New allegations of medicare fraud from overstenting

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..

Syntax Trial: an example of unethical experimentation?

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.

Bariatric Surgery Safety: More than your weight is at risk!

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.

Are we jaded – or is it unsurprising that the lawyer for ‘Get Thin’ is a total slime, who was recently disbarred for attempting to bribe witnesses to suppress / change their stories about conditions at Get Thin clinics?

Nurse Practitioners and Medscape

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.

My day at John Hopkins: Taking a look at Domestic Medical Tourism

Just got back from spending a day at John Hopkins looking at ‘domestic medical tourism’. While the terminology is new, the concept isn’t. Who doesn’t know someone, a friend or family member, who has traveled outside of their own community for treatment? We all do – any many of those people have travelled to those big name facilities that we are all familiar with; the Mayo Clinic, Duke, the Cleveland Clinic and John Hopkins.

John Hopkins, is in fact – a leader in both domestic and international medical tourism. John Hopkins has also ranked #1 for US Hospitals for the last 21 years. While there is some discussion as to the real validity of these rankings, they are still impressive.  As we have discussed before on our sister site, Bogotá Surgery.org  - Hopkins has international affiliations and collaborations with facilities throughout the globe (including Santa Fe de Bogotá).  Hopkins directly manages several other facilities – in places such as Turkey and the Middle East.  They truly are a global healthcare organization.

I visited the International Patient Center and observed the services available for out-of-state patients.  These departments make special efforts to provide convenience and familiarity to their out-of-town patients.  As part of these, patients are escorted to appointments, and appointments are grouped (when patient needs more than one service.)

They also have translators for over twenty different languages, and special accommodations to enable respectful, culturally competent care to patients with special religious or cultural needs.

Many of these out-of-town patients stay at the McElderry House, which is a pleasant, and affordable option, located just across the street from the hospital.    I stayed there during my visit – and the staff are charming, helpful and accommodating.  The rooms are spartan, but the accommodations are homey and comforting.  With full kitchens, these townhouses are perfect for potential long-term visitors.

The story behind McElderry house is sweet and inspiring.

Theresa, the owner, is a former nurse, who worked at John Hopkins as a travel nurse twenty years ago.  During her travel assignment, her daughter was diagnosed with osteosarcoma (a particularly virulent cancer).  Instead of returning to their native Michigan – they stayed in Baltimore for treatment.

Yesterday, I met her daughter – who is doing wonderfully, thriving in fact.

Later. Theresa started McElderry House for patients and families in situations like hers.  She started small and now has multiple townhouses spread over two streets kitty-corner from John Hopkins.  She welcomes patients, families and medical / health professionals like myself.

During my visit – I also managed to interview a wonderful, inspiring surgeon, Dr. Daniela Molena.  I’ll be posting a longer article about her and her work at Hopkins soon.

Yesterday was just a quick peek at John Hopkins  - I hope to be back soon to take another look.

*For patients requiring in-patient care; John Hopkins maintains elegant, luxury upgraded accommodations at the Marburg Pavilion within the John Hopkins facility. (Read here for an article on Forbes about Marburg Pavilion, and other upscale patient facilities).   When these amenities accompany excellent medical care, such as in this case, it’s a plus.  It’s when the accommodations trump the care when it becomes a problem.

Doctors caught accepting kickbacks…

In the Medscape article re-posted below – several physicians on the east coast were caught accepting kickbacks and bribes for referrals to a free-standing imaging center.

In this article, Laird Harrison explains how 14 doctors were caught accepting monetary bribes for patient referrals. (Actually 13 doctors and a nurse practitioner).

December 17, 2011 — In November, internist Maryam Jafari, MD, allegedly accepted a white envelope stuffed with $420 in cash from a man claiming to represent a diagnostic imaging company. At the same meeting, prosecutors say, Dr. Jafari also received a tally of all the patients she had referred to the imaging company in exchange for a total of $2385 in kickbacks.

“I will try to keep you very busy,” Dr. Jafari said, according to a complaint filed by the US Attorney for New Jersey.

