title: Permanent leadless cardiac pacing: results of the LEADLESS trial.
abstract: BACKGROUND
  Conventional cardiac pacemakers are associated with several potential short- and long-term complications related to either the transvenous lead or subcutaneous pulse generator. We tested the safety and clinical performance of a novel, completely self-contained leadless cardiac pacemaker.
  
  
  RESULTS
  The primary safety end point was freedom from complications at 90 days. Secondary performance end points included implant success rate, implant time, and measures of device performance (pacing/sensing thresholds and rate-responsive performance). The mean age of the patient cohort (n=33) was 77±8 years, and 67% of the patients were male (n=22/33). The most common indication for cardiac pacing was permanent atrial fibrillation with atrioventricular block (n=22, 67%). The implant success rate was 97% (n=32). Five patients (15%) required the use of >1 leadless cardiac pacemaker during the procedure. One patient developed right ventricular perforation and cardiac tamponade during the implant procedure, and eventually died as the result of a stroke. The overall complication-free rate was 94% (31/33). After 3 months of follow-up, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range.
  
  
  CONCLUSIONS
  In a prospective nonrandomized study, a completely self-contained, single-chamber leadless cardiac pacemaker has shown to be safe and feasible. The absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing.
  
  
  BACKGROUND
  http://clinicaltrials.gov. Unique identifier: NCT01700244.
authors.affiliation: Helmsley Electrophysiology Center, Mount Sinai School of Medicine, New York, NY (V.Y.R., M.A.M., S.R.D., J.S.K.); Department of Cardiology, Academic Medical Center, University of Amsterdam, The Netherlands (R.E.K., J.R.d.G., A.A.M.W.); Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany (J.S.); Cardiology Department, Homolka Hospital, Prague, Czech Republic (J.P., J.S., L.S., P.N.); Nanostim, Inc, Sunnyvale, CA (P.J., A.O.); Department of Cardiology, Institute of Clinical and Experimental Medicine - IKEM, Prague, Czech Republic (J.K.).
authors.forename: Vivek Y
authors.initials: VY
authors.lastname: Reddy
authors.forename: Reinoud E
authors.initials: RE
authors.lastname: Knops
authors.forename: Johannes
authors.initials: J
authors.lastname: Sperzel
authors.forename: Marc A
authors.initials: MA
authors.lastname: Miller
authors.forename: Jan
authors.initials: J
authors.lastname: Petru
authors.forename: Jaroslav
authors.initials: J
authors.lastname: Simon
authors.forename: Lucie
authors.initials: L
authors.lastname: Sediva
authors.forename: Joris R
authors.initials: JR
authors.lastname: de Groot
authors.forename: Fleur V Y
authors.initials: FV
authors.lastname: Tjong
authors.forename: Peter
authors.initials: P
authors.lastname: Jacobson
authors.forename: Alan
authors.initials: A
authors.lastname: Ostrosff
authors.forename: Srinivas R
authors.initials: SR
authors.lastname: Dukkipati
authors.forename: Jacob S
authors.initials: JS
authors.lastname: Koruth
authors.forename: Arthur A M
authors.initials: AA
authors.lastname: Wilde
authors.forename: Josef
authors.initials: J
authors.lastname: Kautzner
authors.forename: Petr
authors.initials: P
authors.lastname: Neuzil
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001145:Arrhythmias, Cardiac / Q000628:therapy*; D015331:Cohort Studies; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D016896:Treatment Outcome
keywords: cardiac; pacemaker