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.
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.