ASMBS: Gastric Banding Gets Low Marks

Here is another:

TITLE:
LAPAROSCOPIC ADJUSTABLE SILICONE GASTRIC
BANDING FOR OBESITY
AUTHOR:
Jeffrey A. Tice, MD
Assistant Professor of Medicine
Division of General Internal Medicine
Department of Medicine
University of California San Francisco
PUBLISHER:
California Technology Assessment Forum
DATE OF PUBLICATION:
October 28, 2009
PLACE OF PUBLICATION:
San Francisco, CA


QUOTES FROM ABOVE STUDY:

"Long-term complications were more common in the LAGB group and several studies reported large differences in the rates of long-term complications. For instance, in the first trial with matching,67 early complications occurred in 21 patients in the RYGB group and 18 patients in the LAGB group with those in the RYGB requiring reintervention with endoscopic dilation or reoperation in 11 patients compared with only one patient in the LAGB groups. However, the opposite was true for complications occurring after 30 days. There were 14 significant complications, with 11 requiring reoperation in the RYGB group compared with 45 major complications and 27 reoperations in the LAGB group. The length of follow-up was greater in the LAGB group, which may partially explain the difference in the number of major complications. However, the reoperation rates were also higher in the LAGB group in the other trial with participants matched not only on patient characteristics, but also date of surgery (24% LAGB group vs. 19% RYGB group).67 Long-term reoperation rates were also much higher in the LAGB group than the RYGB group in four of the nine other comparative trials reporting reoperations.66, 70, 74, 100 "


Patient satisfaction and quality of life:
Only two of the studies directly comparing LAGB to RYGB reported data on patient satisfaction.66, 91 In the first study, nearly 80% of patients in the RYGB group reported being very satisfied with the procedure and none of the patients in this group were unsatisfied or regretted having the procedure.66 This compares with 46% of the patients in the LAGB group being very satisfied with the procedure and 19% of the patients in the LAGB group reported being unsatisfied or regretted having had the procedure (p=0.006 between the two groups).

Excess weight loss was significantly less for LAGB at all time points including one year (36.5% vs. 64.3%, p<0.05) and four years (45.4% vs. 68.4%, p<0.05). At four years, patients in the LAGB group also had a higher average BMI (35.7 vs. 30.5 kg/m2, p<0.05). Differences in excess weight loss and BMI were stable after the first year. Weight loss failure, defined by the investigators excess weight loss less than 20%, occurred more often in the LAGB group (16.7% vs. 0%, p not reported but less than 0.001 by my calculation). Weight loss was excellent or exceptional (more than 60% of excess weight lost) for 15% of the patients in the LAGB group and 64% of the RYGB group (p not reported, but less than 0.001 by my calculation.

The trials support the general conclusions drawn from the observational trials: mortality is very low with both procedures, perioperative and 30 day outcomes strongly favor LAGB, but weight loss outcomes, overall success rates, and resolution of obesity associated co-morbidities strongly favor RYGB.

Compared to laparoscopic RYGB, LAGB is a technically less demanding procedure with shorter operating time, shorter length of hospital stay, and fewer initial complications.

There is a risk that commercial sponsorship of LAGB may promote the use of these devices over RYGB, which has no commercial sponsor.

Current data clearly demonstrate that weight loss after one to five years is much greater among patients treated with RYGB than among those treated with LAGB. The data regarding measures other than weight loss are less robust, but the findings suggest that significantly more patients would be cured of their diabetes, obstructive sleep apnea, hypertension, and other obesity-associated comorbidities if treated with RYGB rather than LAGB. These effects may in part be mediated by hormonal changes in ghrelin, GLP-1, GIP, and PYY that decrease appetite, increase the sensation of satiety, and increase insulin responsivenes to glycemic loads. When asked, patients who underwent RYGB are more satisfied than comparable patients *****ceived LAGB.

No deaths, hey? How about this obituary:

PARKS

By T.L. Hamilton

Updated: 12.04.08

THE WOODLANDS - Dr. Leslie Parks, a well-known obstetrician/gynecologist in
the community, died from an infection related to a gastric banding procedure,
according to a coroner's report.

