Canto Marcia Irene, Diehl David L, Parker Brett, Abu-Dayyeh Barham K, Kolb Jennifer M, Murray Michael, Sharaiha Reem Z, Brewer Gutierrez Olaya I, Sohagia Amit, Khara Harshit S, Janu Peter, Chang Kenneth
Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland.
Department of Gastroenterology, Geisinger Medical Center, Danville, Pennsylvania.
Gastrointest Endosc. 2025 Jan;101(1):90-102.e1. doi: 10.1016/j.gie.2024.08.016. Epub 2024 Sep 16.
Transoral incisionless fundoplication (TIF) is an established safe endoscopic technique for the management of GERD but with variable efficacy. In the past decade, the TIF technology and technique have been optimized and more widely accepted, but data on outcomes outside clinical trials are limited. We tracked patient-reported and clinical outcomes of GERD patients after TIF 2.0.
Patients with body mass index <35 kg/m, hiatal hernia <2 cm, and confirmed GERD with typical or atypical symptoms from 9 academic and community medical centers were enrolled in a prospective registry and underwent TIF 2.0 performed by gastroenterologists and surgeons. The primary outcomes were safety and clinical success (response in 1 subjective and at least 1 of 3 objective secondary end points). Secondary end points were symptom improvement, acid exposure time (AET), esophagitis healing, proton pump inhibitor (PPI) use, and satisfaction. Outcomes were assessed at last follow-up within 12 months.
A total of 85 patients underwent TIF 2.0, and 81 were included in the outcomes analysis. Clinical success was achieved in 94%, GERD Health-Related Quality of Life scores improved in 89%, and elevated Reflux Symptom Index score normalized in 85% of patients with elevated baseline. Patient satisfaction improved from 8% to 79% (P < .0001). At baseline, 81% were taking at least daily PPI, and after TIF 2.0, 80% were on no or occasional PPI (P < .0001). Esophageal AET was normal in 72%, greater with an optimized TIF 2.0 valve (defined as >300-degree circumference and >3-cm length; 94% vs 57%; P = .007). There were no TIF 2.0-related serious adverse events.
TIF 2.0 is a safe and effective endoscopic outpatient treatment option for selected patients with GERD.
经口无切口胃底折叠术（TIF）是一种已确立的用于治疗胃食管反流病（GERD）的安全内镜技术，但疗效不一。在过去十年中，TIF技术已得到优化并被更广泛接受，但临床试验之外的疗效数据有限。我们追踪了接受TIF 2.0治疗的GERD患者的患者报告结局和临床结局。
来自9个学术和社区医疗中心的体重指数<35kg/m²、食管裂孔疝<2cm且经确诊有典型或非典型症状的GERD患者被纳入一项前瞻性登记研究，并接受由胃肠病学家和外科医生实施的TIF 2.0治疗。主要结局为安全性和临床成功（1项主观指标及3项客观次要终点指标中的至少1项有反应）。次要终点指标为症状改善、酸暴露时间（AET）、食管炎愈合情况、质子泵抑制剂（PPI）使用情况及满意度。在12个月内的最后一次随访时评估结局。
共有85例患者接受了TIF 2.0治疗，81例纳入结局分析。94%取得临床成功，89%的GERD健康相关生活质量评分得到改善，85%基线评分升高的患者反流症状指数评分恢复正常。患者满意度从8%提高到79%（P<. 在基线时，81%的患者至少每日服用PPI，TIF 2.0治疗后，80%的患者无需服用或偶尔服用PPI（P<. 食管AET在72%的患者中恢复正常，使用优化的TIF 2.0瓣膜（定义为周长>300度且长度>3cm）时更高（94%对57%；P=. 未发生与TIF 2.0相关的严重不良事件。
对于选定的GERD患者，TIF 2.0是一种安全有效的内镜门诊治疗选择。 0001）。 0001）。 007）。
