A Critical Evaluation of the MARS Treatment in Finland

The Molecular Adsorbent Recirculating System (MARS) is an extracorporeal albumin dialysis device which is used in the treatment of liver failure patients. This treatment was first utilized in Finland in 2001, and since then, over 200 patients have been treated. The aim of this thesis was to evaluate the impact of the MARS treatment on patient outcome, the clinical and biochemical variables, as well as on the psychological and economic aspects of the treatment in Finland. This thesis encompasses 195 MARS-treated patients (including patients with acute liver failure (ALF), acute-on-chronic liver failure (AOCLF) and graft failure), and a historical control group of 46 ALF patients who did not undergo MARS. All patients received a similar standard medical therapy at the same intensive care unit. The baseline data (demographics, laboratory and clinical variables) and MARS treatment-related and health-related quality-of-life data were recorded before and after treatment. The direct medical costs were determined for a period of 3.5 years.Additionally, the outcome of patients (survival, native liver recovery and need for liver transplantation) and survival predicting factors were investigated. In the outcome analysis, for the MARS-treated ALF patients, their 6-month survival (75% vs. 61%, P=0.07) and their native liver recovery rate (49% vs. 17%, P<0.001) were higher, and their need for transplantations was lower (29% vs. 57%, P= 0.001) than for the historical controls. However, the etiological distribution of the ALF patients referred to our unit has changed considerably over the past decade and the percentage of patients with a more favorable prognosis has increased. The etiology of liver failure was the most important predictor of the outcome. Other survival predicting factors in ALF included hepatic encephalopathy, the coagulation factors and the liver enzyme levels prior to MARS treatment. In terms of prognosis, the MARS treatment of the cirrhotic AOCLF patient seems meaningful only when the patient is eligible for transplantation. The MARS treatment appears to halt the progression of encephalopathy and reduce the blood concentration of neuroactive amino acids, albumin-bound and water-soluble toxins. In general, the effects of the MARS treatment seem to stabilize the patients, thus allowing additional time either for the native liver to recover, or for the patients to endure the prolonged waiting for transplantation. Furthermore, for the ALF patients, the MARS treatment appeared to be less costly and more cost-efficient than the standard medical therapy alone. In conclusion, the MARS treatment appears to have a beneficial effect on the patient outcome in ALF and in those AOCLF patients who can be bridged to transplantation.Vuonna 2001 Suomessa otettiin käyttöön MARS (Molecular Adsorbent Recirculating System ®)-albumiinidialyysilaite, jolla hoidetaan potilaita, joiden maksan toiminta on äkillisesti pettänyt. Tässä väitöskirjassa analysoitiin MARS-hoidon vaikutusmekanismeja, hoitotuloksia ja kustannustehokkuutta Suomessa. Selvitimme, parantaako MARS-hoito maksan vajaatoimintapotilaan eloonjäämisennustetta ja vähentääkö se maksansiirtojen tarvetta, kun se yhdistetään parhaaseen mahdolliseen tehohoitoon. Väitöskirjan tutkimusaineisto koostuu 195:stä potilaasta, jotka saivat MARS-hoitoja vuosina 2001-2007 maksan toiminnan pettämisen vuoksi sekä 46 potilaan historiallisesta verrokkiryhmästä. Potilaista kirjattiin perustiedot, kliininen tila, laboratoriokokeiden tulokset ja itse hoitoon liittyvät tiedot. Suorat hoitokustannukset määritettiin 3.5 vuoden ajalta ja elämänlaatutiedot kerättiin 15D-lomakkeen avulla. Potilaiden selviytymistä analysoitiin eloonjäämisen, oman maksan elpymisen ja maksansiirtojen osalta. MARS-hoitoa saaneiden akuuttia maksan vajaatoimintaa sairastavien potilaiden kuuden kuukauden eloonjääminen oli korkeampi (75 % vs. 61 %) ja maksansiirtojen määrä huomattavasti vähäi-sempi (29 % vs. 57 %) kuin historiallisilla verrokeilla. On kuitenkin huomattava, että viimeisen vuosikymmenen aikana akuuttiin maksan vajaatoimintaan johtavat syyt ovat muuttuneet siten, että potilaiden toipumisennuste on nyt parempi kuin aikaisemmin. Tässä tutkimuksessa tärkeimmät potilaan ennusteeseen vaikuttavat tekijät olivat maksan vajaatoimintaan syy ja akuutissa maksan vajaatoiminnassa potilaiden tajunnan taso ja veren hyytymistekijöiden sekä maksaentsyymien tasot ennen MARS-hoidon aloitusta. Tulostemme perusteella loppuvaiheen maksakirroosia sairastavien potilaiden MARS-hoito ei ole mielekästä erittäin huonon eloonjäämisennusteen vuoksi, mikäli potilaan ei katsota soveltuvan maksansiirtoon. MARS-hoito poistaa tehokkaasti sekä albumiiniin sitoutuneita että vesiliukoisin myrkkyjä, joita kertyy potilaan elimistöön maksan vajaatoiminnan yhteydessä. Lisäksi MARS-hoidolla on suotuisa vaikutus potilaan tajunnan tasoon. Kokonaisuutena MARS-hoito vaikuttaa suotuisasti potilaan yleisvointiin siten, että tämä kykenee odottamaan pidempään oman maksan elpymistä tai sopivan maksasiirrännäisen löytymistä. MARS-hoito vaikuttaa myös tulostemme perusteella kustannushyödyllisemmältä kuin maksan vajaatoiminnan paras mahdollinen perustehohoito. Kokonaisuutena MARS-hoito vaikuttaa tehokkaalta hoitomuodolta akuuttia maksan vajaatoimintaa sairastavilla potilailla sekä niillä kroonista maksan vajaatoimintaa sairastavilla potilailla, joiden katsotaan soveltuvan maksansiirtoon

