Embed Size (px)
Citation preview
A
C
Di
I
i
1d
rchives of Cardiovascular Disease (2012) 105, 146—152
Available online at
www.sciencedirect.com
LINICAL RESEARCH
evelopment of transcatheter aortic valvemplantation (TAVI): A 20-year odyssey
mplantation de valves aortiques par voie percutanée : une odyssée de 20 ans
Alain Cribier
Service de cardiologie, hôpital Charles-Nicolle, université de Rouen, 1, rue de Germont,76000 Rouen, France
Received 17 January 2012; accepted 19 January 2012Available online 16 March 2012
KEYWORDSAortic stenosis;Valve prosthesis;Transcatheter valveimplantation
Summary The development of transcatheter aortic valve implantation (TAVI) by our grouphas been a 20-year odyssey. In 1993, postmortem studies validated the concept of intravalvularstenting in calcific aortic stenosis. The first prototypes of balloon-expandable valves were testedin an animal model in 2000. The first-in-man implantation was performed in Rouen in 2002,rapidly followed by two prospective series in compassionate cases in our centre. TAVI tookflight in 2004 in the hands of Edwards Lifesciences, with major improvements in devices andapproaches. At the same time, the self-expanding CoreValve was launched. Thousands of high-surgical-risk patients were enrolled in feasibility studies, leading to the Conformité Européenne(CE) mark being granted in 2007 for the two devices. A number of postmarketing registries haveshown dramatic improvements in procedural and midterm results and decreased complicationrates, with more experience and improved technology. The results of the randomized PARTNERstudy in the USA recently 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(2300 patients in 33 centres in France in 2011) and the number is consistently increasing. Anoptimal multidisciplinary collaboration and formally trained experienced physicians are thekeys to success. An extension of indications to lower-risk patients might be expected in the
coming years but should be cautiously investigated. Ten years after the first-in-man case, TAVIis here to stay and the future is promising.. All rights reserved.
© 2012 Elsevier Masson SASAbbreviations: AS, Aortic stenosis; AVR, Aortic valve replacement; BAV, Balloon aortic valvuloplasty; TAVI, Transcatheter aortic valvemplantation; THV, Transcatheter heart valve.
E-mail address: [email protected]
875-2136/$ — see front matter © 2012 Elsevier Masson SAS. All rights reserved.oi:10.1016/j.acvd.2012.01.005
Development of TAVI: A 20-year odyssey 147
MOTS CLÉSRétrécissementaortique ;Prothèse valvulaire ;Cathétérismecardiaque ;Cardiologieinterventionnelle
Résumé Le développement du Transcatheter Aortic Valve Implantation (TAVI) par notregroupe a été une odyssée de 20 ans. En 1993, une étude en postmortem a validé le conceptde stenting intravalvulaire dans le rétrécissement aortique calcifié. Les premiers prototypes devalve expansible par ballonnet ont pu être testés sur l’animal en 2000. La première implantationchez l’homme a été réalisée à Rouen en 2002, rapidement suivie de deux études prospectivesréalisées par notre groupe dans des situations compassionnelles. Le TAVI a pris réellement sonessor entre les mains d’Edwards Lifesciences avec des améliorations majeures du matériel etdes approches. À la même époque était lancée la valve autoexpansible CoreValve. Des milliersde patients à haut risque chirurgical ont été enrôlés dans des études de faisabilité aboutis-sant au marquage Conformité Européenne (CE) pour les deux modèles de valve en 2007. Ungrand nombre de registres post-commercialisation ont montré une amélioration très impor-tante des résultats immédiats et à moyen terme et une diminution du taux de complication liéeà l’expérience des équipes et aux avancées technologiques. Les résultats de l’étude randomiséePARTNER aux États-Unis ont récemment confirmé la place importante du TAVI pour les patientsinopérables ou à haut risque chirurgical. Aujourd’hui, plus de 50 000 patients ont bénéficié duTAVI dans le monde (2300 patients dans 33 centres en France pour l’année 2011) et le nombre necesse de croître. Une collaboration multidisciplinaire et un entraînement optimal des équipessont la clef du succès. Une extension des indications aux patients à moindre risque est à prévoirdans les années qui viennent, sous réserve d’investigations contrôlées. Dix ans après le premiercas mondial, le TAVI est une technique bien établie et dont le futur est très prometteur.© 2012 Elsevier Masson SAS. Tous droits réservés.
