Investigative team leader George Dangas, MD, PhD, Professor of Medicine (cardiology) and Director of Cardiovascular Innovation at The Zena and Michael A. Wiener Institute of Cardiology at the Icahn School of Medicine at Mount Sinai. “While previous research has primarily focused on procedural risks, this new risk assessment tool focuses on how to stratify patients after successful completion of TAVR when they are ready to discharge, to improve result.”
Before a patient undergoes TAVR – a minimally invasive procedure, an alternative to open heart surgery, for aortic valve replacement for patients with symptomatic aortic stenosis – doctors will evaluate assess their risk of death after the procedure. This helps them better explain the risks to their patients, guide decision-making before and after the procedure, and select the most appropriate therapies. However, there is no definite risk score for TAVR. Surgeons often rely on the Society of Throacic Surgeons (STS) risk score developed for open heart surgery, or another similar risk score for this procedure. This score has limitations for TAVR because it was obtained from a cohort of patients undergoing aortic valve replacement surgery.
Previous unsuccessful attempts to create a risk score for TAVR patients took place almost a decade ago when the procedure was new and catered to an older population. This test is based on a new dataset in an updated population; Risk scores apply to patients who have undergone recent TAVR in the past five years and who have AF.
Mount Sinai researchers led the international ENVISAGE-TAVI trial at 173 centers in 14 countries to compare the safety and effectiveness of different therapies in AF/TAVR patients requiring anticoagulation. oral route. They analyzed 1,426 patients starting 5 to 12 days after TAVR and followed them for up to a year to assess predictors of death. Of the 178 patients (12.5 percent) who died during that time period, most were over 64 years old; have kidney disease and/or heart failure; higher weight; have non-paroxysmal AF (common, persistent, and permanent AF lasting more than one week); drink more than three alcoholic beverages per day; and have a history of heavy bleeding or a tendency to bleed during the procedure.
The investigators assigned a level of risk to each of those predictors. After calculating the total risk, they classified the patients into three categories: low risk (range 0-10), moderate risk (range 11-15) and high risk (over 16). They validated the risk score and found that the mortality rate was more than double in the intermediate-risk group (10.1%) and three times higher in the high-risk group (17%) compared with low-risk group (4.8%).