Abstract
Aim: To evaluate the outcome of balloon aortic valvuloplasty (BAV) in high-risk patients and severely symptomatic patients with calcified aortic stenosis. Method: Our group of patients included 34 individuals with a mean age of 80.8 +- 6.0 years who, because of their ineligibility for surgical aortic valve replacement (AVR) had 35 BAV procedures for progressive symptomatology in NYHA Classes III and IV.
A total of eight procedures were performed using two-balloon catheters, and 27 procedures using single balloon catheters, with subsequent division of patients into corresponding subgroups (2B and 1B). While, in one case, the procedure was complemented with catheter-based atrial septal defect occlusion, in two cases, BAV made it possible to undertake surgical valve replacement at a later time.
The parameters we evaluated included the technical success rates of the procedure, their major complications, selected pre- and post-procedural echocardiographic and invasively measured hemodynamic parameters, both separately for subgroups 2B and 1B, and overall for the whole group. Other monitored parameters included in-hospital mortality, seven-month survival rates (median, range 4-12 months), and the need for an additional procedure on the aortic valve.
Results: The technical success rates were 75%, 92.6%, and 88.6% for subgroups 2B and 1B, and the whole group, respectively. Immediately after the procedure, peak gradient (PG) measured invasively on the index orifice decreased from an average 63.9 +- 23.2 to 30.8 +- 19.7 mmHg (p < 0.05).
Subsequent echocardiography showed a decrease in maximum PG from an average 85.1 +- 32.7 to 54.8 +- 17.7 mmHg (p < 0.05), mean gradient from 53.9 +- 21.2 to 32.8 +- 10.8 mmHg (p < 0.05) with the aortic orifice area increasing from 0.52 +- 0.16 to 0.74 +- 0.23 cm2 (p < 0.05) and left ventricular ejection fraction rising non-significantly from 0.45 +- 0.16 to 0.48 +- 0.16 (p = NS). Overall in-hospital mortality was 25.7%, being higher in subgroup 2B (50%) as against 1B (18.5%).
There was only one procedure-related death (fatal femoral artery bleeding) being also the only complication (2.9%). Survival per se and survival without the need for an additional catheter-based or surgical procedure on the index aorta during follow-up were 68.6% and 60%, respectively, being lower in subgroup 2B (25% and 12.5%) compared with subgroup 1B (81.5% and 74.1%), respectively.
Conclusion: Our results suggest that BAV is an acceptable therapeutic option in most patients with severe and symptomatic aortic stenosis not indicated for surgical treatment or catheter-based bioprosthesis implantation. A critical consideration in terms of outcome is proper selection of patients.