Percutaneous balloon valvuloplasty for calcific aortic stenosis. A treatment 'sine cure'?

Twenty-five elderly patients with calcific aortic stenosis, 12 male (48%) and 13 female (52%), mean age 74.8 +/- 7.6 years, underwent percutaneous aortic balloon valvuloplasty between March 1986 and September 1987. Twenty-two patients (88%) were in class III-IV of the New York Heart Association, 13 (52%) had a history of previous angina and 7 (28%) of syncopal attacks. All patients had been considered either unsuitable or high-risk candidates for aortic-valve replacement because of age or associated diseases. Balloons of increasing size (area ranging from 1.3 to 3.8 cm2 during inflation) were successively passed retrogradely from the femoral artery and manually inflated to 3-7 atmospheres. Inflation duration ranged from 15 to 260 s (mean 40 s). Post-dilatation there were significant changes in left ventricular peak-systolic and end-diastolic pressures (P less than 0.00001 and P less than 0.01, respectively), mean systolic aortic transvalvular gradient (from 73 to 43 mmHg, P less than 0.000001), mean systolic aortic flow (from 176 to 208 ml s-1, P less than 0.0001) and aortic valve area (from 0.47 to 0.72 cm2, P less than 0.000001). Major complications included: in-hospital deaths of two patients (8%) admitted in cardiogenic shock; left haemiplegia (4%); transient haemianopia (8%); development of grade III aortic insufficiency (4%); and persistent complete atrioventricular block (4%). Complications at the puncture-site occurred in 7 patients (28%)--including two femoral pseudoaneurysms and the need for surgical removal of a balloon remnant after rupture in one patient. No local haemorrhagic complications were observed in the latter eight procedures, performed using a 16.5 French 100-cm long arterial introducer. At a mean follow-up of 13.0 +/- 5.0 months, an important functional improvement persisted in 14 patients (56%), no major changes in pre-valvuloplasty symptoms were observed in 3 patients (12%), while five patients (20%) required surgical treatment after a successful valvuloplasty because of recurrence of symptoms (late valve restenosis). Percutaneous aortic balloon valvuloplasty is a possible palliative therapy in elderly patients with calcific aortic stenosis. However, its inherent immediate risk, limited haemodynamic result and the possible development of valve restenosis at medium-term follow-up, suggest that the application of this technique should be limited to poor surgical candidates.