Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms
Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized. Patients aged 18 to 75 with symptomati...
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| Veröffentlicht in: | The American heart journal 2021-12, Vol.242, p.103-114 |
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| creator | Pavlovic, Nikola Chierchia, Gian-Battista Velagic, Vedran Hermida, Jean Sylvain Healey, Stewart Arena, Giuseppe Badenco, Nicolas Meyer, Christian Chen, Jian Iacopino, Saverio Anselme, Frédéric Dekker, Lukas Scazzuso, Fernando Packer, Douglas L de Asmundis, Carlo Pitschner, Heinz-Friedrich Piazza, Fabio Di Kaplon, Rachelle E Kuniss, Malte |
| description | Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized.
Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary.
Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P |
| doi_str_mv | 10.1016/j.ahj.2021.08.007 |
| format | Article |
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Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary.
Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P <0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 –14.2, P <0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months (P <0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P <0.001).
In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms.
ClinicalTrials.gov number: NCT01803438.
[Display omitted]</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2021.08.007</identifier><identifier>PMID: 34508694</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Ablation ; Adolescent ; Adult ; Aged ; Anti-Arrhythmia Agents - therapeutic use ; Arrhythmia ; Atrial Fibrillation - drug therapy ; Atrial Fibrillation - surgery ; Blanking ; Cardiac arrhythmia ; Catheter Ablation ; Catheters ; Chemotherapy ; Cryosurgery ; Drug therapy ; Fibrillation ; Human health and pathology ; Humans ; Life Sciences ; Mental health ; Middle Aged ; Patients ; Polar environments ; Quality of Life ; Questionnaires ; Rhythm ; Treatment Outcome ; Young Adult</subject><ispartof>The American heart journal, 2021-12, Vol.242, p.103-114</ispartof><rights>2021</rights><rights>Copyright © 2021. Published by Elsevier Inc.</rights><rights>Copyright Elsevier Limited Dec 2021</rights><rights>Attribution - NonCommercial - NoDerivatives</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c458t-1518539a2242990b2361d242836a322ef4405e0cee7267cd61bbe802eb61e5153</citedby><cites>FETCH-LOGICAL-c458t-1518539a2242990b2361d242836a322ef4405e0cee7267cd61bbe802eb61e5153</cites><orcidid>0000-0001-5425-5840 ; 0000-0002-3164-8956 ; 0000-0002-1593-9657 ; 0000-0002-1623-0535 ; 0000-0003-3008-5706 ; 0000-0003-4027-4156 ; 0000-0001-9187-7681 ; 0000-0002-0266-6493 ; 0000-0003-0217-3960 ; 0000-0001-9276-2886 ; 0000-0002-2130-9790 ; 0000-0001-8670-6984</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2588321363?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>230,314,780,784,885,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34508694$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://u-picardie.hal.science/hal-03572217$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Pavlovic, Nikola</creatorcontrib><creatorcontrib>Chierchia, Gian-Battista</creatorcontrib><creatorcontrib>Velagic, Vedran</creatorcontrib><creatorcontrib>Hermida, Jean Sylvain</creatorcontrib><creatorcontrib>Healey, Stewart</creatorcontrib><creatorcontrib>Arena, Giuseppe</creatorcontrib><creatorcontrib>Badenco, Nicolas</creatorcontrib><creatorcontrib>Meyer, Christian</creatorcontrib><creatorcontrib>Chen, Jian</creatorcontrib><creatorcontrib>Iacopino, Saverio</creatorcontrib><creatorcontrib>Anselme, Frédéric</creatorcontrib><creatorcontrib>Dekker, Lukas</creatorcontrib><creatorcontrib>Scazzuso, Fernando</creatorcontrib><creatorcontrib>Packer, Douglas L</creatorcontrib><creatorcontrib>de Asmundis, Carlo</creatorcontrib><creatorcontrib>Pitschner, Heinz-Friedrich</creatorcontrib><creatorcontrib>Piazza, Fabio Di</creatorcontrib><creatorcontrib>Kaplon, Rachelle E</creatorcontrib><creatorcontrib>Kuniss, Malte</creatorcontrib><creatorcontrib>Cryo-FIRST Investigators</creatorcontrib><title>Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized.
Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary.
Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P <0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 –14.2, P <0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months (P <0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P <0.001).
In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms.
ClinicalTrials.gov number: NCT01803438.
