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Posts Tagged ‘CABG’

For internet searches for medical photography – all of my images are free for your use, but please give proper credit for my work, ie. “Photo by K. Eckland”.  For commercial uses, contact me, (so that I can contact the subjects of my work).

Please note that patient privacy is protected – and patient permission is obtained prior to photographs.  For the most part – I photograph surgeons – not patients, or surgery.

Spent much of the weekend in the operating room with Dr. C. Vasquez, cardiac surgeon at two different facilities, and the differences couldn’t be more apparent – and perhaps not what one might expect.  Much of it comes from perspective; as a person behind the lens, I see the scene differently than others might.

harvesting the radial artery

In fact, this prompted me to write an article on the subject of medical photography, complete with a slide show to illustrate the effects of color on surgical photographs. I’ve also re-posted much of the article here (see below).  Once you see the photos from today, you’ll understand the article.

the beige operating room

The case today went beautifully, with the patient extubated in the operating room.

Dr. Vasquez, and Lupita, scrub nurse

While we were there – had an unexpected surprise! Dr. Gutierrez ‘Lalo’ showed up.  I have been trying to get him into the cardiac OR since he confessed his interest in cardiac surgery.  It was great to see him – and I like encouraging him in his educational goals.   (I kind of miss being a mentor, and preceptor to students..)

Lalo peeks over the curtain..

Dr. Gutierrez (Lalo) in the cardiac OR

Medical Photography

Medical photography is many ways is more art, and luck that skill – at least for people like me who never set out to be medical photographers in the first place.  It was a natural development prompted by dire necessity during the early days of interviewing surgeons and medical writing.  I am still learning, and hopefully improving.

But as I said before, much of it is luck, and timing, particularly in this field, where the subjects are always in motion and a slight movement of the hand tying the suture knot can result in either a breath-taking shot or an utter failure to capture the moment.

The most dramatic and vivid photographs often come at mundane moments, or unexpected situations.  In medical photography, where the subject matter combines with a dramatic interplay of color, light and shadow to illustrate some of life’s most pivotal moments such as birth, death and life-saving operations – it is surprising how important the background elements are.

Here in Mexicali, I have been taking photographs of different surgeons for several weeks at different facilities across the city.  But, almost unanimously, all of the photographs, regardless of subject at Hospital Almater are lackluster and uninspiring.  Contrast this with the glorious photos from the public facilities such as Hospital General de Mexicali, and Issstecali.

The culprit is immediately apparent, and it demonstrates how such carefully planned such as aesthetics and interior design can have unintended consequences.  The very studied, casual beigeness used to communicate upscale living in the more public parts of the hospital are destroying the esthetics of the operating room services they are selling.  Whereas, the older facilities, which have continued the use of traditional colored drapes and materials do not have the problem.

Historically, surgical drapes were green for a very specific reason.  As the complementary color to red, it was believed to be a method of combating eye fatigue for surgeons looking at the red, bloody surgical fields for hours at a time.  Over the years, operating room apparel and drapes evolved away from this soft green to a more vivid blue, know as ‘ceil’.  The reasons for this change are probably more related to manufacturing that medicine, and since that evolution, surgical drapes now come in a variety of colors – hence the color matching here, of the paint, the tile, the patients, the operating room and the surgeons itself.  Somewhere, an interior decorator is filled with gleeful satisfaction – but I can only muster up a groan; knowing I will be here again and that most of my photos will be unusable.

While the consequences of poor medical photographs may seem trivial to anyone but myself (and my interviewees) at this junction – it runs far deeper than that.  With the advent of the internet, and the complicated legalities of getty and other corporate images, small, independent photographers such as myself are gaining wider exposure than ever before.   Alas! – much of it is uncredited, but several of my more popular images are downloaded thousands of times per week, to grace slideshows, powerpoint presentations and other illustrations for discussions of anything from medicine and surgery to travel, technology and even risk assessment.  In an era of branding, and logo recognition, places like Hospital Almater are certainly missing out.

