Incidence of Premature Lead Failure in 2088 TendrilTM Pacing Leads: A Single Centre Experience

The saga of tendril leads continues: Should we continue to bury our heads in the sand?

“…Several other studies have since been published (Table 1). 4–6 All of these studies consistently showed that the rate of electrical abnormalities noted with Tendril leads vary from 6%‐19% as compared to less than 2% with non‐Tendril leads over 4–5 years of follow‐up. These results remained true in patients with Abbott and non‐Abbott generators.…”

Fatigue Testing of Wearable Sensing Technologies: Issues and Opportunities

“…For example, in the United States, updated ICD leads can enter the marketplace through the use of a PMA supplement that does not include clinical data demonstrating the safety and efficacy of the updated lead; whereas, under the new regulations adopted by the European Union, the introduction of updated pacemaker leads requires clinical data that address the safety and efficacy of the lead [ 48 , 49 , 66 , 67 ]. Fatigue failures of ICD leads approved via PMA supplementation in the United States are common [ 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 ], but whether the new European Union regulations either prevent the entry of such leads into the market or prevent adverse outcomes by the timely recognition of issues with the leads during post-market surveillance remains unclear [ 68 ].…”

“…ICD leads are subjected to more than 100,000 cycles of flexure per day [ 53 ], and fatigue failures of ICD leads may result in high impedance if the lead is fractured or low impedance if the insulation fails, causing the lead to short circuit [ 70 ]. Additionally, fatigue failures of ICD leads may result in noise in the signal [ 54 , 55 , 57 , 70 ], inappropriate pacing [ 45 , 69 ], inappropriate defibrillation [ 45 ], the delivery of unnecessary shocks resulting from oversensing [ 45 , 46 , 50 ], or mortality [ 46 , 47 ], especially in a failure to detect ventricular fibrillation [ 71 ].…”

“…Based on this definition, currently marketed wearable sensor technologies can be divided into internal sensors that are subcutaneously implanted in the body and external sensors that are worn on the body. Examples of the former include implantable cardioverter defibrillators (ICD), which sense cardiac depolarization [ 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 ]; implantable loop recorders, which are implantable electrocardiograms (EKG or ECG) [ 22 , 23 ]; and invasive continuous glucose monitors (CGM), which use a sensor embedded in the upper arm, abdomen, or gluteus to measure glucose levels from interstitial fluid [ 58 , 59 ], while examples of wearables that fall into the latter include smart watches, sleep and fitness trackers, or ECG sensors ( Figure 1 ). Fatigue failures of wearables, such as ICDs, are widely recognized and result in significant morbidity and mortality [ 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 ]; therefore, understanding the electromechanical fatigue and failure properties of proposed wearable sensors is paramount in insuring patient safety.…”

“…Examples of the former include implantable cardioverter defibrillators (ICD), which sense cardiac depolarization [ 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 ]; implantable loop recorders, which are implantable electrocardiograms (EKG or ECG) [ 22 , 23 ]; and invasive continuous glucose monitors (CGM), which use a sensor embedded in the upper arm, abdomen, or gluteus to measure glucose levels from interstitial fluid [ 58 , 59 ], while examples of wearables that fall into the latter include smart watches, sleep and fitness trackers, or ECG sensors ( Figure 1 ). Fatigue failures of wearables, such as ICDs, are widely recognized and result in significant morbidity and mortality [ 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 ]; therefore, understanding the electromechanical fatigue and failure properties of proposed wearable sensors is paramount in insuring patient safety. Although such failures are recognized with internally implanted sensors, a lack of standardized fatigue testing methods and validation studies [ 38 , 40 ], coupled with sensors fabricated from varying materials, has led to a paucity of comparable data regarding the durability and accuracy of wearable sensors.…”