Category: Peripheral Intervention
Most Interventional Cardiologists throughout Europe support a radial-first approach for PCI. And more and more Interventional Radiologists and Neuro Radiologists admit that radial access plays a prominent role in an operator’s practice. Merit Medical’s ThinkRadialTM program brings together these disciplines with one goal: leverage the benefits of using transradial access (TRA) in reduction of access-site […]
Merit Medical prides itself on proactively meeting customer needs and delivering a diverse range of high-quality products. From diagnostic and interventional wires to catheters and microcatheters, our innovative product lines are designed with you in mind, offering many advantages over competing devices. Take a look at some of our most trusted products and discover how they can meet your clinical needs and improve patient care.
- Merit Laureate® Hydrophilic Guide Wires display true 1:1 torque response and optimum lubricity, when placing devices during diagnostic and interventional procedures. Market studies show the Laureate has definitive turn-for-turn responsiveness, a design feature that aids in minimizing wire whipping and friction and supports rapid catheter exchanges. Its resilient hydrated gel coating provides a constant fluid layer on the wire surface for long-lasting durability. In addition, the Laureate has a nitinol core and a radiopaque jacket designed to provide enhanced visibility.
- The True Form® is a 0.014” reshapable guide wire designed with Shapeable Tip Technology. Truly holding its shape during procedures, the True Form can be shaped and reshaped multiple times for vessel cannulation. Up to 7x more lubricious than the competition, its hydrophilic coating, along with a flexible shaft, helps navigate tortuous anatomy, whereas a stainless steel core gives excellent support for devices. The True Form Reshapable Guide Wire is now preloaded within the Merit Maestro® Microcatheter, a system that adds ease in preparation, potentially saving time and increasing procedural efficiency.
- The Performa® line of Diagnostic Cardiology and Peripheral Catheters is available in both radial and femoral curves and a large variety of shapes for each clinical application. Both devices are engineered with a nylon Pebax® material for improved kink resistance during procedures. The wire braid design offers greater torque and a high degree of maneuverability and pushability. The Performa line is available in 4F, 5F, and 6F, yielding higher flow rates at lower pressures.
- Impress® Hydrophilic Catheters boast several features that support navigation through tortuous anatomy. Its Legato hydrophilic coating is designed to reduce friction and maintain lubricity. Merit’s proprietary braided stainless steel shaft provides excellent tortional torque and maximum flexibility while reducing kinking in a tight radius. In addition, the Impress is designed with a soft, tapered tip that is highly visible under fluoro. Available in a wide range of standard shapes, Impress Hydrophilic Catheters can also be customized to support your professional needs.
- The Merit SureCross® is a hydrophilic support catheter made specifically for crossing tight, difficult lesions. Designed with SureCross Shaft Technology, these support catheters optimize pushability and flexibility, which improves guide wire support, trackability, and lesion crossing. Its low-profile yet robust tapered tip offers triple platinum marker bands that begin at a tip distance of 2 mm, maximizing accuracy of tip location, enhancing tip radiopacity, and providing seamless tip to guide wire transition. The SureCross is compatible with multiple guide wire diameters and is available in several lengths to meet your clinical needs.
- The Merit Maestro® Microcatheter provides the outcomes you expect for small vessel embolization. This multipurpose microcatheter is designed with a nylon ribbon braid that extends the entire length of the catheter, including the tip, giving exceptional torque, kink recovery, and steerability. Distal hydrophilic coating increases trackability through tortuous anatomy while a radiopaque marker allows the clinician to easily identify the catheter tip. The innovative Swan Neck design helps to seat the catheter in the vessel, reducing the recoiling effect of embolic material. Preloaded with the True Form™ Reshapable Guide Wire, this system simplifies preparation, which may save time and boost procedural efficiency.
- For the distal vasculature that seemed out of reach, Merit Pursue™ Microcatheters are designed for pushability and trackability through small and tortuous vessels. Pursue Microcatheters have a small outer diameter that allows for deeper navigation into the vasculature while still being able to deliver the same spherical and non-spherical embolics of larger diameter microcatheters.
- The SeaDragon™ Torque Device is designed to enhance manipulation of both hydrophilic and PTFE-coated guide wire tips: Simply squeeze the top cap to position, reposition, or remove the device. The ergonomic SeaDragon can be operated with one hand, achieving rapid device exchanges. Without having to tighten and untighten, the SeaDragon helps to save clinicians time.
Learn more about how these Merit products can meet your clinical needs by visiting the product pages or speaking with a Merit representative today.
Pebax® is a registered trademark of Arkema France.
