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Atrial fibrillation (AF) is the most common arrhythmia and its prevalence is increasing due to the progressive aging of the population. About 20% of strokes are attributable to AF and AF patients are at five-fold increased risk of stroke. The mainstay of treatment of AF is the prevention of thromboembolic complications with oral anticoagulation therapy. Drug treatment for many years has been based on the use of vitamin K antagonists, but recently newer and safer molecules have been introduced (dabigatran etexilate, rivaroxaban, apixaban, and edoxaban). Despite these advances, many patients still do not receive adequate anticoagulation therapy because of contraindications (relative and absolute) to this treatment. Over the last decade, percutaneous closure of left atrial appendage, main site of thrombus formation during AF, proved effective in reducing thromboembolic complications, thus offering a valid medical treatment especially in patients at increased bleeding risk. The aim of this consensus document is to review the main aspects of left atrial appendage occlusion (selection and multidisciplinary assessment of patients, currently available methods and devices, requirements for centres and operators, associated therapies and follow-up modalities) having as a ground the significant evolution of techniques and the available relevant clinical data.

Objectives: The aim of this study was to develop and validate a device-based diagnostic algorithm to predict heart failure (HF) events., Background: HF involves costly hospitalizations with adverse impact on patient outcomes. The authors hypothesized that an algorithm combining a diverse set of implanted device-based sensors chosen to target HF pathophysiology could detect worsening HF., Methods: The MultiSENSE (Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients) study enrolled patients with investigational chronic ambulatory data collection via implanted cardiac resynchronization therapy defibrillators. HF events (HFEs), defined as HF admissions or unscheduled visits with intravenous treatment, were independently adjudicated. The development cohort of patients was used to construct a composite index and alert algorithm (HeartLogic) combining heart sounds, respiration, thoracic impedance, heart rate, and activity; the test cohort was sequestered for independent validation. The 2 coprimary endpoints were sensitivity to detect HFE >40% and unexplained alert rate <2 alerts per patient-year., Results: Overall, 900 patients (development cohort, n = 500; test cohort, n = 400) were followed for up to 1 year. Coprimary endpoints were evaluated using 320 patient-years of follow-up data and 50 HFEs in the test cohort (72% men; mean age 66.8 ± 10.3 years; New York Heart Association functional class at enrollment: 69% in class II, 25% in class III; mean left ventricular ejection fraction 30.0 ± 11.4%). Both endpoints were significantly exceeded, with sensitivity of 70% (95% confidence interval [CI]: 55.4% to 82.1%) and an unexplained alert rate of 1.47 per patient-year (95% CI: 1.32 to 1.65). The median lead time before HFE was 34.0 days (interquartile range: 19.0 to 66.3 days)., Conclusions: The HeartLogic multisensor index and alert algorithm provides a sensitive and timely predictor of impending HF decompensation. (Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices [MultiSENSE]; NCT01128166)., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: It is known that type 2 diabetic patients are at high risk of atrial fibrillation (AF). However, the early echocardiographic determinants of AF vulnerability in this patient population remain poorly known., Methods: We followed-up for 2years a sample of 180 consecutive outpatients with type 2 diabetes, who were free from AF and ischemic heart disease at baseline. All patients underwent a baseline echocardiographic-Doppler evaluation with tissue Doppler and 2-D strain analysis. Standard electrocardiograms were performed twice per year, and a diagnosis of incident AF was confirmed in affected patients by a single cardiologist., Results: Over the 2-year follow-up period, 14 (7.8%) patients developed incident AF. In univariate analyses, echocardiographic predictors of new-onset AF were greater indexed cardiac mass, larger indexed left atrial volume (LAVI), lower global longitudinal strain (LS SYS ), lower global diastolic strain rate during early phase of diastole (SR E ), lower global diastolic strain rate during late phase of diastole (SR L ), and higher E/SR E ratio. Multivariate logistic regression analysis showed that lower LS SYS remained the only significant predictor of new-onset AF (adjusted-odds ratio 1.63, 95%CI 1.17-2.27; p<0.005) after adjustment for age, sex, diabetes duration, indexed cardiac mass and LAVI. Results were unchanged even after adjustment for body mass index, hypertension and glycemic control., Conclusions: This is the first prospective study to show that early LS SYS impairment independently predicts the risk of new-onset AF in type 2 diabetic patients with preserved ejection fraction and without ischemic heart disease. Future larger prospective studies are needed to confirm these findings., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Aims: Implantable cardioverter defibrillators improve survival of patients at risk for ventricular arrhythmias, but inappropriate shocks occur in up to 30% of patients and have been associated with worse quality of life and prognosis. In heart failure patients with cardiac resynchronization therapy defibrillators (CRT-Ds), we evaluated whether a new generation of detection and discrimination algorithms reduces inappropriate shocks., Methods and Results: We analysed 1983 Medtronic CRT-D patients (80% male, 67 ± 10 years), 1368 with standard devices (Control CRT-D) and 615 with new generation devices (New CRT-D). Expert electrophysiologists reviewed and classified the electrograms of all device-detected ventricular tachycardia/fibrillation episodes. Total follow-up was 3751 patients-years. Incidence of inappropriate shocks at 1 year was 2.8% [95% confidence interval (CI) = 2.0-3.5] in Control CRT-D and 0.9% (CI = 0.4-2.2) in New CRT-D (hazard ratio = 0.37, CI = 0.21-0.66, P < 0.001). In New CRT-D, inappropriate shocks were reduced by 77% [incidence rate ratio (IRR) = 0.23, CI = 0.16-0.35, P < 0.001] and inappropriate anti-tachycardia pacing by 81% (IRR = 0.19, CI = 0.11-0.335, P < 0.001). Annual rate per 100 patient-years for appropriate VF detections was 3.0 (CI = 2.1-4.2) in New CRT-D and 3.2 (CI = 2.1-5.0) in Control CRT-D (P = 0.68), for syncope was 0.4 (CI = 0.2-0.9) in New CRT-D and 0.7 (CI = 0.5-1.0) in Control CRT-D (P = 0.266), and for death was 1.0 (CI = 0.6-1.6) in New CRT-D and 3.5 (CI = 3.0-4.1) in Control CRT-D (P < 0.001)., Conclusion: Detection and discrimination algorithms used in new generation CRT-D significantly reduced inappropriate shocks when compared with standard CRT-D. This result, with no compromise on VF sensitivity or risk of syncope, has important implications for patients' quality of life and prognosis., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Aim: Mitral regurgitation (MR) is a common finding in patients with heart failure with debatable effects on prognosis. Reduction in MR is one of the mechanisms by which cardiac resynchronization therapy (CRT) exerts its beneficial effects. We investigated the prognostic impact of baseline MR and MR persistence after CRT on outcomes of treated patients., Methods and Results: We prospectively followed 1122 CRT patients (66.4 ± 10.3 years, 78% male) who were stratified according to baseline MR severity as having MR- (degree 0-1; n = 508, 45%) or MR+ (degrees 2-3-4; n = 614, 55%). In 916 patients (82%) with MR severity data available at 1-year follow-up, the annual mortality rate was 3.4 and 6.0 per patient-year in the MR- and MR+ group, respectively, with a 1-year incidence rate ratio (IRR) of 1.76 (P < 0.001). Similar results were observed for cardiovascular mortality (1-year IRR 1.72, P = 0.002). When considering survival according to MR severity after CRT, all-cause and cardiovascular mortality were lower in the improved than in the worsened group (1-year IRR 1.87 and 2.33, respectively; both P < 0.001). Regression analysis showed that absence of MR improvement at follow-up was a significant independent predictor of both all-cause and cardiovascular mortality., Conclusions: Baseline significant MR and absence of MR improvement after CRT are strongly predictive of less favourable long-term survival., (© 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.)

