BAV Balloon Rupture David Zhao MD FSCAI FACC

BAV Balloon Rupture David Zhao, MD, FSCAI, FACC Professor of Medicine and Surgery Henry S. Miller Professor in Cardiovascular Medicine Chief, Cardiovascular Medicine Executive Director, Health System Heart and Vascular Center/Service Line Wake Forest Baptist Health Winston Salem, NC, USA

David Zhao, MD I have no relevant financial relationship pertinent to this presentation

Balloon Aortic Valvuloplasty (BAV) • BAV as a stand-alone therapy (ineffective in the long term): FIM Sept 1985 • BAV as a bridge to definitive treatments • BAV pre-TAVR implantation (decrease in application) • BAV post-TAVR dilatation – Vi. V: Surgical bio-prosthesis fracturing

Tyshak® and Tyshak II® (B. Braun) § Therapeutic BAV, Pre-dilatation. § Semi-compliant, low profile, thin wall, and flexible § A higher rate of balloon rupture § Rated burst pressure 1. 5 -5, 1. 5 -6 § 9 F

Z-MED™ & Z-MED II™ (B. Braun) § Therapeutic BAV, Pre- & Post-TAVR dilatation § Faster inflation and deflations times. § Non-compliant and high-pressure balloons: rated burst pressure 1 -10, 3 -15 § 12 -14 F

Nu. Cleus and Tyshak Nu. Cleus (B. Braun) • Therapeutic BAV and pre-dilatation. • Self-locking waist that reduces the need for rapid pacing • Semi-compliant. Rated Burst pressure 2 -4

V 8™ Aortic Valvuloplasty Balloon (Palex Medical) • • • Therapeutic BAV, Pre and Post dilatation Self-Centering onto the annulus Hour glass shape preserved throughout inflation Differential compliance Rapid inflation and deflation 10 -12 F

TRUE® Balloon and Vida Balloon (BD Interventional) • Post-dilatation • Vi. V surgical bio-prosthesis fracturing • Non-compliant & high pressure balloon • 12 -14 F

Balloon Selection • BAV as a stand-alone therapy (Tyshak®, Z-MED™, Nu. Cleus, V 8™, Edwards BAV Balloon) • BAV as a bridge to definitive treatments (as above) • BAV pre-TAVR implantation (as above) • BAV post-TAVR dilatation (Z-MED™, V 8™, Edwards TAVR Balloon, True Balloon, Vida Balloon) • Vi. V: Surgical bio-prosthesis fracturing (True Balloon, Vida Balloon)

Balloon Size Selection • BAV as a stand-alone therapy – 80 -100% annulus (Echo or CT) – Annulus by TTE (1 -4 mm <TEE or CT) • BAV as a bridge to definitive treatments (as above) • BAV pre-TAVR implantation (as above) • BAV post-TAVR dilatation – Severely calcified annulus: minimal diameter if Z-Med, -1 mm if True balloon – Moderately or less calcified annulus: median diameter if Z-Med, -1 mm if True balloon

Balloon Rupture: Risk Factors • Incidence: 2. 7 -4. 5% • Thin wall and low profile balloon • High inflation pressure (select the right type of balloon) • Severe aortic valve and sub-valvular calcification • Complication: annulus rupture, vascular injury, balloon entrapment and separation

Sheath Entrapment in Umbrellaed Distal Balloon Fragment Circumferential bursting creating snag

Circumferential Rupture and Sheath Entrapment JACC Int 2016 ; 9: e 79 -81

Circumferential Rupture and Separation JACC Int 2016 ; 9: e 79 -81

Balloon Separation and Detachment JACC Int 2017, 10: 1593 -5

Sheath Entrapment in Umbrellaed Distal Balloon Fragment: Snare Device Assisted Removal Move sheath back or advance balloon catheter Capture balloon from distal to proximal direction

Summary • Balloon rupture rarely occurs with a relatively low complication rate • Appropriate balloon selection may reduce the occurrence • Balloon entrapment may happen and could cause serious vascular injury • Skills in using various endovascular tools/maneuvers are essential to minimize complication