Exhibit E

Photo by M Clock

It's time for another patient profile.  And it's time for a Band Diabetes success story.

If you haven't already done so, make sure you take a look at the previous section of posts exclusively on the Gastric Band (Backstage Pass to the Band), and take note of it...

The Band is a valuable tool in the battle against Diabesity as well. 

 Maybe not as sexy as the near immediate metabolic benefit of the Sleeve and the Bypass, with the gastric transection required to do the procedure, but it still has it's place and a potential long term benefit.  

Again, as the studies show, surgery beats non-surgical weight loss, in terms of durability, hands down.

Here is this patient's story, I saw her this week in follow up.

Demographic:  45 y/o F

Start Weight:  230 lb  BMI:  35.6

Date of Surgery:  5/2010  Laparoscopic Adjustable Gastric Banding

DM Hx:  Onset of Diabetes type 2 9/2009.  Started oral agent at that time, Glucophage, but quickly discontinued due to GI side effects.  Glipizide ER 7.5 QD was then started with less side effects, with good results.  Meds were initiated after  failed attempt at weight loss to improve her insulin sensitivity and improve her glycemic control.  BG 180 random, glyco was 8.0 at time of referral for Band. Patient wanted a way to curb her appetite and achieve a durable weight loss to help her DM2 and Hyperlipidemia.  No DM complications at time of surgery.

Current DM Hx:  Current weight is 189, BMI of 30.  Off oral DM meds, last Glycohemoglobin  was 6.1.  Much more active now with exercise, and enjoying her sense of decreased hunger in between meals and the reinforced nature of appropriate portion control.  She is also happy about the improvement in her lipid panel- had labs drawn per her PCP recently and she reported an improved total cholesterol, but I didn't get her actual breakdown yet in the mail.  

Take Home Point:  Nice to have a young patient with mild early Diabetic disease undergo a surgical procedure and see such a drastic improvement in her control of glucose, currently off all meds.  That's the way to get the biggest bang for your Bariatric buck.  Add to that her improved sense of well-being, more palatable / tolerable exercise, and improvement in other co morbidities, and we have a winner!

Who also wins though?  The PCP for an easier time managing this patient as far as her co morbidities go.  The health care system for less burdened care with additional Rx and specialist consults potentially in the future, etc. And of course the patient, for the reasons listed above.

In some ways, this is a simple patient presentation, but it also highlights catching the patient early at a lower BMI, earlier in their Diabetic disease, and being responsive to her desire to have the surgery for her well-researched reasons for health benefits beyond medicines. I believe that's a Trifecta!

It also illustrates the fact that even modest weight loss, in the right  setting, can make a huge difference in a patient's health.  Some of you doubters out there may say that the same results can be achieved with lifestyle modification or other non-surgical means, and you may be right... but surgical weight loss has repeatedly stood the test of time vs. non-surgical means.  I agree though, neither is perfect.

Ask someone who has a substantial weight / BMI how many diets and weight loss programs they have tried...and how much weight they have lost...and kept off...   If it were only that "easy"...

  

Thanksgiving, The Day After

Great day yesterday.  A time to take a few moments out to think about gratitude, and to celebrate the family traditions that go along with Thanksgiving Day.

Photo by M Clock

Fried turkey.  A day in the kitchen, working on the uniquely special meal all day, with it's attendant aroma.  Lazing around watching TV.  Some much needed lawn work to complete... not sure why I did it, I guess because "it was there" and it was such  nice day weather-wise.  The post-meal snooze, or this year, a Black Jack tutorial from a seasoned Uncle.  And, most importantly, just taking some time out to enjoy being together as a family, as it subtlety but progressively changes from year to year, starting to really appreciate all that we have as a family, and all the we have had as a family.

