The One-of-a-Kind “Radial Access Sleeve” Finally, an Answer to the Left Radial Prep: “The Black Swan of Radials”
Radial access procedures are becoming increasingly prevalent in the United States. In 2009, radial access in the United States accounted for 1.9% of percutaneous coronary interventions.1 As of 2015, that number is up to 28%.2 Radial access has also been adopted by interventional radiologists, oncologists, neurologists, and vascular surgeons as a point of access for percutaneous procedures. Reduction in bleeding complications, access site complications, earlier ambulation, and overall morbidity has probably driven this trend.3-5 Radial access is also an attractive approach from a cost perspective primarily due to reductions in bed occupancy and decrease in overall hospital costs.6 According to the CARAFE study, patients can ambulate much faster and have overall improved comfort.7
With the “Transradial Revolution” in full swing, cath lab staff have also looked for new and innovative ways to contribute to this paradigm shift. One of these innovations is the Radial Access Sleeve (RAS) (Tesslagra Design Solutions, Staten Island, New York). The RAS is a circumferential sterile sleeve outfitted with a dual fenestration system to ensure precise radial artery site preparation while preserving sterility. It can be utilized for right or left radial access procedures.
Left Radial Access and Drag-Over Technique
The RAS provides a solution to difficult left radial access preps. Its circumferential sterile design allows for the arm to be manipulated across the body without compromising sterility (drag-over technique). Typically the left radial access prep is something that cath lab staff shudders at, but the RAS takes a lot of the work out of the process. The arm is raised and the RAS is simply advanced into place while a sterile gown or half sheet is placed on the arm board. At that point, the prep commences and the entire process is finished in approximately a minute and twenty seconds. Clamps secure the arm into place, and sponges or pillows can support the arm to prevent moving after cannulatation. Commercially available securing devices developed by Tesslagra Design Solutions will be coming to the market soon. The RAS can save 5-7 minutes in prep time. The left radial artery approach has been associated with lower fluoroscopy time, contrast volume, procedure time, and operator exposure.8-12 This is probably driven by an anatomical “obstacle” in the form of the innominate artery arising from the brachiocephalic trunk that is not present from the left radial artery approach. In one study, an almost triple incidence of operator-reported subclavian tortuosity in the right radial artery approach compared to the left was reported.13 The hidden gem with a left radial procedure is, with proper setup, the operator can work right down the center of the procedural table rather than working out to the side (where blood tends to drip on the floor) as with a right radial procedure. The left radial access can be a cumbersome and time-consuming prep in which staff might be somewhat resistant, but the RAS offers a novel solution to previous methodologies.
Right Radial Artery Access and DRI Method
The use of the RRA has been the preferred access route for interventional cardiologists due to familiarity working from the right side of the table and room setup.14 The RAS facilitates a swift prep of the right radial artery, taking approximately 1.5 minutes. The RAS can be used with standard “swivel” boards where the drape would go over the arm and the arm board simultaneously, or can be used over the arm by itself. The RAS is used in lieu of the conventional prep where a sterile field must be fabricated with sterile towels, clamps, Tegaderm, etc.
The RAS can be used over the arm by itself to facilitate a new right radial artery catheterization called the DRI method (drag right in). This technique facilitates a more ergonomic working platform for operators to work in a similar fashion to a transfemoral procedure. This is a hybrid technique previously described by Kirtane et al and Kern15-16, with a twist. The right arm is hyper-adducted and juxtaposed to the femoral access site after cannulation and secured with (Kelly or towel) clamps at the elbow and hand, creating a sling for patient comfort. The wrist is pronated 20-30 degrees to improve the “angle of attack” of the sheath. This rotation will bias the sheath medially, and minimize the medial manipulation of catheters and wires to overcome the lateral orientation of the radial artery. The DRI method eliminates the need for dedicated radial access boards and allows the operator to work over their biggest piece of real estate, the procedural table itself. This method pays its dividends when the use of heavy equipment and multiple exchanges are needed.
The RAS’s main benefit is in decreasing prep times, increasing efficiency, and improving ergonomics. During ST-elevation myocardial infarctions (STEMIs) and other urgent revascularizations, it can cut crucial time out of the prep to improve door-to-balloon times and better patient outcomes. Aside from its primary purpose, the RAS can also be utilized as a pedal access drape. The RAS can accommodate anterior tibial or posterior tibial access sites to facilitate fast pedal preps for a smooth transition into a retrograde approach for peripheral procedures. The second-generation RAS is also being furnished with a brachial fenestration for right heart catheterization from the brachial vein. The RAS is a comprehensive drape that can foster several access sites. The remarkable versatility of this drape could be a great addition to any cath lab’s arsenal.
