人工臓器 最近の進歩 Transcatheter aortic valve implantation. Current status and future perspectives Kentaro HAYASHIDA 1. はじめに 1970 Carpentier-Edwards surgical aortic valve replacement, SAVR activity of daily living ADL 1 transcatheter aortic valve implantation, TAVI TAVI SAVR TAVI TAVI 2002 Rouen Cribier 1 1) 2007 CE 2011 Edwards Lifesciences Sapien valve Food and Drug Administration FDA 7 TAVI 2 TAVI 著者連絡先 160-8582 35 E-mail. k-hayashida@umin.ac.jp 図 1 2010 TAVI SAVR 200 percutaneous coronary intervention, PCI 600 33 TAVI TAVI national registry 2) 2. TAVIにおける周術期死亡率の低下 TAVI 2006, 2007 TAVI transfemoral-tavi, TF-TAVI 20 30 図 2 2012 TF-TAVI 30 5 TAVI TAVI 3. 欧米における経験をいかに日本の患者に応用するか? TAVI TAVI simulate body surface area, BSA 42 3 2013 175
(a) (b) 30-day mortality in Massy 図 1 transcatheter aor tic valve implantation TAVI device a Edwards Sapien XT. Balloon expandable; cobalt chromium; bovine pericardium; 16 18 Fr sheath; 20, 23, 26 and 29 mm, b Medtronic CoreValve. Self expandable; nitinol; porcine pericardium; 18 Fr sheath; 23, 26, 29 and 31 mm. 図 2 30 Institut Cardiovasculaire Paris Sud ICPS 2006 transcatheter aortic valve implantation TAVI 5 表 1 Variables PREVAIL Japan Small Large P value BSA < 1.75 BSA 1.75 small vs large body size Patient number 64 215 209 BSA 1.41 0.14 1.59 0.11 1.89 0.11 0.001 Annulus size TEE mm 20.5 1.3 21.3 1.6 22.8 1.9 0.001 Femoral artery mm 7.59 1.06 8.29 1.34 0.001 Annulus rupture 1 1.6 5 2.3 1 0.5 0.11 Major vascular complication 6.3 13.0 4.3 0.001 BSA body size area, TEE trans-esophageal echocardiogram. Watanabe Y, Hayashida K, Lefèvre T, et al: Transcatheter aortic valve implantation in patients of small body size. Cathether Cardiovasc Interv, [Epub ahead of print], 2013 TAVI 1.75 cutpoint small body size large body size 表 1 small body size large body size 21.3 1.58 vs 22.8 1.86 mm P 0.01 7.59 1.06 vs 8.29 1.34 mm P 0.01 2.3 vs 0.5 P 0.11 major vascular complication 13.0 vs 4.3 P 0.01 3) small body size 2012 Edwards Sapien XT TAVI PREVAIL Japan BSA 1.4 0.14 m 2 small body size 1.59 0.11 m 2 表 1 PREVAIL Japan 1 6.3 TAVI 4. 大動脈弁輪径の計測の重要性 device landing zone rupture 4),5) 図 3 Sapien valve CoreValve Medtronic TAVI sizer 176 42 3 2013
図 3 Sapien XT valve 1 1 contrast protrusion (a) (b) 図 4 AR Mild AR ICPS Hayashida K, Lefèvre T, Chevalier B, et al: Impact of post-procedural aortic regurgitation on mortality after transcatheter aortic valve implantation. JACC Cardiovasc Interv 5: 1247-56, 2012 AR aortic regurgitation, ICPS Institut Cardiovasculaire Paris Sud. 図 5 Computed tomography CT a 24.2 mm 31.7 mm b geometric mean 26.7 mm paravalvular leak 30 6) 1 7) mild paravalvular leak 8) 9) 図 4 3 virtual ring 図 5a 3 2D computed tomography CT 10) 12) TAVI 13) 14),15) CT 図 5b 16) 3D 3 17) 3D 5. 血管アクセスの評価 TAVI major vascular complication 18),19) transfemoral approach 1 mobile plaque alternative approach transapical approach trans-subclavian approach major vascular complication sheath to femoral artery ratio, SFAR 19) 表 2 SFAR cut point 1.05 図 6 1.1 1.0 42 3 2013 177
表 2 SFAR major vascular complication Variables Multivariate P value Odds ratio 95 CI Early experience 0.016 4.02 1.30 12.50 Calcium score of FA 0 3 0.010 2.19 1.20 3.99 SFAR 0.003 119 3.03 4.686 Sheath size Fr 0.140 CI confidence interval, FA femoral artery, SFAR sheath to femoral artery ratio. Hayashida K, Lefèvre T, Chevalier B, et al: Transfemoral aortic valve implantation new criteria to predict vascular complications. JACC Cardiovasc Interv 4: 851-8, 2011 図 6 SFAR threshold SFAR 1.05 major vascular complication 1.1 1.0 AUC of ROC area under the cur ve of receiver operating characteristic, SFAR sheath to femoral artery ratio. 図 7 ICPS Massy, France TAVI TAVI TAVI ICPS Institut Cardiovasculaire Paris Sud, SAVR surgical aortic valve replacement, TAVI transcatheter aortic valve implantation. Hayashida, et al. 21 CVIT 2012 Vancouver 20) 6. Heart team approachの重要性 imaging specialist TAVI 18 Fr PCI early experience CT heart team approach 7. TAVIのSAVR 件数に与える影響 2004 2012 Institut Cardiovasculaire Paris Sud Massy, France SAVR TAVI 図 7 TAVI SAVR 180 2006 2011 350 TAVI SAVR win-win SAVR TAVI 2011 SAVR TAVI TAVI heart team 178 42 3 2013
