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Studies focusing on the effects of telemanagement programs for chronic heart failure (CHF) on functional status are lacking, and the prognostic value of the clinical response to the programs is unknown. In the Lombardy region of Italy, a home-based telesurveillance program (HTP) including multidisciplinary management and remote telemonitoring for patients with CHF was introduced in 2000 and was formally adopted, as part of the services delivered by the regional healthcare system, in 2006. This article reports the effect of the HTP on the functional status and quality of life and describes the main outcomes observed within 1 year from the end of the program.Six-month variations of New York Heart Association (NYHA) class, left ventricular ejection fraction (LVEF), 6-min walking distance (6MWD), and Minnesota Living with Heart Failure Questionnaire (MLHFQ) score were evaluated in 602 CHF patients. Patients showing at least two of the following conditions-NYHA class reduction, increase in LVEF ≥5%, 6MWD30 m, and a reduction of24 points of MLHFQ-were defined as "responders." One-year events included unplanned cardiovascular readmissions and mortality.A significant improvement in NYHA class, LVEF, 6MWD, and MLHFQ was observed. Clinical events occurred in 24.1% of non-responders and in 15.9% of responders (p=0.03). An unfavorable response to the program, the presence of an implantable cardioverter defibrillator, and multiple comorbidities were predictors of poor outcome.The HTP was effective in improving CHF patient functional status, and an unsuccessful response to the intervention seems to be an independent marker of poor prognosis.

to compare the benefit of a personalised outpatient therapy prescribed upon discharge by the cardiology unit to the patients undergoing a percutaneous coronary intervention with drug-eluting stent or bare-metal stent vs. the usual practice.controlled, multicentre, non-randomized study that enrolled patients who underwent coronary stent implantation and treated in the year after stent implantation with two protocols: the treatment group received Clopidogrel directly from the cardiology unit at each monitoring visit; the control group received a prescription for outpatient treatment through the standard retail pharmacy channel.the recruited centres adopting the new treatment protocol are Magenta, Legnano, and Rho (ASL Milano1, Magenta - Lombardy Region, Northern Italy), with 477 patients included; the recruited centres following for the standard protocol are Niguarda and San Carlo (ASL Milano), with 307 patients included. We identified all patients aged ≥40 years, discharged after coronary stent implantation between January 1st, 2010 and March 31st, 2011, and followed for 1 year.all coronary events, second coronary interventions or deaths in the year after hospital discharge.we found differences between the two treatments in relation with coronary events: hazard ratio (HR) for the control group in patients with ST-elevation myocardial infarction (STEMI) is 3.32 (95%CI 1.67- 6.62), HR in patients with non-ST elevation myocardial infarction (NSTEMI) is 2.44 (95%CI 1.07-5.57). The compliance at 1 year is 80% in the treated group vs. 70% in the control group, respectively (p-value0.01).the application of the therapeutic plan, governed by the interventional cardiology, increases treatment adherence and reduces the risk of cardiovascular events subsequent to the insertion of a stent. It is crucial, therefore, to improve the adherence to dual antiplatelet therapy by using high levels of integration between inpatient and outpatient care to reduce adverse health outcomes during post-surgery phase and to ensure the taking in charge of the patient.

Clinical follow-up of patients with cardiac implantable electronic devices is challenging because of the increasing technical complexity of devices and clinical complexity of patients. Remote monitoring (RM) offers the opportunity to optimize clinic workflow and to improve device monitoring and patient management by reducing in-hospital visits, physician and nurse time required for patient follow-up, and hospital and social costs. Continuous RM may lead to early detection of device malfunctions and clinical events, such as arrhythmias and heart failure. Early reaction may improve patient outcome. RM is easy to use and patients show a high level of acceptance and satisfaction. Implementing RM in daily practice may require changes in clinical workflow. Primary nursing-based models have demonstrated the best results. In spite of a favorable cost-benefit ratio, RM reimbursement still represents an issue in several European countries, including Italy, which limits widespread RM utilization. The fee-for-service payment approach, the global budget for device patient follow-up and/or integrated care packages for heart failure management represent the keys to introduce reimbursement and to improve patient care, while reducing healthcare costs.