pp
iaeicurhtsipfitiSat
Ff
Icco1
Background
If the development of transcatheter aortic valve implan-tation (TAVI) by our group in France can be considered a‘‘success story’’ today, it is nothing short of a miracle, asthe project appeared particularly challenging —– not to saytotally unrealistic —– at its origin in the early 1990s. It is quitethrilling, therefore, to observe the current acceptance andexpansion of this technology worldwide, 10 years after the‘‘heroic’’ first-in-man TAVI procedure performed in Rouenon April 16th, 2002.
We report here the main phases of this 20-year odysseyand briefly consider future prospects, as TAVI remains in aprocess of continuous development.
Birth of a concept
The starting point of this adventure took place at the endof the 1980s, with the evidence of the limitations of bal-loon aortic valvuloplasty (BAV), a technique that we hadpioneered since 1985 [1] for the treatment of non-operablecalcific aortic stenosis (AS). The goal of BAV was to providea therapeutic option for patients considered at that time tobe inoperable, often because age more than 75 years per sewas a customary contraindication to aortic valve replace-ment (AVR) in the 1980s. BAV was associated with midtermimprovement in quality of life [2], explaining its rapid adop-tion and explosive growth worldwide. However, the lack ofsurvival benefit and a recurrence rate of 80% at 1 year [3,4]
led to a dramatic decline in its use.For us, addressing the issue of post-BAV valvular resteno-sis soon became an obsession. The idea of placing withinthe diseased valve a large-size stent containing a mounted
itpa
rosthesis (stented valve) was rapidly considered an optimalotential option.
Actually, the concept of transcatheter heart valvemplantation was not new. In the 1970s, several projectsimed at treating aortic regurgitation [5—7] remainedxperimental. In 1989, Henning-Rud Andersen firstmplanted an original model of a balloon-expandableatheter-mounted stented valve within the aorta of pigs,sing a handmade mesh containing a porcine valve. Theesults, published in 1992 [8], were not followed byuman application. Other experimental concepts emergedhereafter [9—11]. In 2000, Philip Bonhoeffer developed atented valve made of a bovine jugular vein conduit insertedn a platinum-iridium stent, which was implanted in theulmonary artery of lambs [12]. Bonhoeffer performed therst human implantation of this device in a right ventricleo pulmonary artery conduit in 2000 [13], followed byntense development of the technology in this indication.imultaneously, we specifically addressed degenerative AS,
highly challenging indication, regarding the specificity ofhe calcific aortic valve and surrounding structures.
irst observations, enthusiasm andrustration
n 1993 to 1994, we demonstrated in 12 fresh specimens ofalcific AS that a Palmaz stent, 23 mm in diameter, couldircularly open each native valve, regardless of the amountf calcification. The ideal height of the stent appeared to be4 to 16 mm to avoid impinging on the coronary ostia, the
ntraventricular septum or the anterior mitral valve leaflet,hus duplicating the subcoronary position of any surgical bio-rosthesis. The stents were well anchored within the aorticnnulus, requiring a high traction force to be dislodged, thus
1
ltctw
cpcnecm
Po
T‘fidhilT
A
Wm2abaehTmcdepctneda5
F
Atpm1fo
clsuctwdHgsueSldwatcasNWorthT
Ttfp
isdmb
F
Atccsbu[saton
48
imiting the risk of embolization. This study, which validatedhe concept of aortic valvular stenting in a model of humanalcific AS, was a fundamental milestone. However, at thatime, the type of valve prosthesis and its physical propertiesere still at the drawing stage.
