BATTLING OBESITY:
ONE DOCTOR’S
BARIATRIC SURGICAL
EXPERIENCE
THE OBESITY EPIDEMIC
More Americans struggle with obesity than ever before.
Diet and exercise simply aren’t enough for many patients with substantial weight to lose.1 Surgery has been shown to be the
best option for patients, and since the American Medical Association classified obesity as a disease in 2013, more patients are
eligible than ever before.2 Yet the number of individuals who choose surgery each year remains low.3
We know that bariatric surgery remains a critical treatment option for obese patients, and we are committed to delivering
innovative tools and resources to meet the demands of this growing patient group and those who treat them. From increasing
awareness of bariatric surgery in the community, to providing tools for a streamlined and consistent operating room
procedure—we support surgeons every step of the way. With our support, surgeons can focus on what is truly important—
helping patients win their struggle with obesity.
Meet Sabrina. As a family physician, Sabrina Tempesta M.D. is committed to her patients’ well-being. Yet when it comes to
counseling overweight patients about the grave health risks of obesity, Sabrina admits she holds her tongue.
Standing just over five feet tall, Sabrina is 350 pounds—morbidly obese. She knows first-hand what her overweight patients are
dealing with, as her many attempts over the years to lose weight through diet and exercise have
failed.
Ready to be a “success story,” as she puts it, Sabrina decided to undergo weight-loss surgery
at the age of 37. Bariatric surgeon Amit Trivedi, M.D., of Hackensack University Medical Center
in New Jersey, performed a sleeve gastrectomy, a laparoscopic procedure, reducing the size of
Sabrina’s stomach and removing the hunger hormone-producing part of the stomach.
“It’s very difficult to
address weight with
my patients when I
obviously have a
problem, too.”
-Dr. Sabrina
Tempesta
1
“I feel fantastic, I can’t believe the amazing results I’ve seen in
just a few weeks. I’m so excited for what the future holds.”
- Dr. Sabrina Tempesta
Sabrina is among the tens of millions of Americans4,5 who struggle with obesity, and have tried unsuccessfully to address it
through traditional diet and exercise. Sabrina says pursuing a different approach has made all the difference. At just one month
post-surgery, Sabrina has lost 27 pounds and says she has more energy and motivation than ever. In the few weeks since
surgery, her previously difficult-to-treat leg ulcer has healed, and she has discontinued her blood pressure medication.
Dr. Trivedi uses Medtronic products to help ensure consistent results for his patients—including Sabrina. “I appreciate
Medtronic’s commitment to surgeons and patients,” says Dr. Trivedi.
DANGEROUS COMORBIDITIES
Being severely overweight brings on a host of related health problems. Sabrina was in the early stages of adult onset diabetes,
and experienced deteriorating joints and a non-healing leg wound.
For patients like her, obesity creates a domino effect of serious health issues, including heart disease, stroke, type 2 diabetes
and certain types of cancer, some of the leading causes of preventable death.6,7
WHEN DIET AND EXERCISE ARE NOT ENOUGH
The National Heart, Lung, and Blood Institute advises that cutting calories, eating smaller portions and increasing physical
activity levels can lead to weight losses of 5 to 10 percent over the course of four to six months.8 While beneficial, this may not
be enough to reverse some of the obesity-related medical conditions such as high blood pressure and type 2 diabetes in obese
people. And unfortunately, most people regain the weight, and then some.