Atrial fibrillation (AF) is the most common arrhythmia and its prevalence is increasing due to the progressive aging of the population. About 20% of strokes are attributable to AF and AF patients are at 5-fold increased risk of stroke. The mainstay of treatment of AF is the prevention of thromboembolic complications with oral anticoagulation therapy. Drug treatment for many years has been based on the use of vitamin K antagonists, but recently newer and safer molecules have been introduced (dabigatran etexilate, rivaroxaban, apixaban and edoxaban). Despite these advances, many patients still do not receive adequate anticoagulation therapy because of contraindications (relative and absolute) to this treatment. Over the last decade, percutaneous closure of left atrial appendage, main site of thrombus formation during AF, proved effective in reducing thromboembolic complications, thus offering a valid medical treatment especially in patients at increased bleeding risk. The aim of this consensus document is to review the main aspects of left atrial appendage occlusion (selection and multidisciplinary assessment of patients, currently available methods and devices, requirements for centers and operators, associated therapies and follow-up modalities) having as a ground the significant evolution of techniques and the available relevant clinical data.

The programming of implantable cardioverter-defibrillators (ICDs) influences inappropriate shock rates. The aim of the study is to analyse rates of patients with appropriate and inappropriate shocks according to detection zones in the OPTION trial. All patients received dual chamber (DC) ICDs randomly assigned to be programmed either to single chamber (SC) or to DC settings including PARAD+ algorithm. In a post-hoc analysis, rates of patients with inappropriate and appropriate shocks were calculated for shocks triggered at heart rates ≥ 170 bpm (ventricular tachycardia zone) and at rates ≥ 200 bpm (ventricular fibrillation zone). In the SC group, higher rates of patients with total and inappropriate shocks were delivered at heart rates ≥ 170 bpm than at rates ≥ 200 bpm (total shocks: 21.1% vs. 16.6%; p = 0.002; inappropriate shocks: 7.6% vs. 4.5%, p = 0.016; appropriate shocks: 15.2% vs. 13.5%; p = n.s.). No such differences were observed in the DC group (total shocks: 14.3% vs. 12.6%; p = n.s.; inappropriate shocks: 3.9% vs. 3.6%; p = n.s.; appropriate shocks: 12.2% vs. 10.4%; p = n.s.). The higher frequency of patients with total shocks with SC settings than with DC settings that benefit from PARAD+ was driven by a higher percentage of patients with inappropriate shocks in the VT zone (170-200 bpm) in the SC population.

Background: Cardiac resynchronization therapy defibrillator can terminate ventricular tachycardia (VT) and fast VT (FVT) via antitachycardia pacing (ATP)., Objectives: We evaluated efficacy and safety of ATP, whether ATP induces ventricular arrhythmias after inappropriate ATP or atrial fibrillation (AF) after appropriate ATP, and whether ATP is associated with mortality., Methods: A total of 1404 patients with a cardiac resynchronization therapy defibrillator were followed in a prospective multicenter observational research. All-cause mortality rates were estimated in patient subgroups in order to uncouple the trigger (VT/FVT or other rhythms causing inappropriate detections) from ATP therapy., Results: Over a median follow-up of 31 months, 2938 VT/FVT episodes were treated with ATP in 360 patients. The adjusted ATP success rate was 63% (95% confidence interval [CI] 57%-69%) on FVTs and 68% (95% CI 62%-74%) on VTs. Acceleration occurred in 55 (1.87%) and syncope in 4 (0.14%) of all ATP-treated episodes. In 14 true VT/FVT episodes in 5 patients, AF followed ATP therapy. In 4 episodes in 2 patients, VT followed ATP inappropriately applied during AF. Death rate per 100 patient-years was 5.6 (95% CI 4.3-7.5) in patients with appropriate ATP and 1.5 (95% CI 0.4-6.1) in patients with inappropriate ATP (P = .045)., Conclusion: ATP was effective in terminating VT/FVT episodes and displayed a good safety profile. ATP therapies by themselves did not increase death risk; prognosis was indeed better in patients without arrhythmic episodes, even if they received inappropriate ATP, than in patients with ATP on VT/FVT episodes. Adverse outcomes observed in patients receiving implantable cardioverter-defibrillator therapies are probably related to the arrhythmia itself, a marker of disease progression, rather than to adverse effects of ATP., (Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Transseptal (TS) catheterization is needed to access the left heart during pulmonary vein isolation (PVI) procedures. In the radiofrequency (RF) ablation procedure, left atrial access is commonly achieved with a double TS puncture; cryoballoon (CB) ablation usually requires only a single TS puncture. Our aim was to compare the incidence of iatrogenic septal defect (IASD) between double transseptal conventional RF and CB ablation., Methods and Results: Individuals having undergone PVI as index procedure by RF or CB ablation and a subsequent transesophageal echocardiography examination during postablation follow-up in our center were consecutively included. A total of 127 patients formed the study group (92 males; mean age 60 ± 11 years). IASD was present in 17 patients (13.4%) after a mean follow-up time of 11.6 months. The incidence of IASD at 1-year follow-up following PVI was significantly higher in the CB ablation group compared with the RF ablation group (22.2% vs 8.5%; P = 0.03). Mean IASD diameter was larger in the CB group (0.60 cm × 0.50 cm vs 0.44 cm × 0.35 cm) without statistical significance. Only left to right atrial shunt was observed. No adverse events were recorded in these patients during the follow-up., Conclusions: the incidence of IASD at 1-year follow-up following CB ablation procedure for PVI is significantly higher with respect to RF procedures. Although no adverse clinical events were recorded in patients with persistence of IASD, more detailed echocardiographic examinations might be advised in all individuals exhibiting this finding., (© 2015 Wiley Periodicals, Inc.)

