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Posts Tagged ‘interventional cardiology’

No – I haven’t changed the name of the blog, just reflecting the nature of my current assignment.  Spending some time in Interventional Cardiology this week as part of a story I am writing about chest pain emergencies for Mexico on my mind.com.  Today, I checked out the cath lab at Hispano Americano Hospital.  It’s a bit crowded, but all the equipment is brand-spanking new, and practically sparkling.  (Don’t worry – I have photos to prove it!)

Nurses in the cath lab at Hospital Hispano Americano

Dr. Fernando Monge was kind of enough to give me a guided tour.  While we were there he (assisted by Dr. Raul Aguilera) placed a stent in a patient with recurrent angina.  A doctor from the ER also stopped by to have him review a couple EKGs..  I’ll post a link when the full story is done.

Also stopped in to talk to Dr. Jose Antonio Olivares Felix, MD, a general surgeon who reports to me that he is doing single port laparoscopy – so of course, that got me interested.  Hoping to set a date to go to the operating room.

I’ll be spending all of tomorrow in the company of Dr. Marnes Molina, MD to learn more about some of the other stuff he’s doing in urology (and hopefully grab a picture of that green laser!)

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The Core Valve by Medtronic

Medtronic, the makers and financial backers of a recent study on the Core Valve used for percutaneous aortic valve replacement (aka non-surgical valve replacement) released their findings showing the six month mortality data on patients receiving this valve.

This study which was performed using data from European cardiologists (who have been using this technology longer) were unsurprising – with a higher risk of stroke and overall mortality.  Notably, this study was performed on patients deemed to be ‘at high risk’ for surgery, not ineligible for surgery.  As we’ve discussed before, the term ‘high risk’ is open to considerable interpretation.

A total of 996 frail, elderly patients at high risk for heart surgery were  implanted with Medtronic’s CoreValve device, used to treat severe narrowing of  the aortic valve. Mortality rates at one month and six months were 4.5% and  12.8%, respectively. Stroke rates were 2.9% and 3.4%.

Medtronic said the rates  were consistent with previously reported data from national registries in Europe.”

Unfortunately, the general media’s coverage of these findings have been less than straightforward as Bloomberg proclaims in blazing headlines, “Edwards heart valve skirts rib-cracking for a 2.5 billion dollar market.”  That’s a pretty eye-opening headline that manages to avoid mentioning the real issues – longevity and durability.

Another article from business week proclaims, “Heart Valves found safe.”  Safe, I guess is a relative term – if you aren’t one of the 12.8% that died within six months..

Illustration showing the core valve in place

More about Aortic Stenosis and Valve Replacement therapies at Cartagena Surgery:  (you can also find a link to these stories under the TAVI tab on the sidebar.)

Aortic Stenosis as Heinz 57

More patients need surgery

Aortic Stenosis, surgery and the elderly

Aortic stenosis and TAVI

Aortic Stenosis: New Recommendations for TAVI

Transcatheter Valve Therapies: an overview

TAVI and long-term outcomes

Peri-operative outcomes with TAVI

Talking about TAVI/ TAVR with Dr. Kevin Brady

Will Medicare cover TAVI?

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Here’s some follow-up information on the current recommendations / guidelines from the ACC (cardiologists) and STS (cardiac surgeons) on the use of TAVI or catheter-based therapies for the treatment of valvular disease.

Read it for yourself and let me know what you think, but I find it to be a nice, concisely worded document that clearly delineates and spells out the current role of TAVI therapies as a limited therapy for specific populations – at least until we have long-term outcome data.  (We can look to Europe and observe their outcomes, in part).

Not for young people, not for people who could withstand surgery (as determined by a surgeon/ sts risk calculator).  Not as part of an ‘easy fix’ mentality that winds up slapping us (and the patient) in the face a few years later.

Let’s hope that all the interventionists keep to the fundamental principles outlined here, as part of our commitment to patient care, safety and well-being.

Re-posted from Cardiosource.com

Title:         Transcatheter Valve Therapy: A Professional Society Overview From the American College of Cardiology Foundation and the Society of Thoracic Surgeons
        Date Posted:         June 27, 2011
        Authors:         Holmes DR Jr, Mack MJ.
        Citation: J Am Coll Cardiol 2011;Jun 27:[Epub ahead of print].
 Perspective:

The following are 10 points to remember about this expert consensus document on transcatheter valve therapy:

1. Transcatheter valve therapy is a transformational technology with the potential to significantly impact the clinical management of patients with valvular heart disease.

2. Although the initial experience is positive, evidence exists from only one randomized clinical trial in patients with aortic stenosis and one in patients with mitral insufficiency.

3. Adoption of these techniques to populations beyond those studied in these randomized trials, therefore, is not appropriate at the current time.

4. It will be important to establish regional centers of excellence for heart valve diseases. Criteria for centers performing interventional therapy in valvular and structural heart disease should be established, and the availability of devices and reimbursement for those procedures should be limited to those centers meeting those criteria.

