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Posts Tagged ‘patient safety’

The answer is “NO” for several disfigured patients in Australia, who later found out that a loophole in Australian licensing laws allowed Dentists and other medical (nonsurgeons) professionals to claim use of the title of ‘cosmetic surgeon’ without any formalized training or certification in plastic and reconstructive surgery (or even any surgery specialty at all).

In this article from the Sydney Morning Herald, Melissa Davey explains how dentists and other nonsurgical personnel skirted around laws designed to protect patients from exactly this sort of deceptive practice, and how this resulted in harm to several patients.

As readers will recall – we previously discussed several high-profile cases of similar instances in the United States, including a doctor charged in the deaths of several patients from his medical negligence.  In that case, a ‘homeopathic’  and “self-proclaimed” plastic surgeon, Peter Normann was criminally indicted in the intra-operative deaths of several of his patients.  The patients died while he was performing liposuction due to improper intubation techniques.

But at least, in both of the cases above – the people performing the procedures, presumably, had at a minimum, some training in a medical/ quasi-medical field..

Surgeon or a handyman

More frightening, is the ‘handyman’ cases that have plagued Las Vegas and several other American cities – where untrained smooth operators have preyed primarily on the Latino community – injecting cement, construction grade materials and even floor wax into their victims.

How to protect yourself from shady characters?  In our post, “Liposuction in a Myrtle Beach Apartment” we discuss some of the ways to verify a surgeon’s credentials.  We also talk about how not to be fooled by fancy internet ads and the like.  (Even savvy consumers can be fooled by circular advertisements designed to look like legitimate research articles as well as bogus credentials/ or ‘for-hire’ credentials*. )

*We will talk about some of the sketchy credentials in another post – but the field is growing, by leaps and bounds..More and more fly-by-night agencies are offering ‘credentials’ for a hefty fee (and not much else.)

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Celebrating book completion with Carla Luna, co-author Carlos Ochoa, and contributor Joanna Calzada.

Celebrating book completion with Carla Luna, co-author Carlos Ochoa, and contributor Joanna Calzada.

So the free pdf version of the book is complete – and available for download.  (It was hosted on the Smashwords site, but their software reformatted the pdf into a bit of a mess, so I’ve posted the original here.)

I am still working on print versions in both color and black and white for readers who prefer paper versions.  Unfortunately, the cost of printing color photos is outrageous – so please note that this is the direct cost – no profit added.

I would love to have an electronic book available but with the extensive footnotes – it’s quite an endeavor, and since I can not afford to hire someone, a little out of my reach right now.

Mexicali book

mexicali-a-mini-gem-guide-to-surgery-in-mexicali-baja-california:pdf

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In health care, we talk about “doing the right thing” all the time; we even have subspecialties in Bioethics to help us decide what that right thing is sometimes, when the situations are complex, entangled or murky.  But knowing what the right thing is from a theoretical perspective, and doing the right thing when it may mean considerable censure are two very separate concepts.

But in my mind, Doing the Right Thing is paramount, particularly when it concerns patient safety, so even though I am doing so with some trepidation (and yes, outright fear) – I am doing it anyway.

I have the hard data to support my claims, and I know in my heart – that it needs to be addressed, and to be talked about.  My fear comes not from the possibility of being wrong (I have been very careful to fact check) but of retaliation; from parties bigger and stronger than I.

After all – I DON’T write for the New York Times (wish I did!) and I don’t have the support of the popular media to protect me.  (And I shouldn’t need them – I am telling the unvarnished truth) but we all know that the truth is not enough these days, especially when large sums of money are involved.

(Not me of course, I’ve never taken a dime from anyone – and I don’t intend to.)  But from all the people selling promises that they can’t safely deliver.   But that’s why, after much thought, consideration and sleepless nights, I have decided to publish information about transplant tourism here in Mexico and a company that is putting their patients at risk.

I hope that my loyal readers will continue to support me, in my efforts to safeguard patients from harm, and to always tell the truth – even when it hurts.

Update:  7 July 2012 New resolution in front of the United Nations on organ trafficking.

9 July 2012 – Insight Crime in Latin America story by Edward Fox

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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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Syringe of unknown contents

 

 

 

Dr. Fix-a-flat (Oneal Morris) in Ft. Lauderdale, Florida has been re-arrested as more victims of his scam surgeries have come forward.

This arrest comes as other American cities, (most notably, Las Vegas) make a concerted push to protect consumers with a new campaign against fraudulent practices and unlicensed physicians.  However, these ‘campaigns’ are primarily informational commercials aimed at the Latino community.

