A worldwide survey on incidence, management, and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: the POTTER-AF study.

AIMS: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. METHODS AND RESULTS: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. CONCLUSION: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.

Risk factors and prognosis for esophageal fistula in patients with esophageal squamous cell carcinoma during radiotherapy.

PURPOSE: To determine risk factors, treatment outcomes, and prognostic factors for esophageal fistula (EF) in patients with esophageal squamous cell carcinoma (ESCC) during radiotherapy. METHODS: Between 2010 and 2018, 109 patients with EF during radiotherapy were retrospectively collected. A controlled cohort including 416 patients who received definitive chemoradiotherapy without EF was used to compare risk factors and survival outcomes. Univariate and multivariate logistic regression analyses were performed to identify predictors of EF. Propensity score matching (PSM) was applied to adjust for potential confounding factors. RESULTS: Multivariate analysis demonstrated that sex, body mass index, alcohol history, esophageal ulceration, primary tumor length, T stage, and absolute lymphocyte count were independent risk factors for EF. After PSM, patients with EF showed remarkably worse prognosis than those without EF (median overall survival: 13.0 versus 20.5 months; P = 0.009). For patients with EF, serum albumin level (≥ 35 g/L), subsequent radiotherapy, and fistula closure were associated with significantly prolonged survival. In addition, esophageal-mediastinum fistula and subsequent radiotherapy were positive predictors for fistula closure. CONCLUSIONS: We identified risk factors for radiotherapy-related EF and its unfavorable prognosis in patients with ESCC. Of them, patients with serum albumin level of ≥ 35 g/L, subsequent radiotherapy after EF, and fistula closure had a more favorable survival.

Risk factors of esophageal fistula induced by re-radiotherapy for recurrent esophageal cancer with local primary site.

PURPOSE: The purpose of the present study was to investigate risk factors for esophageal fistula (EF) in patients with recurrent esophageal cancer receiving re-radiotherapy with or without chemotherapy. METHODS: We reviewed retrospectively the clinical characters and dosimetric parameters of 96 patients with recurrent esophageal cancer treated with re-radiotherapy in Cancer Hospital Affiliated to Shandong First Medical University between August 2014 and January 2021.Univariate and multivariate logistic regression analyses were provided to determine the risk factors of EF induced by re-radiotherapy. RESULTS: The median time interval between two radiotherapy was 23.35 months (range, 4.30 to 238.10 months). EF occurred in 19 patients (19.79%). In univariate analysis, age, T stage, the biologically equivalent dose in the re-radiotherapy, total biologically equivalent dose, hyperfractionated radiotherapy, ulcerative esophageal cancer, the length of tumor and the maximum thickness of tumor had a correlation with the prevalence of EF. In addition, age (HR = 0.170, 95%CI 0.030-0.951, p = 0.044), T stage (HR = 8.369, 95%CI 1.729-40.522, p = 0.008), ulcerative esophageal cancer (HR = 5.810, 95%CI 1.316-25.650, p = 0.020) and the maximum thickness of tumor (HR = 1.314, 95%CI 1.098-1.572, p = 0.003) were risk factors of EF in multivariate logistic regression analysis. CONCLUSIONS: The incidence of EF was significantly increased in patients with recurrent esophageal cancer who underwent re-radiotherapy. This study revealed that age, T stage, ulcerative esophageal cancer and the maximum thickness of the tumor were risk factors associated with EF. In clinical work, patients with risk factors for EF ought to be highly concerned and individualized treatment plans should be taken to reduce the occurrence of EF.

Esophageal fistula after definitive concurrent chemotherapy and intensity modulated radiotherapy for esophageal squamous cell carcinoma.

