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.

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TAVR insights

Is it possible to score two home runs with a single hit? The Society of Thoracic Surgeons achieved that this week during their annual meeting in Orlando, Fla.

Inhospital mortality leaps after TAVR commercialization

Outcomes for patients undergoing traditional surgical and less invasive treatments for aortic stenosis have improved over time, but a recent uptick in the inhospital mortality rate with transcatheter aortic valve replacement (TAVR) may raise concerns. 

Edwards receives European approval for advanced Sapien 3 valve

Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received CE Mark in Europe and is initiating the launch of its most advanced transcatheter aortic valve, the Edwards SAPIEN 3 valve.

Amgen announces positive top-line results from phase 3 GAUSS-2 Trial of Evolocumab (AMG 145) in statin intolerant patients with high cholesterol

Amgen (NASDAQ:AMGN) today announced that the Phase 3 GAUSS-2 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2) trial evaluating evolocumab in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. The mean percent reductions in LDL-C, or "bad" cholesterol, compared to ezetimibe were consistent with results observed in the Phase 2 GAUSS study.

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.

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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.

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Package flaws prompt Merck to recall Liptruzet

Less than a year after it received FDA approval for its combo cholesterol drug, Merck reported it was recalling tablets due to packaging defects.

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Doc dissent offers opportunity for patients

Yale University School of Medicine’s Harlan Krumholz, MD, explains in an NPR blog post how patients can use physician disagreement over a change in guideline recommendations concerning blood pressure targets to receive care that suits their wishes. 

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