Transcatheter Aortic Valve Replacement Update Eberhard Grube MD HELIOS Klinikum Siegburg, Germany Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil Stanford University, Palo Alto, California, USA Siegburg.
Download ReportTranscript Transcatheter Aortic Valve Replacement Update Eberhard Grube MD HELIOS Klinikum Siegburg, Germany Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil Stanford University, Palo Alto, California, USA Siegburg.
Transcatheter Aortic Valve Replacement Update Eberhard Grube MD HELIOS Klinikum Siegburg, Germany Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil Stanford University, Palo Alto, California, USA Siegburg 70’s - Today Standard therapy for critical AS is/was Surgical Aortic Valve Replacement 30day Mortality 3% Options for sAVR: Mechanical Tissue Stentless Siegburg Outcome of AVR in High Risk Patients with severe AS # pts High risk features In-Hosp mortality Late mortality Brogan (1993) 18 LVEF + gradient 33% na Powell (2000) 55 LVEF ≤ 30% 18% na Jegaden (1986) 71 LVEF ≤ 40% 10% 5yr – 28% Connolly (2000) 52 LVEF ≤ 35% + gradient 21% 3yr – 29% Pereira (2002) 68 LVEF ≤ 35% + gradient 8% 1yr – 18% Sundt (2000) 133 ≥ 80 yo 11% 1yr – 20% Mortasawi (2000) 105 ≥ 80 yo 9% 1yr – 10% Kohl (2001) 83 ≥ 80 yo 13% 1yr – 14% Bloomstein (2001) 180 ≥ 70 yo 17% na Bernard (1992) 23 > 75 yo 9% 17% Study High Risk AVR Patients with Poor Outcomes • • • • • • • • Radiation chest wall/heart disease Octogenarians with multiple co-morbidities Cirrhosis with portal hypertension Porcelain aorta COPD Degenerative neurocognitive dysfunction Previous Cardiac Surgery ESRD (esp. on dialysis) Surgery Percutaneous Transcatheter AVR Current Generation Devices Edwards ~4,000 patients CoreValve ~4,000 patients Transcatheter AVR Clinical Data Sources CoreValve Edwards Transseptal Experience (RECAST, I-REVIVE; 36 pts) REVIVE (OUS, TF, 106 pts) TRAVERCE (OUS, TA, 172 pts) REVIVAL (US, TF/TA, 95 pts) PARTNER EU (OUS, TF/TA 125 pts) SOURCE (OUS, TF/TA, 598 pts)* PARTNER FDA* (US/OUS, TF/TA 456 pts) FIRST-in-MAN 25 Fr Transfemoral Experience (14 pts) FEASIBILITY 21 and 18 Fr Transfemoral OUS Experience (177 pts) CE-APPROVAL 18 Fr Transfemoral OUS Experience (1,243 pts)* PIVOTAL RCT PARVIS In Planning with FDA * still enrolling patients Siegburg THV development A long road: 20 Years from concept to real world 2007 2002 2000-02 2000 1999 1994 1987 1985 International TF and TA Feasibility Studies 2005-07 2004 2002-03 CE mark commercialization Edwards Lifesciences Technological improvements Feasibility Studies (antegrade) F.I.M. PHV implantation Large series of animal implantation First animal implantation (sheep) « Percutaneous Valve Technology » (prototypes) Post-mortem studies of intra-valvular stenting Sketches of stented valve Concept of« stented valve », to rule out post-BAV valvular restenosis F.I.M. Balloon Aortic Valvuloplasty Siegburg TAVI – CoreValve Number of Countries & Centers 160 151 Countries Centers 140 120 100 80 59 60 40 20 26 17 6 4 Siegburg Apr Mar Feb 2009-Jan Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb 2008-Jan Dec Nov Oct Sep Aug Jul Jun May 2007-Apr 0 Siegburg 9 Apr 4000 Mar Feb 2009-Jan Dec Nov Oct Sep Aug Jul Jun May 1000 Apr Mar Feb 2008-Jan Dec Nov Oct Sep Aug Jul Jun May 2007-Apr TAVI – CoreValve Number of Cases 3529 3500 3000 2500 2000 1500 763 