Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation

Summary

An upper-extremity approach for secondary access during transfemoral transcatheter aortic valve implantation is associated with fewer secondary access site-related bleeding complications and reduces time to mobilization in patients requiring extended pacing. This protocol aims to provide an extensive overview of the upper-extremity approach and guide operators in adopting this methodology.

Abstract

Transcatheter aortic valve implantation (TAVI) requires multiple access sites, each with a potential risk of access site-related bleeding complications. While most bleeding events occur at the primary TAVI access site, a significant number of bleeding events originate from the secondary access sites. Additionally, a temporary pacing lead prevents early mobilization after TAVI, while prolonged immobilization is associated with an increased rate of post-procedural complications such as delirium and infection. Using alternative secondary access sites may reduce the incidence of access site-related complications and facilitate early mobilization after TAVI. This protocol describes an upper-extremity approach, as recently investigated in the TAVI XS trial, and aims to provide a comprehensive overview of the methodology. For this approach, the radial artery is used for diagnostic access, and the upper arm veins (basilic, cephalic, or brachial vein) are used for temporary pacing lead insertion. To enhance reproducibility, a step-by-step protocol was created on how to perform an upper-extremity secondary access approach during transfemoral TAVI. It was previously demonstrated that an upper-extremity approach for secondary access results in significantly fewer clinically relevant secondary access site-related bleeding complications. Additionally, the approach reduces the time to mobilization for patients who require a pacing lead for an extended period of time. Due to the pragmatic nature of the aforementioned study, the protocol presented here is readily applicable to the majority of transfemoral TAVI patients. The upper-extremity approach reduces periprocedural complications in TAVI patients and may facilitate early mobilization. The presented approach is the next step in minimizing the invasiveness of transfemoral TAVI and should be considered in all eligible TAVI patients.

Introduction

Despite a reduction in sheath sizes and improvements in percutaneous closure over the years, access site-related bleeding remains a prevalent complication after transcatheter aortic valve implantation (TAVI)^1,2. While the primary access, used for inserting the valve prosthesis, has been the main target for reducing these complications, a significant proportion of access site bleeding is related to the secondary access sites^3,4. These access sites include secondary arterial access, which is required for invasive hemodynamic measurements and angiographic guidance, and a third (venous) access site, which is needed for patients requiring a temporary pacing lead. Retrospective studies have reported on the feasibility of using the radial artery as secondary arterial access during TAVI, showing a reduced incidence of bleeding complications related to this secondary access site^3,5. However, randomized data were lacking.

In addition to angiographic guidance, rapid ventricular pacing is usually required for accurate valve deployment. Additionally, rapid ventricular pacing is required during pre- or post-dilatation. Rapid ventricular pacing minimizes cardiac output and creates a short window of opportunity in which the operator can deploy the valve prosthesis. Previously, to perform rapid pacing, a temporary pacing lead was inserted in all TAVI patients using either the femoral or the jugular vein. This temporary pacing lead also provides backup in case high-degree conduction disturbances occur. These disturbances are encountered frequently due to the anatomical location of the conduction pathways near the aortic annulus^6,7. Despite these risks, pacing over the left ventricular stiff wire proved an effective and safe strategy for rapid ventricular pacing in patients with a low pre-procedural risk of conduction disturbances^8,9. This approach concomitantly omitted the need for a third access site in eligible patients. Despite these advancements, temporary pacing leads are still typically placed in patients with a high pre-procedural risk of conduction abnormalities¹⁰, resulting in an increased risk of access site-related complications. In particular, the jugular or femoral veins, which are commonly used for pacing lead insertion, are prone to access site-related bleeding¹¹. Moreover, jugular or femoral venous access for temporary pacing lead insertion precludes early mobilization to prevent lead dislocation after the procedure.