In  other news/ happenings: Upcoming elections!**

Finally found someone to talk to and explain some of the issues in Mexican politics – but he hates Quadri, and doesn’t really explain any of it except to say ‘He’s corrupt..”  (From my understanding, ‘corrupt’ is an understatement, and that all of the parties are corrupt – and it’s pretty well understood by everyone involved – so of course, if I hear something like that – please explain.. explain..)  It’s not like I am capable of voting anyway, but I’d sure like to hear perspectives..

It looks like I’m not the only one who is a little leary of pretty boy pena’s party’s dubious history.  His numbers have fallen in recent polls in advance of tonight’s televised debates.  (Let’s hope these debates are better than the last.)

My personal “favorite”, Quadri is still trailing in the dust, but it looks like Lopez has a chance to take the election from Pena (much like it was ‘taken’ from him in 2006 with his narrow defeat..  Lopez is a socialist which is hard for Americans like me to understand – but then again, it’s not my country, and the levels of inequity here are certainly wider than at home – so maybe someone like Lopez can bring some much needed support to the lower classes.

I mean, a lot of what we take for granted in the USA doesn’t exist here, like a decent free public school education.   (Okay – I know critics will argue about the value of an inner city education – but we still provide a free elementary & secondary school education to all our citizens.)  So socialism for the purpose of providing basic services in all areas of Mexico seems pretty reasonable.  (It would help if I could read some primary source stuff – without using translation software, so I would have a better idea of the specifics of AMLO’s ideas.)

I did ask my friend about the student demonstrations for Yo Soy 132.  I guess as an American growing up after the 1960’s – we tend to not too make much of a big deal over student demonstrators – after all – we have the ‘Occupy’ movements going on right now in our own/ other countries – but he was telling me that this is pretty uncommon in Mexico.

** No, I’m not really into politics but I feel like it’s important to try and understand as much as possible about the places (countries) where I am residing.

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Note:  I owe Dr. Vasquez a much more detailed article – which I am currently writing – but after our intellectually stimulating talk the other day, my mind headed off in it’s own direction..

Had a great sit down lunch and a fascinating talk with Dr. Vasquez.  As per usual – our discussion was lively, (a bit more lively than usual) which really got my gears turning.  Dr. Vasquez is a talented surgeon – but he could be even better with just a little ‘help’.  No – I am not trying to sell him a nurse practitioner – instead I am trying to sell Mexicali, and a comprehensive cardiac surgery program to the communities on both sides of the border..  Mexicali really could be the ‘land of opportunity’ for medical care – if motivated people and corporations got involved.

During lunch, Dr. Vasquez was explaining that there is no real ‘heart hospital’ or cardiac surgery program, per se in Mexicali – he just operates where ever his patients prefer.  In the past that has included Mexicali General, Issstecali (the public hospitals) as well as the tiny but more upscale private facilities such as Hospital Alamater, and Hospital de la Familia..

Not such a big deal if you are a plastic surgeon doing a nip/tuck here and there, or some outpatient procedures – okay even for general surgeons – hernia repairs and such – but less than ideal for a cardiac surgeon – who is less of a ‘lone wolf’ due to the nature and scale of cardiac surgery procedures..

Cardiac surgery differs from other specialties in its reliance on a cohesive, well-trained and experienced group – not one surgeon – but a whole team of people to look out for the patients; Before, During & After surgery..  That team approach [which includes perfusionists, cardiac anesthesiologists (more specialized than regular anesthesia), operating room personnel, cardiology interventionalists and specialty training cardiac surgery intensive care nurses]  is not easily transported from facility to facility.

just a couple members of the cardiac surgery team

That’s just the people involved; it doesn’t even touch on all the specialty equipment; such as the bypass pump itself, echocardiogram equipment, Impella/ IABP (intra-aortic balloon pump), ECMO or other equipment for the critically ill – or even just the infrastructure needed to support a heart team – like a pharmacy division that knows that ‘right now’ in the cardiac OR means five minutes ago, or a blood bank with an adequate stock of platelets, FFP and a wide range of other blood products..

