Incidence and predictors of thermal oesophageal and vagus nerve injuries in Ablation Index-guided high-power-short-duration ablation of atrial fibrillation: a prospective study.

AIMS: High-power-short-duration (HPSD) ablation is an effective treatment for atrial fibrillation but poses risks of thermal injuries to the oesophagus and vagus nerve. This study aims to investigate incidence and predictors of thermal injuries, employing machine learning. METHODS AND RESULTS: A prospective observational study was conducted at Leipzig Heart Centre, Germany, excluding patients with multiple prior ablations. All patients received Ablation Index-guided HPSD ablation and subsequent oesophagogastroduodenoscopy. A machine learning algorithm categorized ablation points by atrial location and analysed ablation data, including Ablation Index, focusing on the posterior wall. The study is registered in clinicaltrials.gov (NCT05709756). Between February 2021 and August 2023, 238 patients were enrolled, of whom 18 (7.6%; nine oesophagus, eight vagus nerve, one both) developed thermal injuries, including eight oesophageal erythemata, two ulcers, and no fistula. Higher mean force (15.8 ± 3.9 g vs. 13.6 ± 3.9 g, P = 0.022), ablation point quantity (61.50 ± 20.45 vs. 48.16 ± 19.60, P = 0.007), and total and maximum Ablation Index (24 114 ± 8765 vs. 18 894 ± 7863, P = 0.008; 499 ± 95 vs. 473 ± 44, P = 0.04, respectively) at the posterior wall, but not oesophagus location, correlated significantly with thermal injury occurrence. Patients with thermal injuries had significantly lower distances between left atrium and oesophagus (3.0 ± 1.5 mm vs. 4.4 ± 2.1 mm, P = 0.012) and smaller atrial surface areas (24.9 ± 6.5 cm2 vs. 29.5 ± 7.5 cm2, P = 0.032). CONCLUSION: The low thermal lesion's rate (7.6%) during Ablation Index-guided HPSD ablation for atrial fibrillation is noteworthy. Machine learning based ablation data analysis identified several potential predictors of thermal injuries. The correlation between machine learning output and injury development suggests the potential for a clinical tool to enhance procedural safety.

[Endoscopic Ultrasound Drainage of the Gallbladder in Acute Cholecystitis in Patients at High Surgical Risk]. / Endosonografische Drainage der Gallenblase wegen akuter Cholezystitis bei Patienten mit hohem Operationsrisiko.

BACKGROUND: The standard treatment for acute cholecystitis is laparoscopic cholecystectomy. Alternative procedures are used for patients at high surgical risk. Percutaneous drainage is widely available. The alternative of transpapillary drainage of the gallbladder via the ductus cysticus has only limited prospects of success. With the widespread use of interventional endoscopic ultrasound and the development of new stent systems, endoscopic ultrasound gallbladder drainage has proven to be a safe and reliable procedure. MATERIAL AND METHOD: We retrospectively report on our experiences in 11 consecutive patients with endoscopic ultrasound gallbladder drainage in acute cholecystitis between December 2018 and January 2021. RESULTS: 11 patients with acute cholecystitis with a mean age of 84.5 years (70-95 years) are reported. All patients had severe general comorbidities or advanced abdominal tumours or a combination of these conditions. After interdisciplinary debate, the indication for interventional therapy was made. This was carried out in 9 cases by means of endosonographic drainage alone and in 2 cases by means of percutaneous and two-stage endosonographic drainage. Technical success was achieved in 10 cases (91%), clinical success in 9 cases (82%). In 2 cases there were procedural complications that led to the operation. CONCLUSION: In the case of high surgical risks, endosonographic drainage of the gall bladder is a safe and definitive therapy. This can be performed alone or in combination with percutaneous drainage. Endoscopic ultrasound drainage is superior to percutaneous drainage alone, due to its lower complication rates and lower rates of necessary follow-up interventions. Therefore, in cases of relatively high surgical risk, endoscopic ultrasound drainage of the gall bladder should be preferred to percutaneous drainage, especially when definitive therapy is required.

Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2).

OBJECTIVE: Acute non-variceal upper gastrointestinal bleeding (NVUGIB) is managed by standard endoscopic combination therapy, but a few cases remain difficult and carry a high risk of persistent or recurrent bleeding. The aim of our study was to compare first-line over-the-scope-clips (OTSC) therapy with standard endoscopic treatment in these selected patients. DESIGN: We conducted a prospective, randomised, controlled, multicentre study (NCT03331224). Patients with endoscopic evidence of acute NVUGIB and high risk of rebleeding (defined as complete Rockall Score ≥7) were included. Primary endpoint was clinical success defined as successful endoscopic haemostasis without evidence of recurrent bleeding. RESULTS: 246 patients were screened and 100 patients were finally randomised (mean of 5 cases/centre and year; 70% male, 30% female, mean age 78 years; OTSC group n=48, standard group n=52). All but one case in the standard group were treated with conventional clips. Clinical success was 91.7% (n=44) in the OTSC group compared with 73.1% (n=38) in the ST group (p=0.019), with persistent bleeding occurring in 0 vs 6 in the OTSC versus standard group (p=0.027), all of the latter being successfully managed by rescue therapy with OTSC. Recurrent bleeding was observed in four patients (8.3%) in the OTSC group and in eight patients (15.4%) in the standard group (p=0.362). CONCLUSION: OTSC therapy appears to be superior to standard treatment with clips when used by trained physicians for selected cases of primary therapy of NVUGIB with high risk of rebleeding. Further studies are necessary with regards to patient selection to identify subgroups benefiting most from OTSC haemostasis. TRIAL REGISTRATION NUMBER: NCT03331224.

Cardiac output states in patients with severe functional tricuspid regurgitation: impact on treatment success and prognosis.

AIMS: To investigate whether there is evidence for distinct cardiac output (CO) based phenotypes in patients with chronic right heart failure associated with severe tricuspid regurgitation (TR) and to characterize their impact on TR treatment and outcome. METHODS AND RESULTS: A total of 132 patients underwent isolated transcatheter tricuspid valve repair (TTVR) for functional TR at two centres. Patients were clustered according to k-means clustering into low [cardiac index (CI) < 1.7 L/min/m2 ], intermediate (CI 1.7-2.6 L/min/m2 ) and high CO (CI > 2.6 L/min/m2 ) clusters. All-cause mortality and clinical characteristics during follow-up were compared among different CO clusters. Mortality rates were highest for patients in a low (24%) and high CO state (42%, log-rank P < 0.001). High CO state patients were characterized by larger inferior vena cava diameters (P = 0.003), reduced liver function, higher incidence of ascites (P = 0.006) and markedly reduced systemic vascular resistance (P < 0.001) as compared to TTVR patients in other CO states. Despite comparable procedural success rates, the extent of changes in right atrial pressures (P = 0.01) and right ventricular dimensions (P < 0.001) per decrease in regurgitant volume following TTVR was less pronounced in high CO state patients as compared to other CO states. Successful TTVR was associated with the smallest prognostic benefit among low and high CO state patients. CONCLUSIONS: Patients with chronic right heart failure and severe TR display distinct CO states. The high CO state is characterized by advanced congestive hepatopathy, a substantial decrease in peripheral vascular tone, a lack of response of central venous pressures to TR reduction, and worse prognosis. These data are relevant to the pathophysiological understanding and management of this important clinical syndrome.

Oesophageal Probe Evaluation in Radiofrequency Ablation of Atrial Fibrillation (OPERA): results from a prospective randomized trial.

