Successfully placing the left ventricular (LV) lead in an optimal clinical location is a recognized challenge of cardiac resynchronization therapy (CRT). And although the rate of failure to place the LV lead in patients has decreased over time, there is always room for improvement. This is where Interventional CRT (I-CRT) comes in.
“I-CRT…forces the operator to think differently about approaching the coronary sinus anatomy and lead placement, and equips him or her with a set of tools that make doing so more accurate, efficient, and effective,” writes Seth Worley, MD, of MedStar Heart & Vascular Institute in Washington, DC, in the June 2018 issue of EP Lab Digest.
The EP Lab Digest article titled, I-CRT: Challenging the Conventional Approach to LV Lead Placement, Literally and Figuratively, discusses the importance of moving beyond the traditional conventions in LV lead placement and the benefits of I-CRT as well as obstacles to wider adoption. Dr. Worley encourages interested electrophysiologists to participate in industry-sponsored physician training programs, such as Merit’s I-CRT course, which he proctors monthly. Furthermore, he addresses why it is essential we utilize the tools and techniques already employed by interventional radiologists and cardiologists.
“Our colleagues in interventional radiology and cardiology have successfully employed percutaneous techniques for decades,” Dr. Worley writes. “And it is time we learn from them.”
If you are interested in being trained in I-CRT tools and techniques through Merit’s specialized ThinkInterventionalCRT course, please visit our I-CRT Education page.
Patients suffering from atrial fibrillation (AF) have a minimally-invasive curative treatment option thanks to advancements in cardiac ablation catheter technology. The use of one such advancement, the steerable sheath, has resulted in higher clinical success rates in comparison to using a traditional fixed sheath.1 But despite its clinical success, operating the steerable sheath has its challenges, such as knowing a sheath’s position when under fluoroscopy.
In an effort to anticipate clinicians’ needs, Merit Medical has designed a procedural solution called the HeartSpan® Steerable Sheath. It allows a clinician to move the distal tip from 0° and 180° to achieve the desired curve within the atrial chamber. Unlike any other steerable sheath on the market, the HeartSpan facilitates catheter navigation by offering a Neutral Position Indicator and a tactile click at the neutral position. For ease of use, its ergonomic handle displays two arrows that indicate the directional plane of the curve as the handle turns.
Reaching the desired catheter position by way of a steerable sheath has been shown to have several benefits. A randomized controlled study by Piorkowski et al. investigated the clinical outcomes of using a steerable sheath in comparison to a fixed sheath.1 The study prospectively included 130 patients with paroxysmal or persistent drug-refractory AF undergoing interventional cardiac ablation for the first time.
Results published in Circulation Arrhythmia and Electrophysiology showed that single procedure success was significantly higher in patients ablated with a steerable sheath (78% vs. 55% after 3 months; 76% vs. 53% after 6 months).1 Additionally, fluoroscopy time was lower in the steerable sheath group (33+/-14min vs. 45+/-17min). The authors concluded that using a steerable sheath improved catheter stability and catheter-to-tissue contact when compared to the traditional fixed sheath.
In addition to the Neutral Position Indicator, the HeartSpan has other state-of-the-art features that support procedural success. For navigating anatomical variations, the HeartSpan is available in three curl sizes. Its braided construction offers kink resistance and curve durability. A lower crossing profile enables seamless dilator to sheath transition for smooth advancement across the atrial septum. Radiopaque marker bands enhance visibility, and an atraumatic tip reduces the risk of atrial wall perforation. The HeartSpan’s shaft body is smooth and lubricious for easy vessel insertion.
Contact your Merit Representative for a clinical evaluation. Because when it comes to cardiac ablation catheters, you should always know your direction.
REFERENCES
Piorkowski, C., Eitel, C., Rolf, S. et al. (2011). Steerable versus non-steerable sheath technology in atrial fibrillation ablation: a prospective randomized study. Circ Arrhythm Electrophysiol, Apr; 4(2): 157-65.
At Merit Medical, we’re dedicated to using the most advanced materials, designs, and manufacturing techniques with the goal of delivering solutions you can always depend on. Our PreludeEASE™ Hydrophilic Sheath Introducer is a perfect example of this commitment. Designed for strength, data shows the PreludeEASE resists compression better than the leading competitor—making it the New Go-To sheath.1
Compression resistance is an essential factor when considering a new sheath. Case studies have shown that if an arterial spasm occurs during a procedure, it can lead to the sheath compressing into the catheter, entrapping it within the vessel, and making removal of the catheter from the sheath difficult.2
Some thin-walled sheaths can be prone to compression and kinking that could result in difficult catheter manipulation. In the event of radial spasm, the catheter and sheath may need to be removed. Using a product with robust sheath tubing, like the PreludeEASE, may help clinicians avoid this problem. When tested against the leading competitor, the PreludeEASE displayed excellent compression-resistance performance.1
Other PreludeEASE advanced features include a large inner diameter for easier transitions and increased device compatibility and hydrophilic coating to facilitate insertion and removal as well as patient comfort.3 Moving smoothly from wire to dilator and dilator to sheath, the PreludeEASE streamlined design requires up to 30% less insertion force in comparison to the leading competitor.1
To accommodate varying patient anatomy, the PreludeEASE is available in multiple size configurations that range from 4F-7F diameters and can be customized in kits and packs to include other tools you need to achieve radial success.
