Ipsilateral Protection and Bailout for Large-Bore Access

This manuscript describes the refinements of ipsilateral wire protection and bailout strategy for large-bore femoral access and especially transcatheter aortic valve replacement. This ipsilateral wire protection requires no additional expenses and can provide effective arteriotomy site protection without the need for contralateral femoral access, especially in cases when contralateral wiring and crossover are not feasible. Ipsilateral wiring can be done both as prophylactic protection and as bailout strategy. The exact steps required for ipsilateral protection and bailout are described. A comparison between ipsilateral wiring with conventional contralateral femoral and transradial wire protection is delineated.

Key words: ipsilateral wire, transcatheter aortic valve replacement, transradial

Vascular complications of large-bore femoral access remain a frequent cause of morbidity, mortality, and excessive hospital stay and cost, particularly following transfemoral transcatheter aortic valve replacement (TAVR) procedures. The most common vascular injury is arteriotomy site complication, which typically occurs at the common femoral artery (CFA) arteriotomy site. The vessel injury can lead to excessive bleeding, limb ischemia, or both.

Some TAVR operators routinely perform protective wiring from the contralateral iliofemoral artery or the radial artery prior to the insertion of the TAVR iliofemoral large-bore sheath (to secure access to the iliofemoral system harboring a large sheath) for either placement of an occlusive iliac balloon (also called the crossover-balloon occlusion technique, or “dry seal”)¹ or for the use of rescue balloon angioplasty, stenting, or covered stent deployment.² Frerker et al³ described ipsilateral superficial femoral arterial (SFA) access (with a 4 Fr sheath) to allow ipsilateral protection of the CFA arteriotomy during TAVR.

We proposed a minimalist version of ipsilateral wire protection⁴ limited to an insertion of an ipsilateral 0.018˝ wire via a separate SFA puncture site after or prior to preclosure of the CFA with 2 Proglides (Abbott Vascular) and prior insertion of the TAVR sheath. We also suggested ipsilateral bailout as an alternative to contralateral bailout in case wiring of the iliofemoral system into the SFA was not done prophylactically. Since our original publication, we have refined the protocol for both prophylactic ipsilateral arteriotomy protection and bailout ipsilateral access.

Prophylactic ipsilateral protection (Figure 1 and Figure 2)

1. After preclosing the arteriotomy site with 2 Proglides and advancing a 6-8 Fr sheath into the TAVR arteriotomy site, the Proglide suture slack is minimized by gentle tug on the Proglide sutures.

2. Using a 21 gauge needle from a 5 Fr MAK-501 Micropuncture kit (Merit Medical) or similar micropuncture kit, we access the SFA at least 5 cm below the CFA arteriotomy site (to allow sufficient space for emergency sheath placement). An 0.018˝ wire of at least 40 cm length is advanced via the 21 gauge needle into the SFA, CFA, and iliac artery, and the wire distal tip is placed distal to the aortic bifurcation. Usually, we use a 40 cm wire from the MAK-501 kit or longer 0.018˝ wires such as V18 (Boston Scientific), both with a gentle, 30°, 1 cm bend. Ideally, the wire should pass posterior to the arteriotomy site 6-8 Fr sheath to avoid being caught in the Proglide sutures (which is a potential concern with all wire-protection methods).

3. The 21 gauge needle is removed and the 0.018˝ wire can be externally taped or secured by a surgical clamp outside the body.

4. After valve deployment, the TAVR sheath is withdrawn into the common iliac artery and injection via the TAVR sheath or a catheter advanced via the TAVR sheath can delineate any common and external iliac complications. If these occur, they get treated via the TAVR sheath. The TAVR sheath lumen (>14 Fr) is spacious enough to accommodate both an occlusive balloon on one wire and a covered stent on a second wire; however, the occlusive balloon must be deflated and removed with its wire prior to the deployment of a stent or covered stent.

5. After protamine administration upon complete removal of the TAVR sheath, manual pressure is initially applied to the arteriotomy to prevent arteriotomy site complication, since the arteriotomy 0.035˝ wire is still extending from the TAVR arteriotomy site through the iliofemoral system into the abdominal aorta.

6. The following step is optional in cases of massive arteriotomy site bleeding: a 10-25 cm, 6 Fr femoral sheath is advanced over the arteriotomy sheath wire, the dilator is removed, and an appropriately sized peripheral balloon is advanced on the wire into the ipsilateral iliac and inflated at low pressure (2-4 atm) to create a dry seal.

7. An ipsilateral 7 Fr radial sheath is advanced on the 0.018˝ wire via the SFA arteriotomy site into the SFA across the arteriotomy region. The dilator is removed after the short 0.018˝ wire is exchanged with a longer wire (0.018˝ or 0.035˝ over a micropuncture dilator for the former or any 4-7 Fr femoral sheath dilator). This is done to obtain out-of-body wire length of 140 cm to allow advancement of all conventional balloons, stents, or covered stents.

8. Balloons, stents, or covered stents can be advanced and precisely positioned with confirmation injections through the 7 Fr sheath originating from the SFA.

