February 11, 2019
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Top stories in cardiology: FDA raises concern with right heart pump system, anti-inflammatory psoriasis agents may help prevent heart disease

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Among the top stories in cardiology last week were the FDA’s alert to health care providers regarding increased mortality in patients with a temporary right heart pump system and a study that found anti-inflammatory biologic therapy for treatment of severe psoriasis reduced coronary artery plaque and may aid in preventing coronary heart disease.

Other highlights included data from the ANNEXA-4 trial that suggested Andexanet alfa reversed the anticoagulation effects in most patients with acute major bleeding caused by a factor Xa inhibitor, Biosense Webster’s announcement that the first patient has been enrolled and treated in an investigational device exemption study of a novel catheter for ablation of patients with atrial fibrillation and a study that found modifiable risk factors were common in patients who had their first myocardial infarction before age 60 years.

FDA alerts health care providers of mortality concern with right heart pump system

The FDA has issued a letter to health care providers regarding the increased rate of mortality in patients who have received a temporary right heart pump system in a recent interim postapproval study compared with what was previously observed in premarket clinical studies. Read more.

Anti-inflammatory psoriasis agents could prevent heart disease

Anti-inflammatory biologic therapy for treatment of severe psoriasis reduced coronary artery plaque, raising questions about whether such agents could have a role in prevention of coronary heart disease, researchers reported in Cardiovascular Research. Read more.

ANNEXA-4: Andexanet alfa successfully reverses factor Xa inhibitor effects

Andexanet alfa reversed the anticoagulation effects in most patients with acute major bleeding caused by a factor Xa inhibitor, according to the full data from the ANNEXA-4 study presented at the International Stroke Conference. Read more.

First patient treated in investigational device exemption trial of novel atrial fibrillation ablation catheter

Biosense Webster, a Johnson & Johnson company, announced that the first patient has been enrolled and treated in an investigational device exemption study of a novel catheter for ablation of patients with atrial fibrillation. Read more.

Modifiable risk factors prevalent in young patients with myocardial infarction

Among patients who had their first myocardial infarction before age 60 years, modifiable risk factors were common and increased in prevalence over time, researchers reported. Read more.