Key result
Serial ambulatory electrocardiography detected significantly more pacing lead failures compared to increased pacemaker clinic surveillance (31% vs 4%, P < 0.001).
Why the study?
Does serial ambulatory electrocardiography improve the detection of pacemaker lead failure compared to increased pacemaker clinic surveillance in patients with Medtronic 4012, 4082, and 4004 leads?
Cohort (n=426)
Does serial ambulatory electrocardiography improve the detection of pacemaker lead failure compared to increased pacemaker clinic surveillance in patients with Medtronic 4012, 4082, and 4004 leads?
Ambulatory electrocardiography is significantly more sensitive than routine clinic surveillance for detecting intermittent pacemaker lead failure.
Answers are grounded in this paper and cite their sources.
May warrant ambulatory ECG for surveillance in patients with recalled leads; leaves open whether adoption improves outcomes.
The suboptimal performance of some polyurethane bipolar pacing leads has highlighted concern about the optimal method of monitoring pacemaker lead performance. Since the manifestations of premature lead failure may be initially intermittent, we hypothesized that ambulatory electrocardiography (AECG) would be a more sensitive tool for the detection of pacing lead failure compared to increased pacemaker clinic surveillance. Since the Medtronic safety alerts on the 4012, 4082, and 4004 leads, we have followed 261 patients by serial AECG and 165 patients by increased pacemaker clinic surveillance. Lead failures were identified in 75 patients: 68 in the AECG group (31%) and 7 in the clinic group (4%, P < 0.001). Repeat AECG confirmed the lead failure in 38 (97%) of 39 patients in which it could be done. Pacing lead failure documented by AECG could be confirmed by a subsequent clinic assessment in only 15 (25%) of 60 patients evaluated (P < 0.001). The actuarial survival of the 4012 lead was significantly lower in the AECG group compared to the clinic group (56% vs 87% survival at 8 years, P < 0.002). Similar trends were observed for the 4082 and 4004 leads. AECG is a more sensitive method of surveillance for pacemaker lead function compared to pacemaker clinic assessment. AECG should be incorporated into the routine follow-up of pacemaker patients.
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Gillis et al. (1997) conducted a cohort in Pacemaker lead safety alerts (Medtronic 4012, 4082, and 4004 leads) (n=426). Serial ambulatory electrocardiography (AECG) vs. Increased pacemaker clinic surveillance was evaluated on Detection of pacing lead failure (p=< 0.001). Serial ambulatory electrocardiography detected significantly more pacing lead failures compared to increased pacemaker clinic surveillance (31% vs 4%, P < 0.001).
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