TAVR Delays During Pandemic’s Peak Led to Hospitalizations, Deaths

(UPDATED) Delaying aortic valve replacement for patients with symptomatic severe aortic stenosis is a risky proposition, particularly for those with impaired left ventricular ejection fraction, comorbid CAD, or multivalvular disease, according to two new studies highlighting clinical outcomes from earlier this year when elective procedures were stopped to combat rising COVID-19 numbers.  

In the first study from New York City, 10% of patients awaiting aortic valve replacement at a busy structural heart program ended up undergoing urgent TAVR or died during in the first 30 days after elective procedures were halted. By 3 months, more than one-third of patients affected by the ban on elective procedures required an urgent intervention or died, the vast majority sent for TAVR because of worsening symptoms.  

The researchers, including senior investigator Stamatios Lerakis, MD, PhD (Icahn School of Medicine at Mount Sinai), say their study also identifies high-risk patients in whom aortic valve replacement shouldn’t be delayed, which is critical in the face of anticipated future outbreaks. “I think it’s important since it’s most likely to happen again as we’re expecting a second wave, either in other countries or other states, and it may go on for a while,” Lerakis told TCTMD.

Across the pond, Swiss researchers reported that nearly one in five patients scheduled for aortic valve replacement who had the procedure delayed reported to hospital with valve-related symptoms or worsening heart failure. Thomas Pilgrim, MD (Bern University Hospital), senior researcher of the prospective Aortic Stenosis Defer (AS-DEFER) study, said elective procedures were halted in Switzerland on March 20, 2020, but they knew they’d have to take on selected patients given their risk.  

“It goes without saying there are patients with aortic stenosis that need to be treated and who can’t wait for an intervention for 3 or 6 months,” he told TCTMD.

Thoralf Sundt, MD (Massachusetts General Hospital, Boston, MA), who wrote an editorial accompanying both studies now published in JAMA Network Open, also called attention to the risks of waiting too long for a new valve. “[A]s we have known for many years, symptomatic aortic stenosis is a life-threatening condition, and its treatment cannot be considered elective in any way,” he writes. “Patients with the most echocardiographically severe stenosis, clinically advanced symptoms, or comorbid coronary artery disease or lung disease belong at the head of the line.”

Should I Delay or Should I Go?

At their structural heart program, Pilgrim said patients with critical aortic stenosis defined by an aortic valve area of 0.6 cm² or less, a transvalvular mean gradient of at least 60 mm Hg, cardiac decompensation during the previous 3 months, or exercise intolerance with clinical symptoms on minimal exertion were considered high risk and sent for expedited TAVR. Conversely, those with stable symptoms and larger valve areas had their treatment deferred.

Between the start of the ban and when it ended on April 26, 71 patients with symptomatic severe aortic stenosis were included in AS DEFER, with 25 sent for expedited TAVR and 46 put on the deferred list. No patients were scheduled for surgical valve replacement.

“For practical purposes, this was what we had to do,” said Pilgrim. “There was no way around it because we just weren’t allowed to do any elective procedures. . . . You need to balance the limited resources you have. You don’t want to bring elderly patients to the hospital unless it’s really necessary. You don’t want to expose them to the risk of infection and you don’t want to occupy hospital beds, particularly ICU beds, with elderly patients because of elective procedures.”  

After a mean follow-up of 31 days, the primary endpoint of all-cause mortality, disabling and nondisabling stroke, and unplanned hospitalization for valve-related symptoms or worsening heart failure occurred in 19.6% of patients in the deferred-TAVR arm and in 4.0% of patients in the expedited group (P = 0.08). With the deferred strategy, unplanned hospitalizations completely drove the primary endpoint (19.5% vs zero in the expedited arm; P = 0.02) and seven of these patients crossed over to expedited TAVR (n = 4) or surgical valve replacement (n = 3).

