Adrian Lobontiu, MD, FACS1, Mircea Beuran, MD, FACS2, Matei Bratu, MD2, Bogdan Diaconescu, MD2, Mihaela Vartic, MD2, Ionut Negoi, MD, PhD2. 1Academic Henri Mondor Hospital, Creteil, Paris, France, 2Academic Emergency Hospital Bucharest
Objective: TIF 2.0 with the latest iteration of EsophyX Z is an endoluminal approach for patients with GERD, creating a partial fundoplication.
Description of technology and method of its use. The new EsophyX Z is the latest device iteration, cleared in 2015 by the FDA. The fastener delivery is automatic by pulling on the device trigger, like any surgical stapler. The fundoplication from within the stomach is greater than 270 degrees in circumference and in average 2.8 cm in length.
Preliminary results: A cohort of ten (10) patients with objective documentation of GERD, all on double dose of PPI’s, all refractory to treatment for more than 9 years, was prospectively included in June 2016.
Inclusion criteria: patients with typical/atypical GERD symptoms, confirmed by abnormal pH tests.
Exclusion criteria: hiatal hernia larger than 2cm.
Location: Tertiary Academic-affiliated Surgical Center.
Primary outcome: elimination of GERD symptoms, measured by GERD – Health Related Quality of Life (GERD-HRQL) questionnaire ¹.
Secondary outcomes: safety, periprocedural and post procedure adverse events according to Clavien Dindo scale, and operative time. For statistical analysis, we used Wilcoxon signed-rank test. The results are presented as median and interquartile range (IQR). All patients have signed the written informed consent. We obtained Ethical Approval from both our Local Academic Hospital and National Institutional Review Board. All patients were evaluated by GERD-HRQL questionnaire preoperatively, with office visits at 2-weeks, 3-months, 6-months and at 1-year follow-up.
There were no perioperative complications reported. The median hospital stay was 2.3 (1.7 – 3.1) days. At 1-year follow-up, 78% of patients, were off daily PPIs. The preoperative scores at screening and 1-Y post TIF 2.0 scores were 28.0 (IQR: 24.0 – 30.5) and 6.0 (IQR: 4.5 – 8.0), respectively. There was a statistical significant improvement in the 1-Y GERD-HRQL score (P = 0.008). All patients were satisfied with their GERD health-related condition of life ¹, with significant improvement in their quality of life and symptom control which confirms sustained symptom control compared with longer time follow up Level 1 RCT’s ².
Conclusions: The EsophyX Z is safe, effective confirming similar clinical outcomes in TIF 2.0 patients with GERD in previous published studies. The TIF 2.0 technique is not new ³. Ninety-five % of a total of 20, 000 patients received this procedure worldwide. TIF 2.0 procedure has now more than 80 peer-reviewed publications with 6Y long term follow up from prospective series 4 and 5Y long term follow up from Randomized Clinical Trial ². The new EsophyX Z several advantages are: enables performing the same standardized TIF 2.0 fundoplication in a significantly shorter time. In our prospective series, the average time is 19 minutes. Compared to average procedure time of 43 minutes with earlier iterations of devices in published randomized clinical trials 5, the EsophyX Z reduced the procedure time by more than half (66.2%). Using EsophyX Z device in our experience is more reproducible and less operator dependent. Fasteners delivery is effective, with all fasteners being contributive in our studied series reported.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 91119
Program Number: ETP834
Presentation Session: Emerging Technology iPoster Session (Non CME)
Presentation Type: Poster