Radiation exposure during sacral neuromodulation lead placement: Multi-institutional descriptive study.

OBJECTIVES: Fluoroscopy has significantly improved lead placement and decreased surgical time for implantable sacral neuromodulation (SNM). There is a paucity of data regarding radiation and safety of fluoroscopy during SNM procedures. Our study aims to characterize fluoroscopy time and dose used during SNM surgery across multiple institutions and assess for predictors of increased fluoroscopy time and radiation dose. METHODS: Electronic medical records were queried for SNM procedures (Stage 1 and full implant) from 2016 to 2021 at four academic institutions. Demographic, clinical, and intraoperative data were collected, including fluoroscopy time and radiation dose in milligray (mGy). The data were entered into a centralized REDCap database. Univariate and multivariate analysis were performed to assess for predictive factors using STATA/BE 17.0. RESULTS: A total of 664 procedures were performed across four institutions. Of these, 363 (54.6%) procedures had complete fluoroscopy details recorded. Mean surgical time was 58.8 min. Of all procedures, 79.6% were performed by Female Pelvic Medicine and Reconstructive Surgery specialists. There was significant variability in fluoroscopy time and dose based on surgical specialty and institution. Most surgeons (76.4%) were considered "low volume" implanters. In a multivariate analysis, bilateral finder needle testing, surgical indication, surgeon volume, and institution significantly predicted increased fluoroscopy time and radiation dose (p < 0.05). CONCLUSIONS: There is significant variability in fluoroscopy time and radiation dose utilized during SNM procedures, with differences across institutions, surgeons, and subspecialties. Increased radiation exposure can have harmful impacts on the surgical team and patient. These findings demonstrate the need for standardized fluoroscopy use during SNM procedures.

Changes in patient reported outcome measures after treatment for female urethral stricture.

INTRODUCTION: There is a paucity of patient reported outcome measure (PROM) data for women with urethral strictures. To address this gap, we aim to evaluate change in PROM among women who underwent surgery for a stricture. METHODS: American Urological Association Symptom Index (AUA-SI) and Urogenital Distress Inventory (UDI-6) data from a multi-institutional retrospective cohort study of women treated for urethral stricture was assessed. RESULTS: Fifty-seven women had either AUA-SS or UDI-6 and 26 had baseline and postoperative data for either. Most women underwent urethroplasty (77%) and the majority (73%) remained stricture free at median follow-up of 21 months (interquartile range [IQR] 7-37). The median baseline AUA-SI was 21 (IQR 12-28) and follow-up was 10 (IQR 5-24). After treatment, there was a median decrease of 12 (IQR -18 to -2) in AUA-SI (p = 0.003). The median AUA Quality of life (QOL) score at baseline and follow-up were 6 (IQR 4-6) and 3 (IQR 2-5), respectively. There was a median AUA-QOL improvement of 2 points (-5,0; p = 0.007) from a baseline 5 (unhappy) to 3 (mixed). Median UDI-6 scores were 50 (IQR 33-75) at baseline and 17 (IQR 0-39), at follow-up. After treatment, there was a median decrease of 19 (-31 to -11; p = 0.01). CONCLUSION: Women with urethral strictures have severe lower urinary tract symptoms which improved after surgery. This study substantiates the claims that recognizing and treating women with urethral stricture disease greatly improves lower urinary tract symptoms and QOL.

Robotic Sacral Colpopexy Using Autologous Fascia Lata Compared with Mesh.

Objective: The objective is to compare robotic sacral colpopexy (RSC) utilizing autologous fascia lata with RSC with synthetic mesh in the treatment of pelvic organ prolapse (POP). Methods: We performed a prospective nonrandomized case comparison trial at a single institution. We compared RSC utilizing either synthetic mesh or autologous fascia lata in women with symptomatic POP, stages II through IV. The primary outcome was anatomic prolapse recurrence determined by the Pelvic Organ Prolapse Quantification (POP-Q) examination. Secondary outcomes included patient-reported outcomes such as the Urogenital Distress Inventory-6 (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7). Complications were also recorded and categorized using the Clavien-Dindo (CD) system. The hypothesis is that autologous fascia lata would provide equivalent anatomic and patient-reported outcomes compared with mesh while eliminating mesh-related complications. Results: Sixty-four women underwent RSC with 19 (29.7%) receiving fascia lata graft. The overall operative time was greater in the fascia lata group with mean fascia lata harvest time of 24.8 ± 7.4 minutes. Intragroup comparisons of the fascia and mesh groups demonstrated significant improvement in pelvic measurements as well as patient-reported outcomes. Intergroup comparison demonstrated equivalent success rates at 12.1 ± 8.7 months follow-up. There was one apical failure in the fascia lata RSC group; however, the difference was not statistically significant (p = 0.30). Significant complications in the fascia lata harvest group included two CD-II and one CD-IIIb. In the mesh group there was one mesh erosion requiring surgical excision (CD-IIIb). Conclusion: This is the first comparison between RSC with autologous fascia lata and mesh. Short-term anatomic outcomes were similar with autologous fascia lata use without the risk of mesh erosion. Morbidity from graft harvest site was not trivial. These results emphasize the need for a randomized controlled trial.