Parks, who worked at Woodlands OB Gyn Associates, was vacationing with her
family, including Parks' 2-year-old twins Virginia and Lucas, in Telluride,
Colo., more than a week ago when she appeared to have altitude sickness along
with the rest of the family.

"But she seemed to be suffering more than the rest of us," her husband
Scott Finley said Monday. "She's a doctor, so the whole time she was trying
to diagnose herself, you know, ruling things out."

She died sometime during the night of Nov. 24.

The coroner's report revealed the mysterious death of a seemingly healthy
38-year-old woman.

Parks died of strepto****al sepsis, or blood poisoning, due to a "massive"
intra-abdominal infection, said Bob Dempsey, coroner for San Miguel County in
Colorado.

"The infection was due to complications of gastric banding," he said.
"She had the surgery three weeks before she died, during he first week of
November."

Gastric banding can bring dramatic weight loss for patients by placing a
restricting band around the stomach to create a small stomach pouch and
restricted opening through which passage of food will be slowed, according to
the National Institute of Health.

On Thursday, Finley declined comment for this story, saying it was too early
for him to discuss Parks' cause of death.

Her father Hubbard Parks, an attorney in San Antonio, said it is "much too
early at this point" to discuss whether the family will seek legal action
against the surgeon, who he and Finley declined to name.

The U.S. Food and Drug Administration approved the procedure for use in June
2001.

I came within a day of biting The Big One from my lapband strangling my guts. My original doctor told me to "get a hobby." I found a new doctor and he wanted to operate on me right that minute. He told me, "You're gonna die if we don't fix this RIGHT NOW."  It was simply by the grace of God that I didn't die from my botched lapbanding.

The belief that the lapband is "reversible" is so insidious. It's NOT reversible. It's removable. And if you're one of the  lucky ones, you'll have it removed in time to save yourself from irreparable damage. ("You" used in the general sense of the word, of course.)

You can read this whole study at the reference listed at the bottom of this post.

But here's a few salient quotes. INTERESTINGLY, contrary to what some of the lapband cheerleaders incorrectly state - which is that there are always symptoms of erosion or slip and that if people just did the right thing (since they definitely have symptoms) - no problem - read below:

Complications after laparoscopic adjustable gastric banding reported in the radiology literature include pouch dilatation, band slippage, and access port complications [5, 8, 9]. As the results of long-term follow-up have become available, a new complication has appeared: intragastric band erosion, in which the silicone ring penetrates the gastric wall and, in some patients, the lumen of the stomach [4, 10]. Erosion of prosthetic material previously had been reported after other bariatric procedures such as vertical banded gastroplasty [11]. It typically is a late-stage complication caused by chronic ischemia due to pressure applied to the gastric wall.
In a review of literature, the reported prevalence of intragastric band erosion varies from none to as much as 11% [4]. These variations could be due to differences in the length of follow-up and the type of routine studies performed during follow-up. In a series of 119 patients reported by Silecchia et al. [4] with a minimum follow-up period of 12 months (mean follow-up, 32 months), the rate of band erosion was 7.5% because all patients, even if asymptomatic, underwent routine gastrointestinal endoscopy. In that series, all patients with eroded intragastric bands were asymptomatic at the time of endoscopic diagnosis. However, if routine endoscopy had not been performed, it is likely that the observed prevalence of erosion would have been lower, with more salient clinical symptoms in most diagnosed cases. Clinical manifestations include nonspecific epigastric or abdominal pain, cessation of weight loss, gastrointestinal bleeding, abdominal abscess, and abscess at the port site. One of our patients presented with peritonitis and pneumoperitoneum. The appropriate treatment of intragastric band erosion is still controversial, including endoscopic follow-up in asymptomatic patients, intragastric endoscopically assisted removal of the band, or laparoscopic band removal (as performed in our series).
A prospective evaluation of intragastric band erosion using barium swallow and upper gastrointestinal endoscopy found that gastrointestinal series could not reveal band erosion in its early stages [4]. However, the radiologic appearance of later-stage intragastric band erosion on upper gastrointestinal series is pathognomonic. Barium swallow shows a flow of contrast material around the part of the band that has eroded into the stomach. If symptoms suggest intraabdominal abscess or open perforation, CT should be used to assess the presence of perigastric abscess or extravisceral air associated with the erosion.
In conclusion, intragastric band erosion is a major complication of laparoscopic adjustable gastric banding, often leading to additional surgery. The prevalence of this complication will probably increase over time because patients may remain asymptomatic for long periods and because band erosion occurs long after band placement. Radiologists in charge of postoperative evaluation of patients after bariatric surgery should be aware of the characteristic imaging findings of this underreported complication to detect it at the earliest possible stage.
Here's the reference:

