Pulmonary artery catheterisation Review

Medical Services Advisory Committee consideration

The Medical Services Advisory Committee (MSAC) considered the review report in March 2012 and provided advice to the Minister for Health, the Hon Tanya Plibersek MP.

MSAC agreed that some of the initial safety concerns which had prompted the review had not been proven to be significant. The Committee also agreed there was no basis to change the PAC item descriptors.

The PAC review report is available below.

Pulmonary Artery Catheterisation Review Report

Executive Summary

This is a summary of the pulmonary artery catheterisation (PAC) review report, prepared by the Department of Health and Ageing.

Review’s background and purpose

PAC has been in clinical use for more than 40 years. Initially developed for the management of acute myocardial infarction, it has gained widespread use in the management of a variety of critical illnesses and surgical procedures. PAC can also be used as a diagnostic tool. PAC items have been included in the Medicare Benefits Schedule since July 1993.

As an invasive procedure, PAC is associated with potentially catastrophic events. Death, major morbidity and need for emergency major surgery are known risks. Difficulties in adequately measuring hemodynamic data are further concerns. The review’s primary purpose was to provide a robust evidence-based analysis to inform recommendations relating to the MBS items for PAC. Specifically, the review focused on the safety and effectiveness of PAC for monitoring cardiac output and evaluated the utility of continuous monitoring of pulmonary wedge pressure (PAWP) and cardiac output monitoring generally.

Health Consult Pty Ltd was engaged to conduct the review, with the assistance of a clinical working group established to provide clinical input and ensure that the review reflected current clinical practice in Australia and drew valid conclusions from the evidence. The members are experts in PAC and were identified by, although they did not formally represent, these clinical craft groups:

Australasian Society of Cardiac and Thoracic Surgeons
Cardiac Society of Australia and New Zealand
College of Intensive Care Medicine of Australia and New Zealand
Australian and New Zealand Intensive Care Society
Australian and New Zealand College of Anaesthetists
Australian Society of Anaesthetists
Australasian College of Emergency Medicine

Scope

The review assessed the eight MBS item numbers relating to PAC services. Refer to the table below for the PAC MBS items and descriptors.

HealthConsult developed clinical research questions to address PAC’s impact on patient management, effectiveness, and safety. The PAC review report consists of a systematic literature review, some preliminary economic evaluation and analysis of relevant MBS and hospital data.

PAC MBS item numbers

Item Number	MBS Item number description as at 01 November 2009
13818	RIGHT HEART BALLOON CATHETER, insertion of, including pulmonary wedge pressure and cardiac output measurement (Anaes.) Fee: $107.45 Benefit: 75% = 80.60 85% = $91.35
13876	CENTRAL VENOUS PRESSURE, pulmonary arterial pressure, systemic arterial pressure or cardiac intracavity pressure, continuous monitoring by indwelling catheter in an intensive care unit and managed by a specialist or consultant physician who is immediately available and exclusively rostered for intensive care – once only for each type of pressure on any calendar day (up to a maximum of 4 pressures) Fee: $72.65 Benefits: 75% = $54.50 85% = $61.80
11600	BLOOD PRESSURE MONITORING (central venous, pulmonary arterial, systemic arterial or cardiac intracavity), by indwelling catheter – once only for each type of pressure on any calendar day, up to a maximum of 4 pressures (not being a service to which item 13876 applies and where not performed in association with the administration of general anaesthesia) Fee: $ 65.45 Benefit: 75% = $49.10 85% = $ 55.65
22012	BLOOD PRESSURE MONITORING (central venous, pulmonary arterial, systemic arterial or cardiac intracavity), by indwelling catheter – once only for each type of pressure on any calendar day, up to a maximum of 4 pressures (not being a service to which item 13876 applies) when performed in association with the administration of anaesthesia (3 basic units) Fee: $56.10 Benefit: 75% = $42.10 85% = $47.70
22014	BLOOD PRESSURE MONITORING central venous, pulmonary arterial, systemic arterial or cardiac intracavity), by indwelling catheter – once only for each type of pressure on any calendar day, up to a maximum of 4 pressures (not being a service to which item 13876 applies) when performed in association with the administration of anaesthesia relating to another discrete operation on the same day (3 basic units) Fee: $56.10 Benefit: 75% = $42.10 85% =$47.70
22015	RIGHT HEART BALLOON CATHETER, insertion of, including pulmonary wedge pressure and cardiac output measurement, when performed in association with the administration of anaesthesia (6 basic units) Fee: $112.2 Benefit: 75% = 84.15 85% = $ 95.40
38200	RIGHT HEART CATHETERISATION, with any one or more of the following: fluoroscopy, oximetry, dye dilution curves, cardiac output measurement by any method, shunt detection or exercise stress test. Fee: $428.55 Benefit: 75% = $321.45 85% = $364.30
38206	RIGHT HEART CATHETERISATION WITH LEFT HEART CATHETERISATION via the right heart or by any other procedure with any one or more of the following: fluoroscopy, oximetry, dye dilution curves, cardiac output measurements by any method, shunt detection or exercise stress test. Fee: $618.30 Benefit: 75% = $463.75 85% = $547.10

