Complications and Outcome of Balloon Aortic Valvuloplasty in High-Risk or Inoperable Patients

Objectives This study aimed to determine the success, complications, and survival of patients after balloon aortic valvuloplasty (BAV). Background The introduction of transcatheter aortic valve implantation (TAVI) BAV has led to a revival in the treatment of patients with severe aortic stenosis. Methods A cohort of 262 patients with severe aortic stenosis underwent 301 BAV procedures. Of these, 39 (14.8%) patients had >= 2 BAV procedures. Clinical, hemodynamic, and follow-up mortality data were collected. Results The cohort mean age was 81.7 +/- 9.8 years, and the mean Society of Thoracic Surgeons and logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 13.3 +/- 6.7 and 45.6 +/- 21.6, respectively. BAV was performed as a bridge to TAVI or to surgical aortic valve replacement in 28 patients (10.6%) and for symptom relief in 234 (89.4%). The mean aortic valve area (AVA) increased from 0.58 +/- 0.3 cm(2) to 0.96 +/- 0.3 cm(2) (p < 0.001). Of these, 111 (45.0%) had final AVA >1 cm(2), and in 195 patients (79%), AVA increased by >40%. De novo BAV resulted in a higher mean increase in AVA 0.41 +/- 0.24 cm(2) versus 0.28 +/- 0.24 cm(2) in redo BAV (p = 0.003). Serious adverse events occurred in 47 patients (15.6%), intraprocedural death in 5 (1.6%), stroke in 6 (1.99%), coronary occlusion in 2 (0.66%), severe aortic regurgitation in 4 (1.3%), resuscitation/cardioversion in 5 (1.6%), tamponade in 1 (0.33%), and permanent pacemaker in 3 (0.99%). A vascular complication occurred in 21 patients (6.9%); 34(11.3%) had a post-procedure rise in creatinine >50%; and 3 (0.99%) required hemodialysis. During median follow-up of 181 days, the mortality rate was 50% (n = 131). The mortality rate in the group with final AVA >1 cm(2) was significantly lower than in the group with final AVA of <1 cm(2) (36.4% vs. 57.9%, p < 0.001). Final AVA was associated with lower mortality (hazard ratio: 0.46, p = 0.03). BAV as a bridge to TAVI or surgical aortic valve replacement had a better outcome compared with BAV alone: mortality rate 7 (25%) versus 124 (52.9%), respectively (p < 0.0001). Conclusions Long-term survival is poor after BAV alone. BAV as a bridge to percutaneous or surgical aortic valve replacement is feasible, safe, and associated with better outcome than BAV alone. (J Am Coll Cardiol Intv 2010;3:1150-6) (C) 2010 by the American College of Cardiology Foundation