Could Wash. U.'s Treatment for Obesity Lead to Fewer Amputations?

First U.S. incision-free procedure for obesity performed at Washington University



By Jim Dryden

July 24, 2008 -- Doctors at Washington University School of Medicine in St. Louis have performed the first non-surgical procedure in the United States that restricts the size of the stomach to treat obesity. The investigational procedure was performed under direct endoscopic visualization with specialized instruments passed into the stomach through the mouth. The first U.S. patient received the treatment on July 23 at Barnes-Jewish Hospital in St. Louis.

Photo by Tim Parker

Sreenivasa Jonnalagadda, M.D., and J. Christopher Eagon, M.D., performing the first TOGA procedure in the United States.

The procedure was performed as part of the TOGA Pivotal Trial, a multi-center study evaluating an incision-free procedure using the TOGA® System (transoral gastroplasty). Like surgery to treat obesity, the TOGA procedure is designed to alter a patient's anatomy to give a feeling of fullness after a small meal. The difference is that the investigational technique delivers the treatment through the mouth, without any incisions.

"This is a shift in the way we approach the surgical treatment of obesity," says Washington University bariatric surgeon J. Christopher Eagon, M.D., who is an assistant professor of surgery and local co-principal investigator for the study. "If this technique provides results close to those achieved with more traditional surgery, it may be an option for people who need to lose a great deal of weight but don't want to have surgery."

In the TOGA procedure, the physician introduces a set of flexible stapling devices through the mouth into the stomach, and then uses the staplers to create a restrictive pouch. The pouch catches food as it enters the stomach, giving patients the feeling of fullness after eating less. This study is evaluating the safety and effectiveness of the investigational procedure.

Between February 2006 and July 2007, 47 subjects had the TOGA procedure in a pilot study at medical centers in Mexico and Belgium. They weighed an average of almost 120 pounds over their ideal body weight. Six months after the procedure, subjects had lost more than a third of their excess body weight. By 12 months, their excess weight loss averaged almost 40 percent.

"That's not as great a loss as we see with gastric bypass surgery, which is still the 'gold standard' for weight-loss procedures," says Washington University gastroenterologist Sreenivasa Jonnalagadda, M.D., who is an associate professor of medicine and co-principal investigator at the St. Louis study site. "The key benefits from an endoscopic procedure as compared to laparoscopic or open surgery are quicker recovery period, shortened hospital stay, decreased risk of complications and an incision-free procedure. And if the restrictive pouch becomes bigger over time, as has been the experience with some obesity surgery patients, it may be possible in the future to further decrease the size of the pouch with this new generation of devices."

Carrie Williamson of Granite City, Ill., was the first U.S. patient. She was given general anesthesia when receiving the TOGA procedure and stayed overnight at Barnes-Jewish Hospital for observation.

Both Eagon and Jonnalagadda expect the TOGA procedure eventually could be performed on an outpatient basis with sedation rather than general anesthesia, depending on the study's results.

Subjects will be evaluated regularly for at least one year. All study-related medical care is provided at no charge, and patients receive medically supervised nutrition counseling. Because she was the first, Williamson knew she was getting the actual treatment, but during this study, one of every three volunteers will be a control patient, receiving anesthesia and an endoscopic evaluation of the stomach, without the TOGA procedure, for comparison purposes.

These control patients will be offered the TOGA procedure after 12 months if the procedure proves to be effective. Investigators will evaluate weight loss and monitor obesity-related health problems such as type 2 diabetes, cholesterol levels and hypertension.

"In patients undergoing gastric bypass surgery, it's common to see blood lipids and blood glucose levels normalize in the days after surgery, even before they lose any weight," Eagon says. "We may see similar benefits from this procedure, but we need to test that hypothesis."

The TOGA study will investigate the technique in at least 275 patients at centers across the United States. Investigators at the Washington University Medical Center site are planning to enroll at least 27 volunteers into the trial. Volunteers must be 18 to 60 years old and 100 pounds or more overweight. Some lighter patients may be considered if they have type 2 diabetes or high blood pressure. Patients with a recent heart attack, stroke, chest pain or severe reflux disease are not eligible.

Obesity affects more than 300 million people worldwide according to the World Health Organization. In the United States, the American Society for Metabolic and Bariatric Surgery estimates 205,000 patients had weight-loss surgery in 2007, but that number is estimated to be less than 2 percent of the eligible patient population.

