Early invasive versus early conservative strategy in non-ST-elevation acute coronary syndrome: An outcome research study.

BACKGROUND: An early invasive strategy (EIS) has been shown to yield a better clinical outcome than an early conservative strategy (ECS) in patients with non-ST-elevation acute coronary syndromes (NSTEACSs), particularly in those at higher risk according to the GRACE risk score. However, findings of the clinical trials have not been confirmed in registries. OBJECTIVE: To investigate the outcome of patients with NSTEACS treated according to an EIS or a ECS in a real-world all-comers outcome research study. METHODS: The primary hypothesis of the study was the non-inferiority of an ECS in comparison with an EIS as to a combined primary end-point of death, non-fatal myocardial infarction and hospital readmission for acute coronary syndromes at one year. Participating centres were divided into two groups: those with a pre-specified routine EIS and those with a pre-specified routine ECS. Two statistical analyses were performed: a) an 'intention to treat' analysis: all patients were considered to be treated according to the pre-specified routine strategy of that centre; b) a 'per protocol' analysis: patients were analysed according to the actual treatment applied. Cox model including propensity score correction was applied for all analyses. RESULTS: The intention to treat analysis showed an equivalence between EIS and ECS (11.4% vs. 11.1%) with regard to the primary end-point incidence at one year. In the three subgroups of patients according to the GRACE risk score (⩽ 108, 109-140, > 140), EIS and ECS confirmed their equivalence (5.3% vs. 3.9%, 8.4% vs. 7.6%, and 20.3% vs. 20.9%, respectively). When the per protocol analysis was applied, a reduction of the primary end-point at one year with EIS vs. ECS was demonstrated (6.2% vs. 15.3%, p=0.021); analysis of the subgroups according to the GRACE risk score numerically confirmed these data (3.1% vs. 6.5%, 5.1% vs. 10.0%, and 10.8% vs. 24.5%, respectively). CONCLUSIONS: In a real-life registry of all-comers NSTEACS patients, ECS was non-inferior to EIS; however, when EIS was applied according to clinical judgement, a reduction of clinical events at one year was demonstrated.

Usefulness of transthoracic echocardiogram in management of cardiac involvement in large B-Cell lymphoma: a case report.

Primary lymphoma often involve the heart, especially the right side. Prompt diagnosis is necessary to start the right therapy and decrease symptoms and death risk rate. Transthoracic echocardiogram is the first line exam to perform when symptoms are suspicious of mediastinal mass.

[Management strategies and choice of antithrombotic treatment in patients admitted with acute coronary syndrome--executive summary for clinical practice. Consensus Document of the Regional Chapters of the Italian National Association of Hospital Cardiologists (ANMCO) and of the Italian Society of Emergency Medicine (SIMEU)]. / Strategie Assistenziali e Scelta della Terapia Antitrombotica nei Pazienti Ricoverati con Diagnosi di Sindrome Coronarica Acuta--Sintesi Operativa per la Pratica Clinica. Documento congiunto delle Sezioni Regionali del Lazio dell'Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO) e della Società Italiana di Medicina di Emergenza-Urgenza (SIMEU).

This document has been developed by the Lazio regional chapters of two scientific associations, the Italian National Association of Hospital Cardiologists (ANMCO) and the Italian Society of Emergency Medicine (SIMEU), whose members are actively involved in the everyday management of Acute Coronary Syndromes (ACS). The document is aimed at providing a specific, practical, evidence-based guideline for the effective management of antithrombotic treatment (antiplatelet and anticoagulant) in the complex and ever changing scenario of ACS. The document employs a synthetic approach which considers two main issues: the actual operative context of treatment delivery and the general management strategy.

Epicardial ganglionated plexus stimulation decreases postoperative inflammatory response in humans.

