Linear accelerator-based stereotactic arrhythmia radioablation for paroxysmal atrial fibrillation in elderly : a prospective phase II trial
© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology..
AIMS: Stereotactic arrhythmia radioablation (STAR) is a novel therapeutic approach for cardiac arrhythmias. The aim of this trial is to investigate the feasibility of STAR for the treatment of paroxysmal atrial fibrillation (AF) in elderly patients.
METHODS AND RESULTS: Inclusion criteria were age >70 years, symptomatic AF, antiarrhythmic drugs failure, or intolerance. All patients underwent to 4D cardiac computed tomography simulation. The clinical target volume was identified in the area around pulmonary veins (PV). Stereotactic arrhythmia radioablation was performed with a total dose of 25 Gy (single fraction) delivered in 3 min. Twenty patients were enrolled and 18 underwent STAR. One patient withdrew informed consent before treatment and one patient was excluded due to unfavourable oesophagus position. With a median follow-up (FU) of 16 months (range 12-23), no acute toxicity more than Grade 3 was reported. Five patients had a Grade 1 oesophagitis 24 h after STAR; eight patients had an asymptomatic Grade 1 pericardial effusion, and one patient had a torsade de pointes treated effectively by electrical cardioversion and subsequent cardiac implantable cardioverter-defibrillator implantation. Most patients had a significant reduction in AF episodes. Five patients, due to arrhythmias recurrences after STAR, performed electrophysiological study documenting successful PV isolation. Finally, a significant improvement of quality of life was documented (48 ± 15 at enrolment vs. 75 ± 15 at 12 months FU; P < 0.001).
CONCLUSION: The present phase II trial demonstrated the feasibility of STAR in paroxysmal AF elderly patients and its potential role in increasing the quality of life. Surely, more robust data are needed about safety and efficacy.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT04575662.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:25 |
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| Enthalten in: |
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology - 25(2023), 12 vom: 06. Dez. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Di Monaco, Antonio [VerfasserIn] |
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| Links: |
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| Themen: |
Atrial fibrillation |
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| Anmerkungen: |
Date Completed 11.12.2023 Date Revised 15.01.2024 published: Print ClinicalTrials.gov: NCT04575662 Citation Status MEDLINE |
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| doi: |
10.1093/europace/euad344 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Di Monaco, Antonio |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Linear accelerator-based stereotactic arrhythmia radioablation for paroxysmal atrial fibrillation in elderly |b a prospective phase II trial |
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| 500 | |a Date Revised 15.01.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT04575662 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. | ||
| 520 | |a AIMS: Stereotactic arrhythmia radioablation (STAR) is a novel therapeutic approach for cardiac arrhythmias. The aim of this trial is to investigate the feasibility of STAR for the treatment of paroxysmal atrial fibrillation (AF) in elderly patients | ||
| 520 | |a METHODS AND RESULTS: Inclusion criteria were age >70 years, symptomatic AF, antiarrhythmic drugs failure, or intolerance. All patients underwent to 4D cardiac computed tomography simulation. The clinical target volume was identified in the area around pulmonary veins (PV). Stereotactic arrhythmia radioablation was performed with a total dose of 25 Gy (single fraction) delivered in 3 min. Twenty patients were enrolled and 18 underwent STAR. One patient withdrew informed consent before treatment and one patient was excluded due to unfavourable oesophagus position. With a median follow-up (FU) of 16 months (range 12-23), no acute toxicity more than Grade 3 was reported. Five patients had a Grade 1 oesophagitis 24 h after STAR; eight patients had an asymptomatic Grade 1 pericardial effusion, and one patient had a torsade de pointes treated effectively by electrical cardioversion and subsequent cardiac implantable cardioverter-defibrillator implantation. Most patients had a significant reduction in AF episodes. Five patients, due to arrhythmias recurrences after STAR, performed electrophysiological study documenting successful PV isolation. Finally, a significant improvement of quality of life was documented (48 ± 15 at enrolment vs. 75 ± 15 at 12 months FU; P < 0.001) | ||
| 520 | |a CONCLUSION: The present phase II trial demonstrated the feasibility of STAR in paroxysmal AF elderly patients and its potential role in increasing the quality of life. Surely, more robust data are needed about safety and efficacy | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov: NCT04575662 | ||
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| 650 | 4 | |a Atrial fibrillation | |
| 650 | 4 | |a Elderly | |
| 650 | 4 | |a Pulmonary vein isolation | |
| 650 | 4 | |a Stereotactic arrhythmia radioablation | |
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| 700 | 1 | |a Romanazzi, Imma |e verfasserin |4 aut | |
| 700 | 1 | |a Troisi, Federica |e verfasserin |4 aut | |
| 700 | 1 | |a Surgo, Alessia |e verfasserin |4 aut | |
| 700 | 1 | |a Vitulano, Nicola |e verfasserin |4 aut | |
| 700 | 1 | |a Quadrini, Federico |e verfasserin |4 aut | |
| 700 | 1 | |a Valenti, Noemi |e verfasserin |4 aut | |
| 700 | 1 | |a Carbonara, Roberta |e verfasserin |4 aut | |
| 700 | 1 | |a Di Guglielmo, Fiorella Cristina |e verfasserin |4 aut | |
| 700 | 1 | |a Ludovico, Elena |e verfasserin |4 aut | |
| 700 | 1 | |a Calbi, Roberto |e verfasserin |4 aut | |
| 700 | 1 | |a Guida, Pietro |e verfasserin |4 aut | |
| 700 | 1 | |a Ciliberti, Maria Paola |e verfasserin |4 aut | |
| 700 | 1 | |a Fiorentino, Alba |e verfasserin |4 aut | |
| 700 | 1 | |a Grimaldi, Massimo |e verfasserin |4 aut | |
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