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The CoreValve United States Clinical Investigators have developed a simple scoring system that effectively stratified early and late mortality rates in extreme- and high-risk patients undergoing transcatheter aortic valve replacement (TAVR).
James B. Hermiller Jr, MD, of St. Vincent’s Heart Center of Indiana in Indianapolis, and colleagues sought to develop a system that incorporated both standard and novel predictor variables. Their findings were published in the Journal the American College of Cardiology.
The authors noted that conventional risk scores do not take into account factors such as the presence of liver disease, use of home oxygen, frailty, and functional disabilities that may exclude a patient from surgery. “No earlier studies integrated both conventional and novel risk factors to determine outcomes after self-expanding TAVR,” they wrote.
Dr Hermiller and colleagues used the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score and other criteria to assess patients’ eligibility for TAVR. A total of 3687 patients (mean age: 83.3 ± 7.8; 46.3% women) were included in the analysis. Patients were randomly divided into either a derivation or validation cohort.
At 30 days, the overall mortality rate was 5.8%, which was predicted by home oxygen use (hazard ratio [HR]: 1.74; 95% confidence interval [CI]: 1.16-2.61; P=.007), assisted living (HR: 1.68; 95% CI: 1.05-2.69; P=.03) albumin levels <3.3 g/dL (HR: 1.60; 95% CI: 1.04-2.47; P=.03), and age >85 years (HR: 1.46; 95% CI: 0.99-2.15; P=.05).
At 1 year, the mortality rate was 22.8%, which was predicted by home oxygen use (HR: 1.90; 95% CI: 1.47-2.44; P<.001), albumin levels <3.3 g/dL (HR: 1.40; 95% CI: 1.04-1.91; P=.03), any falls in the previous 6 months (HR: 1.36; 95% CI: 1.03-1.81; P=.03), STS PROM score >7% (HR: 1.36; 95% CI: 1.05-1.77; P=.02), and a severe (≥5) Charlson comorbidity score (HR: 1.27; 95% CI: 0.98-1.65; P=.07).
Based on these multivariable predictors, researchers created a simple scoring system that effectively stratified risk at 30 days and 1 year into low-risk, moderate-risk, and high-risk categories. The score demonstrated a 3-fold difference in mortality rates for low-risk and high-risk patients at 30 days (3.6% and 10.9%, respectively) and at 1 year (12.3% and 36.6%, respectively). They noted the 1-year mortality model was more stable compared with the 30-day model (C-statistics: 0.79 vs 0.75).
Based on this analysis, patients who are >85 years of age, receive home oxygen, and are unable to care for themselves are at high risk for early death following TAVR.
“Prospective studies should incorporate additional measures of frailty and disability as predictors of outcomes including both survival and quality of life following TAVR,” the authors concluded.
Disclosures: This study was funded by Medtronic (Minneapolis, Minnesota). Dr Hermiller serves on the steering committee for the report trial and the Speakers Bureau for Medtronic. Other authors also reported financial support from pharmaceutical and device companies.
Reference
Hermiller JB, Yakubov SJ, Reardon MJ, et al; for the CoreValve United States Clinical Investigators. Predicting early and late mortality after transcatheter aortic valve replacement. J Am Coll Cardiol. 2016;68(4):343-352. doi: 10.1016/j.jacc.2016.04.057.
