Silvana Nishioka

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.

Incidência de choques e qualidade de vida em jovens com cardioversor-desfibrilador implantável

OBJECTIVES To analyze the incidence and causes of ICD therapies in children and young adults and verify their impact on the quality of life (QoL). METHODS From March/1977 to February/2006, 29 patients (15.7+/-5.4 years old) were submitted to ICD implants. Aborted cardiac arrest (41.5%), sustained ventricular tachycardia (27.6%) and primary prophylaxis of sudden cardiac death (30.9%) indicated device therapy. The number of therapies was evaluated by interviewing patients and by ICD diagnostic data. The SF-36 questionnaire was used to measure the QoL and the results were compared to healthy population. The expectative of freedom from ICD therapies were estimated by the Kaplan-Meier method. RESULTS After 2.6+/-1.8 years follow-up, 8 (27.6%) patients received 141 appropriate ICD shocks due to ventricular tachycardia (6) or ventricular fibrillation (2), and 11 (37.9%) patients received 152 inappropriate ICD shocks due to supraventricular tachyarrhythmias (8) or oversensing (3). Expectative of freedom from appropriate shocks was 74.2+/-9.0% and 66.7+/-10.7% after one and three years, respectively. Compared to healthy population, QoL decreased in physical function (61.7+/-28.7), vitality (64.7+/-19.1), mental health (65.9+/-22.7) and role-emotional domains (66.7+/-38.5). All patients referred fear and concern related to ICD use. CONCLUSION Despite the efficacy of ICD therapies, the high incidence of appropriate and inappropriate shocks interfered in patients QoL and adaptation to the device.

Biventricular Pacing Improves Clinical Behavior and Reduces Prevalence of Ventricular Arrhythmia in Patients with Heart Failure

PURPOSE To analyze the influence of biventricular pacing (BP) on clinical behavior, ventricular arrhythmia (VA) prevalence, and left ventricular ejection fraction (LV EF) by gated ventriculography. METHODS Twenty-four patients with left bundle branch block (LBBB) and NYHA class III and IV underwent pacemaker implantation and were randomized either to the conventional or BP group, all receiving BP after 6 months. RESULTS Sixteen patients were in NYHA class IV (66.6%) and 8 were in class III (33.4%). After 1-year follow-up, 14 patients were in class II (70%) and 5 were in class III (25%). Two sudden cardiac deaths occurred. A significant reduction in QRS length was found with BP (p=0.006). A significant statistical increase, from a mean of 19.13 +/- 5.19% (at baseline) to 25.33 +/- 5.90% (with BP) was observed in LVEF Premature ventricular contraction prevalence decreased from a mean of 10,670.00 +/- 12,595.39 SD or to a mean of 3,007.00 +/- 3,216.63 SD PVC/24 h with BP (p<0.05). Regarding the hospital admission rate over 1 year, we observed a significant reduction from 60. To 16 admissions with BP (p<0.05). CONCLUSION Patients with LBBB and severe heart failure experienced, with BP, a significant NYHA class and LVEF improvement. A reduction in the hospital admission rate and VA prevalence also occurred.

Cardiac Damage from Chronic Use of Chloroquine: A Case Report and Review of the Literature

Chloroquine has been widely used in rheumatological treatment, but potential severe side effects require careful follow-up. Cardiac damage is not a common consequence, but its clinical relevance has not yet been described. We report the case of a 58-year-old woman with rheumatoid arthritis, in whom chronic chloroquine use resulted in major irreversible cardiac damage. She presented with syncopal episodes due to complete atrioventricular block confirmed by electrophysiological study whose changes were concluded to be irreversible and a permanent pacemaker was indicated. Endomyocardial biopsy was also performed to search for histopathological and ultrastructural cardiac damage. We also reviewed the 22 cases of chloroquine-induced cardiopathy described to date as well as its pathophysiology.