Aims: We assessed whether left atrial volume index (LAVI) was associated with the presence of microvascular complications in patients with type 2 diabetes, and whether this association was independent of hemodynamic and non-hemodynamic factors., Methods: We studied 157 consecutive outpatients with type 2 diabetes with no previous history of ischemic heart disease, chronic heart failure and valvular diseases. A transthoracic echocardiography and myocardial perfusion scintigraphy were performed in all participants. Presence of microvascular complications was also recorded., Results: Overall, 51 patients had decreased estimated glomerular filtration rate and/or abnormal albuminuria, 24 had diabetic retinopathy, 22 had lower-extremity sensory neuropathy, and 67 (42.7%) patients had one or more of these microvascular complications (i.e., combined endpoint). After stratifying patients by LAVI, those with LAVI ≥32 ml/m(2) had a greater prevalence of microvascular complication, lower left ventricular (LV) ejection fraction, higher LV mass index and higher E/e' ratio than those with LAVI <32 ml/m(2). Logistic regression analyses revealed that microvascular complications (singly or in combination) were associated with increased LAVI, independently of age, sex, diabetes duration, hemoglobin A1c, hypertension, LV-ejection fraction, LV mass index and the E/e' ratio., Conclusions: These results indicate that microvascular diabetic complications are associated with increased LAVI in well-controlled type 2 diabetic patients with preserved systolic function and free from ischemic heart disease, independently of multiple potential confounders., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose: An optimal active-can lead configuration during implantable cardioverter defibrillator (ICD) placement is important to obtain an adequate defibrillation safety margin. The purpose of this multicenter study was to evaluate the rate of the first shock success at defibrillation testing according to the type of lead implant (single vs. dual coil) and shock polarity (cathodal and anodal) in a large series of consecutive patients who received transvenous ICDs., Methods: This was a multicenter study enrolling 469 consecutive patients. Single- versus dual-coil leads and cathodal versus anodal polarity were evaluated at defibrillation testing. In all cases, the value of the energy for the first shock was set to 20 J less than the maximum energy deliverable from the device., Results: A total of 469 patients underwent defibrillation testing: 158 (34 %) had dual-coil and 311 (66 %) had single-coil lead systems configuration, 254 (54 %) received anodal shock and 215 (46 %) received cathodal shock. In 35 (7.4 %) patients, the shock was unsuccessful. No significant differences in the outcome of defibrillation testing using single- versus dual-coil lead were observed but the multivariate analysis showed an increased risk of shock failure using cathodal shock polarity (OR 2.37, 95 % CI 1.12-5.03)., Conclusions: Both single- and dual-coil transvenous ICD lead systems were associated with high rates of successful ICD implantation, and we found no significant differences in ventricular arrhythmias interruption between the two ICD lead systems configuration. Instead, anodal defibrillation was more likely to be successful than cathodal defibrillation.

Background: We hypothesized that a negative microvolt T-wave alternans (MTWA) test would identify patients unlikely to benefit from primary prevention implantable cardioverter defibrillator (ICD) therapy in a prospective cohort., Methods and results: Data were pooled from 8 centers where MTWA testing was performed specifically for the purpose of guiding primary prevention ICD implantation. Cohorts were included if the ratio of ICDs implanted in patients who were MTWA "non-negative" to patients who were MTWA negative was >2:1, indicating that MTWA testing had a significant impact on the decision to implant an ICD. The pooled cohort included 651 patients: 371 MTWA non-negative and 280 MTWA negative. Among non-negative patients, 62% underwent ICD implantation whereas only 13% of MTWA-negative patients received an ICD (P<0.01). Despite a substantially lower prevalence of ICDs, long-term survival (6.9 years) was significantly better among MTWA-negative patients (68.2% non-negative vs. 87.1% negative, P=0.026)., Conclusions: MTWA-negative patients had significantly better survival than MTWA non-negative patients, the majority of whom had ICDs. Despite a very low prevalence of ICDs, long-term survival among patients with left ventricular ejection fraction ≤40% and a negative MTWA test was better than in the ICD arm of any study to date that has demonstrated a benefit of ICDs. This provides further evidence that MTWA-negative patients are unlikely to benefit from primary prevention ICD therapy.

