Charles Love

Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) Trial

Background— Monitoring implantable cardiac device function and patient condition is important. The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) trial tested the hypothesis that remote home monitoring with automatic daily surveillance (HM) is safe and effective for implantable cardioverter-defibrillator follow-up for 1 year and enables rapid physician evaluation of significant events. Methods and Results— In total, 1339 patients were randomized 2:1 to HM or conventional follow-up. Follow-up checks occurred at 3, 6, 9, 12, and 15 months after implantation. HM was used before office visits at 3 and 15 months in the HM group. At 6, 9, and 12 months, HM only was used but was followed by office visits if necessary. Conventional patients were evaluated with office visits only. Scheduled office visits and unscheduled evaluations, incidence of morbidity, and time elapsed from first event occurrence in each patient to physician evaluation were tracked for each group. HM and conventional patients were similar (age, 63.3±12.8 versus 64.0±12.1 years; gender, 72.0% versus 73.1% male; New York Heart Association class II, 55.9% versus 60.4%; pathology: left ventricular ejection fraction, 29.0±10.7% versus 28.5±9.8%; coronary artery disease, 64.8% versus 71.7%; primary prevention indication, 72.2% versus 73.8%; and dual-chamber implants, 57.8% versus 56.6%). HM reduced total in-hospital device evaluations by 45% without affecting morbidity. In the HM group, 85.8% of all 6-, 9-, and 12-month follow-ups were performed remotely only, indicating that HM provided sufficient assessment in the majority. Median time to evaluation was <2 days in the HM group compared with 36 days in the conventional group (P<0.001) for all arrhythmic events. Conclusions— HM is safe and allows more rapid detection of actionable events compared with conventional monitoring in patients with implantable electronic cardiac devices. Clinical Trials Registration— URL: http:/www.clinicaltrials.gov. Unique identifier: NCT00336284.

Lead Extraction in the Contemporary Setting: The LExICon Study. An Observational Retrospective Study of Consecutive Laser Lead Extractions

OBJECTIVES This study sought to examine the safety and efficacy of laser-assisted lead extraction and the indications, outcomes, and risk factors in a large series of consecutive patients. BACKGROUND The need for lead extraction has been increasing in direct relationship to the increased numbers of cardiovascular implantable electronic devices. METHODS Consecutive patients undergoing transvenous laser-assisted lead extraction at 13 centers were included. RESULTS Between January 2004 and December 2007, 1,449 consecutive patients underwent laser-assisted lead extraction of 2,405 leads (20 to 270 procedures/site). Median implantation duration was 82.1 months (0.4 to 356.8 months). Leads were completely removed 96.5% of the time, with a 97.7% clinical success rate whereby clinical goals associated with the indication for lead removal were achieved. Failure to achieve clinical success was associated with body mass index <25 kg/m(2) and low extraction volume centers. Procedural failure was higher in leads implanted for >10 years and when performed in low volume centers. Major adverse events in 20 patients were directly related to the procedure (1.4%) including 4 deaths (0.28%). Major adverse effects were associated with patients with a body mass index <25 kg/m(2). Overall all-cause in-hospital mortality was 1.86%; 4.3% when associated with endocarditis, 7.9% when associated with endocarditis and diabetes, and 12.4% when associated with endocarditis and creatinine > or =2.0. Indicators of all-cause in-hospital mortality were pocket infections, device-related endocarditis, diabetes, and creatinine > or =2.0. CONCLUSIONS Lead extraction employing laser sheaths is highly successful with a low procedural complication rate. Total mortality is substantially increased with pocket infections or device-related endocarditis, particularly in the setting of diabetes, renal insufficiency, or body mass index <25 kg/m(2). Centers with smaller case volumes tended to have a lower rate of successful extraction.

Right Ventricular Outflow Versus Apical Pacing in Pacemaker Patients with Congestive Heart Failure and Atrial Fibrillation

Introduction: Prior studies suggest that right ventricular apical (RVA) pacing has deleterious effects. Whether the right ventricular outflow tract (RVOT) is a more optimal site for permanent pacing in patients with congestive heart failure (CHF) has not been established.

In vivo model of human pathogen infection and demonstration of efficacy by an antimicrobial pouch for pacing devices.

Background: Device‐related infections represent a significant clinical challenge. Once established, these infections prove difficult to treat with existing antibiotic regimens, compromising the health of device recipients, and usually requiring surgical intervention to resolve.

Postoperative Performance of the Quartet® Left Ventricular Heart Lead

Promote® Q CRT‐D and Quartet® LV Lead Study. Introduction: The Quartet® left ventricular (LV) lead is the first with 4 pacing electrodes (tip and 3 rings) that enables pacing from 10 different pacing vectors. Postoperative performance of this lead was evaluated in a prospective, nonrandomized, multicenter IDE study.

ALTERNATING CURRENT ELECTROCUTION DETECTION AND TERMINATION BY AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

A patient with an ICD accidentally grasped a power line and was electrocuted. He was unable to release the cable during electrocution though he remained conscious. After receiving a shock from his ICD. the powerline was released. ICD interrogation revealed inappropriate detection of alternating current and delivery of a shock.

2018 EHRA expert consensus statement on lead extraction: recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: endorsed by APHRS/HRS/LAHRS

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years. Transvenous lead extraction (TLE), as a part of an overall lead management strategy, has also been increasing, not only as a consequence of this growth, but also because of increasing rates of infection, lead failure, awareness of indications for lead management, and development of extraction tools. Clinical research is essential for understanding efficacy and risks of TLE.

Cardiac Magnetic Resonance Imaging Utilization for Optimal Pacemaker

In dextro-transposition of great arteries (d-TGA), especially in an adult who has undergone both Mustard and superior vena cava (SVC) baffle stenting, permanent pacemaker lead placement can prove to be challenging. Magnetic Resonance Imaging (MRI) can be utilized for procedural planning and locating optimal anatomical sites for lead placement. In this report, we demonstrate dual-chamber permanent pacemaker lead placement through a stented SVC baffle to the left atrium (LA) and left ventricle (LV). This was done after an MRI demonstrated stent patency and anatomical locations within the LA for potential pacing. Knowledge of SVC patency and less-than-optimal anatomy of adults with congenital heart defects are imperative in permanent pacemaker placement.