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• W4310288530 abstract "HomeCirculation: Arrhythmia and ElectrophysiologyVol. 15, No. 12Reproducibility of Paroxysmal Atrial Fibrillation Ablation Clinical Outcomes Using Composite Ablation Index With Different Contact Force-Sensing Catheters Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBReproducibility of Paroxysmal Atrial Fibrillation Ablation Clinical Outcomes Using Composite Ablation Index With Different Contact Force-Sensing Catheters Luigi Di Biase, Paul Tabereaux, Christopher F. Liu, Smit Vasaiwala, Aman Chugh, Walid I. Saliba and for the SURPOINT Postapproval Trial Investigators Luigi Di BiaseLuigi Di Biase Correspondence to: Luigi Di Biase, MD, PhD, Montefiore Medical Center, Albert Einstein College of Medicine, 111 East 210th St, New York, NY 10025, Email E-mail Address: [email protected] https://orcid.org/0000-0001-6508-4047 Montefiore Medical Center, Albert Einstein College of Medicine, New York, NY (L.D.B.). Search for more papers by this author , Paul TabereauxPaul Tabereaux https://orcid.org/0000-0001-5704-6446 Huntsville Hospital, Huntsville, AL (P.T.). Search for more papers by this author , Christopher F. LiuChristopher F. Liu https://orcid.org/0000-0001-8852-4551 New York Presbyterian Hospital – Weill Cornell Medicine, New York, NY (C.F.L.). Search for more papers by this author , Smit VasaiwalaSmit Vasaiwala Loyola University Medical Center, Maywood, IL (S.V.). Search for more papers by this author , Aman ChughAman Chugh University of Michigan, Ann Arbor, MI (A.C.). Search for more papers by this author , Walid I. SalibaWalid I. Saliba https://orcid.org/0000-0003-3324-8611 Cleveland Clinic Foundation, Cleveland, OH (W.I.S.). Search for more papers by this author and for the SURPOINT Postapproval Trial Investigators Search for more papers by this author Originally published29 Nov 2022https://doi.org/10.1161/CIRCEP.122.011561Circulation: Arrhythmia and Electrophysiology. 2022;15Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: November 29, 2022: Ahead of Print Radiofrequency catheter ablation is commonly used for the treatment of paroxysmal atrial fibrillation.1 The advent of the VISITAG SURPOINT Module has improved safety and effectiveness as demonstrated in 2 prospective multicenter studies from the Europe, Middle East, Africa, and US regions.2,3 The Europe, Middle East, and Africa trial included patients treated with both THERMOCOOL SMARTTOUCH SF (STSF), a porous tip contact force catheter, and THERMOCOOL SMARTTOUCH (ST). Meanwhile, the US trial included patients treated with STSF. Both studies reported primary adverse event rates of 3.6% to 4.3% and freedom from atrial arrhythmia recurrence of 89.4% to 92.7%.2,3 Here, we present an additional subset of patients treated with a traditional 6-hole irrigated contact force-sensing catheter (ST) from the US SURPOINT postapproval, prospective, multicenter study. The data that support the findings of this study are available from the corresponding author upon reasonable request. All 5 participating US sites’ Institutional Review Board approved the study protocol. Written informed consent was given by all enrolled participants prior to conducting study procedures. Additional details on the eligibility criteria, ablation procedure, and end points have been previously reported.3Fifty patients were enrolled in the ST patient cohort between April 2019 and June 2020. One patient withdrew from the study; therefore, 49 patients were included in the safety and the effectiveness populations. Baseline patient characteristics were similar to that of the STSF patient cohort with mean age of 62.7 years, 55.1% female, and mean CHA2DS2-VASc score of 1.9.3 Symptomatic atrial fibrillation duration was slightly lower for the ST cohort at 31 months versus 37 months in the STSF group.3Mean procedure time was 202.1 minutes with a mean fluoroscopy time of 8.06 minutes. The fluid delivered via catheter for the ST and STSF patient cohorts were 1256.8±641.0 mL and 670.7±260.1 mL, respectively. Per target recommendations, the mean (±SD) VISITAG SURPOINT achieved Tag Index values was lower posteriorly (366.6±32.2) than anteriorly (510.2±66.0). Both regions of Tag Index values were consistent to those treated in the STSF cohort (posteriorly 382.4±22.2; anterior 519.3±55.3).3One patient was excluded from the primary adverse event rate analysis because they were treated with the ablation procedure but withdrew before completing the 3-month follow-up. Therefore, 3 primary adverse events (2 stroke/cerebrovascular accident; 1 pericarditis) were reported in 48 (6.3%) patients. Both patients with stroke/cerebrovascular accident displayed symptoms 1 day postablation and were treated according to the institution stroke protocol. One patient was discharged 6 days postindex ablation procedure, and at subsequent assessment at 85 days postablation had an modified Rankin Scale score of 0, indicating no neurological deficit. The other patient was discharged 2 days postablation without further neurological assessment as patient showed signs of full recovery at discharge, including electrocardiogram with normal sinus rhythm. All primary adverse events resolved within 2 to 3 months postablation. There were no occurrences of atrioesophageal fistula, myocardial infarction, or pulmonary vein stenosis. Similar to the STSF cohort primary adverse event rate (4.3%),3 the rate is below the 14% performance goal; therefore, the primary safety end point was met.Most targeted veins (91/98, 