Dry Field Closure of Large-Bore Access With Iliac Artery Angioplasty Through the Ipsilateral Sheath: The Single-Access Dry-Closure Technique

The use of large-bore sheaths has risen exponentially in the last decade partly due to the growth of structural heart interventions and various mechanical circulatory support options. Meanwhile, the interventional community has gradually shifted from an open surgical to endovascular closure. However, vascular access complications and bleeding still remain a significant risk. Various techniques involving an additional access site have been described to allow for endovascular bailout of potential complications. However, these by themselves create an additional burden to procedural morbidity. Furthermore, the weight of additional procedural time, contrast, radiation and the need for advanced peripheral endovascular skills constitute considerable downsides to the “second arterial access” strategy. For that reason, we propose an alternative strategy, the “single-access dry-closure” technique, which provides vascular access control without the additional burden and risk of a second arterial access. This involves the use of low-pressure iliac artery occlusive angioplasty, delivered through the ipsilateral sheath during the endovascular closure. We hereby describe the steps, advantages and disadvantages of this novel technique. We also include the description of multiple technical variations depending on the use of one or two preclosed Proglide devices. This novel approach seems to be a safe, effective, simple, fast and economical technique that has the potential to decrease procedural morbidity by avoiding an additional arterial access. It also lowers contrast volume and radiation exposure while improving the overall set-up and operator ergonomics.

J INVASIVE CARDIOL 2021;33(7):E516-E521.

Key words: bleeding, ipsilateral external iliac artery, large-bore sheath

The use of large-bore sheaths has risen exponentially in the last decade partly due to the growth of structural heart interventions and various mechanical circulatory support options. Genuine efforts of the interventional community led to a gradual shift from open surgical closure through cut down to a complete endovascular closure. However, vascular access complications and bleeding still remain a significant risk for procedure-related morbidity and mortality.^1,2

Even though some of these procedures are performed without a second arterial access, various techniques involving an additional access site have been described to maintain control during non-surgical access closure. The goal of these techniques is to minimize bleeding and maintain vascular access for endovascular bailout of potential complications. Depending on patient anatomy and personal experience, the operator may choose one of these techniques:

Contralateral retrograde common femoral artery (CFA) access with up-and-over sheath in place into the ipsilateral external iliac artery.³

Radial access with radial to peripheral (R2P) sheath placed into the ipsilateral external iliac artery.⁴

Ipsilateral retrograde superficial femoral artery (SFA) access.

Ipsilateral retrograde tibio-pedal access.

Each of these approaches has advantages and disadvantages and could potentially add additional risk of vascular complications to a high-risk procedure/patient population.⁵ This has become more relevant with the advent of the Single access technique for high-risk percutaneous coronary intervention (SHiP)⁶ whose advantage is the lack of need for a second arterial access site for the intervention. Moreover, the burden of additional procedural time, contrast, radiation and the need for advanced peripheral endovascular skills constitute considerable downsides to the “second arterial access” strategy.

For that reason, we propose an alternative strategy, the “single access dry closure” technique, which provides vascular access control without the additional burden and risk of a second arterial access. If the SHiP technique consolidates two arterial access sites into one, to perform a high risk percutaneous coronary intervention (PCI) with Impella support, the "single access dry closure” technique consolidates 2 access sites into one for the purpose of dry field closure while allowing for bailout endovascular options for bleeding and other vascular complications.

There are 2 versions of the “single-access dry-close” technique depending on the operator’s preference to deploy one or two preclosed Proglide devices prior to the insertion of a large-bore sheath. Either technique goes through the same steps, but what differentiates them is that, at every step, the maneuvers are simultaneously duplicated with the second Proglide device sutures.

One preclosed Proglide device.

Step 1. After the completion of the procedure and the removal of the equipment from the large-bore sheath, the side port is connected to a pressure transducer (Figure 1).

Step 2. Advance a peripheral balloon (0.035˝ compatible 40 mm long, preferably with a short shaft, with a diameter sized one to one to the external iliac artery), over a stiff 0.035˝ or stiff 0.018˝ wire. The balloon is then inflated to 2-4 atmospheres until the pressure waveform is completely lost at the sheath side port (Figure 2). If the pressure is not almost flat at this inflation pressure, a larger balloon may be necessary. An appropriately sized balloon inflated to low  pressure is essential to avoid iatrogenic iliac artery injury.

Step 3. The non-locking suture of the Proglide device is pulled, and the knot is gently advanced down to around the large-bore sheath without tightening or locking to avoid sheath/balloon entrapment (Figure 3).

Step 4. While the iliac balloon is inflated, the sheath is pulled back slowly over the balloon/wire combination by the assistant. Simultaneously, the Proglide non-locking suture is being pulled up by the operator (Figure 4; Videos 1 and 2).

