Pacing and clinical electrophysiology : PACE · 2009
Long-term performance of the attain model 4193 left ventricular lead.
Клиническое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
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Johnson W Ben, Abraham William T, Young James B, Wheelan Kevin, Smith Andrew L, Chang Yanping, Brinkman Paula, InSync Registry Investigators
Аннотация
BACKGROUND: Cardiac resynchronization therapy (CRT) has proven to be a valuable therapy addition for patients with drug-refractory heart failure and a ventricular conduction delay. Delivery of CRT is dependent upon the successful implantation and chronic performance of a left ventricular (LV) pacing lead. This study assessed the long-term electrical performance and safety of a steroid-eluting, transvenous, over-the-wire, cardiac vein pacing lead.
METHODS: The Attain Model 4193 LV lead (Medtronic, Inc, Minneapolis MN, USA) was successfully implanted in 1,070 patients with 286 patients completing 3 years of follow-up. Clinical data were collected at pre-implant, implant, and at 6-month intervals for 3 years.
RESULTS: Over 3 years, the mean chronic pacing threshold ranged from 1.9 V to 2.1 V, the mean R-wave sensing amplitudes ranged between 13.6 mV and 15.0 mV, and the mean pacing impedance ranged between 562 ohms and 590 ohms. Additionally, the observed freedom from first post-implant LV-lead-related complications was 90.4%. Of 1,070 total patients, 82 experienced 89 LV-lead-related adverse events requiring invasive interventions or resulting in the termination of the CRT therapy. The LV lead was repositioned in 31 patients, replaced in 21 patients, and explanted/capped in four patients. There were no deaths related to the LV lead during implantation or during the follow-up period.
CONCLUSIONS: The data suggest that the 4193 LV lead is safe and effective over time. The LV lead electrical measurements remained stable through follow-up, demonstrating reliable long-term performance within the recommended value range at 36 months and had an acceptable complication rate.
METHODS: The Attain Model 4193 LV lead (Medtronic, Inc, Minneapolis MN, USA) was successfully implanted in 1,070 patients with 286 patients completing 3 years of follow-up. Clinical data were collected at pre-implant, implant, and at 6-month intervals for 3 years.
RESULTS: Over 3 years, the mean chronic pacing threshold ranged from 1.9 V to 2.1 V, the mean R-wave sensing amplitudes ranged between 13.6 mV and 15.0 mV, and the mean pacing impedance ranged between 562 ohms and 590 ohms. Additionally, the observed freedom from first post-implant LV-lead-related complications was 90.4%. Of 1,070 total patients, 82 experienced 89 LV-lead-related adverse events requiring invasive interventions or resulting in the termination of the CRT therapy. The LV lead was repositioned in 31 patients, replaced in 21 patients, and explanted/capped in four patients. There were no deaths related to the LV lead during implantation or during the follow-up period.
CONCLUSIONS: The data suggest that the 4193 LV lead is safe and effective over time. The LV lead electrical measurements remained stable through follow-up, demonstrating reliable long-term performance within the recommended value range at 36 months and had an acceptable complication rate.