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Novel implantable defibrillators (ICDs) allow first (S1) and third (S3) heart sounds to be measured by means of an embedded accelerometer. ICD-measured S1 and S3 have been shown to significantly correlate with hemodynamic changes in acute animal models. The HeartLogic algorithm (Boston Scientific) measures and combines multiple parameters, including S3 and S1, into a single index to predict impending heart failure decompensation. We evaluated the echocardiographic correlates of ICD-measured S1 and S3 in patients with ICD and cardiac resynchronization therapy ICD.The HeartLogic feature was activated in 104 patients. During in-office visits, patients underwent echocardiographic evaluation, and parameters of systolic and diastolic function were correlated with S3 and S1 amplitude measured on the same day as the visit.S3 amplitude inversely correlated with deceleration time of the E-wave (r = -0.32; 95% CI -0.46 - -0.17; P 0.001), and S1 amplitude significantly correlated with left ventricular ejection fraction (r = 0.17; 95% CI 0.03-0.30; P = 0.021). S3 0.9 mG detected a restrictive filling pattern with 85% (95% CI 72%-93%) sensitivity and 82% (95% CI 75%-88%) specificity, while S1 1.5 mG detected ejection fraction35% with 28% (95% CI 19%-40%) sensitivity and 88% (95% CI 80%-93%) specificity.ICD-measured heart sound parameters are significantly correlated with echocardiographic indexes of systolic and diastolic function. This confirms their utility for remote patient monitoring when used as single sensors and their potential relevance when considered in combination with other physiological ICD sensors that evaluate various aspects of heart failure physiology.

There is a growing interest in the study of the mechanisms of heart and brain interactions with the aim to improve the management of high-impact cardiac rhythm disorders, first of all atrial fibrillation. However, there are several topics to which the scientific interests of cardiologists and neurologists converge constituting the basis for enhancing the development of neuro-arrhythmology. This multidisciplinary field should cover a wide spectrum of diseases, even beyond the classical framework corresponding to stroke and atrial fibrillation and include the complex issues of seizures as well as loss of consciousness and syncope. The implications of a more focused interaction between neurologists and cardiologists in the field of neuro-arrhythmology should include in perspective the institution of research networks specifically devoted to investigate 'from bench to bedside' the complex pathophysiological links of the abovementioned diseases, with involvement of scientists in the field of biochemistry, genetics, molecular medicine, physiology, pathology and bioengineering. An investment in the field could have important implications in the perspectives of a more personalized approach to patients and diseases, in the context of 'precision'medicine. Large datasets and electronic medical records, with the approach typical of 'big data' could enhance the possibility of new findings with potentially important clinical implications. Finally, the interaction between neurologists and cardiologists involved in arrythmia management should have some organizational implications, with new models of healthcare delivery based on multidisciplinary assistance, similarly to that applied in the case of syncope units.

During the last 50 years a continuous improvement was observed in the field of cardiac pacing and electrophysiology as for as both technological and clinical aspects were concerned. We moved from the first recording of the His bundle electrogram to the identification of the various mechanisms and sites of supraventricular and ventricular tachyarrhythmias, to three-dimensional mapping and ablation of different reentry circuits and eventually to pulmonary vein isolation for the treatment of atrial fibrillation. As far as cardiac pacing is concerned, we moved from single chamber to dual chamber pacing, to ventricular pacing and implantable automatic defibrillators provided by sophisticated diagnostic and therapeutic algorithms and by remote control. Recently a family of leadless devices (loop recorders, endocavitary pacemakers, subcutaneous defibrillators) have become available for diagnostic and therapeutic purposes and brought a significant benefit in the reduction and management of many device-related troubles.

Background The HeartLogic algorithm measures and combines multiple parameters, i.e. heart sounds, intrathoracic impedance, respiration pattern, night heart rate, and patient activity, in a single index. The associated alert has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation, and the HeartLogic alert condition was shown to identify patients during periods of significantly increased risk of HF events. Purpose To report the results of a multicenter experience of remote HF management with HeartLogic algorithm and appraise the value of an alert-based follow-up strategy. Methods The HeartLogic feature was activated in 104 patients (76 male, 71 ± 10 years, left ventricular ejection fraction 29 ± 7%). All patients were followed according to a standardized protocol that included remote data reviews and patient phone contacts every month and at the time of HeartLogic alerts. In-office visits were performed every 6 months or when deemed necessary. Results During a median follow-up of 13[11-18] months, centers performed remote follow-up at the time of 1284 scheduled monthly transmissions (10.5 per pt-year) and 100 HeartLogic alerts (0.82 alerts/pt-year). The mean delay from alert to the next monthly remote data review was 14 ± 8 days. Overall, the patient time in the alert state (i.e. HeartLogic index above the threshold) was 14% of the total observation period. HF events requiring active clinical actions were detected at the time of 11 (0.9%) monthly remote data reviews and at 43 (43%, p Conclusions HeartLogic alerts are frequently associated with relevant actionable HF events. Events are detected earlier and the volume of alert-driven remote follow-ups is limited when compared with a monthly remote follow-up scheme. The probability of detecting common signs and symptoms of HF at regular remote or in-office assessment is extremely low when the patient is out of HeartLogic alert state. These results support the adoption of an alert-based follow-up strategy.

