Doppler-guided regulation of a telemetrically operated adjustable pulmonary banding system.

OBJECTIVES We report on the Doppler-assessed regulation of an adjustable pulmonary artery band (PAB) in an animal model and in our first group of patients. BACKGROUND Indications for pulmonary artery banding have expanded to include patients requiring a late arterial switch. A telemetry-operated, fully implantable, adjustable PAB system (FloWatch- PAB, Endoart SA, Lausanne, Switzerland) has been developed to facilitate these operations. METHODS The device was implanted in 13 minipigs (age one to five months, weights 3.2 to 12.0 kg). The main study was performed on nine minipigs with adjustments of the PAB at implantation and at 1, 3, 5, 8, and 12 weeks after, assessed by Doppler pressure gradients. Explanation was performed 12 weeks after surgery. A long-term histology study (6 months and 14 months after surgery) was done on the other four minipigs. After approval by the ethics committee, the device was implanted in eight patients with weights between 2.8 and 9 kg to decrease pulmonary blood flow and pressure and to retrain the left ventricle before arterial switch. The device was progressively tightened, with increasing transband Doppler gradients. Follow-up was one to three months. RESULTS An excellent correlation between transbanding systolic pressure gradient and degree of PAB constriction was encountered in the minipig study as well as in the human setting. No early or late deaths or reoperations occurred. Malfunction of the device was noted in three of 21 implanted devices. Two were related to surgically inflicted damage at implantation and one to an electronic problem that was fixed by resetting the control device. CONCLUSIONS The device offers a Doppler-controllable adjustment of pulmonary blood flow. It permits controlled tightening and release of the band, which improves perioperative and postoperative courses and decreases surgical interventions to adjust tightness of the band. It allows a protracted occlusion protocol, which may provide the best effect on retraining the left ventricle.