The future of the artificial kidney: moving towards wearable and miniaturized devices

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Abstract

New directions in dialysis research include cheaper treatments, home based therapies and simpler methods of blood purification. These objectives may be probably obtained with innovations in the field of artificial kidney through the utilization of new disciplines such as miniaturization, microfluidics, nanotechnology. This research may lead to a new era of dialysis in which the new challenges are transportability, wearability and why not the possibility to develop implantable devices. Although we are not there yet, a new series of papers have recently been published disclosing interesting and promising results on the application of wearable ultrafiltration systems (WUF) and wearable artificial kidneys (WAK). Some of them use extracorporeal blood cleansing as a method of blood purification while others use peritoneal dialysis as a treatment modality (ViWAK and AWAK.) A special mention deserves the wearable/portable ultrafiltration system for the therapy of overhydration and congestive heart failure (WAKMAN). This system will allow dehospitalization and treatment of patients with less comorbidity and improved tolerance. On the way to the wearable artificial kidney, new discoveries have been made such as a complete system for hemofiltration in newborns (CARPEDIEM). The neonate in fact is the typical patient who may benefit from miniaturization of the dialysis circuit. This review analyzes the rationale for such endeavour and the challenges to overcome in order to make possible a true ambulatory dialysis treatment. Some initial results with these new devices are presented. We would like to stimulate a collaborative effort to make a quantum leap in technology making the wearable artificial kidney a reality rather than a dream.

Translated abstract

Los nuevos enfoques en la investigación en diálisis incluyen el abaratamiento de los tratamientos, las terapias domiciliarias y métodos más sencillos de purificación sanguínea. Probablemente estos objetivos se consigan gracias a los avances en riñones artificiales mediante el uso de nuevas técnicas, como la miniaturización, los microfluidos o la nanotecnología. Esta línea de investigación podría llevarnos a una nueva era en el campo de la diálisis, en la que los nuevos retos serán la transportabilidad, la portabilidad y, por qué no, la posibilidad de desarrollar dispositivos implantables. A pesar de no haber alcanzado aún ese punto, recientemente se han publicado una serie de trabajos en los que los resultados sobre los sistemas de ultrafiltración portátiles y los riñones artificiales portátiles se revelan prometedores y de gran interés. Algunos de ellos recurren a la modalidad extracorpórea como método de purificación sanguínea, mientras que otros recurren a la diálisis peritoneal como modalidad de tratamiento (ViWAK, Vicenza Wearable Artificial Kidney, y AWAK, Automated Wearable Artificial Kidney). Merece mención especial el sistema de ultrafiltración portátil para la terapia de la sobrehidratación y la insuficiencia cardíaca congestiva (WAKMAN). Este sistema permitirá reducir el número de hospitalizaciones, el tratamiento de pacientes con menor comorbilidad y una mayor tolerancia. Durante la investigación en el riñón artificial portátil se han ido sucediendo nuevos avances, como el desarrollo de un sistema completo de hemofiltración para recién nacidos (CARPEDIEM, Cardio Renal Pediatric Dialysis Emergency Machine). El neonato, de hecho, es el paciente que más podría beneficiarse de la miniaturización del circuito de diálisis. Esta revisión analiza los fundamentos de esta tendencia y los obstáculos que se le presentan a la hora de alcanzar un sistema de diálisis totalmente ambulatorio. Se presentan los resultados iniciales de estos nuevos dispositivos. Con este trabajo nos gustaría promover un esfuerzo común para dar un salto cuantitativo tecnológico y hacer que el riñón artificial portátil sea una realidad y no una quimera.

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Most cited references 53

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Jacobus P. van Wouwe, Lara Charlesworth, Hans Hillege … (2000)

Because renal function is affected by chronic heart failure (CHF) and it relates to both cardiovascular and hemodynamic properties, it should have additional prognostic value. We studied whether renal function is a predictor for mortality in advanced CHF, and we assessed its relative contribution compared with other established risk factors. In addition, we studied the relation between renal function and neurohormonal activation. The study population consisted of 1906 patients with CHF who were enrolled in a recent survival trial (Second Prospective Randomized study of Ibopamine on Mortality and Efficacy). In a subgroup of 372 patients, plasma neurohormones were determined. The baseline glomerular filtration rate (GFR(c)) was calculated using the Cockroft Gault equation. GFR(c) was the most powerful predictor of mortality; it was followed by New York Heart Association functional class and the use of angiotensin-converting enzyme inhibitors. Patients in the lowest quartile of GFR(c) values ( 76 mL/min). Impaired left ventricular ejection fraction (LVEF) was only modestly predictive (P=0.053). GFR(c) was inversely related with N-terminal atrial natriuretic peptide (ANP; r=-0.53) and, to a lesser extent, with ANP itself (r=-0.35; both P<0.001). Impaired renal function (GFR(c)) is a stronger predictor of mortality than impaired cardiac function (LVEF and New York Heart Association class) in advanced CHF, and it is associated with increased levels of N-terminal ANP. Moreover, impaired renal function was not related to LVEF, which suggests that factors other than reduced cardiac output are causally involved.

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Michael J Lysaght (2001)

Despite a general recognition that treatment of end-stage renal disease (ESRD) has become a large-scale undertaking, the size of the treated population and the associated costs are not well quantified. This report combines data available from a variety of sources and places the current (midyear 2001) estimated global maintenance dialysis population at just over 1.1 million patients. The size of this population has been expanding at a rate of 7% per year. Total therapy cost per patient per year in the United States is approximately 66,000 dollars. Assuming that this figure is a reasonable global average, the annual worldwide cost of maintenance ESRD therapy in the year 2001, excluding renal transplantation, will be between 70 and 75 billion US dollars. If current trends in ESRD prevalence continue, as seems probable, the ESRD population will exceed 2 million patients by the year 2010. The care of this group represents a major societal commitment: the aggregate cost of treating ESRD during the coming decade will exceed 1 trillion dollars, a thought-provoking sum by any economic metric.

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A wearable haemodialysis device for patients with end-stage renal failure: a pilot study.

Masoud Beizai, Andrew Davenport, Claudio Ronco … (2007)

More frequent haemodialysis can improve both survival and quality of life of patients with chronic kidney disease. However, there is little capacity in the UK to allow patients to have more frequent haemodialysis treatments in hospital and satellite haemodialysis units. New means of delivering haemodialysis are therefore required. Our aim was to assess the safety and efficiency of a wearable haemodialysis device. Eight patients with end-stage kidney failure (five men, three women, mean age 51.7 [SD 13.8] years) who were established on regular haemodialysis were fitted with a wearable haemodialysis device for 4-8 h. Patients were given unfractionated heparin for anticoagulation, as they would be for standard haemodialysis. There were no important cardiovascular changes and no adverse changes in serum electrolytes or acid-base balance. There was no evidence of clinically significant haemolysis in any patient. Mean blood flow was 58.6 (SD 11.7) mL/min, with a dialysate flow of 47.1 (7.8) mL/min. The mean plasma urea clearance rate was 22.7 (5.2) mL/min and the mean plasma creatinine clearance rate was 20.7 (4.8) mL/min. Clotting of the vascular access occurred in two patients when the dose of heparin was decreased and the partial thromboplastin time returned towards the normal reference range in both of these patients. The fistula needle became dislodged in one patient, but safety mechanisms prevented blood loss, the needle was replaced, and treatment continued. This wearable haemodialysis device shows promising safety and efficacy results, although further studies will be necessary to confirm these results.