Securing Mesh with Delayed Absorbable Suture Does Not Increase Risk of Prolapse Recurrence After Robotic Sacral Colpopexy.

Introduction and Objective: Nonabsorbable monofilament suture is traditionally used to secure vaginal mesh for robot-assisted sacral colpopexy (RASC) but can become exposed postoperatively requiring invasive vaginal removal. Polydioxanone delayed absorbable suture may avoid this. We sought to determine the objective and subjective impact of suture choice for mesh fixation. Materials and Methods: A cohort study was undertaken using a prospective registry and subjects were grouped based on type of suture at the time of RASC. Apical failure was defined as C point descent of >2 cm, anterior compartment failure was defined as pelvic organ prolapse quantification (POP-Q) Ba point of >0, and posterior compartment failure was defined as Bp point of >0. Patient-reported outcomes included urogenital distress inventory (UDI)-6 and QoL. Two-tailed t-test and chi-squared were used for analysis. Results: A total of 119 women underwent RASC between 2009 and 2016. Patients had similar preoperative characteristics (Table 1). All POP-Q, UDI-6, and quality of life (QoL) scores improved postoperatively (Tables 1 and 2). Apical failure was noted in 0, anterior failure was noted in 7 (average Ba +1.1 cm in failures), and posterior failure was noted in 4 (mean Bp +1.0 cm) at 16 months' follow-up. Failures in the anterior compartment were much more common in the nonabsorbable monofilament cohort (Table 2). Failures in the apical and posterior compartments were not significantly different between groups. Nine suture erosions were noted in the nonabsorbable monofilament cohort, five requiring excision in the clinic and two in the operating room. Two suture erosions were noted in the delayed absorbable cohort, 0 required excision. Postoperative UDI-6 and QoL scores did not vary significantly between groups (5.3 ± 4.0 vs 5.1 ± 4.0, p = not significant (NS), 2.8 ± 2.0 vs 2.8 ± 2.2, p = NS). [Table: see text] [Table: see text] Conclusion: Securing mesh with delayed absorbable monofilament did not appear to increase risk of failure in patients undergoing RASC and eliminates the need for suture excision postoperatively.

Treatment of urethral stricture disease in women: A multi-institutional collaborative project from the SUFU research network.

AIM: Female urethral stricture disease is rare and has several surgical approaches including endoscopic dilations (ENDO), urethroplasty with local vaginal tissue flap (ULT) or urethroplasty with free graft (UFG). This study aims to describe the contemporary management of female urethral stricture disease and to evaluate the outcomes of these three surgical approaches. METHODS: This is a multi-institutional, retrospective cohort study evaluating operative treatment for female urethral stricture. Surgeries were grouped into three categories: ENDO, ULT, and UFG. Time from surgery to stricture recurrence by surgery type was analyzed using a Kaplan-Meier time to event analysis. To adjust for confounders, a Cox proportional hazard model was fit for time to stricture recurrence. RESULTS: Two-hundred and ten patients met the inclusion criteria across 23 sites. Overall, 64% (n = 115/180) of women remained recurrence free at median follow-up of 14.6 months (IQR, 3-37). In unadjusted analysis, recurrence-free rates differed between surgery categories with 68% ENDO, 77% UFG and 83% ULT patients being recurrence free at 12 months. In the Cox model, recurrence rates also differed between surgery categories; women undergoing ULT and UFG having had 66% and 49% less risk of recurrence, respectively, compared to those undergoing ENDO. When comparing ULT to UFG directly, there was no significant difference of recurrence. CONCLUSION: This retrospective multi-institutional study of female urethral stricture demonstrates that patients undergoing endoscopic management have a higher risk of recurrence compared to those undergoing either urethroplasty with local flap or free graft.

