Laser tissue soldering in urinary tract reconstruction: First human experience

Objectives: Laser tissue soldering (LTS) in the urinary tract provides an immediate leak-free seal and may avoid complications seen with conventional repair (such as fistula and stricture). We have begun a Phase I clinical trial investigating the use of LTS in performing urologic reconstructive surgery. Methods: Ten patients (aged 3 months to 38 years) underwent urologic reconstruction using LTS with a protein solder composed of human albumin (42%) and indocyanine green dye. In each case standard microsuture repair preceded laser-soldered suture line reinforcement. Anastomotic closure time and immediate leak pressure were measured. Postoperatively, all patients were evaluated for evidence of complications, including stricture, fistula formation, or impaired healing. Results: Using LTS as an adjunct to suturing added an average of 7.9 ± 3.0 minutes (28%) to the overall mean anastomotic time of 28.3 ± 9.4 minutes. Intraoperative leak pressure measurements for laser-soldered anastomoses (≥94.2 ± 24.2 mm Hg) were significantly higher (P < 0.001) than primarily sutured anastomoses (20 ± 2.9 mm Hg). Two instances of suture disruption (20%) occurred during laser activation, neither of which were repaired with sutures. Average follow-up for all patients was 7.1 ± 2.2 months. There were no intraoperative or postoperative complications, including the 2 patients with suture disruption. Conclusions: These initial clinical results indicate that LTS is safe, easy to perform, and, contrary to conventional suturing, provides an immediate leak-free closure. Follow-up in these and other patients, as well as those undergoing sutureless and stent-free procedures, will determine whether our method of LTS benefits patients undergoing urologic reconstruction.