Device dislodgement and embolization associated with a new leadless pacemaker.

Introduction: Currently, there are two approved single chamber leadless pacemakers (LP) in the United States (US), Micra VR™; approved since 2016 and AVEIR VR™; approved in 2022. A potential complication of LPs is dislodgement and/or embolization (D/E) during or after implant. According to the IDE trials, there appears to be a significant difference in D/E rates between the two LPs that have different fixation mechanisms; Micra uses nitinol tines, while AVEIR uses an active screw helix.

Ripple Frequency Determined via a Novel Algorithm Is Associated With Atrial Fibrillation Termination and Freedom From Atrial Fibrillation.

Background: Persistent atrial fibrillation (AF) is a complex arrhythmia, and attaining freedom from AF with ablation has been challenging.

Objectives: This study evaluated a novel CARTO software algorithm based on the CARTO Ripple map for AF termination and 18-month freedom from AF.

Methods: Consecutive patients who underwent first-time ablation for persistent AF were included.

Leadless pacemaker perforations: Clinical consequences and related device and user problems.

Background: Cardiac perforation during leadless pacemaker implantation is more likely to require intervention than perforation by a transvenous lead. This study reports the consequences of Micra pacemaker perforations and related device and operator use problems based on information the manufacturer has submitted to the Food and Drug Administration (FDA).

Methods: FDA's Manufacturer and User Facility Device Experience (MAUDE) database was searched for Micra perforations.

Major adverse clinical events associated with implantation of a leadless intracardiac pacemaker.

Background: Leadless intracardiac pacemakers were developed to avoid the complications of transvenous pacing systems. The Medtronic Micra™ transcatheter pacemaker is one such system. We found an unexpected number of major adverse clinical events (MACE) in the Food and Drug Administration's Manufacturers and User Facility Device Experience (MAUDE) database associated with Micra implantation.

Reliability and longevity of implantable defibrillators.

Purpose: We hypothesized that data in manufacturers' product performance reports (PPRs) can provide clinically valuable ICD and cardiac resynchronization defibrillator (CRT-D) reliability and longevity information.

Methods: Data were obtained from 2019 PPRs. Kaplan-Meier (K-M) probabilities of freedom from malfunction, normal battery depletion (NBD), and NBD + malfunction were calculated for ICD and CRT-D pulse generators (PGs) with LiMnO2 or LiSVO/CFx batteries marketed in the USA from 2010 to 2019 and compared using the log-rank test.

Outcomes Before and After the Recall of a Heart Failure Pacemaker.

Importance: Timely and complete disclosure of medical device defects is necessary to manage patient care safely and effectively.

Objectives: To determine if the manufacturer's recommendations following the recall of a medical device were timely and complete, the follow-up information and data provided to patients and physicians were adequate for managing patient care, and the actions taken by the US Food and Drug Administration (FDA) regarding the recall were appropriate.

Design, Setting, And Participants: This single-center retrospective case series included 90 of 448 patients who were implanted with a cardiac resynchronization therapy pacemaker at the Minneapolis Heart Institute from May 2003 through January 2011; this pacemaker was recalled in November 2015.

High shocking and pacing impedances due to defibrillation lead calcification.

Purpose: We have reported the calcification of Endotak defibrillation leads that required replacement. The aim of this study was to assess calcified Endotak Reliance leads in the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database and compare them to calcified Sprint Fidelis, Sprint Quattro Secure, Riata, and Durata leads in MAUDE.

Methods: We searched the MAUDE database from 2008 to 2019 for defibrillation lead calcification using the terms "calcium," "calcification," and "calcified".

Outcomes after pacemaker implantation in patients with new-onset left bundle-branch block after transcatheter aortic valve replacement.

New-onset left bundle branch block (N-LBBB) after transcatheter aortic valve replacement (TAVR) is a challenging clinical dilemma. In our single-center study, 60 out of 172 patients who underwent permanent pacemaker implantation (PPM) after TAVR had N-LBBB (34.9%).

Outcomes following persistent atrial fibrillation ablation using localized sources identified with Ripple map.

Background: Ablation of persistent atrial fibrillation (AF) remains challenging. Identification and ablation of localized AF drivers may offer the possibility for improved outcomes. Ripple map is a novel software algorithm that may allow improved localization of possible AF drivers through the whole chamber graphical display of continuously recorded bipolar electrograms.

Internal insulation breaches in an implantable cardioverter-defibrillator lead with redundant conductors.

Background: Internal insulation breaches (IBR) may result in implantable cardioverter-defibrillator lead failure and adverse clinical events. Concerns exist that the Durata lead may be prone to IBR.

Objective: The goals of this study were to assess Durata failures in the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database and compare them to failures in MAUDE for Endotak Reliance and Sprint Quattro Secure (QS) leads.

Autosomal-dominant biventricular arrhythmogenic cardiomyopathy in a large family with a novel in-frame DSP nonsense mutation.

