The challenge of maintaining necessary vascular and endovascular services at a referral center in Northern Italy during the COVID-19 outbreak

Introduction

The global spread of Coronavirus disease 2019 (COVID-19) is profoundly affecting health-care practice worldwide. In Italy, the beginning of the outbreak was identified in the Northern area; the Lombardy and the Veneto regions registered the first cases in two small villages, Codogno and Vo’ Euganeo, on 20 and 21 February 2020, respectively. In particular, the main referral Hospital of Vo’ Euganeo is the Padova University Hospital, where the Vascular and Endovascular Surgery Unit acts as a referral center for vascular arterial diseases in a population of about 950,000 inhabitants (Figure 1).

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Figure 1.

Focus on the “red zone’’ towns in Lombardy and Veneto regions.

Since the beginning of February 2020, our Hospital was identified as referral center also for COVID-19 + patients and started several preventive measures and planned radical modifications of standard health-care management. Also the Vascular Surgery Unit (VSU) of the Padova University Hospital changed its daily practice in a “scaled-down” fashion; however, adequate management of this social emergency cannot be based only on a simple scale-down of the standard activity. In order to face the COVID-19 outbreak, we developed dedicated protocols regarding different aspects of the vascular health care, with the following main objectives:

Health preservation from virus spread of both health-care staff and hospitalized vascular patients.

In this paper, we describe the flowcharts for elective and urgent/emergent surgery, clinical and outpatient activity and health-care staff preservation from intra-hospital COVID-19 infection spread. We report the outcomes of this approach during the first month of experience. Although this is not intended or proposed as “gold-standard of care,” we hope that sharing this early experience from one of the epicenters of the pandemic may be helpful in preparing protocols for Vascular Surgical Units in other countries, where the outbreak is not at the same stage at the current time. The challenges of maintaining specialty services during this time are formidable and unprecedented. Available information is imperfect and long-term follow-up will be necessary to better understand how this approach affected patients’ lives and how we might plan better for future crises.

Methods

The Vascular and Endovascular Surgery Clinic of the Padova University Hospital is the main vascular center of the region and represents the referral Institution for all aortic standard and complex diseases, while it also covers all elective and urgent cases of arterial vascular diseases. The entire Hospital Healthcare system has progressively adopted several measures to front the COVID-19 outbreak, with a clear strong asset established by 9 March 2020, when also the VSU started a “scaled-down” activity; this date corresponds also with the start of the Northern Italy lockdown. For this reason, we analyzed a two months period, 30 days before and 30 days after this time point. The adopted measures can be classified into general rules for the entire Hospital Rules (HR), and specific protocols dedicated to the VSU. Many of these protocols are based on the World Health Organization (WHO) and the European Centre for Disease Prevention and Control (ECDC) recommendations;^1–3 however, in the Italian experience each Hospital has based its own dedicated rules depending on specific local characteristics and resources. HR was both structural and behavioral. In brief, structural protocols were based on “COVID-19 +/suspect” dedicated pathways, from the admission to discharge from the hospital. Regarding this issue, it was fundamental for the vascular surgery activity having dedicated paths for emergent cases referred from the Emergency Room (ER). This implies a completely new dedicated “COVID-19 testing area” that was created just outside the Hospital, in order to prevent all people requiring a swab test to be in direct contact with other susceptible subjects. Also the computed tomography (CT) area was adapted, creating an external mobile CT room entirely dedicated to COVID-19 + patients. One operating room (OR) in our department was reserved only for COVID-19 + patients, and the number of intensive care unit (ICU) beds was expanded by 22% overall; our vascular post-operative ICU monitoring request was maintained stable during this period. Hospital behavior rules were fundamental as follows:

All people must wear a surgical mask and maintain social distancing (at least 1 m).

Specific flowcharts for access to elective surgery, emergent/urgent surgery, as to reduce the risk of COVID-19 spread in the clinic are described in Figures 2 to 4, respectively.

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Figure 2.

Process flowchart for elective surgical procedures in the Vascular and Endovascular Surgery Department.

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Figure 3.

Process flowchart for emergent and urgent surgical procedures in the Vascular and Endovascular Surgery Department.

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Figure 4.

Process flowchart regarding the strategy to reduce the risk of COVID-19 spread in our Clinic.

The VSU activity was “scaled-down” both for the OR and outpatients clinic; also several protocols were developed for staff and patients health preservation.