Explore the New Go-To PreludeEASE and all it has to offer by visiting the PreludeEASE product page or talk to a knowledgeable Merit representative today.
REFERENCES
In-House Data
Popma, J. (2013). Radial Artery Complication: Case Presentation. SCAI 2013. [PowerPoint slides].
Kiemeneij, F., Fraser, D., Slagboom, T., et al. (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. Catheter Cardiovasc Interv, Jun; 59(2): 161-164.
Today, August 24th, marks the date 25 years ago when Dr. Ferdinand Kiemeneij performed the first radial access angioplasty in the Netherlands. Merit Medical is so pleased to celebrate this landmark anniversary with the physicians around the world who practice this patient-centric technique and with patients who have had a radial intervention.
Congratulations to Dr. Kiemeneij and fellow ThinkRadial Course Directors Dr. Sandeep Nathan (IC- University of Chicago, Chicago, IL) and Dr. Darren Klass (IR – Vancouver General and UBC Hospitals, Vancouver, CAN) for your efforts to move this technique forward.
In a press release issued last week, Merit Medical announced its Advanced ThinkRadial Program for Interventional Cardiologists (IC’s), with a curriculum focused on complex interventions accessed via the radial artery. The course will be co-proctored by Interventional Cardiologist Dr. Sandeep Nathan (University of Chicago) and special guest of honor, Dr. Ferdinand Kiemeneij (Tergooi Hospital in Blaricum, The Netherlands), the Father of Transradial Intervention. This course is unique because it focuses on moving IC’s with radial experience to the next level of radial interventions. It will include advanced case presentations, hands-on experiences, and a special presentation by Dr. Kiemeneij about left distal transradial access, the Next Generation of the Radial technique.
Merit is very fortunate to have Dr. Nathan and Dr. Kiemeneij co-proctor the upcoming Advanced Course for Interventional Cardiologists, which will be held October 13-14, 2017 at the Merit Medical Education Center in Salt Lake City, Utah. Dr. Kiemeneij will also co-proctor a total of five courses in 2018 at both the Merit Education Centers in Salt Lake City, Utah and in Maastricht, Netherlands.
Fully committed to the radial approach, Merit offers a full portfolio of radial products, from set-up and access to hemostasis, as well as the ThinkRadial Education Program. Dr. Kiemeneij recently tweeted about using the PreludeEASE for left distal transradial access, a next gen radial entry site in the hand. Read more about his statement in the press release or on twitter.
For more information about Merit Medical and the Next Generation of radial products and programs, visit Merit.com/NextGenRadial.
Merit Medical is pleased to announce a new Interventional CRT Center of Excellence at the MedStar Washington Hospital Center, Heart & Vascular Institute, in Washington, DC. Dr. Seth Worley, an internationally recognized expert in cardiac resynchronization therapy, began developing Interventional CRT techniques 18 years ago. He recently moved his practice to MedStar Washington Hospital to launch the hospital’s Interventional CRT program. Training opportunities will be available at the MedStar Center of Excellence beginning this September.
Interventional CRT is a progressive way of implanting LV leads using interventional cardiology tools and techniques. It uses an injection system and specially designed tools to facilitate CS Cannulation and LV lead placement. Utilizing these tools allows implanters to simplify their straightforward cases or provide options for challenging anatomies.
During the MedStar Center of Excellence courses, implanting physicians and fellows learn Interventional CRT techniques including CS Cannulation, Snaring, telescoping, venoplasty, visualization, and wire techniques. Didactic presentations, hands-on workshops, and live case observations make these programs valuable for electrophysiologists looking for options for LV lead implantation.
In addition to in-person training, the Interventional CRT program offers step-by-step guides for cannulating the CS as well as an instructional video to assist implanting physicians. The Step-by-Step Guide is available as a booklet or poster that can be downloaded. New guides for Snaring and other techniques will be available soon.
MedStar Heart and Vascular Institute has been the premier destination for advanced, complex cardiovascular care in the Washington DC Metropolitan region for more than 55 years, and is consistently ranked as one of the top cardiovascular programs in the nation by U.S.News & World Report (www.medstarwashington.org).
For more information about Interventional CRT training opportunities and availability in the MedStar Center of Excellence programs, contact Marni Adams, Program Director ([email protected], 503-867-4150) or visit InterventionalCRT.com.