Speaking of appreciation, if you take a look at our Ellis Medicine Bariatric Care Center page on Facebook, you will notice a number of appreciative posts.  It may be a sense of a new beginning as a patient prepares for surgery or starts the preoperative weight loss phase.  Or a patient who has a surgery date and is looking forward to the day of that new beginning. Or the postoperative patient that is off many of her meds, (especially Diabetes meds!), or a patient enjoying all of his new found quality of life benefits as their weight loss is occurring rapidly and they are able to do so much more than before.

Add to that the multitude of stories we hear in the office nearly every day regarding goals met, milestones achieved, and the numerous outwardly obvious and intimately personal benefits of weight loss surgery success...  These keep us going when the days can be challenging at times.

I guess when you really boil it down the the basics- Thankfulness is as simple as being aware of and appreciating something that you 'have' that you may not necessarily deserve.  And whether you work for it or not, in some way you really don't have total control over that thing, that situation, that relationship- yet you really do, in some way, have it now. Being thankful is a way to enjoy it in a different, but very satisfying way now. We have a choice to see the glass half full all the time!

Happy Thanksgiving!

How Low Can You Go? Post Op Hypoglycemia part 2

From EndlessGroove.com

Now that you suspect a post- Bypass patient is presenting with symptoms of, or issues related to hypoglycemia, here's the work up, treatment modalities, and the attendant potential long term implications.

First off, we want to ascertain whether the hypoglycemia is physiologic (related to behavior and / or dumping syndrome), or from an associated hyperinsulinemic state (which has been described after Bypass).

The vast majority are the former, related to dietary indiscretion of repeated ingestion of simple CHO, not eating enough protein at a meal, and/or not eating in a regular fashion / skipping meals with a prolonged fasting state.

Lab workup should include a fasting glucose, C-Peptide, and fasting insulin level, with perhaps a glycohemoglobin.  Again, an elevated insulin level may indicate the need for further testing, imaging studies, and likely and Endocrine eval for the possibility of Pancreatic Nesidioblastosis.

Blood glucose sampling at the time of the patient's symptoms may help confirm the hypoglycemia, as well as the history of an efficient response to a small amount of simple CHO will also be helpful.

Getting back to proper Bariatric behavior in the way of 3 (or more) meals per day high in protein and low in CHO (especially simple CHO), and avoiding prolonged periods of 'fasting' in between meals has been advocated. Avoiding eating and drinking together slows down the entry of chyme into the small intestine.  Our Dietitian helps the patient sort this out, and reinforce the proper habits.

Having the patient check their BGs prior to driving, exercise, at HS, etc. may help them to have a better sense of control and correlate symptoms with triggers and situations where lowered BG (or syncope) may pose a significant issue.

Should the episodes still continue despite behavioral change, Acarbose can be prescribed.  At 50-100 mg TID, preferrably 10 mins prior to a meal, case reports have shown that the medicine-induced delay in CHO absorption helps with minimizing the associated hypoglycemia as a rebound from a rapid increase in glucose associate with dumping syndrome. Other meds such as Octreotide and Calcium Channel blockers have also been mentioned as potentially helpful.

So, now that we are keeping in mind the presentation of hypoglycemia in post-op Bypass patients, we also need to mention it as a cause of weight regain after surgery.  We always stress the behavioral component as the main etiologic factor, of which there is very often sufficient evidence in the history of repeated indiscretions. However, unchecked hypoglycemia can be a possible factor.  Having a patient go through cycles of hypoglycemia with an acute desire to eat to resolve their symptoms, and have that pattern recur repetitively,  can certainly cause substantial regain of weight over time.

And again, getting back to Bariatric basics for behavior, such as eating properly, exercise, and follow up visits to be reevaluated, is paramount to getting back on track and maintaining good health and weight maintenance long term.

How Low Can You Go? Post Op Hypoglycemia, part 1

From Endless Groove.com

Hypoglycemia is a pretty easy thing to diagnose, usually associated with a Diabetic patient that has a relative excess of insulin from treatment for their Diabetes. The mild symptoms are often either treated by the patient on their own, or perhaps first verified by finger stick and treated accordingly with simple CHOs.  The patient fairly rapidly gets better, and that is that.