Elective surgical activities were continued during this period, selecting only those cases scheduled to be treated within 30 days (“elective non deferrable”): these included symptomatic carotid stenosis (intended as those patients suffering from a carotid territory symptoms within the preceding six months); ⁴ Asymptomatic carotid stenosis were scheduled only in case of severe stenosis (>90%) or stenosis >80% with contralateral stenosis >60%. The size threshold for elective abdominal aortic aneurysm surgery was set up to 6.5 cm; in case of aneurysms with rapid growth or graft infection, the treatments were scheduled. Thoracic or thoraco-abdominal aneurysm or dissections were scheduled if non-deferrable, in particular these included second or third steps to conclude complex endovascular repair of thoraco-abdominal aneurysms on waiting list for more than 30 days. Regarding peripheral arterial disease, “elective non deferrable” were considered Rutherford class 4 with uncontrolled pain at home on medical therapy and Rutherford class 5 in a chronic stable clinical condition. Urgent surgical treatment (intended as to be performed within 24 h) has been reserved for patients with symptomatic carotid stenosis and crescendo transient ischemic attack (TIA) or stroke in evolution or for patients with chronic limb ischemia (CLI) in Rutherford class 5 with rapid worsening of the lesions, signs of osteomyelitis, or signs of sepsis, as also Rutherford class 6. Emergent vascular surgery was regularly guaranteed. In high-risk patients, an endovascular approach was preferred if safe and feasible, to reduce the need for ICU monitoring in the post-operative period. Table 1 reports the detailed classification of urgent and emergent cases.

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Table 1.

Urgent and emergent diseases classification for each major vascular pathology.

	Urgent (within 24 h)	Emergent
Carotid surgery	Crescendo TIA—Stroke in evolution	–
Aortic surgery	Symptomatic AAA	Ruptured AAA/TAAA/TAA
	“High risk” acute aortic syndrome	Complicated acute aortic syndromes
		Aortic trauma
Peripheral arterial disease	Acute limb ischemia (Rutherford class I–IIA)	Acute limb ischemia (Rutherford class IIB–III)
	Critical limb ischemia (Rutherford class 5a/6)	Vascular limbs trauma

^aOnly patients with rapid worsening of lesions, signs of osteomyelitis, or signs of sepsis.TIA: Transient Ischemic Attack; AAA: Abdominal Aortic Aneurysm; TAAA: Thoraco-Abdominal Aortic Aneurysm; TAA: Thoracic Aortic Aneurysm.

Outpatient clinical activity was planned as follows: all patients already scheduled both for “first-time” vascular consultation or follow-up, duplex ultrasounds, or surgical wound care were re-called by the vascular surgeon to evaluate general clinical status; also the motivation of the scheduled visit was evaluated and was suspended if not urgent or deferrable.

Regarding swab test for severe acute respiratory syndrome by coronavirus 2019, at the Padova Hospital there is the possibility to obtain the results as emergent (within 80 min), urgent (within 3–4 h), or elective (between one and five days, depending on the clinical motivation and number of daily requests). Regarding patients management, in the most early phase (weeks 3rd to 7th), only patients admitted from the ER for urgent or emergent surgery had a swab test, while all elective cases scheduled were admitted to the Hospital on the basis of temperature measurement, clinical status, and the suspect of contact at the preliminary phone call. From week 8th, we were able to perform swab tests also to all scheduled elective cases; these patients underwent a swab test the day before surgery (day of hospitalization) and were allocated to a dedicated waiting area; if the swab was negative, the patient was admitted to the Clinic.

Regarding health-care staff, at the beginning of “scale-down,” an initial swab test for COVID-19 was administered to all the workers of the floor, independently from being symptomatic or asymptomatic. During daily practice, every time a health-care provider had a suspect contact without protections with a diagnosed COVID-19 + person, even if asymptomatic, had to undergo a new swab test; even if the first test was negative, this was repeated after 5, 10, and 14 days. Regarding the setting of COVID-19 + OR, this is primarily based on indication from WHO and ECDC.^1,2

Results

Elective activity

Elective vascular surgery activity was scaled down by about 50% starting from 9 March; the percentage of patients refusing elective procedures because of the fear of in-Hospital contamination reached a peak of 35% after two weeks from the beginning of regional complete lockdown. Patients with any type of respiratory symptoms or fever or suspect contacts reached 20% of home-called for elective hospitalization after the first week from complete lockdown (Figure 5). All those who refused were recalled and treated progressively in the two following months with no complications. Those with suspect of COVID-19+ underwent a swab test every two week till negativization and were then scheduled. No untoward events happened in our population.

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Figure 5.

Pre admission telephone interview graph.

For our elective surgical activity, the usual required number of ICU post-operative beds is three/week. During the entire period, thanks to the “flattening” of the epidemic curve obtained in our region, our ICU availability had a minimal decreased with a mean number of 2.5 patients/week during the last month. In one case, a scheduled elective symptomatic carotid stenosis was found to be positive to COVID-19 test; in this case, the intervention was postponed because the patient had a single episode of TIA within the six months before, with no recurrence after double antiplatelet therapy was established.