Current guidelines for the management of patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) recommend the administration of dual antiplatelet therapy with aspirin and an ADP receptor blocker "as early as possible" before angiography (upstream), though this suggestion is not based on the results of randomized clinical trials designed to investigate pre-hospital rather than in-hospital drug administration. The present review analyzed randomized clinical trials, registries and observational studies that assessed clopidogrel, prasugrel and ticagrelor administration in STEMI patients undergoing primary PCI to evaluate if their upstream use may be justified in clinical practice. A significant difference favoring early clopidogrel administration has been demonstrated in observational studies. No evidence is available for prasugrel and ticagrelor; however, the initial delay of their antiplatelet effect in STEMI patients could support an upstream strategy to obtain complete platelet inhibition in the first hours after PCI and prevent major adverse events (e.g., stent thrombosis) despite an increased risk of major bleeding, particularly in case of urgent bypass surgery. Data from specifically designed randomized clinical trials are warranted to establish whether early administration of prasugrel and ticagrelor may favor reperfusion and improve clinical outcome with an acceptable risk-benefit ratio.

We evaluated the handling performance at implant, and the long-term atrial and ventricular electrical performance of a new generation using a very small surface area (1.2 mm2) steroid-eluting electrode (Medtronic CapSure Z). We compared the performance of CapSure Z to that of traditional passive fixation leads, with and without steroid elution. The study was conducted during 2 years of follow-up. We studied 188 patients (105 males and 83 females; mean age 71 +/- 7 years). All of the patients were implanted with a dual chamber pacemaker and the same type of lead in both chambers. Forty-one patients received CapSure Z leads, 25 patients received Target Tip leads (8-mm2 surface area; no steroid elution), 63 patients received CapSure leads (8-mm2 surface area; steroid elution), and 59 patients received CapSure SP leads (5.8-mm2 surface area; steroid elution). The four groups were homogeneous in regards to sex, age, cardiac disease, and reason for implant. At follow-up, the CapSure Z lead showed sensing values comparable to the other leads, with lower pacing thresholds and higher pacing impedance in both chambers. We evaluated the mean current drained from the pacemaker by the different types of leads when using safe, low energy output settings. We found that by using CapSure Z leads, the mean current was significantly lower than that of the other types of leads (0.42 microA for CapSure Z ventricular lead vs 0.85 for CapSure SP, 1.42 for CapSure, and 1.54 for Target Tip). Thus, the use of the CapSure Z lead, combined with low energy output programming, will increase pacemaker longevity compared to the use of traditional leads and standard output programming.

Monitoring of electrograms (EGMs) sensed by pacemakers (PMs) during their lifetime is of the utmost importance, since changes of these signals, due to modifications of the electrode-myocardial interface may occur compromizing the proper functioning of the PM. Since after implantation these intracardiac signals are accessible only by means of a telemetry system, it is necessary to ascertain how faithfully the telemetric signals reproduce the direct ones. To this aim we devised an accurate method, based on linear system theory, which allows the estimation of the transfer function of the PM-telemetry system and the comparison of a set of time and frequency domain parameters (wave amplitude, slew rate, frequency at the spectrum peak and bandwidth) computed on both direct and telemetric signals. To overcome the problem that these two signals cannot be recorded simultaneously, an appropriate model of the input and output signals of the PM-telemetry system and of their interrelationship was identified. This model relies on a set of reasonable assumptions about the nature of the direct signal (supposed to have a fixed morphology within a predefined analysis window) and of noise sources corrupting both the direct and telemetric signals. Owing to the involvement of deterministic and stochastic signals, the theory of quasi-stationary signals was employed to obtain the system transfer function. To test our method, direct and telemetric recordings were performed on 12 patients with atrial sensing carrying Medtronic Pacemakers (Mod Elite 7077/7086, programmer Mod 9760) with unipolar steroid eluting leads (Medtronic Capsure 4523). The results we obtained demonstrate that the specific system considered acts as a low-pass filter with a −3 dB frequency at about 90 Hz: this ensures that the telemetric signal contains almost all the information of the direct one and can be used to monitor the changes of the signals sensed by the PM.

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 P 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.

We assessed the influence of clinically significant mitral regurgitation (MR) on clinical-echocardiographic response and outcome in heart failure (HF) patients treated with a biventricular defibrillator (cardiac resynchronization therapy defibrillator [CRT-D]). METHODS AND RESULTS: A total of 659 HF patients underwent successful implantation of CRT-D and were enrolled in a multicenter prospective registry (median follow-up of 15 months). Following baseline echocardiographic evaluation, patients were stratified into two groups according to the severity of MR: 232 patients with more than mild MR (Group MR+: grade 2, 3, and 4 MR) versus 427 patients with mild (grade 1) or no functional MR (Group MR-). On 6- and 12-month echocardiographic evaluation, MR was seen to have improved in the vast majority of MR+ patients, while it remained unchanged in most MR- patients. On 12-month follow-up evaluation, a comparable response to CRT was observed in the two groups, in terms of the extent of left ventricular reverse remodeling and combined clinical and echocardiographic response. During long-term follow-up, event-free survival did not differ between MR+ and MR- patients, even when subpopulations of patients with ischemic heart disease and with dilated cardiomyopathy were analyzed separately. On multivariate analysis, the only independent predictor of death from any cause was the lack of β-blocker use. CONCLUSIONS: This observational analysis supports the use of CRT-D in HF patients with clinically significant MR; MR had no major influence on patient outcome.