Review methodology

The review methodology comprised consultation with key stakeholders; development of a review protocol document, which outlined the detailed review methodology (including specifying the key clinical/research questions for the systematic review, preparing the clinical flowcharts, and documenting the economic analysis strategy); analysis of secondary data sources (MBS, national hospital morbidity, and mortality data); evidence-based systematic literature review on PAC; and assessment and analysis of all of the evidence to draw conclusions in relation to the clinical/research questions.

Clinical/research questions answered by the review

The PPICO (target Population, Prior tests, the Intervention (i.e. index test), Comparator, Outcomes) criteria were used to develop well-defined clinical/research questions for the review. Three patient populations were identified and included patients scheduled for major surgery, patients with unstable haemodynamic measures in ICU and patients with suspected pulmonary hypertension. The clinical/research questions were:

What are the risks associated with using PAC? What is their incidence? Specifically, what is the risk of pulmonary artery rupture and the likelihood that this is a fatal complication?
What is the benefit of PAC? Does the use of PAC (in respect to what is measured uniquely by PAC) change patient management and alter patient outcomes?
Is there a sub-group of patients for which PAC should be used?
Is it essential to measure pulmonary artery wedge pressure in the assessment of patients with pulmonary hypertension?

Summary of the review’s key findings

The review found that:

there is no compelling evidence to support or refute the use of PAC in theatre and intensive care unit (ICU) settings. There is, however, evidence supporting the use of PAC as a diagnostic tool for patients with pulmonary hypertension;
in Australia, PAC is used for a range of patients in admitted and non-admitted hospital service settings. Most commonly PAC is used pre, peri and post (in the ICU) cardiac surgery. PAC is also performed in the outpatient setting for a differential diagnosis of pulmonary hypertension, and to obtain a pulmonary artery wedge pressure (PAWP) measure for the prescription of Highly Specialised Drug Program drugs on the Pharmaceutical Benefits Scheme;
the evidence on whether therapeutic management of cardiac output and volume status based on pulmonary artery catheter monitoring leads to improved patient outcomes is not conclusive;
it cannot be determined whether PAC has any impact on patient management strategies, as none of the published studies included a specific protocol for use of the PAC data. Therefore, it is not possible to prove whether or not PAC has any value in broadly defined populations of ICU patients;
the same rate of medical morbidities are reported among patients with PAC as without PAC;
there is no statistically significant difference in mortality or length of stay for patients with PAC compared to those with no PAC;
the evidence for the effectiveness of PAC on quality of life indicators or duration of ventilation is not conclusive;
the number of deaths related to PAC in Australia has decreased markedly since 2007, mostly likely as a result of modifications to the pulmonary artery catheter and due to clinicians being more aware of the risks and better trained;
the estimated Australian death rate due to PAC was 0.008% in 2010. This rate is not statistically significantly different from the rate derived by analysis of the published literature;
there is insufficient evidence to support any definition of the characteristics of a sub group of patients for which PAC should be used;
that PAC is currently the only cardiac output measurement device that is able to measure pulmonary artery wedge pressure (PAWP);
PAWP is required for the differential diagnosis of Pulmonary Arterial Hypertension (PAH) due to left heart disease. PAC is therefore essential for the final diagnosis of PAH after other less invasive tests have been carried out; and
in addition to the PAWP measurement being required for the differential diagnosis of PAH, in Australia, it is also required to enable the prescription of one of five drugs on the Highly Specialised Drug Program.
The review of the economic literature relating to PAC found that, on average, costs are higher for patients managed with PAC compared to those managed without; but the evidence relating to benefits is inconclusive.

PAC review protocol

The draft protocol for the review of PAC items underwent a three week public consultation period, which closed on 26 November 2010.

The submissions have been considered and the final review protocol is available below.

Page currency, Latest update: 29 June, 2012

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