TAVR Update: Open vs. Closed Future Directions
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1 TAVR Update: Open vs. Closed Future Directions Michael J. Reardon, M.D. Professor of Cardiothoracic Surgery Methodist DeBakey Heart & Vascular Center
2 Disclosures Advisory Board Medtronic Consultant Medtronic Corevalve trial Surgical local PI National steering committee National screening committee Publication committee SurTAVI trial National PI Steering committee Corevalve is not currently approved in the US
3 Access Routes Safe remote access to the aortic valve is imperative to success Transfemoral access is generally considered first if feasible If transfemoral is not feasible then options include; Subclavian Trans-apical Direct aortic
4 Considerations for Subclavian Access For 18 F sheath Corevalve Minimum 6 mm uncalcified or 7 mm calcified subclavian diameter Patent IMA bypass? Aortic angle Graft/ no graft?
5 Subclavian Access
6 Subclavian Access
7 2 year subclavian data Same survival as TF
8 Patent LIMA? Feasible and safe
9 Trans-apical Direct Aortic Most Direct Access for TAVR Neither limited by peripheral vascular status Neither limited by sheath size Neither limited by aortic angle Both avoid passing device across arch Both allow precise deployment due to proximity
10 Direct Aortic Access Can be done without a thoracotomy less pulmonary impairment Requires no injury to the myocardium Aorta moves much less than cardiac apex Bleeding around the sheath not a problem Can be used for Corevalve or Sapien Can replace ascending aorta All surgeons cannulate the aorta
11
12 Mini AVR Mini Sternotomy Mini thoracotomy
13 Mini Arch Hybrid Approach
14 Mini thoracotomy 2 patients done via small right anterior thoracotomy 2010
15 Mini Thoracotomy 6 patients done via small right anterior thoracotomy with 1 death 2011
16 Mini-Sternotomy patients with transaortic implant via upper hemi sternotomy
17 Direct Aortic Access Approaches Sternotomy Upper Mini Sternotomy Thoracotomy Port Access? Incision Location Sternotomy Upper Stern. Thoracotomy Port Incision Size 12+ cm 5+ cm 4-5 cm - - Visualization Direct Direct Direct Indirect
18 Thoracotomy or Sternotomy? What is behind the sternum?
19 Workflow CT DynaCT Valve Deployment Aortic Root Segmentation from CT & Planning for DA access Non-contrast DynaCT acquired & registered to DynaCT Overlay of landmarks from CT onto live fluoroscopy image
20 Planned Aortic Puncture area 6.8 cm Annulus Plane
21
22 Mini J Upper Sternotomy 6 cm incision Right 3 rd ICS Sternal notch down
23
24
25
26
27 Mini Sternotomy DA Access
28 11
29 Mini Thoracotomy DA Access
30
31 Direct Aortic and Subclavian Aceess will represent about 20% of the Corevalve trial No results will be released until the closure and publication of the trial 2013!
32 European experience of Direct Aortic TAVI with a Self-Expanding Prothesis Neil Moat 1, Hasan Bushnaq 2, Marjan Jahangiri 3, Domenico Mazitelli 4 Hafid Amrane 5, Marian Branny 6, Johan Bosmans 7, Mo Bhabra 8, Peter den Heijer 9, Uday Trivedi 10, Didier Tchetche 11, Rudiger Lange 4, Jean-Claude Laborde 3 and Giuseppe Bruschi 12 1 Royal Brompton, London UK; 2 Martin-Luther-University, Halle an der Saale, Germany; 3 St Georges Hospital, London, UK; 4 German Heart Centre Munich, Munich Germany; 5 Medisch Centrum Leeuwarden; 6 Hospital Podlesi, Czech Republic; 7 Antwerp University Hospital, Antwerp Belgium; 8 University of Birmingham, London UK; 9 Amphia Hospital Breda, Breda, The Netherlands; 10 Brighton and Sussex University Hospitals, Brighton UK; 11 Clinique Pasteur, Toulouse, France, 12 Niguarda Ca Granda Hospital, Milan, Italy Presented at the 48 th meeting of the STS, Fort Lauderdale, Florida, January 2012.
