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Transfemoral Access for Large-Bore Interventions

  • George V. Moukarbel
  • Frederic S. Resnic
Chapter

Abstract

Interventions requiring large-bore access have been rapidly increasing in recent years with the dramatic growth of transcatheter aortic valve replacement (TAVR), use of adjunctive mechanical ventricular support systems, and expanded use of endovascular treatment of aortic disease. Typically these procedures require the use of sheaths ranging from 10 to 24 French in size. The common femoral artery can provide an appropriate access site for such procedures. Adequate anatomical characteristics of the common femoral and iliac arteries can be determined by angiography. Complete percutaneous access and closure are possible with the use of a careful technique and appropriate devices. A preclosure technique is commonly used to secure sutures in the common femoral artery prior to upsizing the arteriotomy. Operators should be prepared to manage potential complications.

Keywords

Large-bore access Preclosure Common femoral 

22.1 Introduction

The advent of catheter-based interventions that require large-bore arterial access has necessitated the development of endovascular strategies for safe access techniques as well as repair and closure of the access site. Generally, diagnostic and interventional procedures performed via the femoral arterial access utilize sheaths that range from 5 to 8 French (5–8F) in size, with a rare need for 9F access. Options for closure of such access sites range from manual compression to utilization of one of several approved and available closure devices, with a high success rate. However, large-bore arterial access procedures, defined as those procedures requiring the use of 10–26F (or larger) sheaths, require meticulous attention to the access technique and novel approaches to arteriotomy site management.

22.2 Access Site Considerations

When a larger-bore arterial access is needed, such as the currently performed and rapidly expanding transcatheter aortic valve repair (TAVR) or endovascular aneurysm repair (EVAR), the adequacy of the access technique becomes of paramount importance to ensure the success and safety of the procedure. These procedures require placement of access sheaths up to 24F in size. The micropuncture technique (see ► Chap.  21: «Transfemoral Retrograde/Antegrade Access») for access and a femoral angiogram through the inner cannula of the micropuncture sheath should be uniformly performed when seeking large-bore access. Importantly, if the initial femoral angiogram demonstrates arterial entry outside the safe zone, the 4F cannula can be removed, manual compression can be applied for 5–10 min, and the same femoral artery can be reapproached above or below the initial access site. Routine use of the micropuncture technique with inner cannula angiography will ensure an adequate access location and provide definition of the anatomy of the vessel (◘ Fig. 22.1). Vessel anatomy, size, tortuosities, and other characteristics determine the suitability of the common femoral artery for access. ◘ Table 22.1 summarizes the optimal requirements of the access location when large-bore access is sought.
Fig. 22.1

Use of a micropuncture access technique to define the anatomy of the common femoral artery prior to committing to the access site. a Optimal access site in a normal right common femoral artery. b Access close to the left common femoral bifurcation. The access was abandoned and repeat access was obtained at a higher location c

Table 22.1

Requirements for adequate large-bore access

Vessel characteristic

Optimal attribute

Location

Mid common femoral

Minimum vessel diameter

 TAVR 14–16F

5–6 mm

 EVAR 12–24F

4–8 mm

 Impella 13–14F

5 mm

 TandemHeart 15F

5–6 mm

Calcifications

None to minimal

Atheromas

None to minimal

Tortuosities

Mild

EVAR endovascular aneurysm repair, TAVR transcatheter aortic valve replacement

22.3 Advancement and Removal of the Sheath

When large-sized sheaths need to be advanced through the iliac arteries, it is very important to define the iliac anatomy, typically via an aorto-iliac angiogram (◘ Fig. 22.2). This will determine the presence of calcification, severe vessel tortuosity, and stenosis or occlusions in the iliac arteries that would challenge the advancement of a large endovascular sheath. Occasionally, percutaneous intervention for iliac stenosis may be required prior to advancing large sheaths. If such an intervention is needed, balloon angioplasty is performed and stenting is deferred until after the large sheath is removed, as manipulation of the sheath may dislocate a freshly implanted stent.
Fig. 22.2

Aorto-iliac angiography helps to determine suitability for advancement of large-sized sheaths. a Normal iliac arteries. b Mildly tortuous iliac arteries with moderate stenosis in the ostium of the right common iliac artery, making the left iliac arteries more suitable for a large sheath. c Highly tortuous, calcific, and diseased iliac arteries bilaterally, making advancement of a large sheath very challenging. d Left iliac angiogram of the patient in panel c, showing a high-grade stenosis just after the common iliac artery bifurcation

It is also critically important to perform all device, dilator, or sheath exchanges over a stiff wire. Typically, 0.035″ Amplatz® or Lunderquist® Super Stiff wires are commonly used for this purpose. This allows larger devices and sheaths to be delivered across subcutaneous tissue and to overcome tortuosities of the iliac arteries.

