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Posts Tagged ‘controversy’


Over at theheart.org they’ve published a whole series of video lectures, articles, and discussions on the phenomena of overstenting and inappropriate PCI.. Of course, you have to be a member to read any of it – which leaves a lot of my readers out in the cold. As longtime blog readers know, we’ve discussed this topic at length in previous posts:

What is overstenting?

The problems with stenting (USAToday report)

I have another re-post from Reed Miller on the topic – which I’ve pasted below.. It’s quite wordy, but I want you to remember while you are reading this – that they are discussing the percentage of inappropriate procedures according to cardiology guidelines – now that’s a particularly important point, because, if you recall – about a month ago: there was an article calling into question the validity and appropriateness of these very guidelines, since the majority of cardiologists that helped draft them were paid large sums of money by stent manufacturers and drug companies.

Also I have placed certain areas in italics.. Areas where I feel the commentary in the article is questionable, or open to debate – such as stenting the left main or three vessel stenting – just because interventional cardiologists have decided that they should perform this procedure doesn’t mean that it benefits the patient – or that the procedure isn’t still somewhat controversal.
So what does this mean to you – it means that we need to continue to focus a critical eye on cardiology, and the current use and indications for stent placement.

So, what should you do if you find yourself in this situation? you or a loved one has just had a cardiac catheterization, and you find yourself wondering about the best/ most appropriate treatment.. Ask to have a cardiac surgeon review your history and films.. A lot of good facilites already do this – to get a second opinion.. A cardiac surgeon is going to be looking at your films with a different perspective – we only want to do surgery once – when it benefits the patient the most, since surgery is nothing to be taken lightly.

NCDR shows 11.6% of nonacute PCIs and 1.1% of acute PCIs are “inappropriate” based on AUC
April 5, 2011 | Reed Miller

“New Orleans – A review of over 500 000 cases presented at the American College of Cardiology (ACC) 2011 Scientific Sessions shows that overuse of PCI is uncommon but that there is still plenty of room for improvement in the number of inappropriate elective PCI procedures.” Really? More than 1 out of ten – and they say it’s uncommon? Pretty darn frequent, you ask me (cartagenasurgery).

This morning, Dr Paul Chan (St Luke’s Mid-America Heart Institute, Kansas City, MO) presented results of a study of over 500 000 cases in the National Cardiovascular Data Registry (NCDR) from July 2009 to June 2010 that categorized each PCI as appropriate, inappropriate, or of uncertain value based on the 2009 coronary revascularization appropriate use criteria (AUC). The AUC writing committee included representatives of the ACC, Society for Cardiovascular Angiography and Interventions (SCAI), and several other cardiology organizations, including two surgical specialty groups.

Chan reported that overall, 84.6% of the procedures in the study that could be categorized were appropriate based on the AUC, while 4.1% were inappropriate and 11.2% were in categories that the AUC deems uncertain.
Former SCAI president and member of the AUC writing committee, Dr Gregory J Dehmer (Texas A&M University College of Medicine, Temple), told heartwire that the study by Chan and colleagues “really gives us our first biopsy of what is the level of appropriateness of PCI care in all of these NCDR hospitals, which include over 900 facilities.”

Dehmer proclaimed that the results are “great news, especially in today’s environment,” referring to the recent cases of interventionalists charged with routinely performing inappropriate PCIs. “It’s very comforting news for both patients and regulators,” he said.

Most of the problems in nonacute procedures

Of the cases that could be categorized by the AUC, 71% were acute patients, and 98.6% of these were deemed appropriate procedures while only 1.1% were inappropriate. Chan also pointed out that there was very little variation among hospitals in their rates of appropriate and inappropriate procedures for acute patients. The acute cases included were ST-elevated MIs (21.3%), non-STEMIs with documented troponin rises (20.5%), and patients with high-risk unstable angina (29%).

However, among the 29% of the categorizable elective PCIs for nonacute patients in the study, 50.4% were categorized as appropriate, 38% were of uncertain value, and 11.6% were inappropriate based on the AUC. About 71% of the inappropriate nonacute patients were low-risk according to their ischemia study results, and two-thirds were asymptomatic to very mildly symptomatic. More detail on the study will be provided when the results are published in a peer-reviewed journal. The paper is currently under review, Chan said.

The study showed wide variation from center to center in the rate of inappropriate intervention in nonacute patients, ranging from below 10% to over 30%, and the median was 10.7%, with an interquartile range of 6% to 16.7%. Some of these cases were appropriate due to special circumstances, Chan said. “However, it is unlikely that exceptions would explain this marked variation across sites” in the rate of inappropriate procedures in nonacute patients.