33 Centre Clinicians Cases; N=93 Niguarda Ca Granda, Milan, Italy Bruschi, Klugmann 23 Royal Brompton Hospital, London, UK Moat, Davies 13 Universitätsklinikum Halle, Germany Bushnaq, Ebelt 10 St Georges, London, UK Jahangiri, Brecker 9 German Heart Centre, Munich Mazzitelli,Lange 8 Medisch Centrum Leeuwarden, NL Amrane, van Boven 6 Hospital Podlesi, Czech Republic Branny, Branny 5 New Cross Hosp, Wolverhampton, UK Bhabra, Khogali 4 Antwerp University Hospital, Belgium Bosmans, Rodrigues 4 Amphia Ziekenhuis, Breda, NL Den Heijer, Bentala 4 Royal Sussex Hosp, Brighton, UK Trivedi, Hildick-Smith 4 Clinique Pasteur, Toulouse, Fr Tchetche, Garcia 3 Presented at the 48 th meeting of the STS, Fort Lauderdale, Florida, January 2012.
34 Procedural Data Minithoracotomy 49/93 (52.5%) Ministernotomy 44/93 (47.5%) Procedural success 92/93 (98.9%) Valve Size 26mm 36/92 (39.1%) Valve Size 29mm 50/92 (54.3%) Valve Size 31mm 6/92 (6.6%) Presented at the 48 th meeting of the STS, Fort Lauderdale, Florida, January 2012.
35 30 day Mortality 9/93 (9.7%) In-hospital Stroke 3/93 (3.2%) Thoracic Aortic Dissection 0/93 (0%) Life Threatening Bleed (VARC) 4/93 (4.3%) Major Vascular Injury (VARC) 4/93 (4.3%) Conversion to Full Sternotomy 4/93 (4.3%) New Permanent Pacemaker 16/93 (17.2%) Presented at the 48 th meeting of the STS, Fort Lauderdale, Florida, January 2012.
36 Results 93 patients underwent TAVI with the Medtronic CoreValve TM via Direct Aortic Access between 6 June 2008 and 31 December 2011 (the FIM experience with any DAA TAVI was in Munich and at the Brompton between June November 2008) 20 (21.6%) implants took place in the 54 months between the first implant and 1/1/11 73/93 (78.4%) of implants took place in the last calender year (1/1/ /12/2011)
37 Presented at the 48 th meeting of the STS, Fort Lauderdale, Florida, January 2012.
38 Presented at the 48 th meeting of the STS, Fort Lauderdale, Florida, January 2012.
39 Presented at the 48 th meeting of the STS, Fort Lauderdale, Florida, January 2012.
40 Presented at the 48 th meeting of the STS, Fort Lauderdale, Florida, January 2012.
41 Presented at the 48 th meeting of the STS, Fort Lauderdale, Florida, January 2012.
42 Direct Aortic Can be done without a thoracotomy less pulmonary impairment Requires no injury to the myocardium Aorta moves much less than cardiac apex Bleeding around the sheath not a problem Aortic cannulation (sheath) more familiar to most cardiac surgeons Can be used for Corevalve or Sapien Sheath size does not matter Direct aortic access is growing rapidly and may largely replace trans-apical
43 Mini J Upper Sternotomy Advantages Fits more anatomies More Real Estate to choose from Axiality can be more difficult Do not enter pleural Initially feels safer to many surgeons Quick and easy in virgin chest
44 Thoracotomy Advantages Safer in redo chest Generally more axial Disadvantages Generally less more to work Pleura crossed
45 Take Home Message DA Access is safe and effective 3D Image Guidance & Planning using CTA & NON-Contrast DynaCT with alignment based on the calcification of the Aorta and AV can help guide puncture and procedure Both thoracotomy and sternotomy work but carry different pros and cons
46 Trans-apical Courtesy Anson Cheung MD
47 Conclusion Transfemoral, Transaxillary, and Transaortic, Transapical The best option is the one that minimizes the risk of the procedure and offers the best result for the patient. The best decision come from a true Heart Team
48 Thank You
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