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Meta-analysis of medical management versus catheter ablation for atrial fibrillation |
Yin-jun Mao1, Hang Wang1, Jian-xing Chen2, Pin-fang Huang1, *( ) |
1Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO.20, Fuzhou, 350000, Fujian, P. R. China
2Department of Anesthesiology, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO.20, Fuzhou, 350000, Fujian, P. R. China |
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Abstract:
Several observational studies have shown a survival benefit for patients with atrial fibrillation (AF) who are treated with catheter ablation (CA) rather than medical management (MM). However, data from randomized controlled trials (RCTs) are uncertain. Therefore, we performed a meta-analysis of RCTs that compared the benefits of CA and MM in treatment of AF. We searched the Cochrane Library, PubMed, and EMBASE databases for RCTs that compared AF ablation with MM from the time of database establishment up to January 2020. The risk ratio (RR) with a 95% confidence interval (CI) was used as a measure treatment effect. Twenty-six RCTs that enrolled a total of 5788 patients were included in the meta-analysis. In this meta-analysis, the effect of AF ablation depended on the baseline level of left ventricular ejection fraction (LVEF) in the heart failure (HF) patients. AF ablation appears to be of benefit to patients with a lesser degree of advanced HF and better LVEF by reducing mortality. Meanwhile, this mortality advantage was manifested in long-term follow-up. CA increased the risk for hospitalization when it was used as first-line therapy and decreased the risk when used as second-line therapy. CA reduced recurrence of atrial arrhythmia for different types of AF (paroxysmal or persistent AF) and CA-related complications were non-negligible. There was no convincing evidence for a reduction in long-term stroke risk after AF ablation, and additional high quality RCTs are needed to address that issue.
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Submitted: 14 April 2020
Revised: 25 June 2020
Accepted: 09 July 2020
Published: 30 September 2020
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*Corresponding Author(s):
Pin-fang Huang
E-mail: huangpinfang@fjmu.edu.cn
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Fig. 1. Flow diagram showing the study selection process for the meta-analysis. The number of studies shown at the bottom of the flow chart represents studies that were ultimately considered eligible for inclusion in this meta-analysis.
Table 1. Baseline characteristics of the included trials.
Study/Year | Patients (n) | Mean age (years) | Male (%) | LAD (mm) | LVEF (%) | PEE (n) | CAD (n) | DM (n) | HTN (n) | Crossover to CA(%) | Follow up (months) | Natale et al., 2000 | 31/30 | 67 8/66 11 | 65/73 | NR | 49.4 5/49.6 3 | NR | 12/11 | NR | NR | NR | 33 | Krittayaphong et al., 2003 | 15/15 | 55 11/49 15 | 73/53 | 39.6 7.7/39.2 7.1 | 63.7 10/61.8 9 | 0/0 | NR | NR | NR | NR | 12 | Wazni et al., 2005 | 33/37 | 53 8/54 8 | NR | 41 8/42 7 | 53 5/54 6 | NR | NR | NR | 8/10 | NR | 12 | Da Costa et al., 2006 | 52/51 | 78.5 5/78 5 | 79/82 | 43 7/43 6 | 56 14/54 14 | NR | NR | 10/11 | 36/34 | NR | 13 | Oral et al., 2006 | 77/69 | 55 9/58 8 | 67/62 | 45 6/45 5 | 55 7/56 7 | 0/0 | 3/4 | NR | NR | 77 | 12 | Stabile et al., 2006 | 68/69 | 62 9/62 11 | 54/64 | 46 5/45.4 5.5 | 59.1 6.7/57.9 5.8 | NR | NR | NR | 36/34 | 52 | 12 | Pappone et al., 2006 | 99/99 | 55 10/57 10 | 70/65 | 40 6/38 6 | 60 8/61 6 | NR | 2/2 | 5/4 | 56/57 | 42 | 12 | Jais et al., 2008 | 53/59 | 50 11/52 11 | 85/83 | 39.5 6/40 6 | 63 11/66 7 | 1/7 | NR | 1/2 | 11/18 | 63 | 12 | Forleo et al., 2009 | 35/35 | 63 9/65 7 | 57/65 | 44 6/45.2 5 | 54.6 7/52.6 9 | 5/3 | 7/7 | 35/35 | 22/24 | NR | 12 | Wilber et al., 2010 | 106/61 | 56 9/56 13 | 69/62 | 40 1.1/40 1.5 | 62.3 2/62.7 2 | 2/2 | NR | 10/7 | 51/30 | 59 | 9 | MacDonald et al., 2011 | 22/19 | 62 7/64 8 | 77/79 | NR | 16.1 7.1/19.6 5.5 | 2/2 | 11/9 | 7/4 | 14/11 | 0 | 6 | Nielsen et al., 2012 | 146/148 | 56 9/54 10 | 68/72 | 40 6/40 5 | 60/60 | 6/5 | 6/2 | 6/10 | 43/53 | 36 | 24 | Packer et al., 2013 | 163/82 | 57 9/56 9 | 77/78 | 40 5/41 6 | 60 6/61 6 | 0/0 | 13/8 | 11/7 | 67/37 | 79 | 12 | Pokushalov et al., 2013 | 77/77 | 56 7/57 7 | 73/77 | 45 7/46 5 | 57 6/58 5 | 5/6 | 8/10 | 9/7 | 24/29 | 56 | 36 | Jones et al., 2013 | 26/26 | 64 10/62 9 | 81/92 | 50 6/46 7 | 22 8/25 7 | NR | 11/13 | NR | NR | 3.8 | 12 | Zhang et al., 2014 | 101/100 | 60 11/58 10 | 70/67 | 45.8 6/45.7 6 | 57.9 6/57.5 7 | 10/6 | 11/13 | 19/20 | 52/48 | 24 | 24 | Mont et al., 2014 | 98/48 | 55 9/55 9 | 78/77 | 41 5/42 5 | 61 8/60 9 | 4/2 | NR | NR | 46/19 | 48 | 12 | Hummel et al., 2014 | 138/72 | 60 8/61 8 | 83/83 | 45 5/46 5 | 54 7/55 6 | 0/0 | 28/12 | 22/8 | 84/40 | 60 | 6 | Hunter et al., 2014 | 26/24 | 55 12/60 10 | 96/96 | 52 11/50 10 | 31.8 7.7/33.7 12 | NR | NR | NR | 8/8 | 0 | 6 | Morillo et al., 2014 | 66/61 | 56 9/54 12 | 77/74 | 40 5/43 5 | 61.4 5/60.8 7 | 3/4 | 6/2 | 1/4 | 28/25 | 43 | 24 | Sohara et al., 2016 | 100/43 | 59 10/61 10 | 80/81 | 38.3 6/38.3 5 | 66.7 6/66.5 7 | NR | 3/2 | 3/4 | 51/24 | 79 | 9 | Di Biase et al., 2016 | 102/101 | 62 10/60 11 | 75/73 | 47 4.2/48 4.9 | 29 5/30 8 | NR | 63/66 | 22/24 | 46/48 | NR | 24 | Prabhu et al., 2017 | 33/33 | 59 11/62 9 | 94/88 | 48 5.5/47 8.2 | 32 9/34 8 | 2/0 | 0/0 | 4/5 | 13/12 | 9 | 6 | Marrouche et al., 2018 | 179/184 | 64 3/64 3 | 87/84 | 48 1.5/49.5 8.3 | 31.5 1.7/32.5 2.2 | 21/21 | 72/96 | 43/67 | 129/136 | 15.6 | 38 | Packer et al., 2019 | 1108/1096 | 68 5/67 5 | 63/63 | NR | NR | 117/103 | 201/216 | 280/281 | 876/900 | 27.5 | 48 | Kuck et al., 2019 | 100/95 | 65 8/65 8 | 88/92 | 50 6/51 5 | 28 9.5/24 8.8 | NR | 30/40 | 24/22 | 56/55 | 4 | 12 | Data are presented as patients receiving CA/patients receiving MM. Age is given as mean SD. CA: catheter ablation; CAD: coronary artery disease; DM: diabetes mellitus; HTN: hypertension; LAD: left atrial diameter; LVEF: left ventricular ejection fraction; MM: medical management; NR: not reported; PEE: previous embolic events. |
Table 2. Risks of bias in the included trials according to the Cochrane risk of bias assessment tool.
