The impact of the pandemic for COVID-negative vascular patients: analysis from the Italian epicenter.

BACKGROUND: To face the "first wave" of the pandemic (01/03/2020-15/05/2020), Lombardy's healthcare system was reorganized according to the "Hub-and-Spoke" model, and deferrable inpatient and outpatient activities were suspended. The limitations imposed by COVID-19, associated with patients' fear of presenting to medical attention, may have led to a delay in diagnosis and treatment of time-dependent pathologies. Our multicenter retrospective cohort study aims at analyzing the impact on COVID-negative patients of the shift of medical resources in Lombardy, the Italian epicenter of the pandemic. METHODS: Inclusion criteria were an age ≥18, COVID-negative condition, and referral to IRCCS Istituto Clinico Humanitas - Rozzano, Milan (Spoke Center) or IRCCS Ospedale San Raffaele - Milan (Hub Center) for acute vascular diseases requiring urgent treatment. SARS-CoV-2 infection, either on admission or during hospitalization, was the exclusion criterion. Data of the "first wave" were compared with the corresponding months of 2019, to highlight differences in vascular pathologies' case rates, clinical presentation, treatment type and post-treatment outcomes (mortality, rate of adverse events, primary and secondary clinical success and of amputation). RESULTS: Two hundred and two patients were treated for acute vascular diseases, 52 in 2019, 150 in 2020 (P<0.001). A later presentation to medical attention (4.3 versus 5.9 days after symptoms onset, P=0.03) and an increased need for urgent treatment for peripheral arterial disease (P=0.04) differentiated 2020. A higher number of peripheral arterial disease patients underwent major amputations (P=0.38). Access to post-surgical rehabilitation programs was restricted (P<0.001). CONCLUSIONS: During the first wave of COVID-19 pandemic, in the face of a radical health care rearrangement, no increase in mortality nor in post-operative adverse event rate was registered. Anyway, urgent hospitalizations for vascular disease increased, more specifically for peripheral ischemia, in which late presentation may have influenced an increase in amputation rate.

Regional Survey in Lombardy, Northern Italy, on Vascular Surgery Intervention Outcomes During The COVID-19 Pandemic.

OBJECTIVE: The characteristics and outcomes of patients undergoing vascular surgery hospitalised and managed in Lombardy are described with a comparison of patients tested positive for COVID-19 (CV19-pos) vs. those tested negative (CV19-neg). METHODS: This was a multicentre, retrospective, observational cohort study which involved all vascular surgery services in Lombardy, Northern Italy. Data were retrospectively merged into a combined dataset covering the nine weeks of the Italian COVID-19 pandemic phase 1 (8 March 2020 to 3 May 2020). The primary outcome was freedom from in hospital death, secondary outcomes were re-thrombosis rate after peripheral revascularisation, and freedom from post-operative complication. RESULTS: Among 674 patients managed during the outbreak, 659 (97.8%) were included in the final analysis: 121 (18.4%) were CV19-pos. CV19-pos status was associated with a higher rate of complications (OR 4.5; p < .001, 95% CI 2.64 - 7.84), and a higher rate of re-thrombosis after peripheral arterial revascularisation (OR 2.2; p = .004, 95% CI 1.29 - 3.88). In hospital mortality was higher in CV19-pos patients (24.8% vs. 5.6%; OR 5.4, p < .001;95% CI 2.86 - 8.92). Binary logistic regression analysis identified CV19-pos status (OR 7.6; p < .001, 95% CI 3.75 - 15.28) and age > 80 years (OR 3.2; p = .001, 95% CI 1.61 - 6.57) to be predictors of in hospital death. CONCLUSION: In this experience of the vascular surgery group of Lombardy, COVID-19 infection was a marker of poor outcomes in terms of mortality and post-operative complications for patients undergoing vascular surgery treatments.

Differences in hub and spoke vascular units practice during the novel Coronavirus-19 (COVID-19) outbreak in Lombardy, Italy.

