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. 2024 Mar 29;13(2):155-164.
doi: 10.21037/acs-2023-afm-15. Epub 2023 Aug 29.

Atrial fibrillation symptom reduction and improved quality of life following the hybrid convergent procedure: a CONVERGE trial subanalysis

Jaswinder Gill  1 , Karl J Crossen  2 , Christopher Blauth  1 , Faraz Kerendi  3 , Saumil R Oza  4 , Anthony R Magnano  4 , Mark A Mostovych  4 , Michael E Halkos  5 , David Tschopp  3 , Jose Osorio  6 , Paul Tabereaux  7 , William Boedefeld  8 , Kenneth Civello  8 , Syed Ahsan  9 , John Yap  9 , Sreedhar Billakanty  10 , Steve Duff  10 , Otto Costantini  11 , Eric Espinal  11 , Andy Kiser  12 , Christian Shults  13 , David Pederson  14 , James Garrison  15 , David M Gilligan  16 , Michael G Link  17 , Marcin Kowalski  18 , Christopher Stees, Jason S Sperling, Israel Jacobowitz, Felix Yang, Yisachar J Greenberg, David B De Lurgio  5
Affiliations

Atrial fibrillation symptom reduction and improved quality of life following the hybrid convergent procedure: a CONVERGE trial subanalysis

Jaswinder Gill et al. Ann Cardiothorac Surg. .

Abstract

Background: CONVERGE was a prospective, multicenter, randomized controlled trial that evaluated the safety of Hybrid Atrial Fibrillation Convergent (HC) and compared its effectiveness to endocardial catheter ablation (CA) for the treatment of persistent atrial fibrillation (PersAF) and longstanding PersAF (LSPAF). In 2020, we reported that CONVERGE met its primary safety and effectiveness endpoints. The primary objective of the present study is to report CONVERGE trial results for quality of life (QOL) and Class I/III anti-arrhythmic drug (AAD) utilization following HC.

Methods: Eligible patients had drug-refractory symptomatic PersAF or LSPAF and a left atrium diameter ≤6.0 cm. Enrolled patients were randomized 2:1 to receive HC or CA. Atrial Fibrillation Severity Scale (AFSS) and the 36-Item Short Form Health Survey (SF-36) were assessed at baseline and 12 months; statistical comparison was performed using paired t-tests. AAD utilization at baseline through 12 and 18 months post-procedure was evaluated; statistical comparison was performed using McNemar's tests.

Results: A total of 153 patients were treated with either HC (n=102) or CA (n=51). Of the 102 HC patients, 38 had LSPAF. AFSS and SF-36 Mental and Physical Component scores were significantly improved at 12 months versus baseline with HC overall and for the subset of LSPAF patients treated with either HC or CA. The proportion of HC patients (n=102) who used Class I /III AADs at 12 and 18 months was significantly less (33.3% and 36.3%, respectively) than baseline (84.3%; P<0.001). In LSPAF patients who underwent HC (n=38), AADs use was 29.0% through 18 months follow-up versus 71.1% at baseline (P<0.001).

Conclusions: HC reduced AF symptoms, significantly improved QOL, and reduced AAD use in patients with PersAF and LSPAF.

Clinicaltrialsgov identifier: NCT01984346.

Keywords: Quality of life (QOL); anti-arrhythmic drug (AAD); atrial fibrillation (AF); catheter ablation (CA); hybrid convergent.

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Conflict of interest statement

