The Efficacy and Safety of Antegrade Inoue-Balloon Aortic Valvuloplasty to Treat Calcific Critical Aortic Stenosis.

BACKGROUND

Critical aortic stenosis (AS) with severe calcific degeneration often resists conventional retrograde percutaneous balloon aortic valvuloplasty (PBAV). To enhance therapeutic efficacy, a novel PBAV technique has been developed by utilizing a single Inoue balloon via an antegrade approach, performing multiple inflations with step-up increases (M-PBAV) of balloon diameter to the size of the surgical valve ring.

PATIENTS AND METHODS

A total of 405 non-surgical patients with critical AS were treated by M-PBAV and the acute therapeutic response and long-term clinical course were evaluated; some patients underwent the procedure on two or three occasions.

RESULTS

In a total of 456 procedures, mean transaortic valve pressure gradient improved from an initial 63.6 ± 17.3 mm Hg to 22.7 ± 8.9 mm Hg post PBAV (P<.01). Mean aortic valve area increased from an initial 0.55 ± 0.15 cm² to 0.98 ± 0.20 cm² immediately after M-PBAV (P<.01). Clinical symptoms (New York Heart Association [NYHA] class) improved over time. Prior to M-PBAV, baseline NYHA class I-II was 9.1%, and NYHA class III-IV was 90.9%. At 12 months post M-PBAV, mortality was 17.1%, with repeat M-PBAV plus surgical AVR at 12.7%, 10.5% NYHA class III-IV, and 59.6% NYHA class I-II. At 24 months post M-PBAV, mortality was 25.8%, with repeat PBAV plus surgical AVR at 19.0%, 8.8% NYHA class III-IV, and 46.2% NYHA class I-II. Adverse events related to the procedure included critical AR (0.5%), cardiac tamponade (1.8%), intraprocedure hemodynamic compromise requiring percutaneous cardiopulmonary support (0.5%), and reversible cerebral ischemia (1.3%). No myocardial infarct or vascular complications occurred.

CONCLUSION

M-PBAV enhanced the therapeutic efficacy and procedural safety of valvuloplasty to treat severely calcified critical AS, and diversified its clinical roles.