INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc. 2013. All.

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Presentation transcript:

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. Coronary Access and CoreValve September 2013 UC EE

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. Coronary Access and TAVR Coronary Complications Following TAVR –Incidence –Multicenter Registry Results PCI Following TAVR with CoreValve –CoreValve Design Facilitates Access –Procedural Examples from the Literature Summary

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. Coronary complications following TAVR is an infrequently reported outcome in large studies / registries. Those that do report on coronary occlusions show this is a rare complication. Coronary Complications After TAVR 1 Linke, et. al. presented at EuroPCR 2013; 2 del Valle, et al., presented at London Valves 2012; 3 Eltchaninoff, et al., Eur Heart J 2011; 32: 191-7; 4 Smith, et al., N Engl J Med 2011; 364: ; 5 Thomas, et al., presented at TCT 2012; 6 Rodes-Cabau, et al. J Am Coll Cardiol 2010; 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. Much of the knowledge about coronary complications following TAVR with either CoreValve or Edwards valves comes from published case reports. –9 published CoreValve cases –24 published Edwards cases (Sapien and Sapien XT) Treatment typically involves hemodynamic mechanical support and prompt PCI, however conversion to open heart surgery may be necessary. Coronary Complications After TAVR

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. Published case reports show the following mechanisms for coronary occlusion: Embolized material (broken leaflet, calcium, thrombus, atheroma, air) 1 Compression of the coronary artery 2 Obstruction of the ostia by displaced native tissue / leaflet 3 Obstruction of the ostia by the sealing cuff of the prosthesis in cases of high implantation, low-lying ostia, or small anatomy 4 Clinical Evidence │ Mechanisms of Occlusion 1 Freixa, et al., Can J Cardiol 2012; epub; 2 Bartorelli, et al., Ann Thorac Surg2010; 89: 953-5; 3 Winther, et. al. J Interv Cardiol 2011; 24: 470-3; 4 Bagur, et al., J Am Coll Cardiol Cardiovasc Int 2010; 3(2): 253-5

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. The published case studies do not give a clear picture of coronary occlusion predictors, or of the clinical impact. A multicenter registry on coronary obstruction including 6,688 patients was created to investigate these questions. Results were first presented at EuroPCR ,2. Clinical Evidence │ Multicenter Registry 1 Ribeiro, et. al. presented at EuroPCR 2013; 2 Ribeiro, et. al., J Am Coll Cardiol 2013; epub

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. Clinical Evidence │ Multicenter Registry 1 Ribeiro, et. al. presented at EuroPCR 2013

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. Coronary occlusions are significantly more common with balloon expandable valves than with self expandable valves (0.81% vs. 0.34%, p=0.028) 1,2. Clinical Evidence │ Multicenter Registry 1 Ribeiro, et. al. presented at EuroPCR 2013; 2 Ribeiro, et. al., J Am Coll Cardiol 2013; epub

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. Coronary occlusion is associated with poor outcomes. The incidence of in- hospital myocardial infarction was 47.7%, and the incidence of in-hospital death was 40.9% 1,2. Clinical Evidence │ Multicenter Registry 1 Ribeiro, et. al. presented at EuroPCR 2013; 2 Ribeiro, et. al., J Am Coll Cardiol 2013; epub

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. Low left coronary ostia height (<12 mm) and narrow aortic root (<30 mm) are anatomical characteristics which may increase the risk of coronary occlusion 1,2. Clinical Evidence │ Multicenter Registry 1 Ribeiro, et. al. presented at EuroPCR 2013; 2 Ribeiro, et. al., J Am Coll Cardiol 2013; epub

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 incidence of coronary occlusion is higher in valve-in-valve procedures compared to normal TAVR 1 (Multicenter Registry: 2.48% vs. 0.62%, p=0.045). Stentless bioprosthetic valves may present a higher risk for coronary occlusion than stented valves 2 Valve-in-Valve StudyIncidence Global Valve in Valve Registry 36 Stenotic bioprosthetic valves (n=182): 3.9% Regurgitant bioprosthetic valves (n=139): 0.8% Combined stenotic/regurgitant bioprosthetic valves (n=139): 0% Multicenter Registry for Coronary Occlusions 35 All V-in-V procedures (n=121): 2.48% Clinical Evidence│ Valve in Valve 1 Ribeiro, et. al. presented at EuroPCR 2013; 2 Kappetein, et al. Valve-in-Valve. Presented at EuroPCR 2013

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. Coronary Access and TAVR Coronary Complications Following TAVR –Incidence –Multicenter Registry Results PCI Following TAVR with CoreValve –CoreValve Design Facilitates Access –Procedural Examples from the Literature Summary

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. Coronary Artery Disease and the TAVR Population Treatment of coronary complications requires access to the coronary arteries for percutaneous interventions after the transcatheter valve is in place. Additionally, as the life expectancy of the TAVR patient population continues to increase, management of progressive CAD, including in-stent restenosis, will be of increasing relevance 1. –Coronary artery disease (CAD) is a frequent comorbidity in patients with severe aortic stenosis, typically found in > 50% of the population 2. The clinical feasibility of PCI in CoreValve patients, both as an emergency bailout maneuver and as treatment for in-stent restenosis, has been demonstrated. 1 Lopez-Otero, et al., Rev Esp Cardiol 2010; 63(9): ; 2 Abdel-Wahab, et al., Clin Res Cardiol 2012; 101:

