K. Nanthakumar et al., WHEN PACEMAKERS FAIL - AN ANALYSIS OF CLINICAL PRESENTATION AND RISK IN 120 PATIENTS WITH FAILED DEVICES, PACE, 21(1), 1998, pp. 87-93
Although pacemaker recalls are common, the optimal mechanism for risk
assessment and triage of patients at risk for sudden loss of device sy
stem function is unknown. A retrospective chart review of 120 patients
with factory proven failed devices was performed. Logistic regression
analysis was used to determine clinical correlates of emergency room
versus outpatient clinic presentation at time of device failure. Twent
y-two patients (18%) presented to emergency and 98 (82%) to clinic. Si
xty-three devices had no device output at the time of presentation. Mu
ltivariate logistic regression analysis revealed that antiarrhythmic d
rug use (odds ratio: 7.4, 95% CI: 2.0-28.0), atrioventricular nodal di
sease as an indication for pacing (odds ratio: 2.8, 95% CI: 1.2-3.0),
and female gender (odds ratio: 2.2, 95% CI: 1.0-4.5) were the only sig
nificant correlates of emergency room presentations. Pacemaker depende
ncy (escape heart rate < 40 beats/min) did not correlate with location
of presentation even though no device output at the time of presentat
ion was associated with emergency room presentation (odds ratio: 2.5,
95% CI: 1.1-5.8). Neither the presence of structural heart disease nor
symptoms at the time of device implantation (syncope or presyncope) w
ere correlated with location of presentation upon unexpected device fa
ilure. Although there were no deaths in the 120 failed devices studied
, there were 26 deaths in the total group of 227 patients with recalle
d devices that could not be studied. Antiarrhythmic drug use, electroc
ardiographic pacing indication, and female gender may be more sensitiv
e predictors of emergency room presentation and significant symptoms i
n the event of unanticipated pacemaker failure. The inability of any r
etrospective analysis to accurately assess mortality in the setting of
pacemaker system failure underscores the need for prospective databas
es in recall situations.