Wearable artificial kidneys...2008. What's new?
1 Fontvielle, Monaco 2 Brown University School of Medicine, RI, USA
Correspondence and offprint requests to: Stanley Shaldon, 25 Le Michelangelo, 7 Avenue des Papalins, Monaco 98000. E-mail: stanley.shaldon{at}libello.com
Keywords: originality; peer review process; wearable artificial kidney (WAK)
Wikipedia defines ‘originality’ as the aspect of created or invented work being new or novel, and thus able to be distinguished from reproductions, clones, forgeries or derivative works. An original work is one not received from others, nor one copied based on the work of others. The recent Lancet [1] and Kidney International [2,3] publications and commentary on a wearable artificial kidney (WAK) [4] cannot claim to be original by any definition. Thus, what motivates authors to make such claims as ‘this study describes the first use of a wearable hemofiltration device to manage fluid overload’ [3]? It cannot be ignorance as a 5-min search in Google or Medline would have revealed the numerous prior publications that the authors failed to cite. The responsibility for allowing such an error in publication to occur must lie more with the editorial and external review process than the authors themselves or the invited favourable commentary in the Lancet [4]. Thus, the purpose of this invited editorial commentary will be to place in its correct perspective the articles on a WAK published virtually simultaneously in two leading international journals of extremely high repute. The Lancet article entitled ‘A wearable haemodialysis device for patients with end-stage renal failure: a pilot study’ [1] created more of a sensation than the Kidney International article that was only available, initially, in its electronic form [2,3]. Before reviewing the extensive uncited prior references [7–9], we will speculate upon the possible motivation of this eminently successful staged media event. Clearly renommé would be the kindest explanation. A defence of ignorance cannot be accepted as the patent application by Gura for the WAK cited all the previous references not mentioned in the Lancet or Kidney International articles [5].
The peer review process has most certainly failed in its basic obligations by allowing this misrepresentation to occur. The sole reference to prior publications was to a largely conceptual article by Stephens et al. [6] that is quoted by the authors in both publications. The articles were thus misleading because they created the impression that the described work was somehow novel and original, a breakthrough, and a significant advance in the quest for a WAK.
Thus, the claims of originality are difficult to substantiate and in effect add very little to the pioneering description by Murisasco and colleagues in 1986 that was presented as a poster at the annual meeting of the American Society of Artificial Organs in Anaheim and subsequently published in the society's journal [7]. They described two ESRD patients treated continuously for 3 months and 1 month, respectively, by a wearable device consisting of a minicartridge containing zirconium phosphate, zirconium oxide, activated carbon and urease. Blood access was from an indwelling forearm AV shunt and did not necessitate a blood pump for circulation through device. The ultrafiltrate obtained from a double Amicon mini-haemofilter was pumped through the minicartridge, and then 80% of the ultrafiltrate was reinjected into the circulation and 20% was removed to maintain constant body weight. Two specially designed battery-operated variable flow minipumps were used, one for regenerated ultrafiltrate that was recirculated and the other for removing ultrafiltrate from the system. The first patient was treated continuously for 3 months using three minicartridges per day. Significant clinical improvement was claimed. Less extensive experience has also been reported by Neff et al. and Shaldon et al. [8,9]. Ultimate patient refusal to continue with the burdensome device was the usual reason for abandonment and return to standard haemodialysis. The latest device was left in place for no more than several hours per day and thus was not continuous and was used in conjunction with, rather than instead of, extracorporal dialysis and thus is at best an adjunctive therapy. It seems to offer very little hope that the long-term experiences reported over 20 years ago will be any different if and when definitive clinical trials are reported. The psychological aspects of being reminded continuously of your dependence upon a 5 kg belted device, with continuous systemic heparinization, and with the possibility of disruption of the blood circulation and consequent potentially fatal exsanguination will always be a major reason for abandonment of the WAK until such time as it becomes possible to be implanted.
Conflict of interest statement. None declared.
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- Davenport A, Gura V, Ronco C, et al. A wearable haemodialysis device for patients with end-stage renal failure: a pilot study. Lancet (2007) 370:2005–2010.[Medline]
- Gura V, Ronco C, Nalesso F, et al. A wearable haemofilter: first human study of slow continuous ambulatory ultrafiltration. In: Kidney Int (2007) doi:10.1038/sj.ki.5002711.
- Gura V, Ronco C, Nalesso F, et al. A wearable haemofilter for continuous ambulatory ultrafiltration. Kidney Int (2008) 73:497–502.[CrossRef][Web of Science][Medline]
- Eknoyan G. Comment: artificial kidneys: progress and promise. Lancet (2007) 370:1977–1978.[Medline]
- Gura V. Wearable continuous renal replacement therapy device. US patent no. 6,960,179 B2, 2005.
- Stephens RI, Jacobsen SC, Atkin-Thor E, et al. Portable/wearable artificial kidney (WAK) initial evaluation. Proc Eur Dial Transplant Assoc (1976) 12:511–518.[Medline]
- Murisasco A, Reynier JP, Ragon Y, et al. Continuous arterio-venous haemofiltration in a wearable device to treat end-stage renal disease. Trans Am Soc Intern Organs (1986) 32:567–571.
- Neff M, Skifkin R, Eiser A, et al. A wearable artificial glomerulus. Proc Clin Dial Transplant Forum (1979) 9:23–27.[Medline]
- Shaldon S, Beau MC, Deschodt G, et al. Continuous ambulatory hemofiltration. Trans Am Soc Intern Organs (1980) 26:210–212.
Accepted in revised form: 26. 6.08
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