Safety and efficacy of biodegradable stents in octogenarian patients with esophageal achalasia

Abstract

Abstract Backgrounds and study aims Treatment of octogenarian patients with achalasia with conventional treatments is effective but with compromised safety. Biodegradable stents (BS) are promising. We aimed to evaluate their safety, efficacy and clinical outcomes at early, mid and long-term in this population. Patients and methods Naïve or previously-treated achalasic octogenarian patients underwent to BS placement (BSP) between December, 2010 and November, 2011, and were followed-up for 9-years. A strict follow-up was performed. Results Thirty-two patients were included, (17 men [53.1 %]; median age 82 years [78–92]). BSP was performed in all patients. At 9y, 18/32 (56.2 %) completed protocol. Mean BSP time was 37.5±12.1 min and 34.4 % presented thoracic pain. At 1 m, six BS were migrated (18.7 %), requiring a second BSP fixed with hemoclips. At 3 m, twenty-three (72.8 %) completed degradation process. At 6 m, eighteen (56.2 %) presented clinical dysphagia, of whom 5/32 (15.6 %) presented stenotic-tissue hyperplasia, responding to balloon dilation in all cases. Pre-BSP Eckardt, Timed barium esophagram and integrated relaxation pressure improved post-BSP 6 m values (9 vs 2, p = 0.001; < 50 % = 93.8 % vs > 80 % = 81.5 %, p = 0.003 and 18.8 ± 3.2 vs 11.1 ± 2.6 mmHg, p = 0.001, respectively), and there were no significant changes up to 9y post-BSP. Esophagitis grade A or B was presented between 4.7 % to 11.2 % and controlled with PPI. After 9 years we had clinical success rates of 94.4 %, 72 %, and 65.4 % for time point evaluation, per protocol and intention to treat analysis, respectively. Conclusions BSP represents a feasible alternative option in octogenarian patients with achalasia who are high risk with other treatments, presenting acceptable early, mid-, and long-term outcomes.