AJR 2005; 184:109-112
© American Roentgen Ray Society
________________________________________Original Report
Intragastric Band Erosion After Laparoscopic Adjustable Gastric Banding for Morbid Obesity: Imaging Characteristics of an Underreported Complication
Bernard Hainaux1,2, Emmanuel Agneessens2, Erika Rubesova1, Vinciane Muls3, Quentin Gaudissart4, Constantin Moschopoulos1 and Guy-Bernard Cadière4
1 Department of Radiology, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles, 322 rue Haute, Brussels 1000, Belgium.
2 Department of Radiology, HIS Site Etterbeek-Ixelles, 63 rue Jean Paquot, Brussels 1050, Belgium.
3 Department of Gastroenterology, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles, Brussels 1000, Belgium.
4 Department of Gastrointestinal Surgery, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles, Brussels 1000, Belgium.
Received March 4, 2004; accepted after revision May 11, 2004.

http://www.ajronline.org/cgi/content/full/184/1/109

Ok when I read reports like this, my first question is “What is this reporter’s and/or researcher’s agenda"? As a famous man once said “Oh, people can come up with statistics to prove anything. 14% of people know that" That famous man was Homer Simpson. D’OH !!

 

Being from a media background, my first question is .. I would like to know where these researchers got all their data. I would also like to know if the research is independent, or working for a company that may have an agenda (such as a company who don't like band devices). Then I would like to know the “history" of the individuals who failed. And try to find out why they failed. Was it device or personal? Did they continue following the rules, did they continue to follow-up with their Doctors, did they continue to take their vitamins/supplements, etc? Studies do show that if a person DOES NOT adhere to what they are suppose to do, they WILL FAIL!!

 

Remember bariatric surgery is a PARTNERSHIP between the individual and the TOOL (be it device or physical alterations). The device ALONE WILL NOT ENSURE SUCCESS

 

With that said, prior to having the operation I did a LOT of research, and to be honest if the band’s success rate was poor I would have never gone through it. And if it was truly poor, why would Doctors continue to do it?

 

The prolong success rate for diet ALONE over five years is 10%. Bariatric surgery success is between 55% and 80% (depending on which operation one has). Band is the lowest, but bypass and Duodenal switches aren’t too far ahead (around 60%)

See: http://www.bariatric.us/bariatric-surgery-results.html

 

The NIH cited clinical studies that show, following weight loss surgery, most patients lose weight rapidly and continue to do so for 18 to 24 months. Patients may lose up to 50 percent of their excess weight in the first six months and 77 percent of excess weight within one year of surgery. Patients were also able to maintain 50 to 60 percent of their weight loss 10 to 14 years after surgery

 

 

http://www.ynhh.org/healthlink/womens/womens_12_02.html

 

 

So far, two years out, I have lost between 185 and 190 pounds. I have surpassed the "band average". So again, who can believe "the numbers".

OK I am off my soapbox !!

