Patency definitions following hemodialysis access intervention

Access primary patency

Interval of time from AV dialysis access creation to the ﬁrst of one of the following events: access thrombosis; any intervention designed to facilitate, maintain, or re-establish patency; the access reaches a censoring event as speciﬁed a priori in the study protocol; or study end.

Access assisted primary patency

Interval of time from AV dialysis access creation until the first of one of the following events: access thrombosis, the access reaches a censoring event as speciﬁed a priori in the study protocol, or study end. This period includes all intervening interventions (surgical or endovascular) designed to maintain the functionality of the dialysis vascular access as long as patency is not lost.

Access cumulative patency*

Interval of time from AV dialysis access creation until access abandonment, the access reaches a censoring event as specified a priori in the study protocol, or study end, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of the access.

Post-intervention^¶ primary patency

The interval of time from the index IDBD until the ﬁrst of one of the following events: access thrombosis; any intervention designed to facilitate, maintain, or re-establish patency; the access reaches a censoring event as speciﬁed a priori in the study protocol; or study end.

Post-intervention^¶ assisted primary patency

The interval of time from the index IDBD intervention to the ﬁrst of one of the following events: access thrombosis, a surgical intervention that excludes the treated lesion from the dialysis access circuit, or the patient reaches a censored event as deﬁned a priori in the study protocol. This period includes all intervening interventions (surgical or endovascular) designed to maintain the functionality of dialysis vascular access.

Post-intervention^¶ cumulative patency*

The interval of time from the index IDBD intervention until the access is abandoned, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of a patent access, the patient reaches a censoring event as deﬁned a priori in the study protocol, or study end.

AV: arteriovenous; IDBD: intervention, drug, biologic, device.
* The term secondary patency has also been used in this context; however, this term has been misused in the literature, which makes it a confusing term that we prefer not to use.
¶ Intervention: Any surgical or endovascular manipulation of the access to maintain or reestablish its functionality.

Adapted with permission from: Shenoy S, Allon M, Beathard G, et al. Clinical trial end points for hemodialysis vascular access: Background, rationale, and definitions. Clin J Am Soc Nephrol 2018; 13:490. Copyright © 2018 American Society of Nephrology.

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Patency definitions following hemodialysis access intervention