AIMS: The aim of the study was to determine the incidence of oesophageal lesions after radiofrequency ablation (RFA) of atrial fibrillation (AF) with or without the use of oesophageal temperature probes. METHODS AND RESULTS: Two hundred patients were prospectively randomized into two groups: the OPERA+ group underwent RFA using oesophageal probes (SensiTherm™); the OPERA- group received RFA using fixed energy levels of 25 W at the posterior wall without an oesophageal probe. All patients underwent post-interventional endoscopy and Holter-electrocardiogram after 6 months. (Clinical.Trials.gov: NCT03246594). One hundred patients were randomized in OPERA+ and 100 patients in OPERA-. The drop-out rate was 10%. In total, 18/180 (10%) patients developed endoscopically diagnosed oesophageal lesions (EDEL). There was no difference between the groups with 10/90 (11%) EDEL in OPERA+ vs. 8/90 (9%) in OPERA- (P = 0.62). Despite the higher power delivered at the posterior wall in OPERA+ [28 ± 4 vs. 25 ± 2 W (P = 0.001)], the average EDEL size was equal [5.7 ± 2.6 vs. 4.5 ± 1.7 mm (P = 0.38)]. The peak temperature did not correlate with EDEL size. During follow-up, no patient died. Only one patient in OPERA- required a specific therapy for treatment of the lesion. Cumulative AF recurrence after 6 (3-13) months was 28/87 (32%) vs. 34/88 (39%), P = 0.541. CONCLUSION: This first randomized study demonstrates that intraoesophageal temperature monitoring using the SensiTherm™ probe does not affect the probability of developing EDEL. The peak temperature measured by the thermoprobe seems not to correlate with the incidence of EDEL. Empiric energy reduction at the posterior wall did not affect the efficacy of the procedure.

Nutritional status in tricuspid regurgitation: implications of transcatheter repair.

AIMS: To characterize the prevalence and clinical relevance of malnutrition in patients undergoing transcatheter tricuspid valve edge-to-edge repair (TTVR). METHODS AND RESULTS: Overall, 86 consecutive patients (mean age 78 ± 7 years) with moderate-to-severe tricuspid regurgitation (TR) at prohibitive surgical risk were analysed. Mini Nutritional Assessment (MNA), quality of life assessment, 6-min walk test distance and laboratory analyses were performed before and 1 month after TTVR. A total of 43 patients (50%) underwent concomitant transcatheter mitral valve repair. According to MNA, 81 patients (94%) were malnourished or at risk of malnutrition before TTVR. Following TTVR, MNA improved in 64 patients (74%). As compared to patients without MNA improvement, patients with increased MNA score had greater reductions in TR [regurgitation volume -17.0 (interquartile range, IQR -25.0; -7.0) mL vs. -26.4 (IQR -40.3; -14.5) mL, P < 0.001] and inferior vena cava diameter. Only patients with increased MNA score displayed a decrease in N-terminal pro-brain natriuretic peptide levels [-320 (IQR -1294; 105) pg/mL vs. +708 (IQR -342; 2708) pg/mL, P = 0.009], improvements in cholinesterase levels (0.0 ± 11.9 µmoL/L vs. +10.9 ± 16.7 µmoL/L, P < 0.001) and renal function during follow-up. Beneficial effects on quality of life scores and 6-min walk test distance following TTVR were observed exclusively in patients with improvement in MNA. During a median follow-up of 6 months, patients with worsened MNA had an increased risk of death and rehospitalization for heart failure. CONCLUSION: Nutritional impairment is common and of prognostic importance in patients undergoing TTVR. Hepatorenal function modestly improves after successful TTVR. Further study of extracardiac implications of TR-associated right heart failure is warranted to improve care in this vulnerable patient population.

Open Surgical versus Minimal Invasive Necrosectomy of the Pancreas-A Retrospective Multicenter Analysis of the German Pancreatitis Study Group.

