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Abstract Background Esophageal injury following catheter ablation of atrial fibrillation (AF) is reported to occur in 35% of patients. Even with a low energy setting (20–25 W), lesions develop in 10% of patients. Body mass index (BMI) has been reported to be a predictor of esophageal injury, indicating that patients with a low BMI (<24.9 kg/m2 ) are at a higher risk. We hypothesized that catheter ablation with a lower energy setting of 20 W controlled by esophageal temperature monitoring (ETM) at 39 °C could prevent esophageal injury even in patients with a BMI <24.9 kg/m2. Methods Twenty patients with AF were included (age, 63±8 years; BMI, 22.9±1.3 kg/m2 , left atrium diameter, 44±11 mm). If the esophageal temperature probe registered a temperature of >39 °C, radiofrequency (RF) application was stopped immediately. RF application could be performed in a “point by point” manner for a maximum of 20 s. Endoscopy was performed 1–5 days after ablation. Results Esophageal mucosal injury was not observed in any patient in the study. Conclusions Catheter ablation using ETM reduced the incidence of esophageal injuries, even in patients with a low BMI.

Abstract Background Even with the use of a reduced energy setting (20–25 W), excessive transmural injury (ETI) following catheter ablation of atrial fibrillation (AF) is reported to develop in 10% of patients. However, the incidence of ETI depends on the pulmonary vein isolation (PVI) method and its esophageal temperature monitor setting. Data comparing the incidence of ETI following AF ablation with and without esophageal temperature monitoring (ETM) are still lacking. Methods This study was comprised of 160 patients with AF (54% paroxysmal, mean: 24.0±2.9 kg/m2 ). Eighty patients underwent ablation accompanied by ETM. The primary endpoint was defined as the occurrence of ETI assessed by endoscopy within 5 d after the AF ablation. The secondary endpoint was defined as AF recurrence after a single procedure. If the esophageal temperature probe registered >39 °C, the radiofrequency (RF) application was stopped immediately. RF applications could be performed in a point-by-point manner for a maximum of 20 s and 20 W. ETI was defined as any injury that resulted from AF ablation, including esophageal injury or periesophageal nerve injury (peri-ENI). Results The incidence of esophageal injury was significantly lower in patients whose AF ablation included ETM compared with patients without ETM (0 [0%] vs. 6 [7.5%], p =0.028), but not the incidence of peri-ENI (2 [2.5%] vs. 3 [3.8%], p =1.0). AF recurrence 12 months after the procedure was similar between the groups (20 [25%] in the ETM group vs. 19 [24%] in the non-ETM group, p =1.00). Conclusions Catheter ablation using ETM may reduce the incidence of esophageal injury without increasing the incidence of AF recurrence but not the incidence of peri-ENI.

Abstract Background The radiofrequency (RF) lesions for atrial fibrillation (AF) ablation can be visualized by delayed enhancement magnetic resonance imaging (DE-MRI). However, the quality of anatomical information provided by DE-MRI is not adequate due to its spatial resolution. In contrast, magnetic resonance angiography (MRA) provides similar information regarding the left atrium (LA) and pulmonary veins (PVs) as computed tomography angiography. We hypothesized that DE-MRI fused with MRA will compensate for the inadequate image quality provided by DE-MRI. Methods DE-MRI and MRA were performed in 18 patients who underwent AF ablation (age, 60±9 years; LA diameter, 42±6 mm). Two observers independently assessed the DE-MRI and DE-MRI fused with MRA for visualization of the RF lesion (score 0–2; where 0: not visualized and 2: excellent in all 14 segments of the circular RF lesion). Results DE-MRI fused with MRA was successfully performed in all patients. The image quality score was significantly higher in DE-MRI fused with MRA compared to DE-MRI alone (observer 1: 22 (18, 25) vs 28 (28, 28), p <0.001; observer 2: 24 (23, 25) vs 28 (28, 28), p <0.001). Conclusions DE-MRI fused with MRA was superior to DE-MRI for visualization of the RF lesion owing to the precise information on LA and PV anatomy provided by DE-MRI.

Abstract Background Atrial tissue fibrosis has previously been identified using delayed-enhancement MRI (DE-MRI) in patients with atrial fibrillation (AF). Although the clinical importance of DE-MRI is well recognized, the visualization of atrial fibrosis and radiofrequency (RF) lesions has still not been achieved in Japan, primarily because of the differences in contrast agents, volume-rendering tools, and technical experience. The objective of this study was to visualize RF lesions by using commercially available tools. Methods DE-MRI was performed in 15 patients who had undergone AF ablation (age, 59±4 years, left atrium diameter, 40±2 mm). Specific parameters for MR scanning obtained from previous reports were modified. Results Of the 15 images, the images of three patients were uninterpretable owing to low image quality. RF lesions could be visualized in 8 (67%) of the 12 patients. Conclusions In the current study, we successfully demonstrated that RF lesions could be visualized in Japanese patients using DE-MRI, although only commercially available tools were used.

Phase I/II clinical trials of S-1 plus cisplatin for advanced gastric cancer have yielded good responses and the treatment was well tolerated. In this S-1 Plus cisplatin versus S-1 In RCT In the Treatment for Stomach cancer (SPIRITS) trial, we aimed to verify that overall survival was better in patients with advanced gastric cancer treated with S-1 plus cisplatin than with S-1 alone. In this phase III trial, chemotherapy-naive patients with advanced gastric cancer were enrolled betweeen March 26, 2002, and Nov 30, 2004, at 38 centres in Japan, and randomly assigned to S-1 plus cisplatin or S-1 alone. In patients assigned to S-1 plus cisplatin, S-1 (40–60 mg depending on patient's body surface area) was given orally, twice daily for 3 consecutive weeks, and 60 mg/m 2 cisplatin was given intravenously on day 8, followed by a 2-week rest period, within a 5-week cycle. Those assigned to S-1 alone received the same dose of S-1 twice daily for 4 consecutive weeks, followed by a 2-week rest period, within a 6-week cycle. The primary endpoint was overall survival. Secondary endpoints were progression-free survival, proportions of responders, and safety. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00150670. 305 patients were enrolled; seven patients were ineligible or withdrew consent, therefore, 148 patients were assigned to S-1 plus cisplatin and 150 patients were assigned to S-1 alone. Median overall survival was significantly longer in patients assigned to S-1 plus cisplatin (13·0 months [IQR 7·6–21·9]) than in those assigned to S-1 alone (11·0 months [5·6–19·8]; hazard ratio for death, 0·77; 95% CI 0·61–0·98; p=0·04). Progression-free survival was significantly longer in patients assigned to S-1 plus cisplatin than in those assigned to S-1 alone (median progression-free survival 6·0 months [3·3–12·9] vs 4·0 months [2·1–6·8]; p<0·0001). Additionally, of 87 patients assigned S-1 plus cisplatin who had target tumours, one patient had a complete response and 46 patients had partial responses, ie, a total of 54% (range 43–65). Of 106 patients assigned S-1 alone who had target tumours, one patient had a complete response and 32 had partial responses, ie, a total of 31% (23–41). We recorded more grade 3 or 4 adverse events including leucopenia, neutropenia, anaemia, nausea, and anorexia, in the group assigned to S-1 plus cisplatin than in the group assigned to S-1 alone. There were no treatment-related deaths in either group. S-1 plus cisplatin holds promise of becoming a standard first-line treatment for patients with advanced gastric cancer.