According to CNN, Edwards Lifesciences’ “Sapien” Replacement Valve has been viewed as a market-expanding product because there are many patients with failing heart valves who are simply too frail to endure traditional heart surgery.

However, it may be tough to prove in certain circumstances that Edwards’ Sapien valve is a better treatment option as some doctors have raised some issues and concerns regarding studies for the device. This news sent Edwards’ publicly traded stock down 10% following potential buy-out rumors.

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The medical advances in heart valve disease research result in clinical highs and clinical lows. Unfortunately, this was one of the lows, as reported yesterday…

According to the Associated Press, Schering-Plough Corp. and Merck & Co.’s cholesterol drug Vytorin doesn’t lower the risk of major heart valve problems (specifically aortic valve stenosis) and the need for related surgical procedures, according to a large-scale study.

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It really is amazing to read and learn about all the new studies and research about heart surgery and heart valve disease.

You may have read my recent posts about minimally invasive aortic valve replacement, the use of statins to reduce complications post-operation, blood transfusion concerns or treating stenotic aortic valves with HDL-increasing drugs.

Well… Here’s another interesting study just released from the University of Michigan Health System.

According to Michigan researchers, nearly half of all heart surgery patients may experience blood sugar levels high enough to require temporary insulin treatment after their operation, even though they’ve never had diabetes. And a significant minority of those patients might need to take medicines for days or even weeks after they leave the hospital.

To read more about Michigan’s research, please click here.

Keep on tickin!

In the past, we have discussed the impact of pumphead on patients after cardiac bypass surgery. However, Science Daily is now reporting that Johns Hopkins researchers have other ideas about the cause of the cognitive deficiencies after heart surgery.

The report reads, “Heart patients often experience lasting problems with memory, language, and other cognitive skills after bypass surgery. However, these problems aren’t caused by the surgery itself or the pump used to replace heart function during surgery, a new study by Johns Hopkins researchers suggests. The findings may lead to better approaches to prevent cognitive decline regardless of which treatment heart disease patients receive.”

Click the link to read more about this unique study about cognitive function after heart surgery.

Keep on tickin!

Adam

The move to minimally invasive procedures for heart valve surgery took another step forward last week when Edwards Lifesciences announced that the first set of patients were treated in a United States feasibility study using the Edwards SAPIEN transcatheter heart valve.

The Edwards SAPIEN valve is used for addressing congenital conditions (e.g. aortic stenosis and pulmonary stenosis). The study will enable physicians to offer a minimally invasive alternative to symptomatic patients with a failing pulmonary valve.

The company said the study of thirty patients at three hospitals would enable the collection of safety and effectiveness data, ultimately in support of a commercial approval application. The U.S. Food and Drug Administration, or FDA, conditionally approved the investigational device exemption clinical trial in late 2007.

Edwards’ physician partners performed the first U.S. transcatheter pulmonic case on a compassionate basis in December 2005, all of which have been successful, the company noted.

The company added that Edwards SAPIEN transcatheter heart valve is also currently being studied in a pivotal trial for the treatment of patients with severe aortic heart valve stenosis, in which narrowing of the aortic valve restricts blood flow.

Keep on tickin!