https://www.clinicaltrials.gov. Unique identifier: NCT01128166.

BackgroundThe transvenous implantable cardioverter‐defibrillator (ICD) lead is the most common source of complications in a traditional ICD system. This investigation aims to determine the incidence, predictors, and costs associated with these complications using a large insurance database.Methods and ResultsData from the OptumLabs™ Data Warehouse, which include diagnosis, physician and procedure codes, and claims from patient hospitalizations, were analyzed. Patients with a de novo ICD or cardiac resynchronization therapy defibrillator implanted from January 1, 2003, through June 30, 2015, were included; those who did not have continuous coverage beginning 1 year before implantation were excluded, resulting in 40 837 patients followed up over an average of 2.3±2.1 years. Patients were followed up until they had the procedure or their last active date in the database. Of 20 580 device procedures, 2165 (5.3%) and 771 (1.9%) had mechanical and infectious complications, respectively. The 5‐year rate of freedom from mechanical complication was 92.0% and 89.3% for ICDs and cardiac resynchronization therapy defibrillators, respectively. Infectious complications were more likely in patients with a history of atrial fibrillation, diabetes mellitus, and renal disease, and the risk increased with subsequent device procedures. Younger age, female sex, lack of comorbidities, and implantations between 2003 and 2008 were associated with more mechanical complications.ConclusionsIncidence of mechanical and infectious complications of transvenous ICD leads over long‐term follow‐up is much higher in the real world than in clinical studies. In our study cohort, 1 of 4 transvenous ICD leads had mechanical complications when followed up to 10 years. The high rate of reintervention leads to additional complications.

Aims This study aims to characterize the range of implantable device-based sensor values including heart sounds, markers of ventilation, thoracic impedance, activity, and heart rate for patients with heart failure (HF) when patients were deemed to be in clinically stable periods against the time course of acute decompensation and recovery from HF events. Methods and results The MultiSENSE trial followed 900 patients implanted with a COGNIS CRT-D for up to 1 year. Chronic, ambulatory diagnostic sensor data were collected and evaluated during clinically stable periods (CSP: unchanged NYHA classification, no adverse events, and weight change ≤2.27 kg), and in the timeframe leading up to and following HF events (HF admissions or unscheduled visits with intravenous HF treatment). Physiologic sensor data from 1667 CSPs occurring in 676 patients were compared with those data leading up to and following 192 HF events in 106 patients. Overall, the mean age was 66.6 years, and the population were predominantly male (73%). Patients were primarily in NYHA II (67%), with a mean LVEF of 29.6% and median NT-proBNP of 754.5 pg/mL. Sensor values during CSP were poorer in patients who had HF events during the study period than those without HF events, including first heart sound (S1: 2.18 ± 0.84 mG vs. 2.62 ± 0.95 mG,

PurposePatients with a cardiac implantable electronic device (CIED) often need device interrogation in an in-hospital environment. A diagnosis-only, remote interrogation device and process for CIED interrogation was developed to address this situation. Here, we describe our initial clinical experience with this system.MethodsThe LATITUDE Consult Communicator is a stand-alone interrogation-only device used to read the patient’s implanted CIED. Once retrieved, the data are securely transmitted via an analog phone line to a central server. The clinician can request a review of the transmitted data at any time. Following FDA approval, we determined the usage and performance of the system.ResultsCommunicators (n = 53) were installed in 42 hospital facilities. The most common location was in the emergency department (n = 32, 60 %). There were 509 discreet transmissions, which were categorized as follows: no arrhythmia episodes in the past 72 h and no out of range measurements (n = 174, 34 %); arrhythmia episodes in past 72 h but no out of range measurements (n = 170, 33 %); and further review recommended (n = 130, 26 %). (In 35 [7 %] instances, interrogation without analysis was requested.) The further review interrogations were then sub-divided into those of a non-urgent and urgent nature. Overall, only 53 (10 %) of the 509 transmissions were classified as urgent. Clinicians had access to full technical consultation in ≤15 min in 89 % of instances.ConclusionOur data demonstrate the feasibility of a new diagnosis-only, remote interrogation device and remote evaluation process for the interrogation of CIEDs in an in-hospital environment.Electronic supplementary materialThe online version of this article (doi:10.1007/s10840-015-0091-4) contains supplementary material, which is available to authorized users.

Background The INGEVITY lead (Boston Scientific, St Paul, MN, USA) has excellent clinical performance. However, its single filar design results in decreased lead tensile strength and a possible challenging extraction. This study's goal is to evaluate techniques for extracting the INGEVITY lead. Methods Two‐ and three‐dimensional models were created to simulate lead extraction from a right atrial appendage lead implant with a left subclavian approach and lead/fibrosis attachment sites. Standard and unique lead extraction preparation strategies were evaluated. Traction forces were measured from a superior approach alone or in combination with a femoral approach. Results For lead extraction via the superior approach, leaving the terminal on the lead was the only factor influencing maximum tolerated load (p‐value = .0007). Scar attachment provided greater lead tensile strength by transferring traction loading forces to the polyurethane outer insulation but dependent on insulation integrity. The strongest extraction rail was seen with a simulated femoral snaring of a locking stylet within the INGEVITY lead. Deployed screw retraction was most successful by rotating a Philips LLD#2 stylet (Philips Healthcare, Amsterdam, Netherlands) within the lead. Conclusion Results from in vitro simulations of INGEVITY lead extraction from an atrial location found the lead has low maximum tensile strength resulting in a poor extraction rail with common extraction tools and methods. However, the strength of the INGEVITY Lead extraction rail can be significantly increased by leaving the lead terminal intact and femoral snaring of the locking stylet within the lead. Such techniques may improve extraction of the INGEVITY lead.