Category: Cardiac Intervention

By Alicia Armeli

For well over a decade, transradial access has been used for coronary interventions. In comparison to the transfemoral approach, research has linked transradial with increased patient preference and fewer vascular complications.^1,2 A more cost-effective approach that has success rates similar to the transfemoral technique, transradial access is expanding into other fields of medicine.^3,4

Once reserved as an alternative mode of arterial access, the interventional radiology community is now debating whether radial artery access could provide higher patient care value under the “best practices” concept.⁵ With the growing number of physicians choosing transradial for interventional coronary and radiology procedures, Merit Medical has developed #NextGenRadial—the only second generation of radial products on the market. Combined with their innovative hands-on ThinkRadial™ training courses, Merit provides the skills and tools physicians need to launch new radial practices or successfully bring existing practices to the next level.

The femoral artery has been the traditional access point for the majority of interventional procedures, but a recent notable shift has taken place. Just last year, the European Society of Cardiology (ESC) gave the radial approach the highest degree of recommendation over femoral access for coronary angiography and Percutaneous Coronary Intervention (PCI) in patients with Acute Coronary Syndromes (ACS).⁶

“New data shows that the radial approach is superior to the femoral not only in terms of vascular complications and major bleeding events but also in reducing all-cause mortality,” said Professor Marco Roffi (Switzerland), Task Force Chairperson in an ESC press release. “It is recommended that centers treating ACS patients implement a transition from transfemoral to transradial access.”⁶

To demonstrate its superiority, multiple studies have emerged. The well-known MATRIX Study, a 2015 randomized multicenter trial by Valgimigli et al. compared radial with femoral access in patients with ACS with or without ST-segment elevation myocardial infarction and who were about to undergo coronary angiography and PCI.⁷ Consisting of 8,404 patients, results showed fewer adverse events among those who underwent the transradial approach (9.8% or 410) in comparison to those who underwent transfemoral (11.7% or 486).

Given these results, the authors of the study concluded that “radial as compared to femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality” and that transradial access should be the “default approach in patients with an acute coronary syndrome undergoing invasive management.”⁷ Other randomized investigations provide data that show transradial access to be associated with shorter hospital stay.⁸ The 2011 multicenter RIVAL trial showed transradial access to be patient-preferred, with 90% of those who underwent the transradial approach designating it as their access site of choice if they needed another procedure.¹

Patients undergoing transradial non-coronary interventions are also seeing benefits. A 2015 feasibility study by Posham et al. reported that transradial access was well tolerated among patients receiving a range of peripheral vascular interventions, including chemoembolization, visceral intervention, and uterine artery embolization.⁹ In this single-center review, 936 patients were evaluated for 1,512 transradial noncoronary procedures between April 2012 and July 2015. Results published in the Journal of Vascular and Interventional Radiology showed transradial access to have a technical success rate of 98.2%. Major complications and minor complications were minimal at 0.13% and 2.38% respectively. A total of 27 cases (1.8%) required crossover to transfemoral access.

Taking patient and clinician safety a step further, a superiority study by Khayrutdinov et al. showed that utilizing the radial technique for UFE and PAE led to reduced procedural time, thereby minimizing radiation exposure.¹⁰

From a cost benefit standpoint, the transradial approach can save money. In 2013, Amin et al. published results of a multicenter study that evaluated costs of transradial and transfemoral PCI from a contemporary hospital perspective.³ Over 7,000 procedures were performed between January 2010 and March 2011. Of these, 17% of patients underwent the transradial approach. In comparison to transfemoral, transradial was associated with shorter hospital stays (2.5 vs. 3.0 days) and fewer bleeding events (1.1% vs. 2.4%).  Total cost savings for transradial access was $830 per patient, of which $130 were procedural savings and $705 were post procedural savings. Even greater savings were seen in high-risk patients.³

Despite these findings, only 20% of interventional procedures in the US are performed via transradial access.¹¹ Low adoption of the transradial approach may be related to challenges learning the technique. And yet, data taken from the CathPCI Registry demonstrate that operator proficiency improves with greater transradial experience. Despite the learning curve of about 30 to 50 cases, patient safety is still maintained with high procedural success and low rates of mortality, bleeding, and vascular complications.¹²

As awareness of the radial technique increases among patients and physicians, Merit has developed the renowned ThinkRadial training program in an effort to provide comprehensive exposure to the next generation of transradial operators. Getting its start in 2014, ThinkRadial invited the best and brightest to spearhead the course. Leading the Interventional Cardiology Courses is Sandeep Nathan, MD, MSc, FACC, FSCAI, an Associate Professor of Medicine and Medical Director of the Cardiac Intensive Care Unit at the University of Chicago Medical Center, where he also serves as the Co-Director of the Cardiac Catheterization Laboratory and Director of the Interventional Cardiology Fellowship Program.

