Background: Standard therapy for severe aortic stenosis (AS) is the surgical aortic valve replacement using a heart-lung machine. Since AS mostly occurs in older and co-morbid patients, who are at high risk for surgical complications, about one-third of older patients are classified as inoperable. At the moment, percutaneous aortic valve replacement (or TAVI / Transcatheter Aortic Valve Implantation) is probably the most rapidly spreading technology in cardiology.

Research question: Is percutaneous aortic valve replacement without open surgery for the treatment of patients with severe aortic stenosis compared to conservative therapy effective and safe?

Methods: A systematic literature search was performed in common medical and HTA databases. The search was restricted to the period 2007-2010 as well as to literature published in English or German. The study results were synthesised according to the GRADE methodology.

Results: The first RCT, which comprised 358 patients treated with TAVI, was published at the end of 2010. Only 12% of all patients screened were deemed inoperable and thus qualified for TAVI. This can be considered as key indicator for the importance of the selection of comorbid and elderly patients. The demonstrated benefit comes along with serious side effects (stroke 10%, severe complications 17%). During the last years, clinical data were collected from more than 6,000 patients – often published in cumulative publications. Within these observational studies a considerable incidence of medium- to high-grade aortic insufficiency (after treatment) was reported, sometimes in even up to 20%.

Conclusion: The available evidence suggests that TAVI is more effective and safer than standard therapy (medicinal therapy) only under certain conditions, but new studies and independent registries will probably have an important influence on the estimated effect. Due to its rapid dissemination, the controlled introduction of TAVI accompanied by mandatory documentation as well as a re-evaluation of this intervention is thus proposed.