Exhibit K: Buried!!

I consider myself fairly well-rounded.  I think most people I know would say so, too.

But, when I was digging out this past weekend from a nice solid snowstorm, and saw the cars heaped in snow, it made me think about the Pancreas.

(Maybe I am not as well rounded as a I thought- but at least I am open-minded.)

Yes, the Pancreas.  A Pancreas overwhelmed by many years of a toxic stew of hyperglycemia, insulin resistance, genetics, and the lack of the byproducts of effective lifestyle modification of diet, exercise, and weight control.

To zone in further on that point, I saw a representative patient in the office last week that illustrates this, and shows the degree of glycemic improvement in the perioperative time frame (1 week post op) that a Gastric Bypass can afford.

I bring you Exhibit K.

Demographics:  43 y/o M

Start Weight:  355#  BMI:  53

Date of Surgery:  12/13  Gastric Bypass

DM 2 Hx:  When he initially presented for Bariatric Surgery, he was taking 100 units of U500 insulin, spread throughout the day, the equivalent of 500 units of insulin per day.  His control was poor with a glycohemoglobin of >10, and the duration of his DM (more than 10 years) was evidenced by his C-Peptide of 1.8 (looking for 3 or higher, see previous blog posts for more info).  He had a history of many previous weight loss attempts, and short-lived successes, and was now looking for a more durable intervention for both his weight and his DM 2.

Further medical issues were HTN, Hyperlipidemia, OSA, and Depression.

Current DM 2 Hx:  Seen at his most recent visit, his weight is now down to 302#, and his DM coverage has been modified significantly.  In the hospital, we got by with a moderate to aggressive scale of Novolog, and with surprisingly reasonable control, he was DC with no DM meds, but with instructions to check at home to see where his sugars settled out,  with the addition of diet and activity.  His readings were in the 160s to 200 range and seemed to persist in that range. He was instructed to follow up with his PCP sooner than his appointed visit for 6 weeks from the time of his visit with us.

Take Home Point: Are you expecting Rah Rah Sis Boom Bah?  There is certainly room for a little of that, but what is more interesting to me is that I am very surprised he has done as well as he has so far.  This is a guy that has very limited pancreatic reserve, with markedly diminished insulin-producing capability, owing to the above factors, and now he is fairly well controlled off of meds / insulin.

I somewhat don't believe it, again not from a chest-thumping point of view, but from a medical / physiologic, experiential point of view.

And, this is why I had him see his PCP sooner, in order to facilitate closer followup, and likely re-initiation of meds, albeit dramatically reduced requirements, to see where he declares himself for the short and longer term.

Our experience with BG management after surgery is that the majority of the beneficial metabolic effect from surgery, and improved glucose autoregulation, is seen within the first 24-36 hrs after surgery.  The weight loss that follows does reinforce that effect somewhat, but the biggest change occurs perioperatively and not later if a patient gets to a magical weight or BMI.

I should also say that the effect you see perioperatively is somewhat variable, dependent upon the severity of the Diabetes, and does not always allow a patient to be off all meds immediately and stay off them permanently.  For example, we had 2 patients earlier this week that were able to cut their basal requirements by 60% right after surgery, but did require that amount when they went home.

Long term, weight loss (both amount loss and amount kept off) seems to play a role in recurrence rates for DM, but a lesser role that you might think.  Again, this plays into the dramatic immediate effect that surgery exacts metabolically.

This patient may also be the kind of guy that, irrespective of his degree weight loss /maintained weight loss, may end up with a higher likelihood of a recurrence of diabetic manifestations a few years down the road.  Again, because he came to surgery at a stage of partial pancreatic failure as part of his preexistent DM process.  Most studies do seem to show this return of DM feature in some patients, but they also point out that the disease at that point is generally easier to manage than it was before the metabolic surgery, if / when it returns.

So, we will see how it goes, but so far so good, and quite impressive at that.

The true take home point?  Maybe you've heard this before... Sooner is better, sooner is better.

The Easy Way!

Our patients will often tell me that one of the most annoyingly common things they hear as they visually shrink and morph back to a normal body weight, once they reveal their method of success is:

"Oh, no wonder! That's the easy way out!"

And, I too,  commonly hear, when I describe to someone 'what I do' (after sorting out Bariatrics from Geriatrics), is:

"Really?  Surgery for (overweight) people?  If they could only stick to a proper diet and exercise, they wouldn't need surgery.  That's the easy way out!"

Similar groups of people giving their sage opinions, widely held at that, with the same judgmental tone.  Not that it's unexpected, but it just gets old. 

They just don't know that they don't know.

As patients accurately portray it, from the initial decision to have surgery for their weight problem, to the exhaustive preoperative work up and weight loss, Psychological eval, and the myriad of diagnostic studies; to the day of general anesthesia for their operation; to the recovery and regular follow up required; and the ongoing daily decisions of modified behaviors to their diet and exercise and their overall life choices (with everyone watching and ready to give their advice without solicitation)..... 

               This Ain't Easy.

And that's just the start of it.  'Rising above' is mandatory for patients to get to their goals and for them to reach their individual benchmarks of success.  But I see it every day in the office, on our patient's faces, that it's worth it.

There will always be more than enough takers out there to impulsively and mindlessly volunteer to take you down and let you know what's what, as far as they see it.

After all they have dieted and had some degree of success, and if you would just eat this way... and do this exercise... and follow this book....  and take this supplement... You get the picture.

To this end, I have provided a copy of a recent article from ObesityHelp.com from a Bariatric Surgeon that has heard the "Easy" verbiage a bit too much as well, and his take on the well-worn phrase is an interesting one indeed. 

Surgery is NOT the Easy Way Out: A Bariatric Surgeon’s Perspective

July 11, 2013

Surgery is NOT the Easy Way Out!

by Matt Metz, MD, FACS

I was at a social function earlier this week and a woman asked me what I do for a living.

“I’m a bariatric surgeon,” I replied.

To which she said, “What do you think about that?  You know, people just taking the easy way out and having surgery for their weight.”

Whenever I tell people what I do for a living, the issues of self-control, discipline, and exercise come up.  I have people judge me as an enabler, and judge all of my patients as weak-willed.  Sometimes, it can be so frustrating that I don’t want to disclose any information about my career.  Then I think about my patients. My patients are hard-working, caring, sensitive, intelligent individuals that are battling a disease.

Should I ask people at parties to tell me from what diseases their grandparents or parents died?

“Your mother had lung cancer?  She shouldn’t have worked in that factory.  Your father had a heart attack?  He should have checked his cholesterol.  Your sister died of breast cancer? She should have gotten screened earlier. “

People that label bariatric surgery as the easy way out just don’t understand the disease process.   My patients have each tried dozens of diets. They have lost hundreds of pounds through aggressive medical weight loss programs, only to gain all the weight back and then some.  It’s not just a simple issue of discipline and a diet.  Obesity is a disease, just like cancer, diabetes, heart disease, and stroke.  Those diseases don’t go away with discipline and diet either!  Our ownAmerican Medical Association officially declared obesity as a disease earlier this year.

