Toggle Malapposition and Femoral Subocclusion as a Potential Complication of Manta Closure Device During TAVR

J INVASIVE CARDIOL 2019;31(10):E300.

Key words: Manta device, TAVR, vascular closure device

A 73-year-old woman with severe aortic stenosis was scheduled for transcatheter aortic valve replacement through the right femoral artery (Figure 1A). Fluoroscopic-guided femoral cannulation was achieved and a 26 mm Evolut Pro valve (Medtronic) was successfully implanted. Femoral closure was intended with the new collagen-based 14 Fr Manta device (Essential Medical). After apparent successful closure, control angiography showed mobile subocclusive intravascular material protruding from the anterior puncture site to the posterior calcified wall (Figures 1B and 1C; Video 1). Moreover, the stainless-steel suture lock appeared to be distant from the vascular wall. After sealing with a 7 mm balloon inflation, repeat angiography showed the resorbable polymer intra-arterial toggle embedded against flow and protruding into the lumen (Figures 1D and 1E; Video 2). A 40 x 8 mm vascular stent-graft was then deployed with optimal result (Figure 1F).

Hemostasis with the Manta closure device depends on optimal alignment between the vessel, collagen, and toggle, achieving complete apposition of the toggle within the vessel wall. Suboptimal apposition of the anchor, which measures 12-13 mm, may occur in calcified vessels or when skin-to-lumen distance is over-estimated, potentially leading to failed vascular closure. To the best of our knowledge, this is the first time this specific complication has been reported using the Manta device, highlighting the importance of accurate device positioning before deploying the collagen.

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From the Department of Cardiology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón. CIBERCV, Complutense University, Madrid, Spain.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein. 

The authors report that patient consent was provided for publication of the images used herein.

Manuscript accepted March 28, 2019.

Address for correspondence: Felipe Díez-Delhoyo, MD, Department of Cardiology, Hospital General Universitario Gregorio Marañón, Doctor Esquerdo, 46, 28007, Madrid, Spain. Email: felipediezdelhoyo@hotmail.com