BACKGROUND: To highlight differences in clinical practice among referral (hub, HH) or satellite (spoke, SH) hospital vascular surgery units (VSUs) in Lombardy, during the COVID-19 pandemic "phase 1" period (March 8 - May 3, 2020). METHODS: The Vascular Surgery Group of Regione Lombardia Register, a real-word, multicenter, retrospective register was interrogated. All patients admitted with vascular disease were included. Patients' data on demographics, COVID-19 positivity, comorbidities and outcomes were extrapolated. Two cohorts were obtained: patients admitted to HH or SH. Primary endpoint was 30-day mortality rate. Secondary outcomes were 30-day complications and amputation (in case of peripheral artery disease [PAD]) rates. Univariate and multivariate analysis were used to compare HH and SH groups and predictors of poor outcomes. RESULTS: During the study period, 659 vascular patients in 4 HH and 27 SH were analyzed. Among these, 321 (48.7%) were admitted to a HH. No difference in COVID-19 positive patients was described (21.7% in HH vs. 15.9% in SH; P=0.058). After 30 days from intervention, HH and SH experienced similar mortality and no-intervention-related complication rate (12.1% vs. 10.0%; P=0.427 and 10.3% vs. 8.3%; P=0.377, respectively). Conversely, in HH postoperative complications were higher (23.4% vs. 16.9%, P=0.038) and amputations in patients treated for PAD were lower (10.8% vs. 26.8%; P<0.001) than in SH. Multivariate analysis demonstrated in both cohorts COVID-19-related pneumonia as independent predictor of death and postoperative complications, while age only for death. CONCLUSIONS: HH and SH ensured stackable results in patients with vascular disease during COVID-19 "phase 1." Despite this, poor outcomes were observed in both HH and SH cohorts, due to COVID-19 infection and its related pneumonia.

Incidence of deep venous thrombosis in COVID-19 hospitalized patients during the first peak of the Italian outbreak.

OBJECTIVES: A high rate of thrombotic events has been reported in COVID-19 population. The study aims to assess the incidence of deep vein thrombosis (DVT) in COVID-19 patients admitted to a single tertiary hospital. METHODS: From April 2nd to April 18th, 2020, hospitalized patients with SARS-CoV-2 infection were screened by lower limb duplex ultrasound (DUS). Patients were on (low molecular weight heparin) LMWH prophylaxis in medical wards, and on therapeutic anticoagulation in intensive care unit (ICU). DVT risk factors, reported by the Padua prediction score and blood tests, were retrieved from institutional electronic charts. The study primary endpoint was the incidence of DVT in the in-hospital COVID-19 population and its association with clinical and laboratory risk factors. The secondary endpoint was the association of DVT with mortality. RESULTS: Two hundred patients (median age 62 years, 72% male, 40 in ICU) received DUS screening. DVT was observed in 29 patients (14.5%), with proximal extension in 16 patients, and in association with symptoms in four patients. The DVT rate was similar in ICU (12.5%) and non-ICU patients (15%). Eighty-seven patients underwent a computed tomography angiography (CTA) that showed pulmonary embolism in 35 patients (40.2%) not associated with DVT in 25/35 cases (71.4%). DVT in the ten patients with pulmonary embolism were symptomatic in four and with a proximal localization in eight cases. A D-dimer level ≥5 mg/l at admission was predictive of DVT (OR 1.02; IC95% 1.03-1.16; p = .003). At the multivariate analysis in-hospital mortality was predicted by age (OR 1.06; 95% CI 0.02-1.15; p = .004) and by being an ICU patient (OR 1.23; 95% CI 0.30-2.25; p = .01). CONCLUSIONS: Despite LMWH prophylaxis or full anticoagulant therapy, the incidence of DVT, mainly asymptomatic, in hospitalized COVID-19 patients was 14.5%. Further research should focus on the appropriate antithrombotic therapy for COVID-19 patients.

Vascular Surgery During COVID-19 Emergency in Hub Hospitals of Lombardy: Experience on 305 Patients.

