3 years after introduction of TAVI in QEH. Michael KY Lee On Behalf of QEH TAVI Heart Team Queen Elizabeth Hospital Hong Kong
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1 3 years after introduction of TAVI in QEH Michael KY Lee On Behalf of QEH TAVI Heart Team Queen Elizabeth Hospital Hong Kong HA Convention 2014
2 Introduction Aortic Stenosis most common valvular heart disease in the elderly 4.6% in adults 75 years of age Once symptomatic, average survival 2-3 years with high risk of sudden death TAVI (Transcatheter Aortic Valve Implantation) or TAVR (Transcatheter AV Replacement) has emerged as a viable alternative in inoperable or high risk elderly patients with symptomatic AS 5-10% immediate complications 30-day mortality of 5.6% % Reduces all-cause mortality by 27% at 3 years
3 CoreValve Transcatheter Procedure Balloon catheter threaded through sheath and into heart CoreValve placed into position over the diseased aortic valve CoreValve in place, procedure completed Experimental Device in the United States and Limited by Federal Law to Investigational Use.
4 TAVI Program in QEH High-risk procedure Multi-disciplinary Heart Team formed in 2009: Interventional Cardiologists Echo Cardiologists Cardiac Surgeons Cardiac Anaesthesiologists Radiologists Cardiac Nurses
5 Since 2002, >120,000 TAVI procedures have been performed in >700 international sites Asia: 33 TAVI centres in 11 Asian countries
6 Country Current Status of TAVI in Asia MDT CoreValve EDW Sapien Venus A- Valve Symetis Acurate Total China Taiwan Hong Kong Korea Japan 81 A 407 B Singapore Philippines Malaysia Thailand Vietnam India TOTAL A Include CoreValve Japan Trial and Private Import Cases Updated Apr 30 th, 2014 B Include Sapien AMT Trial, Sapein XT Japan Trial and commercial launch since Oct 2013
7 Hong Kong Experience Dec 2010 Queen Elizabeth Hospital Nov 2011 Prince of Wales Hospital June 2013 Union Hospital May 2011 HK Adventist Hospital Dec 2012 Queen Mary Hospital
8 Hong Kong Experience Medtronic CoreValve - 61 Edwards Sapien Queen Elizabeth Hospital HK Adventist Hospital Prince of Wales Hospital Queen Mary Hospital Union Hospital TOTAL: 66
9 QEH Registry Characteristics (N = 34) Age (yrs.) Males 22 (64.7%) Procedural Success 97.1% In-hospital Mortality 2.9% 30-day Mortality 2.9% Number (%) or Mean± SD 81.2 ± 5.4 (67 97 years old) 1 subclavian vascular complication treated with stent graft 2 femoral artery dissection with stenting done All femoral wounds closed with Prostar/Proglide x 2 One patient developed coronary artery occlusion after CoreValve implantation. Urgent surgical AVR done with ECMO support. Passed away on Day 2. One patient had PCI to LAD done before TAVI, returned for NSTEMI and with redo-pci done, died 3 months after TAVI because of acute coronary stent thrombosis One patient died of pneumonia and end-stage COPD 1 year after TAVI All patients have functionally normal CoreValve with trivial to mild AR except 3 with mild to mod AR
10 Procedure Direct Aortic 0% Subclavian 2.9% 26mm 31mm 29mm 52.9% 5.9% 41.2% Transfemoral 97.1%
11 Asia CoreValve Registry Participating Centers Country Hong Kong Hong Kong South Korea South Korea Singapore Malaysia Taiwan Taiwan Thailand Philippines China China Center QEH PWH AMC SNUH NHC IJN NTUH Cheng Hsin Chulalongkorn St Luke Chengdu Shanghai
12 Characteristics Comparison of QEH Registry Asia Registry ADVANCE Characteristic QEH Registry N = 34 Asia Registry N = 285 ADVANCE N = 996 Age (yrs.) 81.2 ± ± ± 6 Males 64.7% 54% 49.4% Mean Log EuroSCORE 19.4 ± 12.0% 22 ± 19% 19.2 ± 12.4% Weight (kg) 57.2 ± ± 12.2 NR Height (cm) ± ± 9 NR Mean NYHA 2.7 ± ± 0.7 NR MPG (mmhg) 51.6 ± ± AVA (cm 2 ) 0.7 ± ± LVEF 55.5 ± 11.5% 51 ± 22% NR NR= Not Reported
