Original Title: Oxigenación por membrana extracorpórea (ECMO) en pacientes con insuficiencia cardiaca avanzada o shock cardiogénico

Authors' objectives: • To review the available scientific evidence on ECMO in patients with advanced HF or cardiogenic shock. • To evaluate the economic impact of an ECMO system in a tertiary hospital and other aspects related to the use of the technology (ethical, legal, social and organizational).

Authors' results and conclusions: RESULTS: The systematic literature review yielded 23 articles that met the inclusion criteria. For effectiveness and safety evaluation, 3 systematic reviews and 15 primary studies were included, all observational, of which 10 were comparative studies (cohort studies) and 5 were case series from ELSO international registry. The methodological quality of these primary studies is very low due to their observational design, small sample sizes (cohort studies) and serious risks of bias. Cohort studies comparing ECMO with DAV in adult patients with cardiogenic shock did not find significant differences in survival to hospital discharge between the two devices (49% vs 58%), although there was a great variability due to the population characteristics. The use of ECMO vs DAV after a heart transplant is more controversial: a study recommended ECMO against DAV in patients with primary graft failure (survival of 54% vs 33% at discharge), while another study advised against it as a bridge to re-transplantation (41% vs 53% at 1 year). In patients with low cardiac output after cardiac surgery better results were observed for VAD (50% vs 25% at 30 days). Compared with CPR, ECMO improved survival in adult patients with acute myocardial infarction with ST-segment elevation and especially in those with profound cardiogenic shock (61% vs 28% at 30 days). Case series showed good survival rate for adult patients with myocarditis of HF origin (63% at discharge). In the pediatric population on waiting list for heart transplantation, higher survival in patients treated with VAD was observed (88% vs 69% at discharge). Case series from ELSO registry found low survival in children with congenital heart disease treated with ECMO (21% at discharge). On the other hand, good results were observed in pediatric patients with myocarditis (59% at discharge). Complications are frequent and include kidney injury (56%), major bleeding (41%), rethoracotomy (42%) and infections (30%), but no significant differences were observed between the devices. There is uncertainty whether complications are entirely attributable to the use of ECMO, given the critical conditions of patients. In the efficiency review, two economic evaluations, one systematic review and two cost studies were analyzed. Two studies of cost-utility, from the UK and the US, compared ECMO with CPR in the pediatric population, but did not coincide in their conclusions (ICER: £ 65,645 per QALY vs $ 24,386 per QALY). ECMO hospital costs are high, but could be partially offset by the avoided costs of transporting patients to the referral hospital. The annual cost of the use of one ECMO console, treating 25 patients per year, would amount to 127,466 € and the budgetary impact would be 17,255 € compared to the basecase scenario without the technology. Ethical challenges have been identified, regarding the initiation and especially the finalisation of ECMO treatment in some cases. Each hospital must implement protocols of indication, maintenance and withdrawal of ECMO, with the collaboration of the ethics committee. In addition, the ECMO implementation requires coordination of different units and a team with experience and ongoing training in order to minimize the risk of complications. CONCLUSIONS: Scientific evidence on the use of ECMO in patients with advanced HF or cardiogenic shock is sparse. There are no randomized clinical trials and the evidence is limited to observational studies. In addition there is significant heterogeneity in the populations studied. Compared with conventional resuscitation, ECMO improves survival in patients with advanced HF and cardiogenic shock. Compared to other VAD of short duration, there is insufficient evidence of the superiority of one of the alternatives for any of the indications. Complications are frequent and severe, but there is uncertainty about the proportion of complications attributable to ECMO and those arising from the clinical condition of the patient. Compared to other VAD, ECMO showed no higher complications incidence. There is very limited and controversial scientific evidence on the cost-effectiveness of ECMO versus conventional therapy in the pediatric population. There is no data on the adult population. ECMO hospital costs are high, but could be partially offset by the avoided costs of transporting patients to the referral hospital. Further studies with randomized clinical trial design, standardized selection and diagnosis criteria and long-term monitoring are needed, along with economic evaluations to confirm the benefits of ECMO as salvage therapy in patients with advanced HF or cardiogenic shock.

Authors' recommendations: It is suggested to implement a mechanical circulatory device in selected hospitals to address critical patients with advanced HF or cardiogenic shock. No recommendations can be made on ECMO preference over other VAD of short duration in patients with advanced HF or cardiogenic shock. The new referral hospital must meet the requirements set by ELSO and accumulate enough experience in healthcare excellence to minimize complications and optimize results. The use of ECMO should be done under scientific protocols developed and agreed by experts.

Authors' methods: We performed a systematic review of studies in which the effectiveness, safety and efficiency was evaluated. The search was conducted in several electronic databases in February 2016 and bibliographic lists of papers of interest were also reviewed. Patient of any age treated with veno-arterial ECMO for advanced HF or cardiogenic shock were included. Studies with other indications or mixed population were excluded. For the review of effectiveness and safety, potential comparators were other short-term DAVs or conventional cardiopulmonary resuscitation (CPR), and because of the scarcity of comparative studies, we included also primary studies without comparator (case series) from an international registry and with more than 100 cases included) and systematic reviews. The main outcome measures were survival / mortality and complications. The risk of bias was assessed with different tools, according to the study design. In the efficiency review, complete economic evaluations and cost studies were included. The population and comparators were the same as in the part of effectiveness and safety. The main outcome measure was the incremental cost-effectiveness ratio (ICER). The methodological quality was critically evaluated. An economic analysis was performed, with an estimation of the budgetary impact of the ECMO acquisition for a hospital that currently does not have the technology. In addition, ethical, legal and organizational aspects related to the use of ECMO were analyzed. The evaluation of the quality of evidence and grading of the strength of the recommendations were made following the GRADE methodology.

Project Status: Completed

Year Published: 2016

URL for published report: https://sescs.es/ecmo-pacientes-insuficiencia-cardiaca-avanzada-shock-cardiogenico/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es