Placement of pectus bar for pectus excavatum (Nuss procedure) (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Placement of pectus bar for pectus excavatum (Nuss procedure)
| Pectus excavatum is an abnormality of the chest in which the breastbone sinks inward (sometimes called funnel chest). Problems associated with pectus excavatum are mainly cosmetic, although the condition can impair cardiac and respiratory function. Placement of a pectus bar for pectus excavatum (also known as the Nuss procedure) involves placing one or two steel (pectus) bars under the breastbone with the aim of raising it and correcting the abnormal shape. The bar, which is bent into a curve to fit the patient’s chest, is inserted through small openings in the chest. The bar (or bars) are usually removed within a few years of placement. |
|
The National Institute for Health and Clinical Excellence (NICE) is examining interventional procedure overview of placement of pectus bar for pectus excavatum (Nuss procedure) 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 placement of pectus bar for pectus excavatum (Nuss procedure). 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:
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.
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: 26 May 2009 Target date for publication of guidance: July 2009 |
| 1 | Provisional recommendations |
| 1.1 | Current evidence on the safety and efficacy of placement of pectus bar for pectus excavatum (Nuss procedure) is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. |
| 1.2 | Placement of pectus bar for pectus excavatum should be carried out only in hospitals with cardiac surgical support. |
| 1.3 | This procedure should be carried out only by surgeons with specific training in insertion of the device, who should perform their initial procedures with an experienced mentor. |
| 2 | The procedure |
| 2.1 | Indications and current treatments |
| 2.1.1 | Pectus excavatum is the most common congenital deformity of the sternum and anterior chest wall. The cosmetic disfigurement of pectus excavatum may sometimes be accompanied by impaired cardiac or respiratory function. |
| 2.1.2 | Current surgical treatment options are usually carried out in mid to late childhood, and include open surgical repair, involving subperichondrial resection of abnormal costal cartilages, transverse osteotomy and internal fixation of the sternum (known as the Ravitch procedure). |
| 2.2 | Outline of the procedure |
| 2.2.1 | Placement of pectus bar for pectus excavatum (also known as the Nuss procedure) is carried out with the patient under general anaesthesia. The procedure is performed through several small incisions on either side of the chest, and is usually carried out under visualisation by thoracoscopy. |
| 2.2.2 | After subcutaneous tunnelling, a curved steel (pectus) bar is inserted deep into the ribs and the sternum with its concavity facing anteriorly. The bar is then rotated through 180° using a ‘flipper’ device, so that its convexity faces anteriorly, so pushing out the sternum and correcting the deformity. Sometimes two bars are used. |
| 2.2.3 | Various fixation techniques are used to keep the bars in place, including lateral stabilisers attached to the bars and ribs using wires and/or sutures. |
| 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/IP135aoverview. |
| 2.3 | Efficacy |
| 2.3.1 | Data from a UK register for 260 patients recorded cosmetic appearance scores preoperatively (on a scale from 1 [dislike] to 10 [like]) and postoperatively (from 1 [no change] to 10 [perfect]). Of 109 patients with recorded preoperative scores and 119 patients with recorded postoperative scores, the mean scores were 3.1 and 8.4, respectively (mean follow-up 369 days). A case series of 668 patients reported that of 190 patients who had the bar removed and had a follow-up of at least 1 year, 78% (149/190) had an ‘excellent’ cosmetic result, 13% (25/190) had a ‘good’ result, 5% (9/190) had a ‘fair’ result (method of assessing results not stated), and 4% (7/190) had recurrence of pectus excavatum (range of follow-up 1–15 years). |
| 2.3.2 | In a survey of 45 patients, the mean patient satisfaction score for postoperative appearance was 4.1 (± 0.8) (on a scale from 1 [very dissatisfied] to 5 [extremely satisfied]) at 54-month follow-up. The patients rated their self-esteem preoperatively as 6.3 (± 1.2), which improved to 7.9 (± 0.8) after the procedure (on a scale from 1 [very dissatisfied] to 10 [extremely satisfied]) (mean follow-up 54 months). When asked if they would have the operation again, the mean patient score was 9.1 (on a scale from 0 [no] to 10 [yes]). |
| 2.3.3 | In a survey of 43 patients who had either the Nuss procedure or open surgical repair for pectus excavatum (Ravitch procedure), there were no reported differences in health-related quality of life (assessed using the Child Health Questionnaire) or in physical and psychosocial quality of life (assessed using the Pectus Excavatum Evaluation Questionnaire) between the groups (mean follow-up 16 months). |
| 2.3.4 | The Specialist Advisers listed the key efficacy outcomes as cosmetic appearance and patient satisfaction. |
| 2.4 | Safety |
| 2.4.1 | In two case series of 167 and 172 patients, each reported one case of intraoperative liver perforation. In two case series of 167 and 322 patients, each reported one case of intraoperative cardiac perforation. |
| 2.4.2 | The case series of 167 patients reported 15 cases of intraoperative rupture of the intercostal muscles (in older patients), 10 cases of haemothorax or haematopneumothorax, and seven cases of minor pericardial tears (follow-up not stated). |
| 2.4.3 | Data from the UK register of 260 patients reported perioperative adverse events in 9% (24/260) of patients and postoperative adverse events in 19% (49/260) of patients (follow-up ranged from 4 to 2477 days). |
| 2.4.4 | In the three case series of 668, 322 and 167 patients, bar displacements required surgical revision in 7% (50/668), 3% (11/322) and 2% (3/167) of patients, respectively (follow-up not stated). |
| 2.4.5 | In four case series of 668, 322, 172, and 167 patients and the UK register of 260 patients, pneumothorax occurred in 55% (369/668), 8% (24/322), 3% (5/172), 9% (15/167) and 2% (6/260) of patients, respectively. |
| 2.4.6 | The studies of 668, 322 and 172 patients reported pneumonia in 7, 3 and 3 patients; and pleural effusion in 5, 8 and 3 patients, respectively (follow-up not stated). The studies of 322, 172 and register data for 260 patients reported pericardial effusion in 8, 1 and 1 patients, respectively (timing of events not stated). Pericarditis was reported in the study of 668 patients in 6 patients (timing of event not stated). The UK register reported one case of perioperative lower lobe collapse and one case of persistent air leak. |
| 2.4.7 | The retrospective case series of 863 patients reported metal allergies in 2% (19/863) of patients. |
| 2.4.8 | The case series of 863 patients reported bar infections in less than 1% (6/863) of patients 3 weeks to 8 months after surgery. |
| 2.4.9 | The Specialist Advisers listed adverse events reported in the literature or anecdotally as injury to the lungs, heart, mammary artery and liver; pericarditis, pericardial effusion, bar migration, pleural effusion, pneumothorax, haemothorax, infection, osteochondrodystrophy, pain, metal allergy and anaesthetic complications. |
| 3 | Further information |
| 3.1 | This document is a review of the published NICE interventional procedures guidance IPG3 published in 2003. |
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
April, 2009
This page was last updated: 30 March 2010