TAVR Improves Health-Related QoL in Majority of Extreme-Risk Patients
For patients at extreme surgical risk, transfemoral TAVR results in considerable improvements in disease-specific and general health status, according to data from the Extreme Risk Iliofemoral Study of the CoreValve US Pivotal Trial published in the February 2015 issue of JACC: Cardiovascular Interventions. However, a substantial minority of these patients have poor outcomes, primarily as a result of disability, frailty, and comorbid conditions.
For the prespecified QoL substudy, David J. Cohen, MD, MSc, of Saint Luke’s Mid America Heart Institute (Kansas City, MO), and colleagues looked at 436 patients (mean age 84 years; 49.1% male) who underwent transfemoral TAVR with the CoreValve device (Medtronic) at 41 sites between February 2011 and August 2012.
Patients classified as extreme risk had a 30-day risk of mortality or irreversible morbidity of ≥ 50%. Mean aortic valve gradient was 48 mm Hg, 92% of patients were NYHA functional class III-IV, and the prevalence of chronic medical conditions was high—30% of patients were on home oxygen and 16% were wheelchair bound.
Improvements From Baseline Seen in Most Patients
Health status was assessed at baseline and at 1, 6, and 12 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short Form-12 (SF-12), and the EuroQol-5D (EQ-5D). Substantial improvements were seen across a variety of categories, including physical, social, and mental limitations, as were gains in QoL.
For example, the KCCQ increased from baseline an average of 23.9 points at 1 month, 27.4 points at 6 months, and 27.4 points at 12 months (P < .001 for all). Overall, 58.0% of patients had large KCCQ improvements (≥ 20-point increase from baseline) at 1 month and 59.1% at 12 months. Additionally, the SF-12 physical and mental summary scores showed improvements of approximately 5 points from baseline to 6 and 12 months, while EQ-5D utility values also increased substantially at each time point (P < .003 for all comparisons).
At 1 and 12 months post-TAVR, 52% and 41% of patients, respectively, were considered to have had an excellent outcome (defined as being alive with a large improvement in KCCQ).
Patients who met Valve Academic Research Consortium criteria for procedural success had greater improvements in health status (mainly at 1 month) and were more likely to experience favorable or excellent outcomes at each time point than those who did not.
Disability, Comorbidities Linked to Poorer Outcomes
However, 39% of patients had a poor outcome at 6 months (22% died, 16% reported very poor QoL, and 1.4% reported a decline in QoL). Factors associated with poor outcome included wheelchair dependency, prior CABG, oxygen dependency, low serum albumin, high predicted surgical mortality according to Society of Thoracic Surgeons (STS) score, and lower mean aortic valve gradient (table 1).
Dr. Cohen and colleagues note that while some of these predictors have been known, the identification of low albumin and prior CABG is a novel finding.
“Further work is needed to establish a model that can be applied across all TAVR patients, regardless of valve type and surgical risk, such that patients at high risk for poor outcomes may be identified prospectively,” they write. “In the future, this information could be invaluable to help both patients and physicians decide whether or not to undergo TAVR and also to set realistic expectations for recovery.”
They suggest that a combination of preprocedural clinical, frailty, disability, and physiological factors “may provide further insight into identifying patients who are at high risk for poor outcomes.”
Importantly, Dr. Cohen and colleagues observe, the 5-point increase in the SF-12 seen in the study “represents twice the minimum clinically important difference for an individual patient and is roughly comparable to reversing 10 years of normal decline in health in the general population.”
Osnabrugge RL, Arnold SV, Reynolds MR, et al. Health status after transcatheter aortic valve replacement in patients at extreme surgical risk: results from the CoreValve U.S. trial. J Am Coll Cardiol Intv. 2015;8:315-323.
- The CoreValve Extreme Risk Study was sponsored by Medtronic.
- Dr. Cohen reports receiving grant support and consulting fees from multiple pharmaceutical companies.