At Merit Medical, our commitment to improving the lives of healthcare professionals and their patients goes beyond the manufacturing process. More than just a medical device company, we provide services that ensure our customers get the most out of our products. An excellent example of this service is our newly launched MyAspira.com, a mobile-optimized online […]
We are thrilled to be exhibiting at this year’s 2018 Vascular Annual Meeting of the Society for Vascular Surgery. Come see the Q50®PLUS Stent Graft Balloon Catheter1 – available exclusively from Merit Medical. We have multiple products to help you in your abdominal and thoracic procedures. Additionally, Merit has a broad offering of dialysis products, […]
We’re excited to be exhibiting at this year’s Vascular Access for Hemodialysis Symposium – VASA 2018. The symposium will be held May 10-12 in New Orleans and is considered to be a premier educational event by professionals involved in the management of vascular access. Merit will be hosting an educational symposium as well as showcasing […]
Today, May 1st, marks the 10-year anniversary of the first commercial HeRO Graft (Hemodialysis Reliable Outflow) implantation performed by John R. Ross, MD, founding physician1, lead surgeon, and medical director2 of the Dialysis Access Institute at the Regional Medical Center in Orangeburg, SC.
Designed for high-risk patients with end-stage renal disease, the HeRO Graft bypasses central venous stenosis, creating a pathway for blood to move to the heart. According to Dr. Ross, these patients typically have had multiple accesses and a lengthy total catheter contact time.
“Many of the patients that we’re putting HeROs in now really only have one other option and that’s to have a long-term catheter, which has a far greater mortality and morbidity than having a running-blood access,” explains Dr. Ross. “This is where the HeRO fits in.” 3
Living up to its name for the past decade, the HeRO has been implanted worldwide, offering access-challenged patients who have exhausted all other access options the chance to continue life-saving hemodialysis. Merit Medical recently sat down with Dr. Ross to reflect on the first HeRO Graft implant and the impact this innovation has had on patient care. Watch the above video.
Navigating through difficult vascular anatomy can be challenging, and finding just the right guide wire to do so can be even more difficult. Ultimately, clinicians need a wire that is reliable and that can get them to their destination within the vasculature, even if the path is a tortuous one. Look no further, because the new InQwire Amplatz guide wire was designed to do just that.
A firm inner core, a smooth transition and a lubricous coating are key elements for reliable guide wire navigation. With those elements in mind, the InQwire Amplatz wire was carefully designed to be a tool for precision, agility, and strength. The wire’s firm construction provides an increased level of stiffness that delivers extra support and stability within the vasculature, specifically for enhanced navigation.
A flat outer wire coil allows a larger inner core to provide added stiffness which facilitates catheter placement and advancement of other devices, such as dilatation catheters and stent catheters during contralateral access. A smooth tapered transition from the shaft to the flexible tip, allows atraumatic negotiation of the most difficult vascular anatomy.
A proprietary outer coating was added to the entire surface of the wire to facilitate smooth navigation with less resistance against vessel walls. In testing the wire’s performance against the leading competitor, the InQwire Amplatz proved to be superior and was documented as having a 20% higher lubricity rating*. The Merit InQwire Amplatz wire requires considerably lower force per grams, therefore allowing catheters to move more easily over the wire.
The InQwire Amplatz is compatible with 0.035” & 0.038” devices and for added convenience the Amplatz wires are available in multiple tip configurations to include straight-tip wires in a variety of flexible profiles including 1.0cm, 3.5cm, 4.0cm, 6cm, and 7cm. A J3mm tip configuration is also available.
For additional information visit Merit.com/Amplatz or contact your local Merit representative.
*Data on file
Approximately 80% of patients starting hemodialysis use tunneled dialysis catheters, while 25% of all prevalent patients have one placed as a bridge to permanent vascular access, or because all other options for permanent access have failed.1 And yet, catheter dependency still poses the risk of infection. Current research is now pointing to an alternative to catheter use among access-challenged hemodialysis patients: permanent subcutaneous arteriovenous graft devices. Data has shown that the HeRO™ (Hemodialysis Reliable Outflow) Graft is the only clinically proven permanent subcutaneous arteriovenous graft to reduce the risk of vascular access-related infections by 69% when compared to tunneled catheters.2
Unlike other graft devices, HeRO Graft technology improves long-term hemodialysis by way of a Venous Outflow component that’s placed in the right atrium, which then attaches to an adjacent ePTFE hemodialysis graft via a proprietary titanium connector. This mechanism allows for blood to return from an artery back to the heart, bypassing central venous occlusions—a common complication seen among catheter-dependent long-term dialysis patients.
When the HeRO Graft was compared to tunneled dialysis catheter use, access-related bacteremia rates were significantly lower (0.7 events/ 1000 days). Reported infection only occurred during the bridging period when a catheter was implanted prior to a HeRO Graft being used.2
In an effort to circumvent the 2-4 week bridging period and avoid this risk of infection, Merit launched the Super HeRO™ Adapter in 2016. Made with the same HeRO Graft technology, the Super HeRO Adapter has the advantage of wide range graft compatibility. In this instance, by connecting the Super HeRO Adapter to a compatible early cannulation graft, a patient can be implanted today and dialyzed the next, virtually eliminating the risk of access-related infection due to a bridging catheter.
