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This study sought to compare sex difference for procedural aspects and complications in the European Society of Cardiology CRT Survey II, exploring whether adverse events were related to the type of CRT device implanted.

Aims The European CRT Survey is a joint initiative of the Heart Failure Association (HFA) and the European Heart Rhythm Association (EHRA) of the European Society of Cardiology evaluating the contemporary implantation practice of cardiac resynchronization therapy (CRT) in Europe. Methods and results Patients who had a successful CRT implantation were enrolled from 141 centres in 13 countries between November 2008 and June 2009. Baseline demographics, clinical and implantation data were collected, with a follow-up of ∼1 year (9–15 months). The current report describes clinical outcomes including symptom severity, cardiovascular (CV) hospitalization, and survival. A total of 2438 patients were enrolled, and follow-up data were acquired from 2111 patients (87%). The population included important groups of patients poorly represented in randomized controlled trials, including very elderly patients and those with prior device implantation, atrial fibrillation, and/or QRS duration

Background: Few data exist on the long-term changes and the prognostic value of heart rate variability (HRV) assessed by implanted devices in heart failure (HF) patients treated with resynchronization therapy (CRT). Aims: To analyze the long-term changes in the standard deviation of 5-minute median atrial–atrial sensed intervals (SDANN), and assess its role in predicting CRT efficacy and major cardiovascular events. Methods and results: We included 509 consecutive patients implanted with CRT devices. At 12-month follow-up, 44 patients had died and 86 patients had at least one HF hospitalisation. A significant increase in SDANN occurred after 4 weeks of CRT (from 69±22 ms to 82±27 ms, p

ObjectivesWe investigated whether the reverse remodeling after cardiac resynchronization therapy (CRT) might reduce the occurrence of ventricular arrhythmias (VAs).BackgroundIt is currently debated whether CRT has an effect on the burden of VAs.MethodsThe study included 398 patients treated with a CRT defibrillator and with a follow-up of at least 12 months. Spontaneous VAs detected by the device were reviewed and validated.ResultsA significant reduction in VA episodes and shock therapies was evident during the follow-up with greater decrease after 1 month. After 6 months of CRT, 227 patients (57%) showed a reduction in end-systolic volume of ≥10% and were defined as “responders.” The baseline characteristics were similar between the responders and the nonresponders. Nonetheless, the proportion of patients with recurrence of VA after 1 month of CRT was significantly lower in responders (32% vs. 43%, p = 0.024). Among baseline variables no parameters emerged as predictors of tachyarrhythmia recurrence. However, receiver-operating curve analysis recognized a reduction of left ventricular end-systolic volume at 6 months of 13% as the best cutoff to identify the reduction of VAs (with a sensitivity of 58% and a specificity of 54%).ConclusionsIn patients treated with CRT defibrillators, a reduction in ventricular arrhythmic events occurs during the initial 12 months after implant and is correlated with the degree of ventricular remodeling induced by the therapy. Patients demonstrating reverse remodeling at midterm follow-up show a reduction in arrhythmias soon after the implant, pronounced improvements at long-term, and a better survival.

To assess the longterm outcome of mothers of children with isolated congenital complete heart block (CCHB), and the maternal specific immunoblot pattern and HLA antigens.Fifteen mothers of 16 children with isolated CCHB were investigated; their followup extended up to 15.8 years on average after the index delivery. Anti-Ro and La antibodies were detected by counterimmunoelectrophoresis and ELISA; anti-Ro antibodies were studied by immunoblot. HLA typing was done using a microcytotoxicity test.One mother has systemic lupus erythematosus (SLE) before the index delivery. The other mothers developed only minor symptoms (arthralgia, dry eyes and photosensitivity) resembling primary Sjögren's syndrome more than classic lupus. All 15 mothers were anti-Ro and 9 were also anti-La positive, a mean of 12.5 years after the index delivery. Eight mothers reacted with the 52 kDa SSA(Ro) component, and 2 also with the 60 kDa SSA(Ro) component. The prevalence of the DR3 antigen and of the B44/DR5, DR3/DQ2 and A1/Cw7/B8/DR3/DQ2 haplotypes was significantly increased.The longterm outcome for the mothers of children with CCHB is more reassuring than generally assumed. All the mothers were anti-Ro positive by sensitive ELISA: Reactivity to the denaturated 52 kDa SSA(Ro) component seems characteristic of these mothers, who presented a particular immunogenetic background.