According to the National Institutes of Health, bariatric surgery is considered the most effective means currently available for
obese people to achieve substantial, long-term weight loss.2
THE RISE IN OBESITY IN THE U.S. 1961-2008
80%
70%
Extremely Obese
40%
30%
20%
10%
Obese
60%
Overweight
5.0%
60%
50%
5.4%
5.1%
6.2%
6.0%
3.0%
0.9%
13.4%
1.3%
1.4%
14.5%
15.1%
23.2%
30.9%
31.3%
32.9%
35.1% 34.3%
BMI<25
32.3%
32.1%
32.7%
33.6%
34.4%
33.4%
32.2% 33.6%
1972
1978 1990
2000 2002
2004
2006 2008
BMI>40
44%
52%
51%
41%
32%
10%
0%
1961
30-40
40%
26%
20%
31.5%
25-30
50%
30%
0%
2
PREVALENCE OF SIGNIFICANT
COMORBIDITIES PER WEIGHT10, 11
(AGES 20 AND OLDER)9
15%
7%
28%
23%
14%
10% 10%
24%
18%
16%
4%
DIABETES
15%
3%
ASTHMA
ARTHRITIS
HIGH BLOOD
PRESSURE
0%
CANCER
CENTERS FOR DISEASE CONTROL AND PREVENTION DATA SHOW:
In 1990, 10
states reported
the prevalence
of obesity to be
10%
10%
In 1990, no states
had an obesity
prevalence higher
than
or lower
5
15%
5
By 2014, 45 states
had an obesity
prevalence rate of
at least
25%
12
By 2014,
22 of
those states
were at
30%
30%
or higher12
CLINICAL EVIDENCE SUPPORTS WEIGHT-LOSS SURGERY
FOR OBESE PATIENTS
Weight-loss surgery provides medically significant sustained weight loss for more than four years in most patients.13 Studies
show that overall death rates in the surgery group decreased during an average 10.9 years of follow-up, compared with
matched subjects in the control group. Most patients fared well after surgery and showed a significant improvement in quality
of life.14, 15 Compared with obese people who had no surgery, patients who elected bariatric surgery had mortality rates roughly
half as high, five and 10 years after the operation.16
A COMMITMENT TO PATIENT AWARENESS AND EDUCATION
Deciding to have weight-loss surgery is a major step for an obese patient. Like Sabrina, he or she has likely tried many other
strategies over the years. Learning as much as possible about weight-loss surgery can help a patient know what to expect
before, during and after the procedure.
We are committed to patient awareness and education around obesity across the entire continuum of care, and provide a
plethora of resources to guide patients through their weight-loss journey. Patients can find information about the serious
medical implications of obesity, weight-loss options, the various types of bariatric surgical procedures and financial
implications, requirements to become a candidate for bariatric surgery and many other resources.
WEIGHT-LOSS SURGERY:
The Surgeon’s Perspective
Approaches to bariatric surgery have evolved over time as new technologies have been
developed. “The sleeve gastrectomy is the fastest growing bariatric procedure,” says Dr.
Trivedi. “It has minimal GI impacts, low complication rates and is well tolerated by patients.
And of course, it produces excellent weight loss results.”
The sleeve gastrectomy also offers patients additional benefits that contribute to weight
loss. “In the sleeve gastrectomy, we remove the part of the stomach that contains
the hunger hormone ghrelin,” says Dr. Trivedi. “Without ghrelin, appetite and cravings
decrease—and this contributes to weight loss.”
3
With the trend towards Accountable Care Organizations (ACOs) for the delivery of health care, the sleeve gastrectomy may play
a greater role in choice for weight-loss surgery due to its safe, reproducible results.
As obesity rates continue to climb, it becomes even more important to ensure continued positive results with the sleeve
gastrectomy. These positive results are achieved by creating consistency from one surgeon and procedure to the next. “It is
essential to provide our patients with consistent sleeves,” says Dr. Trivedi, “to ensure that this procedure produces positive
results and remains in favor.”
CHALLENGES WITH CONSISTENCY
While on the rise for its positive weight loss results and low complication rates, surgeons have noted a few inherent challenges
that they face with the sleeve gastrectomy procedure as more surgeons adopt its usage for their patients. First, there is not
a standard size recommendation for creating the sleeve—leading to wide variation in the final appearance. Second, there are
challenges during the procedure, such as spiraling of the sleeve, and placement or visualization of the bougie device (used
to “size” the stomach prior to transection). Ultimately, these challenges make it very difficult to compare results across
institutions.