A novel autosomal-dominant in-frame deletion resulting in a nonsense mutation in the desmoplakin (DSP) gene was identified in association with biventricular arrhythmogenic cardiomyopathy across three generations of a large Caucasian family. Mutations that disrupt the function and structure of desmosomal proteins, including desmoplakin, have been extensively linked to familial arrhythmogenic right ventricular cardiomyopathy (ARVC). Analysis of data from 51 individuals demonstrated the previously undescribed variant p.

Design, Challenges, and Implications of Quality Improvement Projects Using the Electronic Medical Record: Case Study: A Protocol to Reduce the Burden of Postoperative Atrial Fibrillation.

Postoperative atrial fibrillation (POAF) is a frequent complication of cardiac surgery, which results in increased morbidity, mortality, length of stay, and hospital costs. We developed and followed a process map to implement a protocol to decrease POAF: (1) identify stakeholders and form a working committee, (2) formal literature and guideline review, (3) retrospective analysis of current institutional data, (4) data modeling to determine expected effects of change, (4) protocol development and implementation into the electronic medical record, and (5) ongoing review of data and protocol adjustment. Retrospective analysis demonstrated that POAF occurred in 29.

Approach to reduction of ventricular arrhythmias and implantable cardioverter-defibrillator therapies in patients with heart failure.

Purpose Of Review: Prevention of ventricular arrhythmias and implantable cardioverter-defibrillator (ICD) therapies in patients with heart failure will be reviewed.

Recent Findings: ICD utilization in patients with heart failure has resulted in significantly improved long-term survival. However, there is growing evidence that ICD shocks are associated with increased morbidity and mortality.

Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads.

Background: Riata and Riata ST leads (St Jude Medical, Sylmar, CA) are prone to failure. There are no independent multicenter reports regarding Riata or Riata ST lead performance.

Objective: To conduct a retrospective multicenter study of Riata and Riata ST leads that were implanted and followed at 7 centers.

Failure of a novel silicone-polyurethane copolymer (Optim™) to prevent implantable cardioverter-defibrillator lead insulation abrasions.

Aim: The purpose of this study was to determine if Optim™, a unique copolymer of silicone and polyurethane, protects Riata ST Optim and Durata implantable cardioverter-defibrillator (ICD) leads (SJM, St Jude Medical Inc., Sylmar, CA, USA) from abrasions that cause lead failure.

Methods And Results: We searched the US Food and Drug Administration's (FDA's) Manufacturers and User Device Experience (MAUDE) database on 13 April 2012 using the simple search terms 'Riata ST Optim™ abrasion analysis' and 'Durata abrasion analysis'.

Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads.

Background: Riata and Riata ST leads (St Jude Medical, Sylmar, CA) were recalled in 2011. These leads are prone to externalized conductors. However, it is electrical malfunctions that may result in serious adverse events, including death.

Measures of left ventricular dyssynchrony and the correlation to clinical and echocardiographic response after cardiac resynchronization therapy.

There is still no standardized measure of left ventricular (LV) dyssynchrony or definition of response in candidates of cardiac resynchronization therapy (CRT). Recipients of CRT underwent echocardiographic assessment of LV dyssynchrony before and immediately after implantation of a CRT device. Patients were followed for 6 months postimplantation.

Constrictive pericarditis: an unusual clinical entity suggested during dobutamine stress echocardiography.

A 44-year-old female presents with disabling dyspnea and is unable to perform a regular treadmill stress test; instead a dobutamine stress echocardiogram is performed and although negative for ischemia reveals a vigorous paradoxical motion of the interventricular septum with dilatation of the inferior vena cava without respiratory variation and an increased diastolic flow signal in the hepatic veins after expiration with the infusion of dobutamine. The diagnosis of constrictive physiology is confirmed with cardiac magnetic resonance imaging (MRI) and right heart hemodynamics and the patient underwent pericardiectomy without complications with resolution of symptoms.

Effect of statin therapy on risk of ventricular arrhythmia among patients with coronary artery disease and an implantable cardioverter-defibrillator.

Hydroxymethylglutaryl coenzyme-A reductase inhibitors, or statins, have been shown to decrease mortality rates in patients who have coronary artery disease. It has been postulated that part of the mortality benefit conferred by statins is due to a decrease in ventricular arrhythmias. We assessed the effect of statin therapy on recurrent ventricular arrhythmias in 281 patients who developed coronary artery disease after implantable cardioverter-defibrillator placement.

Relation of an exaggerated rise in white blood cells after coronary bypass or cardiac valve surgery to development of atrial fibrillation postoperatively.

This study investigated the correlation between an elevated white blood cell (WBC) count as a marker of inflammation and the development of atrial fibrillation (AF) after cardiac surgery. WBC counts were prospectively followed in 181 consecutive patients who underwent coronary bypass or cardiac valve surgery to determine if a baseline or postoperative WBC count elevation is an independent predictor of postoperative AF.