Over a 4-year period, the search for a biomedicalompany that was interested in the project failed com-letely. A long list of engineering issues and potentialomplications was consistently pointed out, including coro-ary obstruction, aortic and mitral valve complication,arly dislodgement of the device, stroke, mechanicalomplications, etc. The project was even considered ‘‘theost stupid ever heard’’!
ercutaneous valve technologies: the endf the tunnel
o accomplish this venture, a start-up company,‘Percutaneous Valve Technologies’’ (PVT, NJ, USA) wasnally formed in 1999. Engineers from Israel were able toesign the first models of balloon-expandable transcathetereart valve (THV), which consisted of a stainless steel stentntegrating a tri-leaflet polyurethane valve. Considerableaboratory work was done before obtaining the first frozenHV model.
nimal trials: first promising results
ith the help of my collaborator Helene Eltchaninoff, ani-al experiments on the sheep model started in September
000 at the Centre d’experimentation et de rechercheppliquée (CERA; Institute Montsouris, Paris). Through therachiocephalic trunk, the first successful implantation of
THV within the native aortic valve was achieved, withxcellent results and no complications. After this case, wead the inkling that it was the start of an important story.he presentation of this case at various meetings arousedemorable and encouraging enthusiasm from the medical
ommunity! More than 100 implantations at different car-iac sites were subsequently performed by us. Soon, withxperience, we switched to bovine pericardium for the valverosthesis. We learned a lot from this experiment, withase after case contributing to substantial improvements inhe THV and in the delivery systems and implantation tech-iques. We also conceived an original model for the chronicvaluation of the THV in the systemic circulation [14], whichemonstrated the persistence of excellent valve functionnd the integrity of the THV on pathological examination at
months.
irst-in-human implantation
pril 16th, 2002 —– the date of the first-in-human implan-ation [15] —– will remain a memorable day. A 57-year-oldatient with severe AS presented in cardiogenic shock with
ajor left ventricular dysfunction (the ejection fraction was2%!) and multiple comorbidities contraindicating AVR. Afterailed emergent BAV, TAVI appeared to be the last-resortption for this young patient. The indication was particularly
ecso
A. Cribier
hallenging in this critically ill patient who also had subacuteeg ischaemia related to an aortofemoral bypass occlu-ion and severe contralateral atherosclerosis preventing these of the transfemoral retrograde access. All informationoncerning this never-used therapeutic option was giveno the patient’s relatives and the patient himself, all ofhom gave their consent with no hesitation. The proce-ure was performed the following day with my collaboratorselene Eltchaninoff and Christophe Tron, using the ante-rade transseptal approach. This unplanned approach addedtress to the procedure, although we had experience ofsing it in a few BAV cases with no arterial access. Actually,ach step of the procedure was amazingly straightforward.tabilizing the THV across the native valve was quite chal-enging, but after some time, we succeeded and rapidlyeployed it. Haemodynamic and echocardiographic resultsere incredibly improved, with no transvalvular gradientnd a return of blood pressure to normal, allowing discon-inuation of vasopressors. There was no impairment of theoronary ostia or the mitral valve, no atrioventricular blocknd only mild paravalvular aortic regurgitation. On transoe-ophageal echocardiography, valve function was excellent.o words can express the emotion felt by the whole team.e were witnessing a true resurrection. Despite an episodef pulmonary embolism, the patient continued his clinicalecovery. Unfortunately, the perfusion of his leg continuedo worsen and after an above-knee amputation that neverealed properly, the patient passed away 4 months afterAVI.
This first case confirmed the feasibility of implanting aHV in a human on the beating heart using transcatheterechniques, with perfect subcoronary position and no inter-erence with the surrounding structures, thus translating ourostmortem observation of 1993.
The international reaction to this spectacular case defiedmagination. The deafening silence during the video pre-entation of this case in meetings was testament to theegree of emotion and stupefaction of the medical com-unity. Clearly, this first-in-man case can be considered areakthrough in the history of interventional cardiology.
