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Cardio Notes: Device Works in Refractory Angina

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Preliminary results from a randomized trial of a device for refractory angina were positive, and renal denervation will be studied in U.S. patients with moderate uncontrolled hypertension.

Device Shows Benefit for Refractory Angina

The percutaneous Reducer device met its primary endpoint in the of patients with refractory angina, according to top-line results released by Neovasc, the company that makes the device.

The Reducer, which is already available on the European market, works by "altering blood flow in the heart's venous system, thereby increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle," the company said.

In the current trial, which included 104 patients enrolled in centers in Europe and Canada, the device versus a sham control significantly improved functional capabilities and symptoms -- defined as a two-class improvement in scores on the Canadian Cardiovascular Society angina grading scale 6 months after implantation -- in patients with severe disabilities stemming from angina that had not responded to previous treatment.

The treatment was safe and well tolerated, as indicated by a lack of device-related serious adverse events, Neovasc reported. The full results of the trial have been submitted as a late-breaking clinical trial presentation at the upcoming American College of Cardiology meeting in March.

Renal Denervation in Moderate, Stubborn HTN

Renal denervation with Medtronic's Symplicity renal denervation system will be evaluated for the treatment of moderate uncontrolled hypertension in the randomized , which recently enrolled its first patient. Unlike the previous SYMPLICITY trials, this one will enroll patients with a systolic blood pressure of 140 to less than 160 mm Hg, despite use of at least three antihypertensives from different classes.

Success will be based on bringing blood pressure below 140 mm Hg or meeting a prespecified reduction in 24-hour ambulatory blood pressure.

SYMPLICITY HTN-4, which has a planned enrollment of 580 patients, is the second randomized trial of the Symplicity system. The previous SYMPLICITY HTN-3 trial -- the pivotal trial for the technology -- evaluated renal denervation in patients with uncontrolled hypertension and a starting systolic blood pressure of at least 160 mm Hg.

Residency Program Tied to Higher Thrombolytic Use

Thrombolytic therapy was more likely to be used for acute ischemic stroke in hospitals that housed a neurology residency program, a retrospective study published in showed.

Yogesh Moradiya, MD, of Johns Hopkins University, and colleagues matched data from hospitals with an Accreditation Council for Graduate Medical Education-accredited neurology residency program with those from other hospitals in the Nationwide Inpatient Sample for 2000 to 2010. The analysis included 712,433 adults with acute ischemic stroke.

The rate of thrombolysis was higher in hospitals with a neurology residency program (3.74%) compared with other teaching hospitals (2.28%) and nonteaching hospitals (1.44%), and the gaps widened among older patients.

"Efforts to increase utilization among elderly in other teaching hospitals and nonteaching hospitals by interventions such as in-service educational programs for physicians treating acute ischemic stroke can potentially have a large impact on stroke system of care," wrote the authors, who called for further research to determine why the observed differences exist.

Inferior Vena Cava Filters May Help in Trauma

It appears that the use of inferior vena cava filters to prevent pulmonary embolism (PE) in patients with traumatic injuries has some benefit, a meta-analysis showed.

There is some debate about whether prophylactic use of the filters is helpful in the trauma setting, and , of Johns Hopkins Hospital, and colleagues performed a meta-analysis of eight controlled trials comparing use of a filter with no use of a filter to explore the question.

As they reported in , there were significant reductions in PE (RR 0.20, 95% CI 0.06-0.70) and fatal PE(RR 0.09, 95% CI 0.01-0.81) associated with filter placement, but there was no effect on rates of deep vein thrombosis or all-cause mortality. The number needed to treat to prevent one case of PE with filter placement ranged from 109 to 962 depending on the patients' risk of PE at baseline.

The researchers noted that the strength of the evidence was low, and said that "which patients experience benefit enough to outweigh the harms associated with inferior vena cava filter placement remains unclear."