Serial dilatation of the access site with a gradual increase in the caliber of the dilator will allow eventual passage of the large sheath. Care should be taken while advancing the sheath to avoid causing femoral or iliac dissection or rupture. Sheath advancement should be performed slowly in a stepwise fashion, using a controlled «push and release» technique to allow the vessel to elastically expand, as much as feasible, to accommodate the sheath diameter. Some available large-caliber sheaths do not incorporate a locking mechanism for the dilator. Therefore, the operator should ensure that the dilator is fully inserted into the sheath and that both are advanced together, fixed tightly by the operator, over the stiff wire. Occasionally, after the sheath has entered the iliac artery, it is not feasible to advance the sheath and the dilator assembly as a unit over the wire. One option that can be attempted is to try advancing the sheath a few millimeters over the dilator and then readvance the dilator. This maneuver can be repeated as needed to advance the sheath, using this «ladder» technique.

Removal of the large sheath at the end of the procedure also requires care and extreme caution to achieve optimal outcomes and to be prepared to deal expeditiously with any bleeding or acute vascular complication. The large-bore sheath should be withdrawn slowly and smoothly over the 0.035″ wire. In cases where resistance is felt during withdrawal, the operator should immediately stop pulling on the sheath and allow the iliac vessels to release the grip on the sheath. Sometimes, injection of an intra-arterial vasodilating agent (such as verapamil or nitroglycerin) through the sheath helps alleviate iliac spasm. Occasionally, significant force is required to withdraw the sheath; however, this carries a significant risk of transection of the iliac vessel («iliac-on-a-stick») [1]. This complication leads to significant, life-threatening hemorrhage; therefore, always maintaining access to the distal aorta and proximal iliac vessels via the wire allows for quick advancement of an occlusion balloon proximal to the site of the injury. Temporary occlusion of the iliac or common femoral artery is typically well tolerated and controls the bleeding while repair of the vessel is being planned—either percutaneous, with placement of a covered stent, or surgical.

22.4 Strategies for Access Site Closure and Management

There are several proven approaches to closure of large-bore access sites. If an arterial cutdown has been performed, then standard open surgical repair of the arteriotomy is usually performed. This has been less commonly used in recent years, given the predictable success of complete percutaneous access and closure of large-sized arteriotomies, which carry less morbidity for the patient. Complete percutaneous large-bore access is usually performed when removal of the sheath is anticipated at the end of the procedure while the patient is still in the catheterization laboratory or hybrid operating room. There are currently two devices that are commonly used for this purpose: the Abbott Vascular Prostar® XL and the Abbott Vascular Perclose ProGlide®. Both devices require a «preclosure» technique for a large-sized arteriotomy. A new, collagen plug–based device—Manta (Essential Medical, Inc.), which does not require preclosure—is available for use in Europe and is currently undergoing evaluation in a US clinical trial for closure of 10–18F arteriotomies [2].

The Prostar® XL device is approved for use in the USA for closure of 8.5–10F arteriotomy sites. The device can be used for closure of larger arteriotomies up to 24F, using the preclosure technique [3]. For this device, preclosure is performed at the beginning of the procedure after access in the common femoral artery is adequately secured and the initial femoral angiogram has demonstrated an acceptable arteriotomy position. Predilation of the arteriotomy site with temporary insertion of a 6–8F arterial sheath is advised. The skin incision is extended with a scalpel, and blunt dissection with forceps is performed down to the level of the arteriotomy. This step is important to ensure adequate delivery of the Prostar XL sutures. The sheath is retracted, and the device is advanced over the wire, which is then completely removed. Using a rotary motion at the hub, the device is advanced again until blood is seen to continuously come out of the small channel loop. This confirms an adequate position in the vessel. At this time the rounded handle is rotated 90° counterclockwise and pulled back to deploy the needles. The needles are then fully retrieved using a hemostat. All four sutures are then cut close to the needle sites, and the needles are disposed of. The device is retracted, and the sutures are retrieved and spread off to the side of the access site. The suture threads are wrapped in wet gauze and secured with a hemostat for the duration of the procedure. The 0.035″ wire is then reinserted through the device port, and the device is carefully withdrawn and discarded. Additional dilation is then performed over the 0.035″ wire, ultimately permitting insertion of the appropriately sized large-bore access sheath.

