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Medtronic CoreValve ® System Summary of Clinical Experience UC201402534 EE.

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Presentation on theme: "Medtronic CoreValve ® System Summary of Clinical Experience UC201402534 EE."— Presentation transcript:

1 Medtronic CoreValve ® System Summary of Clinical Experience UC EE

2 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Background on aortic stenosis (AS) and introduction to transcatheter aortic valve implantation (TAVI) Overview of the CoreValve clinical portfolio CoreValve clinical performance –All-cause Survival –Efficacy –Other Outcomes Agenda

3 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Background Aortic Stenosis (AS) is the most prevalent native valve disease 1 More than 300,000 patients have severe AS worldwide The mortality rate for untreated severe AS is up to 50%-60% within 2 years of the onset of severe symptoms 1 Carabello BA, et al. Lancet 2009; 373:956-66

4 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Treatment of Severe Aortic Stenosis Surgical aortic valve replacement (SAVR) is the gold standard for treatment of severe AS However, 33% of all patients ≥75 years of age with severe AS are declined for surgery 1 The mortality rate associated with SAVR increases substantially if certain comorbidities are present – Left ventricular dysfunction – Previous cardiac operations – Chronic obstructive pulmonary disease – Liver or renal failure – Frailty 1 lung B, et al. Eur Heart J. 2005; 26(24):

5 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Transcatheter aortic valve implantation (TAVI) is a viable treatment strategy for AS patients at high or extreme surgical risk TAVI has demonstrated significant survival improvements compared to medical management in inoperable patients in the PARTNER B trial 1 High risk patients receiving TAVI had similar survival rates to SAVR in the PARTNER A trial 2 Treatment of Severe Aortic Stenosis PARTNER BPARTNER A 1 Kapadia, et al., presented at TCT Kodali S, et al., presented at ACC 2012

6 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. The Medtronic CoreValve System The Medtronic CoreValve® System has been implanted in more than 45,000 patients in more than 60 countries worldwide. Self-expanding nitinol frame Tri-leaflet porcine pericardial tissue valve with supra-annular function Four sizes (23, 26, 29, and 31 mm) to fit aortic annuli ranging from 18 to 29 mm 18-Fr delivery catheter for all valve sizes Delivery from a transfemoral, subclavian, or direct aortic approach

7 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. CoreValve ® System Clinical Experience Medtronic CoreValve Clinical Research Portfolio Demonstrate Safety and Efficacy Expand Access to New Populations and Markets Confirm Efficacy and Optimize Practice

8 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. CoreValve ® System Clinical Experience Medtronic CoreValve Clinical Research Portfolio References at end of presentation

9 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. CoreValve ® System Clinical Experience National CoreValve Registries References at end of presentation

10 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. All-cause Survival

11 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. When comparing all-cause survival across data sets, it is important to remember that many variables can influence a given rate. Baseline characteristics, patient selection practices, operator experience, complication management techniques, and in the case of registries, reporting practices, all play a role. Comparisons across data sets should be used to convey general trends, not to derive specific conclusions regarding TAVI devices. All-cause Survival

12 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. 1 Chiam, et al., presented at EuroPCR 2013; 2 Meredith, et al., presented at TCT 2012; 5 Linke, et. al. presented at EuroPCR Rueck, et al., presented at London Valves 2012; 5 Tamburino, et al., Circulation 2011; 123: ; 6 Moat, et al. J Am Coll Cardiol 2011; 58(20): ; 7 Godino, et al., J Am Coll Cardiol Intv 2010; 3: ; 8 Avanzas, et al., Rev Esp Cardiol 2010; 63(2): 141-8; 9 Bosmans, et al., ICVTS 2011; 12: 762-7; 10 Gilard, et al. N Engl J Med 2012; 366: All-cause Survival │ 30-day National Registries and Medtronic Sponsored Studies (independent studies, not head-to-head comparisons) CoreValve