500 0 All SAPIEN® Studies, Transfemoral Continued improvement in implantation success REVIVE REVIVAL PARTNER EU TF n=61 Mean Euroscore (%) 28.8 ± 13.4 34.1 ± 18.0 25.7 ± 11.5 25.7 Procedure time (min) 158 ±-138.5 138.0 ± 63.6 140.9 ± 62 NAV Fluoroscopy time (min) 30.56 ±7.6 NAV 28.1 ± 17 NAV Device success composite incl AR <2+ 70.0% 88.9% 91.0 92.5 Freedom from death at 30D 85.9% 92.7% 92% 93.7 Freedom from stroke at 30D 96.7% 90.8% 97% 97.6 90.9 83.6% 98.4% 99.8 Perforation or damage to vessels, myocardium, valvular structures 15.0% 9.1% 19.7% 17.9 Freedom from reoperation at 30D 99.0% 98.1% 98.4% NAV Freedom from Structural valve deterioration 100% 30D 100% 100% 100% Jan 2009 18 Mar 09 May, 2009 Freedom from MI at 30D Data Extract Jan 2009 SOURCE TF Siegburg Edwards Transcatheter AVR Survival at 1, 6 and 12 months Transfemoral Experience 1 month 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 6 months 12 months 92.7 86.8 71.4 67.2 93.6 83.4 78.3 71.9 92.0 90.0 75.8 46.2 40.4 33.6 28.0 iREVIVE (n=22) RECAST (n=24) REVIVE (n=106) REVIVAL (n=59) PARTNER EU (n=54) SOURCE (n=303) REVIVE & REVIVAL Vascular Complications Perforations (n=12) Flow Limiting Iliac Dissection (n=4) Covered Stent - 3 3 Deaths Surgical Bypass - 9 Surgical Repair - 4 2 Deaths In Hospital Mortality in Patients with a Vascular Complication – 36% Vascular Avulsed Iliac Surgical Bypass - 3 Complications Artery (n=3) In Hospital Mortality in Patients without (n=25) a Vascular Complication – 10.3% Aortic Dissection (n=3) Lower Extremity Ischemia (n=4) Surgery - 1 Medical - 2 2 Deaths Surgery - 2 Medical - 2 2 Deaths Siegburg REVIVE improved screening to reduce vascular complications Vascular Access Complication Rate, by patient January 2006 – June 2006 30% Vascular Screening with Columbia University Medical Center Core Lab INSTITUTED (in coordination with DSMB) Vascular Access Complication Rate, by patient August 2006 – December 2007 5.8% P = .006 Siegburg 1.0 TA Survival PARTNER EU & TRAVERCE Overall Survival TRAVERCE vs. PARTNER EU (TA) 0.6 0.4 6M surv: 0.55 0.2 PARTNER EU (TA) TRAVERCE 0.0 Probability (event free) 0.8 6M surv: 0.70 0 1 2 3 4 5 6 Time (months) Siegburg TRAVERCE Transapical Intraprocedural Complications Complications N=25 (18.5%) Descending Ao dissection 1 Apical bleeding/ventricular injury 8 Arrhythmias requiring intervention 4 Hemodynamic instability requiring intervention 3 Severe CHF 4 Partial coronary occlusion 3 Coronary occlusion 2 Siegburg Leipzig TA Experience Survival TA Survival Overall (n=159) 1,0 90 ±3% 76 ±4% 0,8 74 ±4% EuroSCORE 30% STS Score 15% 1 Year 2 Years 0,2 6 Months 0,4 Off-pump Conversion Stroke 30 Days 0,6 132 78 64 20 94.0% 2.5% None Pts at risk 0,0 0 200 400 600 800 1,000 Days Siegburg CoreValve Procedural Results Procedure Success Procedure Mean Time ± SD 300 100% 98.2% 98% 250 96% 200 94.4% 94% 150 205.3 154.1 125.9 92% 90.4% 100 90% 50 88% 86% 0 21F S&E 18F S&E 18F EE Siegburg Global 18-Fr Experience 18 Fr. CVS S&E Study – CE Marking Patients (n) European Registry (Post-CE Mark)* Australian New Zealand Trial* Single Center Experience Munich (Lange) Siegburg (Grube) 112 14 1,424 37 137 102 30D Mortality – All Cause 15.2% 7.1%✚ 10.4% 8.1% 12.4% 10.8% Technical Success 86.5% n.a. 97.3% 98.3% 98.5% 98.2% * Site reported ✚ Un-adjudicated Siegburg ≤ 30-Day Adverse