Patient selection, pacing indications, and subsequent outcomes with de novo leadless single-chamber VVI pacing.

Aims: Patient selection is a key component of securing optimal patient outcomes with leadless pacing. We sought to describe and compare patient characteristics and outcomes of Micra patients with and without a primary pacing indication associated with atrial fibrillation (AF) in the Micra IDE trial.

Methods And Results: The primary outcome (risk of cardiac failure, pacemaker syndrome, or syncope related to the Micra system or procedure) was compared between successfully implanted patients from the Micra IDE trial with a primary pacing indication associated with AF or history of AF (AF group) and those without (non-AF group).

Combining left atrial appendage closure and catheter ablation for atrial fibrillation: 2-year outcomes from a multinational registry.

Aims: Clinical practice guidelines do not recommend discontinuation of long-term oral anticoagulation in patients with a high stroke risk after catheter ablation for atrial fibrillation (AF). Left atrial appendage closure (LAAC) with Watchman has emerged as an alternative to long-term anticoagulation for patients accepting of the procedural risks. We report on the long-term outcomes of combining catheter ablation procedures for AF and LAAC from multicentre registries.

Left atrial appendage closure with WATCHMAN in Asian patients: 2 year outcomes from the WASP registry.

Background: Left atrial appendage closure is a non-pharmacological alternative for stroke prevention in high-risk non-valvular atrial fibrillation patients, but has not been widely studied in Asian patients. The prospective WASP registry assessed real-world outcomes for patients undergoing WATCHMAN implant in the Asia-Pacific region.

Methods: Data were collected from consecutive patients across 9 centres.

Leadless Pacemaker Implantation in Hemodialysis Patients: Experience With the Micra Transcatheter Pacemaker.

Objectives: This study sought to report periprocedural outcomes and intermediate-term follow-up of hemodialysis patients undergoing Micra implantation.

Background: Leadless pacemakers may be preferred in patients with limited vascular access and high-infection risk, such as patients on hemodialysis.

Methods: Patients on hemodialysis at the time of Micra implantation attempt (n = 201 of 2,819; 7%) from the Micra Transcatheter Pacing Study investigational device exemption trial, Micra Transcatheter Pacing System Continued Access Study Protocol, and Micra Transcatheter Pacing System Post-Approval Registry were included in the analysis.

Techniques for successful early retrieval of the Micra transcatheter pacing system: A worldwide experience.

Background: Experience with retrieval of the Micra transcatheter pacing system (TPS) is limited because of its relatively newer technology. Although abandonment of the TPS at end of life is recommended, certain situations such as endovascular infection or device embolization warrant retrieval.

Objective: The purpose of this study was to report the worldwide experience with successful retrieval of the Micra TPS.

Disparity Between Indications for and Utilization of Implantable Cardioverter Defibrillators in Asian Patients With Heart Failure.

Background: Implantable cardioverter defibrillators (ICDs) are lifesaving devices for patients with heart failure (HF) and reduced ejection fraction. However, utilization and determinants of ICD insertion in Asia are poorly defined. We determined the utilization, associations of ICD uptake, patient-perceived barriers to device therapy and, impact of ICDs on mortality in Asian patients with HF.

Combining Watchman left atrial appendage closure and catheter ablation for atrial fibrillation: multicentre registry results of feasibility and safety during implant and 30 days follow-up.

Aims: Long-term results from catheter ablation therapy for atrial fibrillation (AF) remain uncertain and clinical practice guidelines recommend continuation of long-term oral anticoagulation in patients with a high stroke risk. Left atrial appendage closure (LAAC) with Watchman has emerged as an alternative to long-term anticoagulation for patients accepting of the procedural risks. We report on the initial results of combining catheter ablation procedures for AF and LAAC in a multicentre registry.

Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study.

Background: Early performance of the Micra transcatheter pacemaker from the global clinical trial reported a 99.2% implant success rate, low and stable pacing capture thresholds, and a low (4.0%) rate of major complications up to 6 months.

Long-term outcomes in leadless Micra transcatheter pacemakers with elevated thresholds at implantation: Results from the Micra Transcatheter Pacing System Global Clinical Trial.

Background: Device repositioning during Micra leadless pacemaker implantation may be required to achieve optimal pacing thresholds.

Objective: The purpose of this study was to describe the natural history of acute elevated Micra vs traditional transvenous lead thresholds.

Methods: Micra study VVI patients with threshold data (at 0.

Rate adaptive pacing in an intracardiac pacemaker.

Background: The Micra transcatheter pacemaker was designed to have similar functionality to conventional transvenous VVIR pacing systems. It provides rate adaptive pacing using a programmable 3-axis accelerometer designed to detect patient activity in the presence of cardiac motion.

Objective: The purpose of this study was to evaluate the system's performance during treadmill tests to maximum exertion in a subset of patients within the Micra Transcatheter Pacing Study.

Regional and ethnic differences among patients with heart failure in Asia: the Asian sudden cardiac death in heart failure registry.

Aims: To characterize regional and ethnic differences in heart failure (HF) across Asia.

Methods And Results: We prospectively studied 5276 patients with stable HF and reduced ejection fraction (≤40%) from 11 Asian regions (China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Philippines, Singapore, Taiwan, and Thailand). Mean age was 59.

Deterioration of left ventricular systolic function in extended Pacing to Avoid Cardiac Enlargement (PACE) trial: the predictive value of early systolic dyssynchrony.

Aims: Biventricular (BiV) pacing was superior to right ventricular apical (RVA) pacing at extended follow-up in the Pacing to Avoid Cardiac Enlargement (PACE) trial. Early pacing-induced systolic dyssynchrony (DYS) might be related to mid-term result. However, it remains unknown whether early pacing-induced DYS can predict long-term reduction of left ventricular (LV) systolic function.

