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Aims The aim of the present study was to assess the relative prognostic value of clinical variables, the exercise electrocardiography test and the pharmacological stress echocardiography test either with dipyridamole or dobutamine early after a first uncomplicated acute myocardial infarction in a large, multicentre, prospective study.Methods and Results Seven hundred and fifty-nine in-hospital patients (age=56±10 years) with a recent and first clinical uncomplicated myocardial infarction, with baseline echocardiographic findings of satisfactory quality, an interpretable ECG and able to exercise underwent a resting 2D echocardiogram, a pharmacological stress test with either dipyridamole or dobutamine and an exercise electrocardiography test at a mean of 10 days from the infarction; they were followed-up for a median of 10 months. During the follow-up, there were 13 deaths, 23 non-fatal myocardial infarctions and 59 re-hospitalizations for unstable angina. When all spontaneous events were considered, with multivariate analysis, the difference between the wall motion score index at rest and peak stress (delta wall motion score index), and exercise duration were independent predictors of future spontaneous events (relative risk 7·2; 95% CI=2·73–19·1; P=0·000; relative risk 1·1, 95% CI=1·02–1·18; P=0·008, respectively). Kaplan–Meier survival estimates showed a better outcome for those patients with a negative pharmacological stress echocardiography test compared to patients with low dose positivity (94·7 vs 74·8%,P =0·000).Conclusion Stress echocardiography tests provide stronger information than historical and exercise electrocardiography test variables. Pharmacological echocardiography as well as the exercise ECG is able to predict all spontaneously occurring events when the presence as well as the timing, severity, and extension of stress-induced wall motion abnormalities are considered. Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved. [ABSTRACT FROM PUBLISHER]

The scientific assessment of diagnostic tests should not be based upon a small series of results published by the best academic institutions, but ought to require large scale, multicentre validation founded on grass roots institutions with real doctors, real patients and real problems. To this purpose; an international network of stress echo laboratories has been organized, and within a few years has collected data from thousands of studies using pharmacological stress echocardiography, performed with either dipyridamole (EPIC: Echo Persantine International Cooperative Study) or dobutamine (EDIC: Echo Dobutamine International Cooperative Study) stresses.In a widely deregulated field, all network laboratories have agreed: to pass a quality control examination on stress echo reading before entering the study; to adopt an identical drug infusion protocol; to code similarly the LV segments; and to adopt a common scoring system for wall motion analysis. A minimum amount of historical, clinical, and—when available—stress electrocardiographic, angiographic and follow-up data have been collected on each patient, and disseminated in the various centres, facilitating the creation of an international stress echo language that will help, not only the production of high quality scientific data, but also the build up of a common stress echo lab, with a standardized way of making the studies, unifying the methods and terminology, and archiving data. To date, we have 50 echo laboratories from 15 nations across four continents (Europe; America, Asia and Africa) actively involved in this project. These data will ultimately fill the gap between the academic theory of journals and the pragmatic experience of daily life in a busy echocardiographic laboratory. [ABSTRACT FROM PUBLISHER]

Introduction: Heart failure (HF) is a main issue of modern healthcare system. Patient affected are continuously growing in number and age; therefore, an integrated management between different parts of healthcare system is crucial to optimize outcome and sustainability. So far, little is known about clinical pathways of HF patients in Sicily., Methods: On initiative of the Regional HF Group of the Italian Association of Hospital Cardiologists (ANMCO), we decided to census all the Cardiology Unit of Sicily. A simple questionnaire elaborated by the group and exploring clinical and organizational matters of HF was sent to the Units. The answer arrived on a voluntary basis., Results: 41/46 Units sent back the filled questionnaire. Five typologies of units were represented, based on complexity [1. Outpatient units; 2. Units without Intensive Care Unit (ICU); 3. Units with ICU; 4. Units with ICU and Cath Lab; 5. Units with ICU, Cath lab and Cardiac Surgery). A dedicated HF unit is present only in half centers, but it is formally recognized solely in 22% of Units. These Units have scarce dedicated staff and activity is predominantly based on personal initiative. Diagnostic and therapeutic tools are used appropriately in most of them, even though congestion is judged mainly through physical exam and echocardiography. Differently from the indications of the guidelines, post discharge titration of therapy lacks in almost 30% of centers., Discussion and Conclusions: In Sicily, HF is managed on a plan mainly based on personal initiative. The quality is sufficiently good but a more appropriate and structured organization in particular of the follow-up seems a necessary and improvable requirement in view of quality measurers and economic sustainability of health care.

