Multicentre randomised trial comparing contact force with electrical coupling index in atrial flutter ablation (VERISMART trial)
Electrical coupling index (ECI) and contact force (CF) have been developed to aid lesion formation during catheter ablation. ECI measures tissue impedance and capacitance whilst CF measures direct contact. The aim was to determine whether the presence of catheter / tissue interaction information, su...
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| Veröffentlicht in: | PloS one 2019-04, Vol.14 (4), p.e0212903-e0212903 |
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| creator | Begg, Gordon A O'Neill, James Sohaib, Afzal McLean, Ailsa Pepper, Chris B Graham, Lee N Hogarth, Andrew J Page, Stephen P Gillott, Richard G Hill, Nicola Walshaw, Jacqueline Schilling, Richard J Kanagaratnam, Prapa Tayebjee, Muzahir H |
| description | Electrical coupling index (ECI) and contact force (CF) have been developed to aid lesion formation during catheter ablation. ECI measures tissue impedance and capacitance whilst CF measures direct contact. The aim was to determine whether the presence of catheter / tissue interaction information, such as ECI and CF, reduce time to achieve bidirectional cavotricuspid isthmus block during atrial flutter (AFL) ablation.
Patients with paroxysmal or persistent AFL were randomised to CF visible (range 5-40g), CF not visible, ECI visible (change of 12%) or ECI not visible. Follow-up occurred at 3 and 6 months and included a 7 day ECG recording. The primary endpoint was time to bidirectional cavotricuspid isthmus block.
114 patients were randomised, 16 were excluded. Time to bidirectional block was significantly shorter when ECI was visible (median 30.0 mins (IQR 31) to median 10.5mins (IQR 12) p 0.023) versus ECI not visible. There was a trend towards a shorter time to bidirectional block when CF was visible. Higher force was applied when CF was visible (median 9.03g (IQR 7.4) vs. 11.3g (5.5) p 0.017). There was no difference in the acute recurrence of conduction between groups. The complication rate was 2%, AFL recurrence was 1.1% and at 6 month follow-up, 12% had atrial fibrillation.
The use of tissue contact information during AFL ablation was associated with reduced time taken to achieve bidirectional block when ECI was visible. Contact force data improved contact when visible with a trend towards a reduction in the procedural endpoint. ClinicalTrials.gov trial identifier: NCT02490033. |
| doi_str_mv | 10.1371/journal.pone.0212903 |
| format | Article |
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Patients with paroxysmal or persistent AFL were randomised to CF visible (range 5-40g), CF not visible, ECI visible (change of 12%) or ECI not visible. Follow-up occurred at 3 and 6 months and included a 7 day ECG recording. The primary endpoint was time to bidirectional cavotricuspid isthmus block.
114 patients were randomised, 16 were excluded. Time to bidirectional block was significantly shorter when ECI was visible (median 30.0 mins (IQR 31) to median 10.5mins (IQR 12) p 0.023) versus ECI not visible. There was a trend towards a shorter time to bidirectional block when CF was visible. Higher force was applied when CF was visible (median 9.03g (IQR 7.4) vs. 11.3g (5.5) p 0.017). There was no difference in the acute recurrence of conduction between groups. The complication rate was 2%, AFL recurrence was 1.1% and at 6 month follow-up, 12% had atrial fibrillation.
