Safe Reintroduction of Cardiovascular Services During the COVID-19 Pandemic

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## Strategies and evidence

# Ethical considerations
Similar to rationing decisions made in preparation for the initial surge of COVID-19 cases, progressive and thoughtful reintroduction of CV services must be based on robust ethical analysis. [bib_ref] Fair allocation of scarce medical resources in the time of Covid-19, Emanuel [/bib_ref] Relevant values to be operationalized include 14 : 1) maximizing benefits such that the most lives, or life years, are saved so that procedures or tests that are likely to benefit more people and to a greater degree are prioritized over procedures that will benefit fewer people to a lesser degree; 2) fairness such that like cases are treated alike, taking into consideration baseline health inequities; 3) proportionality such that the risk of further postponement is balanced against the risk of exacerbating COVID-19 spread; and 4) consistency such that reintroduction is managed across populations and among individuals regardless of ethically irrelevant factors such as ethnicity, perceived social worth, or ability to pay. Finally, the promotion of procedural justice, with the use of an ethical framework [bib_ref] A framework for rationing ventilators and critical care beds during the COVID-19..., White [/bib_ref] , is essential to ensure that all decisions reflect best available evidence with transparent communication. Collaboration Among Regional Public Health Officials, Health Authorities, and CV Care Providers Some regions have seen an escalation in COVID-19 cases when social restrictions and physical distancing have been eased. Hospital-based CV teams must establish active partnerships with regional public health policymakers to exchange up-to-date information on both the local status of the pandemic and the growing morbidity and mortality on CV waiting lists. This is essential for the safe reintroduction of regular CV services. There should be a sustained reduction in the rate of new COVID-19 admissions and deaths in the relevant geographic area for a pre-specified time interval as determined by local public health officials before changes can be implemented. Importantly, if COVID-19 admissions and deaths start to increase, there must be immediate and transparent cessation of most elective invasive procedures and tests. Resumption of these services would occur in collaboration with regional public health policymakers. As discussed in the following text, COVID-19 testing of potential patients and health care workers (HCWs), as well as personal protective equipment (PPE), must also be carefully monitored to minimize the risk of shortages as the pandemic escalates and abates. A cohesive partnership with regional public health officials will facilitate management of the dynamic balance between provision of essential CV care and responding to ongoing fluctuations in COVID-19 admissions and deaths.

## Protection of patients and hcws
The protection of patients and HCWs must be addressed before any reintroduction of CV procedures and tests.
Regions must have the necessary critical care capacity, PPE, and trained staff available before the recommendations summarized in [fig_ref] Table 1: Safe Reintroduction of Cardiovascular Procedures and Diagnostic Tests During the COVID-19 Pandemic [/fig_ref] can be implemented. Importantly, a transparent plan for testing and retesting potential patients and HCWs for COVID-19 must be operationalized before elective procedures and tests are resumed. Additional considerations include:
1. Physical distancing. Consider strategies to minimize patient contact with HCWs performing invasive CV procedures and diagnostic tests. These may include virtual pre-procedural clinics, virtual consenting for procedures and diagnostic tests, and minimizing the number of HCWs in physical contact with any given patient. Restrictions should be implemented on the number of people that can accompany a patient or visit a patient after a procedure or test. Whenever possible, multiple tests or procedures should be consolidated into a single comprehensive visit. 2. COVID-19 screening. Encourage routine screening of all patients prior to any C procedure or test to ensure the safety of HCWs. This testing may include nasopharyngeal swabs and saliva or rapid antibody tests, and should be guided by local institutional infectious disease experts and closely coordinated with regional public health officials. Key considerations include the availability and accuracy of the previously mentioned tests as well as the frequency and timing of COVID-19 testing and retesting. Appropriate PPE is required to protect HCWs even if patients are asymptomatic, as the sensitivity of available tests is low in this setting. A significant benefit of testing is the opportunity to defer COVID-19-positive patients if they remain clinically stable. 3. PPE. The use of PPE for HCWs during routine CV procedures and diagnostic tests will be an important consideration. The need to ensure staff safety must be balanced against the need to conserve PPE supplies in the event that the pandemic escalates. Emergent cases, such as ST-segment elevation myocardial infarction patients and urgent surgeries, or aerosolgenerating medical procedures will likely continue to require the highest level of PPE for the foreseeable future; thus, available supplies must be carefully monitored.

