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Abstract: FR-PO715

Sirolimus Treated AV Fistulae: Maturation Profile and Impact of Processes of Care

Session Information

Category: Dialysis

  • 704 Dialysis: Vascular Access

Authors

  • Iyer, Sriram, Vascular Therapies, Cresskill, New Jersey, United States
  • Kopyt, Nelson P., Lehigh Valley Hospital, Bethlehem, Pennsylvania, United States
  • Gandhi, Nirav, Southern California Kidney Consultants, Anaheim, California, United States
  • Atray, Naveen K., Capitol Nephrology, Sacramento, California, United States
  • Wooldridge, Thomas D., Nephrology & Hypertension Associates, LTD, Tupelo, Mississippi, United States
  • Lee, Joseph J., Nephrology Associates Medical Group, Riverside, California, United States
  • Hendon, Kendra S., Knoxville Kidney Center, Knoxville, Tennessee, United States
  • Paulson, William D., Augusta University, Augusta, Georgia, United States
  • Khawar, Osman S., Balboa Nephrology Medical Group, Escondido, California, United States
  • Lynn, Robert I., Albert Einstein College of Medicine, Bronx, New York, New York, United States
  • Roy-Chaudhury, Prabir, University of Arizona, Tucson, Arizona, United States
  • DeVita, Maria V., Lenox Hill Hospital- Northwell Health System, New York, New York, United States

Group or Team Name

  • on behalf of the ACCESS Trial investigators
Background

An arteriovenous fistula (AVF) is clinically mature if it can be reproducibly cannulated with 2 large-bore needles and has enough blood flow to support adequate hemodialysis. This analysis relates to AVF maturation data from patients (pts) who received intraoperative sirolimus delivered perivascularly at and around the AVF anastomosis from a collagen membrane (Drug product Vascular Therapies, Cresskill, NJ). The 7 center Hemodialysis Fistula Maturation (HFM) Study (n=602) recently reported impact of care processes on AVF maturation outcomes (Allon AJKD 2018)

Methods

Data for sirolimus treated AVF is from 30 Phase 2 + 22 open label pts. (from an ongoing US multicenter Phase 3 study NCT 02513303) undergoing surgery for a first, single stage upper extremity AVF. Mature AVF is defined as ability to use the AVF for 3 consecutive 2-needle dialysis sessions with a mean flow of ≥300 mL/min for pts on dialysis or vein diameter of 6 mm and blood flow of ≥500 mL/min on ultrasound for patients not on dialysis.

Results

52 pts; 51 ESRD, 1 CKD, 67% Male, mean, age 56±17y, 42% diabetic; 65% forearm AVF. Table compares metrics of AVF that matured without (Gp1) and with (Gp 2) supplementary procedures (SP) which included balloon PTA, vein elevation and exclusion of collateral vein(s)

Conclusion

1. Excluding the 6 AVF that thrombosed early, all (100%) remaining 46 sirolimus treated AVF matured into a useful fistula (HFM: 77.6%)
2. 38/46 (83%) of sirolimus treated AVF matured after a median of 48 days (HFM: 125 days)
3. The median time of 121 days to maturation for the 8/46 (17%) AVF which required supplementary procedure(s) for maturation was roughly 2.5 times > than Gp 1.
4. For 83% of sirolimus treated AVF’s (Gp1) the ONLY metric influencing use of the AVF for dialysis was the anatomical and functional readiness of the fistula for cannulation.
5. For the 17% AVF that required supplementary interventions (Gp2), optimizing processes of care should help in reducing time to first AVF use.

Table
 Median Days (Interquartile Range; IQR ) 
 NSurgery to MaturationSurgery to SPSP to MaturationMaturation Success
Group 13848 (38,56)  100%
Group 28121 (104,127)59 (51,72)40 (17,47)100%
Total46*    

* 6/52 (11.5%) AVF thrombosed within 2 weeks and are excluded from this analysis

Funding

  • Commercial Support