GASTRIC POSITIONING
MOBILIZATION
TRANSECTION
REINFORCEMENT OF THE STAPLE LINE
Understanding the distinct challenges that surgeons face with sleeve gastrectomy, we have developed a suite of products to
help overcome some of these difficulties.
No Standard Sleeve Size Recommendation and Bougie Size Variability
During the sleeve procedure, surgeons insert a bougie into the stomach to “size it” prior to transection. This part of the
procedure can be challenging. The bougie is inserted by a certified anesthetist and can be difficult to place in the optimal
location toward the pylorus, and may become difficult for the surgeon to visualize—possibly adding time to the procedure.
It is also challenging to keep the bougie against the lesser curvature of the stomach to facilitate ease of stapling. With our
GastriSail™ gastric positioning system, LED lights allow for clear visualization of the bougie into the stomach.17 The suction
feature helps to keep the main tube stabilized against the lesser curve to provide a guide during stapling.17
Prior to creating the sleeve, the surgeon must dissect the stomach from the attached anatomy. The LigaSure™ Maryland Jaw
device was designed with the sleeve procedure in mind. It offers a curved jaw to allow a surgeon to follow the natural curvature
of the patient’s stomach while providing improved visibility of the tip and reliable hemostasis.18 This helps to facilitate a more
efficient procedure.18
4
Spiraling of the Stomach
Another critical step of the sleeve procedure is transection. During stapling,
surgeons are challenged with preventing spiraling of the stomach. This can lead to
strictures, or in some cases, leaks.19 The “sail” feature on the GastriSail™ system
works alongside suction to maintain alignment of the anterior and posterior
walls. This process can help to facilitate a more consistent sleeve.17 “Once the
GastriSail™ system hits the greater curvature, it flattens the stomach and pushes
the bougie against the lesser curve,”17 explains Dr. Trivedi. “This puts the stomach
in the optimum position to starting stapling.”17
We collaborate with surgeons
to understand their evolving
needs, and create solutions
to overcome challenges
both inside and outside
the OR. From access to
close, we offer a solution for
every step of the bariatric
procedure.
The GastriSail™ system works well in tandem with the iDrive™ Ultra powered
stapler. With infinite angles of articulation up to 45 degrees, the iDrive™ Ultra
stapler can be positioned in the appropriate location to create a straight staple line.
It provides a controlled, consistent firing speed to provide optimal staple formation compared with manual stapling.20 “With the
iDrive™ Ultra stapler, I can align my stapler perfectly parallel to the GastriSail™ system via the LED lights,” says Dr. Trivedi. “We
end up with a nice straight staple line and no inward scalloping.”
Our Endo GIATM Reinforced Reload with Tri-StapleTM technology is the only stapler on the market preloaded with tissue
reinforcement material to save time and waste in the OR.21 “Since using the Reinforced Reload, I’ve been using 1-2 fewer stapler
reloads in my sleeve procedures, on average,” says Dr. Trivedi. “This has helped make my procedures consistent and more
efficient.”
OUR SERVICES
We remain committed to providing education for patients and continued training opportunities for surgeons at all stages of
their career. Specifically, we provide a number of services to support hospitals in delivering better outcomes, opportunities
for improved patient satisfaction and operational efficiencies, MIS training opportunities, guidance on the rapidly shifting
reimbursement environment and more. Over the years, we have developed and implemented outreach programs working with
referral networks to enable productive conversations with their patients about obesity as well as how and where to refer for
treatment. To learn more, please visit www.medtronic.com /bariatrichealthpartners.
ABOUT US
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology,
services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world.
Medtronic employs more than 85,000 people worldwide, serving physicians, hospitals and patients in more than 160 countries.
