Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: The evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study
Perego G.B.,Instituto Auxologico S Luca Hospital |
Lunati M.,Niguarda Hospital |
Curnis A.,Ospedali Civili |
Guenzati G.,S Carlo Borromeo Hospital |
And 6 more authors.
Circulation | Year: 2012
Background-Heart failure patients with implantable cardioverter- defibrillators (ICDs) or an ICD for resynchronization therapy often visit the hospital for unscheduled examinations, placing a great burden on healthcare providers. We hypothesized that Internet-based remote interrogation systems could reduce emergency healthcare visits. Methods and Results-This multicenter randomized trial involving 200 patients compared remote monitoring with standard patient management consisting of scheduled visits and patient response to audible ICD alerts. The primary end point was the rate of emergency department or urgent in-office visits for heart failure, arrhythmias, or ICD-related events. Over 16 months, such visits were 35% less frequent in the remote arm (75 versus 117; incidence density, 0.59 versus 0.93 events per year; P=0.005). A 21% difference was observed in the rates of total healthcare visits for heart failure, arrhythmias, or ICD-related events (4.40 versus 5.74 events per year; P<0.001). The time from an ICD alert condition to review of the data was reduced from 24.8 days in the standard arm to 1.4 days in the remote arm (P<0.001). The patients' clinical status, as measured by the Clinical Composite Score, was similar in the 2 groups, whereas a more favorable change in quality of life (Minnesota Living With Heart Failure Questionnaire) was observed from the baseline to the 16th month in the remote arm (P=0.026). Conclusions-Remote monitoring reduces emergency department/urgent in-office visits and, in general, total healthcare use in patients with ICD or defibrillators for resynchronization therapy. Compared with standard follow-up through in-office visits and audible ICD alerts, remote monitoring results in increased efficiency for healthcare providers and improved quality of care for patients. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00873899. © 2012 American Heart Association, Inc.
Tavazzi L.,GVM Hospitals of Care and Research |
Senni M.,Papa Giovanni XXIII Hospital |
Metra M.,University of Brescia |
Gorini M.,Research Center |
And 6 more authors.
Circulation: Heart Failure | Year: 2013
Background.Clinical observational studies on heart failure (HF) deal mostly with hospitalized patients, few with chronic outpatients, all with no or limited longitudinal observation. Methods and Results.This is a multicenter, nationwide, prospective observational trial on a population of 5610 patients, 1855 hospitalized for acute HF (AHF) and 3755 outpatients with chronic HF (CHF), followed up for 1 year. The cumulative total mortality rate at 1 year was 24% in AHF (19.2% in 797 patients with de novo HF and 27.7% in 1058 with worsening HF) and 5.9% in CHF. Cardiovascular deaths accounted for 73.1% and 65.3% and HF deaths for 42.4% and 40.5% of total deaths in AHF and CHF patients, respectively. One-year hospitalization rates were 30.7% in AHF and 22.7% in CHF patients. Among the independent predictors of 1-year all-cause death, age, low systolic blood pressure, anemia, and renal dysfunction were identified in both acute and chronic patients. A few additional variables were significant only in AHF (signs of cerebral hypoperfusion, low serum sodium, chronic obstructive pulmonary disease, and acute pulmonary edema), whereas others were observed only in CHF patients (lower body mass index, higher heart rate, New York Heart Association class, large QRS, and severe mitral regurgitation). Conclusions.In this contemporary data set, patients with CHF had a relatively low mortality rate compared with those with AHF. Rates of adverse outcomes in patients admitted for AHF remain very high either in-hospital or after discharge. Most deaths were cardiovascular in origin and .40% of deaths were directly related to HF. © 2013 American Heart Association, Inc.
