Safety of deferring the reimplantation of pacing systems after their removal for infectious complications in selected patients: a 1-year follow-up study.
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.
Marijon
Eloi
E
Département de Rythmologie, Clinique Pasteur, Toulouse, France. eloi_marijon@yahoo.fr
De Guillebon
Maxime
M
Bordachar
Pierre
P
Jacob
Sophie
S
Vahdat
Olivier
O
Sidobre
Laurent
L
Deplagne
Antoine
A
Combes
Nicolas
N
Albenque
Jean-Paul
JP
Clementy
Jacques
J
Haissaguerre
Michel
M
Ritter
Philippe
P
Boveda
Serge
S
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