ACCESS

ELLIPSYS

Introduction

Last updated: apr 5, 2023

Designed for end-stage renal disease (ESRD) patients requiring hemodialysis, the Ellipsys™ system is a unique single-catheter, nonsurgical option for physicians to create an arteriovenous (AV) fistula, a traditionally invasive procedure that — until the advent of percutaneous AVF technology — had not changed in more than 50 years.

 

Presentation

File NameTypePermissionsChanged DateDateSize

My Image
 

Anatomy

File NameTypePermissionsChanged DateDateSize

My Image

At least one outflow should be ≥ 2 mm in diameter throughout.
Median Basilic Vein and Brachial Vein or Median Cephalic Vein and Cephalic Vein

My Image
 

Indications

  • A perforating vein located in the elbow.
  • An adjacent artery, no greater than 1.5 mm away.
  • Renal diameter at least 3 mm.
  • Arterial diameter at least 1.5 mm.

 

Contra indications

Absolute

  • Target vessels that are <2 mm in diameter.
  • A distance between the target artery and vein > 1.5 mm
  • Extensive calcifications

Relative

 

Workup

Ultrasound

  • Diameter perforating vene
  • Diameter proximal radial and ulnar arteries at the level of the perforating vene
  • Distance between radial artery and perforating vene
  • Diameter cephalic vine at the level of the perforating vene
  • Course of the cephalic and basilica vene at the level of the perforating vene

Criteria Ellipsys
  • Target vessel 2mm
  • Distance between artery and vene no more than1.5mm

 

Pre procedural

  • Follow standard perioperative care protocols.
  • Eat until 6 hours prior to surgery.
  • Clear liquids until 2 hours prior to surgery.

 

Materials

Essentials

Non-Essentials

 

Positioning the patient

  • Supine
  • Tourniquet

 

The procedure in steps

Pre-procedural

  • TOP
  • Patient positioned supine.
  • Wash with chlorhexidine and cover sterilely.

Toegang
  • Infiltration with Lidocaine.
  • Ultrasound-guided puncture of the perforating vein.
  • Puncture through to the artery.
  • Insert sheath.
  • Position Ellipsys device.
  • Create anastomosis.
  • PTA (Percutaneous Transluminal Angioplasty) 5 mm in the anastomosis.
  • Measure volume in the brachial artery (see link on the right).

Afronden.
  • Manual compression
  • SOP

My Image
 

Tips and tricks

Modified technique
A direct puncture of the median cephalic (or less commonly, median cubital) vein with the micropuncture needle (Cook, Bloomington, Ind) under ultrasound guidance is performed as previously described. In our current approach, however, we advance the needle down the PVE directly without using a guidewire, ensuring that the echogenic needle tip is visualized at all times. This maneuver is accomplished under ultrasound guidance with the probe in a transverse orientation and allows successful needle passage through even more tortuous perforating veins, helping to avoid guidewire contact with the vein wall that may induce vessel spasm.

Small PRA technique
In cases of a small PRA (<2 mm in diameter) or when difficulty is encountered with the needle crossing into the artery, resulting in a hematoma and poor visualization, angioplasty of the first few centimeters of the PRA approached from the wrist with a 3/40-mm or 3/60-mm balloon, ensuring that the balloon tip extends into the brachial artery, may be used to establish or to restore the appropriate size and visibility of the PRA. The crossing puncture can then be reliably completed. If this technique is to be employed as a salvage technique in case of initial failure with hematoma or spasm hindering clear visualization, the Ellipsys crossing needle should be left in place within the PVE if it is already at the lower part of the vein and adjacent to the artery.

Low flow
IIf low flow is detected after creation of the pAVF, immediate angioplasty of the PRA with a 4/40-mm balloon through radial artery access from the wrist may be necessary for prompt maturation. Low flow may be identified by brachial artery flow <200 mL/min, absence of a thrill, or duplex ultrasound demonstrating low diastolic flow. This is especially important for patients who may have a small atherosclerotic PRA or when the proximal artery may be compressed as a result of angioplasty of the pAVF anastomosis.

Maturation procedures.

Distal radial access only
Distal radial artery access only. A standard 5F sheath is placed in the distal radial artery and a J-configured hydrophilic guidewire is introduced, ensuring that the J is oriented toward the anastomosis while it is being inserted into the sheath (Fig 2, A). In patients with a patent anastomosis and a relatively straight PVE, the wire will invariably cross into the pAVF and then into the cephalic or basilic vein. A 6/40-mm compliant balloon is then used to dilate the anastomosis and PVE, maintaining the distal part of the balloon in the artery. The compliance of the balloon will allow a tapering of the balloon toward the PVE and avoid overdilation of the artery.

