Martino Martinelli

Efficacy of Antibiotic Prophylaxis Before the Implantation of Pacemakers and Cardioverter-Defibrillators: Results of a Large, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial

Background—Although routinely administered, definitive evidence for the benefits of prophylactic antibiotics before the implantation of permanent pacemakers and implantable cardioverter-defibrillators from a large double-blinded placebo-controlled trial is lacking. The purpose of this study was to determine whether prophylactic antibiotic administration reduces the incidence of infection related to device implantation. Methods and Results—This double blinded study included 1000 consecutive patients who presented for primary device (Pacemaker and implantable cardioverter-defibrillators) implantation or generator replacement randomized in a 1:1 fashion to prophylactic antibiotics or placebo. Intravenous administration of 1 g of cefazolin (group I) or placebo (group 2) was done immediately before the procedure. Follow-up was performed 10 days, 1, 3, and 6 months after discharge. The primary end point was any evidence of infection at the surgical incision (pulse generator pocket), or systemic infection related to be procedure. The safety committee interrupted the trial after 649 patients were enrolled due to a significant difference in favor of the antibiotic arm (group I: 2 of 314 infected patients—0.63%; group II: 11 of 335 to 3.28%; RR=0.19; P=0.016). The following risk factors were positively correlated with infection by univariate analysis: nonuse of preventive antibiotic (P=0.016); implant procedures (versus generator replacement: P=0.02); presence of postoperative hematoma (P=0.03) and procedure duration (P=0.009). Multivariable analysis identified nonuse of antibiotic (P=0.037) and postoperative hematoma (P=0.023) as independent predictors of infection. Conclusions—Antibiotic prophylaxis significantly reduces infectious complications in patients undergoing implantation of pacemakers or cardioverter-defibrillators.

Sudden cardiac death in patients with chagas heart disease and preserved left ventricular function.

Sudden Cardiac Death in Patients with Chagas Heart Disease and Preserved Left Ventricular Function EDUARDO BACK STERNICK, M.D., PH.D., MARTINO MARTINELLI, M.D., PH.D.,∗ ROGÉRIO CORREIA SAMPAIO, M.D., LUIZ MÁRCIO GERKEN, M.D., RICARDO ALKMIM TEIXEIRA, M.D.,∗ RICARDO SCARPELLI, M.D., MAURÍCIO SCANAVACCA, M.D., PH.D.,∗ SILVANA D ́ORIO NISHIOKA, M.D.,∗ and EDUARDO SOSA, M.D., PH.D.∗ From the Arrhythmia and Electrophysiology Unit, Biocor Instituto, Nova Lima, Brazil, and ∗Arrhythmia and Pacemaker Unit, Heart Institute, São Paulo University, São Paulo, Brazil

Functional IL18 polymorphism and susceptibility to Chronic Chagas Disease

BACKGROUND Chronic Chagas Disease cardiomyopathy (CCC), a life-threatening inflammatory dilated cardiomyopathy, affects 30% of the approximately 8 million patients infected by Trypanosoma cruzi, the rest of the infected subjects remaining asymptomatic (ASY). The Th1 T cell-rich myocarditis plays a pivotal role in CCC pathogenesis. Local expression of IL-18 in CCC myocardial tissue has recently been described. IL-18 could potentially amplify the process by inducing increased expression of IFN-γ which in turn can increase the production of IL-18, thereby creating a positive feedback mechanism. In order to assess the contribution of the IL-18 to susceptibility to Chronic Chagas Disease, we investigated the association between a single nucleotide polymorphism (SNP) located in the IL-18 gene with the risk of developing Chagas cardiomyopathy. METHODS AND RESULTS We analyzed the rs2043055 marker in the IL18 gene in a cohort of Chagas disease cardiomyopathy patients (n=849) and asymptomatic subjects (n=202). We found a significant difference in genotype frequencies among moderate and severe CCC patients with ventricular dysfunction. CONCLUSIONS Our analysis suggests that the IL18 rs2043055 polymorphism- or a SNP in tight linkage disequilibrium with it- may contribute to modulating the Chagas cardiomyopathy outcome.

