Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease
brief summary
Ventricular tachycardia (VT) is the main cause of sudden death in patients with structural heart diseases. The use of ICD (implantable cardio-defibrillator) could prevent sudden death, however, the occurrence of repetitive shock decreases significantly the quality of life and could increase the mortality rate. Chagas disease in our environment is the most common heart disease and often associated with the occurrence appropriate ICD therapies. The chronic treatment of VT aims to prevent recurrences with the use of antiarrhythmic drugs and catheter ablation, but in many cases, these treatments are insufficient to control the VT. Cardiac Sympathetic Denervation by bilateral sympathectomy has been described as an alternative treatment of VT refractory to medical treatment and radiofrequency ablation, especially in patients with channelopathies. This treatment could have a role in patients with structural heart disease. The objective of this study is to evaluate the efficacy of the bilateral sympathectomy in the reduction of ventricular tachycardia in patients with Chagas cardiomyopathy. In this pilot study, the investigators will select 45 patients with Chagas cardiomyopathy with ICD who presented at least four ICD therapies in the prior six months. These patients will be randomly assigned to three groups, 15 patients in medical therapy group, 15 in catheter ablation and 15 in bilateral sympathectomy.
detailed description
OBJECTIVE
Primary
• Evaluate the efficacy of bilateral sympathectomy in the reduction of VT episodes in patients with Chagas cardiomyopathy.
Secondary
* To compare the efficacy of bilateral sympathectomy against VT ablation and against optimal medical therapy. * To evaluate the density of ventricular premature beats 24-hour Holter and monitor the events recorded by the ICD and the impact of the treatment performed. * To evaluate the length of the hospital stay according to the type of intervention. * To evaluate the rate of clinical complications according to the type of intervention. * To evaluate the impact of treatment on left ventricular function.
Follow up
Outcomes Assessment in six months and one year
* Recurrence rate of appropriate therapies; * Density of ventricular ectopies; * Complication rates per type of intervention; * Number of in-hospital days per type of intervention; * Assessment of LV function;
METHODS
This is a pilot, single-centre, open-label, randomized trial in patients with Chagas disease and multiple appropriate ICD therapies. This study consists of three groups: (1) medical treatment, (2) catheter ablation and (3) bilateral sympathectomy, being included 15 patients in each group.
Inclusion Criteria:
* Patients with Chagas Disease Cardiomyopathy having an ICD * At least four appropriate ICD therapies in the past six months, documented by device interrogation or medical records; * Use of amiodarone and beta blockers in an optimized fashion; * Life expectancy of more than one year * Conditions for following the plan of clinical follow-up of the study.
Exclusion criteria:
* Presence of an absolute contraindication to receive any of the possible treatments of the study; * Pregnant Woman; * Less than 18 years-old; * Renal insufficiency with creatinine \>2.5 mg/dL (221 umol/L); * Mobile thrombus in the left ventricle; * Left Ventricle Ejection fraction \< 10%; * Unstable angina; * Severe aortic stenosis * Primary severe mitral insufficiency; * New York Heart Association (NYHA) functional class IV; * Previous cardiac surgery or scheduled.
official title
Role of Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease - Pilot Study Randomized Controlled Trial