"The TOGA procedure could provide another option for treating obesity," says Jonnalagadda. "Most of the common treatments — such as diet, exercise and drug therapy — have limited success in this population, and not everyone wants to have surgery, so this may help some patients who haven't had success with those more traditional treatments."

For more information about the TOGA study, patients or their families may call Volunteer for Health at 1-866-362-5656 or visit https://vfh.wustl.edu.

---

Manufactured by Satiety, Inc., the TOGA System is not currently approved by the U.S. Food and Drug Administration.

The TOGA Pivotal Trial is funded by Satiety, Inc.

Washington University School of Medicine's 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's Hospitals. The School of Medicine is one of the leading medical research, teaching, and patient care institutions in the nation, currently ranked third in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children's Hospitals, the School of Medicine is linked to BJC HealthCare.

Bill McLellan <bmclellan@pandocare.com> has sent you an article
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EXTREMITY GAMES BEGIN TODAY
Some of the top athletes in the world will show their stuff this weekend in southeastern Michigan, thanks in part to two Macomb County residents.

Advertisement

Two years ago, Eric Robinson of Warren and Beth Geno of Clinton Township, along with Stephanie Wallace of Florida, co-founded the Extremity Games, an extreme sports competition for amputees and other individuals living with limb loss or limb difference.

Today, the third annual Extremity Games begin with Moto-X and BMX competitions at Baja MX in Millington, near Birch Run. Other events, including skateboarding, rock climbing, wakeboarding, kayaking and mountain biking, will take place Friday and Saturday in Rochester and Pontiac.

:
http://www.dailytribune.com/stories/072408/spo_sports04.shtml

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Although a common indicator of PAD is extreme leg or buttock pain caused by walking or exercising, as many as 40 percent of people with PAD never complain of this symptom.

Peripheral Arterial Disease (PAD) Affects One in Three People with Diabetes

Michael Jaff, MD, Medical Director of the Vascular Diagnostic Laboratory at Massachusetts General Hospital, Boston, Mass.
17 July 2008

This press release is an announcement submitted by Massachusetts General Hospital, Boston, Mass, and was not written by Diabetes Health.

Peripheral arterial disease (PAD), a condition commonly correlated with diabetes, affects at least one in every three diabetics over the age of 501 and approximately eight million Americans over the age of 40. Although PAD is common among diabetic and senior populations, current data show that public and physician knowledge of the disease is startlingly low, with only 25 percent of the affected population seeking treatment.2

People with diabetes are at the greatest risk for developing severe PAD and experiencing complications from the disease, as they have difficulty properly processing the sugar they ingest. As a result, plaque (fatty deposits) accumulates in the arteries, triggering changes in internal blood vessel size and elasticity that cause subsequent circulation problems.

Plaque buildup causes a narrowing and hardening of the arteries and can eventually decrease the blood flow to the lower extremities. When blood flow to the legs becomes limited or restricted, the propensity for developing infections, chronic foot ulcers, gangrene and leg lesions dramatically increases. Not only that, but these foot wounds have difficulty healing. In severe cases, the affected limb is so damaged that amputation is required if other treatments fail. Problems with the feet are one of the most common causes of diabetes-related hospitalizations. In fact, people with diabetes are up to 15 times more likely to endure lower limb amputation than those without diabetes.3 Fortunately, new medical devices and drugs are being developed, and in many cases amputation can be avoided or limited.

Although a common indicator of PAD is extreme leg or buttock pain caused by walking or exercising, as many as 40 percent of people with PAD never complain of this symptom4 – and those who do commonly mistake the discomfort for aging pains and fail to seek treatment, allowing the condition to worsen. PAD is highly treatable in its early stages, but as the disease remains undiagnosed, the likelihood of complications greatly increases, as does the probability of heart attack or stroke.

The following are risk factors for PAD:

* Being older than 50 years old (1 in 20 Americans over the age of 50 has PAD)
* Being a current or former smoker (both have an up to four times greater risk of developing PAD)
* Having high blood pressure (high blood pressure increases the likelihood of plaque build-up in the arteries)
* Having a history of heart disease (chances of contracting PAD increase to one in three patients suffering from heart disease)
* Having high cholesterol (excess cholesterol and fat in the blood contribute to the formation of plaque in the arteries)
* Being African American (African Americans, for reasons not yet fully understood, are twice as likely to have PAD as their Caucasian counterparts)

Individuals who have PAD may also have plaques in the arteries to the brain and heart, which could cause stroke or heart attack, respectively. Early detection and treatment of PAD is essential to improve quality of life and reduce the risk of heart attack, stroke, and amputation among diabetics with the condition.

