docKnife or Cath? The Future of Cardiac Surgery is in Percutaneous
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Knife or Cath? The Future of Cardiac Surgery is in Percutaneous
Knife or Cath? The Future of Cardiac Surgery is in Percutaneous Interventions - PRO Friedrich-Wilhelm Mohr, MD, PhD Heart Center Leipzig, Germany AATS 2014, Toronto Transcatheter aortic valve implantation “A revolutionary breakthrough in heart valve technology” (ABC News presented by Martin Leon 01/2009) AVR: The Surgeons domaine in the past, maybe one of the most successful treatment Perspective: ESC 2003 AVR Innovation >> new market All Pat. with AS Growth and sales Careful balance: Percutaneous Intervention Surgeons and Cardiologists Critical View: PCI story? Pat. having surgery Rapid growth in TAVI over the next years Market US market (US$ mil.) European market (US$ mil.) 2008 2009 2010 2011 2012 2013 2014 2008 2009 2010 2011 2012 2013 2014 Tissue Valve Mechanical Annuloplasty TAVI Source: Millenium Research 2009 US and Millenium Research 2009 EU A DEAL WITH THE DEVIL ? The early introduction in Leipzig Hybrid OR Team Approach 2006-2011 Sapien XT Corevalve + CE Mark 2012 Sapien XT Symetis Acurate Corevalve Jenavalve Portico Engager + new valves 2013 Sapien XT Corevalve Symetis Acurate Jenavalve Centera HLT Portico Lotus Engager + new versions of „old“ valves Sapien XT Sapien 3 Symetis Acurate Jenavalve Centera HLT Corevalve Portico Lotus Corevalve Evolute Engager © DGTHG-Leistungsstatistik 2013 AVR at HC Leipzig Isolated AV - Surgery conventional transcatheter (TV + TA) 491 365 402 402 427 318 475 461 341 441 435 378 219 61 2005 2006 91 2007 2008 2009 Year 2010 2011 2012 Isolated AVR / AVI - Leipzig 2008 80 Log. ES [%] TA-AVI (n=100, Mort. 8%) 60 40 p < 0.001 20 0 Conventional AVR (n=430, Mort. 2,1%) Age 0 20 40 60 80 100 TAVI at the high risk patient cohort, too high? TAVR „Anything can happen“ Paravalvular leak Arrhythmia (AV Block) Access related complications (bleeding etc.) Malpositioning Dislocation Annular rupture Durability ? „The impossible became possible“ Valve-in-a-valve: Degenerated Xenograft Valve in a ring post MVR + PCI RCA Choice of different valves for TAVI Matrix of Invasiveness Patient: less invasive TF TAVI punkture minithoracotomy AVR MIC TA/ DAo TAVI ministernotomy full sternotomy Conv. AVR HLM without HLM without general anaesthesia Physician: less invasive Matrix of Invasiveness Patient: less invasive TF TAVI punkture minithoracotomy AVR MIC AVR MIC TA/ DAo TAVI Conv. AVR TF TAVI long term results? TA/ DAo TAVI ministernotomy full sternotomy Conv. AVR HLM without HLM without general anaesthesia Physician: less invasive Primary Endpoint: 1 Year All-cause Mortality ACC 2014 Surgical Transcatheter 19.1 % 4.5% 14.2 % P = 0.04 for superiority 3.3 % 23 „The Old Times“ 2006 Sapien XT Corevalve The search for the ideal transcatheter valve - low gradients, large EOA no paravalvular leaks small delivery catheter no strokes positioning aids easy implantation repositionable, retrievable durable subcoronary position anatomical positioning low PM rate suitable for all valve sizes 2011-2013 Sapien XT Symetis Acurate transapical era Corevalve Jenavalve Engager Symetis • AcurateTM TA • CE mark 11/2011 • More than 1.500 implants • TF system in clinical trial Acurate Valve Conclusions AccurateTM, Symetis Jenavalve • • • • JenavalveTM TA CE mark 11/2011 More than 1500 Implants TF system in development Jena Valve Conclusions JenaValve Jena Valve Conclusions JenaValve Medtronic Engager Valve Design • Control arms • Self-expanding nitinol frame and polyester skirt • Supra-annular valve function • Anatomic alignment • Bovine pericardial tissue Engager │System Advantages • Control arms capture native leaflets and self-expanding