Objectives: The OPTION (Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator Patients Without Pacing Indications) trial sought to compare long-term rates of inappropriate shocks, mortality, and morbidity between dual-chamber and single-chamber settings in implantable cardioverter-defibrillators (ICDs) patients., Background: The use of dual-chamber ICDs potentially allows better discrimination of supraventricular arrhythmias and thereby reduces inappropriate shocks. However, it may lead to detrimental ventricular pacing., Methods: This prospective multicenter, single-blinded trial enrolled 462 patients with de novo primary or secondary prevention indications for ICD placement and with left ventricular ejection fractions ≤40% despite optimal tolerated pharmacotherapy. All patients received atrial leads and dual-chamber defibrillators that were randomized to be programmed either with dual-chamber or single-chamber settings. In the dual-chamber setting arm, the PARAD+ algorithm, which differentiates supraventricular from ventricular arrhythmias, and SafeR mode, to minimize ventricular pacing, were activated. In the single-chamber setting arm, the acceleration, stability, and long cycle search discrimination criteria were activated, and pacing was set to VVI 40 beats/min. Ventricular tachycardia detection was required at rates between 170 and 200 beats/min, and ventricular fibrillation detection was activated above 200 beats/min., Results: During a follow-up period of 27 months, the time to the first inappropriate shock was significantly longer in the dual-chamber setting arm (p = 0.012, log-rank test), and 4.3% of patients in the dual-chamber setting group compared with 10.3% in the single-chamber setting group experienced inappropriate shocks (p = 0.015). Rates of all-cause death or cardiovascular hospitalization were 20% for the dual-chamber setting group and 22.4% for the single-chamber setting group and satisfied the pre-defined margin for equivalence (p < 0.001)., Conclusions: Therapy with dual-chamber settings for ICD discrimination combined with algorithms for minimizing ventricular pacing was associated with reduced risk for inappropriate shock compared with single-chamber settings, without increases in mortality and morbidity. (Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator [ICD] Patients Without Pacing Indications [OPTION]; NCT00729703)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Atrial fibrillation (AF) is common in patients with cardiac implantable electronic devices (CIED) and has been associated with an increased stroke risk. The aim of our project was to assess the clinical value of a web-based application, Discovery Link AFinder, in improving AF detection in CIED patients., Methods and Results: Seven Italian hospitals performed an observational study consisting of four phases. During phase 1, expert nurses and cardiologists prospectively followed-up CIED patients via in-hospital examinations and remote monitoring, and classified clinically relevant events, particularly AF occurrence. During phase 2, Discovery Link AFinder was exploited to identify patients who had suffered AF in the previous 12 months through the systematic scanning of device data remote transmissions. Phases 3 and 4 were repetitions of phases 1 and 2, respectively, and were implemented 6 months after the previous phases. A total of 472 consecutive patients were included in phase 1; AF occurred in 170 patients, 61 of whom were identified as new AF patients. Evidence of AF during this phase prompted prescription of oral anticoagulation (OAC) therapy in 30 patients. In phase 2, AFinder uncovered new AF, unidentified in phase 1, in 54 patients and prompted implementation of OAC therapy in 11 patients. During phase 3, 30 new AF patients were identified by means of remote monitoring, while during phase 4, a further three AF patients were identified by AFinder only., Conclusions: The AFinder web-based software, applied on top of standard in-hospital and remote monitoring, improved AF detection and enabled OAC treatment to be undertaken., (©2014 Wiley Periodicals, Inc.)

Introduction: The left ventricular (LV) pacing site and the magnitude of the electrical delay within the LV, as expressed by prolonged QRS duration, are major determinants of cardiac resynchronization therapy (CRT) efficacy. We investigated the incremental value of positioning the LV lead in areas of late activation in order to enhance the response to CRT in patients with different degrees of QRS complex lengthening., Methods and Results: This analysis was performed on 301 heart failure patients who received a CRT defibrillator. On implantation, the right ventricular (RV)-to-LV interval was measured as the delay between local activations recorded through the RV and LV leads in the final position. After 1 year, 171 (57%) patients displayed reverse LV remodeling, as measured by a ≥15% reduction in the LV end-systolic volume. Both the RV-to-LV interval and its percentage value corrected for the QRS duration were significantly associated with a positive response to CRT. An RV-to-LV interval >80 milliseconds and an RV-to-LV interval/QRS >58% yielded the best prediction of reverse remodeling. Although the response to CRT decreased with shorter QRS duration in the overall population, patients with an RV-to-LV interval >80 milliseconds showed a response rate >65% in all QRS subgroups., Conclusion: A longer RV-to-LV interval is associated with reverse LV remodeling after CRT. On implantation attempts could be made to maximize it when selecting the LV lead position, especially in patients with shorter QRS duration, and thus less likely to respond positively to CRT., (© 2014 Wiley Periodicals, Inc.)

Aims: Heart failure has a relevant healthcare impact. Monitoring of pulmonary fluid overload (PFO), measured by intrathoracic impedance, has been proposed to alert to heart failure worsening before symptoms become patent. The aim of our research was to evaluate whether PFO diagnostics reduce heart failure hospitalizations in heart failure patients receiving single-chamber or dual-chamber implantable cardioverter-defibrillator (ICD) for primary prevention of sudden death., Methods: Twenty-five Italian cardiological centers prospectively followed 221 ICD patients (86% men, 66 ± 11 years, 79% New York Heart Association II and left ventricular ejection fraction 28 ± 5%), of whom 123 received an ICD with PFO monitoring (diagnostics group) and 98 an ICD without such a diagnostics (control group). The association of each patient to a group was assigned a priori, independently of patients' characteristics but based on regional device allocation policies., Results: Patient clinical characteristics and observation period were similar between groups. In a mean follow-up of 17 ± 11 months, heart failure hospitalizations or emergency-room admissions occurred in eight (7%) patients of the diagnostics group and in 16 of the control group (16%; P = 0.02), with an incidence, measured by Kaplan-Meier analysis, of 23% at 2 years and 34% at 3 years in patients of the control group compared with 8% at 2 and 3 years in patients of the diagnostics group (Log rank test P = 0.044)., Conclusion: Our data show that in heart failure patients receiving single-chamber or dual-chamber ICD, the use of intrathoracic impedance monitoring is associated with a significant reduction of heart failure hospitalizations. Our results support the hypothesis that PFO diagnostics improve the likelihood of timely detection of heart failure worsening.

