CRT 2010 Washington DC January 21 2010 Selfexpanding

CRT 2010 Washington DC, January 21, 2010 Self-expanding Subclavian Approach: Techniques and Outcomes Eberhard Grube, MD, FACC, FSCAI St. Elisabeth Hospital, Heart Center Rhein-Ruhr, Essen, Germany Instituto Cardiologico Dante Pazzanese, São Paulo, Brazil

DISCLOSURES Eberhard Grube, MD Consulting Fees – Abbott Vascular, Boston Scientific Corporation, Cordis, a Johnson & Johnson Company, Medtronic Cardio. Vascular, Inc. Honoraria – Biosensors International , Boston Scientific Corporation, Medtronic Cardio. Vascular, Inc Ownership Interest (Stocks, Stock Options or Other Ownership Interest) – Biosensors International , Medtronic Cardio. Vascular, Inc. I intend to reference unlabeled/ unapproved uses of drugs or devices in my presentation. I intend to reference off-label use of stents and valve prosthesis.

Subclavian as an Alternative Access ● Provides an alternate access for both cardiac surgeons and interventional cardiologists ● Enables implanting teams to mitigate risk by better adapting procedure to patient’s anatomy ● Training for subclavian is incremental for both transapical and transfemoral implanters

Subclavian as an Advantage Vs Transapical Ø Mitigates or eliminates trauma to the heart Ø Can be done under local anesthesia Ø Recovery time is faster and lower risk (drainage ports are not needed) Vs Transfemoral Ø Bypasses aortic arch Ø Not limited by femoral vasculature Ø Able to visually control closure Ø Better control of delivery catheter and guidewire

Procedure Access Overall Experience Carotid Axillary/Subclavian < 0. 1 % _ 7% < 0. 1 % Trans aorta < 0. 1_ % Transapical Medtronic Core. Valve Edwards-Sapien Transfemoral approach > 90 % < 10 % <1% > 30 % < 0. 1 % 60 %

Subclavian Access is Growing Globally (Expanded Evaluation Registry) * EER reporting is voluntary and is not indicative of total cases

Access Point Comparison (Expanded Evaluation Registry) Subclavian (Core. Valve - EER) Transfemoral (Core. Valve - EER) Procedural Success 100% 98. 0% 30 day mortality 9. 4% 10. 3% 3. 8%* 2. 2% Conversion to s. AVR 0. 0% 0. 8% Valve migration 0. 0% Tamponade & Vascular Complications 3. 8% 6. 5% Stroke * Cerebral hemisphere Euroscore 28. 6 % 22. 6 %

Access Point Comparison (Personal experience. JC Laborde) Femoral access Subclavian access (n = 626) (n = 81) Complete Retrieval and 2 rd valve 18 2. 9 % 1 1. 2 % Valve Repositioning (Goose-neck catheter) 17 2. 7 % 1 1. 2 % Retrieval in ascending aorta and 2 rd valve 7 1. 1 % 0 Valve-in-valve 8 1. 3 % 0 Tamponnade 12* 1. 9 % 1** Percutaneous drainage 6 Surgical drainage 6* Overall * Death : 4 out of 7 patients 62 1. 2% 1* 9. 9 % ** PMK related 3 3. 7 %

Access Point Comparison EER vs Source Registry Subclavian Transfemoral Transapical (Core. Valve – EER) (Edwards - SOURCE Registry) Procedural Success 100% 95. 6% 92. 9% 30 day mortality 9. 4% 6. 3% 10. 3% Stroke * Cerebral hemisphere 3. 8%* 2. 4% 2. 6% Conversion to s. AVR 0. 0% 1. 7% 3. 5% Valve migration 0. 0% 0. 5% Tamponade & Vascular Complications 3. 8% 17. 9% 17. 1% Euroscore 28. 6 % 25. 7 % 29. 2 %

Femoral Access a) contraindicated b) Unsafe Calcified + Tortuous ++ Diameter = 6. 0 mm

Angio of subclavian vessels Anatomic criteria Calcifications Tortuosity Diameter ≥ 6. 0 mm

Angio of Aortic route Feasibility & Safety Calcifications + Tortuosity ++

Core. Valve TAVR subclavian/trans-axillary Set-Up • General anesthesia • Transoesophagial Echocardiography (T. E. E. ) • Cath-Lab • Clopidrogrel/Aspirin (including loading dose) • Antibiotic prophylaxis

Core. Valve TAVR subclavian/trans-axillary Access Right Radiale artery puncture 5 F Graduated pigtail Right jugular vein puncture Temporary PMK lead Surgical exposure of Left Axillary artery

Core. Valve TAVR subclavian/trans-axillary Medical Equipments 0. 035 guidewire 6 F kink-resistance sheath introducer 5 F Amplatz diagnostic catheter 0. 035 Straight guidewire 0. 035 Superstiff guidewire (pre-shaped) 12 F Introducer (*) 25 mm Balloon valvuloplasty catheter(**) 18 F introducer (pre-shaped) 29 mm Core. Valve catheter (**) 5 F pigtail catheter • : Patient with patent LIMA • ** : Annulus 23 -27 mm in diameter ( 25 mm on TEE)

Core. Valve TAVR subclavian/trans-axillary • Pt desintubate in the cath-Lab • Temporary PMK lead (24 -48 hrs) • EKG monitoring for 5 days (*) • Control T. T. E. at 24 -hrs • No additionnal heparin • Clopidogrel/Aspirin for 6 mths * Except definitive PMK

Procedure Access 2008 -2009 2013 -2014 50 % 75 % 30 % < 10 % 15 % <1% <5% 15 % Femoral Apical Iliac Axillary

Conclusion Subclavian is a lower risk alternative to both transapical and transfemoral for many patients and should be considered in order to improve patient outcomes.

Thank you for your attention !