irst Rouen series
fter three additional cases we obtained permission fromhe French Administration to start a feasibility trial at ourentre. The programme was approved, but restricted toompassionate use. We recruited 16 patients into a firsttudy (I-REVIVE trial), where the THV, further modifiedy the use of an equine pericardial valve, was implantedsing either an antegrade or a retrograde (n = 7) approach16]; 20 additional patients were recruited into in a seconderies (RECAST trial), where the access was antegrade inll patients [17]. Each case was special and each implanta-ion was incredible. These studies confirmed the feasibilityf TAVI (80% procedural success) and the lasting haemody-amic and functional improvement after implantation. As
xpected, several of these critically ill patients died of theiromorbidities within weeks or months but, amazingly, someurvived beyond 2 to 5 years and even as long as 6.5 years inur most striking case, without any prosthesis dysfunction.
mcip9wmCrwatdsi
wirwanTtsmasirfsayi
Scla(wtieimfare
5mTt
Development of TAVI: A 20-year odyssey
The incidence of 25% moderate-to-severe paravalvularaortic regurgitation was related to the unique 23-mm THVsize available. The extension of the protocol to other centresin Europe and the USA clearly demonstrated the limita-tion of this unusual transseptal route in less experiencedhands. Further expansion of TAVI clearly required technicalimprovements, simplification of the procedure, alternativeapproaches and a larger valve size.
Edwards Lifesciences: transcatheter aorticvalve implantation (TAVI) takes flight
With the acquisition of PVT by Edwards Lifesciences (Irvine,CA, USA) in January 2004, TAVI entered a new era. Rapidimprovements were made to the valve prosthesis and deli-very systems and new approaches were developed for THVimplantation.
The Edwards SAPIEN valve (initially the Cribier-Edwardsvalve) consisted of a tri-leaflet bovine pericardium valve,pretreated to decrease calcification, mounted in a balloon-expandable stainless steel stent. The prosthesis becameavailable in two sizes: 23 and 26 mm. The delivery systemincorporated a deflectable Retroflex catheter, brilliantlyconceived for the transfemoral retrograde approach andinitially evaluated by Webb et al. in Vancouver [18]. Simul-taneously, the minimally invasive transapical approach wasdeveloped using another delivery system (Ascendra), evalu-ated by Walther et al. in Leipzig [19]. Unfortunately, Frenchinvestigators could only access these technologies after 1year of delay, in the setting of several European feasibilitystudies (REVIVE, PARTNER and TRAVERSE trials). The satis-factory results of these trials, despite specific complicationswith the two approaches, led to a growing acknowledgementand considerable expansion of TAVI worldwide.
Concurrently, another device had been progressing since2004: the CoreValve [20] (now produced commercially byMedtronic, Irvine, CA, USA) had an autoexpandable nitinolstent containing a porcine pericardial valve, which allowedits transfemoral insertion through smaller sheaths sizes (21Fthen 18F) than the 22F and 24F sizes required for theEdwards devices —– a major appealing feature for a numberof teams. As an alternative to the transfemoral approach,the subclavian access was proposed with the CoreValve. TheConformité Européenne (CE) mark was obtained for bothmodels of valve in 2007.
Setting up transcatheter aortic valveimplantation (TAVI) in the therapeuticarmamentarium for calcific aortic stenosis
Thereafter, acceptance and expansion of TAVI was ama-zing. In line with the statements by the European Associ-ation of Cardiothoracic Surgery (EACTS) and the EuropeanSociety of Cardiology (ESC) [21], several hundred patientswere included in postmarketing registries conducted with
the two models of valves and using the different approaches,including the European SOURCE registry with the EdwardsSAPIEN valve [22]. These registries contributed to betterappraisal of patient screening, improvements in technicalT
IF
149
odalities and better prevention and management ofomplications. The immediate and long-term results keptmproving with experience and advancing technologies; therocedural success rate progressively reached more than5%. Excellent haemodynamic results, comparing favourablyith the results of surgical AVR, lasting functional improve-ent and improved survival were consistently observed.omplications were also shown to decrease with experience,eaching an acceptable level in this high-risk population, andere similar for both valve models, with the exception of
more frequent incidence of conduction disturbances withhe CoreValve. Overall, the results of TAVI became more pre-ictable. A mortality rate of 6 to 10% at 1 month and a 1-yearurvival rate of 80% could be quoted after transfemoral TAVIn the SOURCE registry [22].