The company, Orange Community MRI, in Orange, New Jersey, stayed busy indeed, say prosecutors, who arranged for police to arrest 13 physicians and a nurse practitioner on December 13, charging them all with accepting bribes in exchange for referring patients.

Police arrested Orange Community MRI Executive Director Chirag Patel, as well, for allegedly paying a total of $51,500 in kickbacks to physicians.

In an interview with Medscape Medical News, Joseph Mancano, an attorney representing Orange Community MRI, said the company itself has not been charged. “The charges against these individuals were just brought up, and we’re still looking at them,” he said.

Dr. Jafari and most of the other accused physicians could not be reached or did not return calls from Medscape Medical News. All of them have been released on bail.

An attorney representing John Green, MD, said the West Orange, New Jersey, gastroenterologist was innocent of charges he accepted $1750 in exchange for referring about 8 patients for magnetic resonance imaging (MRI), and about 5 for computed tomography (CAT). “He has not been involved in any criminal activity so far as we are concerned,” said attorney John Plaisted. “He stands innocent of any charges that were filed and he will pursue his remedies in court if necessary.”

It is rare that medical kickback cases go to trial, according to Donald White, a spokesperson for the US Office of the Inspector General. Most are settled out of court. “There are a lot of safe-harbor exceptions that have been built into the law over the years,” he said. “It’s also intent-based, and it gets very complicated. It’s hard to prove in court.”

Considerable Resources for Case

Still, prosecutors have devoted considerable resources to the case. Investigators recruited witnesses to record conversations with the physicians and Patel. More than 65 federal and local agents and officers were involved in the arrests, which US Attorney Paul Fishman announced in a press conference.

According to a press release issued by Fishman’s office, the imaging company began making illegal kickback payments as early as 2010. At the end of each calendar month, prosecutors allege, individuals at the imaging company printed patient reports detailing how many diagnostic tests were referred by each of the defendants.

How much the physicians were paid varied from one physician to another, and also depended on the type of imaging used and the insurance the patients had, the complaints say. “Some of the doctors were only paid for MRI and CAT scan referrals, while other defendants also were paid for the referral of ultrasounds, echocardiograms, and dual-emission X-ray absorptiometries,” according to the press release.

Orange Community MRI paid out the $51,500 during a 2-month period from early October to early December 2011, the release says.

Spokespersons for Fishman’s office said no one was available to be interviewed for this article. “Selling test referrals for cash is illegal,” Fishman said in the press release. “Patients have every right to expect their doctors will recommend medical service providers because they do the best job, not because they provide the best bribes.”

Whether such cases are becoming more or less common is difficult to say, White said. The Office of the Inspector General recorded 9 settlements with companies accused of giving kickbacks in 2008, 15 in 2009, 18 in 2010, and 8 through the end of November 2011.

The law on what constitutes an illegal kickback is complicated enough that the Office of the Inspector General offers to review proposed business arrangements among medical care providers to see whether they violate the law.

The review costs only $86 an hour — far less than posting bail..

I guess they haven’t read the Physicians Ethics Manual…

Sophie’s Choice: Pravastatin versus Crestor..

This story on Heartwire.com will surprise none of my American readers:

Researchers found that ‘Statin’ drugs – the life-saving cholesterol drugs that are prescribed to ALL Americans after a heart attack, stroke, stent placement of bypass surgery cost FOUR times more for Americans than British residents..  (These drugs are also used for several other conditions such as high cholesterol, peripheral vascular disease, carotid stenosis..)

Feeling ripped off much?  This gouging of the American consumer needs to stop.  These business practices when combined with medication shortages are hurting our patients – and hurting our (doctors, nurse practitioners) ability to treat disease.