frame conforms to native annulus to minimize PVL • Fixation of native leaflets and true commissure to commissure alignment ensures clearance for coronary ostia • Stent design allows less crimping forces and pericardial thickness equal to surgical valves for maximum durability • Supra-annular valve position facilitates uncompromised valve function even in elliptical annuli • Control arms provide tactile feedback and secure device during deployment 29 Fr Engager │Procedure Positioning & Deployment Outcomes 2013-2014 new transfemoral era Sapien XT Symetis Acurate Lotus Corevalve Jenavalve Portico Engager Direct flow Centera HLT 2013-2014 new transfemoral era Sapien XT Sapien 3 Corevalve Symetis Acurate Jenavalve Engager Lotus Portico Direct flow Corevalve Evolute Centera HLT Edwards SAPIEN 3 20, 23, 26 and 29 mm sizes Balloon‐expandable Cobalt Chromium Frame The Edwards SAPIEN 3 is an investigational device and not available for commercial sale Bovine Pericardial Tissue Leaflets External Sealing Ring Edwards Certitude Delivery System 18F TA / TAo System with SAPIEN 3 Valve • Designed for TA and TAo approach • • • Refined distal tip for retrograde crossing Articulation for coaxial alignment Ease of use • Dramatically reduced profile • 18F for 20/23/26 mm • 21F for 29 mm valve • • • • • 55 cm working length Pusher-less design Smaller and lighter handle Size by volume for balloon prep CE Mark Clinical Trial to begin Q4 2012 Commander Delivery System 14/16F e-sheath Refined Flex Catheter • Improved distal flexing • Crossing in challenging anatomies • Control of co-axiality for valve positioning and deployment NovaFlex+ The Edwards SAPIEN 3 is an investigational device and not available for commercial sale Commander Next Generation eSheath 2 Design • Incorporate proprietary high elastic polymeric outer layer to maximize expansion and durability. Elastic Outer Layer HDPE /Tecoflex Layer HDPE /Tecoflex Layer PTFE liner PTFE liner eSheath eSheath 2 Videos S3 Progress in Innovation Design Goal: Overcome Clinical Barriers Adapts to fit a broad range of annuli CoreValve Evolut *CoreValve & Evolut have NOT obtained FDA approval. They are not approved in the US for commercialization. CoreValve Progress in Innovation InVia™ Delivery System Design Goals 1 2 Enables predictable deployment through an intuitive handle with 1:1 response and improved valve release Enhances insertion and tracking via a low profile, 18Fr catheter with hydrophilic coating 3 Facilitates delivery with an optional shorter-length catheter for subclavian and direct aortic access *InVia Delivery System has NOT obtained CE Mark or FDA approval. It is not approved in Europe or the US for commercialization. 4 Resheath & Reposition Progress in Innovation Integrated Sheath Design Goals ID and OD of Cook 18FR* ID Becomes Effective Delivery Profile 21.8FR (OD) 18FR 18FR 18FR 18FR 23mm 26mm 29mm 31mm 18FR Medtronic’s Next Generation System includes the option to reduce the outer diameter (OD), which is typically added by the external sheath, by 3‐4 FR Design Goal: Reduce Vascular Complications by Decreasing OD profile Boston Scientific • LotusTM • TF • clinical trial completed Lotus Valve St. Jude Medical • PorticoTM • TF 23mm / 25mm • CE mark 12/2012 • 27mm and 29mm TF in clinical trials Portico™ One Valve – Two Delivery Systems Transfemoral • 18F outer diameter • Designed for flexibility and trackability • Annulus first deployment • Majority of stent can be unsheathed allowing leaflet functionality, to assess: • Valve placement • Repositioning • Retrieval of valve, if necessary Fully Sheathed Partially Unsheathed Functioning leaflets during deployment Majority Unsheathed 59 The Portico system is not available for sale. Portico Portico Portico Portico Which valve for which