SAN FRANCISCO—Patients in the CoreValve Extreme Risk trial experienced a magnitude of improvement in quality of life similar to PARTNER B, David Cohen, MD, said Oct. 29 at the Transcatheter Cardiovascular Therapeutics (TCT) conference. For some, the procedure “reset the clock by 10 years.”
Results presented earlier at TCT showed that patients with severe aortic stenosis who underwent transcatheter aortic valve replacement (TAVR) with a CoreValve (Medtronic) device had an all-cause mortality or stroke rate of 25.5 percent; a one-month major stroke rate of 2.4 percent and a one-year stroke rate of 4.1 percent; and a significant increase in clinical functionality.
Surgeons had determined these patients were at extreme risk of death or morbidities if they were treated by open heart surgery. The PARTNER B trial studied similarly high-risk patients who underwent TAVR with the Sapien valve (Edwards Lifesciences).
From the patient’s perspective, quality of life may surpass clinical measures of success in a procedure such as TAVR. “We know that for this population who are very high-risk and have extreme risk of complications, improvements in quality probably are more important and more what they are looking for than survival,” he explained.
Cohen, director of Cardiovascular Research at Saint Luke's Mid America Heart Institute in Kansas City, Mo., and a PARTNER researcher, applied the same quality-of-life instruments used in the PARTNER trials to the CoreValve population: the Kansas City Cardiomyopathy Questionnaire; the Short Form-12 survey; and the EuroQoL. These were given at baseline, one, six and 12 months after the procedure.
At baseline, the quality-of-life score was on average 37. Among survivors, the score improved by approximately 24 points at one month and 27 points at six months, with a sustained benefit of 27 points at 12-month follow-up. “The minimum clinically important difference is five, so this a very large change on average across the population,” he said.
Measures such as symptoms, physical limitations, social limitations and others followed a similar pattern, with an early benefit after TAVR that held through follow-up. “This was similar to resetting the clock by about 10 years for these very elderly and debilitated patients,” Cohen said.
About 60 percent of surviving patients improved by at least 20 points compared with baseline. But when looking at what is defined as an excellent outcome—they survived and improved by at least 20 points—the results were “more sobering" with between 40 percent and 50 percent of patients then qualifying.
The CoreValve analysis compared patients to baseline. A side-by-side comparison of that analysis with published PARTNER B data showed the results were similar. Cohen emphasized that the comparison was provided only as a reference, was not statistically valid but served as a benchmark.
Predictors of a poor outcome (death within six months of the procedure or they had scores indicating they were New York Heart Association class IV) included being wheelchair bound before TAVR, low albumin, being on oxygen, prior bypass surgery and physiological factors.
“This reinforces the need of identifying patients who will do well and who will not,” Cohen said.