Early Experience with the Biotronik Protego ICD Lead.

Background

In the last decade, newer generation ICD leads have been developed based on mechanistic insides of priorly failing leads. The aim of our study was to assess the long-term performance and mechanisms of failure of the 2013-introduced Biotronik Protego ICD lead in a real-world population.

Methods

All patients, who underwent implantation of a Protego ICD lead at the Heart Centre Lucerne (Lucerne, Switzerland) between November 2013 and March 2017, were followed up with semi-annual device-controls. The primary endpoint was defined as lead failure, secondary endpoints compromised all-cause death, (in)appropriate shocks and the need for reintervention.

Results

A total of 64 patients (mean age 66.7 ± 8.7 years, 30% female) underwent implantation of a Protego ICD lead: 78% for primary prevention, 53% had underlying ischemic heart disease, and 40.6% had a dilated cardiomyopathy (DCM). Mean left ventricular ejection fraction (LVEF) was 32.6 ± 10.5%. A total of 24 patients were treated with cardiac resynchronization therapy (CRT), and their baseline LVEF improved from 27.8 ± 7.3% before to 39.8 ± 12.5 after implantation (p < 0.001). Mean time to follow-up was 5.5 ± 0.9 years. Overall, 14 patients (26.6%) suffered from at least one episode of sustained ventricular tachycardia; in total 10 patients (15.6%) died. Two patients experienced lead failure due to lead fracture after 5.5 and 5.7 years, which was clinically apparent by an abrupt rise in lead impedance (>2000 Ω) and by repetitive inappropriate shocks, respectively.

Conclusions

In this retrospective observational study, the calculated annual lead failure rate of the Biotronik Protego ICD lead was 0.59% per patient—thus, the durability and long-term performance seem to be promising.