Figure 6 reports the number of overall elective cases during the two months period, together with ICU available beds, while Figure 7 reports the change of elective surgery’s volume, stratified by major types of intervention (aortic, cerebrovascular, or lower limb). Table 2 shows the percentage of reduction of activity for each single major vascular pathology, compared to the standard practice period. Regarding outpatients activities, we do not have evidence of any severe complication or unexpected ER admission caused by missed non-deferrable visits. However, long-term evaluation is needed to better evaluate this aspect.

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Figure 6.

Surgical activity trend, before and after the Vascular Surgery “scale-down,’’ for elective versus urgent/emergent overall surgical activity.

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Figure 7.

Surgical activity trend, before and after the Vascular Surgery “scale-down,” for elective overall surgical activity.

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Table 2.

Percentage of reduction in surgical procedures for each single major vascular pathology during the “scale-down,” compared to the standard practice period.

	No. of cases (one-month period) before COVID-19	No. of cases (one-month period) after COVID-19	%
Carotid surgery	30	13	−56.7
Single stenosis > 60%(NASCET method)	13	2	−84.6
Single stenosis > 90%(NASCET method)	14	10	−28.6
Single stenosis > 80% with contralateral  stenosis > 60% (NASCET method)	3	1	−66.7
Aortic surgery	36	17	−52.8
TAAA/TAA	3	4	+33.3
AAA 5.0–6.5 cm	9	1	−88.9
AAA > 6.5 cm	13	8	−38.5
Rapid growth	2	1	−50
Graft infection	0	0	–
Symptomatic TAAA/AAA	1	2	+100
Other aortic procedures	8	1	−87.5
Peripheral arterial disease	30	14	−56.7
CLI (Rutherford stage 4/5)	16	6	−62.5
CLI (Rutherford stage 6)	11	8	−27.3

Note: The boldface numbers are the total numbers for the main treated pathology.NASCET: North American Symptomatic Carotid Surgery Trial; TAAA: ThoracoAbdominal Aortic Aneurysm; TAA: Thoracic Aneurysm Repair; CLI: Critical Limb Ischemia.

Urgent/emergent vascular surgery

Emergent vascular surgery was regularly guaranteed as well as urgent surgery (intended as to be performed within 24 h). Interestingly, the number of urgent/emergent aortic cases remained stable during the two months period, while the number of ER admissions related to CLI decreased after national lockdown by about 20%. Of the five urgent aortic repair procedures performed, only one case was found to be COVID-19 + (Figure 8). This patient presented to ER with fever and chest pain and a history of previous thoracic endovascular aneurysm repair (TEVAR); the CT angiogram excluded severe signs of interstitial pneumonia and demonstrated a type III endoleak of the previous TEVAR, with a large aneurysm and impending rupture. The patient underwent a relining with a new endograft. The post-operative course was regular and he recovered well from both diseases. Of all the five cases of acute ischemia, one was because of acute thrombosis of a previous femoro-popliteal by-pass with a positive swab test for COVID-19, but asymptomatic for any respiratory symptom. He underwent mechanical thrombectomy and was post-operatively treated with anticoagulation; the post-operative course was uneventful. No patients in our experience were referred with acute venous thrombosis or complications of arterovenous (AV) fistula for dialysis access.

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Figure 8.

Surgical activity trend, before and after the Vascular Surgery “scale-down,” for urgent/emergent overall surgical activity trend.

If we compare the severity of peripheral arterial disease treated urgently (before vs. after lockdown), we reported a substantially stable number of cases, but there was an increase of patients with Rutherford class 6, with a decrease of Rutherford 5. This may be related to the fact that many patients, likely because of the fear of in-hospital infection, tend to postpone their access to ER at a more advanced stage; with the cost of a higher major limb amputation rate (about 10%–15%), compared to our standard practice period (between 4% and 8%). At the moment we have not reliable information regarding the course of symptomatic/urgent carotid surgery, because of the low number of events reported in our actual experience (only one case of carotid endoarterectomy for TIA in the month before lockdown, and no referred cases in the following month of scaled-down activity). Of all urgent/emergent cases performed over the entire month, 4 out of 25 cases (16%) were operated in an OR with COVID-19 + setting; 3 were confirmed COVID-19 + (12%) and 1 (4%) was operated as “suspect” COVID-19 + (Figure 8).

