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.

Under Pressure: IIH - A lesser Known CoMorbidity of Obesity

From Ultimateclasssicrock.com

I bet you can hear the bass guitar lead-in to the classic song now in your head...

A classic vintage rock duet, with David Bowie and Queen.   

(click the above link for some mood music for your listening pleasure as you read this post...)

Very appropriate, or perhaps very inappropriate depending on your perspective, as an intro for our topic today.

This obesity-related comorbidity is far less common than many of the others we have discussed in this Blog over the past year, but nonetheless not so benign as its name might imply.  If not diagnosed and treated effectively, disability, persistent severe headache, and blindness can result.

I had a few patients clustered together in the past few weeks that have had very good effects from their weight loss surgery in regard to this process that accompanied their morbid obesity, and I wanted to highlight the issue.

Let's talk about Idiopathic Intracranial Hypertension (IIH), better known as Pseudotumor Cerebri.

IIH is a not-so-common issue.  Its annual incidence is 1-2 per 100,000 population, however there is much higher incidence in obese women between the ages of 15 and 44 years (4 - 21 per 100,000).  There is some evidence to suggest that central obesity can increase intra-abdominal pressure, pleural pressure, cardiac filling pressure, and central venous pressure, which then can lead to increased intracranial venous pressure, and IIH.

Sleep apnea, much more commonly seen in association with obesity, may also play an additional causative role.

Common manifestations of this disorder include usually severe and recalcitrant headaches, transient visual obscurations, intracranial noises (pulsatile tinnitus), photopsia, and perhaps some retrobulbar pain.

Headache is most common complaint, and may have some features of both tension and migraine HAs, but their refractory, persistent, and severe character often leads to further workup.

That workup would include, among other diagnostics,  a lumbar puncture that shows elevated CSF pressure with normal fluid composition, and a correspondingly negative MRI for any space occupying lesion that could be causing the increased CSF pressure.

Treatment is centered on accomplishing significant weight loss as a way to diminish the headache frequency and severity, as well as preserve vision by reducing pappiledema and intracranial pressure. Medicines are utilized as well by Neurology, ranging from Carbonic Anhydrase Inhibitors to Loop Diuretics to steroids; Pain meds are also necessary and frequently narcotics and NSAIDs are prescribed.

Surgical options are occasionally needed, and are usually aimed at CSF shunting.  In fact, we had a patient who was very successful with her weight loss after Gastric Bypass 7/12 (250# / BMI 44 to a recent weight of 158# / BMI 28), and a previous history of IIH.  She was excited to tell me at her last visit that she was recently to her Neuro for follow up, had a trial of shunt clamping that she passed, and had her shunt removed with no significant further headaches!

I can recall 2 other patients I have seen recently, one that was an RN that was able to get back to full time work after she was disabled previously (she actually was a Band removal to Sleeve Gastrectomy), and another patient who had a Bypass and was on much less meds,  with reduced headache frequency and severity.

So, even though we don't see this as frequently as other more common comorbidities, the effect from weight loss can be quality-of-life-saving, as well as quite dramatic.  Keep Pseudotumor Cerebri in mind if you see that obese female patient with a challenging headache pattern that is refractory to your standard care, requiring a further workup or neuro referral.  Keep us in mind!

                                    (That was a lame play on words, sorry)

Exhibit I: A Simpler Solution

From NESN.com

In my baseball playing days, I heard a Coach’s comment that stuck with me.  

And as with most aspects of Baseball, and sport in general, truth often transcends their original context.

"People that don’t know what they are doing can make something easy look difficult".  The converse is also true - those that have a higher level of skill can make something difficult look easy.

A parallel here, and certainly not a judgement on the management team of the patient being highlighted, is that it took a very challenging insulin pump regimen to keep this overweight Type 2 Diabetic in control.  In fact, to the Endocrinologist's credit, his regimen of both U-500 insulin in the pump, as well as 5 different daily basal settings, kept him well controlled with a decent Hemoglobin A1C.

Thankfully, after his Bariatric surgery, things got quite a bit easier.