Obesity has genetic components, well documented in the medical literature.  There are socio-economic factors involved.  Many of our patients have an abuse history, and sub-consciously shroud themselves from unwanted physical attention through their weight; hence, obesity has a psychological component.  There are numerous metabolic issues at play, such as diabetes, hypo-thyroid issues, poly-cystic ovarian syndrome, and leptin insensitivity.

Now consider the thought process involved in undergoing surgery.  Patients need to admit to themselves and their families that they have a disease that is so profound that they need to see a doctor to treat it.  Then they have to see a mental health provider, to evaluate them for untreated mental illness and coping skills.  Next they have to see a dietitian, and may need to undergo 6 months of medically supervised weight loss, depending on their insurance.  Then they have to have a major surgical procedure.  Granted, it’s typically performed laparoscopically, but they still need to undergo general anesthesia, and have someone operate on them in order to help fight this disease.  They may incur significant expense, loss of time from work, and/or time away from school.  Finally, they have to take vitamins for the rest of their lives, and they have to follow up with a mean surgeon (me) forever!

Does that sound like the easy way out?  How do I explain to a woman at a party that, without surgical intervention, only 30% of my patients would live to see their 65th birthday?  How do I explain the humiliation involved in asking for a seat belt extender on an airplane?  To not be able to go to a movie, or an amusement park.  To have to have a family member do your toilet care because you simply cannot reach?  To not be able to run after your child when he or she is in danger? To have people judge you as lazy and slovenly before even shaking your hand?  To be discriminated against when applying for a job, just because of the way you look?

Obese people are the last population that folks think of as socially acceptable to ridicule.  Yet, over 30% of Americans are considered overweight.  While I’m thrilled that the AMA has declared obesity a disease, how long until the rest of society recognizes that ruling and stops discriminating?

To my patients:  I will continue to fight on your behalf. Your bravery, your willingness to take control of your health care, and your dedication to a constant battle makes me proud to be your doctor.  Keep up your efforts, and let’s work together!

Matthew Metz, MD, FACS is a the Medical Director of Bariatric & Aesthetic Surgery Associates and a  Board-Certified, Fellowship Trained, Bariatric Surgeon.  Additionally, Dr. Metz has been certified as a Bariatric Surgery Center of Excellence Surgeon by the American Society for Metabolic and Bariatric Surgeons.  In this capacity, Dr. Metz has completed specialized training and continuing education in bariatric surgery as well as performed a high number of surgeries each year.  Dr. Metz has also been named a Fellow of the American College of Surgeons.  He led Parker Adventist Hospital to achieve the designation as a Bariatric Surgery Center of Excellence (BSCOE).

Newly Studied Predictors of Diabetes Remission at 1 year Post Surgery

Seems like I am getting off easy these days with my Blog.

Maybe you are, too.

I continue to see this Blog as a place for those of you in Primary Care to get the latest updates, as well and some of the timeless facts and experiences of a Bariatric Surgery practice in Real-Time format.

If I am the messenger, so be it.  If the message comes directly from an authority or an article that I can summarize, even better.

Today, I found for you a 4 minute video presentation from a Doctor Philip Schauer, a noted expert Metabolic researcher and Bariatric Surgeon for the Cleveland Clinic.

He was filmed at the recent Obesity Week session that I described earlier in this blog, and he highlighted a just-released study that reinforces other studies out there with similarly big implications.

He reviewed a study from China that integrated remission of type 2 Diabetes at one year after Gastric Bypass, with preop C Peptide, Glycohemoglobin levels, and BMI of the patient.  As you may remember, age of the patient,  duration of Diabetes, and even types of therapy at the time of surgery have also been reviewed, with similar suggestion that residual beta-cell function is where the crux of the issue lies, but those may be of lesser importance.

Furthermore, he comments on additional areas of related impact in the way of when surgery should be performed on these patients (Spoiler Alert: EARLIER is better), and the potential role for Diabetes treatment via metabolic surgery in the sub BMI 35 crowd.

Good stuff.  Arm yourself with this updated information, it will be 4 minutes well spent.

I know you will be able to use it soon!

The Pledge

The Pledge.  Not THE Pledge, but The Pledge to treat Obesity seriously.

This was from a CME activity from the recent Obesity Week conference,  a place where the surgical (ASMBS) met the medical (the Obesity Society) at a recent, first-of-it's kind event.

I suspect you wouldn't be reading this Blog if you didn't take it seriously already, so I am kind of preaching to the choir, but I still thought this was worth putting up today as a gut-check as my Blog post of the week.

Marginal Ulcers: "Aren't Tylenol and Advil the Same Thing?"

Photo of Intraoperative Photo by M Clock

As you may see a recurrent theme in your practice from time to time, we do as well in Bariatric Surgery.  We've had a run on perforated Marginal Ulcers lately.  Three cases in the last few weeks to be exact.

I remember my days of Primary Care, and seeing what seemed like a cluster of Bell's Palsy, or Shingles, or DVT's -  things that you do see from time to time, but over a short interval, interacting with it more frequently than you would ordinarily expect to, given the relative scarcity of it as a common presentation averaged out over the longer haul of regular practice.

Marginal ulcers are not that infrequently seen, but perforated marginal ulcers are certainly less frequently encountered, but the natural end to a smoldering presentation of the former, a logical possible endpoint complicating the run-of-the-mill ulcer or pouch gastritits.

Marginal ulcers are frequently seen in the post Gastric Bypass population, and represent an ulcer of the gastric pouch or more commonly just distal to the gastro-jejunal anastamosis, in the Roux limb (the jejunal limb that connects to the gastric pouch).  The most common presentation is ongoing epigastric abdominal pain, similar to what you may expect for how PUD would present.

The most common risk factors are NSAIDs smoking, and occasionally environmental stressors.

Our patients are repetitively advised to avoid all NSAIDs post op, as they can easily induce an ulcer to form, or rapidly encourage one to go on to perforate, resulting in a trip to the OR for an urgent diagnostic laparoscopy and some form of ulcer repair. We either do a primary closure of the ulcer / perforation, and/or likely a Graham Patch of the area to add further reinforcement to the inflamed and edematous area that perforated.

Often times, when we question patients that either have an ulcer or a perforation, they may admit to getting back to their smoking habit, or (sometimes unknowingly) taking NSAIDs, and that usually cinches the diagnosis, and gets us started with a treatment of Carafate and high-dose BID PPIs.  An EGD may be performed shortly thereafter, if they clinically do not respond as we would expect within a week or two.

