From Karolinska Hospital, Stockholm, Sweden (M.R.); Ruprecht-Karls
University of Heidelberg, Heidelberg, Germany (T.B.); Westfälische
Wilhelms Universität, Münster, Germany (M.B.); Academic Hospital
Maastricht, the Netherlands (K.d.D.); and Bakken Research Center, Maastricht,
the Netherlands (J.M., F.L.).
Correspondence to Mårten Rosenqvist, MD, Department of Cardiology, Karolinska Hospital, 171.76 Stockholm, Sweden. E-mail mro{at}cardio.ks.se
Background—A newly developed
classification system relates adverse events to the surgical procedure
or the function of the implantable defibrillator.
Methods and Results—Adverse events were monitored during
prospective clinical evaluation of the Medtronic model 7219 Jewel ICD
and were classified according to the definitions of the ISO 14155
standard for device clinical trials into 3 groups: severe and mild
device-related and severe non–device-related adverse events. In
addition, events were related to the surgical procedure, treatment with
the device, or cardiac function. Seven hundred seventy-eight patients
were followed up for an average of 4.0 months after ICD implantation.
In total, 356 adverse events were observed in 259 patients. At 1, 3,
and 12 months after ICD implantation, 99%, 98%, and 97% of the
patients, respectively, survived; 95%, 93%, and 92%, respectively,
were free of surgical reintervention; and 79%, 68%, and 51%,
respectively, were free of any adverse event. Twenty patients died: 6
deaths were related to the surgical procedure, 12 deaths were
considered unrelated to ICD treatment, and 2 patients died of an
unknown cause. Of 111 nonlethal severe adverse device effects, 47
required surgical intervention, 19 times for correction of a dislodged
lead. Inappropriate delivery of therapy was observed 128 times in 111
patients, and the events were typically resolved by reprogramming or
drug adjustment. Nine of these required rehospitalization.
Conclusions—Approximately 50% of patients experience an adverse
event within the first year after ICD implantation. The observed
adverse event rate depends on the definitions and the prospective
monitoring. The incidence of inappropriate therapy emphasizes the need
for improved detection algorithms and for quality-of-life evaluations,
especially when considering ICD treatment in high-risk but
arrhythmia-free patients.
© 1998 American Heart Association, Inc.
Clinical Investigation and Reports
Adverse Events With Transvenous Implantable Cardioverter-Defibrillators
A Prospective Multicenter Study
Key Words: events, adverse • tachyarrhythmias • defibrillation • implantable cardioverter defibrillator (ICD)
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