Comparing complication rates between Abbott Tendril 2088 and competitive manufacturer leads: Novel real-world data approach.

Introduction: While several studies have reported on the reliability of cardiac pacing leads, there are limited comparative data on lead performance. We compared long-term performance of Abbott Tendril™ STS 2088TC (Tendril 2088) leads with competitive manufacturer (CM) pacing leads using novel real-world data analytic methods.

Methods: Medicare fee-for-service (FFS) claims and Abbott device registration databases were linked to identify patients implanted with single-chamber or dual-chamber pacemakers with the Abbott Tendril 2088 lead from January 1, 2014 to December 31, 2019 and were followed through December 31, 2021.

Evaluating cardiac lead safety using observational, real-world data: EP PASSION proof-of-concept study.

Background: Traditional post-approval study (PAS) designs have been accepted by regulatory authorities to fulfill postmarketing requirements for cardiac leads, but they have several limitations.

Objective: We conducted a proof-of-concept study of alternative methods that use real-world data (RWD) to evaluate lead safety in large populations of patients.

Methods: Abbott patient device databases were linked with Medicare Fee-For-Service (FFS) claims to identify lead complications in patients implanted with Abbott Optisure lead.

Comparison of outcomes and required tools between transvenous extraction of pacemaker and implantable cardioverter defibrillator leads: Insight from single high-volume center experience.

Introduction: Reports of comparison with procedural outcomes for implantable cardioverter defibrillator (ICD) and pacemaker (PM) transvenous lead extraction (TLE) are old and limited. We sought to compare the safety, efficacy, and procedural properties of ICD and PM TLE and assess the impact of lead age.

Methods: The study cohort included all consecutive patients with ICD and PM TLE in the Cleveland Clinic Prospective TLE Registry between 2013 and 2022.

Mortality Benefit Among Primary Prevention Implantable Cardioverter-Defibrillator Recipients on Contemporary Heart Failure Treatment.

Background: Past clinical trials have shown the benefit of implantable cardioverter-defibrillators (ICDs) for reducing sudden cardiac death in at-risk patients. However, heart failure management and ICD technology have changed since these trials were first published. An updated assessment of ICD mortality benefit is needed.

F-FDG PET/CT and radiolabeled leukocyte SPECT/CT imaging for the evaluation of cardiovascular infection in the multimodality context: ASNC Imaging Indications (ASNC I) Series Expert Consensus Recommendations from ASNC, AATS, ACC, AHA, ASE, EANM, HRS, IDSA, SCCT, SNMMI, and STS.

This document on cardiovascular infection, including infective endocarditis, is the first in the American Society of Nuclear Cardiology Imaging Indications (ASNC I) series to assess the role of radionuclide imaging in the multimodality context for the evaluation of complex systemic diseases with multi-societal involvement including pertinent disciplines. A rigorous modified Delphi approach was used to determine consensus clinical indications, diagnostic criteria, and an algorithmic approach to diagnosis of cardiovascular infection including infective endocarditis. Cardiovascular infection incidence is increasing and is associated with high morbidity and mortality.

Extraction outcomes of implantable cardioverter-defibrillator leads vary by manufacturer and model family.

Aims: Transvenous lead extraction (TLE) of implantable cardioverter-defibrillator (ICD) leads is considered challenging. The structure of each ICD leads is variable between manufacturer and model families. The net impact of lead family on the safety and effectiveness of TLE is poorly characterized.

Initial heart rate score predicts new-onset atrial tachyarrhythmias in pacemaker patients.

Aims: Heart rate score (HRSc), the per cent of atrial paced and sensed event in the largest 10 b.p.m.

Clinical predictors of incomplete coronary sinus lead removal during transvenous lead extraction in patients with cardiac resynchronization therapy.

Background: Reports of coronary sinus (CS) lead removal include small studies with short implant durations. Procedural outcomes for mature CS leads removed with long duration implantation are unavailable.

Objective: The purpose of this study was to examine the safety, efficacy, and clinical predictors of incomplete CS lead removal by transvenous lead extraction (TLE) in a large long implant duration cardiac resynchronization therapy patient cohort.

Mechanics of lumenless pacing lead strength during extraction procedures based on laboratory bench testing.

Background: With the advent of conduction system pacing, use of the Medtronic SelectSecure Model 3830 lead has increased substantially. However, with this increased use, the potential need for lead extraction also will increase. Lumenless lead construction requires an understanding of both applicable tensile forces as well as lead preparation techniques that can influence consistent extraction.

New atrial arrhythmia occurrence in single chamber implantable cardioverter defibrillator patients: A real-world investigation.

Introduction: A current limitation of single chamber implantable cardioverter defibrillators (ICDs) is the lack of an atrial lead to reliably detect atrial fibrillation (AF) episodes. A novel ventricular based atrial fibrillation (VBAF) detection algorithm was created for single chamber ICDs to assess R-R variability for detection of AF.

Methods: Patients implanted with Visia AF™ ICDs were prospectively enrolled in the Medtronic Product Surveillance Registry from December 15, 2015 to January 23, 2019 and followed with at least 30 days of monitoring with the algorithm.