We haven’t even gotten into such things such as a hydrid operating rooms and 24/7 caths labs – all the things you need for urgent/ emergent cases, endovascular interventions – things a city the size of Mexicali should really have..

But all of those things take money – and commitment, and I’m just not sure that the city of Mexicali is ready to commit to supporting Dr. Vasquez (and the 20 – something cases he’s done this year..) It also takes vision..

This is where a company/ corporation could come in and really change things – not just for Dr. Vasquez – and Mexicali – but for California..

It came to me again while I was in the operating room with Dr. Vasquez – watching him do what he does best – which is sometimes when I do what I do best.. (I have some of my best ideas in the operating room – where I tend to be a bit quieter.. More thinking, less talking)..

Dr. Vasquez, doing what he does best..

As I am watching Dr. Vasquez – I starting thinking about all the different cardiac surgery programs I’ve been to: visited, worked in – trained in.. About half of these programs were small – several were tiny, single surgeon programs a lot like his.. (You only need one great surgeon.. It’s all the other niceties that make or break a program..)

All of the American programs had the advantages of all the equipment / specialty trained staff that money could buy***

[I know what you are thinking – “well – but isn’t it all of these ‘niceties’ that make everything cost so darn much?”  No – actually it’s not – which is how the Cardioinfantils, and Santa Fe de Bogotas can still make a profit offering world-class services at Colombian prices…]

The cost of American programs are inflated due to the cost of defensive medicine practices (and lawyers), and the costs of medications/ equipment in the United States****

the possibilities are endless – when I spend quality time in the operating room (thinking!)

Well – there is plenty of money in Calexico, California** and not a hospital in sight – just a one room ‘urgent care center’.  The closest facility is in El Centro, California – and while it boasts a daVinci robot, and a (part-time?) heart surgeon (based out of La Mesa, California – 100 + miles away)– patients usually end up being transferred to San Diego for surgery.

Of course, in addition to all of the distance – there is also all of the expense..  So what’s a hard-working, blue-collar guy from Calexico with severe CAD going to do?  It seems the easiest and most logical thing – would be to walk/ drive/ head across the street to Mexicali.. (If only Kaiser Permanente or Blue Cross California would step up and spearhead this project – we could have the best of both worlds – for residents of both cities.. 

 A fully staffed, well-funded, well-designed, cohesive heart program in ONE medium- sized Mexicali facility – without the exorbitant costs of an American program (from defensive medicine practices, and outlandish American salaries.)  Not only that – but as a side benefit, there are NO drug shortages here..

How many ‘cross-border’ cases would it take to bring a profit to the investors?  I don’t know – but I’m sure once word got out – people would come from all over Southern California and Arizona – as well as Mexicali, other parts of Baja, and even places in Sonora like San Luis – which is closer to Mexicali than Hermasillo..  Then Dr. Vasquez could continue to do what he does so well – operate – but on a larger scale, without worrying about resources, or having to bring a suitcase full of equipment to the OR.

The Mexican – American International Cardiac Health Initiative?

But then – this article isn’t really about the ‘Mexican- American cross-border cardiac health initiative’

It is about a young, kind cardiac surgeon – with a vision of his own.

That vision brought Dr. Vasquez from his home in Guadalajara (the second largest city in Mexico) to one of my favorite places, Mexicali after graduating from the Universidad Autonomica in Guadalajara, and completing much of his training in Mexico (D.F.).  After finishing his training – Dr. Vasquez was more than ready to take on the world – and Mexicali as it’s first full-time cardiac surgeon.

Mexicali’s finest: Dr. Vasquez, (cardiac surgeon) Dr. Campa(anesthesia) and Dr. Ochoa (thoracic surgeon

Since arriving here almost two years ago – that’s exactly what he’s done.. Little by little, and case by case – he has begun building his practice; doing a wide range of cardiovascular procedures including coronary bypass surgery (CABG), valve replacement procedures, repair of the great vessels (aneurysm/ dissections), congenital repairs, and pulmonary thrombolectomies..

