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Brignole M.,Arrhythmology Center | Ammirati F.,Ospedale GB Grassi | Arabia F.,Ospedale Pugliese Ciaccio | Tomaino M.,Ospedale Generale Regionale | And 5 more authors.
European heart journal | Year: 2015

AIMS: Opinions differ regarding the effectiveness of cardiac pacing in patients affected by reflex syncope. We assessed a standardized guideline-based algorithm in different forms of reflex syncope.METHODS AND RESULTS: In this prospective, multi-centre, observational study, patients aged >40 years, affected by severe unpredictable recurrent reflex syncopes, underwent carotid sinus massage (CSM), followed by tilt testing (TT) if CSM was negative, followed by implantation of an implantable loop recorder (ILR) if TT was negative. Those who had an asystolic response to one of these tests received a dual-chamber pacemaker.POPULATION: 253 patients, mean age 70 ± 12 years, median 4 (3-6) syncopes, 89% without or with short prodromes. Of these patients, 120 (47%) received a pacemaker and 106 were followed up for a mean of 13 ± 7 months: syncope recurred in 10 (9%). The recurrence rate was similar in 61 CSM+ (11%), 30 TT+ (7%), and 15 ILR+ (7%) patients. The actuarial total syncope recurrence rate was 9% (95% confidence interval (CI), 6-12) at 1 year and 15% (95% CI, 10-20) at 2 years and was significantly lower than that observed in the group of 124 patients with non-diagnostic tests who had received an ILR: i.e. 22% (95% CI, 18-26) at 1 year and 37% (95% CI, 30-43) at 2 years (P = 0.004).CONCLUSION: About half of older patients with severe recurrent syncopes without prodromes have an asystolic reflex for which cardiac pacing goes along with a low recurrence rate. The study supports the clinical utility of the algorithm for the selection of candidates to cardiac pacing in everyday clinical practice.CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01509534. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Mascioli G.,Arrhythmology | Gelmini G.,Ospedale di Desenzano Del Garda | Reggiani A.,Ospedale Carlo Poma | Giudici V.,Ospedale Bolognini | And 4 more authors.
Journal of Interventional Cardiac Electrophysiology | Year: 2010

Background: Although pacing from the right ventricular outflow tract (RVOT) has been shown to be safe and feasible in terms of sensing and pacing thresholds, its use as a site for implantable cardioverter defibrillator (ICD) leads is not common. This is probably due to physicians' concerns about defibrillation efficacy. To date, only one randomized trial, involving 87 enrolled patients, has evaluated this issue. Objective: The aim of this observational study has been to compare safety (primary combined end point: efficacy of a 14-J shock in restoring sinus rhythm, R wave amplitude >4 mV and pacing threshold <1 V at 0.5 ms) and efficacy (in terms of effectiveness of a 14-J shock in restoring sinus rhythm after induction of VF, secondary end point) of two different sites for ICD lead positioning: RVOT and right ventricular apex (RVA). Methods The study involved 185 patients (153 males; aged 67±10 years; range, 28-82 years). Site of implant was left to physician's decision. After implant, VF was induced with a 1-J shock over the T wave or - if this method was ineffective - with a 50-Hz burst, and a 14-J shock was tested in order to restore sinus rhythm. If this energy was ineffective, a second shock at 21 J was administered and - eventually - a 31-J shock followed - in case of inefficacy - by a 360-J biphasic external DC shock. Sensing and pacing thresholds were recorded in the database at implant, together with acute (within 3 days of implant) dislodgement rate. Results: The combined primary end point was reached in 57 patients in the RVOT group (0.70%) and in 81 patients in the RVA group (0.79%). The 14-J shock was effective in 159 patients, 63 in the RVOT group (77%) and 86 in the RVA group (83%). Both the primary and the secondary end points are not statistically different. R wave amplitude was significantly lower in the RVOT group (10.9±5.2 mV vs. 15.6±6.4 mV, p<0.0001), and pacing threshold at 0.5 ms was significantly higher (0.64± 0.25 V vs. 0.52±0.20 V, p<0.01), but these differences do not seem to have a clinical meaning, given that the lower values are well above the accepted limits in clinical practice. Conclusions: Efficacy and safety of ICD lead positioning in RVOT is comparable to RVA. Even if we observed statistically significant differences in sensing and pacing threshold, the clinical meaning of these differences is - in our opinion - irrelevant. © 2010 Springer Science+Business Media, LLC.

