Two research letters published today in JAMA Network Open describe the serious ramifications of deferring transaortic valve replacement (TAVR) for patients with severe, symptomatic aortic stenosis early in the COVID-19 pandemic.
Worsening heart failure, death
In the first study, researchers from Mount Sinai Hospital in New York City analyzed the data of 77 patients whose TAVR, diagnostic testing, or heart team appointments were canceled after state authorities issued an executive order to halt elective surgeries on Mar 22. The move was done to both minimize spread of COVID-19 in hospitals and preserve resources and staff for anticipated surges of coronavirus patients.
From Mar 23 to Apr 21, 8 of the 77 patients (10%) experienced a cardiac event, with six undergoing emergency TAVR because of worsening shortness of breath, heart pain at rest, heart failure, or syncope (fainting due to inadequate blood flow to the brain), and two dying.
Patients who had a cardiac event had substantially lower left ventricular ejection fraction (indicating less forceful heart contractions) than those who had no event (45% vs 56%). They also were more likely to have obstructive coronary artery disease (87.5% vs 50.7%) and New York Heart Association (NYHA) class 3 heart failure symptoms, indicating severely limited physical activity but comfort at rest (87.5% vs 37.7%).
In an analysis of 1-month follow-up data to Jun 6, when the hospital was able to resume elective procedures, the researchers found that 27 of 77 patients (35%) had a cardiac event, with 24 of them needing emergency TAVR because of worsening symptoms and three dying. In contrast, no patients died of aortic stenosis while waiting for TAVR in the 3 months before the pandemic began.
Patients who had a cardiac event during the follow-up period were more likely than those who did not have an event to have had a previous stroke (22.2% vs 6.0%) and symptoms of NYHA class 3 heart failure (81.5% vs 52.0%) or class 4 heart failure (7.4% vs 2.0%).
Mean patient age was 80 years, 49 (64%) were men, 55 (71.4%) had been scheduled for TAVR, and 22 (28.6%) had had appointments for testing or heart team appointments.
The authors said that providers must proceed with caution when deciding to perform TAVR amid the pandemic but that the procedure must be resumed after localities pass the peak of their initial outbreak and more healthcare resources are available. Patients with advanced stenosis should be given priority for TAVR, they added.
"Patients with advanced symptoms, lower left ventricular ejection fraction, obstructive coronary artery disease, and cerebrovascular accident history represent a high-risk population with [aortic stenosis], and the heart team should consider these factors for earlier access to TAVR during the COVID-19 pandemic," the researchers wrote.
Unplanned hospitalizations, stroke
In the second study, researchers at the University of Bern in Switzerland compared the outcomes of expedited or delayed TAVR in 71 patients who had severe aortic stenosis from Mar 20, when Switzerland banned elective procedures, until they were allowed to resume on Apr 26.
Of the 25 patients assigned to receive urgent TAVR after a mean of 10 days after referral, 1 (4.0%) met the primary end point of death, stroke, or unplanned hospitalization for stenosis-related symptoms or worsening heart failure. In contrast, 9 of the 46 patients whose TAVR was deferred (19.6%) met the primary end point.
After a mean follow-up of 31 days, 19.6% of patients whose TAVR was delayed were hospitalized for stenosis symptoms or worsening heart failure, versus none of the patients whose procedures were expedited. Of the hospitalized patients whose TAVR was deferred, 44.6% had multivalvular disease, compared with 8.6% of those whose procedure was expedited.
Seven of the nine hospitalized patients whose TAVR was deferred required urgent TAVR or surgical aortic valve replacement (AVR) within, on average, 17 days of treatment assignment. While no patients died, one who had urgent TAVR had a nondisabling stroke around the time of the procedure.
Patients who met the primary end point had a similar delay between diagnosis and referral for AVR to those who had no event (average delay, 27 vs 20 days), as well as comparable rates of NYHA class 3 heart failure at baseline (60% vs 41%).
"Deferral of AVR in patients with symptomatic severe aortic stenosis was associated with an increased risk of hospitalization for valve-related symptoms or worsening heart failure," the authors wrote. "Patients with symptomatic severe aortic stenosis in combination with relevant multivalvular disease may particularly benefit from expedited AVR."
In an invited commentary in the same journal, Thoralf Sundt, MD, of Massachusetts General Hospital, said that symptomatic aortic stenosis is a life-or-death situation and that patients with the most advanced aortic stenosis on echocardiography, symptoms of severe disease, or underlying coronary artery or lung disease should be given priority for treatment.
Sundt also said that, although neither study addressed it, transcatheter AVR is preferable to the surgical version from the patient's point of view, owing to the briefer exposure to COVID-19 during a shorter hospital stay.
"This is true from the standpoint of the health care system as well, undoubtedly conserving intensive care unit and hospital beds relative to surgical AVR," he wrote. "Indeed, the same can be said of proceeding with appropriately expedited procedures even if a second wave of COVID-19 hits."