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Radiofrequency Energy Delivery to the Lower Esophageal Sphincter Improves Gastroesophageal Reflux Patient Reported Outcomes in Failed Laparoscopic Nissen Fundoplication Cohort
Mark D. Noar*1,2, Patrick Squires3,1
1The Heartburn and Reflux Center, Endoscopic Microsurgery Associates, Towson, MD; 2Gastroenterology, Johns Hopkins Medicine - Howard County Hospital, Columbia, MD; 3School of Pharmacy, University of Pittsburgh, Pittsburgh, PA
Background: Patients with gastroesophageal reflux disease (GERD) often undergo laparoscopic Nissen fundoplication (LNF). Published long-term LNF follow-up reveals recurring symptoms and a need for continuous medication use in between 53-85% of patients at 10 years. Radiofrequency energy delivery to the lower esophageal sphincter (Stretta) has been used in these patients improve symptoms and medication use. The aim of the study was to evaluate and compare long-term patient reported outcomes of Stretta in refractory patients with and without previous LNF.
Methods: We prospectively assessed patient reported outcomes in 18 refractory LNF and 81 standard refractory GERD patients before Stretta and throughout 10-years follow-up. All patients underwent the standard Stretta procedure. The primary endpoint was improvement of patient reported outcomes for refractory LNF patients before and after Stretta. Secondary endpoint was a comparison of percent change in patient reported outcomes for refractory LNF patients that received Stretta to standard refractory GERD patients that only received Stretta. Patient reported outcomes were measured utilizing GERD-HRQL (Health Related Quality-of-Life), patient satisfaction scores, and medication requirements. Sub-analysis of primary results were evaluated using a two-way repeated measures analysis of variance. The primary evaluation from the repeated measures model was the group-by-time interaction with the Greenhouse-Geisser correction to account for deviations from the assumption of sphericity for the variance-covariance matrix of the data.
Results: At 10-year follow-up, all parameters demonstrated statistically significant improvement across the entire cohort (p<10-6). The refractory LNF subset demonstrated significant improvements in GERD-HRQL, satisfaction, and medication use at follow-up ≥6 months to 10-years and was significant from baseline (p<0.01) except medication requirements at year 10 (p=0.085). Patient reported outcome percent changes from baseline did not significantly differ between refractory LNF and standard refractory GERD subsets at all follow-up ≥6 months to 10-years (p>0.05) after Stretta except: at year 4 with satisfaction (p=0.045) and at year 10 for medication requirements (p=0.01). All procedures were completed without difficulty, with no significant intraoperative or long-term adverse events.
Conclusion: 1) In refractory LNF patients, Stretta results in sustained improvement over 10-years with near equivalence and slightly better outcomes compared to the non-LNF reflux patient. 2) Refractory LNF patients are a subpopulation that may be safely, effectively, and robustly aided by radiofrequency energy delivery to the lower esophageal sphincter.
Table 1. Refractory LNF Longitudinal Mean Improvements after Stretta over 10 Years
| Time (Years) | GERD-HRQL | Satisfaction Score | Medication Use | | On Medications | 21.6±12.3% | 14.4±9.9% | Baseline (On Meds) | | 0.5 | 69.9±12.2% | 49.4±17.8% | 44.7±38.5% | | 1 | 83.2±9.9% | 57.7±15.7% | 53.8±18.5% | | 2 | 88.6±6.9% | 75.0±13.8% | 35.6±22.8% | | 3 | 87.1±7.4% | 67.3±17.8% | 45.6±25.2% | | 4 | 83.0±13.3% | 69.1±16.2% | 58.3±23.7% | | 10 | 67.1±12.2% | 54.0±14.2% | 18.3±26.6%† |
All time points are significantly significant from baseline unless otherwise noted. †Improvement is not statistically significant (p=0.085). Confidence intervals are reported at 95%. Table 2. Baseline to 10-Year Follow-Up Subgroup Comparison | Patient Group | Previous Failed Nissen Fundoplication (n=18) | No Previous Nissen Fundoplication (n=81) | P-Value | | Mean % decrease in medication use | 18±26.6% | 51±8.8% | p<0.01 | | Mean % decrease in GERD-HRQL | 67±12.2% | 72±7.3% | p>0.05 | | Mean % increase in patient satisfaction | 54±14.2% | 49±6.3% | p>0.05 |
Confidence intervals are reported at 95%.
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