JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
VOL. 67, NO. 7, 2016
ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 0735-1097/$36.00
PUBLISHED BY ELSEVIER
http://dx.doi.org/10.1016/j.jacc.2015.11.057
Post-Operative Outcomes in Children With and Without Congenital Heart Disease Undergoing Noncardiac Surgery David Faraoni, MD, PHD, David Zurakowski, PHD, Daniel Vo, MD, Susan M. Goobie, MD, Koichi Yuki, MD, Morgan L. Brown, MD, PHD, James A. DiNardo, MD
ABSTRACT BACKGROUND Significant advances have been made in the diagnosis and treatment of children with congenital heart disease (CHD), allowing for longer life expectancies and an increasing number who will require noncardiac surgery. OBJECTIVES This study sought to compare the incidence of mortality and major adverse post-operative outcomes following noncardiac surgery in children with and without CHD. METHODS Data from the 2012 pediatric database of the American College of Surgeons National Surgical Quality Improvement Program were analyzed. After propensity score matching, and stratification by severity of CHD, mortality and adverse post-operative outcomes were compared between controls and children with CHD. RESULTS Among the 51,008 children included in the database, 4,520 children with CHD underwent noncardiac surgery. After propensity score matching, we included 2,805 children with minor CHD, 1,272 with major CHD, and 417 with severe CHD. Children in each subgroup were matched and compared with controls without CHD who underwent noncardiac surgery of comparable complexity. The incidence of overall mortality was significantly higher in children with moderate (3.9%) and severe (8.2%) CHD compared with their controls (respectively, 1.7% [p < 0.001] and 1.2% [p ¼ 0.001]). Both 30-day and overall mortality were significantly increased in children with severe CHD (odds ratio [OR]: 8.43, 95% confidence interval [CI]: 2.52 to 28.21; p < 0.001; OR: 7.32, 95% CI: 2.83 to 18.90; p < 0.001) compared with their matched controls. Overall mortality was also significantly increased in children with major CHD compared with their controls (OR: 2.28; 95% CI: 1.37 to 3.79; p ¼ 0.002), whereas no difference was observed between children with minor CHD and their matched controls. CONCLUSIONS Children with major and severe CHD, undergoing noncardiac surgery, have an increased risk of mortality compared with children without CHD. Further studies need to identify the optimal environment for surgical procedures, develop trained multidisciplinary teams to care for children with CHD, and define management strategies for improving outcomes in this high-risk population. (J Am Coll Cardiol 2016;67:793–801) © 2016 by the American College of Cardiology Foundation.
O Listen to this manuscript’s
ver the past decades, significant advances
Advances made in surgical procedures (e.g., car-
have been made in the diagnosis and
diac catheterization, systemic-to-pulmonary arterial
treatment
of
children
with
congenital
shunts) and techniques (3,4), in concert with im-
heart disease (CHD) (1). Although the overall inci-
provements in diagnosis, anesthesia practices, inten-
dence of CHD has remained stable during the
sive care, and medical treatments, have transformed
last 50 years, the natural history of lesions and the
many of these fatal lesions into manageable chronic
overall survival rate have significantly changed (2).
conditions (5).
audio summary by JACC Editor-in-Chief Dr. Valentin Fuster. From the Department of Anesthesiology, Peri-operative and Pain Medicine, Boston Children’s Hospital, Harvard Medical School, Boston, Massachusetts. This work was solely supported by the Department of Anesthesiology, Peri-operative and Pain Medicine, Boston Children’s Hospital, Boston. The authors have reported that they have no relationships relevant to the contents of this paper to disclose. Manuscript received October 5, 2015; accepted November 3, 2015.
794
Faraoni et al.
JACC VOL. 67, NO. 7, 2016 FEBRUARY 23, 2016:793–801
Congenital Heart Disease Children and Noncardiac Surgery
ABBREVIATIONS AND ACRONYMS ACS NSQIP = American
As life expectancy of children with CHD has
and throat], plastics, and urogynecology), age, body
improved, this population increasingly seeks
weight, and height. Children were stratified into 5 age
medical attention for other illnesses, and a
groups: 12 years old. Operative complexity was
Surgical Quality Improvement
dergo noncardiac surgeries (6–8). To date,
assessed using each procedure’s relative value unit
Program
studies addressing mortality and adverse
(RVU) based on current procedure terminology codes
ASA = American Society of
outcomes in children with and without CHD
(14). RVUs have replaced the original ACS NSQIP
undergoing noncardiac surgery have largely
complexity score as a measure of surgical complexity,
been performed at single centers and have
and have been shown in database analyses to inde-
included small patient numbers (9–11).
