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Media, News & Topics on prevention, diagnosis & treatment of cardiovascular disease
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Scooped by Seth Bilazarian, MD
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Transcatheter Aortic Valve Replacement: What's in a Name?

Transcatheter Aortic Valve Replacement: What's in a Name? | Heart and Vascular Health | Scoop.it

Keeping up with doctor speak can be a full time job (even for doctors).  I blogged about this previously entitled: STEMI, ADHF, MVO, VTE, CSL: The moving target of acronyms in cardiology

http://blogs.theheart.org/private-practice/2010/9/9/stemi-adhf-mvo-vte-csl-the-moving-target-of-acronyms-in-cardiology

The treatment of severely narrowed aortic valves with a catheter rather than surgery had been called Transcather Aortic Vave Implantation (TAVI) since the old valve is not repalced - the new valve is placed or implanted inside the old one.  The cardiology journal JACC decided to rename this TAVR for replacement instead of implant even though there is no replacement.  If you missed this arbitrary switch it's OK since they have decided to switch back.  Sometimes being behind the news curve is more efficient. For now,  we can say TAVR was the old term before we switched back to the older term TAVI.  What's old is new again.

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FDA panel backs Edwards' Sapien heart valve for lower-risk patients

FDA panel backs Edwards' Sapien heart valve for lower-risk patients | Heart and Vascular Health | Scoop.it

Take Home Message: Aortic stenosis occurs when the aging aortic valve thickens and narrows.  The only treatment for this has been surgery with valve replacement through an open chest.  Edwards' Sapien heart valve is a catheter approach that allows placement of a replacement valve through the groin artery without surgery, vcalled TAVR or TAVI.  The FDA has previously allowed the use of this device for patients who could not have surgery for valve replacment becuase their risk was too high.  This action, if confirmed, by FDA would allow use of this catheter approach for patients who are high risk, but could have surgery.  The study confirmed that catheter and surgery are equivalent on efficacy and safety.

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FDA Approvals Are a Matter of Life and Death

FDA Approvals Are a Matter of Life and Death | Heart and Vascular Health | Scoop.it

Take Home Message:  FDA's charge to evaluate device safety can be accomplished without the slowness of the approval process. I have patient's frankly dying as they wait for this device which has taken 5 years longer to approve here than in Europe, Canada & Australia. Pendulum needs to swing back.

 

In November, FDA approved the Sapien Transcatheter Heart Valve, for treatment of severe aortic valve stenosis. The Sapien valve can be implanted from the groin artery without surgery. It's a boon for patients who are too sick to endure open-heart surgery. Clinical trials found that almost 70% of patients receiving Sapien valves were alive one year after treatment, while only 50% of those without replacement survived that long.

This would be a great story for Americans, but for one frustrating detail: The Sapien valve has been available in Europe since 2007, saving lives there but not here. Today, Americans wait as much as 60% longer than they did in 2005 for new lifesaving and life-enhancing medical devices—such as stents & defibrillators—to reach the market, according to a GAO report.

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