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Electrophysiology & Arrhythmia

 - yield sign

The FDA issued a safety alert on July 13, warning of deaths and severe adverse events associated with the use of SentreHEART's Lariat suture delivery device for left atrial appendage (LAA) exclusion and preventing strokes in patients with atrial fibrillation.

 - electrophysiology, ICD, pacemaker

A retrospective analysis found 7 percent of patients with cardiovascular implantable electronic devices (CIEDs) had a malfunction attributed to radiotherapy. All of the cases occurred during neuron-producing radiotherapy, prompting lead researcher Jonathan D. Grant, MD, to recommend the use of non-neutron-producing radiotherapy when clinically feasible.

 - Medicare_Provider

Fewer than 10 percent of older adults received an implantable cardioverter-defibrillator (ICD) following an MI, according to an analysis of Medicare beneficiaries who had low ejection fraction. Although the patients were at an increased risk of sudden cardiac death, only 8.1 percent were implanted with the device within a year of their MI event.

 - Senior going to surgery

Here’s a bridge you may consider burning: anticoagulation bridging therapy for patients with atrial fibrillation who undergo an elective operation. A randomized clinical trial found no bridging after discontinuing warfarin led to no more thromboembolic events than bridging, with a lower risk of bleeding.

 - SICD

A prospective analysis found 4.3 percent of sudden cardiac deaths in San Francisco were in patients with pacemakers or implantable cardioverter-defibrillators (ICDs). Half of the deaths were related to the devices, and the most common cause of death was ventricular tachycardia or ventricular fibrillation.

 

More Stories

HRS.15: No adverse outcomes in patients with ICD system undergoing MRIs

BOSTON—Patients with the Iforia ProMRI implantable cardiac device (ICD) system had no adverse outcomes related to the device and no significant changes to pacing or sensing parameters after undergoing a thoracic spine or cardiac MRI, according to a multicenter, nonrandomized trial.

HRS.15: WiCS-LV device is clinically effective but has some safety issues

BOSTON—Patients with heart failure who failed standard, optimal cardiac resynchronization therapy (CRT) approaches had significant improvements in clinical outcomes after receiving a novel device that provided endocardial left ventricular stimulation.

HRS.15: Electrical failure occurs in 5.9% of Canadian patients using Riata lead

BOSTON—After a mean follow-up of 7.5 years, electrical failure occurred in 5.9 percent of patients using the Riata lead, according to a prospective, observational study of the Riata leads under advisory in Canada. In addition, 7.4 percent of patients had electrical failure or cable externalization.

HRS.15: Safety and efficacy of VGLB procedure similar to RF ablation

BOSTON—Preliminary results of a randomized trial found the HeartLight visually-guided laser balloon (VGLB) system was as safe and effective as irrigated radiofrequency ablation in patients with paroxysmal atrial fibrillation.

HRS.15: Early Micra TPS analysis shows 100 percent success in implantation

BOSTON—All 140 patients analyzed and enrolled in a single-arm, multicenter trial had successful implants with the Micra Transcatheter Pacing System (TPS), a miniaturized leadless pacemaker that is not yet approved in the U.S. The mean implant time was 37 minutes.

HRS.15: Uninterrupted rivaroxaban rivals warfarin with ablations

Patients with atrial fibrillation who received an uninterrupted novel oral anticoagulant during catheter ablation fared on par with those treated with an uninterrupted vitamin K antagonist. In either case, bleeding rates in the clinical trial were low.

The disconnect in remote monitoring

The evidence favors remote monitoring using implantable cardiac devices yet few take advantage of the resource.

HRS.15: Cryoballoon technique as effective as radiofrequency ablation

BOSTON—A single-center randomized trial found that pulmonary vein isolation with the cryoballoon ablation technique was as effective as open irrigated radiofrequency in patients with paroxysmal atrial fibrillation.

HRS.15: Remote monitoring leads to cost savings, fewer hospitalizations

BOSTON—Patients who had remote monitoring in their implantable electronic cardiac devices had lower all-cause hospitalization costs and recurrent hospitalizations compared with patients without remote monitoring capabilities, according to a large, retrospective, cohort study.

FDA approves shorter, third-gen cryoballoon

The FDA approved Medtronic’s latest generation cryoablation catheter for treating patients with paroxysmal atrial fibrillation. The Arctic Front Advance ST also received CE mark in Europe for a broader indication.

FDA clears Greatbatch’s sutureless pacing lead

The FDA gave Greatbatch Medical the green light to market a sutureless myocardial pacing lead for ventricular pacing and sensing.

Pulmonary-vein isolation alone suffices for persistent AF

More is not better when it comes to catheter ablation to treat persistent atrial fibrillation. A randomized controlled clinical trial found additional ablation did not improve outcomes, a result that may prompt a revision in guidelines.

Off-label use of Lariat device associated with death, urgent cardiac surgery

A systematic review of databases found that off-label use of the Lariat snare device for left atrial appendage exclusion was associated with adverse events, including death and urgent cardiac surgery.

S-ICDs prove safe and effective at 2 years

After two years, fewer than 7 percent of patients who were implanted with a subcutaneous implantable cardioverter-defibrillator (S-ICD) had spontaneous ventricular tachyarrhythmia or ventricular fibrillation events, according to a pooled analysis of two trials.

25% of low-risk patients receive oral anticoagulants unnecessarily

One quarter of patients with atrial fibrillation who were at a low risk for stroke were prescribed oral anticoagulants, contrary to guidelines. The results appeared online April 13 in JAMA Internal Medicine.

Sports-associated sudden cardiac arrest rare in middle-age people

Sports-associated sudden cardiac arrests (SCAs) were rare among a group of middle-age people in the northwestern U.S., according to a prospective, population-based study. Of the SCAs that occurred between February 2002 and January 2013, 5 percent were sports-associated.

Heart monitoring service settles overbilling case for $6.4M

A company that provides outpatient cardiac monitoring agreed to pay $6.4 million to settle a case of what one federal official called “abusive billing practices.”

Hep C therapy may interact with amiodarone

The FDA is warning cardiologists that patients can develop life-threatening symptomatic bradycardia when the hepatitis C drugs ledipasvir/sofosbuvir or sofosbuvir combined with another direct-acting antiviral are taken together with amiodarone.

Janssen ventures into antithrombin antibody-based drugs

Janssen Pharmaceuticals acquired a university spinout company that develops an antithrombin antibody, adding another potential therapy to its portfolio.

FDA OKs pacemaker that allows for MRI scans

The FDA approved a pacemaker system that allows patients with single-chamber pacemakers to undergo full-body cardiac or thoracic MRI scans.