Aims In the Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients study, a novel algorithm for heart failure (HF) monitoring was implemented. The HeartLogic (Boston Scientific) index combines data from multiple implantable cardioverter defibrillator (ICD)‐based sensors and has proved to be a sensitive and timely predictor of impending HF decompensation. The remote monitoring of HF patients by means of HeartLogic has never been described in clinical practice. We report post‐implantation data collected from sensors, the combined index, and their association with clinical events during follow‐up in a group of patients who received a HeartLogic‐enabled device in clinical practice. Methods and results Patients with ICD and cardiac resynchronization therapy ICD were remotely monitored. In December 2017, the HeartLogic feature was activated on the remote monitoring platform, and multiple ICD‐based sensor data collected since device implantation were made available: HeartLogic index, heart rate, heart sounds, thoracic impedance, respiration, and activity. Their association with clinical events was retrospectively analysed. Data from 58 patients were analysed. During a mean follow‐up of 5 ± 3 months, the HeartLogic index crossed the threshold value (set by default to 16) 24 times (over 24 person‐years, 0.99 alerts/patient‐year) in 16 patients. HeartLogic alerts preceded five HF hospitalizations and five unplanned in‐office visits for HF. Symptoms or signs of HF were also reported at the time of five scheduled visits. The median early warning time and the time spent in alert were longer in the case of hospitalizations than in the case of minor events of clinical deterioration of HF. HeartLogic contributing sensors detected changes in heart sound amplitude (increased third sound and decreased first sound) in all cases of alerts. Patients with HeartLogic alerts during the observation period had higher New York Heart Association class (P = 0.025) and lower ejection fraction (P = 0.016) at the time of activation. Conclusions Our retrospective analysis indicates that the HeartLogic algorithm might be useful to detect gradual worsening of HF and to stratify risk of HF decompensation.

Background The HeartLogic algorithm measures data from multiple implantable cardioverter‐defibrillator‐based sensors and combines them into a single index. The associated alert has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. Hypothesis We describe a multicenter experience of remote HF management by means of HeartLogic and appraise the value of an alert‐based follow‐up strategy. Methods The alert was activated in 104 patients. All patients were followed up according to a standardized protocol that included remote data reviews and patient phone contacts every month and at the time of alerts. In‐office examinations were performed every 6 months or when deemed necessary. Results During a median follow‐up of 13 (10–16) months, the overall number of HF hospitalizations was 16 (rate 0.15 hospitalizations/patient‐year) and 100 alerts were reported in 53 patients. Sixty alerts were judged clinically meaningful, and were associated with multiple HF‐related conditions. In 48 of the 60 alerts, the clinician was not previously aware of the condition. Of these 48 alerts, 43 triggered clinical actions. The rate of alerts judged nonclinically meaningful was 0.37/patient‐year, and the rate of hospitalizations not associated with an alert was 0.05/patient‐year. Centers performed remote follow‐up assessments of 1113 scheduled monthly transmissions (10.3/patient‐year) and 100 alerts (0.93/patient‐year). Monthly remote data review allowed to detect 11 (1%) HF events requiring clinical actions (vs 43% actionable alerts, P

Key Clinical Message We report the first case of a patient in whom an implantable cardioverter‐defibrillator (ICD) endowed with HeartLogic, a novel algorithm for heart failure (HF) monitoring, was implanted in clinical practice. The good temporal association between HeartLogic index threshold crossings and HF hospitalizations confirms the high sensitivity in detecting gradual worsening of HF.

Background: GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic t...

Background The HeartLogic (Boston Scientific) index combines data from multiple implantable cardioverter-defibrillator (ICD)-based sensors and has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. Objective To describe a preliminary experience of remote HF management of patients who received a HeartLogic-enabled ICD or cardiac resynchronization therapy ICD (CRT-D) in clinical practice. Methods The HeartLogic feature was activated in 101 patients (74 male, 71±10 years, ejection fraction 30±7%). From implantation to activation (blinded phase), the HeartLogic index trend was not available, thus no clinical actions were taken in response to it. After activation (active phase), remote data reviews and patient phone contacts were performed monthly and at the time of HeartLogic alerts (when the index crossed the nominal alert threshold value of 16), to assess the patient decompensation status. In-office visits were performed when deemed necessary. Results During the blinded phase, the HeartLogic index crossed the threshold value 24 times (over 24 person-years, 0.99 alerts/pt-year) in 16 patients. HeartLogic alerts preceded all hospitalizations and unplanned in-office visits for HF (sensitivity: 100%, median early warning: 38 days for hospitalizations, 12 days for HF visits). No clinical events were detected during or within 30 days of recovery of 10 HeartLogic alerts (unexplained alert rate: 0.41 per patient-year). Thus, the positive predictive value was 58% (14/24). During the active phase, 44 HeartLogic alerts were reported (over 46 person-years, 0.95 alerts/pt-year) in 30 patients. 26 (59%) HeartLogic alerts were judged clinically meaningful (i.e. associated with worsening of HF and/or influenced the clinician's decision to make changes to the subject's management). Conclusions In this first description of the use of HeartLogic in clinical practice, the algorithm demonstrated its ability to detect gradual worsening of HF. The results of the blinded phase of our experience favorably compare with those reported in the validation study. In the active phase, the HeartLogic index provided clinically meaningful information for the remote management of HF patients.

