Precautions and Procedures for Coronary and Structural Cardiac Interventions During the COVID-19 Pandemic: Guidance from Canadian Association of Interventional Cardiology.

The globe is currently in the midst of a COVID-19 pandemic, resulting in significant morbidity and mortality. This pandemic has placed considerable stress on health care resources and providers. This document from the Canadian Association of Interventional Cardiology- Association Canadienne de Cardiologie d'intervention, specifically addresses the implications for the care of patients in the cardiac catheterization laboratory (CCL) in Canada during the COVID-19 pandemic. The key principles of this document are to maintain essential interventional cardiovascular care while minimizing risks of COVID-19 to patients and staff and maintaining the overall health care resources. As the COVID-19 pandemic evolves, procedures will be increased or reduced based on the current level of restriction to health care services. Although some consistency across the country is desirable, provincial and regional considerations will influence how these recommendations are implemented. We believe the framework and recommendations in this document will provide crucial guidance for clinicians and policy makers on the management of coronary and structural procedures in the CCL as the COVID-19 pandemic escalates and eventually abates.

The world is currently in the midst of the global COVID-19 pandemic, which has rapidly resulted in significant morbidity and mortality. , This pandemic has placed considerable stress on health care resources and providers. Acknowledging the strain on the entire health care system, this document specifically addresses the implications for the care of patients in the cardiac catheterization laboratory (CCL).

Cardiovascular disease encompasses a spectrum of clinical conditions associated with significant morbidity and mortality. As long as the capacity of the Canadian health care system allows, clinicians and policy makers must attempt to maintain essential coronary and structural interventional procedures while minimizing additional burdens on hospital and system resources during the COVID-19 pandemic. The operational challenges are evolving rapidly; therefore, this guidance must be interpreted with flexibility and pragmatism. Although some consistency across the country is desirable, provincial and regional considerations will influence how these recommendations are implemented. In collaboration with all 11 affiliates, Canadian Cardiovascular Society (CCS), and Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention (CAIC-ACCI: https://caic-acci.org) have already issued guidance for inpatient and ambulatory cardiovascular care in Canada. In this paper, we provide guidance on the management of coronary and structural procedures in the CCL as the COVID-19 pandemic escalates and eventually abates.

The executive, in collaboration with key subspecialty and general cardiologists from across Canada, embraced the following objectives when creating the Table 1 . The objectives reflect the core ethical principles of public health ethics: respect, the harm principle, fairness, consistency, least coercive and restrictive means, working together, reciprocity, proportionality, preservation of resources, flexibility, and procedural justice (as indicated in parentheses):

Table 1

CAIC-ACCI guidance for the management of coronary and structural procedures as COVID-19 escalates and abates

