[Skip to Content]
[Skip to Content Landing]

Effect of Catheter Ablation vs Antiarrhythmic Medication on Quality of Life in Patients With Atrial FibrillationThe CAPTAF Randomized Clinical Trial

Educational Objective
To learn whether catheter ablation improves quality of life in patients with symptomatic atrial fibrillation.
1 Credit CME
Key Points

Question  Is pulmonary vein isolation more effective than optimized antiarrhythmic drug therapy for improving general health in patients with symptomatic atrial fibrillation?

Findings  In this randomized clinical trial that included 155 patients with paroxysmal or persistent symptomatic atrial fibrillation despite use of antiarrhythmic medication, the improvement in quality of life at 12 months for those treated with catheter ablation compared with antiarrhythmic medication was 11.9 vs 3.1 points on the 0- to 100-point 36-Item Short-Form Health Survey questionnaire, a difference that was statistically and clinically significant.

Meaning  In patients with either paroxysmal or persistent symptomatic atrial fibrillation despite medication, catheter ablation may help improve quality of life.

Abstract

Importance  Quality of life is not a standard primary outcome in ablation trials, even though symptoms drive the indication.

Objective  To assess quality of life with catheter ablation vs antiarrhythmic medication at 12 months in patients with atrial fibrillation.

Design, Setting, and Participants  Randomized clinical trial at 4 university hospitals in Sweden and 1 in Finland of 155 patients aged 30-70 years with more than 6 months of atrial fibrillation and treatment failure with 1 antiarrhythmic drug or β-blocker, with 4-year follow-up. Study dates were July 2008–September 2017. Major exclusions were ejection fraction <35%, left atrial diameter >60 mm, ventricular pacing dependency, and previous ablation.

Interventions  Pulmonary vein isolation ablation (n = 79) or previously untested antiarrhythmic drugs (n = 76).

Main Outcomes and Measures  Primary outcome was the General Health subscale score (Medical Outcomes Study 36-Item Short-Form Health Survey) at baseline and 12 months, assessed unblinded (range, 0 [worst] to 100 [best]). There were 26 secondary outcomes, including atrial fibrillation burden (% of time) from baseline to 12 months, measured by implantable cardiac monitors. The first 3 months were excluded from rhythm analysis.

Results  Among 155 randomized patients (mean age, 56.1 years; 22.6% women), 97% completed the trial. Of 79 patients randomized to receive ablation, 75 underwent ablation, including 2 who crossed over to medication and 14 who underwent repeated ablation procedures. Of 76 patients randomized to receive antiarrhythmic medication, 74 received it, including 8 who crossed over to ablation and 43 for whom the first drug used failed. General Health score increased from 61.8 to 73.9 points in the ablation group vs 62.7 to 65.4 points in the medication group (between-group difference, 8.9 points; 95% CI, 3.1-14.7; P = .003). Of 26 secondary end points, 5 were analyzed; 2 were null and 2 were statistically significant, including decrease in atrial fibrillation burden (from 24.9% to 5.5% in the ablation group vs 23.3% to 11.5% in the medication group; difference –6.8% [95% CI, –12.9% to –0.7%]; P = .03). Of the Health Survey subscales, 5 of 7 improved significantly. Most common adverse events were urosepsis (5.1%) in the ablation group and atrial tachycardia (3.9%) in the medication group.

Conclusions and Relevance  Among patients with symptomatic atrial fibrillation despite use of antiarrhythmic medication, the improvement in quality of life at 12 months was greater for those treated with catheter ablation compared with antiarrhythmic medication. Although the study was limited by absence of blinding, catheter ablation may offer an advantage for quality of life.

Trial Registration  clinicaltrialsregister.eu Identifier: 2008-001384-11

Sign in to take quiz and track your certificates

Buy This Activity

JN Learning™ is the home for CME and MOC from the JAMA Network. Search by specialty or US state and earn AMA PRA Category 1 CME Credit™ from articles, audio, Clinical Challenges and more. Learn more about CME/MOC

Article Information

Corresponding Author: Carina Blomström-Lundqvist, MD, PhD, Department of Medical Science and Cardiology, Uppsala University, S-751 85 Uppsala, Sweden (carina.blomstrom.lundqvist@akademiska.se).

