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Observational Study
. 2024 Mar 18;20(6):e354-e362.
doi: 10.4244/EIJ-D-23-00725.

A systematic algorithm for large-bore arterial access closure after TAVI: the TAVI-MultiCLOSE study

Liesbeth Rosseel  1   2 , Nicholas J Montarello  1 , Philippe Nuyens  1 , Gabriella Tirado-Conte  1 , Angelo Quagliana  1 , Kristoff Cornelis  3 , Vincent Floré  3 , Michael Rosseel  2 , Gintautas Bieliauskas  1 , Lars Sondergaard  4 , Ole De Backer  1
Affiliations
Observational Study

A systematic algorithm for large-bore arterial access closure after TAVI: the TAVI-MultiCLOSE study

Liesbeth Rosseel et al. EuroIntervention. .

Abstract

Background: Despite transcatheter aortic valve implantation (TAVI) having become a routine procedure, access site bleeding and vascular complications are still a concern which contribute to procedure-related morbidity and mortality.

Aims: The TAVI-MultiCLOSE study aimed to assess the safety and efficacy of a new vascular closure algorithm for percutaneous large-bore arterial access closure following transfemoral (TF)-TAVI.

Methods: All consecutive TF-TAVI cases in which the MultiCLOSE vascular closure algorithm was used were prospectively included in a multicentre, observational study. This stepwise algorithm entails the reinsertion of a 6-8 Fr sheath (primary access) following the initial preclosure with one or two suture-based vascular closure devices (VCDs). This provides the operator with the opportunity to perform a quick and easy angiographic control and tailor the final vascular closure with either an additional suture- or plug-based VCD, or neither of these.

Results: Among 630 patients who underwent TF-TAVI utilising the MultiCLOSE algorithm, complete arterial haemostasis was achieved in 616 patients (98%). VCD failure occurred in 14 patients (2%), treated with either balloon inflation (N=1), covered stent (N=12) or surgical repair (N=1). Overall, this vascular closure approach resulted in a minor and major vascular complication rate of 2.2% and 0.6%, respectively. At 30 days, only one new minor vascular complication (0.2%) was noted. In-hospital and 30-day all-cause mortality rates were 0.2% and 1.0%, respectively.

Conclusions: Use of the MultiCLOSE vascular closure algorithm was demonstrated to contribute to an easy, safe, efficacious and durable vascular closure after TF-TAVI, resulting in a major vascular complication rate of less than 1%.

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Conflict of interest statement

G. Bieliauskas, L. Sondergaard, and O. De Backer received institutional research grants and consulting fees from Abbott. G. Tirado-Conte holds a research-training contract with ‘Rio Hortega’ (CM21/00091) from the Spanish Ministry of Science and Innovation (Instituto de Salud Carlos III). The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. MultiCLOSE algorithm for vascular access closure.
Novel and central to this vascular closure algorithm is the insertion of a 6 Fr or 8 Fr sheath following initial closure with one or two suture-based ProGlide/ProStyle(s). This provides the opportunity to perform a quick and easy angiographic control without the need to crossover from the contralateral femoral side or advance a catheter via the radial access, thereby saving time, contrast dye and radiation. A detailed description of this vascular closure algorithm can be read in the Methods section. TAVI: transcatheter aortic valve implantation
Figure 2
Figure 2. Use of the MANTA vascular closure device in the MultiCLOSE algorithm.
Technique A: This methodology should be used in case the skin-to-artery distance is unknown. Step 1: review the fluoroscopically stored image of the needle puncture site in relation to the femur head at the start of the TAVI procedure. Step 2: insert the MANTA sheath over the stiff guidewire and partially retract the dilator to permit fluoroscopic visualisation of the distal edge of the MANTA sheath. Position the distal edge of the MANTA sheath 2 cm cranial to the puncture site. Note the MANTA deployment depth in centimetres at the skin level. Fully reinsert the dilator and advance the MANTA sheath. Step 3: remove the dilator, introduce the collagen plug, retract the MANTA device to the deployment depth determined in Step 2, expose the anchor by rotating the deployment lever, and deploy the MANTA device as usual. Technique B: This methodology can be used when the operator is almost certain of using an Angio-Seal device for final vascular closure. Using the letters on the Angio-Seal sheath, the operator can measure the skin-to-artery distance. The MANTA deployment depth is between +1.5 and +2.0 cm in comparison to the measured skin-to-artery distance. TAVI: transcatheter aortic valve implantation
Figure 3
Figure 3. TAVI primary access site vascular closure management in the TAVI-MultiCLOSE study.
The vascular closure strategies and outcomes in the TAVI-MultiCLOSE study, including 630 TAVI patients treated by a percutaneous transfemoral approach and resulting in a major primary access site-related vascular complication rate of 0.6%. TAVI: transcatheter aortic valve implantation; VCD: vascular closure device
Central illustration
Central illustration. MultiCLOSE algorithm for closure of large-bore transfemoral access in TAVI.
The findings in the TAVI-MultiCLOSE study demonstrate the safety and efficacy of a new and easy-to-implement algorithm for the percutaneous closure of large-bore arterial access after TAVI, offering the TAVI operator a multitude of safety nets, resulting in a low vascular complication rate. TAVI: transcatheter aortic valve implantation; VCD: vascular closure device
See this image and copyright information in PMC

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