Response level	Level 1Minor restriction in regular services	Level 2Major restriction in regular services	Level 3Complete inability to provide services due to staff/resource limitations
Coronary
STEMI	• Patients with low probability of COVID-19 PPCI OR pharmacoinvasive as per current regional practice • Patients with moderate/high probability or COVID-19 +ve: PPCI with aerosol level PPE and N95 mask OR pharmacoinvasive at discretion of the treating team. If pharmacoinvasive with successful fibrinolysis, consider emergent COVID-19 testing with planned PCI within 24 hours.	• Most patients now considered moderate/high probability or COVID-19 +ve: pharmacoinvasive OR PPCI with aerosol level PPE and N95 mask at discretion of the treating team. If pharmacoinvasive with successful fibrinolysis, consider emergent COVID-19 testing with scheduled PCI within 24 hours.	Complete inability to provide PPCI. All patients will be treated with thrombolysis as per regional protocols.
Cardiogenic shock	• Patients with low probability of COVID-19: Continue as per usual regional practice. • Patients with moderate/high probability or COVID-19 +ve: Consider an invasive approach with aerosol level PPE and N95 mask if age OR comorbidities do not preclude a reasonable likelihood of meaningful survival.	• Most patients now considered moderate/high probability or COVID-19 +ve: Consider an invasive approach with aerosol level PPE and N95 mask if age OR comorbidities do not preclude a reasonable likelihood of meaningful survival.	Medical management of all cardiogenic shock cases
Out of hospital cardiac arrest (OHCA)	• Patients with low probability of COVID-19: Continue as per usual regional practice. • Patients with moderate/high probability or COVID-19 +ve - Consider an invasive approach with aerosol level PPE and N95 mask if age OR comorbidities do not preclude a reasonable likelihood of meaningful survival.	• Most patients now considered moderate/high probability or COVID-19 +ve: Consider an invasive approach with aerosol level PPE and N95 mask if age OR comorbidities do not preclude a reasonable likelihood of meaningful survival.	Medical management of all OHCA
NSTEMI (high risk)(Refractory symptoms, hemodynamic instability, significant LV dysfunction, suspected LM or significant proximal epicardial disease, GRACE risk score >140)	• Patients with low probability of COVID-19: invasive approach as per current regional practice. • Patients with moderate/high probability of COVID-19: invasive approach with aerosol level PPE and N95 mask. • COVID-19 +ve: consider invasive strategy with aerosol level PPE and N95 mask	• Most patients now considered moderate/high probability or COVID-19 +ve: Consider an invasive approach with aerosol level PPE and N95 mask.	Medical management of all ACS
Low/medium risk NSTEMI and UA	Invasive approach OR medical management for most patients.If medical management selected and failed, screen (symptom questionnaire AND swab) all patients for COVID-19 prior to invasive approach. If COVID-19 +ve,aerosol level PPE and N95 mask.	Medical management favoured over an invasive approach for most patients.If medical management selected and failed, screen (symptom questionnaire AND swab) all patients for COVID-19 before invasive approach. If COVID-19 +ve,aerosol level PPE and N95 mask.	Medical management of all ACS
Type 2 MI (Consider COVID-19 myocarditis)	Investigations and treatment as per clinical judgement. Consider CT coronary angiography with droplet level PPE instead of an invasive approach.	Investigations and treatment as per clinical judgement. Consider CT coronary angiography with droplet level PPE instead of an invasive approach.	Medical management of all type 2 MI
Outpatients	• Consider cardiac catheterization for outpatients who are clinically considered to be moderate to higher risk. • Screen (symptom questionnaire AND/OR swab) all patients for COVID-19. • All nonurgent/elective cases should be deferred for >30 days.	• Consider cardiac catheterization for “urgent” outpatients only including those with symptoms AND noninvasive testing suggesting high risk for CV events in the short term. • Screen (symptom questionnaire AND/OR swab) all patients for COVID-19. • Others should be considered lower-risk and deferred for >30 days	Medical management for all outpatients
CHIP	• Limited cases that would facilitate hospital discharge. • Screen (symptoms questionnaire AND swab) all patients for COVID-19.	Complete cessation of cases	Complete cessation of cases
CTO	Complete cessation of cases	Complete cessation of cases	Complete cessation of cases
Structural heart
TAVI	High-risk TAVI cases only with short expected LOS (low EF, valve-in-valve with severe AR, or recent hospitalization).	Limited inpatient cases that would facilitate hospital discharge	Complete cessation of cases
MitraClip (Abbott Laboratories)	High-risk cases with history of repeated HF hospitalizations or ED visits	Limited inpatient cases that would facilitate hospital discharge	Complete cessation of cases
Myocardial biopsies	Limited cases in collaboration with transplant team	Limited cases in collaboration with transplant team	Complete cessation of cases
ASD/PFO	Complete cessation of cases	Complete cessation of cases	Complete cessation of cases
LAAC	Complete cessation of cases	Complete cessation of cases	Complete cessation of cases
Adult congenital	Limited cases in collaboration with adult congenital team	Complete cessation of cases	Complete cessation of cases
Pre-solid organ transplant	Complete cessation of cases	Complete cessation of cases	Complete cessation of cases
Pulmonary HTN	Limited cases in collaboration with pulmonary hypertension team	Complete cessation of cases	Complete cessation of cases

ACS, acute coronary syndrome; AR, aortic regurgitation; ASD, atrial-septal defect; CHIP, complex and high-risk interventional procedures; CT, computed tomography; CTO, chronic total occlusions; CV, cardiovascular; EF, ejection fraction; GRACE, global registry of acute coronary events; HF, heart failure; HTN, hypertension; LAAC, left-atrial appendage closure; LM, left main; LOS, length of stay; LV, left ventricular; MI, myocardial infarction; NSTEMI, non-ST elevation myocardial infraction; PFO, patent foramen ovale; PPCI, primary percutaneous coronary intervention; PPE, personal protective equipment; STEMI, ST-elevation myocardial infarction; TAVI, transcatheter aortic valve implantation; UA, unstable angina.