Approximately 1-2% of the adult population in developed countries is affected by heart failure. The costs of heart failure are enormous both in Europe and in the US and are expected to rise. New technologies and remote monitoring, are valid tools for the management and treatment of these patients.This review aims to cover both implantable and non-implantable devices available for monitoring various hemodynamic parameters and clinical features of patients, as well as algorithms implemented in the new generation ICDs and CRTs capable of simultaneous acquisition and transmission of multiple parameters that indirectly evaluate clinical and/or hemodynamic status. Both internet and PubMed searches were used in order to acquire the most recent developments in the technology of the field. Expert commentary: As new technology offers an enormous data flow, the key for success in the battle against heart failure and related hospitalizations is understanding the correct way of utilizing the data acquired and their importance for the treatment of each individual person.

There is a growing interest in the study of the mechanisms of heart and brain interactions with the aim to improve the management of high-impact cardiac rhythm disorders, first of all atrial fibrillation. However, there are several topics to which the scientific interests of cardiologists and neurologists converge constituting the basis for enhancing the development of neuro-arrhythmology. This multidisciplinary field should cover a wide spectrum of diseases, even beyond the classical framework corresponding to stroke and atrial fibrillation and include the complex issues of seizures as well as loss of consciousness and syncope. The implications of a more focused interaction between neurologists and cardiologists in the field of neuro-arrhythmology should include in perspective the institution of research networks specifically devoted to investigate 'from bench to bedside' the complex pathophysiological links of the abovementioned diseases, with involvement of scientists in the field of biochemistry, genetics, molecular medicine, physiology, pathology and bioengineering. An investment in the field could have important implications in the perspectives of a more personalized approach to patients and diseases, in the context of 'precision'medicine. Large datasets and electronic medical records, with the approach typical of 'big data' could enhance the possibility of new findings with potentially important clinical implications. Finally, the interaction between neurologists and cardiologists involved in arrythmia management should have some organizational implications, with new models of healthcare delivery based on multidisciplinary assistance, similarly to that applied in the case of syncope units.

In the last decades we are observing a continuous increase in the number of patients wearing cardiac implantable electronic devices (CIEDs). At the same time, we face daily with a domestic and public environment featured more and more by the presence and the utilization of new emitters and finally, more medical procedures are based on electromagnetic fields as well. Therefore, the topic of the interaction of devices with electromagnetic interference (EMI) is increasingly a real and actual problem.In the medical environment most attention is paid to magnetic resonance, nevertheless the risk of interaction is present also with ionizing radiation, electrical nerve stimulation and electrosurgery. In the non-medical environment, most studies reported in the literature focused on mobile phones, metal detectors, as well as on headphones or digital players as potential EMI sources, but many other instruments and tools may be intentional or non-intentional sources of electromagnetic fields.CIED manufacturers are more and more focusing on new technological features in order to make implantable devices less susceptible to EMI. However, patients and emitter manufacturers should be aware that limitations exist and that there is not complete immunity to EMI.

Background— Syncope in patients with bifascicular block (BFB) is a common event whose causes might be difficult to assess. Methods and Results— Prevention of syncope through permanent cardiac pacing in patients with bifascicular block (PRESS) is a multicenter, prospective, randomized, single-blinded study designed to demonstrate a reduction in symptomatic events in patients with bifascicular block and syncope of undetermined origin implanted with permanent pacemaker. Device programming mode (NASPE/BPEG code) at DDD with a lower rate of 60 ppm is compared with backup pacing at DDI with a lower rate of 30 ppm. The end point consisted of (1) syncope, (2) symptomatic presyncopal episodes associated with a device intervention (ventricular pacing), and (3) symptomatic episodes associated with intermittent or permanent atrioventricular block (any degree). One hundred one patients were enrolled and randomized. Primary end point events at 2 years were observed in 23 patients, with a significant lower incidence in the study group (hazard ratio, 0.32; 95% confidence interval [CI], 0.10–0.96; P =0.042). Reduction of any symptoms, associated or not with device intervention, was superior in DDD60 compared with DDI30 (hazard ratio, 0.4; 95% confidence interval, 0.25–0.78; P =0.0053). Fourteen patients developed other rhythm diseases and met class I indication for pacing. The annual incidence of rhythm disease development was 7.4%. Conclusions— In patients with bifascicular block and syncope of undetermined origin, the use of a dual chamber pacemaker programmed to DDD60 led to a significant reduction of syncope or symptomatic events associated with a cardioinhibitory origin, compared with DDI30 programming. Symptoms associated with a new onset of rhythm disease were found in 15% of the population at 2 years.

Atrial fibrillation-related stroke prevention with anticoagulant drugs is currently evolving towards the introduction into clinical practice of the new oral anticoagulants, including rivaroxaban. Our aim was to evaluate in a real-life setting the characteristics and management of patients with nonvalvular atrial fibrillation to whom Italian doctors decided to prescribe rivaroxaban.Between January and February 2014, a group of 95 physicians collected aggregate retrospective data, through an online questionnaire, on 1127 patients with nonvalvular atrial fibrillation receiving rivaroxaban. Descriptive statistics were performed based on the data collected.Mean age of patients was 76 years; 20% of patients suffered a previous transient ischemic attack and 16% a previous stroke; 16% was anemic or at risk of bleeding. Over 40% of patients was unable to have a good control of the previous antithrombotic therapy, 22% was also taking antiplatelet drugs or nonsteroidal anti-inflammatory drugs, and 85% had been on a previous stroke prevention therapy; among the latter the main causes for switching to rivaroxaban were patient choice (30%), problems in maintaining the prothromin time-international normalized ratio (PT-INR) within the therapeutic range (27%), and logistic problems in attending the PT-INR follow-up visits (20%). Rivaroxaban was prescribed at a dosage of 15 mg in 37.8% of patients and 20 mg in 62.2%; the 15 mg dose was prescribed to 264 of 354 patients with creatinine clearance50 ml/h (74.6%) and in older patients with more comorbidities.In this real-life analysis, patient characteristics were similar to those of patients enrolled in large randomized trials, whereas differences in dose prescriptions were observed.