BACKGROUND: The literature regarding esophageal fistula after definitive concurrent chemotherapy and intensity modulated radiotherapy (IMRT) for esophageal squamous cell carcinoma (ESCC) remains lacking. We aimed to investigate the risk factors of esophageal fistula among ESCC patients undergoing definitive concurrent chemoradiotherapy (CCRT) via IMRT technique. METHODS: A total of 129 consecutive ESCC patients receiving definitive CCRT with IMRT between 2008 and 2018 were reviewed. The cumulative incidence of esophageal fistula and survival of patients were estimated by the Kaplan-Meier method and compared between groups by the log-rank test. The risk factors of esophageal fistula were determined with multivariate Cox proportional hazards regression analysis. RESULTS: Median follow-up was 14.9 months (IQR, 7.0-28.8). Esophageal perforation was identified in 20 (15.5%) patients, resulting in esophago-pleural fistula in nine, esophago-tracheal fistula in seven, broncho-esophageal fistula in two, and aorto-esophageal fistula in two patients. The median interval from IMRT to the occurrence of esophageal fistula was 4.4 months (IQR, 3.3-10.1). Patients with esophageal fistula had an inferior median overall survival (10.0 vs. 17.2 months, p = 0.0096). T4 (HR, 3.776; 95% CI, 1.383-10.308; p = 0.010) and esophageal stenosis (HR, 2.601; 95% CI, 1.053-6.428; p = 0.038) at baseline were the independent risk factors for esophageal fistula. The cumulative incidence of esophageal fistula was higher in patients with T4 (p = 0.018) and pre-treatment esophageal stenosis (p = 0.045). There was a trend toward better survival after esophageal fistula among patients receiving repair or stenting for the fistula than those only undergoing conservative treatments (median survival, 5.9 vs. 0.9 months, p = 0.058). CONCLUSIONS: T4 and esophageal stenosis at baseline independently increased the risk of esophageal fistula in ESCC treated by definitive CCRT with IMRT. There existed a trend toward improved survival after the fistula among patients receiving repair or stenting for esophageal perforation.

High incidence of esophageal fistula on patients with clinical T4b esophageal squamous cell carcinoma who received chemoradiotherapy: A retrospective analysis.

BACKGROUND AND PURPOSE: Despite definitive chemoradiotherapy (CRT) being a recommended therapeutic method for patients with T4b esophageal squamous cell carcinoma (ESCC), treatment response and complications remain unclear. Esophageal fistula is a severe CRT-related complication when treating locally advanced ESCC, but data on risk factors that lead to esophageal fistula formation are limited. The aim of this analysis is to characterize the outcomes of T4b ESCC treated by CRT and investigate the risk factors of esophageal fistula. MATERIALS AND METHODS: We retrospectively analyzed 136 patients with clinically unresectable T4b ESCC who were treated with CRT. Response, survival, and complication rates, particularly the rate of esophageal fistula and its associated risk factors were analyzed. RESULTS: The median progression-free survival and overall survival (OS) of all patients were 7.9 (95% confidence interval [CI]: 6.1-9.7) and 12.2 months (95% [CI]: 8.9-15.4), respectively. The Kaplan-Meier curves showed that the 3- and 5-year OS rates were 29.9% and 20.2%, respectively. The incidence rate of esophageal fistulas was 30.1%. The median OS for patients with esophageal fistula was only 6.9 (95%[CI] = 6.0-7.8) months. The risk for developing esophageal fistulas was significantly high for ulcerative-type tumors (odds ratio [OR] = 3.202; 95%[CI] = 1.036-7.850, P = 0.011) and for those invading the bronchus/trachea (OR = 3.378; 95%[CI] = 1.223-9.332, P = 0.048). CONCLUSION: We demonstrated that CRT for T4b ESCC patients has a curative potential, despite a high incidence of esophageal fistula, which was the main cause of treatment failure. The higher risk for fistula formation were tumors with ulceration or bronchus/trachea invasion.

Definitive chemoradiotherapy plus cetuximab for cancer in the oesophagus or gastro-oesophageal junction.