Several symptoms are warning signs and potential indicators of PAD, including:

* Fatigue or cramping in the leg muscles (known as claudication) when walking
* Pain in the legs and/or feet that disturbs sleep
* Wounds on toes, feet or legs that heal slowly, poorly, or not at all
* Color changes in the skin of the feet (paleness or blueness)
* A lower temperature in one leg compared to the other leg
* Poor nail growth and decreased hair growth on toes and legs

Physicians can quickly and easily test for peripheral arterial disease, which can allow patients to undergo treatment for the condition and effectively arrest the progression of the disease. The most common test is the ankle-brachial index (ABI), a noninvasive process that compares the blood pressure in the ankles with the blood pressure in the arms. An ABI can help determine if someone has PAD, but it cannot identify the location and degree of the obstruction in the artery. A Doppler test, which is also noninvasive, can check a specific artery for blockage. The Doppler test uses ultrasound waves to measure blood flow in arteries within the lower extremities.

Once a clogged artery is identified, patients can consider several treatment options with their physician. Angioplasty is a nonsurgical procedure that is used to widen arteries with constricted or blocked blood flow. During the procedure, a catheter with a balloon on its tip is inserted into the narrowed artery and inflated. Once the artery widens, the balloon is deflated and the catheter is withdrawn, often restoring blood flow.

Another option in certain arteries such as the iliac is a stenting procedure. In this process, a stent (a wire mesh tube) is inserted into the artery, where it is expanded to act as a “scaffold” to hold the artery open and allow blood flow to resume. The procedure is minimally invasive, as the stent is guided into the restricted artery with a catheter inserted through a small opening in the artery. Drug-eluting stents, which are coated with medicine that is slowly released into the artery, were created to prevent plaque from growing around the stent due to inflammation and forming scar tissue, a process called restenosis. These devices have shown clinical effectiveness in treating coronary artery disease.

An investigational device for PAD with this characteristic is the new Zilver PTX Drug-Eluting Stent (www.zilverptxtrial.com) from Cook Medical. Currently in clinical trial for use in the superficial femoral artery (SFA), the largest artery in the leg, the Zilver stent is coated with paclitaxel, a drug used as an anti-cancer agent and used successfully with coronary stents to reduce the recurrence of narrowing in the coronary arteries. The Zilver PTX stent was created to reduce arterial reblockage in the nearly 40 percent of patients who now must endure repeat procedures when arteries renarrow. The Zilver PTX Trial is currently enrolling patients having PAD in the artery between the groin and knee in clinical trial locations around the world, and has commercial approval in New Zealand, Singapore and Hong Kong. Future PAD studies will be conducted to examine the effectiveness of treating obstructions in arteries below the knee to the foot with this technology.

In situations where large sections of an artery are narrowed, arterial bypass is a surgical option. During leg bypass surgery, a vein from another part of the body or a fabricated blood vessel is sewn above and below the clogged area of the artery to detour blood flow around the blockage. Bypass surgery is a largely successful treatment option, but can be risky for patients who suffer from other disorders such as diabetes or high blood pressure.

People who have experienced any of the aforementioned symptoms or are at increased risk for PAD, especially those with diabetes, should speak to their healthcare professional immediately to schedule testing. Identification and diagnosis of peripheral arterial disease is critical, as early treatment can ultimately save a life.

Wii-Hab for Seniors

I found this story at KFMB in San Diego. You can also watch the video.

Video games are generally reserved for grandkids, not grandparents. But not anymore - a nursing home in Escondido is using the Nintendo Wii game system to rehabilitate its patients. It's called "Wii-hab" and it's changing lives.

Shirley Fisher is getting magical results with the wave of her hand. At 73 years old, Shirley is Wii-habbing her hip.

"Oh this is very cute… it's nice," she said.

On the screen, a younger video game version of Shirley struts her stuff. But in real life, Shirley is pitching away the pain. And it's not just baseball. Therapists are using bowling, and even tennis to motivate patients.

"First they just kind of 'I don't want to do that', well, let's try it and pretty soon after three or four treatments they ask us when can we do this," Gene Craven of Life Care of Escondido said.

It's 79-year-old Alejandro Gallegos' turn to take the mound. Up and out of a wheelchair, Alejandro is recovering from a lower leg amputation.