I have had patients tell us that they thought Tylenol was the same as the Alleve they have been taking, because they knew that Aspirin and Advil were off limits.  Or patients say that their Orthopedic doctor put them on a 2 week course of a "pain medicine" (an NSAID) even though the patient told them that they had a Gastric Bypass, but they were reassured that it would be OK.

We had a fairly typical recent case of an out-of-towner who had a Bypass at a hospital in Ohio a couple of years earlier and had 8-12 hours of intense epigastric abdominal pain, went to the ER and was found to have free air, and some CT scan findings implicating the G-J region as causative, suspected to be from a perforated MU (Marginal Ulcer).

The picture above is what we saw upon laparoscopy - a classic look at what was expected with a freshly perforated Marginal Ulcer.

The next photo is the start of the primary closure of the ulcer, with stitches placed above and below the ulcer...

Photo of Intraoperative Photo by M Clock

...Which then are tied, leaving their long tails, so as to add some intrabdominal omental fat to be then sewn / tied on top of the primarily closed ulceratous crater, further sealing it, completing the Graham Patch procedure.

Photo of Intraoperative Photo by M Clock

The result is a primary closure, and then a reinforced sealing of the previous site of the ulcer surgically.  Drains were then placed in the upper abdomen, and copious irrigation was performed as to lessen the chemical and inflammatory peritonitis that rapidly ensued when the perforation occurred.

Oh, and her risk factors? Ongoing Alleve for the past few weeks for a musculoskeletal complaint, and resumption of her smoking that she had quit before she had surgery.  

As is often said - "Common things are Common", but it seems that lately, so are somewhat uncommon things, too!

Adolescent Bariatric Surgery: Where Kids Are More Like Adults

Photo by M Clock

When I look each week to do a blog post on a topic of interest from my current Bariatric Surgery experience, there is usually an issue or an idea that stands out and presents itself throughout the course of the preceeding week or so, and this week is no exception.

Adolescent Bariatric surgery has been in the news, my emails, and on TV all week since a study published this past week in JAMA Pediatrics.  The ASMBS  recently commented in the issue as well, and Medscape Surgery also acutely chimed in.

This JAMA Peds study was a nice foray into the highly controversial subject of adolescent weight loss surgery.  To be honest, I expect there to be a good many Providers who are still not in favor of adults having surgery for obesity, and for those, this topic will likely put them over the proverbial edge.

This highly charged debate stems from many factors, and I really do get it. (We don't do anyone less than 18 years old at our center, and have no plans to do so.)  

Although, to be honest, I am not sure I honestly have a personal stance on the issue, just that it comes up every now and then, and now this hightened increase in publicity has it again at the forefront.  

This is what I can already hear from those concerned about the issue in the health care field...

Why surgery for a "child" with a "behaviorally-induced" malady?  Why not try intensive behavior modification and stick with it instead of surgery?  Can an adolescent really comprehend the nature of their disease, its severity, or the imperative nature of doing something (NOW) to improve their condition?  Aren't there significant psychological and social aspects of morbid obesity in this age group that may not lend itself well to the 'forced' behavior modification that surgery results in?  Is the current disease state of even severe morbid obesity in this age group worth the risk of having surgery for the potential short and  long term benefit?  (These are a few questions that come to my mind as well...)

So, that now that it's out in the open, this study did a go a distance toward addressing some of those questions with it's demographic intake data, and the resultant safety as plotted from its 242 operative cases that were reviewed.  The study was limited to basically perioperative safety and outcomes in its studied adolescent weight loss surgery group.

With the benefit of intake demographic and anthropometric data, one aspect that we wonder about was accurately characterized: Just how sick are these kids?

Of the 242 studied, ranging in age from 13-19 (median age of 17.1), the rate of baseline comorbidites was in fact very similar to a preoperative adult cohort that has been studied many times in the past.  The average BMI was 50.5.

How is this for a hit list?

   *Dyslipidemia     74%   

   *OSA                  57%

   *Joint Pain           46%

   *HTN                  45%

   *Back Pain          45%

   *NASH               37%

   *PCOS                21%

   *Renal Disease    19%

   *DM 2                 14%

Furthermore, this intake data went further to shed light on this population of adolescents that was, on average, 2 fold heavier than ideal weight, in terms of cardiovascular risk factors that we more typically take note of in the adult population.

Nationally representative data demonstrates prevalence rates of HTN, high LDL, and low HDL at 3%, 8%, and 3% respectively in more normal-weighted adolescents.  In this group the numbers were 45%, 9%, and 64% respectively.  

An additional concerning factor was the measurement of C-Reactive Protein, which was abnormally elevated in more than 3/4 of those studied in the surgery group, again showing evidence of systemic inflammation, and all the malady that brings with it.

So, yes, these kids are sick, and even though adolescents are resilient, and usually show a lot of reserve, there is a limit to that physiologic fact of life, and this demonstrates that threshold can be overwhelmed.

And now to safety.  Comparative data for both the adolescents studied and what would be expected in a average adult population of weight loss surgery patients was very similar.  

A study cited by the study from JAMA showed a group of adults who had either Bypass or Sleeve Gastrectomy as experiencing a 30 day complication rate of 27% and 14% respectively.  For the adolescent group, the same surgeries had combined major / minor complication rates of 26% and 16% accordingly.  Essentially the same numbers, as far as safety goes.

So, what is the next logical part of the equation for this issue, an aspect that wasn't a component of this study (yet)?

Yes, the next logical question that will need to be answered is, "So, how did they make out as far as their weight loss and comorbidites?"

The authors write about that portion as to be published later.  But, if you are like me, you need this question answered to clarify a key component (efficacy) of this possible treatment for adolescent super morbid obesity. 

However, so far, maybe so good.  

And for better or for worse, factor this in.  There appears to be no free pass when it comes to the absolutes of some aspects of health and disease.  These kids appear to be more like their adult counterparts than not.

Going against them further is the fact that they have a (hopefully) long road ahead of them jus to get to realize the joys of "true" aging.  Another downside of our accelerated "microwave society"?

Robotic Bariatric Surgery?

From Healthwellnesscolorado.com

Robotic bariatric surgery?

Technically "Robot-Assisted Laparoscopic Bariatric Surgery".

Is it just a trend?  Is there any benefit to this method vs. traditional laparoscopic bariatric surgeries?  Is it available in my area?

I looked into those very questions, as we provide access to Robotic surgery for Bypasses and Sleeves. We don't now perform our surgeries exclusively with the Robot, but patients can generally have their surgery performed that way if they want to.  Our experience is overall quite favorable, in terms of post op pain, length of stay, complications, etc.

