transcatheter heart valve: THV TAVI transcatheter aortic valve implantation

Transcription

1 transcatheter heart valve: THV TAVI transcatheter aortic valve implantation Hideki OSHIMA 1. はじめに transcatheter heart valve: THV 1) transcatheter aortic valve implantation: TAVI transcatheter mitral valve implantation TMVI sutureless valve THV TAVI 2. Two type of THVs for TAVI:balloon- vs. self-( 図 1, 表 1) 2002 Cribier TAVI 100,000 TAVI 2) SAPIEN CoreValve Medtronic CE mark SAPIEN XT CoreValve FDA Food and Drug Administration 6 SAPIEN CoreValve Evolut R SAPIEN XT 3 Core Valve PMDA Pharmaceuticals and Medical Devices 著者連絡先 hoshima@med.nagoya-u.ac.jp Agency ACURATE Neo/TF 15 THV 3) TAVI THV leaflet leaflet 2 1 balloon- valve BEV 1 self- valve SEV BEV radial strength oversizing undersizing paravalvular leak: PVL native aortic annulus oval shape SEV radial-force BEV native aortic annulus CoreValve positioning BEV PVL 4) BEV SAPIEN XT SEV Medtronic CoreValve CHOICE trial 5) device success PVL PVL SEV device success rate BEV 95.9 vs. SEV 77.5 PVL

2 図 1 SAPIEN vs. CoreValve a SAPIEN b SAPIEN XT c SAPIEN d CoreValve e CoreValve Evolut R f Evolut R scalloped sealing skirt. c Bourantas CV, Serruys PW: Evolution of transcatheter aortic valve replacement. Circ Res 114: , 2014 a, b d, e, f Adams 6) BEV CHOICE trial 1 BEV 17.3 SEV 37.6 Adams 6) 19.8 technical failure BEV SEV case-by-case THV EU fitting valve access root comorbidity TAVI 3. Next generation THVs for TAVI( 表 1, 図 2) TAVI THV PVL Accurate positioning reposition retrieve recapture delivery Lower profile TAVI PVL 7),8) PVL undersize positioning aorta-lvot left ventricular outflow tract angle SEV SAPIEN XT CoreValve THV PVL SAPIEN 図 1c PVL skirt SAPIEN valve repositioning retrieving distal flex mechanism fine positioning control system 3 high-risk PVL 3.8 CoreValve Evolut R 図 1e, f CoreValve repositioning retrieving sealing skirt radial force

3 表 1 Currently available valve in JAPAN Valve Company Valve material Stent material Valve size mm Access Deliverly catheter size Fr Expansion Retrievable CE mark FDA SAPIEN Stainless 23, 26 TE, TA 22, 24 TF 26 TA SAPIEN XT Cobalt chromium 20, 23, 26, 29 TF, TA 16, 18 TF 24 TA CoreValve Medtronic Porcine Nitinol 23, 26, 29, 31 TF, TAO SCL 18 Self- Next Generation Valve Company Valve material Stent material Valve size mm Access Deliverly catheter size Fr Expansion Repositionable Repositionable Retrievable CE mark FDA SAPIEN Cobalt chromium 23, 26, 29 TF, TA, TAO 14, 16 TF 18, 21 TA CENTERA Nitinol 23, 26 TF 14 esheath Self- Yes Yes No No CoreValve Evolut R Medtronic Porcine Nitinol 23, 26, 29, 31 TF, TAO SCL 18 Self- Yes No Yes Yes Engager Medtronic Nitinol 23, 26 TA 29 Self- Yes No Yes No Direct Flow Medical Valve Direct Flow Medical No stent polyester fabric cuff 23, 25, 27, 29 TF, SCL 18 Inflation of ring balloons by a polymer Yes Yes Yes No JenaValve JenaValve Technology Porcine native aortic valve Nitinol 23, 25, 27 TA 32 Self- Yes Yes Yes No Sadra Lotus Medical Boston Scientific Nitinol 23, 27 TF 18 Self- Yes Yes Yes No Portico valve St. Jude Medical Porcine Nitinol 23, 25 TF 18 Self- Yes No Yes No Symetis Acurate Symetis Porcine native aortic valve Nitinol 23, 25, 27 TF, TA 18 TF, 28 TA Self- Yes No Yes No Trinity Transcatheter Nitinol 20 TA, TF 30 Self- Yes Yes No No Heart Leaflet Heart Leaflet Porcine Nitinol 21, 23 TF 18 Self- Yes Yes No No Colibri Heart Valve Colibri Heart Valve Porcine Stainless TF 14 No No No No TA, transapical; TAO, transaortic; TF, transfemoral; SCL, subclavian

