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.