Long-Term Evaluation of Biotronik Linox and Linox(smart) Implantable Cardioverter Defibrillator Leads.

INTRODUCTION: Expert consensus holds that post-market, systematic surveillance of ICD leads is essential to ensure confirmation of adequate lead performance. GALAXY (NCT00836589) and CELESTIAL (NCT00810264) are ongoing multicenter, prospective, non-randomized registries conducted to confirm the long-term safety and reliability of Biotronik leads. METHODS AND RESULTS: ICD and CRT-D patients are followed for Linox and Linox(smart) ICD lead performance and safety for 5 years post-implant. All procedural and system-related adverse events (AEs) were assessed at each follow-up, along with lead electrical parameters. An independent CEC of EPs adjudicated AEs to determine AE category and lead relatedness. The analysis used categories of lead observations per ISO 5841-2 (Third edition). A total of 3,933 leads were implanted in 3,840 patients (73.0% male, mean age 67.0 ± 12.2 years) at 146 US centers. The estimated cumulative survival probability was 96.3% at 5 years after implant for Linox leads and 96.6% at 4 years after implant for Linox(smart) leads. A comparison of the Linox and Linox(smart) survival functions did not find evidence of a difference (P = 0.2155). The most common AEs were oversensing (23, 0.58%), conductor fracture (14, 0.36%), failure to capture (13, 0.33%), lead dislodgement (12, 0.31%), insulation breach (10, 0.25%), and abnormal pacing impedance (8, 0.20%). CONCLUSIONS: Linox and Linox(smart) ICD leads are safe, reliable and infrequently associated with lead-related AEs. Additionally, estimated cumulative survival probability is clinically acceptable and well within industry standards. Ongoing data collection will confirm the longer-term safety and performance of the Linox family of ICD leads.

Ampere Hour as a Predictor of Cardiac Resynchronization Defibrillator Pulse Generator Battery Longevity: A Multicenter Study.

BACKGROUND: Cardiac resynchronization defibrillator (CRT-D) devices improve survival for New York Heart Association classes II-IV systolic heart failure patients with QRS > 120 ms and left ventricular ejection fraction < 35%. A limitation of 100% CRT pacing is excess battery depletion and pulse generator (PG) replacement compared to VVI or dual-chamber systems. Ampere hour (Ah) measures PG battery capacity and may predict CRT-D device longevity. METHODS: We performed a multicenter retrospective study of all CRT-D devices implanted at our centers from August 1, 2008 to December 31, 2010. Analysis was performed for survival to elective replacement indicator (ERI) between 1.0 Ah, 1.4 Ah, and 2.0 Ah devices, per manufacturers' specifications. RESULTS: One thousand three hundred and two patients were studied through December 31, 2014. Patients were followed for an average of 3.0 ± 1.3 years (794 1.0 Ah, 322 2.0 Ah, and 186 1.4 Ah devices under study). CRT-D generator ERI occurred in 13.5% of 1.0 Ah systems (107 out of 794), versus 3.8% in 1.4 Ah (seven out of 186), and 0.3% in 2.0 Ah devices (one out of 322) over mean follow-up of 3.0 years. Odds ratio (OR) for reaching ERI with 1.0 Ah device versus 1.4 Ah or 2.0 Ah was 9.73, P < 0.0001. Univariate predictors for ERI included 1.0 Ah device and LV pacing output >3V @ 1 ms (OR: 3.74, P < 0.001). LV impedance >1,000 ohms predicted improved device survival (OR: 0.38, P = 0.0025). CONCLUSIONS: CRT-D battery capacity measured by Ah is a strong predictor of survival to ERI for modern systems. Further study on cost and morbidity associated with early PG change in 1.0 Ah systems is warranted.

Percutaneous Extraction of Embolized Intracardiac Inferior Vena Cava Filter Struts Using Fused Intracardiac Ultrasound and Electroanatomic Mapping.

This report describes the percutaneous extraction of embolized intracardiac inferior vena cava (IVC) filter struts using fluoroscopy and fused intracardiac echocardiography and three-dimensional electroanatomic mapping. Six patients with indwelling IVC filters placed at outside institutions 5 months to 14 years previously presented with cross-sectional imaging of the chest demonstrating fractured IVC filter struts embolized to the myocardial free wall (four patients) or interventricular septum (two patients). All embolized filter struts were successfully retrieved, and open heart surgery was avoided.

Hybrid venous recanalization and cardiac implantable electronic device lead revision procedures: A single-center retrospective analysis of 38 patients.

