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Continuous Quality Improvement in ESRD Care

Discussion on the treatment algorithm, clinical outcomes, and value analysis related to the use of the GORE® ACUSEAL Vascular Graft in dialysis care.

By Sapan S. Desai, MD, PhD, MBA, FACS

According to the United States Renal Data System (USRDS), a National Institute of Diabetes and Digestive and Kidney Diseases data system, 80% of patients initiate hemodialysis via a central venous catheter (CVC).1 Complications associated with CVCs remain a leading cause of death in this vulnerable population and are a major contributor to the $90,971 average annual per person cost of care.1,2 GORE® ACUSEAL Vascular Grafts decrease the use of CVCs and thus reduce the complication rate associated with end-stage renal disease (ESRD) patients who require urgent-start dialysis.3

TREATMENT ALGORITHM

Placement of an arteriovenous fistula (AVF) remains the standard of care for patients with chronic kidney disease (CKD). The ideal patient has stage 3 or 4 CKD and sufficient time (4–8 weeks) to permit maturation of an AVF. However, as noted by the USRDS data, most patients present to the hospital with ESRD and require urgent-start dialysis. As we have recently shown, we believe that the proper management of these patients is placement of a GORE ACUSEAL Vascular Graft.3 GORE ACUSEAL Vascular Grafts are associated with fewer complications compared with CVCs, a low rate of surgical site infections, better clinical outcomes at 1 year compared with CVCs, and a dramatically lower cost of care at 1 year compared with CVC and AVF combinations.3-9

Patients who present with ESRD and require urgentstart dialysis should undergo an appropriate history and physical examination. Basic lab work should be completed, and any significant medical issues should be promptly addressed. Barring symptomatic hyperkalemia or uremia, most patients will be candidates for timely placement of a GORE ACUSEAL Vascular Graft, which permits cannulation for dialysis within 24 hours after placement. Most patients with ESRD who require urgent-start dialysis can be medically stabilized while they await timely placement of arteriovenous access.3

CLINICAL OUTCOMES

We have been able to achieve CVC rates as low as 5.4% in our patient population using this strategy. By opting for a GORE ACUSEAL Vascular Graft instead of a CVC and AVF, we have decreased the cost of care from $17,523 per year to $5,894 (P < .01) at our institution. This approach is also associated with a survival advantage for GORE ACUSEAL Vascular Graft patients (85% for GORE ACUSEAL Vascular Grafts vs 78.6% for AVFs at 1 year; P < .05). Approximately 92% of patients were dialyzed within 24 hours after placement of a GORE ACUSEAL Vascular Graft.3

DIALYSIS ACCESS PROGRAM

Central to the success of our program is our effort to improve care coordination among all key stakeholders. Recognition of the value of a GORE ACUSEAL Vascular Graft in the overall strategy to improve clinical outcomes and decrease the cost of care for dialysis patients is important for nephrologists, surgeons, interventionalists, access centers, hospitals, and the patient. Good communication between the nephrologist and surgeon helps ensure that patients who require urgent-start dialysis are appropriately prioritized. Few patients will require urgent GORE ACUSEAL Vascular Graft placement overnight, but these patients should be prioritized during the day to ensure safe, timely, cost-effective, efficient, and patient-centered care.

Key to this strategy is a robust surveillance program to monitor these patients every 3 months. At each visit, flow velocities are collected along with completion of a duplex ultrasound. Our program has also sought to achieve more transparent information exchange between access centers, interventionalists, and surgeons. Patients who have poor flow velocities or difficulty with cannulation at an access center are promptly referred to the surgeon for further evaluation. The surgeon then helps coordinate care, leveraging interventional resources and early intervention to avoid graft thrombosis. Preferential placement of a GORE® VIABAHN® Endoprosthesis in the venous outflow, even across the elbow joint, is indicated when there is significant outflow stenosis.3 This strategy has helped us to reduce the number of secondary interventions for GORE ACUSEAL Vascular Grafts to just 17% of cases compared with 52.5% for the CVC and AVF combination (P < .001).3

Closing the communication loop is also important. At every episode of care, we update the access center with a drawing of the GORE ACUSEAL Vascular Graft that clearly shows the location of the inflow, conduit, and outflow. Information about depth and other potential pitfalls are also highlighted. This drawing is distributed with the patient and also directly faxed to the access center.

