Expert panel to discuss Interventional CRT Implant Techniques at the Rhythm Theater during HRS 2017

Merit Medical and Discover Interventional CRT would like to invite physicians attending HRS 2017 to save space on their program schedules for an invaluable presentation on Thursday, May 11th from 3:15-4:15pm in Rhythm Theater #2 titled, Interventional CRT Implant Techniques.

Leading the lecture are some of the field’s top electrophysiologists: (Chair) Kenneth A. Ellenbogen, MD, of Medical College of Virginia/VCU School of Medicine in Richmond, VA.; Jagmeet P. Singh, MD, DPhil, of Massachusetts General Hospital Heart Center in Boston, MA.; Seth Worley, MD, of MedStar Washington Hospital Center in Washington, DC; and Kevin Jackson, MD, of Duke University Medical Center in Durham, NC.

Interventional CRT Implant Techniques will explore how these leading physicians are utilizing interventional techniques to overcome difficult anatomy during LV lead placement. Experts will share clinical experience, novel approaches, and discuss whether anatomy or electrical timing should determine LV lead location. For more information about this timely event, please visit https://www.merit.com/hrs2017/. We look forward to seeing you there!

Featuring the HeartSpan® Fixed Curve Transseptal Sheath at HRS 2017

Our excitement for HRS 2017 is building because it means we’re getting closer to showcasing some of our most exciting products.

One highly anticipated product, The HeartSpan® Fixed Curve Transseptal Sheath, is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. Available in a kit that contains a sheath, a dilator, and a J-tipped guidewire, the HeartSpan is designed for seamless dilator to sheath transition for ease of insertion and to reduce trauma when crossing the atrial septum.

To facilitate access to a variety of cardiac structures and sites, the sheaths are available in various sizes, lengths, and tip curve configurations—including the NEW ML1 and ML0 curves with intended anterior to lateral and superior to lateral positions, respectively. Both of these curves can be used as possible pulmonary vein isolation (PVI) ablation targets.

Other key features include:

  • Integrated Hemostatic Valve
    Designed to reduce air introduction and backflow
  • Lubricious Coating
    Reduces friction when exchanging electrophysiology (EP) catheters
  • Radiopaque Dilator
    Enables visualization

To learn more about the HeartSpan and its many product features, stop by booth 1549 for hands-on demonstrations of all Merit EP products.  For a schedule of all educational opportunities offered by Merit Medical at the upcoming HRS2017, visit Merit.com/HRS2017.

We are looking forward to seeing you there!

For a complete step-by-step guide to delivery, refer to instructions for Use. Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

Join Us At HRS 2017!

Merit Medical and Discover Interventional CRT are pleased to announce training opportunities at HRS 2017. From May 10-12 in Chicago, Ill., HRS attendees can learn techniques and technologies from some of electrophysiology’s foremost leaders. Here’s a preview of what you can expect:

Thursday, May 11

LV Lead Delivery: Providing Options with a Simplified Approach
Booth 1549
9:45-10:15am
In-booth presentation by Dr. Seth Worley of MedStar Washington Hospital Center in Washington, DC. Dr. Worley will be available throughout the day for hands-on training.

Rhythm Theater—Interventional CRT Implant Techniques
Rhythm Theater #2
3:15-4:15pm
Dr. Kenneth A. Ellenbogen of Medical College of Virginia/VCU School of Medicine with expert panel discuss how leading physicians are utilizing interventional techniques to overcome difficult anatomy during LV lead placement.
Want more information?

Friday, May 12 

In-Booth Meet the Experts Hands-on Training
Booth 1549
9:30-10:30am and 3:00-4:30pm
Attendees have two opportunities to meet with interventional CRT experts as they share their advanced techniques for LV lead placement.

Throughout HRS, attendees will also get hands-on demonstrations for Merit EP products, including the new ML1 and ML0 HeartSpan® Fixed Curve Transseptal Sheath shapes. For more information about this year’s HRS schedule, visit https://www.merit.com/hrs2017/

Want to Learn More About Transradial Access?

