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APRIL 14, 2020 -- Like so much else these days, the treatment of valvular and structural heart disease (SHD) has been turned on its ear. Elective procedures are canceled in many regions and, as hospitals become overwhelmed with COVID-19 patients, all but the most urgent care is postponed.
Patients in need of SHD interventions constitute a challenging group; many have conditions that may be life-threatening if treatment is inappropriately delayed. For others, the risk of intervention during a pandemic is greater than the risk of waiting.
"It can be really hard to know exactly what is truly elective in cardiology. I think most of what we do, once a decision is made to do it, generally it's felt that it’s better to get it done as soon as possible to prevent any complications from delay in treatment," said Pinak B. Shah, MD, from Brigham & Women’s Hospital, Boston, Massachusetts.
Shah is the lead author of a consensus statement from the American College of Cardiology (ACC) and Society for Cardiovascular Angiography and Intervention (SCAI) on how to triage patients with SHD during COVID-19.
The document, published online April 6 in JACC: Cardiovascular Interventions, takes a broad approach to the triage of patients in need of SHD interventions during COVID-19
"As a 'consensus statement,' we took into consideration the variations in the severity of the epidemic around the country as well as the variability in resources of structural heart programs around the country," Shah told theheart.org | Medscape Cardiology.
The statement provides a framework to guide decision-making about the appropriate timing for an intervention, despite the ongoing pandemic, and addresses the triage of patients needing transcatheter aortic valve replacement (TAVR) and percutaneous mitral valve repair, along with other SHD interventions.
Regarding TAVR, the writing group proposes timing for patients with symptomatic severe aortic stenosis (AS), minimally symptomatic severe to critical AS, and asymptomatic severe to critical AS. For those whose procedures are deferred, weekly telephone follow-up is recommended.
The authors also discuss managing infection risk in the cath lab, such as limiting transesophageal echocardiology to reduce potential for particulate aerosolization, and the conduct of clinical trials (ie, stop enrolling new patients and continue care for patients already enrolled and treated).
Four "general priorities" should guide all decision-making, said the authors: a) minimize exposure to COVID-19 to SHD patients and care providers; b) maintain high quality and durable SHD care; c) reduce the risk that SHD patients use resources that might be needed for COVID-19 management; and d) avoid care delays that increase risk for clinical deterioration, heart failure, and death.
Continually Changing Thresholds
In terms of when to intervene, the consensus document offers suggestions, but Shah notes that there really are no hard-and-fast rules. Processes and procedures require continual adjustment as case counts go up and down.
"Even within our own group, the practices and the criteria for treatment were not necessarily uniform, so we had to be a bit broader regarding our recommendations in order to provide a framework for how a particular center may want to modify their practice based on their situation," said Shah.
"As an example, if your PPE is extraordinarily limited or other hospital resources are very limited, like beds, ICU beds, or ventilators, while we don't expect to need ICU beds or ventilators for structural heart disease patients, I think that would very much raise your threshold for considering an intervention on a patient that you normally would want to treat earlier rather than later," said Shah.
That day has already come for New York City. In what is currently the country's worst coronavirus hotspot, the thresholds for intervention have gotten higher and higher, according to Susheel K. Kodali, MD, the director of the Structural Heart Valve Center at NewYork-Presbyterian/Columbia University Irving Medical Center, New York City, and lead author of a second article published online April 9, this time in the Journal of the American College of Cardiology, on restructuring SHD practice during COVID-19.
Kodali and the team at NewYork-Presbyterian, including first author Christine J. Chung, MD, shared their "crisis-driven recommendations" for ensuring timely delivery of treatment for SHD patients in a safe manner and under resource utilization constraints.
In early and mid-March, said Kodali in an interview, the structural heart team canceled all elective SHD surgeries to save on PPE and free up beds for the impending arrival of COVID-19 patients. Now, COVID-19 has taken over nearly every corner of the hospital.
"The hospital has been overtaken in the last few weeks," he said. "Our cath lab holding areas have been turned into ICUs and many of the ORs are also being used as ICUs. There are very few non–COVID-19 floors in the entire hospital, so we really have to think hard about bringing patients into the hospital for a procedure and worrying that they might contract the coronavirus while they're here."
In their report, the authors suggest triaging SHD patients into three tiers. Tier 1 would be emergent and urgent patients, which would include inpatients that cannot be safely discharged without a procedure and outpatients at high risk for decompensation within the next 2 weeks. An example of such patients would be one with severe aortic stenosis and recurrent syncope.
Urgent but lower risk patients, tier 2, and elective cases, tier 3, can be triaged for treatment according to resource availability.
