Transcatheter aortic valve implantation (TAVI) for treatment of aortic valve stenosis: an evidence-based Analysis (part B).

BACKGROUND Transcatheter aortic valve implantation (TAVI) has become an alternative to surgical aortic valve replacement (sAVR) for patients at high risk for surgery. OBJECTIVE To evaluate the safety, effectiveness, and cost-effectiveness of TAVI for treatment of aortic valve stenosis in symptomatic older adults. REVIEW METHODS A literature search was performed on September 6, 2011, for studies published from January 1, 2007, to September 6, 2011. A combined decision tree and Markov model was developed to compare costs, life years, and quality-adjusted life-years (QALYs) of all treatment options in their respective patient populations over a 20-year time horizon. RESULTS Two studies from the PARTNER trial were identified. The first study compared TAVI to sAVR in patients who were candidates for sAVR. The second study compared TAVI to standard treatment in patients who were not eligible for sAVR. The first study showed that TAVI and sAVR had similar mortality rates at 1 year. The second study showed a significant improvement in patient survival in those undergoing TAVI. However, in both studies, the TAVI group had significantly higher rates of stroke/transient ischemic attack, and major vascular complications. Rates of major bleeding were significantly higher in sAVR group in the first study and significantly higher in TAVI group in the second study. The base-case cost-effectiveness of TAVI was $48,912 per QALY, but the incremental cost-effectiveness ratio ranged from $36,000 to $291,000 per QALY depending on the assumptions made in the longer-term prediction portion of the model (i.e., beyond the follow-up period of the PARTNER trial). CONCLUSIONS TAVI improves survival in patients who cannot undergo surgery. For those who are candidates for surgery, TAVI has a mortality rate similar to sAVR, but it is associated with significant adverse effects. TAVI may be cost-effective for patients who cannot undergo surgery, but is not cost-effective for patients who can.