BACKGROUND: Chemoradiotherapy is standard treatment for localized oesophageal cancer unsuitable for surgery. We aimed to evaluate the efficacy of cetuximab in combination with chemoradiotherapy. METHODS: This non-randomised multicentre phase II trial recruited patients aged 18-75 with WHO performance status 0-2 having squamous cell carcinoma or adenocarcinoma in the oesophagus or gastro-oesophageal junction, T2-4, N0-3, M0 not suitable for surgery. Chemotherapy was three 21-day cycles of fluorouracil 750 mg/m2 D1-5 and oxaliplatin D1 (cycle 1:130mg/m 2, cycle 2-3:85 mg/m 2). Radiotherapy was 50Gy in 2Gy/fraction, 5 days a week, concurrent with cycle 2 and 3 and weekly cetuximab. The primary objective was loco-regional control at one year. RESULTS: 52 patients were included. 51 were eligible for toxicity and survival analysis and 46 for recurrence analysis. Full radiotherapy dose was delivered to 80%, 75% received all three cycles of chemotherapy and 75% received four or more doses of cetuximab. The most common related grade III-IV adverse events were gastro-intestinal(16), hypersensitivity(6) and infection(5). There were two drug-related deaths. Within six months from the end of treatment, six patients died from complications from fistulas. The loco-regional control rate at one year was 47.3%(95%CI 30.9%-62.1%). Overall survival at three years was 29.1%(95% CI 17.4-41.9%). CONCLUSIONS: Oxaliplatin and fluorouracil given concurrent with radiotherapy and cetuximab had an acceptable safety profile and showed a clinical response in patients with locoregionally advanced oesophageal cancer unsuitable for surgery. However, the primary end-point was not met, and the addition of cetuximab to definitive chemoradiotherapy cannot be recommended.

Survival and prognostic factors of patients with esophageal fistula in advanced esophageal squamous cell carcinoma.

The aim of the present study was to investigate the survival and prognostic factors of patients who were with advanced esophageal squamous cell carcinoma (ESCC) and developed an esophageal fistula. The data from 221 patients with advanced ESCC developed esophageal fistula from January 2008 to December 2017 at the Harbin Medical University Cancer Hospital was retrospectively analyzed. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by the Cox proportional hazard models. The median survival time after a diagnosis of the esophageal fistula was calculated using the Kaplan-Meier method. We found that the pathogens infected by patients are common bacteria in nosocomial infection. Besides, the incidence rate of esophagomediastinal fistula was the highest (54.2%) in the lower third of the esophagus. Kaplan-Meier analysis revealed a median survival time of 11.00 months and a median post-fistula survival time of 3.63 months in patients who developed esophageal fistula in advanced esophageal cancer. In the univariate analysis, gender, therapies for ESCC before the development of fistula, type of esophageal fistula, treatment of esophageal fistula and hemoglobin (Hb) level were the factors with significant prognostic value. Gender, type of esophageal fistula and Hb level were identified as independent prognostic factors in further multivariate analysis. In summary, our study demonstrated that several factors are significantly related to patients with esophageal fistula and should be concerned about in clinical practice.

Analysis of fistula formation of T4 esophageal cancer patients treated by chemoradiotherapy.

BACKGROUND AND AIM: Fistula is one of the known complications of T4 esophageal cancer (T4-EC). The standard treatment for T4-EC is chemoradiotherapy, but detailed data about fistula resulting from chemoradiotherapy in this condition are limited. In particular, radiographic findings of T4-EC with fistula have not been reported. This study assessed the risk factors of fistula based on clinical information on patients with chemoradiotherapy for T4-EC. METHODS: We retrospectively reviewed the clinical data of 59 T4-EC patients who had squamous cell carcinoma without any fistula before receiving definitive or palliative chemoradiotherapy. RESULTS: A fistula was observed in 18 patients (31%) throughout their clinical course. The overall survival in the fistula group was significantly shorter than that in the non-fistula group (259 vs. 346 days; p = 0.0341). The axial tumor size on computed tomography (CT) was confirmed as an independent risk factor for esophageal fistula in multivariate analysis of stepwise methods [OR 1.226; 95% CI 1.109-1.411; p < 0.0001]. Twelve out of 14 patients with an axial tumor size of 50 mm or greater had developed a fistula. CONCLUSIONS: A large tumor size on the axial plane on CT is a risk factor for fistula formation.

