VASCC - The Vascular Surgery COVID-19 Collaborative

Project objectives

The COVID-19 pandemic has drastically changed the medical landscape. We hypothesize that this pandemic has presented unanticipated challenges for vascular surgeons and subsequently the care of patients with vascular disease, as well as causing vascular complications in patients infected with COVID-19.

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Target: Assess the impact of the COVID-19 pandemic on patients with vascular disease, as well as the vascular complications of patients infected with COVID-19.

Description: National and international database construction that will be hosted at the University of Colorado Department of Surgery and provide a mechanism to formally evaluate the impact of the COVID-19 pandemic on patients with vascular disease, as well as evaluate vascular complications of patients with COVID-19 infection, in order to evaluate management strategies and provide a framework for future health policy planning for a future health crisis.
III. Preliminary studies/progress report: Not available
IV. Research methods

A. Outcome measures: Anonymised data regarding the impact of COVID-19 on patients with vascular disease, as well as vascular complications in patients infected with COVID-19, which will be collected for future evaluation of specific outcomes retrospectively. We will collect all unidentified blood tests, hemodynamic studies, non-invasive and invasive radiological tests, drugs, surgical and endovascular interventions related to every single meeting for every single patient. This will also include the following:

1. Number of cases with cancellation of scheduled surgery or office visit 
2. Number of cases with cancellation of the scheduled diagnostic test
3. Types of cases that had their scheduled surgery or office visit cancelled 
4. Types of measures taken to mitigate the impact on patients who have had their planned surgery or office visit canceled
5. Number and types of cases moved from elective to urgent due to cancellation of scheduled surgery or office visit
6. Number and types of cases suffered from amputation due to cancellation of scheduled surgery or office visit
7. Number and types of cases who had a TIA or stroke due to cancellation of scheduled surgery or office visit
8. Number and type of cases suffered due to death due to the cancellation of their scheduled surgery or outpatient visit
9. The number of vascular cases had their scheduled surgery or outpatient clinic visit canceled because they tested positive for COVID 19
10. Number and type of cases operated on in urgency
11. Number, types and outcome of cases that were operated on urgently and tested positive for COVID 19
12. Morbidity and mortality
13. Additional outcomes include but are not limited to: major and minor bleeding, major amputation which is defined by major loss of the index limb at or proximal to the transtibial level. Minor amputation due to loss of the distal limb at the transtibial level. Major adverse cardiovascular event (MACE) includes myocardial infarction and stroke as well as death from any cause. Major adverse extremity event (MALE) includes any amputation above the ankle of the index limb or major reoperation (re-bypass graft, graft revision, or thrombectomy/lysis). Reoperation is defined as any repeated vascular procedure in the index limb, which will be divided into major and minor categories to reflect the extent of the surgery and the extent of the effect on the patient. Major reoperations include the need for a new surgical bypass graft, the use of thrombectomy or thrombolysis, or major surgical revision of the graft. Minor reoperations include endovascular procedures (angioplasty, atherectomy, stenting without thrombectomy or thrombolysis, and minor surgical revisions, such as patch angioplasty). Other outcomes include aneurysm growth, progression to symptomatic aneurysm, aneurysm rupture, development of symptomatic carotid stenosis, stroke, TIA, infection. Development of VTE, PE, pneumonia.

B. Description of the population to be enrolled: All patients with vascular disease affected by the COVID-19 pandemic, as well as COVID-19 infected patients with vascular complications from participating sites who have been affected by the COVID-19 pandemic. We are building and hosting the multi-center international database here at the University of Colorado. Countries using the General Data Protection Regulation (EU GDPR) will be added later in a separate amendment after completing all the necessary documents and regulations for this purpose. The data will be collected retrospectively from 1 January 2019 to 31 December 2025.

C. Study design and research methods
A retrospectively collected cross-sectional observational study using an unidentified, password-protected REDCap international vascular surgery registry. We are building and hosting the multi-center international database here at the University of Colorado/Department of Surgery/Division of Vascular and Endovascular Surgery. Every site has an IRB for search, and only anonymous information is sent to the REDcap data we're hosting, which is a HIPAA compliant portal.

D. Description, risks and justification of data collection procedures and tools

Start and end date

January 2019 - December 2025

Project Manager

Prof. Francesco Stilo, Head of Research Unit and Prof. Francesco Spinelli, UOC Director

Coordinating institution of the project

University of Colorado

Other institutions involved in the project