In an attempt to address and improve both secondary access sites, the TAVI XS trial investigated whether using an upper-extremity approach for secondary access would result in fewer clinically relevant access site-related bleeding complications¹². Aside from investigating secondary radial access, the TAVI XS trial aimed to investigate an upper-extremity approach for temporary pacing lead placement. This novel strategy had previously been investigated in a prospective registry, which showed that its use is safe and effective¹¹. Moreover, the use of this upper-extremity approach for temporary pacing lead placement is associated with a significantly shorter time to mobilization compared with a femoral or jugular approach. This is particularly relevant as prolonged immobilization is a known risk factor for delirium^13,14, which is subsequently associated with an increased duration of hospitalization and higher rates of rehospitalization and mortality^15,16.

The TAVI XS trial was a pragmatic study with few exclusion criteria, affirming the scope of the presented approach. All transfemoral TAVI patients, with no evident contraindications for radial- or femoral arterial access (such as known occlusion) and no contraindications for upper-arm or femoral venous access (such as a known disruption of vascular patency) and no intended use for a cerebral embolic protection device, were deemed eligible for participation. As the results of the aforementioned registry and clinical trial show the possible benefit of this approach, the main objective of this protocol is to describe the upper-extremity approach as investigated in the TAVI XS trial, in greater detail. This protocol focuses mainly on the upper-extremity venous access for temporary pacing lead insertion, as most operators will be unfamiliar with this approach. The method presented is readily applicable to most TAVI patients, directly reduces access site-related bleeding complications, and reduces time to mobilization in patients requiring extended pacing. It should, therefore, be considered in all eligible transfemoral TAVI patients.

Protocol

The following method has been investigated in a previous trial (TAVI XS)¹⁷. Written informed consent was obtained from all participants prior to study enrollment. The trial was conducted in accordance with the principles of ICH-GCP, applicable privacy requirements, and guiding principles of the Declaration of Helsinki. The TAVI XS trial has been approved by the Medical Research Ethics Committee Oost-Nederland and the review board of each participating site.

1. Patient inclusion and exclusion

1. All patients aged 18 years or older undergoing transfemoral TAVI should be considered for this method, provided no exclusion criteria are present.
2. Exclude patients with a contraindication for upper-arm venous access (e.g., known disruption of vascular patency after extensive thoracic surgery). Exclude patients if any contraindications for radial arterial access are present (e.g., known arterial occlusion after prior angiography or occlusion of the arteries due to peripheral artery disease). Exclude patients if a cerebral embolic protection device (requiring an additional arterial access) will be used.
3. Treat patients who already have a permanent pacemaker implanted using a pacing-over-the-wire strategy, and consider them ineligible for the method presented in Step 2.
   NOTE: The methods presented below can be performed using only local anesthetics. The use of general anesthesia or conscious sedation depends on patient characteristics and is neither a contraindication nor a requirement for performing the presented methods. Materials used in the methods described below are listed in the Table of Materials. The methods below describe the upper arm venous access and radial arterial access separately, as both approaches can be employed independently based on patient characteristics and procedural requirements.

