[Wearable cardioverter-defibrillators: clinical experience and future perspectives]. / Il defibrillatore indossabile: evidenze cliniche e prospettive future.

Sudden cardiac death (SCD) can affect patients with ischemic or non-ischemic left ventricular dysfunction. Automatic implantable cardioverter-defibrillator (ICD) implantation is the most effective option for the treatment of malignant ventricular tachyarrhythmias; however, the procedure is burdened with known significant risks, even in the long term.In patients at high risk of SCD, either real or perceived, without a definite indication to ICD implantation, wearable cardioverter-defibrillators have been shown to offer effective temporary protection in different clinical settings, for patients with recent high-risk myocardial infarction with left ventricular dysfunction, even after myocardial revascularization procedures, heart failure with reduced ejection fraction, newly diagnosed dilated cardiomyopathy, ICD post-explant phase for infection, and bridge to cardiac transplantation.The purpose of this review is to describe the technical aspects and clinical results available in the literature on the use of wearable cardioverter-defibrillators, with particular reference to safety, efficacy, costs and patient selection, together with current and unconventional indications.The authors also report the first data related to their personal experience.

[Palliative care in the intensive cardiac care unit: a new competence for the cardiac intensivist]. / Cure palliative in unità di terapia intensiva cardiologica: una nuova competenza per il cardiologo intensivista.

Admissions to the intensive care unit at the end of life of patients with chronic non-malignant diseases are increasing. This involves the need for the development of palliative care culture and competence, also in the field of intensive cardiology. Palliative care should be implemented in the treatment of all patients with critical stages of disease, irrespective of prognosis, in order to improve the quality of care at the end of life.This review analyzes in detail the main clinical, ethical and communicational issues to move toward the introduction of basics of palliative care in cardiac intensive care units. It outlines the importance of shared decision-making with the patient and his family, with special attention to withholding/withdrawing of life-sustaining treatments, palliative sedation, main symptom control, patient and family psychological support.

[Implantable cardioverter-defibrillator deactivation at the end of life: ethical, clinical and communication issues]. / La disattivazione del defibrillatore impiantabile alla fine della vita: etica, clinica, comunicazione.

The number of cardioverter-defibrillator implants is increasing worldwide, with the main indication being primary prevention of sudden cardiac death. During the follow-up, patients may die from progression of their underlying heart disease or from nonarrhythmic causes, such as malignancies, dementia and lung disease, without receiving appropriate shocks until the last few days or weeks of their life. These events occur roughly in 30% of patients, mainly in the last 24 hours before death. In this case, inappropriate and even appropriate shock deliveries can no longer prolong life and may simply lead to pain and reduced quality of life. Therefore, it appears important to discuss early with the patients and their relatives about deactivation of the implantable cardioverter-defibrillator (ICD) at the end of life.The goal of this review is to provide an overview of the ethical, clinical and communication issues of ICD deactivation, with a special focus on patients' wishes. It is outlined that patients are not adequately informed about risks and benefits of ICD and the option of ICD deactivation; the doctors are not used to discuss with the patients the topics of end-of-life decisions. Complete information must be part of current informed consent before ICD implantation and should be updated during the follow-up, with special attention to patients with heart failure in relation to their prognosis and advance directives, as suggested by international guidelines.

Takotsubo cardiomyopathy as an early complication of drug-induced suicide attempt.

Takotsubo cardiomyopathy typically presents in menopausal women following episodes of intense physical or mental stress. To our knowledge, the literature contains only two documented cases of Takotsubo cardiomyopathy arising following a suicide attempt, neither of which involved pharmaceutical poisoning. Here, however, we document the case of a young male patient with borderline personality disorder and a clinical and angiographic presentation compatible with Takotsubo cardiomyopathy arising following a suicide attempt by voluntary drug intoxication (risperidone, barbiturates, and benzodiazepine). The potential pathophysiological mechanisms behind this unusual clinical picture are discussed.

A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease: the EXECUTIVE trial (EXecutive RCT: evaluating XIENCE V in a multi vessel disease).

OBJECTIVES: This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD). BACKGROUND: Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD although first-generation DES yielded inferior efficacy and safety compared with surgery. METHODS: Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and a prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months. RESULTS: The primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (-0.03 ± 0.49 mm vs. 0.23 ± 0.51 mm, p = 0.001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs. 0.24 ± 0.50 mm, p < 0.001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry, and 11.1% and 16.5% in the EES and PES randomized groups, respectively (p = 0.30). CONCLUSIONS: The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Libertè, and a low major adverse cardiac event rate at 1 year in patients with 2-to 3-vessel MV-CAD. (EXECUTIVE [EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease]; NCT00531011).

A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease. Study design and rationale of the EXECUTIVE trial.

BACKGROUND: Myocardial revascularization with drug-eluting stents (DESs) is emerging as an alternative to conventional coronary artery bypass surgery in patients with multivessel coronary artery disease (MV-CAD). First-generation DESs have yielded equivalent safety results at mid-term compared with surgery, but inferior efficacy in preventing the recurrence of ischemic symptoms. The outcome of percutaneous coronary intervention with a second-generation everolimus DES as compared with a paclitaxel DES in patients with MV-CAD has not been established. AIM OF THE STUDY: The aim of the study is the assessment of the efficacy and performance of the XIENCE V everolimus-eluting stent in the treatment of de-novo coronary artery lesions in patients with MV-CAD. STUDY DESIGN: The study is composed of two parts: a prospective, double arm, randomized multicenter trial to assess the angiographic efficacy of the XIENCE V everolimus-eluting coronary stent system (EECSS) compared with the Taxus Liberté Paclitaxel Eluting Coronary Stent System (Taxus Liberté Stent) and a prospective, open-label, single arm, controlled registry to analyze the clinical efficacy and safety of XIENCE V EECSS at mid-term and long-term follow-up in patients treated for MV-CAD. ENDPOINTS: For the EXECUTIVE randomized trial, the primary endpoint is in-stent late lumen loss at 9 months. For the EXECUTIVE registry, the primary endpoint is a composite of all death, myocardial infarction (Q-wave and non-Q-wave), and ischemia-driven target vessel revascularization at 12 months. The study will be conducted at 30 study centers in Italy and 600 patients will be enrolled in total: 200 patients will be enrolled (1: 1) in the randomized trial and 400 patients will enter the registry. SAMPLE SIZE: It was calculated that, assuming a mean in-stent late lumen loss of 0.20 +/- 0.41 mm in the XIENCE V EECSS arm and 0.30 +/- 0.53 mm in the Taxus Liberté stent arm, and a noninferiority margin delta of 0.12 (according to the SPIRIT III results), the analysis of 81 lesions per arm would provide over 90% power. Therefore, 200 patients will be enrolled to account for dropouts. CONCLUSION: The present study is expected to provide as yet unavailable information about the performance of second-generation stents in the specific setting of patients with MV-CAD.