Delay associated with worse outcomes, but careful triage can reduce risk

Among patients with severe symptomatic aortic stenosis, delays in performing transcatheter aortic valve replacement (TAVR) early in the Covid-19 pandemic were associated with cardiac events and worse outcomes.

Researchers from Mount Sinai Hospital in New York City reported on 77 cases involving patients with severe aortic stenosis evaluated for TAVR at the institution immediately before the Covid-19 outbreak in the city, including 55 (71.4%) scheduled for TAVR who had their procedures deferred due to Covid-19 and 22 who had their diagnostic testing or appointments cancelled.

On March 22, New York State officials issued an executive order leading to the cancellation of elective procedures. During the following month, 10% of the evaluated patients experienced a cardiac event. Six of the patients required urgent aortic valve replacements, and 2 died due to cardiac causes.

Compared to patients who did not experience cardiac events within the month following the order, those who did had significantly lower left ventricular ejection fraction (mean [SD}, 45% [16%] vs. 56% [14%] (difference, 11%; 95% CI, 0.3%-21%; P=0.04), along with a higher incidence of obstructive coronary disease and New York Heart Association class III and class IV symptoms.

The study is one of two research letters published online Sept. 30 in JAMA Network Open, examining aortic valve replacement triage in the time of Covid-19.

“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,” wrote Mount Sinai researcher Richard Ro, MD, and colleagues.

In the second analysis, researchers in Switzerland evaluated selection criteria similar to those published in a position statement by the American College of Cardiology and Society for Cardiovascular Angiography & Interventions (ACC/SCAI) to identify candidates for expedited aortic valve replacement during Covid-19 outbreaks.

Between March 20 and April 26, a total of 71 patients with symptomatic severe aortic stenosis were prospectively enrolled in the study, with 25 (35.2%) allocated to expedited aortic valve replacement and 46 (64.8%) allocated to the deferred valve replacement group.

“Patients with critical aortic stenosis defined by an aortic valve area of 0.6 cm2 or less, a trans valvular mean gradient of at least 60 mmHg, cardiac decompensation during the previous 3 months, or exercise intolerance with clinical symptoms on minimal exertion were allocated to expedited aortic valve replacement group,” wrote researcher Christoph Ryffel, MD, and researchers from Bern University Hospital, Bern, Switzerland.

Patients with an aortic valve area of 1.0 cm2 or less and greater than 0.6 cm2 and stable symptoms were allocated to deferred aortic valve replacement.

The primary study endpoint was a composite of all-cause mortality, disabling and non-disabling stroke, and unplanned hospitalization for valve-related symptoms or worsening heart failure by intention to treat.

During the study period between mid-March and late-April, all patients allocated to expedited valve replacement underwent TAVR within 10 days of referral, compared to none of the patients in the delayed group.

Among the main findings:

  • Hospitalizations for valve related symptoms or worsening heart failure were more common in patients allocated to deferred aortic valve replacement (AVR) compared with expedited ARV (19.6%vs 0%, P=0.02).
  • Patients in the deferred AVR group who required hospitalization for valve-related symptoms or worsening heart failure more commonly had multivalvular disease (44.4%vs 8.6%, P=0.02).
  • Seven patients (15.2%) hospitalized for valve-related symptoms or worsening heart failure crossed over to expedited transcatheter AVR (n = 4) or surgical AVR (n = 3) within a mean (SD) of 17 (11) days after interdisciplinary allocation of the treatment strategy.
  • One patient allocated to expedited transcatheter AVR experienced a periprocedural nondisabling stroke and none of the patients died.

Compared to patients with no event, patients who experienced a primary outcome–relevant event had a similar delay between confirmation of diagnosis and referral for AVR (mean [SD] delay, 27 [34] days vs 20 [33] days, P=0.58) and comparable rates of New York Heart Association functional class of 3 or more (indicating marked symptoms during daily activity) at baseline (60% vs 41%, P=0.31).

In an accompanying editorial, Massachusetts General Hospital chief of cardiac surgery Thoralf M. Sundt, MD, noted that even though 1 in 5 deferred patients in the study by Ryffel and colleagues reached the composite endpoint, the triage strategy appears to have merit.

“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,” Sundt wrote.

“Most events were hospitalizations, and the only stroke was in a patient who underwent transcatheter AVR. There were no deaths, which highlights the difficulty of composite endpoints that include occurrences with such widely disparate implications as hospitalization and death.”

Sundt noted that together the 2 studies “provide useful guidance,” and he added that while the question was not addressed in the studies “it certainly makes sense that, all things being equal, from the patient’s standpoint transcatheter AVR is preferable to surgical AVR, given shorter hospitalization and consequent exposure of patients to Covid-19 in hospital and rehabilitation centers.”

“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. Indeed, the same can be said of proceeding with appropriately expedited procedures even if a second wave of Covid-19 hits,” he wrote.

  1. Two new studies provide useful guidance for expediting or delaying aortic valve replacement during Covid-19 outbreaks.
  2. Advanced aortic stenosis, advanced symptoms or comorbid coronary and lung diseases are indications for immediate treatment.

Salynn Boyles, Contributing Writer, BreakingMED™

Sahil Khera reported being a consultant for Abbott, Medtronic, and Boston Scientific, and receiving speakers’ honoraria from Medtronic.

Gilbert Tang reported being a physician proctor for Medtronic and a consultant for Medtronic, Abbott Structural Heart, andW. L. Gore & Associates.

Stortecky reported receiving research grants to the institution from Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific and speaker fees from Boston Scientific.

Windecker reported receiving research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CSL Behring, Daiichi Sankyo, Edwards Lifesciences.

Sundt reported no relevant conflicts of interest.


Cat ID: 306

Topic ID: 74,306,306,914,190,926,192,927,151,928,925,934