Direct Aortic approach for TAVI

Dr R.H. (Robin) Heijmen Department of Cardiothoracic surgery

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Consultant for TAVI / TEVAR / Hybrid arch surgery Medtronic Inc, WL Gore, Bolton Medical, Vascutek Ltd

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For patients at high-risk for surgery, TAVI has become an established alternative for AVR PARTNER A CV US PIVOTAL : New Engl J Med, 2014

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For patients at high-risk for surgery, TAVI has become an established alternative for AVR Majority treated by a transfemoral (TF) approach

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For patients at high-risk for surgery, TAVI has become an established alternative for AVR Majority treated by a transfemoral (TF) approach least-invasive … truly percutaneous, using suture-mediated closure devices

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For patients at high-risk for surgery, TAVI has become an established alternative for AVR Majority treated by a transfemoral (TF) approach least-invasive … . Vascular complications 11 % Partner A Trial / ADVANCE Registry 30-day mortality

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For patients at high-risk for surgery, TAVI has become an established alternative for AVR Majority treated by a transfemoral (TF) approach least-invasive … . Vascular complications . Stroke 5.5 % Partner A Trial

3.9 % CV US Pivotal Trial

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For patients at high-risk for surgery, TAVI has become an established alternative for AVR Majority treated by a transfemoral (TF) approach least-invasive … . Vascular complications . Stroke 5.5 % Partner A Trial 2.4 % : 3.9 % CV US Pivotal Trial

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For patients at high-risk for surgery, TAVI has become an established alternative for AVR Majority treated by a transfemoral (TF) approach least-invasive … . Vascular complications . Stroke 5.5 % Partner A Trial 2.4 % : 3.9 % CV US Pivotal Trial

stroke rate after surgical AVR underreported …. ?

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For patients at high-risk for surgery, TAVI has become an established alternative for AVR Majority treated by a transfemoral (TF) approach least-invasive … . Vascular complications . Stroke . Valve positioning PVL PM-rate

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For patients at high-risk for surgery, TAVI has become an established alternative for AVR Majority treated by a transfemoral (TF) approach least-invasive … Some have no suitable femoral access Too small, atherosclerotic, tortuous, calcified (T)AAA Severe angulation

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For patients at high-risk for surgery, TAVI has become an established alternative for AVR Majority treated by a transfemoral (TF) approach least-invasive … Some have no suitable femoral access NEED FOR ALTERNATIVE APPROACH

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For patients at high-risk for surgery, TAVI has become an established alternative for AVR Majority treated by a transfemoral (TF) approach least-invasive … At our hospital, low threshold for alternative accesses > 600 TAVI’s 60 % TF 40 % TA / SC / DA HeartTeam approach, also for TAVI-procedure itself ! (CTS + IC)

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Transapical (TA) approach : well established antegrade, alternative route

Engager TM

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Transapical (TA) approach : well established antegrade, alternative route However, some special technical limitations : severe pulmonary disease compromising pleural space severe calcification/ atheroma of the aortic arch LV functional or anatomical abnormalities, poor LVEF / small ventricular cavity / thin-walled left ventricular myocardium / frail myocardial tissue / chronic steroid therapy

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Transapical (TA) approach : well established antegrade, alternative route However, some special technical limitations : severe pulmonary disease compromising pleural space severe calcification/ atheroma of the aortic arch LV functional or anatomical abnormalities, poor LVEF / small ventricular cavity / thin-walled left ventricular myocardium / frail myocardial tissue / chronic steroid therapy

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Transapical (TA) approach : well established antegrade, alternative route However, some special technical limitations, and also some potential and unique complications : Apical rupture / delayed pseudo-aneurysm LVF due to purse-string suture

S. Arslan et al.

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Trans-subclavian (SC) approach : well established retrograde, alternative route

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Trans-subclavian (SC) approach : well established retrograde, alternative route However, axillary artery is fragile, and not eligible if diameter < 6mm, heavy calcification, excessive tortuosity or subclavian stenosis

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Trans-subclavian (SC) approach : well established retrograde, alternative route However, axillary artery is fragile, and not eligible if diameter < 6mm, heavy calcification, excessive tortuosity or subclavian stenosis Caution in patients with patent LIMA-graft !

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Direct Aortic (DA) approach : retrograde alternative route, which mirrors TF and SC procedures, but with the advantage of high control of valve deployment with no adverse effect on LV structure or function

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Direct Aortic (DA) approach : retrograde alternative route, which mirrors TF and SC procedures, but with the advantage of high control of valve deployment Medtronic Corevalve Edwards Sapien : Medtronic Engager

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De Telegraaf September 2nd, 2014

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DA - TAVI : CoreValve ®

Direct Aortic Global Experience : > 1000 pts CE mark for DA-TAVI, since November 7th, 2011

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DA - TAVI : CoreValve ®

Direct Aortic Global Experience : > 1000 pts

N = 519

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DA - TAVI : Standard patient screening protocol for TAVI TTE / CAG / CTA CT analysis is essential for the planning process (dedicated multi-planar reconstruction analysis software)

entry site evaluation !

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Entry site : . Absence of pathological processes (calc / atheroma / etc) . > 1cm distal to SVG . > 6cm distant from the aortic annulus, to alllow sufficient room for 1. tip of 18Fr sheath 2. valve retainer . aligned sheath placement for co-axial prosthesis deployment

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Surgical approach for DA-TAVI :

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M. Russo et al. CTSNET.org

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M. Russo et al. CTSNET.org

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DA - TAVI : (Hybrid) room setup :

M. Russo et al. CTSNET.org

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DA - TAVI : (Hybrid) room setup :

! occupational radiation dose !

M. Russo et al. CTSNET.org

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DA - TAVI : (Hybrid) room setup :

! occupational radiation dose !

M. Russo et al. CTSNET.org

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DA - TAVI : (Hybrid) room setup : alternatives

M. Russo et al. CTSNET.org

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Standard dataset to 30 European centers, ≥ 3 DA-TAVI cases 20 centers returned the dataset, including 519 pts Jun ’08 – Jan ’14

2008 – 2010 2011 2012 2013

0 50 100 150 200 cases

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Age (yrs) 81.3 range, 58 to 93 Gender (female) 250 48.1 % NYHA class ≥ III 429 82.6 % Diabetes 155 29.8 % Coronary disease 306 58.9 % Prior CABG 109 21.0 % Prior PCI 141 27.1 % Peripheral vascular disease 330 63.6 % Renal failure (< 30 mL/min) 183 35.2 % Mean logistic ES 25.8

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23mm 26mm

29mm

31mm

22 183 228 86 (4.2%) (35.3%) (43.9%) (16.6%)

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30-day all-cause mortality 43 8.2 %

N = 519

2008 – 2010 13.6 % 2011 2012 7.7 % 2013

0 50 100 150 200 cases

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Procedural success 98.2 % Major vascular complication 14 2.7 % In-hospital stroke 7 1.4 % Second valve 4 0.8 % ≥ moderate PVL 2 0.4 % New PM-implant 72 15.9 % Conversion to TA-TAVI 2 0.4 %

N = 519

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Limitations, retrospective, self-reported data no adjudication, no late outcomes

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In conclusion, Direct Aortic TAVI should be considered a true alternative for TF-TAVI, in case of non-suitable femoral access, or complex anatomical or pathophysiological conditions horizontal ascending aorta, large annular size, primary aortic regurgitation Potentially reduces the risk of stroke, currently associated with TF-TAVI