CHronic use of Amiodarone aGAinSt Implantable cardioverter-defibrillator therapy for primary prevention of death in patients with Chagas cardiomyopathy Study: Rationale and design of a randomized clinical trial

BACKGROUND The implantable cardioverter defibrillator (ICD) is better than antiarrhythmic drug therapy for the primary and secondary prevention of all-cause mortality and sudden cardiac death in patients with either coronary artery disease or idiopathic dilated cardiomyopathy. This study aims to assess whether the ICD also has this effect for primary prevention in chronic Chagas cardiomyopathy (CCC). METHODS In this randomized (concealed allocation) open-label trial, we aim to enroll up to 1,100 patients with CCC, a Rassi risk score for death prediction of ≥10 points, and at least 1 episode of nonsustained ventricular tachycardia on a 24-hour Holter monitoring. Patients from 28 centers in Brazil will be randomly assigned in a 1:1 ratio to receive an ICD or amiodarone (600 mg/d for 10 days, then 200-400 mg/d until the end of the study). The randomization sequence will be generated by computer, and the members of the committees responsible for end point validation and data analysis will be blinded to study assignment. The primary end point is all-cause death, and enrolment will continue until 256 patients have reached this end point. Key secondary end points include cardiovascular death, sudden cardiac death, hospitalization for heart failure, and quality of life. We expect follow-up to last 3 to 6 years, and data analysis will be done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov number NCT01722942. CONCLUSION CHAGASICS is the first large-scale trial to assess the benefit of ICD therapy for the primary prevention of death in patients with CCC and nonsustained ventricular tachycardia, who have a moderate to high risk of death.

COMBAT--conventional versus multisite pacing for bradyarrhythmia therapy: rationale of a prospective randomized multicenter study.

COMBAT is a prospective, multicenter, randomized, blinded clinical study, with crossover design. The main objective is the comparative evaluation of atrio‐biventricular versus conventional atrioventricular stimulation (atrio and right ventricle) in patients with heart failure and bradycardia as the primary indication for pacemaker implantation. After successful atrio‐biventricular system implantation, patients will be randomized into two groups: group A—atrioventricular conventional pacing and group B—atrio‐biventricular pacing. Both groups will be programmed in DDD mode with AV delay optimized by echocardiogram. After 3 months, New York Heart Association functional class, ventricular arrhythmia density and complexity, echocardiography outcomes, 6‐min hall walk distance, quality of life and peak oxygen consumption will be assessed in all patients. Then, all patients will crossover to the other pacing regimen, with an additional AV delay adjustment by echo. Patients will be followed up for another 3 months at the end of which all evaluations will be repeated. Patients will then crossover back to their original pacing regimen for a further 3 months. At the end of this 9‐month period, patients will be reprogrammed according to their optimal pacing regime.

Diretriz de interpretação de eletrocardiograma de repouso

Jose Alves Pinho (BA), Mario Sergio de Carvalho Bacellar (BA),Demostenes G. Lima Ribeiro (CE), Rubens Nassar Darwich (MG),Antonio Luiz Pinho Ribeiro (MG), Marcelo Marcos Eloy Dunda (PB),Helio Germiniani (PR), Francisco Faustino Franca (PE),Laurindo Saraiva (PE), Clebia Maria Rios Ribeiro (PE),Paulo Ginefra (RJ), Iseu Gus (RS), Eney Fernandes (SC),Andres Riera (SC), Anisio Pedrosa (SP),Antonio Americo Friedman (SP), Antonio Carlos Firmiani (SP),Cesar Grupi (SP), Claudio Pinho (SP),Eduardo Vilaca Lima (SP), Elisabeth Kaiser (SP),Fabio Sandoli Brito (SP), Gilberto Luiz Castro Vinhas (SP),Helio Schwartz (SP), Jose Grindler (SP), Jose Luiz Aziz (SP),Marcio Figueiredo (SP), Marcos S. Molina (SP),Martino Martinelli (SP), Nancy Tobias (SP),Paulo Cesar R. Sanches (SP), Paulo Jorge Moffa (SP),Severino Attanes Neto (SP), Silvana Nishioka (SP)