pendently predict post-operative morbidity following
Anesthesiologists
CHD = congenital heart disease CI = confidence interval OR = odds ratio
In this study, we compared the incidence of
RVU = relative value unit
mortality
and
major
adverse
general surgery (15–17).
post-
SEE PAGE 802
operative outcomes following noncardiac surgery in a large group of children with and without CHD, after stratification for severity of the underlying CHD.
the study interval, whether within the first 30 days
METHODS
or not), and the incidence of the following major
DATA SOURCE. This study was performed using data
from the 2012 pediatric database of the American College
of
Surgeons
National
Surgical
Quality
Improvement Program (ACS NSQIP Pediatric). The ACS NSQIP Pediatric collects de-identified data on children 5%, or a 30-day follow-up rate 2, the number of elective versus emergent procedures (Table 1) (p ¼ 1.00 for all comparisons). Children with CHD underwent fewer neurosurgical procedures (442 [10%] vs. 761 [17%]),
CHD (1.5%) and their own controls (1.0%; p ¼ 0.07). Both 30-day and overall mortality were significantly increased in children with severe CHD (OR: 8.43, 95% CI: 2.52 to 28.21; p < 0.001; OR: 7.32, 95% CI: 2.83 to 18.90; p < 0.001) compared with their controls (Table 3). Overall mortality (Table 4) was also significantly
increased
in
children
with
major
CHD
(OR: 2.28; 95% CI: 1.37 to 3.79; p ¼ 0.002) compared with their controls, whereas no difference was seen in children with minor CHD (Table 5). In addition, the incidence of post-operative reintubation was higher in children with major and severe CHD (OR: 3.11, 95% CI: 1.31 to 7.39; p ¼ 0.005; OR: 2.46, 95% CI: 1.58 to 3.82; p < 0.001) compared with their controls (Figure 2).
DISCUSSION
and more general pediatric surgical procedures (2,561 [57%] vs. 2,234 [50%]), but no difference was
Children with major and severe CHD undergoing
observed for orthopedic surgery (11%), urologic and
noncardiac surgery have an increased risk of mortal-
gynecological procedures (15%), and plastic surgery
ity, and a higher incidence of post-operative reintu-
(7%). However, the operative complexity, defined as
bation compared with matched controls undergoing
the RVU, was perfectly matched between CHD and
comparable procedures (Central Illustration).
controls (p ¼ 1.00). We included children with CHD
Using the University Hospital Consortium data-
divided into 3 subgroups based on the severity of the
base, Baum et al. (22) reviewed data from 191,261
CHD: 2,805 children with minor CHD, 1,272 with
children undergoing noncardiac procedures between
major CHD, and 417 with severe CHD (Figure 1).
1993 and 1996, and assessed 1-, 3-, and 30-day mor-
Children with CHD had similar length of hospital
tality. The authors reported that 6.5% of the children
stay compared with their matched controls (severe:
undergoing noncardiac surgical procedures had a
Faraoni et al.
796
JACC VOL. 67, NO. 7, 2016 FEBRUARY 23, 2016:793–801
Congenital Heart Disease Children and Noncardiac Surgery
F I G U R E 1 Flow Chart Representing the Number of Children Included in the 2012 ACS NSQIP Pediatric Database
ACS NSQIP Pediatric 2012 N = 51,008
Before Matching
CHD N = 4,520
Controls N = 46,488
After Propensity Score Matching
Minor N = 2,805
Controls N = 2,805
Major N = 1,272
Controls N = 1,272
Severe N = 417
Controls N = 417
The repartition between children with CHD (n ¼ 4,520) and controls (n ¼ 46,488) is shown. After propensity score matching, children with CHD were compared with their matched controls after being stratified according to severity between minor CHD (n ¼ 2,805), major CHD (n ¼ 1,272), and severe CHD (n ¼ 417). ACS NSQIP ¼ American College of Surgeons National Surgical Quality Improvement Program; CHD ¼ congenital heart disease.
