LONGEVITY OF MEDTRONIC SPRINT FIDELIS ICD LEAD DURING OVER 5-YEAR LONG-TERM FOLLOW-UP

T. Tokano, Y. Nakazato, S. Komatsu, M. Sugihara, K. Komatsu, M. Yamase, H. Hayashi, G. Sekita, M. Sumiyoshi, H. Daida

Cardiology, Juntendo Urayasu Hospital, Urayasu, Japan

Abstract

Introduction: Medtronic Sprint Fidelis ICD Lead (FL) has been withdrawn from the market because of frequent conductor failure. The survival rate was estimated at approximately 85%, however, over 5 years longevity has not been well discussed.
Methods: Study subjects were 67 cases (mean 61 year-old, 51 males) in whom FL was implanted. Cephalic venous access was dominant (57 cases). Capture/sensing threshold and lead impedances were measured every 3-6 months. The mean follow-up periods was 5.6±0.5 (range: 5-6.9) years.
Results: Conductor failure occurred in 5 (7%) cases (Table 1). Regarding to these cases, younger age, preserved LVEF and female gender were considered to be high risk. Patient alert worked promptly to avoid inappropriate shock therapies in 2 of them.
Conclusions: FL functioned normally in 93% during over 5 years follow-up in our institution, and it was higher comparing with previous studies. Cephalic venous access may have reduced the risk of conductor failure. However, patient alert must be activated in FL cases, and careful observation, e.g. using remote monitoring should be recommended, especially in high risk cases.


Cases with Conductor Failure
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Gender Age(year-old) UnderlyingDisease LVEF Time to Failure(years) Outcome
Female 59 Sarcoidosis 0.36 4.4 Artificial Noise
Female 50 CAD 0.55 3.5 Impedance? ? Patients Alert
Male 35 HCM 0.40 4.3 Impedance? ? Patients Alert
Male 54 CAD 0.58 2.8 Artificial Noise ? Inappropriate Shock
Female 69 HCM 0.70 3.5 Artificial Noise ? Inappropriate Shock