Robotic Sacral Colpopexy.

INTRODUCTION AND OBJECTIVE: Robot-assisted sacral colpopexy (RASC) is a fast growing approach for surgeons treating patients with advanced stage pelvic organ prolapse (POP). Open abdominal sacral colpopexy has been the gold standard for advanced POP but requires longer hospital stays and a much larger incision. The indications, preoperative preparation, operative positioning, and operative steps are detailed, and an accompanying video shows the approach. METHODS: RASC can be broken down into 11 steps and the reader will be able to reference the article to the corresponding portion of the video. RESULTS: A total of 119 women underwent RASC between 2009 and 2016. Patients had similar preoperative characteristics. All POP-Q, UDI-6, and quality of life scores improved postoperatively. Apical failure was noted in 0, anterior failure was noted in 7 (average Ba +1.1 cm in failures), and posterior failure was noted in 4 (mean Bp +1.0 cm) patients at 15.6 months' follow-up. A total of 11 suture erosions were noted in five patients requiring excision in the clinic and 2 patients in the operating room. Four suture erosions were managed with observation. Two mesh exposure events were noted. CONCLUSION: Outcomes for robotic sacral colpopexy are like those of open abdominal sacral colpopexy.

Prognostic Effect of Carcinoma In Situ in Muscle-invasive Urothelial Carcinoma Patients Receiving Neoadjuvant Chemotherapy.

BACKGROUND: Carcinoma in situ (CIS) is a poor prognostic finding in urothelial carcinoma. However, its significance in muscle-invasive urothelial carcinoma (MIUC) treated with neoadjuvant chemotherapy (NAC) is uncertain. We assessed the effect of CIS found in pretreatment transurethral resection of bladder tumor (TURBT) biopsies on the pathologic and clinical outcomes. MATERIALS AND METHODS: Subjects with MIUC treated with NAC before cystectomy were identified. The pathologic complete response (pCR) rates stratified by TURBT CIS status were compared. The secondary analyses included tumor response, progression-free survival (PFS), overall survival (OS), and an exploratory post hoc analysis of patients with pathologic CIS only (pTisN0) at cystectomy. RESULTS: A total of 137 patients with MIUC were identified. TURBT CIS was noted in 30.7% of the patients. The absence of TURBT CIS was associated with a significantly increased pCR rate (23.2% vs. 9.5%; odds ratio, 4.08; 95% confidence interval, 1.19-13.98; P = .025). Stage pTisN0 disease was observed in 19.0% of the TURBT CIS patients. TURBT CIS status did not significantly affect the PFS or OS outcomes. Post hoc analysis of the pTisN0 patients revealed prolonged median PFS (104.5 vs. 139.9 months; P = .055) and OS (104.5 vs. 152.3 months; P = .091) outcomes similar to those for the pCR patients. CONCLUSION: The absence of CIS on pretreatment TURBT in patients with MIUC undergoing NAC was associated with increased pCR rates, with no observed differences in PFS or OS. Isolated CIS at cystectomy was frequently observed, with lengthy PFS and OS durations similar to those for pCR patients. Further studies aimed at understanding the biology and clinical effect of CIS in MIUC are warranted.

Dorsal Onlay Buccal Urethroplasty in the Female is Associated with High Quality of Life Using Validated Lower Urinary Tract Symptom Instruments.

INTRODUCTION: Female urethral stricture is rare and decreases quality of life. Buccal mucosa has become the most popular graft material for male urethroplasty but little is written about females. Rare case reports of buccal mucosa grafting in the female appear in the literature as an alternate method to more commonly performed vaginal flap urethroplasty (Blandy-style flap) or free vaginal mucosa graft urethroplasty. The hypothesis is that dorsal onlay buccal mucosa grafting will improve quality of life scores and provide acceptable recurrence-free rates. METHODS: We compiled a retrospective case series from 2009 to 2013 to identify female patients treated with dorsal onlay buccal urethroplasty via a suprameatal approach. All patients underwent pelvic exam as well as a supine stress test. Study end points included stricture recurrence verified by cystoscopy, uroflow, post-void residual urine, presence of urinary tract infection, pain, fistula formation, incontinence, and complications at the donor site and the vagina. RESULTS: Six patients were identified. Mean followup was 18.6 months. No stress incontinence was noted preoperatively and none developed postoperatively. No fistulas were noted. Mean stricture length was 1.2 cm and mean graft length was 2.75 cm. Two stricture recurrences (33%) were noted, requiring dilation. Mean pain score went from 7.2 to 0 on a 10-point Likert scale (p = 0.004). The number of urinary tract infections per year decreased from 4.3 to 0.3 (p = 0.038). Maximum voided velocity increased from 5.6 to 13.1 ml per second (p = 0.003) and mean post-void residual urine decreased from 270 to 34 ml (p = 0.094). No urethral or vaginal complications were reported. Two patients reported donor site morbidity but no clitoral anesthesia or pain was reported. CONCLUSIONS: Dorsal onlay buccal urethroplasty provided acceptable but not improved cure rates compared with the published failure rates of alternative methods. Patients experienced significant improvements in pain, urinary flow and quality of life. It can be safely considered instead of ventral onlay vaginal flap urethroplasty or serial dilation in females with stricture.

