Linear accelerator–based stereotactic arrhythmia radioablation for paroxysmal atrial fibrillation in elderly: a prospective phase II trial
Abstract 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 wer...
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| Veröffentlicht in: | Europace (London, England) England), 2023-12, Vol.25 (12) |
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| creator | Di Monaco, Antonio Gregucci, Fabiana Bonaparte, Ilaria Romanazzi, Imma Troisi, Federica Surgo, Alessia Vitulano, Nicola Quadrini, Federico Valenti, Noemi Carbonara, Roberta Di Guglielmo, Fiorella Cristina Ludovico, Elena Calbi, Roberto Guida, Pietro Ciliberti, Maria Paola Fiorentino, Alba Grimaldi, Massimo |
| description | Abstract
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
Graphical Abstract
Graphical Abstract |
| doi_str_mv | 10.1093/europace/euad344 |
| format | Article |
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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
Graphical Abstract
Graphical Abstract</description><identifier>ISSN: 1099-5129</identifier><identifier>EISSN: 1532-2092</identifier><identifier>DOI: 10.1093/europace/euad344</identifier><identifier>PMID: 37988294</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Aged ; Atrial Fibrillation - diagnosis ; Atrial Fibrillation - drug therapy ; Atrial Fibrillation - surgery ; Catheter Ablation - adverse effects ; Catheter Ablation - methods ; Humans ; Particle Accelerators ; Prospective Studies ; Pulmonary Veins - surgery ; Quality of Life ; Recurrence ; Treatment Outcome</subject><ispartof>Europace (London, England), 2023-12, Vol.25 (12)</ispartof><rights>The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. 2023</rights><rights>The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c377t-255ee79530120b4cfda0989ffc5da38e8addf4c585bb026b7ec13d7eb9cbf9bd3</citedby><cites>FETCH-LOGICAL-c377t-255ee79530120b4cfda0989ffc5da38e8addf4c585bb026b7ec13d7eb9cbf9bd3</cites><orcidid>0000-0003-4502-9635 ; 0000-0002-1297-2056 ; 0000-0003-4485-326X ; 0000-0003-0934-8890 ; 0000-0002-9347-8884 ; 0000-0002-4087-3063 ; 0009-0006-5135-5671 ; 0000-0002-4133-2664 ; 0000-0003-4201-5852 ; 0000-0002-4241-1364</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,1598,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37988294$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Di Monaco, Antonio</creatorcontrib><creatorcontrib>Gregucci, Fabiana</creatorcontrib><creatorcontrib>Bonaparte, Ilaria</creatorcontrib><creatorcontrib>Romanazzi, Imma</creatorcontrib><creatorcontrib>Troisi, Federica</creatorcontrib><creatorcontrib>Surgo, Alessia</creatorcontrib><creatorcontrib>Vitulano, Nicola</creatorcontrib><creatorcontrib>Quadrini, Federico</creatorcontrib><creatorcontrib>Valenti, Noemi</creatorcontrib><creatorcontrib>Carbonara, Roberta</creatorcontrib><creatorcontrib>Di Guglielmo, Fiorella Cristina</creatorcontrib><creatorcontrib>Ludovico, Elena</creatorcontrib><creatorcontrib>Calbi, Roberto</creatorcontrib><creatorcontrib>Guida, Pietro</creatorcontrib><creatorcontrib>Ciliberti, Maria Paola</creatorcontrib><creatorcontrib>Fiorentino, Alba</creatorcontrib><creatorcontrib>Grimaldi, Massimo</creatorcontrib><title>Linear accelerator–based stereotactic arrhythmia radioablation for paroxysmal atrial fibrillation in elderly: a prospective phase II trial</title><title>Europace (London, England)</title><addtitle>Europace</addtitle><description>Abstract
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
