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The leadless pacemaker: Safety and cost-effectiveness

C. W. Israel Dept. of Cardiology

Evangelical Hospital Bielefeld Germany

C.W.Israel@em.uni-frankfurt.de

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

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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