Key result
Withholding systematic device reimplantation in low-risk patients after infected pacing system removal was safe, with a 1.3% (95% CI, 0.0-3.9) rate of sudden death and syncope at 12 months.
Why the study?
Does withholding the reimplantation of pacing systems safely prevent sudden death and syncope in low-risk patients after removal for infectious complications?
Cohort (n=188)
Yes
Does withholding the reimplantation of pacing systems safely prevent sudden death and syncope in low-risk patients after removal for infectious complications?
Deferring reimplantation of pacing systems after removal for infection appears safe in carefully selected low-risk patients, with a very low rate of sudden death or syncope at 1 year.
Answers are grounded in this paper and cite their sources.
May support selective deferral of reimplantation after device infection in low-risk patients; leaves open need for randomized confirmation.
INTRODUCTION: 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. METHODS AND 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. CONCLUSION: 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.
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Marijon et al. (2009) conducted a cohort in Infected pacing systems (n=188). Withholding the implantation of pacing systems was evaluated on sudden death and syncope (95% CI 0.0-3.9). Withholding systematic device reimplantation in low-risk patients after infected pacing system removal was safe, with a 1.3% (95% CI, 0.0-3.9) rate of sudden death and syncope at 12 months.
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