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Recurrent ventricular tachycardia (VT) is a potentially life-threatening arrhythmia in patients with structural heart disease. Despite the use of antiarrhythmic drugs, implantable cardioverter-defibrillators (ICDs), and radiofrequency catheter ablation, VT recurrence rates remain high-reaching up to 66% in some series. For patients with refractory VT who are not candidates for further ablation or surgical interventions, there is a significant unmet need for novel, effective, and non-invasive treatment options.
Stereotactic body radiation therapy (SBRT) has recently emerged as a promising approach for treating ventricular arrhythmias through a technique known as stereotactic arrhythmia radioablation (STAR). Preliminary studies, including a phase I/II clinical trial, have demonstrated a substantial reduction in VT burden-up to 99.9%-following treatment, with an acceptable safety profile. Reported adverse events have included manageable pericardial effusion, radiation-induced pericarditis, and pneumonitis. The growing body of evidence supports STAR as a feasible and effective alternative for selected patients with treatment-resistant VT.
The objective of this study is to evaluate the efficacy and safety of stereotactic radiotherapy as a non-invasive ablation technique for the treatment of ventricular tachycardia (VT) in patients with refractory arrhythmias in whom conventional therapies have failed.
This is a retrospective observational study aimed at comparing outcomes between patients who received stereotactic radioablation and those who did not. A matched-pair analysis will be used to adjust for baseline clinical characteristics and ensure comparability between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients who have undergone SBRT | Within this group we find patients who have had all possible canonical treatments for the arrhythmia and also the stereotactic radiation treatment | ||
| patients who have not undergone SBRT | Within this group we find patients who have had all possible canonical treatments for the arrhythmia, but not the stereotactic radiation treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in VT episode frequency compared to the pretreatment period | The number of VT episodes during the 3 months prior to treatment will be compared to the number of episodes recorded during the 3-month period following the post-treatment blanking period. This comparison will help determine whether the treatment provides clinical benefits even at an early stage | Starting from three months before treatment until 3 months later |
| Measure | Description | Time Frame |
|---|---|---|
| Change in antiarrhythmic drug burden compared to the baseline | The study aims to show whether radioablation treatment is associated with a significant reduction in the use of antiarrhythmic drugs compared to patients who did not undergo the procedure | 36 months |
| Change in left ventricular end-diastolic volume compared to the baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting at Fondazione Policlinico Gemelli IRCCS and in all centers that joined the protocol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy) | Rome | ROME | 00168 | Italy |
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Improvement in left ventricular end-diastolic volume, as assessed through specific tests performed by a cardiologist specializing in arrhythmology, especially the Echocardiogram, and a global electrophysiological evaluation |
| 36 months |
| Change in left ventricular end-systolic volume compared to the baseline | Improvement in left ventricular end-systolic volume , as assessed through specific tests performed by a cardiologist specializing in arrhythmology , especially the Echocardiogram, and a global electrophysiological evaluation | 36 months |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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