13 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. 1 Meredith, et al., presented at TCT 2012; 2 Rueck, et al., presented at London Valves 2012; 3 Tamburino, et al., Circulation 2011; 123: ; 4 Avanzas, et al., Rev Esp Cardiol 2010; 63(2): 141-8; 5 Linke, et. al. presented at EuroPCR 2013; 6 Bosmans, et al., ICVTS 2011; 12: 762-7; 7 Moat, et al. J Am Coll Cardiol 2011; 58(20): ; 8 Gilard, et al. N Engl J Med 2012; 366: All-cause Survival │ 1 Year National Registries and Medtronic Sponsored Studies (independent studies, not head-to-head comparisons) CoreValve

14 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. All-cause Survival │ 1 Year Rigorous Industry-Sponsored TAVI Studies (independent studies, not head-to-head comparisons) All routes 1 Meredith, et. al. presented at TCT 2012; 2 Linke, et. al. presented at EuroPCR 2013; 3 Leon, et. al. presented at ACC 2013; 4 Smith, et al. N Engl J Med 2011; 364: ; 5 Leon, et al. N Engl J Med 2010; 363:

15 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. All-cause Survival │ 1 Year Select Contemporary Data Sets (independent studies, not head-to-head comparisons) All routes 1 Meredith, et. al. presented at TCT 2012; 2 Linke, et. al. presented at EuroPCR 2013; 3 Windecker, et. al. presented at EuroPCR 2013; 4 Leon, et. al. presented at ACC 2013; 5 Smith, et al. N Engl J Med 2011; 364: ; 6 Leon, et al. N Engl J Med 2010; 363:

16 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. All-cause Survival │ 1 Year National Registries and Post-Market Approval Studies (independent studies, not head-to-head comparisons) 1 Tamburino, et al., Circulation 2011; 123: ; 2 Linke, et. al. presented at EuroPCR 2013; 3 Windecker, et. al. presented at EuroPCR 2013; 4 Moat, et al. J Am Coll Cardiol 2011; 58(20): ; 5 Thomas, et al., presented at TCT 2012; 6 Gilard, et al. N Engl J Med 2012; 366: All routes

17 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. The Italian registry 1 and the Canadian registry 2 have reported longer-term survival data on patient subsets 1 Ussia, et al., Eur Heart J 2012; 33: ; 2 Rodes-Cabau, et al. J Am Coll Cardiol 2012; 60(19): All-cause Survival │ Longer-Term (independent studies, not head-to-head comparisons)

18 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Efficacy New York Heart Association (NYHA) Class status in the ADVANCE study Health related quality of life (HRQoL) in the ADVANCE study Hemodynamics –1-year CoreValve performance in the ADVANCE study –3-year CoreValve performance in the Italian Registry

19 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Efficacy │ New York Heart Association Class (NYHA) The ADVANCE study demonstrated significant improvement in functional status at 1 month post-TAVI, which was sustained to 1 year 1 Linke et al., presented at EuroPCR 2013

20 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Efficacy │ Health Related Quality of Life 6-month Outcomes from the ADVANCE Study The ADVANCE study demonstrated significant improvements in post-TAVI quality of life using multiple measurement tools 1 Bosmans, et al., presented at TCT 2012

21 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. 1 Linke, et al., presented at EuroPCR 2013 Hemodynamics │ CoreValve ADVANCE Study The ADVANCE study has demonstrated that the CoreValve EOA and mean gradient remain stable out to 1 year

22 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Hemodynamics │ Italian CoreValve Registry 1 Ussia, et al., Eur Heart J 2012; 33: The Italian Registry has demonstrated that the CoreValve EOA and mean gradient remain stable out to 3 years

23 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Safety Acute outcomes in the ADVANCE study Long term safety measures

24 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Safety │ Acute Outcomes The ADVANCE Study The ADVANCE study shows that procedural complications are rare during CoreValve implants 1 Linke, et al., presented at EuroPCR 2013

25 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. a Change in NYHA function resulting from intrinsic valve abnormality resulting in stenosis or regurgitation. Safety │ Long-Term Outcomes Medtronic Foundational Studies Two foundational CoreValve studies report no unexpected valve malfunctions or structural deterioration out to 4 years after implant 1 Gerckens, et al., presented at EuroPCR 2011; 2 Gerckens, et al., presented at ESC 2011