Background: In patients with implantable cardioverter-defibrillators (ICDs), antitachycardia pacing (ATP) is highly effective in terminating fast ventricular tachycardias (FVTs) and lowers the use of high-energy shocks, without increasing the risk of arrhythmia acceleration or syncope., Methods and Results: The aim of the PITAGORA ICD trial was to randomly compare 2 ATP strategies (88% coupling interval burst versus 91% coupling interval ramp, both 8 pulses) in terms of ATP efficacy, arrhythmia acceleration, and syncope. Two hundred six ICD patients (83% male, 67+/-11 years) were enrolled. FVT episodes with cycle lengths between 240 and 320 ms were treated by 1 ATP sequence and, in the event of failure, by shocks. Over a median follow-up of 36 months, 829 spontaneous ventricular tachyarrhythmia episodes were detected in 79 patients. Episode review identified 595 episodes as true ventricular arrhythmias in 72 patients; devices classified 111 (18.7%) episodes as VF, 216 (36.3%) as FVT, and 268 (45.0%) as VT. Fifty-six patients had 214 treated FVT episodes-2 FVTs self-terminated before ATP release; 44 (79%) of these had at least 1 effective ATP intervention, and 34 (61%) were spared ICD shocks. Burst terminated 100 of 133 (75.2%) FVT episodes, whereas ramp terminated 44 of 81 (54.3%; P=0.015). Acceleration occurred in 9 of 214 (4.2%) FVT episodes treated: 6 episodes in 3 ramp patients and 3 episodes in 3 burst patients. Two patients-1 in each group-suffered 1 syncopal event associated to a nonterminated FVT episode., Conclusions: Burst is significantly more efficacious than ramp in terminating FVT episodes. As the first therapy for FVT episodes, ATP carries a low risk of acceleration or syncopal events.

Background: Rhythm control is an important goal in the treatment of recurrent atrial tachyarrhythmias (AT). The PITAGORA study was a randomized trial in patients paced for sinus node disease (SND), designed to test the noninferiority of class IC antiarrhythmic drugs (AADs) to amiodarone in terms of a primary end point composed of death, permanent AT, cardiovascular hospitalization, atrial cardioversion, or AAD change., Methods: Randomization was stratified to assign 2 patients to amiodarone and 2 patients to class IC AADs: propafenone or flecainide. One hundred seventy-six patients (46% men, 72 +/- 8 years) were enrolled. Device diagnostics continuously monitored AT recurrences and duration., Results: In a mean follow-up of 20 +/- 9 months, the primary end point occurred in 23 (30.7%) of 75 class IC patients and in 28 (40.0%) of 70 amiodarone patients. The absolute difference in the end point incidence (-9.3%; 95% CI between 3.7% and -22.3%) confirmed the noninferiority of class IC to amiodarone (P = .007). Kaplan-Meier 1-year freedom from AT episodes >10 minutes, 1 day, and 7 days was 40%, 73%, and 91% for amiodarone and 28%, 78%, and 86% for class IC AADs (P = nonsignificant)., Conclusions: In patients paced for SND and suffering from AT, class IC AADs proved not to be inferior to amiodarone in terms of the primary composite end point described or end points which were differently composed of mortality, efficacy, or AAD side effects. The AADs studied also showed similar results in terms of symptoms, quality of life, and freedom from AT recurrences.