Rate responsive pacemakers (PM) use different strategies to adapt the patient paced rate, with the aim of having the best hemodynamic performance in response to internal or external conditions. Closed-loop stimulation (CLS) uses intracardiac impedance as a sensor principle. The evaluation of impact of different pacing modalities and technologies on the blood pressure (BP) profiles is mainly investigated in short-term laboratory settings, mainly due to the need of reliable daily-based BP values. The impact of CLS pacing on systemic blood pressure (BP) has been studied on short term basis, but data on long term effects are scarse. This study present a telemedicine platform designed for evaluating the effect of the rate responsive technology on daily systolic and diastolic BP data. BP and pacemaker data were collected daily from fourteen patients during a 3 month period. The total number of monitoring days was 1277 (91 day/patient), for a total number of 4455 BP measures. On average 3.5 measure/day/patient were received). The analysis of the BP data showed that CLS pacing results in diastolic pressure closer to the normal values than accelerometer-based pacing, which were associated to lower diastolic pressures.

Recently, the remote transmission of data detected by implantable loop recorders (ILRs) has become available. The aim of this study was to evaluate effectiveness and acceptance of remote monitoring in the clinical management of syncope and palpitations in patients with ILR. Methods and results Consecutive patients implanted with ILR (Reveal DX/XT Medtronic, Inc.) and followed up by means of remote moni- toring (CareLink w ) were included. The patients were requested to transmit the data stored in the ILR every week, via the CareLink system, or more frequently during the first period. Patient acceptance of ILR was evaluated by means of a questionnaire concerning physical and mental components. Forty-seven patients (27 males, average age 64+ 19 years) were enrolled and followed up for 20+ 13 weeks. Thirty-two patients (68%) had at least one ECG recording of a true relevant event. The mean time from ILR implantation to the first true relevant ECG was 28+ 49 days, which was 71+ 17 days less than in the clinical practice of 3-monthly in-office follow-up examinations. Thirty- eight patients (81%) had at least one false arrhythmic event, mainly false asystole and false fast ventricular tachycardia. In the absence of Carelink transmission, at least one episode of memory saturation of ILR would have occurred in 21 patients (45%) that would have limited the diagnostic yield. Patient compliance was good even though one- fifth had some minor psychological concern regarding the ILR implant. CareLink was well accepted and judged easy to use. Conclusion Remote monitoring enhances the diagnostic effectiveness of Reveal, limiting the risk of memory saturation due to the high number of false detections and reducing the time to diagnosis. Both ILR and CareLink were well accepted and well tolerated by the patients, as they were considered useful.

Aims The aim of this study was to determine the long-term effects and determinants of success of cardiac pacing in patients affected by reflex syncope enrolled in the Syncope Unit Project 2 (SUP 2) study. Initial results have validated the effectiveness of a standardized guideline-based algorithm which can be used in clinical practice in order to select suitable candidates for cardiac pacing. Methods and results In this prospective, multicentre, observational study, patients aged >40 years, affected by severe unpredictable recurrent reflex syncope, 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. Of 281 patients who met the inclusion criteria, 137 (49%) received a pacemaker and were followed up for a mean of 26 ± 11 months: syncope recurred in 25 (18%) of them. At 3 years, the actuarial syncope recurrence rate was 20% [95% confidence interval (CI) 12–30] and was significantly lower than in 142 patients who did not receive a pacemaker and were observed by means of an ILR [43% (95% CI 29–57), P = 0.01]. The 3-year recurrence rate was not different among 78 CSM+, 38 TT+, and 21 ILR+ patients, whereas it was lower in 20 patients with negative TT [5% (95% CI 0–15)] than in 61 patients with positive TT [24% (95% CI 10–38)]. Conclusion The benefit of cardiac pacing is maintained at 3 years, irrespective of the index diagnostic test, and is maximum in patients with negative TT. Clinical trial registration URL: . Unique identifier: [NCT01509534][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01509534&atom=%2Feuropace%2F18%2F9%2F1427.atom

To compare the utility of the partners-heart failure (HF) algorithm with the care alert strategy for remote monitoring, in guiding clinical actions oriented to treat impending HF.Consecutive cardiac resynchronization-defibrillator recipients were followed with biweekly automatic transmissions. After every transmission, patients received a phone contact in order to check their health status, eventually followed by clinical actions, classified as "no-action", "non-active" and "active". Active clinical actions were oriented to treat impending HF. The sensitivity, specificity, positive and negative predictive values and diagnostic accuracy of the partners-HF algorithm vs care alert in determining active clinical actions oriented to treat pre-HF status and to prevent an acute decompensation, were also calculated.The study population included 70 patients with moderate to advanced systolic HF and QRS duration longer than 120 ms. During a mean follow-up of 8 ± 2 mo, 665 transmissions were collected. No deaths or HF hospitalizations occurred. The sensitivity and specificity of the partners-HF algorithm for active clinical actions oriented to treat impending HF were 96.9% (95%CI: 0.96-0.98) and 92.5% (95%CI: 0.90-0.94) respectively. The positive and negative predictive values were 84.6% (95%CI: 0.82-0.87) and 98.6% (95%CI: 0.98-0.99) respectively. The partners-HF algorithm had an accuracy of 93.8% (95%CI: 0.92-0.96) in determining active clinical actions. With regard to active clinical actions, care alert had a sensitivity and specificity of 11.05% (95%CI: 0.09-0.13) and 93.6% respectively (95%CI: 0.92-0.95). The positive predictive value was 42.3% (95%CI: 0.38-0.46); the negative predictive value was 71.1% (95%CI: 0.68-0.74). Care alert had an accuracy of 68.9% (95%CI: 0.65-0.72) in determining active clinical actions.The partners-HF algorithm proved higher accuracy and sensitivity than care alert in determining active clinical actions oriented to treat impending HF. Future studies in larger populations should evaluate partners-HF ability to improve HF-related clinical outcomes.

