Impact of Specialist Pediatric Cardiac Transfer on Unplanned Emergency Operations and Mortality in Neonates with Critical Congenital Heart Disease

doi:10.21203/rs.3.rs-4818534/v1

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Impact of Specialist Pediatric Cardiac Transfer on Unplanned Emergency Operations and Mortality in Neonates with Critical Congenital Heart Disease

https://doi.org/10.21203/rs.3.rs-4818534/v1

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Background Neonates with critical congenital heart disease (CCHD) often require early surgical intervention to survive.This study aimed to evaluate whether specialist pediatric cardiac transfer (SPCT) improves surgical outcomes in neonates with critical congenital heart disease (CCHD).

Methods In this retrospective cohort study, we collected clinical data of neonates diagnosed with CCHD who were treated at the cardiac intensive care unit of Shanghai Children’s Medical Center between January 2019 and December 2022. Propensity score matching (PSM) was used to balance the SPCT and non-SPCT groups. The primary outcome was postoperative survival.

Results This study included 357 neonates with CCHD. After propensity score matching (PSM), the SPCT group had significantly lower rates of inotropic drug use (57.3% vs. 77.5%, p = 0.004), unplanned emergency operations (29.2% vs. 53.9%, p = 0.001), and preoperative mortality (0% vs. 4.5%, p = 0.043) compared to the non-SPCT group. Additionally, overall survival was higher in the SPCT group (92.6% vs. 82.0%, p = 0.044). Postoperative mortality did not significantly differ between the groups (2.25% in the SPCT group vs. 7.87% in the non-SPCT group, p = 0.065). However, long-distance transport showed significantly lower overall mortality in the L-SPCT group compared to the L-N-SPCT group (2.67% vs. 12.5%, p = 0.049).

Multivariate analysis revealed low body weight at surgery (hazard ratio [HR]: 0.444, 95% confidence interval [CI]: 0.273–0.711, p= 0.001), Non-SPCT long distance transport (HR: 4.608, 95% CI: 1.436–4.982, p =0.017)and unplanned emergency operation (HR: 5.227, 95% CI: 2.521–10.834, p < 0.001) as independent risk factors for surgical mortality in neonates with CCHD.

Conclusions SPCT reduces the rate of unplanned emergency operations and increases overall survival in neonates with CCHD, particularly in long-distance transfers.

critical congenital heart disease

pediatric cardiac transfer

neonates

intensive care units

surgery

Neonates with critical congenital heart disease (CCHD) require early surgery for survival [1, 2]. CCHD accounts for 25% of all cases of congenital heart disease (CHD) [3]. The main screening methods for this disease include fetal echocardiography and pulse oximetry [1, 4, 5]. Surgery is mandatory for patients with CCHD to improve prognosis [6, 7]. In China, the CHD burden has increased from 1990 to 2017 [8]. Managing CCHD in neonates is challenging due to healthcare inequities [9, 10] as well as high costs and burdens [11]. Prenatal CCHD diagnosis can improve outcomes [12], and prompt pediatric cardiology input is considered beneficial [3]. Furthermore, transfer to specialty neonatal or cardiac intensive care unit an be lifesaving [3]. Studies have demonstrated better CCHD prognosis in patients diagnosed with CHD at maternity hospitals[13, 14], which is key for CCHD [15]. The mode of hospital transfer and preoperative care setting also have an impact on CCHD management. In the UK, interhospital transfers account for ~ 50% of pediatric intensive care unit (ICU) emergency admissions, which are frequently conducted by specialized teams [16]. The transport teams in the US employ mobile ICUs for advanced critical pediatric/neonatal care [17]. However, interhospital transfers are associated with higher mortality than direct admission [18]. Improving hospital transfer may enhance disease outcomes. A small-scale Chinese study reported that integrated transfer improved CHD outcomes [19]. The success rate of CCHD surgery remains lower in China than in developed nations, indicating the need for improvements in hospital transfer mode in China [20]. This study aims to evaluate whether specialist pediatric cardiac transfer (SPCT) can enhance the prognosis of neonates with CCHD, thereby optimizing their management in China.