The Super HeRO Adapter is also designed for long-term, access-challenged hemodialysis patients who still have a working Venous Outflow component but need a new graft. Available through the HeRO Ally™ Revision Kit, this option provides clinicians with the tools they need to replace an old graft with a compatible graft of their choice.
In addition, eliminating risks associated with vascular access infection can lead to healthcare cost-savings. A US healthcare model for provision of dialysis access predicted that in comparison to catheters, implementing HeRO technology could result in an average of 23% annual savings—with infection observed as one of the primary determinants of cost.3
In order to meet the diverse needs of patients, dialysis technology is continuously evolving. By taking advantage of innovative tools, clinicians can improve the dialysis experience for catheter-dependent patients, offering them better treatment and a new outlook on life.
As an option to help improve patient care and save on healthcare related costs, Merit Medical offers an in-depth, hands-on training course – THINK ACCESS – that covers techniques for HeRO graft implantation. To be considered for an upcoming THINK ACCESS course, visit the link below to sign-up.
- Clin J Am Soc Nephrol. 2011;6: 2247-52.
- J Vasc Surg. 2009;50: 600-607.
- J Surg Res. 2012;177: 165-171.
Have you signed up for the September Think Access™ training course yet? September’s training is the first time that superpowers have been combined, adding comprehensive training for both the HeRO®/Super HeRO® Graft and for Peritoneal Dialysis (PD) systems. We are happy to announce that training for this exclusive course will be held at the VISTA lab in Baltimore, Maryland Friday, September 15th through Saturday the 16th.
HeRO Graft and PD training at VISTA means you’ll have the opportunity to learn cutting-edge skills and have access to the latest technologies that will help support the advancement of your interventional and surgical procedures. September’s Think Access course is like no other because you’ll be able to rehearse, perfect, and perform techniques using cadavers (HeRO portion only) and simulators in a state-of-the-art facility. Broken up into two groups for more individualized instruction, training such as placing new implants and catheters as well as complications/tips and tricks will be covered. For HeRO, you’ll revisit existing implants, placement of the venous outflow component from different access sites, identifying the anastomosis and tunneling will be addressed. These topics will be put into practice again in the SIM Lab using VISTA’s advanced training models.
Clinical discussions will also be taking place throughout the course that focus on PD and HeRO Graft tips, troubleshooting, and clinical guidelines. You’ll be invited to dive into several case study discussions with other physicians, enabling you to familiarize yourself with HeRO and PD clinical scenarios that will help prepare you for challenging cases.
You’ll be taught by two of the foremost thought leaders, John H. Crabtree, MD Chair of PD University for Surgeons-North America and Jesse Garcia, MD, Vascular Surgeon at MedStar Heart & Vasculature Institute at MedStar Washington Hospital Center.
Dr. Crabtree has pioneered modifications and enhancements to the laparoscopic placement for peritoneal dialysis patients and has authored numerous articles covering dialysis catheters, implantation techniques, and resolution of dialysis access complications. He currently serves as Visiting Clinical Faculty at Harbor-UCLA Medical Center and as the Activity Director for ISPD-sponsored surgeon education programs for Europe.
Jesse Garcia, MD, is a board-certified general surgeon who specializes in vascular access surgery for patients diagnosed with kidney failure who need dialysis. His passion for practicing medicine began with his father, who led the cardiac surgery program at MedStar Washington Hospital Center into the 1980s.
Dr. Garcia is part of a team of vascular surgeons at MedStar Heart and Vascular
Institute (MHVI) that is performing the greatest volume of HeRO™ graft placements in the country. This unique new technology has made a dramatic impact on patients’ lives because it reduces significantly the risk and frequency of infection associated with the standard venous catheter use.
Sign up today to be part of September’s special Think Access training held at the VISTA Lab in Baltimore. We look forward to seeing you there!
Have you signed up for the June ThinkHeRO course yet? If you haven’t, you’ll want to because June’s training is the last ThinkHeRO course held in 2017 at the world-class Houston Methodist Institute for Technology, Innovation & Education (MITIESM).
What does this mean for you if you attend June’s ThinkHeRO training?
HeRO graft training at MITIE means you’ll have the opportunity to learn cutting-edge skills and have access to the latest technologies that will help support the advancement of your interventional and surgical procedures. June’s ThinkHeRO course is like no other because you’ll have the opportunity to rehearse, perfect, and perform techniques using cadavers in a state-of-the-art cadaver lab. Broken up into two groups for more individualized instruction, skills training such as placing a new implant, revising an existing implant, placing the venous outflow component from different access sites, identifying the anastomosis and tunneling will be addressed. These topics will be put into practice again in the SIM Lab using MITIE’s advanced training models.
Clinical discussions will also be taking place throughout the course that focus on HeRO graft tips, troubleshooting, and clinical guidelines. You’ll be invited to dive into several case study discussions with other physicians, enabling you to familiarize yourself with HeRO clinical scenarios that will help prepare you for challenging cases. At the end of the training, you’ll also receive help on how to build your own HeRO program.
