Dr. Jean-Claude Laborde

Transcription

1 Medtronic CoreValve Experience Alternative Access (Subclavian) and Technology Evolution of the Medtronic CoreValve TAVI System Dr. Jean-Claude Laborde Glenfield Hospital, Leicester, U.K. St George Hospital, London, U.K.

2 Subclavian as an Alternate Access Point 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

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

4 Procedure Access Carotid < 0.1 % _ Trans aorta < 0.1 _ % Overall Experience Axillary/Subclavian 7 % < 0.1 % Medtronic CoreValve Edwards-Sapien Transfemoral approach > 90 % < 1 % < 10 % > 30 % Transapical < 0.1 % 60 %

5 Procedure Access Carotid Trans aorta Axillary/Subclavian < 5 % Transfemoral approach Transapical 30 % 50 % 15 %

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

7 Procedural Success Access Point Comparison Subclavian (CoreValve - EER) Transfemoral (CoreValve - EER) 100% 98.0% 30 day mortality 9.4% 10.3% Stroke 3.8%* * Cerebral hemisphere 2.2% 0.0% 0.8% Conversion to savr Valve migration 0.0% 0.0% Tamponade & Vascular Complications 3.8% 6.5% Euroscore 28.6 % 22.6 %

8 Complete Retrieval and 2rd valve Valve Repositioning (Goose-neck catheter) Femoral vs Subclavian Access Site Femoral access (n = 626) Subclavian access (n = 81) % % % % Retrieval in ascending % 0 aorta and 2rd valve Valve-in-valve % 0 Tamponnade Percutaneous drainage Surgical drainage 6 6* 12* 1.9 % 1* 1** 1.2% Overall % % * Death : 4 out of 7 patients ** PMK related

9 Access Point Comparison Subclavian (CoreValve EER) Transfemoral (Edwards - SOURCE Registry) Procedural Success 100% 95.6% 92.9% 30 day mortality 9.4% 6.3% 10.3% Stroke 3.8%* 2.4% 2.6% * Cerebral hemisphere Conversion to savr 0.0% 1.7% 3.5% Valve migration 0.0% 0.0% 0.5% Tamponade & Vascular Complications 3.8% 17.9% 17.1% Transapical (Edwards - SOURCE Registry) Euroscore 28.6 % 25.7 % 29.2 %

10 Femoral Access a) contraindicated b) Unsafe Calcified + Tortuous ++ Diameter = 6.0 mm

11 Angio of subclavian vessels Anatomic criteria Calcifications Tortuosity Diameter 6.0 mm

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

13 Case Presentation History & Surgical risk evaluation Mr..: 79 year old male PAD CAD/Previous bypass (2003) : LIMA-LAD, Saph-RCA CRF with creatinin : 17 mg/l ( GRF : 22 ml/mn) EF 40 % Highly symptomatic AS : NHYA : III Logistic Euroscore 31.6

14 Set-Up General anesthesia Transoesophagial Echocardiography (T.E.E.) Cath-Lab Clopidrogrel/Aspirin (including loading dose) Antibiotic prophylaxis

15 Access Right Radiale artery puncture 5F Graduated pigtail Right jugular vein puncture Temporary PMK lead Surgical exposure of Left Axillary artery

16 Medical Equipments guidewire 6F kink-resistance sheath introducer 5F Amplatz diagnostic catheter Straight guidewire Superstiff guidewire (pre-shaped) 12F Introducer (*) 25 mm Balloon valvuloplasty catheter(**) 18F introducer (pre-shaped) 29 mm CoreValve catheter (**) 5F pigtail catheter : Patient with patent LIMA ** : Annulus mm in diameter ( 25 mm on TEE)

17 0.035 guidewire 6F kink-resistance sheath introducer 5F Amplatz diagnostic catheter Straight guidewire

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21 12F Introducer sheath 25 mm Balloon catheter

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31 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

32 Procedure Access % 75 % 30 % < 10 % 15 % < 1 % < 5 % 15 %

33 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.