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, […]
Category: Dialysis Access
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.
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
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.