Structural Heart Interventions in the Midst of COVID-19: Today’s Advice, Tomorrow’s Unknowns
Which TAVR can be deferred, which MV should be repaired? Advice from ACC, SCAI, and the heart of the US pandemic.
Many transcatheter interventions for structural heart disease have been cancelled or postponed indefinitely amid the COVID-19 pandemic, but some patients can’t wait, according to a new consensus statement. The joint document issued last week by the American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI) proposes triage considerations to help heart teams decide which procedures should happen ASAP.
The same week, however, a group of physicians at NewYork-Presbyterian/Columbia University Irving Medical Center, in the heart of the US epicenter for COVID-19, released their own set of “crisis-driven recommendations” for structural heart interventions. Led by Christine Chung, MD, their advice and experience serve as a sobering reminder that the decision to intervene in a patient needing a valve procedure will be determined largely by hospital resources and the burden of COVID-19 admissions at any given time.
The consensus document was published last week in both JACC: Cardiovascular Interventions and Catheterization and Cardiovascular Interventions, while the NYP/Columbia group published their paper, complete with case examples, in the Journal of the American College of Cardiology.
“We’d all been contacting each other and saying, what are you doing about this?” Pinak Shah, MD (Brigham and Women's Hospital, Boston, MA), lead author of the ACC/SCAI statement, told TCTMD. “We thought it might be timely to try to put out some sort of consensus statement and what ended up happening, predictably, is that it was hard to come to consensus and there are a few recommendations that we discussed at length before trying to word it appropriately.
“The one thing that was really clear is that all of this is highly dependent on what’s going on in your neighborhood and your institution,” Shah continued. “Some places, like Columbia, are so all-out that the last thing they are thinking of doing is an elective TAVR, no matter what’s going on with the patient. Whereas for us, we’re not necessarily quite that bad yet so if we have a patient [and] we really don’t want them to wait, and we sort of have this window before the surge hits that we can get him in and get him out, we will often want to think about doing it. That’s where a lot of the challenge comes in: trying to put out some guidelines because that bar, that threshold, is going to move depending on what’s going on at your institution at the time.”
We're probably going to lose some patients who need to come in sooner, and I wouldn't be surprised if we bring certain patients in and potentially expose them to COVID-19 and the consequences of that. Pinak Shah
Senior author on the NYP/Columbia paper, Susheel Kodali, MD, speaking with TCTMD, said their recommendations are roughly similar to those of the ACC/SCAI group, but that in certain cases are “much stronger” and “more absolute” given the deluge of infectious COVID-19 patients swamping their institution. He himself called TCTMD after a day spent in the ICU and stressed that decision-making will be different for hospitals depending on where they are relative to the arc of this pandemic.
As detailed in their paper, Chung, Kodali, and colleagues had recently decided to go ahead with a TAVR in a 61-year-old woman with a bicuspid valve and severe, symptomatic aortic stenosis (AS) in whom surgery, while preferable, was deemed to be impossible in the current climate. Importantly, the woman was COVID-19-negative. While the TAVR implant was successful, the woman developed PR-interval prolongation and new left bundle branch block. Rather than keep her in hospital with a temporary transvenous pacemaker, the team decided to implant a permanent pacemaker so that she could be discharged home. She’ll be evaluated for possible explant down the road.
“Though not a typical cost-effective treatment strategy, it was felt to be appropriate in the current pandemic environment, balancing the needs of the patient with the overall needs of the general population,” they write.
This type of balancing act will have to be done by heart teams around the United States in the weeks and months to come. Both Kodali and Shah, who spoke at length with TCTMD, were candid about the many questions left open and the uncertainty around what structural heart interventions and the potential pool of patients will look like even after this crisis has passed.
Urgent or Deferable
The ACC/SCAI document is broken into three main sections dealing with aortic, mitral, and other structural heart interventions. For the latter two categories, encompassing mitral repair using the MitraClip (Abbott) and valve-in-valve mitral valve replacement, as well as patent foramen ovale, atrial septal defect, and left atrial appendage closures plus alcohol septal ablation for hypertrophic cardiomyopathy, the authors say most procedures can be safely deferred. Relatively rare exceptions are inpatients and outpatients with mitral regurgitation and severe heart failure who, for a checklist of reasons, either can’t be safely discharged from the hospital or are at high risk of requiring hospitalization within 30 days, most notably those likely to require ICU-level care.
Where the document may prove most useful is for physicians trying to make tough decisions in patients scheduled for TAVR procedures, now offered at more than 650 US hospitals.
In the context of severe AS, symptoms need to be the driver, Shah explained. For inpatients with critical or severe symptomatic AS that is likely the cause of NYHA class III/IV congestive heart failure or syncope secondary to AS, scheduling them for TAVR is “reasonable,” the document states. The next group are patients with lesser heart failure symptoms (NYHA class I/II) but “critically tight” AS; for them, it’s reasonable to consider either urgent TAVR or close outpatient telemonitoring.
By contrast, said Kodali, at his hard-hit New York hospital, only NYHA class IV patients with severe AS would likely be considered for emergent or urgent interventions, while class III patients would be considered “semi-urgent,” with an intervention happening within 1 to 2 months. As for the class I/II patients, “there’s no way we’d be thinking about doing those here,” he said bluntly.
The third group identified by Shah and colleagues are the asymptomatic severe-to-critical AS patients. “We do know that there is an emerging data set suggesting that perhaps we should intervene earlier in patients with asymptomatic severe aortic stenosis,” Shah said. That’s supported by the RECOVERY trial, while the EARLY TAVR trial is ongoing. “But adverse events that we're looking to prevent are probably happening 3 to 6 months out, or even longer, and not so much in the matter of weeks that we are expecting the COVID situation to last. So we felt that asymptomatic patients we should probably think about not treating them at this point and waiting for the dust to settle,” he added.