Demographics:  47 y/o WM

Start Weight: 386   BMI: 49

Date of Surgery:  5/13  Gastric Bypass

DM2 History:  10 + years having a Diabetes diagnosis.  He was seeing Endo at the time of his entry H&P for management of his DM2.  Control was quite good with last glyco prior to surgery at 7.3, and management was with U-500 insulin in his insulin pump and 5 different basal settings throughout a 24 hour day. He was also taking Metformin 2G per day total.  No diabetic complications thus far.  He works as a truck driver and requires a waiver for his DOT  driver’s license with his Hx of DM and on Insulin. C Peptide on intake with us was 2.7.

Also with comorbidities of HTN, Hyperlipidemia, GERD, chronic LE edema,  OSA on CPap, and fatty liver changes.

Current DM Hx:  Last seen in June at his 3 month follow-up.  He was happy, doing well with no complaints.  His Pump regimen was able to be locked in at a basal rate of 0.25 U/Hr of his U-500 insulin, with his total daily dose of his insulin (in standard concentration dosing from greater than 120 units daily before surgery to now around 30 units per day), and his CHO: insulin regimen also similarly reduced for mealtimes.

He has had no substantial lows since his surgery, and is happier with his control and the more simplistic regimen that the surgery now affords him.

On his last visit at 3 mos post op, his weight is down to 279 now, BMI of 36.8, and he remains on his pravastatin and losartan, but is off Lasix, Metformin, and taking only 1/2 of his Atenolol dose as per previous.

Take Home Points:  Some of the interesting aspects of this case can be divided up into the perioperative Diabetic care, and then the longer term impact of the metabolic change after the surgery – which is still somewhat in evolution.

In the hospital, we took an “educated guess” approach to this patient’s post op insulin needs, taking into consideration his duration of DM, Glyco preop, insulin dosing, and his age.  I added up all of his total insulin for the day (basal + bolus/meal time dosing) which was then converted to U-100 dosing (multiplied by a factor of 5).  In this case he was well above 120 units per day of U-100 equivalent.  We then took roughly a quarter of the total daily dose and gave it to him in basal dosing (Levmir) and monitored his BGs QID. He did fairly well, averaging in the 120’s to 160’s perioperatively on that regimen.

Turns out that he was able to go home on that same dose of Levmir at 30 units per day which equillabrated to restaring his pump at 0.25 u / hr of U-500 insulin (therefore 6 units per day x 5 =30 units total of U-100 strength), until such time  he was to see his Endo for followup a few days post op.

He continues to see Endocrinology, and they are monitoring him to potentially further reduce his insulin needs as he continues to lose weight.  He is happy with his success thus far, and is fully aware that he likely will not completely get off insulin, but with its greatly reduced dose, and ease of administration (pumpless in the future with a fixed dose of Levmir and some metformin?)of his currently efficacious DM / insulin regimen, the future looks bright. 

He is ecstatic about his associated weight loss as well, already his improved quality of life, as well as the shedding of a number of his other meds, and is looking forward to his next visit in 3 mos with us in follow up.

Again, making the difficult look easy is usually the more difficult thing to do, but I am sure this patient is very grateful to live more 'simply' now vs. his life before he had his Bypass.

Gastric Banding Update

You may wonder if I suffer from a little slow-motion Attention Deficit Disorder, as I keep promising that Case Study, and it will come, but not yet.  Soon!

After the last post with some new info on our experiences with Sleeve, I thought I'd follow through on an update for the Band as well.  Things have changed in a similar but different way for this procedure of late.

As mentioned earlier, our Band numbers have dropped from a high of around 25% of our case load 4 or 5 years ago, to currently less than 5% of new procedures being done.  The Sleeve's emergence as a procedure that has Bypass-like legitimate impact on both weight and metabolic disease is likely the biggest reason for that change.

A secondary aspect is the increase in some complications that appear to be related to duration of the how long the Band is in place.  This has occurred nationally with other Band programs, as well as internationally in Europe in the past decade.  The longer the time, and it is designed to be a lifelong implant, the higher the likelihood of some complications for some folks.

While there still is a significant segment of our Band population that is experiencing good results, "Loves" their Band (and how it helps them eat more appropriately and lose / control their weight), and has had their life changed from having the procedure - some aren't so happy these days.