How about in the setting of the absence of anti Diabetic meds, and with the surgical history of a prior Gastric Bypass?

Well, with all good things, there is not uncommonly a downside.  Here is another such case.

The metabolic benefits of Gastric Bypass so touted in this Blog do have the possibility of causing symptomatic hypoglycemia. Although relatively rare, it can occur months to years after surgery, with the associated significant and rapid weight loss.  In some patients, with hypoglycemia unawareness, it can progress to to neuroglycopenia, occasionally resulting in syncope.

What are the mechanisms, presentations, treatments, and what about the potential association with weight regain?

Possible mechanisms encouraging hypoglycemia post-Gastric Bypass:

1.  Lack of reduction of beta-cell mass from pre-weight loss pancreatic state

2.  Gut hormonal activation of new beta-cell formation in the Pancreas

3.  Increased insulin sensitivity after weight loss

4.  Inappropriate beta-cell secretion as a part of the dumping syndrome of early entry of ingested nutrients into the small intestine, and

5.  Abnormal counter-regulatory hormonal responses (Glucagon)

The above article was mainly written for the discussion of a hyperinsulinemic state discovered in an even smaller proportion of hypoglycemic Bypass patients, although the mechanisms are the same for the garden variety cases as well.  The latter is more closely linked to the dumping syndrome described above, which is typically managed with dietary manipulation and/or meds.

Most articles I reviewed described the hypoglycemia as occurring 2-3 years after successful Bypass, and most commonly 2-3 hours after an ingested meal.

The symptoms were fairly typical, with palpitations, sweating, visual changes, diaphoresis, dizziness, and mental status changes.  As described earlier, with a degree of 'unawareness', the first manifestation may be syncope.  Admittedly, there is never really a good time for syncope during one's daily activities.

In Part 2 we will review the workup, the treatments from dietary to pharmacologic, and discuss the likely association of hypoglycemia with the possibility of weight regain years after surgery.

The Who-What-When and Where's of Bariatric Follow Up

Photo by M Clock

Follow up.

Common for medical practices, usually less so for surgical practices.  Bariatric surgery is different. We get to know our patients very well, starting with a number of preoperative visits in preparation for surgery. We often comment that our 'surgical' practice is more like Family Practice as far as follow up goes.

We have heard from more than a few referring practices commenting that staying aware of how their patients are doing can be challenging.  We are moving forward to an EMR early 2013 which should help greatly.  For the time being, we try and send notes through our transcription service, but admittedly it can be inefficient at times. All labs are currently CC'd to the PCPs to keep you in the loop.  This is an area we are working on to improve in our practice.

You as the PCP still retain control over the patient's medical condition for all things, while we see them for surgery-related issues, for both acute care and regular follow up. There can be times of overlap, and our goal is to stay in touch and communicate effectively with you if we get in to a grey area as far as HTN or DM management, or an issue such as anticoagulation is concerned.  

All our patients follow a pretty set schedule of follow up.  Bypasses and Sleeves come in for a 1 week post op check, then 3 weeks later for a 1 month check.  After that, we see them at 3, 6, 9, and 12 mos post surgery, and then every 6 - 12 mos thereafter as well, long term.  We draw labs starting at the 3 mos check, and usually check blood work at each successive visit there after. Again, we do CC all labs to the PCPs to allow you to stay informed of any issues that may arise. 

Our Band patients are a little different.  We also see them 1 week and 1 mos post op, and we start adjusting their Bands at that 1 mos post op visit.  We usually see them every 3 - 4 weeks thereafter for re-evals, and adjustments as needed.  Once their Bands (and their behavior) are tuned up and they are on track, we can safely stretch out their visits.  Given that the Band is much less likely to produce nutritional / micronutrient deficiencies, labs are done a little less frequently, usually around 6 mos and 12 mos after their surgery, or as needed if clinically indicated.  Our Band patients know that if they are in need of an acute visit, we can see them usually the same day to remedy an over tight Band, or within a few days if they have any issues of lesser acuity.

