5 Safety

5 Safety

This section describes 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 interventional procedure overview.

5.1 A non‑randomised comparative study of 40 infants (20 with telemetric adjustable pulmonary artery banding [TA‑PAB] and 20 with conventional pulmonary artery banding [con‑PAB]) reported that no infants died within 30 days in the TA‑PAB group and that 15% (3/20) of infants died at 1, 15 and 20 days after surgery in the con‑PAB group. These 3 deaths were caused by cardiac arrest during tracheal suctioning, inexorable heart failure and multi‑organ failure. There were 2 (10%, 2/20) deaths after 30 days in the TA‑PAB group, 1 attributed to respiratory infection and 1 to neurological damage (2 and 3 months after surgery respectively), and 2 (12%, 2/17) deaths in the con‑PAB group, 1 caused by sepsis and 1 by heart failure.

5.2 In a case report of a 6‑month‑old infant (weighing 6 kg) who had a closure of an inlet muscular ventricular septal defect (VSD), complete erosion by the band causing a large pseudoaneurysm of the main pulmonary artery (with the device floating freely inside the pseudoaneurysm cavity and a significant residual ventricular septal defect) was reported 9 weeks after TA‑PAB. The residual VSD was closed transatrially with a polytetrafluoroethylene patch, the pseudoaneurysm cavity was resected and the pulmonary artery was reconstructed by an end‑to‑end anastomosis. Recovery was uneventful.

5.3 Reoperation 8 days after TA‑PAB for drainage of a pericardial effusion was reported in 1 infant in a case series of 17 infants treated with TA‑PAB for multiple VSDs. Reoperation to remove the TA‑PAB because of haemodynamic compromise related to the bulk of the device was needed in 1 infant in the TA‑PAB group in a non‑randomised comparative study of 19 infants who had PAB (11 with TA‑PAB and 8 with con‑PAB).

5.4 Patch augmentation of the pulmonary artery at the time of corrective surgery was needed in 5 infants (4 in the TA‑PAB group and 1 in the con‑PAB group) in the non‑randomised comparative study of 19 infants. The course of recovery was similar in both groups.

5.5 Persistent sepsis after TA‑PAB developed in 3 infants in a case series of 8 infants. This was successfully treated with antibiotics in all 3 infants, without the need for surgical re‑intervention or removal of the band.

5.6 The specialist advisers listed additional adverse events as: device migration; device removal because of haemodynamic instability; the device losing coupling so it could not be telemetrically adjusted; failure of the band control unit; inability of the band to dilate; pulmonary valve regurgitation; and cardiac compression.

  • National Institute for Health and Care Excellence (NICE)