Double access
 (distal radial and proximal pAVF outflow). This technique (Fig 2, B) is recommended for patients with complete occlusion of the anastomosis or when anatomic configuration indicates that cannulation through the distal radial artery sheath will be technically challenging. A puncture of the pAVF outflow is performed exactly as for the pAVF creation procedure, and following the same initial steps, the micropuncture needle is guided through the PVE into the PRA. When a complete occlusion of the anastomosis is noted with ultrasound imaging in most patients, a small plug is noted but without thrombus in the PVE. In these cases, the needle traverses the anastomosis easily with little or no resistance, and there is a clear tactile difference compared with going through a vessel (vein or artery) wall. Crossing into the artery is usually easier as it has been previously dilated. Once it is in the artery, the 6F Slender sheath is introduced fully into the artery. The distal radial artery is then cannulated with a 5F sheath, and a 0.035-inch hydrophilic wire is advanced into the proximal 6F sheath (the wire will pass easily into the proximal sheath as it occupies the entire radial artery lumen in the mid forearm) until it hits the external valve in the proximal sheath. The 6 F sheath is then removed, and the 0.035-inch wire is then identified outside the skin at the pAVF puncture location (establishing through-and-through access); the wire is then carefully retracted into the cephalic vein and readvanced within the vein toward the shoulder to have a safe wire purchase to complete the angioplasty procedure following the same steps for balloon angioplasty of the PVE and PRA as described in the previous section.

My Image
 

Post-op

Day 0

  • Duplex with flow measurement
Day 7
  • Duplex with flow measurement
Day 21
  • Duplex with flow measurement
Day 42
  • Duplex with flow measurement

If, by week 3, the flow is ≥ 500 ml/min, the shunt is considered mature and should be reported to the dialysis unit. The vascular lab will send a message to the primary caregiver with the dialysis center in CC.

  • Flow Rate Intervention Guidelines:
  • < 250 ml/min: Immediate contact for intervention (preferably on the same day, but within 24 hours).
  • 30% flow reduction: Contact the intervention team to discuss options; intervention often necessary within 24 hours.
  • 250 – 350 ml/min: Contact the intervention team in Gravendeel or Post to discuss options.
  • 350 ml/min with flow reduction compared to baseline: Discuss during access meetings.

For interventions, the follow-up schedule of 1, 2, and 6 weeks restarts.

HIX
 

Report

TOP Patient in rugligging. Wassen met chloorhexidine en steriel afdekken. Infiltratie met Lidocaine. Echogeleid aanprikken van de perforerende vene, doorprikken naar de arterie. Sheath in, wisselen van draad. Ellipsys positioneren. Anastomose branden. Echogeleide PTA met 5 mm ballon in de anastomose.

Manuele compressie. SOP

 

Patient folder

File NameTypePermissionsChanged DateDateSize
pdf
 Ellipsys patient poster pdf 0644 2025070109252901-Jul-2025 09:25 2023030310422403-Mar-2023 10:42 5 MB Preview Print Download

 

Literature

File NameTypePermissionsChanged DateDateSize

  1. J. Mark Ryan, MD, S. M. Key, Siobhan A. Dumbleton, MD, and Tony P. Smith, MD Nonlocalized Lower Gastrointestinal Bleeding: Provocative Bleeding Studies with Intraarterial tPA, Heparin, and Tolazoline J Vasc Interv Radiol 2001 Nov;12(11):1273-7

  2. Baum ST. Arteriographic diagnosis and treatment of gastrointestinal bleeding. In Baum ST, Pentecost MJ, eds. Abrams' angiography interventional radiology. 2nd ed. Philadelphia, Pa:Lippincott, Williams & Wilkins, 2006:488.

  4. Poultsides GA, Kim CJ, Orlando R 3rd, et al. Angiographic embolization for gastroduodenal hemorrhage: safety, efficacy, and predictors of outcome. Arch Surg. 2008;143:457-461.

  5. Eriksson LG, Sundbom M, Gustavsson S, Nyman R. Endoscopic marking with a metallic clip facilitates transcatheter arterial embolization in upper peptic ulcer bleeding. J Vasc Interv Radiol. 2006;17:959-964.

