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Transcatheter aortic valve implantation (TAVI) improved survival and physical function compared with medical management in elderly patients with aortic stenosis, but its impact on psychological well-being seemed to be modest, according to a data review.
An analysis of findings from 62 studies in patients with a mean age of 73 to 93 revealed a clinically relevant decrease in New York Heart Association (NYHA) class 6 to 11 months after the procedure and at 12 to 23 months, wrote , and colleagues in the
Action Points
- In a systematic review, TAVI provided clinically important benefits in physical function and disease-specific measures of quality of life.
- However, there were only modest benefits in psychological and general health measures.
The data also showed improvement in the physical component summary score over 12 months, which was deemed modest yet clinically important. However, change in the mental component summary score was smaller over the same period of time (range 1.0 to 8.9 points), the authors stated.
The results indicate a need for more research on the procedure's impact on functional status and quality of life (QOL) to better inform treatment decision-making, they said.
"On average, we can now say that patients with symptomatic aortic stenosis benefit from [TAVI] compared with conservative treatment," Kim told 番茄社区. "But the benefits vary quite a bit from patient to patient, and some subgroups don't benefit much at all. We need a better understanding of who will benefit from this treatment and who will not."
TAVI is a minimally invasive alternative to surgical aortic valve replacement that was first used in Europe in 2002.
It was approved by the for the treatment of aortic stenosis in patients who are not candidates for surgical valve replacement. In 2012, the FDA expanded the indication to include patients who are candidates for open-heart surgery, but are considered high risk.
Approval was based largely on results from the PARTNER trial, which demonstrated improved QOL similar to surgical valve replacement and improvements over standard treatment in inoperable patients.
Since its approval, TAVI has emerged as a widely used alternative to surgical valve replacement or conservative treatment in very sick or elderly patients with symptomatic aortic stenosis.
The PARTNER trial showed a clear improvement in mortality at 1 and 2 years, but the impact of TAVI on quality of life and functional status in elderly patients has not been well explored, Kim said.
"For patients in their 80s and 90s, survival may not be the most important endpoint if they are suffering from heart failure symptoms and have minimal activity," he explained. "The questions we need to answer for patients are 'How will I feel after surgery?' and 'How will I function in my daily life?' These questions have not really been answered."
Their systematic review included 60 observational studies and two cohorts from the PARTNER trial for a total of 11,205 patients. Studies were conducted from 2002 to 2012.
Studies assessed QOL and functional improvement using either the NYHA functional heart failure 4-class score, the short form physical component summary (PCS) and mental component summary (MCS) scores, or various other measures of function and QOL including the .
Patients who received conservative treatment had little improvement in their PCS and MCS scores. Clinically important improvements were seen in other disease-specific measures, but the improvements in general health measures were less consistent, the group reported.
Study limitations included the paucity of head-to-head trials and the possibility that survivor bias may have overestimated TAVI benefits.
Kim said it is also possible that the NYHA score, which was used in many of the studies, overestimated the functional and QOL benefits of TAVI in this patient population.
He added that future research should focus on identifying patients who will benefit most from TAVI and on comparing the long-term risks and benefits of TAVI and surgical valve replacement.
"Open surgery has been performed for many years, while [TAVI] has been available in the U.S. for only a few years," he said. "There is a lot of interest in this procedure, but there are also still questions that need to be answered about its long-term benefits compared to traditional surgery."
From the American Heart Association:
Disclosures
The study was funded by the Health Resources and Services Administration (HRSA) and Health Resources in Action.
One author disclosed relationships with HRSA and John A. Hartford Foundation. Co-authors disclosed relationships with Medtronic, Boston Scientific, Cordis, Covidien, Abiomed, Cook, Abbott Vascular, The Medical Foundation, and the NIH.
Primary Source
Annals of Internal Medicine
Kim CA, et al "Functional status and quality of life after transcatheter aortic valve replacement" Ann Intern Med 2014; 160(4): 243-254.