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Contemporary TAVI: 7 Years Experience from the “Holy Land”
Haim Danenberg Hadassah Hebrew University Medical Center Jerusalem, Israel CRT, Washington DC , March 24, 2015
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Disclosures Speaker's name: Haim Danenberg
I have the following potential conflicts of interest to report: Consultant: CardioSert, ITGI medical, NitiLoop, EndoCross Proctor: MEDTRONIC Stockholder of a healthcare company: CardioNiti, Great Aspirations
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Background Trans-catheter aortic valve implantation (TAVI) is an emerging novel technology for the treatment of aortic stenosis. There are several commercially available valve systems:
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TAVI in Israel: Innovation
PVT / EDWARDS Ventor / Medtronic Valve Medical Paeion Imaging Closure devices (InSeal, Novogate..) Dedicated wires.. More in the pipeline..
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TAVI in Israel: timeline
First cases: August 2008 –Sapien September 2008 – CoreValve November Lotus January 2010: full reimbursement for TAVI 2011: Establishment of I-TAVI, Israel TAVI ongoing registry.
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10 Centers: Carmel, Haifa Rambam, Haifa Rabin, Petach-Tikva
Tel-Aviv MC, Tel-Aviv Sheba, Ramat-Gan Wolfson, Holon Kaplan, Rechovot Shaare Tzedek, Jerusalem Hadassah, Jerusalem Soroka, Beer Sheba All 10performing at least two valve systems (CV&ES) x2 x5 x2 x1
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2273 Year CoreValve Sapien Portico Lotus Total 2008 17 15 32 2009 59
32 2009 59 42 101 2010 75 55 130 2011 270 215 485 2012 260 250 510 2013 290 200 490 2014 285 220 6 517 1,256 997 2273
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Size doesn’t matter..
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TAVI cases in EU (2011) / Million habitants In 2012: 64/mill
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Diastolic parameters following TAVI
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Israel I-TAVI registry
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Israel I-TAVI registry
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Collection of data All 10 centers: partial data (valve type, approach, mortality) 5 centers (700 patients): full clinical and procedural data Cross check total numbers with both commerical companies
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Patient Characteristics
Mean +/- SD 82± 6 Age (years) 23.3±15 Logistic EuroSCORE (%) 57.3% Female 30 ( ) BMI I-II: 5% III-IV: 95% NYHA 30% DM 11.8±3.9 Hb (g/dl) 1.18±0.67 Creatinine (µmol/L)
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Baseline Characteristics
0.66±0.17 AV area (cm2), hemod 76±23 AV grad, max (mmHg) 48±16 AV grad, mean (mmHg) 54±10 LVEF (%) 22.2±2.1 Annulus (mm) 8 MR (severe, %)
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TAVI in Israel Total implants: 1495
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Procedural Parameters
% 99 Procedural success 56 Local Anesthesia 40 TEE 76 Local Anesth ( ) 3 2nd valve needed
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Mortality – 30d. Total implants: 1495 %
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Mortality – long term
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Adverse Events 4.7% Death Aortic Dissection 2% Cardiac Tamponade 11.2%
Cardiac Tamponade 2% Access Site Complication 11.2% Blood transfusion 18% Myocardial Infarction Pacemaker 21% (29%MDT /6%ES) Renal Failure 3% Major Stroke 2.2% Discharge day (median) >10 d 6 15% 22
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Change in NYHA FC
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TAVI in Israel – Conclusions:
Transcatheter Aortic Valve Implantation is rapidly expanding in Israel The procedure is safe and effective with favorable results in this complex group of high-risk patients Further expansion of the procedure and its indications and improvement of its results and outcome is awaited.
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A glimpse into the future: Valve Medical - True 12 Fr access TAVI system
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TAVI: the team
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Thanks …N. Khader, R. Jaffe, A. Elami, A. Kerner, A. Rogouin, G. Bollotin, R. Kornowski, A. Assali, C. Vaknin-Assa , A. Finkelstein, S. Bazan, Y. Ben-Gal, V. Guetta, A. Segev, E. Raanani, V. Turkisher, Y. Almagor, J. Balkin, S. Silberman, C. Lotan, D. Planer, A. Korach, K. George, O. Ayzenberg, G. Gendelman, C. Cafri, A. Abu-Ful, M. Merkin...
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