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Gasparini M.,Electrophysiology and Pacing Unit | Proclemer A.,Azienda Ospedaliera Universitaria S. Maria Della Misericordia | Klersy C.,IRCCS Policlinico San Matteo | Kloppe A.,Berufsgenossenschaftliches Universitatsklinikum Bergmannsheil | And 8 more authors.
JAMA - Journal of the American Medical Association | Year: 2013

Importance: Using more intervals to detect ventricular tachyarrhythmias has been associated with reducing unnecessary implantable cardioverter- defibrillator (ICD) therapies. Objective: To determine whether using 30 of 40 intervals to detect ventricular arrhythmias (VT) (long detection) during spontaneous fast VT episodes reduces antitachycardia pacing (ATP) and shock delivery more than 18 of 24 intervals (standard detection). Design, Setting, and Participants: Randomized, single-blind, parallel-group trial that enrolled 1902 primary and secondary prevention patients (mean [SD] age, 65 [11] years; 84% men; 75% primary prevention ICD) with ischemic and nonischemic etiology undergoing first ICD implant at 1 of 94 international centers (March 2008-December 2010). Interventions: Patients were randomized 1:1 to programming with long- (n=948) or standard-detection (n=954) intervals. Main Outcomes and Measures: Total number of ATPs and shocks delivered for all episodes (primary outcomes) and inappropriate shocks, mortality, and syncopal rate (secondary outcomes). Results: During a median follow-up of 12 months (interquartile range, 11-13), long-detection group had 346 delivered therapies (42 therapies per 100 person-years, 95% CI, 38-47) vs 557 in the standard-detection group (67 therapies per 100 person-years [95% CI, 62-73]; incident rate ratio [IRR], 0.63 [95% CI, 0.51-0.78]; P < .001). The long-vs the standard-detection group experienced 23 ATPs per 100 person-years (95% CI, 20-27) vs 37 ATPs per 100 person-years (95% CI, 33-41; IRR, 0.58 [95% CI, 0.47-0.72]; P < .001); 19 shocks per 100 person-years (95% CI, 16-22) vs 30 shocks per 100 person-years (95% CI, 26-34; IRR, 0.77 [95% CI, 0.59-1.01]; P =.06), with a significant difference in the probability of therapy occurrence (P < .001); and a reduction in first occurrence of inappropriate shock (5.1 per 100 patient-years [95% CI, 3.7-6.9] vs 11.6 [95% CI, 9.4-14.1]; IRR, 0.55 [95% CI, 0.36-0.85]; P =.008). Mortality (5.5 [95% CI, 4.0-7.2] vs 6.3 [95% CI, 4.8-8.2] per 100 patient-years; HR, 0.87; P =.50) and arrhythmic syncope rates (3.1 [95% CI, 2.6-4.6] vs 1.9 [95% CI, 1.1-3.1] per 100 patientyears; IRR, 1.60 [95% CI, 0.76-3.41]; P =.22) did not differ significantly between groups. Conclusions and Relevance: Among patients receiving an ICD, the use of a longvs standard-detection interval resulted in a lower rate of ATP and shocks, and inappropriate shocks. This programming strategy may be an appropriate alternative. Trial Registration: clinicaltrials.gov Identifier: NCT00617175 ©2013 American Medical Association. All rights reserved. Source

Gaetani P.,IRCCS Policlinico San Matteo | Klinger M.,Istituto Clinico Humanitas | Levi D.,University of Lugano | Bussone G.,Istituto Neurologico Carlo Besta | And 4 more authors.
Headache | Year: 2013

Objective. - To test feasibility, safety, and efficacy of local transplant of stromal fraction of adipose tissue in the treatment of chronic headaches of cervical origin. Background. - Chronic headaches of cervical origin (chronic cervicogenic headache and occipital neuralgia) are characterized by persistent pain due to the involvement of the great occipital nerve, with concurrent myofascial spasm and the consequent nerve entrapment within the trapezoid tunnel. Methods. - Tolerability and effectiveness of treatment of chronic cervicogenic headaches refractory to conventional therapies were evaluated in 24 patients. The visual analog scale of pain and the medication use diary were used in the 3 months preceding treatment; moreover, in order to verify the quality of life, patients are required to fill before surgery the Neck Pain Disability Index, the Headache Disability Index, migraine disability assessment scale questionnaire, and the short-form 12 standard v1 questionnaire. Follow-up examination was performed at 3 and 6 months. Results. - In 19 cases (79.2%), a good clinical response was recorded. At 6-month follow-up analysis, recurrence of occipital pain was recorded in 7 cases (29.2%); there is a significant reduction in disability and pain scores, and also a significant reduction of need for pharmacologic treatment and a fast return to previous work capacities. Conclusions. - The key point of our therapeutic strategy might be the regenerative role of stromal fraction of adipose tissue transplanted in the area of the occipital nerve entrapment; the results of the present study are encouraging both in terms of reduction of pain scores and in terms of quality of life improvement. The technique is minimally invasive, and no complications were recorded; indeed, the procedure seems to be safe and effective, and thus, a randomized study with larger follow-up and in a large series will be started. © 2012 American Headache Society. Source

