Catheter Ablation for Atrial Fibrillation with Heart Failure
2018 · paper · Clinical trials
A randomized trial of catheter ablation versus medical therapy in 363 patients with atrial fibrillation and heart failure. After a median 37.8 months, death or hospitalization for worsening heart failure was lower with ablation (28.5% vs 44.6%).
4 findings
Substance Figure 1 ablation arm: "3 Were excluded at baseline / 2 Withdrew consent / 2 Were withdrawn in accordance with protocol". The reasons add up to 4, not 3.
- p. 5 Figure 1, ablation arm, box 'excluded at baseline'
3 Were excluded at baseline 2 Withdrew consent 2 Were withdrawn in accordance with protocol
- p. 5 Figure 1, ablation group baseline exclusions
3 Were excluded at baseline
Only the authors can say what is right here.
Judge's note: Checked the flow chart image (page 5). 2+2 = 4, but the box total is 3. The total of 3 fits 200-18-3 = 179 and the overall 34 excluded. Every other box sums correctly (run-in 11+4+2+1 = 18 and 4+1+3+1 = 9; medical arm at baseline 1+2+1 = 4). One reason count is wrong, and only the authors can say which.
Second check: another model agreed
Report a problem with this finding
Substance Table 1, left atrial diameter, medical-therapy interquartile range printed as "5.0–55.0" mm, with a median of 49.5 mm.
- p. 6 Table 1, Left atrial diameter, Interquartile range — mm, Medical Therapy column
5.0–55.0
Only the authors can say what is right here.
Judge's note: The page 6 image shows 5.0–55.0, so this is not an extraction artefact. A 25th percentile of 5.0 mm beside a median of 49.5 mm is not plausible (the ablation arm shows 45.0–54.0). A digit appears to be missing, but the intended value (45.0 or 50.0, say) cannot be determined from the files.
Second check: another model agreed
Report a problem with this finding
Reference or label Prashanthan Sanders, M.D., is in the author byline, but the affiliation footnote (which ends "Novosibirsk, Russia (E.P.)") gives no institution for P.S.
- p. 1 Author byline and affiliation footnote
Prashanthan Sanders, M.D.
- p. 1 Affiliation footnote, end
Novosibirsk, Russia (E.P.)
Judge's note: Looked at the byline and the full affiliation footnote on page 1. The footnote gives initials for N.F.M., J.B., D.A., J.P., J.V., J.S., H.S., H.C., D.B., L.B., L.J., B.M. and E.P. It has no entry for P.S. and names no Australian institution, although the Results (page 4) say patients were enrolled at sites in Australia. All 14 other authors are covered.
Second check: another model agreed
Report a problem with this finding
Reference or label "These trials concluded that neither drug was associated with lower mortality ... despite a lowering of the atrial fibrillation burden.27-31" cites refs 28–31, which are ICD trials (SCD-HeFT, AMIOVIRT, MADIT-II "Prophylactic implantation of a defibrillator...", MADIT) rather than sources on the AF-CHF/DIAMOND-CHF conclusions or on AF burden.
- p. 10 Discussion, 3rd paragraph
despite a lowering of the atrial fibrillation burden.27-31
- p. 11 References 28–31
Prophylactic implantation of a defibrilla-tor in patients with myocardial infarction and reduced ejection fraction
Only the authors can say what is right here.
Judge's note: Page 11 reference list: ref 28 is Bardy (amiodarone or an ICD for CHF); ref 29 is Strickberger (AMIOVIRT); ref 30 is Moss 2002 (prophylactic defibrillator after MI); ref 31 is Moss 1996 (implanted defibrillator in coronary disease). The sentence's subject, 'these trials', refers to AF-CHF (ref 7) and DIAMOND-CHF (ref 26), which are not in the cited range. Only ref 27 (amiodarone meta-analysis in persistent AF) plausibly supports the claim. A text search found that refs 28–31 are cited nowhere else in the article, so this may be a misplaced citation range. Only the authors can say which sources were intended.
Second check: another model agreed
Report a problem with this finding
8 minor (typos and the like; most checked by the judge only)
Reference or label Table 1 labels the spreads for age (56–71; 56–73.5) and body-mass index (25.9–32.2; 25.9–32.3) as "Range", while other median rows are labelled "Interquartile range".
- p. 6 Table 1, Age and Body-mass index rows
Range
Only the authors can say what is right here.
Judge's note: Page 6 image checked. The Methods (page 3) say quantitative variables are given as means or as medians with interquartile range. A full range of 56–71 years for 179 patients, or 25.9–32.2 for BMI, is implausible, and the half-year value 73.5 looks like a quartile. The label is probably wrong, but only the authors can confirm.
