Is Left Stellate Ganglionectomy Beneficial to Patients With Life Threatening Ventricular Arrhythmias — Reduce-SCD  

Sudden Cardiac Death Clinical Trial

Official title: Does Left Cardiac Sympathectomy Stellate Ganglionectomy Confer an Added Benefit Over Optimal Medical Therapy in the Reduction of Therapy Delivered From an Implanted Cardioverter Defibrillator in Patients at High Risk of Sudden Cardiac Death

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to determine whether the incidence of recurrent life threatening ventricular arrhythmias in patients with an implanted cardiac defibrillator (ICD) can be reduced if a surgical left stellate ganglionectomy is performed.

Clinical Trial Description

Background: Sudden cardiac death (SCD) is a devastating problem. There is a strong body of evidence which suggests an important role of the autonomic nervous system in the genesis of sudden cardiac death. An increase in vagal tone improves cardiac electrical stability whereas sympathetic hyper-stimulation may precipitate ventricular fibrillation, particularly in the ischaemic heart.

In patients with life threatening ventricular arrhythmias an implanted cardiac defibrillator (ICD) is the treatment of choice. Ventricular arrhythmias can be terminated by either an intra-cardiac shock, often a painful therapy particularly if the patient should remain conscious, or by anti-tachycardia pacing (ATP) which is painless and often is unnoticed.

Despite intensive pharmacological treatment with beta-blockers and often amiodarone, patients may still have up to 20% risk per year of receiving an internal shock for both life threatening and sometimes for a non life threatening arrhythmia. A technique that might reduce the risk of shock delivery over and above current approaches would be an advantage.

It has been suggested that a surgical left stellate ganglionectomy (also referred to as left cardiac sympathetic denervation - LCSD) in patients cardiac arrhythmias may have potential antiarrhythmic benefit particularly in patients with life threatening ventricular arrhythmias and/or at high risk of sudden death (SCD) despite current medical therapy. Recent improvements in surgical techniques has allowed a video assisted minimal access approach (VATS) with a reduction in inpatient stay and increased patient tolerability. The overall risk profile is the same as open thoracotomy but at a much reduced rate.

Current data suggests that LCSD is a reasonable management option in patients with recurrent ventricular arrhythmias.

Hypothesis: Does VATS assisted LCSD in patients with an ICD implanted for secondary prevention, on chronic amiodarone therapy reduce shock frequency and anti-tachycardia pacing compared to optimal medical treatment - a prospective study.

Protocol: All patients with an ICD who present with an intra-cardiac shock or ATP for the termination of a ventricular arrhythmia (VT or VF) will be eligible for this study. All patients will be established on optimal medical treatment (angiotensin-converting-enzyme (ACE) inhibitor/angiotensin receptor blockers (ARB) and beta blockers) and amiodarone (unless documentation exists of amiodarone intolerance), for three months, as defined in inclusion criteria. Patients will be given the Participant Information Sheet describing the study and signed Informed Consent will be obtained.

Baseline tests will be performed in both groups. Patients will be randomised in a 1:1 fashion to either continued medical treatment or continued medical treatment plus minimal access video assisted left stellate ganglionectomy.

Surgery will be performed within two weeks of randomisation. Surgical patients will be discharged from hospital at the discretion of their treating surgeon. The surgical patients will be assessed in a clinic two weeks after discharge.

All patients will be followed for a total of 365 days from randomisation.

Primary Endpoint:

• Intra-cardiac shock frequency and frequency of anti-tachycardia pacing over a 12 month period commencing from time of randomisation to a minimum of 365 days post-study entry.

Secondary Endpoints:

• All-cause mortality

• Heart Failure hospital admissions after randomisation

• Early and late surgical complications -

• death

• Horner's syndrome

• length of hospital stay

• post-operative pain

• sweating in the left hand and axilla

• damage to brachial plexus

• Changes in heart rate variability (HRV)

• Inappropriate intra-cardiac shocks for atrial tachyarrhythmias: atrial fibrillation, flutter and tachycardia

• Changes in left ventricular function (ejection fraction) measured by echocardiography

• Changes in heart-to-mediastinum (H/M) ratio on iodine-131-meta-iodobenzineguanidine (MIBG)

• Alterations in the surface twelve lead ECG including:

• change in the QT interval

• changes in QT dispersion on the surface ECG

• changes in QRS duration

• Changes in ICD device derived parameters:

• Frequency of non-sustained ventricular tachycardia and of ventricular premature contractions

• Changes in heart rate variability

• If appropriate (ICD dependent) changes in transthoracic impedance

• Atrial fibrillation burden

• Quality of life assessment (SF36)

Sample Size Sample size will be based upon a projected 10% shock rate in the first 12 months and a mortality of 5-8% (1,2,3). As this is a pilot study the sample will be 25 patients in each group (medical treatment alone vs. LCSD). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death

• NCT number: NCT02113722
• Study type: Interventional
• Source: Princess Alexandra Hospital, Brisbane, Australia
• Status: Withdrawn
• Phase: N/A
• Start date: July 2014
• Completion date: June 2015