[Display omitted]</description><subject>Ablation</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Anti-Arrhythmia Agents - therapeutic use</subject><subject>Arrhythmia</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Atrial Fibrillation - surgery</subject><subject>Blanking</subject><subject>Cardiac arrhythmia</subject><subject>Catheter Ablation</subject><subject>Catheters</subject><subject>Chemotherapy</subject><subject>Cryosurgery</subject><subject>Drug therapy</subject><subject>Fibrillation</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Life Sciences</subject><subject>Mental health</subject><subject>Middle Aged</subject><subject>Patients</subject><subject>Polar environments</subject><subject>Quality of Life</subject><subject>Questionnaires</subject><subject>Rhythm</subject><subject>Treatment Outcome</subject><subject>Young 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rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms</title><author>Pavlovic, Nikola ; Chierchia, Gian-Battista ; Velagic, Vedran ; Hermida, Jean Sylvain ; Healey, Stewart ; Arena, Giuseppe ; Badenco, Nicolas ; Meyer, Christian ; Chen, Jian ; Iacopino, Saverio ; Anselme, Frédéric ; Dekker, Lukas ; Scazzuso, Fernando ; Packer, Douglas L ; de Asmundis, Carlo ; Pitschner, Heinz-Friedrich ; Piazza, Fabio Di ; Kaplon, Rachelle E ; Kuniss, Malte</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c458t-1518539a2242990b2361d242836a322ef4405e0cee7267cd61bbe802eb61e5153</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Ablation</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Anti-Arrhythmia Agents - therapeutic use</topic><topic>Arrhythmia</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Atrial Fibrillation - surgery</topic><topic>Blanking</topic><topic>Cardiac arrhythmia</topic><topic>Catheter Ablation</topic><topic>Catheters</topic><topic>Chemotherapy</topic><topic>Cryosurgery</topic><topic>Drug therapy</topic><topic>Fibrillation</topic><topic>Human health and pathology</topic><topic>Humans</topic><topic>Life Sciences</topic><topic>Mental health</topic><topic>Middle Aged</topic><topic>Patients</topic><topic>Polar environments</topic><topic>Quality of Life</topic><topic>Questionnaires</topic><topic>Rhythm</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pavlovic, Nikola</creatorcontrib><creatorcontrib>Chierchia, Gian-Battista</creatorcontrib><creatorcontrib>Velagic, Vedran</creatorcontrib><creatorcontrib>Hermida, Jean Sylvain</creatorcontrib><creatorcontrib>Healey, Stewart</creatorcontrib><creatorcontrib>Arena, Giuseppe</creatorcontrib><creatorcontrib>Badenco, 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Frédéric</au><au>Dekker, Lukas</au><au>Scazzuso, Fernando</au><au>Packer, Douglas L</au><au>de Asmundis, Carlo</au><au>Pitschner, Heinz-Friedrich</au><au>Piazza, Fabio Di</au><au>Kaplon, Rachelle E</au><au>Kuniss, Malte</au><aucorp>Cryo-FIRST Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2021-12-01</date><risdate>2021</risdate><volume>242</volume><spage>103</spage><epage>114</epage><pages>103-114</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><abstract>Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized.
Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary.
Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P <0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 –14.2, P <0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months (P <0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P <0.001).
In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms.
ClinicalTrials.gov number: NCT01803438.
[Display omitted]</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>34508694</pmid><doi>10.1016/j.ahj.2021.08.007</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0001-5425-5840</orcidid><orcidid>https://orcid.org/0000-0002-3164-8956</orcidid><orcidid>https://orcid.org/0000-0002-1593-9657</orcidid><orcidid>https://orcid.org/0000-0002-1623-0535</orcidid><orcidid>https://orcid.org/0000-0003-3008-5706</orcidid><orcidid>https://orcid.org/0000-0003-4027-4156</orcidid><orcidid>https://orcid.org/0000-0001-9187-7681</orcidid><orcidid>https://orcid.org/0000-0002-0266-6493</orcidid><orcidid>https://orcid.org/0000-0003-0217-3960</orcidid><orcidid>https://orcid.org/0000-0001-9276-2886</orcidid><orcidid>https://orcid.org/0000-0002-2130-9790</orcidid><orcidid>https://orcid.org/0000-0001-8670-6984</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-8703 |
| ispartof | The American heart journal, 2021-12, Vol.242, p.103-114 |
| issn | 0002-8703 1097-6744 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_03572217v1 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete; ProQuest Central UK/Ireland |
| subjects | Ablation Adolescent Adult Aged Anti-Arrhythmia Agents - therapeutic use Arrhythmia Atrial Fibrillation - drug therapy Atrial Fibrillation - surgery Blanking Cardiac arrhythmia Catheter Ablation Catheters Chemotherapy Cryosurgery Drug therapy Fibrillation Human health and pathology Humans Life Sciences Mental health Middle Aged Patients Polar environments Quality of Life Questionnaires Rhythm Treatment Outcome Young Adult |
| title | Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-26T22%3A15%3A58IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_hal_p&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Initial%20rhythm%20control%20with%20cryoballoon%20ablation%20vs%20drug%20therapy:%20Impact%20on%20quality%20of%20life%20and%20symptoms&rft.jtitle=The%20American%20heart%20journal&rft.au=Pavlovic,%20Nikola&rft.aucorp=Cryo-FIRST%20Investigators&rft.date=2021-12-01&rft.volume=242&rft.spage=103&rft.epage=114&rft.pages=103-114&rft.issn=0002-8703&rft.eissn=1097-6744&rft_id=info:doi/10.1016/j.ahj.2021.08.007&rft_dat=%3Cproquest_hal_p%3E2588321363%3C/proquest_hal_p%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2588321363&rft_id=info:pmid/34508694&rft_els_id=S0002870321002052&rfr_iscdi=true |