15 Dec 2021
How to improve the effectiveness of hemostasis of large bore arteriotomy using a combined approach of suture- and plug-based closure devices
Vascular complications dramatically impact patients outcome after TAVI. This technique is a helpful illustration of how to combine suture and plug based closure devices in order to manage access site successfully.
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Summary
Vascular complications following transfemoral transcatheter aortic valve implantation (TF-TAVI) have been reducing over years thanks to the growing expertise of operators and the refinements of transcatheter systems. Currently, suture-based devices (SBDs) are the most used endovascular systems to obtain femoral access hemostasis after large-bore arteriotomy. Nevertheless, rates of major vascular complications and bleeding still represent an important issue, that impacts patients’ early recovery and mobilization, as well as mid-term prognosis. Recently, it has been demonstrated that the collagen-based AngioSeal (AS) system could be added on top of SBDs to achieve complete hemostasis in case of residual bleeding. In this view, an upfront combined strategy with SBD + AS for endovascular closing has the potential to minimize the risk of major vascular complication and major/life-threatening bleeding after TF-TAVI, compared to the use of SBDs alone.
The problem
The optimization of pre-procedural planning and the improvements of new generation TAVI delivery systems, as well as the consolidated experience of operators with endovascular SBDs contributed to lower the rate of vascular complications and bleeding after TAVI over the past decade. Nevertheless, a not negligible percentage of patients still experience vascular complications after TF-TAVI, which impacts on patients’ early recovery and mobilisation, and mid-term prognosis.
Principal idea
The use of a combined strategy for endovascular closure of large bore arteriotomies is based on the principle that a collagen plug has the potential to fix residual lacerations of artery walls after tightening pre-implanted suture knots. Although an AS may be added as bailout strategy in case of residual bleeding after ineffective closure with Prostar or Proglide SBDs, vascular complications with hidden bleeding could represent a life-threatening condition and require specific treatment. The upfront addition of an AS device on top of SBD could minimize the risk of vascular complications, reducing the need of adjuntive endovascular treatment.
Material needed
- SBDs: either a Prostar, one or two Proglide
- Collagen-based plug device: AngioSeal
- Guidewire: a 0.0035” standard or stiff guidewire
Method step-by-step
Preliminary step
Endovascular closing SBDs should be pre-implanted before the insertion of large diameter sheats/delivery systems.
Step 1
At the end of the procedure, systems must be pulled out leaving a guidewire in situ. The SBD’s knot (one of the two in case of Prostar or double Proglide) is gently pushed towards the common femoral artery, without tightening, in order to reduce actual bleeding.
Step 2
The AS device is advanced through the in-situ guidewire into the artery, and SBD’s knot (both knots in case of Prostar or double Proglide) is tightened over it.
Step 3
Afterwards, the AS device is implanted and SBD’s knot (both knots in case of Prostar or double Proglide) is finally re-tightened.
Watch these videos showing step-by-step techniques with the use of Prostar or single Proglide
Points of specific attention
Despite the simplicity of this technique, few steps require specific attention:
- Prefer a stiff guidewire for advancing SBDs and AS in case of deep common femoral artery or adherences in the subcutaneous tissue
- Avoid the accidental withdrawal of the guidewire after removal of sheats/delivery systems.
- Pre-tighten SBDs’ knots when the AS device is inserted into the common femoral artery. This will avoid the embolization of the collagen plug (that might happen when the arteriotomy is too large to ensure the anchoring of the device to the arterial wall) or the potential injury of the common femoral artery (that might happen when the device is inserted as bailout strategy after tightening of the SBD’s knots).
A word from the reviewer - Alexander Wolf
Vascular complications dramatically impact patients outcome after TAVI, so this technique is a helpful illustration of how to combine suture and plug-based closure devices in order to manage access site successfully.
Related reading
Read this related article in EuroIntervention on "An upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation"
Authors
2 comments
We use the same technique, but put a small piece of surgical tape over the "depth gauge hole" of the Angioseal. For some reason or other this hole on the 8fr Angioseal is a bit too large, and as seen on the video there is some bleeding. After the Proglide has been tightened, the tape is removed and the Angioseal placed. A bit less messy...
Great tip, Christian. Thanks for sharing your experience!