheter aortic valve implantation (TAVI): a health technology assessment .  Belgian Health Care Knowledge Centre.

Vasques, F., Messori, A., Lucenteforte, E. & Biancari, F. (2012).  Immediate and late outcome of patients aged 80 years and older undergoing isolated aortic valve replacement: a systematic review and meta-analysis of 48 studies.  Am Heart J 2012; 163: 477-85.

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New allegations of gross medicare fraud from overstenting and unnecessary interventional procedures has been filed against surgeons in Pennsylvania, including the prestigious UPMC medical center.  This story, (based on cases dating back to 2001 and onwards), comes just as the dust in settling from an outbreak of unnecessary stent cases in neighboring Maryland.

What is overstenting?

Article by Michael R’iordan from the Heart.com re-posted below:

Cardiologists accused of defrauding Medicare by performing unnecessary cardiac procedures

Erie, PA – A new whistle-blower lawsuit filed in US District Court in Erie, PA claims that five cardiologists from two medical practices defrauded Medicare by performing unnecessary cardiac and vascular surgeries and interventional procedures between 2001 and 2005.

The suit, filed under the False Claims Act (FCA) and first reported January 22, 2012 in the Erie Times-News [1], states that as a result of the fraud, Medicare overpaid for these procedures, which wasted substantial public money, and patients were placed at significant and unnecessary risk of harm.

According to a copy of the lawsuit obtained by heartwire, the physicians named are Drs Richard Petrella, Robert Ferraro, Charles Furr, Timothy Trageser, and Donald Zone. The two medical practices named in the lawsuit are Medicor Associates Inc—and its affiliate Flagship Cardiac, Vascular, and Thoracic Surgery (CVTS)—and the University of Pittsburgh Medical Center (UPMC) Hamot (formerly known as Hamot Medical Center). The Medicor practice is the full-service cardiology center affiliated with UPMC Hamot.

The lawsuit states that from June 2001 and earlier, the defendants “knowingly, systematically, routinely, and repeatedly submitted false claims to and received reimbursements from Medicare and other federal healthcare programs for medically unnecessary cardiac catheterizations and cardiac and vascular surgical procedures, including but not limited to . . . PCI.”

As result of the false claims, the physicians received money to “which they were not entitled.”

Paid directorships and kickbacks

Dr Tullio Emanuele, who worked at Medicor and Hamot Medical Center from 2001 to 2005, filed the suit and claims that Medicor engaged in illegal “kickbacks” with Hamot Medical Center and referred cardiac patients to the hospital. In the lawsuit, it is alleged that Hamot signed contracts with Medicor and Flagship CVTS, valued at $75 000 per physician and as high as $525 000 per year, and the doctors would refer patients in need of medical procedures to Hamot Medical Center.

“Specifically, Hamot identified physicians who referred a high volume of patients and/or had potential to refer a high volume of patients for special treatment and offered remuneration to them in the guise of sham contracts for medical directorships or other similar personal service arrangements,” according to the lawsuit.

The claim states the physicians and the participating hospitals violated the federal Anti-Kickback Statute and the federal Stark Act, which says that a hospital is not allowed to submit a claim for reimbursement from Medicare if the procedure has been referred by a physician with improper financial ties to the hospital.

The suit also claims that Emanuele began to grow suspicious in 2004 when he noticed higher rates of intervention among certain physicians within the group. Between 2004 and 2005, 4408 catheterizations were performed, and Petrella, Trageser, and Ferraro had a “rate of surgical intervention following catheterization of double the junior members of the group.”

Emanuele, according to the lawsuit, believes that many of the procedures were performed unnecessarily. For example, Trageser is accused of performing a cardiac catheterization in a patient with chest pain, despite the symptomology being inconsistent with angina. Ferraro is accused of implanting a stent in an artery with moderate stenosis, even though Emanuele previously recommended medical therapy. Zone performed a cardiac catheterization and overstated the severity of stenosis, sending the patient on to CABG surgery, where he/she later died.

UPMC Hamot and the named physicians received copies of the lawsuit last week, according to the Erie Times-News, and have 20 days to respond. If they are found guilty, UPMC Hamot and the Medicor physicians would be required to reimburse Medicare at triple the cost of the original procedure. Emanuele, as the whistle-blower in the case, would be entitled to 30% of the reimbursed money.

More on similar stories here at Cartagena Surgery:

The Ethics of the Syntax Trial

Stent Scandal series:

Cardiology takes another hit

Mark Midei – or the man who started it all..

This is just a sample of the articles available here at Cartagena Surgery.. For more on this topic, look under the cardiology tab..

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As many of my long time readers know, that during the last month or so, I have been reviewing studies, and data on the Syntax trial as part of a presentation at my hospital.  This has been more time-consuming and angst-wrenching than I would have ever expected; the more data I reviewed, the more conflicted I became about the ethical questions involved in a study of this kind.

Granted, I have a sensitive nature, and as a nurse, patient advocacy is one of my primary goals.  But thankfully, I found that I am not alone in questioning the legitimacy of subjecting patients to a ‘non-inferiority’ trial.

