Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new beta-coronavirus first described in patients with pneumonia symptoms in Wuhan, China in December 2019.1,2 In the ensuing few months, the disease caused by SARS-CoV-2 called coronavirus disease 2019 (COVID-19) became a worldwide pandemic with currently over 2 million cases globally. By the end of February 2020, the disease had spread in Northern Italy, with thousands of patients infected, forcing the Italian Government to quickly introduce emergency quarantine measures. Lombardy is one of the most affected areas with the largest number of positive patients and deaths. Treatment and management of COVID-19 patients became an absolute priority; therefore, all elective healthcare services had to be stopped and postponed. This unprecedented emergency situation forced a dramatic change in the way of treating pediatric and adult patients with congenital heart disease (CHD) requiring surgery or other interventional procedures.
Here, we report how the entire congenital cardiac care system was modified in Lombardy and the results of this new management in the health reorganization.
To address the COVID-19 emergency, the Lombardy Regional Government launched on 8 March 2020 a complete overhaul of the regional healthcare system introducing the ‘Hub-and-Spoke’ model3; this is an organizational network composed of centers able to provide a wide spectrum of services (hubs) and secondary satellite centers (spokes) operating as first-line service, and referring to the hub center as per need.4 This model was applied in healthcare in the early 80s to ensure the delivery of healthcare services in rural environments in America. At that time because of the declining population, high poverty, reduced employment opportunities and increased number of uninsured residents, many rural hospitals were closed with the need to create a centralization of services and to guarantee access to healthcare to the population. There are examples in the literature4–6 of how this model provides an efficient and enhanced quality of care. The Lombardy Regional Government's decision to deal with the COVID-19 emergency was to dedicate the majority of public and private hospitals to caring for COVID-19 patients and to apply a modified ‘Hub-and-Spoke’ model to major trauma, stroke, neurosurgical emergencies/urgencies, cardiovascular surgery, interventional cardiology, electrophysiology, and congenital cardiology. There were no changes imposed on the activated ExtraCorporeal Membrane Oxygenation (ECMO) network and on transplantation services.
The hub center should (as outlined in the Lombardy directives):
- (1) guarantee patients’ access/hospitalization with medical teams on active duty 24/7;
- (2) fast track access COVID-19 patients avoiding emergency room transit;
- (3) expect an ever-closer collaboration between Hub-and-Spoke teams, with direct communication and access, in both directions.
Lombardy is the most densely populated Italian region with more than 10 million inhabitants and over 75 000 births per year. There are 59 birthplaces linked to three specialized centers (third level) where congenital cardiac surgical/interventional procedures can be performed (Fig. 1).
These three centers perform between them an average of 900 congenital open-heart surgeries per annum, with the IRCCS-Policlinico San Donato (IRCCS-PSD) performing 52% of the total number of cases (unpublished official data from Italian Society of Cardiac Surgery – Congenital Domain, presented at XXIX National Meeting of SICCH, Rome, 23–25 November 2018). More than 50% are from Lombardy, approximately 30% come from other Italian regions, and the remainder are from abroad (unpublished official data from Italian Society of Cardiac Surgery – Congenital Domain, presented at XXIX National Meeting of SICCH, Rome, 23–25 November 2018). From the Lombardy Regional directive (2), the IRCCS-PSD was identified as the regional hub for congenital cardiac surgery and interventional procedures (Fig. 1). Therefore, wards, ICU units, cath labs, and operative theatres were kept only for CHD patients with healthcare staff exclusively dedicated.
A consensus was agreed between the hub and the spoke centers.
- (1) definition of patients/diseases in emergent, urgent, deferrable, and with prenatal diagnosis and scheduled birth (Fig. 2);
- (2) identification of four birthplaces in Milan where babies with prenatal diagnosis of CHD would be safely delivered and able to manage them until transfer (if necessary) to the hub center (Fig. 3);
- (3) extensive collaboration between the teams of the Hub-and-Spoke centers, including the hitherto unprecedented opportunity for spoke center teams to operate on their patients at the hub center in partnership with the hub team;
- (4) daily, official communication on the number of ICU beds available at the hub center;
- (5) frequent, tele-meetings between the hub and the spoke centers to discuss patients, management strategies, transfer times, and scheduled births.
The outpatient clinic was stopped except for the management of critical patients following triage at the emergency department.
The transplant, VAD, and Heart Failure programs for all patients (not only congenital) were managed by Niguarda Hospital as usual.
To reduce the COVID-19 contagion, the following rules were adopted:
- (1) naso and oropharyngeal COVID swabs were obtained from all patients and from one allowed accompanying parent (if possible) the day before or the day of admission;
- (2) safe transfer to the PSD was ensured;
- (3) intra-hospital transfer (Emergency Department, wards, Operative Theatre, ICU, Radiology) was always planned in advance;
- (4) only one accompanying parent/person was allowed to be with the patient;
- (5) visits from other relatives were not allowed;
- (6) patients in ICU had repeated COVID swabs every 7 days if asymptomatic;
- (7) COVID-19 symptomatic patients needing emergency/urgent surgery would be accepted/admitted in a designated COVID ICU and/or COVID ward;
- (8) nurses and doctors in ICUs, cath labs, operative theatres, and pediatric wards would all be equipped with specific personal protection equipment (PPE).
