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

Surgery may be carried out in mid-to-late childhood, and includes open surgical repair involving subperichondrial resection of abnormal costal cartilages, transverse osteotomy and internal fixation of the sternum (the Ravitch procedure).

2.2 Outline of the procedure

2.2.1

Placement of pectus bar for pectus excavatum 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 behind the ribs and sternum with its concavity facing anteriorly. The bar is then rotated through 180 degrees using a 'flipper' device, so that its convexity faces anteriorly, 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.

2.3 Efficacy

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.

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 preoperative scores and 119 patients with postoperative scores, the mean scores were 3.1 and 8.4, respectively (mean follow-up 369 days). A case series of 947 patients reported that of 521 patients who had the bar removed and had a follow-up of 2 years, 83% had an 'excellent' cosmetic result, 12% had a 'good' result, 2% had a 'fair' result (method of assessment not stated) and 2% had recurrence of pectus excavatum (absolute figures not stated; follow-up 1 to 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). This score 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 the 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 2 case series of 167 and 172 patients, each reported 1 case of intraoperative liver perforation. In 2 case series of 167 and 322 patients, each reported 1 case of intraoperative cardiac perforation. A case report described cardiac injury during surgery in all 4 patients resulting in 1 death.

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 7 cases of minor pericardial tears (follow-up not stated).

2.4.3

Data from the UK register reported perioperative adverse events in 9% (24 of 260) of patients and postoperative adverse events in 19% (49 of 260) of patients (follow-up 4 to 2477 days).

2.4.4

In 3 case series, bar displacements required surgical revision in 7% (50 of 668), 3% (11 of 322) and 2% (3 of 167) of patients, respectively (follow-up not stated).

2.4.5

In 4 case series and the UK register, pneumothorax occurred in 55% (369 of 668), 7% (24 of 322), 3% (5 of 172), 9% (15 of 167) and 2% (6 of 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 and 172 patients and the UK register data for 260 patients reported pericardial effusion in 8, 1 and 1 patients, respectively (timing of events not stated). In the study of 668 patients, pericarditis was reported in 6 patients (timing of event not stated). The UK register reported 1 case of perioperative lower lobe collapse and 1 case of persistent air leak.

2.4.7

The retrospective case series of 863 patients reported metal allergies in 2% (19 of 863) of patients.

2.4.8

The Specialist Advisers listed adverse events 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.