Thirty- and 90-Day Morbidity and Mortality by Clavien-Dindo 30 and 90 Days after Surgery for Antireflux and Hiatal Hernia.

BACKGROUND: The historic morbidity and mortality rates of anti-reflux and hiatal hernia surgery are reported as 3-21% and 0.2-0.5%, respectively. These data come from either large national/population level or small institutional studies, with the former focusing on broad 30-day outcomes while lacking granular data on complications and their severity. Institutional studies tend to focus on long-term and quality of life outcomes. Our objective is to describe and evaluate the incidence of 30 and 90-day morbidity and mortality in a large, single institution dataset. STUDY DESIGN: We retrospectively reviewed 2342 cases of anti-reflux and hiatal hernia surgery from 2003-2020 for intra-operative complications causing post-operative sequelae, as well as morbidity and mortality within 90 days. All complications were graded using the Clavien-Dindo (CD) Grading System. The highest-grade of complication was used per patient during 30-day and 31-90-day intervals. RESULTS: Out of 2342 patients, the overall 30-day morbidity and mortality rates were 18.2% (427/2342) and 0.2% (4/2342), respectively. Most of the complications were CD<3a at 13.1% (306/2342). In the 31-90-day post-operative period, morbidity and mortality rates decreased to 3.1% (78/2338) and 0.09% (2/2338). CD<3a complications accounted for 1.9% (42/2338). CONCLUSIONS: Anti-reflux and hiatal hernia surgery are safe operations with rare mortality and modest rates of morbidity. However, the majority of complications patients experience are minor (CD<3a) and are easily managed. A minority of patients will experience major complications (CD≥3a) that require additional procedures and management to secure a safe outcome. These data are helpful to inform patients of the risks of surgery, and guide physicians for optimal consent.

The Milan score: A novel manometric tool for a more efficient diagnosis of gastro-esophageal reflux disease.

OBJECTIVE: A definitive diagnosis of gastroesophageal reflux disease (GERD) depends on endoscopic and/or pH-study criteria. However, high resolution manometry (HRM) can identify factors predicting GERD, such as ineffective esophageal motility (IEM), esophago-gastric junction contractile integral (EGJ-CI), evaluating esophagogastric junction (EGJ) type and straight leg raise (SLR) maneuver response. We aimed to build and externally validate a manometric score (Milan Score) to stratify the risk and severity of the disease in patients undergoing HRM for suspected GERD. METHODS: A population of 295 consecutive patients undergoing HRM and pH-study for persistent typical or atypical GERD symptoms was prospectively enrolled to build a model and a nomogram that provides a risk score for AET > 6%. Collected HRM data included IEM, EGJ-CI, EGJ type and SLR. A supplemental cohort of patients undergoing HRM and pH-study was also prospectively enrolled in 13 high-volume esophageal function laboratories across the world in order to validate the model. Discrimination and calibration were used to assess model's accuracy. Gastroesophageal reflux disease was defined as acid exposure time >6%. RESULTS: Out of the analyzed variables, SLR response and EGJ subtype 3 had the highest impact on the score (odd ratio 18.20 and 3.87, respectively). The external validation cohort consisted of 233 patients. In the validation model, the corrected Harrel c-index was 0.90. The model-fitting optimism adjusted calibration slope was 0.93 and the integrated calibration index was 0.07, indicating good calibration. CONCLUSIONS: A novel HRM score for GERD diagnosis has been created and validated. The MS might be a useful screening tool to stratify the risk and the severity of GERD, allowing a more comprehensive pathophysiologic assessment of the anti-reflux barrier. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT05851482).

High-Risk Features of Esophageal Adenocarcinoma Following Neoadjuvant Chemoradiation: Patients for Whom Surgery Should Not Be Delayed.

OBJECTIVE: Clinical predictors of pathological complete response have not reliably identified patients for whom an organ-sparing approach following neoadjuvant chemoradiation be undertaken for esophageal cancer patients. We sought to identify high-risk predictors of residual carcinoma that may preclude patients from a selective surgical approach. BACKGROUND: Patients treated with neoadjuvant chemoradiation followed by esophagectomy for esophageal adenocarcinoma were identified. PATIENTS AND METHODS: Correlation between clinical and pathologic complete responses were examined. Regression models and recursive partitioning were utilized to identify features associated with residual carcinoma. External validation of these high-risk factors was performed on a data set from an independent institution. RESULTS: A total of 326 patients were identified, in whom clinical complete response was noted in 104/326 (32%). Pathologic complete response was noted in only 33/104 (32%) of these clinical complete responders. Multivariable analysis identified that the presence of stricture ( P =0.011), positive biopsy ( P =0.010), and signet ring cell histology ( P =0.019) were associated with residual cancer. Recursive partitioning corroborated a 94% probability of residual disease, or greater, for each of these features. The positive predictive value was >90% for these characteristics. A SUV max >5.4 at the esophageal primary in the absence of esophagitis was also a high-risk factor for residual carcinoma. External validation confirmed these high-risk factors to be implicated in the finding of residual carcinoma. CONCLUSIONS: Clinical parameters of response are poor predictors of complete pathologic response leading to challenges in selecting candidates for active surveillance. However, we characterize several high-risk features for residual carcinoma which indicate that esophagectomy should not be delayed.