We are closing in on our 100th case done this way, but I found an article that was helpful to compare the experiences of another established practice that reviewed the results of their first 100 Robotic-Assisted Gastric Bypass cases, contrasting them with a similar group of 100 patients from their practice done through the traditional laparoscopic approach.

History

Traditionally an open procedure started by Dr. Mason, Gastric Bypass operations started to go to the laparoscopic approach in 1994 as performed by  Dr. Wittgrove and his associates.  Within a relatively short amount of time, the experience proved both beneficial to patients, and morbidity and mortality of this operation have decreased substantially to the current very low levels.

The Da Vinci surgical robotic system has been on the surgical scene for the past 5-10 years, and has  beneficial applications to urologic, gynecological, general, and cardiovascular surgeries to name a few.  DaVinci robotic surgery has the benefits of an enhanced 3-D HD surgeon viewer,  improved wrist articulation (extra-anatomical) interaction with the surgical instruments, as well as a remote-centering of the trocars that enhances the surgery as done laparoscopically,  which can result in less post op pain for most patients.

To be honest, robotic application to some surgical procedures makes a huge difference (such as open vs. staying laparoscopic- ex. uterine myomectomy, radical prostatectomy), and/or enables patients to have less pain (and discharge them sooner), and/or reduce the risk of complications (possibly with the prostatectomy) due to the technology used to do these operations.

However, some procedures are aided by the robotic approach, and are able to be done that way, yet don't offer such an overwhelming advantage that comfortably usurps the tried and true approach of the existing standard of a laparoscopic approach.  Bariatrics, specifically Gastric Bypass, likely falls in to this category.

The Study

The group in the study looked at the first 100 Gastric Bypass Robotic cases, and contrasted them with 100 traditional cases done in the same group, of similar demographic and medical makeup.  They looked at both the progression of their robotic cases in terms of complications and duration of the surgery, and how the overall results of the first 100 cases compared with the latter group of 100 standard laparoscopic cases.

What they found was interesting and mimicked our experiences quite closely.

OR case time decreased over the"learning curve" of the robotic timeline, and approached the time of laparoscopic cases.  Stricture rates were a little higher early in the robotic group, but decreased to below their laparoscopic levels by the second 50 cases.  Mortality was at 0% for both groups.  Two patients returned to the OR within 90 days in the robotic group, and only 1 patient required a transfusion for post op bleeding in the robotic group vs. the lapsaroscopic group (5 pts.).

The biggest difference favoring the robotic group was the length of stay, which showed a significant decrease  vs. the laparoscopic group.  Sixty percent of the robotic patients left the hospital after only a 1 night stay, as compared to 4% o patients in the laparoscopic group.

I have to  imagine this was due to less pain (due to no need for fascial closure, and/or the remote centering trocar movement of the robot that can put less torque on the abdominal wall), and perhaps a more rapid transition to PO diet, and a willingness to send them home earlier than the standard 2 days, as we do in our practice fairly routinely.

The "willingness"  I refer to is the comfort level of sending a patient home that meets a general criteria (PO analgesic pain control, ambulation, urination ability, stable VS, tolerating PO satisfactorily, and absence / or control of significant additional comorbidities) as being able to do so.  Perhaps this was skewed to look more closely at the likelihood to DC a patient POD 1 than their contrasted laparoscopic group, but in any event the readmission rate,  or complication rate did not seem to reveal this as an issue.

The paper does note that the two groups were not equivalent, and that is true.  The traditional laparoscopic group represented 7 years of prior experience, and nearly 800 cases performed.  In the robotic series, it was a fresh 100 cases that implied a learning curve during that time.

However,  in a way, with such similar results among the 2 groups, this may be of even more significance in terms of safety and efficacy vs. the laparoscopic standard.  This also speaks to the Robotic approach as not an entirely new entity, but an "add-on" platform to existing technology that can enhance the already excellent standard of surgical approach to Gastric Bypass in this case.

In a practical sense, that is how we approach it in our practice.  The surgeon is able to offer that technique for a patient's choice of surgery, and it has its benefits as well as its logistic issues (namely access to the robot when needed), but it is a more similar than different surgical approach to a Gastric Bypass than the traditional approach.

Moreover, as with technology in all fields, once further advances are made to the the robotic platform, we are ready to keep pace, especially if there is a marked benefit to our patients and to us in performing the surgery.

Exhibit J: Ted's Red Chair in Fenway

Photo by M Clock

I was lucky enough to get to a raucous playoff win for the Red Sox a couple of weekends ago.  We were able to get in early enough to take a look around and watch some BP on a beautifully warm October twilight, with just a subtle suggestion of Fall in the air.

I was able to go and see the infamous Red Chair that sets itself apart in an otherwise uniform sea of green seats in the RF bleachers.  Some of you, I am sure, have seen it and are aware of it's significance.  That seat marks the landing spot of the longest HR hit at Fenway park - 502 feet - by Mr. Ted Williams, many years ago.

I thought of that chair when I saw a post op Bypass patient in followup this week, and her 'smashing' success is worth mention here as one of our metabolic case studies.

Demographics:  45 y/o F

Start Weight:  267 lbs  BMI:  42.9

Date of Surgery:  3/13  Gastric Bypass

DM 2 History:  She said her Diabetes began when she was pregnant with her first child in '93.  She was diet controlled, and remitted after delivery.  She retained some of her "baby weight", then gained some more, and by '95 she had elevated sugars again, this time in the absence of pregnancy.  Her blood sugar control was fair to poor since that time, and she saw an endocrinologist, and despite persistent additions and alterations to her med list she came to us with an A1C over 10.  Her med list she held in hand as she came for her initial visit:

Lantus 95 units bid, Humalog 20 units at meal time, Metformin 1 G bid, and Januvia

Other comorbidities are h/o MI, Dyslipidemia, and HTN.

Current DM History:  She is ecstatic about her newfound control on a much simpler regimen with Lantus 20 units daily, and scaled Humalog up to 10 units  pre-meals.  Her most recent A1C was 7.2 and she was enjoying eating again, with controlled portions and getting in sync with her sugars, diet, meds, and activities / exercise.  In the past she related that no matter what she did, 'even without eating', her sugars were elevated and uncontrollable. She is very happy she initiated the referral to our Center, and had a relatively easy time getting her PCP and Endocrinologist to endorse her to us.  She has lost 60 lbs to date, and is also off her BP med.

Take Home Points:  Standing (or sitting in the case of Ted William's chair) out in the crowd is usually a good thing.  With the crowd of folks with obesity and its associated metabolic diseases out there these days, it remains unusual for someone to take charge of their health situation, such as this patient has, have surgery, and follow through to see the dramatic benefit that bariatric surgery can offer.

As I have stated many times earlier, having the patients come to us as early as possible, once they qualify for surgery BMI-wise, and have failed more conservative approaches (lifestyle, weight loss, meds, specialty care), will ensure the best possible result for them in terms of preserving pancreatic function, lessening the chance of end-stage complications from their DM, and getting them successfully off meds for glycemic control, and more likely keeping them off them.

