Development of transcatheter aortic valve implantation (TAVI): a 20-year odyssey.

The development of transcatheter aortic valve implantation (TAVI) by our group has been a 20-year odyssey. In 1993, postmortem studies validated the concept of intravalvular stenting in calcific aortic stenosis. The first prototypes of balloon-expandable valves were tested in 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 took flight in 2004 in the hands of Edwards Lifesciences, with major improvements in devices and approaches. 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 have shown dramatic improvements in procedural and midterm results and decreased complication rates, with more experience and improved technology. The results of the randomized PARTNER study 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. An optimal multidisciplinary collaboration and formally trained experienced physicians are the keys 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, TAVI is here to stay and the future is promising.

[1]  S. Wallace,et al.  Development and initial experimental evaluation of a prosthetic aortic valve for transcatheter placement. Work in progress. , 1992, Radiology.

[2]  A. Cribier,et al.  Five month study of percutaneous heart valves in the systemic circulation of sheep using a novel model of aortic insufficiency. , 2006, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[3]  J. Fajadet,et al.  Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sapien and Medtronic CoreValve bioprostheses in a mixed population. , 2010, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[4]  P. Bonhoeffer,et al.  Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction , 2000, The Lancet.

[5]  A. Cribier,et al.  Results of percutaneous transluminal valvuloplasty in 218 adults with valvular aortic stenosis. , 1988, The American journal of cardiology.

[6]  Nadir Saoudi,et al.  PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY OF ACQUIRED AORTIC STENOSIS IN ELDERLY PATIENTS: AN ALTERNATIVE TO VALVE REPLACEMENT? , 1986, The Lancet.

[7]  M. Cheitlin Percutaneous Aortic Valve Implantation Retrograde From the Femoral Artery , 2007 .

[8]  Assaf Bash,et al.  Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis: First Human Case Description , 2002, Circulation.

[9]  J Kachaner,et al.  Transcatheter implantation of a bovine valve in pulmonary position: a lamb study. , 2000, Circulation.

[10]  S. Pocock,et al.  Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. , 2010, The New England journal of medicine.

[11]  W. O’Neill Predictors of long-term survival after percutaneous aortic valvuloplasty: report of the Mansfield Scientific Balloon Aortic Valvuloplasty Registry. , 1991, Journal of the American College of Cardiology.

[12]  J. Sochman,et al.  Percutaneous Transcatheter One-Step Mechanical Aortic Disc Valve Prosthesis Implantation: A Preliminary Feasibility Study in Swine , 2006, CardioVascular and Interventional Radiology.

[13]  Antonio Colombo,et al.  One-Year Outcomes of Cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry: The European Registry of Transcatheter Aortic Valve Implantation Using the Edwards SAPIEN Valve , 2011, Circulation.

[14]  Mirko Doss,et al.  Transapical Minimally Invasive Aortic Valve Implantation: Multicenter Experience , 2007, Circulation.

[15]  Michael J. Mack,et al.  Transcatheter versus surgical aortic-valve replacement in high-risk patients. , 2011, The New England journal of medicine.

[16]  M. Oz,et al.  Transluminal aortic valve placement. A feasibility study with a newly designed collapsible aortic valve. , 1996, ASAIO journal.

[17]  A. Cheung,et al.  Atrioventricular block after transcatheter balloon expandable aortic valve implantation. , 2008, JACC. Cardiovascular interventions.

[18]  J M Hasenkam,et al.  Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. , 1992, European heart journal.

[19]  Alec Vahanian,et al.  Results of transfemoral or transapical aortic valve implantation following a uniform assessment in high-risk patients with aortic stenosis. , 2009, Journal of the American College of Cardiology.

[20]  N. Al-Attar,et al.  Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). , 2008, European heart journal.

[21]  J. Kovac,et al.  Prosthesis-patient mismatch after transcatheter aortic valve implantation with the Medtronic-Corevalve bioprosthesis. , 2010, European heart journal.

[22]  A. Vahanian,et al.  Transcatheter valve implantation for patients with aortic stenosis , 2010, Heart.

[23]  Assaf Bash,et al.  Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. , 2004, Journal of the American College of Cardiology.

[24]  Alain Prat,et al.  Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. , 2011, European heart journal.

[25]  M. Deutsch,et al.  Improvements in transcatheter aortic valve implantation outcomes in lower surgical risk patients: a glimpse into the future. , 2012, Journal of the American College of Cardiology.

[26]  J. López-Sendón,et al.  Cause of complete atrioventricular block after percutaneous aortic valve implantation: insights from a necropsy study. , 2009, Circulation.

[27]  H. Davies CATHETER-MOUNTED VALVE FOR TEMPORARY RELIEF OF AORTIC INSUFFICIENCY , 1965 .

[28]  Y. Castier,et al.  Vascular complications of transfemoral aortic valve implantation with the Edwards SAPIEN prosthesis: incidence and impact on outcome. , 2010, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[29]  Volkmar Falk,et al.  Transapical minimally invasive aortic valve implantation; the initial 50 patients. , 2008, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[30]  Fabian Nietlispach,et al.  Transcatheter Aortic Valve Implantation: Impact on Clinical and Valve-Related Outcomes , 2009, Circulation.

[31]  M. Morice,et al.  Transfemoral aortic valve implantation new criteria to predict vascular complications. , 2011, JACC. Cardiovascular interventions.

[32]  M. Leon,et al.  Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis First Human Case Description , 2002 .

[33]  P. Cascade,et al.  A temporary catheter-tip aortic valve: hemodynamic effects on experimental acute aortic insufficiency. , 1976, The Annals of thoracic surgery.

[34]  Fabian Nietlispach,et al.  Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. , 2010, Journal of the American College of Cardiology.

[35]  E. Tay,et al.  Transcatheter Aortic Valve Implantation: Durability of Clinical and Hemodynamic Outcomes Beyond 3 Years in a Large Patient Cohort , 2010, Circulation.

[36]  Thomas Walther,et al.  Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. , 2007, Journal of the American College of Cardiology.

[37]  A. Cribier,et al.  Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term follow-up from the initial feasibility studies: the French experience. , 2006, Journal of the American College of Cardiology.

[38]  Ronen Gurvitch,et al.  Transcatheter Valve-in-Valve Implantation for Failed Bioprosthetic Heart Valves , 2010, Circulation.

[39]  L. Anthopoulos,et al.  Catheter-mounted aortic valves. , 1971, The Annals of thoracic surgery.

[40]  M. Forsting,et al.  Silent and Apparent Cerebral Ischemia After Percutaneous Transfemoral Aortic Valve Implantation: A Diffusion-Weighted Magnetic Resonance Imaging Study , 2010, Circulation.

[41]  L. Wilkins Percutaneous Balloon Aortic Valvuloplasty: Acute and 30‐Day Follow‐up Results in 674 Patients From the NHLBI Balloon Valvuloplasty Registry , 1991, Circulation.