Fifty-six consecutive patients underwent total correction of truncus arteriosus. Median age at repair was 41 days, with a range of 2 days to 8 months. In 71% the operation was done in the first 2 months of life. Nine patients had complex forms of truncus and 11 patients had aortic insufficiency. The truncal aortic root was transected, which provides a clear exposure of the coronary ostia. The aorta was reconstructed by direct end-to-end anastomosis, and the truncal valve was preserved in every case. Several different techniques were used for pulmonary reconstruction, including three types of anatomic reconstruction of the pulmonary valve with a trisigmoid leaflet system and two types of nonanatomic reconstruction. The anatomic techniques included use of 33 Dacron valved conduits, eight homograft valved conduits, and one porcine aortic root bioprosthesis. The nonanatomic reconstructions included direct anastomosis to the right ventricle in nine patients and insertion of autologous pericardial valved conduits in five. The hospital mortality was 16% (9/56; 95% confidence limits, 2% to 30%). Multivariate analysis outlines two independent incremental risk factors for hospital death: nonanatomic pulmonary valve reconstruction techniques and age younger than 1 month. The hospital mortality was 7.1% in the group with anatomic pulmonary valve reconstruction versus 43% in the group with nonanatomic pulmonary valve reconstruction (p = 0.015). The hospital mortality was 5.7% in those older than 1 month versus 33% in those younger than 1 month of age (p = 0.04). There were two late deaths. The actuarial freedom from reoperation and angioplasty at 7 years was 100% for patients receiving pericardial conduits, 80% for those undergoing direct anastomosis, 77% for those receiving Dacron conduits, and only 43% for those receiving homografts (p = 0.02). In conclusion, anatomic reconstruction of the pulmonary valve seems important at the time of the operation, age younger than 1 month remains an incremental risk factor, and the truncal valve can be preserved.
Introduction The ZSI 475FtM is a new prosthesis that has recently been specifically designed for phalloplasty. It has several functions that have been conceived to answer the challenges of implantation after phalloplasty: a large base for pubic bone fixation, realistically shaped hard glans, and a pump shaped like a testicle. Aim To assess the safety, feasibility, and patient satisfaction of the ZSI 475 FtM. Methods Surgical outcomes were analyzed after implantation of the prosthesis between June 2016 and September 2017 (single institution, single surgeon). Patients were then asked to answer a satisfaction questionnaire that included the International Index of Erectile Function–5, Erectile Dysfunction Inventory of Treatment Satisfaction, and Self-Esteem and Relationship, as well as other non-validated questions. Main Outcome Measure Complication rates and the scores of the different questionnaires were reviewed. Results 20 patients who had gender dysphoria and underwent operation for a female-to-male procedure were included. The mean age was 37.9 years. Complications after 21 implantations included 2 (9.5%) infections that were medically treated (Clavien II), 1 (4.7%) infection treated by explantation (Clavien IIIb), 2 (9.5%) mechanical failures (Clavien IIIb), and 1 (4.7%) malpositioning (Clavien IIIb). The mean follow-up was 8.9 months (SD 4.0), with 50% of the implanted patients having >12 months of follow-up. 14 patients (70%) answered the satisfaction questionnaire. 12 patients (85.7%) had regular penetrative sexual intercourse. The mean International Index of Erectile Function–5 score was 20.2 of 25 (standard deviation [SD] 7.9), the mean Self-Esteem and Relationship score was 84.5 of 100 (SD 9.9), and the mean Erectile Dysfunction Inventory of Treatment Satisfaction score was 82 of 100 (SD 17.5). 13 patients (92.8%) were satisfied or very satisfied with the prosthesis. Clinical Implications This new innovative prosthesis could better answer the challenges faced by the implantation of an erectile device by phalloplasty. Strength & Limitations Our study is the first to report data on this new prosthesis. The main limitation is the small number of patients and the short follow-up. Conclusion Preliminary results for the ZSI 475 FtM are encouraging. Safety seems to be satisfactory, and patient satisfaction is high. Long-term studies are needed for further analysis.
Introduction The creation of a neophallus is a complex surgery that must meet functional and esthetic requirements. It is a long and demanding surgical process whose final stage consists of the implantation of a rigid or inflatable material that can be used to reproduce an erection. Data in the literature are scarce, with only the pioneering series present, which includes the use of the first devices and techniques. Aim To report the outcome of patients with phalloplasty after implantation of erectile implants using standardized surgical techniques and the use of recent prosthesis types with or without a vascular graft. Methods This is a retrospective hospital-based analysis of all patients with phalloplasty who underwent implantation of an erectile prosthesis from March 2007 to May 2015. Factors associated with complications were investigated by multivariate logistic regression analysis. Main Outcome Measures Early-onset (during the first month after surgery) and late-onset complications, including erosion, infections, malpositioning, and dysfunction. Results Sixty-nine patients were included in the study and 95 procedures were analyzed. After a median follow-up of 4 years (minimum = 169 days, maximum = 6.1 years), the original prosthesis was still in place in 43 patients (62.3%). Patients underwent phalloplasty after female-to-male transsexualism (n = 62, 89.9%), malformation (n = 4, 5.8%), or trauma (n = 3, 4.3%). The proportions for the different types of phalloplasty were 58% for forearm free flap phalloplasty (n = 40), 33.3% for suprapubic phalloplasty (n = 23), and 7% for other (n = 6). The erectile prostheses used were the two-piece AMS Ambicor (n = 71, 74.7%), the Ambicor with a vascular graft (n = 19, 20.0%), and the AMS 700CXR, AMS 700CX, or AMS600-650 (n = 5, 5.2%). There were no early-onset complications in 89 procedures (93.7%) and, when present, they were always related to infection (n = 4, 4.2%). Late-onset complications were erosion (n = 4, 4.2%), infection (n = 4, 4.2%), dysfunction (n = 10, 10.5%), and malpositioning (n = 12, 12.6%). No significant difference was observed for malpositioning (12.7% vs 10.5%, P = .87) and dysfunction (7.0% vs 10.5%, P = .78) between the AMS Ambicor prosthesis and the Ambicor prosthesis with a vascular graft. Conclusion This study provides updated data on complications after the implantation of erectile implants. Multicenter studies, including the evaluation of patient satisfaction, are needed to increase our understanding of factors associated with the outcomes.
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