Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery
2010 · paper · Clinical trials
A randomized trial in 358 patients with severe aortic stenosis unsuitable for surgery, comparing transcatheter valve implantation with standard therapy. One-year death from any cause was 30.7% versus 50.7%, though strokes and vascular complications were more frequent with implantation.
0 findings
None that passed a second check.
4 minor (typos and the like; most checked by the judge only)
Reference or label Reference 8 reads "(Writing Committee to Revise the 1988 Guidelines for the Management of Patients With Valvular Heart Disease)"; the revised guidelines are presumably the 1998 ACC/AHA guidelines.
- p. 11 Reference 8
Committee to Revise the 1988 Guidelines
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the ACC/AHA valvular heart disease guidelines being revised date from 1998, not 1988. The p11 crop does print '1988' in Reference 8.
Second check: another model agreed
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Wording Procedural Outcomes says that "During the TAVI procedure or in the first 24 hours after the procedure ... 2 (1.1%) underwent multiple (≥2) valve implantations", but Table 2 footnote ‡‡ says "Three patients underwent a repeat TAVI within 24 hours after the index TAVI procedure" (Repeat TAVI 3 (1.7) at 30 days), and this is not reconciled.
- p. 4 Results, Procedural Outcomes
2 (1.1%) underwent multiple (≥2) valve implantations
- p. 7 Table 2, footnote ‡‡
Three patients underwent a repeat TAVI within 24 hours after the index TAVI procedure
- p. 8 Results text, top of left column
Three patients in the TAVI group (1.7%) had to undergo an additional pro-
Only the authors can say what is right here.
Judge's note: I checked the p4 crop (2 patients, 1.1%), the Table 2 footnote ‡‡ and Repeat TAVI row on p7 (3 (1.7)), and the p8 text (three patients, 1.7%, repeat TAVI for aortic regurgitation). The two descriptions cover the same window (the procedure or the first 24 hours) but give different counts. They might be reconciled if 'multiple valve implantations' means a second valve placed during the index session and 'repeat TAVI' means a separate procedure, or if the valve-embolization case is counted differently. The paper states neither, so only the authors can say which count is right.
Second check: another model agreed
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Wording In the Table 2 endocarditis row at 1 year, "2 (1.1) 1 (0.6) 0.31": the counts and the P value do not correspond under the declared test (Fisher's exact test on frequencies).
- p. 7 Table 2, Endocarditis row, 1 Year
2 (1.1)
- p. 4 Statistical Analysis
Categorical variables were compared with the use of Fisher’s exact test.
- p. 7 Table 2, Endocarditis row, 1 Year P value
2 (1.1) 1 (0.6) 0.31
Only the authors can say what is right here.
Judge's note: The p7 image shows 0.31. The Methods (p4) say categorical variables were compared with Fisher's exact test, and Table 2 footnote † says P values compare event frequencies at each time point. For 2/179 vs 1/179 the two-sided Fisher P is 1.00, because every possible table has probability ≤ 0.376. Other small-count rows match Fisher's test (4 vs 1 = 0.37, 1 vs 3 = 0.62, 1 vs 1 = 1.00). The authors should confirm which test produced 0.31.
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Wording Table 1 gives pulmonary hypertension as "50/118 (42.4)" (TAVI) and "53/121 (43.8)" (standard), whereas the Figure 2 pulmonary-hypertension subgroups are Yes 82 / 85 and No 69 / 66 (151 per arm); no different definition is stated.
- p. 5 Table 1, Pulmonary hypertension row
50/118 (42.4)
- p. 9 Figure 2, Pulmonary hypertension: Yes
29/82 (35.4)
Only the authors can say what is right here.
Judge's note: I checked the Table 1 crop on p5 and Figure 2 on p9. The figure's subgroup sizes (69+82 = 151 TAVI; 66+85 = 151 standard) do not match Table 1's counts or denominators (118 and 121). Neither the Figure 2 legend nor the text defines pulmonary hypertension differently for the subgroup analysis (for example, an echocardiographic threshold). The authors should clarify the definition and the population.
Second check: another model agreed