There is a new statewide task force aimed at addressing these incidents, but as of yet – there have been no legislative changes to protect victims of these scams.  Equally disturbing, in at least one of these cases – one of the pretend doctors used his fake status to sexually assault his victims.

In another disturbing sidenote out of Nevada – Teva pharmaceuticals settled a case against them for the distribution of propofol outside of proper channels/ and in improper quantities.  (If you remember, this is how Dr. Conrad Murray obtained the anesthetic for use on Michael Jackson.)  As a result of this distribution of multi-use medications that should be exclusively used in hospital settings – several patients were inadvertently exposed to Hepatitis C (including the plaintiff who developed Hepatitis C as a result.)

[Multi-use vials mean that the same container of medication is used for multiple people – if the medication is drawn up using needles or other instruments that have already been exposed to patients – this places future patients in contact with blood and infectious agents.]   Multi-use vials are a cost-containment measure for many institutions.

I hope that someone takes issue with out-patient colonoscopies as a whole since this in itself can be a very dangerous practice – and the research proves it.  (The issue behind outpatient procedures such as colonoscopies is the use of unmonitored anesthesia.  Most patients aren’t on monitors, no anesthesiologist is present, and the doctors performing the procedure are often unprepared in the event that a patient loses his airway (or stops breathing.)  There was a landmark study several years ago – that showed that 70% of nonaesthesiologists underestimated the level of sedation in patients undergoing out-patient / office procedures.  [I will continue looking for the link to this source.]

Frighteningly, a related paper demonstrated similar findings in a pediatric population.  This South African paper voices similar concerns.

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While extreme plastic surgery makeovers (or multiple plastic surgery procedures at once) make for great television – they aren’t safe.  Prolonged (multi-hour, multi-procedure) surgeries place patients at greater risk of complications from anesthesia, bleeding, etc.  These ‘Mommy Makeovers’ sound like a good idea to patients – one surgery, less money and faster results – but the truth is – they just aren’t a good or safe idea.

Now an article by Laura Newman, [originally published  in Dermatol Surg. 2012;38:171-179] and re-posted at Medscape.com drives home that fact.

Combination Cosmetic Surgeries, General Anesthesia Drive AEs

February 9, 2012 — The use of general anesthesia, the performance of liposuction under general anesthesia, and a combination of surgical procedures significantly increase the risk for adverse events (AEs) in office-based surgery, according to reviews of statewide mandatory AE reporting in Florida and Alabama. More than two thirds of deaths and three quarters of hospital transfers were associated with cosmetic surgery performed under general anesthesia, according to an article published in the February issue of Dermatologic Surgery.

The study, derived from 10-year data from Florida and 6-year data from in Alabama, “confirms trends that have been previously identified in earlier analyses of this data,” write the authors, led by John Starling III, MD, from the Skin Cancer Center, Cincinnati, and the Department of Dermatology, University of Cincinnati, Ohio.

In a companion commentary, C. William Hanke, MD, from the Laser and Skin Surgery Center of Indiana, Indianapolis, presses for 3 patient safety practices: “(1) Keep the patient awake!… 2) Think twice before supporting a patient’s desire for liposuction that is to be done in conjunction with abdominoplasty under general anesthesia…. 3) “[B]e advocates for prospective, mandatory, verifiable adverse event reporting…[that] should include data from physician offices, ambulatory surgical centers, and hospitals to define and quantify problems that can be largely prevented and eliminated.”

The authors and editorialist are especially critical of liposuction performed under general anesthesia. The study revealed that although liposuction is perhaps one of the most common cosmetic surgical procedures, no deaths occurred in the setting of local anesthesia. “Liposuction under general anesthesia accounted for 32% of cosmetic procedure-related deaths and 22% of all cosmetic procedure-related complications,” the researchers write.

The researchers analyzed mandatory physician AE reports in ambulatory surgery submitted to their respective states, encompassing 10-year data in Florida and 6-year data in Alabama. A total of 309 AEs were reported during an office-based surgery during the 10-year period in Florida, including 46 deaths and 263 reportable complications or transfers to hospital. Cosmetic surgeries performed under general anesthesia accounted for the vast majority of deaths in Florida, with liposuction and abdominoplasty the most frequent procedures.

Six years’ worth of data from Alabama revealed 52 AEs, including 49 complications or hospital transfers and 3 deaths. General anesthesia was implicated in 89% of reported incidents; 42% were cosmetic surgeries. Pulmonary complications, including pulmonary emboli and pulmonary edema, were implicated in many deaths in both states.