A Leadless Intracardiac Transcatheter Pacing System.

Background: A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead.

Methods: In a prospective multicenter study without controls, a transcatheter pacemaker was implanted in patients who had guideline-based indications for ventricular pacing. The analysis of the primary end points began when 300 patients reached 6 months of follow-up.

An International Observational Prospective Survey Assessing the Control of Atrial Fibrillation in Asia-Pacific: Results of the Record-AFAP Registry.

A prospective 1-year observational survey was designed to assess the management and control of atrial fibrillation (AF) in eight countries within the Asia-Pacific region. Patients (N = 2,604) with recently diagnosed AF or a history of AF ≤1 year were included. Clinicians chose the treatment strategy (rhythm or rate control) according to their standard practice and medical discretion.

Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study.

Aims: Permanent cardiac pacing is the only effective treatment for symptomatic bradycardia, but complications associated with conventional transvenous pacing systems are commonly related to the pacing lead and pocket. We describe the early performance of a novel self-contained miniaturized pacemaker.

Methods And Results: Patients having Class I or II indication for VVI pacing underwent implantation of a Micra transcatheter pacing system, from the femoral vein and fixated in the right ventricle using four protractible nitinol tines.

A Comparison of Dabigatran With Warfarin for Stroke Prevention in Atrial Fibrillation in an Asian Population.

Background: The Asian population with atrial fibrillation (AF) have a higher risk of stroke than the caucasian population and a higher risk of intracranial bleeding when anticoagulated with warfarin. There are few real-world studies comparing the efficacy of non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin among Asian patients to assess its outcomes of ischemic stroke and hemorrhagic stroke.

Methods: A retrospective cohort study of 1000 patients on dabigatran and warfarin from 2009 to 2013.

The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker.

Aims: Recent advances in miniaturization technologies and battery chemistries have made it possible to develop a pacemaker small enough to implant within the heart while still aiming to provide similar battery longevity to conventional pacemakers. The Micra Transcatheter Pacing System is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. The pacemaker is implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and insertion of a pacing lead, thereby potentially avoiding some of the complications associated with traditional pacing systems.

Long-term follow-up results of the pacing to avoid cardiac enlargement (PACE) trial.

Aims: We report the results of long-term follow-up of the Pacing to Avoid Cardiac Enlargement (PACE) trial, a prospective, double-blinded, randomized, multicentre study that confirmed the superiority of biventricular (BiV) pacing compared with right ventricular apical (RVA) pacing in prevention of LV adverse remodelling and deterioration of systolic function at 1 and 2 years.

Methods And Results: Patients with bradycardia and preserved LVEF were randomized to receive RVA (n = 88) or BiV pacing (n = 89). Co-primary endpoints were LV end-systolic volume (LVESV) and LVEF measured by echocardiography.

A single centre experience of the efficacy and safety of dabigatran etexilate used for stroke prevention in atrial fibrillation.

The use of novel anticoagulants such as dabigatran are increasing. Despite increased risks of intracerebral haemorrhage with warfarin among Asians, there is little published data on dabigatran to assess 'real world' efficacy and safety of dabigatran therapy in Asia. This was a retrospective observational study of patients prescribed dabigatran between 2010 and 2013.

Prospective randomized study to assess the efficacy of site and rate of atrial pacing on long-term progression of atrial fibrillation in sick sinus syndrome: Septal Pacing for Atrial Fibrillation Suppression Evaluation (SAFE) Study.

Background: Atrial-based pacing is associated with lower risk of atrial fibrillation (AF) in sick sinus syndrome compared with ventricular pacing; nevertheless, the impact of site and rate of atrial pacing on progression of AF remains unclear. We evaluated whether long-term atrial pacing at the right atrial (RA) appendage versus the low RA septum with (ON) or without (OFF) a continuous atrial overdrive pacing algorithm can prevent the development of persistent AF.

Methods And Results: We randomized 385 patients with paroxysmal AF and sick sinus syndrome in whom a pacemaker was indicated to pacing at RA appendage ON (n=98), RA appendage OFF (n=99), RA septum ON (n=92), or RA septum OFF (n=96).

The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study.

Background: During follow-up of between 1 and 3 years in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial, 2 doses of dabigatran etexilate were shown to be effective and safe for the prevention of stroke or systemic embolism in patients with atrial fibrillation. There is a need for longer-term follow-up of patients on dabigatran and for further data comparing the 2 dabigatran doses.

Methods And Results: Patients randomly assigned to dabigatran in RE-LY were eligible for the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit.

Dabigatran versus warfarin: effects on ischemic and hemorrhagic strokes and bleeding in Asians and non-Asians with atrial fibrillation.

Background And Purpose: Intracranial hemorrhage rates are higher in Asians than non-Asians, especially in patients receiving warfarin. This randomized evaluation of long-term anticoagulation therapy subgroup analysis assessed dabigatran etexilate (DE) and warfarin effects on stroke and bleeding rates in patients from Asian and non-Asian countries.

Methods: There were 2782 patients (15%) from 10 Asian countries and 15 331 patients from 34 non-Asian countries.

Asian Sudden Cardiac Death in Heart Failure (ASIAN-HF) registry.

Our aim is to determine mortality and morbidity in Asian patients under clinical management for heart failure (HF). Specifically, we will define the incidence of, and risk factors for, sudden cardiac death, as well as the socio-cultural factors influencing therapeutic choices in these patients. Methods This is a prospective observational multinational Asian registry of 5000 patients with symptomatic HF (stage C) and LV systolic dysfunction (EF ≤ 40%) involving 44 centres across 11 Asian regions (China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Philippines, Singapore, Taiwan and Thailand).