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TIF 2.0 procedure for GERD

Data supports durability and efficacy of TIF 2.0 procedure

TIF 2.0 procedure provides improved quality of life and elimination of daily PPI use for up to ten years in patients with symptomatic GERD
TIF 2.0 procedure combined with laparoscopic hiatal hernia repair is a safe and effective option for patients with severe GERD and hiatal hernia

Two presentations highlighting the efficacy of Transoral Incisionless Fundoplication (TIF) 2.0 procedure for gastroesophageal reflux disease (GERD) have been presented at Digestive Disease Week (DDW) in Washington, DC. The TIF 2.0 procedure is a minimally invasive procedure that enables physicians to perform an endoscopic gastric fundoplication. The first abstract reports follow-up data to ten-year post-TIF 2.0 procedure and the second reports results of TIF 2.0 procedure immediately following laparoscopic hiatal hernia repair in patients with GERD.

The first study, ‘Transoral Incisionless Fundoplication with EsophyX (TIF 2.0) For Gastro-Esophageal Reflux Disease: Three- To Ten-Year Outcomes in A Prospective Observational Single-Center Study’, presented Professor Pier Alberto Testoni from the San Raffaele Hospital, Milano, Italy, reported the outcomes from a single-centre study utilising TIF 2.0 procedure using EsophyX device in a series of 50 consecutive patients with symptomatic GERD responsive to PPIs. For the three- to ten- year post-TIF period patients underwent annual assessment using the GERD-HRQL questionnaire and recording of PPI usage and results were compared with pre-TIF baseline values.

The key study findings include:

  • Over the ten-year follow-up the mean GERD-HRQL score was significantly reduced compared with the pre-TIF score (46±19) but appeared substantially unchanged between two and ten years post-TIF procedure
  • The percentages of patients who stopped or halved their PPI therapy three, five, seven and ten years after TIF procedure were 84.4%, 73.5%, 83.3%, and 91.7%, respectively; this rate remained substantially stable and similar to that at two years (87.8%)
  • TIF 2.0 procedure using the EsophyX device achieved a significant GERD-HRQL score improvement, compared to baseline and lasting elimination of daily dependence on PPI in about 73-91% of patients for up to ten years

The second study, ‘Efficacy of Combined Transoral Incisionless Fundoplication and Laparoscopic Hiatal Hernia Repair’, presented by Dr Viktor E Eysselein from Harbor UCLA Medical Foundation, California, evaluated TIF 2.0 procedures performed immediately after laparoscopic hiatal hernia repair in GERD patients with hiatal hernia greater than 2cm and concluded the procedure is safe and an effective therapeutic option for patients with severe GERD and large hiatal hernia.

Between June 2015 and September 2017, 27 patients with chronic GERD symptoms refractory to double-dose PPI and with a Hill Grade >2, underwent the concomitant procedure. Patients were evaluated for indication, PPI use, pre- and post-procedure symptoms, patient satisfaction and complications 1-29 months post procedure (median follow-up was 11 months).

Key study findings include:

  • Daily PPI use was eliminated in 85% (23/27) of patients
  • At post-procedure follow-up, 96% (26/27) of patients reported satisfaction with concomitant procedure set
  • Specific GERD symptom prevalence improvements after treatment were noted: heartburn 70% to 26%; regurgitation 63% to 11%; cough 26% to 15% and hoarse voice 11% to 3%
  • There were no postoperative complications, and no dysphagia or gas-bloating symptoms were reported

“These results underscore the clinical benefits the TIF 2.0 procedure can provide to a broad array of GERD patients. The improvements in health-related quality of life scores and elimination of daily proton pump inhibitor therapy (PPIs) use for up to ten-years suggests that the TIF 2.0 procedure is a viable and important treatment option for patients who do not want to undergo traditional more invasive surgical procedures or are intolerant to PPIs,” said Dr Peter Janu, Director of the Ascension NE WI Reflux Center of Excellence. “Additionally, while the TIF 2.0 procedure has been shown to be effective in GERD patients with hiatal hernia less than 2cms, this new data continues to reinforce that in combination with laparoscopic hiatal hernia repair, it’s also a safe and effective option for patients with a larger hiatal hernia.”

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