At the completion of the procedure, a 0.035″ wire is inserted through the sheath in order to maintain access until complete hemostasis is achieved. The sheath is then carefully retracted over the wire, as described above, and the crossing suture ends are used to form two sliding, self-locking surgical knots. The two knots are then sequentially advanced to the arteriotomy site, using a provided knot pusher. Once they are tightened and hemostasis is achieved, the ends of the sutures are cut. The skin and subcutaneous incisions are sutured, using standard techniques.

The Perclose ProGlide® device is approved in the USA for closure of 5–21F arteriotomies [4]. At least two devices and use of the preclosure technique are required for closure of access sites larger than 8F, using the ProGlide device [5]. Following arterial access and femoral angiography confirming an adequate access site location, the two devices are deployed sequentially while a stiff wire maintains access into the lumen of the artery. Typically, the first device is deployed at a 10 o’clock position and the second at a 2 o’ clock position (12 o’ clock represents the anterior aspect of the patient) (◘ Fig. 22.3). Careful dilatation of the subcutaneous track down to the level of the arteriotomy prior to advancement of the devices is important for adequate deployment of the sutures. The sutures are deployed using the usual technique but not tightened. The suture threads are wrapped in wet gauze and secured with a hemostat for the duration of the procedure.
Fig. 22.3

Preclosure technique using two Perclose devices deployed in the 10 o’clock position a and the 2 o’clock position b. The suture threads are secured by hemostats and the large-bore sheath is inserted c

At the end of the procedure, a wire is inserted to maintain access until hemostasis is achieved. The knots are sequentially advanced to the level of the arteriotomy. If adequate hemostasis is achieved, the wire is removed and the sutures are tightened. The suture threads are then cut as per the usual technique.

22.5 Special Tips

  1. 1.

    Use of a stiff wire after initial access—over which dilators, sheaths, and devices are advanced—is of paramount importance.

     
  2. 2.

    Occasionally, where there is significant iliac stenosis, balloon dilatation may be needed in order to be able to pass the large-bore access sheath. If stenting is needed, this is better deferred and done after withdrawal of the access sheath, as manipulation of the access sheath may lead to dislodgement or migration of a freshly deployed stent.

     
  3. 3.

    Prior to deployment of the suture devices, it is necessary to perform dissection of the subcutaneous tissue down to the level of the arteriotomy in order to allow for adequate deployment of the sutures.

     
  4. 4.

    Keep the sutures wet at all times to stop them drying out, which may prevent adequate advancement of the knots.

     
  5. 5.
    When tightening the sutures, the wire is maintained in position until adequate hemostasis is achieved. If bleeding is not controlled, then two options are available:
    1. 1.

      Advancement and deployment of another closure device (options would be a Perclose ProGlide® or an 8F Angioseal® device [6]).

       
    2. 2.

      Through contralateral femoral access, the aorto-iliac bifurcation is crossed and an angiogram with possible intervention is performed, depending on the findings (◘ Fig. 22.4). Options include balloon occlusion or deployment of a stent graft.

       
     
  6. 6.

    Avoid excessive force while pulling on the suture threads, as the suture may break.

     
  7. 7.

    Ascertain return of pulses and blood flow distal to the access site to baseline status. Rarely, complete occlusion of the common femoral artery has been described as a complication of closure and requires either endovascular repair via contralateral access or open surgical repair. Distal thromboembolization is another potential complication.

     
  8. 8.

    If percutaneous closure fails to achieve hemostasis, compression (either manual or aided by a Femostop™ device) remains a reliable option for management of continued bleeding. One can also consider reversal of anticoagulation with protamine to aid in hemostasis of the arteriotomy. Surgical repair is uncommonly needed.