As you can see here, we didn't get to this patient all that early in her Diabetes disease process, yet a marked improvement in her Diabetes, and therefore both her short and long term health, has been realized.

And I still can't say it enough...Earlier is better.  Earlier is better. Earlier is better.

Unless it's shaving we speak of, then better to wait...  Go Sox!

"This ain't my first rodeo..."

I honestly have never been to a rodeo, and I paused when I thought of the title for this blog this week, as this saying is a little tired.  But I think I can make it work here....

From meco1.blogspot.com

Please read on.

I discovered another weight loss surgery article this week, entitled Surgical Skill and Complication Rates after Bariatric Surgery, from this week's NEJM.

The article was intriguing for a couple of reasons. It revealed an effective way to assess an independent factor for surgical complications, one that has heretofore been either overlooked or avoided, for it has been difficult to assess.  The implication of this lack of published data on this specific variable, that seemingly defies logic, has been that this factor is not truly a primary determinant to surgical outcomes. It has been easier to study related issues, such as perioperative care algorithms, but not the central issue on full display in this study.

The surgeon and his /her skills were on review, and there was a significant correlation with complication rates and the aptitude of their skills, as reviewed by a group of their peers.

In the study, 20 Bariatric surgeons in Michigan were involved in a statewide collaborative improvement program, and submitted a single representative video of one of their Gastric Bypass cases. A group of their peers reviewed the critical aspects of the recorded procedure (creation of gastric pouch,  gastro-jejunomostomy, and jejuno-jejunostomy). The blinded video was assessed in a number of established categories for an overall score rating surgeon skill.

The background for this study acknowledged a few important points. It is known that surgical skill, in any specialty can vary widely. Results of surgery, and specifically Bariatric surgery, can also vary significantly, in terms of weight loss results as well as complication rates. In many previous studies involving outcomes and complications, numerous other factors have been evaluated, mostly in the realm of perioperative care protocols.  Again, studying complications was the focus here, including such untoward effects as surgical site infection, wound dehiscence, intrabdominal abscess, anastamotic stricture, bowel obstruction, bleeding, respiratory failure, VTE, MI, cardiac arrest, and death, as well as unplanned reoperation, readmission, and ER visits.

And lastly, it is also widely understood that the skill level in performing Gastric Bypasses, as a common but technically demanding and complex procedure, would therefore likely demonstrate what they aimed to appraise - the suspected relationship between surgeon skill and complication rate.

So..... What did they find?

1.  Greater skill, as demonstrated by the peer video review process, did correlate positively with a lower complication rate, (along with less reoperations and readmissions) as well as with a shorter duration of operative procedure time.

2. Those surgeons with higher skill, and thus lower complication rates (etc. as above) had an important common bond. It wasn't related to years in Bariatric surgery practice, status in terms of completion of a fellowship in an advanced or laparoscopic bariatric fellowship, or current practice at a teaching or non teaching hospital. What was it?

The higher skill level was strongly related to surgical volume, as in the number of cases already performed.

3. On a personal note, the article specifically noted that the possible extent to which the First Assistant to the surgeon (that would be one of my job duties) could influence the ease of the procedure by the surgeon, and therefore complication rates, was not studied at this time*.

4. And finally, as researchers have a proclivity to do, the results of the study seemed to validate that the peer rating process of surgical skill itself, looks to be an effective strategy for assessing a surgeon's proficiency.

Good stuff overall, and an effective current and trustworthy resource for the argument that high volume centers are the standard for the most effective patient care in terms of a lower complication rate, and perhaps even can be extrapolated to results as well, but that was not covered here.

All of this kind of flies in the face the recent CMS proclamation that Medicare will no longer require that designation in order to approve bariatric surgery for one of their patients (see previous blog post, "One Bad Apple Could Spoil the Whole Bunch (Girl)"), but such is life...


*Note:  The surgical "team", inclusive of a well-trained OR Tech, Nurse,  First Assistant, as well as Anesthesia personnel,  PACU and Med-Surg Floor staff were studied in the past and deemed essential to good outcomes, as occurs in other surgical subspecialties such as CardioThoracic surgery.

Mixed Nuts, Part 2

From Fineartamerica.com

I thought I would mix it up a bit.

Change the metaphor.

You know, the "Crazy as a Loon" thing.  Just trying to keep it interesting...

So, part 2 of this salient topic will cover the latter parts of the article I recently reviewed on the psychological profile of the morbidly obese.  Still to get to will be Eating Behavior, Social Integration, and Quality of Life.

Eating Behavior

No stereotypical surprise here.  The reviewed studies did show significant differences in the eating behavior of normal subjects as opposed to the morbidly obese.  More often, morbidly obese subjects exhibited patterns of compulsive eating, binge eating disorder (BED - a rapid ingestion of a large amount of food with a resultant feeling of loss of control and subsequent guilt and self-condemnation), and/or "grazing" (eating smaller amounts of food frequently throughout the day).  'Mindless eating' is also more common, as well as self-reported frequent snacking on high calorie foods.

Going back to the BED, most studies showed that its incidence was closer to 2-5% in the general population, as opposed to the morbidly obese, where it is noted to be present in 30-50% in one study of those seeking medical care for their obesity.

Behaviorally, there was also a notable correlation with emotional eating, that is, overeating in response to emotional distress.

Social Integration

Social discrimination and numerous stigmata are frequently cited in articles. Psychological consequences can lead to low self-esteem,  as patients deal with prejudice and social bias.  The negative social judgements, such as name-calling and labels ("stupid", "ugly", "lazy", "sloppy") reflect negative attitudes that imply that these individuals are responsible for their obesity through lack of control and lack of will power.

That sense is frequently reinforced by their environment, one that can cause embarrassment in regard to fitting in chairs, clothes that don't fit, difficulties with aisles and hallways to name a few, as well as having challenges with personal cleanliness and odor.

Social isolation, as well as employmental isolation often leads the morbidly obese patient to stay at home, which only serves to reinforce the problem.

Quality of Life

Quality of Life refers to the patient's satisfaction with his or her personal life and the overall effects of medical conditions on the physical, mental, and social functioning and well-being of the subject being evaluated.  It is self-reported by the patient.

The article's review of the literature showed those seeking surgical care for their obesity reported a significantly lower Quality of Life.  Often those patients stated that they had little to fear, given they had the perception of little to lose vs. the potential benefit that weight loss surgery could bring.


So, in summary, there were some new discoveries for me, as far as the implication for some of the trends described.  What the article did say was that, all in all, the obese are not a truly homogenous group.  A number of distinct subgroups were noted, but to be fair, not enough to allow for generalities that are an accurate representation.  Many of those generalities persist, even among health care providers.