De Gregori M.,University of Pavia | Allegri M.,IRCCS Policlinico San Matteo | De Gregori S.,Unit of Clinical Pharmacokinetics | Garbin G.,University of Pavia | And 4 more authors.
Current Drug Metabolism | Year: 2010

Cytochromes P450 are members of a superfamily of hemoproteins that catalyze a variety of oxidative reactions in the metabolism of endogenous and exogenous hydrophobic substrates. Fifty-eight cytochrome P450 (CYP) isoenzymes belonging to 18 families have been identified in human cells; the corresponding genes are highly polymorphic, and genetic variability underlies interindividual differences in drug response. The polymorphisms of CYP2D6 significantly affect the pharmacokinetics of about 50% of the drugs in clinical use, which are CYP2D6 substrates. The number of functional CYP2D6 alleles per genome determines the existence of four different phenotypes, i.e. poor, intermediate, extensive, and ultrarapid metabolizers. CYP2D6 genetic variants include copy number variations, single nucleotide substitutions, frameshift and insertion/deletion mutations. This review reports some of the different methodological approaches used to screen for CYP2D6 variants and focuses on methods that have improved variation detection, from conventional techniques to more recent microarray technology and high throughput DNA sequencing. In addition, this review reports some results on clinical relevance of CYP2D6 polymorphisms and provides examples of variability in drug response associated with interindividual phenotypic differences. © 2010 Bentham Science Publishers Ltd. Source

Pai M.,Imperial College London | Valek V.,University Hospital Brno Bohunice | Tomas A.,University Hospital Brno Bohunice | Doros A.,Semmelweis University | And 5 more authors.
CardioVascular and Interventional Radiology | Year: 2014

Purpose: The major complication occurring with biliary stents is stent occlusion, frequently seen because of tumour in-growth, epithelial hyperplasia, and sludge deposits, resulting in recurrent jaundice and cholangitis. We report a prospective study with the results of first in man percutaneous intraductal radiofrequency (RF) ablation to clear the blocked metal stents in patients with malignant biliary obstruction using a novel bipolar RF catheter. Methods: Nine patients with malignant biliary obstruction and blocked metal stents were included. These patients underwent intraductal biliary RF ablation through the blocked metal stent following external biliary decompression with an internal-external biliary drainage. Results: All nine patients had their stent patency restored successfully without the use of secondary stents. Following this intervention, there was no 30-day mortality, haemorrhage, bile duct perforation, bile leak, or pancreatitis. Of the nine patients, six are alive and three patients are dead with a median follow-up of 122 (range 50-488) days and a median stent patency of 102.5 (range 50-321) days. Six patients had their stent patent at the time of last follow-up or death. Three patients with stent blockage at 321, 290, and 65 days postprocedure underwent percutaneous transhepatic drain insertion and repeat ablation. Conclusions: In this selective group of patients, it appears that this new approach is safe and feasible. Efficacy remains to be proven in future, randomized, prospective studies. © 2013 Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE). Source

Melani F.,University of Florence | Mei D.,University of Florence | Pisano T.,University of Florence | Savasta S.,IRCCS Policlinico San Matteo | And 4 more authors.
Developmental Medicine and Child Neurology | Year: 2011

Aim: Cyclin-dependent kinase-like 5 (CDKL5) gene abnormalities cause an early-onset epileptic encephalopathy. We performed video-electroencephalography (video-EEG) monitoring early in the course of CDKL5-related epileptic encephalopathy in order to examine the early electroclinical characteristics of the condition. Method: We used video-EEG to monitor six infants (five females, one male) with CDKL5-related epileptic encephalopathy (five mutations; one deletion), at ages 45days to 12months and followed them up to the ages of 14months to 5years (mean age 23mo). We focused our analysis on the first year of life. The results were evaluated against those of a comparison group of nine infants (aged below 1y) with epileptic encephalography who had tested negative for CDKL5 mutations and deletions. Results: One infant exhibited normal background activity, three exhibited moderate slowing, and two exhibited a suppression burst pattern. Two participants had epileptic spasms and four had a stereotyped complex seizure pattern, which we defined as a 'prolonged' generalized tonic-clonic event consisting of a tonic-tonic/vibratory contraction, followed by a clonic phase with series of spasms, gradually translating into repetitive distal myoclonic jerks. Seizure duration ranged from 2 to 4minutes. The EEG correlate of each clinical phase included an initial electrodecremental event (tonic vibratory phase), irregular series of sharp waves and spike slow waves (clonic phase with series of spasms), and bilateral rhythmic sharp waves (time locked with myoclonus). Interpretation: Infants with CDKL5-related early epileptic encephalopathy can present in the first year of life with an unusual electroclinical pattern of 'prolonged' generalized tonic-clonic seizures. © The Authors. Journal compilation © Mac Keith Press 2011. Source

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