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TAVR improves QOL in patients at extreme surgical risk
Transcatheter aortic valve replacement yielded substantial improvements in disease-specific and health-related quality of life among patients with severe aortic stenosis at extreme surgical risk, according to new data from the CoreValve U.S. Extreme Risk Pivotal Trial.
The new analysis characterized health status outcomes after TAVR with a self-expanding prosthesis (CoreValve, Medtronic). Researchers assessed the health status of patients at baseline and at 1, 6 and 12 months after the procedure using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short Form-12 and the EuroQol-5D surveys. Death, KCCQ overall summary score less than 45 or decline in KCCQ overall summary score of 10 points at 6 months indicated poor outcome after TAVR.
The transfemoral approach was used in 471 patients. Of those, 93% completed the baseline health status survey, the results of which indicated considerable impairment in all health status measures at baseline.
The KCCQ overall summary scores increased by 23.9 points at 1 month, 27.4 points at 6 months and 27.4 points at 12 months (P < .001 for all comparisons). Individual KCCQ subscales that measured total symptoms, physical limitations, social limitations and quality of life showed similar results.
Short Form-12 physical and mental scores improved by approximately 5 points from baseline to follow-up at 6 and 12 months (P < .001 for all comparisons). “This increment 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,” the researchers wrote.
Substantial increases in EuroQOL-5D utilities from baseline to follow-up at 6 and 12 months were also reported (P < .003).
The proportion of patients with large KCCQ overall summary score improvement was 58% at 1 month and 59% at 12 months. The proportion of patients with an excellent outcome, defined as survival with a large improvement in KCCQ overall summary score, was 52% at 1 month and 41% at 12 months.
In contrast, the proportion of patients with a poor outcome was 39% at 6 months; 22% had died and 16% had very poor quality of life. Preprocedural factors independently associated with poor outcome included wheelchair dependency, lower aortic valve gradient, previous CABG, need for home oxygen and Society of Thoracic Surgeons mortality risk greater than 15%. These factors may provide future insight into the identification of patients at high risk for poor outcome, according to the researchers.
“Previous studies have also reported substantial improvements in health status after surgical aortic valve replacement and TAVR. However, most of these studies have only examined changes in general health status. … The current study thus confirms that the health status benefits of TAVR are not restricted solely to balloon-expandable transcatheter valves, but also apply to the CoreValve self-expanding transcatheter valve,” the researchers wrote. – by Rob Volansky
Disclosure: The study was funded by Medtronic. Several researchers report associations with Edwards Lifesciences and Medtronic.