Two of the Leaders in IR Transradial Access Invite Interventional Radiologists to Attend a Special “Intro to Transradial” Dinner Event

By Alicia Armeli

On Monday, March 27, 2017, from 6-9p at Ristorante Morini in Midtown, NYC, Merit Medical and ThinkRadial™ will host a special “introduction to transradial” dinner event to promote clinical benefits and present introductory training information to interventional radiologists. A uniquely beneficial learning opportunity, attendees will have the chance to listen to well-known interventional radiology radialists, Dr. Aaron Fischman of Mount Sinai in NYC and Dr. Darren Klass of Vancouver General and UBC Hospitals in Vancouver, Canada, as they give informational didactic presentations over dinner.

Topics for discussion will include the clinical benefits of transradial access and fundamental tips to get started, such as case selection, patient prep, room setup, catheter selection, and hemostasis. What’s more, Dr. Fischman and Dr. Klass will share their expertise by offering a valuable Q & A radial panel discussion.

Aaron Fischman, MD, is the Director of Vascular and Interventional Radiology at The Mount Sinai Health System and Associate Professor of Radiology and Surgery at the Icahn School of Medicine at Mount Sinai. He is also Associate Professor of Radiology and Surgery in the Division of Vascular and Interventional Radiology at The Mount Sinai Medical Center. A leader of the transradial technique, Dr. Fischman has led the way using transradial for oncologic liver interventions and uterine fibroid embolization. Dr. Fischman has shared his knowledge and experience by authoring and co-authoring many peer-reviewed publications and lecturing worldwide about novel techniques for minimally invasive interventions.

Darren Klass, MD, PhD, MRCS, FRCR, FRCPC, is a Clinical Assistant Professor at the University of British Columbia and an Interventional Radiologist with Vancouver Coastal Health, as well as Vancouver Imaging, practicing at Vancouver General and UBC Hospitals. His hospital appointments include Medical Head of MRI. Performing the first transradial radioembolization and chemoembolization of the liver in Canada, Dr. Klass has performed over 400 radial interventions, including renal and splenic interventions and embolization procedures throughout the abdomen and pelvis to treat acute hemorrhage. Well-versed in the radial technique, his current practice is approximately 90% radial access for liver interventions and fibroid embolization.

This one-of-a-kind dinner event is open to interventional radiologists who want to learn the basics of transradial access and how to get started. Merit representatives will also be available to answer any “next-step” questions physicians may have. Seating is limited!
RSVP today at Merit.com/Education

Alicia Armeli is a paid consultant of Merit Medical. For a complete step-by-step guide to delivery, refer to instructions for Use. Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

“Father of Transradial Intervention,” Ferdinand Kiemeneij, MD, PhD, to be the Special Guest of Honor and Co-Proctor for Upcoming ThinkRadial™ Education Program in April

Father of Transradial Intervention Dr. Kiemeneij during lecture

By Alicia Armeli

In order to keep up with the growth and progress of interventional medicine, Merit Medical is hosting a dynamic ThinkRadial™ training course on April 21-22 at Merit Medical headquarters in Salt Lake City, Utah. For the first time in the US, world-renowned Interventional Cardiologist Ferdinand Kiemeneij, MD, PhD, will be attending as the special guest of honor, co-proctoring the interventional radiologist and brand new advanced interventional cardiologist courses, lecturing at both training sessions.

Recognized as the “Father of Transradial Intervention,” Dr. Kiemeneij first began applying transradial access to angioplasty and stent placement procedures as early as 1992. This led to stenting on an outpatient basis in 1994. Since then, Dr. Kiemeneij has been lecturing and teaching physicians the transradial technique, as well as its many advantages over transfemoral access. More than two decades later, the European Society of Cardiology (ESC) gave the transradial approach the highest degree of recommendation over transfemoral access for coronary angiography and Percutaneous Coronary Intervention (PCI) in patients with Acute Coronary Syndromes (ACS).1

Sought after worldwide, Dr. Kiemeneij was invited in 2013 to build an intervention program at the Tergooi Hospital in The Netherlands. The author of numerous clinical articles and a 2016 book entitled, Transradial Coronary Interzentions, Dr. Kiemeneij has built his practice by combining writing, proctoring, lecturing, and training fellow physicians the world over.