26 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Procedural Success

27 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Procedural Success National Registries and Medtronic Sponsored Studies (independent studies, not head-to-head comparisons) CoreValve 1 Chiam, et al., presented at EuroPCR 2013; 2 Moat, et al. J Am Coll Cardiol 2011; 58(20): ; 3 Meredith, et al., presented at TCT 2012; 4 Avanzas, et al., Rev Esp Cardiol 2010; 63(2): 141-8; 5 Bosmans, et al., ICVTS 2011; 12: 762-7; 6 Gilard, et al. N Engl J Med 2012; 366: ; 7 Linke, et. al. presented at EuroPCR 2013; 8 Rueck, et al., presented at London Valves 2012; 9 Tamburino, et al., Circulation 2011; 123: ;

28 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Major Vascular Complications Definition Predictors Incidence

29 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. According to VARC 1, Major Vascular Complications include all complications that can be caused by a wire and/or are related to vascular access, which lead to death, need for significant blood transfusions, unplanned intervention, or irreversible end-organ damage: The VARC 2 definition 2 downgraded unplanned intervention during the index procedure to a minor vascular complication, except if it was associated with qualifying consequences. VARC 1 Definition 1 Ventricular perforation Aortic dissection or rupture Iliofemoral dissection or rupture Pseudoaneurysms Closure failure 1 Leon, et al., J Am Coll Card 2011; 57 (3): ; 2Kappetein, et al., J Am Coll Cardiol 2012; 60: Major Vascular Complications │ Definition

30 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Femoral artery calcium score 2, 4 Female gender 1 Patient-Related Factors Sheath to femoral artery ratio (SFAR) 2 Vessel tortuosity 4 Learning curve 2 Complication management 3 Percutaneous closure device failure 5 Patient selection 3 Anatomical Factors Procedural Factors (Device / Operator) 1 Genereux, et al. J Am Coll Cardiol 2012; 60(12): ; 2 Hayashida, et al., J Am Coll Cardiol Cardiovasc Int 2011; 4(8): 851-8; 3 Webb, et al., presented at TCT 2012; 4 Vavuranakis, et al. Cardiovasc Ther 2013; epub; 5 Cockburn, et al., Cath and Cardiovasc Interv 2012; 79: Major Vascular Complications │ Predictors

31 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Major Vascular Complications │ Predictors 1 Van Mieghem, et al., Am J Cardiol 2012; 110(9): Effect of sheath size: the PRAGMATIC initiative showed patients treated with a 22F or 24F delivery sheath had significantly more vascular complications than patients treated with smaller caliber devices (green bar represents Sapien, yellow is a mixture of Sapien XT and CoreValve)

32 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. 1 Fearon, et al., presented at ACC 2013; 2 Hayashida, JACC Card Int 2011; 4(8): 851-8; 3 Nuis, Am J Cardiol 2011; 107: ; 4 Toggweiler, JACC 2012; 59(2): Effect of learning curve: four studies confirm that increased operator experience decreases the incidence of major vascular complications Major Vascular Complications │ Predictors (independent studies, not head-to-head comparisons)

33 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Major vascular complication rate can be impacted by variables unrelated to the TAVI device (e.g., patient selection practices, operator experience and technique, complication management strategy, percutaneous closure device function, reporting practices in the case of registries). Examining outcomes over the wider clinical experience may lessen the impact of any one of these variables and provide a sense of TAVI device performance. However, it is important to be mindful that all of these factors do contribute to the incidence of major vascular complications and should be considered when doing incidence comparisons across studies. Major Vascular Complications │ Incidence

34 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. 1 Linke, et al., presented at EuroPCR 2013; 2 Gilard, et al. N Engl J Med 2012; 366: ; 3 Meredith, et al., presented at TCT 2012; 4 del Valle, et al., presented at London Valves 2012; 5 Ussia, et al., presented at EuroPCR 2012 Major Vascular Complications │ Incidence Registry Data on CoreValve According to VARC 1 (independent studies, not head-to-head comparisons)