Dr. Vasquez, Mexicali’s cardiac surgeon

Dr. Cuauhtemoc Vasquez Jimenez, MD

Cardiac Surgeon

Calle B No. 248 entre Obregon y Reforma

Col. Centro, Mexicali, B. C.

Email: drcvasquez@hotmail.com

Tele: (686) 553 – 4714 (appointments)

Notes:

*The Imperial Valley paper reports that Calexico makes 3 million dollars a day off of Mexicali residents who cross the border to shop.

***In all the programs I visited  – there are a couple of things that we (in the United States do well..  Heart surgery is one of those things..)

**** Yes – they charge us more in Calexico for the same exact equipment made in India and sold everywhere else in the world..

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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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By popular request from several readers – I have re-posted an article summarizing the 2010 Syntax trial results (3 year data in this on-going trial).  This article was originally published at www.theheart.com.  I have also posted the link to a blog discussing these results in context.. Please note the heavily biased language (in favor of stenting) in both of these re-posts. Hard to dismiss the results showing CAGB to be SO much better for patients and longevity, but it seems like several of the cardiologists quoted attempt to do exactly that.

Three-year SYNTAX results extend CABG advantage to intermediate-risk patients

Sep 13, 2010     Shelley Wood

Geneva, Switzerland – Three-year results for the landmark SYNTAX trial are bringing some clarity to a finding just hinted at—then strenuously debated—at the two-year mark: “intermediate-risk” patients with complex coronary disease by SYNTAX score are probably better off getting open-heart surgery than PCI with a Taxus paclitaxel-eluting stent, investigators say. Cumulative event rates also point to ongoing separation of event curves for both MI and even all-cause death, although the latter by no means was statistically significant at three years.

Dr A Pieter Kappetein (Erasmus Medical Center, Rotterdam, the Netherlands), who presented the three-year results at the European Association of Cardiothoracic Surgery 2010 Annual Meeting, called the findings in the intermediate-risk subgroup the “most remarkable” difference to emerge between the two- and three-year mark, although not necessarily surprising. Indeed, Dr Manuel J Antunes (University Hospital, Coimbra, Portugal), who discussed the two-year results after their presentation last year, predicted that between-group differences that were statistically different at year one would remain so and that differences that trended in favor of one group would reach statistical significance in due time.

Dr David Cohen (Saint Luke’s Mid America Heart Institute, Kansas City, MO), commenting on the results for heartwire, said he was not “particularly concerned” by the three-year results, which, he noted, were only marginally different from the two-year results and continue to be driven by a higher revascularization rate in the Taxus/PCI-treated patients. He did single out as “interesting” the “continued gradual separation of the curves for both MI and all-cause mortality” to year three.

“These findings may relate to a variety of factors, including very late stent thrombosis, progression of disease at unstented segments, or the more complete revascularization afforded by initial CABG in these highly complex patients.  Although I suspect that some of these late events might have been avoided with the current generation of drug-eluting stents [DES], which are safer than the paclitaxel-eluting stents used in SYNTAX, bypass surgery continues to set a very high standard for our patients.”

The SYNTAX trial
As previously reported by heartwire, SYNTAX was an 1800-patient trial randomizing patients with left main coronary disease and/or three-vessel disease to either CABG or PCI using the Taxus DES. At one year, PCI failed to meet the prespecified margin of noninferiority against CABG, after the primary end point (major adverse cardiac and cerebral events [MACCE]) occurred significantly more often among PCI-treated patients than among CABG-treated patients, driven by repeat procedures in the PCI group. For the “harder” end point of death/stroke/MI, rates were almost identical between the two groups; the stroke rate was higher in the CABG-treated patients. Two-year results, presented at last year’s European Society of Cardiologymeeting, showed MACCE rates continuing to diverge, still driven by higher repeat-revascularization rates and a signal of increased MI among PCI-treated patients.-SW

At three years, 95% of the original cohort of 1800 patients was available for follow-up. Rates of the primary end point, 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 end point of all-cause death, stroke, and MI out to three years, there were no differences between groups.