Relationship between nutritional status and esophageal fistula formation after radiotherapy for esophageal cancer.

PURPOSE: Chemoradiotherapy and radiotherapy for esophageal cancer sometimes cause esophageal fistulas. Esophageal fistulas often require additional procedures and are associated with a high mortality rate. The present study was conducted to determine the risk factors associated with esophageal fistulas in patients with esophageal cancer. PATIENTS AND METHODS: We reviewed the cases of 206 patients who were treated with definitive radiotherapy for esophageal cancer. The planning dose, which ranged from 44 to 64.8Gy (median: 59.4Gy), was delivered to the primary lesion and regional lymph nodes. Descriptive statistics were calculated, and time-to-event analyses were performed using Cox proportional hazards regression analysis. RESULTS: None of the 68 patients with T1 or T2 esophageal cancer developed esophageal fistulas. Among the 138 patients with T3 or T4 esophageal cancer, esophageal fistulas were detected in 20 (14.5%) patients. Multivariate analysis of the 138 patients with T3 or T4 esophageal cancer revealed low body mass index (BMI) to be an independent risk factor for esophageal fistula formation (P=0.0055). The optimal BMI cut-off value for predicting esophageal fistula formation was 20 kg/m2 (P=0.0121, odds ratio=4.130). CONCLUSION: In patients with esophageal cancer treated with definitive radiotherapy, a BMI below20kg/m2 is a risk factor for esophageal fistula formation. A well-designed randomized controlled trial comparing the incidence of esophageal fistulas between patients with esophageal cancer who do and do not receive nutritional support before radiotherapy is required.

Prevalence and prevention of oesophageal injury during atrial fibrillation ablation: a systematic review and meta-analysis.

AIMS: Atrio-oesophageal fistula (AOF) is a potentially lethal complication of atrial fibrillation (AF) ablation. Many studies have evaluated the presence and prevention of endoscopically-detected oesophageal lesions (EDOL) as a proxy measure for risk of AOF. This systematic review and meta-analysis sought to determine the prevalence of EDOL and effectiveness of general preventive measures during AF ablation. METHODS AND RESULTS: We searched electronic databases for studies reporting prevalence or prevention of EDOL post-AF ablation. Pooled prevalence were reported with 95% confidence intervals (CI) while studies evaluating preventive measures including oesophageal temperature monitoring (OTM), esophageal manipulation and type of anaesthesia were analyzed descriptively or by random-effects modeling. Twenty-five studies were included in the analysis. Any and ulcerated EDOL pooled prevalence was 11% (95%CI, 6-15%) and 5% (95%CI, 3-7%), respectively. In six studies, there was no difference in EDOL with or without OTM (pooled OR 1.65, 95%CI, 0.22-12.55). There was no difference using a multi-sensor versus single-sensor OTM (one study) nor when using a deflectable probe (two studies). Oesophageal displacement was associated with significant instrumentation injury in one study. Two studies evaluating Oesophageal cooling showed conflicting results. General anaesthesia was associated with more EDOL than conscious sedation in two studies. CONCLUSION: The pooled prevalence of any and ulcerated EDOL post-ablation was 11% and 5%, but varied between studies. Techniques such as OTM and oesophageal displacement or cooling have not conclusively demonstrated a reduction in EDEL, while general anaesthesia may be associated with higher EDOL risk. Further randomized data are critically needed to validate and develop measures to prevent EDOL and AOF.

Risk factors for esophageal fistula in thoracic esophageal squamous cell carcinoma invading adjacent organs treated with definitive chemoradiotherapy: a monocentric case-control study.

