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Observational Study
. 2021 May 18;77(19):2382-2394.
doi: 10.1016/j.jacc.2021.03.304.

Impact of Major Residual Lesions on Outcomes After Surgery for Congenital Heart Disease

Meena Nathan  1 , Jami C Levine  2 , Maria I Van Rompay  3 , Linda M Lambert  4 , Felicia L Trachtenberg  3 , Steven D Colan  2 , Iki Adachi  5 , Brett R Anderson  6 , Emile A Bacha  7 , Aaron Eckhauser  8 , J William Gaynor  9 , Eric M Graham  10 , Benjamin Goot  11 , Jeffrey P Jacobs  12 , Rija John  5 , Jonathan R Kaltman  13 , Kirk R Kanter  14 , Carlos M Mery  15 , L LuAnn Minich  4 , Richard Ohye  16 , David Overman  17 , Christian Pizarro  18 , Geetha Raghuveer  19 , Marcus S Schamberger  20 , Steven M Schwartz  21 , Shanthi L Narasimhan  22 , Michael D Taylor  23 , Ke Wang  3 , Jane W Newburger  2 ; Pediatric Heart Network Investigators
Affiliations
Observational Study

Impact of Major Residual Lesions on Outcomes After Surgery for Congenital Heart Disease

Meena Nathan et al. J Am Coll Cardiol. .

Abstract

Background: Many factors affect outcomes after congenital cardiac surgery.

Objectives: The RLS (Residual Lesion Score) study explored the impact of severity of residual lesions on post-operative outcomes across operations of varying complexity.

Methods: In a prospective, multicenter, observational study, 17 sites enrolled 1,149 infants undergoing 5 common operations: tetralogy of Fallot repair (n = 250), complete atrioventricular septal defect repair (n = 249), arterial switch operation (n = 251), coarctation or interrupted arch with ventricular septal defect (VSD) repair (n = 150), and Norwood operation (n = 249). The RLS was assigned based on post-operative echocardiography and clinical events: RLS 1 (trivial or no residual lesions), RLS 2 (minor residual lesions), or RLS 3 (reintervention for or major residual lesions before discharge). The primary outcome was days alive and out of hospital within 30 post-operative days (60 for Norwood). Secondary outcomes assessed post-operative course, including major medical events and days in hospital.

Results: RLS 3 (vs. RLS 1) was an independent risk factor for fewer days alive and out of hospital (p ≤ 0.008) and longer post-operative hospital stay (p ≤ 0.02) for all 5 operations, and for all secondary outcomes after coarctation or interrupted arch with VSD repair and Norwood (p ≤ 0.03). Outcomes for RLS 1 versus 2 did not differ consistently. RLS alone explained 5% (tetralogy of Fallot repair) to 20% (Norwood) of variation in the primary outcome.

Conclusions: Adjusting for pre-operative factors, residual lesions after congenital cardiac surgery impacted in-hospital outcomes across operative complexity with greatest impact following complex operations. Minor residual lesions had minimal impact. These findings may provide guidance for surgeons when considering short-term risks and benefits of returning to bypass to repair residual lesions.

Keywords: Residual Lesion Score; days alive and out of the hospital; outcomes.

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Conflict of interest statement

Funding Support and Author Disclosures This study was supported by grants (U24HL135691, U10HL068270, HL109818, HL109778, HL109816, HL109743, HL109741, HL109673, HL068270, HL109781, HL135665, HL135680) from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Drs. Nathan and Anderson were supported by K23 grants (NHLBI/NIH HL119600and HL133454, respectively). The views expressed in this paper are those of the authors and do not necessarily represent the views of the NHLBI, NIH, or U.S. Department of Health and Human Services. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

