In figure 1, word Model was misspelled as Madel and the lead is Model 6937. The correct figure 1 is below:

Background: The Micra Coverage with Evidence Development (CED) Study is a novel comparative analysis of Micra (leadless VVI) and transvenous single-chamber ventricular pacemakers (transvenous VVI) using administrative claims data. Objective: To compare chronic complications, device reinterventions, heart failure hospitalizations, and all-cause mortality after 3 years of follow-up.  Methods: U.S. Medicare claims data linked to manufacturer device registration information were used to identify Medicare beneficiaries with a de novo implant of either a Micra VR leadless VVI or transvenous VVI pacemaker from March 9, 2017-December 31, 2018. Unadjusted and propensity score overlap-weight adjusted Fine-Gray competing risk models were used to compare outcomes at 3 years.   Results: Leadless VVI patients (N=6,219) had a 32% lower rate of chronic complications and a 41% lower rate of reintervention compared with transvenous VVI patients (N=10,212) (chronic complication hazard ratio [HR] 0.68; 95% CI, 0.59-0.78; reintervention HR 0.59; 95% CI 0.44-0.78). Infections rates were significantly lower among patients with a leadless VVI (<0.2% versus 0.7%, P<0.0001). Patients with a leadless VVI also had slightly lower rates of heart failure hospitalization (HR 0.90; 95% CI 0.84-0.97). There was no difference in the adjusted 3-year all-cause mortality rate (HR 0.97; 95% CI, 0.92-1.03).  Conclusion: This nationwide comparative evaluation of leadless VVI versus transvenous VVI de novo pacemaker implants demonstrated that the leadless group had significantly fewer complications, reinterventions, heart failure hospitalizations, and infections than the transvenous group at 3 years, confirming that the previously reported shorter-term advantages associated with leadless pacing persist and continue to accrue in the medium-to-long-term.

Predictive Modeling of Lead Durability, An Important Step ForwardGeorge H. Crossley MD, FHRS, FACCVanderbilt Heart and Vascular Institute, Nashville, TN; and Cardiovascular Diseases Section, Vanderbilt University School of MedicineRWI: Dr. Crossley consults for Medtronic, Boston Scientific, and Phillips.Running Title: Lead Durability AnalysisWord Count: 893

Introduction Most currently available pacing and defibrillation leads utilize a stylet-based design that facilitates implantation. This has advantages, but also increases the lead diameter and adds the potential for metal fatigued-based conductor failure. Methods A systematic literature search was conducted, and the authors add their twenty-year experience with this lead design. Results The global experience with lumenless leads was reviewed both for “standard” positioning and with conduction system pacing. Methods for both placement and system modification are reviewed. Conclusions Lumenless leads have the potential to improve the durability of endocardial pacing and facilitate conduction system pacing.

A document by George Crossley. Click on the document to view its contents.

Background: Implantable cardioverter defibrillators (ICD) are indicated for primary and secondary prevention of sudden cardiac arrest. Despite enhancements in design and technologies, the ICD lead is the most vulnerable component of the ICD system and failure of ICD leads remains a significant clinical problem. A novel, small diameter, lumenless, catheter delivered, defibrillator lead was developed with the aim to improve long term reliability. Methods and Results: The Lead Evaluation for Defibrillation and Reliability (LEADR) study is a multi-center, single-arm, Bayesian, adaptive design, pre-market interventional pivotal clinical study. Up to 60 study sites from around the world will participate in the study. Patients indicated for a de novo ICD will undergo defibrillation testing at implantation and clinical assessments at baseline, implant, pre-hospital discharge, 3 months, 6 months, and every 6 months thereafter until official study closure. Patients will participate for a minimum of 18 months to approximately 3 years. Fracture-free survival will be evaluated using a Bayesian statistical method that incorporates both virtual patient data (combination of bench testing to failure with in-vivo use condition data) with clinical patients. The clinical subject sample size will be determined using decision rules for number of subject enrollments and follow-up time based upon the observed number of fractures at certain time points in the study. The adaptive study design will therefore result in a minimum of 500 and a maximum of 900 patients enrolled. Conclusion: The LEADR Clinical Study was designed to efficiently provide evidence for short- and long-term safety and efficacy of a novel lead design using Bayesian methods including a novel virtual patient approach.

There is an increasing recognition of the importance of tricuspid valve disease. Surgical treatment has been less than optimal and medical therapy has poor results. Catheter based delivery has revolutionized the delivery of aortic valve prostheses and trials of catheter based tricuspid valve prostheses are ongoing. Like surgical tricuspid interventions, these procedures are associated with a significant risk of heart block, as expected from their anatomic location. The complexity of these valve prostheses makes placement of a standard transvenous system undesirable. We present a series of patients who had successful placement of a leadless pacemaker system through the valve orifice.

A document by Emily Zeitler. Click on the document to view its contents.

Leadless Pacemaker Implantation after Lead Extraction for Cardiac Implanted Electronic Device InfectionJamia Kowal, D.O.andGeorge H. Crossley, M.D., F.H.R.S, F.A.C.C.