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. Coronary Access│ Uncomplicated PCI Cases Several case reports of uncomplicated PCI in CoreValve patients have been published. Different brands of guide catheters were used successfully to engage the coronary ostia. No publications describe a failed attempt at gaining access. References follow at end of presentation

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. An 88 year old patient with a 2.75 x 23 mm bare metal stent in the mid LAD (Multilink Vision; Abbot Corp, Illinois, USA) and a 29 mm CoreValve presented with disabling angina. Severe diffuse in-stent restenosis was treated through the CoreValve with a 3.0 x 33 mm everolimus-eluting stent (Xience Prime LL; Abbot Corp, Illinois, USA) Coronary Access│ PCI Case Example Michiels, et al., Heart 2011, 97: 1458

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. Coronary Access and TAVR Coronary Complications Following TAVR –Incidence –Multicenter Registry Results PCI Following TAVR with CoreValve –CoreValve Design Facilitates Access –Procedural Examples from the Literature Summary

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. Coronary complications after TAVR are rare. They typically occur during the procedure, however cases of late presentation have been published. Statistically, post TAVR coronary complications are more common with balloon expandable valves than they are with CoreValve. Treatment of coronary occlusions at the time of TAVI, or of stenotic lesions at any time post-TAVI, require the ability to engage the coronary ostia while the transcatheter valve is in place. The feasibility of interventional maneuvers such as stent placement or rotational atherectomy while CoreValve is in place has been demonstrated through multiple case reports. Summary

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. Summary of Case Reports Coronary Complications

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. Clinical Evidence │ Case Reports References follow at end of presentation

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. Clinical Evidence │ Case Reports References follow at end of presentation

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. Clinical Evidence │ Case Reports References follow at end of presentation

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. Clinical Evidence │ Case Reports References follow at end of presentation

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. Clinical Evidence │ Case Reports References follow at end of presentation

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 1.Webb, et al., Circ 2006; 113: Geist, et al., Cath and Cardiovasc Interv 2009; 73: Gerckens, et al., Clin Res Cardiol 2009; 98: Kapadia, et al., Cath and Cardiovasc Interv 2009; 73: Stabile, et al., EuroIntervention 2010; 6: Rodes-Cabau, et al., J Am Coll Cardiol 2010; 55(11): Lopez-Otero, et al., Rev Esp Cardiol 2010; 63(9): Bagur, et al., JACC Cardiovasc Interv 2010; 3(2): Bartorelli, et al., Ann Thorac Surg 2010; 89: Eltchaninoff, et al., Eur Heart J 2011; 32: Winther, et al., J Interven Cardiol 2011; 24: Dagdelen, et al., Anadolu Kardiyol Derg 2011; 11: Ielasi, et al., Rev Esp Cardiol 2011; 64(12): Gogas, et al., Cath and Cardiovasc Interv 2011; 77: Crimi, et al., Cath and Cardiovasc Interv 2011; 78: Michiels, et al., Heart 2011; 97: Kukucka, et al., ICVTS 2011; 12: Saia, et al., J Invasive Cardiol 2011; 23: E Van Mieghem, et al., Cath and Cardiovasc Interv 2011; epub. 20.Modine, et al., J Thorac Cardiovasc Surg 2012; 144: Spiro, et al., J Invasive Cardiol 2012; 24(5): Toeg, et al., Can J Cardiol 2012; 28: 611e1-e3. 23.Abdel-Wahab, et al., Clin Res Cardiol 2012; 101: Fiorina, et al., Cardiovasc Revasc Med 2012; 13: 142e5-e9. 25.Barge-Caballero, et al., J Am Coll Cardiol 2012; 59(18): epub. 26.Seipelt, et al., ICVTS 2012; 14: Gul, et al., Anadolu Kardiyol Derg 2012; 12: Thomas, et al., The SOURCE Multicenter EU Registries (Including XT). Presented at TCT Linke, et al., Medtronic CoreValve ADVANCE Study. Presented at TCT Del Valle, et al., The Ibero-American Transcatheter Aortic Valve Implantation Registry: Acute and Long-Term Results. Presented at PCR London Valves Zahn, et al. Clin Res Cardiol 2013; epub.

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 32.Gokdeniz, et al., Heart, Lung, and Circulation 2013; epub 33.Freixa, et al., Can J Cardiol 2012; epub 34.Kleczynski, et al., Kardiol Pol 2013; 71(6): Ribiero, et al. Coronary Obstruction Following Transcatheter Aortic Valve Implantation (TAVI) in High Risk Patients. Presented at EuroPCR Dvir, et al. Transcatheter Aortic-Valve Implantation for the Treatment of Degenerative Bioprosthetic Surgical Valves: Results from the Global Valve-in-Valve Registry. Presented at TCT Kappetein, et al. Valve-in-Valve. Presented at EuroPCR Stangl, et al., Am J Cardiol 2012; epub. 39.Kim, et al., Cath and Cardiovasc Interv 2013; epub. 40.Okuyama, et al., Cath and Cardiovasc Interv 2013; epub. 41.Greenberg, et al., J Invasive Cardiol 2013; 25(7): CoreValve® is a registered trademark of Medtronic CV Luxembourg S.a.r.l.