The NHLBI expert panel from the recent past described obesity as 'a heterogeneous chronic disorder'.  

However, there is no looking past a lot of the similarities that the morbidly obese present with, or "as".  And, as with most other medical disorders that impact patient's lives, those common traits can be used for gain by health care providers in order to make a profound connection with the patient, in order to get them the medical care they need to improve their total health and better their life situation.

Mixed Nuts

From Walmart.com

"Your patients are nuts!" a nurse at the hospital said to me recently.  She had a difficult time with one of our patients on the surgical floor post op, and was frustrated in trying to care for her.

This is not the first time I've heard this, and I've always thought this broad summation of a fairly diverse population with obesity was understandable, but unfair.  Or was it?

I've rationalized to myself, with nearly 10 years of bariatric surgical care experience (both inpatient, intraoperative, and outpatient) that those comments were due to inexperience with seeing the full spectrum of care as I see it on a daily basis, with mixed types of patients on their journey toward wellness at various points along their preoperative and postoperative course.

There is something deeply satisfying about caring for this population, which we are all seeing, and acting as part of a multidisciplinary skilled team to assist them to wellness /"wholeness" if you will, in a way that no other health care facility in our area can. Good stuff.

Are we occasionally effected by a "nutsy" patient, or a difficult patient care situation? Do similar or even more dramatic situations occur in a Family Practice or ER setting, or other similar venues? Most assuredly, the answer to both questions is yes.

I would argue, though, that the patient's BMI is not the common denominator in most of these cases.

Which brings me to the subject of this Blog: What does the literature say about the psychological profile of the morbidly obese?

I looked up just such an article recently, and it had some interesting descriptors of the morbidly obese.  The article was written in 2004, but did have a nice systematic literature search on the subject and came to some interesting conclusions.

As the article states, Bariatric surgery does in fact represent 'forced' behavior modification.  However, the surgery does not result in equal results in each patient.  Psychological factors do play an important role in these results.  The degree that patients can successfully adapt to use their "tool" that the surgery provides, quite directly reflects their success in losing weight and keeping it off after surgery.

The article went through the published results on the morbidly obese, as studied in terms of Personality, Psychopathology, Eating Behavior, Social Integration, and Quality of Life.

Let's start with the first two.

Personality

Personality studies in the morbidly obese described three main interactions.  Firstly, personality may predispose to overeating and weight gain. Secondly, existing with long term obesity can certainly influence personalty.  Also, personality and weight can also relate in a way that is a combination of the two.

No specific personality was found that was consistent in the majority of the population studied.  There was a wide variety of traits discovered as commonly associated.

*Passive-dependent as well as Passive-aggressive
*Overly sensitive interpersonally, and most had difficulties expressing their aggressive feelings
*Poor impulse control
*Despondency and Hopelessness
*Eccentric, Anxious,  and Dramatic cluster traits
*Tended toward Somatization
*Passive Coping Behaviors, with a 'wait and see' approach

Psychopathology

This was reported as difficult to assess, as even the methodology as to discerning whether specific pathology exists is highly controversial.  More recently, this is becoming more acceptable as an identified co-morbidity, either leading to the obesity primarily, or becoming a diagnosed condition secondarily.

Some studies seemed to show what was described as psychopathology as the result of the burden of obesity, whereas others did not show that direct of a link.  Some researchers noted a 40-50% prevelance of psychiatric disorders in the obese.  The most common disorders were

*Depressive Disorders
*Anxiety either associated with above, or as a singular entity

In terms of family relationships, many obese patients studied had a history of early parental loss, parental alcoholism, and also have marital dysfunction in their own lives.  The presence of sexual and non-sexual abuse was also common.  One study did comment, however, that the rates were not all that different than that of abuse in the general, non-obese population.

Also, females, more than males, were shown to be more likely per capita to have preoperative pathology, in terms of depression, interpersonal sensitivity, somatization, obsessions-compulsions, anxiety, as well as hostility.

For the next segment, we will go over the findings on Eating Behavior, Social Integration, and Quality of Life.

K.I.$.$ : Annual Diabetes Pharmaceutical Sales

Photo from Schenectady Gazette

K.I.$.$

You know the phrase.  Simple and true.  Even so when it comes to money, disease, and cost / benefit ratios.

I saw this graphic in the paper the other day, and just had to use it.

In place of a lot of potentially pompous verbiage, I will elect to rely on the intelligence of the reader (that would be You) to sort out the impact for yourself and your patients as to the impact of what we all do every day, on the front lines of Diabetes.

It is impressive, however,  to see where Diabetes treatment lies among the total costs of medicines, the amount spent ($40 Billion dollars in the year 2012), and the potential for significant impact with earlier treatment with more efficacy for long term effect, and / or resolution.

I will leave the rest to You...

STAMPEDE Trial Follow up Substudy

pastorblog.cumcdebary.org

I had mentioned the results of the STAMPEDE trial (Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently) in a past Blog post, but there is new information that is worth mentioning.  In the new substudy, the same participants have been reevaluated and the findings are interesting.

To review, the STAMPEDE trial, with its initial results published in 2010, compared the efficacy of intensive medical therapy (IMT) alone, vs. IMT combined with one of two Bariatric procedures, Sleeve Gastrectomy or Gastric Bypass.  The studied participants had Type 2 DM, and a BMI of 27-42.

After 12 months, the main outcome was measured: HbA1C of <6.0%.  They found that among the groups, 12% of the IMT group got to goal, and 42% of the Bypass and 37% of the Sleeve groups got to goal.  It was also concluded that all groups improved in their glycemic control, but the surgical groups did outperform the IMT group, and showed superior weight loss and measured improvement in insulin resistance.

In the follow up substudy, 60 of the original participants were rechecked at 24 months after the study was completed.  They were evaluated for the ongoing effects of the three original treatments in terms of glucose regulation, pancreatic beta-cell function, and body composition.

Glycemic control improved for all three groups at 24 months.  Reduction in body fat was similar for each of the 2 surgical groups, but the Bypass groups showed a greater absolute decrease in truncal fat vs. the Sleeve Gastrectomy group, which did correlate positively with an associated improvement in insulin sensitivity and significantly improved beta-cell function over the Sleeve patients.

The take home point?  Both bariatric surgery groups had a durable and significant improvement in glycemic control, with the addition of improved body composition / decreased body fat.  The favoring of the Bypass results seems to go along with its likely heightened mechanism of metabolic action, as to how and where the weight loss occurs.

Beta-cell failure defines the pathophysiology in DM2, and the exact surgical effects on reversing this cascade to end stage disease is an area of  ongoing study and research.  The exact placement, practically, of metabolic surgery in the aramentarium against Diabetes is the next real question that needs to be answered.  Studies like STAMPEDE, and now its 24 month substudy, will go a long way toward developing these protocols, and best practice scenarios.

