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This article was originally published in The Gray Sheet

Executive Summary

TORAY'S INOUE BALLOON VALVULOPLASTY DEVICE SHOULD BE APPROVED for treatment of hemodynamically significant mitral valve stenosis from commissural fusion, provided that certain conditions are met, FDA's circulatory system devices panel unanimously concluded at its Aug. 3 meeting in Bethesda, Maryland. The panel members agreed with chairperson Jeffrey Brinker, MD, The Johns Hopkins Hospital, Baltimore, that "mitral balloon valvuloplasty" with the Inoue device "should be considered in patients with hemodynamically significant mitral valve stenosis resulting primarily from commissural fusion and in which echocardiography demonstrates probable amenability to this procedure." If approved by FDA, the Inoue would be the first percutaneous transvenous mitral commissurotomy (PTMC) balloon valvuloplasty device marketed for treatment of mitral valve stenosis. A premarket approval application for the device was submitted in September 1991 by Toray Industries (America) Inc., the American arm of the Japanese parent company. The three-layer latex and polyester mesh Inoue balloon, which utilizes a "slenderizing" metal tube, is inserted into the right side of the heart via a hole made in a femoral vein. The device then is passed through the septum into the left atrium and positioned across the mitral valve with the aid of a steering stilette. The Inoue balloon is 25 mm long and is available with maximum diameters of 26 mm, 28 mm or 30 mm. The catheter itself is 12 French, with a length of 70 cm, according to the firm. The balloon catheter system includes all accessories necessary to carry out the procedure. The panel based its approval recommendation on the results of a 770-patient nonrandomized trial; the PMA originally contained data on only 290 patients and was later supplemented by the firm. Overall, the device had a technical success rate of 97%, with success defined as completion of the procedure with balloon inflation across the mitral valve. Clinical success, defined as an increase in mitral area of 35% or greater, was seen in 76.6% of patients. The average gain in mitral area among all patients in whom the procedure was completed was 83%. Complications leading to an incomplete procedure, including inability to cross the mitral valve, hospital mitral valve replacement, or death, occurred in 5.7% of patients. The event- free survival rate at three years post-procedure -- defined as being free from repeat procedure, mitral valve replacement, and death -- was approximately 75%. The study defined restenosis at followup using three different criteria. When defined as return to pre-PTMC New York Heart Association functional class, valve restenosis was observed in 16% of patients at one year, 20% at two years and 29% at three years. When restenosis was defined as a valve area of less than 1.5 square centimeters (regardless of the effect of the initial procedure), it was seen in 40% of patients at one year. In the third scenario, when restenosis was defined as a mitral valve area representing less than 35% improvement over the pre-PTMC area, the one year rate was 34%. Among the conditions specified for approval was that transesophageal echocardiography be performed prior to PTMC to evaluate the presence of thrombosis. The panel also agreed with Brinker's recommendation that "in-house surgical backup to the degree offered by [percutaneous transluminal coronary angioplasty] is necessary." Brinker suggested that balloon inflation during the procedure "should be evaluated by pressure, and/or echo doppler, and/or angiography to determine whether increases in balloon diameter are necessary." The recommendation stemmed in part from concerns about mitral regurgitation, a potential side effect of the procedure. The role of anticoagulation therapy prior to treatment was also discussed by the panel. Commenting on the anticoagulation issue, Brinker said: "Certainly patients who are fibrillating probably should be anticoagulated up until the time they get the procedure." However, he stopped short of recommending anticoagulation for any broader patient group, adding: "I don't think we should necessitate any pre-procedural anticoagulation." The panel unanimously concluded that "the role of anticoagulation prior to valvuloplasty should be discussed in labeling."

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