Cost-utility of molecular adsorbent recirculating system treatment in acute liver failure

Peer reviewe

Introduction

Finnish Society for Practise Based Inquiry (Praba; www.praba.fi) opened a call of papers in autumn 2018. The call was based on the 17th Congress of Methodology in Hämeenlinna on April 24, 2018. The theme of the Congress was Human and Nature, organized by Praba and Häme University of Applied Sciences (www.hamk.fi)

Human and Nature

This book is collection of articles edited by the Finnish Society for Practice Based Inquiry (Praba). The intention of the book is to characterize the relationship between human and nature. The articles aim to offer several different perspectives to the topic both from micro and macro perspectives. Interaction brings the articles together – the focus in all articles is interaction between human and nature. Interaction has as many different models as there are authors: physical or mental, bare or hidden. Globalization is also strongly present in the relationship between human and nature – when changing the environment, human beings must relocate themselves and find their position in the new nature. In all, this book aims to generate both an opportunity and duty to open our eyes and minds to the reality, and to support and encourage us to take concrete steps towards a sustainable future

Effect of Health-Related Quality-Of-Life Instrument and Quality-Adjusted Life Year Calculation Method on the Number of Life Years Gained in the Critical Care Setting

AbstractObjectivesHealth-related quality of life (HRQoL) and quality-adjusted life-years (QALYs) gained are basic elements in the cost-utility evaluations of health care. Different HRQoL instruments produce different scores for the same patient, and thus also a different number of QALYs. We examined the effect of these factors on the number of QALYs gained and the cost per QALY in the critical care setting.MethodsIn 937 patients having been treated in the critical care setting in the Helsinki University Central Hospital the HRQoL scores were measured by the EQ-5D and 15D 6 and 12 months after start of treatment, and QALYs were calculated using four different sets of assumptions regarding recovery from disease.ResultsThe mean number of QALYs gained during the first year after treatment ranged from 0.178 ± 0.206 to 0.550 ± 0.508 and the consequent cost per QALY from €38,405 to €118,668 depending on HRQoL instrument and assumptions used in the calculations regarding recovery from disease.ConclusionsThe HRQoL instrument and the assumptions employed regarding recovery from disease have a great influence on the results of cost-utility analyses and should, therefore, be explicitly described in studies reporting QALYs. Furthermore, a common consensus on which calculation method should be used within critical care would be urgently needed