At this point, not even all tier 1 patients are being sent to the cath lab. "It becomes a question of whether the risk of delaying the procedure outweighs the risk of bringing these patients into the hospital during a heavy census," said Kodali. They've done only a handful of cases in the last few weeks and he, personally, has become a COVID-19 healthcare provider, pulling shifts in the ICU to help out.
At Brigham and Women's, there is currently one cardiologist staffing two cath labs while three others have essentially closed down, said Shah. Caseloads have dropped from about six to 12 TAVRs a week, a handful of MitraClips and other procedures, to just one or two TAVRs a week. "At this point we're really only treating inpatients who cannot be sent home without a procedure," said Shah.
Kodali adds that at NewYork-Presbyterian they are opting for less-invasive procedures as a means to limit resource utilization; additionally, they're trying to offer same-day or next-day discharge without ICU occupancy.
"Some of these patients who in the past we might have sent for surgery, we're now doing TAVRs on, and some patients we might have sent for TAVR, we're keeping them home and trying to manage medically," said Kodali.
How this will change when the worst of the COVID-19 rush is over and things start to return to normal is unknown, but Kodali suspects they may be doing primarily TAVRs on all patients for a while yet just because of the lower clinical risk and resource needs.
"Though flattening of the curve should prevent some hospitals from being overwhelmed, this pandemic is likely to have a long 'tail' and adjustments to usual practice will be necessary well into the foreseeable future," write Kodali and colleagues.
Already things are being done differently in different places. For example, cath lab PPE requirements differ between hospitals inundated with COVID-19 and those not overwhelmed. At the Brigham, where COVID-19 patients are present but not to a level of inundation, Shah said they're still using typical PPE in the cath lab — a sterile gown and standard gloves and mask — assuming they've been able to confirm beforehand that the patient doesn't have COVID-19.
Kodali, on the other hand, said all interventions done at NewYork-Presbyterian are now done in full PPE, including a face shield and N95 mask. In both places, trainees and nonessential personnel have not been allowed in the cath lab during procedures to conserve PPE and limit the risk of infection.
"We are testing everyone before they come in the cath lab, but even despite the testing, I think right now there is enough community spread and enough variability in the testing that we don't really know the true 'false-negative' rate," said Kodali. He added that many of the Italian healthcare workers who became infected early on were cardiologists treating patients who presented with atypical symptoms of myocardial infarction but were COVID-19 positive.
"I would argue that you need to do a full PPE in the cath lab at this point because we don't know the true asymptomatic carrier rate," said Kodali.
Telemedicine Comes of Age
Telemedicine has advanced in fits and starts for several decades, but has Zoomed ahead during COVID-19.
The experience in New York is telling. When the call came from the hospital administration to cancel all nonurgent patient visits and either convert appointments to a telemedicine encounter or postponed to a future date when in-person encounters are safer, Kodali's group saw some clear self-selection bias, such that patients with greater symptoms opted for the telemedicine visit while those who were less symptomatic and more stable pushed appointments off.
Also, telehealth can present challenges for elderly patients who may not be adept at telecommunication tools like Zoom. And family members who might come to help can't in the name of social distancing.
"A video encounter offers distinct advantages over a phone call alone, as it enables subjective assessments of frailty, dyspnea, and limited evaluation of volume status," write Kodali and colleagues. "Albeit imperfect, a web camera positioned at a patient's legs can convey severity of peripheral edema."
"We've seen this interesting shift from patients wanting their procedures done as soon as possible to most of our patients really not wanting to come into the hospital right now," said Shah. "We've been evaluating our patients pretty much at the same rate as before, just all the visits are virtual."
Importantly, as outlined in the Kodali et al article, a phone call will now be acknowledged for coverage by Medicare. Beginning March 6 and for the duration of COVID-19, Medicare expanded coverage for telemedicine using a wider range of communications tools, including smartphones, and enabling beneficiaries to receive many health services without incurring the risk of in-person visits.
To further boost telemedicine, the Centers for Medicare & Medicaid Services waived state-specific licensing requirements allowing physicians to see patients across state lines and the Health and Human Services Office for Civil Rights waived penalties for providers acting in good faith to perform telemedicine visits using technologies (eg, FaceTime) that are not HIPAA-compliant.
"The technology is a bit of a challenge sometimes, but we try to see as many patients virtually as we can and we're making judgement calls on when we might need to bring someone in," said Kodali.
At the end of the day, while articles such as these are invaluable guides, there are a lot of risk–benefit ratios being calculated on the fly. "I wouldn't ever have imagined what's happening right now in my hospital — that the ORs and holding areas would be ICUs, that I'd be working in an ICU, all of it," said Kodali. "I never would have imagined it."