BACKGROUND: Standard treatment for unresectable esophageal squamous cell carcinoma (ESCC) without distant metastasis is definitive chemoradiotherapy (dCRT), in which the incidence of esophageal fistula (EF) is reported to be 10-12%. An ad hoc analysis of JCOG0303, a phase II/III trial of dCRT for patients with unresectable ESCC (including non-T4b), suggested that esophageal stenosis is a risk factor for EF. However, risk factors for EF in patients limited to T4b ESCC treated with dCRT have yet to be clarified. The aim of this study was to investigate risk factors for EF in T4b thoracic ESCC treated with dCRT. METHODS: We retrospectively analyzed the data of consecutive T4b thoracic ESCC patients who were treated with dCRT (cisplatin and fluorouracil) at Shizuoka Cancer Center between April 2004 and September 2015. RESULTS: Excluding 8 patients with esophageal fistula clearly attributable to other iatrogenic interventions, the data of 116 patients who met the inclusion criteria were analyzed. Esophageal fistula was observed in 28 patients (24%). Although the fistula was closed in 5 patients, overall survival was significantly shorter in patients who experienced esophageal fistula (8.0 vs. 26.8 months; p < 0.0001). Among four potential variables extracted in univariate analysis, namely, total circumferential lesion, elevated CRP level, elevated white blood cell count, and anemia, the first two were revealed as risk factors for esophageal fistula in multivariate analysis. CONCLUSIONS: This study demonstrated that total circumferential lesion and CRP ≥1.00 mg/dL are risk factors for esophageal fistula in T4b thoracic ESCC treated with dCRT. TRIAL REGISTRATION: This study was retrospectively registered.

Logistic regression analysis of the risk factors of anastomotic fistula after radical resection of esophageal-cardiac cancer.

BACKGROUND: This study was conducted to investigate the risk factors of anastomotic fistula after the radical resection of esophageal-cardiac cancer. METHODS: Five hundred and forty-four esophageal-cardiac cancer patients who underwent surgery and had complete clinical data were included in the study. Fifty patients diagnosed with postoperative anastomotic fistula were considered the case group and the remaining 494 subjects who did not develop postoperative anastomotic fistula were considered the control. The potential risk factors for anastomotic fistula, such as age, gender, diabetes history, smoking history, were collected and compared between the groups. Statistically significant variables were substituted into logistic regression to further evaluate the independent risk factors for postoperative anastomotic fistulas in esophageal-cardiac cancer. RESULTS: The incidence of anastomotic fistulas was 9.2% (50/544). Logistic regression analysis revealed that female gender (P < 0.05), laparoscopic surgery (P < 0.05), decreased postoperative albumin (P < 0.05), and postoperative renal dysfunction (P < 0.05) were independent risk factors for anastomotic fistulas in patients who received surgery for esophageal-cardiac cancer. Of the 50 anastomotic fistulas, 16 cases were small fistulas, which were only discovered by conventional imaging examination and not presenting clinical symptoms. All of the anastomotic fistulas occurred within seven days after surgery. Five of the patients with anastomotic fistulas underwent a second surgery and three died. CONCLUSION: Female patients with esophageal-cardiac cancer treated with endoscopic surgery and suffering from postoperative hypoproteinemia and renal dysfunction were susceptible to postoperative anastomotic fistula.

Progression From Esophageal Thermal Asymptomatic Lesion to Perforation Complicating Atrial Fibrillation Ablation: A Single-Center Registry.

BACKGROUND: Up to 40% of patients demonstrate endoscopically detected asymptomatic esophageal lesions (EDEL) after atrial fibrillation ablation. METHODS AND RESULTS: Patients undergoing first atrial fibrillation ablation and postinterventional esophageal endoscopy were included in the study. Occurrence of esophageal perforating complications during follow-up was related to documented EDEL (category 1: erythema/erosion; category 2: ulcer). In total, 1802 patients underwent first atrial fibrillation ablation procedure between January 2013 and August 2016 at our institution. Out of this group, 832 patients (506 male patients, 61%; 64.0±10.0 years) with symptomatic paroxysmal (n=345; 42%) or persistent atrial fibrillation underwent postprocedural esophageal endoscopy. Patients were ablated using single-tip ablation with conventional or surround flow irrigation and circular ablation catheters with open irrigation (nMARQ). In 295 of 832 patients (35%), a temperature probe was used. EDEL occurred in 150 patients (18%; n=98 category 1 EDEL, n=52 category 2 EDEL). In 5 of 832 patients (0.6%), an esophageal perforation (n=3) or an esophagopericardial or atrioesophageal fistula (n=2) occurred 15 to 28 days (19±6 days) after ablation. Two patients (1 atrioesophageal fistula and 1 esophagopericardial fistula) died. Esophageal perforation occurred only in patients with category 2 lesions (absolute risk, 9.6%). In a logistic regression analysis, ulcers were identified to be a significant predictor for esophageal perforating complications. CONCLUSIONS: Postablation endoscopy seems to identify patients at high risk of esophageal perforating complications only occurring in patients with category 2 EDEL. One out of 10 postablation esophageal ulcers progressed to perforation, and no patient without esophageal thermal ulcers showed the occurrence of perforating esophageal complications.