BACKGROUND: Surgical cardiac revascularization produces a high degree of systemic inflammation and the secretion of several cytokines. Intensive postoperative inflammation may increase the incidence of postoperative atrial fibrillation and favor organ dysfunctions. No data documenting the anti-inflammatory properties of epicardial vagal ganglionated plexus stimulation are available. OBJECTIVE: To verify the feasibility and safety of postoperative inferior vena cava-inferior atrial ganglionated plexus (IVC-IAGP) burst stimulation and the effectiveness of this approach in reducing serum levels of inflammatory cytokines. METHODS: In 27 patients who were candidates for off-pump surgical revascularization, the IVC-IAGP was located during surgery, a temporary wire was inserted, and a negative atrioventricular node dromotropic effect was obtained in 20 patients on applying high-frequency burst stimulation. In 5 patients atrial fibrillation or phrenic nerve stimulation was induced, and the remaining 15 patients served as the experimental group. Twenty additional patients underwent off-pump surgical revascularization without IVC-IAGP stimulation and served as the control group. On arrival in the intensive care unit, the experimental group underwent IVC-IAGP stimulation for 6 hours. Blood samples were collected at different times. RESULTS: The serum levels of cytokines were not statistically different at baseline and on arrival in the intensive care unit between the groups, while they proved statistically different after 6 hours of stimulation: interleukin-6 (EG: 121 ± 71 pg/mL vs CG: 280 ± 194 pg/mL; P = .004), tumor necrosis factor-α (EG: 2.68 ± 1.81 pg/mL vs CG: 5.87 ± 3.48 pg/mL; P = .003), vascular endothelial growth factor (EG: 93 ± 43 pg/mL vs CG: 177 ± 86 pg/mL; P = .002), and epidermal growth factor (EG: 79 ± 48 pg/mL vs CG: 138 ± 76 pg/mL; P = .012). CONCLUSIONS: Prolonged burst IVC-IAGP stimulation after surgical revascularization appears to be feasible and safe and significantly reduces inflammatory cytokines in the postoperative period.

n-3 polyunsaturated fatty acids for the prevention of arrhythmia recurrence after electrical cardioversion of chronic persistent atrial fibrillation: a randomized, double-blind, multicentre study.

AIMS: Persistent atrial fibrillation (AF) often recurs after direct current electrical cardioversion (ECV). As several experimental and clinical studies suggest that n-3 polyunsaturated fatty acids (PUFAs) may have antiarrhythmic properties even at the atrial level, we aimed to evaluate whether oral supplementation with PUFAs, in addition to conventional antiarrhythmic drugs, could reduce the recurrence rate of the arrhythmia after ECV of persistent AF. METHODS AND RESULTS: Two hundred and four patients (mean age 69.3 years, 33% females) with persistent AF were randomly assigned to receive 3 g/day of PUFAs until ECV and 2 g/day thereafter (104 patients) or placebo (100 patients) for 6 months, beginning at least 1 week before ECV. Selection of conventional antiarrhythmic prophylaxis was left to local medical advice. The cardiac rhythm was assessed by both trans-telephonic monitoring and clinical visits. Primary end-point was the recurrence rate of AF. Sinus rhythm was restored, either spontaneously or after ECV, in 187 patients (91.7%); 95 patients (91.4%) on PUFAs and 92 patients (92.0%) on placebo (P=not significant). AF relapsed in 56 (58.9%) of the PUFAs patients and in 47 (51.1%) of the placebo patients (P=0.28). The mean time to AF recurrence was 83±8 days in the PUFAs group and 106±9 days in the placebo group (P=0.29). CONCLUSION: Our results do not support the hypothesis that, in patients undergoing ECV of chronic persistent AF, supplementation with PUFAs in addition to the usual antiarrhythmic treatment reduces recurrent AF.

Endocardial vagal atrioventricular node stimulation in humans: reproducibility on 18-month follow-up.

