RESUMO
PURPOSE: The Biotronik LinoxSmart DX implanted cardioverter defibrillator (ICD) lead is a novel VDD lead with the advantage of integrated atrial sensing dipole combined with a special augmentation and filtering mechanisms. We sought to determine the efficacy of the Biotronik LinoxSmart DX ICD lead. METHODS: Non-randomized consecutive patients implanted with Biotronik LinoxSmart DX lead at Sheba Medical Center were included in this study. Electrical parameters and arrhythmic events were recorded during follow up of one year. RESULTS: Seventy-three patients (69 males (94.5%), mean age 61 ± 12 years) were included. All patients were successfully implanted with a Biotronic VR-T DX device and LinoxSmart DX ICD lead (DX-17 in 37% and DX-15 in 63% patients). Mean P wave amplitude at time of implantation was 3.66 ± 2.9 mV and improved significantly throughout the follow-up (5.29 ± 4.39 mV, p = 0.009). Appropriate atrial sensing (defined as P wave amplitude of ≥0.8 mV) rate of 100% at implantation significantly decreased to 89% (p = 0.015) at 12 months. Three out of 67 (4.5%) patients without a known history of atrial fibrillation had documented new onset paroxysmal atrial fibrillation. Appropriate shocks occurred in 4 (5.5%) patients. One patient with atrial sensing less than 0.4 mV had inappropriate shock. CONCLUSIONS: Among patients implanted with the Biotronik LinoxSmart DX ICD lead in our single center, appropriate atrial sensing rate decreased over 12 months. Larger studies are needed to evaluate the reliability of long term appropriate atrial sensing.
RESUMO
BACKGROUND: An early failure of Biotronik Linox implantable cardioverter defibrillator (ICD) leads has been reported from several centers. AIM: To compare the performance of Linox ICD leads with different other ICD leads as a report of the Sheba Medical Center experience. METHODS: All patients who had implantation of Linox ICD leads between 2007 and 2016 were included in this study. ICD lead failure was defined as low- or high-voltage impedance; failure to capture, sense, or defibrillate; or the presence of nonphysiological signals not due to external interference. The survival probability of Linox leads was determined and compared to Medtronic Sprint Quattro ICD leads. RESULTS: A total of 340 patients (age 64.4 ± 1.8 years) were included in this analysis. They were followed up to 105 months (mean 45.7 ± 7, median 44 (Interquartile range (IQR) 26-63) months). Twelve patients (3.5%) met the criteria for lead failure within 61.2 ± 22.9 months (median 66.5 [IQR 48-85 months]) post implantation. Noise with inappropriate ventricular arrhythmias detection, with or without therapy, was seen in 10 patients (83%). High pacing thresholds and high impedances were detected in two patients (17%). The survival probability of Linox leads at 60 months (97.3%) was similar to the survival probability of Sprint Quattro leads (98.2%) (P = .58). Nevertheless, the survival probability at 105 months was much lower (81% vs 97%, Linox ICD lead and Sprint Quattro lead, respectively, P = .0039). CONCLUSION: Linox ICD leads have higher late failure rates compared to Sprint Quattro leads. These findings need to be confirmed in larger scale studies.
Assuntos
Desfibriladores Implantáveis , Eletrodos Implantados , Análise de Falha de Equipamento , Idoso , Feminino , Humanos , Israel , Masculino , Pessoa de Meia-IdadeRESUMO
The aim of this study was to evaluate the dual chamber uni/bipolarpacemaker Minidual 50, manufactured by Sorin Biomedica. Between 1995 and 1998, 66 Minidual 50 models were implanted at the Heart Institute. During the follow-up period of 33 +/- 12.8 months (range 0-50 months), total function loss in seven (10.6%) units and false threshold measurement of sensing and pacing in three (4.5%) patients were observed. Average time from implantation to malfunction was 37 months (range 28-42). Malfunction was unrelated to battery status and could not be predicted by any measures obtained during the pacemaker follow-up period. Kaplan Meyer survival curve predicted a 70% 4-year malfunction-free survival of that pacemaker model. Given this high rate of total malfunction and the unpredictable nature of its occurrence, the authors recommend the replacement of all remaining Minidual 50 units at risk, at least in dependent patients.