## Areas of uncertainty
Leaders from the North American CV societies acknowledge that the recommendations in this guidance document are based predominantly on expert opinion. This reflects the global challenge of managing a new and rapidly evolving pandemic where evidence is limited. [fig_ref] Table 1: Safe Reintroduction of Cardiovascular Procedures and Diagnostic Tests During the COVID-19 Pandemic [/fig_ref] harmonizes recommendations from major North American CV societies and provides guidance on the safe reintroduction of invasive CV procedures and diagnostic tests during the COVID-19 pandemic. Important considerations when implementing [fig_ref] Table 1: Safe Reintroduction of Cardiovascular Procedures and Diagnostic Tests During the COVID-19 Pandemic [/fig_ref] 1. Decisions regarding transitioning between response levels requires close collaboration with public health officials and health systems. It is expected that this process will be dynamic and continue to evolve as new information becomes available.

## Guidance from professional societies

## A transparent collaborative plan for covid-19
testing and PPE use must be in place before a safe reintroduction of procedures and tests can occur. 3. It is expected that different regions will be at different response levels as the pandemic escalates and abates. 4. Within a given region, different invasive procedures and diagnostic tests may be at different response levels depending on local COVID-19 penetrance and infrastructure requirements. 5. In general, a minimally invasive procedure with a shorter length of stay is preferable if both strategies have similar efficacy and safety. 6. A less invasive test or alternative imaging modality should be considered if both tests have similar efficacy. 7. The language in [fig_ref] Table 1: Safe Reintroduction of Cardiovascular Procedures and Diagnostic Tests During the COVID-19 Pandemic [/fig_ref] was chosen to give clinicians, health systems, and policy makers the maximum flexibility when moving between response levels in their region. COVID-19 prevalence, admission, and death rates as well as appropriate time intervals for safe reintroduction will change, and thus, we utilized "selective" cases and "some" or "most" CV procedures in [fig_ref] Table 1: Safe Reintroduction of Cardiovascular Procedures and Diagnostic Tests During the COVID-19 Pandemic [/fig_ref]. 8. Maintaining reserve capacity to ensure the ability to manage a possible second surge in COVID-19 cases is a key competing priority. This balance should be actively managed as regions pass through different levels of restriction to ensure the capability of supporting both elements of care delivery focused on net population health.

# Conclusion
This consensus report provides harmonized guidance from North American CV societies. It provides an ethical framework with appropriate safeguards for the gradual reintroduction of invasive CV procedures and diagnostic tests after the initial peak of the COVID-19 pandemic. A collaborative approach will be essential to mitigate the ongoing morbidity and mortality associated with untreated CV disease.
[table] Table 1: Safe Reintroduction of Cardiovascular Procedures and Diagnostic Tests During the COVID-19 Pandemic: Guidance From North American Society Leadership ACS, acute coronary syndromes; AF, atrial fibrillation; AGMP, aerosol-generating medical procedure; ASD, atrial septal defect; CCT, cardiac computed tomography; CHF, congestive heart failure; COVID-19, coronavirus disease-2019; EVAR, endovascular repair of aortic aneurysm; GRACE, Global Registry of Acute Coronary Events; ICD, implantable cardioverter-defibrillator; LAAC, left atrial appendage closure; LV, left ventricular; LM, left main; MI, myocardial infarction; NSTEMI, non-ST-segment elevation myocardial infarction; PFO, patent foramen ovale; PCI, percutaneous coronary intervention; PPE, personal protective equipment; PPM, permanent pacemaker; STEMI, ST-segment elevation myocardial infarction; TAVR, transcatheter aortic valve replacement; TEE, transesophageal echocardiography; TEVAR, thoracic endovascular aortic repair; TTE, transthoracic echocardiography; UA, unstable angina; VAD, ventricular assist device; VT, ventricular tachycardia; ve, positive; -ve, negative. [/table]