Cardioversion in patients with newly diagnosed non-valvular atrial fibrillation: observational study using prospectively collected registry data

OBJECTIVE To investigate the clinical outcomes of patients who underwent cardioversion compared with those who did not have cardioverson in a large dataset of patients with recent onset non-valvular atrial fibrillation. DESIGN Observational study using prospectively collected registry data (Global Anticoagulant Registry in the FIELD-AF-GARFIELD-AF). SETTING 1317 participating sites in 35 countries. PARTICIPANTS 52 057 patients aged 18 years and older with newly diagnosed atrial fibrillation (up to six weeks' duration) and at least one investigator determined stroke risk factor. MAIN OUTCOME MEASURES Comparisons were made between patients who received cardioversion and those who had no cardioversion at baseline, and between patients who received direct current cardioversion and those who had pharmacological cardioversion. Overlap propensity weighting with Cox proportional hazards models was used to evaluate the effect of cardioversion on clinical endpoints (all cause mortality, non-haemorrhagic stroke or systemic embolism, and major bleeding), adjusting for baseline risk and patient selection. RESULTS 44 201 patients were included in the analysis comparing cardioversion and no cardioversion, and of these, 6595 (14.9%) underwent cardioversion at baseline. The propensity score weighted hazard ratio for all cause mortality in the cardioversion group was 0.74 (95% confidence interval 0.63 to 0.86) from baseline to one year follow-up and 0.77 (0.64 to 0.93) from one year to two year follow-up. Of the 6595 patients who had cardioversion at baseline, 299 had a follow-up cardioversion more than 48 days after enrolment. 7175 patients were assessed in the analysis comparing type of cardioversion: 2427 (33.8%) received pharmacological cardioversion and 4748 (66.2%) had direct current cardioversion. During one year follow-up, event rates (per 100 patient years) for all cause mortality in patients who received direct current and pharmacological cardioversion were 1.36 (1.13 to 1.64) and 1.70 (1.35 to 2.14), respectively. OBJECTIVE To investigate the clinical outcomes of patients who underwent cardioversion compared with those who did not have cardioverson in a large dataset of patients with recent onset non-valvular atrial fibrillation. DESIGN Observational study using prospectively collected registry data (Global Anticoagulant Registry in the FIELD-AF-GARFIELD-AF). SETTING 1317 participating sites in 35 countries. PARTICIPANTS 52 057 patients aged 18 years and older with newly diagnosed atrial fibrillation (up to six weeks' duration) and at least one investigator determined stroke risk factor. MAIN OUTCOME MEASURES Comparisons were made between patients who received cardioversion and those who had no cardioversion at baseline, and between patients who received direct current cardioversion and those who had pharmacological cardioversion. Overlap propensity weighting with Cox proportional hazards models was used to evaluate the effect of cardioversion on clinical endpoints (all cause mortality, non-haemorrhagic stroke or systemic embolism, and major bleeding), adjusting for baseline risk and patient selection. RESULTS 44 201 patients were included in the analysis comparing cardioversion and no cardioversion, and of these, 6595 (14.9%) underwent cardioversion at baseline. The propensity score weighted hazard ratio for all cause mortality in the cardioversion group was 0.74 (95% confidence interval 0.63 to 0.86) from baseline to one year follow-up and 0.77 (0.64 to 0.93) from one year to two year follow-up.Of the 6595 patients who had cardioversion at baseline, 299 had a follow-up cardioversion more than 48 days after enrolment. 7175 patients were assessed in the analysis comparing type of cardioversion: 2427 (33.8%) received pharmacological cardioversion and 4748 (66.2%) had direct current cardioversion. During one year follow-up, event rates (per 100 patient years) for all cause mortality in patients who received direct current and pharmacological cardioversion were 1.36 (1.13 to 1.64) and 1.70 (1.35 to 2.14), respectively. CONCLUSION In this large dataset of patients with recent onset non-valvular atrial fibrillation, a small proportion were treated with cardioversion. Direct current cardioversion was performed twice as often as pharmacological cardioversion, and there appeared to be no major difference in outcome events for these two cardioversion modalities. For the overall cardioversion group, after adjustments for confounders, a significantly lower risk of mortality was found in patients who received early cardioversion compared with those who did not receive early cardioversion. STUDY REGISTRATION ClinicalTrials.gov NCT01090362

Effect of neoadjuvant chemotherapy using gemcitabine and S1 before surgery for pancreatic cancer on quality of life.

e15719 Background: To improve the poor prognosis of patients with pancreatic cancer, we examined the effect of 6 months of neoadjuvant chemotherapy (NAC) using gemcitabine and S1 before surgery and found significantly prolonged survival. Clinical use of this treatment is expected in the future. However, preoperative NAC may increase the physical burden on patients as well as their psychological burden due to the longer waiting time. Thus, it is necessary to confirm that the treatment does not reduce quality of life (QOL). Methods: In this observational study of patients who underwent resection after this NAC, a QOL questionnaire survey was administered preoperatively and at postoperative months 3, 6, and 12, to consenting patients from those enrolled in randomized controlled trials (RCTs). The intervention group (planned surgery and NAC) had added pre- and post-treatment QOL surveys. We used the Short Form 36 Health Survey version 2 (SF-36v2 Standard, Japanese) to measure health-related QOL. Overall differences among the groups were evaluated by paired t test and two- and three-way ANOVA. All statistical analyses were performed using SPSS (ver. 21) software. Results: In total, 55 patients (mean age 66.0 years), about 15% of those enrolled in the RCTs, responded to the questionnaire (NAC group, n = 22; control group, n = 33). QOL was not significantly reduced in the NAC group pre- and post-treatment ( p= 0.19-0.96). Notably, there were no significant differences in post-treatment QOL, with improvement in the Physical Functioning (75.9→79.4), Bodily Pain (70.5→72.5), Vitality (59.6→59.9), and Mental Health (66.5→69.7) SF-36 domains compared with before preoperative treatment. This suggests that patients had good preoperative physical and mental QOL. QOL at each time point did not differ significantly in the 8 domains with or without NAC; the Mental component summary score was significantly higher in the NAC group compared with the control group at 3 months (54.9 vs 49.3, p= 0.04). NAC and QOL did not differ significantly by time, sex, and operation type. Conclusions: NAC using gemcitabine and S1 before surgery for pancreatic cancer does not reduce QOL. Improved prognosis can be expected with no adverse effect on QOL. </jats:p