Background: Most clinical trials that have tested pacing therapies to prevent and treat atrial tachyarrhythmias (AT) have chosen endpoints such as AT frequency or burden (defined as percentage of time a patient is in AT), but failed to show unequivocal evidence of a clinical impact., Aim: The aim of our multicenter prospective observational study was to measure the variability of AT burden and estimate its impact on study outcomes., Methods and Results: Two hundred and fifty patients indicated for permanent pacing and suffering from AT (age 71 +/- 9 years; 47.2% male) received a dual-chamber pacemaker. AT burden was measured in two consecutive, 2-month observation periods; the Monte Carlo method was then applied to simulate findings of a crossover design study. We simulated several models of therapy impact, each model being characterized by the percentage of responder patients and the percentage reduction in AT burden. To show a significant impact of AT therapies in a sample of 250 patients in whom 100, 75, or 50% would be theoretical responders to therapies, AT burden reduction should be at least 27, 32, or 57%, respectively. Temporal fluctuations in AT burden were so high that about 60% of patients would falsely appear as responders or nonresponders in a crossover study, regardless of AT burden reduction., Conclusions: In patients paced for bradycardia and suffering from AT, high intrapatient variability in AT burden was measured. Various models of therapy impact showed that, in crossover trials of AT therapies, time-related fluctuations in AT burden negatively impact on sample sizes and impair the ability to identify patients as responders or nonresponders.

Aims: Atrial tachycardia and flutter frequently occur in association with atrial fibrillation and may be treated by overdrive pacing in patients who receive pacemakers with antitachycardia pacing (ATP) capabilities. The PITAGORA trial was a multi-centre, randomized, cross-over study aimed at comparing two different ATP modes for atrial tachyarrhythmia (AT) termination in patients suffering from sinus node disease (SND)., Methods and Results: One hundred and seventy-six patients (72 M, age 71+/-9 years) received a Medtronic AT500 pacemaker. All patients were on class IC or III antiarrhythmic drugs. After a 5-month observation period, 170 patients were randomized to either Ramp or Burst+ ATP therapy; 4 months later they crossed over. One hundred and fifty-seven patients completed the 13 months of follow-up; 114 (72.6%) suffered 6088 AT episodes. In 75 patients, 1904 AT episodes were treated and 934 (49.1%) successfully terminated. The median value of individual patients' ATP efficacy was 60%. Burst+ terminated 387 out of 873 AT episodes (44%) in 58 patients. Ramp terminated 547 out of 1031 AT episodes (53%, P<0.001) in 56 patients. Ramp efficacy was significantly (P<0.01) and directly correlated with AT cycle length (ATCL), whereas Burst+ efficacy was not. Ramp showed higher (P<0.001) termination efficacy than Burst+ for ATCL >240 ms. Quality of life, as measured by the EuroQoL questionnaire, and number of symptoms significantly improved in the overall population. This improvement was significantly higher in patients with ATP efficacy >60%., Conclusion: In patients suffering from SND and AT, Ramp therapy shows higher termination efficacy than Burst+ therapy in AT episodes with ATCL >240 ms. Further studies are required to show the impact of ATP on clinical outcomes.

Aims: Many sinus node disease (SND) patients suffer from atrial fibrillation (AF). Anti-arrhythmic drugs (AADs) are the therapeutic mainstay for AF prophylaxis. The PITAGORA trial has a multicentre, prospective, randomized, single blind design to compare amiodarone with Class IC AADs in patients who have an AF history and are paced for SND., Methods and Results: Starting from January 2001, 176 patients received a Medtronic AT500 pacemaker. AADs were randomly assigned with a 3 : 2 ratio between Class III and Class IC. Randomization was stratified in order to assign two patients to amiodarone and one patient to sotalol every three Class III AAD patients. After a 5-month observational period, Ramp or Burst+ ATP therapies were enabled in a randomized way, maintained for 4 months, and then crossed over. Total follow-up period is 21 months. The primary long-term objective is to show the non-inferiority of IC AADs compared with amiodarone in terms of time to first occurrence of a composite endpoint (death, atrial cardioversion, hospitalizations due to AF or heart failure, or change of AADs). Data will be analysed on an intention-to-treat basis. The primary short-term objective is to compare Ramp vs. Burst+ efficacy in terminating atrial tachyarrhythmias treated by the device. Secondary endpoints are major clinical events, medication toxicity, symptoms, AF burden, and quality-of-life., Conclusion: Given the high morbidity and healthcare costs associated with AF, new therapeutic strategies are needed. The results of the PITAGORA trial may help in guiding AADs therapy and ATP programming in SND patients suffering from AF.

