Results of Transapical Valves. A.P. Kappetein Dept Cardio-thoracic surgery

Transcription

1 Results of Transapical Valves A.P. Kappetein Dept Cardio-thoracic surgery Rotterda am, The Netherlands

2 2002 FIM THV THV Cribier-Edwards Edwards Edwards Sapien Sapien XT Bovine pericardium Stainless steel frame 23mm Preclin. & FIM Equine pericardium Stainless steel frame 23mm New transapical approach Bovine pericardium Cobalt Stainless Chrome steel frame 23 and 26mm Next: 20-29mm 24F 22F 22F 18F 24F 19F

3 Edwards SAPIEN THV Most recent clinical Results. First in Man Feasibility Randomized Control Post Market Procedural success in humans Demonstrate reasonable safety & effectiveness Effectiveness vs. control (AVR & medical therapy) Evaluate transition to commercial use Procedural success & clinical outcomes RECAST REVIVE REVIVE I REVIVAL I REVIVE II REVIVAL II IDE TRAVERCE PARTNER EU PARTNER IDE SOURCE

4 Contraindications for TF approach Iliac arteries Aorta severe calcification tortuosity small diameter previous ao fem bypass severe atheroma of the arch coartation aneurysm with protruding thrombus Bulky atherosclerosis of the ascending Aorta or Transverse aorta

5 Size Calcifications Tortuosity Stenosis Degree lenght Atheromatous disease

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8 Insertion of Amplatz Ultra stiff 0,35 Cook Wire

9 Contraindications fo or TA approach Previous surgery of the LV (Dor) Calcified pericardium Severe respiratory insufficiency Dislocated LV apex

10 Advantages e ach Technique Transapical No or fewer peripheral access issues No limiting delivery system size Short delivery distance to target Bailout/conversion simpler Avoids atherosclerotic aorta Distal protection more feasible Mitral valve more accessable Transfemoral No thoracotomy No apical trauma Smaller delivery system Anaesthesia option Staged implants (BAV then THV at later date) Reduced risk of bleeding Shorter ICU & hospital stay Fewer pain management issues

11 1 year Transf femoral Outcome 1.0 bility (eve ent free) Proba D 0.92 Nrisk: 56 Survival at 1 Year = 78% 6M 0.9 1Y 0.78 Nrisk: 54 Nrisk: Time (months) 12

12 1 year Trans sapical Outcome ent free) 1.0 Proba ability (ev Survival at 1 Year = 50% 30D M Y Nrisk: 56 Nrisk: 38 Nrisk: Time (months)

13 1 Year Survival - cause Early Deaths ( 30 days) Sudden death or arrhythmia Myocardial infarction Heart failure Bleeding Multiorgan, renal, respiratory failure or sepsis Late Deaths (>30 days to 1 year) Sudden death or arrhythmia Myocardial infarction Heart failure Stroke Multiorgan, renal, respiratory failure or sepsis Other Total 1 year deaths of death Transfemoral Transapical (25%) 35 (51%)

14 Methods Sou urce Registry 34 Centres Initial ly Participating in Commercial Launch 1123 patients Excluded: 2 Centres / 85 Patients Unable to obtain Ethic Cte approval Unable to secure administrative support One missing patient due to admin. error Included: 32 Centres 1038 Patients The SOURCE Registry has 100% procedure data 98% 30 day data All consecutively enrolled

15 Baseline Demographics and Risk Factors TF (n=463) TA (n=575) P-value Age (yrs) NS Female % 56% NS Pulmonary Disease 25.4% 29.4% NS Renal Failure 26.3% 32.9% Logistic EuroSCORE < Peripheral Vascular Disease 10.9% 27.5% <0.001 Carotid Artery Stenosis 7.6% 17.1% <0.001 (>50%) Incidence of CAD 47.4% 56.0% <0.006 Porcelain Aorta 4.6% 11.5% <0.001 Prior CABG 17.6% 26.9% <0.001 Mitral Valve Disease 16.1% 32.8% <0.001

16 Risk Analysis: Logistic Eur roscore 49% 48% Patients Pe ercent of % 37% 16% 12% Transapical Transfemoral 6% 3% 0 < > 60 As EuroSCORE gets higher, ratio of TA to TF is greater

17 Major Complications (< 30 Days) TF (n=463) Death 29 (6.3%) Stroke 11 (2.4%) TA (n=575) Total (n=1038) 59(10.3%) 88(8.5%) 16 (2.6%) 27(2.5%) Renal Failure Requiring Dialysis 23(5.0%) 69 (11.7%) 92 (8.7%) Permanent Pacemaker 31 (6.7%) 42 (7.3%) 73 (7.0%)

18 The SOURCE Registry 30 Day Results: Trans femoral Survival* NYHA MI Stroke Vascular Complications (n=204) 93.6% Class I: 39.4% Class II: 50.5% Class III: 9.1% Class IV: 1.0% 1.0% 3.4% 7.4% *Population analyzed = Patients with Sapien in place and alive post-procedure (no conversion)

19 The SOURCE Registry (TA) 30 Day Results (n=173) Survival* NYHA MI Stroke Vascular Complications Transapical 89.6% Class I: 38.2% Class II: 56.4% Class III: 5.5% Class IV: 0% 1.2% 06% 0.6% 0.6% *Population analyzed = Patients with Sapien in place and alive post-procedure (no conversion)

20 Transcatheter aortic valves Currently undergoing FIM or safety and efficacy testing Direct Flow Medical Sadra Medical Heart Leaflet Technology Jena Valve

21 Percutaneous aortic valve endovascular resection of in situ replacement after human aortic valves Quaden R. J Thorac Cardiovasc Surg 2008;135:1081-6

22 Cerebral embolic protection device Goal to improve the safety of the procedure Embrella Embolic Deflector Device

23 TAVI with embolic protec ction Embrella Device Right radial access 6 F Covering all aortic arch vessels

24 Getting involved with TAVI Just do it but beware of the following Adequate expertise Heart Team Knowledge on treatment of valvular heart disease, interventional skills, procedural training Adequate site logistics Team approach, CV surgery, Hybrid-OR, CCU, personnel capacity and training Identify the right patients Screening Stay up to date on recommende ed inclusion criteria and stick to it, established screening pathways (e.g. CT) Choice of prosthesis Know about advantages / disad dvantages of each and choose accordingly

25 Take Home Message Rapid expansion percutaneous heart va alves Percutaneous valve implantation in intermediate risk patient an alternative? The only way to find out is a randomized trial