Atrial-oesophageal fistula following percutaneous radiofrequency catheter ablation of atrial fibrillation: the risk still persists.

Aims: Atrial-oesophageal fistula is a serious complication related to ablation of atrial fibrillation. As its occurrence is rare, there is a great lack of information about their mechanisms, incidence, presentations, and treatment. The objective of this manuscript is to present a series of cases of atrial-oesophageal fistula in Brazil, focusing on incidence, clinical presentation, and follow-up. Methods and results: This is a retrospective multicentre registry of atrial-oesophageal fistula cases that occurred in eight Brazilian centres from 2003 to 2015. Ten cases (0.113%) of atrial-oesophageal fistula were reported in 8863 ablation procedures in the period. Most of the subjects were male (70%) with age 59.6 ± 9.3 years. Eight centres were reference units in atrial fibrillation ablation with an experience over than 200 procedures at the time of fistula occurrence. Oesophageal temperature monitoring was performed in eight cases using coated sensors in six. The first atrial-oesophageal fistula clinical manifestation was typically fever (in six patients), with a median onset time of 16.5 (12­43) days after ablation. There was a delay of 7.8 ± 3.3 days between the first manifestation and the diagnosis in five patients. The treatment was surgical in six cases, clinical in three and stenting in one. Seven patients died (70%) and two developed permanent neurological sequelae. Conclusion: Atrial-oesophageal fistula remains a serious complication following AF ablation despite the incorporation of protective measures and increased technical experience of the groups. The high morbidity and mortality despite the treatment indicates the need to develop adequate preventive strategies.

Efficacy of endoscopic management of leak after foregut surgery with endoscopic covered self-expanding metal stents (SEMS).

INTRODUCTION: Anastomotic or staple-line leak after foregut surgery presents a formidable management challenge. In recent years, with advancement of endoscopy, self-expanding covered stents have been gaining popularity. In this study, we aimed to determine the safety and effectiveness of self-expanding covered stents in management of leak after foregut surgery. METHODS: Consecutive patients who received a fully covered self-expandable metal stent (SEMS) due to an anastomotic leak after upper gastrointestinal surgery between 2009 and 2014 were retrospectively reviewed. Demographic data, stent placement and removal, clinical success, time to resolution, and complications were collected. Predictive factors for clinical success rate were assessed. RESULTS: A total of 20 consecutive patients underwent placement of fully covered SEMS for anastomotic leak, following esophagectomy (n = 5), esophageal diverticulectomy (n = 1), gastric sleeve (n = 4), gastric bypass (n = 3), partial gastrectomy (n = 4), and total gastrectomy (n = 3). All the stents were removed successfully, and clinical resolution was achieved in 18 patients (90 %) after a median of two (range 1-3) procedures and a mean of 6.2 weeks (range 0.4-14). Complications presented in 12 patients (60 %), including stent migration (n = 8), mucosal friability (n = 4), tissue integration (n = 2), and bleeding (n = 2). Two (10 %) patients' treatment was complicated by aorto-esophageal fistula formation resulting in one death. Demographic factors, comorbidities, and type of surgery were not predictive of clinical success rate or time to resolution. CONCLUSION: SEMS are effective tools for the management of leaks after foregut surgery. The biggest challenge with this approach is stent migration. Caution is warranted due to the risk of fatal complications such as aorto-esophageal fistula formation. No type of surgery or particular patient factor, including age, sex, BMI, albumin, history of radiation, malignancy, and comorbid diabetes or coronary artery disease, appeared to be correlated with success rate. Larger studies are needed to determine factors predictive of clinical success.