Study Design and Patients

In this retrospective cohort study, we collected the clinical data of neonates diagnosed with CCHD who underwent treatment at Shanghai Children’s Medical Center between January 2019 and December 2022. This study was approved by the Ethics Committee of Shanghai Children’s Medical Center (SCMCIRB-K2023026-1). Furthermore, it was certified in the ethics approval notice of the Institutional Review Board of Shanghai Children’s Medical Center affiliated with Shanghai Jiao Tong University School of Medicine. Due to the retrospective nature of the study, the need for informed consent was waived by Shanghai Children’s Medical Center ethics committee.

The inclusion criteria were as follows: 1) neonates diagnosed with CCHD and 2) those aged 0–28 days. Neonates with incomplete clinical data or simple CHD were excluded. The neonates were classified into SPCT and non-SPCT groups according to the hospital transfer mode. The patients with > 200 km named as long-distance transport group were further divided into two groups: the long-distance transport SPCT group(L-SPCT group)and the long-distance transport non-SPCT group(L-N-SPCT group).SPCT is performed by a cardiac intensivist and cardiac intensive care nurse through ambulance service using the medical equipment of circulatory and respiratory assist. In contrast, non-SPCT is performed by a general prehospital emergency physician through regular ambulance service or by parents through public transit.

Data Collection

The preoperative and interventional data as well as the outcomes of the neonates were collected from the electronic medical record system. Preoperative data included age, body weight, diagnosis, preoperative Risk Adjustment for Congenital Heart Surgery (RACHS-1), and biochemical data after hospital admission. Interventional data mainly included surgical data and perioperative treatment. The outcomes included postoperative survival rate, overall survival rate.

Statistical Analysis

All statistical analyses were conducted using SPSS 25.0 (SPSS, Chicago, USA). A 1:1 propensity score matching (PSM) was performed on the groups. Specifically, the factors that matched between the groups included age, body weight, extracorporeal membrane oxygenation transfer, and preoperative cardiopulmonary resuscitation (CPR). The caliper value was 0.02, and 89 pairs of neonates who underwent cardiac surgery were obtained after fuzzy matching.

Continuous data were tested for normal distribution using the Kolmogorov–Smirnov test. Those with a normal distribution were expressed as means ± standard deviations and analyzed using the independent t-test. Contrarily, continuous data with a skewed distribution were expressed as medians (ranges) and analyzed using the Mann–Whitney U test. Categorical data were expressed as n (%) and analyzed using the chi-squared test. For the multivariate analysis, neonatal survival was used as the dependent variable, whereas variables with statistical significance in the univariate analysis and variables without statistical significance but that could possibly be closely associated with the outcome according to clinical practice and the literature were included as independent variables for binary Cox regression. Kaplan–Meier curves were used for the survival analysis. Two-sided p-values of < 0.05 were considered to indicate statistical significance.

During the study period, 549 neonates were admitted to Shanghai Children’s Medical Center. Among them, 74 neonates with simple CHD were excluded, of whom 61 were premature babies with patent ductus arteriosus and 13 had ventricular or atrial septal defects without heart failure. An additional 118 neonates with CCHD were excluded, of whom 95 did not require surgery in the neonatal period and were discharged for follow-up within 48 h of admission. A total of 23 neonates needed emergency surgery but were lost to follow-up due to their parents’ refusal of the surgery. Finally, 357 neonates with CCHD (263 and 94 in non-SPCT and SPCT groups, respectively) were included in the analysis.

