An observational study in VA-ECMO for Postcardiotomy Cardiogenic Shock, sponsored by National Institute of Cardiovascular Diseases, Slovakia. Completed at 1 site in Slovakia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by National Institute of Cardiovascular Diseases, Slovakia · Observational
Some patients develop severe heart failure during or after cardiac surgery and require temporary support for circulation and oxygenation. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a form of life support that circulates blood outside the body through a pump and an oxygenator while the heart recovers.
This retrospective study examines 128 adults who received VA-ECMO for postcardiotomy cardiogenic shock at the National Institute for Cardiovascular Diseases in Bratislava, Slovakia, between January 2013 and June 2026. The study includes 78 patients who started support during the operation or because they could not be separated from cardiopulmonary bypass, and 50 patients who started support later in the intensive care unit after postoperative deterioration.
The main objective is to evaluate the association between the timing of VA-ECMO initiation and death before hospital discharge. Additional outcomes include successful removal of ECMO with survival for at least 24 hours after decannulation, duration of ECMO support, and length of hospitalization. Existing clinical records are used to account for measured differences in patient condition and surgical complexity. All treatment decisions were made by the treating clinical team during routine care.
This retrospective observational study evaluates the association between the timing of VA-ECMO initiation and in-hospital outcomes in adult patients with refractory postcardiotomy cardiogenic shock. The cohort comprises 128 patients treated at the Department of Cardiac Surgery, National Institute for Cardiovascular Diseases, Bratislava, Slovakia, between January 2013 and June 2026.
VA-ECMO was initiated for persistent circulatory failure during or after cardiac surgery despite optimization of preload, vasoactive and inotropic support, and correction of reversible causes. Initiation, cannulation strategy, ECMO configuration, and left-sided cardiac unloading were determined by the treating multidisciplinary team according to the patient's clinical condition. Treatment timing was not assigned by the study.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
This study's enrollment of 128 is below the median of 200 across 155 observational studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →National Institute of Cardiovascular Diseases, Slovakia is the lead sponsor of 3 studies on the registry; none are open to participants now.
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The study population consists of adult patients identified from institutional clinical records who received VA-ECMO for postcardiotomy cardiogenic shock. Patients of all sexes were eligible. Healthy volunteers were not included.
Patients with hybrid configurations or subsequent configuration changes were included when these formed part of their VA-ECMO treatment for postcardiotomy cardiogenic shock.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Initial VA-ECMO implantation during the cardiac operation or immediately following inability to separate from cardiopulmonary bypass. A total of 78 participants.
Initial VA-ECMO implantation in the intensive care unit following postoperative hemodynamic or respiratory deterioration after the cardiac operation. A total of 50 participants.
All-cause in-hospital mortality
Number and percentage of participants who died from any cause during the index hospitalization in which VA-ECMO was initiated. This includes death during ECMO support and death after ECMO discontinuation before hospital discharge. The denominator is the total number of participants in the respective timing group. Survival to hospital discharge is the complementary outcome.
Time frame: From initial VA-ECMO initiation until death from any cause or discharge from the index hospitalization, whichever occurred for up to 37 days.
Successful ECMO weaning
Number and percentage of participants in whom ECMO was explanted or discontinued and who survived for at least 24 hours after decannulation. Death during ECMO support, inability to separate from ECMO, or death before completion of 24 hours after decannulation constitutes weaning failure. A subsequent death during the same hospitalization does not reverse successful weaning once the 24-hour survival criterion has been met. The denominator is the total number of participants in the respective timing group.
Time frame: From initial VA-ECMO initiation through 24 hours after decannulation, or until death if earlier, during the index hospitalization, assessed up to 226 hours.
Duration of ECMO support
Duration of ECMO support in hours, measured from initiation to discontinuation of support or death during support. Duration is summarized as the median and interquartile range for each timing group, including participants who survived and those who died during support.
Time frame: From initial VA-ECMO initiation until discontinuation of ECMO support or death during support, whichever occurred first, during the index hospitalization, assessed up to 250 hours.
Length of index hospitalization
Length of the index hospital stay in days, measured from hospital admission to hospital discharge or in-hospital death. Length of stay is summarized as the median and interquartile range for each timing group and includes both survivors and nonsurvivors.
Time frame: From admission for the index hospitalization until hospital discharge or in-hospital death, whichever occurred first, assessed up to 37 days.
Additional clinical outcomes
Complications documented in the clinical records were described by timing group: infection, sepsis, pulmonary complications, hepatorenal failure, bleeding, surgical re-exploration, Harlequin syndrome, and peripheral vascular complications. Each category was assessed separately using recorded clinical diagnoses or procedures. Death during ECMO, death after discontinuation, and recorded cause of death were also characterized during the index hospitalization.
Time frame: From admission for the index hospitalization until hospital discharge or in-hospital death, whichever occurred first, assessed up to 37 days.
Plan to share: Yes — The research is part of a PhD thesis, which will be published in its entirety following its successful defense. Partial results have already been published (https://link.springer.com/article/10.1007/s44411-026-00733-9), while a manuscript presenting the overall results has been prepared and is currently under review.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Information will be available after the defense of the thesis (approximately from January 2027) for a period of at least 30 years
Access criteria: The entire work will be freely accessible on the website - https://opac.crzp.sk/?fn=AdvancedSearchChildE26KI\&search=advanced\&entity=0\&seo=CRZP-H%C4%BEadanie\&routeID=crzp_ostry_4
Data sharing details ↗ · opac.crzp.sk
Ran from Jan 2013 to primary completion in Jun 2026, 161 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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National Institute of Cardiovascular Diseases, Slovakia