And in case you wondered, there are a number of additional studies in the works on similar subjects, as well as another substudy in 24 more months to the same STAMPEDE group.

Nuts and Bolts of Band Revisional Surgery, Part 3

From fun107.com

We just got back from returning one of our kids to college.  Talk about a time ripe for the unexpected!  As one of my sons says,  sometimes in a taunting fashion, "You don't know what you don't know".

How true, especially when it comes to this time of (hopeful) maturation into adulthood, a journey that college automatically provides on so many levels.

I think the corollary to the saying of what you don't know is equally as helpful, and can take some of the angst out of what is coming up.  If you know you don't know (everything), then that's a safer place to start from.  Because not to know that you really don't know, is really the truest definition of not to know... Ya know?

If you can follow that, the rest of this entry will be a piece of cake (no bariatric pun intended).

Part 3

To quickly summarize, we have discussed the issues leading to the necessity of Band revisional surgery,  and have covered what it takes to undergo an additional surgery to improve upon some form of an undesirable situation with a Band patient. And now,  the final portion.

Which surgery type is the best for a patient to have once they have "failed" their Banding procedure, either through lack of weight loss (or substantial weight regain), or they have experienced an untoward effect of the Band, or both, as described earlier?

There are subtleties involved here, as the only 2 other procedures we perform in our practice are Bypasses and Sleeve Gastrectomies.  Both will work here, and we have successfully done both as revisional procedures.  Yet, as much as we may want to separate the two, from a revisional sense, they are essentially more similar than different, and both excellent options for a number of reasons.

Both are metabolic, that is they have beneficial metabolic effects, as contrasted to the Band which essentially does not.  Both have a better track record of generally inducing a larger degree of weight loss than the Band, and certainly at a faster rate than the Band.  Most studies also show that each procedure keeps off weight longer and to a greater extent than the Band does.

Either procedure can be performed as a one stage procedure, (that is Band out to Bypass, or Band out to Sleeve) but occasionally it is safer to do it in 2 stages. That situation may arise if the stomach is significantly inflamed or irritated from a pre-existent mechanical issue with the Band, or if surgical landmarks are just not clear enough to risk the conversion in one stage.  In that case, we would take out the Band and access port at the first operation, then come back for the new procedure.  Certainly it is better to wait than risk a complication that may either delay or even negate the chance at performing a revisional surgery.

So, in summary, all is not necessarily lost if a patient does not do well after Band surgery,  or if they develop a significant untoward effect from the Band.  Revisional surgery, for those who qualify, is a possible option to be reviewed with the patient by our Bariatric staff,  keeping in mind that old standard yet simple equation: risk vs. benefit.

We are here to help in any way we can, especially if we can reduce what a patient doesn't know about what they may not know :)

Nuts and Bolts of Band Revisional Surgery, Part 2

Photo by M Clock

So, in keeping with the theme of the unexpected-

We went on a charter fishing trip out of Rock Harbor in Cape Cod recently.  We had a great time, caught some nice Bluefish and Sea Bass.  I came across a sticker that some may find unusual.

Why is the Captain against seals on Cape Cod?  You would think that he would be pro-sea life in general, not just certain kinds of sea inhabitants.

There is a good reason he's anti-seal of late, and you may be aware of at least part of the problem, as it involves increasing numbers of Great White sharks off of Chatham, and some of the outer Cape beaches.

Since the seals are included in a congressional act passed a number of years ago that protects them and other endangered sea life, it seems that the program has been in some ways essentially too successful.  Seals are becoming quite a nuisance, given their bloated numbers on Monmoy, and are not only an attractant to Great White Sharks, but also eating up the fish in the Bay, as well as terrorizing the commercial fisherman in the Cape Cod Bay's catch, and hence their livelihood.  More info can be found at this link to a recent NBC news report from this month.

Anyway, back to the issue at hand - Band revisional surgery.  You might want to grab a cup of coffee or tea...this one will take a little to get through.

Part 2

So, we have come to the conclusion that a patient needs a Band revisional procedure.  The next step is putting all the needed components together to assure the best chance at post operative success.  Just as important, and somewhat out of order in this discussion, is the question as to whether insurance will even cover the procedure in the first place.

There are a number of questions to ask to be able to assure insurance reimbursement, which is imperative to both the patient and ourselves, the surgical group that will do the procedure.  There are a few relatively hard and fast rules, and then a number of other variables to keep in mind. There is also the reality that things do change as far as insurance company coverage goes, and we frequently find these out in retrospect as "new" ground rules.

The easy part are the main concepts that are fairly constant.  'Covered' revisional procedures usually stem from a mechanical failure of one of the components of the Band (Band itself, or access port), or the occasional acute or chronic issues that are not able to be remedied through fluid adjustments or conservative means.  Chronic and severe reflux, recurrent gastric prolapse, and Gastric erosion falls into this category.

For the 'failure to lose weight' category, it gets a little more sticky.  Firstly, we need to screen these folks to assure that they have given the post operative care a reasonable try with regular visits, dietary adherence, exercise schedules, and adequate time from surgery (usually around 2 years).  The behavioral component by the patient will be required no matter what procedure we are converting their Band to, and weight loss and maintenance of that loss is very directly related to compliance on those behavioral variables to be successful.

Secondly, the insurance again comes in to play.  Most, but certainly not all, insurance plans follow the initial guidelines of BMI and comorbidites to 're-qualify' a patient, (BMI 35-39 with comorbidities, BMI of 40 or greater)but some consider those same standards a bit more strictly, perhaps looking for a reason not to reimburse the revisional procedure.

For example, we had a patient who didn't qualify for surgery with a BMI of 38 even with OSA recently, as the Pulmonary consult note characterized the OSA as "mild, yet still requiring an appliance" (C Pap).  We have also had experiences with patients having HTN and DM2 who were denied in the recent past due to the 'controlled' nature of their diseases, due to the fact they were only on 1 medicine (HTN) and not on insulin yet (DM 2).  The majority of our previous experience was that OSA, DM 2, and usually HTN, were relatively absolute qualifiers for insurance coverage for surgery, but not so anymore, especially when a revision is on the table.

One commonly-held local / regional HMO is adamant that no revisional procedure will be approved without a peer to peer review, and most of these remain unapproved even with that level of interaction and 'expected' qualification for surgery.

I do understand the position of the insurance company to a degree.  First, the dramatic increase in Bariatric surgeries over the past 8-10 years, and now another potential wave of 're-do's" that may need to be done.  Difficult to budget for from their perspective, and difficult to get excited about, as there truly is a paucity of evidenced-based data out there, thus far, on the likelihood of success after undergoing such a procedure.