(a) (b) 図 8 Sapien XT a b mistake major problem 2007 CE TAVI team Japan 8. 将来への展望 TAVI 2013 first in man 1) 11 valve in valve 図 8 valve in valve Edwdards Lifesciences Sapien XT 2013 6 10 Medtronic CoreValve Sapien, CoreValve 1 2 CE CE 9. 最後に TAVI TAVI minor 利益相反の開示 Edwards Lifesciences TAVI 文献 1) Cribier A, Eltchaninoff H, Bash A, et al: Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aor tic stenosis: first human case description. Circulation 106: 3006-8, 2002 2) Gilard M, Eltchaninof f H, Iung B, et al: Registr y of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 366: 1705-15, 2012 3) Watanabe Y, Hayashida K, Lefèvre T, et al: Transcatheter aortic valve implantation in patients of small body size. Cathether Cardiovasc Interv, [Epub ahead of print], 2013 4) Pasic M, Unbehaun A, Dreysse S, et al: Rupture of the device landing zone during transcatheter aor tic valve implantation: a life-threatening but treatable complication. Circ Cardiovasc Interv 5: 424-32, 2012 5) Hayashida K, Bouvier E, Lefèvre T: Successful management of annulus rupture in transcatheter aortic valve implantation. JACC Cardiovasc Interv 6: 90-1, 2013 6) Abdel-Wahab M, Zahn R, Horack M, et al: Aor tic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry. Heart 97: 899-906, 2011 7) Tamburino C, Capodanno D, Ramondo A, et al: Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation 123: 299-308, 2011 8) Kodali SK, Williams MR, Smith CR, et al: Two-year outcomes after transcatheter or surgical aor tic-valve replacement. N Engl J Med 366: 1686-95, 2012 9) Hayashida K, Lefèvre T, Chevalier B, et al: Impact of postprocedural aor tic regurgitation on mor tality after transcatheter aortic valve implantation. JACC Cardiovasc Interv 5: 1247-56, 2012 10) Schultz CJ, Moelker AD, Tzikas A, et al: Cardiac CT: necessar y for precise sizing for transcatheter aor tic implantation. EuroIntervention 6(Suppl G): G6-G13, 2010 11) Messika-Zeitoun D, Serfaty JM, Brochet E, et al: Multimodal assessment of the aortic annulus diameter: implications for 42 3 2013 179
transcatheter aortic valve implantation. J Am Coll Cardiol 55: 186-94, 2010 12) Piazza N, de Jaegere P, Schultz C, et al: Anatomy of the aortic valvar complex and its implications for transcatheter implantation of the aortic valve. Circ Cardiovasc Interv 1: 74-81, 2008 13) Schultz C, Rossi A, van Mieghem N, et al: Aortic annulus dimensions and leaflet calcification from contrast MSCT predict the need for balloon post-dilatation after TAVI with the Medtronic CoreValve prosthesis. EuroIntervention 7: 564-72, 2011 14) Willson AB, Webb JG, Labounty TM, et al: 3-Dimensional aortic annular assessment by multidetector computed tomography predicts moderate or severe paravalvular regurgitation after transcatheter aortic valve replacement: a multicenter retrospective analysis. J Am Coll Cardiol 59: 1287-94, 2012 15) Jilaihawi H, Kashif M, Fontana G, et al: Cross-sectional computed tomographic assessment improves accuracy of aor tic annular sizing for transcatheter aor tic valve replacement and reduces the incidence of paravalvular aortic regurgitation. J Am Coll Cardiol 59: 1275-86, 2012 16) Hayashida K, Bouvier E, Lefèvre T, et al: Impact of CT-guided valve sizing on post-procedural aor tic regurgitation in transcatheter aortic valve implantation. EuroIntervention 8: 546-55, 2012 17) Zamorano JL, Badano LP, Br uce C, et al: EAE/ASE recommendations for the use of echocardiography in new transcatheter interventions for valvular heart disease. Eur Heart J 32: 2189-214, 2011 18) Généreux P, Webb JG, Svensson LG, et al: Vascular complications after transcatheter aortic valve replacement: insights from the PAR TNER (Placement of AoR Tic TraNscathetER Valve) trial. J Am Coll Cardiol 60: 1043-52, 2012 19) Hayashida K, Lefèvre T, Chevalier B, et al: Transfemoral aortic valve implantation new criteria to predict vascular complications. JACC Cardiovasc Interv 4: 851-8, 2011 20) Toggweiler S, Gurvitch R, Leipsic J, et al: Percutaneous aortic valve replacement: vascular outcomes with a fully percutaneous procedure. J Am Coll Cardiol 59: 113-8, 2012 21) Hayashida K, Lefèvre T, Chevalier B, et al: T r ue percutaneous approach for transfemoral aor tic valve implantation using the Prostar XL device: impact of learning curve on vascular complications. JACC Cardiovasc Interv 5: 207-14, 2012 180 42 3 2013