Manual pressure

Whilst the rule that ‘the person making the femoral artery puncture should be the person to close it’ may not suit all units and operators, the basic tenet that an interventional cardiologist must be an expert in care of the puncture site is a sound one.

There is definitely a ‘learning curve’ to negotiate when training in femoral sheath removal and an experienced operator will engender far fewer bleeding complications than a novice, and secure the groin site in less time.

As a rule 10–20 minutes should be allotted to pressing on a groin. Patients should be well hydrated, have IV access that is functioning well and be comfortable. If the effects of local anaesthesia at the groin site has worn off the site should be re infiltrated. Some units advocate the pre-treatment of all patients with atropine, to avoid unwanted vagal reactions, in addition to intravenous sedation with a benzodiazepine or opiate sedatives. These latter measures may not be required if the patient is comfortable and pain free, however.

Digital pressure is applied at the site of arterial puncture (not the site of skin puncture). Supra-systolic pressure should be applied for one minute, and then released slightly until flow can be felt, but there is no leak from the puncture site. This pressure is maintained for five minutes and then pressure gently released over the next four minutes.

This procedure should lead to effective haemostasis in the majority of cases. If at any point there is bleeding from the site, or formation of a haematoma, the pressure can be increased and the cycle repeated.

Mechanical pressure devices

Manual pressure following the removal of a femoral sheath remains the ‘gold standard’, however, for many, practical concerns such as staff and resource utilisation mean that mechanical pressure devices have found a niche.

Thankfully sandbags on the groin and pressure bandage techniques to press on the femoral puncture site have largely been replaced by more sophisticated devices. The most commonly used of these is the FemoStop®.

This device has a transparent inflatable pressure element fitted to a rigid beam, which in turn is strapped to the patients lower torso. The inflatable element allows the degree of pressure to be varied, and visualisation of the compression and puncture sites (Fig. 11.1).

Figure 11.1 A FemoStop device being deployed.

There are conflicting reports as to whether this device reduces complications when compared to manual compression,^4,5 and some evidence that there may be some increased discomfort when compared to the use of a vascular closure device.⁶ It is, therefore, important to ensure adequate patient preparation prior to siting a FemoStop (adequate hydration, analgesia and possibly sedation).

The FemoStop major role is, therefore, in reducing manual pressure times, freeing staff for other duties. This is particularly important in patients being treated with aggressive anti-platelet and anticoagulant regimens whereby manual pressing time would be prohibitively long.

Arterial closure devices

Arterial closure devices have been developed as an alternative to manual pressure or external pressure devices in an attempt to reduce haemostasis times, enhance early mobilisation and reduce discomfort for the patient and staff. Early hopes that direct arterial closure would reduce complications and, therefore, lead to safer treatment of the groin site have been largely unsubstantiated, however.^7,8

The heterogenous nature of the ileo-femoral arterial system and the possibility of occult peripheral vascular disease mandate the use of femoral angiography, simply performed through the femoral sheath, prior to using a closure device. Manual pressure should be used as the closure technique if the puncture is in a heavily diseased artery, in a small vessel or involved in a bifurcation. Obviously closure devices are themselves associated with novel complications, principally failure to prevent haemostasis with subsequent haematoma formation, or peripheral vessel occlusion with distal limb ischaemia.

The three most commonly used devices are the Angioseal, the Vasoseal (both collagen plug devices) and the Perclose suturing device.

One recent meta-analysis of closure device use has suggested that there is no specific advantage or increased risk in using arterial closure devices vs. manual compression in diagnostic cases, but when applied to interventional cases the same was true for Angioseal and Perclose devices, but not Vasoseal. This latter device appeared to have a disadvantage when compared to mechanical compression in the PCI group.⁸ A further meta-analysis failed to show conclusively that arterial closure devices are superior to manual compression both in terms of safety and effectiveness.

Angioseal

The Angioseal device seals the femoral puncture site by sandwiching the arteriotomy between an intra luminal absorbable polymer ‘anchor’ and a collagen sponge on the external surface of the artery. The two are joined by a self tightening suture. The residual components are absorbed at between 60 and 90 days.

The femoral sheath is replaced over a guidewire with a specific introducer sheath (Fig. 11.2a). Therafter the anchor/collagen introducer is passed into the sheath (Fig. 11.2b) and deployed (Fig. 11.2c) leaving the ‘foot’ adjacent to the endoluminal surface and the collagen pressed on the external surface of the artery.

Figure 11.2 A, The femoral sheath is replaced over a guidewire with a specific introducer sheath. B, Thereafter the anchor/collagen introducer is passed into the sheath. C, Deployed leaving the ‘foot’ adjacent to the endoluminal surface and the collagen pressed on the external surface of the artery.

Perclose

The Perclose device is a semi-automated suture device. This device does not require a thrombin or collagen plug and thereby leaves no foreign material in the lumen. The device is advanced into the femoral artery and the correct depth is signalled by a flush back of blood. Following this a suture ‘foot’ is deployed into the artery and the sutures advanced and tightened. The excess suture material is then trimmed off with a specific device (Fig. 11.3).

Figure 11.3 The Perclose device showing deployment of the needles and suture.

Vasoseal

This system relies on a collagen plug that is positioned against the external aspect of the arteriotomy. The collagen plug then expands in the sheath tract, effecting haemostasis.

This system does not require an intra-arterial component.

Briefly, a specific arterial locator is passed through the intra-arterial sheath and the sheath removed. A J segment within the artery allows accurate positioning of first a dilator sheath and then the collagen deployment catheter which is used to place the collagen plug on the external surface of the artery (Fig. 11.4).

Figure 11.4 The Vasoseal device ready to be deployed. The inset shows that the plug is accurately located over the arterial puncture

All three of these devices have found a niche in contemporary interventional practice, however, there are a number of other devices available or in development at the present time.