TAVR benefits less pronounced in psychological, general health measures

Transcatheter aortic valve replacement was associated with clinically meaningful improvements in physical function and disease-specific quality-of-life outcomes, but only modest improvements in psychological and general health measures, according to a recent review analysis.

The investigators reviewed 60 studies from Medline, Embase and the Cochrane Central Register of Controlled Trials from 2002 to Sept. 30, 2013, for findings on the functional and QOL benefits of TAVR. They suggested that these benefits remain undefined.

The final analysis included 11,205 patients from 56 pre-post comparison and four head-to-head comparison studies and two randomized controlled trials. Data were not pooled due to heterogeneity.

NYHA class, Short Form-12/36 Health Survey physical and mental component summary (points) and other measures of functional status underwent evaluation.

Patients were assessed for the mean change in primary outcome measures.

Results indicated clinically important decreases in NYHA class at 6 to 11 months (range, 0.8-2.1 classes) and 12 to 23 months (range, 0.8-2.1 classes).

At 12 months, an improvement of 4.9 to 26.9 points was reported in the physical component score of the Short Form-12/36 Health Survey. Also at that time point, the change in mental score ranged from 1 to 8.9 points.

The researchers reported consistent clinically important improvements in disease-specific outcomes. However, there was less consistency in improvement in general health measures, according to the results.

The study may be limited by a paucity of head-to-head trials and survivor bias, the researchers wrote.

“More comparative studies on functional status and quality of life are needed for informed treatment decision-making,” they concluded.

Disclosure: The researchers report receiving grants or personal fees from Abbott Vascular, Abiomed, Boston Scientific, Cook Cordis, Covidien, Health Resources and Services Administration, John A. Hartford Foundation, Medtronic and The Medical Foundation, a division of Health Resources in Action.