Currently – I prescribe $4 generics for most of my patients – but this still hinders my ability to treat patients at the highest level of the care – should I prescribe the recommended version (which much of the latest research is based on) BUT my patient can’t afford?  Or do I settle for a drug that may be (who knows?*) second best – so my patient can actually afford to take it…

What about other classes of drugs.. ARBS are a perfect example – as there are no ARBS on the national chain pharmacies $4 lists.. But sometimes patients need them.. Ultimately,  I think it actually hurts drug companies.. Since ACEs are recommended equally for the treatment of heart failure, and cardiac care after myocardial infarction (heart attack) or heart surgery but have several versions AND doses listed in the low price formularies** – I probably prescribe this class of drugs FIFTY times more often.  I’m now way, way more familiar with these drugs as a result (in comparison to ARBS – since I use them so frequently, and follow the research on them.)

It’s part of a conversation I have with all my patients before they leave the hospital – as we discuss the risks, benefits and alternatives to the Rx available.  I try to allow patients to weigh in on the discussion – but for many people there is no real option..  It’s either four of five RX that will cost $400. a month or those same type of medications for 12.00 to 16.00 a month.. For the majority of people, particularly those without prescription drug benefits – it’s not really a choice at all..

What’s the answer???  It’s not prescription drug coverage for all – that just means the pharmaceutical companies gouge the government (which still costs all of us money..)  The answer needs to be a change in the way the companies do business in this country.  With over 300 million people in the USA (and most people on at least one prescription medication) - volume sales alone ensure profits for all players.

** Research results vary as to whether certain more costly statins offer benefits over other versions for the majority of patients.  In fact, one of the older statins, pravastatin sodium is actually preferred in patients on amiodarone (black box warning) and in patients that tolerate other statins poorly.

* ACE drugs also have additional ‘side benefits’ for many of my patients that make them preferable for treating the majority of my patients.  But that is not always the case..

Original Heartwire.com Article re-posted below:

Statins cost four times more in US than UK

January 11, 2012

Shelley Wood

Boston, MA (updated) - The cost of statins in the US is radically higher than the costs paid for the same brands in the UK, and many more insured Americans are prescribed statins, raising the overall costs in that country [1]. According to Dr Hershel Jick (Boston University School of Medicine, MA) and colleagues, who used 2005 numbers for their analysis, statin costs were as much as 400% higher in the US than in the UK. They report their findings in the January 2012 issue of Pharmacotherapy.

Speaking with heartwire, Jick pointed to an earlier study he did looking at prescribing patterns in the US and the UK, showing that drugs were prescribed in far greater numbers in the US [2]. This new paper provides a missing piece that wasn’t available previously, Jick said, adding that the sheer difference in costs should shock others as much as it did him.

“I don’t like to talk too much about my science, and I have to remain impartial,” he said. “But this really blew me away.”

Jick et al looked at US citizens aged 55 to 65 who were covered by private insurance plans who’d been prescribed at least one drug in 2005. UK subjects, whose data are housed in the public UK General Practice Research Database and whose drug costs were covered under the public plan, were matched by age and sex with 280 000 insured American patients.

Of these, write Jick et al, 33% of Americans were prescribed a statin as compared with 24% of the matched British subjects. The analysis included only patients who received continuous statin therapy over the course of the year.

Researchers then explored the type of statins being prescribed in both countries and the cost of those drugs, yielding some surprises. While the lowest-priced statin in the US at the time, generic lovastatin, cost $313 per year, the lowest-priced statin in the UK, generic simvastatin, cost just $164. At the high end, nongeneric simvastatin in the US cost $1428 per patient per year, while the top-priced statin in Britain was nongeneric atorvastatin, which cost $509 per patient per year.

Indeed, different statins were generic in the two countries in 2005: in the US, lovastatin was the only generic statin on the market, whereas in the UK in 2005 both simvastatin and pravastatin were generic and lovastatin was not sold. For brand-name drugs available in both countries, however, American costs were double the British costs for both atorvastatin ($997 vs $509) and rosuvastatin ($903 vs $467), while the cost of fluvastatin was nearly three times higher in the US than in the UK ($763 vs $258).

“I’ve done a lot of research of this variety, and I knew the cost would be higher in the US,” Jick said. “But frankly, I was pretty stunned by the difference.”