Additionally, with some of the patients, it could be argued that there is a significant behavioral component to their failure, and it is furthermore difficult to predict who will likely do well after a revisional Band procedure.

Sorry for the lengthy insurance diversion, but it is necessary to review potential barriers to access to surgery, for better and for worse.

And lastly, from a semantics standpoint, we do require the patient to go through a majority of the same initial process that they participated in the first time, getting to their first surgical procedure.  They will need to see Psych again, their PCP for clearance, likely lose some weight (5-10%) before surgery,  get a full battery of labs tests and possibly an EGD, as well as seeing the Dietitian again to discuss both their lack of weigh loss after their last procedure in addition to the education involved in their new procedure of choice.

It is stressed throughout this pathway, essentially from the start as we entertain the possibility of a revision, that revisional surgeries are not a walk in the park.  They generally take a number of hours more to do, nationally have a 30% higher likelihood of complications, and are not guaranteed on their own to finally get the patient to lose weight long term and keep it off.

Having the patient understand that a revision is not "the easy way out", a guarantee of long term success, or a whimsical choice because "the Band isn't working for me" is key to getting off to a good start as we pursue this kind of surgery.

All the above being said, we do Band revisional surgeries with some frequency.  We have had a number of successful conversions from Band to Bypass or Sleeve.  And,  especially in the cases where patients have complications from their Bands, they are very happy to have their revisional procedures done, ameliorate their complaints, and get back to the business of losing weight and keeping it off..

The Nuts and Bolts of Band Revisional Surgery

Photo by M Clock

You don't always get what you expect.

Take the example of the water temperature on Cape Cod.  If your expectation is that the water should be warm based on your previous ocean experiences, you will be in for a surprise.  The Caribbean it is not, but unto itself it is a beautiful place in so many ways.

The more I thought about writing this post, the more the idea resonated as an increasingly important concept to share.  The more I thought about it, and saw patients this week in the office that this directly applied to, the more I envisioned this post growing substantially in length.

As I have referred to before, one of the 'secrets' of a rip-snorting Blog is that the posts are succinct and bite-sized in their approach.  So....

Let's do this in three parts.  Part one will identify the scope of the problem.  Next will be the process the patient goes through to get the revisional procedure, including the insurance aspects, and I will finish up with Part 3, detailing how we tailor the surgery choice based on the individual patient's needs and presentation.

Part 1

Band revisions are being done a little more commonly these days in our practice.  This stems from a small segment of our Band population having mechanical issues, such as Gastric Prolapse, pouch dilation, esophageal issues non-remedied by extracting fluid from the Band, as well as the rare case of gastric erosion.

Probably the most common reason, though, is lack of weight loss.  This usually has a significant behavioral side (not eating the correct foods the correct way, or lack of consistent exercise, or poor office follow up) but that can be occasionally be exacerbated by other mechanical issues of improper restriction which can 'encourage' maladaptive eating patterns that lead to weight loss plateaus, weight gain, or weight regain.

We commonly deal with these issues on an acute level in follow up, as long as the patient presents for us to offer our assistance and our clinical expertise. However when left unchecked for months or years on a subacute or smoldering level, they can become difficult to overcome.

Even so, both we and the patient's insurance company generally want to see a proven record of a reasonable attempt of usually 2 years of consistent effort at following through on the necessities of aftercare that are stressed repetitively in a multidisciplinary way.

Next up will be a more detailed description on what the patient needs to go through to get their revisional weight loss surgery, including some of the insurance hoops that have become necessary, as well as the risk/benefit ratio of going to the OR again to improve upon a patient's suboptimal outcome with their Gastric Banding.

One last comment.  As I have stated a few times earlier in this Blog, the majority of our Band patients are still doing well with their weight loss and are enjoying their "tool" as they gain control over their eating habits and resultantly their weight.  Some of those patients, for the first time in their lives.  But if that is what is needed / desired, it can usually be accomplished by switching out to a different procedure such as a Bypass or a Sleeve as either a one-time procedure, or occasionally in a 2 stage process.

One Bad Apple Could Spoil the Whole Bunch (Girl!)

Photo by M Clock

(Yes, those are cherry tomatoes, not apples...but I think the same principle applies)

So, why is this post labeled the way it is?

I think it the saying truly can mean what it implies - that one small part of a whole group is capable of ruining the homogenous group via it's unique way of deviating from the norm. Just by the mere fact that it is, for it's greater part, a genuine part of the whole group doesn't free it from possibly doing damage to the whole. In fact, that characteristic can uniquely enable it to do so if not cared for in the proper way.

So where are we going with this?

Glad you asked.

"Way back" in 2006, the decision was made by CMS (Centers for Medicare and Medicaid Services) to require centers that provide Bariatric Surgery services to become certified to do so, as a Center of Excellence (COE), in order to approve of the location that provides the surgical service as well as clear payment to those centers for reimbursement.

The idea at the time was to encourage high volume centers to go through the process to become certified, and therefore be able to establish a a new standard benchmark, ensuring quality prospectively from that point on. Historically, Bariatric Surgery was becoming safer at that time, and the reason resided in the fact that the learning curve in going from open surgeries to laparoscopic procedures was being realized nationally.

Significant gains in safety and outcome have in fact been realized across the rapidly expanding Bariatric Surgery sub specialty, but the consideration of a new ruling on the matter by CMS has that situation potentially in a bit of jeopardy.

CMS is considering a new ruling this Fall that could lift the facility certification / COE designation as a requirement for coverage of approved services, which may open the door for access to non-accredited centers for these patients, it could substantially increase morbidity and mortality of these patients.

CMS is basing their consideration this issue as a result of a study that came out earlier this year showing "no significant difference" between designated COE's and non-accredited centers in terms of complications and outcome.

Just this week, the ASMBS, ACS, The Obesity Society, The American Society of Bariatric Physicians, and The Society of American Gastrointestinal Endoscopic Surgeons collectively wrote that they "strongly oppose" the CMS's decision to overturn the current established policy.

A counter argument to that study (and the current position of CMS on changing their policy), apart from reasonable intuition that higher volume centers have better outcomes, will be argued by a study currently in press,  in the journal of Surgical Endoscopy.  That study showed an alarming increased in-hospital mortality rate of 3X higher in non-accredited centers vs. those that were COE's (0.22% vs. 0.06%).

While access to care may be the effect that CMS is after by "freeing up" the ability of more centers to be able to do weight loss procedures, should more frequent events of morbidity and mortality occur than is currently the case, access may in fact be diminished as referring physicians once agin think twice, or more, about referring their patient for surgery in the first place.

In this specialty, what happens "globally" can certainly effect local perception of safety, which would be a shame after we, as a specialty, have come so far.  I will stay on top of any developments in this issue, and make you aware what, or IF, any changes occur.