Project summary
Standard care or a rapid early invasive management (STORM) approach to patients with life-threatening heart rhythm disorders.
What is the issue for NSW?
Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder that leads to sudden cardiac death (SCD)/cardiac arrest. Approximately 15,000 Australians die of SCD each year. Cardiac arrest survivors receive a specialised pacemaker implanted under the skin called a defibrillator. If a patient experiences VT again, the defibrillator will internally shock the patient and prevent a cardiac arrest. There are an increasing number of cardiac arrest survivors in Australia who are recipients of a defibrillator.
Whilst a defibrillator will stop VT when it occurs, thus avoiding a cardiac arrest, up to 40% of defibrillator recipients will experience a highly malignant condition called VT Storm. This is when ≥3 episodes of VT occur within 24 hours. Storm results in an 18-fold increase risk of death, and major psychological trauma from recurrent painful shocks. Hospitalisation and medical costs dramatically escalate after an episode of storm. Currently, storm is treated with powerful doses of medications called anti-arrhythmic drugs (AADs). AADs tend to have potent side effects, and a delayed onset of action resulting in prolonged hospitalisation (for two or more weeks) and are limited in their effectiveness in controlling storm.
What does the research aim to do and how?
An alternate option is to perform a cardiac keyhole procedure called ablation. Ablation involves navigating electrical wires up through the veins to the heart, to identify, cauterise and destroy the abnormal heart muscle tissue causing VT. Observational studies show that ablation has the potential to cure storm in 95% of patients, and leads to early discharge from hospital (within a few days), with a potential reduction in health care costs. However, ablation carries a risk of 1-5% risk of complications.
No prior study has directly compared the effectiveness of the two treatment approaches (AAD vs. cardiac ablation) for VT storm. The Code STORM study is a randomised controlled trial of ablation compared to the traditional approach of AAD for the treatment of storm. The primary outcomes will compare if one strategy is superior to the other in abolishing storm, preventing future recurrence of VT, survival, quality of life and medical costs. We hypothesise that ablation will result in reduction in recurrence of VT, complications related to hospitalisation and use of AADs, improved survival, improved quality of life and a cost advantage relative to AADs.
This world first, innovative clinical trial will provide robust evidence for a clear pathway for VT storm management that will be adopted in treatment guidelines, policy and clinical practice.