Medtronic device a disruptive force in renal disease

MedTech & Diagnostics News: In an era marked by an aging population and longer survival rates for individuals grappling with chronic illnesses such as cancer, diabetes, and cardiovascular disorders, one issue looms large on the public health stage: end-stage renal disease. Dr Shueh Hao Lim and his team at Te Whatu Ora Capital, Coast, and Hutt Valley, have successfully performed the first Ellipsys endovascular fistula-creation procedure in Wellington, New Zealand.

Traditionally, surgically-created arteriovenous fistulas (AVFs) have been the go-to solution for patients requiring dialysis. However, recent developments by Medtronic and Becton Dickinson have ushered in a new era of percutaneous/endovascular arteriovenous fistulas by their respective products, Ellipsys and WavelinQ.

According to a recent review by Mallios et al, in a landscape characterised by incremental progress, endovascular arteriovenous fistula creation has emerged as a disruptive force. It introduces an addition to vascular access options that have seen little innovation in over half a century. The central question, however, revolves around the potential cost implications of percutaneous AVF devices, especially in an environment where cost containment remains a top priority when compared to traditional surgical procedures.

Notably, percutaneous AVFs do require more frequent early-year reinterventions to render them functional. This phenomenon is attributed to the smaller size of the anastomosis and the learning curve for dialysis personnel in accessing single outflow high-pressure conduits. However, once the healthcare providers become familiar with percutaneous AVFs, accessing the fistula becomes reliable and akin to the performance of a distal radiocephalic fistula, complete with multiple venous outflows. These modest flow and pressure percutaneous AVFs are associated with less intimal hypertrophy and fewer high-flow or pressure-related complications, such as access-related hand ischemia, infections, aneurysm formation, bleeding episodes, and high-flow congestive heart failure – issues that remain relatively rare compared to their surgical counterparts.

Seeking to shed light on this matter, Yang et al. delved into US Medicare data, comparing 60 percutaneous AVF patients with 60 surgical AVF patients, meticulously matching baseline demographic and clinical characteristics. The results were staggering: patients with percutaneous fistulas required significantly fewer reinterventions post-creation (0.59 vs. 3.43 per patient year), translating into an overall cost savings of US$11,240 for the percutaneous group during the initial year. While sceptics might question the seemingly excessive number of reinterventions for the surgical group, these findings underscore the substantial potential for cost savings in the post-creation period.

Further substantiating these findings, data from the United States Renal Data System (USRDS) have been examined to gauge the rate of AVF interventions performed in the first year and associated costs for surgical AVFs created from 2011 to 2013, in comparison with data from the NEAT trial. The evidence was compelling: endovascular AVFs boasted an event rate of 0.74 per patient-year versus a staggering 7.22 per patient-year for surgical AVFs, resulting in a cost difference of $16,494 in favour of the former. Similar results emerged in the case of prevalent patients, with an event rate of 0.46 per patient-year for percutaneous AVFs versus 4.10 per patient-year for surgical AVFs, culminating in a cost differential of $13,389.

It is crucial to note that percutaneous AVFs may not be suitable for all patients due to anatomical considerations. Approximately 50% of new patients qualify for this procedure, though this figure may rise with increased physician experience. Traditional surgical techniques will continue to be indispensable for many patients, especially in locations where percutaneous AVF creation procedures are not readily available.

With time, dialysis units and other healthcare practitioners involved in vascular access will become increasingly proficient in handling this innovative AVF technology, promising a brighter future for renal disease patients.

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