The use of tissue contact information during AFL ablation was associated with reduced time taken to achieve bidirectional block when ECI was visible. Contact force data improved contact when visible with a trend towards a reduction in the procedural endpoint. ClinicalTrials.gov trial identifier: NCT02490033.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0212903</identifier><identifier>PMID: 30943196</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Ablation ; Ablation (Surgery) ; Adult ; Aged ; Aged, 80 and over ; Analysis ; Atrial fibrillation ; Atrial flutter ; Atrial Flutter - diagnosis ; Atrial Flutter - surgery ; Biology and Life Sciences ; Capacitance ; Cardiac arrhythmia ; Cardiac Catheters ; Cardiology ; Catheter Ablation - instrumentation ; Catheter Ablation - methods ; Catheters ; Clinical trials ; Conduction ; Contact force ; Coupling ; Diagnosis ; Earth Sciences ; Electric contacts ; Electrocardiography ; Electrocoagulation - instrumentation ; Electrocoagulation - methods ; Engineering and Technology ; Female ; Fibrillation ; Flutter ; Follow-Up Studies ; Humans ; Male ; Medical instruments ; Medicine and Health Sciences ; Middle Aged ; Patients ; Physical Sciences ; Prospective Studies ; Randomization ; Recording ; Recurrence ; Research and Analysis Methods ; Risk factors ; Secondary Prevention - instrumentation ; Secondary Prevention - methods ; Teaching hospitals ; Time Factors ; Tissues ; Treatment Outcome ; Vibration</subject><ispartof>PloS one, 2019-04, Vol.14 (4), p.e0212903-e0212903</ispartof><rights>COPYRIGHT 2019 Public Library of Science</rights><rights>2019 Begg et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2019 Begg et al 2019 Begg et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-94e7d93f8d656b250df1b7b0025d2ae28cd2ba73e65f8c0ae1fc54c56c6f8f733</citedby><cites>FETCH-LOGICAL-c692t-94e7d93f8d656b250df1b7b0025d2ae28cd2ba73e65f8c0ae1fc54c56c6f8f733</cites><orcidid>0000-0002-1773-6511</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6447159/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6447159/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79343,79344</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30943196$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Begg, Gordon A</creatorcontrib><creatorcontrib>O'Neill, James</creatorcontrib><creatorcontrib>Sohaib, Afzal</creatorcontrib><creatorcontrib>McLean, Ailsa</creatorcontrib><creatorcontrib>Pepper, Chris B</creatorcontrib><creatorcontrib>Graham, Lee N</creatorcontrib><creatorcontrib>Hogarth, Andrew J</creatorcontrib><creatorcontrib>Page, Stephen P</creatorcontrib><creatorcontrib>Gillott, Richard G</creatorcontrib><creatorcontrib>Hill, Nicola</creatorcontrib><creatorcontrib>Walshaw, Jacqueline</creatorcontrib><creatorcontrib>Schilling, Richard J</creatorcontrib><creatorcontrib>Kanagaratnam, Prapa</creatorcontrib><creatorcontrib>Tayebjee, Muzahir H</creatorcontrib><title>Multicentre randomised trial comparing contact force with electrical coupling index in atrial flutter ablation (VERISMART trial)</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Electrical coupling index (ECI) and contact force (CF) have been developed to aid lesion formation during catheter ablation. ECI measures tissue impedance and capacitance whilst CF measures direct contact. The aim was to determine whether the presence of catheter / tissue interaction information, such as ECI and CF, reduce time to achieve bidirectional cavotricuspid isthmus block during atrial flutter (AFL) ablation.
Patients with paroxysmal or persistent AFL were randomised to CF visible (range 5-40g), CF not visible, ECI visible (change of 12%) or ECI not visible. Follow-up occurred at 3 and 6 months and included a 7 day ECG recording. The primary endpoint was time to bidirectional cavotricuspid isthmus block.
114 patients were randomised, 16 were excluded. Time to bidirectional block was significantly shorter when ECI was visible (median 30.0 mins (IQR 31) to median 10.5mins (IQR 12) p 0.023) versus ECI not visible. There was a trend towards a shorter time to bidirectional block when CF was visible. Higher force was applied when CF was visible (median 9.03g (IQR 7.4) vs. 11.3g (5.5) p 0.017). There was no difference in the acute recurrence of conduction between groups. The complication rate was 2%, AFL recurrence was 1.1% and at 6 month follow-up, 12% had atrial fibrillation.
The use of tissue contact information during AFL ablation was associated with reduced time taken to achieve bidirectional block when ECI was visible. Contact force data improved contact when visible with a trend towards a reduction in the procedural endpoint. ClinicalTrials.gov trial identifier: NCT02490033.</description><subject>Ablation</subject><subject>Ablation (Surgery)</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Analysis</subject><subject>Atrial fibrillation</subject><subject>Atrial flutter</subject><subject>Atrial Flutter - diagnosis</subject><subject>Atrial Flutter - surgery</subject><subject>Biology and Life Sciences</subject><subject>Capacitance</subject><subject>Cardiac arrhythmia</subject><subject>Cardiac Catheters</subject><subject>Cardiology</subject><subject>Catheter Ablation - instrumentation</subject><subject>Catheter Ablation - methods</subject><subject>Catheters</subject><subject>Clinical trials</subject><subject>Conduction</subject><subject>Contact force</subject><subject>Coupling</subject><subject>Diagnosis</subject><subject>Earth Sciences</subject><subject>Electric contacts</subject><subject>Electrocardiography</subject><subject>Electrocoagulation - instrumentation</subject><subject>Electrocoagulation - methods</subject><subject>Engineering and Technology</subject><subject>Female</subject><subject>Fibrillation</subject><subject>Flutter</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Male</subject><subject>Medical instruments</subject><subject>Medicine and Health Sciences</subject><subject>Middle Aged</subject><subject>Patients</subject><subject>Physical Sciences</subject><subject>Prospective Studies</subject><subject>Randomization</subject><subject>Recording</subject><subject>Recurrence</subject><subject>Research and Analysis Methods</subject><subject>Risk factors</subject><subject>Secondary Prevention - instrumentation</subject><subject>Secondary Prevention - methods</subject><subject>Teaching hospitals</subject><subject>Time Factors</subject><subject>Tissues</subject><subject>Treatment 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James</au><au>Sohaib, Afzal</au><au>McLean, Ailsa</au><au>Pepper, Chris B</au><au>Graham, Lee N</au><au>Hogarth, Andrew J</au><au>Page, Stephen P</au><au>Gillott, Richard G</au><au>Hill, Nicola</au><au>Walshaw, Jacqueline</au><au>Schilling, Richard J</au><au>Kanagaratnam, Prapa</au><au>Tayebjee, Muzahir H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multicentre randomised trial comparing contact force with electrical coupling index in atrial flutter ablation (VERISMART trial)</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2019-04-03</date><risdate>2019</risdate><volume>14</volume><issue>4</issue><spage>e0212903</spage><epage>e0212903</epage><pages>e0212903-e0212903</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Electrical coupling index (ECI) and contact force (CF) have been developed to aid lesion formation during catheter ablation. ECI measures tissue impedance and capacitance whilst CF measures direct contact. The aim was to determine whether the presence of catheter / tissue interaction information, such as ECI and CF, reduce time to achieve bidirectional cavotricuspid isthmus block during atrial flutter (AFL) ablation.
