Transoral Incisionless Fundoplication Scroll down for details of MUSE and EndoCinch
60 years of fundoplication have proved its efficacy in reducing reflux. For the last 20 years the operation has been performed laparoscopically offering minimal invasive surgery. There have been many attempts to develop a method of performing fundoplication via the oesophagus itself - endoluminal gastroplication.
The Esophyx® Transoral Incisionless Fundoplication device by Endogastric Solutions "enables the creation of a 2-3 cm, 270° esophogastric fundoplication by using proprietary tissue manipulating elements and 12 or more full-thickness polypropylene fasteners. The device is used in conjunction with a flexible video endoscope, which provides visualization throughout the TIF® procedure."
An article in World Journal of Surgery in 2008, "Anti-reflux Transoral Incisionless Fundoplication using EsophyX: 12-month results of a Prospective Multicenter study," written by surgeons employed by Endogastric solutions, concluded, "12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms." [r-ix]
This helped the device get FDA approval for use in the US.
However, the paper also stated, "Global assessment revealed that 56% of patients were “cured” of their GERD based on the clinically significant reduction of their heartburn and complete cessation off PPIs."
The fastener technique was being revised at this stage to produce Esophyx®2 with this optimistic message: "The tailored fastener placement technique (TIF2.0) is expected to further improve on these results and support the use of EsophyX-TIF for the treatment of GERD."
In 2009, another Endogastric solutions sponsored study published in Surgical Endoscopy [r-x] reporting "Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using Esophyx" concluded: "The results at 2 years supported the long-term safety and durability of TIF and its sustained effect on the elimination of heartburn, esophagitis, ≤2 cm hiatal hernia, and daily dependence on PPIs" with "a ≥50% improvement in GERD-HRQL scores compared with those at baseline on PPIs was sustained by 64% of patients."
A 2011 paper, "Clinical and pH-metric outcomes of transoral esophagogastric fundoplication for the treatment of gastroesophageal reflux disease," [r-xi] funded by Endogastric solutions, concluded: "using the EsophyX device significantly improved symptomatic and objective outcomes in over 70% of patients at median 6-month follow-up."
A review by MedGadget in 2013, "EsophyX for Transoral Incisionless Fundoplication (TIF) Proves Itself in Trial" [r-xii] reported, "Twenty-four months after the EsophyX2® device was used in TIF procedures, more than two-thirds of patients completely eliminated the need for daily proton pump inhibitor (PPIs) therapy. Symptom control achieved at six months remained stable over time indicating durability of TIF procedure."
A 2014 report published in the American Journal of Gastroenterology and reported in Medscape, "TIF Underperforming as Long-Term GERD Treatment" [r-xiii], concluded: "Although TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients, no long-term objective reflux control was achieved." Further, one of the doctors commentating on the findings stated, "Numerous uncontrolled trials have demonstrated rapid deterioration of TIF results. Since the TIF procedure does not allow mobilization of the gastric fundus, tension on the wrap causes the TIF fasteners to pull apart. The TIF procedure has no proven long-term benefit."
Medigus Ultrasonic Surgical EndostaplerIsraeli developed MUSE stapler is newer and still undergoing initial trials with first MUSE procedures performed in Turkey [r-xiv] and Italy [r-xv].
The tip of the stapler, guided by the video system, is bent round the fundus section at the gastro-oesophageal junction until too close to see clearly when the ultrasound takes over to ensure the staple is positioned through the correct tissue thickness.
A paper, "Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial" funded by Medigus, published in Surgical Endoscopy in 2014 [r-xvi], concluded: "The initial 6-month data reported in this study demonstrate safety and efficacy of this endoscopic plication device. Early experience with the device necessitated procedure and device changes to improve safety, with improved results in the later portion of the study."
As a result of this study, the system was FDA cleared and CE marked for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach.
NICE guidance on Endoluminal Gastroplication for Gastro-Oesophageal Reflux Disease [r-xvii] says, "The evidence on endoluminal gastroplication for gastro-oesophageal reflux disease (GORD) raises no major safety concerns. Evidence from a number of randomised controlled trials (RCTs) shows a degree of efficacy in terms of reduced medication requirement in the short term, but changes in other efficacy outcomes are inconsistent and there is no good evidence of sustained improvement in oesophageal pH measurements. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research."
It pulled some of the wall of the esophagus into a chamber at the end of a special endoscope where it was plicated (stitched) to form pleats.
Early reports were favourable. In 2003, the Britism Medical Journal, Gut reported: "The Endocinch procedure is an effective and safe outpatient procedure that offers GORD patients significant improvement in symptomatology, QOL, and reduced requirements for PPIs over at least a one year period." [r-xviii]
However, a couple of years later, the same journal reported a different story:
" Endoscopic gastroplication (EndoCinch) is a safe and minimally invasive endoscopic treatment for GORD with reasonable short term results. In contrast, long term outcome is disappointing, probably due to suture loss in the majority of patients. Therefore, technical improvements to ensure suture durability are mandatory before endoscopic suturing can evolve as a therapeutic option for GORD treatment." [r-xviv]
In 2007, another Gut article reported: "the retention of stitches seems to be a major problem reported with this technique" referenced in a Healthline item [r-xx] which also reported a German study of 2005 that recommended that, "even though it’s considered safe and easy to perform, EndoCinch endoluminal gastroplication shouldn’t be used as a treatment for gastroesophageal reflux disease 'until further technical refinements allow sutures to be maintained in the long term.'"
The manufacturers Bard, have since stopped producing the device.
Endogastric Solutions (who now market the Esophyx® TIF device described above), developed Stomaphyx® using a similar technique to suture the connection between the stomach pouch and small intestines resulting in slower emptying of the stomach and earlier satiety and more weight loss also shrinking the stomach pouch and making it small, similar to the outcome of the original gastric bypass surgery." However, like EndoCinch, long term outcomes showed the procedure wasn't durable. [r-xxi]
NICE guidlines on Endoluminal gastroplication for gastro-oesophageal reflux disease [r-xxviii] state, "The evidence on endoluminal gastroplication for gastro-oesophageal reflux disease (GORD) raises no major safety concerns. Evidence from a number of randomised controlled trials (RCTs) shows a degree of efficacy in terms of reduced medication requirement in the short term, but changes in other efficacy outcomes are inconsistent and there is no good evidence of sustained improvement in oesophageal pH measurements. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research."