2. Upper-extremity temporary pacing lead placement

1. Patient positioning
   1. Instruct the patient to get into a supine position on the catheterization table. Make sure the arm (preferably left) is fully extended at a 90° angle relative to the thorax while remaining in the same vertical plane (Figure 1).
      NOTE: The materials required are shown in Figure 2.
   2. Support the extended arm of the patient by making use of an armrest. Let the patient overextend and supinate their arm, by doing so presenting the medio-ventral side of the upper arm towards the operator.
2. Access site preparation
   1. Make sure the access site is disinfected with either chlorhexidine or povidone-iodine by disinfecting the whole upper arm. This is important as prior to ultrasound, the exact location of the puncture is unknown.
   2. Place a tourniquet around the upper arm as proximally as possible and tighten it to enhance the visibility of the upper arm veins (basilic, cephalic, and brachial vein).
   3. Create a sterile field by placing a sterile cover that only reveals the disinfected upper arm.
   4. Prepare ultrasound-guided puncture using a vascular probe, sterile probe cover, and ultrasound gel.
3. Access site puncture
   1. Use ultrasound to localize a suitable vein for puncture, a suitable vein is usually located 5-10 cm proximally to the elbow crease. In most cases this will either be the basilic vein (medio-ventral) or the cephalic vein (lateral). In some cases, the brachial vein is the most optimal for puncture.
   2. Determine the suitability of the vein based on the factors described below.
      1. Select based on proximity to related structures prone to result in complications when punctured. For example, in some cases, a suitable vein is located very close to one of the arteries. In this case, try following the vein more proximal or distal to find an alternative location.
      2. Select based on the depth of the vein; a superficially located vein is preferable.
      3. Select based on the diameter of the vein, i.e., larger veins are more suitable for puncture.
      4. Select based on location of the puncture site, puncturing close to the elbow crease potentially causes pacemaker malfunction when the RV pacing lead is kept in place after the procedure. Make sure flexing of the arm is possible without compromising the pacing lead.
   3. Once a suitable vein is chosen, confirm that it is a vein by compressing it with the echo probe before puncturing. A vein should collapse, whereas an artery will not.
   4. Infiltrate the subcutaneous space of the desired access site with 1-2 mL of 1% lidocaine solution (Figure 3A).
   5. Puncture the vein with a hollow needle, which is usually present in the 6 Fr sheath kit, using direct ultrasound guidance and make sure that sufficient backflow is present (Figure 3B,C).
   6. Directly afterward, insert a guidewire in the hollow needle and advance the guidewire (Figure 3D). After doing so, remove the tourniquet and remove the hollow needle back over the wire.
   7. Flush the sheath and side port before introducing it to make sure there is no air within the system.
   8. Introduce the 6 Fr sheath over the wire and then remove the guidewire and dilator. After this step, a 6 Fr lumen is created through which a temporary pacing lead can be inserted with additional room for the side port to inject intravenous fluids when required (Figure 3E).
   9. Introduce a 5 Fr flow-directed pacing catheter through the sheath with the balloon deflated. Advance the pacing lead following step 2.4.
4. Imaging guidance set-up and lead advancement
   1. Use fluoroscopy when advancing the pacing lead towards the right ventricle. Use an anterior-posterior (0°/0°) view.
   2. Advance the pacing lead; the lead should naturally follow the vasculature toward the right ventricle without any resistance.
   3. Once the tip of the lead is situated within the subclavian vein, inflate the balloon tip to assist in directing the catheter tip towards the right ventricle.
      NOTE: Once the tip of the catheter is situated medial to the head of the humerus (which can be confirmed using fluoroscopy), the tip is likely situated in the subclavian vein. If there is any resistance during the advancement of the lead, a contrast injection can be used to confirm that the tip of the catheter is situated in a vessel with a large enough diameter to inflate the balloon (the vessel diameter should be at least twice the diameter of the deflated catheter tip).
   4. If the pacing lead instead enters either the contralateral subclavian vein (which can be identified by the pacing lead advancing to the contralateral side surpassing the median line) or the jugular vein (which can be identified by the pacing lead advancing cranially after passing the midclavicular line), partially retrieve the lead and try to rotate the pre-shaped angulated tip of the pacing lead before advancing again.
      NOTE: Contrast injections through the side port of the 6 Fr sheath can be used to facilitate proper passage of the lead and to confirm the pacing wire is advancing towards the right ventricle.
   5. Pass the tricuspid valve by slightly rotating the pacing lead towards the right ventricle and pass the tricuspid valve with an inflated balloon tip.
   6. In the right ventricle, make contact with the right ventricular apex and deflate the balloon afterward.
5. Connecting and testing the pacing lead
   1. When the pacing lead is in the right position, connect the electrode plugs to the corresponding ports on the adapter.
   2. Perform a capture threshold test of the temporary pacing lead by pacing 20 beats per minute above the intrinsic heart rate at maximum pacemaker output and slowly decrease output amperage until malcapture (defined as pacing stimuli not resulting in depolarization, which can be identified by the presence of an irregular heartbeat and a heart rate that is lower than expected based on the pacemaker settings). The chosen pacemaker setting should exceed at least 2x this threshold value.
   3. When a threshold of > 3 mA is found, reposition the pacing lead to achieve lower thresholds.
6. Fixating the pacing lead
   1. Fixate the temporary pacing lead by using a large transparent film dressing covering the access site and about 10 cm of the remaining extrabodily located part of the pacing lead (Figure 4). Position this part of the pacing lead in a rolled-up fashion to prevent pacing lead dislocation due to movement of the upper arm or pacemaker device.
   2. Make sure the pacing lead is properly fixated in case patients require extended pacing or backup of the temporary lead (this allows mobilization with the pacing lead in situ).
7. Access closure (in case of lead removal after the procedure)
   1. If removal of the pacing lead is warranted, reassure the balloon is deflated and retrieve the pacing lead with slight traction.
   2. Make sure the 6 Fr. Sheath remains in situ until activated clotting time (ACT) is normalized. Thereafter, remove the sheath manually.
   3. Use manual compression of the access site for 2 min. Place a sterile bordered gauze or island dressing afterwards for access site closure. If deemed necessary, use a bandage with slight compression instead.

