A large-scale international study led by Mount Sinai has yielded the first risk score that can help predict mortality in patients with atrial fibrillation (AFib) who have undergone successful transcatheter aortic valve replacement (TAVR) and been discharged home .
The results of the study, known as the ENVISAGE-TAVI AF trial and the largest of its kind, could lead to better management of care and outcomes for this patient population. They were announced on Sunday August 28 as a last-minute clinical trial at the Congress of the European Society of Cardiology (ESC Congress 2022).
“Our study focuses only on high-risk TAVR patients with atrial fibrillation, which is a well-recognized surrogate for poor prognosis,” says lead researcher George Dangas, MD, PhD, professor of medicine (cardiology) and director of the Cardiovascular Innovation at The Zena and Michael A. Wiener Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai. “Although previous research has focused primarily on procedural risk, this new risk assessment tool focuses on how to stratify patients after successfully completing TAVR when they are ready to be discharged, in order to ‘improve results.’
Before patients undergo TAVR — a minimally invasive procedure, an alternative to open-heart surgery, to replace the aortic valve in patients with symptomatic aortic stenosis — doctors assess their mortality risk after the procedure. This helps them better explain the risks to the patient, guide decision-making before and after the procedure, and choose the most appropriate therapies. However, there is no definitive risk score for TAVI. Surgeons often rely on the Society of Throacic Surgeons (STS) risk score that was developed for open-heart surgery, or other similar risk scores for this procedure. This score has limitations for TAVR because it was derived from cohorts of patients undergoing surgical aortic valve replacement.
Previous unsuccessful attempts to create a risk score for TAVR patients occurred almost a decade ago when the procedure was new and aimed at an older patient population. This trial was based on a new data set in an updated population; the risk score applies to patients who have recently undergone TAVI within the last five years and who have AF.
Mount Sinai researchers conducted the international ENVISAGE-TAVI trial in 173 centers in 14 countries to compare the safety and efficacy of different therapies in patients with AF/TAVR requiring oral anticoagulation. They analyzed 1,426 patients starting 5 to 12 days after TAVI and followed them up to a year to assess predictors of mortality. Of the 178 patients (12.5%) who died within this time, most were over 64; had kidney disease and/or heart failure; higher weight; had non-paroxysmal AF (common, persistent and permanent AF lasting more than one week); consumed more than three glasses of alcohol per day; and had a history of major bleeding or predisposition to bleeding during the procedure.
Investigators assigned a risk level to each of these predictors. Once they calculated the total risk, they classified the patients into three categories: low risk (between 0 and 10), moderate risk (between 11 and 15) and high risk (greater than 16). They validated the risk score and found that the mortality rate was more than double in moderate-risk patients (10.1%) and triple in the high-risk group (17%) compared to the low-risk group. (4.8%).
“We will continue to perform targeted analyzes on patients at high risk of TAVR based on combinations of different/other clinical risks to improve our understanding of the risks to patients after TAVR so that we can then plan clinical investigations into the improved prognosis,” adds Dr. Dangas.
ENVISAGE-TAVI AF was sponsored by Daiichi Sankyo Inc. with scientific collaboration between scientists at Icahn Mount Sinai and Daiichi Sankyo’s Global Specialty Medical Affairs.
Figure 1: One-year mortality rate by risk rating category
Figure 2: Components of the derived risk score and corresponding weights
Analyzes were Yes versus No, unless otherwise specified.
AF, atrial fibrillation; CrCl, creatinine clearance; NYHA, New York Heart Association.
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