Stroke, which at one year had significantly favored the DES-treated patients, was no different between the two groups by three years and nearly identical between years one and two and between two and three. MI rates, which had numerically favored the CABG-treated patients at one year and had reached statistical significance by the two-year mark, continued to be significantly lower in CABG group from year two to three and cumulatively were significantly lower in the CABG-treated patients over three years, with an absolute difference of 3.5%.

Cumulative event rates to three years

Cumulative event rate CABG (%) Taxus (%) p
MACCE 20.2 28.0 < 0.001
Death, stroke, MI 12.0 14.1 0.21
All-cause death 6.7 8.6 0.13
Stroke 3.4 2.0 0.07*
MI 3.6 7.1 0.002
Repeat revascularization 10.7 19.7 < 0.001
*Stroke rate between one and two years 0.6% vs 0.7% and between two and three years 0.5% vs 0.6%

For the analysis of outcomes according to baseline SYNTAX score—developed to characterize complex coronary vasculature in patients with high-risk left main and/or three-vessel disease—Kappetein reminded heartwire that at both one and two years, the lowest-risk patients by SYNTAX score (score of 0-22) had MACCE rates that were very similar for both CABG- and DES-treated patients. By contrast, in patients with the highest SYNTAX scores (>33), reflecting the most complex disease, the SYNTAX trial clearly showed that CABG was the best option. As such, surgeons and interventionalists have largely been in agreement that PCI is a reasonable option for the lowest-risk group, while surgery is the clear winner for the highest-risk patients.

In intermediate-risk patients (23-32), the two-year results showed a trend toward improved outcomes with CABG, but no statistically significant differences, leading some to argue that PCI could still be considered for patients with an intermediate SYNTAX score—particularly if they had left main disease, but not triple-vessel disease. The three-year MACCE results in these intermediate-risk patients, however, show that the event curves have continued to separate, reaching 27.4% for DES-treated patients and 18.9% for the CABG-treated patients, a difference that now reaches statistical significance (p=0.02).

What’s clear from these three-year results, Kappetein told heartwire, is that it is only the lowest-risk patients by SYNTAX score in whom both PCI and CABG can be considered to be reasonable options.

What MI type?

According to Kappetein, the increased MACCE rate in the intermediate-risk group was driven by repeat-revascularization procedures, but also by the uptick in MIs among PCI-treated patients. But he acknowledged that it is not yet clear what kinds of MIs are driving this difference. Of note, rates of stent thrombosis (4.5%) among PCI-treated patients at three years were not statistically different from the rates of symptomatic graft occlusion (3.5%), hinting that the MIs being counted were not being caused solely by late stent thrombosis.

Asked if the bulk of these MIs were periprocedural “enzyme leaks,” Kappetein said: “We don’t know that yet, but we need to look deeper into that.”

Cohen, for his part, stressed that the “enduring lesson” from SYNTAX is that revascularization for chronic, complex coronary disease needs to be individualized to coronary anatomy, comorbidities, and patient preferences.

“The real value of SYNTAX continues to be in helping to provide high-quality, objective information to inform these complex decisions,” he commented. “I do think that is an important yet often-unappreciated aspect of SYNTAX. We often focus too much on ‘winners’ and ‘losers.’ The real winner here is the patient.”

Cohen has received grants for clinical research from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Eli Lilly, Daiichi Sankyo, and Medtronic; has served as an advisor or consultant for Eli Lilly, Medtronic, Cordis, Schering-Plough, and Merck; and served as a speaker or a member of a speakers’ bureau for Eli Lilly and the Medicines Company. Kappetein disclosed having no conflicts of interest.

 

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The newest study (meta-analysis) on the use of clopidogrel for ACS (acute coronary syndrome) gives dramatically different results that previously published studies, and years of clinical experience.  This study, (abstract lifted from cardiosource and re-posted below) attributes adverse events and increased mortality in the patients receiving clopidogrel to underlying cardiac status.  In this patient population – that could certainly be true.

