Aetna: Draft letter #3 : DS is not investigational (very long)

[Guest guest]

Dear Group,

I recently received 10 full length papers through the Lonsome Doc

service, and I have incorporated the new information into my revised

(but still draft) letter.

Meanwile Dr. Anthone's office just sent in a request for a " pre-

determination letter " , and this is required first before they can

request pre-authorization. The only info I could get was that pre-

determination was to evaluate medical necessity of surgery while pre-

authorization was to approve the specific surger, hospital, and

surgeon.

Hull

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Dear Aetna,

I would like to address your claim that the biliopancreatic diversion

with duodenal switch (BPD/DS) procedure being " investigational " . I

have read Aetna's Coverage Policy Bulletin (CPB) #157 and would like

to respond to the points made in that bulletin.

Before doing that, I would like to briefly discuss the disadvantages

of the alternatives.

Vertical-Banded Gastrectomy: Not an effective procedure

The Vertical-Banded Gastrectomy (VBG) suffers from the problem of

staple line breakdown as well as poor behavior reinforcement. The

extremely small opening to the stomach, which is restricted with a

silastic ring, allows high calorie beverages and sweets to be eaten,

but makes more nourishing foods difficult to eat. Balsiger, in his 10-

year follow up study at the Mayo Clinic reports " only 26% of the VBG

patients have maintained a weight loss of at least 50% of excess body

weight " . In addition he reports that " Vomiting one or more times per

week continues to occur in 21% and heartburn in 14% " . Balsiger

concludes with " Thus the VBG is not an effective, durable bariatric

operation " . [1] MacLean also reports poor long-term results of the

VBG procedure. [35]

Roux-N-Y Gastric Bypass: The " Gold Standard " is getting tarnished

The other procedure approved (RNY) has a number of significant

disadvantages. The pyloric valve is bypassed and the rate of food

movement into the small intestine is not regulated. This results in

the well-known phenomena called " dumping syndrome " which can cause an

individual to feel sick or even faint. Supporters of the procedure

actually refer to this unpleasant side effect as a benefit because it

helps the patient form an aversion to sugar [2]; however, Mallory

reported that his " study fails to demonstrate a significant

relationship between dumping severity and weight loss " [3]. The

extremely small " pouch " (1 oz) that replaces the stomach causes

vomiting whenever the patient eats even the slightest amount beyond

what the pouch can handle. [4] In addition, the patient cannot eat

and drink at the same time. Meat intolerance is reported in the

majority of the patients [5]. The volume of food that the patient is

allowed to consume is so small that it causes severe social problems

in restaurants and other social eating occasions. Patients will

vomit or get food stuck in their pouch if it is not mashed into the

tiniest peaces before swallowing. Sanyal reports a rate of stenosis

and ulceration of 12.5% and 12% respectively. [6]

The RNY procedure has mixed results in terms of efficacy. Initial

weight loss is reported to be 60-70% peaking at 18-24 months.

[1,7,8,9,10,11,12,13,14]. However, long term studies consistently

show weight regain after 3 yrs leading to excess weight loss of only

50.9% and 57.5% at 4-5 yrs [11,12]. reports 62% excess weight

loss at 10 years [42]. Avinoh reported in a 6-9 year follow-up that

24% of the patients were once again morbidly obese, and only 74% of

the patients had lost more than 50% of their excess weight. [15].

More recently reported, in a 16 year follow-up study, that

18.9% of the RNY patients were once again morbidly obese. [42] Brolin

reported that 37 out of 91 patients regained greater than 15% of

their excess weight. [7].

I have experienced these problems first hand. Both my wife and

father-in-law had the RNY procedure in 1997 and 1996 respectively.

Although I have been morbidly obese for many years and my physician

originally recommended bariatric surgery for me in January of 2000, I

was hesitant to undergo this surgery given the consequences I have

personally observed.

When I learned about the BPD/DS procedure, my point of view changed.

This procedure does have side effects (foul stools, vitamin

supplementation required), but I consider these to be much more

reasonable side effects to live with than the RNY.