Limit cardiac use of overall system capacity, especially with inpatient/intensive care unit beds (working together, proportionality).

Minimize risk to health care workers (reciprocity, care provider safety, and sustainability).

Maximize preservation of personal protective equipment (preservation of resources).

Maximize compliance with social and health care distancing (the harm principle).

Minimize the incremental risk of patients acquiring COVID-19 related to cardiac investigations or procedures (the harm principle, proportionality).

Maintain essential interventional cardiology service to patients at high risk of cardiovascular events in the short term (preservation of resources).

Minimize adverse outcomes for cardiovascular patients during the COVID-19 pandemic (the harm principle).

Ensure decisions are made in a consistent manner (procedural justice, accountability, reasonableness).

Ensure that decisions are communicated in a transparent and sensitive manner (respect and transparency).

Given the unavoidable interaction of these individual recommendations, the order does not necessarily reflect priority ranking. Relative prioritization will vary over time and in different regions, as the crisis evolves.

These principles are predicated on balancing anticipated benefits and risks for individual patients while also considering societal needs during this crisis. A reduction in CCL activity is inevitable, at least over the short term and possibly longer; criteria are therefore based on identifying groups of patients most likely to benefit from a specific intervention or, conversely, most likely to suffer harm without such an intervention. In situations for which the treatment effect is small—or evidence uncertain—alternate approaches that place less burden on hospital resources may be used, even if these deviate from the usual pattern of care.

The recommendations are outlined in the Table 1. As the COVID-19 pandemic evolves, procedures will be increased or reduced, based on the current level of restriction to health care services. Recommendations also vary based on the likelihood of COVID-19 in the population to mitigate the risk of transmission to both health care workers and patients. CAIC-ACCI acknowledges that this document is predominantly based on consensus agreement. This approach reflects the considerable challenge of making practice recommendations in the face of a rapidly evolving global pandemic, with limited scientific evidence to guide clinical practice. The unknown duration of the crisis mandates timely review of these recommendations. Postponement, rather than cancellation, may be appropriate for many procedures; however, lengthy delays (several months) could have a significant negative impact on morbidity and mortality, even for patients facing relatively low short-term risk.

A few important additional considerations: (1) We encourage all Canadian research teams to track cardiovascular outcomes carefully in the coming months and focus on key research gaps recently identified. If we document a large increase in potentially avoidable cardiac deaths from unavailable procedures, difficult but necessary discussions about allocation of resources to infection vs emergent cardiovascular procedures will be crucial. (2) Certain cardiac catheterization staff with comorbidities associated with adverse events in the setting of contracting COVID-19 (age > 60 years; patients with diabetes, hypertension, or pre-existing cardiovascular disease) may wish to refrain from procedures with an increased risk of aerosolization if adequate personal protective equipment cannot be provided. Depending on their level of competency, and in accordance with their training programs, trainees may also wish to refrain from cardiac catheterization procedures. (3) Use of personal protective equipment, including correct donning and doffing, changing scrubs and showering between cases with a high likelihood of COVID-19, and changing civilian clothes and footwear upon entering and leaving the hospital will remain our best defense during the pandemic. (4) The threshold for performing percutaneous vs surgical coronary and valvular interventions may vary as the pandemic escalates and abates. After review by the heart team, multivessel percutaneous coronary intervention, transcatheter aortic valve intervention, or MitralClip (Abbott Laboratories, Lake Bluff, IL) may be appropriate to facilitate hospital discharge and reduce length of stay. (5) In the setting of ST-elevation myocardial infarction or other situations requiring emergent cardiac catheterization, prehospital screening for symptoms of influenza-like illnesses, pre-existing knowledge of COVID-19 positivity, and—if available in the future—rapid COVID-19 testing should be strongly encouraged so that patients can receive appropriate care and bypass the emergency department. (6) The goal of rapid but safe discharge with teleconference or telephone follow-up should be promoted to facilitate maximizing the use of bed capacity and avoid hospital exposure.

In summary, we believe this framework, and the recommendations in the Table 1, will provide crucial guidance for clinicians and policy makers on the management of coronary and structural procedures in the CCL as the COVID-19 pandemic escalates and eventually abates.

Funding Sources

The authors report no funding sources relevant to the contents of this paper.

Disclosures

The authors have no conflicts of interest to disclose.