BACKGROUND: Necrotising pancreatitis, and particularly infected necrosis, are still associated with high morbidity and mortality. Since 2011, a step-up approach with lower morbidity rates compared to initial open necrosectomy has been established. However, mortality and complication rates of this complex treatment are hardly studied thereafter. METHODS: The German Pancreatitis Study Group performed a multicenter, retrospective study including 220 patients with necrotising pancreatitis requiring intervention, treated at 10 hospitals in Germany between January 2008 and June 2014. Data were analysed for the primary endpoints "severe complications" and "mortality" as well as secondary endpoints including "length of hospital stay", "follow up", and predisposing or prognostic factors. RESULTS: Of all patients 13.6% were treated primarily with surgery and 86.4% underwent a step-up approach. More men (71.8%) required intervention for necrotising pancreatitis. The most frequent etiology was biliary (41.4%) followed by alcohol (29.1%). Compared to open necrosectomy, the step-up approach was associated with a lower number of severe complications (primary composite endpoint including sepsis, persistent multiorgan dysfunction syndrome (MODS) and erosion bleeding: 44.7% vs. 73.3%), lower mortality (10.5% vs. 33.3%) and lower rates of diabetes mellitus type 3c (4.7% vs. 33.3%). Low hematocrit and low blood urea nitrogen at admission as well as a history of acute pancreatitis were prognostic for less complications in necrotising pancreatitis. A combination of drainage with endoscopic necrosectomy resulted in the lowest rate of severe complications. CONCLUSION: A step-up approach starting with minimal invasive drainage techniques and endoscopic necrosectomy results in a significant reduction of morbidity and mortality in necrotising pancreatitis compared to a primarily surgical intervention.

Successful nonsurgical treatment of esophagopericardial fistulas after atrial fibrillation catheter ablation: a case series.

BACKGROUND: Esophageal perforations are a rare but devastating complication of atrial fibrillation catheter ablation. Rapid treatment is crucial to avoid permanent disabilities and death. Surgical treatment is considered the treatment of choice. Alternatively, single case reports describe successful esophageal stenting, but others discourage this approach because of fatal consequences. METHODS AND RESULTS: We present 3 patients who developed esophagopericardial fistulas after radiofrequency catheter ablation of atrial fibrillation. Diagnosis and management with pericardial drainage and esophageal stenting, as well as long-term follow-up are described. Esophagopericardial fistulas occurred 26, 9, and 18 days after the ablation procedure. Symptoms leading to admission were recurrence of atrial fibrillation (n=1), elective control endoscopy for thermal lesion (n=1), and pain with swallowing (n=1). Computed tomography revealed esophagopericardial fistulas with pericardial effusion in all patients, while contrast leakage and air in the left atrium could be excluded. Broad-spectrum antibiotics were initialized, and minimally invasive pericardial drainage and esophageal stenting were performed. Stent dislocation occurred in 2 patients and was resolved by repositioning and clipping of the proximal stent end. After 45, 22, and 28 days, respectively, fistulas appeared closed and stents were removed. During follow-up, no embolic or septic events occurred. However, 2 patients underwent dilation of symptomatic esophageal stenosis in the formerly stented region. CONCLUSIONS: An early minimally invasive approach consisting of pericardial drainage and esophageal stenting proved effective in treating patients with esophagopericardial fistulas. However, constant interdisciplinary communication and attention is needed to recognize and manage potential evolving complications promptly.

Chemotherapy-Induced Ischemic Colitis in a Patient with Jejunal Lymphoma.

The occurrence of acute ischemic colitis may be associated with the intake of various drugs. However, colitis during antineoplastic chemotherapy usually is due to toxic effects or neutropenia and not caused by ischemia. We describe a 51-year-old man with jejunal B-cell lymphoma who developed recurrent episodes of ischemic colitis following chemotherapy with cyclophosphamide, vincristine, doxorubicine and prednisolone plus rituximab (R-CHOP). After switching chemotherapy to bendamustin plus rituximab no further episodes of colonic ischemia occurred during the following cycles of chemotherapy. In conclusion, chemotherapy of lymphoma using a standard protocol with CHOP and rituximab may cause ischemic colitis.

Thermal esophageal lesions after radiofrequency catheter ablation of left atrial arrhythmias.