patient Symetis Acurate Jenavalve Sapien 3 Portico Direct flow Lotus Corevalve Engager Which valve for which patient Sapien 3 Jenavalve Corevalve Symetis Acurate Lotus Portico Direct flow Engager Which valve for which patient Sapien 3 Symetis Acurate Jenavalve Corevalve 80-90% Lotus Portico Direct flow Engager Which valve for which patient Sapien 3 Jenavalve transapical Symetis Acurate Engager Which valve for which patient Sapien 3 Symetis Acurate Jenavalve transfemoral subclavian direct aortic Corevalve Lotus Portico Direct flow Engager Which valve for which patient Symetis Acurate Jenavalve Corevalve very old & fragile Portico Direct flow Engager Lotus Which valve for which patient Sapien 3 Symetis Acurate bicuspid Corevalve Which valve for which patient Jenavalve aortic regurgitation Engager Corevalve Which valve for which patient Sapien 3 Symetis Acurate Corevalve Valve-in-valve Portico Engager Which valve for which patient Sapien 3 + Very large anulus Corevalve Which valve for which patient Sapien 3 Symetis Acurate Jenavalve CAD PCI likely Corevalve Lotus Portico Direct flow Engager Which valve for which patient Sapien 3 Symetis Acurate Jenavalve Redo AV likely Portico Direct flow Corevalve Which valve for which patient Jenavalve Symetis Acurate Anulus size unclear No CT Engager Corevalve Which valve for which patient Sapien 3 Mitral / tricuspid Valve-in-valve / ring The search for the ideal transcatheter valve goes on - low gradients, large EOA no paravalvular leaks small delivery catheter no strokes positioning aids easy implantation repositionable, retrievable durable subcoronary position anatomical positioning low PM rate suitable for all valve sizes The search for the ideal transcatheter valve goes on - low gradients, large EOA no paravalvular leaks small delivery catheter no strokes positioning aids easy implantation repositionable, retrievable durable subcoronary position anatomical positioning low PM rate suitable for all valve sizes - all (almost) Sapien 3, Lotus S3, Corevalve, Portico ? Symetis, Jenavalve, Engager Engager, Jenavalve, Symetis Portico, CV Evolute, Lotus ? S3, Symetis, Enager, Jenavalve Symetis, Enager, Jenavalve Symetis, jenavalve Portico ? Thank you Pivotal Trial Design ACC 2014 83 Primary Endpoint: 1 Year All-cause Mortality ACC 2014 Surgical Transcatheter 19.1% 14.2% 4.5% P = 0.04 for superiority 3.3% 84 2-Year All-cause Mortality ACC 2014 85 All-Cause Mortality or Major Stroke ACC 2014 86 Limitations • More patients refused surgical replacement after randomization assignment than refused transcatheter replacement (there were no important differences between treated and withdrawn patients) • Patients had a lower 30-day mortality rate than was specified in our study inclusion criteria, and the trial population may have been at lower risk than was intended 87 Conclusion • We assessed the safety and effectiveness of TAVR with the CoreValve prosthesis compared to surgical valve replacement in symptomatic patients with severe aortic stenosis at increased surgical risk • We found that survival at 1 year was superior in patients that underwent transcatheter replacement with CoreValve 88 Kaplan-Meier mortality by procedure Euro-Score log-rank test p-values AVR+ CABG TV TAVI TA TAVI log-rank test p-values AVR < 0.001 < 0.001 < 0.001 AVR < 0.001 < 0.001 AVR+CABG (GH: <0.001) AVR+CABG (GH: =0.001) 0.376 TV TAVI log-rank test p-values (GH: <0.001) AVR+ CABG TV TAVI TA TAVI AVR+CABG TV TAVI 0.005 < 0.001 TA TAVI 0.200 < 0.001 0.282 0.135 0.003 TV TAVI log-rank test p-values (GH: <0.001) AVR+ CABG 0.164 TV TAVI TA TAVI 0.103 < 0.001 0.836 0.012 < 0.001 AVR+CABG 0.162 TV TAVI 0.041 AVR AVR AVR+ CABG < 0.001 TV TAVI < 0.001 0.011 89 Kaplan-Meier mortality by procedure German AV-Score (AKL-Score) 90