Aims: In candidates for cardiac resynchronization therapy (CRT), the choice between pacemaker (CRT-P) and defibrillator (CRT-D) implantation is still debated. We compared the long-term prognosis of patients who received CRT-D or CRT-P according to class IA recommendations of the European Society of Cardiology (ESC) and who were enrolled in a multicentre prospective registry., Methods and Results: A total of 620 heart failure patients underwent successful implantation of a CRT device and were enrolled in the Contak Italian Registry. This analysis included 266 patients who received a CRT-D and 108 who received a CRT-P according to class IA ESC indications. Their survival status was verified after a median follow-up of 55 months. During follow-up, 73 CRT-D and 44 CRT-P patients died (rate 6.6 vs. 10.4%/year; log-rank test, P = 0.020). Patients receiving CRT-P were predominantly older, female, had no history of life-threatening ventricular arrhythmias, and more frequently presented non-ischaemic aetiology of heart failure, longer QRS durations, and worse renal function. However, the only independent predictor of death from any cause was the use of CRT-P (hazard ratio, 1.97; 95% confidence interval, 1.21-3.16; P = 0.007)., Conclusion: The implantation of CRT-D, rather than CRT-P, may be preferable in patients presenting with current class IA ESC indications for CRT. Indeed, CRT-D resulted in greater long-term survival and was independently associated with a better prognosis.

Objective: The performances of implantable cardioverter defibrillators and leads are important issues for healthcare providers and patients. In 2007 Sprint Fidelis leads were found to be associated with an increased failure rate and so the purpose of the study was to evaluate long-term mortality and clinical outcomes in patients implanted with Sprint Fidelis leads compared with Sprint Quattro leads., Design, Setting, Patients: 508 patients with Sprint Fidelis leads and 468 with Sprint Quattro leads were prospectively followed in 12 Italian cardiology centres., Main Outcome Measures: Information on hospitalisations and other clinical events were collected during scheduled and unscheduled hospital visits. Deaths were identified from medical records or via phone contacts with patients' family members or through the National Office of Vital Statistics., Results: Over a mean follow-up of 27±18 months 141 deaths occurred in the overall population. No death was observed in patients with diagnosed failing lead. Kaplan-Meier patient survival differed between the two lead groups (80±2% in Fidelis leads vs 70±4% in the Sprint Quattro leads at 4 years, p=0.002). Multivariate analyses showed that mortality was neither associated with lead type nor with diagnosed failed lead. The annual rate of lead failure was 1.8% patient-year for Fidelis leads and 0.2% for the Sprint Quattro leads., Conclusions: In our multicentre research, the clinical outcomes of patients with Fidelis leads differed from those of patients with Sprint Quattro leads. Nevertheless, neither mortality nor the combined endpoint of mortality and heart failure hospitalisations was associated with the lead type. http://clinicaltrials.gov/ct2/show/NCT01007474.

Introduction: The characteristics and outcomes of patients who undergo cardiac resynchronization therapy (CRT) device implantation in current clinical practice may differ from those of reference trial populations. Study objectives were to assess 2-year outcomes in a population implanted with a CRT plus defibrillator device in accordance with the standard of care and to evaluate any independent association between clinical variables and outcome., Methods and Results: A total of 406 patients enrolled at 35 centers in Italy were followed up prospectively for 2 years. All patient management decisions were left to the treating physician's discretion, in accordance with clinical practice. ACTION-HF patients had a better baseline clinical status than patients enrolled in the COMPANION study: shorter HF history (1 vs 3.5 years, P < 0.01), less advanced NYHA functional class (III-IV: 73% vs 100%, P < 0.01), higher LVEF (26% vs 21%, P < 0.01), higher SBP (122 vs 112 mmHg, P < 0.01), and less diabetes (27% vs 41%, P < 0.01). This status was reflected in lower mortality (11.5% vs 26%) and a lower incidence of appropriate ICD shocks (12.1% vs 19.3%). AF history was an independent predictor of the combination of all-cause mortality and cardiac-cause hospitalization (HR: 3.31; P < 0.001). Recurrent or new atrial arrhythmias were independently associated with the development of ventricular arrhythmias (HR: 3.4; P < 0.001)., Conclusions: This population appears clinically less compromised and had a lower incidence of adverse clinical outcomes than those of reference trials. However, we recorded a substantial burden of atrial arrhythmias, which was independently associated with a higher incidence of ventricular arrhythmias., (© 2012 Wiley Periodicals, Inc.)

Background: 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., (©2011, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.)

Background: Abnormal microvolt T-wave alternans (MTWA), a marker of ventricular arrhythmic risk, is a highly prevalent condition in patients with type 2 diabetes mellitus (T2DM) and is correlated with glycemic control. However, there is uncertainty as to whether central or peripheral hemodynamic factors are associated with abnormal MTWA in T2DM individuals., Methods and Results: We studied 50 consecutive, well-controlled T2DM outpatients without a history of ischemic heart disease and with normal systolic function. All patients underwent a complete echocardiographic Doppler evaluation with spectral tissue Doppler analysis. MTWA analysis was performed noninvasively during submaximal exercise. Effective arterial elastance, arterial compliance, and heart rate variability were also measured. Compared with patients with MTWA negativity (n = 38), those with MTWA abnormality (n = 12, 24%) had significantly lower e' (7.6 ± 1.3 versus 9.1 ± 1.7 cm/s; P < 0.01), a' (10.2 ± 1.6 versus 12.7 ± 1.9 cm/s; P < 0.001) and s' velocities (8.7 ± 1.1 versus 10.2 ± 1.5 cm/s; P = 0.001) and higher indexed left ventricular mass (121.3 ± 16.4 versus 107.5 ± 16.5 g/m2; P = 0.016), indexed left atrial volume (33.5 ± 11.9 versus 23.6 ± 5.6 mL/m2; P < 0.001), and E/e' ratio (8.8 ± 1.4 versus 6.5 ± 1.3; P < 0.001). Multivariable logistic regression analysis revealed that higher E/e' ratio was the only independent correlate of abnormal MTWA (adjusted odds ratio, 3.52; 95% confidence interval, 1.19 to 10.6; P = 0.02) after controlling for glycemic control and other potential confounders., Conclusions: In this pilot study, we found that early diastolic dysfunction, as measured by tissue Doppler imaging, is independently associated with MTWA abnormality in T2DM individuals with normal systolic function. Further larger studies are needed to examine the reproducibility of these results.

