Problem
Ventricular tachycardia, or VT, is when the lower chambers of the heart beat rapidly. This reduces the efficiency of the pumping heart and can cause sudden cardiac arrest, requiring immediate medical attention. There are multiple causes of VT, but it is most caused by damages to the heart tissue, for example after a heart attack, or inflammation.
Atrial Fibrillation, or AF, is with the upper chambers of the heart and it is the most common cardiac arrhythmias and increased the chance to cause stroke by 500%.
Cardiac arrhythmias are already a major socioeconomic concern, and the prevalence of these diseases are increasing due to the aging of these populations. Currently over 5 million individuals worldwide suffer from VT, and over 33 million people suffer from AF. This has been predicted to more than double by 2030, making it a very and immediate socio-economic concern.
Today, pharmacological treatment is the first line treatment of heart arrhythmia, however, it leads to toxicity and results are never long term. The second line treatment for VT patients is an implantable defibrillator. They deliver special shocks however, reduce the quality of life of the patients.
The current standard of care is a surgical procedure called ablation. Major drawbacks of surgical VT ablations are as follows:
- It is an invasive procedure involving inserting catheters in the heart. It is painful and the patients require partial or total anaesthesia;
- It is challenging to perform, has high short-term mortality, and several severe side effects. There is a high risk of complications due to the catheters and the long duration of the procedure. 31-day mortality reaches 5% and this can be explained by the co-morbidities of the patients, as well as what physicians do to the patients during the procedure;
- Requires at least 2 days of hospitalization and costing up to €16,500 per procedure.
- The execution of the procedure is different in different hospitals. Catheter ablation is only effective in 50% of cases, usually there is a need of a 2nd procedure
- Long-term mortality reaches 35% mainly due to VT recurrence and progression of heart failure. This is because the source of the problem often cannot be eliminated with existing solutions.
Overall objectives of the program are to create a better patient experience for VT treatment, enable a totally non-invasive procedure, so that we can also treat fragile patients in the future, and make it overall safer:
- Ablation will be achieved through a non-invasive procedure without catheters, by simple external radiation using Proton Equipment.
- The procedure will take less than an hour, with a standardized workflow making it both reproducible and highly effective.
- A single fraction (dose) of protons delivered in less than 10 minutes, supported by 1 -2 technicians, meaning it can be performed in an out-patient setting.
- Highly effective procedure with a high dose of radiation, well controlled by the Proton Machine, we aim to safely reduce by 90% VT burden and improved quality of life. The physiologic explanation is that the EP effect is closely related to apoptotic cell death & fibrosis.
- Increased survival compared to invasive ablation procedures. This is because the source of the problem is eliminated by Protons, and the delivered radiation dose optimized by the CardioKit