Among the 357 neonates, 16 in the non-SPCT group died before surgery. Postoperative mortality included 23 neonates, with 20 from the non-SPCT group and 3 from the SPCT group. All 16 neonates who were initially diagnosed with CCHD in local hospitals of other regions were transferred to Shanghai Children’s Medical Center for emergency treatment; 13 of them were transferred by their parents and 3 via regular ambulance service, but finally died before the surgery. Most cases involved arterial duct-dependent systemic or pulmonary circulation CCHD, and the transferred neonates were in extremely poor condition.

The differences between the two groups in terms of the transport process are listed in Table 1. No difference was observed in terms of the transport distance and time. The transport distance ranged from 5 to 2500 km. Among the 357 neonates, 235 (65.8%) were transfered over a distance of more than 200 km. The proportion of long-distance transport was higher in SPCT group,In long-distance transport, non-SPCT group had higher preoperative and postoperative mortality. In the SPCT group, children required greater respiratory, circulatory, and drug support and continuous monitoring. In the non-SPCT group, only the parents and prehospital emergency physician conducted the transport and high-speed rail was considered an important mode of transportation.

Table 1

Comparison of the transport process between the two groups.
	Non-SPCT group (263)	SPCT group (94)	p
Personnel in the transport	Neonatologist (170) or Parents (93)	Cardiologist and nurse (94)	0.001
Transfer time, hours	4.6 (0.5–14.5)	5 (0.4–15)	0.52
Transfer distance, kilometre	450 (5-2450)	455 (5.5–2500)	0.63
transfer media	Highway (138) or high-speed rail (125)	Highway (92) or airplane (2)	0.02
respiratory and circulatory assist	34 (12.9%)	63 (67%)	0.03
appropriate drug support	59 (22.4%)	90 (95.7%)	0.012
Continuous vital signs monitoring	84 (31.9%)	91 (96.8%)	0.001
Transfer distance > 200km Died before surgery Died after surgery	150(57%) 10(6.67%) 10(6.67%)	75(79.8%) 0 2(2.67%)	0.04 0.001 0.003
SPCT:specialist pediatric cardiac transfer

Table 2 summarizes the characteristics of the neonates. Before propensity score matching (PSM), the SPCT group had younger neonates with higher rates of invasive ventilation transfer, prenatal diagnosis, and overall survival but lower RACHS-1 scores (≥ 3) and lower rates of acidosis at ICU admission, preoperative CPR, and unplanned emergency operations (all p < 0.05). After PSM, the demographic and clinical characteristics between the two groups were similar (all p > 0.05). The SPCT group had lower rates of inotropic drug use (57.3% vs. 77.5%, p = 0.004), intubation before surgery (49.4% vs. 62.9%, p = 0.07), unplanned emergency operations (29.2% vs. 53.9%, p = 0.001), and preoperative mortality (0% vs. 4.5%, p = 0.043), but higher overall survival (92.6% vs. 82%, p = 0.044). For long-distance transfers, the SPCT group had lower mortality. Univariate analysis of neonates who underwent surgery showed that age (p = 0.013), body weight at surgery (p = 0.001), preterm birth (p = 0.002), preoperative CPR (p = 0.013), non-SPCT long-distance transport (p = 0.002), unplanned emergency operations (p = 0.0001), preoperative acid-base imbalance (p = 0.001), preoperative acidosis (p = 0.0001), and preoperative lactic acid levels (p = 0.0001) were associated with mortality (Table 3). Multivariate analysis revealed that body weight at surgery (HR: 0.444, 95% CI: 0.273–0.711, p = 0.001), non-SPCT long-distance transport (HR: 4.608, 95% CI: 1.436–4.982, p = 0.017), and unplanned emergency operations (HR: 5.227, 95% CI: 2.521–10.834, p < 0.001) were independent risk factors for mortality in neonates with CCHD (Table 4).