Locati E.T.,Niguarda Hospital |
Vecchi A.M.,Niguarda Hospital |
Vargiu S.,Niguarda Hospital |
Cattafi G.,Niguarda Hospital |
Lunati M.,Niguarda Hospital
Europace | Year: 2014
Aims: To assess the diagnostic yield of new external loop recorders (ELRs) in patients with history of syncope, pre-syncope, and sustained palpitations. Methods and results: Since 2005, we have established a registry including patients who consecutively received ELR monitoring for unexplained syncope or pre-syncope/palpitations. The registry included 307 patients (61 females, age 58 ± 19 years, range 8-94 years) monitored by high-capacity memory ELR of two subsequent generations: SpiderFlash-A® (SFA®, Sorin CRM), storing two-lead electrocardiogram (ECG) patient-activated recordings by loop-recording technique (191 patients, 54 patients with syncope, years 2005-09), and SpiderFlash-T® (SFT®), adding auto-trigger detection for pauses, bradycardia, and supraventricular/ventricular arrhythmias (116 patients, 38 patients with syncope, years 2009-12). All the patients previously underwent routine workup for syncope or palpitation, including one or more 24 h Holter, not conclusive for diagnosis. Mean monitoring duration was 24.1 ± 8.9 days. Among 215 patients with palpitations, a conclusive diagnosis was obtained in 184 patients (86 diagnostic yield for palpitation). Among 92 patients with syncope, a conclusive diagnosis was obtained in 16 patients (17 clinical diagnostic yield for syncope), with recording during syncope of significant arrhythmias in 9 patients, and sinus rhythm in 7 patients. Furthermore, asymptomatic arrhythmias were de novo detected in 12 patients (13), mainly by auto-trigger detection, suggesting an arrhythmic origin of the syncope. Conclusions: The diagnostic yield of ELR in patients with syncope, pre-syncope, or palpitation of unknown origin after routine workup was similar to implantable loop recorder (ILR) within the same timeframe, therefore, ELR could be considered for patients candidate for long-term ECG monitoring, stepwise before ILR. All rights reserved. © The Author 2013.
Piano M.,Niguarda Hospital |
Valvassori L.,Niguarda Hospital |
Quilici L.,Niguarda Hospital |
Pero G.,Niguarda Hospital |
Boccardi E.,Niguarda Hospital
Journal of Neurosurgery | Year: 2013
Object. The introduction of flow diverter devices is revolutionizing the endovascular approach to cerebral aneurysms. Midterm and long-term results of angiographic, cross-sectional imaging and clinical follow-up are still lacking. The authors report their experience with endovascular treatment of intracranial aneurysms using both the Pipeline embolization device and Silk stents. Methods. From October 2008 to July 2011 a consecutive series of 104 intracranial aneurysms in 101 patients (79 female, 22 male; average age 53 years) were treated. Three of the 104 aneurysms were ruptured and 101 were unruptured. Silk stents were implanted in 47 of the aneurysms and Pipeline stents in the remaining 57. In 14 cases a combination of flow diverter devices and coils were used to treat larger aneurysms (maximum diameter > 15 mm). Patients underwent angiographic follow-up examination at 6 months after treatment, with or without CT or MRI, and at 1 year using CT or MRI, with or without conventional angiography. Results. In all cases placement of flow diverter stents was technically successful. The mortality and morbidity rates were both 3%. Adverse events without lasting clinical sequelae occurred in 20% of cases. Angiography performed at 6 months after treatment showed complete aneurysm occlusion in 78 of 91 cases (86% of evaluated aneurysms) and subocclusion in 11 (12%); only in 2 cases were the aneurysms unchanged. Fifty-three aneurysms were evaluated at 1 year after treatment. None of these aneurysms showed recanalization, and 1 aneurysm, which was incompletely occluded at the 6-month follow-up examination, was finally occluded. Aneurysmal sac shrinkage was observed in 61% of assessable aneurysms. Conclusions. Parent artery reconstruction using flow diverter devices is a feasible, safe, and successful technique for the treatment of endovascular treatment of cerebral aneurysms. © AANS, 2013.
