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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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The primary objective for this retrospective Electronic Health Record (EHR) analysis is to evaluate the clinical outcomes associated with the utilization of a pulmonary artery catheter (PAC), for monitoring purposes, within patients undergoing cardiac surgeries (isolated coronary artery bypass graft [CABG], valve, aortic surgery, multi-procedures, other complex nonvalvular procedures and heart transplants). The study will be conducted using prospectively collected hospital inpatient data over a duration of over 5 years (Jan. 1, 2010 - June 30, 2015) using a large US electronic health database (Cerner HealthFacts; Kansas City, MO).
A retrospective study will be conducted using prospectively collected hospital inpatient data over a duration of over 5 years (Jan. 1, 2010 - June 30, 2015) using a large US electronic health database (Cerner HealthFacts; Kansas City, MO). Patients who underwent a qualifying cardiac surgery (verified through use of selected valid International Classification of Diseases-9 procedure codes and/or Current Procedural Terminology [CPT] codes) will be included. Each patient's cohort designation will be defined based upon whether he/she did or did not receive a pulmonary artery catheter (PAC) for monitoring purposes. Propensity scores, which take into account patient and hospital demographics, patient comorbidities, surgical type (isolated coronary artery bypass graft [CABG], valve, aortic surgery, multi-procedures, other complex nonvalvular procedures and heart transplants), and pre-operative condition (via an adapted EuroSCORE II) will be utilized to "match" patients who received a PAC for monitoring purposes with those who did not, to form a matched study cohort. Clinical outcomes will be monitored through index visit discharge and up to 90 days post index visit discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary artery catheter (PAC) | Patients received a PAC for monitoring purposes |
| |
| No pulmonary artery catheter (PAC) | Patients did not receive a PAC for monitoring purposes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulmonary artery catheter | Device | PAC must be placed between the day of admission and the day following a qualifying cardiac surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital mortality during index visit | Admission through up to 180 days (hospital discharge) | |
| Hospital length-of-stay (LOS) | Index hospital visit LOS | Admission through up to 180 days (hospital discharge) |
| Hospital readmission | Rate of hospital readmissions | Through 30 days |
| Hospital readmission | Rate of hospital readmissions | Through 60 days |
| Hospital readmission | Rate of hospital readmissions | Through 90 days |
| Major Adverse Cardiac Events (MACE) | Through 30 days | |
| Major Adverse Cardiac Events (MACE) | Through 60 days | |
| Major Adverse Cardiac Events (MACE) | Through 90 days | |
| Major morbidity composite | Through 30 days | |
| Major morbidity composite | Through 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| New organ failure (cardiovascular, respiratory, coagulation, liver systems, renal) | Day 1 to discharge (up to 180 days) | |
| Requirement for mechanical ventilation | Day 1 to discharge (up to 180 days) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing an isolated CABG, isolated valve, aortic procedure, complex nonvalvular procedures, multi-procedures or a heart transplant who receives or does not receive a pulmonary artery catheter (PAC) for monitoring purposes
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Shaw, MB, FRCA, FFICM, FCCM | Vanderbilt University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30386591 | Derived | Shaw AD, Mythen MG, Shook D, Hayashida DK, Zhang X, Skaar JR, Iyengar SS, Munson SH. Pulmonary artery catheter use in adult patients undergoing cardiac surgery: a retrospective, cohort study. Perioper Med (Lond). 2018 Oct 25;7:24. doi: 10.1186/s13741-018-0103-x. eCollection 2018. |
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| Major morbidity composite | Through 90 days |
| Hemorrhage requiring blood transfusion | Day 1 to discharge (up to 180 days) |
| Acute kidney injury (KDIGO staging) | Day 1 to day 10 |
| Infectious complications | Day 1 to discharge (up to 180 days) |
| Gastrointestinal complication (hepatic) | Day 1 to discharge (up to 180 days) |
| Respiratory failure | Day 1 to discharge (up to 180 days) |
| Sequential Organ Failure Assessment (SOFA) scores | Day 1 to discharge (up to 180 days) |
| Neurologic complication | Day 1 to discharge (up to 180 days) |