One more reason you’ll want to reserve your seat for June’s ThinkHeRO course is that you’ll be taught by one of ThinkHeRO’s foremost leaders, Eric Peden, MD, Chief of Vascular Surgery at Methodist DeBakey Heart and Vascular Center. Dr. Peden has a rich history as both a surgeon and an instructor with vast experience and expertise that he’ll share with ThinkHeRO attendees. As the recipient of multiple accolades, Dr. Peden has been awarded the A.O.R.N. Distinguished Surgeon Award and Attending Teaching Award (Vascular Surgery Fellows). His stellar background also includes instructing at Baylor College of Medicine as Assistant Professor of Vascular Surgery before joining Methodist as Assistant Professor of Cardiovascular Surgery.
Visit us at https://www.merit.com/education/course_dates/#Hero and sign up today to be part of June’s special ThinkHeRO training held at MITIE. We look forward to seeing you there!
By Alicia Armeli
March 30-31 marks the start of this year’s Think HeRO Graft™ training courses. Held at the Houston Methodist Institute for Technology, Innovation & Education (MITIESM), the course will be led by HeRO® Graft pioneer Eric Peden, MD.
One of Houston’s own, Dr. Peden is Chief of Vascular Surgery at Methodist Cardiovascular Associates, Methodist Hospital at the Texas Medical Center in Houston, Texas. He also serves as Assistant Professor of Cardiovascular Surgery at the Institute for Academic Medicine—Houston Methodist and Weill Cornell Medical College in New York City, NY. Previous to these posts, Dr. Peden was an Assistant Professor of Vascular Surgery at Baylor College of Medicine.
Dr. Pedens experience with the HeRO Graft goes back over a decade. One of its principal investigators, Dr. Peden was one of the first to research the outcomes of HeRO Graft use in access-challenged patients with venous obstruction. His passion and dedication in the field of peripheral vascular disease continues as he currently oversees various ongoing outcomes projects and is principal investigator for multiple clinical trials.
At the top of his field in both surgery and instruction, Dr. Peden is a Fellow of the American College of Surgeons (FACS) and received the A.O.R.N. Distinguished Surgeon Award in 2008 and Attending Teaching Award (Vascular Surgery Fellows). In other leadership roles, he was elected to the Board of Directors of VASA in 2013, has served as a VASA Practicum lecturer, and a regular speaker at SVS and ASDIN.
Register now because space is limited! To participate in this upcoming Think HeRO Graft training course and learn from Dr. Peden himself, 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.
By Alicia Armeli
Proper drainage is necessary for the removal of fluid buildup, as well as diagnosis. From access to intervention, Merit Medical provides a diverse portfolio of drainage products to support procedural needs throughout each step. With products designed in multiple configurations for specific drainage needs and kits that can be tailored to meet clinical challenges head-on, Merit helps deliver patient-care that’s efficient, while still being cost-effective.
At the start of every drainage procedure, avoiding delays and complications could be as simple as choosing the right introducer system. Merit’s MAK-NV™ Introducer System and Valve Adapter—for mini access in non-vascular applications—were designed to help circumvent clinical challenges, such as introducer tip peel-back, inability to determine the exact location of the introducer tip, and difficulty visualizing the needle tip. In doing so, the MAK-NV Introducer System makes for easy visualization that leads to quick access into the drainage area.
Starting with a tapered dilator and introducer tip, the MAK-NV allows for smooth transitions and movement over the guide wire, which can help minimize buckling and the incidence of introducer peel back during insertion. Introducer systems without tapered tips may be more prone to catching on tissue, potentially leading to peel back. Once inserted, the MAK-NV Introducer System’s distally placed radiopaque marker tip can help to determine its precise location more easily. For better needle visualization, the MAK-NV Needle has 1 cm echo-enhancement also placed at the distal end. Other needles without echo-enhancement technology may not be as easy to visualize when using ultrasound imaging.
Echo-enhancement can be beneficial, particularly during interventional centesis procedures. Pneumothorax is a common complication of thoracentesis. Yet, studies have shown that using real-time ultrasonography is a modifiable factor that reduces pneumothorax risk.1 Merit’s One-Step™ Centesis Catheters have echo-enhanced needles that aid with visualization when using ultrasound. What’s more, the Valved One-Step™ Centesis Catheter has a self-sealing valve to decrease the risk of pneumothorax, as well as prevent fluid leakage during centesis procedures. Both the One-Step and Valved One-Step Centesis Catheters employ a tapered tip for smooth transitions that can decrease resistance and patient discomfort. To maximize performance, each device is designed with large drainage holes and pigtail tips.
Merit drainage products reach beyond centesis procedures. For biliary and all-purpose drainage needs, the ReSolve® line of biliary, locking, and non-locking drainage catheters are designed to help lessen trauma to surrounding tissue, support more precise placement, and provide unimpeded drainage.
