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 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%).

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.

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'.

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.