Abstract
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.