  6. Dixon S, Chan V, Shrivastava V et al. Is there a role for empiric gastroduodenal artery embolization in the management of patients with active upper GI hemorrhage? Cardiovasc Intervent Radiol. 2013 Aug;36(4):970-7.

  7. Shin JH. Recent update of embolization of upper gastrointestinal tract bleeding. Korean J Radiol 2012;13 Suppl 1:S31-S39.

  9. van Leerdam ME. Epidemiology of acute upper gastrointestinal bleeding. Best Pract Res Clin Gastroenterol. 2008;22(2):209-24.

  10. Sildiroglu O, Muasher J, Arslan B, Sabri SS, Saad WE, Angle JF, Matsumoto AH, Turba UC. Outcomes of patients with acute upper gastrointestinal nonvariceal hemorrhage referred to interventional radiology for potential embolotherapy. J Clin Gastroenterol. 2014;48(8):687-92.

  11. Strate LL, Gralnek IM. ACG Clinical Guideline: Management of Patients With Acute Lower Gastrointestinal Bleeding. Am J Gastroenterol. 2016 Apr;111(4):459-74.

  13. van Dam J, Brugge WR. Endoscopy of the upper gastrointestinal tract. N Engl J Med. 1999;341(23):1738-48.

  15. Lefkovitz Z, Cappell MS, Lookstein R, Mitty HA, Gerard PS. Radiologic diagnosis and treatment of gastrointestinal hemorrhage and ischemia. Med Clin North Am. 2002 Nov;86(6):1357-99.

  16. Lee EW, Laberge JM. Differential diagnosis of gastrointestinal bleeding. Tech Vasc Interv Radiol 2004; 7: 112-22

  18. Strate LL, Gralnek IM. ACG Clinical Guideline: Management of Patients With Acute Lower Gastrointestinal Bleeding. Am J Gastroenterol. 2016 Apr;111(4):459-74.

  19. Chaudhry V, Hyser MJ, Gracias VH, Gau FC. Colonoscopy: the initial test for acute lower gastrointestinal bleeding. Am Surg. 1998 Aug;64(8):723-8.

  20. Cummings CL. Value of early capsular endoscopy for severe gastrointestinal bleeding. J Natl Med Assoc. 2004;96(12):1653-6.

  21. Appleyard M, Glukhovsky A, Swain P. Wireless-capsule diagnostic endoscopy for recurrent small-bowel bleeding. N Engl J Med. 2001;344(3):232-3.

  24. Lim JK, Ahmed A. Endoscopic approach to the treatment of gastrointestinal bleeding. Tech Vasc Interv Radiol. 2004 Sep;7(3):123-9.

  25. Nicholson AA, Ettles DF, Hartley JE, et al. Transcatheter coil embolotherapy: a safe and effective option for major colonic haemorrhage. Gut 1998; 43:79–84.

  26. Zuckier LS. Acute gastrointestinal bleeding. Semin Nucl Med. 2003 Oct;33(4):297-311.

  27. Imbembo AL, Diverticular disease of the colon. In: Sabiston D, Editor. Textbook of Surgery (14th edn). Philadelphia, PA:WB Saunders, 1992:910.

  29. Loffroy R, Rao P, Ota S, De Lin M, Kwak BK, Geschwind JF. Embolization of acute nonvariceal upper gastrointestinal hemorrhage resistant to endoscopic treatment: results and predictors of recurrent bleeding. Cardiovasc Intervent Radiol. 2010 Dec;33(6):1088-100. doi: 10.1007/s00270-010-9829-7. Epub 2010 Mar 16.

  31. Eriksson LG, Sundbom M, Gustavsson S, Nyman R. Endoscopic marking with a metallic clip facilitates transcatheter arterial embolization in upper peptic ulcer bleeding. J Vasc Interv Radiol. 2006 Jun;17(6):959-64.

  32. Anthony S, Milburn S, Uberoi R. Multi-detector CT: review of its use in acute GI haemorrhage. Clin Radiol. 2007 Oct;62(10):938-49.

  33. Ernst O, Bulois P, Saint-Drenant S, Leroy C, Paris JC, Sergent G. Helical CT in acute lower gastrointestinal bleeding. Eur Radiol. 2003;13(1):114-7

  34. Mirsadraee S, Tirukonda P, Nicholson A, Everett SM, McPherson SJ. Embolization for non-variceal upper gastrointestinal tract haemorrhage: a systematic review. Clin Radiol 2011;66:500-509.

