The efficacy of the LinoxSmart DX ICD lead from a single center experience.

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.

Clinical efficacy and safety of an implantable cardioverter-defibrillator lead with a floating atrial sensing dipole.

BACKGROUND: The concept of a single-lead implantable cardioverter-defibrillator (ICD), with a floating dipole, has been proven safe and functional. METHODS AND RESULTS: The studied active-fixation, steroid-eluting lead (Linox(smart) S DX, BIOTRONIK SE & Co KG, Berlin, Germany) is one French thinner than its predecessor and coated with lubricious SilGlide to improve lead handling. A dedicated ICD device has a self-adaptive atrial input stage including a fourfold amplifier. The amplification, filtering, and adapted atrial input stage are located in the Lumax 540 VR-T DX (BIOTRONIK). The Linox(smart) S DX ICD lead delivers only the signal. The lead was evaluated during implantation; at predischarge; and 1-, 3-, and 6-month follow-up examinations. The primary endpoint (efficacy) was the rate of appropriate atrial sensing tests. The secondary endpoint (safety) was freedom from lead-related invasive reinterventions. Both safety and efficacy were expected to be significantly higher than 90%. The study enrolled 116 patients at 25 clinical sites. Skin-to-skin operation time was 52.4 ± 26.2 minutes. The investigators graded lead insertion as "easy" in 87% of patients. Mean P-wave amplitudes (preamplified) varied from 5.0 to 6.1 mV in different body positions. Both primary and secondary endpoints were met, as 93.8% (364/388; P = 0.005) of specific sensing tests indicated appropriate atrial sensing, and 94.8% (110/116; P = 0.048) of patients were free from reinterventions (lead dislodgement). Analysis of arrhythmia episodes stored in ICDs and elective 24-hour Holter electrocardiogram tests raised no concerns about lead functionality. CONCLUSION: The studied ICD lead with a floating atrial sensing dipole met the predefined safety expectation and demonstrated appropriate atrial sensing performance.

The utilization of atrial sensing dipole in single lead implantable cardioverter defibrillator for detection of new-onset atrial high-rate episodes or subclinical atrial fibrillation: A systematic review and meta-analysis.

This meta-analysis aims to evaluate the performance of atrial sensing dipole in single lead implantable cardioverter defibrillator (VDD-ICD) recipients in particular diagnosing new-onset atrial high-rate episodes (AHREs) defined as rate threshold of 200 beats per minute, or subclinical atrial fibrillation (SCAF) defined as device-detected AF without symptoms. We comprehensively searched PubMed, Embase, and ClinicalTrials.gov. Studies comparing contemporary single- and dual-chamber ICD (VVI-/DDD-ICD) versus VDD-ICD were included. Restricted maximum likelihood method for random effect model and Mantel-Haenszel method for fixed effect model were used to estimate the effect size of new-onset AHREs, or SCAF detection in each group. Three prospective studies were identified and total of 991 participants were included. There were 330 (33.3%) in VDD-ICD and 661 (66.7%) in VVI-/DDD-ICD. Most (78%) participants were men. Median follow-up was from 365 days to 847 days. VDD-ICD has a higher likelihood of detecting AHREs or SCAF as compared to VVI-/DDD-ICD [(OR random effect : 2.6; 95% CI: 1.2, 5.8; p = .018); I-squared = 67.8%, p = .019]. This difference was more apparently seen in the comparison between VDD-ICD and VVI-ICD [(OR random effect: 3.8; 95% CI: 2.1, 6.6, p < .001), I-squared = 0.0%, p = .518]. The result is same as fixed effect. Rate of AHREs detection observed in VDD-ICD was not statistically different when compared to the only group with DDD-ICD from SENSE trial. In conclusion, this meta-analysis reveals that the use of floating atrial sensing dipole in VDD-ICD increases the detection of new-onset AHREs or SCAF when compared to VVI-ICD, with similar atrial sensing performance to DDD-ICD.

Single lead catheter of implantable cardioverter-defibrillator with floating atrial sensing dipole implanted via persistent left superior vena cava.

Persistent left superior vena cava (LSVC) is a congenital anomaly with 0.3%-1% prevalence in the general population. It is usually asymptomatic but in case of transvenous lead positioning, i.e., for pacemaker or implantable cardioverter defibrillator (ICD), may be a cause for significant complications or unsuccessful implantation. Single lead ICD with atrial sensing dipole (ICD DX) is a safe and functional technology in patients without congenital abnormalities. We provide a review of the literature and a case report of successful implantation of an ICD DX in a patient with LSVC and its efficacy in treating ventricular arrhythmias.