Aim: The aim of this study was to investigate the potential cross-talk between implantable cardioverter defibrillator device (ICD) and implantable neuromodulation device (IND) during the implantation procedure and the ventricular fibrillation induction test and in daily life., Methods: We present two cases of patients with an IND who underwent ICD implantation and one case of a patient implanted with a biventricular ICD who received an IND 6 months later. Two of these patients had a spinal cord stimulator (SCS), while the other had a sacral neuromodulator., Results: No cross-talk was recorded in the patient with the sacral neuromodulator and the ICD. Temporary damage to one of the SCSs was observed after multiple ICD shocks., Conclusions: When implanted contemporarily with sacral or spinal neurostimulators, cardiac devices appear to be safe, as confirmed by the appropriate detection and interruption of arrhythmic episodes. On the other hand, neuromodulation devices could be temporarily or permanently damaged by multiple ICD discharges. It is recommended that the neurostimulator be interrogated after an ICD shock, in order to check the state of the device., (©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.)

Background: Studies on the physiology of the cardiovascular system suggest that generation of the heart rate (HR) signal is governed by nonlinear dynamics. Linear and nonlinear indices of HR variability (HRV) have been shown to predict outcome in heart failure (HF). Aim of the present study is to assess if a HR-related complexity predicts adverse clinical and cardiovascular events at 1 year in patients implanted with cardiac resynchronization therapy (CRT)., Methods: In sixty patients implanted with CRT (Renewal), 24-hour HR data were retrieved at patient discharge and 1-year follow-up. A set of linear indices of HRV were considered: mean HR, standard deviation of normal beat to normal beat (SDANN), and HR footprint. Two novel nonlinear indices were calculated by means of a specific algorithm (OntoSpace): HR-complexity (HR-Co) and HR-entropy (HR-En). Predictors of adverse clinical outcome (functional class deterioration or major hospitalizations for cardiovascular causes or all-cause mortality) and of HRV recovery were sought by means of multivariate analysis., Results: HR-Co and HR-En were found to be highly correlated with the other traditional indices of HRV. Lower baseline values of COMPLEXITY WERE ASSOCIATED WITH ADVERSE CLINICAL OUTCOMES (HAZARD RATIO [HR] 0.71; 95% CONFIDENCE INTERVAL [CI] 0.54-0.95; P < 0.02)., Conclusion: Complexity and entropy indices, calculated from 24-hour normal beat to normal beat (RR) intervals well represent patient's autonomic function. In this limited set of data, HF patients with lower baseline complexity-related indices, representing a more compromised autonomic function, present worse clinical outcome at 1-year follow-up., (©2010, Wiley Periodicals, Inc.)

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.

Background: Several studies have searched for predictors of clinical outcome in patients with heart failure (HF). However, since they were collected in clinical trials, most data were subject to selection biases and do not specifically apply to patients with nonischemic heart disease. This study examined the impact of several variables on combined all-cause mortality and hospitalization for cardiac causes, in consecutive ambulatory patients with HF included in the ALPHA registry., Methods and Results: This analysis included 446 patients with HF and nonischemic heart disease, in New York Heart Association functional class II or III, and a left ventricular (LV) ejection fraction below 40%. In 126 patients (73%) the disease was idiopathic dilated cardiomyopathy, in 72 (16%) hypertensive, in nine (2%) valvular, and in 39 (9%) of other etiologies. The median age was 61 years (range 51-69 years) and 349 (78%) patients were men. Over a median follow-up of 31 months (range 23-40), 82 patients (18%) died or were hospitalized for cardiac causes. In a proportional hazard (Cox) regression model, maximal oxygen consumption (HR 0.9, P = 0.001), LV end-diastolic diameter (HR 1.07, P < 0.001), resting systolic blood pressure (HR 0.97, P < 0.005), and hemoglobin (HR 0.86, P < 0.05) were independent predictors of the combined study endpoint., Conclusions: In an unselected population of patients with HF and nonischemic heart disease, a reduced exercise capacity, large LV end-diastolic diameter, low systolic blood pressure, and hemoglobin were correlated with long-term all-cause mortality or hospitalization for cardiac causes. These observations may help stratifying and tailoring the treatment of patients with HF and nonischemic heart disease.

Objectives: The aim of this study was to assess the prognostic value of T-wave alternans (TWA) in New York Heart Association (NYHA) functional class II/III patients with nonischemic cardiomyopathy and left ventricular ejection fraction (LVEF) < or =40%., Background: There is a strong need to identify reliable risk stratifiers among heart failure candidates for implantable cardioverter-defibrillator (ICD) prophylaxis. T-wave alternans may identify low-risk subjects among post-myocardial infarction patients with depressed LVEF, but its predictive role in nonischemic cardiomyopathy is unclear., Methods: Four hundred forty-six patients were enrolled and followed up for 18 to 24 months. The primary end point was the combination of cardiac death + life-threatening arrhythmias; secondary end points were total mortality and the combination of arrhythmic death + life-threatening arrhythmias., Results: Patients with abnormal TWA (65%) compared with normal TWA (35%) tests were older (60 +/- 13 years vs. 57 +/- 12 years), were more frequently in NYHA functional class III (22% vs. 19%), and had a modestly lower LVEF (29 +/- 7% vs. 31 +/- 7%). Primary end point rates in patients with abnormal and normal TWA tests were 6.5% (95% confidence interval [CI] 4.5% to 9.4%) and 1.6% (95% CI 0.6% to 4.4%), respectively. Unadjusted and adjusted hazard ratios were 4.0 (95% CI 1.4% to 11.4%; p = 0.002) and 3.2 (95% CI 1.1% to 9.2%; p = 0.013), respectively. Hazard ratios for total mortality and for arrhythmic death + life-threatening arrhythmias were 4.6 (p = 0.002) and 5.5 (p = 0.004), respectively; 18-month negative predictive values for the 3 end points ranged between 97.3% and 98.6%., Conclusions: Among NYHA functional class II/III nonischemic cardiomyopathy patients, an abnormal TWA test is associated with a 4-fold higher risk of cardiac death and life-threatening arrhythmias. Patients with normal TWA tests have a very good prognosis and are likely to benefit little from ICD therapy.

