How Transcatheter Aortic Valve Implantation (TAVI) Was Born: The Struggle for a New Invention

Abstract

This story is about the invention of transcatheter aortic valve implantation (TAVI), and the people who transformed it from a concept and primitive device to a breakthrough lifesaving treatment for hundreds of thousands of patients with aortic valve stenosis. It is an inspirational example of a new disruptive technology that began with an idea most dismissed. The story describes the ups and downs from idea, design, construction, animal testing, proof-of-concept, scientific publication hurdles, a patent, license agreement, cooperation with several companies, fighting in patent courts in Europe and USA and finally how multinational companies financially bypassed the inventor. It is also a story about the struggles and battles the inventor experienced when injected into a world of lawyers and patent fights. I hope my personal story and journey can provide an inspiration and word of caution for new inventors.

The Technological Basis of a Balloon-Expandable TAVR System: Non-occlusive Deployment, Anchorage in the Absence of Calcification and Polymer Leaflets

“…Being the most common heart valve pathology in the Western World, it provided the patient numbers needed for non-inferiority studies in comparison with an established low-mortality procedure such as surgical aortic valve replacement (SAVR). Since in high-income countries (HIC) where TAVR was pioneered ( 1 , 5 ), pure aortic regurgitation (AR) occurs less frequently than AS ( 4 , 6 , 7 ) pure AR did not have enough traction to influence developments. This is still reflected in contemporary TAVR designs whose simple mesh structures are sufficient to anchor the stents in the rigid calcific deposits of AS.…”

“…During several decades of development, transcatheter aortic valve replacement almost exclusively focused on the treatment of calcific aortic stenosis (AS) (1)(2)(3)(4). Being the most common heart valve pathology in the Western World, it provided the patient numbers needed for non-inferiority studies in comparison with an established low-mortality procedure such as surgical aortic valve replacement (SAVR).…”

Novel predictors of permanent pacemaker implantation following transcatheter aortic valve replacement

“…Transcatheter aortic valve replacement (TAVR) has emerged as a less invasive therapeutic option with proven survival benefits for the management of these patients regardless of their surgical risks after evaluation by a multidisciplinary heart valve team[ 2 , 3 ]. Since the TAVR idea was conceptualized in 1989 and the first-in-human procedure successfully performed thirteen years later by Alain Cribier in France, TAVR procedure has caused a therapeutic paradigm shift, is a safer, non-inferior alternative to surgical aortic valve replacement which is contraindicated in about a third of patients due to prohibitive surgical risks[ 4 - 8 ].…”

Evolving Devices and Material in Transcatheter Aortic Valve Replacement: What to Use and for Whom

“…Nonetheless, considering the frailty and the relevant burden of comorbidities of many elderly patients with symptomatic AS, a considerable portion of this population was left untreated, due to high or prohibitive surgical risk. Transcatheter aortic valve replacement (TAVR) was originally conceptualized in the early 1990s [ 4 ], largely inspired by the pioneering experiences in the field of percutaneous transluminal coronary angioplasty. Following different studies in animal models [ 5 ], the first TAVR procedure was performed in 2002 for the treatment of AS in a patient with several comorbidities and cardiogenic shock.…”