Outcomes in CArdiogenic SHock Patients Treated by MEchanical Circulatory suppoRt devicE : Impact of Shock Team

Study Overview
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Brief Summary
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In this before-after monocenter study, the authors teste the hypothesis that the implementation of a dedicated shock team could improve the outcome of patients with refractory cardiogenic shock assisted by mechanical circulatory support.

Detailed Description
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Short Term Mechanical Circulatory Support (STMCS) are the last resort therapeutics when refractory cardiogenic shock occurs. Growing technical possibilities like impella make the right choice at the right time challenging. At Bordeaux University Hospital, we have gathered the main protagonists which are the surgeon, the interventional cardiologist,and the intensivist as a shock team in January 2013. From that time, diagnosis of refractory cardiogenic shock triggers a multidisciplinary meeting driven by a common algorithm. The objective of this study is to perform a before-after comparison between decision of STMCS for refractory cardiogenic shock without shock team from january 2007 to january 2013 and after implementation of the shock team from April 2013 to April 2019.

Official Title
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Outcomes in CArdiogenic SHock Patients Treated by MEchanical Circulatory suppoRt devicE : Impact of Shock Team

Conditions
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Cardiogenic Shock, Short Term Mechanical Circulatory Support, Shock Team

Intervention / Treatment
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* Other: standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cardiogenic shock >1 sign of refractory cardiogenic shock : Dobutamine >10µg/kg/mn, epinephrine>0.25µg/kg/mn or Milrinone > 0.5µg/kg/mn ; ScvO2<55% ; pO2/FiO2<100 No major counter indication to short term mechanical circulatory support : SOFA score > 15, prolonged cardiac arrest, severe chronic disease, direct LVAD implantation or heart transplantation, counter indication for systemic anticoagulation Exclusion Criteria: Age < 18years Post cardiotomy cardiogenic shock Implantation of Impella 2.5 alone Implantation of Intra Aortic Balloon Pump alone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Without Shock Team<br>Before January 2013, patients with refractory cardiogenic shock were implanted with short term mechanical circulatory device without involvment of a dedicated shock team | Other: standard of care<br>* retrospective study : standard of care<br>|
| With Shock Team<br>After April 2013, patients with refractory cardiogenic shock were implanted with short term mechanical circulatory device following a collegial meeting of a shock team (cardiac surgeon, cardiologist, intensivist) using a common algorythm. | Other: standard of care<br>* retrospective study : standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital status | Proportion of patients alive | One year after short term mechanical circulatory support initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital status | proportion of patients alive | 30 days after short term mechanical circulatory support initiation | 
| Vital status | proportion of patients alive | 3 months after short term mechanical circulatory support initiation | 
| Vital status | proportion of patients alive | 6 months after short term mechanical circulatory support initiation | 
| Lenght of stay | Intensive Care Unit length of stay | up to Intensive Care Unit discharge, an average of 15 days | 
| Lenght of stay | Hospital length of stay | up to one year | 
| Long term mechanical circulatory support | proportion of patients bridged to long term mechanical circulatory support | up to intensive care unit discharge, an average of 15 days | 
| Heart transplantation | proportion of patients bridged to heart transplantation | up to intensive care unit discharge, an average of 15 days | 
| Weaning from short term mechanical circulatory support | proportion of patients sucessfully weaned from short term mechanical circulatory support | up to seven days from weaning attempt | 
| New renal replacement therapy | proportion of patients needing renal replacement therapy | up to intensive care unit discharge, an average of 15 days | 
| Limb ischaemia | proportion of patients with limb ischaemia | through short term mechanical circulatory support weaning, an average of 6 days | 
| Stroke | proportion of patients with stroke | through short term mechanical circulatory support weaning, an average of 6 days | 
| Short term mechanical circulatory support duration | Short term mechanical circulatory support duration | through short term mechanical circulatory support weaning, an average of 6 days | 
| Severe haemorrage | proportion of patients with severe haemorrage (massive haemorrhage according to SFAR or use of Novoseven or rescue surgery for bleeding) | through short term mechanical circulatory support weaning, an average of 6 days | 
| Extra Corporeal Membrane Oxygenation circuit clotting | proportion of patients in which Extra Corporeal Membrane Oxygenation circuit clotting occured | through short term mechanical circulatory support weaning, an average of 6 days | 
| Sepsis | proportion of patients in which sepsis occured | up to intensive care unit discharge, an average of 15 days | 
| Vital status | proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted | One year after short term mechanical circulatory support initiation | 
| Vital status | proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted | 30 days after short term mechanical circulatory support initiation | 
| Vital status | proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted | 3 months after short term mechanical circulatory support initiation | 
| Vital status | proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted | 6 months after short term mechanical circulatory support initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extra Corporeal Membrane Oxygenation, Cardiogenic Shock, Impella, Shock Team, Long Term Mechanical Circulatory Support