March 20, 2019 — Cook Medical is recalling one lot of its Transseptal Needle due to a manufacturing error that resulted in some needle tips missing the back bevel that creates a sharp tip. Without a back bevel, the needle tip could damage the inside of the introducer sheath during insertion of the needle, resulting in detached plastic fragments.

Prevencio Inc. announced data confirming the high accuracy of its artificial intelligence (AI)-driven, multiple-protein HART CVE Test for predicting cardiovascular events (CVE) and HART CAD Test for diagnosing coronary artery disease (CAD). Researchers believe these findings, presented at the 2019 American College of Cardiology (ACC) Scientific Sessions, March 16-18 in New Orleans, demonstrate the robustness and accuracy of these tests. The new data, from two additional hospitals, confirm results previously published from Massachusetts General Hospital and James Januzzi, M.D.

iSchemaView announced the company’s co-founder Gregory Albers, M.D., has received the Distinguished Clinical Research Achievement Award, presented by the Clinical Research Forum. The Distinguished Clinical Research Achievement Awards are presented to the top two studies that show creativity, innovation, or a novel approach that demonstrates an immediate impact on the health and well-being of patients.

The Bristol-Myers Squibb-Pfizer Alliance announced results from the Phase 4 AUGUSTUS trial evaluating Eliquis (apixaban) versus vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) and recent acute coronary syndrome (ACS) and/or undergoing percutaneous coronary intervention (PCI). Results show that in patients receiving a P2Y12 inhibitor with or without aspirin (antiplatelet therapies), the proportion of patients with major or clinically relevant non-major (CRNM) bleeding at six months was significantly lower for those treated with Eliquis compared to those treated with a VKA (10.5 percent vs. 14.7 percent, respectively; hazard ratio [HR]: 0.69, 95 percent confidence interval [CI]: 0.58-0.81; p-superiority<0.001).


The American College of Cardiology (ACC) released a list of the latest practice-changing presentations at the ACC.19 annual meeting March 16-18, 2019, in New Orleans. This includes five late-breaking clinical trial (LBCT) sessions and three featured clinical research sessions. There also are two LBCT deep-dive sessions where the experts will break down the hottest trials and attendees can find out what the impact might be on the practice of cardiology and patients.

Late-breaking results confirm the HeartFlow FFRct (fractional flow reserve computed tomography) Analysis enables efficient identification of which patients, despite symptoms suggestive of coronary artery disease (CAD), have a low risk of adverse cardiovascular events and can safely avoid invasive testing out to one year. These results from the ADVANCE trial were presented as a late-breaking trial during the American College of Cardiology’s (ACC) 68th Annual Scientific Session, March 16-18 in New Orleans, and simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Imaging.

DrChrono Inc. and 3D4Medical have teamed up so practices across the United States can access 3-D interactive modeling and animation videos from within their electronic health record (EHR) to better educate patients.

ACC/AHA Update Guidance for Preventing Heart Disease; Stroke

The choices we make every day can have a lasting effect on our heart and vascular health. Adopting a heart healthy eating plan, getting more exercise, avoiding tobacco and managing known risk factors are among the key recommendations in the 2019 Primary Prevention of Cardiovascular Disease guideline from the American College of Cardiology (ACC) and the American Heart Association (AHA). Also, it is recommended that aspirin should only rarely be used to help prevent heart attacks and stroke in people without known cardiovascular disease.
SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram.
SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram.
Greg Freiherr

As many as one in four patients who undergo cath lab interventions can benefit from a technology that identifies the location of stenoses not resolved by initially performed percutaneous coronary interventions (PCIs) to relieve restricted blood flow.

Researchers from the Stanford University School of Medicine presented preliminary results of the Apple Heart Study, a virtual study with over 400,000 enrolled participants, at the American College of Cardiology (ACC) 68th Annual Scientific Sessions, March 16-18 in New Orleans. The researchers reported that wearable technology can safely identify heart rate irregularities that subsequent testing confirmed to be atrial fibrillation, a leading cause of stroke and hospitalization in the United States.

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