Accepted for Publication: January 13, 2019.

Author Contributions: Dr Blomström-Lundqvist had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Blomström-Lundqvist, Schwieler, Jensen, Bergfeldt.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Blomström-Lundqvist.

Critical revision of the manuscript for important intellectual content: Blomström-Lundqvist, Gizurarson, Schwieler, Jensen, Bergfeldt, Kennebäck, Rubulis, Malmborg, Raatikainen, Lönnerholm, Mörtsell.

Obtained funding: Blomström-Lundqvist.

Administrative, technical, or material support: Blomström-Lundqvist, Schwieler, Jensen, Bergfeldt, Kennebäck, Rubulis, Malmborg, Raatikainen, Lönnerholm, Höglund, Mörtsell.

Supervision: Blomström-Lundqvist, Schwieler, Jensen, Kennebäck, Raatikainen, Bergfeldt.

Other: Bergfeldt.

Conflict of Interest Disclosures: Dr Blomström-Lundqvist reports receiving grants from Medtronic during the conduct of the study; and personal fees from Bayer, Sanofi, Boston Scientific, and Merck Sharp & Dohme outside the submitted work. Dr Gizurarson reported a patent pending (WO 2015/149153A1). Dr Bergfeldt reports receiving personal fees from Sanofi, Bristol-Myers Squibb, Bayer, and Pfizer outside the submitted work. Dr Raatikainen reports receiving grants from Biosense Webster outside the submitted work. No other disclosures were reported.

Funding/Support: The study received unrestricted grants from the Swedish Heart-Lung Foundation (20150751), the Swedish Research Council (2014-36708-117759-70), and Medtronic AB.

Role of the Funder/Sponsor: No sponsor had any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 3.

Additional Contributions: Erika Nyberg, data manager, and Patrik Öhagen, statisticians at Uppsala Clinical Research Centre, Uppsala University, provided data management and statistical analysis and received compensation for their work. Stefan Lind, MD, Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden, collected data at follow-up visits, for which he received no compensation.

References
1.
Kirchhof  P, Benussi  S, Kotecha  D,  et al; ESC Scientific Document Group.  2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS.  Eur Heart J. 2016;37(38):2893-2962. doi:10.1093/eurheartj/ehw210PubMedGoogle ScholarCrossref
2.
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(10):e275-e444. doi:10.1016/j.hrthm.2017.05.012PubMedGoogle ScholarCrossref
3.
Mont  L, Bisbal  F, Hernández-Madrid  A,  et al; SARA Investigators.  Catheter ablation vs antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study).  Eur Heart J. 2014;35(8):501-507. doi:10.1093/eurheartj/eht457PubMedGoogle ScholarCrossref
4.
Packer  DL, Kowal  RC, Wheelan  KR,  et al; STOP AF Cryoablation Investigators.  Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial.  J Am Coll Cardiol. 2013;61(16):1713-1723. doi:10.1016/j.jacc.2012.11.064PubMedGoogle ScholarCrossref
5.
Oral  H, Pappone  C, Chugh  A,  et al.  Circumferential pulmonary-vein ablation for chronic atrial fibrillation.  N Engl J Med. 2006;354(9):934-941. doi:10.1056/NEJMoa050955PubMedGoogle ScholarCrossref
6.
Forleo  GB, Mantica  M, De Luca  L,  et al.  Catheter ablation of atrial fibrillation in patients with diabetes mellitus type 2: results from a randomized study comparing pulmonary vein isolation versus antiarrhythmic drug therapy.  J Cardiovasc Electrophysiol. 2009;20(1):22-28. doi:10.1111/j.1540-8167.2008.01275.xPubMedGoogle ScholarCrossref
7.
Morillo  CA, Verma  A, Connolly  SJ,  et al; RAAFT-2 Investigators.  Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of paroxysmal atrial fibrillation (RAAFT-2): a randomized trial.  JAMA. 2014;311(7):692-700. doi:10.1001/jama.2014.467PubMedGoogle ScholarCrossref
8.
Stabile  G, Bertaglia  E, Senatore  G,  et al.  Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation for the Cure of Atrial Fibrillation Study).  Eur Heart J. 2006;27(2):216-221. doi:10.1093/eurheartj/ehi583PubMedGoogle ScholarCrossref
9.
Wazni  OM, Marrouche  NF, Martin  DO,  et al.  Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial.  JAMA. 2005;293(21):2634-2640. doi:10.1001/jama.293.21.2634PubMedGoogle ScholarCrossref
10.
Jaïs  P, Cauchemez  B, Macle  L,  et al.  Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study.  Circulation. 2008;118(24):2498-2505. doi:10.1161/CIRCULATIONAHA.108.772582PubMedGoogle ScholarCrossref
11.
Cosedis Nielsen  J, Johannessen  A, Raatikainen  P,  et al.  Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation.  N Engl J Med. 2012;367(17):1587-1595. doi:10.1056/NEJMoa1113566PubMedGoogle ScholarCrossref
12.
Ware  JE, Snow  KK, Kosinski  M, Gandek  B.  SF-36 Health Survey: Manual and Interpretation Guide. Boston, MA: Nimrod Press; 1993.
13.
Lönnerholm  S, Blomström  P, Nilsson  L, Oxelbark  S, Jideus  L, Blomström-Lundqvist  C.  Effects of the maze operation on health-related quality of life in patients with atrial fibrillation.  Circulation. 2000;101(22):2607-2611. doi:10.1161/01.CIR.101.22.2607PubMedGoogle ScholarCrossref
14.
Singh  SN, Tang  XC, Singh  BN,  et al; SAFE-T Investigators.  Quality of life and exercise performance in patients in sinus rhythm versus persistent atrial fibrillation: a Veterans Affairs Cooperative Studies Program substudy.  J Am Coll Cardiol. 2006;48(4):721-730. doi:10.1016/j.jacc.2006.03.051PubMedGoogle ScholarCrossref
15.
Sullivan  M, Karlsson  J, Ware  JE  Jr.  The Swedish SF-36 Health Survey–I: evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden.  Soc Sci Med. 1995;41(10):1349-1358. doi:10.1016/0277-9536(95)00125-QPubMedGoogle ScholarCrossref
16.
Wilber  DJ, Pappone  C, Neuzil  P,  et al; ThermoCool AF Trial Investigators.  Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial.  JAMA. 2010;303(4):333-340. doi:10.1001/jama.2009.2029PubMedGoogle ScholarCrossref
17.
Walfridsson  H, Walfridsson  U, Nielsen  JC,  et al.  Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation: results on health-related quality of life and symptom burden: the MANTRA-PAF trial.  Europace. 2015;17(2):215-221. doi:10.1093/europace/euu342PubMedGoogle ScholarCrossref
18.
Björkenheim  A, Brandes  A, Magnuson  A, Chemnitz  A, Edvardsson  N, Poçi  D.  Patient-reported outcomes in relation to continuously monitored rhythm before and during 2 years after atrial fibrillation ablation using a disease-specific and a generic instrument.  J Am Heart Assoc. 2018;7(5):e008362. doi:10.1161/JAHA.117.008362PubMedGoogle ScholarCrossref
19.
Härdén  M, Nyström  B, Kulich  K, Carlsson  J, Bengtson  A, Edvardsson  N.  Validity and reliability of a new, short symptom rating scale in patients with persistent atrial fibrillation.  Health Qual Life Outcomes. 2009;7:65. doi:10.1186/1477-7525-7-65PubMedGoogle ScholarCrossref
20.
Hindricks  G, Piorkowski  C, Tanner  H,  et al.  Perception of atrial fibrillation before and after radiofrequency catheter ablation: relevance of asymptomatic arrhythmia recurrence.  Circulation. 2005;112(3):307-313. doi:10.1161/CIRCULATIONAHA.104.518837PubMedGoogle ScholarCrossref
21.
Pontoppidan  J, Nielsen  JC, Poulsen  SH, Hansen  PS.  Symptomatic and asymptomatic atrial fibrillation after pulmonary vein ablation and the impact on quality of life.  Pacing Clin Electrophysiol. 2009;32(6):717-726. doi:10.1111/j.1540-8159.2009.02357.xPubMedGoogle ScholarCrossref
22.
Pappone  C, Augello  G, Sala  S,  et al.  A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF study.  J Am Coll Cardiol. 2006;48(11):2340-2347. doi:10.1016/j.jacc.2006.08.037PubMedGoogle ScholarCrossref
23.
Kottkamp  H, Tanner  H, Kobza  R,  et al.  Time courses and quantitative analysis of atrial fibrillation episode number and duration after circular plus linear left atrial lesions: trigger elimination or substrate modification: early or delayed cure?  J Am Coll Cardiol. 2004;44(4):869-877.PubMedGoogle Scholar
24.
Piorkowski  C, Kottkamp  H, Tanner  H,  et al.  Value of different follow-up strategies to assess the efficacy of circumferential pulmonary vein ablation for the curative treatment of atrial fibrillation.  J Cardiovasc Electrophysiol. 2005;16(12):1286-1292. doi:10.1111/j.1540-8167.2005.00245.xPubMedGoogle ScholarCrossref
25.
Ziegler  PD, Koehler  JL, Mehra  R.  Comparison of continuous versus intermittent monitoring of atrial arrhythmias.  Heart Rhythm. 2006;3(12):1445-1452. doi:10.1016/j.hrthm.2006.07.030PubMedGoogle ScholarCrossref
26.
Botto  GL, Padeletti  L, Santini  M,  et al.  Presence and duration of atrial fibrillation detected by continuous monitoring: crucial implications for the risk of thromboembolic events.  J Cardiovasc Electrophysiol. 2009;20(3):241-248. doi:10.1111/j.1540-8167.2008.01320.xPubMedGoogle ScholarCrossref
27.
Ricci  R, Santini  M, Padeletti  L,  et al.  Atrial tachyarrhythmia recurrence temporal patterns in bradycardia patients implanted with antitachycardia pacemakers.  J Cardiovasc Electrophysiol. 2004;15(1):44-51. doi:10.1046/j.1540-8167.2004.03317.xPubMedGoogle ScholarCrossref
28.
Lim  HS, Lip  GY.  Asymptomatic atrial fibrillation on device interrogation.  J Cardiovasc Electrophysiol. 2008;19(8):891-893. doi:10.1111/j.1540-8167.2008.01194.xPubMedGoogle ScholarCrossref
29.
Hindricks  G, Pokushalov  E, Urban  L,  et al; XPECT Trial Investigators.  Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: results of the XPECT trial.  Circ Arrhythm Electrophysiol. 2010;3(2):141-147. doi:10.1161/CIRCEP.109.877852PubMedGoogle ScholarCrossref
30.
Dagres  N, Hindricks  G, Kottkamp  H,  et al.  Complications of atrial fibrillation ablation in a high-volume center in 1,000 procedures: still cause for concern?  J Cardiovasc Electrophysiol. 2009;20(9):1014-1019. doi:10.1111/j.1540-8167.2009.01493.xPubMedGoogle ScholarCrossref
31.
Hoyt  H, Bhonsale  A, Chilukuri  K,  et al.  Complications arising from catheter ablation of atrial fibrillation: temporal trends and predictors.  Heart Rhythm. 2011;8(12):1869-1874. doi:10.1016/j.hrthm.2011.07.025PubMedGoogle ScholarCrossref
If you are not a JN Learning subscriber, you can either:
Subscribe to JN Learning for one year
Buy this activity
jn-learning_Modal_LoginSubscribe_Purchase
Close
If you are not a JN Learning subscriber, you can either:
Subscribe to JN Learning for one year
Buy this activity
jn-learning_Modal_LoginSubscribe_Purchase
Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close

Name Your Search

Save Search
Close
With a personal account, you can:
  • Track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
jn-learning_Modal_SaveSearch_NoAccess_Purchase
Close

Lookup An Activity

or

Close

My Saved Searches

You currently have no searches saved.

Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close