However, when a meta-analysis comes up with results that our dramatically different from the previous studies it’s using for its composite – then it’s time to take a closer look at the data they used to compile their conclusions..

Without further access to the rest of the study (abstract published ahead of article publication), we will just have to wait..

But in the meantime, I’d still recommend judicious/ cautious clopidogrel use prior to the operating room.  Ten years of clinical reports and multiple studies showing increased bleeding/ bleeding complications/ MACE can’t be undone by one statistical analysis.. (At least until methodology is examined.)

Also the phrasing of the study is pretty precarious – I’ve italicized some of the results – where the authors skirt around the results to try and prove the hypothesis that they want.. Re-operation is increased in patients receiving clopidogrel BUT.. it’s increased in all patients receiving clopidogrel, not just ACS patients..  [That’s kind of a thready conclusion, in my humble opinion..]

Readers, what do you think?

Abstract:  Safety of Clopidogrel Being Continued Until the Time of Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome: A Meta-Analysis of 34 Studies

        Authors:   Nijjer SS, Watson G, Athanasiou T, Malik IS

        Citation:

        Safety of Clopidogrel Being Continued Until the Time of Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome: A Meta-Analysis of 34 Studies
        June 2, 2011
        Nijjer SS, Watson G, Athanasiou T, Malik IS.
Eur Heart J 2011;May 24:[Epub ahead of print].
 
Study Question:
      What is the risk of mortality, reoperation, perioperative myocardial infarction (MI), and stroke in the acute coronary syndrome (ACS) population undergoing coronary artery bypass grafting (CABG) while on clopidogrel?

        Methods:

Thirty-four studies with 22,584 patients undergoing CABG were assessed. Patients with recent clopidogrel exposure (CL) were compared with those without recent clopidogrel (NC). Uni- and multivariate meta-regression was performed for the main outcomes of mortality, reoperation, postoperative MI, and stroke using the logarithm of the odds ratio (OR) as the dependent variable. Interaction analysis was performed creating interaction terms between the variable ACS status and the following variables: year of study, the use of on-pump surgery, patient urgency status, and use of concomitant antiplatelet agents, including aspirin and glycoprotein IIb/IIIa antagonists.

        Results:

Although mortality is increased in CL versus NC (OR, 1.6; 95% confidence interval [CI], 1.30-1.96; p < 0.00001), it is influenced by the ACS status and case urgency in these mainly nonrandomized studies. In ACS patients, there is no significant difference in mortality (OR, 1.44; 95% CI, 0.97-2.1; p = 0.07) or in postoperative MI (OR, 0.57; 95% CI, 0.31-1.07; p = 0.08) and stroke rates (OR, 1.23; 95% CI, 0.66-2.29; p = 0.52). Combined major adverse cardiovascular events (MACE) (stroke, MI, and death) were not different in the two groups (OR, 1.10; 95% CI, 0.87-1.41; p = 0.43). Reoperation rates are elevated on clopidogrelbut have reduced over time, and were specifically not different in ACS patients (OR, 1.5; 95% CI, 0.88-2.54; p = 0.13).

        Conclusions:

The authors concluded that ACS patients requiring urgent CABG proceed with surgery without delay for a clopidogrel-free period.

        Perspective:

This meta-analysis suggests that continuing dual antiplatelet therapy until the day of CABG reduces the risk of recurrent ischemic events in ACS patients and reduces MI postoperatively. While mortality and reoperation rates are increased after recent clopidogrel exposure, event rates were still low and overall MACE rates did not appear to be significantly increased in the clopidogrel group. These data demonstrate the need for a randomized clinical trial assessing different discontinuation times prior to CABG to definitively answer the question. Meanwhile, the evidence appears to suggest that many ACS patients can undergo CABG safely with recent clopidogrel exposure in expert hands.

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Today’s headline is a bit like alphabet soup for readers, but don’t worry, we’ll sort it all out for all of you.

PCI – percutaneous intervention (stenting)

CABG – coronary artery bypass surgery “bypass surgery”

ACS – acute coronary syndrome – acute ischemia, if untreated leads to acute myocardial infarction (AMI) also known as a heart attack.