"Alejandro had a hard time. He wasn't too happy about things. He stayed in his room, now he comes out more and every time he sees it he just lights up," occupational therapist Rachel Solis-Hoover said.

Wii is working to help Alejandro grow stronger one Fountain of Youth fastball at a time.

"It's like when he was young. He feels strong, he feels good," Solis-Hoover said.

We want to wish Alejandro a happy birthday today and wish him well as he works his way towards a prosthetic leg.

P & O Care Expands South

Prosthetic and Orthotic Care is growing, and many of its new patients have been coming from areas south of St. Louis, like Washington, Jefferson, St. Genevieve, and Perry Counties. So, this provider of artificial limbs and braces has decided to open a new office across from Jefferson Memorial Hospital at 1479-D US Hwy 61, Festus, MO 63028. The new location will enable P&O Care to better serve its current patients and provide more localized service for rural Missourians who otherwise would have to travel to St. Louis. More accessible care means that patients will take a more proactive role in making sure that their devices fit safely and comfortably, and it increases the likelihood that a patient will actually wear their arm, leg, or brace—or actually fill that doctor’s order for diabetic shoes!

Fully staffed during the work week with certified prosthetists and orthotists, and equipped with a full-service fabrication laboratory, the new facility will be known as P&O’s Jefferson County Care Center. The company will also begin referring to their Missouri and Illinois locations as the St. Louis County Care Center and the St. Clair County Care Center. They will continue to operate their outfitted minivans, known as Mobile Care Units, which prosthetists and orthotists can drive to patient’s homes or nursing homes. From Festus, P&O Care will have better access to outlying towns like Potosi, De Soto, Farmington, St. Genevieve, Chester (IL), and Perryville. They will even go to Cape Girardeau.

Jim Weber, President of P&O Care, says he hopes to have the new facility operational by late July or early August. Until then, his company is willing to go the extra mile, even with gas prices as high as they are, to service the entire region south of St. Louis from their St. Louis County Care Center in Des Peres.

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Ratio of Prosthetic and Orthotic Practitioners to Potential Patients in State Population

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Healthcare Market Strategy

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From A Friend: ' New Drug Hoping To Heal Diabetic Foot Ulcers - Health News Story - WCVB Boston'

Bill McLellan has sent you a link: " New Drug Hoping To Heal Diabetic Foot Ulcers - Health News Story - WCVB Boston"

The link:
http://www.thebostonchannel.com/health/16820998/detail.html?taf=bos

STLtoday article: Choosing a hospital: A refresher course from bmclellan@pandocare.com

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has been sent to you by: "bmclellan@pandocare.com"

Choosing a hospital: A refresher course
By <A HREF="mailto:mjfeldstein@post-dispatch.com" CLASS="storyByline">Mary
Jo Feldstein</A>
ST. LOUIS POST-DISPATCH

Below is the link to the story.
http://www.stltoday.com/stltoday/business/columnists.nsf/maryjofeldstein/story/0919AF333159E14286257481000D7C69?OpenDocument

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STLtoday article: How we pay doctors is key to prognosis for prevention from bmclellan@pandocare.com

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prevention"-- has been sent to you by: "bmclellan@pandocare.com"

How we pay doctors is key to prognosis for prevention
By <A HREF="mailto:mjfeldstein@post-dispatch.com" CLASS="storyByline">Mary
Jo Feldstein</A>
ST. LOUIS POST-DISPATCH

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Oregon Mill Accident Victim Fit with iLimb Hand

Silverton man learning to live with bionic hand

James Bristol of Silverton shows his new bionic right arm.

Story Published: Jul 8, 2008 at 5:24 PM PDT

Story Updated: Jul 8, 2008 at 11:48 PM PDT

By KATU Web Staff

PORTLAND, Ore. - A Silverton man who lost his right hand in a mill accident is now one of the first people in Oregon to be fitted with a bionic hand.

James Bristol lost his hand about a year ago. Thanks to the revolutionary i-LIMB technology, his new bionic hand looks and acts like a human one.

Five individual motors power each finger, giving patients more maneuverability.

Bristol is now in the process of re-training his brain and his body using his new hand.

"You know you lose it and suddenly you are plunged into a whole new realm of doing things," he said. "So learning, you feel like a little kid that's learning to walk again."

The i-LIMB was launched last summer. Wounded soldiers from Iraq and Afghanistan are also being fitted with the prosthetic.

The hand can cost anywhere between $50,000 and $80,000.

The Care Digest Volume 2 Issue 2

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