Background: Although a more favorable neurohormonal balance may contribute to improving symptoms following cardiac resynchronization therapy (CRT), no information is available regarding the effects of CRT on insulin-like growth factor-1 (IGF-1). This study assessed the effects of CRT on IGF-1 levels and their correlation with changes in quality of life and left ventricular (LV) function., Methods and Results: Patients with cardiomyopathy in New York Heart Association class III or IV (n = 18; age 71 +/- 10 years), left ventricular ejection fraction (LVEF) < or = 40% and QRS > or = 130 ms or ventricular dyssynchrony were enrolled in the study and followed up for 6 months. After 3 months, there was an improvement in LVEF (from 29 +/- 7 to 33 +/- 10%, P = 0.0136) and quality of life (from 33 +/- 14 to 13 +/- 12, P = 0.0000) and an increase in IGF-1 levels (from 137 +/- 79 to 175 +/- 111 ng/ml, P = 0.01353). The change in quality of life correlated with changes in IGF-1 levels (P = 0.02) but not with LVEF changes., Conclusions: In patients with advanced heart failure, CRT leads to a significant increase in plasma IGF-1 levels within 3 months. This increase is correlated with the improvement in quality of life, whereas the increase in LVEF is not. This finding suggests that IGF-1 may play a role as a mediator in the early phase of symptomatic improvement after CRT.

Background: Abnormal microvolt T-wave alternans (TWA) predicts the risk of ventricular arrhythmias and sudden cardiac death. Although type 2 diabetes is associated with an increased risk of these events, there is a dearth of available data on microvolt TWA measurements in type 2 diabetic populations., Methods: We studied 59 consecutive type 2 diabetic outpatients without manifest cardiovascular disease (CVD) and 35 non-diabetic controls who were matched for age, sex, and blood pressure values. Microvolt TWA analysis was performed non-invasively using the CH-2000 system during a sub-maximal exercise with the patient sitting on a bicycle ergometer., Results: The frequency of abnormal TWA was significantly higher in diabetic patients than in controls (25.4 vs 5.7%; P < 0.01). Among diabetic patients, those with abnormal TWA (n = 15) had remarkably higher hemoglobin A1c (HbA1c) (8.1 +/- 0.9 vs 7.1 +/- 0.8%, P < 0.001) and slightly smaller time-domain heart rate variability parameters (i.e., RMSSD, root mean square of difference of successive R-R intervals) than those with normal TWA (n = 44). Gender, age, body mass index, lipids, blood pressure values, cigarette smoking, diabetes duration, microvascular complication status, QTc interval, and current use of medications did not significantly differ between the groups. In multivariate regression logistic analysis, HbA1c (OR 13.6, 95% CI 2.0-89.1; P = 0.0076) predicted abnormal TWA independent of RMSSD values and other potential confounders., Conclusions: Our findings suggest that abnormal TWA is a very common condition (approximately 25%) among people with type 2 diabetes without manifest CVD and is closely correlated to glycemic control.

Objectives: The aim of our study was to evaluate arterial embolism (AE) occurrence rates and predictors in patients suffering from bradycardia and wearing a pacemaker with antitachycardia pacing therapies., Background: Atrial fibrillation (AF) is associated with a high incidence of AE., Methods: A total of 725 patients (360 men, age 71 +/- 11 years) were implanted with a DDDRP pacemaker (Medtronic AT500, Medtronic Inc., Minneapolis, Minnesota). At baseline 225 (31.0%) patients received antiplatelet therapy and 264 (36.4%) patients received anticoagulation agents., Results: Over a median 22-month follow-up (25th to 75th interquartile range 16 to 30 months), AE occurred in 14 (1.9%) patients: 7 patients suffered a nonfatal ischemic stroke (0.6% per year), 4 patients had transient ischemic attack (0.34% per year), and 3 patients had embolic complications. Among baseline patients' characteristics, multivariate logistic analysis showed that embolic events are independently associated to ischemic heart disease (7.0 odds ratio [OR], 95% confidence interval [CI] 2.3 to 21.3, p = 0.001), prior embolic event (7.3 OR, 95% CI 1.2 to 43.9, p = 0.029), diabetes (5.0 OR, 95% CI 1.2 to 15.7, p = 0.032), and hypertension (4.1 OR, 95% CI 1.1 to 15.6, p = 0.036). The risk of embolism, adjusted for known risk factors, was 3.1 times increased (95% CI 1.1 to 10.5, p = 0.044) in patients with device-detected atrial fibrillation episodes longer than one day during follow-up., Conclusions: In a cohort of patients with bradycardia and AF, arterial embolism was common in patients with ischemic cardiopathy, hypertension, diabetes mellitus, and in patients with known stroke risk factors. Atrial fibrillation occurrences longer than one day were independently associated with embolic events.