In 2015, Merit extended its cutting-edge ThinkRadial course to interventional radiologists by bringing on Interventional Radiology ThinkRadial Course Director Darren Klass, MD, PhD, MRCS, FRCR, FRCPC, an Interventional Radiologist at Vancouver General and UBC Hospitals, and head of the MRI Division for Vancouver Acute in Vancouver, Canada. Well-known across borders, Dr. Klass performed the first transradial radioembolization and chemoembolization of the liver in Canada.

Throughout the program, ThinkRadial attendees are split into cardiology and radiology specific tracks, but also have several opportunities to learn from each other as a combined group. In their specific tracks, they participate in didactic presentations and discuss taped cases that cover a range of topics, including patient selection, access technique, and potential complications. What’s more, hands-on training with cadavers and simulation training models provide physicians at every level of experience with radial solutions needed for their own practice.

“After attending the ThinkRadial course, I had all the tools I needed to begin transitioning my practice to radial,” said Shivank Bhatia, MD, Interventional Radiologist at the University of Miami Health System, and ThinkRadial Alumni, January 2016. “My first case post ThinkRadial was supported by Merit Medical; their reps did a great job with in-service for the entire support staff, making the introduction of radial products seamless. Using a radial approach has led to great patient experiences, reduced procedure time and overall improved patient satisfaction. I intend to be “radial first” within the next six months to one year.”¹³

Crossing continental lines, ThinkRadial courses are offered in Europe, South Africa, South America, and Asia—in addition to the US courses offered both at Merit Medical’s Utah headquarters and regionally.

The Course Directors emphasize providing a full radial “education,” as opposed to just a training, so that attendees have the knowledge they need to personalize the experience once they head back to their practice. “The class provided me with a template approach but the foresight to adapt the training to my practice as I saw fit,” explained Mohammad A. Bilal, MD, DABR, Director of Vascular and Interventional Radiology at John T Mather Memorial Hospital, Port Jefferson in Long Island, NY, and ThinkRadial Alumni, April 2016. “I was most excited to leave with the proper set of tools to implement the approach.”¹³

To fully equip this next generation of experts, Merit provides one-of-a-kind #NextGenRadial products to facilitate each step of transradial access.

Set-up: Merit Rad Board® and Accessories

The reusable Rad Board fits all cath lab and radiology procedure tables and is reversible for right- or left-side access—making it an economical choice.  Putting safety first, a section of Xenolite TB is embedded in the Rad Boards and has shown to help reduce radiation scatter exposure levels by up to 44% at waist height and up to 25% at neck height, according to an independent survey.* Convenient uprights on the sides form a reservoir with the drape to keep devices and fluids on the board. Cutout handles allow for convenient moving and transport.

Each Rad Board accessory—Rad Board Xtra™, Rad Trac™ and Rad Rest®—provide additional support for radial access procedures. The Rad Board Xtra allows for 90° perpendicular extension of the arm during access, while the Rad Trac encourages easy placement of the Rad Board when the patient is on the table. The soft Rad Rest arm cushion boosts patient comfort by providing ergonomic wrist and elbow support during radial access procedures.

Access: PreludeEASE™ Hydrophilic Sheath Introducers

PreludeEASE is Merit’s newest line of Hydrophilic Sheath Introducers. Studies show that hydrophilic coating on sheath introducers can reduce the incidence of artery spasm and improve patient comfort during transradial diagnostic and interventional coronary procedures.¹⁴

PreludeEASE kink-resistant tubing helps to provide procedural reliability. Smooth transitions between wire to dilator and dilator to sheath were designed for ease of insertion and can help enhance patient comfort. Available in 4F through 7F diameters and multiple lengths, PreludeEASE anticipates various clinical needs and diverse patient anatomy without compromising its slim profile and large inner diameter.

Diagnostics: Performa® Diagnostic Cardiology Catheters

Merit’s Performa diagnostic cardiology catheter is designed with improved shaft strength for better pushability and torque. Made from Nylon Pebax® material selected to give the Performa improved kink resistance, its flat-wire braid design offers greater stability and increased torque. A large inner lumen enables increased flow rates. The Performa’s winged polycarbonate hub offers enhanced handling and control and the radiopaque tip allows shaft visualization under fluoroscopy to ensure accurate placement. Anticipating individual patient needs, Merit’s diagnostic catheters come in radial specific shapes and lengths. Also available is the Performa Multipack, which combines all three typical workhorse catheters in one convenient package.

Hemostasis: Safeguard Radial™ Compression Device

The Safeguard Radial Compression Device is a 26-cm long self-adhesive wristband designed to assist with hemostasis following radial access procedures. The band allows for adjustable compression of the radial puncture site with an inflatable bulb and standard Luer valve for easy inflation and deflation with any standard Luer syringe.

A clear window allows for better visualization of the puncture site and the size and shape of the bulb minimizes compression of surrounding nerve structures or other areas. The one-size-fits all cloth wristband offers greater patient comfort and fits securely around the wrist.

