title: Safety of deferring the reimplantation of pacing systems after their removal for infectious complications in selected patients: a 1-year follow-up study.
abstract: BACKGROUND
  Recent expert consensus guidelines mention that one of the principles for infected device replacement following removal is to "reevaluate carefully if there is a continued need for a new cardiac device replacement." This is a Class I recommendation, which nevertheless suffers from a very low level of evidence (level of evidence C), since no study has revisited the systematic practice of reimplanting the same device based on a meticulous clinical reassessment. In the present paper, we examined the safety of withholding the implantation of pacing systems in selected patients.
  
  
  RESULTS
  Between January 2005 and December 2007, 188 consecutive patients underwent extractions of infected pacing systems at 2 medical centers. "Low-risk" patients were identified by (1) a spontaneous heart rate >45 bpm, (2) no symptomatic asystole during monitoring, (3) QRS duration <120 ms when history of AV block was noted, (4) no high-degree AV block during continuous monitoring. They remained device-free, unless an adverse clinical event occurred mandating the reimplantation. The primary study endpoint was rate of sudden death and syncope after a 12-month follow-up. Among the 74 (39.4%) "low-risk" patients, a single patient suffered a bradycardia-related syncopal event corresponding to a 1.3% (95% CI, 0.0-3.9) rate of primary endpoint. Pacing systems were also reimplanted in 24 patients (32.4%) for syncope (n = 1), nonsevere bradycardia-reated symptoms (n = 17), cardiac resynchronization (n = 2), and for reassurance in 4 asymptomatic patients.
  
  
  CONCLUSIONS
  After removal of infected pacing systems, these preliminary data demonstrated that a strategy of nonsystematic device reimplantation associated with close surveillance was safe in "low-risk" patients, allowing the administration of antimicrobials in a device-free state.
authors.affiliation: Département de Rythmologie, Clinique Pasteur, Toulouse, France. eloi_marijon@yahoo.fr
authors.forename: Eloi
authors.initials: E
authors.lastname: Marijon
authors.forename: Maxime
authors.initials: M
authors.lastname: De Guillebon
authors.forename: Pierre
authors.initials: P
authors.lastname: Bordachar
authors.forename: Sophie
authors.initials: S
authors.lastname: Jacob
authors.forename: Olivier
authors.initials: O
authors.lastname: Vahdat
authors.forename: Laurent
authors.initials: L
authors.lastname: Sidobre
authors.forename: Antoine
authors.initials: A
authors.lastname: Deplagne
authors.forename: Nicolas
authors.initials: N
authors.lastname: Combes
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Albenque
authors.forename: Jacques
authors.initials: J
authors.lastname: Clementy
authors.forename: Michel
authors.initials: M
authors.lastname: Haissaguerre
authors.forename: Philippe
authors.initials: P
authors.lastname: Ritter
authors.forename: Serge
authors.initials: S
authors.lastname: Boveda
mesh_terms: D000368:Aged; D001145:Arrhythmias, Cardiac / Q000503:physiopathology / Q000628:therapy; D054537:Atrioventricular Block / Q000150:complications; D016757:Death, Sudden, Cardiac / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006339:Heart Rate / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects; D019919:Prosthesis Implantation / Q000009:adverse effects; D016459:Prosthesis-Related Infections / Q000601:surgery*; D012086:Reoperation; D018570:Risk Assessment; D012772:Shock, Septic / Q000150:complications; D016896:Treatment Outcome