OBJECTIVE: During the most aggressive phase of the COVID-19 outbreak in Italy, the Regional Authority of Lombardy identified a number of hospitals, named Hubs, chosen to serve the whole region for highly specialised cases, including vascular surgery. This study reports the experience of the four Hubs for Vascular Surgery in Lombardy and provides a comparison of in hospital mortality and major adverse events (MAEs) according to COVID-19 testing. METHODS: Data from all patients who were referred to the Vascular Surgery Department of Hubs from 9 March to 28 April 2020 were collected prospectively and analysed. A positive COVID-19 polymerase chain reaction swab test, or symptoms (fever > 37.5 °C, upper respiratory tract symptoms, chest pain, and contact/travel history) associated with interstitial pneumonia on chest computed tomography scan were considered diagnostic of COVID-19 disease. Patient characteristics, operative variables, and in hospital outcomes were compared according to COVID-19 testing. A multivariable model was used to identify independent predictors of in hospital death and MAEs. RESULTS: Among 305 included patients, 64 (21%) tested positive for COVID-19 (COVID group) and 241 (79%) did not (non-COVID group). COVID patients presented more frequently with acute limb ischaemia than non-COVID patients (64% vs. 23%; p < .001) and had a significantly higher in hospital mortality (25% vs. 6%; p < .001). Clinical success, MAEs, re-interventions, and pulmonary and renal complications were significantly worse in COVID patients. Independent risk factors for in hospital death were COVID (OR 4.1), medical treatment (OR 7.2), and emergency setting (OR 13.6). COVID (OR 3.4), obesity class V (OR 13.5), and emergency setting (OR 4.0) were independent risk factors for development of MAEs. CONCLUSION: During the COVID-19 pandemic in Lombardy, acute limb ischaemia was the most frequent vascular disease requiring surgical treatment. COVID-19 was associated with a fourfold increased risk of death and a threefold increased risk of major adverse events.

Management of acute and chronic aortic disease during the COVID-19 pandemic-Results from a web-based ad hoc platform.

BACKGROUND: To share the results of a web-based expert panel discussion focusing on the management of acute and chronic aortic disease during the coronavirus (COVID-19) pandemic. METHODS: A web-based expert panel discussion on April 18, 2020, where eight experts were invited to share their experience with COVID-19 disease touching several aspects of aortic medicine. After each talk, specific questions were asked by the online audience, and results were immediately evaluated and shared with faculty and participants. RESULTS: As of April 18, 73.3% answered that more than 200 patients have been treated at their respective settings. Sixty-four percent were reported that their hospital was well prepared for the pandemic. In 57.7%, the percentage of infected healthcare professionals was below 5% whereas 19.2% reported the percentage to be between 10% and 20%. Sixty-seven percent reported the application of extracorporeal membrane oxygenation in less than 2% of COVID-19 patients whereas 11.8% reported application in 5%-10% of COVID-19 patients. Thirty percent of participants reported the occurrence of pulmonary embolism in COVID-19 patients. Three percent reported to have seen aortic ruptures in primarily elective patients having been postponed because of the anticipated need to provide sufficient ICU capacity because of the pandemic. Nearly 70% reported a decrease in acute aortic syndrome referrals since the start of the pandemic. CONCLUSION: The current COVID-19 pandemic has-besides the stoppage of elective referrals-also led to a decrease of referrals of acute aortic syndromes in many settings. The reluctance of patients seeking medical help seems to be a major driver. The number of patients, who have been postponed due to the provisioning of ICU resources but having experienced aortic rupture in the waiting period, is still low. Further, studies are needed to learn more about the influence that the COVID-19 pandemic has on the treatment of patients with acute and chronic aortic disease.

Emergency management of the COVID-19 pandemic in a vascular surgery department of a large metropolitan hospital in Italy. Preparation, escalation, de-escalation, and normal activity.

BACKGROUND: During the first phase of coronavirus disease-2019 (COVID-19) pandemic in Italy, several strategies have been taken to deal with the pandemic outbreak. AIM OF THE STUDY: To report the remodeling of the Vascular Surgery Department of San Raffaele Hospital as regards the strategies of preparation, escalation, and return to normal activities during the COVID-19 pandemic. PREPARATION, ESCALATION, DE-ESCALATION: The Regional Authority of Lombardy remodeled the hospitalization system to allocate appropriate resources to treat patients with COVID-19 and to identify "Hub/Spoke" hospitals for highly specialized medical activities. The Hubs hospitals were required to guarantee full-time evaluation of all patients presenting with cardiovascular diseases with an independent pathway for patients with suspect or confirmed COVID-19 infection. San Raffaele Hospital was identified as Hub for cardiovascular emergencies and the Vascular Surgery Department was remodeled to face this epidemic situation. Surgical treatment was reserved only to symptomatic, urgent, or emergent cases. Large areas of the hospital were simultaneously reorganized to assist patients with COVID-19. RESULTS: During this period, 135 patients were referred to San Raffaele Vascular Surgery Department. COVID-19 was diagnosed in 24 patients and, among them, acute limb ischemia was the most common cause of admission. At this time, the COVID-19 trend is in decline in Italy, and the local authorities reorganized the healthcare system to return to normal activities avoiding new escalations of COVID-19 cases. The COVID-19 pandemic will be remembered in Lombardy as a cataclysm. Nevertheless, the HUB/spoke system has proven to be a valid model in the management of ischemic emergencies. Continuous surveillance, cooperation, coordination, and communication to effectively respond to COVID-19 pandemic is crucial because COVID-19 reference centers could face similar issues in the near future.