Transfemoral pediatric permanent pacing: Long-term results

COSTA, R., et al.: Transfemoral Pediatric Permanent Pacing: Long‐term Results. The femoral vein has been used as an alternative conduit to implant pacemakers in children of any weight. Such method associates endocardial pacing and good cosmetics. The aim of this study was to evaluate prospectively, since 1981, the long‐term follow‐up of 99 children, from newborn to 13 years old (average = 4.1 ± 3.6 years, 56 girls), who underwent the implantation of pacemakers via the femoral vein. Atrioventricular block was present in 88% of patients, of congenital etiology in 39% and postoperative in 54%. Single chamber pacemakers were implanted in 92% of patients. During a mean follow‐up of 5.3 ± 5.0 years (maximum = 18.2 years), 5 patients died of cardiac causes, 4 of infection, 2 suddenly, and 3 of unknown causes. The 5‐, 10‐ and 15‐year actuarial survival rates were 83.7%, 75.7%, and 75.7%, respectively. Transfemoral leads were used for a mean of 48.9 ± 44.0 months. Reasons for lead explantations were pacing failure in five patients, infection in eight, and elective in nine. The 2‐, 5‐ and 10‐year actuarial survivals of transfemoral leads were 87.6%, 73.8%, and 31.8%, respectively. The mean lead survival was 97 months. Overall, 105 reoperations were performed, 38 for battery depletion, 24 for body growth, 14 for infection or pocket revisions, and 27 for miscellaneous reasons. In conclusion, the durability and overall long‐term performance of transfemoral leads were excellent. (PACE 2003; 26[Pt.II:487–491)

Clinical and electrophysiologic features of syncope in chronic chagasic heart disease.

Syncope in CCHD. Introduction: Syncope in patients with chronic Chagasic heart disease (CCHD) is a frequent hut poorly studied problem.

Friedreich's ataxia: cardiac evaluation of 25 patients with clinical diagnosis and literature review.

OBJECTIVE Cardiac evaluation (clinical, electrocardiographic and echocardiographic) of 25 Brazilian patients with clinical diagnosis of Friedreichs ataxia (FA) related to the frequency and the size of GAA repeats (unstable expansion of trinucleotide repeats that results in the disease). METHODS Clinical and cardiac study including electrocardiogram and echocardiogram of all patients and molecular analysis to detect the frequency and the size of GAA expansion, by polymerase chain reaction analysis. RESULTS Homozygous GAA expansion was detected in 17 patients (68%) - all typical cases. In 8 (32%) cases (6 atypical and 2 typical), no GAA expansion was observed, therefore it was not considered Friedreichs ataxia. All patients with GAA expansion (100%) had electrocardiographic abnormalities, and only 25% of the cases without GAA expansion had some abnormality on this exam. However, only 6% of all patients revealed some signals/symptoms suggestive of cardiac involvement. CONCLUSION A molecular analysis is essential to confirm the diagnosis of Friedreichs ataxia; however, an adequate cardiac evaluation, including an electrocardiogram, was extremely useful to better screening the patients which should perform these molecular analysis.

Is Isolated Congenital Heart Block Associated to Neonatal Lupus Requiring Pacemaker A Distinct Cardiac Syndrome

Isolated congenital heart block (ICHB) is frequently associated with neonatal lupus syndrome (NLS). Therefore few data are available regarding the long‐term cardiac outcome of newborns with ICHB and the pathogenic mechanisms are not yet defined. In order to compare demographic features and cardiological outcome of patients with ICHB submitted to pacemaker (PM) implantation with and without NLS, forty ICHB patients were evaluated pre‐ and post‐PM implantation, by clinical, electrocardiogram, Holter Monitoring, treadmill test, and electrophysiological study. According to the presence of antibodies to 52 and 60 kDa Ro/SSA and La/SSB proteins in mothers sera, it was found that 60% (24/40) of patients had ICHB associated to NLS (ICHB/NL+). Twenty‐three of 24 ICHB/NL+ patients were asymptomatic, and 16 (67%) were female (P = 0.013). The frequency of syncope, mitral insufficiency (MI), and congestive heart failure (CHF) was similar pre‐PM implantation in both ICHB/NL+ and ICHB/NL− groups (P > 0.05). After PM implantation, MI and CHF were only observed in ICHB/NL+ patients, although not statistically significant. Interestingly, 67% of ICHB/NL+ were noticed before one year of age while only one fourth of ICHB/NL− was diagnosed in this period (P = 0.024). Almost half (46%) of ICHB/NL+ patients required PMs in the first 24 months of life, whereas only one in the ICHB/NL− received a PM at the same age (P = 0.02). In ICHB patients requiring PM implantation, the antibody‐mediated lesion seems to be associated with an earlier onset and a more severe heart disease, in spite of the uniform criteria for PM indication. (PACE 2004; 27:615–620)

Evidence for cardiac safety and antiarrhythmic potential of chloroquine in systemic lupus erythematosus.

