Incidence and clinical significance of cerebral embolism during atrial fibrillation ablation with duty-cycled phased-radiofrequency versus cooled-radiofrequency: a randomized controlled trial

OBJECTIVES The purpose of this study was to randomly compare the incidence of asymptomatic cerebral embolism (ACE) between the second-generation pulmonary vein ablation catheter (PVAC Gold) and the irrigated Thermocool catheter.BACKGROUND Pulmonary vein isolation (PVI) with the PVAC is associated with ACE. The PVAC Gold was designed to avoid this complication.METHODS Patients with paroxysmal atrial fibrillation were randomized 1:1 to PVI with the PVAC Gold or Thermocool catheter. Cerebral magnetic resonance imaging was performed in the days before and after ablation and repeated after 3 months in case of a new lesion. Monitoring for microembolic signals (MES) was performed by using transcranial Doppler ultrasonography. Parameters of coagulation were determined before, during, and after ablation. Neuropsychological tests and questionnaires were applied 10 days before and 3 months after ablation.RESULTS Seventy patients were included in the study (mean age 61 +/- 9 years; 43 male subjects; CHA(2)DS(2)-VASc [congestive heart failure, hypertension, age >= 75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category] score 1.6 +/- 1.2; international normalized ratio 2.7 +/- 0.5; activated clotting time 374 +/- 24 s; p > 0.05 for all parameters). Procedural duration was shorter in the PVAC Gold group (140 +/- 34 vs. 207 +/- 44 min; p < 0.001). Eight (23%; 7 infarcts) patients in the PVAC Gold group exhibited a new ACE, compared with 2 (6%; no infarcts) patients in the Thermocool group (p = 0.042). Median number of MES was higher in the PVAC Gold group (1,111 [interquartile range, 715-2,234] vs. 787 [interquartile range, 532-1,053]; p < 0.001). There were no differences between groups regarding coagulation and neuropsychological outcomes.CONCLUSIONS PVI with the new PVAC Gold was associated with a higher incidence of ACE/cerebral infarcts and number of MES. Both catheters induced a comparable procoagulant state. Because there were no measurable differences in neuropsychological status, the clinical significance of ACE remains unclear. (Cerebral Embolism [CE] in Catheter Ablation of Atrial Fibrillation [AF] [CE-AF]; NCT01361295) (C) 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation

Properties that influence business process management maturity and its effect on organizational performance

Abstract BPM maturity is a measure to evaluate how professionally an organization manages its business processes. Previous research provides evidence that higher BPM maturity leads to better performance of processes and of the organization as a whole. It also claims that different organizations should strive for different levels of maturity, depending on their properties. This paper presents an empirical investigation of these claims, based on a sample of 120 organizations and looking at a selection of organizational properties. Our results reveal that higher BPM maturity contributes to better performance, but only up to a point. Interestingly, it contradicts the popular belief that higher innovativeness is associated with lower BPM maturity, rather showing that higher innovativeness is associated with higher BPM maturity. In addition, the paper shows that companies in different regions have a different level of BPM maturity. These findings can be used as a benchmark and a motivation for organizations to increase their BPM maturity

The denial of cancer interview: development and first assessment of psychometric properties in lung cancer patients

Based on Weissman and Hackett's comprehensive definition of denial, a semi-structured interview was developed to measure denial in cancer patients. The denial in cancer interview (DCI) covers both the patients' recount of their illness experience and the expert's impression of the level of denial in the patient story. This paper describes the development and first psychometric analyses of the instrument. The development of the DCI was based on clinical observation, the expert opinion of eight specialised psychiatrist as well as three small pilot studies to assess feasibility. The DCI is composed of two parts: a semi-structured interview consisting of nine specific items to be answered by the patient and two items covering the interviewer's clinical impression of the patient's type and level of denial. Follow-up interviews were held at 8, 16 and 32 weeks after the baseline assessment (T2-4). To measure the inter-rater reliability, interviews were recorded and rated independently by one interviewer and one of the study's co-workers. One hundred and ninety-five consecutive newly diagnosed lung cancer patients were interviewed. The internal consistency of the DCI (Cronbach's alpha) was 0.84 at first interview and 0.85, 0.82 and 0.83 at T2-4, respectively. The inter-rater agreement was good for the DCI overall and the patient's assessment scale, and satisfactory for the clinical impression items. Content validity was supported by clinical observation, in depth open interviewing and expert opinion. The DCI proved to be a feasible and reliable instrument for measuring denial in lung cancer patients. Further testing in other oncology settings will provide insight in wider applicability. The DCI can be used in future studies concerning denial in cancer patients. Insight in denial and its background will help us to adequately address denial in patients and communicate with the

Clinical Mycobacterium conspicuum Isolation from Two Immunocompetent Patients in The Netherlands▿

Contains fulltext : 51520.pdf (publisher's version ) (Open Access

Verhoogd risico op diabetes mellitus type 2 en hart-en vaatziekten na diabetes gravidarum

Objective To determine the longterm risk of developing type II diabetes (T2D) and cardiovascular disease (CVD) for women with a history of gestational diabetes mellitus. Design Systematic review and metaanalysis. Method Two search strategies were used in PubMed and Embase to determine the longterm risks of developing T2D and CVD after a pregnancy complicated by gestational diabetes mellitus. After critical appraisal of the papers found, 11 papers were included, involving a total of 328,423 patients. Absolute and relative risks (RRs) were calculated. Results Eight studies (n=276,829) reported on the longterm risk of T2D and 4 (n=141,048) on the longterm risk of CVD. Followup ranged from 3.5 to 11.5 years for T2D and from 1.2 to 74.0 years for CVD. Women with gestational diabetes had a risk of T2D varying between 9.5% and 37.0% and a risk of CVD of between 0.28% and 15.5%. Women with gestational diabetes were at increased risk of T2D (weighted RR: 13.2 95% CI: 8.520.7) and CVD (weighted RR: 2.0 95% CI: 1.13.7) compared to women without gestational diabetes. Conclusion Women with prior gestational diabetes mellitus have a significantly increased risk of developing T2D and CVD. It is very important that gestational diabetes is recognised as a cardiovascular risk factor in daily practice. It would be desirable to screen this group of women for the presence of hyperglycaemia and other cardiovascular risk factors. Further research is required to be able to specify the longterm risk of T2D and CVD and to demonstrate whether such screening is costeffective. Conflict of interest: none declared. Financial support: none declared