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History and Future of Aortic Valve Implantation OTTAVIO ALFIERI S.Raffaele University Hospital Milano Aetiologies of Single Valvular Heart Diseases in the Euro Heart Survey 43% 13% 32% 12% 100% 80% Other Ischemic Congenital Inflammatory Endocarditis Rheumatic Degenerative 60% 40% 20% 0% AS AR MR MS (Iung. Eur Heart J 2003;24:1244-53) Aortic Stenosis: Survival Onset of symptoms % Survival 97.2% alive Surgery 45% alive Failure Syncope Angina 3 15 Years NEJM 1997;337;32-41 and UK Heart Valve Registry Patient Characteristics in the Euro Heart Survey AS Age (years) 69±12 70 years (%) 56 1 comorbidity (%) 36 AR 58±16 25 26 MS 58±13 18 22 MR 65±14 44 42 (Iung. Eur Heart J 2003;24:1244-53) Surgical Risk vs. Benefit Surgical Risk Optimum Value Limited Value Poor value: •Patient •Purchaser •Physician ? Clinical Benefit Increasing age 22 centres, 67,764 patients, 4,743 octogenarians 12 Complications (%). . 10 8 6 Mortality Renal failure Stroke 4 2 0 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85-90 Age (years) Central Cardiac Audit Database, UK Survival after Isolated Aortic Surgery in patients aged 80+: Influence of pulmonary disease No lung disease COPD/emphysema/asthma Discharge 96.7% 75.7% 1 year 90.6% 69.6% 2 years 88.9% 54.9% 5 years 63.6% 20.0% Central Cardiac Audit Database, UK Survival after Isolated Aortic Surgery in patients aged 80+: Influence of peripheral vascular disease No PVD PVD Discharge 96.0% 79.6% 1 year 90.2% 68.2% 2 years 88.3% 52.3% 5 years 57.8% 28.5% Central Cardiac Audit Database, UK Not surprisingly…. One third of patients did not undergo surgery because of age, comorbidities or LV dysfunction Severe symptomatic AS Severe AS : Valve Area ≤ 0.6 cm²/m² BSA or Mean Gradient 50 mmHg Symptomatic AS : NYHA Class III or IV or Angina Aortic Stenosis 75 years N=408 No Severe AS (n=114) Severe AS (n=284) NYHA III :106 NYHA IV : 36 No Symptoms N=68 Symptoms N=216 No Intervention N=72 (33%) Angina : 148 Intervention N=144 (67%) (Iung. Eur Heart J 2005;26:2714-20) At least 30-40% of Cardiologists’ AS Patients Go Untreated Severe Symptomatic Aortic Stenosis No AVR Percent of Cardiology Patients Treated AVR 100 90 80 41 32 30 31 60 70 45 48 60 50 40 68 30 70 69 59 55 52 40 20 10 0 Boum a 1999 Iung* 2004 Pellikka 2005 Charlson 2006 Bach Spokane (prelim ) Vannan (Pub. Pending) 1. Bouma B J et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999;82:143-148 2. Iung B et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal 2003;24:1231-1243 (*includes both Aortic Stenosis and Mitral Regurgitation patients) 3. Pellikka, Sarano et al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. Circulation 2005 4. Charlson E et Decision-making and outcomes in severe symptomatic aortic stenosis al.. J Heart Valve Dis2006;15:312-321 Under-treatment especially prevalent among patients managed by Primary Care physicians Aortic Valve Implantation The Evolving Process Conventional midline sternotomy Invasiveness Surgical through Minimal Incision On pump, arrested heart sutureless valve replacement Transaortic, beating heart delivery Transapical delivery Percutaneous - antegrade or retrograde BAV Sept 1985 200 100 0 F.I.M.: 20mm Balloon First attempt of treating non surgical AS patients THE LANCET, JANUARY 11, 1986 Thousand of cases performed worldwide Hemodynamic / symptomatic improvement No effect on patient’s