Given the greater proportion of patients taking statins and the higher costs, researchers estimate the total cost of statin use in the US in 2005 at $64.9 million compared with just $15.7 million in the UK. Jick et al’s sample included just 1% of the US population in this age group who were taking a statin over the course of the year, so this represents just a fraction of the US spending on statins.

Finally, in an addendum to their paper, Jick et al note that generic simvastatin was approved in the US market in mid-2006, prompting them to do some recalculations. They noted that in the six months postapproval, more than 60% of US users switched from brand-name simvastatin to a generic formulation, leading to a 60% drop in US costs. Even still, the US price for generic simvastatin remained nearly four times higher than the cost of the generic formulation available in the UK.

Jick notes that private insurers cover roughly 200 million US citizens, but that the military, veterans, government employees, the elderly, and other groups have their drugs covered by the government, and there is no publicly available information as to just what the price is that the government pays companies for the same products. Estimates of drug costs in these groups “could provide a useful basis for further insight into the nature of the remarkable difference—at least for statins—in prescription drugs costs between the US and UK,” the authors write.

Additional References (full text unless noted)

Therapeutic Interchange & Economic Benefits of generic drugs- British paper discussing different implications of drug substitution from both economic and patient derived health benefits.

American study on cost-savings with statin substitution

Pravastatin has superior results in triple therapy compared to atorvastatin in diabetic patients.  (in press)

Crestor associated with negative metabolic side effects compared to pravastatin (note dose discrepancy in this study.  Generally Crestor 5mg = Pravastatin 40mg)

Hospital General de Mexicali

Following surgery at Hospital Alamater, we proceed to the Hospital General de Mexicali.  This is the largest public facility in Mexicali, and is surprisingly small.  After a recent earthquake, only three floors are currently in use, with the two remaining upper floors undergoing demolition for repair after earthquake-related damage.  The facility is old and dated, and it shows.  There are ongoing construction projects and repairs throughout the facility.

On the medical and surgical floors there are dormitory style accommodations with three patients in each room.  Sandwiched across from the nursing station are several rooms designated as ‘Intermediate’ care.  These rooms are full with patients requiring a higher level of care, but not needing the intensive care unit which is located downstairs adjacent to the operating theater.

 

surgical nurses at Hospital General

The intensive care unit itself is small and crowded with patients.  There are currently five patients, all intubated and in critical condition.  Equipment is functional and adequate but not new, with the exception of hemodynamic monitors.  There is no computerized radiology (all films are printed and viewed at bedside.)

We visit several post-operative patients upstairs on the surgical floors, and talk with the patients at length.  All of the patients are doing well, including several patients who were hospitalized after holiday-related trauma (stabbing with chest and abdominal injuries.) The floors are busy with internal medicine residents and medical students on rounds.

Despite it’s unattractive facade, and limited resources – the operating room is similar to operating rooms across the United States.. Some of the equipment is older, or even unavailable (Dr. Ochoa brings his own sterile packages of surgical instruments for cases here.)  However, during a case at the facility – all of the staff demonstrate appropriate knowledge and surgical techniques. The anesthesiologist invites me to look over his shoulder (so to speak) and read through the chart..

Since respiratory therapy and pulmonary toileting is such an important part of post-operative care of patients having lung surgery – we stopped in to check out the Respiratory department.  I met with Jose Luis Barron Oropeza who is the head of Respiratory Therapy.  He graciously explained the therapies available and invited me to the upcoming symposium, which he is chairing.  (The symposium for respiratory therapy in Mexicali is the 18^th thru the 20^th of this month.  If anyone is interested in attending, send me an email for further details.)

After rounding on patients at the General Hospital – despite the late hour (it is after midnight) we make one more stop, back at the Hospital Alamater for one last look at his patients there.  Dr. Ochoa makes a short stop for some much-needed food at a small taco stand while we make plans to meet the next morning.

Due to the limitedavailable resources, I wouldn’t recommend this facility for medical tourists.  However, the physicians I encountered were well-trained and knowledgeable in their fields.