Merit Medical is committed to the radial approach, with a comprehensive portfolio of radial products supporting radial procedures from set-up and access through hemostasis, as well as the ThinkRadial training program for Interventional Cardiologists and Radiologists. And in this year, the 25th anniversary of radial access, we are happy to spotlight some of our key radial products, starting with the sheath used to gain access to the radial artery.
The has evolved to address the needs of radial interventionalists. The smooth transitions between wire to dilator, and dilator to sheath, have been fine tuned for patient comfort, resulting in up to 30% less insertion force, as compared to the leading competitor1. The hydrophilic coating further facilitates insertion and removal as well as patient comfort.2
Studies also show that the hydrophilic coating on sheath introducers can reduce the incidence of artery spasm and improve patient comfort during transradial diagnostic and interventional coronary procedures.3
The PreludeEASE™ maintains a robust design that resists kinking while still providing a large inner diameter for increased device compatibility. Combining a slim profile and a large inner diameter, the PreludeEASE provides optimal dimensions without compromising integrity or performance.
On May 31, 2017, Dr. Ferdinand Kiemeneij, “@ferdikiem”, tweeted about the PreludeEASE:
Available in 4F through 7F diameters and multiple lengths. Discover what the next generation of radial access products from Merit can do at merit.com/nextgenradial. #nextgenradial
6F data on file
Kiemeneij F, Fraser D, Slagboom T, Laarman G, van der Wieken R. Hydrophilic coating aids radial sheath withdrawal and reduces patient discomfort following transradial coronary intervention: a randomized double-blind comparison of coated and uncoated sheaths. Catheter Cardiovasc Interv. 2003 Jun;59(2) 161-4.
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
Merit Medical will be hosting the next ThinkRadial Education Course on October 13-14 for Interventional Cardiologists and Radiologists. Physicians are already looking forward to this course and the opportunity to learn from the “Father of Transradial Intervention,” Dr. Ferdinand Kiemeneij. Merit is honored to once again have Dr. Kiemeneij proctor this course, to share his extensive knowledge and experience, as he did in the April ThinkRadial Course. This course will be held at the Merit Medical Global headquarters in Salt Lake City, UT on Friday, October 13 and Saturday, October 14, 2017.
Interventional Cardiologists who currently practice the transradial access technique, who want to advance their skills for more complex interventional procedures, will be proctored by Dr. Sandeep Nathan (University of Chicago) as well as Dr. Ferdinand Kiemeneij. Interventional Cardiologists attending the course will present their own complex cases for discussion and troubleshooting as well as observe complex taped cases. These physicians will learn how to navigate potential complications and increase their use of transradial for complex interventions.
Interventional Radiologists who are new to the radial approach as well as those who want to increase their knowledge and skill will be proctored by Dr. Darren Klass (Vancouver General and UBC Hospitals). Interventional Radiologists will be taught the data and economics supporting transradial access, learn about patient selection, room set-up, and equipment selection. They will learn and practice access and hemostasis techniques and discuss how to navigate potential complications. Both groups will have the opportunity to practice the radial technique on cadavers.
Dr. Kiemeneij performed the first transradial coronary angioplasty in 1992, followed by transradial stenting in the same year and stenting on an outpatient basis in 1994.
Dr. Klass is an expert in transradial radioembolization and is developing a robust hardware platform for radial access to the liver. His practice is 90% radial for liver interventions and fibroid embolization.
Dr. Nathan describes his mindset as “radial first” and utilizes the transradial approach in more than 75% of his coronary cases. He believes that transradial “is a golden opportunity to improve patient comfort and safety, without compromising procedural efficacy.”
The October ThinkRadial Course is a full day and a half of didactic presentations, taped cases and hands-on training opportunities, complimented by a group dinner and presentation by the guest of honor, Dr. Ferdinand Kiemeneij.
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!
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!
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.
Today is the first day of our April ThinkRadial™ course and we couldn’t be more excited to have Guest of Honor Dr. Ferdinand Kiemeneij, MD, PhD, co-proctoring the IR and Advanced IC sections.
Dr. Kiemeneij is working side-by-side with co-proctors Sandeep Nathan, MD, MSc, FACC, FSCAI, interventional cardiologist at the University of Chicago Medical Center in Chicago, Ill., and Darren Klass, MD, PhD, MRCS, FRCR, FRCPC, interventional radiologist at Vancouver General and UBC Hospitals in Vancouver, Canada.
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/
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.
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 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.
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.
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.
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.
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.
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
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
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
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
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
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
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
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
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/
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.
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
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
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
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
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
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
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.
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.
Merit Medical is pleased to announce a new Interventional CRT Center of Excellence at the MedStar Washington Hospital Center, Heart & Vascular Institute, in Washington, DC. Dr. Seth Worley, an internationally recognized expert in cardiac resynchronization therapy, began developing Interventional CRT techniques 18 years ago. He recently moved his practice to MedStar Washington Hospital to launch the hospital’s Interventional CRT program. Training opportunities will be available at the MedStar Center of Excellence beginning this September.