Figure 1.
Figure 1.. Study Outcomes by Operation*.
(A) Boxplot of Days Alive and Out of Hospital†,‡; (B) Boxplot of Total Ventilation Time †; (C) Boxplot of Total Postoperative Length of ICU Stay†; (D) Bar Chart of Incidence of Major Medical Events‡,§,║* Number and percentage of patients in the three RLS classes are provided below the boxplot. † p-values Kruskal-Wallis test ‡ within 30 days for TOF, CAVSD, ASO, Arch/VSD; within 60 days for Norwood. § p-values Fisher’s exact test. ║ Includes mortality/transplant, cardiac arrest, extracorporeal membrane oxygenation, cardiac failure, mediastinitis, bleeding, neurologic event, renal failure, necrotizing enterocolitis, diaphragmatic paralysis, vocal cord paralysis, prolonged ventilation, sepsis, multisystem organ failure, non-cardiac reoperation, hemothorax, and readmission. Arch/VSD = coarctation/hypoplastic or interrupted arch with VSD; ASO = arterial switch operation; CAVSD = complete atrioventricular septal defect; ICU = intensive care unit; RLS = residual lesion score; TOF = tetralogy of Fallot with pulmonary stenosis.
Figure 1.
Figure 1.. Study Outcomes by Operation*.
(A) Boxplot of Days Alive and Out of Hospital†,‡; (B) Boxplot of Total Ventilation Time †; (C) Boxplot of Total Postoperative Length of ICU Stay†; (D) Bar Chart of Incidence of Major Medical Events‡,§,║* Number and percentage of patients in the three RLS classes are provided below the boxplot. † p-values Kruskal-Wallis test ‡ within 30 days for TOF, CAVSD, ASO, Arch/VSD; within 60 days for Norwood. § p-values Fisher’s exact test. ║ Includes mortality/transplant, cardiac arrest, extracorporeal membrane oxygenation, cardiac failure, mediastinitis, bleeding, neurologic event, renal failure, necrotizing enterocolitis, diaphragmatic paralysis, vocal cord paralysis, prolonged ventilation, sepsis, multisystem organ failure, non-cardiac reoperation, hemothorax, and readmission. Arch/VSD = coarctation/hypoplastic or interrupted arch with VSD; ASO = arterial switch operation; CAVSD = complete atrioventricular septal defect; ICU = intensive care unit; RLS = residual lesion score; TOF = tetralogy of Fallot with pulmonary stenosis.
Figure 1.
Figure 1.. Study Outcomes by Operation*.
(A) Boxplot of Days Alive and Out of Hospital†,‡; (B) Boxplot of Total Ventilation Time †; (C) Boxplot of Total Postoperative Length of ICU Stay†; (D) Bar Chart of Incidence of Major Medical Events‡,§,║* Number and percentage of patients in the three RLS classes are provided below the boxplot. † p-values Kruskal-Wallis test ‡ within 30 days for TOF, CAVSD, ASO, Arch/VSD; within 60 days for Norwood. § p-values Fisher’s exact test. ║ Includes mortality/transplant, cardiac arrest, extracorporeal membrane oxygenation, cardiac failure, mediastinitis, bleeding, neurologic event, renal failure, necrotizing enterocolitis, diaphragmatic paralysis, vocal cord paralysis, prolonged ventilation, sepsis, multisystem organ failure, non-cardiac reoperation, hemothorax, and readmission. Arch/VSD = coarctation/hypoplastic or interrupted arch with VSD; ASO = arterial switch operation; CAVSD = complete atrioventricular septal defect; ICU = intensive care unit; RLS = residual lesion score; TOF = tetralogy of Fallot with pulmonary stenosis.
Figure 1.
Figure 1.. Study Outcomes by Operation*.
(A) Boxplot of Days Alive and Out of Hospital†,‡; (B) Boxplot of Total Ventilation Time †; (C) Boxplot of Total Postoperative Length of ICU Stay†; (D) Bar Chart of Incidence of Major Medical Events‡,§,║* Number and percentage of patients in the three RLS classes are provided below the boxplot. † p-values Kruskal-Wallis test ‡ within 30 days for TOF, CAVSD, ASO, Arch/VSD; within 60 days for Norwood. § p-values Fisher’s exact test. ║ Includes mortality/transplant, cardiac arrest, extracorporeal membrane oxygenation, cardiac failure, mediastinitis, bleeding, neurologic event, renal failure, necrotizing enterocolitis, diaphragmatic paralysis, vocal cord paralysis, prolonged ventilation, sepsis, multisystem organ failure, non-cardiac reoperation, hemothorax, and readmission. Arch/VSD = coarctation/hypoplastic or interrupted arch with VSD; ASO = arterial switch operation; CAVSD = complete atrioventricular septal defect; ICU = intensive care unit; RLS = residual lesion score; TOF = tetralogy of Fallot with pulmonary stenosis.
Central Illustration.
Central Illustration.. Distribution of Residual Lesion Score by Operation.
RLS 1 is represented in green, RLS 2 in amber and RLS 3 in red. RLS ranged as follows: RLS 1 in 11–33%, RLS 2 in 30–53% and RLS 3 in 15–35% of patients. Arch/VSD = coarctation/hypoplastic or interrupted arch with VSD; ASO = arterial switch operation; CAVSD = complete atrioventricular septal defect; RLS = residual lesion score; TOF = tetralogy of Fallot with pulmonary stenosis.
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