National Trends in the Performance of Robot-Assisted Sacral Colpopexy.

PURPOSE: Robot-assisted sacral colpopexy (RASC) utilization trends and influencing factors were examined. RASCs were compared with nonrobotic vaginal suspension procedures (non-RASC) used to treat patients with vaginal prolapse. Hospital costs associated with each approach were also examined. The presence of certain factors may predict increased use of RASC. METHODS: The National (Nationwide) Inpatient Sample database was queried from 2009 to 2011 to identify patients undergoing RASC and non-RASC. Multivariable logistic regression was used to evaluate variables associated with RASC utilization, adjusting for age, comorbidities, concurrent procedures, hospital region, primary payer, and year. Multiple linear regression was used to evaluate variables associated with hospital costs when adjusting for operative approach, concurrent procedures, comorbidities, presence of complications, hospital region, and year. RESULTS: Of the 125,869 patients who underwent vaginal vault suspension of any type, 14,601 (12%) were RASC. Total in-hospital complication rates were similar between RASC and non-RASC (8% RASC, 7% non-RASC, P=0.360). The proportion of patients undergoing RASC increased throughout the study period (odds ratio [OR] 1.58, P<0.001), with this increase being most pronounced in the South (OR 2.22, P<0.001). Fifty-four percent of RASC patients vs 48% of non-RASC patients underwent concurrent hysterectomy (P=0.007). Patients with private insurance (OR 1.73, P=0.001) or Medicare (OR 1.43, P=0.033) as their primary payer were at significantly increased odds of RASC compared with Medicaid patients, and private insurance was associated with increased reimbursement. On multiple linear regression, RASC was independently associated with a $4825 increase in hospital costs (95% confidence interval $4161-$5490, P<0.001). There were independent regional differences in cost associated with vaginal suspension, with the West being the most expensive (P<0.001). CONCLUSION: While RASC utilization increased over the study period as a treatment option for vaginal prolapse, the majority of vaginal suspension procedures were still performed via non-RASC methods. RASC was associated with equivalent complications yet significantly higher costs.

Sacral neuromodulation for refractory urge incontinence is less effective following spinal surgery.

Patients with neurogenic disorders and voiding dysfunction have been reported to respond poorly to sacral neuromodulation. We report on our experience in treating voiding symptoms with sacral neuromodulation after spinal surgery. The medical charts of patients evaluated for sacral neuromodulation from 2000-2008 were retrospectively reviewed. Indications, need for explantation, and clinical success (>50% symptom improvement) were recorded. The cohort of patients who had undergone prior spinal surgery was compared to patients with no history of spinal surgery or neurological disease. Thirty-two patients with a history of spinal surgery and 136 with no history of neurologic disease underwent sacral neuromodulation testing. Twenty men and women (62.5%) from the spinal surgery group ultimately underwent permanent implantation. Seventeen of the 32 patients were diagnosed with urge incontinence, of whom 52.9% reported a successful outcome at a mean of 2.3 years of follow-up, compared to an 80.3% success rate in patients with no history of spinal surgery (p=0.018). Sixteen of 32 carried a diagnosis of urgency/frequency with 62.5% success at last follow-up, compared 73.9% (p=0.35) of those without a history of spinal surgery or neurological disease. Thirteen of 32 patients diagnosed with urinary retention experienced a 61.5% long-term success rate, compared with 63.6% for those without spinal surgery and urinary retention. Six of 20 (30.0%) in the spinal surgery group were explanted at a mean time of 2.9 years, compared with 27 of 102 (26.5%) of the non-neurologic patients. Clinical success can be achieved using sacral neuromodulation in patients with voiding dysfunction and a history of spinal surgery; however, those with urge incontinence are less likely to report significant improvement.

