Technology assessment of nonsurgical closure of patent ductus arteriosus: an evaluation of the clinical effectiveness and costs of a new medical device.

ABSTRACT

OBJECTIVE: To assess the clinical efficacy and cost impact of a new medical device for the nonsurgical closure of patent ductus arteriosus (PDA). METHODS: This was a before-after study comparing the most recent 20 surgical procedures with the first 20 nonsurgical procedures for PDA using a new medical device. Clinical outcome, hospital stay, device cost, and physician fees were compared. RESULTS: Surgical closure was effective in all 20 patients, with an average cost of $4667. In a similar patient group, nonsurgical closure was achieved in 18 of 20 patients (90%), with an estimated average cost per successful procedure of $4690. A clinically insignificant PDA leak persisted beyond 12 months in four nonsurgically managed patients. CONCLUSION: Nonsurgical closure of PDA can be recommended as an effective new medical technique that is not associated with a measurable increase in direct costs and that provides significant indirect and intangible cost advantages.