Biliary drainage procedures are associated with significant catheter-related complications that occur in up to 22% of procedures.2 A common complication of percutaneous biliary drainage is catheter obstruction—usually the result of bile stones, biliary sludge, blood clots, or intestinal debris.2 Bench top data show Merit drainage catheters to have larger drainage holes, faster flow rates, larger drainage area, and larger catheter inner diameters when compared to leading competitors.
These qualities can be observed in the ReSolve® Biliary Locking Drainage Catheters, which have multiple large holes laid out in two different drainage hole patterns to accommodate targeted drainage of various lesion locations, thus offering up to 4x more drainage area when compared to leading competitors. In combination with radiopaque marker bands, the ReSolve Biliary Locking Drainage Catheter also has depth markers to facilitate fast and accurate positioning. To increase patient comfort and avoid irritating surrounding tissue, the hydrophilic-coated tip of the catheter is located inside an atraumatic pigtail curve. The ReSolve Biliary Locking Drainage Catheter can either be locked to prevent movement, or unlocked to reposition the catheter. If needed, its polyurethane material allows for long-term indwelling time.
For all-purpose drainage needs such as nephrostomy procedures, Merit offers the ReSolve® Locking and Non-Locking line of drainage catheters. Featuring many of the same advantages as their biliary counterpart, ReSolve Locking and Non-Locking Catheters employ hydrophilic coating and tapered tips. The tip of the locking drainage catheter can be found inside a locking pigtail, while non-radiopaque depth markers on the catheter shaft act as a reference for correct positioning. Large drainage holes of locking catheters maximize percutaneous drainage.
To emphasize cost savings and time efficiency, Merit offers ReSolve+™ Biliary Locking Drainage Catheters and ReSolve+™ Locking Drainage Catheters. Both offer all the same clinical benefits of their parent ReSolve products but with fixation device options. Each come with either the Revolution™ Catheter Securement Device or the StayFIX® Fixation Device.
Fixation and securing devices can improve patient comfort by reducing irritation to tissue surrounding the catheter, as well as avoiding the potential for catheter dislodgment. The Revolution Catheter Securement Device is a needleless and economical product designed with patient and clinician safety in mind. Easily positioned, the Revolution Catheter Securement Device holds a catheter in place, leaving the insertion site visible for cleaning and monitoring.
Its sister product—the suture-free StayFIX Fixation Device—is made only for percutaneous non-vascular catheters. This cost-savings option is designed to stop catheter migration, movement, and accidental removal. Made of soft water-resistant material, StayFIX remains secure for up to 7 days, allowing for patients to shower without removing the device. Additionally, its hydrocolloid material can reduce skin irritation by absorbing any fluid leaking from the insertion site.
Working alongside Merit’s catheters are several more accessories that together aim to improve the overall patient experience and increase procedural efficiency.
This includes innovative devices created for common difficulties clinicians face. For example, abscess drainage and thrombus aspiration are often associated with clinician hand fatigue. To avoid this challenge and associated procedural delays, Merit has developed the VacLok® Vacuum Pressure Syringe. The VacLok creates a sustained negative vacuum by pulling back on the plunger and locking the device in place. With a clear polycarbonate barrel available in several sizes, fluid can be continuously collected and its volume monitored.
For procedures that don’t use syringes but collect fluid in drainage bags, Merit supplies Drainage Depot™ Drainage Bags along with adjustable length drainage tubing and a VELCRO® brand leg strap that can meet a variety of patient sizes. With easy-to read volume markings, a twist valve for tidy disposal, and an internal anti-reflux valve—Depot Drainage Bags assist in improving the drainage process.
Taking efficiency to another level, the Merit Marquis® Series Stopcock accessories provide an added element of control to catheter procedures. With a larger easy-to-hold handle, the Marquis is simple to use with an effortless grip and turn motion. Described as “a cut above the rest,” the Marquis Series Stopcock is available in different pressure ratings, luer options, and has a patented airless rotator that prevents air bubbles from forming.
To increase convenience of drainage procedures, Merit offers standalone drainage options, kit configurations, or procedural trays. The MAK-NV kit comes with a variety of needles and guide wires, along with a large diameter introducer. Examples of ready-to-use trays include the ReSolve Locking Drainage Catheter Tray, the Safety Paracentesis Procedure Tray, and the Thoracentesis & Paracentesis Set (TAPS). Each kit includes all the products needed to perform a corresponding drainage procedure—minimizing procedural delays, while still ensuring a safe working environment.
Each member of Merit’s drainage family works together to provide an integrative approach to drainage procedures. By understanding and supporting clinician needs, Merit can help you deliver patient-centered, efficient, and cost-effective care. Welcome to the family.
Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.
- Gordon, C., Feller-Kopman, D., Balk, E., & Smetana, G. (2010). Pneumothorax following thoracentesis: a systematic review and meta-analysis. Archives of Internal Medicine, 170(4): 332-339. doi: 10.1001/archinternmed.2009.548. https://www.ncbi.nlm.nih.gov/pubmed/20177035
- Huang, S., Engstrom, B., Lungren, M., & Kim, C. (2015). Management of dysfunctional catheters and tubes inserted by interventional radiology. Seminars in Interventional Radiology, 32(2): 67-77. doi: 10.1055/s-0035-1549371. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4447882/
Alicia Armeli is a Freelance Writer and Editor who specializes in medical technology, health, and wellness.
