Evolving Technologies to Improve Outcomes of T-AVR

Transcription

1 Evolving Technologies to Improve Outcomes of T-AVR A Pichard, L Satler, R Waksman, P Corso, S Boyce, Itsik BenDor, G Maluenda, N Bernardo, K Kent, W Suddath, S O Donnell, C Akbari, S Goldstein, Z Wang, G Weigold, G Weissman, J Waidel, H Cooper, T Weddington, P Okubazi, N Puig, J Lindsay, J Panza. Washington Hospital Center Washington Hospital Center Washington, D.C.

2 Conflict of Interest Proctor for Edwards Lifesciences Speaker Bureau St Jude Medical

3 Evolving Technologies to Improve Outcomes of T-AVR Access: expandable sheaths TA percutaneous options Carotid protection Lower profile valves Accurate Valve Positioning Better patient selection Heart team MRI for fibrosis TAVR Risk Score

4 Vascular Access is the Achiles Tendon of TAVR

5 Balloon Expandable Sheath

6 Expandable 16F Sheath. pa dab e 6 S eat Edwards LifeSciences

7 Evolving Technologies to Improve Outcomes of T-AVR Access: expandable sheaths TA percutaneous options Carotid protection Lower profile valves Better patient selection Heart team MRI for fibrosis TAVR Risk Score Accurate Valve Positioning

8 Devices for Percutaneous TA Access Numerous devices are been developed to access the apex: without thoracotomy with safe closure (no bleeding, no pseudoaneurysm, etc.). h d i ld d h i di i These devices could expand the indications for TA access.

9 Hybrid perventricular procedure Kanishka Ratnayaka et al

10 Collagen vascular closure device (Angio Seal): Early hemostasis; Late Lt fil failure 3 hours 6 days 2 weeks a b c Mid term and long k 50% term FAILURE d e f Mid term failure with 50% long term SUCCESS Barbash et al, Cathet Cardiovasc Interven 2011 epub

11 Permissive pericardial tamponade (through a separate catheter) * * * * * * Separate the pericardial layers with injection of fluid Empty the pericardium after device is deployed Barbash et al, Cathet Cardiovasc Interven 2011 epub

12 Nitinol Implant: Amplatzer Device Barbash, Saikus et al

13 Amplatzer Device in Apex Left ventriculogram indicate no significant leakage at access site Dark blood sequence to identify occluder position Barbash, Saikus et al

14 Other Access Options. 1. Subclavian (Axillary) 2. Ascending Aorta

15 Evolving Technologies to Improve Outcomes of T-AVR Access: expandable sheaths TA percutaneous options Carotid protection Lower profile valves Accurate Valve Positioning Better patient selection Heart team MRI for fibrosis TAVR Risk Score

16 CVA/TIA in first 30 days: 2-5% The etiology is not well understood: d Aortic arch atheroma embolized during or after the procedure? Calcific debris form the valve embolized during the procedure? Platelet/Fibrin emboli originating on the valve assembly? Peri procedural AF? Thrombiforming between the valve assembly and the aortic sinuses?

17 EMBRELLA deflector Average # of TCD HITS/Subject Embrella Control BAV/TAVI Unprotected Insert Protect Retrieve

18 Claret Dual Filter Device Handle Filters Filters Sheathed Filters Deployed

19 Embolic Material JIM Live Transmission February 2011 Courtesy E. Grube

20 SMT Medical Technologies

21 Evolving Technologies to Improve Outcomes of T-AVR Access: expandable sheaths TA percutaneous options Carotid protection Lower profile, repositionable valves Better patient selection Heart team MRI for fibrosis TAVR Risk Score Accurate Valve Positioning

22 Valves in development A: Heart Leaflet Technologies valve (Heart Leaflet Technologies Inc., USA); B: Lotus Valve System (Boston Scientific Inc., USA); C: JenaClip (JenaValve Technology G bh Munich, GmbH, M i h Germany); G ) D: Direct Flow Medical Aortic Valve (Direct Flow Medical Inc., USA); E: ATS 3f Entrata valve (ATS Medical, Minneapolis, MN); F: AorTx Device (Hansen M di l Inc, Medical I M Mountain t i View, Vi CA); G: PercevalPercutaneous (Sorin Group, Milan, Italy); H: Paniagua Heart Valve (Endoluminal Technology Research, Miami, FL); I: E Engager valve l (f (formerly l Ventor) (Medtronic, Minneapolis, MN).

23 Evolving Technologies to Improve Outcomes of T-AVR Access: expandable sheaths TA percutaneous options Carotid protection Lower profile, repositionable valves Accurate Valve Positioning Better patient selection Heart team MRI for fibrosis TAVR Risk Score

24 Dyna CT for optimal Ao Sinus Alignement. Wood et al. Vancouver (TVT 2010)

25 Computerized Assistance for Valve Positioning. C-THV Paieon System

26 Philips Navigator

27 Philips Navigator Pre planning Live Guidance

28 Alignement of Aortic Sinuses. Rotating Aortogram 25 cc of diluted contrast at 15 cc/sec, 600 PSI. RV Pacing.

29 Rotating Aortogram. Rotating Aortogram. 12º Caudal, RAO to LAO. 15 cc/sec, cc diluted contrast. Rapid RV pacing

30 Evolving Technologies to Improve Outcomes of T-AVR Access: expandable sheaths TA percutaneous options Carotid protection Lower profile valves Accurate Valve Positioning Btt Better patient t selection Heart team MRI for fibrosis TAVR Risk Score

31 «Heart Team» Assigns Patient to: Low Risk High Risk Too Sick to Benefit from any intervention SAVR TAVI MEDICAL TREATMENT

32 Too Sick for T-AVR? The patient with multiple comorbidities and multisystem failure will not feel different with or without aortic stenosis. (STS, EuroScore, T-AVR Score)

33 Is Severe LV Dysfunction Irreversible? Myocardial Fibrosis by MRI Weideman et al. Circulation. 2009;120:

34 Aortic Valvuloplasty to help Select T-AVR Candidate 1. Excellent tool to evaluate: Reversibility of severe LV dysfunction, severe MR, severe pulmonary hypertension. Improvement of symptoms. 2. It may improve Outcome of AVR (S or T), specially ill in the verysick ikpatients: Data from Tissot et al (PCR 2010), WHC, and preliminary data from Partner.

35 Conclusions 1. The advent of T-AVR (TAVI) has initiated a revolution in the treatment of severe aortic stenosis and in Medicine in general. 2. Major advances in technology will expand the indications and outcomes of T-AVR. 3. Optimal patient selection remains most important.

36 The end