The story behind Cardiac Rehab

A new article on MedPage underscores the importance of cardiac rehabilitation.  The article reviews a meta-analysis on the benefits of cardiac rehabilitation by Sandercock et. al (2011).  This analysis of data from 38 different studies surrounding cardiac rehabilitation and exercise after cardiac events reinforces the principles of aerobic exercise for rehabilitation after MI (heart attack), stent placement/ angioplasty or cardiac surgery.

As we discuss daily with our patients – several studies show that patients that complete the 12 week out-patient exercise program live longer than people who don’t.   These patients also enjoy a better quality of life, and a faster return to baseline health than patients who do not participate in formal exercise program after a cardiac event.

As Piotrowicz (of Poland) states, Cardiac rehabilitation can be effective in all stable patients.

 

References:

The effects of cardiac tertiary prevention program after coronary artery bypass graft surgery on health and quality of life.  [Iranian study, full free text].  Mosayebi A, Javanmard SH, Mirmohamadsadeghi M, Rajabi R, Mostafavi S, Mansourian M. Int J Prev Med. 2011 Oct;2(4):269-74

Exercise rehab can reduce the mortality of cardiac patients with poor heart rate recovery = article from the Heart.org

Rev Port Cardiol. 2011 May;30(5):479-507.  Age does not determine the physical, functional and psychosocial response to a cardiac rehabilitation program.  [Article in English, Portuguese]  Rocha A, Araújo V, Parada F, Maciel MJ, Azevedo A.

Why aren’t all cardiac patients referred to cardiac rehab?

Rev Port Cardiol. 2011 May;30(5):509-14.  Barriers to participation in cardiac rehabilitation programs.  [Article in English, Portuguese]  Mendes M.

Cardiac Rehabilitation Programs and Health-Related Quality of Life. State of the Art. Cano de la Cuerda R, Alguacil Diego IM, Alonso Martín JJ, Molero Sánchez A, Miangolarra Page JC.  Rev Esp Cardiol. 2012 Jan;65(1):72-79. Epub 2011 Oct 19. English, Spanish.  Discusses the use of cardiac rehab in areas of endemic poverty and limited resources.

Now don’t forget about your incentive spirometer.

2011 in Review: the year in Cardiology

I’ve re-posted a Medscape.com article by Black et. al on the ten biggest developments in the field of cardiology.  Most of these will be familiar to readers.  The original article can be accessed here.  After reading this article, I think one of our future discussions will be on ‘the non-inferiority’ study and what that really means…

From Medscape Cardiology,

2011 Top Game Changers in Cardiology

Henry R. Black, MD; David J. Maron, MD; Ileana L. Pina, MD; Carol Peckham

 Posted: 11/23/2011

10. Death Rates Diverge but no Change in Advice: SYNTAX (or CABG remains KING)

SYNTAX was an 1800-patient trial conducted in Europe and the United States that randomized patients with left main coronary disease and/or 3-vessel disease to either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) using the Taxus® drug-eluting stent (DES; Boston Scientific Corp., Quincy, Massachusetts).^[1] At 3 years, rates of the primary endpoint, major adverse cardiac and cerebrovascular event (MACCE), remained statistically lower in the CABG-treated patients, driven by the lower rates of repeat revascularization procedures — just under 11% in the CABG-treated patients vs nearly 20% in the PCI/DES group. For the hard composite endpoint of all-cause death, stroke, and MI out to 3 years, there were no differences between groups.

On October 25th, 2011 at the European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting, 4-year data from the SYNTAX trial showed, for the first time, a divergence in death rates between the patients who were treated with bypass surgery and those who underwent PCI with a Taxus stent. All-cause mortality and cardiac death were both significantly higher in the PCI group compared with the surgery group, as was MI, and the excess rate of strokes initially observed in the CABG group has now leveled out.

In a discussion about who had “won” the SYNTAX trial, Dr Michael Mack (Medical City Dallas Hospital, Texas), a surgeon and chair of the session, said, “The surgeon would say the longer you go in follow-up, the better surgery looks. We knew this was going to look good 4 to 5 years out. But as an interventionalist, you might say, “We don’t use Taxus stents any more, we use the everolimus-eluting Xience® [Abbott Laboratories], and the results wouldn’t be the same.”