The results of the pivotal PARTNER randomized studyith the Edwards SAPIEN prosthesis, conducted from 2009
n 26 centres in USA and including 1056 high-surgical-isk patients, were eagerly expected [23,24]. Patientsere divided into two cohorts: operable patients randomlyssigned to TAVI (transfemoral or transapical) or AVR andon-operable patients randomly assigned to transfemoralAVI or medical treatment. Briefly, the results confirmedhat in non-operable patients TAVI is highly superior totandard therapy, markedly reducing the rate of all-causeortality and repeat hospitalization at 1 year (with an
bsolute increase in survival of 20%), whereas in high-urgical-risk patients, TAVI is not inferior to surgical AVRn terms of all-cause mortality at 1 year. In view of theseesults, TAVI was approved by the FDA in November 2011or non-surgical candidates; approval for high-risk-patientshould hopefully occur soon. Subsequent to FDA approval,bout 400 centres should open for TAVI within a couple ofears in USA and active training has already been initiatedn new centres.
Innovations in valve and delivery systems are ongoing.ince 2010, the new SAPIEN-XT valve, which includes aobalt chromium highly resistant frame, a new valve andeaflet design and an additional valve size (29 mm), has beenvailable in Europe. This comes with new delivery systemsthe NovaFlex for the transfemoral approach is compatibleith smaller sheath sizes [18F and 19F], which increases
he rate of transfemoral access to 80% of patients) and anmproved delivery system for the transapical approach. Sev-ral other advances are already in use or under evaluation,ncluding a smaller valve size (20 mm) and other valveodels by Edwards. The new AcuTrack delivery system
or CoreValve implantation should also improve further theccuracy of valve placement. There is no doubt that theseapidly evolving technologies will markedly contribute to thexpansion of TAVI in the near future.
To date, it is estimated that 50,000 patients in more than00 European centres have benefited from TAVI with the twoodels of prosthesis and the technique continues to evolve.his obviously supports the clear-cut clinical need for thisechnology.
he situation in France
t is unfortunate that administrative constraints preventedrance, which had been pioneering TAVI, from participating
1
igTutowteyGt[otA
F
IEbwasnfsamot
tvus
7msmb[cpfifs
IitTttit
ga
ovtpa
mfild5C6osiafgf
taiP
crtammo
C
Tctmbarspif
pgntc
pa
50
n the development of the technology, with each technolo-ical advance being first evaluated in Canada or Germany.his led to slow growth of the procedure in our countryntil 2010. Thanks to many colleagues and partners fromhe industry, reimbursement of TAVI was obtained fromur national insurance (Sécurité Sociale) in January 2010,ith the subsequent approval of 33 TAVI centres throughout
he country. Subsequently, the number of TAVI proceduresxploded in France, reaching nearly 2300 patients for theear 2011 —– a number still more than twofold lower than inermany. Nevertheless, among a number of national regis-ries, the French experience, as reflected in the FRANCE25] and FRANCE 2 registries, which included 3500 patients,ffers the largest prospective and exhaustive overview ofhe state of the art in real life with the two models of valve.n increased number of TAVI centres in France is pending.
uture prospects
t has already been observed that lower-risk patients inurope are receiving TAVI [25] and that clinical outcomes areetter [26]. Extension of TAVI to intermediate-risk patientsill be evaluated in European studies (the SURTAVI trial)s well as in the PARTNER 2 study in the USA. Exten-ion of the indication to younger and low-risk patients,ot to say to all AS patients, would certainly requireurther technical improvements and better prevention ofevere complications, particularly vascular, haemorrhagicnd cerebral complications, as well as conduction abnor-alities and paravalvular leak, and greater knowledge
f the long-term durability of valves and platform sys-ems.
Reductions in sheath size and new approaches (transaor-ic) are expected to further decrease haemorrhagic andascular complications, which occur in 2 to 30% of patientsndergoing TAVI [27,28] and have a negative impact on thehort-term clinical follow-up [22,29].