35 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. 1 Leon, et al., presented at ACC 2013; 2 Fearon, et al., presented at ACC 2013; 3 Sack, et al., presented at TCT 2012; 4 Linke, et al., presented at EuroPCR 2013; 5 Treede, et al., presented at EuroPCR 2013; 6 Gilard, et al. N Engl J Med 2012; 366: ; 7 Meredith, et al., presented at TCT 2012; 8 del Valle, et al., presented at London Valves 2012; 9 Ussia, et al., presented at EuroPCR 2012 Major Vascular Complications │ Incidence Select Data Sets Reporting According to VARC 1* (independent studies, not head-to-head comparisons)

36 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Aortic Regurgitation (AR) Definition Predictors Incidence –Select Studies –CoreValve ADVANCE Study Outcomes Clinical Impact

37 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Aortic regurgitation (AR) can be transvalvular (central), paravalvular (PVL) or both. Total AR = PVL + Transvalvular Leak What is clinically relevant is the total volume of flow through the valve Image courtesy of Dr. J. Sinning, University of Bonn Aortic Regurgitation │ Definition

38 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Calcified annulus (commissures, cusps, landing zone) 3,4 Male gender 2,3 Renal failure 2 Peripheral vascular disease 1 NYHA Class IV 3 Patient-Related Factors LVOT-AO angle 1 Large annulus 2 Elliptical annulus 3 LVOT diameter 5 Transfemoral approach 9 Implant depth 1,5,8 Learning curve 6 Cover index (patient- prosthesis mismatch) 4,5,6,7 Anatomical Factors Procedural Factors (Device / Operator) 1 Sherif, et al., J Am Coll Cardiol 2010; 56: ; 2 Abdel-Wahab, et al., Heart 2011; 97: ; 3 Unbehaun, et al., J Am Coll Cardiol 2012; 59: ; 4 Gripari, et al., Heart 2012; 98: ; 5 Italy: Petronio, et al. The Italian CoreValve Registry. TCT 2012; 6 Detaint, et al., J Am Colll Cardiol Intv 2009; 8: 821-7; 7 Santos, et al., Eur H J Cardiovasc Img 2012; 13: ; 8 Chorianopoulos, et al., J Interven Cardiol 2012; 25: ; 9 Van Belle, et. al. Peri-valvular Aortic Regurgitation in Balloon-expendable and Self-expendable TAVI procedures: Predictors and Impact on clinical outcome - Insights from the FRANCE2 Registry; TCT 2012 Aortic Regurgitation │ Predictors

39 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Effect of approach: FRANCE 2 1 and PARTNER 2,3 demonstrate that the transfemoral approach (TF) results in approximately 50% more total AR than the transapical (TA) approach Aortic Regurgitation │ Predictors 1 Van Belle, et. al., presented at TCT 2012; 2 Kodali, et al., presented at TCT 2012; 3 Dewey, et. al., presented at TCT 2012;

40 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Images of increasing levels of valve calcification 1 Mechanism of PVL in calcified valves 2 Aortic Regurgitation │ Predictors Effect of calcification: heavy calcification may prevent perfect apposition to the native annulus, increasing the risk of PVL 1 John, et al., J Am Coll Cardiol Intv 2010; 3: ; 2 Sinning, et al, J Am Coll Cardiol 2012; 59:

41 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Mechanism of PVL in deep implant 1 Mechanism of PVL in shallow implant 1 Aortic Regurgitation │ Predictors Effect of implant depth: appropriate implant depth minimizes potential flow around the valve skirt. With CoreValve, a depth of 4-6 mm is currently recommended to minimize paravalvular leak. 1 Sinning, et al, J Am Coll Cardiol 2012; 59: ; 2 Tchetche, et al., EuroIntervention 2012; epub

42 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. CoreValve ADVANCE | Aortic Regurgitation

43 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. CoreValve ADVANCE | Paravalvular Leak

44 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. CoreValve ADVANCE | Transvalvular Regurgitation