Read the full news story on this trial here.

9. STICH: Viability Testing Didn’t Affect Treatment Outcomes

At the American College of Cardiology 2011 meeting, results of a substudy of STICH were presented and were later published in The New England Journal of Medicine.^[2] STICH (see no. 8 for main results) is a randomized comparison of CABG surgery and medical therapy alone in 1212 patients with a left ventricular ejection fraction (LVEF) less than 35% and coronary artery disease amenable to CABG. The substudy found that overall, substantial viable myocardium evident at baseline imaging studies had no independent bearing on all-cause mortality over 5 years; and such viability didn’t influence the relative effectiveness of the 2 treatment strategies, either for all-cause mortality or the secondary endpoints of cardiovascular (CV) mortality and CV hospitalization.

The substudy also questions the value of the decades-old practice of assessing myocardial viability with perfusion scans or other functional imaging methods to predict benefit from coronary revascularization — at least in the type of patients included in STICH: considered amenable to CABG, LVEF less than 35%, and no significant left-main coronary disease.

Read the full news story on this trial here.

8. STICH “Hypothesis One” Supports CABG in Heart Failure

Also at the ACC 2011 meeting in April, Dr. Eric Velazquez (Duke Clinical Research Institute, Durham, North Carolina) presented the long-awaited results of “hypothesis one” from the National Institutes of Health-sponsored STICH.^[3] The primary endpoint was all-cause death. CABG was associated with an early risk of death as a result of the surgical intervention, but this disadvantage for surgery disappeared 2 years after the procedure. Over a median follow-up of 56 months, 41% of the medical therapy group and 36% of the CABG group died (P = .12), but the difference was statistically significant following adjustment for baseline characteristics. Dr. Bernard Gersh (Mayo Clinic, Rochester, Minnesota) called it “…an incredible trial. A stunning achievement.” ACC 2011 co-chair Dr. Edward McNulty (University of California, San Francisco) agreed, saying that the STICH study was “…precisely the kind of comparative-effectiveness study that is vitally needed.”

Read the full news story on this trial here.

7. DOSE Trial Published: How to Give Intravenous Diuretics in Acute Heart Failure

The DOSE trial published in March 2011 provided solid guidance on the question of whether high-dose IV diuretics might compromise the kidneys and even survival compared with low-level dosing in acute decompensated heart failure and relieved the uncertainty over the efficacy of intermittent intravenous bolus compared with continuous administration. In a Heartwire interview, Dr. Gregg C Fonarow (Ronald Reagan University of California, Los Angeles Medical Center) suggested that the lesson learned from the trial was that “aggressive decongestion is a critical part of achieving good outcomes in acute heart failure. It may seem to come at the cost of transient worsening renal function, but that doesn’t seem to be a major problem, as long as it’s monitored carefully.”

Read the full news story on this trial here.

6. PARTNER Cohort A: TAVI Noninferior to Surgery [in the short-term/ in very select high risk patients]

Long-awaited results from the PARTNER cohort A,^[4] comparing transcatheter valve replacements (TAVR) with surgery for severe aortic stenosis, were announced at the April ACC meeting. Principal investigator Dr. Craig Smith (Columbia University, New York, New York) said that the results “indicate that TAVR is an acceptable alternative to aortic valve replacement in selected high-risk operable patients.” One of the panel members discussing the presentation, Dr. Martyn Thomas (London, UK), called it “an absolutely spectacular trial.” Dr. David Moliterno (University of Kentucky, Lexington), another panelist who was not involved in the study, told members of the press: “You really are witnessing history in the making. This is one of the biggest steps in cardiovascular medicine in our lifetime.”

[Cartagena readers:: Note that this is a 'non-inferiority study'..

Read the full news story on this trial here.

