Heart Failure Beat: HVAD Sales Halted, PCOS and CVD Risk Linked in Women, and More

Medtronic Heeds FDA Warning, Stops Sales of HVAD System

Following receipt of more than 100 complaints, 14 of which were patient deaths and 13 involving necessary explantation, Medtronic has halted sales of its HeartWare Ventricular Assist Device (HVAD), reports Practical Cardiology™. The device was initially approved by the FDA in November 2012.

Medtronic has also issued an urgent call to clinicians to stop new implants and provided an Urgent Medical Device Communication Notification Letter to both clinicians and patients, which contains guidance on next steps.

The sale stoppage follows 2 previous moves Medtronic took, in December 2020 and March 2021, in which it recalled pump implant kits due to risk of potential patient harm. The recalled kits were shown to fail to start or restart or be delayed in restarting after stoppage.

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PCOS Associated With Greater CVD Risk in Women

A 26% greater chance of adverse cardiovascular disease (CVD)–related outcomes was seen among women with polycystic ovary syndrome (PCOS) following a matched analysis with those without PCOS, Practical Cardiology™ reports.

The study, published in Journal of Clinical Endocrinology and Metabolism, had a primary end point of time to major adverse cardiovascular event (MACE; heart attack, stroke, angina, revascularization, and CV mortality). Elevated risks were also seen among women with PCOS for heart attack (HR, 1.38; 95 CI, 1.11-1.72), angina (HR, 1.60; 95% CI, 1.32-1.94), and revascularization (HR, 1.50; 95% CI, 1.08-2.07).

In addition, history of type 2 diabetes (HR, 2.40; 95% CI, 1.76-3.30) and social deprivation (HR, 1.53; 95% CI, 1.11-2.11) were shown to significantly increase the risk of progressing to a MACE, suggesting these as potential targets to modify risk.

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New Study Investigates QI Strategies in CVD

In a review that encompassed studies from 45 countries and 150,148 patients, an investigation to measure the impact of quality improvement (QI) strategies in CVD showed that most efforts evaluated outcomes among patients with heart failure (37.9%), followed by stoke (27.6%), post heart attack (14.0%), and stable coronary artery disease (10.1%), according to HCPLive®.

Patient support, information communication technology, community support, supervision, and high-intensity training were the QI strategies most often evaluated for their impact on patients. With the review results showing variations in effectiveness and implementation success, the authors of the study are calling for “a comprehensive map of CV QI strategies for future identification of improvements in CV outcomes.”

Future investigations need to gauge outcomes in the longer term to better understand how QI strategies affect CV health, they concluded.

You can read the full article here.