Trial: Clinical experience with pacemaker pulse generators and transvenous leads: an 8-year prospective multicenter study

Authors: Hauser RG, Hayes DL, Kallinen LM, Cannom DS, Epstein AE, Almquist AK, Song SL, Tyers GF, Vlay SC, Irwin M

Reference: Heart Rhythm 2007 Feb;4(2):154-60. Epub 2006 Oct 12.  PMID:  17275749

Purpose: To examine the reasons pacemaker pulse generators and transvenous leads were removed from service. The authors evaluated the causes and major adverse clinical events associated with device end-of-service life behavior and how they were detected and managed.

Number of Patients: 2652 pulse generators

Number of Centers: Multicenter registry

Design: Prospective observational study

Authors Conclusion:   Overall pulse generator performance was satisfactory. Differences in battery longevity were observed among models. In some patients, elective replacement indicators signifying normal battery depletion resulted in major adverse clinical events. Pacemaker follow-up effectively identified pulse generator end-of-service life and often detected impending lead failure, thus avoiding major adverse clinical events. Long-term studies are needed to assess chronic lead performance so that appropriate clinical management strategies, including recommendations for lead extraction, can be developed.