Aims Exercise-related syncopal spells in athletes receive great attention and are a source of anxiety in the sporting world. The aim of the present study is to describe the clinical presentation, the yield of the initial diagnostic work-up and the long-term outcome of a series of consecutive competitive athletes with recurrent exercise-related syncopal spells. Methods and Results The study cohort included 33 athletes (20 females, mean age 21·43·2 years) referred for recurrent unexplained episodes of exercise-related syncope (mean number of spells before evaluation 4·661·97). All athletes underwent an extensive evaluation, including echocardiography, 24-h electrocardiographic monitoring, exercise testing, cardiac electrophysiological study and head-up tilt testing. The echocardiographic examination revealed the presence of a mitral valve prolapse in two cases (6·0%). During maximal exercise testing, four athletes (12·1%) developed hypotension associated with presyncope. Twenty-two subjects (66·6%) showed a positive response to head-up tilt testing. During follow-up (33·517·2 months) 11/33 athletes (33·3%) showed at least one recurrence of exercise-related syncope (mean time to first recurrence 20·414·5 months). No other adverse event of any kind was noted during follow-up. The Kaplan– Meier estimates of first recurrence of exercise-related syncope after 12, 36 and 60 months were 9·1%, 24·4% and 42·9%. The number and frequency of exercise-related syncopal spells before evaluation were found to be univariate predictors of syncope recurrence (P

Transient loss of consciousness is a common symptom in the general population; it is estimated that approximately 40 % individuals will faint at least once in their lifetime. Vasovagal syncope (VVS), characterized by paroxysmal reflex-mediated hypotension associated with bradycardia, is the most common of the neurally mediated syncopal syndromes. The neurally mediated vasovagal reflex is caused by a rapid increase in vagal tone, which results in bradycardia or asystole, associated with hypotension, caused by the reduction in peripheral sympathetic activity, leading to systemic vasodilation with consequent global cerebral hypoperfusion and loss of consciousness.

Head-up tilt testing potentiated by sublingual nitroglycerin (NTG), advocated by an Italian group, is a simple and safe but still not a standardized, diagnostic tool for the investigation of syncope. In fact, owing to its rapid spread, the original protocol received, often arbitrarily, many subsequent modifications. We now define the best methodology of the test on strictly evidence-based criteria as: stabilization phase of 5 min in the supine position; passive phase of 20 min at a tilt angle of 60 degrees; provocation phase of further 15 min after 400 micrograms NTG sublingual spray. Test interruption is made when the protocol is completed in the absence of symptoms, or there is occurrence of syncope, or occurrence of progressive (> 5 min) orthostatic hypotension. We intend that this protocol, named by us as 'The Italian Protocol', will be accepted as the standard methodology of the tilt test potentiated by sublingual nitrates.

Background Low energy internal cardioversion is a safe and effective procedure to restore sinus rhythm in patients with atrial fibrillation refractory to external cardioversion. However the procedure is invasive and fluoroscopy is mandatory. Aim of the study To assess the efficacy, safety and tolerability of a new simplified procedure of low energy internal cardioversion. Methods Twenty-five consecutive patients (19 males and 6 females) with persistent atrial fibrillation were submitted to low energy internal cardioversion using a step-up protocol (in steps of 50V, starting from 300V). A large surface area lead (cathode) was positioned in the oesophagus, 45cm from the nasal orifice. A second large surface area lead (anode) was positioned in the right atrium. A quadripolar lead was positioned at the right ventricular apex to achieve ventricular synchronization and back-up pacing. Oesophageal endoscopy was performed within 24h of the end of the procedure and repeated after 48h, if injury to the oesophageal mucosa had occurred. Results Sinus rhythm was restored in 23 patients (92%) with a mean delivered energy of 15·74J (range 5–27) and a mean impedance of 48Ω. In two patients, endoscopy revealed that small burns had occurred in the oesophageal mucosa. Such lesions spontaneously healed after 48h. Conclusions This new technique of performing low energy internal cardioversion is effective and safe and avoids the positioning of a lead in the coronary sinus or in the left pulmonary artery, thereby simplifying the procedure.

