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Ross F.M.,Salisbury District Hospital | Avet-Loiseau H.,University of Nantes | Ameye G.,Cliniques Universitaires Saint Luc Brussels | Gutierrez N.C.,University of Salamanca | And 25 more authors.
Haematologica | Year: 2012

The European Myeloma Network has organized two workshops on fluorescence in situ hybridization in multiple myeloma. The first aimed to identify specific indications and consensus technical approaches of current practice. A second workshop followed a quality control exercise in which 21 laboratories analyzed diagnostic cases of purified plasma cells for recurrent abnormalities. The summary report was discussed at the EHA Myeloma Scientific Working Group Meeting 2010. During the quality control exercise, there was acceptable agreement on more than 1,000 tests. The conclusions from the exercise were that the primary clinical applications for FISH analysis were for newly diagnosed cases of MM or frank relapse cases. A range of technical recommendations included: 1) material should be part of the first draw of the aspirate; 2) samples should be sent at suitable times to allow for the lengthy processing procedure; 3) most importantly, PCs must be purified or specifically identified; 4) positive cut-off levels should be relatively conservative: 10% for fusion or breakapart probes, 20% for numerical abnormalities; 5) informative probes should be combined to best effect; 6) in specialist laboratories, a single experienced analyst is considered adequate; 7) at least 100 PC should be scored; 8) essential abnormalities to test for are t(4;14), t(14;16) and 17p13 deletions; 9) suitable commercial probes should be available for clinically relevant abnormalities; 10) the clinical report should be expressed clearly and must state the percentage of PC involved and the method used for identification; 11) a retrospective European based FISH data bank linked to clinical data should be generated; and 12) prospective analysis should be centralized for upcoming trials based on the recommendations made. The European Myeloma Network aims to build on these recommendations to establish standards for a common European data base to define subgroups with prognostic significance. © 2012 Ferrata Storti Foundation.

Stefano B.,Fatebenefratelli Hospital | Pietro R.R.,San Filippo Neri Hospital | Maurizio G.,IRCCS Instituto Clinico Humanitas | Maurizio L.,Niguarda Ca Granda Hospital | And 8 more authors.
American Heart Journal | Year: 2011

Background: Clinical practice with regard to defibrillation threshold (DFT) testing during implantable cardioverter-defibrillator (ICD) implantation varies considerably, even among experienced implanting centers. International guidelines do not as yet mandate DFT testing. Objective: The objective of this project is to assess current clinical decision making regarding DFT testing during ICD implantation. Methods: The ALIVE project collected data on DFT testing from a multicenter network of Italian clinicians sharing a common system for the collection, management, analysis, and reporting of clinical and diagnostic data from patients with Medtronic (Minneapolis, MN) implantable devices. Results: Data on 2,082 consecutive patients implanted with a Medtronic ICD in 111 Italian centers, over the period 2007 to 2010, were analyzed. Defibrillation threshold testing was performed in 33% of cases (678/2,082). The main reasons for performing the test were physician's clinical practice ("I always perform DFT") (80%) and secondary prevention implantation (12%). The main reasons for not performing DFT testing were centers' practice (44%), primary prevention (31%), and device replacement (15%). In 22 patients, ventricular fibrillation induction was not achieved; 656 patients completed DFT testing: 633 patients (96%) performed a single test, 19 patients (3%) performed a second induction test, and 4 patients (0.6%) underwent an additional induction test. Conclusions: The preliminary results of the ALIVE project show that a great number of implant procedures are performed without DFT testing in the common practice of the participating centers. We also measured an inhomogeneous, center-dependent DFT testing behavior, which suggests the importance of defining a common guideline for ICD implant testing. Follow-up data on our patients will provide more information on the clinical value of the test. © 2011 Mosby, Inc. All rights reserved.

Gasparini M.,Humanitas Research Hospital | Leclercq C.,University Hospital Rennes | Lunati M.,Niguarda Ca Granda Hospital | Landolina M.,Fondazione Policlinico San Matteo IRCCS | And 8 more authors.
JACC: Heart Failure | Year: 2013

Objectives: The purpose of this study is to determine whether, in patients with atrial fibrillation (AF) undergoing cardiac resynchronization therapy (CRT), atrioventricular junction ablation (AVJA) is associated with a better outcome than treatment with rate-slowing drugs. Background: Different trials have demonstrated that CRT is effective in treating heart failure (HF) patients who are in sinus rhythm (SR). No trials have addressed whether CRT confers similar benefits on AF patients, with or without AVJA. Methods: The clinical outcomes of CRT for patients with permanent AF undergoing CRT combined with either AVJA (n= 443) or rate-slowing drugs (n= 895) were compared with those of SR patients (n= 6,046). Results: Median follow-up was 37 months. Total mortality (6.8 vs. 6.1 per 100 person-years) and cardiac mortality (4.2 vs. 4.0) were similar for patients with AF+AVJA and patients in SR (both p= NS). In contrast, the AF+drugs group hada higher total and cardiac mortality than the SR group and the AF+AVJA group (11.3 and 8.1, respectively; p< 0.001). On multivariable analysis, AF+AVJA had total mortality (hazard ratio [HR]: 0.93, 95% confidence interval [CI]: 0.74 to 1.67) and cardiac mortality (HR: 0.88, 95% CI: 0.66 to 1.17) similar to that of the SR group, independent of known confounders. The AF+drugs group, however, had a higher total mortality (HR: 1.52, 95% CI: 1.26 to 1.82) and cardiac mortality (HR: 1.57, 95% CI: 1.27 to 1.94) than both the SR group and the AF+AVJA group (both p< 0.001). Conclusions: Long-term survival after CRT among patients with AF+AVJA is similar to that observed among patients in SR. Mortality is higher for AF patients treated with rate-slowing drugs. © 2013 American College of Cardiology Foundation.

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