AIMS: Control of atrioventricular (AV) node conduction by means of high-frequency stimulation (HFS) of efferent AV node vagal stimulation (AVNS) fibres enables the ventricular rate (VR) to be modulated during atrial fibrillation (AF). The aims of this study were to verify, on 18-month follow-up, the reproducibility of the dromotropic effect obtained on implantation and the long-term reliability of the system in patients who received an implantable cardioverter-defibrillator (ICD) with a standard atrial lead positioned at a location suitable for AVNS. METHODS AND RESULTS: We enrolled 12 patients with paroxysmal or persistent AF who were candidates for ICD. The right atrium was mapped to locate the pacing site, and a transvenous screw-in lead was implanted in that region. The voltages required for VR modulation (25% VR reduction) and complete AV block at different pulse durations (from 0.1 to 0.5 ms) were recorded. Eleven out of 12 patients underwent 18-month follow-up examination. Atrial pacing parameters were adequate and did not differ from the baseline values (all P > 0.05): pacing threshold 0.9 ± 0.5 V (0.5 ms pulse duration) and impedance 556 ± 121 Ω, with P-wave amplitude of 1.6 ± 0.7 mV. High-frequency stimulation induced VR modulation in nine patients and complete AV block in eight patients at pulse durations ≥0.3 ms. No differences were observed in the voltages for VR modulation and complete AV block between implantation and 18-month examination (all P > 0.100). CONCLUSION: Ventricular rate control during AF was obtained under HFS 18 months after implantation in patients with the atrial lead positioned at a location suitable for AVNS. The pacing outputs needed to achieve the dromotropic effect were comparable to those measured on implantation.

[Secondary cardiovascular prevention after acute coronary syndrome in clinical practice]. / Prevenzione cardiovascolare secondaria dopo sindrome coronarica acuta nella pratica clinica.

Secondary prevention after acute coronary syndromes should be aimed at reducing the risk of further adverse cardiovascular events, thereby improving quality of life, and lengthening survival. Despite compelling evidence from large randomized controlled trials, secondary prevention is not fully implemented in most cases after hospitalization for acute coronary syndrome. The Lazio Region (Italy) has about 5.3 million inhabitants (9% of the entire Italian population). Every year about 11 000 patients are admitted for acute coronary syndrome in hospitals of the Lazio Region. Most of these patients receive state-of-the art acute medical and interventional care during hospitalization. However, observational data suggest that after discharge acute coronary syndrome patients are neither properly followed nor receive all evidence-based treatments. This consensus document has been developed by 11 Scientific Societies of Cardiovascular and Internal Medicine in order develop a sustainable and effective clinical approach for secondary cardiovascular prevention after acute coronary syndrome in the local scenario of the Lazio Region. An evidence-based simplified decalogue for secondary cardiovascular prevention is proposed as the cornerstone of clinical intervention, taking into account regional laws and relative shortage of resources. The following appropriate interventions should be consistently applied: smoking cessation, blood pressure control (blood pressure < 130/80 mmHg), optimal lipid management (LDL cholesterol < 80 mmHg), weight and diabetes management, promotion of physical activity and rehabilitation, correct use of antiplatelet agents, beta-blockers, renin-angiotensin-aldosterone system blockers.

Vagal tone augmentation to the atrioventricular node in humans: efficacy and safety of burst endocardial stimulation.

BACKGROUND: Control of atrioventricular (AV) nodal conduction by endocardial stimulation of efferent AV nodal vagal fibers [atrioventricular nodal vagal stimulation (AVNS)] is a promising approach for long-term device-based modulation of ventricular rate during atrial fibrillation (AF). However, few data on the efficacy of AVNS delivered as high-frequency stimulus packages (burst AVNS) in humans are available. OBJECTIVE: The purpose of this study was to determine whether burst AVNS can to modulate AV nodal conduction during AF and whether burst AVNS delivered during sinus rhythm (SR) in the effective atrial refractory period allows safe implantation of a permanent lead in a position suitable for AVNS. METHODS: Twenty patients (10 in SR and 10 in AF) who were candidates for dual-chamber pacemaker implantation for sick sinus syndrome were enrolled in the study. The posteroseptal right atrium was mapped to identify a location at which burst AVNS would achieve AV nodal conduction modulation (lengthening of PR interval in SR and reduction of ventricular rate in AF). Subsequently, a lead was screwed in at that site and burst stimulation (pulse rate 50 Hz, burst duration 180 ms) was delivered at different burst rates, pulse durations, and amplitudes. RESULTS: In all SR patients, PR-interval prolongation was evoked at 90 and 120 bursts/minute with pulse durations < or =1 ms. Specifically, the mean voltages required to obtain PR-interval prolongation and advanced AV block were 4.3 +/- 2.2 V and 5.4 +/- 1.8 V (at 90 bursts/minute and 1 ms), respectively. Similarly, ventricular rate reduction was obtained in all AF patients, starting from 90 bursts/minute and 0.5-ms pulse duration (at 5.4 +/- 1.8 V). Ventricular arrhythmias were never induced during AVNS. CONCLUSION: Endocardial right atrial burst AVNS reduces ventricular rate during AF. Burst AVNS delivered during SR in the effective atrial refractory period allows optimization of lead positioning for AVNS.