Single-Center Vascular Hub Experience after 7 weeks of COVID-19 Pandemic in Lombardy (Italy).

BACKGROUND: The aim of this study was to report the experience of one of the major "hubs" for vascular surgery in Lombardy, Italy, during the first 7 weeks after total lockdown due to COVID-19 pandemic. METHODS: Data from all patients treated at our Department since the decision of the regional healthcare authorities of Lombardy to centralize surgical specialties creating a hub/spoke system (March 9, 2020) were prospectively collected and compared with a retrospectively collected cohort from the same period of year 2019. Primary study end point was defined as primary clinical success. Secondary end points were defined as in-hospital mortality and/or any in hospital major adverse event or lower limb amputation. RESULTS: One hundred sixteen patients were treated (81 men, 70%; median age: 71 years, IQR 65-81). Thirty-two patients (28%) were addressed from spoke hospitals directly referring to our hub, 19 (16%) from hospitals belonging to other hub/spoke nets, 48 (41%) came directly from our emergency department, and 17 (15%) were already hospitalized for COVID-19 pneumonia. Acute limb ischemia was the most observed disease, occurring in 31 (26.7%), 12 (38.7%) of whom were found positive for COVID-19 pneumonia on admission, whereas 3 (9.7%) became positive during hospitalization. Chronic limb ischemia was the indication to treatment in 24 (20.7%) patients. Six (5.2%) patients underwent primary amputation for irreversible ischemia. Aortic emergencies included 21 cases (18.1%), including 13 (61.9%) symptomatic abdominal aortic or iliac aneurysms, 4 (19.0%) thoracoabdominal aortic aneurysms, 2 (9.5%) cases of acute type B aortic dissection (one post-traumatic). Seventeen (14.7%) patients were admitted for symptomatic carotid stenosis (no COVID-19 patients); all of them underwent carotid endarterectomy. Seventeen (14.7%) cases were treated for other vascular emergencies. Overall, at a median follow-up of 23 ± 13 days, primary clinical success was 87.1% and secondary clinical success was 95.9%. We recorded 3 in-hospital deaths for an overall mortality rate of 2.6%. Compared with the 2019 cohort, "COVID era" patients were older (72 vs. 63 years, P = 0.002), more frequently transferred from other hospitals (44% vs. 21%, P = 0.014) and more frequently with decompensated chronic limb threatening ischemia (21% vs. 3%, P = 0.015); surgical outcomes were similar between the 2 cohorts. CONCLUSIONS: Since its appearance, SARS-CoV-2 has been testing all national healthcare systems which founds themselves facing an unprecedented emergency. Late referral in the pandemic period could seriously worsen limb prognosis; this aspect should be known and addressed by health care providers. Vascular surgical outcomes in pre-COVID and COVID era were comparable in our experience.

A Case of Covid-19 Patient with Acute Limb Ischemia and Heparin Resistance.

Heparin resistance is an uncommon phenomenon defined as the need for high-dose unfractionated heparin (UFH) of more than 35,000 IU/day to achieve the target activated partial-thromboplastin time ratio or the failure to achieve the desired activated clotting time after a full UFH dose. This rare phenomenon is being more commonly observed in Covid-19 patients in a hypercoagulable state. We describe a Covid-19 patient confirmed by reverse-transcriptase polymerase chain reaction assay, with acute limb ischemia, who developed heparin resistance. The patient was managed by the departments of vascular surgery, anesthesia and intensive care, and the Coagulation Service and Thrombosis Research from San Raffaele Scientific Institute, Milan, Italy.