Initial Results Published From Small Study of TVA Medical's everlinQ System for Hemodialysis Access

 

August 23, 2017—The first results were published from an eight-patient evaluation of endovascular creation of an arteriovenous fistula (AVF) for hemodialysis access using the everlinQ system (TVA Medical, Inc.). The study by Christoph Georg Radosa, MD, et al is available online ahead of print in CardioVascular and Interventional Radiology (CVIR).

According to the investigators, surgical creation of a radiocephalic fistula is the gold standard of vascular access for hemodialysis; however, the recent development of an endovascular approach for upper arm fistula creation may offer an alternative to open surgery. This series of eight cases evaluated the feasibility, early complications, and outcomes of this novel treatment option.

As summarized in CVIR, the investigators created an endovascular AVF in eight patients between July 2015 and February 2016. Indications for endovascular AVF were confirmed by a multidisciplinary vascular board upon the exclusion for Cimino fistula candidates. Patients were suitable for the procedure after a pretherapeutic ultrasound showed adequate brachial and ulnar vessels and no ipsilateral central venous stenosis.

The investigators retrospectively assessed patient characteristics, technical success, total patient radiation dose, complication rates, time to maturation of the endovascular AVF, and clinical effectiveness at 6 months.

Use of an endovascular AVF using the everlinQ device was successful in all eight cases. There was one minor intraprocedural complication. There were no postoperative complications. Median time to AVF maturation was 63 days (range, 26–137 days). One patient was lost to follow-up after the first monitoring visit. In the remaining seven patients, hemodialysis was started without problems. Patency after 6 months was 100%.

The findings demonstrated that endovascular AVFs are safe and feasible for hemodialysis access, but further studies with more patients and longer follow-up periods are needed to assess long-term outcomes and comparability to surgical dialysis access creation, concluded the investigators in CVIR.

 

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