Background: Atrial tachyarrhythmias (AT) are considered progressive diseases. Several rhythm control therapies for treatment of AT have been proposed., Objectives: The Italian AT500 Registry was designed to prospectively study long-term AT evolution in patients paced for the brady-tachy form of sinus node disease (BT-SND)., Methods: Three hundred forty-six BT-SND patients received an antitachycardia dual-chamber pacemaker and were followed-up for a minimum of 12 months (median 19 months). Prevention and antitachycardia pacing (ATP) features were enabled in all patients., Results: During the observation period, 224 (65%) patients were treated by antiarrhythmic drugs and 45 (13%) patients were cardioverted. Five patients suffered a stroke, 4 transient ischemic attack, 22 permanent AT, and 98 AT recurrences longer than 7 days. AT mean cycle length changed from 246 to 270 ms, and the percentage of patients with AT-related hospitalizations significantly decreased with an annual 28% relative reduction. AT burden and the percentage of patients with AT recurrences longer than 2 days remained constant with time in the overall population but decreased significantly in the subgroup of patients who did not develop permanent AT. High ATP efficacy was associated with an increasingly higher prevention of AT recurrences longer than 2 days., Conclusion: In a long-term observation of BT-SND patients, AT-related hospitalizations decreased significantly and mean AT cycle length increased significantly. The data suggest that rhythm control therapies induce inversion of AT progression.

This report describes a patient with a previous myocardial infarction who presented with syncope. The patient had a positive microvolt T wave alternans test, a negative electrophysiological study, and a normal heart rate variability. In hospital, the patient had episodes of ventricular tachycardia and fibrillation. An implantable cardioverter defibrillator was implanted and during the following week it discharged appropriately.

Between January and December 1992 an epidemiological survey on the risk factors for cardiovascular disease in eighteen-year old boys during call-up has been performed in Verona. The study involved 3426 subjects: 100% of the boys coming from the metropolitan area and 65% of those coming from the non-metropolitan areas. A family history of hypertension was found in 9.54% of the subjects and a family history of myocardial infarction or sudden death was found in 4.54% of the subjects. 0.18% of the population reported diabetes and 2% hypertension. Prevalence of smoke addiction was 39.1% and in this group 17.54% smoked > or = 20 cigarettes/day. Prevalence of smoke addiction was significantly greater in the boys having one or both smoking parents (p < 0.001), in working people in respect to students (p < 0.001), in boys from metropolitan in respect to those from non-metropolitan areas (p = 0.033), and among those not practising sport activity (p < 0.001). Mean systolic and diastolic blood pressure were 130.16 +/- 13/74.48 +/- 9 mm Hg and 90th percentile was 149/87 mm Hg. Systolic and diastolic blood pressure were significantly lower in boys from metropolitan in respect to those from non-metropolitan areas and in smokers in respect to non smokers. A body mass index > or = 30 was found in 3.04% of the subjects, the body mass index being directly related to systolic and diastolic blood pressure (p < 0.001). Total cholesterol performed on a voluntary basis from capillary blood samples by Reflotron System was determined in 80.06% of the subjects. Mean blood cholesterol was 139.1 +/- 28 mg/dL and 90th percentile's value was 182 mg/dL. Mean blood cholesterol was significantly lower in non-metropolitan in respect to metropolitan areas (p = 0.033). 44.48% of the subjects had one or more risk factors, 5.22% had two risk factors and 0.67% three or more risk factors for cardiovascular disease. This study shows that 1) in this population of young people a significant part is exposed to one or more cardiovascular risk factors; 2) social and environmental factors affect, sometimes deeply, the prevalence of cardiovascular risk factors; 3) The visit for call-up appears to be important in the setting-up of a strategy of primary prevention for cardiovascular disease.

The antihypertensive effect of the angiotensin-converting enzyme (ACE) inhibitor lisinopril administered in a single dose of 20 mg was evaluated by ambulatory blood pressure monitoring (ABPM) in a double-blind, placebo-controlled, cross-over study. Twenty-four patients (21 men and 3 women, mean age 52 +/- 6 years) with mild to moderate hypertension were included in the study and randomly assigned to two consecutive treatments with lisinopril 20 mg and placebo, each administered for 4 weeks. On the last day of each treatment, BP was assessed by noninvasive 24-h ABPM. BP was significantly lower after lisinopril than after placebo in a 24-h period (mean 24-h systolic BP (SBP) with lisinopril 120 +/- 7 mm Hg and with placebo 135 +/- 9 mm Hg; mean day SBP with lisinopril 125 +/- 3 mm Hg and with placebo 142 +/- 5 mm Hg; mean night SBP with lisinopril 112 +/- 4 mm Hg and with placebo 124 +/- 6 mm Hg; mean 24-h diastolic BP (DBP) with lisinopril 76 +/- 6 mm Hg, and with placebo 87 +/- 8 mm Hg; mean day DBP with lisinopril 80 +/- 3 mm Hg and with placebo 93 +/- 4 mm Hg; mean night DBP with lisinopril 69 +/- 2 mm Hg and with placebo 79 +/- 5 mm Hg, p less than 0.001). Mean 24-h, mean day, and mean night heart rate (HR) did not differ significantly between placebo and lisinopril treatments. Repeated-measures analysis of variance (ANOVA) showed a significant influence on SBP (p less than 0.001) and DBP (p less than 0.001) throughout the treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

With the aim of investigating the functional result of the coronary angioplasty (PTCA) and verifying the predictive value of the exercise test for detecting restenosis, 165 patients who underwent successful PTCA were evaluated through exercise stress tests performed 10, 75 and 165 days after PTCA and through coronary angiography performed 5 to 6 months after PTCA. The percentage of negative tests and the rate-pressure product (RPP) increased significantly with respect to the tests performed before PTCA, both in patients with single-vessel and those with multivessel disease. Maximal ST segment depression and ST/HR were significantly reduced only in patients with complete revascularization. The percentage of positive tests 10 days after PTCA was lower in patients with single-vessel than in those with multivessel disease (2.5% versus 10.8%) and, of the latter, in patients with complete rather than incomplete revascularization (0% versus 13.5%). In patients with complete revascularization, the mean exercise time rose significantly (703 s versus 538 s). The percentage of positive tests increased progressively with time, in accordance with probable increasing restenosis. In comparison with the results of angiography, sensitivity of the exercise stress test proved to be poor (59%), especially in patients with single-vessel disease (45%), while the specificity was very high (98%). The predictive value of a negative test was 77% in patients with multi-vessel and 87% in patients with single-vessel disease. The predictive value of a positive test was over 90% in both groups of patients.