Now that we have that all sorted out, we will continue our discussion on the latest Medscape article by Megan Brooks – which is re-posted below.

Generally, when a person is found to have significant coronary artery disease (CAD) or blockages, the decision whether to stent, treat with medicines or surgery is made based on several criteria including the amount of blockages, the number of places with blockages and the location of blockages.

For many years, doctors (cardiologists and surgeons) followed a few general guidelines when determining whether a patient should have stents or surgery.  Surgery was generally indicated in the following cases (provided the patient could tolerate surgery):

1. Multi-vessel disease (blockages in more than one artery)

2. Left main disease (because anatomically the left main serves two arteries – making it multiple vessel disease).  Left main disease was also considered a specific entity because of the consequences – patients rarely survive an infarction caused by the left main, which is how it received it’s nickname, ‘the widowmaker’.

(There are some other guidelines, and quite a bit more goes into the decision-making process but we will just talk about these two for now.)

Left main disease is particularly deadly for this reason, because in many people, they are asymptomatic (without chest pain or other physical symptoms) until the left main artery becomes very, very narrowed.  This disease pattern (or pattern of blockages also runs in families, and is sometimes seen in younger people (forties). Due to the importance of this vessel for survival, and due to the known durability of bypass surgery – this patients were usually sent automatically for a surgical referral.  These are also the patients that sometimes skipped right ahead to surgery – particularly if they came into the hospital with chest pain/ and had chest pain in the cath lab. (The ACS portion of the title)

But as stenting grew in popularity, not just with cardiologists but with patients (medicine is market-driven, just like cars or anything else) cardiologists began placing more and more stents in more and more people for disease that had traditionally been treated with surgery.  (Every time you seen an article about decrease in bypass surgery rates – think more stents – people don’t have less disease, they are just having less surgery to treat it.)

People began receiving four, five even six stents at a time, in multiple vessels.. Then cardiologists started stenting the left main..  All of this was done under the guise of “it’s what the patients want” which is a pretty important point to consider.  Now, in the five plus years I’ve been doing this, I’ve never, ever had a patient in the cath lab, or in the office come to me, or the surgeons I’ve worked for and say, “Hey – I’d like to have heart surgery.”  But we managed to stay pretty busy all the same – because it’s not about if the patient wants surgery – that’s using semantics..

But if I were to ask those same patients, “Do you want a proven therapy for your disease with good 20 year outcomes?”  then we get a very different answer, and surgery becomes a necessary evil – to get to that twenty years – to the children’s graduation, fiftieth anniversary and all of those other milestones of life.

Now researchers are looking at the data behind PCI for left main and comparing it to CABG.  That always tends to be fraught with danger because it seems that so many times, these trials are bought and paid for by drug companies – the ones that make the devices, and the drugs used in the cath lab..  So often when looking at the methodology for studies comparing surgery to stents – the researchers are actually comparing apples to oranges.

The other big error that a lot of these studies do – is ignore the long-term data.  They usually stop looking after six months or a year.  We know that stents can usually last a year if patients take their medication (clopidogrel, statins, aspirin, etc.) and we also know that surgery is proven to last twenty years or more.. But, invariably, the researchers stop the trials, and stop looking so we don’t see how all those patients with left main stents, or five stents fared even five years later.  Did they need more stents?  Did they have a heart attack?  Did they die? 

This image from the Texas Heart Institute to illustrate our discussion:

Coronary anatomy

I’ve added my own comments in [brackets and italics].

PCI for left main CAD and ACS linked to more adverse events

By Megan Brooks

NEW YORK (Reuters Health) May 16 – In patients with left main coronary artery disease (CAD) and acute coronary syndrome (ACS), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) carry similar risks of death and re-infarction, new research from Italy shows.

However, PCI carries a significantly higher risk of major adverse cardiac events, driven by more frequent repeat revascularizations, the researchers found. [this means the patient had to come back and get another stent – or ended up having surgery later].

