2. Karl Eugen Hauptmann, MD Trier - Germany Nothing to disclose March 9 – 14,2014

3. Krankenhaus der Barmherzigen Brüder Trier „Heart navigator“ and alternative access improves Patient selection and outcome of TAVI. Karl Eugen Hauptmann

4. Isolated aortic valve replacement Germany 2000 - 2012

5. GARY ( German Aortic Valve Registry ) 07.2010 – 07.2012 26 000 Patient Result of the first 13 860 AVR Age mean: 68,3 Mortality in hospital 2,1 %, + By. 4,5% TAVI Age m.: fem.: 81,0 ap. : 80,3 Mort. i. h. : fem.: 5,1 % ap. : 7,7% It is not bad But not optimal

6. Early TAVI Devices for Severe Aortic Stenosis Significant benefit for inoperable/high-risk patients, but… * Kodali, NEJM 2012;366:1685; Tamburino, Circ 2011;123:299; Abdel-Wahab, Heart 2011;97:899 Current devices have limitations 2 nd generation devices should Paravalvular regurgitation Paravalvular regurgitation – Associated with increased mortality * Valve malpositioning Valve malpositioning – Valve migration, embolization, ectopic deployment, TAV-in-TAV Stroke Stroke Reduce aortic regurgitation Reduce aortic regurgitation Have simple, precise & atraumatic aortic/ventricular repositioning Allow full atraumatic retrieval We are not sure if the outcome of the 2nd generation is better.

7. ? How to improve the outcome of our very old patients ? Heart Team: We discussed the following: -Patient selection -Access -Way of Implantation -Amount of radiopaque -Lost of Blood We checked the last 200 patients, and discussed the patients which died within 30 days. We have not allways done a perfect job

8. Perfect Setting: -Hybrid OP -During all procedures one heart surgeon assists

9. We recognized important parameters 1)Selection 2)Access 3)Procedure

10. Navigator For every candidate we do the common diagnosis: TTE TEE Cardiac catheter CT of the heart Calcium detection

11. Heart team Patient selection and therapie We analyse all the results in the heart team. Bedside check the patients together. Do selection TAVI vs. Valve replacement. Discuss alternative access and valves.

12. Alternative access

13. Ministernotomie Minithorakotomie Direct aortic access Aggresiv technique, not minimal invasive !!!! After some patients we stop this kind of technique.

14. This is not a good candidate for TF or TA access ! This patient is not a problem for subclavian access !

15. Subclavian access left or right Positiv Vessel with less calcium Rare stenosis Less angulation Negativ Take care of LIMA Pacemaker Angulation at the ostium TF Subvlavia : Less stress for the Aortic arche.

17. A. Subclavia (Axillaris)

18. After preperation the vessel we fix a short protesis at the A. axillaris. We do the puncture through the prothesis to avoid a dissection Than we insert a short sheat.

19. A. Subclavia access experience from Trier 62 Patients since 03.2012 1 dissection ( Stent implantation ) Less lost of blood Less pain Less days in the hospital

20. Alternative access access selection Direct aortic access : we don´t use this access. Subclavian access ( A. axillaris ): If the vessel is too small or the grade of calcification is too high. …Obesity 15% We will double the number. Trans apikal access: porcelain aorta, heavy calcification of the a. fem.. 15% Trans femoral access: Most of the patient. Calcium at the planned puncture site we do surgical cut. All the other patient we use the access by direct puncture. We implant a short covered stent if the vessel is not closed completly after using the closing device. 70%

21. Software Heart Navigator The second importand change to improve the outcome of our TAVI patients was to use a new software while implanting the valve.

22. HeartNavigator Step 1: The „HeartNavigator“-software automatically does the segmentation of the heart, based on the pre-operative CT ( LV.,the aortic valve and the aorta including the coronary ostia ). After that we do additional measurements.( Annulus – LCA or RCA ) Step 2: The HeartNavigator automatically calculates views in line with the valve. We store these views to use it during the procedure.( virtual device implantation ) SegmentationView calculation Measurement of the distance between valve plane and coronary ostia

23. Segmentation

24. Measurements:

26. HeartNavigator Step 3 : Registration :We must register 2D images from the x-ray sytem with the CT model.The two registration runs should be acquired with a difference in rotation angle of at least 60 degrees. Step 4 : Live Guidance: Now the HeartNavigator provide an overlay image showing the fluoroscopy in relation to the outline of the aortic root derived from the CTA.

28. Overlay – Projection = > Less radiation, less contrastmedium

29. TAVI Optimize outcome The combination of team work and optimal technique optimize the outcome of our patients. It is very important to use always the best access for the patient. We should not hesitate to use new technical help to implant TAVI

30. We started to change the proceedings 01.07.2013 01.07.2013 – 28.02.2014 = 110 TAVI TA = 17 Subcl. = 23 TF = 70 ( surgical access 50% ) Same Euroscore II and STS Score We lost 2 patients during the first 30 days. 1 Pat. at day 23 with AV-Block III, chron dialysis patient 1 PAT: day 10, Pat. embolism a. mesenterica day 5. We used significant less radiopaque material and did need significant less units of stored blood.

31. Thank you! It´s done !