Mostly good news, but plenty of room to do better

Chan agreed that the study results show that “on the whole, the US angioplasty community is doing a decent job in ensuring that most procedures are appropriate when you look at the acute and nonacute procedures all together, but we do have some work to do in the nonacute setting.” He added that “no other subspecialty has taken the lead on self-regulation and self-reflection like cardiology has, and it’s a tribute to organizations like the ACC that are moving this field.”

Really? Didn’t several cardiologists have to be charged with malpractice for ‘the subspecialty to take the lead’?? Didn’t state legislature (maryland) have to become involved for an investigation to take place?? (cartagenasurgery)

Chan and Dehmer both emphasized that while there is plenty of room for reduction of unnecessary procedures, no center should expect to have a rate of 0% inappropriate procedures. There will be cases where patient characteristics not considered in the AUC make an otherwise inappropriate procedure appropriate for a particular patient. The AUC categorizes 198 clinical scenarios based on acuity of presentation, extent of coronary disease, the extent and magnitude of ischemia, the intensity of medical therapy, and the severity of symptoms, but the AUC do not consider potentially critical factors such as age, Dehmer pointed out. “For example, what you’d do for a 45-year-old guy who can’t hold down a job because of his coronary disease might be different from what you do for an 85-year-old grandmother who just sits and knits all day.”

Sounds like the 45 year old might need CABG or TMR versus 27 stents that will close in a year or two. (cartagenasurgery)

“But when you have some hospitals exceeding 17%, in the upper quartile, and others at 6%, we need to learn what the hospitals with lower rates are doing differently,” Chan said.

Chan also pointed that about 19% of the PCI cases that the investigators originally looked at for inclusion in the study could not be categorized by the AUC because the case record is missing some relevant information. For example, the study had to exclude patients who had stress tests but whose ischemia risk was not recorded by the referring physician. “That’s something that we can improve” by emphasizing to the NCDR sites and referring physicians the importance of collecting all of the information needed to show that a procedure is appropriate.

He also noted that the AUC will soon be updated to reflect more recent clinical trials on left main and three-vessel disease, although most of those procedures are already categorized as appropriate.

this wisdom of doing PCI on the above mentioned patients is still hotly under debate, but as we’ve discussed before- long term data favors CABG (in these patients with SEVERE disease.) The studies they mention only look at six month outcomes. (cartagenasurgery)

Interventionalists must use the data wisely

In the future, centers participating in the NCDR will receive quarterly reports detailing the rates of appropriate, uncertain, and inappropriate PCI procedures performed at their facility, with benchmark data on how other centers are performing. The centers will also receive a line-item list of all the cases that were classified as inappropriate for that quarter so that they can subsequently develop internal quality improvements to better understand why those procedures were performed. “Maybe there are all sorts of reasons to explain it, but we need to find out why. It causes the questions to be asked and then, hopefully, if there is a reason, those reasons can be rectified,” Dehmer said.

Dehmer also pointed out that the continued collection of these data will identify “gaps in our knowledge” and which types of procedures need more study. It may also help to stimulate more discussion among interventionalists about appropriateness. A recent survey by Chan et al found widespread variability of opinion among cardiologists on the appropriateness of some PCI indications.

“Hospitals should look at their rates in relationship to other hospitals and how far above or below the median they are and then look at the list of the inappropriate cases and go back and better understand if there were extenuating circumstances that made them [actually appropriate],” Chan said. “But if there is a pattern such that the majority of those inappropriate cases didn’t have exceptions, then it provides a red flag, and the interventional cardiologists should discuss how this should inform their future practice. Even hospitals with low rates of inappropriate cases can use that information to see if there is further improvement they can make.

“It will be interesting to see how hospitals and physicians work together to develop the quality-improvement effort to look at these questions,” he said. “The use of the reports will dictate how useful the information we’re providing to physicians will be. If the reports are just put on a shelf, they won’t provide hospitals any benefit.”

Also, it appears if you document poorly, when the cardiologists review the data – they will note any discrepancies as ‘uncertain’ instead of ‘inappropriate’ which saves them from admitting what the real incidence of inappropriate PCI is. In 1 out of 5 cases, the cardiologist couldn’t bother to chart completely, but I bet they were more diligent in the billing department…

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Why Colombia for medical tourism/ surgical tourism?

