Interventional procedure consultation document

Insertion of metal rib reinforcements to stabilise a flail chest wall

The condition in which multiple rib fractures allow a segment of the rib cage to move independently from the main chest wall is called a flail chest. The effect compromises breathing and may be life-threatening.

In this procedure, metal (usually titanium) is used to stabilise the ‘flail’ segment of chest wall. This procedure aims to improve lung function and reduce the length of critical care and hospital stay.

The National Institute for Health and Clinical Excellence (NICE) is examining insertion of metal rib reinforcements to stabilise a flail chest wall and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about insertion of metal rib reinforcements to stabilise a flail chest wall.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 23 June 2010

Target date for publication of guidance: September 2010

1   Provisional recommendations

1.1   Current evidence on insertion of metal rib reinforcements to stabilise a flail chest wall is limited in quantity but consistently shows efficacy. In addition, there are no major safety concerns in the context of patients who have had severe trauma with impaired pulmonary function. Therefore the procedure may be used provided that normal arrangements are in place for clinical governance, consent and audit.

1.2   Patient selection should be carried out by critical care specialists, chest physicians and thoracic surgeons with appropriate training and experience.

2   The procedure

2.1   Indications and current treatments

2.1.1   Chest wall injury is common as a result of major blunt trauma (for example, motor vehicle accidents). It varies in severity from minor bruising or an isolated rib fracture to severe crush injuries leading to respiratory compromise.

2.1.2   A flail chest occurs when a segment of the thoracic cage moves independently from the rest of the chest wall. A flail chest causes paradoxical movement of this segment of the chest wall – in-drawing on inspiration and moving outwards on expiration – and this segment of chest wall fails to contribute to lung expansion. Flail chest been defined in a variety of ways, but at least 2 fractures per rib in at least 2 ribs are needed to produce a flail segment. Large flail segments may extend bilaterally or involve the sternum, and may compromise respiration sufficiently to require mechanical ventilation.

2.1.3   Management of chest wall injury is directed towards protecting the underlying lung, achieving adequate ventilation and oxygenation, and preventing infection. Analgesia sufficient to allow normal respiration and coughing may be sufficient for mild cases. More severe cases require ventilatory support, and suction to remove mucus or secretions from the airways to prevent atelectasis.

2.2   Outline of the procedure

2.2.1   Surgical stabilisation with metal rib reinforcements aims to allow earlier weaning from ventilatory support, to reduce acute complications, and to avoid chronic pain sometimes associated with permanent deformity of the chest wall.

2.2.2   With the patient under general anaesthesia, an incision is made, generally in a postero-lateral or antero-lateral position, and the fractured ribs are reduced. The intercostal muscles are dissected from the ribs at the sites where metal plates or screws will be placed. The affected ribs are stabilised using struts or metal plates, fixed with screws or intramedullary wires. These metal plates and screws are usually left in place in the long term.

2.2.3   There are many variations in the materials and techniques used to stabilise flail chest with metal rib reinforcements. It should be noted that Kirschner wires, used alone, are not covered by this guidance.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/guidance/IP/825/overview

2.3   Efficacy

2.3.1   A randomised controlled trial (RCT) of 37 patients treated by surgical stabilisation (n = 18) or mechanical ventilation (n = 19) reported a significantly lower proportion of patients with pneumonia at day 21 in the surgical stabilisation group compared to the mechanical ventilation group (22% [4/18] vs 89% [17/19]) (p < 0.05).

2.3.2   The RCT of 37 patients reported a mean critical care stay of 16.5 days in the surgical stabilisation group and 26.8 days in the mechanical ventilation group (p < 0.05).

2.3.3   The RCT of 37 patients reported a mean percentage of forced vital capacity at 12 months of 96% and 80% respectively (p < 0.05). A case series of 66 patients reported that 52% (26/50) of patients had normal pulmonary function at 6-month follow-up.

2.3.4   The RCT of 37 reported that a significantly higher percentage of patients had returned to full-time employment at 6 months in the surgical group compared to the mechanical ventilation group (61% [11/18] vs 5% [1/19], p < 0.01).

2.3.5   The Specialist Advisers listed additional key efficacy outcomes as survival, duration of ventilation, long-term stabilisation of chest wall, pain and patient satisfaction.

2.4   Safety

2.4.1   Death was reported in 30% (3/10) of patients with pulmonary contusion treated by surgical stabilisation in a non-randomised comparative study of 42 patients. Of these deaths, 2 were from massive haemorrhage and 1 was from sepsis with multiorgan failure. No deaths were reported in patients without pulmonary contusion treated by surgical stabilisation.

2.4.2   Persistent pain at the operative site was reported in 11% (6/57) and 24% (5/21) of patients in a case series of 66 patients at 6-month follow-up and a case series of 23 patients at 3-month follow-up respectively. This improved in 3 and 2 patients respectively after removal of stabilisation plates and screws at 6 months.

2.4.3   The Specialist Advisers considered theoretical adverse events to include migration of metalwork, fracture of stabilisers, lung injury from stabilisers, screw loosening or separation, infection and allergy.

3   Further Information

3.1   For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

May 2010

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}