Cardiac Radioablation for Ventricular tachycardia
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0004302
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Background: Noninvasive cardiac radioablation is reported to be effective and safe for the treatment of ventricular tachycardia (VT). Objective: This study aimed to analyze the acute and long-term effects of VT radioablation. Methods: Patients with intractable VT or premature ventricular contraction (PVC)-induced cardiomyopathy were included in this study and treated using a single-fraction 25-Gy dose of cardiac radioablation. To quantitatively analyze the acute response after treatment, continuous electrocardiography monitoring was performed from 24 hours before to 48 hours after irradiation and at the 1-month follow-up. Long-term clinical safety and efficacy were assessed 1-year follow-up. Results: From 2019 to 2020, 6 patients were treated with radioablation for ischemic VT (n = 3), nonischemic VT (n = 2), or PVC-induced cardiomyopathy (n = 1). In the short-term assessment, the total burden of ventricular beats decreased by 49% within 24 hours after radioablation and further decreased by 70% at 1 month. The VT component decreased earlier and more dramatically than the PVC component (decreased by 91% and 57% at 1 month, respectively). In the long-term assessment, 5 patients showed complete (n = 3) or partial (n = 2) remission of ventricular arrhythmias. One patient showed recurrence at 10 months, which was successfully suppressed with medical treatment. The posttreatment PVC coupling interval was prolonged (+38 ms at 1 month). Ischemic VT burden decreased more markedly than nonischemic VT burden after radioablation. Conclusion: In this small case series of 6 patients, without a comparison group, cardiac radioablation appeared to decrease the intractable VT burden. A therapeutic effect was apparent within 1-2 days after treatment but was variable by etiology of cardiomyopathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 6
1) Documented ventricular tachycardia
[1] Symptomatic ventricular tachycardia over 2 times on 12-leads ECG, Rhythm strip or implantable devices, within recent 6 months
[2] ICD therapy (shock or ATP) within 6 months
[3] In the case of PVC induced heart failure (LVEF <50%): PVC burden is over 15% on holter monitoring
2) Failed standard therapy for ventricular tachycardia
[1] Patients who are unable to adapt to antiarrhythmic medications or whose ventricular tachycardia is uncontrolled even after 2 months of adequate treatment
--AND--
[2] Previous failed catheter ablation for ventricular tachycardia or were not suitable for catheter ablation (left ventricular thrombosis, severe lung disease, vascular abnormality, heart malformation, etc.)
3) Those whose life expectancy is expected to decrease due to ventricular tachycardia (required by the expert cardiologist)
4) Left ventricular ejection function = 15%
5) Functional class: NYHA class = II
6) 19 years old or older
1) Those who do not agree to study registration
2) Those whose radiation therapy is not medically appropriate
-When a suitable posture for radiation therapy is not possible
-Others who are judged unsuitable by the judgment of radiation oncologist.
3) Those who have an extracorporeal circulatory system (ECMO) or left ventricular assist device or who require high-dose inopropics due to a cause other than ventricular tachycardia, (if the dose of Dopamine or Dobutamine is higher than 10 mcg / kg / min)
4) Life expectancy is less than 12 months, even if there is no ventricular tachycardia due to other diseases.
5) Pregnant or breast feeding
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute safety;Efficacy outcome
- Secondary Outcome Measures
Name Time Method Overall mortality;Late toxicity;Health related quality of life: HRQOL;Stricter efficacy (50% reduction);Stricter efficacy (95% reduction);Clinically important treatment efficacy (ICD treatment frequency or LVEF improvement);Long-term durability