Author/Study(year) | Random sequence generation (selection bias) | Allocation concealment (selection bias) | Blinding of participants and personnel (performance bias) | Blinding of outcome assessment (detection bias) | Incomplete outcome data (attrition bias) | Selective reporting (reporting bias) | Other bias | Natale et al., 2000 | Unlcear | Low | High | High | Low | Low | Unlcear | Krittayaphong et al., 2003 | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Wazni et al., 2005 | Low | High | Unclear | Unclear | Low | Low | Unclear | Da Costa et al., 2006 | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Oral et al., 2006 | Low | Unclear | Unclear | Unclear | Low | Unclear | High | Stabile et al., 2006 | Low | Unclear | High | Low | Low | Low | High | Pappone et al., 2006 | Unclear | Unclear | High | Low | Low | Low | Unclear | Jais et al., 2008 | Low | Unclear | Low | Unlcear | Low | Low | High | Forleo et al., 2009 | Low | High | Unclear | Unlcear | Low | Low | Unlcear | Wilber et al., 2010 | Low | Low | High | Unlcear | Low | Low | High | MacDonald et al., 2011 | Low | Low | High | High | Low | Low | Unclear | Nielsen et al., 2012 | Low | Low | High | Low | Low | Low | Unclear | Packer et al., 2013 | Unlcear | Low | High | Unclear | High | Low | High | Pokushalov et al., 2013 | Low | Low | High | Low | Low | Low | High | Jones et al., 2013 | Low | High | High | Low | Low | Low | Unclear | Zhang et al., 2014 | Low | High | High | Low | Low | Low | Unclear | Mont et al., 2014 | Low | High | High | Unclear | Low | Low | Unclear | Hummel et al., 2014 | Unclear | Unclear | Unclear | Unclear | Low | Unclear | High | Hunter et al., 2014 | Low | Low | High | High | Low | Low | Unclear | Morillo et al., 2014 | Low | Unclear | Unclear | Low | Low | Low | Unclear | Sohara et al., 2016 | Unlcear | Unclear | High | Low | High | Low | High | Di Biase et al., 2016 | Low | Low | High | High | High | Low | Unlcear | Prabhu et al., 2017 | Low | Low | High | High | Low | Low | Unlcear | Marrouche et al., 2018 | Low | Low | High | Unclear | High | Low | Unlcear | Packer et al., 2019 | Low | Low | High | Low | Low | Low | Unlcear | Kuck et al., 2019 | Low | Low | High | Low | High | Low | Unlcear |
Fig. 2. The pooled outcome of all-cause mortality. A forest plot illustrating the all-cause mortality during follow-up among AF patients randomized to CA versus MM. Packer-(Non-HF), Packer-(HF), and Marrouche-(AHF) used composite endpoints.
Fig. 3. Sensitivity analysis for all-cause mortality. (A) Sensitivity analysis for all-cause mortality among patients without HF. (B) Sensitivity analysis for all-cause mortality among patients with HF. (C) Sensitivity analysis for all-cause mortality among patients with AHF.
Fig. 4. The pooled outcome of hospitalization risk for patients treated with CA versus MM. A forest plot illustrating results of the subgroup analysis that was performed based on CA provided as first-line or second-line therapy (upper panel shows the pooled outcome for CA when used as first-line therapy; lower panel shows the pooled outcome for CA when used as second-line therapy).
Fig. 5. The pooled outcome of hospitalization risk when CA was used as first-line therapy. A forest plot illustrating the risk of hospitalization when CA was performed as first-line treatment, after excluding the study by Wazni et al. (2005).
Fig. 6. The pooled outcome of stroke/TIA risk associated with CA versus MM. The forest plot illustrates results of a subgroup analysis that was performed based on the source of stroke (upper panel shows the pooled outcome for stroke directly induced by AF itself; lower panel shows the pooled outcome for stroke caused by ablation procedure).
Fig. 7. The pooled outcome of peri-procedural complications in the CA group versus the MM group. The forest plot illustrates results of the stratification analysis that was performed based on the types of complications (upper panel shows the pooled outcome for major bleeding, the middle panel shows the pooled outcome for pulmonary vein stenosis, and lower panel shows the pooled outcome for pericardial complications).
Table 3. Complications related to CA.