By Alicia Armeli
Short of leaping tall buildings at a single bound, the Super HeRO™ Adapter is living up to its name.
“The Super HeRO gives you options to customize your approach—unique patients unique procedures.” –Dr. Stephen E. Hohmann, MD, FACS, Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas, Texas
“The new HeRO Graft Adaptor gives vascular access surgeons a variety of options on which graft to use instead of the standard PTFE. I currently use the ACUSEAL graft, which can be cannulated in 24 hours and there is no need for a bridge catheter. Removing the permcath at the same time as the insertion of the HeRO Graft decreases the risk of infection for these dialysis patients with central vein pathology and no need to come back for an additional procedure to remove the catheter.” –Dr. Jesse Garcia, MD, MedStar Washington Hospital Center, Washington, DC
“The Hero Adapter has opened a new window of opportunity in the creation and rescue of complex hemodialysis access.”—Dr. David Varnagy, MD, FACS, Vascular Institute of Central Florida, Orlando, Fla.
These are only a few of the positive comments made by vascular surgeons regarding the newest addition to the growing family of Merit Medical dialysis devices. The Super HeRO Adapter and its accompanying HeRO Ally™ Revision Kit are a one-of-a-kind dynamic duo of dialysis technology that offer surgeons the same safety and efficiency of the original HeRO™ (Hemodialysis Reliable Outflow) Graft—but with the added flexibility of more graft options to choose from.
Proper vascular access is essential for dialysis adequacy. And yet vascular access complications are the leading cause of morbidity among dialysis patients and add to high healthcare costs.1 It’s these same complications that lead to hospitalization of dialysis patients between one and two times every year.2
Central venous stenosis is a common and serious vascular complication that involves the narrowing of the veins leading to the heart. These central veins are often the final common route used for dialysis, and once occluded, vascular access is eventually lost and life expectancy diminishes.3
This is a serious health risk for patients requiring dialysis, especially those who are catheter-dependent. Central venous stenosis is linked to external catheterization, as studies have shown that approximately one out of four patients with venous stenosis has a history of central venous catheter placement.4
Catheters are used in approximately 80% of patients starting dialysis and 25% of all prevalent patients as a bridge to permanent vascular access or because all options for permanent access have been exhausted.5 Patients using a catheter are not only at risk for venous stenosis but are four times more susceptible to access-related infection than patients with a graft and eight times more at risk than those who have a fistula.6
To bypass venous stenosis and improve long-term dialysis, various permanent subcutaneous arteriovenous graft devices have been manufactured as a solution for dialysis patients who have exhausted all other access options.
One such product called the HeRO Graft was approved by the FDA in 2008. In comparison to catheters, it’s the only clinically proven permanent subcutaneous arteriovenous graft to reduce the risk of vascular access-related infections by 69%, improve adequacy of dialysis by up to 32% (1.7 Kt/V), and cut interventions needed to maintain access function by more than half.7 Studies have also linked the HeRO Graft to high cumulative patency rates that reach 87% at two years.8
But unlike other graft products, the HeRO Graft doesn’t depend on venous anastomosis to bypass venous stenosis. Instead, a radiopaque silicone Venous Outflow component reinforced with kink and crush-resistant nitinol braid is placed in the right atrium and securely attaches to an adjacent ePTFE hemodialysis graft by way of a proprietary titanium connector. This mechanism allows for blood to return from the veins back to the heart.
Now, eight years after the launch of the HeRO Graft, the Super HeRO Adapter emerges as an additional way to help access-challenged patients with central venous stenosis.
Graft compatibility is what makes the Super HeRO Adapter a one-of-a-kind product and a superior alternative to catheters. By having the same safety, dialysis adequacy, and patency advantages of the standard HeRO Graft but with a wider range of compatible graft products to choose from, using the Super HeRO could mean the difference between contracting and avoiding infection.
Researchers at the University of Miami Hospital in Miami, Fla., demonstrated the validity of this premise by examining the safety and efficacy of the standard HeRO Graft in comparison to tunneled dialysis catheters. Thirty-six access-challenged patients with venous stenosis were implanted with the HeRO Graft and followed over a course of almost 9 months.7
Results published in the Journal of Vascular Surgery showed that access-related bacteremia rates were significantly lower among patients using the HeRO Graft (0.7 events per 1000 days), but that infection only occurred during the bridging period when a catheter was implanted prior to the HeRO graft being used.7
Circumventing the 2-4 week bridging period and avoiding the risk of infection is one of the major advantages of the Super HeRO Adapter, especially since infection is a frequent cause of hospitalization and the second most common cause of death among dialysis patients.9 By connecting the Venous Outflow component to an early cannulation graft, a patient can be implanted today and dialyzed the next, virtually eliminating the risk of access-related infection due to a bridging catheter.
