Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease
Chagas Cardiomyopathy, Ventricular Arrythmia
About this trial
This is an interventional treatment trial for Chagas Cardiomyopathy focused on measuring Ventricular Tachycardia,, Chagas Disease, Catheter Ablation, Bilateral Sympathectomy, Cardiac Sympathetic Denervation
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic Chagas' with at least four appropriate ICD therapies in the last six months;
- Use of amiodarone and beta blockers optimized or maximum tolerated dose treatment;
- Life expectancy of more than one year;
- Conditions for following the plan of clinical follow-up of the study
- Signed consent form.
Exclusion Criteria:
- Pregnant Woman;
- less than 18 years-old;
- renal insufficiency with creatinine >2.5;
- mobile thrombus in the left ventricle;
- ejection fraction of the left ventricle <10%;
- unstable angina;
- aortic stenosis,
- mitral insufficiency with rupture of the package leaflet;
- functional class of heart failure IV;
- previous cardiac surgery or scheduled.
Sites / Locations
- Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Active Comparator
Experimental
Medical therapy group
Catheter ablation
Bilateral sympathectomy
Arm 1 - 15 patients allocated to this group will receive conventional antiarrhythmic medical treatment according the guidelines with additional impregnation of amiodarone, incremental dose of beta-blocker and if possible ICD reprograming.
Intervention Arm 2 -15 patients allocated to this group will undergo epicardial and endocardial catheter ablation with the use of irrigated contact sensor tip catheter. Voltage electroanatomical mapping using Carto System will be performed in all cases and if hemodynamically stable VT is induced, activation mapping will also be performed. The result of ablation will be defined as (1) complete success (all VTs non-inducible); (2) partial success (clinical VT non inducible, but other morphologies still inducible) and (3) failure (clinical VT still inducible).
Interventional Arm 3 - 15 patients allocated to this group will undergo bilateral sympathectomy, which will be performed using video assisted thoracoscopy using the Ethicon Ultracision device. The denervation consists of lower 1/3 stellate ganglion and T3- T4 thoracic interspinal space videothoracoscopic cutting, isolating the whole sympathetic chain between these two points using ultracision device on the nerve branches. The cephalic portion of the stellate ganglion will be preserved to avoid Horner's syndrome and the electrocautery use will also be avoided for the same reason. Hemodynamic and echocardiographic behaviors will be continuously monitored during these surgical maneuvers.