Table 2

Baseline characteristics and clinical data of neonates before and after PSM.
	Before PSM			After PSM
	Non-SPCT group (n = 263)	SPCT group (n = 94)	p	Non-SPCT group (n = 89)	SPCT group (n = 89)	p
Age (days)	12 (0–29)	10 (0–28)	0.007	10 (0–29)	10 (0–28)	0.929
Body weight (kg)	3.30 (1.83–4.70)	3.20 (1.05–4.20)	0.349	3.19 (1.83–4.60)	3.30 (1.64–4.20)	0.272
Preterm birth, n (%)	38 (14.4)	15 (16.0)	0.724	13 (14.6)	12 (13.5)	0.829
Prenatal diagnosis, n (%)	109 (41.4)	50 (53.2)	0.059	55 (61.8)	47 (52.8)	0.225
RACHS-1 score ≥ 3, n (%)	217 (82.5)	68 (72.3)	0.035	72 (80.9)	65 (73.0)	0.213
Internal environment disorder on ICU arrival, n (%)	31 (11.8)	4 (4.3)	0.453	9 (10.1)	4 (4.5)	0.150
Intubation before surgery, n (%)	122 (46.4)	47 (50.0)	0.547	56 (62.9)	44 (49.4)	0.070
Preoperative CPR, n (%)	42 (16.0)	6 (6.4)	0.019	12 (13.5)	6 (6.7)	0.136
Preoperative use of inotropic drug, n (%)	134 (51)	53 (56.4)	0.571	69 (77.5)	51 (57.3)	0.004
Unplanned emergent operation, n (%)	145 (55.1)	29 (30.9)	0.0001	48 (53.9)	26 (29.2)	0.001
Total Survival, n (%)	227(86.3)	91 (96.8)	0.045	73 (82.0)	86 (92.6)	0.044
Died before surgery	16 (6.1)	0	0.014	4 (4.5)	0	0.043
Died after surgery	20 (8.1%)	3(3.19%)	0.079	7(7.87%)	2 (2.25%)	0.065
Mortality of long distance transfer,n(%)	20(13.3%)	3(4%)	0.002	14(15.7%)	2(2.25%)	0.001
PSM: propensity score matching; SPCT: cardiac intensive care unit; RACHS-1: Risk Adjusted classification for ;long distance > 200km
Congenital Heart Surgery; ICU: intensive care unit; ECMO: extracorporeal membrane oxygenation;
CPR: cardiopulmonary resuscitation; CHF: chronic heart failure.

Table 3

Comparison of the baseline and clinical data of neonates with different prognoses who underwent surgery.
Variable	Total (n = 341)	Survival (n = 318)	Mortality (n = 23)		p
Age at surgery (days)	12 (0–28)	12 (0–28)	10 (0–27)		0.013
Body weight at surgery (kg)	3.3 (1.05–4.70)	3.30 (1.64–4.60)	3.10 (1.05–4.70)		0.001
Premature, n (%)	48 (14.1)	34 (11.5)	14 (30.4)		0.002
Twin pregnancy, n (%)	26 (7.6)	17 (5.8)	9 (19.6)		0.004
Prenatal diagnosis, n (%)	147 (43.1)	122 (41.4)	25 (54.3)		0.107
RACHS-1 score ≥ 3, n (%)	269 (78.9)	234 (79.3)	35 (76.1)		0.639
Intubation before surgery, n (%)	153 (44.9)	128 (43.4)	25 (54.3)		0.171
Preoperative use of inotropic drug, n (%)	171 (50.1)	142 (48.1)	29 (63.0)		0.271
Preoperative CPR, n (%)	32 (9.4)	23 (7.8)	9 (19.6)	0.013
Unplanned emergent surgery, n (%)	158 (46.3)	121 (41.0)	37 (80.4)	0.0001
Internal environment disorder on ICU arrival, n (%)	122 (35.8)	101 (34.2)	21 (45.7)	0.126
Preoperative hypercapnia, n (%)	34 (10.0)	23 (7.8)	11 (23.9)	0.001
Preoperative hypoxia, n (%)	119 (34.9)	100 (33.9)	19 (41.3)	0.330
Preoperative acidosis, n (%)	55 (16.1)	39 (13.2)	16 (34.8)	0.0001
Preoperative lactic acid (mmol/L)	1.8 (0.3–28.0)	1.7 (0.3–26.0)	2.8 (0.7–28.0)	0.0001