Our experience with [131I]metaiodobenzylguanidine (131I-MIBG) therapy in two patients with carcinoid tumor is described. These patients were selected because of multiple areas of uptake on 131I-MIBG scan, consistent with the extent of the disease. Both patients presented diarrhea and liver metastases. Para-aortical lymphonodes and skeletal metastases were present in the first and the second patient, respectively. Previous treatment involved r-alpha-interferon, surgery or radiotherapy. In both cases 131I-MIGB therapy was started in December 1990 and is still continuing. No haematologic or hepatic side-effects have been observed. Mild hypotension (90/60 mmHg) occurred in one patient during the first course of therapy and was resolved by corticoid treatment. A stabilization of disease and a progressive reduction of diarrhea have been observed in both patients. In the second patient an initial decrease in liver metastases was confirmed by ultrasonography 7 months after the beginning of therapy.

Our experience with palliative [131I]metabenzylguanidine (131I-MIBG) therapy in 7 patients (6 children and 1 adult) affected by advanced neuroblastoma is reported. All patients (classified as IV stage) showed a progression following initial intensive therapy, including chemotherapy and, in some cases, hemi-body irradiation and surgery for their primary tumor. 131I-MIBG activity ranged for a single course between 2.77 GBq to 5.55 GBq on the basis of age, intensity of uptake, and the hematological assessment. Four patients received only one course of therapy due to progressive disease (2), early death (1) or persistent thrombocytopenia unrelated to 131I-MIBG therapy (1). Two patients received two courses and showed a partial response lasting 4 months and stable disease lasting 3 months respectively. Therapy was thereafter discontinued due to progression. One patient received 4 courses of therapy (cumulative activity = 19.61 GBq) in 5 months. A partial response for 9 months in the bone metastases was documented, but the therapy was discontinued due to persistent thrombocytopenia (58,000 plts/microL) lasting 4 months. Thrombocytopenia was the major side-effect, occurring in 5/7 patients over 8 courses of therapy for a mean period of 37 days (7-120 d). Thus, in our experience thrombocytopenia is the major factor limiting the therapeutic effect of 131I-MIBG therapy in palliative treatment.

Intradermal skin test antigen (Varidase, Mumps, Candidine) and contact sensitization with 2,4-dinitrochlorobenzene (DNCB) were employed in 35 previously untreated children with neuroblastoma and malignant lymphoma, to evaluate delayed cutaneous hypersensitivity. Cutaneous responses were correlated to stage of disease and survival. The limited number of patients prevents any definitive conclusion. It is apparent, however, that in childhood non-Hodgkin's lymphoma anergy to DNCB is correlated to advanced stages with rapid progressive disease. In neuroblastoma and Hodgkin's disease patients skin test sensitization seems to be of questionable clinical value.

Background Selection of appropriate outcome measures is crucial in clinical trials in order to minimize bias and allow for precise comparisons of effects between interventions [1-3]. Objective We aimed to assess the frequency and completeness of outcome measures in randomized controlled trials (RCTs) included in Cochrane systematic reviews (SRs), focusing on evaluations of the efficacy and safety of rehabilitation interventions for mechanical LBP. Materials and methods We performed a cross-sectional study of all RCTs included in all Cochrane SRs (full-text) published on The Cochrane Database of Systematic Reviews in February 2013. Two authors independently evaluated the type and frequency of each outcome measure reported in the fulltext of RCTs, the methods used to measure outcomes, and the proportion of outcomes fully replicable based on the reported information (Figure 1). Results Our literature search identified 11 Cochrane SRs, including 185 RCTs. Across all RCTs, thirty-six different outcomes were investigated. The outcomes most commonly reported were pain (165/185; 89,2%, 95% Confidence Interval (CI) 84.7% – 93.7 %), disability (118/185; 63,8%, 95% CI 56.9% – 70.7 %), range of motion (72/185; 38.9% 95% CI 31.9% – 45.9%), and quality of life (45/185; 24,3%, 95% CI 18.1% – 30.5%) measured respectively by 70, 43, 41, 19 different measurement instruments (Figure 2). The procedure of blinding assessment was reported in 49.7% of the RCTs for pain (n= 82 RCTs) and 45% of RCTs for disability (n=53 RCTs). Pain, disability, range of motion, and quality of life outcomes were reported as fully replicable in 10.3% (n= 17 RCTs), 10.1% (n= 12 RCTs), 5.5% (n= 4 RCTs), and 6.6% (n= 3 RCTs) of the RCTs, respectively (Figure 3). Conclusions A large number of outcome measures and a myriad of measurement instruments were used across all RCTs. The reporting was largely incomplete, suggesting better opportunities for the standardization of approaches and reporting.