ANMCO/AIIC/SIT Consensus Information Document: definition, precision, and suitability of electrocardiographic signals of electrocardiographs, ergometry, Holter electrocardiogram, telemetry, and bedside monitoring systems.

The electrocardiogram (ECG) signal can be derived from different sources. These include systems for surface ECG, Holter monitoring, ergometric stress tests, and telemetry systems and bedside monitoring of vital parameters, which are useful for rhythm and ST-segment analysis and ECG screening of electrical sudden cardiac death predictors. A precise ECG diagnosis is based upon correct recording, elaboration, and presentation of the signal. Several sources of artefacts and potential external causes may influence the quality of the original ECG waveforms. Other factors that may affect the quality of the information presented depend upon the technical solutions employed to improve the signal. The choice of the instrumentations and solutions used to offer a high-quality ECG signal are, therefore, of paramount importance. Some requirements are reported in detail in scientific statements and recommendations. The aim of this consensus document is to give scientific reference for the choice of systems able to offer high quality ECG signal acquisition, processing, and presentation suitable for clinical use.

ANMCO-SIMEU Consensus Document: in-hospital management of patients presenting with chest pain.

Chest pain is a common general practice presentation that requires careful diagnostic assessment because of its diverse and potentially serious causes. However, the evaluation of acute chest pain remains challenging, despite many new insights over the past two decades. The percentage of patients presenting to the emergency departments because of acute chest pain appears to be increasing. Nowadays, there are two essential chest pain-related issues: (i) the missed diagnoses of acute coronary syndromes with a poor short-term prognosis; and (ii) the increasing percentage of hospitalizations of low-risk cases. It is well known that hospitalization of a low-risk chest pain patient can lead to unnecessary tests and procedures, with an increasing trend of complications and burden of costs. Therefore, the significantly reduced financial resources of healthcare systems induce physicians and administrators to improve the efficiency of care protocols for patients with acute chest pain. Despite the efforts of the Scientific Societies in producing statements on this topic, in Italy there is still a significant difference between emergency physicians and cardiologists in managing patients with chest pain. For this reason, the aim of the present consensus document is double: first, to review the evidence-based efficacy and utility of various diagnostic tools, and, second, to delineate the critical pathways (describing key steps) that need to be implemented in order to standardize the management of chest pain patients, making a correct diagnosis and treatment as uniform as possible across the entire country.

ANMCO Position Paper: hospital discharge planning: recommendations and standards.

The hospital discharge is often poorly standardized and affected by discontinuity and fragmentation of care, putting patients at high risk of both post-discharge adverse events and early readmission. The present ANMCO document reviews the modifiable components of the hospital discharge process related to adverse events or re-hospitalizations and suggests the optimal methods for redesigning the whole discharge process. The key principles for proper hospital discharge or transfer of care acknowledge that the hospital discharge: • is not an isolated event, but a process that has to be planned as soon as possible after the admission, ensuring that the patient and the caregiver understand and contribute to the planned decisions, as equal partners; • is facilitated by a comprehensive systemic approach that begins with a multidimensional evaluation process; • must be organized by an operator who is responsible for the coordination of all phases of the hospital patient journey, involving afterward the general practitioner and transferring to them the information and responsibility at discharge; • is the result of an integrated multidisciplinary team approach; • appropriately uses the transitional and intermediate care services; • is carried out in an organized system of care and continuum of services; and • programs the passage of information to after-discharge services.

INtegration of care for reaching targetS In Diabetic patiEnts: Design of the INSIDE Study.