As most of you are aware, we are available daily M - F to see patients acutely for a 'sick visit', for an acute Bariatric issue, or one that is suspected to be so.  We are always available to speak with you on the phone if you have a patient management question or a Bariatric issue that needs attention.  Ask to speak with our Nurse Clinical Coordinator, or myself at 518-831-7001 as needed.  We will be happy to take the call.

Coming in the next post is an interesting issue that is fairly common in follow up after a Gastric Bypass, and can lead to both acute problems and long term frustration in the form of weight regain - Hypoglycemia.

Coming To a Neighborhood Near You

View of a snowy Giant Mt. from the Ausable Mt. Club  11/4/12

How many shopping days left 'til Christmas?

Spent the day hiking in the Adirondacks today, and saw what is to come...maybe even a Nor'easter is forecast this week!

As one who loves weather and Winter, it was kind of fun to see it.  Today was  good mental health day-away.

But now that I have you captive, please help me to help you with this Blog by leaving comments or feedback as to any questions that may have arisen regarding a post, or a topic we haven't covered yet that you need some more information on.

We are just geting started!

Thanks!!

This Post is Brought to You By the Number 3

Photo by L Clock

Yes, the number 3.

 This isn't a Sesame Street thing, timed as a 'November Surprise' to help sway the election.  This may actually be more important than that to a lot of patients out there with type 2 Diabetes and obesity.

I already let you know we were in Vegas recently, some of the Bariatric group at Ellis, to attend the Fall meeting of the ASMBS.  One of the eventful things I got out of the meeting was a review of a recent study that qualified the preoperative predictors for a Diabetic patient and the likelihood of Diabetes remission after Gastric Bypass at 1 year post op.

"Predicting the Glycemic Response to Gastric Bypass Surgery in Patients with Type 2 Diabetes" was a study published in Diabetes Care  October 1, 2012.  It looked at 154 ethnic Chinese subjects, and how their glycemic response was influenced by Bypass at 1 year post op.  It defined remission as a HbA1c of less than or equal to 6%.  Remission was achieved in 107 patients (70%) at 12 mos.

The three (as in 3, our magic # for this post) independent preoperative predictors, and therefore 3 clinically useful cutoffs were as follows:

   1.  Diabetes duration of < 4 years.
   2.  BMI of > 35
   3.  Fasting C-Peptide concentration of 2.9 (let's call it 3 for the fun of it...)

The study further concluded, the combination of 2 of 3 of the clinical predictors allowed for a sensitivity of 82% and a specificity of 87% for remission.

This is huge, Caroline, HUG-E.

I have detailed in this Blog, in previous posts, specific Case Studies supporting this degree of remission after Gastric Bypass surgery.  We have discussed the physio-endocrine mechanisms for the remission, or at least, substantial improvement of glycemic control following Bypass, and to a similar degree Sleeve Gastrectomy.

What this study now shows is two-fold, as I see it.  One, it further underscores the power of the procedure- Gastric Bypass causing Diabetes remission.  And two, it shows that sooner is better, and qualifies the clinical cutoffs for when referring a patient sooner is better.

Sending patients for Bariatric surgical consideration when they still have significant Pancreatic Islet Cell reserve, as implied by the "less than 4 years of Diabetes",  and specifically measuring it by C-Peptide as above 2.9 (greater than 3) will give your patient the best chance at the best result from their Bariatric procedure.

So, perhaps the C-Peptide is a more sensitive indicator for referral then which / how many PO Diabetes medicines the patient is on; how much insulin the patient is on; what type of insulin the patient is on (short or long acting); or how heavy (BMI) the patient is.

It is said, Everything happens in 3's... and maybe it's true...

*3 clinical cutoffs for the best timing for Bypass for best chance of Diabetes remission

*A C-Peptide of 3 or higher will likely lead to greater likelihood of Diabetes remission after surgery

*and, of the 3 common procedures we offer,  Bypass and Sleeve are the most likely to give you the greatest metabolic (Diabetes) benefit for your buck perioperatively.

