Vascular Solutions Zerusa, a subsidiary of Vascular Solutions, is recalling the Guardian II and Guardian II NC hemostasis valves used in catheterization procedures. Specific lots of the products have been recalled because they pose a slightly increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death.

A study using registry data on more than 3.3 million PCI procedures found that patients with major bleeding had a significantly higher inhospital mortality rate compared with patients who did not experience bleeding.

SAN FRANCISCO—Off-pump surgery in high-risk patients is associated with a lower incidence of serious complications, and is a safer way of direct revascularization in these patients, according to the late-breaking PRAGUE-6 trial, presented March 11 at the American College of Cardiology (ACC) scientific session.

SAN FRANCISCO—In patients 75 years of age or older, there was no significant difference between on-pump and off-pump CABG in the composite outcome of death, stroke, MI, repeat revascularization or new renal-replacement therapy within 30 days and within one year after surgery, according to the late-breaking GOPCABE trial, presented March 11 at the American College of Cardiology (ACC) scientific session.

SAN FRANCISCO—On- and off-pump CABG remained neck-and-neck at the one-year mark in the CORONARY trial. One-year results released March 11 at the American College of Cardiology scientific session showed similar outcomes in patients treated with either approach, akin to findings at 30-days.

SAN FRANCISCO—The rates of major adverse cardiac events at 30 days and 12 months were similar among patients randomized to PCI at Massachusetts hospitals with and without cardiac surgery services. The research was presented March 11 at the American College of Cardiology (ACC) scientific session and published concurrently in the New England Journal of Medicine.

SAN FRANCISCO—The SELECT-ACS trial, which sought to determine the efficacy of inclacumab, suggests that the P-selectin antagonist inclacumab reduces myocardial damage after PCI in patients with NSTEMI. The trial was presented as a late-breaking clinical trial at the 62nd American College of Cardiology (ACC) scientific session.

SAN FRANCISCO—Cangrelor significantly reduced the rate of ischemic events, including stent thrombosis, during PCI, with no significant increase in severe bleeding, based on the late-breaking CHAMPION PHOENIX trial, presented March 10 at the American College of Cardiology (ACC) scientific session. However, some still question its role in clinical practice, if approved by the FDA.