INTRODUCTION: Three Italian scientific associations of different specialties (AMD, Associazione Medici Diabetologi-for diabetologists; ANMCO,Associazione Nazionale Medici Cardiologi Ospedalieri-for cardiologists; SIMG, Società Italiana di Medicina Generale-for General Practitioners) designed this study to assess whether an integrated care organization comprising three different specialists can improve adherence and can achieve the guidelines targets in a population of individuals with type 2 diabetes, without established cardiovascular disease but at high risk (≥ 20% at 10 years according to the CUORE.ISS risk cards) compared with the current standards of care provided by the Italian National Health Service. METHODS: Thirty primary care centers (general practitioners, GPs), 30 cardiology centers and 30 diabetes centers have been selected by the scientific associations, disseminated in the national territory, on the basis of proven previous cooperation in other studies. Each primary care center will enroll 100 type 2 diabetic subjects, > 45 years old, with no established cardiovascular disease, but with a high risk due to the presence of at least one other risk factor besides diabetes over the cutoff [hypertension > 135/80 mmHg, LDL cholesterol > 70 mg/dl, tobacco smoke, first-degree familiarity for CHD (coronary heart disease), central obesity according the WHO criteria]. Fifteen of 30 selected primary care centers, chosen randomly, will continue the treatment of the 100 identified patients according to their "usual care," driven by Good Clinical Practice and by current guidelines (control group or "UC"-usual care), collecting all available clinical and instrumental data and transferring them to the electronic CRF. The remaining 15, after informed consent, will submit their 100 patients each in a specific integrated pathway, which entails the mandatory operational integration and exchange of information with the diabetes specialists and cardiologists pertaining to the same previously identified area. The integrated care path for the patients in the proband group (IC, integrated care) is based on application of the recommendations of the Italian Guidelines aimed at achieving the proposed targets for the main risk factors [LDL < 70 mg/dl; SBP < 130 mmHg; HbA1c (glycated hemoglobin) ≤ 7% (52 mmol/mol]. All the clinical data will be recorded on a shared electronic CRF. The trial will last 3 years: 6 months for the enrollment and randomization of the centers, 6 months for the enrollment of the probands and control subjects, and 2 years of follow-up. The study will be conducted according the Helsinki Declaration on human experimentation ethics. PLANNED OUTCOMES: The primary planned outcome is represented by the increase in the percentage of people that achieve the target values of at least two out of three of the considered risk factors [HbA1c, SBP (systolic blood pressure), LDL cholesterol] compared with the percentage actually achieved in the control group. The secondary outcomes are: (1) a MACE (major adverse cardiac event) composite: non-fatal myocardial infarction, non-fatal stroke, mortality from any cause and hospitalization for cardiovascular disease; (2) the number of early diagnoses of new onset complications; (3) evaluation of adverse events and safety of the probands and control patients; (4) comparative cost analysis and cost-effectiveness analysis.

[ANMCO/SICI-GISE/SIC/SIECVI/SIRM Consensus document: Appropriateness of multimodality imaging in cardiovascular disease]. / Documento di consenso ANMCO/SICI-GISE/SIC/SIECVI/SIRM: Appropriatezza dell'imaging multimodale nelle patologie cardiovascolari.

The complexity of cardiovascular diseases has led to an extensive use of technological instruments and the development of multimodality imaging. This extensive use of different cardiovascular imaging tests in the same patient has increased costs and waiting times.The concept of appropriateness has changed over time. Appropriateness criteria address the need for specific cardiovascular imaging tests in well-defined clinical scenarios, and define the kind of cardiovascular imaging that is appropriated for each clinical scenario in different stages of the disease. The concept of appropriateness criteria has replaced the old idea of appropriate use criteria and reflects the increasing effort of the international Scientific Societies to create and review in a critical way the management of diagnostic tests used by clinicians.The aim of this Italian consensus document is to address the use of multimodality imaging in the diagnosis and management of the major cardiovascular clinical scenarios, taking into consideration not only the international guidelines and scientific documents already published, but also the reality of Italian laws as well as the various professional profiles involved in patient management and availability of technological diagnostic instruments.

[ANMCO/FADOI/SIAARTI/SIC/SIMG/SIMI/SIMEU consensus document: The clinical care pathway of acute heart failure patients from symptom onset to discharge from the emergency department]. / Documento di consenso ANMCO/FADOI/SIAARTI/SIC/SIMG/SIMI/SIMEU: Il percorso clinico-diagnostico e terapeutico del paziente con scompenso cardiaco acuto dal domicilio alla dimissione dal Pronto Soccorso/ Dipartimento di Emergenza-Accettazione.