Background This multicenter, prospective, randomized, controlled, parallel trial compares the efficacy of biventricular (BIV) versus right ventricular (RV) antitachycardia pacing (ATP) in terminating all kinds of ventricular tachycardia (VT). Methods Five hundred twenty-six patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device were enrolled and randomized 1:1 to either BIV (266) or RV (260) ATP (single burst 8 pulse, 88% coupling interval) and were followed up for 12 months. Results During 12 months' follow-up, 1,077 ventricular episodes in 180 patients were detected and classified: 634 true VTs divided into 69 ventricular fibrillation (VF) (11%), 202 fast ventricular tachycardia (FVT) (32%), and 363 VT (57%). A comparable first ATP efficacy (BIV 65% vs RV 68%, P = .59) was observed in FVT + VT, in VT zone (BIV 62% vs RV 71%, P = .25), and in FVT zone (BIV 71% vs RV 61%, P = .34). A trend toward lower accelerations during ATP applied to FVT was observed in the BIV group (3.5% BIV vs 10.2% RV, P = .163). No syncope/presyncope occurred during ATP for FVT in the BIV group versus 4 events (3.2%) in the RV group ( P = .016). biventricular ATP was more effective in treating FVT in coronary artery disease (CAD) patients ( P = .032), whereas both modalities presented similar efficacy in patients with non-CAD etiology ( P = .549). Conclusions Antitachycardia pacing is effective in patients implanted with a CRT-D device. No significant differences in efficacy emerged between BIV- and RV-delivered ATP in the general population, whereas BIV ATP seems to present a safer profile in ischemic patients.

To achieve a reduction of time to reperfusion through the organization of an interhospital network and the involvement of the Regional Health Authority.Four major endpoints were identified: institutional governance action, clinical management of acute ST-elevation myocardial infarction (STEMI), priority actions for cardiac arrest and early defibrillation, actions to avoid the delay related to decision-making, and logistic factors. Since 2001 in the urban area of Milan a network has been operating among 23 coronary care units, the 118 Dispatch Center (national free number for medical emergencies) and the Health Country Government Agency named Group for Prehospital Cardiac Emergency. In order to monitor the network activity and time to treatment and clinical outcomes a periodic monthly survey, called MOMI (One Month Monitoring Myocardial Infarction), was undertaken and repeated twice yearly. Data were evaluated according to hospital admission modality.Global times are: symptom onset to first medical contact 116 min (interquartile range [IQR] 189), time to first ECG 7 min (IQR 12), door-to-balloon time 77 min (IQR 81.7). Non-parametric test showed that the modality of hospital admittance was the most critical determinant of door-to-balloon time. The shortest one (49.5 min) was that of patients transported by means of advanced rescue units with 12-lead ECG teletransmission and activation of a fast track directly to the cath lab.Our data show how in a complex urban area the organization of an interhospital network and the availability of ECG teletransmission are effective in reducing time to reperfusion, in the treatment of major arrhythmias and in pre-alert of coronary care units and cath labs in case of confirmed STEMI. This experience also stimulated an improvement in technological equipment of rescue units with extension of 12-lead teletransmission to basic life support units. Through the Health Country Government Agency and the Scientific Societies we carry on with our job to create a regional network for cardiac emergency involving all the hospitals.

Background Heart failure patients with implantable defibrillators (ICD) frequently visit the clinic for routine device monitoring. Moreover, in the case of clinical events, such as ICD shocks or alert notifications for changes in cardiac status or safety issues, they often visit the emergency department or the clinic for an unscheduled visit. These planned and unplanned visits place a great burden on healthcare providers. Internet-based remote device interrogation systems, which give physicians remote access to patients' data, are being proposed in order to reduce routine and interim visits and to detect and notify alert conditions earlier. Methods The EVOLVO study is a prospective, randomized, parallel, unblinded, multicenter clinical trial designed to compare remote ICD management with the current standard of care, in order to assess its ability to treat and triage patients more effectively. Two-hundred patients implanted with wireless-transmission-enabled ICD will be enrolled and randomized to receive either the Medtronic CareLink® monitor for remote transmission or the conventional method of in-person evaluations. The purpose of this manuscript is to describe the design of the trial. The results, which are to be presented separately, will characterize healthcare utilizations as a result of ICD follow-up by means of remote monitoring instead of conventional in-person evaluations. Trial registration ClinicalTrials.gov: NCT00873899