Here are several of the reasons I have decided to focus on Colombia as one the emerging destinations for medical tourism:

1. It’s close to the United States (and North America): direct flights to several cities in Colombia are only 2 – 3 hours from Miami, Orlando and many other southern US cities.
This should be first and foremost in people’s minds – for more than just consumer comfort. Those coach-class seats can kill.
The risk of venous thromboembolism (VTE), a potentially fatal complication of air travel (and other stationary conditions) is very real; and this risk increases dramatically with flight duration. Flights to Asia can be anywhere from 16 to 20 hours – which is an endurance test for even the healthiest and heartiest of individuals.

This risk for DVT/ VTE which can lead to pulmonary embolism, and death is enhanced in elderly people, people with chronic diseases (diabetes, lung diseases, etc.), obesity and people who have recently had surgery.   Some data suggests this enhanced post-surgical risk may persist for up to 12 weeks. While there are treatments to prevent thromboembolism or blood clots, none of these strategies are fool-proof. (Some of these safety strategies for air travel are mentioned in the above attached links).

Proximity – Close to the USA/ North America:
-Cheaper flights (all the flights to Asia are in the thousands – and you shouldn’t be travelling alone)
– Shorter flight duration (safer, more comfortable)

2. Cost:
This includes medical travel costs as briefly mentioned above. Most cities in Colombia are relatively affordable for other travel accommodations (though this is sometimes included if medical tourism packages/ planning are used.) This is in addition to the known cost-savings of medical care outside of the United States, which is the main reason behind the popularity of medical tourism. For example, a recent CT scan at a local hospital cost around $250.00, versus several thousand.

For actual surgical procedures, the savings are much greater. Heart surgery in the USA ranges from $80,000 – 180,000.. of course, if you have good insurance – your costs are much lower.. If, of course, you have good insurance – and insurance doesn’t cover everything!
In Colombia, heart surgery costs around $12,000 – and most cardiac programs  (and other surgeons/ hospitals) here accept American insurance – so your 20% co-pay is going to be a lot more reasonable..

3. Similar culture, similar values, similar ideals – yes, the language is different (but many people and providers speak English) but the underlying primary core values, and core medical values are the same. This means, that while the US medical system is plagued with problems – some of these problems are related to our values such as the sanctity of life, and the preciousness of life.. That value is shared here – which is important – since that is not the case in many places – even western europe where medicine, surgery and expensive treatments are rationed, and sometimes denied – particularly to people over the age of 65.

Medical providers, nurses, and staff here care about their patients the same way, we do at home.. And arguably, in most cases, the doctor- patient relationship is a lot closer, and more personal here. Doctors want and expect patients to contact them – they give patients their email and cell phone numbers on their business cards, for just that reason, and they aren’t put out or annoyed if you use it.. (I know, I’ve been with doctors when patients call.)

4. Surgical proficiency, medical education, and available resources – this is the primarily reason I am currently here in Bogota, Colombia; the high level of skill and training among surgeons in Colombia. These doctors are professionals in the highest sense of the word, and have attended well-known, well-respected and accredited institutions. In many cases, these surgeons are at the forefront of emerging technologies, that are just now becoming popular in the USA.
As far as medical technology goes – many of the doctors, and hospitals I visited have the latest technology, which rivals if not beats what I’ve seen in the US. (Now, for those of you who have never stepped inside a rural hospital in the United States – you would be surprised at what resources they do and DON’T have.) Americans in general, and American medical professionals tend to view the world from this little bubble, thinking that we always have the latest and greatest – even when we know it’s not always true. It may have been true twenty years ago, but sadly, it’s not always true now.

Come back for part two – and we’ll discuss Why not India, why not Thailand.. (but in the meantime, here’s some food for thought)

* Antibiotic resistant infections of any sort (MRSA, VRE) are still fairly rare in Colombia.
Superbug Hits UK from Medical Tourism from India

Indian Resistant Bacteria from Medical Tourism

More articles/ links on SuperBug

Of course, to be fair, our own food supply contributes to this problem too..

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It’s becoming a cardiologist’s worst nightmare: after years of minimal outside oversight, with multiple physicians operating on the fringes of medical legitimacy (stenting the left main, three vessel stenting, overstenting vulnerable populations like diabetics*) new legal and medical scrutiny is being placed on cardiologists and cath labs in the wake of widespread reports of overstenting. (Overstenting is the use of medical devices called stents when surgery, medications or other modalities are called for.)