Factors That Affect Stent-Related Complications in Patients with Malignant Obstruction of the Esophagus or Gastric Cardia.

BACKGROUND/AIMS: Self-expandable metallic stent (SEMS) placement is effective for dysphagia that results from malignant obstruction of the esophagus or gastric cardia; however, stent-related complications may be life-threatening. Thus, the goal of this study was to identify risk factors associated with complications following esophageal stenting. METHODS: Of the 71 patients who underwent SEMS placement for dysphagia as a result of malignant stricture of the esophagus or gastric cardia, 53 patients with squamous cell carcinoma or adenocarcinoma, without previous SEMS placement, without a fistula, and without recurrent tumor after surgery were retrospectively identified. The occurrence of stent-related complications was used as an endpoint. RESULTS: Stent-related complications were identified in 26 patients (49.1%), and major complications occurred in 14 patients (26.4%). The use of an Ultraflex stent (odds ratio [OR], 6.81; 95% confidence interval [CI], 1.54 to 30.00; p=0.011) and prior chemotherapy (OR, 6.13; 95% CI, 1.46 to 25.70; p=0.013) were significantly associated with stent-related complications. Moreover, the use of an Ultraflex stent (OR, 19.60; 95% CI, 2.26 to 170.00; p=0.007) and prior radiation (OR, 25.70; 95% CI, 2.37 to 280.00; p=0.008) significantly increased the risk of major complications. CONCLUSIONS: The use of an Ultraflex stent and prior radiation and/or chemotherapy may represent risk factors for complications following esophageal SEMS placement.

Atrioesophageal fistula formation with cryoballoon ablation is most commonly related to the left inferior pulmonary vein.

BACKGROUND: Collateral damage has been reported with use of the cryoballoon for pulmonary vein isolation. OBJECTIVE: The purpose of this study was to determine the incidence and characteristics associated with atrioesophageal fistula (AEF) after cryoballoon use. METHODS: Cases of AEF reported with use of the cryoballoon since 2011 were collected from the Manufacturer and User Facility Device Experience (MAUDE) database, publications, and the manufacturer's database. Lowest balloon temperatures were compared with matched control patients undergoing cryoballoon ablation without AEF formation. Location of AEF was compared with AEF associated with radiofrequency ablation. RESULTS: A total of 11 cases of AEF were identified from a worldwide experience that exceed 120,000 cases. Mean age was 60 (range 31-78 years), and 80% of patients were male. Although mean lowest balloon temperatures were no different between patients with AEF and those with no AEF (-58.5°C ± 7.2°C vs -56°C ± 2.6°C, P = NS), balloon inflation times were longer in patients with AEF (238.8 ± 54.8 seconds vs 178.1 ± 37.5 seconds in the non-AEF group, P ≤.001) All cases of AEF for which location was identified occurred in relation to the left pulmonary veins. The left inferior pulmonary vein (LIPV) was involved in 8 of 10 patients with cryoballoon compared to 0 of 11 patients in the radiofrequency group (P <.05). Mortality for cryoballoon-associated AEF was 64%. CONCLUSION: AEF after cryoballoon use is rare (<1 in 10,000) and most commonly was identified near the LIPV. Proximity of the esophagus to the LIPV and evidence of esophageal luminal cooling should be considered indications to limit cryoablation at this vein.

Non-adherence to the rule of 3 does not increase the risk of adverse events in esophageal dilation.