Aims To analyse the effectiveness of cardiac resynchronization therapy (CRT) in patients with valvular heart disease (a subset not specifically investigated in randomized controlled trials) in comparison with ischaemic heart disease or dilated cardiomyopathy patients. Methods and results Patients enrolled in a national registry were evaluated during a median follow-up of 16 months after CRT implant. Patients with valvular heart disease treated with CRT ( n = 108) in comparison with ischaemic heart disease ( n = 737) and dilated cardiomyopathy ( n = 635) patients presented: (i) a higher prevalence of chronic atrial fibrillation, with atrioventricular node ablation performed in around half of the cases; (ii) a similar clinical and echocardiographic profile at baseline; (iii) a similar improvement of LVEF and a similar reduction in ventricular volumes at 6–12 months; (iv) a favourable clinical response at 12 months with an improvement of the clinical composite score similar to that occurring in patients with dilated cardiomyopathy and more pronounced than that observed in patients with ischaemic heart disease; (v) a long-term outcome, in term of freedom from death or heart transplantation, similar to patients affected by ischaemic heart disease and basically more severe than that of patients affected by dilated cardiomyopathy. Conclusion In ‘real world’ clinical practice, CRT appears to be effective also in patients with valvular heart disease. However, in this group of patients the outcome after CRT does not precisely overlap any of the two other groups of patients, for which much more data are currently available.

The aim of the present study is to evaluate if remote monitoring with the CareLink Network may improve clinical management of tachyarrhythmias and heart failure episodes in patients treated with biventricular defibrillators (CRT-D). Patients implanted with CRT-D for more than 6 months received the CareLink monitor and were trained to perform device interrogation. At-home transmissions were scheduled at 2 weeks, 1 and 2 months after training, with a final in-office visit after 3 months. Sixty-seven patients performed 264 data transmissions. Twenty-three unscheduled data transmissions were requested by the centers after patient contact. Ventricular tachyarrhythmias were reported in nine patients during 16 data reviews. Thirteen data reviews (81%) were performed remotely via CareLink transmissions (nine scheduled and four unscheduled), in seven patients. Of these events, in two cases (15%) in-hospital visits were requested, while in 11 (85%) no action was needed and no additional in-clinic visits were scheduled. During the study period, in 20/28 (71%) intra-thoracic impedance alerts, the patients remotely transmitted their device data. After remote data review, in ten cases drug therapy was adjusted by phone and in four cases no action was needed and the patient reassured. In six episodes an in-hospital extra visit was scheduled. On the whole, in 14 cases (70%), the patient could be managed remotely avoiding a visit to the hospital. Our study showed that remote follow-up is an efficient method to manage tachyarrhythmias and heart failure episodes in CRT-D patients. Early reaction to clinical events may improve overall patient care.

Background: Few data exist on the long-term changes and the prognostic value of heart rate variability (HRV) assessed by implanted devices in heart failure (HF) patients treated with resynchronization therapy (CRT). Aims: To analyze the long-term changes in the standard deviation of 5-minute median atrial–atrial sensed intervals (SDANN), and assess its role in predicting CRT efficacy and major cardiovascular events. Methods and results: We included 509 consecutive patients implanted with CRT devices. At 12-month follow-up, 44 patients had died and 86 patients had at least one HF hospitalisation. A significant increase in SDANN occurred after 4 weeks of CRT (from 69±22 ms to 82±27 ms, p

Launch of remote follow-up systems in Europe is currently underway. However, there is insufficient understanding of postimplant practices with respect to device follow-up, reprogramming of device features, and postshock clinic visits.We analyzed device-stored data from patients implanted with biventricular defibrillators (CRT-ICD) to characterize the management of patients in current clinical practice and the potential impact of remote follow-up systems.Two hundred and seventeen patients were identified, all with complete device-data for at least one year. Over a follow-up period of 570 +/- 158 days, 1,959 device interrogations were performed. Of these, the majority (1,280, 65%) involved the reprogramming of device parameters. The mean time interval between interrogations was 70 +/- 25 days. Overall, a marked reduction of interrogations requiring reprogramming was observed between the first six months of follow-up and subsequent periods (from 3.6 +/- 1.8 to 1.1 +/- 1.0 interrogations/six months). A mean of 6.0 +/- 5.9 device parameters was reprogrammed during the first six months of follow-up, versus 4.4 +/- 5.6 (P = 0.000) during the subsequent period. From multivariate analysis, a higher-than-median number of interrogations was found to be significantly associated with defibrillator shocks (OR:2.51; 95%CI:1.42-4.42). Following a shock, a total of 133 interrogations in 60 patients were performed with 80% of these occurring within five days of the shock, and 49% did not require device reprogramming.Six months after implant, reprogramming of device parameters is significantly less frequent, making the use of remote follow-up systems a practical alternative for patients and physicians. Moreover, a considerable portion of post-shock interrogations does not involve reprogramming and may therefore be performed remotely.