Overstenting is a combination of two different problems:

1. the placing of a stent in an artery without a severe blockage (aka unnecessary stenting) – this places the patient at risk for cardiac cath lab, and stent complications unnecessarily in patients who DON’T NEED IT. One of the reasons this practice is so prevalent is that patients don’t understand that this is a dangerous practice – this isn’t a preventative measure like a seatbelt or a vaccine.. Not all disease progresses at the same rate, and just because someone has a fifty percent narrowing – it MAY NEVER WORSEN.. But fifty percent sounds scary, doesn’t it? So patients never realize that they’ve been had..

Maybe doctors get away with it much of the time, but what about the patients with acute stent thrombosis – where a blood clot lodges in the stent (the stent is a piece of metal, a foreign body that irritates the walls of the artery, causing increased risk of clot formation.)

Now this patient with the clot – is going to have a heart attack, and potentially even die from this.. Because of a treatment they didn’t even need..

2. Now the second class of patients – these patients are the sick patients.. These people go to the cath lab – and they have lots of blockages and severe blockages (75%, 90%, 100% blocked) in more than one place. These people should have bypass surgery – AND WE KNOW THIS. We know this from thousands and thousands of patients followed over time, in multiple studies.. Survival expectancy in patients with multi-vessel coronary artery disease (CAD) is a MEAN of 17 years.. There isn’t a stent on the planet that has lasted or will last seventeen years. So placing a stent (or lots of stents) in these patients is VERY dangerous – these people will clog up their stents – maybe have heart attacks (damaging their heart muscle); causing congestive heart failure or even death.

ALSO, all those stents make later heart surgery more difficult – imagine the surgeon trying to work around all these little metal coils to find a place to attach a bypass graft. Not pretty.

* Diabetes are considered a vulnerable population because we know that stents don’t last in these patients.

So, now that I’ve had my say – I’m re-posting this article from The Heart.org which is a subscription, paid site, so the rest of you can read it for yourselves.. Just a note to readers: PCI means angioplasty stent placement (PerCutaneous Intervention)

Cardio groups ask Maryland legislature to consider upping cath-lab oversight in wake of over-stenting debacle
March 2, 2011 | Reed Miller
Annapolis, MD – Two major cardiovascular professional societies are taking the unusual step of asking a state government for more oversight of their practice to restore what they perceive to be sinking public confidence in cardiovascular interventionists.

Speaking on behalf of the Society for Cardiovascular Angiography and Interventions (SCAI), Dr Mark Turco (Washington Adventist Hospital, Takoma Park, MD) told heartwire that after the allegations surfaced against interventionalist Dr Mark Midei (St Joseph Medical Center, Towson, MD) and Dr John R McClean (Peninsula Regional Medical Center, Salisbury, MD) many patients began telling their physicians that they did not have confidence in stents.

“Interventional cardiology is a big user of health care dollars and we’re concerned that the public has a perception that we are often moved to treat patients on the basis of relationships with [drug and device] vendors,” Turco said. Turco is also president-elect of the American College of Cardiology’s Maryland Chapter.

Current ACC Maryland Chapter President Dr Sam Goldberg (Bethesda, MD) told heartwire “when the news broke about the inappropriate use of stenting at St Joe’s hospital in 2009 and 2010, I felt that we needed to be proactive in dealing with this issue, so we started reviewing what our own physicians do and what kind of oversight we have and . . . I felt we needed some greater oversight.”

Today, Goldberg and Turco testified before committees of the Maryland General Assembly to pass the Maryland Cardiovascular Patient Safety Act (Senate Bill 742, House Bill 690). They met with the House of Delegates Health and Government Operations Committee a few hours after addressing the Senate Finance Health Subcommittee.

“Rarely do [doctors] develop our own legislation,” Turco testified before both committees. “And rarely do we advocate for more oversight! The fact that we have done both shows how strongly we feel about the need for this legislation.”

Rarely do [doctors] develop our own legislation. And rarely do we advocate for more oversight! The bills, if passed into a law, would launch three new initiatives. It would mandate that the Maryland Health Services Cost Review Commission use data in the Maryland Health Care Commission’s CATH-PCI and ACTION registries, along with administrative data, in order to get the most accurate picture of cath lab practices.

The bills also call for the creation of a system of independent peer review and external oversight that would audit a cath lab’s practices to ensure that they are consistent with the current professional guidelines and in patients’ best interest. “Looking into the [current] in-hospital peer review process, which is a legally protective process, that is done within the hospital . . . I saw that there were very few guidelines about how it’s done and it’s an inherently biased process because you have cardiologists who all know each other reviewing each other, and some are business partners and colleagues, and it’s very difficult for them to be very critical of some things and I felt we needed some greater oversight,” Goldberg said.

