We analyzed the results and the follow-up in our first 80 patients after percutaneous balloon aortic valvuloplasty (BAV) since November 1986. Mean age was 74 +/- 10 years, 78 patients were in the NYHA functional classes III or IV. Initially we used relatively small balloons (15-18 mm), later balloons of 20 mm and, with increasing frequency, of 23 mm diameter were utilized, providing very strong inflations at the end of the procedure. The average valve area after BAV increased from initially 0.75 +/- 0.18 to 0.87 +/- 0.28 cm2 after July 1987. Using the 23-mm balloon a mean valve area of 1.05 +/- 0.19 cm2 was obtained. The procedure-related mortality was 2.5%, the total early mortality (30 days) was 6.25%. Other non-fatal complications included two cases of severe valve incompetence requiring valve replacement, one dissection in the aortic root, one cerebrovascular accident, and eight cases of arterial damage (surgical repair). Twenty-six patients with initially successful dilation were restudied hemodynamically, 12 of whom had a restenosis (46%) after 5 months; 13 patients had a second dilatation. The clinical improvement was remarkable (at least 1 NYHA functional class) in 79% of the patients. 33% were improved 1 year and 20% 18 months after the first or eventually the second BAV. Eighteen of the discharged patients died in the follow-up period (two after valve replacement); 20 patients had aortic valve replacement due to restenosis. Our results show a correlation of the maximal balloon size to the valve area after BAV. However, even a perfect technique cannot prevent the restenosis that occurs mostly during the first year. Therefore, BAV may be useful and appropriate for selected patients with inoperable aortic stenosis, but it is no alternative to valve replacement.