Open Recovery Of The Vascularized Composite Bladder Allograft For Bladder Transplantation

Prior to the first human bladder transplant (NCT#06337942), a standardized method for vascularized composite bladder allograft (VCBA) recovery compatible with routine donation-after-brain-death (DBD) multi-organ recovery workflow was necessary. A reproducible open surgical technique for VCBA recovery was developed and implemented and is described herein. Under an IRB-approved protocol (IRB#4B-21-5), open VCBA recoveries were performed on 10 DBD donors during standard multi-organ recovery. The primary objective was to develop and refine a reproducible technique to recover the bladder maintaining arterial, venous, and pelvic vascular structures needed for transplantation, without disrupting conventional abdominal organ recovery. Operative sequencing, organ recovery team coordination, graft perfusion, and technical feasibility metrics were evaluated. Median donor age was 35.5 years, with equal distribution between male and female donors. Mean operative times for VCBA recovery and back-table reconstruction were 93 and 35 minutes, respectively. Hypothermic continuous bladder irrigation preceded aortic cross-clamping. Pelvic organ perfusion and successful preservation of bilateral internal iliac vascular pedicles were achieved in all cases. All grafts demonstrated appropriate tissue blanching. Bilateral splanchnic nerves were preserved in the final four recoveries. This open approach enabled expeditious VCBA retrieval without disrupting standard multi-organ recovery, establishing a practical, scalable strategy for clinical VCBA transplantation. Clinical Trial and IRB Reference Numbers: NCT#05462561, NCT#06337942, IRB#4B-21-5.