Article Figures & Data
Figures
- FIGURE 1
Patient flow diagram. A total of 549 patients were enrolled, randomly assigned, and underwent the Norwood operation in the original SVR, and 370 of these patients were alive at the screening for the Single Ventricle Reconstruction Trial Extension Study (SVR II); of these 370 patients, 325 consented to the SVR II, and by 6 years of age, 291 were transplant-free survivors. Parent-response instruments were completed for 240 to 250 subjects. All instruments were available in both English and Spanish, except the Vineland-II, which was only available in English.
- FIGURE 2
SVR sample scores for the BASC-2: box and whisker plots for BASC-2 domains. A, Components of the behavioral symptoms index are on the x-axis. B, Components of the Adaptive skills composite are on the x-axis. The solid lines represent the normative sample means. The dashed lines mark the bounds of the normal range. Lower scores are better for the behavioral symptoms index and its components. Higher scores are better for the adaptive skills composite and its components. Higher scores indicate more concerns on the BASC-2 behavior symptoms index and its components. Lower scores indicate more concerns on the BASC-2 adaptive skills composite and its components.
- FIGURE 3
Factors included in multivariable models for each outcome with R2 > 0.10. Major outcome domains for which multivariable models explained at least 10% of variability are listed across the top row. Row headings represent candidate risk factors included in at least 1 of the models. An X in the box indicates that a candidate risk factor was an independent predictor in the multivariable model for the outcome at the top of the column. G/GJ, gastirc/gastric jejunal; SES, socioeconomic status; WHO, World Health Organization.
Tables
Instrument and Domain SVR Cohort Mean (SD) Abnormal (>1 SD) From Normative Mean (%)a Abnormal (>2 SD) From Normative Mean (%)b Normative Sample Mean (SD) Pc Vineland-II Communication 104.3 (18.6) 24/222 (10.8) 10/222 (4.5) 100 (15) <.001 Daily living skills 102.3 (21.8) 17/215 (7.9) 15/215 (7.0) 100 (15) .035 Socialization 104.6 (19.5) 17/182 (9.3) 6/182 (3.3) 100 (15) <.001 Motor skills 90.3 (17.8) 49/215 (22.8) 24/215 (11.2) 100 (15) <.001 Adaptive behavior composite 101.1 (19.9) 26/171 (15.2) 10/171 (5.8) 100 (15) .218 BASC-2 Internalizing behavior 48.2 (9.9) 11/245 (4.5) 8/245 (3.3) 50 (10) <.001 Externalizing behavior 49.4 (10.1) 18/244 (7.4) 10/244 (4.1) 50 (10) .040 Behavior symptoms index 50 (10) 24/244 (9.8) 10/244 (4.1) 50 (10) .318 Adaptive skills composite 47.3 (11.8) 54/244 (22.1) 16/244 (6.6) 50 (10) .001 PedsQL generic module Physical function 70.6 (23.2) 55/248 (22.2) 26/248 (10.5) 80.4 (20.8) <.001 Emotional function 77.0 (18.2) 33/248 (13.3) 19/248 (7.7) 80.1 (15.9) .007 Social function 76.1 (19.0) 62/248 (25.0) 5/248 (2.0) 80.6 (20.4) <.001 School function 70.1 (20.1) 57/247 (23.1) 12/247 (4.9) 77.4 (19.5) <.001 Psychosocial health 74.4 (15.6) 59/248 (23.8) 12/248 (4.8) 79.4 (15.3) <.001 Total score 73.1 (16.7) 57/248 (23.0) 19/248 (7.7) 79.7 (15.9) <.001 CHQ-PF50 Physical summary T-score 43.1 (12.3) 53/248 (21.4) 38/248 (15.3) 53.1 (10.4) <.001 Psychosocial summary T-score 51.7 (8.7) 38/248 (15.3) 16/248 (6.5) 52.5 (7.6) .156 FSII(R) Total score 92.4 (9.4) 30/249 (12.0) 49/249 (19.7) 97.7 (4.5) <.001 - TABLE 2
Models for Each Outcome With R2 > 0.10: Vineland-II Adaptive Behavior Composite: Standard Score (n = 152, Adjusted R2 = 0.32)
Variable Estimate P Adjusted R2 Male sex −8.5 .002 0.05 Perfusion type .04 0.03 DHCA only 2.6 — — RCP and DHCA time ≤10 min −5.2 — — RCP and DHCA with DHCA time >10 min Reference — — Need for ECMO during hospitalization −12.8 .02 0.02 Need for catheterization after stage 2 surgery −19.4 .02 0.03 Seizures reported before 6 y −11.4 .006 0.04 Vision problems in first year −17 .006 0.06 Total complications from 2 y to Vineland-II −1.03 .002 0.02 DHCA, deep hypothermic circulatory arrest; RCP, regional cerebral perfusion; —, not applicable.