Aims This single-blinded, randomized, placebo-controlled study was designed and undertaken to assess the efficacy of intravenous atropine administration on haemodynamic impairment induced by head-up tilt testing in patients with vasovagal syncope. Methods and Results One hundred and thirteen consecutive patients (62 male and 51 female, mean age 46·3 years) with recurrent syncope, no evidence of cardiac, neurological or metabolic disease and a positive head-up tilt test were included in the study. Within 2 weeks of the first head-up tilt test all patients underwent a second tilt test. During this second test, all patients were randomized to receive a bolus of either atropine (0·02mg.kg−1) or placebo (isotonic saline solution). The administration of atropine or placebo was performed at the onset of the haemodynamic modifications (heart rate and/or blood pressure fall) in conjunction with typical vasovagal prodromal symptoms. Treatment was taken as effective when symptoms aborted and the test was completed. In 29 of 113 patients the second tilt test was negative and these patients were excluded from final data analysis. Forty-one patients received placebo, which was effective in nine cases (21·9%). Atropine was administered to 43 patients and was effective in 30 cases (69·7%, P

Background.Discomfort related to low-energy internal cardioversion (LEIC) represents a real problem in patients (pts) with atrial fibrillation (AF). The aim of our study was to verify if a single shock could restore sinus rhythm (SR) with a lower discomfort for the pt. Methods. Thirty pts with chronic AF were randomized to receive a single 350 V shock (15 pts) or multiple shocks of increasing energy (15 pts). Three leads were positioned, respectively, in the coronary sinus and in the lateral right wall for shock delivery, and in the right ventricular apex for R wave synchronization. Truncated, biphasic shocks were used. In the first group a single 350 V shock was directly delivered and a second 400 V shock was given only if SR has not been restored. In the second group, beginning at 50 volts the voltage was increased in steps of 50 volts until SR restoration. No patient was sedated. After each shock the pts were asked to rate their discomfort on a scale of 1 to 5 (1 = not perceived, 5 = severe discomfort) Results. SR was restored in all the subjects. In group 1 SR was obtained in 12/15 (80%) pts with the first 350 V (8.1±0.8 joules) shock, while the remaining 3 patients required the second 400 V (10.2±10.3 joules) shock. In group 2 the mean atrial defibrillation threshold was 346.7±29.7 volts (8.0±1.5 joules). Then discomfort score was 2.5±0.6 in group 1 and 3.3±0.6 in group 2 (p < 0.01). Conclusions. A single shock of 350 V restores SR in the majority of pts with chronic AF; by use this new approach, LEIC is tolerated better than the multiple shocks step-up protocol.

Background and Purpose— We sought to determine whether the introduction of EEG monitoring during head-up tilt testing could significantly improve the understanding of the cerebral events occurring during tilt-induced vasovagal syncope and the potential danger to the patient of this diagnostic procedure. Methods— EEG monitoring was performed during head-up tilt testing in a group of 63 consecutive patients (27 males and 36 females; mean age, 41.5 years) with a history of recurrent syncope of unknown origin despite extensive clinical and laboratory assessment. Results— Syncope occurred in 27 of 63 patients (42.8%) during head-up tilt testing and was found to be cardioinhibitory in 11 of 27 (40.7%) and vasodepressor in 16 of 27 (59.3%). All patients with a negative response to head-up tilt testing showed no significant EEG modifications. In patients with vasodepressor syncope, a generalized high-amplitude, 4- to 5-Hz (theta range) slowing of EEG activity appeared at the onset of syncope, followed by an increase of brain-wave amplitude with the reduction of frequency at 1.5 to 3 Hz (delta range). The return to the supine position was associated with brain-wave amplitude reduction and frequency increase to 4 to 5 Hz, followed by restoration of a normal EEG pattern and arousal (mean total duration of syncope, 23.2 seconds.). In patients with cardioinhibitory syncope, a generalized high-amplitude EEG slowing in the theta range was noted at the onset of syncope, followed by a brain-wave amplitude increase and slowing in the delta range. A sudden reduction of brain-wave amplitude then ensued, leading to the disappearance of electrocerebral activity (“flat” EEG). The return to the supine position did not allow either the immediate resolution of EEG abnormalities or consciousness recovery, both of which occurred after a further time interval (mean total duration of syncope, 41.4 seconds.). Conclusions— EEG monitoring during head-up tilt testing allowed recording and systematic description of electrocerebral abnormalities developing in the course of tilt-induced vasovagal syncope.

A series of in vivo trials were carried out in order to verify whether the electromagnetic field radiated by GSM (Groupe Systemes Mobiles) mobile cellular phones might affect implanted pacemakers. Two European GSM phones of 2-watt power were tested and trials conducted on 101 pacemaker implanted outpatients attending day hospital for routine check-up, who volunteered for trials. Forty-three pacemaker models from 11 manufacturers were tested in all. When the sensing threshold of the pacemakers was set at a minimum and the antenna of the phone was in direct contact with the patient's chest, interference was detected for 26 implanted pacemakers. Specifically, pulse inhibition in 10 of 101 cases, ventricular triggering in 9 of 46 DDD-VDD pacemakers, and asynchronous pacing in 4 of 52 devices. Pulse inhibition was also observed combined with asynchronous pacing in 1 of 52 cases and with ventricular triggering in 2 of 46 cases. Minimum effect duration was ca. 3 seconds but in 6 cases effects continued as long as the interfering GSM signal was on. No permanent malfunctioning or changes in the programmed parameters were detected. Whenever interference was detected, trials were repeated to determine the maximum sensing threshold at which interference persisted (with the antenna in contact with the skin over the pacemaker). Then maximum distance between antenna and pacemaker at which interference occurred was determined at pacemaker maximum and minimum sensing threshold. Under our experimental conditions electromagnetic interference effects were detected at a maximum distance of 10 cm with the pacemaker programmed at its minimum sensing threshold.(ABSTRACT TRUNCATED AT 250 WORDS)

