Development of transcatheter aortic valve implantation (TAVI): A heart-warming adventure

Abstract

The development of transcatheter aortic valve implantation (TAVI) spearheaded by our group has been a great adventure since we validated the concept in the early 1990s in aortic stenosis (AS) postmortem studies. We first tested prototypes in animal models before performing the daring first-in-man implantation in 2002. Prospective compassionate use series followed, accompanied by ongoing technological innovation of devices and of delivery systems. High surgical risk patients were enrolled in feasibility studies, which led to the Conformité Européenne (CE) mark being granted in 2007. Data from post-marketing registries involving thousands of patients have shown remarkable results and increasingly smaller complication rates, as a result of growing experience and improved technology. Survival and quality of life results from the landmark randomized PARTNER Edwards SAPIEN study have confirmed the important place of TAVI in non-operable and high surgical risk patients. To date, more than 50,000 patients have benefited from TAVI worldwide. TAVI is now recommended in the European Society of Cardiology (ESC), the European Association for Cardio-Thoracic Surgery (EACTS) guidelines, and by the Food and Drug Administration in the United States for the treatment of AS patients who are not suitable or at high risk for surgery, as assessed by a multidisciplinary heart team, and in whom a less invasive approach is favored. Multidisciplinary heart teams are critical in patient selection and in successful procedures. In future, TAVI may be extended to use in lower risk patients, although further clinical investigation is necessary. Just over 10years after the first-in-man case, TAVI has quickly become an established AS treatment option.