FDA Panel Discusses Side Effects from TAVI Heart Procedure

FDA Panel Discusses Side Effects from TAVI Heart ProcedureA revolutionary alternative to open heart surgery may increase the risk of strokes in those who receive the procedure. Representatives from the U.S. Food and Drug Administration were in Maryland recently to discuss the complications associated with transcatheter aortic valve implantations (TAVI), reports Cardiovascular Business.

A clinical trial, called the Cohort B PARTNER trial, has uncovered the possibility of strokes in patients who have received the procedure. Of the 358 patients in the study, half were treated with TAVI while the others received traditional therapy.

Suspected strokes and transient ischemic attacks (TIA) did occur in clinical trials, according to The Heart, a website dedicated to cardiology news and research. Dr. Martin Leon, co-principal investigator for the Cohort B PARTNER trial, said that a 5 percent higher stroke rate was seen in TAVI patients during the first 30 days. Leon voiced his findings at the Transcatheter Cardiovascular Therapeutics Conference in 2010.

According to the Journal of Invasive Cardiology, the strokes could have been caused by a number of occurrences. An embolization from the valve could have happened during balloon valvuloplasty or valve deployment, the aortic atheroma could have embolized during the passage of the device, or hypotension could have played a role.

During the Cohort B PARTNER trial, the average age of patients enrolled was 83, and one-fifth of the patients were 90 or older, The Heart reports.

TAVI treatments have had a positive impact on many patients, according to University of Pennsylvania Medicine. Clinical trials held in 2010 at the Hospital of the University of Pennsylvania found that TAVI afforded the opportunity for doctors to correct heart issues in patients with severe aortic valve stenosis who were too old or sickly for open heart surgery. Approximately one-third of heart patients at Penn were not candidates for surgery.

Open heart surgery is the traditional procedure to treat this disorder, which is classified by a narrowing of the aortic valve that prevents it from opening fully. The extra work required to pump blood with this condition leads to fatigue, dizziness and serious heart issues if not treated.

Before TAVI entered the picture, the only way to deal with the condition in high-risk patients was through medical management, but the long-term prognosis was much more dismal without surgery. Patients who underwent a TAVI procedure had significantly lower rates of mortality in the clinical trial.