Purpose: The Medtronic CareLink allows remote implantable device follow-up. In this first European experience with CareLink, we assessed the ease of use of the system, the acceptance, and satisfaction of patients and clinicians. Methods: Patients implanted with biventricular defibrillators for more than 6 months received the CareLink monitor and were trained to perform home device interrogation and transmission. Patient and clinician experience and preference were evaluated through specific questionnaires. Results: Sixty-seven patients were enrolled and were able to perform data transmissions during the 3-month study duration. The overall duration of interrogation procedure was 7 ± 5 minutes, and frequently the procedure did not require the assistance of a caregiver. Patients reported a general preference for remote versus in-clinic follow-up and described a sense of reassurance created by the remote monitoring capability. In the centers, the review procedure was successful; its mean duration was 5 ± 2 minutes per transmission and the users indicated that the access and navigation of the review website were easy. At the end of the evaluation, the data available for remote review were judged complete and adequate to provide almost the same standard of care as that offered in traditional in-clinic visit. In general, the remote monitoring was seen as a potential tool to improve the clinical management of patients with device. Conclusions: The ease of use, satisfaction, and acceptance of the CareLink Network in European clinical practice appears elevated both for patients and for clinicians. (PACE 2008; 31:1259‐1264)

In patients with acute ST-elevation myocardial infarction (STEMI), in order to shorten the time to definitive treatment, it is essential to coordinate the intervention between the local healthcare system and the hospitals. In 1999, a Working Group for Prehospital Emergency in Cardiology was established in Milan, and a network for 12-lead ECG transmission between advances life support (ALS) ambulances, the headquarter of 118 Rescue Service and the Coronary Care Units (CCU) or Divisions of Cardiology was developed: between February 1, 2001 and May 1, 2005, 6821 patients with suspected heart attack were rescued and their ECG recorded and transmitted (177 patients/month, 20% of them with an ST-segment shift, 11% ST-segment elevation, 9% non-ST-segment elevation, 24% with normal ECG). The rate of false positive automatic diagnosis of acute myocardial infarction was 0.3%, the rate of false negative was 0.8%. Forty-six patients with ventricular fibrillation underwent DC-shock. After May 1, 2004, clinical data of patients with STEMI transferred to the hospitals by ALS ambulances were reported in a database: 82% of the 89 patients were treated with primary angioplasty. The time (median, interquartile ranges) between ECG arrival to the CCU and the ECG report was 2 min (1-5), between ECG arrival to the CCU and patient arrival to the hospital was 34 min (24-42), between ECG arrival to the CCU and primary angioplasty was 69 min (50-93); the door-to-balloon time was 33 min (22-60). The telephone ECG transmission has been demonstrated to be a useful and rapid tool, easy to use; the automatic ECG diagnosis was accurate. In patients with STEMI the telephone ECG transmission shortened the time of delivery of therapy, helped to recover arrhythmic complications, allowed both the coordination between the 118 System and the Divisions of Cardiology and the implementation of the triage for primary angioplasty. Increasing the technological level of the service will be the next step of the program: the protocol will be upgraded in order to increase the number of patients rescued, to shorten the time of operation and to administer prehospital fibrinolytic therapy in selected patients.

Recent international and national surveys on the management of ST-elevation myocardial infarction have described a number of crucial issues regarding the prehospital phase, the criteria to address patients to primary angioplasty, the organization of interhospital transfers. GestIMA is a perspective survey organized by the Lombardy Sections of the Italian Cardiology Societies (ANMCO and SIC) aimed to investigate the management of the acute phase of myocardial infarction in the Lombardy Region.Between October 15 and November 14, 2003, consecutive patients hospitalized for ST-elevation myocardial infarction in the coronary care units of 60 hospitals in Lombardy were enrolled into the study.Among 612 patients (median age 67 years, interquartile range 56-76 years, 68% males, 43% with acute anterior myocardial infarction), 43% reached the hospital using the 118 emergency medical service, in 20% an ECG was recorded before arrival (reported in 47%), 1.5% were treated with thrombolysis and 1.0% with glycoprotein IIb/IIIa inhibitors before hospital admission. Sixty-eight percent of patients underwent a reperfusion treatment: 43% with primary angioplasty (6% facilitated), 25% with thrombolysis (18% of them had rescue angioplasty). Primary angioplasty was mainly performed in younger patients and in those directly admitted to centers equipped with interventional facilities. During the acute phase of myocardial infarction, 10% of patients arrived to the coronary care units from 39 peripheral hospitals without coronary care unit; 21% of patients had a secondary transport between hospitals with coronary care unit (47% for primary angioplasty).In the Lombardy Region, where a high rate of patients with ST-elevation myocardial infarction was treated with primary angioplasty in 2003, the 118 emergency medical service and the transmission of ECG by telephone are still underutilized. Moreover, the prehospital pharmacological treatment, the prehospital triage of patients to address to primary angioplasty and the organization of secondary transfer need to be improved.