Step 5. The Proglide suture knot is gently pushed down, without tightening it, on the balloon shaft to avoid entrapment. The field should be dry without manual pressure, while the iliac balloon is inflated (Figure 5).

At this point, the operator has a decision to make: complete the closure without an angiogram, or proceed with an angiogram first (Figure 6).

Pathway A: No angiogram (Figure 7).

Step 6. While the Proglide non-locking suture is pulled up the balloon is deflated completely and pulled out gently with the wire left in place (Figure 8; Video 3). It is essential to avoid pulling against resistance in order to prevent further widening of the arteriotomy site.

Step 7. If only mild oozing is noted without pulsatile bleeding, the wire is pulled out, the suture knot is pushed down tightly to the arteriotomy, then locked in place to finalize closure.

Step 8. If moderate oozing or pulsatile bleeding is noted after step 6, manual pressure or a second closure device will be necessary. Options for a second closure device include 6 Fr Angio-Seal (Figure 9), 8 Fr Angio-Seal (Figure 10), 6 Fr Mynx (Figure 11) or another Proglide,⁷ depending on operator experience and common femoral artery anatomy, with the goal of achieving adequate hemostasis.

Pathway B: Angiogram before closure

Step 6. While the Proglide non-locking suture is pulled up, an angiogram can be performed in 3 different ways here: (1) through the iliac balloon lumen after the 0.035˝ wire is pulled out; (2) through a Tuohy valve connected to the 0.035˝ iliac balloon lumen over an 0.018 wire maintained in the aortic position; (3) through a 4-6 Fr short sheath exchanged for the balloon over the wire which is maintained in the aortic position.

Step 7. If there is no significant extravasation, the wire is pulled out, the Proglide suture knot is tightened down and locked in position, then a short manual hold is performed to reach adequate hemostasis.

Step 8. If significant extravasation is encountered after step 6 in this pathway, then a second closure device is recommended as noted in Step 8 of Pathway A.

Two preclosed Proglide devices. As described above, the same steps are applied simultaneously with the sutures of the two Proglide devices (Figure 12). Obviously, the likelihood of residual bleeding requiring a third closure device is significantly lower with this approach, though still possible, and can be managed using the algorithm in Figure 7.

To our knowledge, this is the first reported description of the single access dry closure technique through ipsilateral iliac artery occlusion. We believe that this technique adds significant value to the current standard of care where either no dry-closure is used, or strategies involve a second arterial access.

This technique is safe, simple and effective requiring less time, contrast and radiation, with the potential for less bleeding. The set-up is easy for the catheterization lab staff and better ergonomically for the operator. There is no need for an additional assistant to hold manual pressure while the closure devices are deployed.

This requires less advanced endovascular skills and there is no additional limb hypoperfusion risk from a contralateral or second ipsilateral access. Moreover, it avoids the need to adopt dedicated large-bore closure devices which are currently not cost effective. It is cost effective with the peripheral angioplasty balloon being the only additional equipment needed.

Residual bleeding can be easily managed with additional “small bore” closure devices familiar to most operators. Some vascular complications, such as external iliac artery dissection and thrombosis, can be managed through the ipsilateral access. Finally, there is no additional morbidity and no equipment costs associated with the second arterial access. This technique can be especially advantageous in patients with limited secondary access options.

This approach does have potential downsides. Iatrogenic iliac artery injury from the occlusive angioplasty balloon can occur if the balloon is oversized, or if PTA is performed at higher pressures. There is a possible risk of balloon entrapment if the Proglide knots are pushed down too aggressively over the balloon shaft. The arteriotomy could be enlarged if the balloon is not fully deflated prior to balloon removal. There is an inability to occlude ipsilateral iliac flow or perform balloon tamponade of the arteriotomy if the final closure results in substantial bleeding. Finally, certain vascular complications such as Proglide-induced stenosis at the arteriotomy, access site thrombosis, common femoral artery dissection/pseudo-aneurysm/AV fistula, or distal embolization cannot be managed with this approach.

Importantly, operators should be cautioned against extrapolating this technique to other access sites without special considerations. There are inherent anatomical, technical and physiological differences between large-bore access sites. Bailout options are site specific and require careful planning.

This novel technique describing controlled large-bore single access closure with iliac artery occlusive angioplasty through the ipsilateral sheath is a simple, safe, effective and economical technique that has the potential to decrease procedural morbidity by avoiding an additional arterial access. This has the potential to shorten procedure time and lower contrast/radiation exposure while improving overall set up and ergonomics. Further studies and experience may help elucidate patient and anatomical substrates where this technique can be employed.