Neurological event rates, reported to range from 1.7 to% [22,25,30—32], remain an issue. The cause of stroke isultifactorial but most periprocedural and postprocedural
trokes may be of embolic origin, as shown by post-TAVIagnetic resonance imaging: new cerebral lesions haveeen reported in 58 to 91% of patients undergoing TAVI33], with no assessment of corresponding neurocognitiveonsequences. Approaches to embolic prevention includeorous membranes covering the carotid ostia and carotidlters, which deserve further investigation, and a searchor optimal periprocedural and postprocedural antiplatelettrategies.
Complete heart block is frequently reported after TAVI.t is apparent that the 9 to 36% rate of new pacemakermplantation with the CoreValve is much higher than the 3o 12% rate reported with the Edwards device [25,34,35].HVs implanted lower into the left ventricular outflowract against the interventricular septum may increasehe risk of heart block [30]. Better THV positioning withmproved delivery systems might decrease the incidence of
his complication.Moderate to severe (> grade 2) paravalvular aortic regur-itation is infrequent, observed in less than 10% of casesnd is typically due to bulky calcification, technical sizing
wiil
A. Cribier
r positioning errors [30,36]. Better determination of aorticalve anatomy and calcification, optimal valve size and posi-ioning using advanced imaging techniques, as well as newrosthesis design, might decrease the rate of paravalvularortic insufficiency in the future.
Importantly, it is unknown whether the favourableidterm durability of the currently used THV will be con-rmed in the long term. Although clinical follow-up remains
imited, structural THV failure has only been reported anec-otally. One report documents normal valve function 3 to
years after implantation of the SAPIEN precursor, theribier-Edwards valve [37], and the longest follow-up is.5 years in our series. Again, structural failure was notbserved. The similar manufacturing of the Edwards THV andurgical bioprosthesis and the circumferential frame open-ng of the THV, avoiding inappropriate leaflet overlapping,re promising, but this has to be addressed in longer-termollow-up. Whether THV implantation will offer similarlyood results in congenital bicuspid valves, which occur morerequently in younger patients, remains uncertain.
Other indications for TAVI have emerged recently, withhe treatment of degenerated bioprosthesis. The first resultsre highly encouraging [38], but formal evaluation of valve-n-valve therapy is planned in the upcoming SAPIEN-XTARTNER 2 and CoreValve REDO studies.
Finally, a number of next-generation THVs are in earlylinical evaluation. The aim was to incorporate features toeduce delivery catheter profile, facilitate accurate posi-ioning, reduce paravalvular leaks and allow for retrieval,nd they are generally self-expanding. Although theseodels of THV might represent the future of TAVI, mini-al information is available to date on efficacy, procedural
utcomes and durability.
onclusions
he development of TAVI has been a 20-year odyssey fromoncept to real world, but it has been a fascinating adven-ure and the procedure is here to stay. TAVI already plays aajor role in the management of patients with AS and cane considered the standard of care in non-operable patients,s well as a valuable alternative for patients at high surgicalisk. An optimal multidisciplinary collaboration for patientcreening and procedures and formally trained experiencedhysicians are the keys to success. Each indication for TAVIs a matter of clinical judgment and it should be reservedor the subset of patients in whom a good outcome is likely.
One can proudly observe the excellence and unequalledartnership generated by TAVI. Cardiologists, cardiac sur-eons, anaesthesiologists, imaging specialists, geriatricians,urses and technicians have learned to work togetherowards a unique goal: making TAVI possible, safe and suc-essful with optimal patient outcome.
Within 5 years, an extension of indications to lower-riskatients can be expected, as well as an explosion of centresnd investigators worldwide. Simplified and safer techniques
ill soon be available, with rapid and consistent technolog-cal improvement. Although work still needs to be done tomprove techniques and outcomes further, the future of TAVIooks bright.
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
Development of TAVI: A 20-year odyssey
Disclosure of interest
Alain Cribier is a consultant for Edwards Lifesciences.
References
[1] Cribier A, Savin T, Saoudi N, et al. Percutaneous transluminalvalvuloplasty of acquired aortic stenosis in elderly patients: analternative to valve replacement? Lancet 1986;1:63—7.
[2] Letac B, Cribier A, Koning R, et al. Results of percutaneoustransluminal valvuloplasty in 218 adults with valvular aorticstenosis. Am J Cardiol 1988;62:598—605.