Unhappiness with their Band is usually in large part from behavioral indiscretion, leading to recurrent emesis, and possible a Band slip (Gastric Prolapse).  It may take the form of lack of follow up, insufficient adherence to the quality/quantity of dietary intake to facilitate meaningful weight loss, or lack of consistent exercise as also required to lose weight.

It does seem that time may not be on a patient's side that does not adhere to the above behavioral requirements, as not achieving and maintaining meaningful weight loss is the end result of all these issues that could be cited as truly the biggest complication from unsuccessful Banding-Patient lifestyle.

Resultantly, we have seen an increase in patients needing their Band out due to chronic dysphagia, odynophagia, or lack of substantial weight loss.  Occasionally we see esophageal issues with atypical chest pain that needs to be remedied be fluid removal from the Band.

With more frequency now, we have been converting those interested patients that qualify in a revisional procedure such as converting to a Bypass or a Sleeve at the time of Band removal.  Moreover, early experience with these Revisional procedures have a substantial weight loss benefit over the more traditional revisional procedure in a patient with weight gain after a Bypass with some mild mechanical issue that may or may not (likely not) be the culprit in the weight regain.


So, the take home message- "Should we even be doing the Band", or, "Should I even refer a patient who wants to have a gastric Band performed?"

Yes, to both.

 If a patient is only interested in a Band and needs a weight loss procedure, it still is superior, and worth the 'risk' vs. taking your chances with medical models of weight loss, and the likelihood of success for the majority of patients who try lifestyle modification alone that need to lose more than 10% of their excess weight and keep it off.

Gastric Banding still has its place in our armamentarium, and we will continue both to place Bands and service our Band population with expert after care as we do now.

Having them come in to see us as a potential new patient, after you have referred them with their letter of medical necessity, allows them to come to an orientation first and find out which procedure is best for them.

 Their surgeon will then work with them to decide:  Band,  Bypass or Sleeve?

Sleeve Gastrectomy Update

From Bariatric.templehealth.org

Before I get to that promised case presentation, I wanted to give a quick update on our experience with the Sleeve Gastrectomy as a metabolic and weight loss procedure.  I saw an article from a December  2012 Summit on Sleeve Gastrectomy in New York, NY, and I thought there would be interest in giving our recent history and impressions as well.

Firstly, and paralleling a presentation on a 6 year study on involving 547 patients in Florida, we have seen a dramatic increase in the number of patients requesting a Sleeve, and following through to have them done. Earlier in this blog, essentially within the past year, I reported our case mix (of our 700+ surgeries per year) as roughly 75% Bypass, 20% Band, and 5% Sleeve.  Now, the mix is more like 70% Bypass and nearly 25-30% Sleeve with a rare Band being done currently.

Additionally, the Metabolic benefits of the Sleeve Gastrectomy are nearly comparable to the Bypass, which is great news for Diabetic or pre-Diabetic patients.  I was just speaking with one of our Surgeons the other day, about how this has shown to be even better than was originally expected, which has been savored by both patients and Endocrinologists alike!

Weight loss amounts have also been very good, again a little more than we had expected, vs. the known track record of the Bypass which is and has been the Gold Standard.  Weight losses over 100 pounds have been common, I even saw a patient today who had lost 180#, now down to a BMI of 29.  The aforementioned study showed average weight loss of just over 60% Excess Weight Lost, with the mean of 137 pounds.  The EWL at 48 months and 60 months post op was 47% and 31% respectively.

Our initial concerns with the Sleeve were mainly centered around it's apparent unimodal mechanism of action : Restriction, and the decreased size of the Gastric reservoir..  We had thought it was more Band-like than Bypass-like in that regard.  We honestly expected relatively easy weight regain from maladaptive eating behaviors just after the 9-12 month time frame.  We have been doing Sleeve Gastrectomies now for over 2 years, and we haven't really seen that as a common theme yet.  This study seemed to support that notion, making it similar to Bypass in rates and degree of weight regain, but no worse.

So with the Sleeve's preservation of the more native GI anatomy, the added metabolic effect from alteration in gut hormones, and the reduction in micronutrient deficiencies from minimized malabsorption, it appears that the Sleeve Gastrectomy is a durable and effective Bariatric and Metabolic procedure that is here to stay.