Lovaglio P.G.,University of Milan Bicocca |
Monzani E.,Niguarda Hospital
Quality of Life Research | Year: 2012
Purpose To explore the internal structure of the Health of the Nation Outcome Scales (HoNOS-12), proposing a shorter one-dimensional version for routine use in community- oriented Mental Heath services. Methods A validation study involving four Mental Health Departments, located in the Province of Milan (Italy). Eligible patients were outpatients and residential inpatients rated on three occasions during the year 2009, with a range of mental illnesses and diagnoses. Methodologically, we use both exploratory factor analysis (EFA) with holdout validation and Rasch approaches and parallel analysis. Results EFA, Rasch analysis and parallel analysis demonstrate a large violation of unidimensionality. Both EFA (training sample) and Rasch analyses yield convergent results, generating the same unidimensional abbreviated version of the HoNOS-12, resulting in a six-item scale (HoNOS-6) which demonstrates unidimensionality, good item fit, a solid factor structure (strong loadings and communalities) and acceptable model fit, evaluated using confirmatory factor analysis on a validation sample. Conclusions The HoNOS-12 does not measure a single, underlying construct of mental health status. Nevertheless, the instrument can be utilized in a reduced version (HoNOS- 6), as a clinically acceptable outcome scale (measuring self-perceived clinical and social needs for community support, rather than global mental disorder) for routine use in a community setting population. © Springer Science+Business Media B.V. 2012.
Lovisetti G.,Menaggio Hospital |
Sala F.,Niguarda Hospital
Injury | Year: 2013
This retrospective review reports on forty-five tibial non-unions who underwent docking site treatment for non-union using closed versus open and endoscopic strategies. In this cohort of patients, all but twelve were infected non-unions. Sixteen patients initially treated with single compression were compared to twenty-three patients treated with open revision of the docking site, and six endoscopic procedures. In the single compression group, an average of 6.4 cm of bone was resected and index lengthening was 2.01. In the open revision group, a mean of 9.4 cm was resected and the index lengthening was 1.72. In the endoscopic group, an average of 8.6 cm of bone was resected and index lengthening was 1.71. Consolidation at the docking site occurred in 41 cases out of 45 following the first procedure. There was no statistical difference between the three groups. Conclusive evidence of superiority of one modality of treatment over the other cannot be drawn from our data. The simple compression procedure requires less invasive surgery and is probably less demanding and more cost-effective in short transports, although the two cases of failure due to recurrence of sepsis were observed after this procedure. Further studies are desirable to investigate the effectiveness of open docking site grating procedures. © 2013 Elsevier Ltd. All Rights Reserved.
Sirtori C.R.,Niguarda Hospital |
Sirtori C.R.,University of Milan
Pharmacological Research | Year: 2014
Statins, inhibitors of the hydroxymethylglutaryl-CoA (HMG-CoA) reductase enzyme, are molecules of fungal origin. By inhibiting a key step in the sterol biosynthetic pathway statins are powerful cholesterol lowering medications and have provided outstanding contributions to the prevention of cardiovascular disease. Their detection in mycetes traces back to close to 40 years ago: there were, originally, widely opposing views on their therapeutic potential. From then on, intensive pharmaceutical development has led to the final availability in the clinic of seven statin molecules, characterized by differences in bioavailability, lipo/hydrophilicity, cytochrome P-450 mediated metabolism and cellular transport mechanisms. These differences are reflected in their relative power (mg LDL-cholesterol reduction per mg dose) and possibly in parenchymal or muscular toxicities. The impact of the antagonism of statins on a crucial step of intermediary metabolism leads, in fact, both to a reduction of cholesterol biosynthesis as well as to additional pharmacodynamic (so called "pleiotropic") effects. In the face of an extraordinary clinical success, the emergence of some side effects, e.g. raised incidence of diabetes and cataracts as well as frequent muscular side effects, have led to increasing concern by physicians. However, also in view of the present relatively low cost of these drugs, their impact on daily therapy of vascular patients is unlikely to change. © 2014 Elsevier Ltd.
