Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Retrospective Analysis of Clinical Outcomes Associated With Use of the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients Within the Cerner HealthFacts Database

Conditions
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Cardiac Surgery, Thoracic Surgery, Heart Surgery, Heart Transplant

Intervention / Treatment
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* Device: pulmonary artery catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient undergoes a qualifying cardiac surgery between Jan 1, 2010 and January 1, 2015. 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

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 |
| --- | --- |
| Pulmonary artery catheter (PAC)<br>Patients received a PAC for monitoring purposes | Device: pulmonary artery catheter<br>* PAC must be placed between the day of admission and the day following a qualifying cardiac surgery<br>* Other names: Swan-Ganz catheter;|
| No pulmonary artery catheter (PAC)<br>Patients did not receive a PAC for monitoring purposes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| Major morbidity composite |  | Through 90 days | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary artery catheter, Swan-Ganz catheter