OBJECTIVES: Radiofrequency catheter ablation in patients with left atrial arrhythmias may cause esophageal damage because of the close proximity between the posterior wall of the left atrium and the esophagus. The aim of this prospective study was to determine the incidence, endoscopic characterization, and endoluminal temperature dependency of esophageal thermal lesions after catheter ablation. METHODS: In all, 185 consecutive patients with symptomatic atrial fibrillation or left atrial macro-re-entrant tachycardia who underwent left atrial radiofrequency catheter ablation were scheduled for upper gastrointestinal endoscopy. During the ablation procedure, a non-fluoroscopic three-dimensional system for catheter orientation, computed tomography (CT) image integration, and activation mapping was used. The esophagus was intubated with a temperature probe for visualization within the three-dimensional image and for real-time intraluminal temperature monitoring. RESULTS: A total of 27 (14.6%) asymptomatic ulcer-like or hemorrhagic esophageal thermal lesions with a diameter of 2-16 mm were observed. Esophageal lesions did not occur below an intraluminal esophageal temperature of 41 degrees C. The maximal temperature in the esophagus was significantly higher in patients with thermal lesions than in patients without lesions (42.6+/-1.7 degrees C vs. 41.4+/-1.7 degrees C, P=0.003). For every 1 degrees C increase in endoluminal temperature, the odds of an esophageal lesion increased by a factor of 1.36 (95% confidence interval (CI) 1.07-1.74, P=0.012). No progression of the lesions was observed during follow-up endoscopies. CONCLUSIONS: Localized esophageal ulcer-like lesion is a frequent event after left atrial catheter ablation and can be found in patients whose intraluminal temperature has reached at least 41 degrees C.

[Multiple gastrointestinal stromal tumors in neurofibromatosis type 1]. / Multiple gastrointestinale Stromatumoren bei Neurofibromatose Typ 1.

BACKGROUND: Gastrointestinal stromal tumors (GIST) are generally rare, but appear more frequently in patients with neurofibromatosis type 1. Mostly asymptomatic, GIST can also cause relevant clinical appearances such as gastrointestinal bleeding, obstruction, or invagination. In recent years, a significant expert knowledge was gained in biology and treatment of these tumors. CASE REPORT: The case of a 50-year-old man with a history of neurofibromatosis type 1 and acute gastrointestinal bleeding is described. In the index upper endoscopy an ulcerated tumor of the proximal small bowel was found. The histopathologic examination showed a GIST. Segmental small bowel resection was carried out. Over the course of 1 year, there has been no evidence of a recurrence, metastases, or metachronous GIST. CONCLUSION: Considering the distinct biology of GIST in patients with neurofibromatosis type 1, the recommendation for a generous endoscopic examination or a routine endoscopy in this population is discussed.

[Sonographic findings in the diagnostic course of vascular access for hemodialysis]. / Sonographische Funktionsbeurteilung von Hämodialysefisteln.

BACKGROUND AND PURPOSE: Hemodialysis and related procedures require a reliable vascular access and the Brescia-Cimino shunt of the nondominant forearm has proven to be its most important form. Today, color Doppler sonography is regarded as the main method in the diagnosis of vascular access dysfunction. The aim of this study was to evaluate the impact of the Resistive Index (RI) of the fistula's feeding artery on the fistula's blood flow. PATIENTS AND METHODS: 47 patients with arteriovenous fistulas were investigated by means of color Doppler sonography. The fistulas' blood flow, morphological details and the RI of the arteries distal as well as proximal to the fistulas were determined. Furthermore, systolic blood pressure of the second and third fingers of both hands was measured. Comparisons were made between the fistula's blood flow and the RI of the feeding artery. RESULTS: On the arm of the fistulas, the proximal and distal RI and the systolic blood pressure were lower than on the contralateral arm. The blood flow of the upper arm fistulas was higher than that of the forearm fistulas due to a higher vascular diameter. No linear correlations existed between the RI and the fistula's blood flow. 50% of the forearm fistulas showed a proximal RI > or = 0.53 and a blood flow < 400 ml/min. CONCLUSION: The RI of the supplying artery of the forearm fistulas is a reliable value to detect insufficient blood flow. In such cases, further diagnostic procedures are necessary. Also, numerous influences on the measurement of the fistula's blood flow exist. Therefore, intraindividual investigations to evaluate the fistulas' further development are recommended to get better options for their control.