VALUE ANALYSIS

We recently completed a study of 397 patients who required urgent-start dialysis for ESRD. We measured patient demographics, comorbidities, interventions, complications, and the cost of care. ESRD patients who initiate dialysis via a GORE ACUSEAL Vascular Graft were significantly more likely to have permanent access for hemodialysis at 1 year compared with patients who initiated dialysis via a CVC and AVF (P < .01). This translated into a significantly lower rate of CVC days (17.6% for AVF patients vs 3.4% for GORE ACUSEAL Vascular Graft patients; P < .01).

A lower rate of CVC usage, lower rate of complications, lower mortality, and fewer secondary interventions translated into a significantly lower cost of care for patients with GORE ACUSEAL Vascular Grafts compared with CVC and AVF patients, with a lower cost evident just 1 month after the index procedure.3 When combined with a robust monitoring program and the use of aspirin and clopidogrel in GORE ACUSEAL Vascular Graft patients, we were able to achieve an 80.8% primary-assisted patency rate and 84% secondary patency rate for GORE ACUSEAL Vascular Graft patients.3

Conclusion

GORE ACUSEAL Vascular Grafts are associated with significantly improved clinical outcomes and a lower cost of care compared with CVCs and AVFs when used for ESRD patients who require urgent-start dialysis. Fewer CVC-related complications and secondary interventions result in a greater quality of life for dialysis patients.

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  1. United States Renal Data System. https://www.usrds.org/. Accessed January 31, 2019.
  2. Section K: Healthcare Expenditures for ESRD, 2018 USRDS. United States Renal Data System. https://www.usrds.org/2018/ref/ESRD_Ref_K_Expenditures_2018.xlsx. Accessed January 31, 2019.
  3. Desai SS. Impact of early cannulation grafts on quality and cost of care for ESRD patients. Ann Vasc Surg. In press.
  4. Murray E, Eid M, Traynor JP, et al. The first 365 days on haemodialysis: variation in the haemodialysis access journey and its associated burden. Nephrol Dial Transplant. 2018;33:1244-1250.
  5. Al-Balas A, Lee T, Young CJ, et al. The clinical and economic effect of vascular access selection in patients initiating hemodialysis with a catheter. J Am Soc Nephrol. 2017;28:3679-3687.
  6. Shechter SM, Chandler T, Skandari MR, Zalunardo N. Cost-effectiveness analysis of vascular access referral policies in CKD. Am J Kidney Dis. 2017;70:368-376.
  7. Wagner JK, Truong S, Chaer R, et al. Current experience and midterm follow-up of immediate-access arteriovenous grafts. Ann Vasc Surg. 2018;53:123-127.
  8. Aitken EL, Jackson AJ, Kingsmore DB. Early cannulation prosthetic graft (Acuseal) for arteriovenous access: a useful option to provide a personal vascular access solution. J Vasc Access. 2014;15:481-485.
  9. Glickman MH, Burgess J, Cull D, et al. Prospective multicenter study with a 1-year analysis of a new vascular graft used for early cannulation in patients undergoing hemodialysis. J Vasc Surg. 2015;62:434-441.
GORE VIABAHN Endoprosthesis

Proven across a broad range of complex cases, the versatility of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface* enables you to deliver high patency and durable outcomes to minimize interventions for your patients.

GORE ACUSEAL Vascular Graft

The GORE® ACUSEAL Vascular Graft allows for earlier removal or avoidance of a central venous catheter (CVC), providing an alternative for your hemodialysis patients.

Endovascular Today June 2019 Supplement

Endovascular Today June 2019 Supplement
Raising the Standards for Dialysis Access Care

 

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Sapan S. Desai, MD, PhD, MBA, FACS
Vascular Surgeon & Director of Performance Improvement
Northwest Community Healthcare
Arlington Heights, Illinois

Disclosures: Consultant for Gore & Associates.