  35. Loffroy R, Guiu B, D'Athis P, Mezzetta L, Gagnaire A, Jouve JL, Ortega-Deballon P, Cheynel N, Cercueil JP, Krausé D. Arterial embolotherapy for endoscopically unmanageable acute gastroduodenal hemorrhage: predictors of early rebleeding. Clin Gastroenterol Hepatol. 2009 May;7(5):515-23.

  36. Aina R, Oliva VL, Therasse E, et al. Arterial embolotherapy for upper gastrointestinal hemorrhage: outcome assessment. J Vasc Interv Radiol 2001;12:195-200.

  37. Mirsadraee S, Tirukonda P, Nicholson A, Everett SM, McPherson SJ. Embolization for non-variceal upper gastrointestinal tract haemorrhage: a systematic review. Clin Radiol 2011;66:500-509.

  38. Loffroy R, Guiu B, Cercueil JP, Lepage C, Latournerie M, Hillon P, Rat P, Ricolfi F, Krausé D. Refractory bleeding from gastroduodenal ulcers: arterial embolization in high-operative-risk patients. J Clin Gastroenterol. 2008 Apr;42(4):361-7.

  39. Loffroy R, Guiu B, D'Athis P, Mezzetta L, Gagnaire A, Jouve JL, Ortega-Deballon P, Cheynel N, Cercueil JP, Krausé D. Arterial embolotherapy for endoscopically unmanageable acute gastroduodenal hemorrhage: predictors of early rebleeding. Clin Gastroenterol Hepatol. 2009 May;7(5):515-23.

  40. Poultsides GA, Kim CJ, Orlando R 3rd, Peros G, Hallisey MJ, Vignati PV. Angiographic embolization for gastroduodenal hemorrhage: safety, efficacy, and predictors of outcome. Arch Surg 2008;143:457-461.

  42. Gordon RL, Ahl KL, Kerlan RK, Wilson MW, LaBerge JM, Sandhu JS, Ring EJ, Welton ML. Selective arterial embolization for the control of lower gastrointestinal bleeding. Am J Surg. 1997;174(1):24-8.

  43. Funaki B, Kostelic JK, Lorenz J, Ha TV, Yip DL, Rosenblum JD, et al. Superselective microcoil embolization of colonic hemorrhage. AJR Am J Roentgenol 2001;177:829-836 7.

  44. Bandi R, Shetty PC, Sharma RP, Burke TH, Burke MW, Kastan D. Superselective arterial embolization for the treatment of lower gastrointestinal hemorrhage. J Vasc Interv Radiol 2001;12:1399-1405.

  45. Maleux G, Roeflaer F, Heye S, Vandersmissen J, Vliegen AS, Demedts I, et al. Long-term outcome of transcatheter embolotherapy for acute lower gastrointestinal hemorrhage. Am J Gastroenterol 2009;104:2042-2046

  46. Leitman IM, Paull DE, Shires GT 3rd. Evaluation and management of massive lower gastrointestinal hemorrhage. Ann Surg 1989;209:175-180

  47. Rosenkrantz H, Bookstein JJ, Rosen RJ, Goff WB 2nd, Healy JF. Postembolic colonic infarction. Radiology 1982;142:47-51.

  48. Koh DC, Luchtefeld MA, Kim DG, Knox MF, Fedeson BC, Vanerp JS, et al. Efficacy of transarterial embolization as definitive treatment in lower gastrointestinal bleeding. Colorectal Dis 2009;11:53-59

  49. Lipof T, Sardella WV, Bartus CM, Johnson KH, Vignati PV, Cohen JL. The efficacy and durability of super-selective embolization in the treatment of lower gastrointestinal bleeding. Dis Colon Rectum 2008;51:301-305

DISCLAIMER

The information contained herein has been obtained from sources believed to be reliable. However, no warranty as to the accuracy, completeness or adequacy of such information is implied. No liability is accepted for errors, omissions or inadequacies in the information contained herein or for interpretations thereof. The reader assumes sole responsibility for the selection of these materials to achieve its intended results. The opinions expressed herein are subject to change without notice.

Thank you! ×
Opps! Some went wrong... Your submission did not go through :-(×
Stacks Image 14

WEBDESIGN

Stacks Image 20

PHOTOGRAPHY

Stacks Image 26

E-COMMERCE

Stacks Image 32

SEO

Stacks Image 38

COLORS

Stacks Image 44

CRM

EXCELLENCE IS NOT A SKILL, IT'S AN ATTITTUDE

WEBDESIGN - PHOTOGRAPHY - GRAVENDEEL