45 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. ASE / ESC guidelines, which are also recommended by VARC, are typically used to grade the severity of AR using echo. –NOTE: Until VARC 2, there was no consensus for measuring paravalvular leak in transcatheter valves. Standardized criteria can be open to interpretation. It is important to verify that the severity grading criteria are the same when comparing AR across studies. –Is “mild” AR included in the study-specific definition of “significant” AR? In addition to the semi-quantitative nature of AR grading, intraobserver variability and variable baseline and procedural characteristics make it very difficult to do a robust comparison of AR across studies. Medtronic- and Edwards-sponsored TAVI studies apply similar echo criteria to grade the severity of AR, making it reasonable to compare the outcomes of these studies. It is difficult to draw strong conclusions about a TAVI device by doing cross- study comparisons. Aortic Regurgitation │ Incidence

46 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Aortic Regurgitation │ Incidence at 1 Year Select Contemporary Data Sets (independent studies, not head-to-head comparisons) 1 Leon, et. al. presented at ACC 2013; 2 Linke, et. al. presented at EuroPCR 2013; 3 Leon, et al. N Engl J Med 2010; 363: ; 4 Smith, et al. N Engl J Med 2011; 364: ; 5 Windecker, et. al. presented at EuroPCR 2013

47 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Paravalvular Leak (PVL) │ Incidence at 1 Year Select Contemporary Data Sets (independent studies, not head-to-head comparisons) 1 Leon, et. al. presented at ACC 2013; 2 Linke, et. al. presented at EuroPCR 2013; 3 Leon, et al. N Engl J Med 2010; 363: ; 4 Smith, et al. N Engl J Med 2011; 364: ; 5 Windecker, et. al. presented at EuroPCR 2013

48 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Paravalvular Leak (PVL) │ Incidence at 1 Year Select Contemporary Data Sets—Transarterial Cohorts (independent studies, not head-to-head comparisons) 1 Leon, et. al. presented at ACC 2013; 2 Kodali, et al., presented at TCT 2012; 3 Linke, et. al. presented at EuroPCR 2013; 4 Leon, et al. N Engl J Med 2010; 363: ; 5 Treede, et. al. presented at EuroPCR 2013

49 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. *At discharge Aortic Regurgitation* │ Clinical Impact Medtronic CoreValve ADVANCE Study 1 Linke, et al. Presented at EuroPCR 2013

50 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Stroke Predictors Timing Incidence

51 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. History of CABG 1 History of stroke 3,5 Coronary artery disease 3 Peripheral vascular disease 5 Baseline NYHA class 3 Chronic atrial fibrillation 5 Late Stroke (30 days to 1 year after TAVI) (30 days to 1 year after TAVI) Female gender 1 Surgical cutdown for access 1 New onset atrial fibrillation 2 Baseline aortic regurgitation 3+ 2 Smaller aortic valve area 3 COPD 4 BMI <25 kg/m 4 Multiple implant attempts 4 Valve dislodgement 5 Balloon post-dilatation 5 Early Stroke (within 30 days of TAVI) 1 Bosmans, et al., presented at EuroPCR 2013; 2 Nuis, et al., Am J Cardiol 2012; 109: ; 3 Miller, et al., J Thorac Cardiovasc Surg 2012;143( ): e13; 4 Stortecky, et al., EuroIntervention 2012; 8: 62-70; 5 Nombela-Franco, et al., Circulation 2012; 126(25): Stroke │ Predictors Risk factors of early stroke tend to implicate embolization of annular debris, while risk factors of late stroke point to comorbid conditions.

