Should vBloc Neurometabolic Therapy Ever Be Performed?January 27, 2016
This article is written in response to Bariatric News: vBloc Neurometabolic Therapy.
How the vBloc Neurometabolic Therapy Works
The vBloc is the first new medical device approved by the FDA in 2015. Delivered by a pacemaker-like device, the Maestro® Rechargeable System, vBloc Therapy works by blocking communication on the nerve, the vagus nerve, which serves as the “highway” between the brain and the stomach. According to the manufacturer, by putting up a “roadblock” on the nerve, the communication stops, leading to less hunger and longer periods of fullness.
This device has been studied for many years with very poor results. As an experienced bariatric surgeon of 17 years, I have reviewed the data for weight loss for this device. I am quite baffled how this device ever received FDA approval, and how any ethical bariatric surgeon would recommend this device to patients.
The Study Results on vBloc/Maestro Device
The ReCharge study enrolled 239 patients of which 2/3 had the Maestro device implanted. The patients with the device implanted had 24.4% excess weight loss, as compared to the control group, that did not have the device, and lost 15.9% excess weight.
The study failed to meet its expected end points. At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss. 38% achieved 25% or more excess weight loss vs 32% in the sham (control) group that achieved 20% or more loss, and 23% that achieved 25% or more loss. The device, procedure, or therapy–related serious adverse event rate in the vagal nerve block group was 3.7%.
Important Info for Patients
This procedure is not a minimally invasive surgery but is quite involved and does carry serious potential risks and extensive laparoscopic dissection to place the leads around the vagus nerves. It is true that it probably has fewer risks than the other traditional weight loss surgeries, however, the incision required to implant the device below the skin is quite large. It is much larger than is required for the Lap-Band or Laparoscopic Vertical Sleeve Gastrectomy.
Another burdensome part of this procedure is that the patient needs to recharge the device each evening. It makes no sense to offer this procedure to patients when there are alternatives that offer dramatically better weight loss results, require much smaller incisions, are covered by insurance, and require no daily maintenance of recharging a device each evening. I find it unethical for any surgeon to offer this procedure with nominal weight loss results, and not covered by any insurance when there are superior procedures available that are covered by insurance.
The manufacturer's website states that this procedure is “a weight loss option that allows you to eat the same kinds of foods as friends and family, a safe alternative that provides meaningful weight loss without impacting your lifestyle.” These are clearly misleading advertising claims on the manufacturer’s website.
How is it possible that you can eat the same kinds of foods as friends and family and lose weight? How is it possible that you continue your current lifestyle that has contributed to your weight gain and lose weight?
After this device was approved by the FDA, I was approached by the manufacturer to offer this procedure in my practice, The New York Bariatric Group. After reviewing the data and costs, I determined that this is not a procedure that should ever be offered to bariatric surgery patients.
It is important that bariatric surgeons be knowledgeable about all of the procedures available to patients, and educate them about the various options. To offer a “new” procedure to appear as though you are on the “cutting edge” when the benefits to a patient have been shown to be minimal, making large incisions in a patient’s abdomen as well as charging tens of thousands of dollars seems completely unethical.
It is important for the industry to develop new technology that is less invasive and offers excellent results to the public. Bariatric surgeons that support the industry should abandon procedures when studies fail to show adequate results.
ABOUT THE AUTHORDr. Shawn Garber completed his general surgery training at Long Island Jewish Medical Center and went on to complete one of the first advanced laparoscopic surgery fellowships in the country at the The George Washington University Medical Center with world famous laparoscopic surgeon Dr. Jonathan Sackier. Dr. Garber then trained with Dr. Alan Wittgrove mastering the laparoscopic gastric bypass procedure. For more information, visit http://www.bellyballoon.com and http://bariatric.stopobesityforlife.com
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