survival 1985 ONE MAIN LIMITATION Early valve restenosis: 80% at one year F.I.M. Balloon Aortic Valvuloplasty THE GOAL…. CE mark commercialization 2007 International TF Feasibility Studies 2005-07 2004 2002-03 2002 2000-02 2000 1999 1989 1987 1985 First in Man Corevalve 25 F Feasibility Studies (antegrade) F.I.M. PHV implantation Large series of animal implantation First animal implantation(self exp) « Percutaneous Valve Technology » (prototypes) First animal implantation (balloon exp) in pig Post mortem studies of intra-valvular stenting Concept of« stented valve », to rule out post-BAV valvular restenosis F.I.M. Balloon Aortic Valvuloplasty The pioneers Henning Andersen (May 1st 1989) First successful pig implant Granted with 2 patents Alain Cribier (April 16, 2002) Parallel research and proof of concept Implanted first percutaneous aortic valve on a patient via an antegrade approach F.I.M Alain Cribier 2002 8 days post-implantation F.I.M. and Feasibility Studies pre CE approval RESULTS Procedural success about 90% Mortality at 30 days ranges from 5 to 18% Acute myocardial infarction in 2 to 11% Severe AR in about 5% Vascular complications in 10 to 15% Stroke in 3 to 9% AV bock in 4 to 20% Survival :70 to 80% at 2 y. CE-MARKED DEVICES Core Valve (Transfemoral / Transaxillary) Edwards SAPIEN (Transfemoral / Transapical) CoreValve evolution Generation 1 25Fr Endovascular 14 patients Generation 2 21Fr Endovascular Generation 3 18Fr 65 patients Percutaneous >3000 patients * 18 French Procedural Progress Evolution to a « real cath lab procedure » within the first 40 Patients of 18 Fr study • • • • • General anesthesia Surgical cutdown/repair Ventricular assistance Pre-closing with ProStar™ Local Anesthesia Beating heart Valve delivery without rapid pacing No cardiac assistance Edwards SAPIEN Developments and Improvments Untreated Equine Tissue Cribier-Edwards™ THV 23mm Treated Bovine Tissue Edwards SAPIEN™ THV 23mm, 26mm Heamodynamic Performance Low profile Cobalt-chrome Ascendra Introducer Sheath 26Fr. RetroFlex II Durability Edwards SAPIEN™ THV II 23mm, 26mm Profile – Ease of Use Edwards SAPIEN evolution RETROFLEX DELIVERY SYSTEM Stainless Steel Braid – BETTER TORQUE Front end rotational grip – SINGLE HANDED ARTICULATION Joint Task Force Positioning Paper: ‟Transcatheter valve implantations for patients with Aortic Stenosis” INDICATION TAVI is reserved to pts. with severe AS and symptoms who are inoperable or at high risk for surgery STEPS OF PTS. SELECTION -Confirmation of severity of AS -Evaluation of symptoms-QoL -Analysis of surgical risk -Evaluation of life expectancy -Assessment of feasibility and exlusion of contraindications Gradients ECHO and Valve Area TT and TEE Hemodynamics CT MRI D obutamine testing MDCT MRI TEE Pouleur AC , et al, Radiology, 2007;244: 745-754 Analysis of surgical risk Logistic Euroscore > 20 STS Score > 10 (new M & M) Parsonnet Ambler Mini Nutritional Assesment (Geriatric Version) Contraindicatios (general) Aortic annulus (too small or to large) Bicuspid valve ( ? ) Asymmetric heavy valvular calcification Aortic root dilatation (for self-expandable) Presence of LV thrombus TT<TEE<CT Risk of embolism Risk of coronary occlusion Prosthesis selection Contraindications for TF approach Iliac arteries severe calcification tortuosity,small diameter;previous aofem.by-pass Aorta:severe atheroma of the arch,coartation,aneurysm with protruding