Atrioventricular (AV) node vagal stimulation by transvenous permanent lead implantation to modulate AV node function: safety and feasibility in humans.

BACKGROUND: Atrioventricular (AV) node vagal stimulation (AVNVS) has recently emerged as a novel approach to controlling AV dromotropic function. Animal studies have demonstrated that selective epicardial AVNVS is effective in controlling ventricular rate (VR) acutely and in the long term. Endocardial AVNVS has been shown to significantly reduce VR acutely during atrial fibrillation (AF) in humans. However, no data are available on its long-term reproducibility. OBJECTIVES: The purpose of this study was to demonstrate that the posteroseptal right atrium is a suitable site for permanent pacing and allows AVNVS in humans both acutely and during follow-up. METHODS: In 12 candidates for implantable cardioverter-defibrillator with a history of AF, the atrial lead was implanted in the posteroseptal right atrium, where advanced AV block was achieved during temporary high-frequency stimulation (HFS). On implantation and 3-month follow-up examination, HFS was delivered through the permanent lead to demonstrate the possibility to gradually slow the VR until complete AV block. RESULTS: On implantation, VR during AF was gradually slowed until complete AV block, which was elicited at 4.3 V (0.2 ms, 50 Hz). After 3 months, this effect remained reproducible. No significant change in pacing thresholds was observed after 3 months. We observed one dislodgment and one microdislodgement of atrial leads. CONCLUSIONS: Our study demonstrates, for the first time in humans, that selective placement of the atrial lead yields electrical characteristics suitable for permanent pacing and enables VR to be significantly reduced under HFS. These results, which were reproducible during follow-up, provide data for the development of device-based control of VR during AF.

Primary prevention implantation of cardioverter defibrillator without defibrillation threshold testing: 2-year follow-up.

BACKGROUND: Even though the intraoperative threshold testing of the implantable cardioverter defibrillator (ICD) may cause hemodynamic impairment or be unfeasible, it is still considered required standard practice at the time of implantation. We compared the outcome of ICD recipients who underwent defibrillation threshold testing (DFT) with that of patients in whom no testing was performed. METHODS: A total of 291 subjects with ischemic dilated cardiomyopathy received transvenous ICDs between January 2000 and December 2004 in five Italian cardiology centers. In two centers, DFT was routinely performed in 137 patients (81% men; mean age 69+/-9 years; mean ejection fraction 26+/-4%) (DFT group), while three centers never performed DFT in 154 patients (90% men; mean age 69+/-9 years; mean ejection fraction 27+/-5%) (no-DFT group). RESULTS: We compared total mortality, total cardiovascular mortality, sudden cardiac death (SCD), and spontaneous episodes of ventricular arrhythmia (sustained ventricular tachycardia, VT, and ventricular fibrillation, VF) between these groups 2 years after implantation (median 23 months, 25th-75th percentile, 12-44 months). On comparing the DFT and no-DFT groups, we found an overall mortality rate of 20% versus 16%, cardiovascular mortality of 13% versus 10%, SCD of 3% versus 0.6%, VT incidence of 8% versus 10%, and VF incidence of 6% versus 4% (no significant difference in any comparison). CONCLUSIONS: No significant differences in the incidence of clinical outcomes considered emerged between no-DFT and DFT groups. These results should be confirmed in larger prospective studies.

Ventricular dyssynchrony: 12-month evaluation in ischemic versus nonischemic CRT patients.