Biliopancreatic Diversion with Duodenal Switch: The Platinum Standard

Now, on to the issue of the BPD/DS being claimed to

be " investigational " . According to our insurance contract:

" … A procedure will be determined to be experimental or

investigational if there are insufficient outcomes data available

from controlled clinical trials published in the peer reviewed

literature to substantiate its safety and effectiveness for the

disease or injury involved. "

I will set out to first prove the efficacy of this procedure by

sighting peer-reviewed literature including some of your own

references! Then I will site more recent references that show the

safety of this procedure. Finally I will demonstrate that there is

sufficient data currently available to substantiate these conclusions.

Effectiveness of the BPD/DS procedure:

You own policy bulletin #157 admits that the BPD/DS is

effective: " this procedure is reported to have a higher rate of

weight loss " .

Sugarman reports, " the biliopancreatic diversion has had excellent

weight loss results " , [34]

In fact, not a single author among those on your reference list (or

any others that I have found) has stated even the slightest doubt

about the efficacy of the BPD and BPD/DS procedure.

In addition, all of the seven references included report equal or

better weight loss with the BPD/DS procedure when compared to the

standard Roux-n-Y (RNY) gastric bypass. Results of the BPD procedure

without DS have shown little or no weight regain even out to 20 years

[16].

Mean excess weight loss is reported to be in the 70-80% range

[17,18,19,21,42]

Dietel reports, " The BPD has produced the most effective and

sustained loss of excess weight of any of the operations thus far. "

[40]

Forestieri in discussing the merits of restrictive versus

malabsorptive processes notes, " Without a doubt, the BPD gives good

results in terms of weight loss and more stability than gastric

restriction procedures " . The author then goes on to claim that

comparable results can be achieved with restrictive procedures, but

is only able to produce anecdotal evidence to substantiate this claim.

Sugarman reports in 1993 " the biliopancreatic diversion has had

excellent weight loss results. " [34]

So the efficacy of the BPD and BPD/DS procedures cannot be

questioned. The BPD and BPD/DS are the most effective procedures for

weight loss in existence today.

Safety of the BPD/DS procedure:

Having shown the efficacy, the key remaining question becomes the

safety of this procedure.

Operative and late mortality rates of the BPD and BPD/DS procedures

are shown to be comparable to other gastric bypass procedures.

[16,17].

Dietel reports that with the duodenal switch modification of the

BPD, " This procedure is followed by surprisingly few complications,

mainly some soft stools and malodorous gas in a minority. " [40]

Forestieri reports that surgical complications of BPD are comparable

to the gastric restrictive procedures. Postoperative complications

are reported to be somewhat higher. Forestieri also reports, " BPD, on

the other hand, requires careful management only when complications

occur, as they do in a limited number of cases. tieri

concludes, " When all of the above factors are considered these two

types of surgeries are both viable options for the treatment of

obesity. " [41].

I will discuss the problems raised regarding the BPD and BPD/DS

procedure:

Liver Failure?

Grimm reports a single case of liver failure [37] and Langdon reports

two cases of liver failure [38]. However, Grimm reports that the

patient was non-compliant and anorexic. " She refused most oral

medications prescribed in hospital, including metronidazole " . Langdon

reports one patient " refused surgical takedown on multiple occasions "

and the other patient " began (drinking) alcohol surreptitiously " .

And Grimm also reports " the rarity of liver disease after BPD

contrasts sharply with the situation after the JI bypass … " . Hess

in his series of 440 patients reports only a single instance of liver

failure, which was associated with multiple organ failure. He

concludes, " that liver disease is not a problem with this procedure "

[17]. Baltasar reports on a single case out of a series of 125

patients of liver failure. [18] Scopinaro reported that, with the

classic BPD, 96% of the patients showed elimination or improvement of

fatty liver and 4% had no change. [16]. And Marceau reports, " BPD,

like gastric bypass, improves liver condition " . [44]

Most Traumatic Procedure?