Time- and frequency-domain analysis of heart rate variability (HRV) has been proven effective in describing alteration of autonomic control mechanisms and in identifying patients with increased cardiac and arrhythmic mortality. Patients with implantable cardioverter defibrillators offer the opportunity to evaluate HRV patterns before ventricular tachycardia (VT) and under control conditions. We therefore analyzed time- and frequency-domain parameters of short-term HRV and power-law behavior of RR interval time series at rest, at 15 to 30 minutes, and immediately before VT. In comparison to control conditions, lower values of mean cycle length duration and total power were observed before VT. Spectral analysis indicated that the low- to high-frequency ratio was significantly higher (5.5 +/- 0.6 vs 2.8 +/- 0.3) immediately before VT than during rest. Both findings were consistent with the shift of sympathovagal balance toward sympathetic predominance and reduced vagal tone. Before VT, a more negative value of the scaling exponent beta of the power-frequency relation (-1.57 +/- 0.04 vs -1.33 +/- 0.04) also confirmed the presence of an altered HRV pattern in comparison to controls. Thus, both abnormal autonomic modulation and dynamic patterns of HRV seem to characterize the minutes before arrhythmia onset in these patients.

We assessed the time course of electrograms sensed both in the atrium and ventricle by two different steroid-eluting electrodes: Medtronic Capsure SP (with an area of 5.5 mm2) and Z (with an area of 1.2 mm2). We considered 68 unipolar electrodes: 31 atrial (19 Capsure SP 4523 and 12 Capsure Z 4533) and 37 ventricular (24 Capsure SP 4023 and 13 Capsure Z 4033) implanted in 47 consecutive patients (30 men and 17 women, with an age of 72 +/- 9.4 years). The pacemaker model was Medtronic Elite 7077-7086 (DDD-DDDR) in 25 patients and Medtronic Legend 8419-8424 (VVIR-AAIR) in 22 patients. The endocavitary signal (all patients had spontaneous rhythm) was telemetrically obtained by a Medtronic 9790 device and acquired on a personal computer at implantation and 7, 30, and 180 days thereafter. The signal was studied both in the time domain and in the frequency domain by spectral analysis. The following parameters were calculated: amplitude (A): peak-to-peak value of the complex; slew rate (SR) peak negative first derivative; F0: frequency at which the power spectrum reaches its maximum value; and bandwidth (Bw): expressed as the distance between the -3 dB points and statistically analyzed by a two-way analysis of variance with factors "time" (four measurements) and "electrode" (Capsure SP and Z) and repeated measurements on the former. Ventricular sensing: no time or electrode effect (P0.1 in all comparisons) was found for F0, Bw, or SR, while a time effect (P0.04) not dependent on the type of electrode was found for the amplitude of the signal. In particular, a significant increase was found between the measurement at 6 months and that at implantation (P0.004). Atrial sensing: A, F0, and bandwidth were not affected by time or electrode (P0.09), while SR behaved differently over time (P0.05) in the two electrodes (the Capsure Z showed an increase at sixth month [P0.04] compared to implantation). In conclusion, the Medtronic Capsure SP and Z electrodes proved to be valid and substantially equivalent as far as concerns the measurement of the intracardiac potential despite the difference between their surface areas. Further studies should be devised to assess whether transitory decreases of atrial Bw in the first month of follow-up observed in a few patients for both electrodes could be responsible for clinical episodes of sensing deficit.

BackgroundHeart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up. ObjectiveWe hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators. MethodsTwo hundred patients implanted with a wireless transmission–enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained. ResultsOverall, remote monitoring did not show significant annual cost savings for the health care system (€1962.78 versus €2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (€291.36 versus €381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of €888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution. ConclusionsRemote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations. Trial RegistrationClinicalTrials.gov NCT00873899; http://clinicaltrials.gov/show/NCT00873899 (Archived by WebCite at http://www.webcitation.org/6H0BOA29f).