Plastic surgeons were linked to nearly 45% of all reported complications in Florida and 42.3% in Alabama, write the researchers. Office accreditation, physician board certification, and hospital privileges all revealed no clear pattern.

One limitation acknowledged by the authors is that case logs of procedures performed under general and intravenous sedation are required in Florida, but are not public domain, and so were unavailable for analysis. In addition, investigators were not able to obtain data on the total number of liposuction procedures performed in either state. The lack of those data prevented them from calculating the overall fatality rate.

As readers of my previous publications know, the majority of surgeons I interviewed expressly do not perform multiple procedures during one surgery.  Also, many of them perform the majority of their procedures under conscious sedation with local anesthesia (which means you are awake, but you don’t care – and you don’t feel anything).

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As readers know, I recently gave a CME presentation on The Syntax Trial   and discussed the new Revascularization guidelines that were released last month.  I’ve posted the slides for anyone who wants to use them.  (It would be nice if you mentioned where you got them – but feel free to use them.)

Now – new criticisms of these revised guidelines are already emerging.  But before tackling these new criticisms, we should review the old controversies surrounding the previous guidelines.

In a interesting article (by one of my favorite summarists) Reed Miller over at The Heart.org reviews the issues behind the old (2009) guidelines..  It’s a good article that talks about many of the issues behind the 2012 revisions. I’ve re-posted the article below.

PCI appropriateness criteria draw criticism

(originally posted February 8th, 2012 at the Heart.org)

Kansas City, MO – The interminable controversy about appropriate use and overuse of PCI is being stirred up again [1].

Dr Steven P Marso (St Luke’s Mid-America Heart Institute, Kansas City, MO) and five other cardiologists have published a paper online February 8, 2012 in the Journal of the American College of Cardiology: Cardiovascular Interventions criticizing both the 2009 coronary revascularization appropriate-use criteria (AUC) and how those criteria have been applied to the study of contemporary practice patterns.

As reported by heartwire, the AUC were created by a technical committee representing six professional societies. Last summer, Marso’s colleague in Kansas City, Dr Paul Chan (St Luke’s Mid-America Heart Institute), led a study of PCI cases in the National Cardiovascular Data Registry (NCDR) that showed that only 50.4% of nonacute cases in the registry during the yearlong study period would be classified as appropriate under the AUC and that 11.6% of nonacute cases were classified as inappropriate.

“We are duty bound to evaluate appropriate use of PCI and other medical procedures,” Marso told heartwire. “The problem is that we are no closer to being able to identify overuse based upon these appropriate-use criteria than before they were created. The reason is that there are too many assumptions and too much variability that go into that 11.6% inappropriate rate.”

For example, Marso et al argue that the AUC put too much emphasis on stress testing without precise definitions to guide the interpretation of those tests. “The vast majority of AUC scenarios require knowledge of preprocedural stress-test findings . . . [but] the NCDR does not require interpreting physicians to determine this risk. Therefore, this data-collection burden falls onto the data abstractors, who are required to assign a risk category based on vague guidelines,” they say. “Essentially, they are required to interpret the interpretation.”

Chan told heartwire that the appropriateness criteria were never intended to be perfect, but they are the best effort to sort out which procedures are supported by evidence and which are not. They will evolve over several iterations, including the recent update, which provides more detail on patients with unstable angina. However, Chan does not expect any major changes from the 2009 version to be made soon.

Chan also pointed out that the purpose of the AUCs is to explain the existing evidence base, not pass judgment on each procedure, so nobody should interpret “inappropriate” in the AUCs to mean “fraudulent.”

“Ultimately, my main concern is that we don’t lose sight of the forest for the trees. Our profession of cardiology has taken an amazing leadership role in defining quality and appropriateness of care—in a way that no subspecialty has done to date. In so doing, we have moved the quality yardstick forward,” Chan said. “[But] we need to be humble as physicians to recognize that sometimes we may actually be doing procedures that have little evidence to support their use . . . and that not only are we not providing benefit but perhaps subjecting patients to unnecessary procedure risks and costs.”

Who decides which side is “right” and which side is “wrong?”

Marso et al are especially concerned with the AUC’s treatment of patients with one- or two-vessel disease, no proximal left anterior descending artery involvement or prior coronary artery bypass graft, class I or II symptoms, low-risk noninvasive findings, and on no or minimal medications. The AUC state that PCI in this scenario, labeled scenario 12b, is “inappropriate.” This scenario accounted for nearly 40% of the inappropriate nonacute procedures categorized by Chan et al as inappropriate, making it the most common type of procedure in this category.

