Adaptations in the catheterization laboratory and beyond are needed to ensure timely treatment of people with structural heart disease (SHD) while minimizing the risk of COVID-19 exposure to patients and healthcare workers, according to the American College of Cardiology (ACC) and Society for Cardiovascular Angiography and Interventions (SCAI).
Choosing which SHD procedures can wait is especially important during the ongoing pandemic, according to a consensus statement from the groups, published online in .
"The current pandemic will require physicians to make challenging decisions regarding the proper triage and deferral of patients as necessary. There remains significant uncertainty regarding the trajectory of the COVID-19 pandemic, but based on experience of other nations, the United States health care system must be prepared for a surge of critically ill patients in the coming weeks," according to the temporary guidance.
Clinicians from New York City -- the current epicenter of the COVID-19 outbreak -- went one step further and suggested a triage approach to SHD patients based on the urgency of their procedures.
"In the absence of analytic outcomes data to guide evidence-based decision-making, reality-based considerations are necessary surrogates in formulating clinical pathways in the context of a global pandemic," according to Susheel Kodali, MD, and colleagues at NewYork-Presbyterian Hospital/Columbia University Irving Medical Center. Their report is to be published soon in the .
In early March, the New York group cancelled all procedures over the next 2 months then re-prioritized patients under a three-tier system:
- Tier 1 (emergent/urgent): highest-risk cases requiring a procedure within days or 1-2 weeks (e.g., severe aortic stenosis with New York Heart Association [NYHA] Class IV symptoms, recurrent/refractory heart failure requiring hospitalization, or recurrent syncope)
- Tier 2 (semi-Urgent): cases requiring close monitoring at weekly intervals and an intervention within 1-2 months (e.g., severe aortic stenosis with rapidly progressive or worsening NYHA Class III symptoms; severe tricuspid regurgitation with worsening NYHA Class IV symptoms and evidence of progressive organ system dysfunction)
- Tier 3 (elective): lower-risk cases that may be postponed for 2 months or longer (e.g., severe aortic stenosis with NYHA Class I-II symptoms; severe mitral regurgitation with NYHA Class I-II symptoms on optimal pharmacotherapy; and severe tricuspid regurgitation with NYHA Class I-III symptoms on medical pharmacotherapy)
"The goal is to intervene on Tier 2 patients at the earliest reasonable time while continuing to minimize risk of exposure to COVID-19 and to exercise responsible stewardship of limited resources. Same-day or next-day discharge without ICU occupancy should be prioritized whenever possible," Kodali and colleagues urged.
Interventions that are unlikely to directly impact clinical care or outcomes over the next 2-3 months should be considered elective and be postponed, Kodali's team urged, citing procedures like left atrial appendage occlusion and closure of atrial septal defects and patent foramen ovales.
Transcatheter aortic valve replacement (TAVR) candidates who are asymptomatic may have the procedure postponed for 3 months or until after hospital operations resume elective procedures, according to the ACC/SCAI writing group led by Pinak Shah, MD, of Brigham and Women's Hospital in Boston.
"We recommend that the TAVR team convene virtually on at least a weekly basis to review the status of patients on the 'waiting' list. A single interventional cardiologist and cardiac surgeon should assume a leadership position and be given the authority to arbitrate challenging cases," Shah and colleagues wrote.
Among other SHD procedures that can be safely deferred are most percutaneous mitral valve repairs, according to the group's recommendations.
However, Shah and colleagues noted that valve-in-valve transcatheter mitral valve replacement should still be considered for congestive heart failure patients with severe bioprosthetic mitral stenosis or regurgitation.
Changes in the Procedural Suite
ACC and SCAI recommend that those who scrub for procedures don , including an N95 respirator and a face shield, given the risk of emergent intubation and need for cardiopulmonary resuscitation.
To preserve PPE, the presence of personnel in each cardiac catheterization laboratory or hybrid operating room should be limited to essential staff -- no trainees allowed, Kodali's group suggested.
PPE is especially important to consider in imaging during SHD interventions. "To offset the risk of particulate aerosolization, pre-procedural TEE [transesophageal echocardiography] should be limited in use," Shah's group said.
"If a patient is planned for an emergent percutaneous mitral valve repair procedure, on-table TEE will suffice in case planning at experienced centers. For any high-risk SHD procedure requiring interventional imaging support with TEE, emphasis must be placed on availability of full PPE for the interventional imager," the group recommended.
"In the absence of sufficient PPE, alternative imaging modalities should be considered (intracardiac echo if possible) as there is high risk of COVID-19 exposure with TEE performance," according to the ACC/SCAI guidance.
And in aortic valve replacement, transcatheter procedures may be a reasonable alternative to surgery to conserve ICU beds and to reduce the risk of COVID-19 exposure with inpatient admission.
Case in point: in New York, a patient was allowed to undergo TAVR (instead of surgery) despite her young age and bicuspid anatomy, according to Kodali and colleagues.
"TAVR should be performed with a modified minimalist approach including use of conscious sedation, avoidance of TEE, and specific plans to minimize the length of stay in the hospital," they noted.
Telemedicine in Outpatient Management
In March, SHD outpatients at Kodali's center were offered two options: either keep the original appointment and change it to a telemedicine encounter, or postpone until a future date when it is safer for an in-person visit.
Across the U.S., self-isolation measures in response to COVID-19 have forced many patient-clinician interactions online. Kodali and colleagues noted that the adoption of telemedicine at their New York center was facilitated by a relaxing of several regulations:
- Medicare coverage temporarily expanded to cover telemedicine using a wider range of communication tools, including smartphones
- Temporary waiver of state-specific licensing requirements allowing physicians to see patients residing in neighboring states
- Penalties waived for providers acting in good faith who perform telemedicine visits using mainstream services that are not HIPAA-compliant (e.g., FaceTime, Zoom)
Moreover, the has allowed in-person visits to be substituted with telephone or virtual visits for 30-day and 1-year follow-up, the ACC/SCAI document noted. "While some elements of these registries cannot be collected with remote follow-up, this will need to be addressed at a future date."
For clinicians engaging in telemedicine, clear and frequent communication with patients was stressed by Kodali's team. SHD patients in particular should receive specific instructions on how to self-monitor symptoms at home and when to call the clinic or go to the emergency room, they said.
The fact that some patients will need more help than others should not be overlooked, either.
"Conducting a comprehensive new patient evaluation for SHD remotely is labor-intensive and presents challenges for elderly patients who may lack sophisticated knowledge of technology and access to a device with a streaming video camera," according to the New York group.
Disclosures
Kodali reported institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; consulting fees from Abbott, Admedus, and Meril Life Sciences; and equity options from BioTrace Medical and Thubrikar Aortic Valve. Other authors also reported extensive relationships with industry.
Shah is proctor for Edwards and has received educational grants from Edwards, Medtronic, and Abbott. Co-authors also reported relationships with industry.
Primary Source
Journal of the American College of Cardiology
Chung CJ, et al "The restructuring of structural heart disease practice during the COVID-19 pandemic" J Am Coll Cardiol 2020.
Secondary Source
JACC: Cardiovascular Interventions
Shah PB, et al "Triage considerations for patients referred for structural heart disease intervention during the coronavirus disease 2019 (COVID-19) pandemic: an ACC /SCAI consensus statement" JACC Cardiovasc Interv 2020; DOI: 10.1016/j.jcin.2020.04.001.