CRT 2010 Washington DC, January 21, 2010 Medtronic CoreValve Trans-Femoral TAVI System. Dealing with Complications! Eberhard Grube, MD, FACC, FSCAI St.Elisabeth Hospital, Essen, Germany Heart Center Rhein-Ruhr Instituto Cardiologico Dante Pazzanese, São Paulo, Brazil

Eberhard Grube, MD DISCLOSURES Consulting Fees Honoraria Abbott Vascular, Boston Scientific Corporation, Cordis, a Johnson & Johnson Company, Medtronic CardioVascular, Inc. Honoraria Biosensors International , Boston Scientific Corporation, Medtronic CardioVascular, Inc Ownership Interest (Stocks, Stock Options or Other Ownership Interest) Biosensors International , Medtronic CardioVascular, 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.

Medtronic CoreValve implantation Tips and Tricks Avoid complications (femoral access route) Balloon valvuloplasty Prosthesis positioning Options to correct mal-positioned prosthesis Treatment options for access site complications

Wiring the aortic valve Technique with AL1/2 and straight Terumo (alternativelly straight 0,035‘‘) Wire LAO 15  CAVEAT: do not engage the Coronaries Exchange for a 5 F Pigtail using a 260 Wire Simultaneous Pressure Recording

Wiring the aortic valve

Placing the stiff wire Amplatz Superstiff ST1 (short floppy tip 1 cm) Alternative stiff wires Longer floppy tips aimmanually bending the stiff part into a pigtail shape 18 French sheath always over the stiff wire

Balloon Valvuloplasty Balloon catheters: Nucleus 12 F (Inoue like behavior) Stabilize position Z-med X 12 F Tyshak II (9 F to 25mm) rated burst 1.0-1.5 Atm or other Valvuloplasty Balloons possible Rapid RV stimulation ~180 - 200 BPM (systolic pressure <60 mmHg)

Balloon valvuloplasty with Nucleus (Balloon Rupture !)

Balloon Valvuloplasty using a 25 mm ZMed Balloon and simultaneous Dye Injection in a 28 mm Anulus (measured by CT)

Aortic regurgitation III / IV after valvuloplasty (2-5%)

Always have the Prosthesis loaded for immediate implantation

Angiographic Result after 26mm CV

Aortic Regurgitation IV after Valvuloplasty Acute Aortic Regurgitation IV resulting in Acute LV overload Acute LV failure / asystole or VF due to Volume-loading of the LV

...also during CPR (ongoing V-Fib)

...also during CPR (ongoing V-Fib)

Spontaneous Return to Sinus Rythm after implant

Aortic Dissection after Valvuloplasty

Aortic Dissection after Valvuloplasty treated by CV Implantation

Aortic Dissection after Valvuloplasty treated with Prosthesis

Push the wire to stabilize CoreValve position during delivery („ostial stenting“)

Aortic Regurgitation after Delivery of the Prosthesis

Aortic regurgitation after delivery of the prosthesis

Prosthesis with insufficient radial force (due to calcification ) AR III

Post-dilatation with bigger balloon

Final result

AR due to too deep prosthesis (paravalvular leakage)

Re-positioning using a Goose Neck ‚snare‘ (15/20 mm) from femoral 6F

Controlled during continuous pulling by monitoring of the diastolic blood pressure

Example of a malpositioned prosthesis ( too deep ) >> repositioning mandatory

Example of a ‘too deep’ prosthesis, re-positioned with a snare From femoral unsuccessful

Example of a ‘too deep’ prosthesis, re-positioned with a snare From brachial successful

Example of a ‘too deep’ prosthesis, re-positioned with a snare Final result