Acute heart failure (AHF) represents a relevant burden for emergency departments worldwide. AHF patients have markedly worse long-term outcomes than patients with other acute cardiac diseases (e.g. acute coronary syndromes); mortality or readmissions rates at 3 months approximate 33%, whereas 1-year mortality from index discharge ranges from 25% to 50%.The multiplicity of healthcare professionals acting across the care pathway of AHF patients represents a critical factor, which generates the need for integrating the different expertise and competence of general practitioners, emergency physicians, cardiologists, internists, and intensive care physicians to focus on care goals able to improve clinical outcomes.This consensus document results from the cooperation of the scientific societies representing the different healthcare professionals involved in the care of AHF patients and describes shared strategies and pathways aimed at ensuring both high quality care and better outcomes. The document describes the patient journey from symptom onset to the clinical suspicion of AHF and home management or referral to emergency care and transportation to the hospital, through the clinical diagnostic pathway in the emergency department, acute treatment, risk stratification and discharge from the emergency department to ordinary wards or home. The document analyzes the potential role of a cardiology fast-track and Observation Units and the transition to outpatient care by general practitioners and specialist heart failure clinics.The increasing care burden and complex problems generated by AHF are unlikely to be solved without an integrated multidisciplinary approach. Efficient networking among emergency departments, intensive care units, ordinary wards and primary care settings is crucial to achieve better outcomes. Thanks to the joint effort of qualified scientific societies, this document aims to achieve this goal through an integrated, shared and applicable pathway that will contribute to a homogeneous care management of AHF patients across the country.

[Appropriateness in Cardiology: a statement of the ANMCO Veneto Region]. / L'appropriatezza prescrittiva in Cardiologia: documento dell'ANMCO Regione Veneto.

Inappropriate tests are responsible for longer waiting lists, higher economical costs for the National Health System and major clinical risks due to radiation exposure from prescription abuse of diagnostic testing. Clinical inappropriateness frequently derives from poor knowledge of guidelines, "defensive medicine" approach and/or repeat requests of patients and family members. About one third of non-invasive imaging tests are considered inappropriate.In order to define the most appropriate instruments for the follow-up of the most common cardiovascular diseases with the highest risk of inappropriateness, all the cardiologists of the Veneto Region (Italy), along with the local chapters of the main national cardiology societies and general practitioners have been involved by the Regional Section of the Italian Association of Hospital Cardiologists (ANMCO) in several scientific meetings on the following topics: hypertension, chronic ischemic heart disease, valvular heart disease, heart failure, and atrial fibrillation. This has led to the present document where: (i) the most appropriate clinical and diagnostic strategies are taken into account, and (ii) the most robust scientific evidence is provided for the regulatory commission of the Veneto Region Health Service to identify inappropriateness, prescription unsuitability, and economical sustainability.

[ANMCO/AIIC/SIT Consensus document: Definition, precision and appropriateness of the electrocardiographic signal of electrocardiographic recorders, ergometry systems, Holter systems, telemetry and bedside monitors]. / Documento di consenso ANMCO/AIIC/SIT: Definizione, precisione e appropriatezza del segnale elettrocardiografico di elettrocardiografi, sistemi per ergometria, sistemi Holter ECG, telemetrie e monitor posto-letto.

The ECG signal can be derived from different sources. These include systems for surface ECG, Holter monitoring, ergometric stress tests and systems for telemetry and bedside monitoring of vital parameters, useful to rhythm and ST-segment analysis and ECG screening of cardiac electrical sudden death predictors. A precise ECG diagnosis is based upon a correct recording, elaboration and presentation of the signal. Several sources of artifacts and potential external causes may influence the quality of the original ECG waveforms. Other factors that may affect the quality of the information presented depends upon the technical solutions employed to improve the signal. The choice of the instrumentations and solutions used to offer a high quality ECG signal are therefore of paramount importance. Some requirements are reported in detail in scientific statements and recommendations. The aim of this consensus document is to offer a scientific reference for the choice of systems able to offer a high quality ECG signal acquisition, processing and presentation suitable for clinical use.

[ANMCO/SIMEU Consensus document: In-hospital management of patients presenting with chest pain]. / Documento di consenso ANMCO/SIMEU: Gestione intraospedaliera dei pazienti che si presentano con dolore toracico.