"So far, two years out, I have lost between 185 and 190 pounds. I have surpassed the "band average". So again, who can believe "the numbers". "

This is annoying.  The average is there as a median - you realize that there are people who are much lower than average and some (like yourself) who are much higher than average, yes?  Your impressive loss does not refute "the numbers" any more than the 1/100 (or fewer) people who use Weigh****chers that loses 200 pounds and keeps it off for life through diet and exercise.  There's a reason commercials who tout those who beat the average (like yourself) have a disclaimer at the bottom that says, "Results not typical."

Your results are not typical.  Your results are impressive, but they do not negate "the numbers."

As for the website you're referencing, I've been there before and have never quite figured out why that website exists, quite honestly.  Who runs it?  Why do they run it?  The amount of google ads made me initially think that they were just pulling in ad hit dollars, because the lack of a page explaining who runs the show is a stark absence.  Regardless, I will refer you here:

http://obesity1.tempdomainname.com/education/advisor.shtml
American Obesity Association.  HEAVILY referenced article.  Says the following about the band in particular: A three year study with Lap-Band resulted in 62% of patients who lost at least 25% of their excess weight; 52% lost at least 33%; 22% lost at least 50% and 10% lost at least 75%

You are in the 10% range.  Your results are not typical.  Here's what they say about the malabsorbtive procedures:
Over two years, gastric bypass surgery patients have been shown to lose two-thirds of excess weight.⁸  The success rate for weight loss for RGB is 68 to 72% of excess body weight over a three year period, and 75% for BPD.¹  After five years, the average excess weight loss from gastric bypass surgery ranges from 48 to 74%

(sadly, they speak of the BPD but not the full DS).

Also, here's a link with some additional info:
http://www.thinnertimes.com/weight-loss-surgery/lap-band/lap -band-complications.html

Study #1 says that gastric banding looks promising in the first few years then results decline. Appx 60% of banded patients without major complications will maintain "an acceptable EWL" (excess weight loss) in the long term.  Additionally, every year the band stays, in, there is a 3-4% increase in the chance of major complications.  It says there's a 40% 5 year failure rate, 43% 7-year success rate (EWL > 50%), and concludes "LGB should no longer be considered as the procedure of choice for obesity."

... I do note, that with such an affirmation in the conclusion of the article, one might want to investigate the researchers prior to singing the conclusion to the rafters.

The second article specifically addresses those 10% of GBand patients who need a second operation due to insufficient weight loss or complications of the device.  Of those who were operated on a second time, the 5% annual fail rate seemed to be corrected, and then 73% of the patients achieved the success rate for weight loss (again, defined at >50% EWL).

The third study is more promising, noting that LABG patients enjoy appx 60% EWL after 8 years (with the caviat that they weeded out those whom the device failed), and mean BMI dropped from 46.8 to 32.3.

I am not posting to either begin, or continue, an argument. While many folks may have a negative view of the band, there are many of us successful folks who are thrilled with our results.

 

I know folks who have had bypass and have gained all their weight back, only to have a band on top of the bypass. I know folks who had bands, only to eventually get a bypass. As with ANY operation, there will be those who thrive and those who will fail. When someone fails, what needs to be investigated is WHY they failed. Was it the operation or the person's lack of adhereing to what is demanded of them.

 

It seems some bariatric folks fall into the “my operation is the best operation" mindset, and I find that upsetting.

 

I’ve seen DS patients argue with RYN patients who argue with Band patients who argue with Sleeve patients who argue with BIB patients, etc.

 

We should be happy that, no matter which operation we had, we are trying to get ourselves healthier. For a bunch of people who were “oppressed and prejudiced" because of “our condition", it’s disheartening to see when there is no room for acceptance and assistance of another person’s bariatric choice.

 

As I mention in many seminars, for me bariatric surgery is like going to New York City. Some folks take a car; some take a bus; others trains; others boat; few take planes; some take the Tunnels; other Bridges – how and what device you use to go on the journey isn’t what’s important, what is important is getting to the final destination.

 

I can finds tons of articles which would be pro band, and anti-other options. But what's the point? As I said from the beginning: no matter what article you read, you need to ask yourself “WHAT IS THE WRITER’S AGENDA?"