Sirtori C.R.,Niguarda Hospital |
Sirtori C.R.,University of Milan |
Mombelli G.,Niguarda Hospital |
Triolo M.,Niguarda Hospital |
Laaksonen R.,Zora Biosciences Oy
Annals of Medicine | Year: 2012
Statins represent a major advance in the treatment of hypercholesterolemia, a significant risk factor for atherosclerosis. There is, however, notable interindividual variation in the cholesterolemic response to statins, and the origin of this variability is poorly understood; pharmacogenetics has attempted to determine the role of genetic factors. Myopathy, further, has been reported in a considerable percentage of patients, but the mechanisms underlying muscle injury have yet to be fully characterized. Most statins are the substrates of several cytochrome P450s (CYP). CYP polymorphisms may be responsible for variations in hypolipidemic activity; inhibitors of CYPs, e.g. of CYP3A4, can significantly raise plasma concentrations of several statins, but consequences in terms of clinical efficacy are not uniform. Pravastatin and rosuvastatin are not susceptible to CYP inhibition but are substrates of the organic anion-transporting polypeptide (OATP) 1B1, encoded by the SLCO1B1 gene. Essentially all statins are, in fact, substrates of membrane transporters: SLCO1B1 polymorphisms can decrease the liver uptake, as well as the therapeutic potential of these agents, and may be linked to their muscular side-effects. A better understanding of the mechanisms of statin handling will help to minimize adverse effects and interactions, as well as to improve their lipid-lowering efficiency. © 2012 Informa UK, Ltd.
Baudo F.,Niguarda Hospital |
Caimi T.,Niguarda Hospital |
de cataldo F.,Niguarda Hospital
Haemophilia | Year: 2010
Acquired haemophilia (AH) is an autoimmune syndrome characterized by acute bleeding in patients with negative family and personal history, and factor VIII depletion. Its incidence is 1.6 × 106 population per year. AH is associated with autoimmune diseases, solid tumours, lymphoprolipherative diseases, pregnancy; 50% of the cases idiopathic. Spontaneous or after minor trauma severe bleeding associated with a prolonged activated partial thromboplastin time, not corrected by incubation with normal plasma, with a normal prothrombin time are the diagnostic hallmarks. The goals of management are the control of bleeding and the suppression of inhibitor. First-line haemostatic treatment includes recombinant factor VIIa and activated prothrombin complex concentrate. Prednisone ± cyclophosphamide and other immunosuppressive agents are the standard intervention for inhibitor eradication. © 2010 Blackwell Publishing Ltd.
Gentile M.G.,Niguarda Hospital
Nutrients | Year: 2012
Severe undernutrition nearly always leads to marked changes in body spaces (e.g., alterations of intra-extracellular water) and in body masses and composition (e.g., overall and compartmental stores of phosphate, potassium, and magnesium). In patients with severe undernutrition it is almost always necessary to use oral nutrition support and/or artificial nutrition, besides ordinary food; enteral nutrition should be a preferred route of feeding if there is a functional accessible gastrointestinal tract. Refeeding of severely malnourished patients represents two very complex and conflicting tasks: (1) to avoid -refeeding syndrome" caused by a too fast correction of malnutrition; (2) to avoid -underfeeding" caused by a too cautious rate of refeeding. The aim of this paper is to discuss the modality of refeeding severely underfed patients and to present our experience with the use of enteral tube feeding for gradual correction of very severe undernutrition whilst avoiding refeeding syndrome, in 10 patients aged 22 ± 11.4 years and with mean initial body mass index (BMI) of 11.2 ± 0.7 kg/m2. The mean BMI increased from 11.2 ± 0.7 kg/m2 to 17.3 ± 1.6 kg/m2 and the mean body weight from 27.9 ± 3.3 to 43.0 ± 5.7 kg after 90 days of intensive in-patient treatment (p < 0.0001). Caloric intake levels were established after measuring resting energy expenditure by indirect calorimetry, and nutritional support was performed with enteral feeding. Vitamins, phosphate, and potassium supplements were administered during refeeding. All patients achieved a significant modification of BMI; none developed refeeding syndrome. In conclusion, our findings show that, even in cases of extreme undernutrition, enteral feeding may be a well-tolerated way of feeding. © 2012 by the authors; licensee MDPI, Basel, Switzerland.