Valgimigli M.,Erasmus University Rotterdam | Calabro P.,The Second University of Naples | Cortese B.,Ospedale Fatebenefratelli | Frigoli E.,Cardiostudy | And 12 more authors.
Journal of Cardiovascular Translational Research | Year: 2014

Early invasive management and the use of combined antithrombotic therapies have decreased the risk of recurrent ischaemia in patients with acute coronary syndrome (ACS) but have also increased the bleeding risk. Transradial intervention (TRI) and bivalirudin infusion compared to transfemoral intervention (TFI) or unfractionated heparin (UFH) plus glycoprotein IIb/IIIa inhibitors (GPI) decrease bleeding complications in patients with ACS. To what extent, a bleeding preventive strategy incorporating at least one of these two treatment options translates into improved outcomes is a matter of debate. The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX study is a large-scale, multicenter, prospective, open-label trial, conducted at approximately 100 sites in Europe aiming to primarily assess whether TRI and bivalirudin infusion, as compared to TFI and UFH plus provisional GPI, decrease the 30-day incidence of death, myocardial infarction or stroke across the whole spectrum of ACS patients. © 2014 Springer Science+Business Media New York.

Gaggioli G.,Ospedale Villa Scassi | Laffi M.,Ospedale Villa Scassi | Montemanni M.,Medicina Del Lavoro | Mocini A.,Ospedale Villa Scassi | And 2 more authors.
Europace | Year: 2014

Aims Little is known regarding the overall prevalence of syncope in a population of workers and the risk of occurrence during working time. Methods and Results A total of 452 consecutive workers (mean age: 46 ± 9 years) were invited to answer an anonymous questionnaire. They had been employed for 22 ± 10 years for a total of 9765 years worked. In the cohort, 160 subjects (35%) reported a total of 465 episodes of syncope during their lives; 64 (14%) suffered a syncopal episode after the start of employment, but only 26 (5.7%) reported syncope at work, 7 (1.5%) having had 2 episodes, and 1 (0.2%) 3 episodes (total: 36 episodes). The risk of syncope during work was 4.6 times higher for those who had a prior history of syncope [18 of 138 (13%)] than for those who did not [8 of 314 (3%), P = 0.001]. The occurrence of syncope during work for the patients with a history of syncope was one syncopal episode in every 99 years worked and for those who had already had an episode during work, one episode in every 16 years worked. Only one patient experienced minor trauma as a consequence of syncope during work and three were referred to the emergency department. All patients continued their employment without any problems. Conclusion The prevalence of syncope during work is low and its impact is benign. The probability of syncope during work is higher for subjects with a history of syncope. © 2013 Published on behalf of the European Society of Cardiology. All rights reserved. The Author 2013.

Brignole M.,Arrhythmologic Center | Botto G.L.,Ospedale S. Anna | Mont L.,Hospital Clinic i Provincial | Oddone D.,Arrhythmologic Center | And 11 more authors.
Heart | Year: 2012

Objective: To evaluate the 2-year clinical improvement after 'Ablate and Pace' therapy and to identify the variables able to influence the efficacy of this therapy in patients with permanent atrial fibrillation (AF). Design: Prospective multicentre observational study. Setting: Cardiology departments of 19 general hospitals in Italy, Spain and Greece. Patients: 171 patients with drug-refractory severely symptomatic permanent AF considered for AV junction ablation. Interventions: Patients underwent AV junction ablation, received a right ventricular (RV) pacing or echo-guided cardiac resynchronisation (CRT) pacing and were followed-up to 24 months. Main outcome measures: Non-responders to Ablate and Pace therapy were defined those patients who, during the follow-up period had clinical failure (defined as death or hospitalisation due to heart failure, or worsening heart failure) or showed no improvement in their clinical condition. Results: Responders were 63% of RV-paced patients and 83% of CRT-paced patients. Another 27% showed no clinical improvement (7%) or worsened (20%) (nonresponders group). On multivariable Cox regression analysis, CRT mode and echo-optimised CRT were the only independent protective factors against nonresponse (HR=0.24, 95% CI 0.10-0.58, p=0.001 and HR=0.22, 95% CI 0.07-0.77, p=0.018 respectively). On comparing freedom from non-response, a trend in favour of echo-optimised CRT versus simultaneous biventricular pacing (p=0.077) was seen. Conclusions In patients affected by severely symptomatic permanent AF, Ablate and Pace therapy yielded a clinical benefit in 63% of RV-paced patients and 83% of CRT-paced patients. CRT pacing and echooptimised CRT were the only independent predictor of clinical benefit.

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