Elective patients already hospitalized in Hub-and-Spoke centers at the time of reorganization were discharged home whenever possible, or otherwise transferred to the hub. Patients from abroad (Romania, Egypt, and Tunisia) already hospitalized because of international flight restrictions were operated on before repatriation on military flights organized by their own countries. A total of 46 elective CHD cases hospitalized or scheduled in March for hospitalization into our hospital (the hub center) were postponed. Two adult cases (a case of heart failure with a history of severe stenosis of a bicuspid aortic valve and severe aortic coarctation and a second case with partial atrio-ventricular canal status/post aortic and mitral valve replacement and tricuspid valve repair), already operated on at the moment of the lockdown, became COVID-positive during the postoperative period. They were both transferred to the COVID-19 ward, making an uneventful recovery. None of them needed intensive care treatment.
From 9 March to 15 April, 21 cardiac surgeries for CHD were performed, 4 diagnostic cardiac catheterizations, 3 CT scans, and 2 MRI (Table 1).
In three prenatal diagnosis cases, the birth was scheduled. The spoke centers referred us six CHD cases. The postop ECMO support was needed in two cases, one patient died (a pediatric patient with Williams syndrome, a severe ascending aortic stenosis, and severe bilateral pulmonary hypoplasia after 10 days of ECMO support from sepsis and because of the cardiac output syndrome).
In Table 2, we report the type of cardiac surgeries performed for CHD.
None of these patients nor their parent or accompanying person was COVID-19-positive; 2 pediatric intensivists from the hub center became COVID-19-positive and needed hospitalization, but no mechanical ventilation; 13 nurses had positive COVID swabs (4 with symptoms), and all of them were managed and isolated at home.
We present our early experience at a ‘Hub-and-Spoke’ model for managing CHD in Lombardy in response to the COVID-19 pandemic.
Optimization of the care of CHD patients (from fetal to adult age), and the safety of our healthcare force and our community were our chief concerns.
Remarkably, our hospital converted within a few days its facilities by activating a COVID-19 center with 28 ICU-ventilated and 250 beds for severely symptomatic COVID-19 patients.
The proposed COVID-19-protecting rules (for patients and staff) were implemented promptly but lack of PPE and some organizational difficulties at the beginning of that operation caused two COVID-19-positive patients already hospitalized and several staff members to become infected.
In the current situation, only surgical and cardiological emergencies are treated. Our preliminary data suggest that the model adopted herewith met the immediate needs with a good outcome without increased mortality, nor COVID-19 exposure for the patients who underwent procedures. We do not know, however, how long this pandemic will last and how long we will have to continue with this reorganized care. What we know and what we wait in provision for is that there are many CHD patients on the waiting list for surgery, interventional procedures, and conventional outpatient follow-up.
The dramatic impact of the COVID-19 pandemic has resulted, amongst many other changes, in a substantial overhaul of the healthcare system within the Lombardy region focusing on COVID treatment and emergencies in all areas of medicine. In the specific context of CHD of all ages, a modified Hub-and-Spoke model was applied with good early outcomes. Elements of this model may be considered long term: innovation and cooperation are key to progress.
Plans are currently being made for returning to the increased volume of work and lessons must be learned for dealing with future pandemics both regionally and globally.
- (1) What is already known about this subject?
- (1) This is an emergency model and to the best of our knowledge, no previous data were reported.
- (2) What does this study add?
- (2) It is an organizational model that may be rapidly and easily applied in emergencies.
- (3) How might this impact on clinical practice?
- (3) We should start as soon as possible to return to a normal plan, but we should accompany it with plans dedicated to the emergency for possible future scenarios, and this manuscript may suggest a way to deal with it.
A special note of thanks is extended to Giovanni Giamberti for providing invaluable technical help.
Authorship: M.C., A.G., A.V., A.M.C., S.M.M. designed the study. A.A., M.C., A.F.D., P.F., S.M. collected the data and organized the tele-meeting to discuss the data and the results. S.M., A.M., L.P., A.S., N.U., G.V. reviewed the manuscript. All authors have reviewed and approved the final version of the manuscript.
Funding: This work was supported by the IRCCS Policlinico San Donato, a Clinical Research Hospital recognized and partially supported by the Italian Ministry of Health.
Ethical considerations: The study did not require a formal research ethics committee, as it was a descriptive study on healthcare management during the COVID-19 pandemic infection. No patient-identifiable and sensible information was available to researchers and used in this study. All reported information was searched from our administrative network.
Data availability: All data relevant to the study are included in the article. Extra data are available from the corresponding author on reasonable request.
Conflicts of interest
There are no conflicts of interest.
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