4 図 2 New generation THVs a Direct Flow Medical b Symetis ACURATE c JenaValve d Engager e Portico f Sadra Lotus Medical g CENTERA h Heart Leaflet i Trinity j Colibri Heart Valve. a, c, g j Bourantas CV, Serruys PW: Evolution of transcatheter aortic valve replacement. Circ Res 114: , 2014 b Maeda K, Kuratani T, Torikai K, et al: New Self-Expanding Transcatheter Aortic Valve Device for Transfemoral Implantation- Early Results of the First-in-Asia Implantation of the ACURATE Neo/TF(TM) System. Circ J 79: , e Portico and St. Jude Medical are trademarks of St. Jude Medical, Inc. or its related companies. Reprinted with permission of St. Jude Medical,. All rights reserved. d e f PVL aorta-lvot angle fitting Direct Flow Medical 図 2a THV THV Direct Flow Medical valve double polyester cuff cuff cuff cuff positioning cuff polymer Schofer device success PVL 1.4 9) Symetis ACURATE 図 2b Stabilization arches upper crown inner and outer anti-pvl skirts 2 upper crown upper crown stabilization arch delivery sheath positioning self-seating PVL self-sealing ACURATE TA registry success rate PVL ) JenaValve 図 2c 2 3 feeler native valve positioning JenaClip anchoring system JenaClip feeler JenaClip native valve paper clip mechanism Native valve PVL JUPITER registry PVL 1 11) Engager 12) 図 2d Medtronic BEV JenaValve main frame support frame 2 support frame native aortic leaflet JenaValve feeler polyester sleeve main frame

5 support frame native leaflet THV Seiffert Engager JenaValve Symetis PVL PVL 13) CENTERA 14) 図 2g SEV CENTERA BEV SAPIEN nitinol stent SAPIEN cobalt chromium SAPIEN radial force valve deployment motorized system manual unsheathing deployment unsheathing THV positioning Sadra Lotus Medical 図 2f THV deploy release positioning release nitinol adaptive seal Gooley PVL CoreValve 16.7 Lotus ) 4. 終わりに 2002 epoch-making TAVI TAVI sutureless valve TMVI THV THV COI 文献 1) Bourantas CV, Serruys PW: Evolution of transcatheter aortic valve replacement. Circ Res 114: , ) Agarwal S, Tuzcu EM, Krishnaswamy A, et al: Transcatheter aortic valve replacement: current perspectives and future implications. Heart 101: , 3) Maeda K, Kuratani T, Torikai K, et al: New Self-Expanding Transcatheter Aortic Valve Device for Transfemoral Implantation- Early Results of the First-in-Asia Implantation of the ACURATE Neo/TF(TM) System. Circ J 79: , 4) Barbanti M, Leipsic J, Binder R, et al: Underexpansion and ad hoc post-dilation in selected patients undergoing balloon transcatheter aortic valve replacement. J Am Coll Cardiol 63: , ) Abdel-Wahab M, Mehilli J, Frerker C, et al; CHOICE investigators: Comparison of balloon- vs self valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA 311: , ) Adams DH, Popma JJ, Reardon MJ, et al; U.S. CoreValve Clinical Investigators: Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 370: , ) Généreux P, Head SJ, Hahn R, et al: Paravalvular leak after transcatheter aortic valve replacement: the new Achilles heel? A comprehensive review of the literature. J Am Coll Cardiol 61: , ) Mack MJ, Leon MB, Smith CR, et al; PARTNER 1 trial investigators: 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet 385: , 9) Schofer J, Colombo A, Klugmann S, et al: Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. J Am Coll Cardiol 63: 763-8, ) Kempfert J, Holzhey D, Hofmann S, et al: First registry results from the newly approved ACURATE TA TAVI system. Eur J Cardiothorac Surg 48: , 11) Wendler O, Kappert U, Ensminger S, et al: The JUPITER registry: thirty-day primary endpoint results of a second generation transapical TAVI system. EuroPCR ) Sündermann SH, Holzhey D, Bleiziffer S, et al: Medtronic Engager bioprosthesis for transapical transcatheter aortic valve implantation. EuroIntervention 9 Suppl: S97-100, ) Seiffert M, Conradi L, Kloth B, et al: Single-centre experience with next-generation devices for transapical aortic valve implantation. Eur J Cardiothorac Surg 47: 39-45, 14) Binder RK, Schäfer U, Kuck KH, et al: Transcatheter aortic valve replacement with a new self-expanding transcatheter heart valve and motorized delivery system. JACC Cardiovasc Interv 6: 301-7, ) Gooley RP, Talman AH, Cameron JD, et al: Comparison of Self-Expanding and Mechanically Expanded Transcatheter Aortic Valve Prostheses. JACC Cardiovasc Interv 8: ,