In several cases of clinically suspected massive pulmonary embolism (MPE), a lung perfusion scanning and/or a pulmonary angiography are not quickly available or feasible.Fifty patients admitted to our ICU with a clinically suspected MPE underwent an echocardiographic (Echo) investigation very shortly after onset (within 2 hours in 38 cases, and within 6 hours in 12). An Echo-Doppler study was also performed in 18 patients.Highly significant differences (p0.001) emerged between patients with PE and healthy age-mates for each type of Echo measurement and in all views. The RVDD/LVDD ratio turned out to be the most frequently affected parameter, being altered in 96% of cases. An abnormal diastolic leftward shift of the interventricular septum was detected in 81% of cases. Only one of our 50 patients failed to show any evidence of RV pressure overload; however, this was a patient with a severe dilated cardiomyopathy. In 22 cases in whom hemodynamic monitoring was performed, no significant correlation emerged between RVDD and LVDD, on one hand, mean PAP and cardiac index on the other. All 18 patients examined by Echo-Doppler had mild to moderate tricuspid regurgitation with a peak RV-RA gradient of 38 +/- 7 mm Hg (range 31-53 mm Hg). Seven patients (14%) were found to harbor right heart thrombi when first examined. Overall mortality in this uncommonly high risk population was as high as 28%.In a clinical setting suggesting a MPE, an Echo study conducted very shortly after onset may corroborate a tentative diagnosis of PE, thereby permitting timely fibrinolytic therapy pending a lung scan and/or angiography, or in situations where such imaging facilities are not available or readily usable.

The clinical benefit of aspirin in the acute phase of myocardial infarction is dramatically suggested by the results of the ISIS-2 trial. However, the time course of pathophysiological events that lead to such a determining involvement of platelets still appears uncertain and further study is needed to single out exactly how early and how long antiplatelet drugs should be given, since there is a risk of bleeding complications due to the combination of the different antithrombotic therapies. Thrombolytic agents and heparin are in fact widely used for patients with acute myocardial infarction, even if the optimal schedule of treatment, including anti-aggregating therapy, is not yet firmly established. To avoid rethrombosis and to enhance the efficacy of coronary thrombolysis, thus reducing early mortality, several newer antiplatelet agents other than aspirin, such as antibodies against the platelet receptor of adhesive proteins, the glycoprotein IIb/IIIa and the RGD peptides, are currently under investigation.

Massive pulmonary embolism (MPE), as seen in cardiac care units (CCU), is almost invariably characterized by severe obstruction of the pulmonary vasculature and/or a background of poor cardiorespiratory conditions, all contributing their share to a grave overall situation, often compounded by cardiogenic shock and not exceptionally eventuating in cardiocirculatory arrest (CCA). In such circumstances, echocardiography offers both direct and indirect diagnostic elements that may help, among other things, differentiate pulmonary embolism from acute myocardial infarction--the latter not always easily identified, also in view of its possible occurrence in association with MPE. Conversely, some problems are still open concerning the meaning and treatment of right-sided intracavitary thrombus formations revealed by echocardiography. Among less familiar hemodynamic aspects we must consider right-sided pulsus alternans and the so-called ventricularization of pulmonary pressure curves--a phenomenon to be viewed with caution because of possible modifications imputable to the recording system. Bedside pulmonary angiography, now generally feasible with standard CCU equipment, may readily diagnose or rule out MPE in situations where an angiography room is not available or momentarily not accessible. Numerous personal anatomoclinical observations bear witness to the role of electromechanical dissociation (EMD) as a cause of CCA in patients with MPE. Such dissociation may prove at least temporarily reversible, especially in cases not featuring bradycardia and showing narrow QRS complexes; the concurrent administration of fibrinolytic agents along with cardiopulmonary resuscitation may prove successful while it does not seem to invite important hemorrhagic complications.

The experience on 101 cases of permanent cardiac stimulation is reported; in all of them, the access was via the subclavian vein. Punction of the subclavian artery, transient injury of the brachial plexus and pneumothorax, were seen in 4.3 and 3% respectively. Early electrode luxation was observed in 5% of the patients. As late complications there where two cases of destruction of the electrode protecting sheet and one electrode rupture. In spite of the potential risks directly related to the vein puncture, the subclavian puncture offers an excellent alternative for placing definitive pacing electrodes.

A case of recurrent syncopal attacks in a 70-year-old woman with oesophageal hiatus hernia is reported. Dynamic ECG recording showed paroxysmal II and III degree A-V block during solid food swallowing. Electrophysiologic examination was normal in the basal condition and showed a II degree A-V nodal block with 2: 1 conduction ratio during solid food swallowing. This phenomenon was not reproducible after atropine administration. A permanent cardiac pacemaker (VVIP) rendered the patient completely symptomfree. The likely pathogenetic mechanism of "swallowing A-V block" is described.