This clinical investigation was designed and undertaken to test the hypothesis that the addition of high-dose atorvastatin (80 mg/day) to conventional medical treatment early after either unstable angina pectoris (UAP) or non–Q-wave acute myocardial infarction (AMI) could reduce ischemic recurrences.  All patients consecutively admitted to our institution between January 1999 and July 2001 for UAP or non–Q-wave AMI were prospectively screened for inclusion in the study. In all cases the diagnosis of UAP or non–Q-wave AMI was made in accordance with previously reported criteria. 1 To be enrolled in the trial, patients were required to meet the following criteria: (1) angiographic evidence of severe and diffuse coronary artery disease, that was not amenable to direct revascularization by coronary artery bypass grafting or percutaneous transluminal coronary angioplasty, as determined by a cardiac surgeon and an interventional cardiologist during the index admission; (2) objective evidence of symptomatic reversible myocardial ischemia (0.1 mV ST-segment depression on the electrocardiogram) at a low exercise workload (4 METs) while receiving medical treatment (2 antianginal medications at maximal tolerated doses), as assessed by treadmill ergometry (Bruce’s protocol) before discharge; and (3) left ventricular ejection fraction 35%. Exclusion criteria were the presence of congestive heart failure, the need for continuous use of intravenous antianginal medications, and the presence of any major concurrent illness. The study was planned as an open-label, prospective, randomized, controlled trial with parallel groups. Before enrollment, all patients were receiving maximal conventional combination therapy (nitrates, calcium antagonists, and blockers), including 2 medications at maximal tolerated doses in all cases. All patients provided informed consent to take part in the investigation. At discharge from the hospital, included patients

Cardiac resynchronization therapy (CRT) is an established treatment for symptomatic patients with heart failure (HF), a prolonged QRS duration, and reduced ejection fraction (EF). The latest 2013 European Society of Cardiology Guidelines on cardiac pacing and cardiac resynchronization therapy [(1

We report a case of a 78-year-old woman admitted to hospital due to cardiac tamponade 3 months after surgical mitral valve repair. The patient developed an early left ventricular dysfunction after removal of the pericardial effusion, with complete recovery within 10 days. Transient ventricular dysfunction after pericardiocentesis is a very rare complication, we present a review of the different mechanisms suggested in the literature to explain the pathophysiology of this rare phenomenon.

Aims Although an organizational model for syncope management facilities was proposed in the 2004 guidelines of the European Society of Cardiology (ESC), its implementation in clinical practice and its effectiveness are largely unknown. Methods and results This prospective study enrolled 941 consecutive patients referred to the Syncope Units of nine general hospitals from 15 March 2008 to 15 September 2008. A median of 15 patients per month were examined in each unit, but the five older units had a two-fold higher volume of activity than the four newer ones (instituted

Timely reperfusion therapies (primary angioplasty and pre-hospital thrombolysis) remain a key component in improving the survival of patients with ST-segment elevation myocardial infarction (STEMI). The Lazio Region emergency organization has a complex mixed logistic (the large city of Rome, presence of complex orography), therefore the use of telemedicine technologies by the emergency medical system (EMS) is mandatory. Emergency clinical pathways (ECP) for the management of STEMI patients were designed, focusing on early pre-hospital diagnosis and best appropriate treatment through the ECG transmission and teleconsultation among EMS and cardiologists in coronary care units (CCU).To evaluate the effectiveness of ECP-STEMI in the current practice, a prospective observational cohort study of ambulance-transported patients with cardiovascular symptoms was conducted in a selected area of the Lazio Region during a 6-month period. The implementation of the ECP was carried out by educational activities for the EMS personnel based on the "experiential learning" methods.From October 2005 to March 2006, 287 patients were enrolled in the study and a pre-hospital ECG was performed in 66% of them. One hundred and fifty-two patients were referred to hospital and only 34 had discharged diagnosis of acute myocardial infarction, of whom 23 were STEMI. In the 34 acute myocardial infarction patients the medium time from "call to the EMS" to "arrival to the hospital" was 41 min (range 29-63 min) and 3 had their ECG telematically transmitted from the ambulance to the CCU. All of these cases were STEMI. Twenty-eight acute myocardial infarctions were discharged alive, 2 were transferred in other hospitals, 4 died. No patients received pre-hospital thrombolysis. Prior to the ECP implementation the ECG for STEMI patients has never been transmitted by EMS to the CCU in the Lazio Region.Our study suggests that adherence to ECP improved the appropriateness of STEMI patient referral and treatment in the CCU in the Lazio Region. The EMS personnel, during the study, showed a high interest in the protocol trying to change their current practice. The Regional Administration plans to expand the utilization of ECP to all regional emergency network (EMS and Emergency Departments) and to improve its use.

Aims Aim of this observational study is to evaluate the clinical performance of a Syncope Unit, in order to assess whether the implemented organization really improves syncope management. Methods and results The study enrolled patients with unexplained syncope who were consecutively referred to our Syncope Unit, either as outpatients or during hospitalization, in a 2-month period. The design of this observational study consists in three phases: a retrospective analysis of their clinical management in the 9 months prior to the first attendance at the Syncope Unit (phase one), their subsequent clinical management in the Syncope Unit (phase two) and a 9-month follow-up (phase three). The retrospective analysis of phase one showed that 25% of patients had already been hospitalized without diagnosis. After Syncope Unit evaluation, diagnosis was obtained in 82% of patients, with 15% of patients indicated to pacing. In the follow-up, 23% of patients experienced a syncopal recurrence. Our analysis indicated an 85% reduction of hospital costs in the follow-up period. Conclusion The clinical and economic analysis of the three phases of our study demonstrates that a Syncope Unit allows an improved management of patients with syncope.