[3] Percutaneous balloon aortic valvuloplasty. Acute and 30-dayfollow-up results in 674 patients from the NHLBI Balloon Valvu-loplasty Registry. Circulation 1991;84:2383—97.
[4] O’Neill WW. Predictors of long-term survival after percuta-neous aortic valvuloplasty: report of the Mansfield ScientificBalloon Aortic Valvuloplasty Registry. J Am Coll Cardiol1991;17:193—8.
[5] Davies H. Catheter-mounted valve for temporary relief of aor-tic insufficiency. Lancet 1965;285:250.
[6] Moulopoulos SD, Anthopoulos L, Stamatelopoulos S,et al. Catheter-mounted aortic valves. Ann Thorac Surg1971;11:423—30.
[7] Phillips SJ, Ciborski M, Freed PS, et al. A temporary catheter-tip aortic valve: hemodynamic effects on experimental acuteaortic insufficiency. Ann Thorac Surg 1976;21:134—7.
[8] Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implan-tation of artificial heart valves. Description of a newexpandable aortic valve and initial results with implanta-tion by catheter technique in closed chest pigs. Eur Heart J1992;13:704—8.
[9] Moazami N, Bessler M, Argenziano M, et al. Transluminal aor-tic valve placement. A feasibility study with a newly designedcollapsible aortic valve. ASAIO J 1996;42:M381—5.
[10] Pavcnik D, Wright KC, Wallace S. Development and ini-tial experimental evaluation of a prosthetic aortic valvefor transcatheter placement. Work in progress. Radiology1992;183:151—4.
[11] Sochman J, Peregrin JH, Rocek M, et al. Percutaneous tran-scatheter one-step mechanical aortic disc valve prosthesisimplantation: a preliminary feasibility study in swine. Cardio-vasc Intervent Radiol 2006;29:114—9.
[12] Bonhoeffer P, Boudjemline Y, Saliba Z, et al. Transcatheterimplantation of a bovine valve in pulmonary position: a lambstudy. Circulation 2000;102:813—6.
[13] Bonhoeffer P, Boudjemline Y, Saliba Z, et al. Percutaneousreplacement of pulmonary valve in a right ventricle to pul-monary artery prosthetic conduit with valve dysfunction.Lancet 2000;356:1403—5.
[14] Eltchaninoff H, Nusimovici-Avadis D, Babaliaros V, et al. Fivemonth study of percutaneous heart valves in the systemic cir-culation of sheep using a novel model of aortic insufficiency.EuroIntervention 2006;1:438—44.
[15] Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous tran-scatheter implantation of an aortic valve prosthesis for calcificaortic stenosis: first human case description. Circulation2002;106:3006—8.
[16] Cribier A, Eltchaninoff H, Tron C, et al. Early experience withpercutaneous transcatheter implantation of heart valve pros-thesis for the treatment of end-stage inoperable patients withcalcific aortic stenosis. J Am Coll Cardiol 2004;43:698—703.
[17] Cribier A, Eltchaninoff H, Tron C, et al. Treatment of calcificaortic stenosis with the percutaneous heart valve: midtermfollow-up from the initial feasibility studies: the French expe-rience. J Am Coll Cardiol 2006;47:1214—23.
151
18] Webb JG, Chandavimol M, Thompson CR, et al. Percutaneousaortic valve implantation retrograde from the femoral artery.Circulation 2006;113:842—50.
19] Walther T, Falk V, Kempfert J, et al. Transapical minimally inva-sive aortic valve implantation; the initial 50 patients. Eur JCardiothorac Surg 2008;33:983—8.
20] Grube E, Schuler G, Buellesfeld L, et al. Percutaneousaortic valve replacement for severe aortic stenosis inhigh-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device successand 30-day clinical outcome. J Am Coll Cardiol 2007;50:69—76.
21] Vahanian A, Alfieri O, Al-Attar N, et al. Transcatheter valveimplantation for patients with aortic stenosis: a positionstatement from the European Association of Cardio-ThoracicSurgery (EACTS) and the European Society of Cardiology(ESC), in collaboration with the European Association of Per-cutaneous Cardiovascular Interventions (EAPCI). Eur Heart J2008;29:1463—70.