We have compared the efficacy of Propafenon and Mexiletine in 12 subjects (7 males and 5 females, age range of 22-61 year) affected by chronic ventricular extrasystolic beats. Propafenon and Mexiletine were orally administered in doses of 900 mg/day and 600 mg/day respectively in a single blind, cross-over fashion. Our results show that: Propafenon is better tolerated; Propafenon has caused a statistically significant reduction of the total number of ventricular ectopic beats/24 hours; the efficacy of Propafenon has been greater than that of Mexiletine (66% and 25% respectively); with both drugs, in 2 cases, there was an increase of the total number of ventricular ectopic beats/24 hours; Propafenon has induced clear-cut electrocardiogram changes (statistically significant lengthening of P-Q and Q-T intervals).

The Authors have verified in a group of 38 patients with chronic obstructive pulmonary disease (COPD) and suspected pulmonary arterial hypertension (PAH) of precapillary origin the possibility to forsee the pressure within the lesser circulation starting from some electrocardiographic and vectorcardiograhic criteria. The vectorcardiographic analysis has not been shown to be more reliable than the traditional ECG as far as the identification of an eventual PAH is concerned. The matching of both scalar and vectorial criteria has significantly increased the efficiency of the estimate, i.e. the possibility to foresee the right ventricular systolic pressure (RVSP) and the mean pulmonary arterial pressure (PAP), but the same efficiency has remained at unsatisfactory level (S = +/- 10,30 Torr as far as the PAP is concerned. With regard to the value of the various scalar and vectorial criteria or parameters, among the electrocardiographic criteria the most reliable has been the inversion of the T wave in the right precordial leads. This sign, however, did not often appear in the present series (18% of the cases). As to the VCG the analysis made by the Authors stresses as the most reliable criterion the direction of QRS loop rotation on the horizontal plane and the magnitude of the maximum rightward spatial vector. These two elements, among other things, escape detection on the traditional electrocardiographic investigation. The above mentioned conclusions, obviously, only apply to the PAH secondary to COPD, in which particular noncardiac (lung hyperinflation, lowering of the diaphgram, etc.) and cardiac (associated left ventricular hypertrophy) factors contribute to limit the diagnostic value of both the ECG and the VCG.

The authors describe the case of a 38 year old woman who ate some buds of "Helleborus viridis" collected in the mountains mistaken for wild asparagus. The clinical patterns were like in the digitalic toxicosis: the woman presented both ventricular and supraventricular threatening arrhythmias, gastro-enteric troubles, systemic hypotension. The patient improved with the glucose, potassium chloride and magnesium sulphate infusion and intravenous xylocaine. The authors conclude that in case of patient with threatening arrhythmias of unknown genesis it is useful to pay attention to the wild vegetables ingestion.

To make operative two medical computerized programs, one dedicated to the cardiological clinical record (PAC) and the other to permanent cardiac stimulation (PGP), we codified about 4000 terms concerning the general medical field and particularly the cardiological area. The importance of standardization of the medico-cardiological language is emphasized, specially in relation to the systematization of the information, necessary to work with computerized systems.

Sustained ventricular tachycardia (VT) in coronary heart disease (CHD) represents a major risk factor for sudden death. The Authors evaluated the prophylactic efficacy of the chronic administration of amiodarone (A) on this arrhythmia and simultaneously the trend of ventricular extrasystole during the antiarrhythmic treatment. Twenty-three patients were examined, 17 with post-infarction cardiopathy and 6 with mixed angina. They showed either 1 or more episodes (2 patients) of sustained VT involving hemodynamic difficulties. The ejection fraction (EF) ranged between 20 and 45% average (35.2 +/- 9). All patients underwent a basal 24 hour ECG 3 days after the VT cardioversion, and every 6 months. All subjects took A orally for a period ranging from 7 to 67 months (average 23.04 +/- 14) at the dose of 800 mg/day 7 for days, and then 200 or 400 mg/day according to the presence or absence of ventricular extrasystoles (VE) greater than or equal to 30/hr and/or Lown's class (L) greater than or equal to 3. No patients died suddenly during the follow-up; 6 of them died for causes other than arrhythmia. Four of them showed only 1 sustained VT relapse after a period of 6 to 11 months. Two of these 4 patients showed a persistent increase of the number of VE and L-class while, in the remaining 2 patients, the number of VE remained substantially unchanged.(ABSTRACT TRUNCATED AT 250 WORDS)