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Siegburg Transcatheter Aortic Valve Replacement Update Eberhard Grube MD HELIOS Klinikum Siegburg, Germany Instituto Dante Pazzanese de Cardiologia, São.

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Presentation on theme: "Siegburg Transcatheter Aortic Valve Replacement Update Eberhard Grube MD HELIOS Klinikum Siegburg, Germany Instituto Dante Pazzanese de Cardiologia, São."— Presentation transcript:

1 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

2 Siegburg Standard therapy for critical AS is/was Surgical Aortic Valve Replacement 30day Mortality 3% Mechanical TissueStentless Options for sAVR: 70s - Today

3 Outcome of AVR in High Risk Patients with severe AS Study # pts High risk features In-Hosp mortality Late mortality Brogan (1993) 18 LVEF + gradient LVEF + gradient33%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) yo 80 yo11% 1yr – 20% Mortasawi (2000) yo 80 yo9% 1yr – 10% Kohl (2001) yo 80 yo13% 1yr – 14% Bloomstein (2001) yo 70 yo17%na Bernard (1992) 23 > 75 yo 9%17%

4 High Risk AVR Patients with Poor Outcomes Radiation chest wall/heart disease Radiation chest wall/heart disease Octogenarians with multiple co-morbidities Octogenarians with multiple co-morbidities Cirrhosis with portal hypertension Cirrhosis with portal hypertension Porcelain aorta Porcelain aorta COPD COPD Degenerative neurocognitive dysfunction Degenerative neurocognitive dysfunction Previous Cardiac Surgery Previous Cardiac Surgery ESRD (esp. on dialysis) ESRD (esp. on dialysis)

5 SurgeryPercutaneous

6 Edwards ~4,000 patients CoreValve ~4,000 patients Current Generation Devices Transcatheter AVR

7 Siegburg Transcatheter AVR Clinical Data Sources PARTNER FDA* (US/OUS, TF/TA 456 pts) PARTNER FDA* (US/OUS, TF/TA 456 pts) PIVOTAL RCT * still enrolling patients CE-APPROVAL 18 Fr Transfemoral OUS Experience (1,243 pts)* PARTNER EU (OUS, TF/TA 125 pts) SOURCE (OUS, TF/TA, 598 pts)* PARTNER EU (OUS, TF/TA 125 pts) SOURCE (OUS, TF/TA, 598 pts)* FEASIBILITY 21 and 18 Fr Transfemoral OUS Experience (177 pts) REVIVE (OUS, TF, 106 pts) TRAVERCE (OUS, TA, 172 pts) REVIVAL (US, TF/TA, 95 pts) Transseptal Experience (RECAST, I-REVIVE; 36 pts) FIRST-in-MAN 25 Fr Transfemoral Experience (14 pts) Edwards CoreValve PARVIS In Planning with FDA PARVIS In Planning with FDA

8 Siegburg F.I.M. Balloon Aortic Valvuloplasty 1985 Concept of« stented valve », to rule out post-BAV valvular restenosis Post-mortem studies of intra-valvular stenting Sketches of stented valve « Percutaneous Valve Technology » (prototypes) 1999 First animal implantation (sheep) 2000 Large series of animal implantation F.I.M. PHV implantation 2002 Feasibility Studies (antegrade) Edwards Lifesciences Technological improvements 2004 International TF and TA Feasibility Studies CE mark commercialization years THV development A long road: 20 Years from concept to real world June, 2009 – ~4,000 implanted worldwide

9 Siegburg TAVI – CoreValve Number of Countries & Centers

10 Siegburg TAVI – CoreValve Number of Cases 9

11 Siegburg All SAPIEN ® Studies, Transfemoral Continued improvement in implantation success REVIVEREVIVAL PARTNER EU TF n=61 SOURCE TF Mean Euroscore (%)28.8 ± ± ± Procedure time (min)158 ± ± ± 62NAV Fluoroscopy time (min)30.56 ±7.6NAV28.1 ± 17NAV Device success composite incl AR <2+70.0%88.9% Freedom from death at 30D85.9%92.7%92%93.7 Freedom from stroke at 30D96.7%90.8%97%97.6 Freedom from MI at 30D %98.4%99.8 Perforation or damage to vessels, myocardium, valvular structures 15.0%9.1%19.7%17.9 Freedom from reoperation at 30D99.0%98.1%98.4%NAV Freedom from Structural valve deterioration 30D 100% Data ExtractJan Mar 09May, 2009

12 Edwards Transcatheter AVR Survival at 1, 6 and 12 months Transfemoral Experience

13 Siegburg REVIVE & REVIVAL Vascular Complications Vascular Complications (n=25) Perforations (n=12) Aortic Dissection (n=3) Flow Limiting Iliac Dissection (n=4) Avulsed Iliac Artery (n=3) Lower Extremity Ischemia (n=4) Covered Stent - 3 Surgical Bypass - 9 Surgical Repair - 4 Surgical Bypass - 3 Surgery - 1 Medical - 2 Surgery - 2 Medical Deaths 2 Deaths In Hospital Mortality in Patients with a Vascular Complication – 36% In Hospital Mortality in Patients without a Vascular Complication – 10.3%

