Are the standard criteria for TAVI too lax or too strict?
- University Hospitals of Leicester, Leicester, UK
- Correspondence to Dr Jan Kovac, University Hospitals of Leicester, Groby Road, Leicester LE3 9QP, UK; jankovac2{at}hotmail.com
- Published Online First 23 September 2009
Aortic stenosis is the commonest valvular disease in adults in the Western world and, when severe and symptomatic, carries a poor prognosis. Among the elderly, however, up to 30–40% of cases are considered too high risk or inappropriate for conventional open heart surgery and hence remain unreferred and untreated.1 2 Transcatheter aortic valve implantation (TAVI—term coined at the joint ESC/EACTS consensus meeting in 2008 as best describing the procedure which involves valve implantation rather than replacement), offers considerable promise in treating these high-risk patients.3
TAVI has become a rapidly evolving technique with potential to create a paradigm shift similar to the introduction of percutaneous transluminal coronary angioplasty (PTCA) in the early 1980s. Two devices are currently available and marketed in Europe and around the world: the Edwards Sapien balloon expandable bioprosthesis (Edwards Lifesciences, Irvine, CA, USA) and the Medtronic-CoreValve self-expanding bioprosthesis (Medtronic Inc, Minneapolis, MN, USA).
Following initial data from pivotal safety trials4 5 both devices were CE marked in 2007. The number of prostheses implanted is growing rapidly in Europe, with around 8000 devices implanted by the end of June 2009. Published information from single-centre experiences, safety trials and published registries suggests that the 30-day mortality with this procedure is around 10%, with one year survival around 70% with late mortality almost exclusively related to comorbidity of these patients.6 7
While evidence for the position of these devices in relation to conventional surgery and conservative management is being sought via ongoing (US Partner) or …