9. Once ready for stent deployment, the iliac occluding balloon (if one was used for dry seal) is deflated, and the deflated balloon, TAVR arteriotomy site wire, and TAVR arteriotomy 6 Fr sheath are removed. The stent or covered stent is then deployed. Injection via the SFA sheath or via the stent balloon (in the case of balloon-expandable stents) can be used to assess the result. If additional stents, covered stents, or postdilation are required, they should be done via the 7 Fr SFA sheath. Final arteriotomy site imaging can be done by injecting directly via the SFA sheath. The SFA 7 Fr sheath can be removed with manual pressure applied.

10. In the more common case when the arteriotomy site does not display significant bleeding or vessel compromise after Proglide closure, the MAK-501 dilator is advanced over the 0.018˝ wire via the SFA access site, and the 0.018˝ wire is removed. A digital subtraction angiography using hand injection through the MAK-501 dilator confirms optimal vessel closure. Subsequently, the dilator can be removed with application of brief manual pressure hemostasis.

In case of bailout ipsilateral protection after sheath removal (Figure 3)

1. Manual pressure is applied. A 6 Fr femoral sheath is advanced over the 0.035˝ TAVR arteriotomy wire via the injured femoral TAVR arteriotomy site (in the CFA) and the 6 Fr dilator is removed. An optional peripheral balloon is advanced into the appropriate segment of the iliac and inflated at low pressure (2-4 atm) to perform dry seal.

2. Access with a 21 gauge micropuncture needle into the ipsilateral SFA ≥5 cm distal to the arteriotomy site and a long 0.018˝ wire like V18 wire is advanced beside the arteriotomy sheath or wire into the descending aorta underneath the inflated iliac balloon.

3. A 7 Fr radial sheath is advanced via the SFA puncture site, across the SFA and CFA beyond the TAVR arteriotomy site region and the dilator is removed.

4. Stages 7-9 are done in the same manner.

Table 1 compares the different wire-protection and bailout methods described in the literature. Ipsilateral wire protection is perfectly suitable for the current trend of large-bore access and TAVR while avoiding a second femoral access.⁵ While some centers use ipsilateral access when contralateral access is not feasible,⁶ we use it as the default prophylactic wire protection strategy and as an optional bailout.

Ipsilateral wire protection offers considerable advantages over contralateral wire protection:

1. It allows the use of the left or right radial or ulnar artery and avoids contralateral femoral access. Using the left radial⁷ or ulnar artery access as an alternative was adapted by some operators and was shown to reduce vascular and bleeding complications.⁸

2. It is compatible with hostile aortic bifurcation or lower-extremity tortuosity and calcification, or occluded or severely diseased contralateral iliofemoral system.

3. For prophylactic wiring, it is not associated with any cost, since the same 0.018˝ wire and micropuncture kit used for the TAVR arteriotomy access can be used for the prophylactic wire protection.

4. It requires less procedure time and fluoroscopy time than contralateral wiring and almost always allows relatively fast and easy bailout.

5. When there is difficulty obtaining a second access for pigtail catheter, the SFA access can serve as pigtail access.

6. In cases of large-bore access such as required for the Impella device (Abiomed), an ipsilateral digital subtraction angiography via the dilator of a 5 Fr micropuncture kit can be done to confirm optimal arteriotomy site closure (if a suboptimal arteriotomy site results in bleeding or ischemia, it can be accessed with a 7 Fr radial sheath and treated). Moreover, if the Impella sheath is occlusive, the ipsilateral SFA site can be accessed to serve as a perfusion port for the ischemic leg.

Burzotta⁹ and Junquera¹⁰ described their experience with a novel method for radial or ulnar access for protective wiring of the TAVR arteriotomy site along with the use of a 5 Fr pigtail catheter for aortography during the TAVR procedure. In the latter study, left radial and right radial access were used in 74% and 26% of cases, respectively. In this selective cohort, 62.5% of required 200 cm length Oceanus balloon (IVascular) and 37.5% required 140 cm Oceanus balloons; 48% of the patients required especially long wires, such as the 0.035˝ 450 cm Visiglide (Olympus) or the 0.025˝ 450 cm Jagwire (Boston Scientific), while the remaining patients required a variety of 300 cm wires.

This wrist-based, crossover-balloon occlusion technique suffers from numerous disadvantages:

1. A considerable proportion of TAVR patients have challenging (tortuous, calcified, and disease) radial or ulnar and upper-extremity arterial anatomy and may not be able to accommodate 6 Fr sheaths.

2. Six Fr sheaths do not accommodate Oceanus balloons exceeding 12 mm or any covered stent; hence, endovascular repair versatility is compromised.

3. Tall patients or right radial approach may require balloons, stents, and covered stents with working length or shaft of 200 cm, which are not commercially available in the United States, and 400 cm wires, which are not available in most labs.

4. The described procedure is far more complex than the ipsilateral protection technique, creates considerable “working space” issues, and bailout is likely to require considerably more planning, procedural time, contrast use, and additional tools.

Ipsilateral protection and bailout is the easiest, least costly large-sheath femoral arteriotomy protection strategy and is applicable to practically all femoral anatomies. Consequently, ipsilateral arteriotomy site protection and bailout should be a strategy in which all large-bore femoral sheath users are familiar.