Electrophysiology & Arrhythmia

Major electrophysiology and cardiology societies released an expert consensus statement on Nov. 19 on optimal implantable cardioverter-defibrillator (ICD) programming and testing.

On Nov. 17, the FDA approved the MyCareLink Smart Monitor, the first app-based remote monitoring system in the U.S. for patients with implantable pacemakers.

Despite an FDA safety alert in July, physicians are still using the Lariat suture delivery device, STAT reports. SentreHeart CEO Russell Seiber, who founded the company in 2005, defended the Lariat device in an interview.

Six months after implantation with an investigational leadless intracardiac transcatheter pacing system from Medtronic, 96 percent of patients did not have system-related or procedure-related major complications, according to a prespecified interim analysis of a prospective, multicenter study.

Wireless pacemakers today are rising in popularity as the right choice for many patients.

The FDA approved the Evera MRI Surescan implantable cardioverter defibrillator (ICD) as the first ICD system for use with MRI scans. The system is expected to be available this month.

After six months of nonsurgical implantation with an active-fixation leadless cardiac pacemaker, 90 percent of patients had an acceptable pacing threshold and sensing amplitude, according to a prespecified analysis of an ongoing study. In addition, 6.7 percent of patients had device-related serious adverse events.

The American College of Cardiology (ACC) announced it plans on launching two clinical registry programs to track outcomes in patients with atrial fibrillation. The registries will be part of the National Cardiovascular Data Registry, which currently includes eight cardiovascular data registries.

Johnson & Johnson will give outside researchers access to clinical data on diagnostics and medical devices through Yale University, but the largesse applies only to products approved in 2014 or later. That makes the ThermoCool SmartTouch catheter available for scrutiny, the New York Times reports. 

Meet retired electrophysiologist David Mann, MD, not to be confused with all the other doctors with the same name. Except unfortunately for him, he was, and in the one of the thorniest places imaginable—the Centers for Medicare & Medicaid Services’ Open Payments System. 

Researchers at Cedars-Sinai Heart Institute in Los Angeles tested a “biological pacemaker” in pig hearts using gene therapy. The approach is at least three years away from human trials, the New York Times reports.

Bloomberg News reported that Boehringer Ingelheim provided the FDA with one analysis showing a lower rate of fatal bleeding events in patients treated with dabigatran (Pradaxa) than was found in a second analysis that the company chose not to share.