Telemetric adjustable pulmonary artery banding for pulmonary hypertension in infants with congenital heart defects

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.