Dr. Kiemeneij co-proctoring advanced interventional cardiologist attendees

Dr. Kiemeneij will co-proctor advanced interventional cardiologist attendees with venerated Interventional Cardiologist Sandeep Nathan, MD, MSc, FACC, FSCAI, of the University of Chicago Medical Center in Chicago, Ill. He will co-proctoring the interventional radiologist portion with esteemed Darren Klass, MD, PhD, MRCS, FRCR, FRCPC, Interventional Radiologist at Vancouver General and UBC Hospitals in Vancouver, Canada. Dr. Kiemeneij will also share his knowledge and expertise during the groups’ hands-on trainings. Following the Friday sessions, Dr. Kiemeneij will give an invaluable presentation at a special group dinner event.

Space for this program is limited. To submit your interest in this upcoming Think Radial training course and learn from the “Father of Transradial Intervention,” talk to your Merit Representative or visit Merit.com/Education.

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.

  1. European Society of Cardiology. (2015). ESC Guidelines Recommend Radial Approach for Percutaneous Coronary Interventions in ACS. Retrieved February 11, 2017, from http://www.escardio.org/The-ESC/Press-Office/Press-releases/esc-guidelines-recommend-radial-approach-for-percutaneous-coronary-interventions-in-acs

#NextGenRadial Provides Tools and Skills Clinicians Need for Transradial Access

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.

403359001/A

Achieve Radial Access with Ease

Merit Medical PreludeEase Hydrophilic Sheath Introducers

By Alicia Armeli

PreludeEase™—Merit Medical’s newest line of Hydrophilic Sheath Introducers—has made the transradial artery approach even better. 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.1

In recent years, the transradial approach has become increasingly popular for diagnostic and interventional coronary procedures. In comparison to transfemoral access, the transradial approach is linked to fewer vascular complications, shorter hospital stays, and reduced mortality.2 Financially, using the transradial technique may reduce direct and indirect hospital costs, while minimizing the overall financial burden from a larger social perspective.3,4

Notwithstanding these benefits, vascular complications can arise. More specifically, radial artery spasm is a common complication during transradial procedures and can lead to severe patient discomfort and diminished procedural success.1,5

A team of researchers at the Liverpool Heart and Chest Hospital in Liverpool, UK, examined the impact hydrophilic-coated sheath introducers had on the rate of radial artery spasm.1 In all, 790 patients scheduled for a transradial coronary procedure were randomly assigned hydrophilic-coated or uncoated sheath introducers. Results published in the Journal of the American College of Cardiology showed that radial artery spasm was seen significantly less in patients using a hydrophilic-coated sheath introducer (19.0% vs. 39.9%). Within the hydrophilic-coated group, less discomfort was also reported (15.1% vs. 28.5%). Sheath length didn’t influence these outcomes.

These results only mirror findings of numerous other studies. Saito et al. found sheath introducers with hydrophilic coating to lessen friction resistance by 70% in an in vitro model, which helped with sheath removal.6

A study published in Catheterization and Cardiovascular Interventions further investigated whether hydrophilic coating reduced the required force of sheath removal and any associated patient discomfort.5 Through a randomized double-blind comparison, Kiemeneij et al. analyzed 90 patients undergoing transradial percutaneous coronary intervention. Each patient received a sheath of identical length and diameter—the only difference being the presence or absence of hydrophilic coating.

Findings showed 3 patients (7%) in the coated group reported discomfort versus 12 patients (27%) in the uncoated group. Required force, measured in maximum and mean pullback force, was also significantly lower in the coated group.5

In addition to hydrophilic coating that extends to the sheath tip, the kink-resistant PreludeEASE 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.

PreludeEASE sheaths are available in a variety of kit configurations, including one and two-part access needles, several guide wire options, a BowTie™ Guide Wire Insertion Device, and more. In addition, Merit can customize PreludeEASE radial access kits to meet both specific and a wide variety of clinical needs.

PreludeEASE Hydrophilic Sheath Introducers complement Merit’s growing line of products designed to support radial access procedures from preparation to hemostasis. In this way, PreludeEASE can help interventional cardiologists not only perform radial access procedures with success—but with ease.

Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

REFERENCES

  1. 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
  2. Schussler, J., Vasudevan, A., von Bose, L., Won, J., & McCullough, P. (2016). Comparative efficacy of transradial Versus transfemoral approach for coronary angiography and percutaneous coronary intervention. The American Journal Of Cardiology, 118(4): 482-488. http://dx.doi.org/10.1016/j.amjcard.2016.05.038
  3. Amin, A., House, J., Safley, D., Chhatriwalla, A., Giersiefen, H., & Bremer, A., et al. (2013). Costs of transradial percutaneous coronary intervention. JACC: Cardiovascular Interventions, 6(8): 827-834. doi: 10.1016/j.jcin.2013.04.014. https://www.ncbi.nlm.nih.gov/pubmed/23871512
  4. Kołtowski, Ł., Filipiak, K., Kochman, J., Pietrasik, A., Huczek, Z., & Balsam, P. et al. (2016). Cost-effectiveness of radial vs. femoral approach in primary percutaneous coronary intervention in STEMI – Randomized, control trial. Hellenic Journal Of Cardiology, 57(3): 198-202. http://dx.doi.org/10.1016/j.hjc.2016.06.005
  5. Kiemeneij, F., Fraser, D., Slagboom, T., Laarman, G., & van der Wieken, R. (2003). Hydrophilic coating aids radial sheath withdrawal and reduces patient discomfort following transradial coronary intervention: A randomized double-blind comparison of coated and uncoated sheaths. Catheterization And Cardiovascular Interventions, 59(2): 161-164. http://dx.doi.org/10.1002/ccd.10444
  6. Saito, S., Tanaka, S., Hiroe, Y., Miyashita, Y., Takahashi, S., & Satake, S. et al. (2002). Usefulness of hydrophilic coating on artery sheath introducer in transradial coronary intervention. Catheterization And Cardiovascular Interventions, 56(3): 328-332. http://dx.doi.org/10.1002/ccd.10202

Alicia Armeli is a Freelance Writer and Editor who specializes in medical technology, health, and wellness.

Article: Transradial access for IR’s is gaining traction –An interview with three Interventional Radiologists

Interventional Radiologists interviewed about transradial access

In its November issue, Interventional News reports that transradial access for Interventional Radiologists is gaining traction, as evidenced by the full room of attendees at a satellite symposium about the radial approach, sponsored by Merit Medical during the Cardiovascular and Interventional Radiological Society of Europe’s annual meeting in September. In the article, Interventional News interviews the three symposium speakers, all interventional radiologists who are experts in the radial approach: Dr. Christoph Binkert, a professor of Radiology in Zurich, Switzerland; Dr. Aaron Fischman, an Interventional Radiologist and assistant professor of Radiology and Surgery, Mount Sinai Medical Center, New York, USA; and Dr. Darren Klass, Interventional Radiologist, Vancouver Coastal Health, Vancouver, Canada.

The three physicians outline the benefits to patients of radial artery access over transfemoral access and potential complications and data that shows a very low complication rate. They also comment on the need for radial-specific devices. In his commentary Dr. Klass discusses reasons why many interventional radiologists are hesitant to change to the radial approach and some of the reasons why these hesitations should be overcome. Finally, the article includes the top tips for starting a radial service, as provided by Dr. Klass.

Read the full Interventional News article.

Ostial PRO® Debuts in Turkey

Ostial PRO in Turkey

Merit Medical’s Ostial PRO Stent Positioning System was recently used for the first time in Turkey. The case was a renal aorto-ostial lesion performed by a cardiovascular surgeon at a University Hospital.

“The case went very well, and the cardiovascular surgeon liked the product very much,” Bahadir Şenol, Merit Medical Clinical Sales Specialist, said. “The surgeon plans to purchase additional Ostial PROs to have on-hand as they are needed.”

The Ostial PRO stent positioning system is an alignment tool with gold-plated “feet” that engage the aortic wall and allow easier assessment of the coronary or renal ostia, improving accuracy of stent positioning. In clinical studies, the Ostial PRO significantly increased the accuracy of aorto-ostial stent placement.1

“This is a product that can save lives,” Şenol said, adding that Merit Medical offers clinical support to doctors and hospitals that are interested in utilising the Ostial PRO. To learn more, contact your Merit Sales Representative or visit the Ostial Pro page on our website, which features a product video, several case studies, and documents such as brochures and instructions.

1 Data on file.