diagnosis of CHD, and observed a 3.5 higher incidence of 30-day mortality (95% CI: 3.2 to 3.9) in this population compared with children without CHD. They also observed that children with severe CHD had
T A B L E 2 Propensity Matching for Controls and CHD Patients
Before Matching Matching Criteria
Male
CHD (n ¼ 4,520)
Controls (n ¼ 46,488)
2,516 (56)
26,689 (57)
VOL. 67, NO. 7, 2016
ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 0735-1097/$36.00
PUBLISHED BY ELSEVIER
http://dx.doi.org/10.1016/j.jacc.2015.11.057
Post-Operative Outcomes in Children With and Without Congenital Heart Disease Undergoing Noncardiac Surgery David Faraoni, MD, PHD, David Zurakowski, PHD, Daniel Vo, MD, Susan M. Goobie, MD, Koichi Yuki, MD, Morgan L. Brown, MD, PHD, James A. DiNardo, MD
ABSTRACT BACKGROUND Significant advances have been made in the diagnosis and treatment of children with congenital heart disease (CHD), allowing for longer life expectancies and an increasing number who will require noncardiac surgery. OBJECTIVES This study sought to compare the incidence of mortality and major adverse post-operative outcomes following noncardiac surgery in children with and without CHD. METHODS Data from the 2012 pediatric database of the American College of Surgeons National Surgical Quality Improvement Program were analyzed. After propensity score matching, and stratification by severity of CHD, mortality and adverse post-operative outcomes were compared between controls and children with CHD. RESULTS Among the 51,008 children included in the database, 4,520 children with CHD underwent noncardiac surgery. After propensity score matching, we included 2,805 children with minor CHD, 1,272 with major CHD, and 417 with severe CHD. Children in each subgroup were matched and compared with controls without CHD who underwent noncardiac surgery of comparable complexity. The incidence of overall mortality was significantly higher in children with moderate (3.9%) and severe (8.2%) CHD compared with their controls (respectively, 1.7% [p < 0.001] and 1.2% [p ¼ 0.001]). Both 30-day and overall mortality were significantly increased in children with severe CHD (odds ratio [OR]: 8.43, 95% confidence interval [CI]: 2.52 to 28.21; p < 0.001; OR: 7.32, 95% CI: 2.83 to 18.90; p < 0.001) compared with their matched controls. Overall mortality was also significantly increased in children with major CHD compared with their controls (OR: 2.28; 95% CI: 1.37 to 3.79; p ¼ 0.002), whereas no difference was observed between children with minor CHD and their matched controls. CONCLUSIONS Children with major and severe CHD, undergoing noncardiac surgery, have an increased risk of mortality compared with children without CHD. Further studies need to identify the optimal environment for surgical procedures, develop trained multidisciplinary teams to care for children with CHD, and define management strategies for improving outcomes in this high-risk population. (J Am Coll Cardiol 2016;67:793–801) © 2016 by the American College of Cardiology Foundation.
O Listen to this manuscript’s
ver the past decades, significant advances
Advances made in surgical procedures (e.g., car-
have been made in the diagnosis and
diac catheterization, systemic-to-pulmonary arterial
treatment
of
children
with
congenital
shunts) and techniques (3,4), in concert with im-
heart disease (CHD) (1). Although the overall inci-
provements in diagnosis, anesthesia practices, inten-
dence of CHD has remained stable during the
sive care, and medical treatments, have transformed
last 50 years, the natural history of lesions and the
many of these fatal lesions into manageable chronic
overall survival rate have significantly changed (2).
conditions (5).
audio summary by JACC Editor-in-Chief Dr. Valentin Fuster. From the Department of Anesthesiology, Peri-operative and Pain Medicine, Boston Children’s Hospital, Harvard Medical School, Boston, Massachusetts. This work was solely supported by the Department of Anesthesiology, Peri-operative and Pain Medicine, Boston Children’s Hospital, Boston. The authors have reported that they have no relationships relevant to the contents of this paper to disclose. Manuscript received October 5, 2015; accepted November 3, 2015.
794
Faraoni et al.
JACC VOL. 67, NO. 7, 2016 FEBRUARY 23, 2016:793–801
Congenital Heart Disease Children and Noncardiac Surgery
ABBREVIATIONS AND ACRONYMS ACS NSQIP = American
As life expectancy of children with CHD has
and throat], plastics, and urogynecology), age, body
improved, this population increasingly seeks
weight, and height. Children were stratified into 5 age
medical attention for other illnesses, and a
groups: 12 years old. Operative complexity was
Surgical Quality Improvement
dergo noncardiac surgeries (6–8). To date,
assessed using each procedure’s relative value unit
Program
studies addressing mortality and adverse
(RVU) based on current procedure terminology codes
ASA = American Society of
outcomes in children with and without CHD
(14). RVUs have replaced the original ACS NSQIP
undergoing noncardiac surgery have largely
complexity score as a measure of surgical complexity,
been performed at single centers and have
and have been shown in database analyses to inde-
included small patient numbers (9–11).