52 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Stroke │ Type and Timing The ADVANCE study showed that most strokes fall within 30 days of TAVI. However, due to their multi-morbid conditions, TAVI patients remain at risk for stroke long after their procedure. 1 Bosmans, et al., presented at EuroPCR day Stroke Rate in ADVANCE: 3.0%

53 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. In the ADVANCE study, the overall stroke rate was low and remained relatively stable over time Stroke │ Rate over Time 1 Bosmans, et al., presented at EuroPCR 2013

54 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Multicenter registry data on 4,563 patients indicate that CoreValve has a historically low stroke rate, staying below 4.5% for any given cohort. It appears there is minimal learning curve effect for this outcome. Arrows indicate implant period and the reported rate of total stroke for the CoreValve cohort Stroke │ Learning Curve

55 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Stroke rate is strongly impacted by patient comorbidities, and the timing of stroke events may indicate different mechanisms at play. When doing a comparison of stroke rate across studies, it is important to remember that the baseline patient characteristics can vary greatly. It is very difficult to draw conclusions about the performance of a particular TAVI device when comparing the incidence of stroke rate across studies. Stroke │ Incidence

56 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Stroke │ Incidence at 30 Days Select Data Sets (independent studies, not head-to-head comparisons) 1 Leon, et al. N Engl J Med 2010; 363: ; 2 Smith, et al. N Engl J Med 2011; 364: ; 3 Thomas, et al., presented at TCT 2012; 4 Leon, et al., presented at ACC 2013; 5 Meredith, et al., presented at TCT 2012; 6 Bosmans, et al., presented at EuroPCR 2013

57 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Permanent Pacemaker Implantation (PPI) Predictors Incidence Clinical Impact –Post-TAVI PPI –Post-TAVI Left Bundle Branch Block (LBBB)

58 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Right Bundle Branch Block (RBBB) 2,3,4,5,7 Other pre-existing conduction disturbances 3,4,8,9 Male gender 3 Age > 75 years 9 Previous MI 3 Patient-Related Factors Variations in location of LBBB exit point 1 Septum thickness 1,6 Thickness of the non- coronary cusp 1 Implant Depth 2,3,7 Application of PPI guidelines 10 Learning Curve 11 Balloon Aortic Valvuloplasty 8 Radial force of the prosthesis 3 Anatomical Factors Procedural Factors (Device / Operator) More than 25 studies have been published on predictors of post-TAVI conduction disturbances (CDs) and permanent pacemaker implant (PPI) 1 Jilaihawi, et al. Am Heart J 2009; 2 Munoz-Garcıa, et. al. JACC CV 2012; 3 Piazza et. al. EuroIntervention 2010; 4 De Carlo, et. al. Am Heart J 2012; 5 Calvi, et. al. JICE 2011; 6 Saia, et. al. Cath Card Intv 2012; 7 Fraccarao, et. al. Am J Card 2011; 8 Khawaja, et. al. Circ 2011; 9 Schroeter et. al. EuroPACE 2011; 10 Wenaweser, et. al. presented at EuroPCR 2013; 11 Meredith, et. al. presented at TCT 2012 Permanent Pacemaker Implantation │ Predictors

59 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. 1 Tchetche, et al. EuroIntervention 2012; 2 Munoz-Garcıa, et. al. JACC CV 2012; 3 Piazza et. al. EuroIntervention 2010; 4 De Carlo, et. al. Am Heart J 2012; 5 Calvi, et. al. JICE 2011; 6 Saia, et. al. Cath Card Intv 2012; 7 Fraccarao, et. al. Am J Card 2011; 8 van der Boon, et. al. Int J Card 2013; Effect of implant depth: data from independent studies plotted on the same graph show the strong relationship between PPI rate and implant depth Permanent Pacemaker Implantation │ Predictors

60 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. PPM rates in 6-mo blocks of pt enrollment, except most recent is 8-mo. Enrolling centers: 6910 Effect of learning curve: the rate of PPI in the CoreValve Australia-New Zealand Study decreased over time as operators gained experience Permanent Pacemaker Implantation │ Predictors 1 Muller, et al. Presented at EuroPCR 2013

61 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Effect of PPI guideline use: varying 30-day pacemaker rates across geographies in the ADVANCE study may reflect differences in the application of PPI guidelines Countries with less than 15 implants not shown Permanent Pacemaker Implantation │ Predictors 1 Wenaweser, et al. Presented at EuroPCR 2013

62 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. The permanent pacemaker implantation rate can be impacted by variables unrelated to the TAVI device (e.g., baseline conduction disturbances, anatomical differences, clinician preference for prophylactic pacemaker use, and operator experience). These factors should be kept in mind when comparing the incidence of permanent pacemaker implantation across studies. Permanent Pacemaker Implantation │ Incidence