Carmichael touches only briefly on the BPD procedure stating, " This

procedure is the most traumatic of all anti-obesity procedures and

induces massive metabolic changes " . However, the author neglects to

include a single reference or give a single clinical case to

substantiate his claim. [39]

Metabolic Complications

In 1993, Sugarman reported that with the classic BPD there are

problems with " severe protein-calorie malnutrition, … fat soluble

vitamin deficiencies, calcium loss, and iron deficiency. " [34]

I will discuss each of these issues and what the most recent

literature reports on them:

Protein Malnutrition (PM):

Scopinaro reports in 1998 that, in the classical BPD procedure,

increasing the mean gastric volume to 350ml reduced the incidence of

PM to 15.1%. Increasing the length of the alimentary limb to 300cm

for patients with a carbohydrate rich diet reduced the incidence of

protein malnutrition to 3%. [16]

Clare shows that modifying Scopinaro's procedure by using equal limb

lengths for the alimentary and bilio limbs reduces the rate of

protein malnutrition from 8% to 2%. Protien malnutrion generally

occurred in the first 6 months, with protein levels returning to near

normal levels at 3 years using the equal limb length technique [22]

Hess reports in 1998 that 8 out of 440 patients (1.8%) undergoing the

BPD/DS patients required revisions due to protein malnutrition or

excess weight loss. Rather than choosing a fixed limb length, Hess

choose to measure the small intestine and make the alimentary limb

40% of the total intestinal length while the common channel was made

to be 10%. The mean common channel was increased from 50cm as in

Scopinaro to 75cm. [17]

Marceau reports that by increasing the common channel from 50cm to

100cm, his yearly revision rate on BPD/DS is only 0.1% per year

compared with 1.7% for the classic BPD procedure. [19] This 17 fold

reduction in revision rate demonstrates a substantial benefit of the

DS procedure over the classic BPD procedure. Marceau also reported a

reduction in hospitalization rate for malnutrition dropped from

1.72%/year with the classic BPD procedure to 0.93%/year with the

BPD/DS procedure. [19]

Marceau in reviewing all the literature on BPD and protein

malnutrition concludes, " there are differences in surgical techniques

that may account for the different results and different

interpretations " . He goes on to say that " three factors that

influence the degree of protein deficiency after BPD (1) the size of

the remaining stomach (2) the degree of restriction to nutrient

ingestion (3) the initial nutritional state of the patient " [42]

In a modified version of the BPD/DS where temporary gastric

restriction was obtained by use of a self-dissolving band, Vassallo

reports " At 2 and 33 years follow-up there has been no case of

dysproteinemia " . [43]

To summarize, the modern literature reports a PM rate between 1-3%.

PM can be reduced by careful selection of the gastric volume, common

channel length, and total alimentary length.

Further, protein malnutrition is not unique to the BPD/DS procedure.

Kusher reports on a case of severe malnutrition after RNY surgery

[24]. Brolin reported that " , iron deficiency and anemia are

potentially serious problems after RYGB, " [30]

Iron Deficiency/Anemia:

Hess reports that 9% of his patients required iron supplementation

and that " all anemia were correctable with the proper iron or

surgical therapy. [17]

Scopinaro reports that Anemia appears only in BPD patients with

chronic bleeding (menstruation, hemorrhoids, or stomal ulcer).

Baltasar reports that oral iron was insufficient in 10% of the female

patients. [16]

Marceau reports that the prevalence of iron deficiencies dropped from

13% preoperatively to 9% postoperatively with the BPD/DS procedure.

Laboratory results indicate a slight drop in the mean serum iron

levels from 14 umol/L to 13umol/L with an associated drop in the

standard deviation. Marceau states " Iron malabsorption is relatively

easy to manage medically with oral iron and occasionally

intramuscular iron [19]

Clare reports that the incidence of anemia was reduced from 20% to

10% when the equal limb length technique was used. [22]

Here again, anemia is not unique to the BPD/DS procedure. Halverson

reported that " anemia developed on more than one-third of the

patients " following the RNY procedure. [25]

Fat Soluble Vitamin Deficiency:

Baltasar reports " liposoluble vitamins should be monitored, but so

far none of our patients have presented deficits " . [18] Marceau

reported that the serum levels of vitamin B12 were actually increased

slightly in the BPD/DS procedure and the percentage of patients with

abnormal serum B12 levels was 3% both pre and post operatively. [19]

Clare reported that the incidence of Vitamin A and D deficiency in a

group of patients with equal bilo and alimentary limbs was 0% and

1.4% respectively.