3. Upper-extremity secondary arterial access

NOTE: Step 3 can be performed independently from step 2 (e.g. when a pacing-over-the-wire strategy is used). In case both steps are performed, step 3 can be performed directly after 2.6.2.

1. Patient positioning
   1. Instruct the patient to get into a supine position on the catheterization table. Make sure the arm (either left or right) is extended fully and position the arm parallel to the body.
   2. Support the extended arm of the patient by making use of an armrest. Have the patient supinate the lower arm so that the ventral side of the wrist becomes accessible and faces upward.
2. Access site preparation
   1. Palpate the radial artery to assess the location suitable for puncture and make sure the wrist is disinfected with either chlorhexidine or povidone-iodine.
   2. Let the patient overextend their wrist to improve accessibility of the radial artery. Create a sterile field by placing a sterile cover that only reveals the disinfected wrist.
3. Access site puncture
   1. Infiltrate the subcutaneous space around the intended puncturing site with 1-2 mL of 1% lidocaine solution.
   2. Puncture the radial artery directly with a hollow needle (usually present within the sheath kit). Pulsatile backflow through the hollow needle confirms successful puncture of the radial artery.
   3. Directly afterward, insert a guidewire into the hollow needle. Advance the guidewire for at least 5 cm to ensure arterial access is maintained. Subsequently, retrieve the hollow needle back over the wire.
   4. Flush the sheath and side port before introducing it to ensure there is no air within the system. Introduce a 5 or 6 Fr sheath over the wire and then remove the guidewire and dilator. Introduce a pigtail catheter through the sheath.
4. Advancing catheter
   1. Advance the pigtail catheter using direct fluoroscopy. Use an anterior-posterior (0°/0°) view.
   2. Position the pigtail catheter in the Non-Coronary Cusp (NCC). Check the positioning of the pigtail catheter by performing contrast injections of 10 mL of contrast medium in a cusp-overlap view. The tip of the pigtail catheter should be situated in the NCC.
5. Access site closure
   1. Once the TAVI prosthesis has been deployed and the primary access site has been closed, achieve hemostasis by removing the pigtail catheter and by placing a compression device.
   2. Let the device exert compression for at least 2 h and afterward slightly release pressure every 10-15 min.
   3. To prevent access site bleeding, make sure the patient minimizes arm use during the first 24 h. An arm sling can assist in achieving this.
   4. Once the compression device is completely deflated, remove the device and cover the puncture site with an island dressing or bandage.