63 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. 1 Chiam, et al., presented at EuroPCR 2013; 2 Tamburino, et al., Circulation 2011; 123: ; 3 Brito, et.al., presented at TCT 2011; 4 Gilard, et al. N Engl J Med 2012; 366: ; 5 Moat, et al., J Am Coll Cardiol 2011; 58(20): ; 6 del Valle, et al., presented at London Valves 2012; 7 Wenaweser, et al., presented at EuroPCR 2013; 8 Muller, et al., presented at EuroPCR 2013 Permanent Pacemaker Implantation │ Incidence CoreValve Outcomes in National Registries and Studies (independent studies, not head-to-head comparisons)

64 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Both the ADVANCE study 1 and the Australia-New Zealand Study 2 showed no impact of a new permanent pacemaker implant on mortality 1 Wenaweser, et al. Presented at EuroPCR 2013; 2 Muller, et al. Presented at EuroPCR 2013 Permanent Pacemaker Implant │ Clinical Impact

65 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. LBBB Post-TAVI NO Mortality Impact Houthuizen, et. al. Circulation 2012, (N=679) Urena, et. al. JACC 2012, (N=202) De Carlo, et. al. AHJ 2012, (N=275) LBBB Post-TAVI Mortality Impact Patients not receiving permanent pacemaker before discharge. Muller, et. al. EuroPCR 2013, (N=200) Current Research is Inconclusive Regarding Mortality Impact of LBBB Post –TAVI Left Bundle Branch Block │ Clinical Impact

66 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Both the ADVANCE study 1 and PARTNER 2 showed no impact of a new LBBB on mortality Left Bundle Branch Block │ Clinical Impact 1 Wenaweser, et al. Presented at EuroPCR 2013; 2 Nazif, et al. Presented at ACC 2013

67 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. Both the ADVANCE study 1 and the Australia-New Zealand Study 2 showed no significant adverse effect of a new LBBB at discharge on the mean LV ejection fraction 1 Wenaweser, et al. Presented at EuroPCR 2013; 2 Muller, et al. Presented at EuroPCR 2013 Left Bundle Branch Block │ Clinical Impact

68 INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All Rights Reserved. Non destiné au marché français. References for slides 8, 9, and ClinicalTrials.gov Identifier: NCT Buellesfeld L, et al. J Am Coll Cardiol 2011; 57: ClinicalTrials.gov Identifier: NCT ClinicalTrials.gov Identifier: NCT Meredith IT, et al. Presented at TCT Medtronic CoreValve Japan Trial, protocol MDT ClinicalTrials.gov Identifier: NCT Linke A, et al. Presented at EuroPCR ClinicalTrials.gov Identifier: NCT ClinicalTrials.gov Identifier: NCT France II Registry. Eltchaninoff H, Presented at TVT Italian Registry. Ussia GP, et al. Presented at EuroPCR Italian Registry. Petronio AS, et al., Presented at TCT Israel Registry. Kornowski R, et al. Presented at EuroPCR UK Registry. Moat NE, et al. J Am Coll Cardiol 2011; 58: UK Registry. Moat NE, et al. Presented at TCT Belgian Registry. Bosmans J, et al. Presented at EuroPCR Bosmans J, et al., Interact Cardiovasc Thorac Surg 2011; 12(5): Brazilian Registry. Brito FS, et al. Presented at TCT Spanish Registry. Avanzas P, et al., Rev Esp Cardiol. 2010;63: Milan Registry. Buchanan GL, et al. Presented at EuroPCR Asia Registry. Chiam P, Presented at EuroPCR del Valle R, et al., Presented at PCR London Valves Ruck A, et al., Presented at PCR London Valves Figulla H, et al., Presented at TCT GARY, Mohr F, Presented at ACC German TAVI Registry: Sinning, et al., Am Heart J 2012; 164: e1 CoreValve ® is a registered trademark of Medtronic CV Luxembourg S.a.r.l.


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