4 Efficacy

4 Efficacy

This section describes efficacy 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.

4.1 In a non‑randomised comparative study of 40 infants who had pulmonary artery banding (20 with telemetric adjustable pulmonary artery banding [TA‑PAB] and 20 with conventional pulmonary artery banding [con‑PAB]), postoperative mechanical ventilation time was significantly shorter after TA‑PAB than con‑PAB (3.0 plus or minus [±] -3.1 days versus 10.4±11.2 days, p<0.01), as was length of stay in the intensive care unit (5.3±4.6 days versus 20.3±19.9 days, p<0.005) and in hospital (15.4±6.4 days versus 45.6±41.6 days, p<0.005).

4.2 A non‑randomised comparative study of 19 infants who had PAB (11 with TA‑PAB and 8 with con‑PAB) reported no differences between groups with respect to postoperative ventilation time (230±302 hours versus 109±174 hours, p=0.3), or length of stay in the intensive care unit (11.2±12.9 days versus 7.8±10.7 days, p=0.4) or in hospital (18±10 days versus 17±9 days, p=0.9).

4.3 In a case series of 17 infants with multiple muscular apical ventricular septal defects, all infants had percutaneous adjustments of the TA‑PAB, with a mean of 4.8 adjustments per patient (range from 2 to 9 times) to tighten the band and a mean of 1.1 adjustments per patient (range from 0 to 3 times) to loosen the band with the patient's growth. All adjustments were guided by doppler echocardiography.

4.4 In a non‑randomised comparative study of 20 infants with complete atrioventricular septal defects (7 treated with TA‑PAB and 13 with con‑PAB), sternal closure was not delayed in any of the 7 infants in the TA‑PAB group, compared with delayed closure in 46% (6/13) of infants in the con‑PAB group (p<0.05).

4.5 In the non‑randomised comparative study of 20 infants, left atrioventricular valve regurgitation decreased in 2 infants (from severe to moderate) in the TA‑PAB group (n=7) and increased in 2 infants (from mild to moderate in 1 and moderate to severe in 1) in the con‑PAB group (n=13), and remained unchanged in all other infants in both groups.

4.6 A non‑randomised comparative study of 10 infants with late‑referral transposition of the great arteries who underwent retraining of the left ventricle (4 with TA‑PAB and 6 with con‑PAB) reported that the mean pulmonary gradient across the banding increased in the TA‑PAB group, with progressive closure from 25.50±4.43 mmHg at the time of placement to 63.50±9.80 mmHg at the time of an arterial switch procedure (4 months after banding). In the con‑PAB group, the mean pulmonary gradient increased with growth from 49.20±21.40 mmHg at the time of placement to 68.40±7.86 mmHg at the time of the arterial switch procedure (4 months after banding). The difference in gradient at the time of the switch procedure was not statistically significant between the 2 groups. The authors state that the difference between the groups at baseline was due to the TA‑PAB not being tightened in the operating room. The pulmonary gradient at final follow up (19.78±17.7 months) was similar in both groups (13±3.4 mmHg in the TA‑PAB group and 14.5±10.34 mmHg in the con‑PAB group, p value not given).

4.7 The specialist advisers listed additional key efficacy outcomes as control of hypertension in children with high pulmonary blood flow, retraining of a low pressure ventricle and survival to corrective surgery.

  • National Institute for Health and Care Excellence (NICE)