Chest pain is a common general practice presentation that requires careful diagnostic assessment because of its diverse and potentially serious causes. However, the evaluation of acute chest pain remains challenging, despite many new insights over the past two decades. The percentage of patients presenting to the emergency departments because of acute chest pain appears to be increasing. Nowadays, there are two essential chest pain-related issues: 1) the missed diagnoses of acute coronary syndromes with a poor short-term prognosis; 2) the increasing percentage of hospitalizations of low-risk cases.It is well known that hospitalization of a low-risk chest pain patient can lead to unnecessary tests and procedures, with an increasing trend of complications and burden of costs. Therefore, the significantly reduced financial resources of healthcare systems induce physicians and administrators to improve the efficiency of care protocols for patients with acute chest pain. Despite the efforts of the Scientific Societies in producing statements on this topic, in Italy there is still a significant difference between emergency physicians and cardiologists in managing patients with chest pain. For this reason, the aim of the present consensus document is double: first, to review the evidence-based efficacy and utility of various diagnostic tools, and, second, to delineate the critical pathways (describing key steps) that need to be implemented in order to standardize the management of chest pain patients, making a correct diagnosis and treatment as uniform as possible across the entire country.

[ANMCO Position paper: Hospital discharge planning]. / Position paper ANMCO: Gestione della dimissione ospedaliera.

Hospital discharge is often poorly standardized and is characterized by discontinuity and fragmentation of care, putting patients at high risk of post-discharge adverse events and early readmission. The present ANMCO position paper reviews the modifiable components of the hospital discharge process related to adverse events or rehospitalizations and suggests the optimal methods for redesign the whole discharge process. The key principles for proper hospital discharge or transfer of care acknowledge that hospital discharge:- is not an isolated event, but a process that has to be planned immediately after admission, ensuring that the patient and the caregiver understand and contribute to the planned decisions as equal partners;- is facilitated by a comprehensive systemic approach that begins with a multidimensional evaluation process;- must be organized by an operator who is responsible for the coordination of all phases of the hospital patient pathway, involving afterwards the physician and transferring to them the information and responsibility;- is the result of an integrated multidisciplinary team approach;- uses appropriately the transitional and intermediate care services;- is carried out in an organized system of care and continuum of services;- programs the passage of information to after-discharge services.

[Hospital epidemiology of ST-segment elevation myocardial infarction and feasibility of primary percutaneous coronary intervention in an interhospital network: data from a multicenter, prospective and observational study VENERE (VENEto acute myocardial infarction REgistry]. / Epidemiologia ospedaliera dell'infarto miocardico acuto con sopraslivellamento del tratto ST ed applicabilità dell'angioplastica primaria nel contesto di rete interospedaliera: studio prospettico osservazionale e multicentrico VENERE (VENEto acute myocardial infarction REgistry).

BACKGROUND: Primary percutaneous coronary intervention (pPCI) is the most effective reperfusion treatment of acute ST-segment elevation myocardial infarction (STEMI), but logistic- and organization-related problems affect its feasibility. The aim of this study was to investigate a) the requirements of reperfusion therapies, and b) the feasibility of pPCI as suggested by the current guidelines, in the Veneto Region. METHODS: With the aim to treat with pPCI most of the patients with high-risk STEMI regardless of the type of admitting hospital, a single treatment protocol was developed and shared by the majority of Cardiology Departments in the Veneto Region. Data of all consecutive patients with STEMI were prospectively recorded and subsequently and independently compared with administrative data. RESULTS: In 28 participating hospitals, 1160 consecutive patients with STEMI were enrolled during a 6-month period: in 999 symptom onset was < 12 hours. Based on the registry data, it is possible to estimate that 697 patients/million of inhabitants/year are admitted in Cardiology Departments with the initial diagnosis of STEMI: 86% are admitted < 12 hours from symptom onset and 58% of them have at least one characteristic of high risk. The strategy of immediate coronary angiography and possible PCI was carried out in 52.3% of eligible patients: in 55.8 and 47.5% of high- and low-risk STEMI and from 17.1 to 75.1% based on the type of admitting hospital. Recanalization with pPCI was obtained < 90 min from the diagnosis in 70 and 32% of patients treated on site and transferred, respectively. CONCLUSIONS: The absolute number of patients with STEMI eligible for reperfusion therapies is lower than previously reported. The reperfusion strategy based on pPCI was much more related to the type of admitting hospital than to the clinical characteristics of the patients. pPCI performed as suggested by the current guidelines is feasible in patients admitted in hospitals with interventional facilities available 24 hours/day, but in those who need to be transferred it is necessary to modify the existing pathways and/or treatment protocols.