The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
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REFERENCES
1
Ochner C., Tsai A.G., Kushner R.F., Wadden T.A. Treating obesity seriously: when recommendations for lifestyle change confront biological adaptations. Lancet
Diabetes & Endocrinology 2015; 3(4): 232-234.
2
Longitudinal Assessment of Bariatric Surgery (LABS). National Institute of Diabetes, Digestive and Kidney Diseases. http://www.niddk.nih.gov/healthinformation/health-topics/weight-control/Bariatric-Surgery/Pages/labs.aspx. Accessed January 6, 2016.
3
Mechanick J.I. et al. Clinical Practice Guidelines for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Surgery Patient--2013
Update: Cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery.
Surgery for Obesity and Related Diseases 2013; (9): 159-91.
4
Ogden C, et al. JAMA 2014; 311(8): 806-814.
5
Obesity Trends Among U.S. Adults Between 1985 and 2010. Centers for Disease Control and Prevention. http://www.cdc.gov/obesity/downloads/obesity_
trends_2010.pdf.
6
Malnick S.D., Knobler H. The medical complications of obesity. QJM 2006; 99(9):565-579.
7
Adult Obesity Facts. Centers for Disease Control and Prevention. http://www.cdc.gov/obesity/data/adult.html. Accessed January 6, 2016.
8
National Institutes of Health, National Heart, Lung, and Blood Institute. Aim for a Healthy Weight Facts about Healthy Weight, Accessed March 15, 2016.
http://www.nhlbi.nih.gov/health-pro/resources/heart/aim-facts-html.
9
National Center for Health Statistics Data. Centers for Disease Control and Prevention. http://www.cdc.gov/NCHS/data/hestat/obesity_adult_07_08/
obesity_adult_07_08.pdf. Accessed January 6, 2016.
10
Mokdad A.H., Ford E.S., Bowman B.A., et al. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA 2003;289:76.”
Calle E.E., Rodriguez C., Walker-Thurmond K., et al. Overweight, obesity and mortality from cancer in a prospectively studied cohort of US adults. New Engl J
Med 2003; 348:1625.
11
Prevalence* of Self-Reported Obesity Among U.S. Adults by State and Territory, BRFSS, 2013. Centers for Disease Control and Prevention. http://www.cdc.
gov/obesity/data/prevalence-maps.html. Accessed January 6, 2016.
12
Wittgrove A.C., Clark G.W. Laparoscopic gastric bypass, Roux-en-Y- 500 patients: technique and results, with 3-60 month follow-up. Obes Surg 2000;
10(3):233-9.
13
14
Sjostrom L. et al. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med 2007; 357(8):741-52.
15
Sullivan M. et al. Why Quality of Life Measures Should Be Used in the Treatment of Patients with Obesity. International Textbook of Obesity 2001; 485-510.
16
Arterburn D.E. et al. Association between bariatric surgery and long-term survival. JAMA 2015; 313(1):62-70.
Bench top testing, cadaver lab with 4 surgeons, Comparison of GastriSail versus Standard Bougie in Sleeve Gastrectomy in a Cadaver Model Report # PCG025_r1 1/13/15.
17
18
Based on independent surgeon feedback collected during Covidien-sponsored porcine labs conducted on April 16-18, 2013 and April 30-May 3, 2013.
Barnard S.A., Rahman H., Foliaki A. The postoperative radiological features of laparoscopic sleeve gastrectomy. J Med Imaging Radiat Oncol 2012; Aug;
56(4):425-31.
19
When compared to ECHELON FLEX* Powered ENDOPATH* stapler with ECHELON Black Reload with Gripping Surface Technology. Covidien Engineering
Report # PCG-019 in an ex vivo porcine stomach model (p<0.015).
20
“Survey of tissue reinforcement users to determine waste and time loss attributed to separately loaded buttress materials in the OR.” Online national sample
of 125 surgeons and 125 OR nurses. Covidien-sponsored study by ORC International, November 9, 2011.
21
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