- TABLE 3
Models for Each Outcome With R2 > 0.10: BASC-2 Adaptive Skills Composite: Standard Score (n = 212, Adjusted R2 = 0.20)
Variable Estimate P Adjusted R2 Male sex −5.3 .0006 0.04 Race .02 0.02 African American −4.25 — — Other 7.56 — — White Reference — — Need for additional operations after Norwood procedure −7.3 .009 0.02 Seizures reported before 6 y −5.6 .01 0.02 Vision problems in first year −8.2 .02 0.05 SES score 0.44 .005 0.04 WHO wt z score at 14 mo 1.8 .02 0.01 Lowest temperature obtained during bypass −0.7 .05 0.01 SES, socioeconomic status; WHO, World Health Organization; —, not applicable.
- TABLE 4
Models for Each Outcome With R2 > 0.10: PedsQL Physical Functioning Score at 6 Years (n = 209, Adjusted R2 = 0.25)
Variable Estimate P Adjusted R2 Race .04 0.02 African American 1.83 — — Other 20.02 — — White Reference — — Hollingshead score (SES) 0.22 .02 0.02 Cross-clamp time at Norwood procedure .0006 0.06 0.0–39.5 −9.8 — — >39.5–51.0 −17.1 — — >51.0–65.0 −10.7 — — >65.0–194.0 Reference — — Steroids used during Norwood procedure 12.4 .005 0.03 Fontan procedure hospitalization duration −0.2 .04 0.05 Total surgeries −2.7 .001 0.04 Protein-losing enteropathy −29.2 .0007 0.04 Any early intervention services 7.4 .02 0.02 Ever had GJ tube −25.0 .008 0.03 GJ, gastric jejunal; SES, socioeconomic status; —, not applicable.
- TABLE 5
Models for Each Outcome With R2 > 0.10: Multivariable Model for PedsQL Psychosocial Health Summary Score at 6 Years (n = 206, Adjusted R2 = 0.17)
Variable Estimate P Adjusted R2 Any early intervention up to Vineland-II −6.2 .005 0.03 Ever had G-tube −5.9 .03 0.02 WHO wt z score before Norwood procedure 1.46 .03 0.02 Total support time 0.02 .03 0.02 Total complications from 2 y to Vineland-II −0.80 .0018 0.05 G-tube, gastric tube; WHO, World Health Organization.
- TABLE 6
Models for Each Outcome With R2 > 0.10: CHQ Physical Summary T-Score at 6 Years (n = 223, Adjusted R2 = 0.31)
Variable Estimate P Adjusted R2 Ever had genetic syndrome or abnormality .004 0.03 No 4.8 — — Unknown 6.3 — — Yes Reference — — Complications during stage 2 surgery admission .002 0.03 0.0–0.0 2.8 — — >0.0–1.0 7.6 — — >1.0–16.0 Reference — — Protein-losing enteropathy −10.0 .005 0.02 Total complications from 2 y to Vineland-II −1.4 <.0001 0.23 —, not applicable.
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