Events* 21F S&E Study (N = 52) 30-Day All Mortality 18F S&E Study (N = 124) 18F EE Registry (N = 1243) 15.4% 14.5% 6.7% Cardiac Deaths 7.7% 11.2% 3.9%† Myocardial Infarction 3.8% 3.4% 0.7% Major Arrhythmias 25.0% 18.5% 4.9% Pacemaker 17.3% 25.8% 12.2% 5.8% 4.8% 1.2% 17.3% 6.5% 1.4% TIA 0.0% 5.6% 0.3% Structural Valve Dysfunction 0.0% 0.0% 0.0% Valve Migration 0.0% 0.0% 0.0% Renal Failure Stroke * Multiple events in same patients = data not cumulative † Includes 4 deaths where cause is not known Siegburg Siegburg CoreValve Experience Total number of patients*: Gen 1 (2005) Gen 2 (2005-2006) Gen 3 (since 2006) in 2008 in 2009 387 10 26 257 217 6-10/week 30 Day Mortality: Gen 1 Gen 2 Gen 3 in 2008 *Status of Nov 2008 40.0% 20.8% 8.6% 4.8% Siegburg TAVI Candidate Today: Who is Eligible? Morphological Criteria: (Mandatory) Clinical Criteria: • • • • Native Aortic Valve Disease Severe AS: AVAI ≤0.6 cm2/m2 27mm ≥AV annulus ≥20mm Sino-tubular Junction ≤43mm Logistic EuroSCORE ≥20% (21F) ≥15% (18F) Age ≥80 y (21F) ≥75 y (18F) ? Age ≥65 y plus 1+ of the following: • 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 Siegburg Age Distribution of CoreValve Patients 2006-2008 HELIOS Heart Center Siegburg N=280 100 80 60 40 20 0 0 50 100 150 Younger Population will be approached with increasing evidence on safety and feasibility… Siegburg Morphologic Criteria must be met Morphological Quantification Siegburg Which is the preferred access? Surgical Transapical Subclavian Interventional Transfemoral Complexity / Invasiveness Siegburg Future Challenges Design Features (e.g.Profile) Indication Controversies: Which Technique? Which Access Site? Which performing Discipline? Siegburg ‘Percutaneous Devices for Aortic Valve Replacement’ Potential problems of current devices – Paravalvular leackage – Inaccuracies in Positioning – Embolization (Edwards prosthesis) – ‘One shot’ procedure Siegburg CoreValve Aortic Regurgitation post-interventional 1.5 0 0.7 1.7 100% 90% 100% 19.1 18.2 90% 30.9 80% 80% 70% 70% 4+ 3+ 60% 50% 2+ 50% 40% 1+ 0 40% 60% 54.4 51.2 34.6 Unchanged Improved 30% 30% 20% 20% 24.3 34.6 28.9 10% 10% A Worsened 0% B Pre Post 0% Pre-Post Siegburg The Sadra Lotus Valve Device Features and Rationale TM Locking mechanism AdaptiveTM Seal At this point the device can be fully retracted, back to step 1, and repositioned Lotus Valve Siegburg The Direct Flow Medical (DFM) Aortic Valve Prosthesis Tri-leaflet Valve constructed of Bovine Pericardium Ventricular and Aortic Rings -Inflate independently so device can be repositioned -deflatable so that device can be fully retrieved Multilumen Slightly Tapered, Conformable Polyester Fabric Cuff Position Fill Lumens (PFLs) -Used to position/reposition valve -Complete Inflation Media Exchange Investigational device currently in European clinical trial Not available for sale Direct Flow Aortic Valve Valve loaded in Delivery Catheter (22F) Introducing Tip advanced Delivery sheath pulled back; Valve inflated My Prediction: Repetition of an Old Story TAVI PCI sAVR CABG 1980’s, 1990’s 2000’s, 2010’s With the same result… Siegburg Transcatheter AVR My Rosey Prophecy Surgery – The PAST In the next 5-10 years, most patients with severe AS requiring AVR will be treated using transcatheter lesser-invasive modalities! TAVR – The Future Siegburg Vielen Dank Siegburg