Patients with paroxysmal or persistent AFL were randomised to CF visible (range 5-40g), CF not visible, ECI visible (change of 12%) or ECI not visible. Follow-up occurred at 3 and 6 months and included a 7 day ECG recording. The primary endpoint was time to bidirectional cavotricuspid isthmus block.
114 patients were randomised, 16 were excluded. Time to bidirectional block was significantly shorter when ECI was visible (median 30.0 mins (IQR 31) to median 10.5mins (IQR 12) p 0.023) versus ECI not visible. There was a trend towards a shorter time to bidirectional block when CF was visible. Higher force was applied when CF was visible (median 9.03g (IQR 7.4) vs. 11.3g (5.5) p 0.017). There was no difference in the acute recurrence of conduction between groups. The complication rate was 2%, AFL recurrence was 1.1% and at 6 month follow-up, 12% had atrial fibrillation.
The use of tissue contact information during AFL ablation was associated with reduced time taken to achieve bidirectional block when ECI was visible. Contact force data improved contact when visible with a trend towards a reduction in the procedural endpoint. ClinicalTrials.gov trial identifier: NCT02490033.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>30943196</pmid><doi>10.1371/journal.pone.0212903</doi><tpages>e0212903</tpages><orcidid>https://orcid.org/0000-0002-1773-6511</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2019-04, Vol.14 (4), p.e0212903-e0212903 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2203266887 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Free Full-Text Journals in Chemistry; Public Library of Science (PLoS) |
| subjects | Ablation Ablation (Surgery) Adult Aged Aged, 80 and over Analysis Atrial fibrillation Atrial flutter Atrial Flutter - diagnosis Atrial Flutter - surgery Biology and Life Sciences Capacitance Cardiac arrhythmia Cardiac Catheters Cardiology Catheter Ablation - instrumentation Catheter Ablation - methods Catheters Clinical trials Conduction Contact force Coupling Diagnosis Earth Sciences Electric contacts Electrocardiography Electrocoagulation - instrumentation Electrocoagulation - methods Engineering and Technology Female Fibrillation Flutter Follow-Up Studies Humans Male Medical instruments Medicine and Health Sciences Middle Aged Patients Physical Sciences Prospective Studies Randomization Recording Recurrence Research and Analysis Methods Risk factors Secondary Prevention - instrumentation Secondary Prevention - methods Teaching hospitals Time Factors Tissues Treatment Outcome Vibration |
| title | Multicentre randomised trial comparing contact force with electrical coupling index in atrial flutter ablation (VERISMART trial) |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-03T19%3A25%3A46IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Multicentre%20randomised%20trial%20comparing%20contact%20force%20with%20electrical%20coupling%20index%20in%20atrial%20flutter%20ablation%20(VERISMART%20trial)&rft.jtitle=PloS%20one&rft.au=Begg,%20Gordon%20A&rft.date=2019-04-03&rft.volume=14&rft.issue=4&rft.spage=e0212903&rft.epage=e0212903&rft.pages=e0212903-e0212903&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0212903&rft_dat=%3Cgale_plos_%3EA581128110%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2203266887&rft_id=info:pmid/30943196&rft_galeid=A581128110&rft_doaj_id=oai_doaj_org_article_c85125532b8e470cbb6bdc2f0b7abb42&rfr_iscdi=true |