Gilbert Simoni, MD, of Los Robles Hospital in Thousand Oaks, Calif., and founder of Advanced Gastroenterology, Inc. recently performed his 100th transoral incisionless fundoplication (TIF) procedure. Here, Dr. Simoni discusses his experience performing TIF procedures and what he believes it means for the future of GERD treatment. Question: Why do you think TIF is an important step forward in GERD treatment?
Dr. Gilbert Simoni: Currently, TIF is the only completely endoscopic procedure for the treatment of GERD that truly rebuilds the patient’s anatomical valve. For decades, we simply had at our disposal two choices; medications or invasive surgery. Medications have several published side effects around long term use and surgical interventions were accompanied by longer periods of anesthesia, hospitalization and the risk of a higher complication rate.
Approximately six years ago the FDA approved the EsophyX device used to perform the TIF procedure. This device essentially uses the same principles as surgical interventions such as Nissen fundoplication, but without the need for incisions on the body. Like more invasive surgery, TIF repairs the dysfunctional valve but without the high risk of side effects, complications or longer hospital stays.
The TIF procedure does not place any foreign objects into the body like some past failed and even some currently available reflux treatments. Living with a foreign object inside the body is a concern for many of my patients.
TIF has been highly effective. Nearly 100 percent of my patients have completely stopped using medication and are free of their GERD symptoms after the TIF procedure.
Q: How long has TIF been a part of your practice?
GS: I have been performing the procedure since December of 2009. AGI Medical was the first GI practice to offer TIF on the West Coast. We are proud to have recently completed our 100th case and pleased to see the widespread acceptance of TIF by the local medical community.
Q: What kind of recovery time do patients generally require after the procedure?
GS: TIF is incision free so I can generally manage each case as an outpatient procedure. I like to observe the patient for up to 6 hours and sometimes they stay overnight. There are some dietary restrictions that last over a six-week period. For the first week post-procedure, patients will be on a liquids-only diet. During the second week patients progress to a soft foods diet, such as pudding or mashed potatoes. In week three and four patients can begin to take on foods such pasta or fish. During the final two weeks they can begin having breads and meats.
Patients will generally have a sore throat for a few days from intubation and some bloating due to some swelling around their new valve. There may be some belching and mild difficulty in swallowing. However, after two to three weeks, these side effects go away permanently. To date, in over 100 TIF procedures I have never had a patient experience chronic discomfort.
To allow the patient’s new valve to heal properly there are some restrictions around strenuous physical activity in the first month after the procedure. Patients who have a sedentary office type job are able to return to work within 2-3 days. Those who engage in more physically active work will need 3-4 weeks of light duty before returning to their full work capacity.
My patients all say it’s worth it!
Q: What kinds of equipment do physicians need to perform TIF procedures?
GS: TIF requires a disposable device called the EsophyX and a flexible endoscope. The EsophyX device fits over the endoscope and is passed through the mouth into the stomach. Once in the stomach the camera on the endoscope provides visualization for the physician to rebuild the patient’s valve.
Q: What type of training do physicians need to begin performing TIF procedures?
GS: There is a definite learning curve. I actually serve as a faculty trainer for the procedure and train other surgeons and GI physicians. The training includes a full day of didactic and hands-on learning. Afterwards, physicians have access to clinical support for their cases.
TIF works very well, but it can be a demanding procedure. A physician performing the procedure should be an interventional gastroenterologist or general surgeon with ample endoscopy experience. I believe it is necessary to have a lot of experience with endoscopic procedures prior to adopting TIF into ones practice.
Operating room or endoscopy technologists will need additional training to properly manage the scope for maximum visualization.
During the first 10 cases a physician performs the procedure will most likely take around 90 minutes. The key is to perform cases on a weekly basis as we do here at our Heartburn Treatment Program. My procedure time now is less than 40 minutes on average.
I would add that by approximately 50 cases a TIF physician would gain the expertise needed to teach others. This, of course, depends on the individual’s passion for the procedure and comfort level in translating their knowledge.
Q: Do you think TIF is overtaking existing procedures as the standard treatment for GERD?
GS: I predict TIF will become more adopted by the GI community. When I first started, only two other GI physicians were trained in the US to perform TIF procedures, and mostly General Surgeons were leading the implementation of this technology.
Now there are close to 25 GI’s trained in the US as they see TIF becoming an essential tool to treat reflux in their practice.
I think with the TIF procedure we have seen a dramatic difference in patients’ lives. Reflux can cause a host of seemingly unrelated health issues such as high blood pressure, sleep apnea and asthma. After TIF, we are seeing patients with these health issues stop taking medications for them along with cessation of their heartburn medicine.
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