13 30-day Outcomes Comparison of QEH Registry Asia Registry ADVANCE Variables QEH Registry N = 34 Asia Registry N=285 ADVANCE N=996 Mortality 2.9% 3.2% 4.5% Stroke 0% 1.8% 2.9% NYHA NR Pacemaker Implantation 14.7% 15.4% 26.3% NR= Not Reported
14 30-Day All-Cause Mortality 1. Medtronic Data on File. COR : 18 Fr Safety & Efficacy Study Re-Analysis, August 14, Meredith. VARC-adjudicated Outcomes in Inoperable and High Risk AS Patients. TCT 2010, Washington, DC. 3. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63: Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 5. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 6. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 7. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 8. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
15 Primary Endpoint: 1 Year All-cause Mortality ACC 2014 Surgical Transcatheter 19.1% 14.2% 4.5% P = 0.04 for superiority 3.3% 16
16 30-Day Stroke Rate 20.0% 15.0% 10.0% 9.6% 5.0% 0.0% 4.5% 4.0% 4.0% 1.9% 2.5% 1.7% 1.8% 0.0% 18 Fr S&E 1 ANZ 2 French 3 Belgian 4 German 5 UK 6 Italian 8 Asia QEH 1. Medtronic. Data on file. COR : 18 Fr Safety & Efficacy Study Re-Analysis, August 14, Meredith. VARC-adjudicated Outcomes in Inoperable and High Risk AS Patients. TCT 2010, Washington, DC. 3. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 4. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 5. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 6. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 7. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
17 Pacemaker Implantation Rates Across Studies 1. Meredith I.T. 12 Month Results from ANZ CoreValve TAV Study. Presented at: TCT Avanzas P, et al. Rev Esp Cardiol. 2010;63: Cribier A. FRANCE II Multicenter TAVR Registry. Presented at: TCT Bosmans J. Belgian TAVI Registry. Presented at: London Valves Zahn R., et al. European Heart Journal. 2011; 32: Moat N.E., et al. JACC. 2011; Brito F.S. Brazilian Registry. Presented at TCT Petronio AS. Italian Registry. Presented at: EuroPCR Ruiz C.E. Weighted meta-analysis of CoreValve Outcomes.Presented at: EuroPCR 2011 (analysis sponsored by Medtronic, Inc.).
18 QEH Symptom Status (NYHA Class) 100% NYHA Classification 80% 36% 60% 61% 86% Class I Class II 40% 20% 57% 32% Class III Class IV 0% 7% 7% 14% Pre-TAVI Post-TAVI 30-day Post-TAVI 6-month * NYHA: New York Heart Association Functional Classification for Heart Failure Stages (Class I = Best, Class IV = Worst)
19 Meters 6-Minute Walk Test Pre-TAVI Post-TAVI Paired-sample t-test: p<0.05
20 Measurement for Quality of Life (SF-12) Physical Component Pre-TAVI Post-TAVI Mental Component Score Physical Component Paired-sample t-test: p<0.05 Mental Component Paired-sample t-test: p<0.05
21
22 Pre TAVI (n = 34) 1 month Post TAVI (n = 32) 1 year Post TAVI (n = 23) 2 years Post TAVI (n = 13) 3 years Post TAVI (n = 5) AVA / / / / / MPG / / / / / Cumulative Mortality % 8.8% 8.8% 8.8%
23 Mean Gradient & Valve Area QEH Registry The PARTNER Trial CoreValve ADVANCE Study
24 2-Year All-cause Mortality ACC 2014 QEH TAVI 14.2% 8.8% 25
25
26 Surgical AVR The Past TAVI The Future
27 Conclusions TAVI rapid adoption worldwide as a viable treatment option for inoperable or high-risk symptomatic severe AS patients Improve survival with better quality of life (QoL) and functional capacity Multi-disciplinary Heart Team approach Promising short- and intermediate-term outcome results in Hong Kong Benefits maintained at 3 years after TAVI
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