5. The heart team approach should be used with formation of multidisciplinary heart teams within these centers led by primary cardiologists, cardiac surgeons, and interventional cardiologists.

6. Performance of isolated procedures without construction of a dedicated valve therapy program to encompass all aspects of care—including preprocedural assessment in common clinics, joint procedure performance, and common patient care pathways—is not recommended.

7. A national registry of valvular heart disease to perform post-market surveillance, long-term outcome measurement, and comparative effectiveness research should be established. This could be accomplished by linking the ACC’s NCDR® and STS clinical databases to the Social Security Death Master file and Centers for Medicare & Medicaid Services administrative databases in a national ‘research engine.’ This will, in effect, create a national registry of valvular heart disease.

8. Training and credentialing criteria for practitioners in this field need to be developed. Development of criteria for the formation of fellowship programs, as well as postgraduate training with appropriate experience for adequate patient care leading to guidelines for credentialing, is currently underway by multiple professional societies working together.

9. Interpretation of the current evidence by expert consensus documents and appropriate use criteria need to be developed.

10. With society leadership, multidisciplinary partnerships, and cooperation, a reasoned, balanced introduction of this new therapy can be accomplished.

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Here’s another re-post from Heartwire :

Midei and unnecessary stents—or lack thereof—make news again

April 25, 2011            |            Shelley Wood

Baltimore, MD and Greensburg, PA – “Unnecessary stents” and the people who place them have been back in the news this past week with a confusing twist of the tale in Pennsylvania, previously reported by heartwire, where two cardiologists stepped down on charges of unnecessary stenting [1], and a published Commentary, by Dr Mark Midei, in the Baltimore Sun [2].

The latest development in the Greenburg, PA case, reported Saturday in the Pittsburgh Tribune-Review, involves an admission by the hospital’s chief medical officer that at least six of 141 Westmoreland Hospital patients sent letters telling them they may have received “unnecessary stents” in fact never got stents in the first place. Instead, the hospital now says, these six patients underwent angioplasty procedures that appeared, on review, to not have been medically warranted, although no stents were placed.

The two cardiologists who treated the 141 patients—Drs Ehab Morcos and George Bousamra—voluntarily resigned after hospital administrators first questioned the medical necessity of the procedures. Those questions stemmed from the conclusions of eight independent cardiologists, as part of a review by the American Medical Foundation in Philadelphia. The hospital alerted patients to the situation via a letter, and 19 patients have since launched lawsuits against the two cardiologists and the parent health organization for the hospital, Excela Health.

The hospital has now sent new letters “of clarification,” the Tribune-Review reports, a move that has been slammed by lawyers handling the lawsuits and by outside observers.

“It is confusing,” Dr Gregory J Dehmer (Texas A&M University College of Medicine, Temple) is quoted in the article. “The bottom line is that it was an unnecessary procedure, whether they got a stent or not.”

Midei’s day in the Sun

Meanwhile, Dr Mark Midei, whose predicament in Baltimore is viewed by many as the catalyst for the stepped-up scrutiny of interventionalists around the US, once again lays out his side of the story—this time in the Baltimore Sun, the newspaper that has meticulously covered this saga. In the article, published Friday, Midei notes that he will soon be appearing before the Maryland Board of Physicians to “make the case for retaining my license to practice medicine” but in the meantime wants his voice heard.

Midei repeats an allegation he made when he first spoke out on the case, in an interview with heartwire, saying that St Joseph used him as a “decoy” when the hospital was embroiled in a federal investigation.  He has also, he says, been falsely portrayed as “manipulating” the peer-review process at the hospital, when in fact “any doctor, nurse, technologist, or physician assistant could suggest additional cases for review.” As well, he notes, he was not paid by the hospital based on the number of cases he performed, as press reports have suggested.

As for his relationship with stent manufacturers, he says he never accepted gifts or offers from companies, and any personal honoraria were donated to outside charities or foundations. He does not specifically address the now famous “appreciation pig roast” paid for by Abbott held for St Joseph’s cardiac staff in Midei’s backyard.

But he does, with some humility, acknowledge that may not “have been perfect in my practice of medicine; no doctor can make that claim.”

And he concludes: “I can say unequivocally that my decisions as a doctor have been motivated by one thing only: The well-being of my patients.”

As reported by heartwire, two cardiology organizations recently asked the state of Maryland to legislate cath lab oversight in an effort to avoid the tangles unraveling in Baltimore and Pittsburgh; that plan has since been nixed.

Update: 22 July 2011 – Dr. Midei’s medical license has been revoked. (article re-post – Heartwire.com in another report by Shelley Wood).

Dr Mark Midei’s medical license revoked

July 13, 2011            |            Shelley Wood

Baltimore, MD (updated) – The Maryland Medical Board has concluded its review of Dr Mark Midei, deciding to revoke his license, calling his violations of the Medical Practice Act “repeated and serious.”

