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  • Title: Case series of bail-out procedures with a balloon-expandable sheath after unsuccessful introduction of the NovaFlex device.
    Author: Fusari M, Bona V, Biglioli P.
    Journal: Innovations (Phila); 2012; 7(1):45-51. PubMed ID: 22576035.
    Abstract:
    OBJECTIVE: Vascular complications remain the main problem of transcatheter aortic valve replacement, despite downsizing of delivery catheter diameter and judicious patient selection. In case of diffusely calcified and/or very tortuous access vessels, the SoloPath Balloon Expandable TransFemoral Introducer (Onset Medical Corporation, Irvine, CA USA), providing the smallest insertion profile of any sheath in its class, may enable exceptional trackability and offer the largest working diameter, thus helping to prevent feared vascular complications. We report the successful use of SoloPath sheath to face six cases of NovaFlex (Edwards Lifesciences Inc, Irvine, CA USA) sheath failed insertion due to vessel tortuosity and calcifications. METHODS: In six patients enrolled for transfemoral transcatheter Edwards SAPIEN XT replacement, resistance to NovaFlex sheath pushing was encountered, subsequent to the bending of the distal portion of the sheath due to vessel tortuosity and calcifications. Damaged Edwards sheaths were exchanged for a SoloPath sheath with a 21-French inner diameter. SoloPath Controlled Deployment Technology design provides the introducer, once expanded, with great radial and pillar resistance. RESULTS: The unexpanded SoloPath sheath-dilator combination tracked without resistance or kinking over a stiff guide wire through the iliofemoral axis and then was expanded. All transcatheter prostheses were successfully deployed within the native annulus, showing good hemodynamic function. CONCLUSIONS: We report six successful bail-out procedures with the SoloPath Balloon Expandable TransFemoral sheath after unsuccessful introduction of the NovaFlex device. If similar results are confirmed, use of the SoloPath during transcatheter aortic valve replacement may help prevent vascular complications and eliminate the need for other preoperative steps (eg, vascular stenting), therefore reducing procedural mortality, surgical expense, and patient recovery time.
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