Newly unveiled results from Edwards Lifesciences (NYSE:EW) transcatheter aortic valve studies showed mixed results for its Sapien TAVI system when compared with surgical aortic valve replacement.
Transfemoral TAVI treatment was the standout in terms of cost-effectiveness and quality-of-life-years following treatment, but TAVI treatment via the transapical approach looked less favorable than open-heart aortic valve surgery.
The study was the 1st attempt to direct attempt to assess costs of TAVI procedures relative to surgery in patients who are at high risk but still candidates for surgery, researchers noted.
Considering TAVI as a whole, the less-invasive heart-valve repair procedure was similar to open surgery, but significant differences arose when separately considering transfemoral and transapical access for TAVI treatment.
Overall, patients in the TAVI group who were treated transfemorally had better outcomes than patients who received surgery, who in turn had better outcomes than TAVI patients who were treated transapically.
Similarly, the transfemoral TAVI patients represented a lower cumulative 1-year resource cost compared with surgical patients, but transapical TAVI patients were more costly to treat, according to study results.
At 12 months researchers recorded cumulative costs for surgical patients between about $98,000-$99,500. Transfemoral TAVI patients represented a cumulative 1-year cost of about $96,700 and transapical patients cost about $109,400.
"These differences in cost-effectiveness are explained by differences in both hospital resource use and short-term clinical outcomes of TAVR according to access site," according to the study.
Procedural costs for the TAVI procedures were significantly higher than for surgery, driven almost entirely by the cost of the Sapien device, researchers noted. In the transfemoral cohort, however, those costs were eventually offset by substantially shorter hospital stays.
The mixed outcomes left something to be desired, but the transfemoral outcomes were "remarkably positive for a relatively new technology in the early phase of clinical use," the authors wrote.
That could represent another boon for medical device company Edwards Lifesciences, which late last month saw some Wall Street love after releasing 3-year study results demonstrating sustained and increasing survival benefits for patients treated with its Sapien TAVI system.
Sapien, which in mid-October won expanded FDA approval to treat lower-risk patients, continues to be the only TAVI system approved for the U.S. market.