Through evidence-based data, education, and products, Merit Medical’s #NextGenRadial toolkit provides physicians with the skills, products—and above all—the confidence they need to take full advantage of the radial approach. A technique where the data speaks for itself, radial access is no longer the future of medicine—but the present. Will you be part of the Next Generation?

Alicia Armeli is a paid consultant of Merit Medical. Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

REFERENCES

1. Jolly, S., Yusuf, S., Cairns, J., et al. (2011). Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. The Lancet, 377(9775): 1409-1420. doi: http://dx.doi.org/10.1016/S0140-6736(11)60404-2
2. Feldman, D., Swaminathan, R., Kaltenbach, L., et al. (2013). Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention—an updated report from the National Cardiovascular Data Registry (2007–2012). Circulation, 127: 2295-2306. doi: http://dx.doi.org/10.1161/CIRCULATIONAHA.112.000536
3. Amin, A., House, J., Safley, D., Chhatriwalla, A., Giersiefen, H., Bremer, A., Hamon, M., Baklanov, D., Aluko, A., Wohns, D., Mathias, D., Applegate, R., Cohen, D., & Marso, S. (2013). Costs of transradial percutaneous coronary intervention. Journal of the American College of Cardiology Cardiovascular Interventions, 6(8): 827-834. doi: 10.1016/j.jcin.2013.04.014. https://www.ncbi.nlm.nih.gov/pubmed/23871512
4. Rao, S., Ou, F., Wang, T., Roe, M., Brindis, R., Rumsfeld, J., Peterson, E. (2008). Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention—a report from the National Cardiovascular Data Registry. Journal of the American College of Cardiology Cardiovascular Interventions, 1(4). doi: 10.1016/j.jcin.2008.05.007. https://www.ncbi.nlm.nih.gov/pubmed/19463333
5. Guimaraes, M., Tamada, R., Anderson, et al. (2016). Radial access for interventional radiology procedures. Just an alternative access or an excellent model aligned with the upcoming changes of the healthcare reform? Journal of Vascular and Interventional Radiology, 27(3): S47-S48. doi: http://dx.doi.org/10.1016/j.jvir.2015.12.133
6. European Society of Cardiology. (2015). ESC Guidelines Recommend Radial Approach for Percutaneous Coronary Interventions in ACS. Retrieved November 14, 2015, from http://www.escardio.org/The-ESC/Press-Office/Press-releases/esc-guidelines-recommend-radial-approach-for-percutaneous-coronary-interventions-in-acs
7. Valgimigli, M., Gagnor, A., Calabró, P., et al. (2015). Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. The Lancet, 385(9986): 2465-2476. doi: http://dx.doi.org/10.1016/S0140-6736(15)60292-6
8. Romagnoli, E., Biondi-Zoccai, G., Sciahbasi, A., et al. (2012). Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. Journal of the American College of Cardiology, 60(24): 2481-2489. doi: 10.1016/j.jacc.2012.06.017. http://www.sciencedirect.com/science/article/pii/S0735109712023662
9. Posham, R., Biederman, D., Patel, R., et al. (2016). Transradial approach for noncoronary interventions: a single-center review of safety and feasibility in the first 1,500 cases. Journal of Vascular and Interventional Radiology, 27(2): 159-166. doi: 10.1016/j.jvir.2015.10.026. https://3g6fc347p04i2t7uf32fjw56-wpengine.netdna-ssl.com/wp-content/uploads/2016/04/Posham-Fischman-TRA-Non-Coronary-Sinai.pdf
10. Khayrutdinov, E., Arablinskiy, A., Vorontsov, A., Moscow/RU, & Omsk/RU. (2015). The Olbert International Radiology Symposium—The benefit of transradial artery approach in patients undergoing peripheral artery embolization. Retrieved November 14, 2016, from https://3g6fc347p04i2t7uf32fjw56-wpengine.netdna-ssl.com/wp-content/uploads/2015/01/IROS-2015.pdf
11. Bilazarian, S. (2015). Medscape. Radial Access: Get Onboard or Get Left Behind. Retrieved November 16, 2016, from http://www.medscape.com/viewarticle/837729
12. Hess, C., Peterson, E., Neely, M., et al. (2014). The learning curve for transradial percutaneous coronary intervention among operators in the United States: a study from the National Cardiovascular Data Registry. Circulation, 129(22): 2277-2286. doi: 10.1161/CIRCULATIONAHA.113.006356. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4048735/
13. ThinkRadial Transradial Intervention Course. (Oct 2016). Attendee Testimonial.
14. 14. Rathore, S., Stables, R., Pauriah, M., Hakeem, A., Mills, J., & Palmer, N. et al. (2010). Impact of length and hydrophilic coating of the introducer sheath on radial artery spasm during transradial coronary intervention. JACC: Cardiovascular Interventions, 3(5): 475-483. https://www.ncbi.nlm.nih.gov/pubmed/20488402

*In-house data

Alicia Armeli is a freelance writer and editor who specializes in medical technology, health, and wellness.

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