Author + information
- Received April 29, 2020
- Accepted April 29, 2020
- Published online June 22, 2020.
- David A. Wood, MDa,b,∗ (, )
- Ehtisham Mahmud, MDc,
- Vinod H. Thourani, MDd,
- Janarthanan Sathananthan, MBChB, MPHa,b,
- Alice Virani, MA, MS, MPH, PhDe,
- Athena Poppas, MDf,
- Robert A. Harrington, MDg,
- Joseph A. Dearani, MDh,
- Madhav Swaminathan, MDi,
- Andrea M. Russo, MDj,
- Ron Blankstein, MDk,
- Sharmila Dorbala, MDk,
- James Carr, MDl,
- Sean Virani, MD, MSc, MPHa,b,
- Kenneth Gin, MDa,b,
- Alan Packard, PhDm,
- Vasken Dilsizian, MDn,
- Jean-François Légaré, MDo,
- Jonathon Leipsic, MDa,b,
- John G. Webb, MDa,b and
- Andrew D. Krahn, MDa,b
- aCentre for Cardiovascular Innovation, St Paul’s and Vancouver General Hospital, Vancouver, British Columbia, Canada
- bCentre for Heart Valve Innovation, St Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada
- cUniversity of California, San Diego Sulpizio Cardiovascular Center, La Jolla, California
- dDepartment of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, Georgia
- eDepartment of Medical Genetics, University of British Columbia, Vancouver, British Columbia, Canada
- fBrown University School of Medicine, Providence, Rhode Island
- gDepartment of Medicine, Stanford University, Stanford, California
- hDepartment of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota
- iDepartment of Anesthesiology, Duke University School of Medicine, Durham, North Carolina
- jCooper Medical School of Rowan University, Camden, New Jersey
- kBrigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
- lNorthwestern University Feinberg School of Medicine, Chicago, Illinois
- mDivision of Nuclear Medicine and Molecular Imaging, Department of Radiology, Children’s Hospital Boston/Harvard Medical School, Boston, Massachusetts
- nDepartment of Diagnostic Radiology and Nuclear Medicine, University of Maryland School of Medicine, Baltimore, Maryland
- oNew Brunswick Heart Centre, Dalhousie University, Saint John, New Brunswick, Canada
- ↵∗Address for correspondence:
Dr. David A. Wood, Centre for Cardiovascular Innovation, St. Paul’s and Vancouver General Hospitals, University of British Columbia, 2775 Laurel Street (9th Floor), Vancouver, British Columbia V5Z 1M9, Canada.
- cardiac computed tomography
- cardiac magnetic resonance imaging
- cardiovascular procedures
- cardiovascular surgery
- COVID-19 pandemic
- diagnostic tests
- interventional cardiology
- nuclear cardiac imaging
The coronavirus disease-2019 (COVID-19) pandemic has led to marked global morbidity and mortality (1–3). There have been appropriate but significant restrictions on routine medical care to comply with public health guidance on physical distancing and to help preserve or redirect limited resources. Most invasive cardiovascular (CV) procedures and diagnostic tests have been deferred with North American CV societies advocating for intensified triage and management of patients on waiting lists (4). Unfortunately, patients with untreated CV disease are at increased risk of adverse outcomes (5). Delays in the treatment of patients with confirmed CV disease will be detrimental. Similarly, reduced access to diagnostic testing will lead to a high burden of undiagnosed CV disease that will further delay time to treatment. Although there will be a myriad of competing demands from multiple disciplines, this risk warrants the prioritization of CV patients as health care systems return to normal capacity (4). Although COVID-19 has had a global impact, there are regional differences in the burden of the pandemic. Some regions have not experienced a significant surge of cases variably related to social and health care adaptation measures, or the surge has passed and was less substantial than predicted. In these areas, there are available health sector resources that can be redeployed quickly. As regions move along the journey of managing the COVID-19 pandemic, there is an opportunity to reintroduce regular CV care in a progressive manner with appropriate safeguards.
The CV societies have released a number of position or guidance statements that predominantly focus on the provision of CV care during the peak of the pandemic (6–12). These documents highlight the central theme of balancing essential CV care services while reducing exposure and preserving health care resources to address the pandemic. As the COVID-19 pandemic abates, developing appropriate strategies to reintroduce routine CV care will be crucial. Unprecedented times require unprecedented collaboration. In this consensus report, we harmonize recommendations from North American CV societies and provide guidance on the safe reintroduction of invasive CV procedures and diagnostic tests after the initial peak of the COVID-19 pandemic.
Strategies and Evidence
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 (13). 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 (15), 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 Table 1 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 aerosol-generating 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.
Guidance From Professional Societies
Table 1 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 Table 1 include:
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.
2. 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 Table 1 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 Table 1.
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.
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.
North American Cardiovascular Societies represented: American College of Cardiology, American Heart Association, Canadian Cardiovascular Society, Canadian Association of Interventional Cardiology, Society for Cardiovascular Angiography and Interventions, Heart Valve Society, American Society of Echocardiography, Society of Thoracic Surgeons, Heart Rhythm Society, Society of Cardiovascular Computed Tomography, American Society of Nuclear Cardiology, Society of Nuclear Medicine and Molecular Imaging, Society for Cardiovascular Magnetic Resonance, Canadian Heart Failure Society, and the Canadian Society of Cardiac Surgeons.
This paper has been co-published in the Journal of the American College of Cardiology, the Canadian Journal of Cardiology, and The Annals of Thoracic Surgery.
Dr. Wood has received unrestricted grant support from Edwards Lifesciences and Abbott Vascular; and has served as a consultant to Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific. Dr. Mahmud has served as a consultant for Abiomed, Medtronic, and Boston Scientific; has received clinical trial support from Corindus; has served as Chairman of the Data Safety Monitoring Board for CAD III and CAD IV studies sponsored by Shockwave, Inc.; and has served as Chairman of the Data Safety Monitoring Board for the EluNIR-HBR Study sponsored by Medinol. Dr. Thourani has served as an advisor for and/or received research support from Edwards Lifesciences, Abbott Vascular, Gore Vascular, Boston Scientific, and JenaValve. Dr Sathananthan has served as a consultant for Edwards Lifesciences and Medtronic. Dr. Harrington has served on an Advisory Committee for Element Science. Dr. Russo has received grant support from Boston Scientific and Medilynx; and has served as a steering committee member (without honoraria) for Boston Scientific and Apple. Dr. Dorbala has served as an advisor and has received institutional research support from Pfizer and GE Healthcare. Dr. Carr has received research funding from Siemens, Bayer, and Guerbet; and has served as a consultant for Siemens and Bayer. Dr. Virani has served as an advisor to Medtronic; and has served as a consultant to Abbott Vascular. Dr. Leipsic has served as a consultant to and has stock options in HeartFlow and Circle CVI; has received research support from GE Healthcare and Edwards Lifesciences; has CT core laboratory research agreements with Edwards, Abbott, Medtronic, and NEOVASC, for which he takes no compensation; and has served on the Speakers Bureau of GE Healthcare and Philips. Dr. Webb has served as a consultant to Edwards Lifesciences, Abbott, and Boston Scientific. Dr. Krahn has served as a consultant for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.
- Abbreviations and Acronyms
- coronavirus disease-2019
- health care worker
- personal protective equipment
- Received April 29, 2020.
- Accepted April 29, 2020.
- 2020 American College of Cardiology Foundation, the Canadian Cardiovascular Society, and The Society of Thoracic Surgeons
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