92.9%) achieved first-pass isolation with no acute reconnection requiring touch-up after a 30-minute waiting period. The 12-month Kaplan-Meier estimated freedom from primary effectiveness failure was 77.1% (Figure 1A), above the 50% performance goal; thus, the primary effectiveness end point was met. The Kaplan-Meier estimated 12-month freedom from first documented atrial fibrillation/atrial tachycardia/atrial flutter recurrence was 79.1% via stringent monitoring and 97.8% via standard-of-care monitoring (excluding transtelephonic monitoring). Freedom from repeat ablation was 93.4%. Figure 1B summarizes effectiveness outcomes among the ST and STSF cohorts.Download figureDownload PowerPointFigure 1. Short- and Long-Term Effectiveness for Patients Treated with VISITAG SURPOINT. A, Kaplan-Meier analysis of freedom from primary effectiveness failure. B, Side-by-side comparability of acute- and long-term effectiveness data amongst the ST and STSF populations. ST indicates THERMOCOOL SMARTTOUCH; and STSF, THERMOCOOL SMARTTOUCH SF.Patients experienced clinically meaningful (≥3 points)4,5 improvement in quality of life via 12-Item Short-Form Survey questionnaire as early as 3-month postablation, which sustained through 12-month follow-up. The baseline mean (±SD) physical component summary score was 47.8±9.08 and increased during the 3-, 6-, and 12-month follow-ups to 50.7±7.79, 49.4±8.69, and 51.4±8.62, respectively, representing a 6.8% to 11.3% increase from baseline. The baseline mean mental component summary score was 51.0±7.78, then 54.3±7.67, 56.5±5.99, and 54.5±6.04 at 3, 6, and 12 months, respectively, representing a 6.9% to 12.2% increase from baseline.In summary, this substudy demonstrates reproducible, safe, and clinically effective paroxysmal atrial fibrillation ablation when VISITAG SURPOINT is coupled with THERMOCOOL SMARTTOUCH and SMARTTOUCH SF catheters.Article InformationSources of FundingThis study was funded by Biosense Webster, Inc.Nonstandard Abbreviations and AcronymsPAFparoxysmal atrial fibrillationSTTHERMOCOOL SMARTTOUCHSTSFTHERMOCOOL SMARTTOUCH SFVSVISITAG SURPOINT ModuleDisclosures Dr Di Biase has received consulting fees from Biosense Webster, Inc, Stereotaxis, and Rhythm Management; and has received speaker honoraria/travel compensation from Biosense Webster, Inc., St. Jude Medical (now Abbott Medical), Boston Scientific, Medtronic, Biotronik, AtriCure, Baylis, and Zoll. Dr Tabereaux has received grants/contracts from Biosense Webster, Inc., Boston Scientific, and Abbott Medical. The other authors report no conflicts.FootnotesRegistration: URL: https://clinicaltrials.gov; Unique identifier: NCT03624881.For Sources of Funding and Disclosures, see page 840.Correspondence to: Luigi Di Biase, MD, PhD, Montefiore Medical Center, Albert Einstein College of Medicine, 111 East 210th St, New York, NY 10025, Email [email protected]comReferences1. Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation.Heart Rhythm. 2017; 14:e275–e444. doi: 10.1016/j.hrthm.2017.05.012CrossrefMedlineGoogle Scholar2. Duytschaever M, Vijgen J, De Potter T, Scherr D, Van Herendael H, Knecht S, Kobza R, Berte B, Sandgaard N, Albenque JP, et al. Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial.Europace. 2020; 22:1645–1652. doi: 10.1093/europace/euaa157CrossrefMedlineGoogle Scholar3. Di Biase L, Monir G, Melby D, Tabereaux P, Natale A, Manyam H, Athill C, Delaughter C, Patel A, Gentlesk P, et al; SURPOINT Postapproval Trial Investigators.Composite index tagging for PVI in paroxysmal AF: a prospective, multicenter postapproval study.JACC Clin Electrophysiol. 2022; 8:1077–1089. doi: 10.1016/j.jacep.2022.06.007CrossrefMedlineGoogle Scholar4. Jones PW, Brusselle G, Dal Negro RW, Ferrer M, Kardos P, Levy ML, Perez T, Soler-Cataluña JJ, van der Molen T, Adamek L, et al. Health-related quality of life in patients by COPD severity within primary care in Europe.Respir Med. 2011; 105:57–66. doi: 10.1016/j.rmed.2010.09.004CrossrefMedlineGoogle Scholar5. Samsa G, Edelman D, Rothman ML, Williams GR, Lipscomb J, Matchar D. Determining clinically important differences in health status measures: a general approach with illustration to the Health Utilities Index Mark II.PharmacoEconomics. 1999; 15:141–155. doi: 10.2165/00019053-199915020-00003CrossrefMedlineGoogle Scholar eLetters(0)eLetters should relate to an article recently published in the journal and are not a forum for providing unpublished data. Comments are reviewed for appropriate use of tone and language. Comments are not peer-reviewed. Acceptable comments are posted to the journal website only. Comments are not published in an issue and are not indexed in PubMed. Comments should be no longer than 500 words and will only be posted online. References are limited to 10. Authors of the article cited in the comment will be invited to reply, as appropriate.Comments and feedback on AHA/ASA Scientific Statements and Guidelines should be directed to the AHA/ASA Manuscript Oversight Committee via its Correspondence page.Sign In to Submit a Response to This Article Previous Back to top Next FiguresReferencesRelatedDetails December 2022Vol 15, Issue 12 Advertisement Article InformationMetrics © 2022 American Heart Association, Inc.https://doi.org/10.1161/CIRCEP.122.011561PMID: 36445824 Originally publishedNovember 29, 2022 Keywordsradiofrequency ablationparoxysmal atrial fibrillationatrial fibrillationcatheter ablationPDF download Advertisement SubjectsAtrial Fibrillation" @default.
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