Graphical Abstract
Graphical Abstract</description><subject>Aged</subject><subject>Atrial Fibrillation - diagnosis</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Atrial Fibrillation - surgery</subject><subject>Catheter Ablation - adverse effects</subject><subject>Catheter Ablation - methods</subject><subject>Humans</subject><subject>Particle Accelerators</subject><subject>Prospective Studies</subject><subject>Pulmonary Veins - surgery</subject><subject>Quality of Life</subject><subject>Recurrence</subject><subject>Treatment Outcome</subject><issn>1099-5129</issn><issn>1532-2092</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><sourceid>EIF</sourceid><recordid>eNqFkb2u1DAQhS0E4v5AT4VcIqGAY8ebmA5dwWWllWigjsb2WGuUrMPYQWx3H4CON-RJMOxeWqqZ4jtnfg5jz1rxqhVGvcaV0gIOawNedd0DdtlqJRspjHxYe2FMo1tpLthVzl-EEL00-jG7UL0ZBmm6S_ZjFw8IxME5nJCgJPp199NCRs9zQcJUwJXoOBDtj2U_R-AEPiawE5SYDjwk4gtQ-n7MM0wcCsVaQrQUpzMSDxwnjzQd33DgC6W8YDX9hnzZ10l8u-V_VU_YowBTxqfnes0-v3_36eZDs_t4u715u2uc6vvSSK0Re6OVaKWwnQsehBlMCE57UAMO4H3onB60tUJubI-uVb5Ha5wNxnp1zV6cfOsqX1fMZZxjrvdPcMC05lEORm42bTfoiooT6urWmTCMC8UZ6Di2YvyTwXifwXjOoEqen91XO6P_J7h_egVenoC0Lv-3-w0jDJsU</recordid><startdate>20231206</startdate><enddate>20231206</enddate><creator>Di Monaco, Antonio</creator><creator>Gregucci, Fabiana</creator><creator>Bonaparte, Ilaria</creator><creator>Romanazzi, Imma</creator><creator>Troisi, Federica</creator><creator>Surgo, Alessia</creator><creator>Vitulano, Nicola</creator><creator>Quadrini, Federico</creator><creator>Valenti, Noemi</creator><creator>Carbonara, Roberta</creator><creator>Di Guglielmo, Fiorella Cristina</creator><creator>Ludovico, Elena</creator><creator>Calbi, Roberto</creator><creator>Guida, Pietro</creator><creator>Ciliberti, Maria Paola</creator><creator>Fiorentino, Alba</creator><creator>Grimaldi, Massimo</creator><general>Oxford University Press</general><scope>TOX</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-4502-9635</orcidid><orcidid>https://orcid.org/0000-0002-1297-2056</orcidid><orcidid>https://orcid.org/0000-0003-4485-326X</orcidid><orcidid>https://orcid.org/0000-0003-0934-8890</orcidid><orcidid>https://orcid.org/0000-0002-9347-8884</orcidid><orcidid>https://orcid.org/0000-0002-4087-3063</orcidid><orcidid>https://orcid.org/0009-0006-5135-5671</orcidid><orcidid>https://orcid.org/0000-0002-4133-2664</orcidid><orcidid>https://orcid.org/0000-0003-4201-5852</orcidid><orcidid>https://orcid.org/0000-0002-4241-1364</orcidid></search><sort><creationdate>20231206</creationdate><title>Linear accelerator–based stereotactic arrhythmia radioablation for paroxysmal atrial fibrillation in elderly: a prospective phase II trial</title><author>Di Monaco, Antonio ; Gregucci, Fabiana ; Bonaparte, Ilaria ; Romanazzi, Imma ; Troisi, Federica ; Surgo, Alessia ; Vitulano, Nicola ; Quadrini, Federico ; Valenti, Noemi ; Carbonara, Roberta ; Di Guglielmo, Fiorella Cristina ; Ludovico, Elena ; Calbi, Roberto ; Guida, Pietro ; Ciliberti, Maria Paola ; Fiorentino, Alba ; Grimaldi, Massimo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c377t-255ee79530120b4cfda0989ffc5da38e8addf4c585bb026b7ec13d7eb9cbf9bd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Aged</topic><topic>Atrial Fibrillation - diagnosis</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Atrial Fibrillation - surgery</topic><topic>Catheter Ablation - adverse effects</topic><topic>Catheter Ablation - methods</topic><topic>Humans</topic><topic>Particle Accelerators</topic><topic>Prospective Studies</topic><topic>Pulmonary