Fascicular tachycardia is an uncommon idiopathic ventricular tachycardia, originating from the left ventricle; it usually occurs in young male patients, with a high prevalence in south-east Asiatic people. Electrocardiographic aspects of this unique ventricular tachycardia (right bundle branch block morphology and left or right-axis deviation, with a moderate QRS widening) and verapamil sensitivity make it often difficult the differential diagnosis with other forms of supraventricular tachycardia. Reentry is believed to be the operative mechanism of fascicular tachycardia, with the reentrant circuit located in the Purkinje network, in the region of the left posterior or anterior fascicle. The slow conduction zone participating in the reentry circuit, made up of partially depolarized Purkinje fibers, seems to be located in a relatively wide area, from the basal to the apical left interventricular septum. Intravenous verapamil is elective in acute treatment; however oral verapamil shows poor efficacy in preventing tachycardia relapses. Ablative approach is very effective; success is achieved in approximately 90% of patients, with rare complications. Recently diastolic potentials during fascicular tachycardia have been reported and these findings have given rise to new electrophysiological hypotheses and new indications about the successful ablation site.

Background: Spinal cord stimulation has been used for many years in the treatment of refractory angina pectoris. Its anti-anginal and anti-ischemic effect has been well documented in several studies, but the long-term efficacy, safety and survival rate are not well known. The aim of this study was to carry out a retrospective analysis of a series of patients from the Italian Multicenter Registry, the data of which were collected in five centers, by means of a questionnaire., Methods: One hundred and thirty patients (83 males, 47 females, mean age 74.8 +/- 9.8 years) were submitted to spinal cord stimulator implantation for refractory angina pectoris in the period 1988-1995 and controlled during a mean follow-up of 31.4 +/- 25.9 months. A previous myocardial infarction had already occurred in 69.3% of patients, whereas in 67.6% multivessel coronary artery disease was documented. A left ventricular dysfunction (ejection fraction < 0.40) was present in 34% of patients; bypass surgery and coronary angioplasty were performed in 49.6% and in 27% of patients respectively. In 96.3% of cases revascularization procedures were not advisable., Results: A complete follow-up of 116 patients (89.2%) was available. The spinal cord stimulator induced a significant reduction in NYHA functional class from 2.5 +/- 1.2 to 1.5 +/- 0.9 (p < 0.01). During the follow-up 41 patients (35.3%) died, and in 14.2% a new acute myocardial infarction developed. The total percentage of minor spinal cord stimulation-related complications was 6.8%. No major complications occurred. The annual total mortality rate was 6.5%, whereas the cardiac mortality rate was 5%. Compared to the survivors, patients who died showed a higher incidence of left ventricular dysfunction, previous myocardial infarction and bypass surgery at implantation., Conclusions: In our experience, spinal cord stimulation is an effective therapy in patients affected by refractory angina pectoris and who cannot undergo revascularization procedure. The complication rate is low, with the total and cardiac mortality showing a trend as that reported for patients with similar coronary disease.

Background: Atrial fibrillation (AF) is common in patients with sick sinus syndrome (SSS) treated with dual-chamber pacing and it may complicate their management. This study was undertaken to establish the usefulness of atrial vulnerability (AV), determined by means of transesophageal electrophysiological study (TES), in predicting the risk of developing AF and in deciding the type and program of pacemaker (PM) to be implanted in patients with SSS., Method: AV was assessed preoperatively using TES in 81 consecutive patients with SSS. AV (AF > 1 min) was divided into "low threshold" (induction with burst < or = 300/min) and "high threshold" (induction with burst > or = 350 min or with incremental ramp). The PM was programmed to ensure constant atrial capture in all patients. Follow-up lasted three years. No patients received antiarrhythmic drugs., Result: AV was positive in 52% of patients (Group A) and negative in 48% of patients (Group B). A history of paroxysmal AF was present in 52% of patients in Group A and in 12% of patients in Group B. At follow-up, 38% of Group A and 2% of Group B patients had chronic AF. AV had sensitivity, specificity, positive predictive value (ppv) and negative predictive value (npv) of 94, 59, 38 and 97%, respectively. Thirty-eight percent of patients showed low threshold vulnerability, with sensitivity, specificity, ppv and npv of 87, 92, 87 and 93%, respectively. Sensitivity, specificity, ppv and pnv for history of AF were 93, 100, 98 and 84%, respectively. When the vulnerability threshold and the history of paroxysmal AF were considered together, the sensitivity, specificity, ppv and npv was 94, 100, 100 and 83%, respectively. Multivariate analysis was shown to be an independent predictive value only for history of AF (p = 0.0002)., Conclusion: AV determined by means of TES, especially with a low induction threshold, shows excellent sensitivity and specificity in evaluating the risk of chronic AF. It could be useful in patients with SSS undergoing cardiac pacing who have never had AF, thus allowing a more accurate choice of the type and program of PM to be implanted. Case histories of paroxysmal AF could represent useful criteria for selecting patients at a high risk of developing chronic AF.