That’s largely in keeping with the NYP/Columbia group’s recommendations, which categorize these patients, as well as severe MR and severe tricuspid regurgitation patients with class I to II heart failure as “elective, Tier 3.”
And how to handle a patient showing symptoms of COVID-19 or who has already tested positive? This was discussed by the writing group, Shah said. “We felt that if a patient with severe aortic stenosis became incredibly ill with COVID-19 and they became unstable and if it was thought that their aortic stenosis was really causing a major problem for their recovery, [then] that may be a situation where we would consider TAVR or perhaps consider a balloon valvuloplasty to try to get them through the initial insult.”
On the other hand, Shah acknowledged, the “trajectory of illness” needs to be considered. “If a patient developed severe pneumonia, we know [their risk of] mortality goes way up and that might not necessarily be the right time to think about putting in a new heart valve,” he observed.
All of this kind of thinking represents a shift for practitioners around the US who have been trying to ramp up their caseloads in order to serve an ever-growing patient population, particularly after the US Food and Drug Administration’s approval of low-risk TAVR. “Every valve program in the country was trying to figure out, before COVID-19, how to get their cases done as quickly as possible, because we know the longer we wait on these patients the worse their outcomes are,” Shah said. “Now we're suddenly shifting gears and thinking about every way not to treat these patients, because we are worried about what is going on at our own institutions with the COVID-19 influx of patients.”
Today and Tomorrow
Shah stressed repeatedly that the guidance will be interpreted differently at different centers—those not flooded with COVID-19 patients may choose to move ahead with less-urgent TAVR and mitral cases as capacity allows, if only to try to get these patients home before the COVID-19 situation worsens.
Chung et al make the same point. “The degree to which individual programs are constrained in their ability to divert resources such as anesthesia care and ICU beds to their structural patients will be significantly impacted by the local COVID-19 case burden. For instance, in geographic areas where the rate of increase in and overall case burden of COVID-19 is relatively low, there may be capacity to continue offering structural interventions to Tier 1 patients throughout the pandemic, then to begin intervening on Tier 2 patients as the disease burden tapers further,” they write.
Both groups emphasize the critical role of telemedicine in patients whose procedures are deferred.
It hasn't been a struggle to convince patients that their procedures need to be put off. Pinak Shah
“We need to maintain a line of communications with those patients and at least once every 2 weeks, if not weekly, just to do a check-in to make sure things haven’t changed dramatically and make sure they're doing okay,” Shah said. “If we find that things are getting worse or patients are getting super anxious about waiting, which is understandable, then we would think about trying to bring them in despite the COVID-19 crisis.”
What’s been interesting, Shah continued, has been a palpable change in attitudes among his patients. “I feel like in my valve clinic, when patients are very symptomatic, they just want this thing done as soon as possible. Now that COVID has hit and all my visits are virtual, it’s amazing how patients who are symptomatic do not want to come to the hospital because they are so scared about contracting this virus. . . . So it hasn't been a struggle to convince patients that their procedures need to be put off. Most of them felt very relieved about that—they didn't want to come.”
This is the trade-off that all structural heart programs are now solemnly debating, Shah said. “We're all struggling with this: are we potentially putting patients at risk by delaying procedures or are we putting them at more risk by having them come to the hospital to have a procedure when resources are going to be tight and . . . quite frankly, where COVID-19 is going to be the most concentrated?”
It’s not always clear what risk is worse, Shah continued. “I think it's a very likely we're going to make mistakes on both ends. We're probably going to lose some patients who need to come in sooner, and I wouldn't be surprised if we bring certain patients in and potentially expose them to COVID-19 and the consequences of that.”
As for what TAVR and other structural heart disease programs will look like in the future, that remains to be seen. Kodali pointed out that COVID-19 will not end abruptly but will “have a long tail,” meaning that balancing the risks of delaying interventions against an increased risk of infection will remain a concern for some time. And as that infection risk drops, it’s not just structural heart procedures that will start to ramp up, but also all of the other nonurgent/elective procedures across hospital departments that are being cancelled or postponed today. This, too, will put a lasting strain on hospital resources for the foreseeable future, Kodali noted.
Shah noted that for many hospitals, including his, TAVR is a profitable procedure and not something administrators will be looking to cut, but whether payers will feel any differently is unclear. The broader economic impact this outbreak is having in the United States and elsewhere may have unexpected consequences for the healthcare system, he said.
“Certainly in the United States, there are huge relief packages going out to try to help small businesses and American citizens. The question is then, does that affect how Medicare is going to get funded and will the DRGs change? Will there be stronger concerns by the government?” Shah asked. “We might be thinking more strongly about the 99-year-old with severe symptomatic aortic stenosis. Is that really where we ought to be putting even tighter healthcare dollars? I think it's going to be a really interesting discussion depending on what happens. I hope I'm wrong and I hope that by August it's like this was just a bad dream and we're back to life like before, but I'm a little skeptical.”
Shah PB, Welt FGP, Mahmud, E, 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. J Am Coll Cardiol Intv. 2020;Epub ahead of print.
Chung CJ, Nazif TM, Wolbinski M, et al. The restructuring of structural heart disease practice during the COVID-19 pandemic. J Am Coll Cardiol. 2020;Epub ahead of print.
- Shah reports being a proctor for Edwards and having received educational grants from Edwards, Medtronic, and Abbott.
- Chung reports no relevant conflicts of interest.
- Kodali reports institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; consulting fees from Abbott, Admedus, and Meril Lifesciences; and equity options from Biotrace Medical and Thubrikar Aortic Valve Inc.