Table 4

Analysis of factors influencing the postoperative outcomes of patients (before PSM).
	HR	95%CI	p
Body weight	0.444	0.273,0.711	0.001
Non-SPCT long distance tansport	4.608	1.436,4.982	0.017
Unplanned emergent surgery	5.227	2.521,10.834	< 0.001
HR: hazard ratio; CI: confidence interval.

Survival analysis was conducted on the neonates who underwent surgery with a median follow-up time of 411 days. No statistically significant differences were observed between the groups in terms of survival (Fig. 1).

This study identified low body weight at surgery and unplanned emergency operations as independent risk factors for surgical mortality in neonates with CCHD. Although SPCT was not directly associated with postoperative survival, the SPCT group exhibited lower overall mortality, reduced internal environment disturbances, less frequent use of inotropic drugs, and decreased rates of preoperative intubation and CPR. Importantly, the SPCT group had significantly lower mortality in long-distance transfers.

Previous studies have demonstrated that prenatal diagnosis improves the prognosis of neonates with CCHD [12, 21, 22]. Prenatal diagnosis allows time for discussion with parents, consultation among specialists [3], and surgical planning. It also enables close monitoring of the neonate immediately after birth. In our data, no statistically significant difference was observed in the prenatal diagnosis rate between the groups, particularly after PSM. Furthermore, not all neonates who were prenatally diagnosed with CCHD were transferred to the study institution but instead treated locally and excluded from this study. Nevertheless, the SPCT group had significantly lower total mortality and fewer unplanned emergency operations compared to the non-SPCT group. Multivariate analysis confirmed that non-SPCT long-distance transport and unplanned emergency operations are independent risk factors for surgical mortality, suggesting that SPCT can increase overall survival by reducing these risks.

Missed CCHD diagnoses can result in death within days of birth, eliminating the chance for timely transfer [23]. Singh et al. [3] suggested that timely cardiotonic drugs (e.g., prostaglandin E1) and pediatric cardiologist consultation could be lifesaving. Wang et al. [19] reported that an integrated NICU transfer approach for patients with CCHD led to shorter diagnosis/hospitalization intervals and lower risk for surgical mortality, particularly for transposition of the great arteries. Peterson et al. [13] and Jegatheeswaran et al. [14] found better CHD infant prognosis in maternity hospital versus general hospitals, likely due to greater pediatric cardiologist access and CCHD surgery experience. Approximately 20% of neonates with CCHD are diagnosed post-discharge from maternity, with 43% in circulatory shock upon cardiology admission [24]. Brown et al. [25] reported a higher rate of heart failure and end-organ dysfunction in neonates with CCHD discharged from obstetric units rather than cardiology units. Fixler et al. [26] found high mortality rate due to nonreferral of neonates with CCHD to cardiac specialty centers.

In our study, preoperative deaths occurred exclusively in the non-SPCT group, where inadequate specialist monitoring and management before or during transfer likely led to complications and lost surgical opportunities [27]. The transfer of newborns with CCHD involves long-distance movement and equipment handling, which may destabilize respiratory/circulatory systems and lead to accidents, affecting the prognosis. A safe transfer requires stable vital signs, secured airway/venous access, ensured catheter safety, and appropriate predeparture monitoring. Hospitals should establish transfer plans for neonates with CCHD based on the distribution of medical resources and treatment capabilities. Furthermore, transfer staff should have a thorough understanding of the pathophysiology and hemodynamics of CCHD and develop accurate transfer strategies based on clinical environment and evidence [28]. A comparison of the apparent differences between the groups in the transfer process is shown in Table 1, fully demonstrating the necessity of SPCT. Neonates in the SPCT group required greater respiratory, circulatory, and drug support and continuous monitoring. In the non-SPCT group, only the parents and prehospital emergency physician carry out the transport, with high-speed rail as an important mode of transportation. Although high-speed rail is faster than the highway, there is a lack of the necessary respiratory and circulatory support equipment on high-speed rail. Although the distance between high-speed rail and hospital was substantial, no difference was noted in the final transfer time. The SPCT group involved aircraft transfers equipped with respiratory and circulatory support, leading to better outcomes such as lower rates of ICU admission acidosis, preoperative CPR, and unplanned emergency operations, and higher overall survival. In the study of Mesned AR, a high number of patients with critical CHD died while waiting for acceptance and transfer to a tertiary cardiac center, which demonstrated the necessity of professional transfer for CCHD [29].