 

I won’t belabor this any longer, except to tell ALL WHO HAD BARIATRIC SURGERY – I admire your strength in having an operation; I admire your strength in deciding the operation you choose, I admire your strength in continuing to make your decision work for you; and I am here to help and/or support you as you travel along this journey.  

"We should be happy that, no matter which operation we had, we are trying to get ourselves healthier."

I do not disagree with that at all.  My primary point of contention is to using the exception to the rule (e.g., your drastic weight loss) to dismiss the facts when it comes to average excess weight loss.  Those who are considering banded surgery must know the facts going in - and the fact is that your tremendous success is an exception to the rule and should not be used as a primary measuring stick.

Questioning the agenda of the researcher and publisher of studies is necessary and prudent.  Knowing the background and/or agenda of the researchers can reveal bias.  Even if the bias is recognized and accounted for, it may be under or over compensated so we still need to be aware of it.

Statistics are important because we generally cannot look at each case and evaluate how each person performed, for a number of reasons:

1) The information simply is not available to us, the public;
2) Often, the information on compliance is subjective.  A patient's perception of their compliance may not reflect actual compliance.
3) Time.  Aside from the detail information not being available, we wouldn't have time to assimilate it if it were available.

Additionally, from a human standpoint, we tend to explain away negatives and emphasise positives of the option we would prefer, so not only is researcher bias important, but our own bias is equally important, which is one reason statistics are perhaps more useful since they are harder to explain away.   But, the tendency is still there, we go to studies that show what we would like them to show, or point out (and perhaps over emphasise) perceived or possible flaws in a negative study.

So, to get an overview of the situation, the scientists (or doctors) compile data from patients, preferably a lot of patients.  From this, we get 'statistics'.  And, as noted by Mark Twain "There are lies, damned lies, and statistics."  Statistics can be manipulated to illustrate what the Statistician wants to demontrate if such a bias exists.

All of this is roughly agreeing with the previous post.

What people don't get with Statistics is they are not predictive.  If 60% of people in the study succeed, that doesn't mean YOU or I will succeed 60% of the time.  It means only what it states, ie That in the study, with the study parameters, 'X'% of the study poplulation experienced situation 'Y'.  Statistics are a statement of PROBABILITY.

As an example, if 90% of people die from a surgery, I think we can agree it is a dangerous surgery.  Once you've HAD the surgery, 90% doesn't matter.  You either died, or didn't.

So with made up numbers so I don't have to go research for an example, the LapBand may not 'be successful' (however that is defined in the study) for 70% of patients.  But once you've had the surgery, the percentages don't matter anymore.  Now, you are a study of ONE, and what happens with you is what happens with you.

Now, if you look at the Statistics of the different surgeries, you are comparing Risk and Reward rates.  Using the same measurements, DS may have a 75% success rate, RNY may have 65%, LapBand 35%.  On the flip side, DS may have a 50% complication rate, RNY 40%, Lapband 45%.  We use these statistics to look at probabilities, but once we have whichever surgery, the statistics are meaningless and we are now in our own study of ONE.

We always hear that smoking causes people to die younger (studies demonstrate this effectively), but you will read of Joe or Jane Blow that smokes 3 packs of non-filtered Camels a day and are still ticking at 107 years old.  They just beat the odds, it doesn't mean everyone can get away with it.

did you read the article?

"No outside funding was reported for the study. Aarts reported that he had no relevant disclosures."

"Aarts and colleagues evaluated results in 201 patients who had laparoscopic adjustable gastric banding procedures during 1995 to 2003. All the patients had rigorous follow-up at three-month intervals during the first year and then annually thereafter. As a result, 99% of the patients had complete follow-up data, which spanned an average of 9.6 years."

Action Points  

---

• Explain to patients that this study showed that weight loss achieved with adjustable gastric banding was not maintained over time in most cases.
  
  
   
• The findings were based on a retrospective review of medival records at a single hospital in The Netherlands. The findings' applicability to use of adjustable gastric banding in the United States is unclear.
  
  
   
• Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
   

What kind of agenda would you suggest?