“Similarly to non-ACS presentations, PCI patients experience a higher risk of re-intervention, perhaps inflated by a more liberal use of follow-up angiography compared to CABG,” said co-author Dr. Davide Capodanno from Ferrarotto Hospital in Catania, in e-mail to Reuters Health.

The best way to manage patients with left main CAD and ACS remains uncertain, he and his colleagues said in a May 5 online paper in the American Journal of Cardiology.

Using registry data, the researchers analyzed one-year outcomes of patients with left main CAD and ACS who were treated with PCI and drug-eluting stents (n = 222) or CABG (n = 361), since 2002.  [another one year study].

They found that the rate of major adverse cardiac events was significantly higher in the PCI group than the CABG group (14.4% vs 5.3%; P < 0.001).  [Note that this is almost three times higher – or 1 in 6].

The difference was driven by a higher rate of target lesion revascularization with PCI (8.1% vs 1.7%; P = 0.001). This difference persisted after statistical adjustment for major adverse cardiac events (adjusted hazard ratio 2.7) and target lesion revascularization (adjusted hazard ratio 8.0).

Follow-up angiography was significantly associated with higher odds of major adverse cardiac events and target lesion revascularization at one year (P < 0.001 for both). There were no statistically significant differences in rates of death (6.3% for PCI vs 3.6% for CABG) or myocardial infarction (1.8% vs 0.6%). [not statistically significant but  PCI carries double the rate of CABG patients].

The diagnosis – either ST-segment elevation myocardial infarction (STEMI), or unstable angina/non-STEMI – was not correlated with treatment, a finding the authors say is noteworthy.

It seems from our data that the clinical scenario in which a left main stenosis is detected does not significantly interact with the type of revascularization offered to the patient,” Dr. Capodanno told Reuters Health.

“Decision making might not necessarily rely on whether the patients present with an ACS or not,” he said. “This is consistent with the notion that score algorithms — such as the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score – have been proven to work well in stable angina patients as well as in those with an ACS,” he noted. [actually multiple studies showed the ‘Syntax score’ was a poorly validated tool, and essentially useless, which is why it was revised multiple times.]

The findings could mean that guidelines for using scores to aid decision-making in left main disease “may also theoretically apply to ACS patients,” he said. “However, the impact of other clinical variables could be not negligible. Therefore, careful patient selection on a case-by-case basis is necessary.”

The observational nature of a registry study is the most important limitation of the current analysis, he and his colleagues note in their report, adding that “only randomization can provide an unbiased estimation of effects of a treatment.”

In addition, because the “presumptive benefit of CABG is likely to increase over time, longer follow-up would add meaningfully to the present report.”

Additional references:

In an unrelated report – on the use of NSAIDS following myocardial infarction. : NSAIDs (acetaminophen, ibuprofen, as well as COX-2 inhibitors) unsafe after heart attack. I don’t usually write posts on pharmacology (with the exception of clopidogrel) because I usually leave that to my co-writer, Dr. Albert Klein (PharmD), a clinical pharmacist.  But in this instance, I think it is an important reminder to readers – that even over-the-counter medications can prove harmful.

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There are plenty of reasons to consider medical tourism, and it’s not all about money.  While financial considerations may be the driving force today – I expect that to change over the next ten years as the developing surgeon shortage becomes more acute.  American surgeons are becoming older – and we aren’t attracting, training or replacing enough of them to keep up with demand.. Right now the shortage isn’t noticeable… or Is it?

A new article on Medscape (free subscription required, but multiple pages, and difficult to re-post) from the Annals of Surgery discusses increasing wait times for cancer surgery..

The surgeon shortage is expected to impact all specialties, but particularly cardiothoracic surgery where differing experts predict a 2,000 surgeon shortage by either 2020 (9 years!) or 2030, just as they estimate demand will double.  Currently, there are only about 4,500 cardiothoracic surgeons, if that gives you an idea of the scope of the problem.. Right now, the average age of these surgeons is 56 – 57 years old – and training programs are only at 65 – 67% occupancy..

(I can post references if anyone would like for these statistics.)

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