[Impact of reperfusion strategies on in-hospital outcome in ST-elevation myocardial infarction in a context of interhospital network: data from the prospective VENERE registry (VENEto acute myocardial infarction REgistry]. / L'impatto delle diverse strategie riperfusive sull'esito intraospedaliero dell'infarto miocardico acuto con sopraslivellamento del tratto ST nel contesto di rete interospedaliera: studio prospettico osservazionale e multicentrico VENERE (VENEto acute myocardial infarction REgistry).

BACKGROUND: Primary angioplasty (pPCI) is the most effective reperfusion treatment of acute ST-elevation myocardial infarction (STEMI), but logistic- and organization-related problems could affect the outcome. The aim of this study was to investigate the in-hospital outcome according to reperfusion strategy in the Veneto Region cardiology network. METHODS: A treatment protocol, aimed to treat patients with high-risk STEMI by pPCI on-site or after transport, was developed and shared by the majority of cardiology departments in the Veneto Region. Data of all consecutive patients with STEMI were prospectively recorded during a 6-month period. RESULTS: 999 patients with symptom onset < 12 hours were admitted to the 28 participating hospitals: 860 were treated on-site and 139 were transferred from the admitting hospital to an interventional center for PCI. Overall, 82% of patients were treated with reperfusion therapy. Ten patients died immediately before any treatment could be initiated. In 170 patients who did not receive any reperfusion treatment, in 302 patients who received fibrinolysis (and eventually rescue PCI) and in 517 patients sent to pPCI, the following in-hospital outcome was observed respectively: mortality rate 10, 6.95 and 6.57%; reinfarction rate 0.6, 1 and 0.4%; incidence of stroke 1.7, 1.4 and 0.9%; the need for urgent revascularization procedure 6.5, 10 and 2.3%. After adjustment for confounding variables, the in-hospital occurrence of the combined events was significantly lower in patients treated with pP-CI (odds ratio 0.33, confidence interval 0.20-0.53, p < 0.01) as well as a trend for a reduced in-hospital mortality was observed (odds ratio 0.51, confidence interval 0.26-1.03, p = 0.06). CONCLUSIONS: In the VENERE registry, patients treated with pPCI had a better in-hospital outcome as compared to those treated with fibrinolytic strategy.

Immediate and long-term clinical outcome after spinal cord stimulation for refractory stable angina pectoris.

The treatment of patients with angina pectoris refractory to medical therapy and unsuitable for revascularization procedures has yet not been well standardized. Previous retrospective studies and small prospective studies have suggested beneficial effects of spinal cord stimulation (SCS) in these patients. We created a Prospective Italian Registry of SCS to evaluate the short- and long-term clinical outcome of patients who underwent SCS device implantation because of severe refractory angina pectoris. Overall, 104 patients were enrolled in the registry (70 men, aged 68 +/- 17 years), most of whom (83%) had severe coronary artery disease. Average follow-up was 13.2 +/- 8 months. Overall, 17 patients (16%) died, 8 (8%) due to cardiac death. Among clinical variables, only age was found to be significantly associated both with total mortality (p = 0.04) and cardiac mortality (p = 0.02) on Cox regression analysis. A significant improvement of anginal symptoms (> or =50% reduction of weekly anginal episodes, compared with baseline) occurred in 73% of patients, and Canadian Cardiovascular Society angina class improved by > or =1 class in 80% and by > or =2 classes in 42% of patients, with a relevant reduction in the rate of hospital admission and days spent in the hospital because of angina (p <0.0001 for both). No life-threatening or clinically serious complications were observed. The most frequent side effect consisted of superficial infections, either at the site of puncture of electrode insertion or of the abdominal pocket, which occurred in 6 patients. In conclusion, our prospective data point out that SCS can be performed safely and is associated with a sustained improvement of anginal symptoms in a relevant number of patients with refractory stable angina pectoris.