thrombus…. Bulky atherosclerosis of the asc. aorta Transverse asc.aorta Size Calcifications Tortuosity Stenosis Degree lenght Atheromatous disease Insertion of Amplatz Ultra stiff 0,35 Cook Wire Contraindications for TA approach Previous surgery of the LV (Dor) Calcified pericardium Severe respiratory insufficiency Dislocated LV apex The procedure requires the close cooperation of a team of specialists in valve disease, including clinical cardiologists, echocardiographists, interventional cardiologists, cardiac surgeons, and anaesthesiologists. Interventionalist anesthesiologist others Surgeon cardiologist Teamwork 40 Hybrid room Cath lab Operating room NO COMPROMISES Imaging quality Sterility Instrumentation Ergonomics Device availability Appropriate environment POST CE MARK RESULTS (from registries) Edwards THV Clinical Studies Program Methods 34 Centres Initially 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 Source Registry Baseline Demographics and Risk Factors TF (n=463) TA (n=575) P-value 81.7 80.7 NS Female 55.2% 56% NS Pulmonary Disease 25.4% 29.4% NS Renal Failure 26.3% 32.9% 0.024 25.7 29.2 <0.005 10.9% 27.5% <0.001 7.6% 17.1% <0.001 47.4% 56.0% <0.006 4.6% 11.5% <0.001 Prior CABG 17.6% 26.9% <0.001 Mitral Valve Disease 16.1% 32.8% <0.001 Age (yrs) Logistic EuroSCORE Peripheral Vascular Disease Carotid Artery Stenosis (>50%) Incidence of CAD Porcelain Aorta Risk Analysis: Logistic EuroSCORE Baseline EuroSCORE - The SOURCE Registry 49% 48% 50 Percent of Patients 37% 40 Transapical Transfemoral 30% 30 16% 12% 20 6% 3% 10 0 < 20 20 - 40 41 - 60 > 60 As EuroSCORE gets higher, ratio of TA to TF is greater Survival TF (n=459) TA (n=571) 93.7% 89.7% EuroSCORE <20 94.6% (Mean 12.5) 93.4% (Mean 12.4) EuroSCORE >20 93.3% (Mean 33.7) 63% of pts 88.1% (Mean 36.3) 70% of pts 30 day SOURCE 30 Day All Cause Mortality -- Transfemoral Approach Stratified by Logistic EuroSCORE SOURCE 30 Day All Cause Mortality -- Transapical Approach Stratified by Logistic EuroSCORE 1 1 0.95 0.95 0.9 0.85 Survival Survival 0.9 0.8 0.85 0.8 0.75 0.75 < 20 p=0.068 >= 20 0.7 0.7 0.65 0.65 < 20 >= 20 0.6 0.6 0 0.1 0.2 0.3 0.4 0.5 0.6 Fraction of Months post Procedure 0.7 0.8 0.9 1 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 Fraction of Months post Procedure Survival of TA pts with ES< and >20 are significantly different (93.4 vs. 88.1) (p=0.067) 1 Procedure Complications (<30 Days) TF (n=463) TA (n=575) Total (n=1038) Acute procedure success 436/95.6% 523/92.9% 959/94.1% n=456 n=563 n=1019 Device Success Comp 428/92.4% 522/90.8% 950/91.5% 8/1.7% 20/3.5% 28/2.7% 15 (3.2%) 34 (5.9%) 49 (4.7%) Valve Migration 0(0.0%) 3(0.5%) 3(0.3%) Valve Malposition 8(1.7%) 8 (1.4%) 16(1.5%) Coronary Obstruction 3(0.7%) 3(0.5%) 6 (0.6%) Conversion to sAVR AR >+2** Major Complications (< 30 Days) TF (n=463) TA (n=575) Total (n=1038) Death 29 (6.3%) 59(10.3%) 88(8.5%) Stroke 11 (2.4%) 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%) Major Vascular / Access Complications TF : 10.6 % (not significant predictor of 30 d. survival) TA: 2.4 % (significant predictor of 30 d. survival) CoreValve post CE mark experience 18 F Expanded Evaluation Registry(EER) CLINICAL INDICATIONS Native Aortic Valve Disease Severe AS: AVAI ≤0.6 cm2/m2 27mm ≥AV annulus ≥20mm Sino-tubular Junction ≤43mm Age ≥80 y (21F) ≥75 y (18F) Logistic EuroSCORE ≥20% (21F) Age ≥65 y ≥15% (18F) +1 or more Primary Endpoints: • Procedural success • 30-Day outcomes • Long term outcomes Liver cirrhosis (Child A or B) Pulmonary insufficiency: FEV1<1L Previous cardiac surgery PHT (PAP>60mmHg) Recurrent P.E’s RV failure Hostile thorax (radiation, burns,etc) Severe connective tissue disease Cachexia Patient Demographics In-Training Solo Total EER N = 918 80.8 ±6.7 N = 565 81.7 ±5.9 N = 1483 81.2 ±6.4 22.2 ±13.6 23.2 ±13.7 22.6 ±13.7 55.8% 54.7% 55.4% I-II: 17.2% III-IV: 82.8% I-II: 14.4% III-IV: 85.6% I-II: 16.1% III-IV: 83.9% AorticValve ValveArea Area (cm2) 2) Aortic (cm 0.65 ±0.18 0.61 ±0.17 0.64 ±0.18 Peakgradient Gradient (mmHg) Peak (mm Hg) 78.3 ±26.1 81.3 ±25.8 79.5 ±26.1 Mean Gradient (mmHg) Mean gradient (mm Hg) 48.4 ±16.4 50.4 ±16.0 49.2 ±16.3 52.9 ±13.8 51.4 ±13.7 52.3 ±13.8 Mean ± SD or % Age (years) Age (years) Logistic Euro SCORE Logistic EuroSCORE (%) Female Female NYHA I-II NYHA III-IV NYHA LVEF LVEF(%) (%) 52 Procedural Results Procedure Mean Time (minutes) Procedural Success 100% 97.7% 98.4% 98.0% SD 200 180 80% 160 140 60% 120 131.2 120.5 100 40% 80 60 20% 40 20 0% 0 In-Training (N = 867) Solo (N = 511) Total EER (N = 1378) 127.2 Mortality Rate 30- Day 30-Day 24-Hour 24 - Hour 12% 12% 12% 12% 10% 10% 8% 8% 6% 6% 6% 6% 4% 4% 2.6% 2% 1.9% 10.7% 9.7% 10.3% 2.4% 2% 0% 0% 0% 0% In Training Solo In-Training Solo (N = 918) (N = 565) Total EER Total EER In Training In-Training Solo Solo Total TotalEER EER (N = 1483) (N = 918) (N = 565) (N = 1483) ≤ 30-Day Adverse Events* In-Training CARDIAC Deaths† Aortic Dissection Cardiac Tamponade Cardiac Perforation Access Site Complication Major Bleeding Conversion to Surgery Myocardial Infarction Major Arrhythmia Pacemaker Renal Failure Stroke TIA Structural Valve Dysfunction Valve Migration * Multiple events in same patients = data not cumulative † Includes deaths where cause is not known 5.4% 0.7% 3.5% 2.3% 2.5% 5.1% 0.6% 0.9% 9.1% 18.8% 1.9% 2.2% 0.2% 0.0% 0.0% Certified 3.9% 0.2% 2.2% 1.8% 0.7% 3.3% 0.9% 0.4% 4.6% 17.8% 1.5% 2.2% 0.4% 0.0% 0.0% Both 4.9% 0.6% 3.0% 2.1% 1.8% 4.4% 0.7% 0.7% 7.5% 18.4% 1.7% 2.2% 0.3% 0.0% 0.0% CONSIDERATIONS Multidisciplinary approach and team work essential Both systems and different access routes should be available to increase the spectrum of treatable pts. The “real world” post commercialization experience shows a high procedure success with a relatively low 30day mortality A relatively low rate of complications is documented Experience in managing complications improves the outcome Expanded indications are expected Pts. selection remains critical Advances and refinements in technology are ongoing and will facilitate the procedure and improve outcome My Wish List (P.Block,June 2009) True percutaneous insertion No need of general anesthesia Multiple valve sizes Smallest size possible < 16 Fr Smooth outer surface to pass through aorta Easy transition over arch Easy transit through valve “Self seating” Adequate radial strength Repositionable and retrivable if needed No valve gradient Conforms to annulus without AR Long term durability PERSPECTIVES Progress in delivery systems and valve manufacturing will lead to lower profile,repositionable,retrievable and more durable devices, as well as a wider range of prosthetic dimensions Improved imaging, such as on-line 3-D reconstruction and stereotaxis could facilitate valve implantation Indications will be expanded, but randomized trials are highy desirable