Conflicts of Interest: J.G. reports research funding from Abbott and lecture honoraria from AtriCure. C.B. has consulted for New Cardioplegia Solutions as well as proctoring for AtriCure. F.K. has received research grants from AtriCure; he has consulted for CryoLife, Edwards, LivaNova, and Medtronic. S.R.O. has consulted for Biosense Webster and has received compensation for services from AtriCure. M.A.M. has received compensation for services from AtriCure. M.E.H. reports advisory board membership and consultant fees from Medtronic. D.T. has received compensation for services from AtriCure. J.O. has consulted for Biosense Webster and Boston Scientific and has received compensation for services from AtriCure. S.A. reports speaker bureau membership for AtriCure. A.K. reports advisory board membership and consultant fees from AtriCure. C.S. reports consultant fees and honoraria from Abbott Laboratories, AtriCure, and Medtronic. D.M.G. has received compensation for services from AtriCure. M.K. reports consultant fees from Medtronic. I.J. reports advisory board membership and consultant fees from AtriCure. F.Y. reports advisory board membership and consultant fees from AtriCure. D.B.D.L. is a consultant and speaker for AtriCure and Boston Scientific, and a consultant to Medtronic. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
AFSS composite and symptoms scores at baseline and 12 months. Mean AFSS Composite Scores for Hybrid AF Convergent (A) overall and (B) LSPAF populations. Overall AFSS Symptoms Scores for Hybrid AF Convergent (C) overall and (D) LSPAF populations. Mean AFSS symptoms for Hybrid AF Convergent (E) overall and (F) LSPAF populations. Data are shown at baseline (pre-procedure) and 12 months follow-up post-procedure. Patients with missing data were excluded from the analysis. AFSS Composite Scores range from 3 to 30, and higher values represent greater burden. AFSS Symptoms Scores range from 1 = less severe to 35 = more severe. P value based on paired t-test for baseline vs. 12 months. AF, atrial fibrillation; AFSS, Atrial Fibrillation Symptom Severity Scale; LSPAF, longstanding persistent AF.
Figure 2
Figure 2
SF-36 MCS and Mental Health Scale Scores at baseline and 12 months. Mean SF-36 MCS for Hybrid AF Convergent for (A) overall and (B) LSPAF populations. Mean SF-36 Mental Health Scale Scores for Hybrid AF Convergent (C) overall and (D) LSPAF populations. Data are shown at baseline (pre-procedure) and 12 months follow-up post-procedure. SF-36 scores range from 0 to 100, and higher values represent better quality of life. Patients with missing data were excluded from the analysis. P value based on paired t-test for baseline vs. 12 months. MCS, Mental Component Score; AF, atrial fibrillation; LSPAF, longstanding persistent AF; ITT, intention to treat.
Figure 3
Figure 3
SF-36 PCS and Physical Health Scores at baseline and 12 months. Mean SF-36 PCS for Hybrid AF Convergent (A) overall and (B) LSPAF populations. Mean SF-36 Physical Health Scale scores for Hybrid AF Convergent (C) overall and (D) LSPAF populations. Data are shown at baseline (pre-procedure) and 12 months follow-up post-procedure. SF-36 scores range from 0 to 100, and higher values represent better quality of life. Patients with missing data were excluded from the analysis. P value based on paired t-test for baseline vs. 12 months. PCS, Physical Component Score; AF, atrial fibrillation; LSPAF, longstanding persistent AF; ITT, intention to treat.
Figure 4
Figure 4
Class I/III AAD use among Hybrid AF Convergent populations. Proportions of patients on Class I/III AAD medication at baseline (pre-procedure) and 12 and 18 months with Hybrid AF Convergent (A) overall and (B) LSPAF populations. P value from McNemar’s tests. AAD, anti-arrhythmic drug; AF, atrial fibrillation; LSPAF, longstanding persistent AF.
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References

    1. Dorian P, Jung W, Newman D, et al. The impairment of health-related quality of life in patients with intermittent atrial fibrillation: implications for the assessment of investigational therapy. J Am Coll Cardiol 2000;36:1303-9. 10.1016/s0735-1097(00)00886-x - DOI - PubMed
    1. Guédon-Moreau L, Capucci A, Denjoy I, et al. Impact of the control of symptomatic paroxysmal atrial fibrillation on health-related quality of life. Europace 2010;12:634-42. 10.1093/europace/euq007 - DOI - PMC - PubMed
    1. Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm 2017;14:e275-444. 10.1016/j.hrthm.2017.05.012 - DOI - PMC - PubMed
    1. Randolph TC, Simon DN, Thomas L, et al. Patient factors associated with quality of life in atrial fibrillation. Am Heart J 2016;182:135-43. 10.1016/j.ahj.2016.08.003 - DOI - PMC - PubMed
    1. Charitakis E, Barmano N, Walfridsson U, et al. Factors Predicting Arrhythmia-Related Symptoms and Health-Related Quality of Life in Patients Referred for Radiofrequency Ablation of Atrial Fibrillation: An Observational Study (the SMURF Study). JACC Clin Electrophysiol 2017;3:494-502. 10.1016/j.jacep.2016.12.004 - DOI - PubMed

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