Pandemic AVR: Making Patients Wait May Do More Harm Than Good
Recent cardiac events suffered by patients with symptomatic severe aortic stenosis (AS) could be tied to whether their hospitals expedited aortic valve replacement (AVR) in select cases or paused these procedures in response to COVID-19, two reports suggested.
In the first, a Swiss hospital showed success selecting patients for expedited AVR despite safety concerns during the pandemic, whereas a New York City center that pushed these procedures back for everyone had a substantial number of patients subsequently die or require urgent transcatheter AVR (TAVR) while waiting, the second found.
Both reports were published online in JAMA Network Open.
“Taken together, these studies provide useful guidance. First, as we have known for many years, symptomatic AS is a life-threatening condition, and its treatment cannot be considered elective in any way. 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,” according to Thoralf Sundt, MD, of Massachusetts General Hospital and Harvard Medical School in Boston.
“Whether one chooses to interpret the current state of the pandemic as an ongoing first wave — perhaps with a nadir in some regions — or as the quiet before a second wave, there is a clear need for tools permitting precise triage of patients by the urgency with which procedures should be performed,” he emphasized in an accompanying editorial.
Selective AVR in Switzerland
Certain people with critical AS were good candidates for expedited AVR during a nationwide ban on elective procedures, according to the prospective AS DEFER study.
A cohort of 71 patients referred for AVR from March 20 to April 26, a period when Switzerland banned elective procedures in all hospitals, were divided into two treatment groups according to a prespecified algorithm:
- Expedited (n=25): Patients with critical AS (i.e., aortic valve area ≤0.6 cm2, transvalvular mean gradient ≥60 mm Hg, cardiac decompensation during the previous 3 months, or exercise intolerance with clinical symptoms on minimal exertion) who underwent TAVR at a mean 10 days after referral
- Deferred (n=46): Patients with a larger aortic valve area and stable symptoms
Adverse cardiac outcomes were not statistically more likely for either group at an average 31 days after treatment allocation: the composite endpoint of all-cause mortality, disabling and nondisabling stroke, and unplanned hospitalization for valve-related symptoms or worsening heart failure reached 4.0% of the expedited group versus 19.6% of those deferred (log rank P=0.08), reported Thomas Pilgrim, MD, MSc, of Inselspital, Bern University Hospital, and colleagues.
Hospitalizations were more likely in the deferred AVR arm than the expedited arm (19.6% vs 0.%, P=0.02) and accounted for all the primary outcome events in the former. No patient died.
Among deferred AVR patients, those who wound up requiring hospitalization for valve-related symptoms or worsening heart failure had more commonly presented with multivalvular disease (44.4% vs 8.6%, P=0.02), suggesting that this group in particular may benefit from expedited AVR, Pilgrim’s group said.
“I cannot tell if the authors considered this to be evidence of success or failure, but perhaps apart from adding patients with combined valve disease to the expedited list, it looks to me like success. Most events were hospitalizations, and the only stroke was in a patient who underwent transcatheter AVR,” Sundt commented.
The investigators noted that their treatment algorithm is similar to the triage recommendations in the American College of Cardiology and Society for Cardiovascular Angiography and Interventions consensus statement released in April.
Study participants averaged age 78, and fewer than half were women.
Of the deferred AVR group, seven people crossed over to expedited AVR after unplanned hospitalization.
“Study limitations include the low patient number owing to the short duration of the ban of elective procedures and the locally modest numbers of SARS-CoV-2 infections, which did not exceed available health care resources,” Pilgrim’s group said.
AVR Shutdown in New York
Cancelling TAVR procedures across the board resulted in bad outcomes for some people waiting for them to resume, one New York City center found.
A statewide ban on elective procedures was enacted on March 22 this year under an executive order by the New York State government.
Among 77 patients with severe AS who had been evaluated for TAVR at Mount Sinai Hospital before COVID-19, six underwent urgent TAVR and two died from March 23 to April 21. By June 6, when elective procedures were finally allowed to resume in the city, 24 had received urgent TAVR and three died.
“During the COVID-19 pandemic, vigilance is needed for patients with AS awaiting TAVR, because 10% of our patients experienced a cardiac event during the first month, and 35% did so over the course of the next 3 months,” reported Stamatios Lerakis, MD, PhD, of Icahn School of Medicine at Mount Sinai, and colleagues.
In contrast, no patient died of AS waiting for TAVR in the 3 months before March, they said.
Thus, deferring all patients pending accelerating symptoms of dyspnea, angina at rest, heart failure, or syncope “is clearly an undesirable approach,” Sundt commented.
People who suffered cardiac events tended to have lower ejection fractions and were more likely to have obstructive coronary artery disease, New York Heart Association class III and IV symptoms, or a history of cerebrovascular accident.
“[T]he heart team should consider these factors for earlier access to TAVR during the COVID-19 pandemic,” Lerakis’ group urged.
Of the 77 AS patients in the study (mean age 80; 64.0% men), 55 had been scheduled for TAVR. Over a quarter had diagnostic testing or heart team appointments canceled because of COVID-19.
“We must be judicious when deciding to intervene, because there are additional risks to consider for both the patient and the heart team. In addition, it is necessary to resume required interventions as we pass the initial peak of COVID-19 hospitalizations and health care resources become available,” study authors concluded.
They nevertheless acknowledged the limited sample of their single-center study.
Pilgrim disclosed support from, and/or relevant relationships with, Boston Scientific, Biotronik, and HighLife SAS.
Lerakis disclosed no relevant relationships with industry. Co-authors disclosed relevant relationships with Abbott, Medtronic, Boston Scientific, and W.L. Gore & Associates.
Sundt disclosed no relevant relationships with industry.