     
Fig. 22.4

Left iliac angiogram obtained through a catheter advanced around the aorto-iliac bifurcation from the contralateral access. This was performed after removal of the large-bore sheath from the left common femoral artery and tightening of the preclosure sutures. The access wire still remains in place. Absence of extravasation of contrast indicates adequate hemostasis

22.6 Caval–Aortic Access

If the common femoral or iliac arteries are not adequate for large-bore intervention (small size, diffuse high-grade atherosclerotic or calcific disease) and cannot be safely treated with endovascular techniques to accommodate large-bore arterial access, then some patients may be approached via caval–aortic access. This technique was developed to facilitate TAVR procedures in such patients [7]. Access is obtained in the common femoral vein, using the usual techniques, and preclosure of the femoral vein is performed as described above. Simultaneously, 6F access is obtained either from the femoral approach (if the anatomy is amenable) or from the radial approach. A percutaneous snare is then advanced to the distal aorta and prepared in an «open» position. Guided by previously obtained computed tomography (CT) arteriography images, the location where the inferior vena cava (IVC) and the descending aorta are closest to each other is identified. Using a stiff 0.014″ wire and support catheter assembly delivered via a guiding catheter, the aorta is accessed through direct puncture from the IVC. Alternatively, a Brokenbrough needle can be used to enter the aorta from the IVC. With either technique used to gain access to the descending aorta, the stiff 0.014″ guidewire is advanced and then snared from the aortic side in order to provide adequate support to advance the guiding catheter or Brokenbrough cannula into the aorta. The position of the guide catheter or cannula is confirmed through pressure monitoring, and the catheter is then used to deliver a stiff 0.035″ wire into the proximal aorta. Over the wire, the delivery sheath of the TAVR valve is then advanced, and the procedure is carried out per usual. At the end of the procedure, an appropriately sized Amplatzer® duct occluder or muscular ventricular septal defect (VSD) occluder device is deployed across the IVC and aortic access to maintain hemostasis. Aortography and IVC venography can confirm adequate hemostasis prior to device release.

22.7 Summary

Large-bore arterial interventions are feasible with purely percutaneous approaches. With careful consideration of the anatomy of the ilio-femoral vessels, an adequate access technique, and use of appropriate equipment, large-bore access interventions can be performed safely and successfully. The operator should be aware of, and prepared to deal with, many serious complications of such access as they arise.

References

  1. 1.
    Obon-Dent M, Reul RM, Mortazavi A. Endovascular iliac rescue technique for complete arterial avulsion after transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2014;84(2):306–10.CrossRefPubMedGoogle Scholar
  2. 2.
    MANTA Vascular Closure Device Clinical Study (MANTA). Updated 9 Jan 2017. Available from: https://clinicaltrials.gov/ct2/show/NCT02908880?term=manta&rank=1.
  3. 3.
    Haulon S, Hassen Khodja R, Proudfoot CW, Samuels E. A systematic literature review of the efficacy and safety of the Prostar XL device for the closure of large femoral arterial access sites in patients undergoing percutaneous endovascular aortic procedures. Eur J Vasc Endovasc Surg. 2011;41(2):201–13.CrossRefPubMedGoogle Scholar
  4. 4.
    Perclose ProGlide® 6F Suture-Mediated Closure (SMC) System instructions for use.: Abbott Vascular. Updated 4 May 2015. Available from: http://www.abbottvascular.com/docs/ifu/vessel_closure/eIFU_Perclose_ProGlide.pdf.
  5. 5.
    Griese DP, Reents W, Diegeler A, Kerber S, Babin-Ebell J. Simple, effective and safe vascular access site closure with the double-ProGlide preclose technique in 162 patients receiving transfemoral transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2013;82(5):E734–41.CrossRefPubMedGoogle Scholar
  6. 6.
    Kiramijyan S, Magalhaes MA, Ben-Dor I, Koifman E, Escarcega RO, Baker NC, et al. The adjunctive use of Angio-Seal in femoral vascular closure following percutaneous transcatheter aortic valve replacement. EuroIntervention. 2016;12(1):88–93.CrossRefPubMedGoogle Scholar
  7. 7.
    Greenbaum AB, O’Neill WW, Paone G, Guerrero ME, Wyman JF, Cooper RL, et al. Caval–aortic access to allow transcatheter aortic valve replacement in otherwise ineligible patients: initial human experience. J Am Coll Cardiol. 2014;63(25 Pt A):2795–804.CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.University of Toledo Medical Center, Division of Cardiovascular MedicineToledoUSA
  2. 2.University of Toledo College of MedicineToledoUSA
  3. 3.Department of Cardiovascular MedicineThe Landsman Cardiovascular CenterBurlingtonUSA
  4. 4.Comparative Effectiveness Research Institute, Lahey Hospital and Medical CenterBurlingtonUSA
  5. 5.Tufts University School of MedicineBostonUSA

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