PURPOSE: The purpose of this study was to describe the safety and efficacy of hybrid recanalization procedures in a series of patients with obstructed central veins requiring cardiac implantable electronic device (CIED) revision. METHODS: Between 2008 and 2016, 38 consecutive patients (24 M; age 60.5 ±â€¯16.2 years; range 25-87 years) with central venous obstruction underwent 42 recanalization interventions performed in conjunction with CIED revision or extraction. Fifty percent of patients (19/38) presented with veno-occlusive symptoms, and 13% (5/38) of patients had CIED leads with an ipsilateral upper extremity dialysis conduit. RESULTS: Ninety-one percent (38/42) of all procedures resulted in successful recanalization and CIED revision. Twenty-four percent (9/38) of all patients required secondary procedures due to recurrent stenosis, and 78% (7/9) of those requiring secondary procedures had indwelling dialysis conduits and/or clinical symptoms related to venous occlusion before the initial procedure. There were complications in 2 patients related to recanalization, and in 3 related to CIED revision. CONCLUSIONS: Recanalization of central venous stenosis/occlusion in patients with CIED can be technically challenging but is successful in most patients. Symptomatic patients and those with dialysis conduits often require more aggressive revascularization interventions and may be at increased risk of complication or need for secondary interventions.

Patient-centered management of atrial fibrillation: applying evidence-based care to the individual patient.

Atrial fibrillation is the most common arrhythmia encountered in clinical practice, and it is one of the most common cardiac conditions requiring hospitalization of a patient. Several national organizations have developed guidelines for the management of atrial fibrillation. These guidelines were updated in 2011 to incorporate new advances in antiarrhythmic drug therapy and anticoagulant therapy, as well as progress in the field of catheter ablation. Many decisions about patient care involve consideration of issues related to lifestyle and quality of life rather than survival. These decisions also involve addressing the key topics of heart rate control, heart rhythm control, and stroke prevention. During the past decade, important advances in the management of atrial fibrillation have created a number of treatment options that have roughly equivalent therapeutic efficacies when they are used for several common clinical situations encountered in clinical practice. The range of available treatments for patients with atrial fibrillation provides an important opportunity for the physician to deliver patient-centered care, which uses patient values to determine the best course of treatment.

A restrictive inflow pattern does not predict implantable cardioverter-defibrillator therapy in primary prevention.

BACKGROUND: Current guidelines for the use of implantable cardioverter-defibrillators (ICDs) are broad and significantly increase the cost of caring for patients with heart failure. In an effort to identify the specific subset of patients who benefit from this therapy, the predictive value of numerous echocardiographic parameters have been studied. Severe diastolic dysfunction has been shown to predict adverse events in a group of patients who received an ICD for secondary prevention, but has not been tested in those who receive ICDs for primary prevention. HYPOTHESIS: We tested the hypothesis that a restrictive mitral inflow pattern on echocardiography will predict the risk of appropriate therapy in this patient population. METHODS: This retrospective study identified 145 consecutive patients who met primary prevention criteria for ICD implantation and had an echo performed no more than 1 year prior to receiving the ICD. A restrictive pattern was defined as a mitral inflow E/A > 2 or a deceleration time < 150 ms. RESULTS: A restrictive pattern was present in 69 patients (40.7% of the group). Appropriate ICD therapy occurred in 8 (11.5%) subjects with a restrictive pattern and 14 (18.4%) with a nonrestrictive pattern over 680 days of average follow-up (P = not significant). Cox regression analysis showed the presence of a restrictive pattern was not helpful in predicting time to first ICD therapy. CONCLUSIONS: In a population of patients who received ICDs for primary prevention, echocardiographic findings of severe diastolic dysfunction were not helpful in targeting the use of ICDs to those at highest risk.

Curative catheter ablation for atrial fibrillation.

With the recent advances in the understanding of the mechanisms of atrial fibrillation, radiofrequency catheter ablation has emerged as an effective therapeutic modality for patients with atrial fibrillation. Techniques for catheter ablation evolved from elimination of triggers that often originate within the pulmonary veins and initiate atrial fibrillation, to additional left atrial ablation using a variety of approaches to also eliminate the mechanisms that play a role in perpetuation of atrial fibrillation. With the current ablation strategies, atrial fibrillation can be eliminated in approximately 85% of patients with paroxysmal, and in approximately 70% of patients with chronic, atrial fibrillation with a low incidence of significant complications. In symptomatic patients with paroxysmal or chronic atrial fibrillation who have failed antiarrhythmic drug therapy, catheter ablation is an effective treatment strategy for maintenance of sinus rhythm.