Balloon Aortic Valvuloplasty Studied in High-Risk or Inoperable Patients

November 22, 2010—Itsik Ben-Dor, MD, et al conducted a study that sought to determine the success, complication, and survival rates of patients after balloon aortic valvuloplasty (BAV). The findings were published in the Journal of the American College Cardiology: Cardiovascular Interventions (2010;3:1150–1156). The investigators concluded that long-term survival is poor after BAV alone; however, BAV as a bridge to percutaneous or surgical aortic valve replacement is feasible, safe, and associated with a better outcome than BAV alone.

In the study, a cohort of 262 patients with severe aortic stenosis underwent 301 BAV procedures. Of these, 39 patients (14.8%) had two BAV procedures. Clinical, hemodynamic, and follow-up mortality data were collected.

As detailed by the investigators, the cohort mean age was 81.7 ± 9.8 years, and the mean Society of Thoracic Surgeons and logistic EuroSCORE was 13.3 ± 6.7 and 45.6 ± 21.6, respectively. BAV was performed as a bridge to percutaneous or to surgical aortic valve replacement in 28 patients (10.6%) and for symptom relief in 234 patients (89.4%). The mean aortic valve area (AVA) increased from 0.58 ± 0.3 cm² to 0.96 ± 0.3 cm² (P < .001). Of these, 111 (45%) had a final AVA > 1 cm², and in 195 patients (79%), the AVA increased by > 40%. De novo BAV resulted in a higher mean increase in AVA in redo BAV (0.41 ± 0.24 cm² vs 0.28 ± 0.24 cm²; P = .003).

The investigators reported that serious adverse events occurred in 47 patients (15.6%), including five intraprocedural deaths (1.6%), six strokes (1.99%), two coronary occlusions (0.66%), four cases of severe aortic regurgitation (1.3%), five resuscitations/cardioversions (1.6%), one tamponade (0.33%), and three permanent pacemaker implantations (0.99%). A vascular complication occurred in 21 patients (6.9%), 34 patients (11.3%) had a postprocedure rise in creatinine > 50%, and three patients (0.99%) required hemodialysis.

During median follow-up at 181 days, the mortality rate was 50% (n = 131). The mortality rate in the group with a final AVA > 1 cm² was significantly lower than in the group with a final AVA of < 1 cm² (36.4% vs 57.9%; P < .001). Final AVA was associated with lower mortality (hazard ratio, 0.46; P = .03). BAV as a bridge to percutaneous or surgical aortic valve replacement had a better mortality outcome compared with BAV alone: seven deaths (25%) versus 124 deaths (52.9%), respectively (P < .0001).