Discussion

This comprehensive approach to front the COVID-19 outbreak allowed Padova to maintain the Hospital free from widespread contamination. In our opinion, the war against COVID-19 spread is played pushing as much as possible the prevention both in the territory and in the Hospitals. Our Veneto region adopted a policy of diffuse use of swab testing, starting from health-care workers and extended also to selected categories in the population, based on the risk of possible contamination. When comparing the numbers of swab tests performed in our region to those performed in Lombardy (the comparison is only based on the fact that the two regions had similar timeline starting point of the virus spread and are geographically adjacent), it is visible the higher percentages of tests per number of inhabitants. Veneto has about 5,000,000 people for about 163,500 swab tests performed up to the time point considered in this report, while Lombardy has 10,000,000 people for about 168,000 tests; thus meaning a mean tested population of 3.3% for Veneto versus 1.7% for Lombardy. The two outbreaks’ curves of this analyzed month show that Veneto has significantly “flattened” the curve compared to Lombardy (Figure 9).

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Figure 9.

COVID-19 spread (confirmed cases) in Lombardy and Veneto Italian regions.

Obviously, this has not to be intended as a precise result, but more as a “trend” of the moment, and it is not actually still clear if the number of tests performed by its own may impact significantly on the curves trend, also because several other confounding factors may have influence them. Our feeling is that intra-hospital contamination represents a crucial moment in the spread and needs to be avoided as much as possible during the outbreak.

It has to be clarified also that the use of swab tests at that time has been extremely uncertain and difficult for several reasons: we were the first two world regions out of China to face COVID-19 pandemia and we did not know how long and how strong the outbreak curve would have been and how much the resources optimization would have been. Finally, in the early phase, also regional and national laws did not authorize swab tests as a valid routine screening method. The elderly, the immunocompromised, men and smokers, appear to be at greater risk of infection, and these demographic characteristics are highly pertinent to vascular patients. For these reasons, we were extremely aggressive in trying to identify signs of infection in our patients in the Clinic. In particular, lung ultrasound associated with the other routine known tests, in our experience seems to be extremely useful for an early diagnosis in hospitalized patients. ⁵ Obviously for those professionally directly exposed or at risk of exposure with COVID-19 + patients, dedicated Personal Protection Devices as recommended by the WHO need to be used.

Generally, a doctor or nurse who is asymptomatic but positive for COVID-19 may have a strong potential of contamination both into the hospital and at home, and the Hospitals may represent the primary driving force of exponential outbreak in a population. In our small cluster of vascular surgery doctors, we were able to rapidly exclude from daily practice 3 out of 22 doctors (13.6%) since the very beginning of the outbreak, when they were still asymptomatic, and this probably reduced the exponential risk of in-Hospital and clinic contamination. Obviously, this aspect has to deal with the big problem of the availability of all the equipment needed for tests in large quantities and in a short time. Looking at our personal protocols for the VSU, a major difficult has been to define the most appropriate choices in each single new rule or flowchart. Obviously, the WHO and ECDC recommendation largely define most of the general and specific protocols for COVID-19 Hospital management that we adopted.^2,5 Differently, specific adaptation of rules to daily Vascular surgery practice are more complex to define for two main reasons. First, because of the total unexpected and rapid evolution, as societies recommendations often have been transmitted afterwards compared to Northern Italy outbreak; second, several updates are continuously needed over time in relation to upcoming new evidences.^6,7 Another unexpected issue, but of great impact, is patients’ fear of in-hospital COVID-19 infection. This represents the major cause of treatments refuse of non-deferrable elective cases, and its effect will be better understood in the near future. Elective vascular surgery in our opinion should be guaranteed as much as possible, and the grade of scale-down should be tailored in consideration of the single Hospital beds and ICU availability during the outbreak. Truly emergent cases, as acute aortic diseases, or acute limb ischemia did not decrease in number. On the other side, ER access for non-emergent cases (as Rutherford class 4/5 limb ischemia with stable condition) decreased, and patient’s fear of in-hospital infection may play a role also in this case. We also observed an increase of cases presenting to the ER with Rutherford class 6 limb ischemia; this aspect is already cause of an initial increased major limb amputation rate in peripheral arterial disease. Our preliminary results seem to describe a scenario where, if the curve of the outbreak in the regional population is flattened, in association with appropriate hospitals containment rules, it may be possible to continue the activity of the VSUs, even if with reduced volume, to guarantee the minimal standard of care to patients with arterial vascular disease. In fact, at the present time, we did not registered death or major complications related to delayed diagnosis or delayed treatment due to a Vascular Unit practice deficiency in the early period.

On the other side, if the outbreak is uncontrolled, there is no way to maintain a reasonable surgical care for standard pathologies and accurate health-care management must leave room to a “war-medicine setting.” In this phase, Hospital Resources have obviously to be directed to COVID+ patient care, but a fundamental effort needs to be done toward resources for COVID-19 outbreak prevention both in the territory and especially in-Hospital and within single Units.