PORTICO CE TRIAL ASSESSMENT OF THE ST. JUDE MEDICAL PORTICO TRANSCATHETER AORTIC VALVE IMPLANT AND THE TRANSFEMORAL DELIVERY SYSTEM

Transcription

1 PORTICO CE TRIAL ASSESSMENT OF THE ST. JUDE MEDICAL PORTICO TRANSCATHETER AORTIC VALVE IMPLANT AND THE TRANSFEMORAL DELIVERY SYSTEM Preliminary Results: Acute and 1-Year Outcomes Ganesh Manoharan, MBBCh, MD, FRCP Consultant Cardiologist Royal Victoria Hospital Belfast, UK CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use. ID A EN (12/13) 1

2 Challenges of TAVR Procedures Control and placement accuracy Paravalvular aortic regurgitation Development of heart block necessitating permanent pacemaker implantation Vascular access Associated complication rate G Manoharan, Presentation TCT, October, 2013 ID A EN (12/13) 2

3 Portico Overview Self-expanding stent designed to be: Fully resheathable* Repositionable* (proximally and distally*) in-situ Retrievable* Nonflared annulus section of the stent frame Portico 23 mm: mm Portico 25 mm: mm Bovine leaflets and porcine pericardial sealing cuff Transfemoral delivery system compatible with 18 F introducer sheath Leaflet functionality after partial deployment, allowing controlled deployment without rapid pacing Aortic Section Annulus Section The 23 mm Portico system is approved for CE Mark. Caution: Investigational Device. Limited by Federal (or United States) law to investigational use *Until fully deployed Nonflared annulus section ID A EN (12/13) 3

4 Study Design Objective Design Primary Endpoint To assess the safety and performance of the St. Jude Medical Portico heart valve and the St. Jude Medical transfemoral transcatheter delivery system in subjects with severe symptomatic aortic stenosis. Prospective; non-randomized; multi-center trial Max 50 subjects for each valve size Study included 23 mm and 25 mm Portico valves F/U at discharge, 30 d, 3 mo., 6 mo., 12 mo. All-cause mortality at 30 days Lead Investigators Ganesh Manoharan, MBBCh, MD, FRCP Thomas Walther, MD, PhD ID A EN (12/13) 4

5 Secondary Endpoints Safety: Adverse Event Rates (VARC Definitions) Cardiovascular mortality Myocardial infarction (MI) Disabling stroke (Major Stroke) Efficacy: Functional improvement from baseline as compared to 30 days NYHA Functional Classification Six Minute Walk Test Effective Orifice Area (EOA) Non-disabling stroke (Minor Stroke) Acute kidney injury (AKI) Vascular access site and access-related complications Bleeding Composite of periprocedural encephalopathy, all stroke, all TIA ID A EN (12/13) 5

6 Study Clinical Centers Heart Team Center 23 mm n (%) Ganesh Manoharan, MD* Mark Spence, MD Jan Kovac, MD* Raj Rajendra, MD / Amerjeet Banning, MD Martyn Thomas, MD* Simon Redwood, MD Thomas Walther, MD, PhD* Helge Möllmann, MD David Holzhey, MD* Axel Linke, MD Karl-Heinz Kuck, MD, PhD* Ulrich Schäfer MD, PhD Royal Victoria Hospital (Belfast, UK) 25 mm n (%) Total n (%) 10 (20) 10 (30.3) 20 (24.1) Glenfield Hospital (Leicester, UK) 7 (14) 2 (6.1) 9 (10.8) St. Thomas Hospital (London, UK) Kerckhoff-Klinik GmbH (Bad Nauheim, DE) Universität Leipzig Herzzentrum (Leipzig, DE) Asklepios Klinik St. Georg (Hamburg, DE) 8 (16) 1 (3.0) 9 (10.8) 7 (14) 4 (12.1) 11 (13.3) 18 (36) 12 (36.4) 30 (36.1) (12.1) 4 (4.8) * Principal Investigator All sites 50 (100) 33 (100) 83 (100) ID A EN (12/13) 6

7 Baseline Characteristics Characteristic All Subjects Age, yrs 83.8 ± 4.9 Gender % Female 96.3% NYHA class II NYHA class III/IV 22.2% 77.8% STS score (mortality) 6.1 ± 3.4 Logistic EuroSCORE 16.3 ± 7.9 Aortic valve area (cm 2 ) 0.6 ± 0.2 Mean gradient (mmhg) 45.6 ± 13.1 Left ventricular ejection fraction (%) 65.6 ± minute walk (meters) 167 ± 110 ID A EN (12/13) 7

8 Baseline Risk Factors Risk Factor Incidence n=82 Coronary artery disease 47.6% Renal failure/insufficiency 35.4% Pulmonary hypertension 26.3% PTCA with stent 17.1% Carotid artery disease 15.9% Myocardial infarction 11.0% Transient Ischemic Attack 9.8% Cerebral Vascular Accident 9.8% Permanent pacemaker 7.3% Peripheral vascular disease 6.1% Coronary artery bypass 4.9% Cerebral vascular disease 3.7% Porcelain Aorta 3.7% Risk Factor Incidence (n) Cardiac arrhythmia 54.9% (45/82) Atrial fibrillation 48.9% (22/45 ) Left bundle branch block 11.1% (5/45) Other arrhythmia 44.4% (20/45) ID A EN (12/13) 8

