Structural Heart Disease

Structural heart diseases include any issues preventing normal cardiovascular function due to damage or alteration to the anatomical components of the heart. This is caused by aging, advanced atherosclerosis, calcification, tissue degeneration, congenital heart defects and heart failure. The most commonly treated areas are the heart valves, in particular the mitral and aortic valves. These can be replaced through open heart surgery or using cath lab-based transcatheter valves or repairs to eliminate regurgitation due to faulty valve leaflets. This includes transcatheter aortic valve replacement (TAVR). Other common procedures include left atrial appendage (LAA) occlusion and closing congenital holes in the heart, such as PFO and ASD. A growing area includes transcatheter mitral repair or replacement and transcatheter tricuspid valve repair and replacement.

FDA places dose limits on anemia drugs

The FDA has modified recommendations for erythropoiesis-stimulating agents (ESAs) after the agency found clinical evidence that the drug class could increase cardiovascular event risk in chronic kidney disease patients. The FDA has recommended that more conservative doses of the drug be administered.

Diamyd stops U.S. Phase III diabetes drug trial

Following consultation with the FDA, Diamyd Medical has decided to suspend dosing in a U.S. Phase III study, DiaPrevent, with the antigen-based therapy Diamyd and to initiate closure of the study.

JAMA: Is statin use linked to diabetes, regardless of dose?

While statin therapy is meant to reduce a patients risk of cardiovascular events, a meta-analysis has found that the drug class was associated with an excess risk on new-onset diabetes. The meta-analysis was published in the June 21 issue of the Journal of the American Medical Association.

Boehringer inks $64M diabetes, obesity drug deal

Zealand Pharma, a Copenhagen-based biopharmaceutical company, and Boehringer Ingelheim have signed an exclusive global license and collaboration agreement for dual-acting glucagon and GLP-1 receptor agonists for the treatment of patients with type 2 diabetes and patients with obesity.

FDA alters Actos label, while France and Germany pull it off shelves

Research originating from France has shown an increased incidence of bladder cancer when diabetic patients were administered pioglitazone (Actos, Takeda Pharmaceuticals). As a direct response to these results, the French Medicines Agency (Afssaps) said it would pull the drug from the market, and now Germany has followed suit. The FDA also warned the public about the increased risk and has decided to revise the medication's label.

Study: Newer LVAD may trigger more complications; what can be done?

Data presented at this years American Society of Artificial Internal Organs (ASAIO) symposium have shown that the HeartMate II continuous-flow left ventricular assist device (LVAD) increased both the incidence of gastrointestinal bleeds and stroke in patients implanted with the device. However, previous data comparing HeartMate II to the pulsatile-flow device HeartMate XVE may contradict these findings.

Baxter pays $625K in first heparin contamination suit

Patients affected by Baxter Healthcare's tainted heparin caught a win after a Cook County judge awarded $625,000 to the estate of 63-year-old Chicagoan Steven Johansen, who died due to adverse events linked with the contamination. The case was the first of hundreds of lawsuits alleging that Baxter distributed contaminated heparin drug vials.

One step back for Amylin in case against Lilly

The U.S. District Court for the Southern District of California ruled in Eli Lilly's favor, vacating a temporary restraining order and denying a request by Amylin Pharmaceuticals for a preliminary injunction that sought to impose restrictions on the Lilly Diabetes sales force and other relief.

Around the web

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.