22] Thomas M, Schymik G, Walther T, et al. One-year outcomes ofcohort 1 in the Edwards SAPIEN Aortic Bioprosthesis EuropeanOutcome (SOURCE) registry: the European registry of tran-scatheter aortic valve implantation using the Edwards SAPIENvalve. Circulation 2011;124:425—33.
23] Leon MB, Smith CR, Mack M, et al. Transcatheter aortic valveimplantation for aortic stenosis in patients who cannot undergosurgery. N Engl J Med 2010;363:1597—607.
24] Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus sur-gical aortic valve replacement in high-risk patients. N Engl JMed 2011;364:2187—98.
25] Eltchaninoff H, Prat A, Gilard M, et al. Transcatheter aor-tic valve implantation: early results of the FRANCE (FRenchAortic National CoreValve and Edwards) registry. Eur Heart J2011;32:191—7.
26] Lange R, Bleiziffer S, Mazzitelli D, et al. Improvements intranscatheter aortic valve implantation outcomes in lower sur-gical risk patients a glimpse into the future. J Am Coll Cardiol2012;59:280—7.
27] Hayashida K, Lefevre T, Chevalier B, et al. Transfemoralaortic valve implantation new criteria to predict vascularcomplications. JACC Cardiovasc Interv 2011;4:851—8.
28] Tchetche D, Dumonteil N, Sauguet A, et al. Thirty-day out-come and vascular complications after transarterial aorticvalve implantation using both Edwards Sapien and MedtronicCoreValve bioprostheses in a mixed population. EuroInterven-tion 2010;5:659—65.
29] Ducrocq G, Francis F, Serfaty JM, et al. Vascular complicationsof transfemoral aortic valve implantation with the EdwardsSAPIEN prosthesis: incidence and impact on outcome. EuroInt-ervention 2010;5:666—72.
30] Himbert D, Descoutures F, Al-Attar N, et al. Results of trans-femoral or transapical aortic valve implantation following auniform assessment in high-risk patients with aortic stenosis. JAm Coll Cardiol 2009;54:303—11.
31] Rodes-Cabau J, Webb JG, Cheung A, et al. Transcatheteraortic valve implantation for the treatment of severesymptomatic aortic stenosis in patients at very high orprohibitive surgical risk: acute and late outcomes of the mul-ticenter Canadian experience. J Am Coll Cardiol 2010;55:1080—90.
32] Webb JG, Altwegg L, Boone RH, et al. Transcatheter aorticvalve implantation: impact on clinical and valve-related out-comes. Circulation 2009;119:3009—16.
33] Kahlert P, Knipp SC, Schlamann M, et al. Silent and appar-
ent cerebral ischemia after percutaneous transfemoralaortic valve implantation: a diffusion-weighted mag-netic resonance imaging study. Circulation 2010;121:870—8.
1
[
[
[
[
52
34] Moreno R, Dobarro D, Lopez de Sa E, et al. Cause of com-plete atrioventricular block after percutaneous aortic valveimplantation: insights from a necropsy study. Circulation2009;120:e29—30.
35] Sinhal A, Altwegg L, Pasupati S, et al. Atrioventricular block
after transcatheter balloon-expandable aortic valve implanta-tion. JACC Cardiovasc Interv 2008;1:305—9.36] Jilaihawi H, Chin D, Spyt T, et al. Prosthesis-patientmismatch after transcatheter aortic valve implantation
[
A. Cribier
with the Medtronic CoreValve bioprosthesis. Eur Heart J2010;31:857—64.
37] Gurvitch R, Wood DA, Tay EL, et al. Transcatheter aorticvalve implantation: durability of clinical and hemodynamicoutcomes beyond 3 years in a large patient cohort. Circulation
2010;122:1319—27.38] Webb JG, Wood DA, Ye J, et al. Transcatheter valve-in-valveimplantation for failed bioprosthetic heart valves. Circulation2010;121:1848—57.