“In our opinion, the Syntax study disregarded the safety of the patients, by including death and major complications of a primary end-point of a non-inferiority study.”
— Mantovani et. al (2010).
Mantovani et al. (2010) Non-inferiority randomized trials, an issue between science and ethics: the case of the Syntax study.  Scandinavian Cardiovascular Journal, 2010; 44: 321-324.  Mantovani et al. full text pdf.   They question the benefit of subjecting patients to unproven therapies using a trial design that really fails to prove much at all about the effectiveness of the proposed treatment, (in this case, PCI).  They have an excellent discussion (and definitions for the uninitiated) on trial designs and what they really mean, in real terms.
As they point out – studies with this kind of trial design – really don’t prove anything at all.  It was a methodology designed by pharmaceutical companies in order to get new drugs on the market (whether or not these newer, more expensive versions of existing drugs were an improvement over older, safer, cheaper versions or not.)
But in this case – the real results were the unintended ones! Despite a skewed set of accounting (weighing heavily in cardiology’s favor) the results were determinedly negative, showing worse patient outcomes with stents, more deaths, more serious adverse events with stents.
As I delved even further into the data,  I began to question the concept of patient ‘informed consent’ all together.  Can a patient really comprehend the risks involved and what these outcomes really mean in practical terms for something like this?  Would anyone in the study actually break it down in a honest and straight-forward (no BS) fashion to potential study participants?
And how do patients (lay public) understand all of this anyway?  Their perceptions might radically differ from what we (researchers) think we’ve presented.  And, in fact – there are some HUGE differences, as multiple studies attest.  What patients hear and understand is DRAMATICALLY different from what we might expect.
Somehow, I don’t expect that researchers said to patients (for example):
“Mr. X, you are 50 years old, with HTN, diabetes and severe CAD affecting all three major arteries.  Since your labs, and general health is otherwise unremarkable, according to experience and the STS risk calculator, your risk for death with bypass surgery is Y (pretty darn safe). However, we would like to put you in a study where you may receive anywhere from 3 to 20 stents with extensive exposure to nephrotoxic (kidney-harming) dye,  and radiation.  These stents may close either acutely (stent thrombosis) or over time, causing a potentially fatal heart attack.  Stent occlusion happens much more frequently then bypass graft occlusion.  Oh, and by the way – we aren’t doing this study to see if stents are better than bypass surgery (we already know it isn’t) – we are doing it to see how much worse it is – within acceptable margins, of course [whatever than may be].”
No, somehow – I don’t think it went down like that.
More on the Syntax Trial comparing PCI and CABG:
Syntax, part II: New guidelines for revascularization
More on PCI appropriateness  (we have an entire series on PCI here at Cartagena Surgery)

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Dying to be thin?  These patients are… A look at the Get-Thin clinics in Beverly Hills, California..

This series from LA Times writers, Michael Hiltzik and Stuart Pfiefer highlights the importance of safety and the apparent lack of regulation in much of the bariatric procedure business here in the United States.

In these reports – which follow several patient deaths from lap-band procedures, both surgeons and surgical staff alike have made numerous reports against the ‘Get Thin” clinics operating in Beverly Hills and West Hills, California.  These allegations include unsafe and unsanitary practices.  One of the former surgeons is involved in a ‘whistle-blower’ lawsuit as he describes the dangerous practices in this clinic and how they led to several deaths.

Regulators ignore complaints against Beverly Hills clinics despite patient deaths  – in the most recent installment, Hiltzik decries the lack of action from regulatory boards who have ignored the situation since complaints first arose in 2009!

House members call for probe into Lap-Band safety, marketing – California legislators call for action, but the clinics stay open. (article by Stuart Pfiefer)

Plaintiffs allege ‘gruesome conditions’ at Lap-Band clinics – mistakes and cover-ups at the popular weight loss clinics.  (article by Stuart Pfiefer)  This story detailing a patient’s death made me ill – but unfortunately reminded me of conditions I had seen at a clinic I wrote about in a previous publication..  The absolute lack of the minimum standards of patient care – is horrifying.  This woman died unnecessarily and in agony.  It proves my point that anesthesiologists need to be detailed, and focused on the case at hand.. (not iPhones, crosswords or any of the other distractions I’ve seen in multiple cases.. Now this case doesn’t specifically mention a distracted anesthesiologist – but given the situation described in the story above, he couldn’t have been paying attention, that’s for sure.

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A couple of new articles over at Medscape highlight the role of Nurse Practitioners (and Physician’s Assistants) in patient care.

The Role of Nps and PAs with MDs in today’s care

A study from Loyola showed that surgical NPs reduced emergency room visits  : here’s a link to the article abstract by Robles et al. (2011).

Reducing cardiovascular risk with NPs: the Coach trial

And yet again, Nurse Practitioners trump physicians in patient satisfaction surveys.

This is just a sampling of the articles featured over at Medscape’s NP perspective.

From the free-text files: a selection of articles showing the growing use of Nurse Practitioners around the world

Nurse practitioners improve quality of care in chronic kidney disease: two-year results of a randomised study.  – a study from the Netherlands

A Parallel Thrombolysis Protocol with Nurse Practitioners As Coordinators Minimized Door-to-Needle Time for Acute Ischemic Stroke.  A taiwanese study showing the impact of nurse practitioners in reducing door-to-needle time in acute coronary syndromes.

Helping patients attain and maintain asthma control: reviewing the role of the nurse practitioner.

Type 2 diabetes, cardiovascular disease and the utilisation of primary care in urban and regional settings.  An Austrailian study discussing the impact of NPs in rural care.

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