New TAVR Study Shows Alternative Approaches Offer Comparable Outcomes

October 2013

According to a study in the October 2013 issue of The Annals of Thoracic Surgery, patients with aortic stenosis who are ineligible for surgical valve replacement as well as the traditional approach to transcatheter aortic valve replacement (TAVR) may have comparable outcomes when the surgeon uses an alternative access TAVR approach.

"Our experience demonstrated that cardiac surgeons and cardiologists must utilize a multitude of access options in TAVR to achieve minimal morbidity and mortality with excellent outcomes," says Dr. Vinod Thourani, an Emory University cardiothoracic surgeon-scientist and lead author of the study. Dr. Thourani also co-directs the Structural Heart and Valve Center at Emory University with Emory interventional cardiologist Dr. Vasilis Babaliaros.

TAVR using the transfemoral approach (via the groin) was recently approved in the United States for inoperable or high-risk patients with aortic stenosis, the most common acquired valvular disease in adults. Aortic stenosis is characterized by a narrowing of the opening to the aortic valve. Surgical aortic valve replacement is the treatment of choice; however, 25% of patients may be ineligible for surgery for reasons such as frailty or additional disease.

Transfemoral TAVR was approved for these high-risk or inoperable patients, but some patients have too much disease in the femoral artery to permit using the method.

To properly evaluate the outcomes from other TAVR approaches, Dr. Thourani and his Emory colleagues conducted an Emory-based retrospective review of 44 inoperable patients who underwent alternative access TAVR from November 2011 to April 2012. Alternative access approaches included transapical (TA; via the heart muscle), transaortic (Tao; via the aorta), and transcarotid (TCa; via the right common carotid artery) TAVR.

Of the 44 patients reviewed, 18 were eligible for TF, while 11 underwent TA, 12 underwent TAo, and three underwent TCa procedures.

Thirty days after the TAVR procedures, the researchers found no difference among the groups in mortality and no incidents of myocardial infarction or stroke. Study participants implanted using a non-TF approach, however, experienced longer average lengths of hospital stays.

"What we have learned from this study," said Dr. Thourani, "is that the TAVR physician, be they a cardiologist or cardiac surgeon, should feel comfortable utilizing a variety of TAVR techniques. This will allow the most appropriate tailoring of the TAVR procedure for optimal patient outcomes."

The FDA recently announced its approval of alternative access approaches for TAVR using the Edwards Sapien Transcatheter Heart Valve, making the procedure available to an expanded group of patients who have inoperable aortic valve stenosis. The new device labeling removes references to specific access points, now making it available for inoperable patients who require one of these alternative access points.

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