World VIEw
Invention and uptake of TAVI over
the first 20 years
Alain Cribier
Transcatheter aortic valve implantation (TAVI) is a breakthrough technology to replace the aortic
valve in patients with severe aortic stenosis using simple cardiac catheterization instead of
thoracic surgery. Initiated 20 years ago by my colleagues and me, TAVI has been performed
in >1.5 million patients globally and has profoundly altered the landscape of cardiovascular
medicine.
One could wonder what the world of interventional a stent with a valve inside could maintain the initial posi
cardiology would be like today if that first transcatheter tive results of balloon expansion. The diseased, calcified
aortic valve implantation (TAVI) had failed. The current native valve should not be removed, but instead used as
dynamism of the field of valvular and structural heart an anchor. We could validate the concept of aortic valve
disease can be traced to the excitement of that first stenting with autopsy studies and determine the correct
successful TAVI on 16 April 2002. dimensions of the stented valve, ensuring that no dam-
Credit: Hélène Eltchaninoff
The challenges that we faced in the mid-1980s were age would occur to surrounding structures such as the
enormous. As we know, the survival of patients with coronary arteries or mitral valve.
degenerative aortic stenosis is severely impaired if the But translating the idea into reality required a com-
disease is left untreated after the onset of symptoms: bination of rigorous scientific research, skilled engineer-
death occurs in 80% of patients within 3 years. For dec- ing and the finances to advance the project. We needed
ades, the only therapeutic option was open-heart sur- a prototype but could not convince any biomedical
gery for aortic valve replacement (SAVR), which was manufacturers to develop one. However, near the end
often declined by the surgeons at that time, especially in of the 1990s, together with two engineers, Stan Rowe
patients aged >70 years. At least 50% of patients were left and Stan Rabinovich, and a great cardiologist, Martin
untreated and died. This high mortality was the unmet Leon, we founded a start-up company: Percutaneous
clinical need that we faced. Valve Technology. With the help of an Israeli company,
In September 1985, I decided to adapt balloon aortic Aran R&D, we produced a prototype of a percutaneous
valvuloplasty, an existing technology from the field stented valve, extensively tested in the laboratory and,
of congenital valve disease1, to treat a highly sympto- in collaboration with Hélène Eltchaninoff, in a sheep
matic, female patient aged 72 years with severe aortic model. We performed extensive studies to evaluate and
stenosis, who had repeatedly been declined for SAVR. prove the feasibility of the prototype valve3.
I performed the first human balloon aortic valvuloplasty In April 2002, the first human implantation was
to dilate her stenotic valve, using a balloon catheter performed as an option of last resort in a male patient
advanced from the femoral artery. The patient showed aged 57 years who was dying from cardiogenic shock.
immediate improvement, with symptom relief and a We had to use an unplanned, transseptal approach to
return to normal life. We subsequently reported in The implant the valve in the absence of patent femoral arter-
Lancet2 an initial series of patients with severe aortic ies. The publication of this case study in Circulation4
stenosis treated by balloon aortic valvuloplasty, and the had an explosive effect on the medical community.
technique quickly spread around the world. However, Thereafter, in Rouen, France, we conducted the first
the initial enthusiasm was soon met by profound prospective study of TAVI, limited to compassionate
disappointment, because balloon aortic valvuloplasty cases using the transseptal approach. The initial series
did not provide long-lasting results, owing to early valve of 36 patients showed an 80% procedural success rate5.
Department of Cardiology, restenosis. Several patients survived for several years with no device
Charles Nicolle Hospital, After this setback, we faced virulent criticism that failure and a dramatic improvement in quality of life.
University of Rouen,
Rouen, France.
could be matched only by our continued wish to find A woman aged 83 years who had undergone TAVI in
a safe way to prevent valve restenosis, which led to the the worst possible clinical condition recovered and was
e-mail: alain.cribier@
chu-rouen.fr idea of a dedicated stented valve. We had observed that able to travel to the USA 1 year later to speak about the
https://doi.org/10.1038/ the circular shape of the balloon could expand the dis- procedure. This success contributed enormously to
s41569-022-00721-w eased aortic valve, despite calcification. We believed that the acceptance of TAVI in Europe and North America.