AIMS To perform a comprehensive evaluation of heart rhythm disorders and the influence of disease/therapy factors in a large systemic lupus erythematosus (SLE) cohort. METHODS AND RESULTS Three hundred and seventeen consecutive patients of an ongoing electronic database protocol were evaluated by resting electrocardiogram and 142 were randomly selected for 24 h Holter monitoring for arrhythmia and conduction disturbances. The mean age was 40.2 ± 12.1 years and disease duration was 11.4 ± 8.1 years. Chloroquine (CQ) therapy was identified in 69.7% with a mean use of 8.5 ± 6.7 years. Electrocardiogram abnormalities were detected in 66 patients (20.8%): prolonged QTc/QTd (14.2%); bundle-branch block (2.5%); and atrioventricular block (AVB) (1.6%). Age was associated with AVB (P = 0.029) and prolonged QTc/QTd (P = 0.039) whereas anti-Ro/SS-A and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores were not (P > 0.05). Chloroquine was negatively associated with AVB (P = 0.01) as was its longer use (6.1 ± 6.9 vs. 1.0 ± 2.5 years, P = 0.018). Time of CQ use was related with the absence of AVB [odds ratio (OR) = 0.103; 95% confidence interval (CI) = 0.011-0.934, P = 0.043] in multiple logistic regression. Holter monitoring revealed abnormalities in 121 patients (85.2%): supraventricular ectopies (63.4%) and tachyarrhythmia (18.3%); ventricular ectopies (45.8%). Atrial tachycardia/fibrillation (AT/AF) were associated with shorter CQ duration (7.05 ± 7.99 vs. 3.63 ± 5.02 years, P = 0.043) with a trend to less CQ use (P = 0.054), and older age (P < 0.001). Predictors of AT/AF in multiple logistic regression were age (OR = 1.115; 95% CI = 1.059-1.174, P < 0.001) and anti-Ro/SS-A (OR = 0.172; 95% CI = 0.047-0.629, P = 0.008). CONCLUSIONS Chloroquine seems to play a protective role in the unexpected high rate of cardiac arrhythmias and conduction disturbances observed in SLE. Further studies are necessary to determine if this antiarrhythmic effect is due to the disease control or a direct effect of the drug.

Neurohumoral behavior in recipients of cardiac pacemakers controlled by a closed-loop autonomic nervous system-driven sensor.

The purpose of a sensor‐driven pacing system is to physiologically correct chronotropic incompetence (CI). The aim of this study was to evaluate the changes in heart rate provided by a sympathetically driven pacemaker (PM) compared with normal sinus function (NSF). Nine men and six women (age 37–80 years) with AV block and a PM controlled by a closed‐loop system were studied. Group I included eight patients with CI, and group II included seven patients with NSF. All patients underwent Valsalva maneuver and tilt table testing with measurements of plasma catecholamines and renin activity. Pacing was initially programmed in the DDDC mode at a lower rate (60 ppm) and upper rate limit (0.85 × [220 ‐ age]), then in DDDR in group I and VVIR in group II. The second phase of the study consisted of nitroglycerin and phenylephrine infusions, and the third phase of physiological provocative maneuvers. The second and third phases were performed in three patients from each group with sensor activity On and Off. In group I, heart rate changed during tilt only in the DDDR mode. In group II, heart rate changes were comparable in both modes. Catecholamine levels in group I were higher during DDDC than during DDDR pacing (P < 0.05). In group I, heart rate did not change during phases II and IV of the Valsalva maneuver in the DDDC mode, but behaved nearly physiologically after sensor activation. A late and a paradoxical response to nitroglycerin was observed in groups I and II and to phenylephrine in group I. During physiological maneuvers, significantly greater variations in heart rate were observed during DDDR than during DDDC pacing. Sympathetic SDP provides physiological modulations of the heart rate were provided by a sympathetically driven pacing system in patients with AV block and CI.