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Leadless pacing meets the real world: The maturation of clinical evidence behind a miniaturized pacemaker

      Since its inception, transvenous pacing has been used worldwide in millions of patients. Continued advancements have yielded smaller, more technically advanced pulse generators with a multitude of programmable features. Concomitant improvements in lead design and construction have resulted in smaller caliber and more reliable leads. However, despite these advances, the inherent risks associated with transvenous pacemaker implantation have not changed. Because there is no national registry of patients undergoing transvenous pacemaker implantation, the overall incidence of complications has been difficult to define. What we do know is use of pacemakers has increased over the years, and patients now being implanted are older and have more comorbidities.
      • Greenspon A.J.
      • Patel J.D.
      • Lau E.
      • et al.
      Trends in permanent pacemaker implantation in the United States from 1993 to 2009: increasing complexity of patients and procedures.
      Thus, it is not entirely surprising that a recent retrospective review showed a 10% complication rate even with de novo single-chamber transvenous pacemaker implantation.
      • Kirkfeldt R.E.
      • Johansen J.B.
      • Nohr E.A.
      • Jorgensen O.D.
      • Nielsen J.C.
      Complications after cardiac implantable electronic device implantation: an analysis of a complete, nationwide cohort in Denmark.
      Similarly, high complication rates were observed in a prospective registry.
      • Zuithoff N.P.A.
      • van Hemel N.M.
      • de Cock C.C.
      • et al.
      Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study.
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