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

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

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).

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Thoracic Surgery; Heart Surgery; Heart Transplant
• Intervention / Treatment: Device: pulmonary artery catheter

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 Type: Observational
• Enrollment (Actual): 6844

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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: Swan-Ganz catheter
No pulmonary artery catheter (PAC); Patients did not receive a PAC for monitoring purposes

What is the study measuring?

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	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)

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: Andrew D Shaw, MB, FRCA, FFICM, FCCM, Vanderbilt University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: pulmonary artery catheter; Swan-Ganz catheter
• Other Study ID Numbers: 161377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No