pendently predict post-operative morbidity following
Anesthesiologists
CHD = congenital heart disease CI = confidence interval OR = odds ratio
In this study, we compared the incidence of
RVU = relative value unit
mortality
and
major
adverse
general surgery (15–17).
post-
SEE PAGE 802
operative outcomes following noncardiac surgery in a large group of children with and without CHD, after stratification for severity of the underlying CHD.
the study interval, whether within the first 30 days
METHODS
or not), and the incidence of the following major
DATA SOURCE. This study was performed using data
from the 2012 pediatric database of the American College
of
Surgeons
National
Surgical
Quality
Improvement Program (ACS NSQIP Pediatric). The ACS NSQIP Pediatric collects de-identified data on children 5%, or a 30-day follow-up rate 2, the number of elective versus emergent procedures (Table 1) (p ¼ 1.00 for all comparisons). Children with CHD underwent fewer neurosurgical procedures (442 [10%] vs. 761 [17%]),
CHD (1.5%) and their own controls (1.0%; p ¼ 0.07). Both 30-day and overall mortality were significantly increased in children with severe CHD (OR: 8.43, 95% CI: 2.52 to 28.21; p < 0.001; OR: 7.32, 95% CI: 2.83 to 18.90; p < 0.001) compared with their controls (Table 3). Overall mortality (Table 4) was also significantly
increased
in
children
with
major
CHD
(OR: 2.28; 95% CI: 1.37 to 3.79; p ¼ 0.002) compared with their controls, whereas no difference was seen in children with minor CHD (Table 5). In addition, the incidence of post-operative reintubation was higher in children with major and severe CHD (OR: 3.11, 95% CI: 1.31 to 7.39; p ¼ 0.005; OR: 2.46, 95% CI: 1.58 to 3.82; p < 0.001) compared with their controls (Figure 2).
DISCUSSION
and more general pediatric surgical procedures (2,561 [57%] vs. 2,234 [50%]), but no difference was
Children with major and severe CHD undergoing
observed for orthopedic surgery (11%), urologic and
noncardiac surgery have an increased risk of mortal-
gynecological procedures (15%), and plastic surgery
ity, and a higher incidence of post-operative reintu-
(7%). However, the operative complexity, defined as
bation compared with matched controls undergoing
the RVU, was perfectly matched between CHD and
comparable procedures (Central Illustration).
controls (p ¼ 1.00). We included children with CHD
Using the University Hospital Consortium data-
divided into 3 subgroups based on the severity of the
base, Baum et al. (22) reviewed data from 191,261
CHD: 2,805 children with minor CHD, 1,272 with
children undergoing noncardiac procedures between
major CHD, and 417 with severe CHD (Figure 1).
1993 and 1996, and assessed 1-, 3-, and 30-day mor-
Children with CHD had similar length of hospital
tality. The authors reported that 6.5% of the children
stay compared with their matched controls (severe:
undergoing noncardiac surgical procedures had a
Faraoni et al.
796
JACC VOL. 67, NO. 7, 2016 FEBRUARY 23, 2016:793–801
Congenital Heart Disease Children and Noncardiac Surgery
F I G U R E 1 Flow Chart Representing the Number of Children Included in the 2012 ACS NSQIP Pediatric Database
ACS NSQIP Pediatric 2012 N = 51,008
Before Matching
CHD N = 4,520
Controls N = 46,488
After Propensity Score Matching
Minor N = 2,805
Controls N = 2,805
Major N = 1,272
Controls N = 1,272
Severe N = 417
Controls N = 417
The repartition between children with CHD (n ¼ 4,520) and controls (n ¼ 46,488) is shown. After propensity score matching, children with CHD were compared with their matched controls after being stratified according to severity between minor CHD (n ¼ 2,805), major CHD (n ¼ 1,272), and severe CHD (n ¼ 417). ACS NSQIP ¼ American College of Surgeons National Surgical Quality Improvement Program; CHD ¼ congenital heart disease.
diagnosis of CHD, and observed a 3.5 higher incidence of 30-day mortality (95% CI: 3.2 to 3.9) in this population compared with children without CHD. They also observed that children with severe CHD had
T A B L E 2 Propensity Matching for Controls and CHD Patients
Before Matching Matching Criteria
Male
CHD (n ¼ 4,520)
Controls (n ¼ 46,488)
2,516 (56)
26,689 (57)