Prostatitis: diagnosis and treatment.

Prostatitis ranges from a straightforward clinical entity in its acute form to a complex, debilitating condition when chronic. It is often a source of frustration for the treating physician and patient. There are four classifications of prostatitis: acute bacterial, chronic bacterial, chronic prostatitis/chronic pelvic pain syndrome, and asymptomatic. Diagnosis of acute and chronic bacterial prostatitis is primarily based on history, physical examination, urine culture, and urine specimen testing pre- and post-prostatic massage. The differential diagnosis of prostatitis includes acute cystitis, benign prostatic hyperplasia, urinary tract stones, bladder cancer, prostatic abscess, enterovesical fistula, and foreign body within the urinary tract. The mainstay of therapy is an antimicrobial regimen. Chronic pelvic pain syndrome is a more challenging entity, in part because its pathology is poorly understood. Diagnosis is often based on exclusion of other urologic conditions (e.g., voiding dysfunction, bladder cancer) in association with its presentation. Commonly used medications include antimicrobials, alpha blockers, and anti-inflammatory agents, but the effectiveness of these agents has not been supported in clinical trials. Small studies provide limited support for the use of nonpharmacologic modalities. Asymptomatic prostatitis is an incidental finding in a patient being evaluated for other urologic problems.

Buccal mucosal graft urethroplasty in the treatment of urethral strictures: experience using the two-surgeon technique.

At our institution, the majority of buccal mucosal graft urethroplasties are performed using a two-team approach with an otolaryngologic surgeon. We report our two-surgeon experience with buccal mucosal grafting for reconstruction of all anterior urethral strictures. Twenty-four men underwent autologous buccal mucosal graft urethroplasty between October 2001 and September 2008 for recurrent urethral stricture disease. Twenty-two underwent a single-stage repair and two underwent a two-stage repair. Medical charts were retrospectively reviewed for demographics, comorbidities, etiology, location and length of stricture, and prior interventions in order to identify predictors of buccal urethroplasty success, defined as no evidence of stricture recurrence. All patients underwent retrograde urethrogram and cystoscopy. Operative and anesthesia times were evaluated. We determined an overall success rate of 83.3% (20 of 24 cases). Mean anesthesia time for single-stage urethroplasty was 155 min and mean operative time was 123 min. One of the two two-stage urethroplasties experienced stricture recurrence (50%). The single-stage buccal graft success rate was 86.4% (19 of 22 cases). Two of the four who developed recurrent stricture disease that required intervention had undergone a previous mesh urethroplasty. Complications developed in four of 24 patients (16.6%), including superficial wound infection (one), superficial wound dehiscence (two), and abscess/fistula formation requiring reoperation (one). The buccal mucosa is an ideal tissue for both single- and two-stage substitution urethroplasty for patients with recurrent stricture disease. Our two-surgeon technique minimizes anesthesia and operative times, and contributes to the overall high success rate and relatively low complication rate.

Long-term outcomes of urgency-frequency syndrome due to painful bladder syndrome treated with sacral neuromodulation and analysis of failures.

PURPOSE: We present our long-term experience with sacral neuromodulation devices placed in patients with painful bladder syndrome to determine whether the benefit decreases over time. MATERIALS AND METHODS: Between January 2000 and July 2004, 32 women and 7 men with interstitial cystitis/painful bladder syndrome in whom previous conventional therapy failed underwent sacral neuromodulation test stimulation. Before 2003 a percutaneous test lead was placed in the clinic setting. After 2003 a quadripolar permanent lead was placed in the operating room. Permanent generators were implanted if the patient had more than 50% relief from the presenting complaint, which was defined as urinary or pelvic pain, urgency, or urinary frequency. Long-term outcomes included battery depletion, device malfunction, infection or loss of benefit as well as any change in need for medications. RESULTS: Of 39 patients 22 went from test stimulation to permanent generator implantation. There were significant differences in short-term but not long-term outcomes between the 2 methods of test stimulation. Of 33 patients undergoing percutaneous nerve evaluation 13 (39.4%) met the criteria for permanent generator implantation, while 9 of 11 (81.8%) evaluated with the quadripolar lead met these criteria (p = 0.015). Long-term success between the groups was similar at 92.3% (12 of 13) vs 77.8% (7 of 9) (p = 0.329) during an average followup of 59.9 months. Eleven (50.0%) devices required explantation. Of 22 patients 3 (13.6%) lost benefit over time. CONCLUSIONS: These patients appear to respond best to permanent quadripolar lead placement but long-term results do not appear to be independently affected by the method of test stimulation. Loss of benefit over time is not common.

