Mark D. Noar

Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later

AbstractBackgroundnPatients with gastroesophageal reflux disease (GERD) often seek alternative therapy for inadequate symptom control, with over 40xa0% not responding to medical treatment. We evaluated the long-term safety, efficacy, and durability of response to radiofrequency treatment of the lower esophageal sphincter (Stretta).nMethodsUsing an intent-to-treat analysis, we prospectively assessed 217 patients with medically refractory GERD before and after Stretta. There was no concurrent control group in the study. Primary outcome measure was normalization of GERD-health-related quality of life (GERD-HRQL) in 70xa0% or greater of patients at 10xa0years. Secondary outcomes were 50xa0% reduction or elimination of proton pump inhibitors (PPIs) and 60xa0% or greater improvement in satisfaction at 10xa0years. Successful treatment was defined as achievement of secondary outcomes in a minimum of 50xa0% of patients. Complications and effect on existing comorbidities were evaluated. The results of a 10-year study are reported.ResultsThe primary outcome was achieved in 72xa0% of patients (95xa0% confidence interval 65–79). For secondary outcomes, a 50xa0% or greater reduction in PPI use occurred in 64xa0% of patients, (41xa0% eliminating PPIs entirely), and a 60xa0% or greater increase in satisfaction occurred in 54xa0% of patients. Both secondary endpoints were achieved. The most common side effect was short-term chest pain (50xa0%). Pre-existing Barrett’s metaplasia regressed in 85xa0% of biopsied patients. No cases of esophageal cancer occurred.ConclusionsIn this single-group evaluation of 217 patients before and after Stretta, GERD-HRQL scores, satisfaction, and PPI use significantly improved and results were immediate and durable at 10xa0years.

Radiofrequency energy delivery to the lower esophageal sphincter improves gastroesophageal reflux patient-reported outcomes in failed laparoscopic Nissen fundoplication cohort

BackgroundPatients 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.MethodsWe 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.ResultsThe refractory LNF subset demonstrated median improvements in GERD-HRQL, satisfaction, and medication use at all follow-up time points ≥6xa0months to 10 years, which was significant from a baseline of both on- and off-medications (pxa0<xa00.05). Specifically at 10 years, median GERD-HRQL decreased from 36 to 7 (pxa0<xa00.001), satisfaction increased from 1 to 4 (pxa0<xa00.001), and medication score decreased from 7 to 6 (pxa0=xa00.040). 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 ≥6xa0months to 10 years (pxa0>xa00.05) after Stretta. At 10 years, no significant differences were noted between refractory LNF and standard Stretta subsets regarding medication use (pxa0=xa00.088), patient satisfaction (pxa0=xa00.573), and GERD-HRQL (pxa0=xa00.075). Stretta procedures were completed without difficulty or significant intraoperative or long-term adverse events.ConclusionWithin 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.

Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss

BACKGROUNDnObesity is a significant health problem and additional therapies are needed to improve obesity treatment.nnnOBJECTIVEnDetermine the efficacy and safety of a 6-month swallowable gas-filled intragastric balloon system for weight loss.nnnSETTINGnFifteen academic and private practice centers in the United States.nnnMETHODSnThis was a double-blind, randomized sham-controlled trial of the swallowable gas-filled intragastric balloon system plus lifestyle therapy compared with lifestyle therapy alone for weight loss at 6 months in participants aged 22 to 60 years with body mass index 30 to 40 kg/m2, across 15 sites in the United States. The following endpoints were included: difference in percent total weight loss in treatment group versus control group was >2.1%, and a responder rate of >35% in the treatment group.nnnRESULTSnThree hundred eighty-seven patients swallowed at least 1 capsule. Of participants, 93.3% completed all 24 weeks of blinded study testing. Nonserious adverse events occurred in 91.1% of patients, but only .4% were severe. One bleeding ulcer and 1 balloon deflation occurred. In analysis of patients who completed treatment, the treatment and control groups achieved 7.1 ± 5.0% and 3.6 ± 5.1% total weight loss, respectively, and a mean difference of 3.5% (Pu202f=u202f.0085). Total weight loss in treatment and control groups were 7.1 ± 5.3 and 3.6 ± 5.1 kg (P < .0001), and body mass index change in the treatment and control groups were 2.5 ± 1.8 and 1.3 ± 1.8 kg/m2 (P < .0001), respectively. The responder rate in the treatment group was 66.7% (P < .0001). Weight loss maintenance in the treatment group was 88.5% at 48 weeks.nnnCONCLUSIONSnTreatment with lifestyle therapy and the 6-month swallowable gas-filled intragastric balloon system was safe and resulted in twice as much weight loss compared with a sham control, with high weight loss maintenance at 48 weeks.