9 Procedural Information Parameter Anaesthesia type* - Local - Conscious sedation - General All Subjects 56.6% 32.5% 36.1% Procedure Time (mins) 40.0 ± 19.0 Multiple valves in same subject 4.8% (4) Valve Resheathed - Resheath successful - Placement in recommended landing zone 23.2% (19) 100% 91% (17) Depth of implant into LV (mm) 5.8 ± 2.7 * ~20% of patients had a combination of local and conscious sedation ID A EN (12/13) 9

10 Clinical Safety Results As adjudicated by clinical events committee Event 30 day Rate (%) (per subject basis)* n=83 Overall Rate (%) day 1 up to 1 year (per subject basis)* n= Death - Cardiovascular Death Disabling (Major) stroke 2.4 Non-disabling (Minor) stroke 1.2 New pacemaker implantation Myocardial infarction Acute kidney injury Stage 3 AKI Major vascular complication Minor vascular complication Life threatening or disabling bleeding* Major bleeding* Minor bleeding* * Four adverse events adjudicated both as Bleeding (Life threatening = 1, Major bleed = 2, Minor bleed = 1) and Vascular complication events are presented as only Vascular Complications ID A EN (12/13) 10

11 Core Laboratory Echo Results Changes observed from baseline to 30 days are sustained at the 12-month follow-up Mean Gradient Average Mean Gradient (mmhg) Peak Gradient p =<.0001 p =< Average Peak Gradient (mmhg) Average Peak Gradient (mmhg) 0 Peak Velocity Baseline 30 days 3 months 6 months 12 months n=61 n=59 n=44 n=33 n= Valve Area 2 p =<.0001 p =<.0001 Average Ao Valve Area (cm 2 ) Baseline 30 days 3 months 6 months 12 months n=61 n=59 n=44 n=33 n= Baseline 30 days 3 months 6 months 12 months n=61 n=59 n=44 n=33 n=31 0 Baseline 30 days 3 months 6 months 12 months n=58 n=56 n=42 n=33 n=30 ID A EN (12/13) 11

12 Paravalvular Aortic Regurgitation 100% 30 Days (n=57) 6 Months (n=31) 80% 60% 65% Moderate to Severe 5% 68% Moderate to Severe 3% 40% 30% 29% 20% 0% 5% 3% 0% 0% 2 PVL at 30 days and 1 at 6 months were reported between categories by the core lab and were included in the lesser category. ID A EN (12/13) 12

13 NYHA Classification 100% 90% 3% 2% 0% 0% 14% 16% 21% 80% 70% 60% 50% 40% 75% 52% 37% 42% NYHA IV NYHA III NYHA II NYHA I 30% 20% 10% 22% 33% 47% 36% 0% Baseline 30 Days 6 Month 12 Month ID A EN (12/13) 13

14 6 Minute Walk Test Baseline (n=69) days (n=56) Meters ID A EN (12/13) 14

15 Conclusions The results suggest that TAVR with the St. Jude Medical Portico system produces clinically meaningful and sustained improvements in patient outcomes. Preliminary data on the Portico 23 mm and 25 mm valves demonstrate exceptional hemodynamic performance and improvements in the New York Heart Association (NYHA) class. The 18 F St. Jude Medical Portico system with resheathable technology allows for precise and reproducible valve placement. This study establishes an excellent safety profile with the 18 F Portico system depicted by low rates of pacemaker implantation, moderate-severe PV leak, vascular complications, stroke and death. CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use. ID A EN (12/13) 15

16 ID A EN (12/13) 16 St. Jude Medical Inc. Global Headquarters One St. Jude Medical Drive St. Paul, Minnesota USA Fax St. Jude Medical International Division One Lillehei Plaza St. Paul, Minnesota USA Fax St. Jude Medical S.C., Inc. U.S. Division 6300 Bee Cave Road Bldg. Two, Suite 100 Austin, TX USA Fax SJM Coordination Center BVBA The Corporate Village Da Vincilaan 11-Box F1 B-1935 Zaventem, Belgium Fax St. Jude Medical Brasil Ltda. Rua Itapeva, 538 5º ao 8º andares São Paulo SP Brazil Fax St. Jude Medical (Hong Kong) Ltd. Suite 1608, 16/F Exchange Tower 33 Wang Chiu Road Kowloon Bay, Kowloon Hong Kong SAR Fax St. Jude Medical Japan Co., Ltd. Shiodome City Center 15F Higashi Shinbashi, Minatoku Tokyo Japan Fax St. Jude Medical Australia Pty, Ltd. 17 Orion Road Lane Cove, NSW 2066 Australia Fax SJMprofessional.com Rx Only Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the ninesquares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies St. Jude Medical, Inc. All Rights Reserved.