BACKGROUND AND AIMS: Although the rule of 3 is recommended to minimize the risk of perforation when esophageal dilation is performed using bougie dilators, there are no data to validate its use. Our aim was to investigate the association between the rule of 3 and adverse events (AEs) in esophageal dilation. METHODS: A retrospective chart review in patients who underwent esophageal bougie or balloon dilation between December 1991 and February 2013 at a tertiary hospital was performed. Data collection included patient demographics, stricture and procedural characteristics, AEs, and follow-up. Univariate logistic regression models were used to assess the risk of AEs and perforations. RESULTS: A total of 297 patients (median age, 63 years; 60% men) underwent 2216 esophageal bougie or balloon dilations. Major AEs occurred in 22 (1%) dilation sessions, including 11 (0.5%) perforations, 4 (0.2%) fistulas, 3 (0.1%) hospitalizations for pain management, 2 (0.09%) clinically significant hemorrhages, 1 (0.04%) fever, and 1 (0.04%) tracheoesophageal voice prosthesis leak. Mean duration of treatment was 43.2 months (standard deviation, 47.7 months). Most strictures were benign (n = 275; 93%) and complex in nature (n = 198; 67%). Non-adherence to the rule of 3 occurred in 190 (13%) dilations with bougie dilators. Non-adherence was not associated with a higher rate of major AEs (1/190, 0.5% vs 15/953, 1.6%; P = .18) and perforations (0/190, 0% vs 7/952, 0.7%; P = .18). Gender, complex strictures, location of the stricture, type of dilator, and additional interventions were also not associated with major AEs or perforations. However, malignant strictures were associated with an increased risk of major AEs (odds ratio, 3.5; 95% confidence interval, 1.1-12.0) and perforations (odds ratio, 8.3; 95% confidence interval, 2.2-31.9). CONCLUSIONS: Non-adherence to the rule of 3 does not appear to increase the risk of AEs, particularly perforation, after esophageal dilation using bougie dilators. Caution is needed with the dilation of malignant strictures, as there is an increased risk of perforations and AEs. However, large prospective studies are needed to verify the results of this study.

Atrio-oesophageal fistula: dismal outcome of a rare complication with no common solution.

Atrio-oesophageal fistula caused by diffusion of ablative energy through the left atrial wall to the oesophagus is a lethal complication. A high level of suspicion, rapid diagnosis and early correction are of crucial importance. In this review, we highlight the key points that will aid in the thought processes and provide guidance in the prevention, early diagnosis and management to reduce complications and improve outcome when atrio-oesophageal fistula is suspected.

Incidence and Predictors of Complications During Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation.

BACKGROUND: Cryoballoon pulmonary vein isolation (PVI) has emerged as an alternative to radiofrequency PVI for atrial fibrillation (AF). Data are lacking to define the rates and predictors of complications, particularly phrenic nerve injury (PNI). METHODS AND RESULTS: We evaluated a single-center prospective registry of 450 consecutive patients undergoing cryoballoon PVI between 2011 and 2015. Patients were 59±10 years old, 26% were women, 58% had hypertension, their mean CHA2DS2VASc score was 1.7±1.3, 30% had persistent atrial fibrillation, and 92% received a second-generation 28-mm balloon. Predefined major complications were persistent PNI, pericardial effusion, deep vein thrombosis, arteriovenous fistula, atrioesophageal fistula, bleeding requiring transfusion, stroke, and death. PNI was categorized as persistent if it persisted after discharge from the laboratory. Logistic regression was performed to identify predictors of complications and specifically PNI. We identified a major complication in 10 (2.2%) patients. In 49 (10.8%) patients, at least transient PNI was observed; only 5 persisted beyond the procedure (1.1%). All cases of PNI resolved eventually, with the longest time to resolution being 48 days. We also describe 2 cases of PNI manifesting after the index hospitalization. Regression analysis identified 23-mm balloon use (16.3% versus 5.2%, odds ratio 2.94, P=0.011) and increased age (62.8±7.7 versus 58.7±0.12 years, odds ratio 1.058, P=0.014) as independent significant predictors of PNI. There were no significant predictors of major complications. CONCLUSIONS: In a large contemporary cohort, cryoballoon PVI is associated with low procedural risk, including lower rates of PNI than previously reported. Older age and 23-mm balloon use were associated with PNI. Our low rate of PNI may reflect more sensitive detection methods, including compound motor action potential monitoring and forced double-deflation.