The idea of the RAS was conceived several years ago by a few cath lab colleagues in New York. In the beginning, nobody wanted to prep radials, especially the left radial, so a cath lab technologist had an idea: “Why couldn’t we just have a sleeve?” The idea itself was simplistic in nature, but made a lot of sense. Several steps went into making the idea a reality. First, the correct dimensions needed to be determined. This is a step that seems elementary, but many thought processes were involved to make it fit universally. Secondly, the dual fenestration system was imperative for preserving sterility. If a sterile field passed through the underside of the sleeve where the fingers weren’t sterile, the chance of cross-contamination is very high. Lastly, the process of finding a manufacturer who had the vision to believe in the idea was also tumultuous. Several manufacturers were looked at before the ideal one was selected. All of these hurdles proved to be a very arduous process, but persistence is paramount in order to achieve your goals.
The RAS has now come to fruition through hard work, fortitude, and perseverance. Cardiac cath lab staff inherently have to be innovative to solve the daily problems they are faced with. The cardiac cath lab is a proverbial breeding ground for good ideas and solutions to hurdles that are faced every day. The RAS is just one example of innovation that was formulated in an environment that demands solutions catering to procedural outcomes, patient satisfaction, cost savings, and ergonomics.
Note: Images created in a non-clinical setting.
For more information, contact rcasazza@tesslagra.com or dscharoun@angiosystems.com.
References
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- Fornell D. Update on U.S. transradial access adoption with Sunil Rao at TCT 2015. Interview online at https://www.dicardiology.com/videos/update-us-transradial-access-adoption-sunil-rao-tct-2015.
- Kiemeneij F, Laarman GJ, Odekerken D, et al. A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the access study. J Am Coll Cardiol. 1997 May; 29(6): 1269-1275.
- Hildick-Smith DJR, Lowe MD, Walsh JT, et al. Coronary angiography from the radial artery experience, complications and limitations. Int J Cardiol. 1998 May 15; 64(3): 231-239.
- Agostoni P, Biondi-Zoccai GG, de Benedictis ML, et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systemic overview and meta-analysis of randomized trials. J Am Coll Cardiol. 2004 Jul 21; 44(2): 349-356.
- Rinfret S, Kennedy WA, Lachaine J, Lemay A, Rodés-Cabau J, Cohen DJ, et al. Economic impact of same-day home discharge after uncomplicated transradial percutaneous coronary intervention and bolus-only abciximab regimen. JACC Cardiovasc Interv. 2010 Oct; 3(10): 1011-1019. doi: 10.1016/j.jcin.2010.07.011.
- Louvard Y, Lefèvre T, Allain A, Morice M. Coronary angiography through the radial or the femoral approach: The CARAFE study. Catheter Cardiovasc Interv. 2001 Feb; 52(2): 181-187.
- De Rosa S, Torella D, Caiazzo G, et al. Left radial access for percutaneous coronary procedures: From neglected to performer? A meta-analysis of 14 studies including 7603 procedures. Int J Cardiol. 2014 Jan 15;171(1):66-72. doi: 10.1016/j.ijcard.2013.11.046.
- Hu HY, Fu Q, Chen W, et al. Randomized comparative study of left versus right radial approach in the setting of primary percutaneous coronary intervention for ST-elevation myocardial infarction. Clin Interv Aging. 2015 Jun 24;10:1003-8. doi: 10.2147/CIA.S81568.
- Sciahbasi A, Romagnoli E, Burzotta F, et al. Transradial approach (left vs right) and procedural times during percutaneous coronary procedures: TALENT study. Am Heart J. 2011 Jan; 161(1): 172-179. doi: 10.1016/j.ahj.2010.10.003.
- Kado H, Patel AM, Suryadevara S, Zenni MM, Box LC, Angiolillo DJ, et al. Operator radiation exposure and physical discomfort during a right versus left radial approach for coronary interventions: a randomized evaluation. JACC Cardiovasc Interv. 2014 Jul; 7(7): 810-816. doi: 10.1016/j.jcin.2013.11.026.
- Dominici M, Diletti R, Milici C, et al. Operator exposure to x-ray in left and right radial access during percutaneous coronary procedures: OPERA randomised study. Heart. 2013 Apr; 99(7): 480-484. doi: 10.1136/heartjnl-2012-302895.
- Norgaz T, Gorgulu S, Dagdelen S. A randomized study comparing the effectiveness of right and left radial approach for coronary angiography. Catheter Cardiovasc Interv. 2012 Aug 1; 80(2): 260-264. doi: 10.1002/ccd.23463.
- Rao SV, Cohen MG, Kandzari DE, et al. The transradial approach to percutaneous coronary intervention: historical perspective, current concepts, and future directions. J Am Coll Cardiol. 2010 May 18;55(20):2187-2195. doi: 10.1016/j.jacc.2010.01.039.
- Kern MJ. The Cardiac Catheterization Handbook, 3rd ed. St. Louis, MO: Mosby International; 1998. Pages 48-49.
- Kirtane AJ, Généreux P, Rinfret S. Prepping patients for radial access procedures. Diagnostic and Interventional Cardiology. May 13, 2013. Available online at https://www.dicardiology.com/article/prepping-patients-radial-access-procedures. Accessed December 21, 2016.