Early assessment of coronary flow reserve by transthoracic Doppler echocardiography predicts late remodeling in reperfused anterior myocardial infarction.

BACKGROUND: Microvascular integrity is an essential determinant of favorable late outcome in reperfused myocardial infarction. Coronary flow reserve (CFR) can be assessed by transthoracic Doppler echocardiography and provides a functional estimate of microvascular integrity downstream from the patent infarct-related vessel. OBJECTIVE: We sought to assess the effects of CFR in predicting late left ventricular (LV) remodeling in patients with reperfused acute anterior myocardial infarction treated with primary angioplasty. METHODS: In all, 31 patients admitted with acute anterior myocardial infarction underwent primary angioplasty of the infarct-related vessel. After angioplasty, angiographic thrombosis in myocardial infarction (TIMI) grade and myocardial blush were scored. On the first day, all underwent stress echocardiography and CFR evaluation of left anterior descending coronary artery by transthoracic Doppler. All patients had resting 2-dimensional echocardiography at 1, 3, and 6 months for assessment of LV function. RESULTS: CFR could be successfully assessed in 31 patients. After 6 months 5 patients showed LV dilatation (group I), whereas 26 patients did not show significant variation (group II). On day 1, CFR was higher (group I = 1.43 +/- 0.11 vs group II = 1.67 +/- 0.26, P =.005) and the deceleration time of diastolic left anterior descending coronary artery flow velocity was longer (group I = 212 +/- 41.4 milliseconds vs group II = 286 +/- 106.7 milliseconds, P <.02) in patients without, compared with those with LV remodeling, whereas there was no difference in angiographic parameters. CONCLUSION: Early assessment of CFR and the pattern of baseline diastolic coronary flow velocity by transthoracic Doppler echocardiography is feasible, safe, and more useful than angiographic indices in identifying patients at high risk of remodeling in spite of successful primary angioplasty.

[Thrombocytopenia associated with massive cardiac thrombosis during treatment with non-fractionated heparin: description of a clinical case]. / Trombocitopenia associata a trombosi cardiaca massiva in corso di trattamento con eparina non frazionata: descrizione di un caso clinico.

Thrombosis associated with a drop in the platelet count may occur in 33-50% of the patients who develop heparin-induced thrombocytopenia (HIT) during treatment with unfractionated heparin; the deep veins are commonly involved while cardiac thrombosis is considered as a rare complication. We report the case of a 64-year-old woman who was treated with unfractionated heparin following a myocardial infarction and an episode of deep vein thrombosis which occurred 13 days after myocardial revascularization including triple coronary artery bypass grafting; a drop in the patient's platelet count was documented and a transesophageal echocardiogram revealed massive thrombosis of the four cavities of her heart. The diagnosis of HIT was supported by high blood levels of PF4-antiheparin antibodies. Heparin infusion was stopped and the patient was started on sodium warfarin therapy; the platelet count promptly returned to normal and the size of the clots slowly decreased, although they were still detectable 1 month later. Aspirin (325 mg daily) was then prescribed as an adjunct to warfarin and 6 months later we documented the total disappearance of the thrombotic masses without embolic complications.

Left ventricular apical ballooning syndrome in men: a case series.

