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Structural Heart

 - Gavel

A federal court called for a preliminary injunction limiting the sale of the CoreValve device in the U.S. but granted a reprieve before the injunction is scheduled to go into effect.

 - sick child

Pediatric interventional cardiologists may proceed with more confidence with bridge treatments for patients with congenital heart disease, based on a late-breaking clinical trial presented March 30 at the American College of Cardiology (ACC) scientific session in Washington, D.C. The post-approval analysis of a transcatheter valve gave it high marks in real-world practice.

 - plaque

Darapladib did not significantly reduce the risk of cardiovascular death, MI or stroke associated with coronary heart disease, according to study results presented March 30 at the American College of Cardiology (ACC) scientific session in Washington, D.C.

 - choice, path, equal

Using a balloon-expandable valve instead of a self-expandable valve may be a better option among patients undergoing transcatheter aortic valve replacement (TAVR), based on research presented March 30 at the American College of Cardiology (ACC) annual scientific session in Washington, D.C. Researchers found more device success with the balloon-expandable device and similar rates of mortality and complications.

 - CoreValve

WASHINGTON, D.C.—The FDA skipped convening an expert panel after release of positive results for the CoreValve Extreme Risk cohort and later approved the device. Will it do the same for CoreValve as a treatment for patients who are considered at high surgical risk, based on findings presented March 29 at the American College of Cardiology scientific session in Washington, D.C.?


More Stories

Edwards wins latest TAVR patent tussle

Déjà vu? A federal jury determined that Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) device infringed on a patent owned by Edwards Lifesciences, a finding Medtronic indicated it would appeal. The jury awarded Edwards Lifesciences $394 million in damages.

FDA approves CoreValve for inoperable patients

The FDA gave CoreValve its blessing, approving the device in patients with severe aortic stenosis who are considered too high risk of death for standard open-heart surgery and instead undergo transcatheter aortic valve replacement.

In-hospital STEMI may carry worse outcomes

Patients who develop STEMI in the hospital may fare considerably worse than patients who experience one outside the hospital and arrive via ambulance or get driven, a study published online Jan. 3 in Circulation found. Treatment time and length of stay after an in-hospital STEMI are longer and mortality is higher, the authors found.

Timing of antibiotics may reduce cardiac surgery-related infections

Administering prophylactic antibiotics up to two hours before cardiac surgery may significantly decrease surgical site infection rates, according to a study published in the January issue of Infection Control and Hospital Epidemiology.

Physical inactivity linked to depression after cardiac surgery

Depression is fairly common after cardiac surgery, and a group of Canadian researchers identified several preoperative factors that may predict depression postoperatively, including a low left ventricular ejection fraction, physical inactivity and being either depressed or at-risk for depression prior to surgery.

Endocarditis burden remains high in elderly

Endocarditis continues to cause considerable morbidity and mortality among older Americans, according to a study published Dec. 10 in the Journal of the American College of Cardiology. Although guidelines called for a reduction in the use of antibiotic prophylaxis for endocarditis, the rates of hospitalization and mortality have not increased, but remain high.

Overview sets foundation for catheter-based mitral valve therapies

Four cardiovascular societies offered recommendations to help get use of transcatheter therapies for mitral regurgitation off on the right foot in an overview released Nov. 25.

U.S. TAVR outcomes match trial results

The transition of transcatheter aortic valve replacement (TAVR) from a procedure performed at an initial 17 clinical trial sites with highly trained physicians to almost 250 facilities in the U.S. appears to be going smoothly, the registry leaders reported in the Nov. 20 issue of JAMA.

Mortality rates higher in TAVR patients with severe mitral regurgitation

Mortality rates for patients with moderate to severe mitral regurgitation who underwent transcatheter aortic valve replacement (TAVR) were significantly higher than for patients with mild or no mitral regurgitation in an analysis of multicenter registry data.

FDA OKs MitraClip for inoperable patients

The FDA approved the MitraClip as a treatment for patients with mitral regurgitation who are considered too high risk for mitral valve surgery.

Beta-blocker may improve prognosis in patients with septic shock

The use of esmolol, a short-acting beta-blocker, was associated with a better prognosis in patients with septic shock when compared with standard treatment, a preliminary communication published Oct. 23/30 in JAMA reported.

FDA reports tissue erosion with Amplatzer device

The FDA is warning physicians that heart tissue surrounding the St. Jude Medical Amplatzer atrial septal occluder can erode. That can lead to life-threatening emergencies that require immediate surgery, according to the FDA.

Congenital heart defects may raise kids’ risk of endocarditis

Certain congenital heart defects may raise children’s risk of developing infective endocarditis (IE), Canadian researchers found in a study published Sept. 24 in Circulation. Children with cyanotic congenital heart disease lesions, left-sided lesions and endocardial cushion defects were at highest risk for IE.

Based on registry data, FDA revises Sapien label

The FDA broadened the pool of patients with inoperable aortic valve stenosis by approving revised labeling for the Sapien Transcatheter Heart Valve. The agency based its decision in part on data from the Transcatheter Valve Therapy Registry.

Certain risk factors may predict poor pediatric cardiomyopathy prognosis

The existence of certain risk factors at the time children are diagnosed with hypertrophic cardiomyopathy may signal a worse prognosis, according to a study published online Sept. 3 in The Lancet. Researchers found that diagnosis at younger than one year of age, inborn errors of metabolism, mixed types of hypertrophic cardiomyopathy, low body weight, congestive heart failure or abnormal structure or function of the left ventricle as indicated by echocardiography were associated with a higher risk of death or heart transplantation.

ESC.13: Colchicine may offer protection against recurrent pericarditis

Colchicine may not be just for gout anymore. In a study based out of Italy, researchers found that the drug, when used in conjunction with anti-inflammatory medications, reduced the rate of recurrent pericarditis in patients who suffered an initial acute episode. The drug, however, is not approved for this use in North American or Europe. The findings were presented Sept. 1 at the European Society of Cardiology Congress 2013 in Amsterdam and simultaneously published in The New England Journal of Medicine.

Treatment of hypertension critical in patients with aortic stenosis

For patients with low gradient severe aortic stenosis (AS) with preserved ejection fraction, treatment of hypertension with vasodilators, such as sodium nitroprusside, could help lower left ventricular (LV) afterload, leading to decreased LV filling pressures and pulmonary artery pressures.

MRI shows increase in aortic regurgitation after TAVI

Using cardiac MRI, researchers found that aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) did not decrease over time. Instead, the incidence and severity of paravalvular AR increased slightly at six-month follow-up.

No more wait & see: Mitral registry data give edge to early surgery

For cardiac surgeons, the wait may be over. Patients with flail mitral valve regurgitation who underwent early surgery had better long-term survival and lower risk of heart failure than counterparts who were medically managed, according to a study published Aug. 14 in JAMA. But watchful waiting still may be the best approach in some circumstances.

Gore wins patent tussle over Helex device

A judge ruled in favor of W. L. Gore & Associates in a patent dispute over a device used to treat structural heart defects.