| Death, N (%) | Stroke/ TIA, N (%) | Major bleeding, N (%) | Pulmonary vein stenosis, N (%) | Pericardial complications, N (%) | Natale (N 31) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | Krittayaphong (N 15) | 0 (0.0%) | 1 (6.7%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | Wazni (N 33) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (6.1%) | 0 (0.0%) | Da Costa (N 52) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | Oral (N 77) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | Stabile (N 68) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.5%) | Pappone (N 99) | 0 (0.0%) | 1 (1.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.0%) | Jais (N 53) | 0 (0.0%) | 0 (0.0%) | 2 (3.8%) | 1 (1.9%) | 2 (3.8%) | Forleo (N 35) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | Wilber (N 106) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (0.9%) | MacDonald (N 22) | 0 (0.0%) | 0 (0.0%) | 2 (9.1%) | 0 (0.0%) | 2 (9.1%) | Nielsen (N 146) | 1 (0.7%) | 1 (0.7%) | 0 (0.0%) | 1 (0.7%) | 3 (2.1%) | Packer (2013) (N 163) | 0 (0.0%) | 1 (0.6%) | 3 (1.8%) | 5 (3.1%) | 1 (0.6%) | Pokushalov (N 77) | 0 (0.0%) | 0 (0.0%) | 2 (2.6%) | 0 (0.0%) | 2 (2.6%) | Jones (N 25) | 0 (0.0%) | 0 (0.0%) | 1 (4.0%) | 0 (0.0%) | 1 (4.0%) | Zhang (N 101) | 0 (0.0%) | 2 (2.0%) | 1 (1.0%) | 0 (0.0%) | 1 (1.0%) | Mont (N 98) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.0%) | 3 (3.1%) | Hummel (N 138) | 0 (0.0%) | 4 (2.9%) | 0 (0.0%) | 5 (3.6%) | 5 (3.6%) | Hunter (N 26) | 0 (0.0%) | 1 (3.8%) | 1 (3.8%) | 0 (0.0%) | 1 (3.8%) | Morillo (N 66) | 0 (0.0%) | 0 (0.0%) | 4 (6.0%) | 1 (1.5%) | 4 (6.1%) | Sohara (N 100) | 0 (0.0%) | 2 (2.0%) | 0 (0.0%) | 7 (7.0%) | 0 (0.0%) | Di Biase (N 102) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.0%) | Prabhu (N 33) | 0 (0.0%) | 0 (0.0%) | 2 (6.0%) | 0 (0.0%) | 0 (0.0%) | Marrouche (N 179) | 0 (0.0%) | 0 (0.0%) | 4 (2.2%) | 1 (0.6%) | 3 (1.7%) | Packer (2019) (N 1108) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (0.09%) | 8 (0.7%) | Kuck (N 98) | 1 (1.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (2.0%) | Total (N 3051) | 2 (0.06%) | 13 (0.4%) | 22 (0.7%) | 25 (0.8%) | 42 (1.4%) |
Table 4. Outcome for recurrence of atrial arrhythmia in AF patients with normal or reduced LVEF who underwent CA or MM in the included trials.
Recurrence of atrial arrhythmia | No. of studies | Patients CA/MM | Events CA/MM | P value | Effect estimate RR (95% CI) | I | Incidence after CA/MM | Overall | 26 | 2533/2249 | 882/1525 | 0.00001 | 0.43 (0.37, 0.51) | 82% | 34.8%/67.8% | Follow-up duration | Follow-up 1 year | 20 | 2113/2003 | 730/1309 | 0.00001 | 0.43 (0.36, 0.53) | 83% | 34.5%/65.4% | Follow-up 2 years | 8 | 1313/1330 | 531/858 | 0.00001 | 0.58 (0.48, 0.69) | 72% | 40.4%/64.5% | Follow-up 3 years | 3 | 867/890 | 398/623 | 0.001 | 0.60 (0.45, 0.82) | 85% | 45.9%/70% | Follow-up 4 years | 1 | 611/629 | 305/437 | 0.00001 | 0.72 (0.65, 0.79) | — | 49.9%/69.5% | Type of MM | CA vs. rhythm control | 14 | 992/863 | 291/617 | 0.00001 | 0.38 (0.30, 0.49) | 76% | 29.3%/71.5% | CA vs. rate control | 4 | 104/101 | 18/99 | 0.008 | 0.17 (0.05, 0.63) | 88% | 17.3%/98% | Number of ablation | Single ablation | 12 | 756/606 | 311/481 | 0.00001 | 0.51 (0.45, 0.58) | 46% | 41.1%/79% | Multiple ablations | 19 | 2330/2102 | 804/1401 | 0.00001 | 0.45 (0.38, 0.54) | 83% | 34.5%/66.7% | Type of AF | Paroxysmal AF | 7 | 864/799 | 287/527 | 0.0001 | 0.43 (0.29, 0.66) | 93% | 33.2%/66% | Persistent AF | 8 | 803/743 | 308/475 | 0.00001 | 0.54 (0.44, 0.68) | 66% | 38.4%/63.9% | Level of LVEF | Normal LVEF | 19 | 1966/1675 | 696/1116 | 0.00001 | 0.44 (0.37, 0.54) | 83% | 35.4%/66.6% | Reduced LVEF | 8 | 567/566 | 186/409 | 0.00001 | 0.42 (0.30, 0.60) | 81% | 32.8%/72.2% | AF: atrial fibrillation; CA: catheter ablation; CI: confidence interval; LVEF: left ventricular ejection fraction; MM: medical management; RR: risk ratio. |
Fig. 8. A Begg’s funnel plot of all studies included in the meta-analysis. The absence of asymmetry indicates that there was no publication bias.
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