July 21, 2016
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New scoring system may help identify patients for TAVR

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Researchers reported that they developed a simple scoring system using novel predictors of outcome that effectively categorized early and late mortality risks in extreme- and high-risk patients and may assist in identifying candidates for transcatheter aortic valve replacement.

Michael Mack

Michael J. Mack

“What is unique about this risk prediction algorithm is that, in addition to the usual variables predictive of death, assessments of frailty and disability were also used,” Michael J. Mack, MD, and Elizabeth M. Holper, MD, MPH, both from the Heart Hospital Baylor Plano in Texas, wrote in a related editorial. “The decreasing 30-day and 1-year mortality rates in patients undergoing TAVR present an opportunity to focus on mitigating risk in the higher-risk groups and optimizing outcomes in the lower-risk groups.”

 James B. Hermiller, MD, from St. Vincent’s Heart Center of Indiana in Indianapolis, and colleagues analyzed data from 3,687 patients from the Medtronic CoreValue U.S. Pivotal Trial program, who were stratified into a derivation cohort (n = 2,482) and a validation cohort (n = 1,205).

The researchers considered data for predictors of all-cause death and used objective criteria such as The Society of Thoracic Surgeons predicted risk of mortality score and subjective criteria to gauge patients’ suitability for TAVR. Each patient was assigned a risk score.

Predictive variables

In the cohort, the overall mortality rate was 5.8% at 30 days and 22.8% at 1 year. Death at 30 days was predicted by home oxygen use (HR = 1.74; 95% CI, 1.16-2.61), assisted living (HR = 1.68; 95% CI, 1.05-2.69), albumin level less than 3.3 g/dL (HR = 1.6; 95% CI, 1.04-2.47) and age older than 85 years (HR = 1.46; 95% CI, 0.99-2.15). Predictors of mortality at 1 year included falls in the last 6 months (HR = 1.36; 95% CI, 1.03-1.81), an STS predicted risk of mortality score greater than 7% (HR = 1.36; 95% CI, 1.05-1.77) and severe ( 5) Charlson comorbidity score (HR = 1.27; 95% CI, 0.98-1.65), as well as home oxygen use (HR = 1.9; 95% CI, 1.47-2.44) and albumin levels less than 3.3 g/dL (HR = 1.4; 95% CI, 1.04-1.91).

Scoring system

From this cohort and variables, the researchers crafted a scoring system to assess mortality risk at 30 days and 1 year by stratifying patients into three categories: low risk, moderate risk and high risk. The system demonstrated a threefold difference in mortality risk at 30 days for the low-risk (3.6%) and high-risk (10.9%) groups, as well 1-year mortality for low risk (12.3%) and high risk (36.6%), Hermiller and colleagues wrote.

The 1-year mortality model showed more stability than the 30-day model (C statistic: 0.79 vs. 0.75). – by James Clark

Disclosure: Hermiller reports serving on the steering committee for the CoreValve trial, which was funded by Medtronic, and serving on the speakers bureau for Medtronic. Please see the full study for a list of the other researchers’ relevant financial disclosures. Mack reports serving as the principal investigator of a national trial sponsored by Abbott Vascular and serving as the uncompensated co-principal investigator of trials sponsored by Abbott Vascular and Edwards Lifesciences. Holper reports serving on the medical advisory board for Boston Scientific.