Second check: another model agreed
Report a problem with this finding
Wording Methods say the analysis "included only deaths and not other events during the first 12 weeks", but the Table 2 footnote reads "Deaths and cerebrovascular accidents were evaluated at baseline and 12 weeks after baseline for hospitalizations".
- p. 3 Statistical Analysis
included only deaths and not other events during the first 12 weeks
- p. 7 Table 2 footnote
Deaths and cerebrovascular accidents were evaluated at baseline and 12 weeks after baseline for hospitalizations
Only the authors can say what is right here.
Judge's note: Read Statistical Analysis (page 3) and the Table 2 footnote (page 7). The Methods count only deaths during the 12-week blanking period. The footnote's garbled sentence appears to say that cerebrovascular accidents were also counted from baseline. As printed the two disagree on how strokes in the blanking period were handled; only the authors can say which is right.
Second check: another model agreed
Report a problem with this finding
Wording Figure 3 legend: "Hazard ratios and P values for interaction are based on Cox logistic-regression analyses". The Methods describe Cox regression only.
- p. 9 Figure 3 legend
based on Cox logistic-regression analyses
- p. 4 Statistical analysis
Cox regression analyses
Judge's note: Page 9 legend and page 4 Statistical Analysis checked. The Methods say hazard ratios come from 'Cox regression analyses'. 'Cox logistic-regression' names two different models. This is evidently a wording slip for Cox regression.
Second check: another model agreed
Report a problem with this finding
Wording "was 50.0% (75 of 151 patients)": 75/151 is 49.7%.
- p. 8 Results, Other Outcomes (continued), right column
was 50.0% (75 of 151 patients)
Only the authors can say what is right here.
Judge's note: Page 8 image checked. 75/151 = 49.67%, which rounds to 49.7, not 50.0. 50.0% would need a denominator of 150, and no other denominator is stated. The difference is small.
Second check: another model agreed
Report a problem with this finding
Wording Discussion says patients with paroxysmal and persistent AF were included "and found that both groups benefited from catheter ablation (Fig. 3)", but in Figure 3 the paroxysmal subgroup is 0.60 (0.34–1.08), an interval that includes 1.
- p. 10 Discussion, paragraph 2
found that both groups benefited from catheter ablation (Fig. 3)
- p. 9 Figure 3, Paroxysmal row
0.60 (0.34–1.08)
Only the authors can say what is right here.
Judge's note: On page 9, the Figure 3 Paroxysmal row reads 17/54 vs 34/64, 0.60 (0.34–1.08). The Persistent row reads 0.64 (0.41–0.99). The interaction P is 0.90. The cited figure shows point estimates favouring ablation in both subgroups and no heterogeneity, but the paroxysmal interval is not below 1. 'Both groups benefited' therefore goes further than the cited figure shows. This is a wording point for the authors. The separator part of reviewer note 3 is an extraction artefact: the image shows an en dash.
Second check: another model agreed, code check
Report a problem with this finding
Typo The Introduction expands CASTLE-AF as "Catheter Ablation versus Standard Conventional Therapy in Patients with Left Ventricular Dysfunction and Atrial Fibrillation", but the cited design paper (ref. 20) is titled "...Standard Conventional Treatment in Patients with Left Ventricular Dysfunction...".
- p. 2 Introduction, last sentence
Catheter Ablation versus Stan-dard Conventional Therapy in Patients with Left Ventricular Dysfunction and Atrial Fibrillation
- p. 11 Reference 20
Ablation versus Standard Conventional Treatment in Patients with Left Ventric-ular Dysfunction
Judge's note: Compared the Introduction (page 2) with reference 20 (page 11). The two expansions of the acronym differ by one word ('Therapy' vs 'Treatment'). This is cosmetic and the meaning is unchanged.
Second check: none (judge only)
Report a problem with this finding
Typo The Figure 1 legend opens a parenthesis that is never closed: "(for details, see the Supplementary Appendix."
- p. 4 Figure 1 legend
(for details, see the Supplementary Appendix.
Judge's note: On the page 4 image, the legend sentence ends with a period and no closing parenthesis.
Second check: none (judge only)
Report a problem with this finding
Typo The same company is spelled "Liva Nova" (Dr. Sanders) and "Liva-nova" (Dr. Brachmann, hyphenated at a line break, i.e. Livanova) in the Disclosures.
- p. 10 Disclosures, Dr. Sanders
Liva Nova
- p. 10 Disclosures, Dr. Brachmann
Liva-
Judge's note: Rests on outside knowledge: that the company's official name is 'LivaNova'. The page 10 image shows the two different spellings in the same Disclosures paragraph. That inconsistency is a cosmetic point.
Second check: none (judge only)