the leadless pacemaker: safety and cost-effectiveness › wp-content › uploads › 2015 ›...
TRANSCRIPT
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The leadless pacemaker: Safety and cost-effectiveness
C. W. Israel Dept. of Cardiology
Evangelical Hospital Bielefeld Germany
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CONFLICTS OF INTEREST Medtronic, St. Jude Medical
(Speaker’s bureau, honoraria, safety advisory board, travel grants)
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First Concepts
Leadless pacemaker
Spickler, J Electrocardiol 1970;3:325-31
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First Concepts
Leadless pacemaker
Spickler, J Electrocardiol 1970;3:325-31
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First Concepts
Leadless pacemaker
Vardas, Eur J Card Pacing Electrophysiol 1991;1:27-30
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Nanostim (St. Jude Medical)
Ring electrode
docking interface
screw, tip electrode
Leadless pacemaker
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Nanostim (St. Jude Medical)
Leadless pacemaker
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Nanostim (St. Jude Medical)
Leadless pacemaker
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Nanostim (St. Jude Medical)
Leadless pacemaker
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Nanostim (St. Jude Medical)
Leadless pacemaker
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Nanostim (St. Jude Medical)
Leadless pacemaker
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Nanostim (St. Jude Medical)
Leadless pacemaker
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Nanostim (St. Jude Medical)
Leadless pacemaker
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Nanostim (St. Jude Medical)
Leadless pacemaker
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Nanostim (St. Jude Medical)
Leadless pacemaker
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Nanostim (St. Jude Medical)
Leadless pacemaker
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Nanostim (St. Jude Medical)
Leadless pacemaker
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Nanostim (St. Jude Medical)
Cortesy Johannes Sperzel, Bad Nauheim, Germany
Leadless pacemaker
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Nanostim (St. Jude Medical)
Leadless pacemaker
Cortesy Johannes Sperzel, Bad Nauheim, Germany
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Nanostim (St. Jude Medical)
Leadless pacemaker
Cortesy Johannes Sperzel, Bad Nauheim, Germany
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Nanostim (St. Jude Medical)
Leadless pacemaker
Cortesy Johannes Sperzel, Bad Nauheim, Germany
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Nanostim (St. Jude Medical)
Leadless pacemaker
Cortesy Johannes Sperzel, Bad Nauheim, Germany
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Nanostim (St. Jude Medical)
Leadless pacemaker
Cortesy Johannes Sperzel, Bad Nauheim, Germany
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LEADLESS-Trial
Reddy, Circulation 2014;129:1466-71
94% (31/33) free of complications
Leadless pacemaker
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LEADLESS-Trial: Complications
Reddy, Circulation 2014;129:1466-71
• 1 cardiac tamponade with hemodynamic collapse after repositioning of the LCP + manipulation of the delivery catheter in the RV apex
• pericardial drainage, sternotomy on cardiopulmonary bypass, surgical repair of perforation of the RV apex
• on day 5 hemiplegia due to ischemic infarct, progressive cerebral edema, died on postprocedure day 18
• 1 inadvertent LV positioning via a patent foramen ovale, • Retrieval by a trilooped snare through the patent foramen
ovale, new device implanted in the RV apex. Retrieval took 6 minutes
Leadless pacemaker
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LEADLESS Trial: 1 year Data
Knops, J Am Coll Cardiol 2015;65:1497-504
Leadless pacemaker
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LEADLESS II Trial
Reddy, New Engl J Med 2015;73:1125-35
Successful implantation: 95.8%
Leadless pacemaker
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LEADLESS II Trial
Reddy, New Engl J Med 2015;73:1125-35
Leadless pacemaker
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LEADLESS II Trial
Reddy, New Engl J Med 2015;73:1125-35
Leadless pacemaker
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LEADLESS II Trial
Reddy, New Engl J Med 2015;
73:1125-35
2 procedure-related deaths (groin hematoma, perforation)
Leadless pacemaker
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Micra (Medtronic)
Leadless pacemaker
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Micra (Medtronic) • Size
– 0.8 cm³, 2.0 g – Length: 25.9 mm – Outer diameter: 6.7 mm
• Bipolar sensing/pacing • Fixation mechanism: Nitinol tines • Battery
– Lithium silver vanadium oxide/ Carbon monoflouride
– Longevity: 7.4/10.1 year (2.0/1.5V output, 60 bpm, 100% paced)
• Capabilities – VVIR – RV capture management – Sensing assurance – Diagnostics
• Deactivated to OOO at EoL
Ac#ve&Fixa#on&�Tines�&
Cathode (2.5mm2) CapSure Sense steroid
eluting
Anode (27mm2 )
Leadless pacemaker
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Micra (Medtronic)
27 French outer diameter introducer
Leadless pacemaker
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Micra (Medtronic)
Leadless pacemaker
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Micra (Medtronic)
Leadless pacemaker
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Micra (Medtronic)
Leadless pacemaker
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Micra (Medtronic)
Leadless pacemaker
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Micra (Medtronic)
Leadless pacemaker
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First Data from Micra®
Leadless pacemaker
Ritter, Eur Heart J 2015;36:2510-9
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Leadless pacemaker
Ritter, Eur Heart J 2015;36:2510-9
First Data from Micra®
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Leadless pacemaker
Ritter, Eur Heart J 2015;36:2510-9
First Data from Micra®
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Leadless pacemaker
Ritter, Eur Heart J 2015;36:2510-9
First Data from Micra®
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Micra Study
Leadless pacemaker
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LEADLESS-Trial
Reddy, Circulation 2014;129:1466-71
Leadless pacemaker
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Leadless pacemaker
First Data from Micra®
Ritter, Eur Heart J 2015;36:2510-9
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Thank you very much for your
attention!
Leadless pacemaker