The disciplinary actions alert published on the board’s website today notes that the board will not accept any application for reinstatement by Midei for at least two years. At that time, it is up to the board whether it will consider reinstatement of his license.

As previously reported by heartwire, Midei is alleged to have implanted hundreds of unneeded stents when he worked at St Joseph Medical Center in Towson, MD. The imbroglio was ultimately taken up by the US Senate Finance Committee, which issued a damning report back in December 2010.

For years, however, watchers have been waiting to hear what the Maryland Board of Physicians concluded, having charged Midei with violating the Medical Practice Act back in July 2010, focusing specifically on five patients it was alleged may have received stents unnecessarily. A subsequent seven-day hearing before an administrative law judge (ALJ) led to her issuing a 77-page “proposed decision” that Midei have his license revoked for having violated five provisions of the act, specifically those prohibiting:

  • Unprofessional conduct in the practice of medicine.
  • Willfully making a false report or record in the practice of medicine.
  • Gross overutilization of health care services.
  • Violations of the standard of quality care.
  • Failure to keep adequate records.

In its “findings of fact,” the board concluded that Midei implanted six cardiac stents unnecessarily in four out of the five cases reviewed and noted in his charts that the extent of the stenosis was 80%, when in fact it was lower “and in most cases much lower.” In three cases he falsely reported that patients had unstable angina, when in fact they didn’t, and in all five patients he failed to obtain the active coagulation time and instead administered heparin while inserting the catheter. In one of the patients, Midei “also failed to look at or disregarded the hospital’s note that the patient had already been given an anticoagulant and should not be given another.”

In June, Midei filed exceptions with the board in an oral hearing, which was considered in advance of today’s announcement. Those included a request by Midei that the board reverse the judge’s opinion on which expert reviewer to believe. The ALJ had used Dr Matthews Chacko (Johns Hopkins Hospital, Baltimore, MD) as expert reviewer, whereas Midei’s primary expert witness was Dr William O’Neill (University of Miami, FL). The board’s “consideration of exceptions” notes that all of the experts were “qualified” but that the ALJ “made her determination based on the consistency of Dr Chacko’s testimony and his clear presentation and demeanor” as well as her consideration of professional publications. By contrast, the ALJ “noted some inconsistencies or equivocations in the testimony” of O’Neill. Also at issue was the fact that Chacko was paid $1400 for his report and expert testimony—something Midei raised as problematic. The board report notes that O’Neill, Midei’s expert, was “paid more than 20 times that much.”

Asked to comment, O’Neill emailed heartwire to say: “I think it’s a tragedy that a fine doctor’s reputation and livelihood are ruined when there was never a single shred of proof that he harmed any patient. I stand by my [previous] comment that after reviewing all the records and films personally, I would have no problem letting Dr Midei treat me or a family member. I pity any interventional cardiologist practicing in Maryland today; if Dr Midei can lose his license, any of them could.”

The board agreed with the ALJ’s conclusions and, “using its own expertise,” agreed that Chacko’s testimony “represents an accurate statement of the standard of quality care.” The board clearly took exception to Midei’s suggestion that he sometimes wrote “80%” as a form of shorthand for blockages that in fact were less than 50%, calling that “a justification for a blatant falsehood that resulted in patients receiving unneeded stents as well as the creation of false records.”

The board also questioned the believability of Midei’s testimony that his decision to stent certain patients was on the basis of “remembered” symptoms not recorded in patients’ medical records. “The ALJ found it not credible that Dr Midei could remember these unrecorded symptoms in the cases of patients who were among thousands that he saw only once, for very brief period of time (from 20 to 37 minutes) three years previously.”

As reported by heartwire, Midei, who is being sued by hundreds of former patients believing they received unnecessary devices, is himself suing his former hospital, St Joseph, alleging in part that he was a scapegoat in “an epic campaign of corporate deception, trickery, and fraud” relating to past business deals and a federal investigation. In his medical-board hearing, Midei was permitted to present evidence to support this claim; the board, ultimately, agreed with the ALJ that “nothing St Joseph Medical Center did or failed to do is relevant to the issues of this case.”

The final decision and order, signed by board chair Dr Paul T Elder, contains a number of scalding conclusions about Midei’s conduct, stating that he failed to deal honestly with patients and colleagues and that his reports intentionally and nonaccidentally “exaggerated” patient symptoms and degree of stenosis.

“Dr Midei’s violations were repeated and serious. They unnecessarily exposed his patients to the risk of harm,” the decisions states. “They increased the cost of the patients’ medical care. Dr Midei’s willful creation of false percentage numbers for the degree of occlusion of coronary arteries is indefensible and amounts to a deliberate and willful fabrication of medical records.”

Requests for a reaction from Midei’s lawyers have not been returned. Midei has 30 days to ask for a judicial review of the decision.

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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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