Percutaneous arteriovenous fistula creation with the 4F WavelinQ EndoAVF System
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Affiliation
New York University Medical Center; St. Paul's Hospital, Vancouver; Queen Elizabeth Hospital Birmingham; Albany Medical College/Albany Medical Center Hospital; SyntactxOther Contributors
Bala, SaravananBenck, Urs
Berland, Todd L.
Brunkwall, Jan
Chan, Tze
Clement, Jason
Dellanna, Frank
Ebner, Adrian
Gilbert, James
Griffin, Joseph
Haage, Patrick
Inston, Nicholas
Kiaii, Mercedeh
Kreienberg, Paul
Lichtenberg, Michael
Peden, Eric K.
Scheinert, Dierk
Schmitz-Rixen, Thomas
Rosenkranz, Alexander
Schwindt, Arne
Tavakoli, Afshin
Tordoir, Jan
Wadoodi, Ashar
Weiss, Norbert
Westin, Gregory G.
Publication date
2021-10-01
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Background: Percutaneous devices for creation of native arteriovenous fistulae offer an alternative to traditional open surgical techniques. The 4F WavelinQ EndoAVF System was developed as a lower profile alternative to facilitate access through smaller vessels and minimize access site complications; The current report is the original first experience of this device, assessing outcome in 120 patients followed for 6 months. Methods: The use of the 4F WavelinQ system in three studies, EASE (32 patients), EASE-2 (24 patients), and the EU postmarket clinical follow-up study (64 patients) was aggregated and analyzed. Patients were followed with duplex ultrasound at discharge and follow-up visits at 1, 3, and 6 months. Primary, assisted primary, and secondary patency rates were evaluated as Kaplan-Meier estimates and standard errors. Time to maturity and time to successful cannulation were defined as the mean ± standard deviation days from the procedure in patients enrolled on dialysis. Results: Procedural success was achieved in 116 patients (96.7%). Primary, assisted-primary, and secondary 6-month patency rates were 71.9% ± 4.5%, 80.7% ± 4.1%, and 87.8% ± 3.3%, respectively. Time to maturity averaged 41 ± 17 days. Time to successful cannulation averaged 68 ± 51 days. Device-related serious adverse events were reported in 3 of 120 patients (2.5%) and procedure-related serious adverse events occurred in 7 of 120 patients (5.8%). Arterial or venous access complications were not reported in any of the patients. Access circuit reinterventions were performed in 23 patients (19.2%), split between those performed for EndoAVF maturation (13/120 [10.8%]) and maintenance (11/120 [9.2%]). Conclusions: Percutaneous creation of native dialysis fistulae with the 4F WavelinQ EndoAVF System is safe and effective, with favorable durability and a low rate of serious complications and reinterventions through 6-month follow-up. Use of the 4F device allows for percutaneous fistula creation between the radial artery and radial vein or the ulnar artery and ulnar vein. These findings suggest that the 4F device is a useful percutaneous alternative to open surgical AVF or endovascular AVF with larger bore devices.Citation
Berland T, Clement J, Inston N, Kreienberg P, Ouriel K; WavelinQ 4 French Investigators. Percutaneous arteriovenous fistula creation with the 4F WavelinQ EndoAVF System. J Vasc Surg. 2022 Mar;75(3):1038-1046.e3. doi: 10.1016/j.jvs.2021.09.025. Epub 2021 Oct 1Type
ArticlePMID
34601046Journal
Journal of Vascular SurgeryPublisher
Elsevierae974a485f413a2113503eed53cd6c53
10.1016/j.jvs.2021.09.025