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In this retrospective observational multicenter study the authors tested the hypothesis that the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular Assist Device (LVAD).
End stage heart failure patients admitted in Intensive Care Unit (ICU) for refractory cardiogenic shock requiring short-term mechanical circulatory support as a bridge to a long-term LVAD might benefit from early mobilization and rehabilitation with IMPELLA™ inserted via the axillary artery. The aim of this study is to compare the early rehabilitation and outcomes after LVAD implantation between patients previously treated by IMPELLA™ or ExtraCorporeal Life Support (ECLS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMPELLA™ alone as bridge to LVAD | patients assisted by IMPELLA™ pump alone during the days preceding the implantation of long term LVAD (at least 48 hours for patients for whom an ECLS was previously used) |
| |
| ECLS alone or with IMPELLA™ as bridge to LVAD | patients assisted by ECLS (ExtraCorporeal life support) alone or simultaneously with IMPELLA™ until the implantation of LVAD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard of care | Other | retrospective study: standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8 at 30 days after the LVAD implantation | Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8) at 30 days after the LVAD implantation | Day 30 after Left Ventricular Assist Device (LVAD) implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Complication and rehabilitation under Short-term Mechanical Circulatory support | Duration of support, bleeding, hemolysis, surgical re-exploration, thombus, renal replacement therapy, blood products transfusion, stroke, tracheal extubation, mobilization (chair, walking and ergometry) | The day of Left Ventricular Assist Device (LVAD) implantation |
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Inclusion Criteria:
Exclusion Criteria:
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consecutive patients implanted by IMPELLA™ pump or ECLS as a bridge to long duration LVAD between January 2012 and December 2018 in five university hospital centers.
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre OUATTARA, MD, PhD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Dijon-Bourgoigne | Dijon | 21079 | France | |||
| CHU de Montpellier |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Organ dysfunction before LVAD implantation | Need for mechanical ventilation, Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome] | The day before LVAD implantation |
| complication Under LVAD | bleeding, right ventricular dysfunction, vasoplegia | The day of Intensive Care Unit (ICU) discharge |
| SOFA score | Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome] | The day of Short Term Mechanical Circulatory Support (STMCS) implantation |
| SOFA score | Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome] | The day of LVAD implantation |
| SOFA score | Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome] | Day 1 post LVAD implantation |
| SOFA score | Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome] | Day 3 post LVAD implantation |
| SOFA score | Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome] | Day 5 post LVAD implantation |
| SOFA score | Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome] | Day 7 post LVAD implantation |
| Vital status | mortality after LVAD implantation | 1 month after LVAD implantation |
| Vital status | mortality after LVAD implantation | 3 months after LVAD implantation |
| Vital status | mortality after LVAD implantation | 6 months after LVAD implantation |
| length of stay | Intensive Care Unit length of stay | up to Intensive Care Unit (ICU) discharge (not more than 6 months after LVAD implantation) |
| length of stay | hospital length of stay | up to hospital discharge (not more than 6 months after LVAD implantation) |
| Montpellier |
| 34295 |
| France |
| CHU de Bordeaux | Pessac | 33604 | France |
| CHU de Rennes | Rennes | 35000 | France |
| CHU de Toulouse | Toulouse | 31059 | France |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |