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Meta-Analysis
. 2016 Aug 22;2016(8):CD011814.
doi: 10.1002/14651858.CD011814.pub2.

Concomitant atrial fibrillation surgery for people undergoing cardiac surgery

Mark D Huffman  1 , Kunal N Karmali, Mark A Berendsen, Adin-Cristian Andrei, Jane Kruse, Patrick M McCarthy, S C Malaisrie
Affiliations
Meta-Analysis

Concomitant atrial fibrillation surgery for people undergoing cardiac surgery

Mark D Huffman et al. Cochrane Database Syst Rev. .

Abstract

Background: People with atrial fibrillation (AF) often undergo cardiac surgery for other underlying reasons and are frequently offered concomitant AF surgery to reduce the frequency of short- and long-term AF and improve short- and long-term outcomes.

Objectives: To assess the effects of concomitant AF surgery among people with AF who are undergoing cardiac surgery on short-term and long-term (12 months or greater) health-related outcomes, health-related quality of life, and costs.

Search methods: Starting from the year when the first "maze" AF surgery was reported (1987), we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library (March 2016), MEDLINE Ovid (March 2016), Embase Ovid (March 2016), Web of Science (March 2016), the Database of Abstracts of Reviews of Effects (DARE, April 2015), and Health Technology Assessment Database (HTA, March 2016). We searched trial registers in April 2016. We used no language restrictions.

Selection criteria: We included randomised controlled trials evaluating the effect of any concomitant AF surgery compared with no AF surgery among adults with preoperative AF, regardless of symptoms, who were undergoing cardiac surgery for another indication.

Data collection and analysis: Two review authors independently selected studies and extracted data. We evaluated the risk of bias using the Cochrane 'Risk of bias' tool. We included outcome data on all-cause and cardiovascular-specific mortality, freedom from atrial fibrillation, flutter, or tachycardia off antiarrhythmic medications, as measured by patient electrocardiographic monitoring greater than three months after the procedure, procedural safety, 30-day rehospitalisation, need for post-discharge direct current cardioversion, health-related quality of life, and direct costs. We calculated risk ratios (RR) for dichotomous data with 95% confidence intervals (CI) using a fixed-effect model when heterogeneity was low (I² ≤ 50%) and random-effects model when heterogeneity was high (I² > 50%). We evaluated the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework to create a 'Summary of findings' table.

Main results: We found 34 reports of 22 trials (1899 participants) with five additional ongoing studies and three studies awaiting classification. All included studies were assessed as having high risk of bias across at least one domain. The effect of concomitant AF surgery on all-cause mortality was uncertain when compared with no concomitant AF surgery (7.0% versus 6.6%, RR 1.14, 95% CI 0.81 to 1.59, I² = 0%, 20 trials, 1829 participants, low-quality evidence), but the intervention increased freedom from atrial fibrillation, atrial flutter, or atrial tachycardia off antiarrhythmic medications > three months (51.0% versus 24.1%, RR 2.04, 95% CI 1.63 to 2.55, I² = 0%, eight trials, 649 participants, moderate-quality evidence). The effect of concomitant AF surgery on 30-day mortality was uncertain (2.3% versus 3.1%, RR 1.25 95% CI 0.71 to 2.20, I² = 0%, 18 trials, 1566 participants, low-quality evidence), but the intervention increased the risk of permanent pacemaker implantation (6.0% versus 4.1%, RR 1.69, 95% CI 1.12 to 2.54, I² = 0%, 18 trials, 1726 participants, moderate-quality evidence). Investigator-defined adverse events, including but limited to, need for surgical re-exploration or mediastinitis, were not routinely reported but were not different between the two groups (other adverse events: 24.8% versus 23.6%, RR 1.07, 95% CI 0.85 to 1.34, I² = 45%, nine trials, 858 participants), but the quality of this evidence was very low.

Authors' conclusions: For patients with AF undergoing cardiac surgery, there is moderate-quality evidence that concomitant AF surgery approximately doubles the risk of freedom from atrial fibrillation, atrial flutter, or atrial tachycardia off anti-arrhythmic drugs while increasing the risk of permanent pacemaker implantation. The effects on mortality are uncertain. Future, high-quality and adequately powered trials will likely affect the confidence on the effect estimates of AF surgery on clinical outcomes.

PubMed Disclaimer

Conflict of interest statement

DECLARATIONS OF INTEREST This review is supported by a contract from the European Society of Cardiology to inform its 2016 clinical practice guidelines on the management of atrial fibrillation. MDH receives support from the World Heart Federation for its Emerging Leaders program through unrestricted educational grants from AstraZeneca, Boehringer Ingelheim, and Bupa. KNK has received support from a training grant from the NHLBI (T32 HL069771). AA is a steering committee member at Articure and received salary support in role of biostatistician for pilot study Implantable Monitor-Guided Anticoagulation for Non-Permanent AF from NIH/NHLBI. SCM receives honoraria from Edwards, Bolton, Baxter, and Abiomed for speaking and consulting activities. No other authors declare competing interest.

Figures

1
1
PRISMA flow chart of included studies.
2
2
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
4
4
Funnel plot of comparison: 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, outcome: 1.2 Freedom from atrial fibrillation, atrial flutter, and atrial tachycardia off anti‐arrhythmic medications > 3 months after surgery.
5
5
Funnel plot of comparison: 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, outcome: 1.3 Freedom from atrial fibrillation, atrial flutter, or atrial tachycardia.
1.1
1.1. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 1 All‐cause mortality.
1.2
1.2. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 2 Freedom from atrial fibrillation, atrial flutter, and atrial tachycardia off anti‐arrhythmic medications > 3 months after surgery.
1.3
1.3. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 3 Freedom from atrial fibrillation, atrial flutter, or atrial tachycardia.
1.4
1.4. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 4 Adverse events as defined by investigators.
1.5
1.5. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 5 Permanent pacemaker implantation.
1.6
1.6. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 6 30‐day mortality.
1.7
1.7. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 7 Mediastinitis.
1.8
1.8. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 8 Cardiac tamponade.
1.9
1.9. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 9 Neurologic or thromboembolic events.
1.10
1.10. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 10 Need for surgical re‐exploration.
1.11
1.11. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 11 Cardiovascular mortality.
1.12
1.12. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 12 Fatal and nonfatal cardiovascular events.
1.13
1.13. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 13 Freedom from atrial fibrillation.
1.14
1.14. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 14 30‐day rehospitalisation.
1.15
1.15. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 15 Need for post‐discharge direct current cardioversion.
1.16
1.16. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 16 Freedom from atrial fibrillation, flutter, or tachycardia >3 months (paroxsymal atrial fibrillation only).
1.17
1.17. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 17 Freedom from atrial fibrillation, flutter, or tachycardia >3 months (cut‐and‐sew only).
1.18
1.18. Analysis
Comparison 1 Atrial fibrillation surgery versus no atrial fibrillation surgery, Outcome 18 Freedom from atrial fibrillation, flutter, or tachycardia >3 months (non‐mitral valve surgery only).
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Update of

  • doi: 10.1002/14651858.CD011814

References

References to studies included in this review

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Khargi 2001 {published data only}
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Pokushalov 2012 {published data only}
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References to studies excluded from this review

Ailawadi 2011 {published data only}
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Deneke 2001 {published data only}
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Deneke 2002a {published data only}
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Dunning 2013 {published data only}
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ECRI 2004 {published data only}
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Emmert 2014 {published data only}
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Healey 2005 {published data only}
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Hornero 2001 {published data only}
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Hornero 2003 {published data only}
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Kearney 2014 {published data only}
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Khargi 2005 {published data only}
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Kong 2009 {published data only}
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Kong 2010 {published data only}
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Krul 2013 {published data only}
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Lebedev 2008 {published data only}
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Lemke 2000 {published data only}
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Lins 2010 {published data only}
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Liu 2010 {published data only}
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MacDonald 2012 {published data only}
    1. MacDonald DR, Maruthappu M, Nagendran M. How effective is microwave ablation for atrial fibrillation during concomitant cardiac surgery?. Interactive Cardiovascular and Thoracic Surgery 2012;15(1):122‐7. - PMC - PubMed
Molina 2008 {published data only}
    1. Molina Linde JM, Villegas Portero R, Lacalle Remigio JR, Porras Martin C, Perez Duarte E, Gonzalez Calle A, et al. [Standards for health technologies appropriateness: Indications of intra‐operative ablation in patients with atrial fibrillation. Development of criteria for appropriateness]. Seville: Andalusian Agency for Health Technology Assessment (AETSA). Seville: Andalusian Agency for Health Technology Assessment (AETSA), 2008:1‐115.
Nagpal 2009 {published data only}
    1. Nagpal AD, Torracca L, Fumero A, Denti P, Cioni M, Alfieri O. Concurrent prophylactic left atrial appendage exclusion: results from a randomized controlled trial pilot study. European Journal of Cardiothoracic Surgery 2009;36:553‐7. - PubMed
NCT00157807 {unpublished data only}
    1. NCT00157807. Clinical and economic consequences of left atrial bipolar radiofrequency ablation of persistent and permanent AF during cardiac surgery. clinicaltrials.gov/ct2/show/NCT00157807 (accessed 7 May 2016).
NICE 2005 {published data only}
    1. National Institute for Clinical Excellence. Radiofrequency ablation for atrial fibrillation in association with other cardiac surgery. NICE interventional procedure guidance, Report No. IPG121. London: National Institute for Clinical Excellence (NICE), 2005:245.
NICE 2005a {published data only}
    1. National Institute for Clinical Excellence. Microwave ablation for atrial fibrillation in association with other cardiac surgery. NICE interventional procedure guidance, Report No. IPG122. London: National Institute for Clinical Excellence (NICE), 2005:266.
NICE 2005b {published data only}
    1. National Institute for Clinical Excellence. Cryoablation for atrial fibrillation in association with other cardiac surgery. NICE interventional procedure guidance, Report No. IPG123. London: National Institute for Clinical Excellence (NICE), 2005:271.
NICE 2006 {published data only}
    1. National Institute for Health and Clinical Excellence. High‐intensity focused ultrasound for atrial fibrillation in association with other cardiac surgery. NICE interventional procedure guidance, Report No. IPG184. London: National Institute for Health and Clinical Excellence (NICE), 2006:312.
NICE 2010 {published data only}
    1. National Institute of Health and Care Excellence. Thoracoscopic epicardial radiofrequency ablation for atrial fibrillation. NICE interventional procedure guidance, Report No. IPG286. Seoul: Committee for New Health Technology Assessment (CNHTA), 2010:IP 716.
Ninet 2005 {published data only}
    1. Ninet J, Roques X, Seitelberger R, Deville C, Pomar JL, Robin J, et al. Surgical ablation of atrial fibrillation with off‐pump, epicardial, high‐intensity focused ultrasound: results of a multicenter trial. Journal of Thoracic and Cardiovascular Surgery 2005;130(3):803‐9. - PubMed
Ontario 2006 {published data only}
    1. Health Quality Ontario. Ablation for atrial fibrillation: an evidence‐based analysis. Ontario Health Technology Assessment Series. Toronto: Medical Advisory Secretariat, Ontario Ministry of Health and Long‐Term Care (MAS), 2006; Vol. 6, issue 7:1‐63. - PMC - PubMed
Padanilam 2015 {published data only}
    1. Padanilam BJ, Foreman J, Prystowsky EN. Patients with minimal atrial fibrillation events should not undergo concomitant atrial ablation during open heart procedures. Cardiac Electrophysiology Clinics 2015;7(3):395‐401. - PubMed
Passage 2010 {published data only}
    1. Passage J, Borger MA, Seeburger J, Rastan A, Walther T, Doll N, et al. Cryoablation for the treatment of atrial fibrillation in patients undergoing minimally invasive mitral valve surgery Technique and recent results. Aortic Root Surgery: The Biological Solution 2010:291‐301.
Phan 2014 {published data only}
    1. Phan K, Xie A, Meir M, Black D, Yan TD. Surgical ablation for treatment of atrial fibrillation in cardiac surgery: A cumulative meta‐analysis of randomised controlled trials. Heart 2014;100:722‐30. - PubMed
Phan 2014a {published data only}
    1. Phan K, Xie A, Tian DH, Shaikhrezai K, Yan TD. Systematic review and meta‐analysis of surgical ablation for atrial fibrillation during mitral valve surgery. Annals of Cardiothoracic Surgery 2014;3:3‐14. - PMC - PubMed
Phan 2015 {published data only}
    1. Phan K, Xie A, Kumar N, Wong S, Medi C, Meir M, et al. Comparing energy sources for surgical ablation of atrial fibrillation: a Bayesian network meta‐analysis of randomized, controlled trials. European Journal of Cardio‐Thoracic Surgery 2015;48(2):201‐11. - PubMed
Pires 2010 {published data only}
    1. Pires LM, Leiria TL, Lima GG, Kruse ML, Nesralla IA, Kalil RA. Comparison of surgical cut and sew versus radiofrequency pulmonary veins isolation for chronic permanent atrial fibrillation: a randomized study. Pacing and Clinical Electrophysiology: PACE 2010;33:1249‐57. - PubMed
Quenneville 2009 {published data only}
    1. Quenneville SP, Xie X, Brophy JM. The cost‐effectiveness of Maze procedures using ablation techniques at the time of mitral valve surgery. International Journal of Technology Assessment in Health Care 2009;25:485‐96. - PubMed
Reents 2014 {published data only}
    1. Reents W, Diegeler A, Babin‐Ebell J, Boning A, Whitlock RP. Rationale and trial design of the Left Atrial Appendage Occlusion Study (LAAOS III). Thoracic and Cardiovascular Surgeon 2014;62:45‐54. - PubMed
Reston 2005 {published data only}
    1. Reston JT, Shuhaiber JH. Meta‐analysis of clinical outcomes of maze‐related surgical procedures for medically refractory atrial fibrillation. European Journal of Cardio‐Thoracic Surgery 2005;28:724‐30. - PubMed
Senatore 2001 {published data only}
    1. Senatore G, Carreras G, Taglieri C, Giordano B, Ingignoli B, Mazza A, et al. Intraoperative radiofrequency catheter ablation of atrial fibrillation: Randomized study. Europace 2001:579‐82.
Tsai 2015 {published data only}
    1. Tsai YC, Phan K, Munkholm‐Larsen S, Tian DH, Meir M, Yan TD. Surgical left atrial appendage occlusion during cardiac surgery for patients with atrial fibrillation: a meta‐analysis. European Journal of Cardio‐Thoracic Surgery 2015;47:847‐54. - PubMed
Vicol 2005 {published data only}
    1. Clinical and economic consequences of left atrial bipolar radiofrequency ablation of persistent and permanent atrial fibrillation during cardiac surgery. Clinicaltrials.gov: NCT00157807.
Whitlock 2013 {published data only}
    1. Whitlock RP, Vincent J, Blackall MH, Hirsh J, Fremes S, Novick R, et al. Left atrial appendage occlusion study II (LAAOS II). Canadian Journal of Cardiology 2013;29:1443‐7. - PubMed
Wong 2006a {published data only}
    1. Wong JW, Mak KH. Impact of maze and concomitant mitral valve surgery on clinical outcomes. Annals of Thoracic Surgery 2006;82:1938‐47. - PubMed
Zhang 2012 {published data only}
    1. Zhang GX, Han L, Zhong K, Li L, Lu FL, Wang C, et al. Double atrial ablation with monopolar irrigated radiofrequecy for atrial fibrillation during minimally invasive mitral valve surgery via right thoracotomy: A clinical controlled study. [Chinese]. Academic Journal of Second Military Medical University 2012; Vol. 33, issue 11:1212‐6.

References to studies awaiting assessment

ChiCTR‐TRC‐07003039 {unpublished data only}
    1. ChiCTR‐TRC‐07003039. A prospective single‐center clinical trial of radiofrequency ablation maze procedure in surgical treatment of rheumatic heart valve disease. www.chictr.org.cn/showprojen.aspx?proj=6518 (accessed 6 May 2016).
NCT00735722 {unpublished data only}
    1. NCT00735722. A(f)MAZE‐CABG Study (AFMAZE‐CABG). clinicaltrials.gov/ct2/show/NCT00735722 (accessed 6 May 2016).
NCT01791218 {unpublished data only}
    1. NCT01791218. Surgical pulmonary vein isolation efficiency study (FIN‐PVI). clinicaltrials.gov/ct2/show/NCT01791218 (accessed 6 May 2016).

References to ongoing studies

ISRCTN14454361 {unpublished data only}
    1. ISRCTN14454361. A randomised controlled trial to investigate the biochemical and myocardial effects of ablation for AF at concomitant elective cardiac surgery with two different methods, freezing versus heating (RAFT‐MSR). www.isrctn.com/ISRCTN14454361 (accessed 6 May 2016).
ISRCTN82731440 {unpublished data only}
    1. ISRCTN82731440. A randomised controlled trial to investigate the clinical and cost effectiveness of adding an ablation device‐based maze procedure as a routine adjunct to elective cardiac surgery for patients with pre‐existing atrial fibrillation (AMAZE). www.isrctn.com/ISRCTN82731440. Health Technology Assessment, (accessed 6 May 2016). - PMC - PubMed
NCT01360918 {unpublished data only}
    1. NCT01360918. Concomitant epicardial pulmonary vein isolation in patients with AF undergoing elective cardiac surgery (CONTROL‐AF). clinicaltrials.gov/ct2/show/NCT01360918 (accessed 6 May 2016).
NCT01649544 {unpublished data only}
    1. NCT01649544. Comparison of treatment of atrial fibrillation (AF) between surgical ultrasonic technology or drug therapy for patients with AF requiring mitral valve surgery (EPICAF). https://clinicaltrials.gov/ct2/show/NCT01649544 (accessed 6 May 2016).
UMIN000016129 {unpublished data only}
    1. UMIN000016129. Surgical Ablation for Non Mitral Operation: Randomized multi‐Institutional Trial and optimiZation (SANMORITZ study). upload.umin.ac.jp/cgi‐open‐bin/icdr_e/ctr_view.cgi?recptno=R000018712 (accessed 6 May 2016).

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