Background: Rational prognostic algorithm should be developed considering the logical progression of the information as it becomes available to the physician, with clinical data first, ECG data second and stress imaging data last. The aim of the present study was to assess in a clinically realistic fashion the relative prognostic value of exercise electrocardiography test (EET) and dipyridamole-echocardiography test (DET) early after first acute uncomplicated myocardial infarction., Methods and Results: Five hundred and forty-seven in-hospital patients (age = 56 +/- 9 years) with recent clinically uncomplicated first myocardial infarction, baseline echocardiographic findings of satisfactory quality, interpretable ECG and capability to exercise underwent a resting 2D echocardiogram, a DET and an EET at a mean of 10 days from the infarction and were followed up for 16.2 +/- 11 months. During the follow-up, there were 17 cardiac deaths, 19 non-fatal myocardial infarctions and 49 unstable angina. When cardiac death was considered as the only significant event, with multivariate analysis, peak dipyridamole Wall Motion Score Index was the only significant predictor (chi 2 = 5.66; p = 0.013; relative risk estimate = 4.7; confidence intervals = 1.35-16.08). In presence of a negative exercise electrocardiography test for both chest pain and electrocardiographic criteria, the death rate was 2%., Conclusion: DET provides stronger information in comparison with historical and EET variables. However, a negative maximal EET is sufficient to identify a very low risk subset in whom additional testing may not be warranted.

Objectives: This study sought to compare, head to head, the two most popular pharmacologic stress echocardiographic tests--dipyridamole and dobutamine--with state of the art protocols in a large multicenter prospective study., Background: In the continuing quest for ideal diagnostic accuracy, pharmacologic stress echocardiography has quickly moved over the years from low to high dose regimens and is currently performed with atropine coadministration., Methods: Dobutamine (up to 40 microgram/kg body weight per min) plus atropine (up to 1 mg over 4 h) and dipyridamole (up to 0.84 mg/kg per min over 10 h) plus atropine (up to 1 mg over 4 h) stress echocardiography was performed on different days, in random order and within 1 week in 360 patients with chest pain syndrome. Thirteen different echocardiographic laboratories, all fulfilling quality control criteria for stress echocardiographic reading, contributed to the study., Results: No major complications occurred during either test. The test was interrupted before achievement of predetermined end points for limiting side effects in 37 dobutamine-atropine and 7 dipyridamole-atropine stress echocardiographic studies (feasibility 90% vs. 98%, p < 0.01). Diagnostic accuracy was assessed in a subset of 110 patients with no obvious rest dyssynergy (akinesia or dyskinesia) who underwent coronary angiography independently of test results and within 1 week of testing. Significant coronary artery disease (> or = 50% diameter reduction in at least one major coronary vessel by quantitative coronary angiography) was found in 92 patients. Sensitivity for detection of coronary artery disease was 84% (77 of 92) for dobutamine-atropine and 82% (75 of 92) for dipyridamole-atropine stress echocardiography (p = NS), with a specificity of 89% (16 of 18) for dobutamine-atropine and 94% (17 of 18) for dipyridamole-atropine stress echocardiography (p = NS). A significant correlation was present between peak wall motion score index during dipyridamole-atropine and dobutamine-atropine stress echocardiography (r = 0.83, p < 0.0001)., Conclusions: Dobutamine-atropine and dipyridamole-atropine stress echocardiography are safe and feasible, although submaximal studies are more frequent with dobutamine. The two stresses have comparable accuracy in the detection of angiographically assessed coronary artery disease, although dobutamine is marginally more sensitive and dipyridamole marginally more specific. Stratification of the ischemic response in the space domain is also comparable with the two stresses.