Early cannulation grafts compatible with the Super HeRO Adapter include GORE® ACUSEAL grafts and FLIXENE® Standard Wall grafts. If an early cannulation graft isn’t used, the Super HeRO Adapter also works with single-wall options, including GORE-TEX® and IMPRA®.
Cost savings advantages seen with the standard HeRO Graft can also be applied to the Super HeRO Adapter. A US healthcare model for provision of dialysis access predicted that in comparison to catheters, using the HeRO Graft could result in an average of 23% annual savings.10 Dialysis centers could save over $3000 per patient each year.11 And hospitals can save thousands in hefty admission costs that accrue because of device-related infections—rates that would commonly range between $23K to $56K per stay.12,13
These cost savings are being recognized around the globe. At the University Hospital at Birmingham, a British economic study analyzed the cost of introducing the HeRO Graft in the UK.14 Shakarchi et al. compared the cost of the HeRO Graft versus tunneled dialysis catheters by carrying out a 1-year cost-consequence decision analytic model that measured vascular access function, infection, device thrombosis, and associated costs over four 3-month intervals.
Based on a 100-patient cohort managed with the HeRO Graft, results of the study revealed 6 fewer failed devices, 53 fewer access-related infections, and 67 fewer device thromboses compared to patients managed with catheters.14 The authors concluded that even though the initial device and placement costs for the HeRO Graft are more expensive than catheters, the savings that occur because of fewer device complications and longer effective device patency minimizes these costs. Overall, a net 1-year savings of £1200 per patient was estimated for patients managed with the HeRO Graft.
Another cost-effective option offered by the Merit team is the HeRO Ally Revision Kit—a viable solution for long-term dialysis patients who still have a functioning Venous Outflow component—but need a new graft. The Revision Kit contains the tools needed to place a new Super HeRO compatible graft, which includes the Adapter, Support Seal, Graft Expander, Vascular Clamp, and Syringe for Heparinized Saline. Sold separately from the Super HeRO itself and compatible grafts, the HeRO Ally gives clinicians the freedom to purchase their compatible graft of choice.
By using these tools—whether it’s the Super HeRO, HeRO Ally Revision Kit, or the standard HeRO Graft—clinicians are offering access-challenged patients who’ve exhausted all other options a longer life expectancy and—above all—hope.
“It’s exciting to know that there’s something out there,” said Kay, referring to the HeRO Graft.15 After experiencing failure with traditional access grafts and catheters, Kay was faced with no other options—until her doctor suggested the HeRO Graft. “I’m not so depressed now,” Kay told Merit Medical. “I’m on the go more. I go places more and do things more.”
The HeRO products can also give loved ones peace of mind. “We have less to worry about,” explained Katie, Kay’s daughter and caregiver.14 “We’re not worried about infection. We’re not worried about clotting. The dialysis is just more efficient. She feels better.”
Merit Medical’s HeRO technology not only saves the lives of countless dialysis patients, but also enhances them. “I consider it my lifeline,” Kay said. “It keeps me alive.” And if that’s not the true mark of a superhero, I don’t know what is.
- Hemachandar, D. (2015). Analysis of vascular access in haemodialysis patients—single center experience. Journal of Clinical and Diagnostic Research, 9(10): OC01-4. doi: 10.7860/JCDR/2015/13342.6611. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4625272/
- Adib-hajbagheri, M., Molavizadeh, N., Alavi, N. S., & Abadi, M. H. M. (2014). Factors associated with complications of vascular access site in hemodialysis patients in Isfahan Aliasghar hospital. Iranian Journal of Nursing and Midwifery Research, 19(2): 208-214. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4020033/
- Beathard, G. A. (2016). Central vein stenosis associated with hemodialysis access. Retrieved October 5, 2016, from http://www.uptodate.com/contents/central-vein-stenosis-associated-with-hemodialysis-access
- Kundu, S. (2009). Central venous obstruction management. Seminars in Interventional Radiology, 26(2): 115-121. doi: 10.1055/s-0029-1222454. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3036427/
- Al-Solaiman, Y., Estrada, E., & Allon, M. (2011). The spectrum of infection sin catheter-dependent hemdialysis patients. Clinical Journal of the American Society of Nephrology, 6(9): 2247-2252. doi: 10.2215/CJN.03900411. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3359000/
- National Kidney Foundation. (2012). A Clinical Update on an Alternative Vascular Access for the Catheter-Dependent Hemodialysis Patient. Retrieved October 6, 2016, from https://www.kidney.org/sites/default/files/12-10-4487_KBB_ClinicalUpdateOnAlternateiveVA.pdf
- Katzman, H., McLafferty, R., Ross, J., Glickman, M., Peden, E., & Lawson, J. (2009). Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. Journal Of Vascular Surgery, 50(3): 600-607.e1. doi: 10.1016/j.jvs.2009.04.014. http://dx.doi.org/10.1016/j.jvs.2009.04.014
- Gage, S., Katzman, H., Ross, J., Hohmann, S., Sharpe, C., Butterly, D., & Lawson, J. (2012). Multi-center experience of 164 consecutive Hemodialysis Reliable Outflow [HeRO] Graft implants for hemodialysis treatment. European Journal Of Vascular And Endovascular Surgery, 44(1): 93-99. doi: 10.1016/j.ejvs.2012.04.011. http://dx.doi.org/10.1016/j.ejvs.2012.04.011
- Laurin, L., Harrak, H., Elftouh, N., Ouimet, D., Vallee, M., Lafrance, J. (2015). Outcomes of infection-related hospitalization according to dialysis modality. Clinical Journal of the American Society of Nephrology, 10(5): 817-824. doi: 10.2215/ CJN.09210914. http://cjasn.asnjournals.org/content/10/5/817.full
- Dageforde, L., Bream, P., & Moore, D. (2012). Hemodialysis Reliable Outflow (HeRO) device in end-stage dialysis access: a decision analysis model. Journal Of Surgical Research, 177(1): 165-171. doi: 10.1016/j.jss.2012.04.041. http://dx.doi.org/10.1016/j.jss.2012.04.041
- Yost, L., Dinwiddie, L. (2010, Nov.). Impact of the use of the HeRO vascular access graft vs. tunneled dialysis catheters on dialysis provider economics in an era of bundling. Poster session presented at ASN, American Society of Nephrology, Denver, CO.
