MATERIALS AND METHODS
This is an observational cohort study on all cardio-vascular consecutive
patients evaluated and/or treated at Poliambulanza Foundation Hospital
in Brescia (Italy) in the first 30 days of activity as a hub center.
Written informed consent to participate in anonymous data collection was
obtained from all patients. The study protocol conforms to the ethical
guidelines of the 1975 Declaration of Helsinki as reflected in a priori
approval by the institution’s committee.
The Lombardia region, with its 10.6 million inhabitants, is the most
populated and productive region of the north of Italy, and it was the
largest affected area in Europe 11European Centre for Disease
Prevention and Control
https://www.ecdc.europa.eu/en/cases-2019-ncov-eueea,2.
The Lombardy RHCS decided to establish a hub and spoke network for all
the major clinical and surgical pathologies across the region to face
the Sars-Cov19 pandemia and to continue to assure highly specialized
care. The decree issued the 08th of March 2020 by the RHCS regarding
cardiovascular surgical pathologies22Lombardy Regional Council
Ordinance (DGR) n° XI/2906, divided the Lombardy region into four
major areas choosing for each of them a core hospital with a referral
network of up to 5 cardiac surgery spoke centers and up to 10 vascular
surgery spoke centers. Poliambulanza Foundation Hospital, a no-profit
private hospital site in Brescia, was appointed Hub center for the
cardio-vascular surgical activity to cover an area of 3.145.312
inhabitants located in the east of the region (fig. 1). Role of the Hub
hospital was to guarantee 24/7 active guard on-site and at least two
on-call teams for both vascular and cardiac surgery urgencies and
emergencies. Meanwhile, spoke centers could free human and logistic
resources to expand their capability to accept COVID patients requiring
hospitalization. Regardless of public or private property, all the
hospitals with cardiac or vascular surgery departments were involved in
the new organization extremizing the already existing territorial
hub-spoke network. Night and day shifts were organized with mixed staff
coming from different centers to collaborate in the Hub surgical
activity. Though spokes centers had been converted to treat patients
with Covid-19 infection, some of them maintained an on-call team
available on site for the management of non-transferable cases linked to
Emergency Department direct admittance or emergency complications of
other surgical or medical activities (transplant, trauma center, stroke,
myocardial infarction etc.)5
As in war scenario, Rules of Engagement were established in a collegial
remote meeting between Hub centers. Eligibility and exclusion criteria
for surgery are summarized in table I. All elective surgery
interventions were postponed. Not deferrable cases (class A indication
according to Health Care National System recommendations)33Ministero
della salute , Italia, National Plan for hospital waiting list,
2019-2021 http://www.salute.
gov.it/portale/listeAttesa/dettaglioPubblicazioniListeAttesa.jsp?lingua=italiano&id=2824
(16 April 2020 last access were singularly discussed to create a
co-shared waiting list between hub and spokes.
For what concern vascular diseases, the ones that deserve a
non-deferrable vascular intervention were identified and inspired by the
“Elective Case Triage Guidelines for Surgical Case” edited by the
American College of Surgeon44American College of Surgeons.
COVID-19: recommendations for management of elective surgical
procedures. Available at:
https://www.facs.org/about-acs/covid-19/information-for-surgeons
/elective-surgery. Accessed the 19th of March, 2020 (tab. I).
All urgent and scheduled patients were preoperatively tested with a
nasopharyngeal swab and/or a thorax CT scan. In case of emergency
surgery, the patient was considered and treated as infected until the
results of a complete screening were obtained.
A color-based triage was applied: red tag for COVID affected patients,
yellow tag for patients with pending COVID test, and green tag for
patient resulted negative at the swab test. Separate track and
in-hospital stays were instituted to assure a safe pathway for non-COVID
patients from admittance to discharge. Red, yellow, and green wards and
ICU units were set up.
All preoperative and perioperative variables were collected and
summarized in table III-IV-VI, including referral center and transfer
time for acute peripheral ischemia. Patients who underwent evaluation
but who were discarded for surgery were collected separately, signaling
the reason for the exclusion.
Data entry was managed by physicians directly involved in patients’
care. Records were recorded and analyzed with Microsoft Excel (Microsoft
Corp, Redmond, Wash). Continuous variables were tested for normality
using the Shapiro-Wilk’s test. Variables that were normally distributed
are presented as means ±standard deviation (SD) and their range;
otherwise they are presented as median and interquartile range (IQR).
Categorical variables are presented as frequencies and percentages.
Categorical variables were analyzed using a chi-square test or Fisher’s
exact test where necessary. An independent samples Student’s T-test was
used for continuous variables. All reported P values are 2-sided; a P
value <0.05 is considered significant.