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TRANSCRIPT
The leadless pacemaker: Safety and cost-effectiveness
C. W. Israel Dept. of Cardiology
Evangelical Hospital Bielefeld Germany
CONFLICTS OF INTEREST Medtronic, St. Jude Medical
(Speaker’s bureau, honoraria, safety advisory board, travel grants)
First Concepts
Leadless pacemaker
Spickler, J Electrocardiol 1970;3:325-31
First Concepts
Leadless pacemaker
Spickler, J Electrocardiol 1970;3:325-31
First Concepts
Leadless pacemaker
Vardas, Eur J Card Pacing Electrophysiol 1991;1:27-30
Nanostim (St. Jude Medical)
Ring electrode
docking interface
screw, tip electrode
Leadless pacemaker
Nanostim (St. Jude Medical)
Leadless pacemaker
Nanostim (St. Jude Medical)
Leadless pacemaker
Nanostim (St. Jude Medical)
Leadless pacemaker
Nanostim (St. Jude Medical)
Leadless pacemaker
Nanostim (St. Jude Medical)
Leadless pacemaker
Nanostim (St. Jude Medical)
Leadless pacemaker
Nanostim (St. Jude Medical)
Leadless pacemaker
Nanostim (St. Jude Medical)
Leadless pacemaker
Nanostim (St. Jude Medical)
Leadless pacemaker
Nanostim (St. Jude Medical)
Leadless pacemaker
Nanostim (St. Jude Medical)
Leadless pacemaker
Nanostim (St. Jude Medical)
Cortesy Johannes Sperzel, Bad Nauheim, Germany
Leadless pacemaker
Nanostim (St. Jude Medical)
Leadless pacemaker
Cortesy Johannes Sperzel, Bad Nauheim, Germany
Nanostim (St. Jude Medical)
Leadless pacemaker
Cortesy Johannes Sperzel, Bad Nauheim, Germany
Nanostim (St. Jude Medical)
Leadless pacemaker
Cortesy Johannes Sperzel, Bad Nauheim, Germany
Nanostim (St. Jude Medical)
Leadless pacemaker
Cortesy Johannes Sperzel, Bad Nauheim, Germany
Nanostim (St. Jude Medical)
Leadless pacemaker
Cortesy Johannes Sperzel, Bad Nauheim, Germany
LEADLESS-Trial
Reddy, Circulation 2014;129:1466-71
94% (31/33) free of complications
Leadless pacemaker
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
LEADLESS Trial: 1 year Data
Knops, J Am Coll Cardiol 2015;65:1497-504
Leadless pacemaker
LEADLESS II Trial
Reddy, New Engl J Med 2015;73:1125-35
Successful implantation: 95.8%
Leadless pacemaker
LEADLESS II Trial
Reddy, New Engl J Med 2015;73:1125-35
Leadless pacemaker
LEADLESS II Trial
Reddy, New Engl J Med 2015;73:1125-35
Leadless pacemaker
LEADLESS II Trial
Reddy, New Engl J Med 2015;
73:1125-35
2 procedure-related deaths (groin hematoma, perforation)
Leadless pacemaker
Micra (Medtronic)
Leadless pacemaker
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
Micra (Medtronic)
27 French outer diameter introducer
Leadless pacemaker
Micra (Medtronic)
Leadless pacemaker
Micra (Medtronic)
Leadless pacemaker
Micra (Medtronic)
Leadless pacemaker
Micra (Medtronic)
Leadless pacemaker
Micra (Medtronic)
Leadless pacemaker
First Data from Micra®
Leadless pacemaker
Ritter, Eur Heart J 2015;36:2510-9
Leadless pacemaker
Ritter, Eur Heart J 2015;36:2510-9
First Data from Micra®
Leadless pacemaker
Ritter, Eur Heart J 2015;36:2510-9
First Data from Micra®
Leadless pacemaker
Ritter, Eur Heart J 2015;36:2510-9
First Data from Micra®
Micra Study
Leadless pacemaker
LEADLESS-Trial
Reddy, Circulation 2014;129:1466-71
Leadless pacemaker
Leadless pacemaker
First Data from Micra®
Ritter, Eur Heart J 2015;36:2510-9
Thank you very much for your
attention!
Leadless pacemaker