Treatment of bladder diverticula, impaired detrusor contractility, and low bladder compliance.

Bladder diverticula are common enough to be encountered by most urologists in practice but are reported less frequently in the literature than they were 50 years ago. Some patients can be managed nonoperatively, whereas others will need surgical intervention consisting of bladder outlet reduction and possibly removal of the diverticulum itself. In addition to the decision to operate, the timing of each intervention deserves careful consideration. Cystoscopy, computed tomography with contrast, urodynamic studies, cytology, and voiding cystourethrography play important roles in informing the clinician. Many new techniques for treatment of the bladder outlet and the diverticulum are available, such as laparoscopy and robotic surgery.

Contribution of renal innervation to hypertension in rat autosomal dominant polycystic kidney disease.

The kidney has both afferent (sensory) and efferent (sympathetic) nerves that can influence renal function. Renal innervation has been shown to play a role in the pathogenesis of many forms of hypertension. Hypertension and flank pain are common clinical manifestations of autosomal dominant (AD) polycystic kidney disease (PKD). We hypothesize that renal innervation contributes to the hypertension and progression of cystic change in rodent PKD. In the present study, the contribution of renal innervation to hypertension and progression of renal histopathology and dysfunction was assessed in male Han:SPRD-Cy/+ rats with ADPKD. At 4 weeks of age, male offspring from crosses of heterozygotes (Cy/+) were randomized into either 1) bilateral surgical renal denervation, 2) surgical sham denervation control, or 3) nonoperated control groups. A midline laparotomy was performed to allow the renal denervation (i.e., physical stripping of the nerves and painting the artery with phenol/alcohol). Blood pressure (tail cuff method), renal function (BUN) and histology were assessed at 8 weeks of age. Bilateral renal denervation reduced the cystic kidney size, cyst volume density, systolic blood pressure, and improved renal function (BUN) as compared with nonoperated controls. Operated control cystic rats had kidney weights, cyst volume densities, systolic blood pressures, and plasma BUN levels that were intermediate between those in the denervated animals and the nonoperated controls. The denervated group had a reduced systolic blood pressure compared with the operated control animals, indicating that the renal innervations was a major contributor to the hypertension in this model of ADPKD. Renal denervation was efficacious in reducing some pathology, including hypertension, renal enlargement, and cystic pathology. However, sham operation also affected the cystic disease but to a lesser extent. We hypothesize that the amelioration of hypertension in Cy/+ rats was due to the effects of renal denervation on the renin angiotensin system.

Outcomes of lung transplantation in patients with scleroderma.

Patients with pulmonary insufficiency due to scleroderma have long been considered suboptimal candidates for lung transplantation. This has been supported by small single-center experiences that did not reflect the entire U.S. experience. We sought to evaluate the outcome of patients with scleroderma who underwent lung transplantation. We conducted a retrospective review of 47 patients with scleroderma who underwent lung transplantation at 23 U.S. centers between 1987 and 2004 and were reported to the United Network for Organ Sharing. Women constituted 57% of the patients. The mean age was 46 years. Twenty-seven patients received single lung transplants (57%), and the remaining received double lung transplants. The mean cold ischemia time was 4.1 hours. There were 7 early deaths (< or =30 days) and 17 late deaths (> 30 days). The causes of early death were primary graft failure and a cardiac event in two patients each and bacterial infection and stroke in one patient each. Late mortality was due to infection in seven patients, respiratory failure in three, malignancy in two, and multisystem organ failure, rejection, pulmonary hypertension, and a cardiac event in one patient each. The causes of early and late death were not recorded for two patients. One patient received a second transplant owing to graft failure of the first. Twenty-three patients (49%) were alive at a mean follow-up of 24 months. The Kaplan-Meier 1- and 3-year survival rates were 67.6% and 45.9% respectively, which are not significantly different from those of 10,070 patients given transplants for other lung conditions during the same period (75.5% and 58.8% respectively, P = 0.25). Donor gender, recipient's age, and type of transplant did not affect survival. In carefully selected patients with scleroderma who have end-stage lung disease, lung transplantation is a valid life-saving therapeutic option. Available data suggest acceptable short-term morbidity and mortality and a long-term survival similar to that of patients given transplants for other lung conditions.