Lastly, 3 has always been my son's favorite number.  Go Red Dragons!

Enough said.  Viva Las Vegas!

Backstage Pass, Part 3...

                                                                                                   Photo by M Clock

OK, so what's the catch?

What's the catch for a shorter operation time, outpatient procedure, quicker return to work, and no transection of the stomach or intestinal interposition?

Less complications!  I guess that's not really a catch, but it is something to think about, and it holds up over time vs. Bypass and Sleeve, reported as "3x less than Sleeve Gastrectomy and 4x greater than Gastric Bypass" on the Lapband site.

Those would be the complications of bleeding, staple line leak, and port site infection early; and port site hernia, stricture, marginal ulcer, bowel obstruction and nutritional deficiencies, which may occur later.

So, what's the catch?  Still haven't answered the question, have I?  Maybe I should go into car sales- the best answer is another question... Using my insight and experience, as well as Risk Information from the Lapband site let's clarify:

1. There are the practical issues of slower weight loss -generally 1-2 lbs a week if all goes well.  Not really a 'complication', but a side effect, and one that the patient may forget from time to time even when they are doing well with the Band.

2. Temporary "over-restriction"  which is a relative over-tightening of the band, either by too much fluid given at an adjustment, or a patient eating in a non Band-friendly fashion (too fast, too much, too dry, too coarse of a texture).  Usually treated quite easily by removing a small amount of fluid, with dietary re-education as needed.

3. Mechanical failures of port malfunction (usually leaking, although rare), band leakage (never seen it, but reported), and detached or poorly positioned access port which may cause pain and may need reattaching to the abdomina wall.  Occasionally a port is very difficult to access, and may need X Ray / fluoro to access.

4. A "slip" (11%) is another way to describe a gastric prolapse that may occur over time, usually as a result of recurring vomiting, as a result from, again, over-tightening of the Band and/or behavioral influences.  It can run the spectrum of asymptomatic to the severe pain of impending gastric infarction if not recognized early.  A re-operation may be needed if the patient does not respond to the conservative, but very often successful, removal of fluid to let the band / stomach pouch rest.

5. An erosion of the Band (1%) can occur due to the foreign body effect of the Band over time, certainly encouraged by smoking and NSAID usage.

6. The more nuisance side effect of GERD (34%), is usually remediated by taking some fluid out of the Band, or coaching the patient again on proper eating habits.

Yikes, sounds worse than it really seems to be in every day practice.  We have done well over 500 Bands in our practice, and although there is an occasional difficulty with the Band patient and "side effects", most Band patients love their Band and come to enjoy it's automatic portion control and hunger suppression as they lose their weight.

In our experience however, the Band seems to be the procedure that's easiest to beat.  It relies the most on proper behavior and frequent follow up to achieve significant and lasting weight loss, and likely has the lowest weight loss of the 3 procedures, net, in comparison.  That being said, in some studies, such as the Swedish Obesity Study the Band held it's own over the 15 year study time period.

To summarize - you get what you pay for.

Avoiding some possible complications of a likely more effective procedure, for a simpler technical procedure that has the higher potential to be suboptimal in its effect is a patient's choice.  Often a Band patient will either have a Band or no weight loss surgery at all. We inform all of our patients the risks and benefits of all the procedures we offer (Band /Bypass/Sleeve) during their 2 preoperative visits with the surgeon, and generally let them decide which is best for them.  Having a patient "buy in" to how the surgical tool of their choice will work is a huge part of the process, is reviewed and reinforced preoperatively by our Registered Dietitian, and is linked directly with weight loss success.

In final summary, all information aside, all 3 of these tools are safe and effective, significantly more effective than non-surgical weight loss, and very likely markedly safer than no weight loss at all.  The choice is up to the patient, and up to you to be informed and have a good idea of potential candidates that would benefit form weight loss surgery, whether it be Band, Bypass, or Sleeve.

Sometimes, even in Obesity, To Cut Is To Cure.