Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pulmonary artery catheter (PAC) Patients received a PAC for monitoring purposes |
Device: pulmonary artery catheter
PAC must be placed between the day of admission and the day following a qualifying cardiac surgery
Other Names:
|
| No pulmonary artery catheter (PAC) Patients did not receive a PAC for monitoring purposes |
Outcome Measures
Primary Outcome Measures
- Hospital mortality during index visit [Admission through up to 180 days (hospital discharge)]
- Hospital length-of-stay (LOS) [Admission through up to 180 days (hospital discharge)]
Index hospital visit LOS
- Hospital readmission [Through 30 days]
Rate of hospital readmissions
- Hospital readmission [Through 60 days]
Rate of hospital readmissions
- Hospital readmission [Through 90 days]
Rate of hospital readmissions
- 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]
- Major morbidity composite [Through 90 days]
Secondary Outcome Measures
- 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)]
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patient undergoes a qualifying cardiac surgery between Jan 1, 2010 and January 1,
- If multiple qualifying surgeries are present, the first in database will be utilized
-
Inpatient with a LOS of at least 48 hours
-
Treated arm receives a PAC for monitoring purposes within admission date and qualifying cardiac surgical day plus one via specified ICD-9 or CPT-4 codes, or EHR recorded PAC readings
Exclusion Criteria:
-
Cardiac surgery patients with age <18 years on index procedure date
-
Non-treated arm derived from an institution which does not have database documented use of ICD-9 or CPT-4 PAC placement codes for monitoring purposes [Lessens the likelihood that the untreated arm is indeed treated by ensuring that the patient would likely be coded if he/she had a PAC in place for monitoring purposes]
-
Patient record must have the demographics populated of age, gender, and race. ICD-9 diagnosis and procedure codes must be present in record for index visit, as well as medications administered over index visit
-
Patient must be treated at a hospital which performs a minimum of 100 qualifying cardiac procedures per year
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Vanderbilt University
- Edwards Lifesciences
Investigators
- Principal Investigator: Andrew D Shaw, MB, FRCA, FFICM, FCCM, Vanderbilt University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 161377