We were surprised just how urgent a lot of these patients were. Thomas Pilgrim

Pilgrim said they had initially thought that patients deemed noncritical and deferred for TAVR would be fine. “We were surprised just how urgent a lot of these patients were,” he said. “We thought they could wait but we realized that a lot of them can’t wait, particularly if they have multivalvular disease.”

In their analysis, 44.4% of patients deferred for treatment who required hospitalization for valve-related symptoms or worsening heart failure had multivalvular disease. The classic parameters for assessing aortic stenosis—transvalvular mean gradient, aortic valve area—might underestimate the degree of stenosis in patients with other damaged valves, he said.

For that reason, should a second wave or a surge in COVID-19 cases lead to future bans on elective procedures, Pilgrim said their criteria—which are in line with triage considerations from the American College of Cardiology and Society for Cardiovascular Angiography and Interventions—are likely sufficient for patients with isolated aortic stenosis. However, physicians need to be a bit more cautious with patients with multivalvular disease.

“I would probably be much more open to treating these patients and including them for expedited treatment,” said Pilgrim.

In the editorial, Sundt calls the triage approach a success, noting that there were no deaths with the deferred-TAVR approach and that all events were unplanned cardiac hospitalizations with the presence of multivalvular disease a risk factor. Like Pilgrim, Sundt says he believes the presence of multivalvular disease would justify fast-tracking the procedures.

Toby Rogers, MD, PhD (MedStar Heart & Vascular Institute, Washington, DC), said the increased risks among patients who delayed or deferred their valve replacement procedure aren’t surprising, citing the poor outcomes of symptomatic severe aortic stenosis patients treated with medical therapy in the earliest TAVR trials of patients at extreme risk for surgery. Even as COVID-19 started to spread this spring, the DC area and their hospital were spared somewhat, and they continued to offer TAVR because they felt the “clinical need justified it.”

“We were lucky in that we weren’t hit as bad as New York City,” said Rogers, noting they were at one time the sole center doing TAVRs in the mid-Atlantic region. “That gave the hospital more time to prepare.”

While some patients initially delayed treatment thinking the virus might pass, as it dragged on they came to realize they might as well as get it done, seeing that circumstances were unlikely to change anytime soon, said Rogers. The hospital modified protocols to reduce the patient’s time in hospital, such as doing workups the same day as the procedure and encouraging rapid discharge whenever possible, he added. They also minimized the amount of contact family could have with the patient, which was challenging.

New York City Experience

In New York City, as part of a statewide executive order, elective procedures were canceled on March 22, 2020. At that time, 77 patients (mean age 80 years; 64.0% men) with symptomatic severe aortic stenosis were scheduled for TAVR at Mount Sinai Hospital. Unlike the Swiss experience, none of the patients were recommended for an expedited procedure.

These were sick patients who needed to have the procedure emergently. If they didn’t have it, they’d have died. Stamatios Lerakis

At 1 month, six patients underwent urgent TAVR for accelerating symptoms of dyspnea, angina at rest, heart failure, or syncope and two patients died of severe aortic stenosis. These eight patients had significantly lower LVEFs, were more likely to have obstructive coronary artery disease, and were more likely to have more severe heart failure symptoms.

“These were sick patients who needed to have the procedure emergently,” Lerakis told TCTMD. “If they didn’t have it, they’d have died.”

Analyzed again on June 6, 2020, when procedures were allowed to resume, three patients had died and 24 underwent urgent TAVR for worsening symptoms. At this time, those who died or underwent urgent TAVR were more likely to have a history of cerebrovascular accident and have NYHA class III or IV symptoms. These patients had slightly lower LVEFs, but the difference compared with those who didn’t have a cardiac event wasn’t significant.

“Again, symptoms played an important role in terms of which patients didn’t do well,” said Lerakis. These clinical characteristics—low LVEF, presence of atherosclerotic CVD, or NYHA class III or IV symptoms, among others—could be used to prioritize patients for expedited TAVR if there is another ban on elective procedures, he said. Even outside the pandemic, the study helps identify patients who might benefit from an earlier valve replacement over an extended wait.