Permanent and temporary pacemaker implantation after orthotopic heart transplantation

PURPOSE To determine the indication for and incidence and evolution of temporary and permanent pacemaker implantation in cardiac transplant recipients. METHODS A retrospective review of 114 patients who underwent orthotopic heart transplantation InCor (Heart Institute USP BR) between March 1985 and May 1993. We studied the incidence of and indication for temporary pacing, the relationship between pacing and rejection, the need for permanent pacing and the clinical follow-up. RESULTS Fourteen of 114 (12%) heart transplant recipients required temporary pacing and 4 of 114 (3.5%) patients required permanent pacing. The indication for temporary pacing was sinus node dysfunction in 11 patients (78.5%) and atrioventricular (AV) block in 3 patients (21.4%). The indication for permanent pacemaker implantation was sinus node dysfunction in 3 patients (75%) and atrioventricular (AV) block in 1 patient (25%). We observed rejection in 3 patients (21.4%) who required temporary pacing and in 2 patients (50%) who required permanent pacing. The previous use of amiodarone was observed in 10 patients (71.4%) with temporary pacing. Seven of the 14 patients (50%) died during follow-up. CONCLUSION Sinus node dysfunction was the principal indication for temporary and permanent pacemaker implantation in cardiac transplant recipients. The need for pacing was related to worse prognosis after cardiac transplantation.

Silent Atrial Fibrillation in Elderly Pacemaker Users: A Randomized Trial Using Home Monitoring

Pacemaker with remote monitoring (PRM) may be useful for silent atrial fibrillation (AF) detection. The aims of this study were to evaluate the incidence of silent AF, the role of PRM, and to determine predictors of silent AF occurrence.

Effects of cardiac resynchronization therapy on muscle sympathetic nerve activity.

Muscle sympathetic nerve activity (MSNA) is an independent prognostic marker in patients with heart failure (HF). Therefore, its relevance to the treatment of HF patients is unquestionable.

Criteria for pacemaker explant in patients without a precise indication for pacemaker implantation.

MARTINELLI, M., et al.: Criteria for Pacemaker Explant in Patients Without a Precise Indication for Pacemaker Implantation. Unnecessary pacemaker implantation may cause significant social and psychological consequences, the inconvenience of periodic office visits, and the expense of pulse generator replacement. Establishing adequate criteria for explanting pacemakers is crucial and has not yet been described. This study presents the results of a study protocol for explanting the pacemaker in patients without a clear indication for pacemaker implantation. Seventy pacemaker users without a clear reason for the implantation were included in the study conducted from August 1986 to November 1998 and were prospectively followed. The investigation consisted of clinical and neurological evaluations, echocardiogram, exercise testing, and tilt table testing. When these tests were negative, the pulse generator energy and stimulation rates were reprogrammed to the lowest values. Periodic Holter monitoring was conducted during follow‐up. When asymptomatic for 1 year, patients underwent an electrophysiological evaluation of sinus and atrioventricular junction function and ventricular vulnerability. When the electrophysiological study was negative, pacemaker explantation was performed. Of the 70 patients, 35 had their pacemaker explanted; 3 were excluded due to a positive tilt table test and electrophysiological study, and 3 are waiting for pacemaker explantation. Mean follow‐up after pacemaker explantation was 30.3 months, and all patients remained asymptomatic, except for one patient who died of a noncardiac cause. Critical analysis of pacemaker users without a well‐established indication is justified because it may allow pacemaker explant in a significant proportion of these patients, and it may bring considerable social, economic, and psychological benefits.