- Ramanathan, V., Chiu, E., Thomas, J., Khan, A., Dolson, G., & Darouiche, R. (2007). Healthcare costs associated with hemodialysis catheter–related infections: a single‐center experience. Infection Control And Hospital Epidemiology, 28(5): 606-609. doi: http://dx.doi.org/10.1086/513617
- O’Grady, N., Dellinger, E., Gerberding, J., Heartd, S. Maki, D., Masur, H., McCormick, R., Mermel, L., Pearson, M., Raad, I., Randolph, A., & Weinstein, R. (2002). Guidelines for the prevention of intravascular catheter-related infections. The Hospital Infection Control Practices Advisory Committee, Center for Disease Control and Prevention, U.S. Pediatrics, 110(5): e51.
- Al Shakarchi, J., Inston, N., Jones, R., Maclaine, G., & Hollinworth, D. (2016). Cost analysis of the Hemodialysis Reliable Outflow (HeRO) Graft compared to the tunneled dialysis catheter. Journal Of Vascular Surgery, 63(4): 1026-1033. doi: 10.1016/j.jvs.2015.10.089. http://dx.doi.org/10.1016/j.jvs.2015.10.089
- Merit Medical Systems, Inc. (2016, Aug 26). HeRO® Graft – Kay and Katie: A Patient’s Story of Receiving a HeRO Graft. [Video File]. Retrieved from https://youtu.be/OztHLxZ2CG8
Alicia Armeli is a Freelance Writer and Editor who specializes in medical technology, health, and wellness.
Merit Medical’s inaugural Think HeRO Graft Training Course was held at the Methodist Institute for Technology, Innovation & Education (MITIE) in Houston, TX on September 22 and 23.
ThinkHeroGraft is an education program that prepares surgeons and physicians to use the HeRO® Graft as a method for end-stage dialysis access, for patients with central venous stenosis who would otherwise be catheter-dependent.
Proctor Dr. Eric Peden, Chief of Vascular Surgery at the Houston Methodist DeBakey Heart & Vascular Center, led engaging discussions and hands-on training with a cadaver lab, which allowed attendees to practice actual implantation procedure steps.
Dr. Peden, who has over 10 years of experience working with HeRO Graft and was one of its principal investigators, shared his best practices in patient selection, implantation techniques and maintenance strategies.
Attendees learned the clinical science and healthcare economics of the Hero Graft, identification of patient candidates and contraindications, as well challenges and complications.
Please contact your Merit Representative for future Think Hero Graft training opportunities.
We are excited to announce the release of the new high flow Pigtail Valved One-Step™ Centesis Catheter!
These catheters have been designed for safe, controlled insertion with decreased procedure times.
The distal obturator prevents the needle from puncturing and shearing the catheter, and protects the clinician from accidental needlestick. The self-sealing valve also minimizes the risk of air infiltration, and fluid leakage.
The sharp needle and smooth transitions ease insertion and decrease patient discomfort, while the depth markers and echo-enhanced needle help with fast and accurate placement.
Procedure times may be decreased due to the fast flow rates. When compared with a leading competitor, the high flow Valved One-Step Centesis Catheter has a 16% faster flow rate*. The fast flow rates are due to the pigtail protecting the large drainage holes from occlusion, kink-resistant material, and large catheter and hub inner diameters.
To incorporate the high flow Pigtail Valved One-Step Centesis Catheter into your practice, contact your Merit Medical sales professional today or visit merit.com to learn more.
*Tested with 5F X 10 cm straight catheters