14 Siegburg P =.006 Vascular Access Complication Rate, by patient January 2006 – June % Vascular Screening with Columbia University Medical Center Core Lab INSTITUTED (in coordination with DSMB) Vascular Screening with Columbia University Medical Center Core Lab INSTITUTED (in coordination with DSMB) Vascular Access Complication Rate, by patient August 2006 – December % REVIVE improved screening to reduce vascular complications

15 Siegburg TA Survival PARTNER EU & TRAVERCE Overall Survival TRAVERCE vs. PARTNER EU (TA) Probability (event free) PARTNER EU (TA) TRAVERCE 6M surv: M surv: 0.55 Time (months)

16 Siegburg Complications N=25 (18.5%) Descending Ao dissection1 Apical bleeding/ventricular injury8 Arrhythmias requiring intervention4 Hemodynamic instability requiring intervention 3 Severe CHF4 Partial coronary occlusion3 Coronary occlusion2 TRAVERCE Transapical Intraprocedural Complications

17 Siegburg TA Survival Overall (n=159) EuroSCORE 30% STS Score 15% Pts at risk 30 Days 6 Months 1 Year Off-pump94.0% Conversion 2.5% StrokeNone 2 Years ,000 0,0 0,2 0,4 0,6 0,8 1,0 90 ±3% 76 ±4% 74 ±4% Days Leipzig TA Experience Survival

18 Siegburg CoreValve Procedural Results 21F S&E18F S&E18F EE

19 Siegburg Global 18-Fr Experience 18 Fr. CVSS&E Study – CE Marking European Registry (Post-CE Mark)* Australian New Zealand Trial* Single Center Experience Munich (Lange) Siegburg (Grube) Patients (n)112141, D 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

20 Siegburg 30-Day Adverse Events* 30-Day Adverse Events* * Multiple events in same patients = data not cumulative Includes 4 deaths where cause is not known Includes 4 deaths where cause is not known 21F S&E Study (N = 52) 18F S&E Study (N = 124) 18F EE Registry (N = 1243) 30-Day All Mortality 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% Renal Failure 5.8%4.8%1.2% Stroke 17.3%6.5%1.4% TIA 0.0%5.6%0.3% Structural Valve Dysfunction 0.0% Valve Migration 0.0%

21 Siegburg Siegburg CoreValve Experience Total number of patients*:387 Gen 1 (2005)10 Gen 2 ( )26 Gen 3 (since 2006)257 in in /week 30 Day Mortality: Gen 140.0% Gen 220.8% Gen 38.6% in % *Status of Nov 2008

22 Siegburg Native Aortic Valve Disease Severe AS: AVAI 0.6 cm 2 /m 2 27mm AV annulus 20mm Sino-tubular Junction 43mm Age 80 y (21F) 75 y (18F) Logistic EuroSCORE 20% (21F) 15% (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.Es RV failure Hostile thorax (radiation, burns,etc) Severe connective tissue disease Cachexia TAVI Candidate Today: Who is Eligible? Morphological Criteria: (Mandatory) Clinical Criteria: ?

23 Siegburg Age Distribution of CoreValve Patients HELIOS Heart Center Siegburg N=280 Younger Population will be approached with increasing evidence on safety and feasibility…

24 Siegburg Morphological Quantification Morphologic Criteria must be met

25 Siegburg Which is the preferred access? Transfemoral Complexity / Invasiveness Surgical Interventional Transapical Subclavian

26 Siegburg Future Challenges Indication Controversies: Which Technique? Which Access Site? Which performing Discipline? Design Features (e.g.Profile)

27 Siegburg Percutaneous Devices for Aortic Valve Replacement Potential problems of current devices –Paravalvular leackage –Inaccuracies in Positioning –Embolization (Edwards prosthesis) –One shot procedure

28 Siegburg CoreValve Aortic Regurgitation post-interventional AB

29 The Sadra Lotus TM Valve - Device Features and Rationale Adaptive TM Seal Locking mechanism

30 Siegburg At this point the device can be fully retracted, back to step 1, and repositioned Lotus Valve

31 Investigational device currently in European clinical trial Not available for sale Multilumen Slightly Tapered, Conformable Polyester Fabric Cuff Tri-leaflet Valve constructed of Bovine Pericardium Position Fill Lumens (PFLs) -Used to position/reposition valve -Complete Inflation Media Exchange Ventricular and Aortic Rings -Inflate independently so device can be repositioned -deflatable so that device can be fully retrieved The Direct Flow Medical (DFM) Aortic Valve Prosthesis

32 Direct Flow Aortic Valve Valve loaded in Delivery Catheter (22F) Introducing Tip advanced Delivery sheath pulled back; Valve inflated

33 Siegburg PCI CABG 1980s, 1990s My Prediction: Repetition of an Old Story TAVI sAVR 2000s, 2010s With the same result…

34 Siegburg Transcatheter AVR My Rosey Prophecy Surgery – The PAST TAVR – The Future In the next 5-10 years, most patients with severe AS requiring AVR will be treated using transcatheter lesser-invasive modalities!

35 Siegburg Vielen Dank


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