OBJECTIVE: Few data exist about the potential differences in the dyssynchrony status of cardiac resynchronization therapy (CRT) candidates stratified by etiology of heart failure, and about the evolution of dyssynchrony at long-term follow-up. We provided a description of intra-ventricular dyssynchrony at baseline, 6 months and 12 months in ischemic and nonischemic CRT patients. METHODS: Tissue Doppler Imaging was performed in 35 CRT candidates (18 ischemic, 17 nonischemic) at baseline, and at 6-month and 12-month follow-up. A group of 11 healthy subjects was considered for comparison. RESULTS: At baseline, the standard deviation and the maximum activation delay between any 2 segments were significantly greater in ischemic (38+/-33ms, 94+/-76ms) and nonischemic (38+/-24ms, 96+/-62ms) patients versus controls (9+/-7ms, 22+/-15ms) (all p<0.05). The average time to activation for posterior and lateral wall was significantly higher in nonischemic patients, while the anterior septum activated later in ischemic patients. At 6-month follow-up, standard deviation and maximum delay did not vary in nonischemic while decreased in ischemic group. All changes persisted at 12 months. CONCLUSIONS: No baseline differences were observed between ischemic and nonischemic patients using studied indices. At 6- and 12-month follow-up, only ischemic patients presented a significant reduction in dyssynchrony values, although in both groups CRT did not lead to a complete normalization of LV synchronism.

Home defibrillation: a feasibility study in myocardial infarction survivors at intermediate risk of sudden death.

BACKGROUND: Out-of-hospital cardiac arrest occurs at home in 65-80% of cases and is often witnessed. We designed a study to explore the feasibility of a home defibrillation program (a) evaluating the retention of cardiopulmonary resuscitation and automated external defibrillators (AED) use skills (BLSD) (b) assessing the impact on anxiety, depression, and quality of life and (c) recording the critical issues emerging from program implementation. METHODS: Thirty-three post-myocardial infarction patients and their 56 relatives received BLSD training and an AED. Assessment of BLSD skills, levels of anxiety, and depression and quality of life were scheduled every 3 months for 1 year or until a common stopping date. RESULTS: Overall BLSD score was 26 +/- 3 at baseline vs. 22 +/- 5 at 3 months (P < .0001), 21 +/- 6 at 6 months (P < .0001), 22 +/- 4 at 9 months (P < .0001) and 23 +/- 5 at 12 months (P = .001). Conversely, the BLSD component AED use" remained stable throughout the study. Quality of life, anxiety, and depression scores remained constant. Compliance to BLSD retraining sessions and AEDs checks decreased over time and was influenced by a concomitant clinical appointment. CONCLUSIONS: BLSD performance of families of post-myocardial infarction patients decreases over time, even though the ability to operate AEDs appears to be the least affected component. Compliance with retraining sessions and AED checks declines over time and is improved if they are combined with clinical appointments. The implementation of a home defibrillation program does not affect anxiety, depression, or the quality of life.

Atrial tachyarrhythmia burden modelling by some electrophysiological parameters in pacemaker-recipient patients with Brady-Tachy syndrome.

AIMS: (1) To correlate atrial tachyarrhythmia (AT) burden of pacemaker-recipient Brady-Tachy syndrome (BTS) patients with a number of diagnostics-derived parameters after 1 month of DDD pacing; (2) to asses whether the activation of atrial overdrive or conventional rate-responsive pacing may affect relevant variables and their correlation. METHODS AND RESULTS: After 1 month of DDD pacing, rate-responsive function or persistent atrial overdrive was randomly activated for 3 months, in 92 BTS patients. Some pacemaker diagnostics parameters collected at 1- and 4-month follow-ups were included in multiple linear regression models, whose dependent variable was the Log transformation of AT burden and compared. With 1-month data, the only variables significantly correlating with Log AT burden were average (with a regression coefficient estimate of -0.07, P=0.02) and standard deviation (0.10, P=0.007) of atrial rate, mean premature atrial contraction (PAC) coupling interval (CI) (-0.005, P=0.001), frequency of PACs with CI<500 ms (1.30, P<10(-6)). Atrial pacing percentage (APP) and ventricular pacing percentage (VPP), PACs with CI>500 ms did not significantly correlate. Four-month data largely confirmed these results, except that in DDDR atrial rate average and standard deviation no longer correlated. Overdrive significantly increased APP and reduced PACs with CI>500 ms. CONCLUSION: AT burden showed significant dependence in DDD and during overdrive on atrial rate average and standard deviation. Highly premature PACs always significantly correlated with AT burden. Though increasing APP, which unexpectedly never correlated, overdrive could only reduce less premature PACs.