Is Left Stellate Ganglionectomy Beneficial to Patients With Life Threatening Ventricular Arrhythmias
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
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.
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
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.
• 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.
- All-cause mortality
- Heart Failure hospital admissions after randomisation
- Early and late surgical complications -
- 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
- 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
- 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).
Sudden Cardiac Death
Sudden cardiac death, Ganglionectomy, Ventricular arrhythmia, Cardiac surgery, Implanted cardiac defibrillator
Princess Alexandra Hospital, Brisbane, Australia