Incomplete neo-endothelialization of left atrial appendage closure devices is frequent after 6 months: a pilot imaging study.

PURPOSE: To bridge neo-endothelialization (NE) of implanted left atrial appendage closure (LAA/LAAC) devices, dual antiplatelet therapy is prescribed. Cardiac computed tomography angiography (cCTA) has been proposed for the evaluation of interventional LAAC. This prospective longitudinal observational study applied a standardized imaging protocol to detect progression of NE of LAAC devices 6 months after implantation. METHODS: Consecutive cCTA datasets of patients six months after LAAC were acquired and the standardized multi-planar reconstruction LAA occluder view for post-implantation evaluation (LOVE) algorithm was used. Residual flow of contrast agent inside the LAA without a peri-device leak (PDL) was defined as incomplete neo-endothelialization. Absence of residual flow was defined as complete neo-endothelialization. Since PDL allows residual flow in the LAA, irrespective of neoendothelialization, PDL were excluded from this study. Diabetes mellitus, liver disease, body-mass-index, age, device sizes and type will be assessed as predictors for incomplete NE. RESULTS: 53 consecutive patients were recruited for cCTA imaging. 36 (68%) showed no PDL and were included in the study (median age 77 years, 19% female). At median follow-up of 6 months (median 180 days, IQR 178-180), 44% of patients showed complete NE compared to 56% with NE still incomplete. Age, BMI, device type and size as well as prevalence of diabetes mellitus and liver disease did not show significant correlation with the completeness of NE. CONCLUSION: This pilot study showed that neo-endothelialization is still incomplete in a majority of patients at mid-term follow-up of 6 months after successful LAAC therapy. Further investigation on the consequences of incomplete endothelialization is needed to guide antiplatelet therapy schedules.

[Sensitivity and Specificity of the Reizdarm-Fragebogen]. / Sensitivität und Spezifität des Reizdarm-Fragebogens.

BACKGROUND: The Reizdarm-Fragebogen (RDF) is the first German questionnaire to assess subjectively perceived symptom severity of irritable bowel syndrome (IBS). Thus far, this was only possible in the context of a medical examination by a practitioner. The goal of the current study was to assess differences in RDF scores among IBS patients and other clinical and non-clinical populations. Further, the study aimed to define a cut-off score for the presence of IBS and thereby, to evaluate the RDF as screening instrument in IBS diagnosis. MATERIALS AND METHODS: The study sample consisted of 372 individuals (62.6% male, mean age=41±17 years). 17.5% (of the sample) were IBS patients, 9.9% received treatment for chronic inflammatory bowel disease, 12.1% of the participants were recruited from a psychosomatic clinic, and 50.5% belonged to a control group. All participants filled out the 13 item RDF. RESULTS: The IBS patients' RDF scores differed significantly from those of other clinical and non-clinical subsamples [t(98.82)=13.61, p<0.001]. Except for the subscale "bloating" this difference was consistently found for all RDF subscales ("diarrhea", "constipation", and "pain and feeling of tension"). With respect to the identification of a cut-off for IBS diagnosis, a score of 32 showed both good sensitivity (90.80%) and specificity (75.56%). DISCUSSION AND CONCLUSION: The RDF is an efficient instrument for the assessment of subjectively perceived symptom severity in IBS. Based on the current findings and its good psychometric properties it can be used as a screening instrument for IBS in both clinical practice and research.

Design and validation of a German version of the GSRS-IBS - an analysis of its psychometric quality and factorial structure.

BACKGROUND: Currently, a suitable questionnaire in German language is not available to monitor the progression and evaluate the severity of irritable bowel syndrome (IBS). Therefore, this study aimed to translate the Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) into German and to evaluate its psychometric qualities and factorial structure. METHODS: This study is based on a total sample of 372 participants [62.6% female, mean age = 41 years (SD = 17 years)]. 17.5% of the participants had a diagnosis of IBS, 19.9% were receiving treatment for chronic inflammatory bowel disease, 12.1% of the participants were recruited from a psychosomatic clinic, and 50.5% belonged to a control group. All participants completed the German version of GSRS-IBS (called Reizdarm-Fragebogen, RDF), as well as the Gießen Subjective Complaints List (GBB-24) and the Hospital Anxiety and Depression Scale - German version (HADS-D). RESULTS: The internal consistency of the RDF total scale was at least satisfactory in all subsamples (Cronbach's Alpha between .77 and .92), and for all subscales (Cronbach's Alpha between .79 and .91). The item difficulties (between .25 and .73) and the item-total correlations (between .48 and .83) were equally satisfactory. Principal axis analysis revealed a four-factorial structure of the RDF items, which mainly resembled the structure of the English original. Convergent validity was established based on substantial and significant correlations with the stomach-complaint scale of the GBB-24 (r = .71; p < .01) and the anxiety (r = .42; p < .01) and depression scales (r = .43; p < .01) of the HADS-D. CONCLUSION: The German version of the GSRS-IBS RDF proves to be an effective, reliable, and valid questionnaire for the assessment of symptom severity in IBS, which can be used in clinical practice as well as in clinical studies.