Results

Step 2 has previously been investigated in both a prospective registry and a randomized clinical trial^11,17. The prospective registry demonstrated that using the upper arm veins for temporary pacing lead placement results in a shorter time to mobilization when compared to the conventional approach using the femoral or jugular vein. Moreover, the incidence of access site bleeding was significantly lower¹¹. Time to mobilization remained sign...

Discussion

Access site-related bleeding remains one of the most prevalent complications after TAVI^1,2. The method described in this paper for upper-extremity access helps to reduce secondary access site-related bleeding. Additionally, the procedures described in this paper reduce time to mobilization in case a patient requires a temporary pacing lead after the procedure, either for active pacing or serving as backup. Furthermore, a non-statistically significant difference i...

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Bordered island dressing (any size covering the access site)	N/A	N/A	N = 1; used for access site closure after sheath removal
Chlorhexidine 0.5% in 70% ethanol solution	N/A	N/A	Used for disinfecting the access site
Compression device (TR Band)	Terumo	TRB24-REG	N = 1; used for access site closure
Empty sterile cup (in our case a 60 mL cup is used)	N/A	N/A	N = 1; used for holding the lidocaine 1%
Flow directed 5 Fr pacing catheter (Pacel)	Abbott Laboratories	401761	N = 1; temporary pacing lead
Gauze (in our case a 7,5 * 7,5 cm gauze)	N/A	N/A	N = 5-10; used for disinfection
Hollow needle: 21 Gauge * 5 cm	N/A	N/A	N = 1; used for filling the syringe with either sodium-chloride or lidocaine
Injection needle: 18 Gauge * 4 cm	N/A	N/A	N = 1; used for lidocaine infiltration
Introducer sheath kit 6 Fr (Glidesheath Slender - including hollow needle, guidewire, dilator and sheath)	Terumo	RM*RS6J10PQ	N = 1; used for creating a 6 Fr lumen with side-port
Lidocaine 1% injection fluid	N/A	N/A	10 mL; used for local anesthesia
Sterile 0.9% sodium-chloride solution	N/A	N/A	Liberal ~50 mL; used for flushing the sheath and side-port
Sterile coat for the operator	N/A	N/A	N = 1; used for sterile placement of pacing lead
Sterile cover for patient 110 * 90 cm with 12,5 cm opening. Other sizes work as well as long as the opening is the right size to reveal the upper arm.	N/A	N/A	N = 1; used for creating sterile workfield
Sterile cover for patient with an opening only revealing the disinfected wrist	N/A	N/A	N = 1; used for creating sterile workfield
Sterile cover for workfield 75 * 75 cm	N/A	N/A	N = 1; used for creating sterile workfield (tray table)
Sterile cup (in our case a 60 mL cup is used)	N/A	N/A	N = 2; used for holding sterile sodium-chloride (0.9%) and for holding the lidocaine 1%
Sterile disposable adapters for temporary pacing lead	Fiab	PG922/2TPS2	N = 1; one set of two pieces (red and black)
Sterile gloves for the operator	N/A	N/A	N = 1; used for sterile placement of pacing lead
Sterile ultrasound gel (usually included with probe cover)	Exact Medical	E6434	N =1; used for working sterile with ultrasound
Sterile ultrasound probe cover 15*244 cm	Exact Medical	E6434	N =1; used for working sterile with ultrasound
Syringe (10 mL)	N/A	N/A	N = 2; used for both sodium-chloride and lidocaine
Temporary pacemaker device	local preference	local preference	Used for pacing
Tourniquet (Disposable, 47 cm * 2.5 cm)	E.g. Eikon Medical Solutions	Unkown	N =1; used for improving success rate of venous puncture by compressing the vein
Transparent film dressing (10 * 12 cm)	3M	DH888848289	N = 2; usually one piece would suffice, sometimes two are required
Ultrasound device with vascular probe	local preference	local preference	Used for visualization of upper arm vasculature
Universal MYO/Wire disposable patient cable (1.8m)	A&E Medical corp.	119-535	N = 1; used for connecting lead to pacemaker device