5. The NICE Hypertension Guidelines: A Monitoring Revolution

In August 2011, the UK's National Institute for Health and Clinical Excellence launched an update of their Hypertension Guideline -- the first guidelines in the world to formally recommend ambulatory blood-pressure monitoring as a "key priority" in diagnosing suspected hypertension, particularly if a clinic blood pressure reading is 140/90 mm Hg or higher, according to the chair of the writing committee. According to a long-time "reference standard" for tricky blood pressure readings, ambulatory monitoring should now become the go-to test for diagnosing hypertension in all patients, authors of a new analysis say.

In a Medscape commentary, Rajiv Agarwal, MD (Indiana University School of Medicine; Indianapolis) observes, "I think that they are revolutionary. Ambulatory blood pressure monitoring has never been recommended by any guideline to confirm the diagnosis of hypertension, but we have known for a long time that white-coat hypertension and masked hypertension are real problems. This is the first guideline that takes this problem and addresses it by asking to do ambulatory blood pressure monitoring in all patients at the first visit."

Watch the complete commentary from George Bakris and Rajiv Agarwal.

4. AIM-HIGH: Results Raise Controversy Over Early Discontinuation

The AIM-High study was designed to examine whether raising HDL using extended-release niacin would be beneficial in patients who had been treated with statin therapy for elevated low-density lipoprotein (LDL)-cholesterol levels, but who had low levels of high-density lipoprotein (HDL) cholesterol. The AIM-HIGH trial randomized 3414 patients with established heart disease, low HDL levels, and increased triglyceride levels to extended-release niacin (1500-2000 mg per day) or placebo. All patients also received simvastatin plus ezetimibe if needed to maintain LDL levels below 80 mg/dL, On April 25, 2011, the study's independent data and safety monitoring board made a decision to stop the trial after a mean follow-up of three years. The statement from the National Heart Lung and Blood Institute at the time said that niacin was showing no additional benefits over placebo and there was also a small, unexplained increase in ischemic stroke in the niacin group.

However, the final results of the trial that were presented at AHA 2011 and published in The New England Journal of Medicine^[5] appear to suggest that the signal of increased ischemic stroke with niacin could have been the play of chance, with the final P value for ischemic stroke coming in at a nonsignificant .11. At 2 years, niacin therapy had increased HDL levels from a median of 35 to 42 mg/dL, decreased triglyceride levels from 164 to 122 mg/dL, and decreased LDL levels from 74 to 62 mg/dL. Speculation on the reason for the lack of benefit with niacin is focusing on the low LDL level achieved in the trial. Lead investigator Dr. William Boden (University at Buffalo School of Medicine, New York) commented to Heartwire: “if you are starting off with an LDL of 70, it may not be possible to show any incremental benefit.”

Read the full news story on this trial here.

3. FDA Approves Rivaroxaban for Stroke Prevention in Atrial Fibrillation

In November 2011, the US Food and Drug Administration (FDA) approved rivaroxaban, an oral factor Xa inhibitor, for treating patients with atrial fibrillation. Following dabigatran, rivaroxaban is the second in a surge of novel oral anticoagulants to go before the FDA’s advisors for the atrial fibrillation/stroke indication. The approval for rivaroxaban is based largely on the results of ROCKET-AF. One of the biggest hurdles rivaroxaban faced with the FDA advisory committee was in its comparison to warfarin, and more specifically, the amount of time the warfarin-treated patients spent at the optimal international normalized ratio (INR). In ROCKET-AF, the warfarin-treated patients spent just 57.8% of the time in therapeutic range, which was lower than that in other trials with warfarin, including the RE-LY trial with dabigatran etexilate (Pradaxa®, Boehringer Ingelheim).

A third drug, apixaban (Eliquis®, Bristol-Myers Squibb/Pfizer), is approved in Europe, but not the United States, for the prevention of venous-thromboembolic events in patients who have undergone elective hip- or knee-replacement surgery. The ARISTOTLE trial suggests that apixaban is noninferior to warfarin in the atrial fibrillation/stroke setting.

Read the full news story on this trial here.