This study revealed low body weight at surgery and unplanned emergency operation as risk factors for mortality in neonates with CCHD. Mehmood et al. [30] reported high ICU morbidity and mortality in neonates weighing < 2.2 kg who underwent cardiac surgery. Oster et al. [31] found low birth weight to be associated with high 1-year mortality in neonates with CHD/CCHD. Emergency surgery is required for neonates exhibiting sudden deterioration, which indicates more severe conditions and poorer prognosis. Among the 16 newborns who died preoperatively, 13 were transferred by their parents alone and 3 via regular ambulances, 10 was long distance transfer and most of them died after the initial rescue. This study demonstrated that SPCT reduces the rate of unplanned emergency operations, highlighting the potential advantages of SPCT for neonates with CCHD. Although safe and effective transportation through SPCT did not affect postoperative survival in neonates with CCHD, it reduced the rates of unplanned emergency operation and preoperative mortality. SPCT enables neonates to obtain appropriate preoperative status and timely intervention, provides assurance for the transfer of neonates with CCHD, and offers appropriate surgical opportunities for these newborns. Professional transfer is crucial for improving the prognosis of these vulnerable patients.

Limitations

This study has some limitations. First, it was a retrospective, single-center study with limited available chart data, which introduces potential bias, and a relatively small sample size. Sencond, the exact rationale for SPCT was not clearly documented, thus limiting the analysis. Local practices may also introduce bias. Therefore, large prospective multicenter studies are warranted to obtain high-grade evidence of SPCT transfer. Nevertheless, this study highlights the importance of specialized transfer for neonates with CCHD to improve preoperative stability and reduce mortality risk. Further research should be conducted to clearly define optimal transfer protocols and practices.

Low body weight at surgery, non-SPCT long-distance transport, and unplanned emergency operations are independent risk factors for surgical mortality in neonates with CCHD. While SPCT does not directly reduce surgical mortality, it significantly lowers unplanned emergency operations and increases overall survival, particularly in long-distance transfers. Implementing specialized transfer protocols can enhance the prognosis of these vulnerable patients.

Ethical approval and consent to participate

The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Shanghai Children’s Medical Center affiliated with Shanghai Jiaotong University School of Medicine (SCMCIRB-K2023026-1), and individual consent for this retrospective analysis was waived.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Funding

This study was funded by the National Natural Science Foundation of China (Grant No. 81970439), and the Development Fund for Shanghai Talents (Grant No. 2020114).

Author contributions

LM Zhu and HB Zhang contributed to the conception and design of this study. CX Li and LM Zhu designed the study, performed the statistical analysis, and drafted the manuscript. XL Gong, ZM Xu, and JL Liu collected the clinical data. All authors read and approved the final manuscript.

Acknowledgments

We highly acknowledge the contribution of the participating researchers: Mingjie Zhang, Yujie Liu, and Liping Liu.

Data availability

The datasets used or analyzed during the current study are available from the corresponding author upon reasonable request.

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Impact of Specialist Pediatric Cardiac Transfer on Unplanned Emergency Operations and Mortality in Neonates with Critical Congenital Heart Disease

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