Purpose: To determine the prognostic capability of the dipyridamole echocardiography test (DET) early after an acute myocardial infarction., Patients and Methods: On the basis of 11 different echocardiographic laboratories, all with established experience in stress echocardiography and fulfilling quality-control requirements for stress echocardiographic readings, 925 patients were evaluated after a mean of 10 days from an acute myocardial infarction and followed up for a mean of 14 months., Results: During the follow-up, there were 34 deaths and 37 nonfatal myocardial infarctions; 104 patients developed class III or IV angina and 149 had coronary revascularization procedures (bypass or angioplasty). Considering all spontaneous events (angina, reinfarction, and death), the most important univariate predictor was the presence of an inducible wall motion abnormality after dipyridamole administration (chi 2 = 45.8). With a Cox analysis, echocardiographic positivity, age, and male gender were found to have an independent and additive value. Considering survival (and, therefore, death as the only event), age was the most meaningful parameter, followed by the wall motion score index during dipyridamole administration (chi 2 = 12.1). Among other parameters, the resting wall motion score index was a significant predictor of death. In a multivariate analysis, the prognostic contributions of age (relative risk estimate = 1.08) and wall motion score index during dipyridamole administration (relative risk estimate = 4.1) were independent and additive. In particular, considering death only, the event rate was 2% in patients with negative DET results, 4% in patients with positive high-dose DET results, and 7% in patients with positive low-dose DET results., Conclusions: DET is feasible and safe early after uncomplicated myocardial infarction and allows effective risk stratification on the basis of the presence, severity, extent, and timing of the induced dyssynergy.

Background: Any new diagnostic test should follow a pathway similar to that of a new drug, from initial studies in highly selected populations under strictly controlled conditions, up to large scale multicenter trials more likely to represent the true performance of the test in the clinical arena., Aim of the Study: To evaluate the capability of prognostic stratification of high dose (up to 0.84 mg/kg over 10') dipyridamole-echocardiography test (DET) early after an acute myocardial infarction in a "phase IV" study, based upon 11 different echocardiographic laboratories, all with established experience in stress echo and fulfilling quality control requirements for stress echo readings., Study Population: Nine-hundred twenty five patients were evaluated after a mean of 10 days from an acute myocardial infarction and followed up for a mean of 14 months., Results: During DET, one major adverse reaction occurred, consisting of a prolonged ischemia resistant to aminophylline and nitrates, and progressing to small uncomplicated reinfarction. In 11 patients the lower dipyridamole dose (0.56 mg/kg over 4') gave limiting side effects. Patients were followed up for 14 +/- 9.9 months (range = 1.53). During the follow-up, there were 34 deaths and 37 non-fatal myocardial infarctions; 104 patients developed class III or IV angina, and 149 had coronary revascularization procedures (bypass or angioplasty). Considering all spontaneous events (angina, reinfarction and death), the most important univariate predictor was the result of DET (chi-square = 45.8). With a Cox analysis, echocardiographic positivity, age and sex were found to have an independent and additive value. Considering survival (and therefore death as the only event) age was the most meaningful parameter, followed by the Wall Motion Score Index during dipyridamole (chi-square = 12.1); among other parameters, the resting Wall Motion Score Index was a significant predictor of death. By Cox analysis, age (relative risk estimate = 1.02) and Wall Motion Score Index during dipyridamole (relative risk estimate = 14) showed an independent and additional prognostic value. In particular, considering death only, the event rate was of 2% in patients with negative DET, 4% in patients with high dose positive DET and 7% in patients with low dose positive DET., Conclusions: Dipyridamole echocardiography is feasible and safe early after uncomplicated myocardial infarction and allows an effective risk stratification on the basis of the presence, severity, extent and timing of the induced dyssynergy. In particular, the risk of death doubles in patients with high dose positivity and almost quadruples in patients with low dose positivity.