INTRODUCTION: Several recent studies have raised concern about noise detections on Tendril pacemaker leads, which may represent insulation failure or algorithm-driven overreporting of physiologic signals. METHODS: We identified all pacemaker leads actively followed at Albany Medical Center, of which 1111 leads (262 Abbott Tendril, 576 Medtronic CapSure, 30 Fineline, 195 Ingevity, 48 Dextrus) in 703 patients were included in this observational study. Electrical abnormalities, comprising low-impedance measurements <200 Ω and repeated noise detections, were catalogued, as was initial management and subsequent need for surgical intervention. RESULTS: During 54 months median follow-up (interquartile range 24-105), 63 leads (5.7%) demonstrated electrical abnormalities, including low impedances in 21 and noise in 59. Tendril leads manifested abnormalities most frequently (n = 50; 19.1%) compared with CapSure (n = 9; 1.6%), Fineline (n = 0), Ingevity (n = 0), and Dextrus (n = 4; 8.3%) leads. The risk of abnormalities was significantly higher in Tendril leads (HR 9.6, 95% CI 5.2-17.6; p < .001). Low impedances were measured on 19 Tendril leads, a significantly higher risk than on other leads (HR 23.8, 95% CI 5.5-102.1; p < .001). Although observation and reprogramming sensitivity were the initial management strategy for 45 and 7 leads, respectively, 18 ultimately required surgical intervention, including 15 Tendrils. No electrical abnormalities were observed in 12 non-Tendril leads attached to Abbott devices compared with 48 of 252 Tendrils attached to Abbott devices (log-rank p = .035). CONCLUSION: Tendril leads demonstrate significantly higher risk of repeated low impedances and noise compared to other manufacturers' models, raising concern that these findings reflect early insulation failure. Increased scrutiny is warranted.
INTRODUCTION: Several recent studies have raised concern about noise detections on Tendril pacemaker leads, which may represent insulation failure or algorithm-driven overreporting of physiologic signals. METHODS: We identified all pacemaker leads actively followed at Albany Medical Center, of which 1111 leads (262 Abbott Tendril, 576 Medtronic CapSure, 30 Fineline, 195 Ingevity, 48 Dextrus) in 703 patients were included in this observational study. Electrical abnormalities, comprising low-impedance measurements <200 Ω and repeated noise detections, were catalogued, as was initial management and subsequent need for surgical intervention. RESULTS: During 54 months median follow-up (interquartile range 24-105), 63 leads (5.7%) demonstrated electrical abnormalities, including low impedances in 21 and noise in 59. Tendril leads manifested abnormalities most frequently (n = 50; 19.1%) compared with CapSure (n = 9; 1.6%), Fineline (n = 0), Ingevity (n = 0), and Dextrus (n = 4; 8.3%) leads. The risk of abnormalities was significantly higher in Tendril leads (HR 9.6, 95% CI 5.2-17.6; p < .001). Low impedances were measured on 19 Tendril leads, a significantly higher risk than on other leads (HR 23.8, 95% CI 5.5-102.1; p < .001). Although observation and reprogramming sensitivity were the initial management strategy for 45 and 7 leads, respectively, 18 ultimately required surgical intervention, including 15 Tendrils. No electrical abnormalities were observed in 12 non-Tendril leads attached to Abbott devices compared with 48 of 252 Tendrils attached to Abbott devices (log-rank p = .035). CONCLUSION: Tendril leads demonstrate significantly higher risk of repeated low impedances and noise compared to other manufacturers' models, raising concern that these findings reflect early insulation failure. Increased scrutiny is warranted.
Authors: Allan G S Sánchez; Josué Soto-Vega; Esteban Tlelo-Cuautle; Martín Antonio Rodríguez-Licea Journal: Micromachines (Basel) Date: 2021-05-21 Impact factor: 2.891