BACKGROUND: Little is known of the variations of the heart rate during spontaneous cardioinhibitory neurally-mediated syncope. Their knowledge has both academic and practical implications for the optimization of rate drop response (RDR) pacing mode. METHODS AND RESULTS: We describe variations of the rhythm occurring during 48 syncopal episodes documented by implantable loop recorder. The presyncopal phase of 18 s (interquartile range 9-65) was characterized by a fall in heart rate from 83 +/- 20 bpm to maximal bradycardia or (multiple) asystolic pauses which lasted a median of 19 s (10-30). The recovery phase lasted 22 s (7-52). The total duration of the cardioinhibitory reflex was 85 s (47-116). We then calculated the potential increase in benefit that an optimally programmed drop rate detection could provide compared with a reference Lower Rate detection. Compared with Lower Rate detection (defined as two consecutive beats at 40 bpm), drop rate detection (assumed to be drop size = 20 bpm, detection window = 1 min, and drop rate = 50 bpm) would have been able to introduce intervention pacing, a median of 5.7 s (interquartile range -5.1- -10.4) earlier in 28 cases (58%). CONCLUSION: Cardioinhibitory neurally-mediated reflex varies widely from a few seconds to some minutes. In our data the total duration was

Based on the relevant literature, the aim of this study was to analyze the psychosocial characteristics of patients with vasovagal syncope and to evaluate these factors as possible etiopathological components.The study sample consisted of 60 subjects divided as follows: the syncope group (n = 30) and the control group (n = 30, without prominent diseases). The two groups were matched with regard to age, sex, education and civil status. Each participant filled in the Twenty-Item Toronto Alexithymia Scale, acceptance of emotions scale, profile of mood state, attachment style questionnaire, and childhood traumatic events scale.The syncope group showed a higher number of somatic diseases (p0.0002) and a higher drug use (p0.0001) than the control group. Moreover, the syncope group showed higher scores at the childhood traumatic events scale (p0.04) and more difficulties in emotion regulation (p0.02). The syncope group also showed higher scores at the need for approval scale (p0.0006) and lower scores at the confidence scale (p0.02) of the attachment style questionnaire, which reflect an insecure style of relationship with others.A high number of traumatic events in infancy and adolescence, difficulties in the expression of emotions and an insecure style of relationship seem to characterize subjects with vasovagal syncope. These data show that syncope could be at least partiality due to a relational and emotional imbalance that finds expression through the body in the presence of insufficient mental processing. Treatment of this syndrome should therefore take these aspects into consideration.

The aim of this study was to evaluate how the main tests for the diagnostic assessment of syncope are currently performed in the Italian hospitals.During the early 2003 dedicated questionnaires were administered to about 400 Italian hospitals. About each test information was requested relative to: test protocol, laboratory equipment, patients evaluated during 2002.Eighty-four hospitals answered the questionnaire. A syncope-dedicated ambulatory (at least once a week) was available during 2002 in 59/84 hospitals, and 56 were dependent on the Cardiology Division. Carotid sinus massage was performed either in clinostatic and in orthostatic position in 60 Centers and was repeated after atropine in 15. To define the test positivity, 35 Centers followed the "symptom method". Only 15 Centers performed100 procedures during 2002 (range 3-500). Tilt testing was performed in 72 hospitals. A dedicated tilting bed was available in 65 Centers, continuous beat-to-beat pressure measurement in 22. Out of the 72 Centers, 55 followed the so-called "Italian protocol" as the main methodology of the test. Only 17 Centers performed100 procedures during 2002 (range 3-500). Adenosine test was performed in 26 hospitals, the median dose of drug was 18 mg (range 6-20 mg); 25 out 26 Centers considered the test as positive when an asystolic pauseor = 6 s was observed. Only 6 Centers performed15 procedures during 2002 (range 1-204). An implantable loop recorder was available in 48 Centers. The number of implant procedures during 2002 varied among the Centers from 1 to 22.A great variability was observed concerning the methodology of each test and the number of procedures performed. Thus, a standardization effort about the methodology of syncope study is still needed by the medical associations.

Background —This clinical investigation was performed to compare the effects of permanent dual-chamber cardiac pacing with pharmacological therapy in patients with recurrent vasovagal syncope. Methods and Results —Patients from 14 centers were randomized to receive either a DDD pacemaker provided with rate-drop response function or the β-blocker atenolol at the dosage of 100 mg once a day. Inclusion criteria were age >35 years, ≥3 syncopal spells in the preceding 2 years, and positive response to tilt table testing with syncope occurring in association with relative bradycardia. The primary outcome was the first recurrence of syncope after randomization. Enrollment was started in December 1997, and the first formal interim analysis was performed on July 30, 2000. By that time, 93 patients (38 men and 55 women; mean age, 58.1±14.3 years) had been enrolled and randomized, although follow-up data were available for all patients (46 patients in the pacemaker arm, 47 patients in the pharmacological arm). The interim analysis showed a significant effect in favor of permanent cardiac pacing (recurrence of syncope in 2 patients [4.3%] after a median of 390 days) compared with medical treatment (recurrence of syncope in 12 patients [25.5%] after a median of 135 days; OR, 0.133; 95% CI, 0.028 to 0.632; P =0.004). Consequently, enrollment and follow-up were terminated. Conclusions —DDD pacing with rate-drop response function is more effective than β-blockade for the prevention of syncopal recurrences in highly symptomatic vasovagal fainters with relative bradycardia during tilt-induced syncope.