OBJECTIVES: Apical ballooning syndrome usually involves elderly women. We reported the profile of this syndrome in men. METHODS: We identified 54 consecutive patients with the syndrome: among them, seven were men (13%, group M) and 47 were women (87%, group F). RESULTS: Men were younger than women (group M 61.7 years vs. group F 72.8 years, median age, P < 0.01) and emotional triggers predominated in women ( group M 14.3% vs. group F 44.7%, P = 0.01) compared with physiological ones which were more frequent in men (group M 42.9% vs. group F 19.1%, P = 0.02). At onset, men were more compromised than women (group M 42.9% vs. group F 6.4%, P = 0.004). At the median follow-up of 18.5 months, more men died than women (group M 28.6% vs. group F 8.5%, P = NS), but only women had cardiac-related deaths (group M 0% vs. group F 6.4%, P = NS). Cardiac outcome was similar in both groups (group M 14.3% vs. group F 23.4%, P = NS). Left ventricular ejection fraction increased in both sexes from 41% to more than 56% (P < 0.01). CONCLUSION: In this small case series, left ventricular apical ballooning syndrome showed similar features in both sexes. However, men seemed to be more affected at younger age, presented more physiological triggers and more compromised clinical status at admission. Despite this, cardiac outcome was good in both sexes.

Spinal cord stimulation for the treatment of refractory angina pectoris: a multicenter randomized single-blind study (the SCS-ITA trial).

Spinal cord stimulation (SCS) is believed to be effective in treating refractory angina. The need for SCS-related chest paresthesia, however, has hitherto made impossible placebo-controlled trials. Subliminal (non paresthesic) SCS, however, might be also effective on anginal pain. In this trial we compared subliminal SCS with paresthesic SCS and with sham SCS. Twenty-five refractory angina patients, who had never received SCS before, underwent SCS device implantation and were randomized to three groups: paresthesic SCS (group PS; n=10), subliminal SCS (group SS; n=7) or "sham" SCS (group NS; n=8). After 1month group NS patients were randomized to either group PS or SS. After 1month, changes in angina episodes (p=0.016), nitroglycerin use (p=0.015), angina class (p=0.02), quality of life score (p=0.05), and items 2 (p=0.008) and 3 (p=0.009) of Seattle angina questionnaire differed significantly among groups. Group PS showed significant improvement in outcomes compared to group NS, whereas there were no significant differences between groups SS and NS; furthermore, only nitroglycerin use differed significantly between groups PS and SS. At 3months, a significant difference between groups PS and SS was observed in angina attacks (p=0.002), but not in other variables. Thus, in this study, paresthesic, but not subliminal SCS was superior to sham SCS in improving clinical status in refractory angina patients. The lack of significant differences between PS and SS groups in this small study suggests that a possible role for subliminal SCS in individual patients deserves to be assessed in larger trials with appropriate statistical power.

Long-term outcome and sex distribution across ages of left ventricular apical ballooning syndrome.

OBJECTIVE: Apical ballooning syndrome is a rare clinical entity that predominantly involves elderly women and is considered to be benign. We report our experience regarding this syndrome in terms of sex distribution and long-term outcome. METHODS: Between 1999 and 2006, we identified 28 consecutive patients affected by the apical ballooning syndrome. Inclusion criteria were an onset of mimicking acute myocardial infarction, transient akinesia/dyskinesia of the mid-apical left ventricular segments and no significant obstructive coronary artery disease. Patients with a recent brain disease, pheocromocytoma, hypertrophic cardiomyopathy and suspected myocarditis were excluded. Sex distribution was assessed across different ages according to quartiles: less than 61 years of age (group 1), 61-71 years (group 2), 72-77 years (group 3) and more than 77 years (group 4). In-hospital and follow-up events were observed. RESULTS: The apical ballooning syndrome represented 1.69% of ST-segment elevation acute coronary syndromes. There were more women than men in groups 2 (85.7 vs. 14.3%), 3 (85.7 vs. 14.3%) and 4 (100 vs. 0%), but there were fewer women than men in group 1 (42.9 vs. 57.1%), with an overall supremacy of women (78.6 vs. 21.4%) (P=0.02). In-hospital events were one (3.6%) cardiac death and five (17.9%) nonfatal events. At the median follow-up of 24 months, one patient was lost and two (7.7%) died of cardiac causes, thus, the total cardiac mortality was 10.7% (3/28 patients); no recurrence occurred and left ventricular ejection fraction increased from 40.4 to 58.6% (P<0.01). CONCLUSION: In our population, left ventricular apical ballooning syndrome included several typical features. However, a peculiar sex tendency across various age groups was observed and, although older women predominated, men seemed to be more affected than women at a younger age. The long-term prognosis seems to be favourable.