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.
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Method Article
Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation
In This Article
Summary
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 sites3,4. These access sites include secondary arterial access, which is required for invasive hemodynamic measurements and angiographic....
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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
- All patients aged 18 years or older undergoing transfemoral TAVI should be considered for this met....
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Results
Step 2 has previously been investigated in both a prospective registry and a randomized clinical trial11,17. 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.......
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Discussion
Access site-related bleeding remains one of the most prevalent complications after TAVI1,2. 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.......
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Disclosures
Marleen H. van Wely reported receiving personal fees from Abbott Vascular and Boston Scientific Corporation. Robert Jan van Geuns reported receiving consulting and speaker's fees from Abbott Vascular, AstraZeneca, Sanofi SA, Amgen Inc., and InfraRedx Inc. and receiving institutional research grant funding from Amgen Inc., InfraRedx Inc., AstraZeneca, and Sanofi SA. Robin H. Heijmen has been a consultant for Medtronic. Niels van Royen has received research funding from Abbott, Philips, Medtronic and Biotronik, has served as a consultant for RainMed, Castor and Medtronic and received speaker fees from Abbott and Bayer. The other authors do not have any disclosures to report.
Acknowledgements
This work was supported by a research grant (A 1678426/SVZ) from Medtronic.
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Materials
| 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 |
References
- Van Nieuwkerk, A. C., et al. Bleeding in patients undergoing transfemoral transcatheter aortic valve replacement: Incidence, trends, clinical outcomes, and predictors. JACC Cardiovasc Interv. 16 (24), 2951-2962 (2023).
- Avvedimento, M., Nuche, J., Farjat-Pasos, J. I., Rodés-Cabau, J.
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