Prior to the release of the 2009 AUCs, Chan et al surveyed 85 cardiologists—including 44 interventionalists and 41 noninterventional cardiologists—on the appropriateness of 68 coronary revascularization indications also addressed by the AUCs. That group classified scenario 12b as “uncertain.” Instead of assuming that the cardiologists in the survey need to be educated about the appropriateness of this procedure, Marso et al suggest it’s the technical panel that could learn something from the cardiologists in the survey. “These are 80 clinical cardiologists who answered questions about what they thought was appropriate, driven by medical decision-making, and they concluded that the technical panel just plain got it wrong,” Marso told heartwire.

In response to this specific point, Chan told heartwire, “The decision of the AUC technical panel to make this scenario inappropriate was based on the lack of available clinical evidence to support PCI in patients who have only mild to moderate symptoms with intermediate stress tests without a trial of medical therapy. This is, indeed, consistent with the COURAGE trial, wherein medical therapy was found to be comparable to PCI for patients with even greater symptoms and more severe ischemia.

“Although the COURAGE quality-of-life substudy did find that patients who underwent PCI, compared with medical therapy, had modestly improved angina relief during the first year, this benefit was likely concentrated in those COURAGE patients who had far greater symptoms than [Canadian Cardiovascular Society (CCS)] class I or II—eg, CCS class II or IV,” Chan said. “Dr Marso’s assertion that this indication should be uncertain, however, is not supported by any evidence to date.”

Who decides who gets to decide?

Marso et al also object to the composition of the technical panel, which included only four interventionalists out of 16 total members. The panel was put together according to the so-called Rand method to prevent conflicts of interest. Marso objects to the technical panel’s insinuation that “interventional cardiologists are inherently biased due a financial bias or an intellectual bias, that their ideas are preconceived, and that they are unwilling to evaluate data in an objective manner.” He points out that the FDA, which certainly has a vested interest in rooting out both financial and intellectual bias from its advisory panels, does not limit whole categories of experts from serving on these panels. Instead, it evaluates the background and potential conflicts of interest of each individual.

Dr John Spertus, the director of outcomes research at Saint Luke’s Mid America Heart Institute and senior author of the AUC writing group, does not agree that the AUC technical committee needs more interventionalists. “The benefits of revascularization should be very transparent. Clinicians caring for patients should all be on the same page with the same perspectives of revascularization of patients. That isn’t information that is uniquely known to the interventional community,” he said. “While they have extensive expertise and knowledge around the technical aspects of doing the procedure, whether it should be done or not is something that all clinicians caring for patients with coronary disease should know, appreciate, and be able to communicate to their patients.”

The missing voice: The patient

In an accompanying editorial [2], Dr James Blankenship (Geisinger Medical Center, Danville, PA) argues that the AUC “will never fully define the best treatment decision for a particular patient . . . because occasionally, patients will have exceptional circumstances that dictate treatment different from that recommended by AUC and guidelines; and different patients experience a given level of symptoms differently.

“Determinations of appropriateness by the AUC based on angina class fail to take patients’ perceptions and preferences into account. This is a fundamental flaw, because patients’ perceptions and preferences are a critical component of decision making,” Blankenship argues. However, he acknowledges that “factoring in patient preferences raises a host of new problems. Patients’ preferences are routinely based on incorrect perceptions and nonobjective factors; [they] routinely overestimate the benefits of PCI, underestimate its risks, and underestimate the efficacy of medical therapy [and] tend to discount the sometimes-superior benefits of one treatment (eg, CABG for very complex triple-vessel disease), because those benefits accrue later, and instead prefer the more immediate but lesser benefits of another treatment (eg, PCI) because they accrue sooner (temporal discounting).”

More data on the way

Chan said that a prospective study of 7000 to 8000 patients measuring the change in quality of life from baseline to six months among patients who have undergone PCI will soon be complete. Results of this study, intended to validate the ratings of the AUC, will probably be available this summer, he said.

“We anticipate that we will find that patients with inappropriate AUC ratings will have little to no improvement in quality of life at six months, appropriate AUC ratings will have substantial improvements in quality of life, and uncertain AUC ratings will have modest improvements in quality of life,” Chan said. “Once we have these results, we will be able to say with confidence whether indications such as 12b should be kept as inappropriate or changed to uncertain.”

Spertus said that the AUC will be updated when there are methodological or technical deficiencies in the current approach or if important new evidence on PCI is published. One of the goals of the AUC is to identify gaps in the scientific knowledge that need further study.

Marso reports no personal conflicts of interest during the previous 24 months.

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