2. New Data Show COURAGE Findings Are Not Being Implemented

In 2007, the landmark COURAGE study found that in patients with stable coronary artery disease, optimal medical therapy was just as good at preventing future events as receiving a stent on top of optimal medical therapy.^[6] In May 2011, a survey covering almost 500,000 patients from > 1000 hospitals in the ACC National Cardiovascular Data Registry^[7] showed that, at least among patients ultimately treated with PCI, there was little change in prescribing practice from pre- to post-COURAGE. The author of COURAGE, Dr. William E Boden (Buffalo General Hospital, New York), told Heartwire that he was not really surprised by the registry data. “This is consistent with other observations that have been made previously for years, that there is this ‘phase lag’ — an educational gap — between the results of a randomized trial and them being incorporated into clinical practice.”

Read the full news story on this trial here.

And the Top Game Changer Is…

1. The results of the EMPHASIS-HF trial, published in January 2011,^[8] showed that aldosterone antagonist eplerenone (Inspra®, Pfizer) produced large reductions in both the risk for death and the risk for hospitalization compared with placebo in patients with systolic heart failure and mild symptoms. Aldosterone blockade, with either spironolactone or eplerenone, had already shown benefits in class 3-4 heart failure and in post-MI patients with heart failure. These results extended the benefit to patients with mild heart failure, a much broader population. As reported in Heartwire, Dr. Mariel Jessup (University of Pennsylvania School of Medicine, Philadelphia) said: “We have very good data now that aldosterone antagonists work for patients with heart failure and are saving lives, but we need to better understand the hyperkalemia and how exactly these drugs are working. This is an exciting day indeed, as we have a large new patient population for this drug, but we still have a lot of work ahead of us.”

Read the full news story on this trial here.

The EPHESUS trial,^[9] published in October 2011, found that at least 3 separate therapeutic properties of the aldosterone antagonist contributed to the drug’s significant clinical benefits vs placebo. The authors stated that the clinical gains with eplerenone “cannot be explained solely by the drug’s diuretic and potassium-sparing properties.” They concluded that the analysis provides strong evidence for beneficial pleiotropic effects of the drug in patients with heart failure, at least in the post-MI setting.

Read the full news story on this trial here.

References

1. Kappetein AP, Feldman TE, Mack MJ, et al. Comparison of coronary bypass surgery with drug-eluting stenting for the treatment of left main and/or three-vessel disease: 3-year follow-up of the SYNTAX trial. Eur Heart J. 2011;32:2125-2134. Abstract
2. Bonow RO, Maurer G, Lee KL, et al; STICH Trial Investigators. Myocardial viability and survival in ischemic left ventricular dysfunction. N Engl J Med. 2011;364:1617-1625. Abstract
3. Velazquez EJ, Lee KL, Deja MA, et al. STICH Investigators. Coronary-artery bypass surgery in patients with left ventricular dysfunction. N Engl J Med. 2011;364: 1607-1616. Abstract
4. Smith CR, Leon MB, Mack MJ. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187-2198. Abstract
5. The AIM-HIGH investigators. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. N Engl J Med 2011; DOI:10.1056/oa1107579.
6. Boden WE, O’rourke RA, Teo KK, et al; COURAGE Trial Co-Principal Investigators and Study Coordinators.The evolving pattern of symptomatic coronary artery disease in the United States and Canada: baseline characteristics of the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial. Am J Cardiol. 2007;99:208-212. Abstract
7. Borden WB, Redberg RF, Mushlin AI, Dai D, Kaltenbach LA, Spertus JA. Patterns and intensity of medical therapy in patients undergoing percutaneous coronary intervention. JAMA. 2011;305:1882-1889. Abstract
8. Zannad F, McMurray JJ, Krum H, et al; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011;364:11-21. Abstract
9. Rossignol P, Ménard J, Fay R, et al. Eplerenone survival benefits in heart failure patients post-myocardial infarction are independent from its diuretic and potassium-sparing effects: insights from an EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study) substudy. J Am Coll Cardiol 2011;58:1958-1966.

 

 

 

 

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