New Risk Score Predicts Mortality in Atrial Fibrillation Patients Undergoing Catheter-Based Aortic Valve Replacement | Mount Sinai

  • New York, NY
  • (August 28, 2022)

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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The Mount Sinai Health System is one of the largest academic medical systems in the New York metropolitan area, with more than 43,000 employees working in eight hospitals, more than 400 outpatient practices, nearly 300 laboratories, a nursing school and a leading medical and medical school. Higher Education. Mount Sinai advances health for everyone, everywhere, by addressing the most complex health challenges of our time – discovering and applying new knowledge and scientific knowledge; developing safer and more effective treatments; train the next generation of medical leaders and innovators; and supporting local communities by providing high quality care to all who need it.

Through the integration of its hospitals, laboratories and schools, Mount Sinai offers comprehensive healthcare solutions from birth to geriatrics, leveraging innovative approaches such as artificial intelligence and IT while keeping patients’ medical and emotional needs at the center of all treatments. The health system includes approximately 7,300 primary and specialty care physicians; 13 joint venture day surgery centers in the five boroughs of New York, Westchester, Long Island and Florida; and over 30 affiliated community health centers. We are regularly ranked by US News and World Report‘s Best Hospitals, receiving a high “Honor Roll” status, and are highly ranked: #1 in Geriatrics and top 20 in Cardiology/Cardiac Surgery, Diabetes/Endocrinology, Gastroenterology/Gastrointestinal Surgery, Neurology/Neurosurgery, orthopaedics, pulmonology/lung Surgery, rehabilitation and urology. New York Eye and Ear Infirmary of Mount Sinai is ranked #12 in ophthalmology. US News and World ReportMount Sinai Kravis Children’s Hospital’s “Best Hospitals for Children” ranking is one of the best in the country in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is one of three medical schools that has distinguished itself by several indicators: it is consistently ranked in the top 20 by US News and World Report“Best Medical Schools”, aligned with a US News and World Report “Honor Roll” Hospital, and among the top 20 in the nation for funding from the National Institutes of Health and among the top 5 in the nation for many areas of basic and clinical research. NewsweekThe “World’s Best Smart Hospitals” ranks Mount Sinai Hospital number one in New York and among the top five in the world, and Mount Sinai Morningside in the top 20 globally.

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