Nature Reviews | Cardiology volume 19 | July 2022 | 427
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World View
By 2004, the start-up was acquired by Edwards devices, leading to growing accessibility and availability
Lifesciences, leading to further development of both in developing countries.
devices and techniques. Various iterations of the initial The evolution of TAVI over the past 20 years has been
Cribier–Edwards valve were produced (the Edwards nothing less than a revolution in the practice of cardi-
SAPIEN valve). New delivery systems allowed easier ology. TAVI remains a disruptive technology that influ-
device implantation — not only retrograde via the fem- ences the way in which we practise medicine. TAVI has
oral artery6, but also anterograde, using a less invasive galvanized interest in structural heart disease, spurring
surgical transapical approach7, which persuaded cardiac on a vital and creative dialogue that has led to promis-
surgeons who until then had viewed TAVI with major ing percutaneous transcatheter treatments for the mitral
scepticism. A healthy competition began with the launch and tricuspid valves, essential developments in cardiac
of the self-expanding CoreValve (later the Medtronic imaging and changes in the way in which specialists
CoreValve), leading to quicker growth and acceptance work together in the heart team. TAVI has inspired a
of the TAVI procedure8. Soon, in 2007, both devices new generation of specialists and shown how an experi-
received European Certification. enced group of individuals can respond to a challenge,
TAVI is the perfect example of a successful transla- encourage device and clinical innovation, and improve
tional research pathway and has been the subject of a vast the lives of all our patients.
series of scientific evaluations, national and international 1. Lababidi, Z., Wu, J. R. & Walls, J. T. Percutaneous balloon aortic
registries, and randomized clinical trials. These elements, valvuloplasty: results in 23 patients. Am. J. Cardiol. 53, 194–197
(1984).
together with improved devices and increased clinical 2. Cribier, A. et al. Percutaneous transluminal valvuloplasty of
experience, explain why a treatment that was originally acquired aortic stenosis in elderly patients: an alternative to
valve replacement? Lancet 1, 63–67 (1986).
limited to compassionate use could be extended by the 3. Eltchaninoff, H. et al. Five month study of percutaneous heart valves
North American and European guidelines to include in the systemic circulation of sheep using a novel model of aortic
insufficiency. EuroIntervention 1, 438–444 (2006).
patients at high or intermediate surgical risk and finally, 4. Cribier, A. et al. Percutaneous transcatheter implantation of an
in 2021, to those at low surgical risk9. This expansion has aortic valve prosthesis for calcific aortic stenosis: first human case
description. Circulation 106, 3006–3008 (2002).
led to the use of TAVI in >1.5 million patients world- 5. Cribier, A. et al. Treatment of calcific aortic stenosis with the
wide, with the number of TAVI procedures surpassing percutaneous heart valve: mid-term follow-up from the initial
that of SAVR in many countries. Currently, TAVI is per- feasibility studies: the French experience. J. Am. Coll. Cardiol. 47,
1214–1223 (2006).
formed in >90% of patients using the simplified percu- 6. Webb, J. G. et al. Percutaneous aortic valve implantation retrograde
taneous transfemoral approach under local anaesthesia from the femoral artery. Circulation 113, 842–850 (2006).
7. Walther, T. et al. Transapical minimally invasive aortic valve
that we pioneered10 and is associated with short hospital implantation; the initial 50 patients. Eur. J. Cardiothorac. Surg.
stays and a rapid return to normal life. 33, 983–988 (2008).
8. Grube, E. et al. Percutaneous aortic valve replacement for severe
I believe that the number of TAVI procedures per- aortic stenosis in high-risk patients using the second- and current
formed will continue to grow owing to ongoing improve- third-generation self-expanding CoreValve prosthesis: device success
and 30-day clinical outcome. J. Am. Coll. Cardiol. 50, 69–76
ments in the technology, the increasing experience of (2007).
operators and the expansion of specialized centres. The 9. Vahanian, A. et al. 2021 ESC/EACTS guidelines for the management
of valvular heart disease. Eur. Heart J. 43, 561–632 (2022).
demonstration of long-term durability of the implanted 10. Durand, E. et al. Transfemoral aortic valve replacement with
valves, the arrival of new-generation devices and several the Edwards SAPIEN and Edwards SAPIEN XT prosthesis using
exclusively local anesthesia and fluoroscopic guidance: feasibility
new indications under investigation will also have a role and 30-day outcomes. JACC Cardiovasc. Interv. 5, 461–467 (2012).
in the future expansion of TAVI. Furthermore, the cost Competing interests
of TAVI will decrease as a result of competition between A.C. is a consultant for Edwards Lifesciences.
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