Key result
Measurement of vessel depth using the Angio-Seal device showed a high correlation (r=0.99) with the vendor-specific tool, providing an accurate option for bail-out MANTA insertion after TAVI.
Why the study?
The MANTA device requires exact vessel depth measurement when used as a bail-out closure option after TAVI, but measurement techniques required validation against the vendor-specific tool.
Does perioperative measurement with an Angio-Seal device improve the accuracy of vessel depth estimation compared to preoperative MDCT for potential plug-based vascular closure device insertion in patients undergoing TAVI?
Observational (n=168)
Does perioperative measurement with an Angio-Seal device improve the accuracy of vessel depth estimation compared to preoperative MDCT for potential plug-based vascular closure device insertion in patients undergoing TAVI?
Perioperative measurement of femoral artery depth using an Angio-Seal device is highly accurate and superior to MDCT for guiding bail-out plug-based vascular closure after TAVI.
Introduction and objectives: Vascular complications remain a potential problem after transcatheter aortic valve implantation (TAVI). Although suture-based vascular closure devices are most often used for vascular closure purposes, alternative plug-based vascular closure devices like the MANTA (Essential Medical Inc., United States) stand as a bail-out option for patients with failed suture-based closure devices. Since knowing the exact vessel depth is essential to use this device correctly before inserting the large introducer, we aimed to validate 2 different measurement techniques including preoperative multidetector computer tomography (MDCT) plus an alternative technique with the Angio-Seal device (Terumo Medical Corporation, United States) compared to a vendor specific measuring tool. Methods: In patients eligible for TAVI, the depth of the femoral artery was measured preoperatively using MDCT, and then perioperatively with the Angio-Seal device. Both measurements were associated with the actual depth after puncture using the vendor-specific tool of the MANTA device. Results: In a total of 168 patients treated with transfemoral TAVI, the depth of the vessel was measured both pre and perioperatively. The measurements obtained from the preoperative MDCT revealed the existence of a moderate correlation compared to the preoperative measurements obtained (r = 0.64; P < .001). Measurements obtained with the Angio-Seal device revealed a high correlation with the measuring tool included (r = 0.99; P < .001). Overall, 10 patients required the bail-out option with the MANTA device due to failed suture-based vascular closure devices. Conclusions: In case of a failed suture-based vascular closure device after TAVI, the plug-based MANTA device can be used as a bail-out strategy. However, the measurement of the vessel depth obtained from preoperative MDCTs is not accurate enough for safe MANTA insertions. Measurements with the Angio-Seal device before inserting the large TAVI sheath stand as a simple solution to obtain exact measurements facilitating the use of the bail-out MANTA in case of failed suture-based closure vascular devices after TAVI.
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Blumenstein et al. (2021) conducted an observational in Severe aortic stenosis (n=168). Vessel depth measurement using Angio-Seal device vs. Vessel depth measurement using preoperative MDCT was evaluated on Correlation of vessel depth measurement with vendor-specific MANTA measuring tool (p=<0.001). Measurement of vessel depth using the Angio-Seal device showed a high correlation (r=0.99) with the vendor-specific tool, providing an accurate option for bail-out MANTA insertion after TAVI.
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