Mark Noar1, Patrick Squires2, Sulman Khan3. 1. Endoscopic Microsurgery Associates PA, Heartburn and Reflux Study Center, 7402 York Road 100, Towson, MD, 21204, USA. mnoar@gastro-doc.com. 2. University of Pittsburgh, School of Pharmacy, 3501 Terrace Street, Pittsburgh, PA, 15261, USA. 3. University of Maryland Baltimore County, 1000 Hilltop Circle, Baltimore, MD, 21250, USA.
Abstract
BACKGROUND: Patients with uncontrollable gastroesophageal reflux disease (GERD) often undergo laparoscopic Nissen fundoplication (LNF); however, long-term there are often recurring symptoms and need for continuous medication use. Refractory LNF patients may receive radiofrequency energy delivery to the lower esophageal sphincter (Stretta) to ameliorate symptoms and medication requirements. The aim was to assess and compare long-term patient-reported outcomes of Stretta in refractory patients with and without previous LNF. METHODS: We prospectively assessed and compared patient-reported outcomes in 18 refractory LNF patients and 81 standard refractory GERD patients that all underwent Stretta during 10-year follow-up. Patient-reported outcomes measured were GERD-HRQL (health-related quality of life), patient satisfaction scores, and daily medication requirements. RESULTS: The refractory LNF subset demonstrated median improvements in GERD-HRQL, satisfaction, and medication use at all follow-up time points ≥6 months to 10 years, which was significant from a baseline of both on- and off-medications (p < 0.05). Specifically at 10 years, median GERD-HRQL decreased from 36 to 7 (p < 0.001), satisfaction increased from 1 to 4 (p < 0.001), and medication score decreased from 7 to 6 (p = 0.040). Nine patients decreased medication use by half at 10 years. No significant differences existed between refractory LNF and standard refractory GERD subsets at any follow-up time point ≥6 months to 10 years (p > 0.05) after Stretta. At 10 years, no significant differences were noted between refractory LNF and standard Stretta subsets regarding medication use (p = 0.088), patient satisfaction (p = 0.573), and GERD-HRQL (p = 0.075). Stretta procedures were completed without difficulty or significant intraoperative or long-term adverse events. CONCLUSION: Within a small cohort of refractory LNF patients, Stretta resulted in sustained improvement over 10 years with equivalent outcomes to non-LNF standard Stretta patients. Refractory LNF patients are a subpopulation that may be safely, effectively, and robustly aided by Stretta with fewer complications compared to redo of Nissen or chronic medication use.
BACKGROUND:Patients with uncontrollable gastroesophageal reflux disease (GERD) often undergo laparoscopic Nissen fundoplication (LNF); however, long-term there are often recurring symptoms and need for continuous medication use. Refractory LNF patients may receive radiofrequency energy delivery to the lower esophageal sphincter (Stretta) to ameliorate symptoms and medication requirements. The aim was to assess and compare long-term patient-reported outcomes of Stretta in refractory patients with and without previous LNF. METHODS: We prospectively assessed and compared patient-reported outcomes in 18 refractory LNF patients and 81 standard refractory GERD patients that all underwent Stretta during 10-year follow-up. Patient-reported outcomes measured were GERD-HRQL (health-related quality of life), patient satisfaction scores, and daily medication requirements. RESULTS: The refractory LNF subset demonstrated median improvements in GERD-HRQL, satisfaction, and medication use at all follow-up time points ≥6 months to 10 years, which was significant from a baseline of both on- and off-medications (p < 0.05). Specifically at 10 years, median GERD-HRQL decreased from 36 to 7 (p < 0.001), satisfaction increased from 1 to 4 (p < 0.001), and medication score decreased from 7 to 6 (p = 0.040). Nine patients decreased medication use by half at 10 years. No significant differences existed between refractory LNF and standard refractory GERD subsets at any follow-up time point ≥6 months to 10 years (p > 0.05) after Stretta. At 10 years, no significant differences were noted between refractory LNF and standard Stretta subsets regarding medication use (p = 0.088), patient satisfaction (p = 0.573), and GERD-HRQL (p = 0.075). Stretta procedures were completed without difficulty or significant intraoperative or long-term adverse events. CONCLUSION: Within a small cohort of refractory LNF patients, Stretta resulted in sustained improvement over 10 years with equivalent outcomes to non-LNF standard Stretta patients. Refractory LNF patients are a subpopulation that may be safely, effectively, and robustly aided by Stretta with fewer complications compared to redo of Nissen or chronic medication use.
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