Once again the problem of vitamin deficiency is not unique to the

BPD/DS procedure. Rhode and Brolin report problems with vitamin B12

deficiency in post RNY patients. [26,27] Buffington reports vitamin D

deficiencies in both post-operative RNY patients as well as pre-

operative. [28]

Calcium Deficiency/Bone Loss:

Hess reports, " these results indicate that if the patients take their

vitamin D and calcium they can maintain the proper levels and in some

cases increase their calcium and vitamin D to levels higher than

those before surgery. [17]

Scopinaro reports that with the classic BPD procedure the " older and

heavier patients showed a sharp improvement in bone mineralization

compared with the preoperative state. " [16]

Marceau reports a drop in serum calcium levels from 2.28 (mmol/L)

preoperatively to 2.22 (mmol/L postoperatively). The rate of

abnormal levels of serum calcium did rise from 4% to 8%. Marceau also

states, " the incidence of bon fracture has been 2% per year, which

was within normal limits for the general population … further the

correlations of lower alkaline phosphate levels and higher phosphate

levels with time elapsed after surgery may represent a positive

trend. " The drop in serum calcium levels about ½ as large with the

BPD/DS procedure compared with the classic BPD/ procedure [19]

Clare states that " A major factor in the appearance of disturbed bone

metabolism is patient non-compliance with respect to diet and

nutritional supplements. Fortunately, it responds to aggressive

medical treatment " [22]

Concerns regarding calcium loss and osteoporoses have also been

raised for the Roux-en-Y procedure. Ott reports, " The biochemical

pattern suggests the development of metabolic bone disease following

RGB " . [29]

Sufficiency of data:

In your CPB 157 It is stated, " … this (BPD procedure) … is rarely

performed in the United States due to the high risk of various

metabolic complications. "

While the classic BPD procedure is rarely performed in the US, the

BPD/DS procedure is frequently performed. Currently there are 30 US

surgeons performing this procedure with 18 performing it as their

primary procedure. Thousands of BPD/DS procedures are done each

year. The metabolic complication rates have dropped dramatically now

that it is common practice to make the alimentary limb length 40-50%

of the total intestinal length [17,18,19,21].

Scopinaro published a paper 3 years ago based on over 2000 patients

who underwent the classic BPD. His report includes following patients

for up to 20 years, and he claims that this is the longest

longitudinal study ever reported on in the literature! [16].

Silio, in his long term study of the classic BPD states: " In

conclusion, biliopancreatic bypass surgery enables a significant

weight loss to be achieved together with an improved glycolipid

status without leading to nutritional deficiencies " [31]

Since BPD/DS is newer than the classic BPD procedure, the lengths of

the studies are shorter. However, in 1998 Hess reported on a series

of 440 patients who underwent BPD/DS followed up to 8 years. [17]

Marceau reports on 465 patients who underwent BPD/DS a mean of 4.1

years prior to his report. [19]

Baltasar reports on 125 patients who underwent BPD/DS, and Rabkin

reports on 105 patients who underwent BPD/DS.

By contrast, Dr. Wittgorve's paper on laprascopic RNY cites only 500

cases over a maximum of 5 years, and yet it is considered to be the

authoritative study on laprascopic RNY [23].

Regarding the 1991 NIH conference, the conclusions at that time were

groundbreaking. [33] However, 10 years of research, as well as

research prior to the 1991 conference but published after 1991

conference, have shown that some of the conclusion of that conference

need to be revised. Brolin states in 1996 that " It seems likely that

a consensus panel on the same subject would be worthwhile in the next

decade to carefully evaluate such procedures as biliopancreatic

bypass … " [32]

Specifically VBG has been shown to be rather ineffective, while

BPD/DS has been shown to be safe an extremely effective.

There now exists a large body of evidence to show that the

Biliopancreatic diversion (with or without duodenal switch) is safe

and effective (as long as it is modified from the classic procedure

to increase the common channel length).

Several thousand patients have been reported on with follow-ups as

long as 20 years. The author of your policy bulletin effectively

admits that it is as safe and effective as distal RNY (which is an

approved procedure) and more effective than proximal RNY. Over the

last 3 years there have been numerous articles showing the long-term

safety and efficacy of this procedure. Those that claim otherwise

are either confusing the procedure with JIB or are unaware of the

more recent data.

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