Veins - surgery</topic><topic>Quality of Life</topic><topic>Recurrence</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Di Monaco, Antonio</creatorcontrib><creatorcontrib>Gregucci, Fabiana</creatorcontrib><creatorcontrib>Bonaparte, Ilaria</creatorcontrib><creatorcontrib>Romanazzi, Imma</creatorcontrib><creatorcontrib>Troisi, Federica</creatorcontrib><creatorcontrib>Surgo, Alessia</creatorcontrib><creatorcontrib>Vitulano, Nicola</creatorcontrib><creatorcontrib>Quadrini, Federico</creatorcontrib><creatorcontrib>Valenti, Noemi</creatorcontrib><creatorcontrib>Carbonara, Roberta</creatorcontrib><creatorcontrib>Di Guglielmo, Fiorella Cristina</creatorcontrib><creatorcontrib>Ludovico, Elena</creatorcontrib><creatorcontrib>Calbi, Roberto</creatorcontrib><creatorcontrib>Guida, Pietro</creatorcontrib><creatorcontrib>Ciliberti, Maria Paola</creatorcontrib><creatorcontrib>Fiorentino, Alba</creatorcontrib><creatorcontrib>Grimaldi, Massimo</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Europace (London, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Di Monaco, Antonio</au><au>Gregucci, Fabiana</au><au>Bonaparte, Ilaria</au><au>Romanazzi, Imma</au><au>Troisi, Federica</au><au>Surgo, Alessia</au><au>Vitulano, Nicola</au><au>Quadrini, Federico</au><au>Valenti, Noemi</au><au>Carbonara, Roberta</au><au>Di Guglielmo, Fiorella Cristina</au><au>Ludovico, Elena</au><au>Calbi, Roberto</au><au>Guida, Pietro</au><au>Ciliberti, Maria Paola</au><au>Fiorentino, Alba</au><au>Grimaldi, Massimo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Linear accelerator–based stereotactic arrhythmia radioablation for paroxysmal atrial fibrillation in elderly: a prospective phase II trial</atitle><jtitle>Europace (London, England)</jtitle><addtitle>Europace</addtitle><date>2023-12-06</date><risdate>2023</risdate><volume>25</volume><issue>12</issue><issn>1099-5129</issn><eissn>1532-2092</eissn><abstract>Abstract
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
Graphical Abstract
Graphical Abstract</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>37988294</pmid><doi>10.1093/europace/euad344</doi><orcidid>https://orcid.org/0000-0003-4502-9635</orcidid><orcidid>https://orcid.org/0000-0002-1297-2056</orcidid><orcidid>https://orcid.org/0000-0003-4485-326X</orcidid><orcidid>https://orcid.org/0000-0003-0934-8890</orcidid><orcidid>https://orcid.org/0000-0002-9347-8884</orcidid><orcidid>https://orcid.org/0000-0002-4087-3063</orcidid><orcidid>https://orcid.org/0009-0006-5135-5671</orcidid><orcidid>https://orcid.org/0000-0002-4133-2664</orcidid><orcidid>https://orcid.org/0000-0003-4201-5852</orcidid><orcidid>https://orcid.org/0000-0002-4241-1364</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1099-5129 |
| ispartof | Europace (London, England), 2023-12, Vol.25 (12) |
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| source | Oxford Journals Open Access Collection; MEDLINE; EZB-FREE-00999 freely available EZB journals; PubMed Central; Alma/SFX Local Collection |
| subjects | Aged Atrial Fibrillation - diagnosis Atrial Fibrillation - drug therapy Atrial Fibrillation - surgery Catheter Ablation - adverse effects Catheter Ablation - methods Humans Particle Accelerators Prospective Studies Pulmonary Veins - surgery Quality of Life Recurrence Treatment Outcome |
| title | Linear accelerator–based stereotactic arrhythmia radioablation for paroxysmal atrial fibrillation in elderly: a prospective phase II trial |
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