The bills also calls for all cath labs in the state of Maryland to be accredited by a nationally recognized accreditation body such as the fledgling Accreditation for Cardiovascular Excellence (ACE) set up by SCAI. Mary Heisler, Executive Director of ACE, also testified before both legislative committees. She said that her group could accredit a Maryland hospital to run a cath lab for under $25 000 a year. “While we recognize this is a difficult economic time, this will avoid the problems that just cost [St Joseph hospital] $22 million,” she said. “This fee is the equivalent to the reimbursement a hospital receives for approximately two stent procedures.”

Denise Matricciani, the Maryland Hospital Association’s (MHA) Vice President for Government Relations, testified that her organization broadly supports the aims of the bills, but that the MHA does not support mandating accreditation at this time. She pointed out that ACE has not yet performed the kinds of surveys of appropriateness envisioned by the bills’ supporters and that there are no data yet to support the effectiveness of its process. Also, MHA is not convinced that an accreditation process would do much to stop inappropriate procedures.

“Accreditation may have merit in the future, we just don’t believe that mandatory accreditation is appropriate at this juncture,” she told the house committee. She also refuted the insinuation of the ACC representatives that MHA’s opposition is based only on cost concerns.

Matricciani outlined some of the efforts her group is undertaking to root out waste and abuse and improve public confidence in cath labs. For example, MHA recently created a Necessary Care Work Group, with medical directors and quality leaders, to study and make recommendations to the Department of Health and Mental Hygiene (DHMH) and the legislature on issues related to inappropriate percutaneous coronary interventions and other medical procedures.

The group also created Guidelines to Ensure the Appropriateness of PCI Procedures. “As this body has witnessed over the years, we can do a lot with our members in terms of doing what’s right,” Matricciani told the house committee. “These guidelines strive to ensure patients, the public, and practitioners that stent placements are appropriate and necessary and right for the patient.”

In his testimony before both committees, Turco argued that internal efforts by the hospitals to oversee the cath labs will not be sufficient to prevent problems like those at Peninsula and St Joseph.

“To those who would advocate for the same old system with ‘suggested regulation’ rather than legislation to fix problems, I would ask—can you explain why and how that regulation would be enforced? And I would ask, if it was so easy to just regulate, why has it not been done in the past, and how have we found ourselves in this situation today?”

He continued: “Accreditation will provide needed oversight for hospitals, while removing much of the variability in care from one center to another.” He added that although accreditation of cath labs would be a new requirement and possible burden on hospitals, the hospitals are already accustomed to handle a variety of accreditation processes for other procedures and departments, so preparing for cath lab accreditation would not be overly burdensome.

Turco also told heartwire that he believes that regulation of cath labs and medicine in general is probably only going to increase in the future regardless, so it behooves the hospitals and the physicians to be proactive in proposing an oversight system to legislators instead of waiting for outsiders to impose one on them.

Update: 17 march 2011

Saw this little gem in my cardiology newsletter – which conveniently, I might add, neglects to mention LONG – TERM outcomes, which as my readers know have been definitively proven to be better with cardiac surgery.. (Come on people, play fair.. it’s hard enough for patients out there without all this deceit..)

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If you’ve been following the cardiology and vascular surgery journals – then you’ve been bombarded with articles about strokes in the last two days.

The first series has blazing headlines linking the increased rate of strokes in young people with diet soda consumption (excess salt consumption, obesity, poor dietary habits).

The second series of articles discuss the very topics we’ve been discussing here at Cartagena Surgery.. Surgery versus Stenting..  But as people have been asking, are the two related??

Probably not.  The proposed causes of the increased incidence of stroke in people aged 15 – 44 is theorized to be related to increased sodium intake – which in turn causes hypertension.  Hypertension itself may increase the ‘chipping’ effect on plaques in the carotid artery (in people with pre-existing carotid disease)

or may cause strokes themselves by causing blood vessels in the brain to rupture from the increased pressure.  In young people, it is usually the latter.. (because it usually takes a long time to accumulate carotid plaques.) Unfortunately, it’s this younger population that often goes undetected/ untreated or fails to realize the significance of the diagnosis.  Hypertension/ high blood pressure is a serious condition, and aggressive treatment is warrented.. It’s never just high blood pressure.. It’s THE number one cause of kidney failure, the number one cause of heart failure, and a major cause of stroke (just to name a few.)  and it’s usually easily treatable.

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