JOURNAL OF ENDOUROLOGY Volume 20, Number 5, May 2006 Mary Ann Liebert, Inc.

Rapid Communication Initial Experience with Full-Length Metal Stent to Relieve Malignant Ureteral Obstruction
JAMES F. BORIN, M.D., ORI MELAMUD, M.D., and RALPH V. CLAYMAN, M.D.

ABSTRACT Ureteral obstruction caused by extrinsic compression by a malignancy generally can be overcome initially with a ureteral stent. However, the long-term failure rate is high, usually necessitating placement of a nephrostomy tube. Herein, we present the initial case, in this country, of intractable ureteral obstruction managed successfully with the newly developed all-metal Resonance stent (Cook Ireland Ltd., Limerick, Ireland) constructed of MP35N alloy, a composite of nonmagnetic nickelcobaltchromiummolybdenum. The patient is a 64-year-old woman with metastatic breast cancer causing retroperitoneal fibrosis and ureteral obstruction diagnosed laparoscopically. The obstruction failed to respond to placement of a single 7F double-J stent and then of two 6F double-J stents in the left ureter. As a last resort, in order to avoid nephrostomy-tube placement, the 6F metal stent was placed; this provided unobstructed flow of urine, as documented on a subsequent Whitaker test and, most recently, on a renal scan, 4 months after initial stent placement.

INTRODUCTION

RETERAL OBSTRUCTION BY CARCINOMA can usually be temporized initially with a ureteral stent. However, the long-term failure rate of stents in the setting of malignant extrinsic compression is high, usually 50%.1,2 As the median survival time of patients with metastatic cancer causing ureteral obstruction is generally less than 7 months, avoiding body-altering invasive procedures, such as nephrostomy tubes, is important to maintain quality of life.3 In addition, the percutaneous nephrostomy tube represents a point of entry for bacteria that is ideally avoided, especially in patients destined to undergo chemotherapy. Herein, we present the initial case, in this country, of intractable malignant ureteral obstruction managed successfully with an all-metal indwelling ureter-specific stent.

CASE REPORT
A 64-year-old woman underwent bilateral radical mastectomy for breast cancer; lymph node dissections were positive

for metastatic disease. She underwent chemotherapy, first with epirubacin and taxotere, and later with cyclophosphamide, methotrexate, and 5-fluorouracil, as well as aromatase inhibitors. Tumor markers, including CA-27 and CA-29, continued to rise, and surveillance CT imaging 2 years after presentation revealed left hydronephrosis with mantling of tissue over the aorta and inferior vena cava. Follow-up CT a few months later showed worsened left hydronephrosis and new-onset right hydronephrosis (Fig. 1). There was no evidence of metastatic disease elsewhere. Because of the CT findings consistent with retroperitoneal fibrosis, the patient was taken to the operating room for bilateral stent placement, laparoscopic retroperitoneal biopsy, and possible laparoscopic ureterolysis. The left ureter was found to be encased in fibrotic tissue, some of which was dissected and biopsied; intraoperative frozen-section examination revealed metastatic breast cancer. As such, ureterolysis was not performed, and a 7F silicone stent (Black Beauty; Cook Urological, Spencer, IN) was placed on the right side and a 7F polyurethane stent (Applied Urology, Rancho Santa Margarita, CA) was placed on the left side.

Department of Urology, University of California, Irvine, Orange, California.

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FIG. 1. Initial CT scan showing bilateral hydronephrosis and periaortic soft-tissue mantling (arrows).

mally until the pigtail is deployed in the renal pelvis. The 10F sheath is then retracted with the inner catheter held in place until the distal pigtail is deployed in the bladder. Stent placement was uneventful, and 3 days later, the patient capped her nephrostomy tube. One week later, a repeat leftsided Whitaker test with antegrade pyelogram revealed no hydronephrosis, with contrast freely flowing to the bladder (Fig. 4). The pressure differential ranged from 13 to 18 cm H2O. The left nephrostomy tube was removed. Six weeks after stent placement, a renal scan demonstrated no obstruction with a T1/2 of 6.9 minutes. A repeat renal scan at 4 months indicated no hydronephrosis, with a T1/2 of 11.7 minutes. The serum creatinine concentration remains stable at 1.0. The patient continues without flank pain 4 months after initial stent placement; however, she does note common stent symptoms of urgency and frequency, which are unaccompanied by incontinence.

DISCUSSION
The patient had an uncomplicated postoperative course until day 3, when she became anuric and the serum creatinine concentration rose from baseline of 1.3 to 2.4 mg/dL. A renal ultrasound scan confirmed bilateral hydronephrosis, greater on the right than the left. The patient was taken to the operating room, and two 6F hydrophilic polyurethane stents (InLay; C.R. Bard, Murray Hill, NJ) were placed within the right and left ureters, as described by Liu and Hrebinko4 (Fig. 2). Immediate diuresis ensued, and by the next morning, her creatinine concentration had fallen to 1.8 mg/dL. Later that day, the urine output dropped again, and a repeat creatinine measurement was 2.3 mg/dL. At this point, bilateral nephrostomy tubes were placed. Antegrade nephrostograms with the double stents still in place demonstrated complete ureteral obstruction with no flow of contrast to the bladder from either ureter. With the nephrostomy tubes in place, the creatinine concentration rapidly fell to baseline. Subsequently, all four ureteral stents were removed, and retroperitoneal radiation therapy was initiated. She received 4700 rads from the diaphragm to the iliac vessels over a course of 5.5 weeks, which resulted in a significant decrease in tumor markers and near resolution of her retroperitoneal lymphadenopathy. Eight weeks later, Whitaker tests revealed a patent, unobstructed right ureter (pressure gradient 1 cm H2O) but markedly impaired drainage via the left ureter (pressure gradient 39 cm H2O). The right nephrostomy tube was capped for 3 weeks and subsequently removed; the left nephrostomy tube remained to drainage (Fig. 3). The patient continued to do well but strongly desired an alternative to nephrostomy drainage of her left kidney. After discussion of several treatment options that included the patients husband and emphasized the newness of the metal stent, the patient elected to proceed with placement of the 6F metal ureteral stent (Resonance; Cook Ireland Ltd., Limerick, Ireland). During the cystoscopic procedure, initially, an introduction set similar to an 8/10F dilator was passed over a guidewire into the renal pelvis. As the metal stent is closed on both ends, it cannot be placed over a guidewire but rather has to be passed through the 10F introducer sheath. The wire and inner catheter are removed, and the latter is used to help advance the stent proxiThe 6F Resonance metal stent is a continuous unfenestrated metal coil with an inner safety wire welded to both closed, tapered ends (Fig. 5). It is constructed of MP35N alloy, a composite of nonmagnetic nickelcobaltchromiummolybdenum possessing a unique combination of ultrahigh tensile strength and excellent resistance to corrosion, sulfidation, high-temperature oxidation, and hydrogen embrittlement. This alloy is used in the construction of other medical devices, including cardiac

FIG. 2. ureters.

Plain radiograph showing double stents placed in both

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FIG. 3. In this prone antegrade nephrostogram, right system is noted to be patent, whereas on left, there is no flow of contrast below proximal ureter.

stents. Its superelastic properties provide tremendous strength as well as flexibility, and it is compatible with a 1.5T MRI scan. Various designs of short metal stents have been used in clinical practice over the past 15 years, but none has been in the style of an indwelling ureteral stent. In 1991, Lugmayr and Pauer5 first reported their experience with self-expanding metal stents of a defined length (310 cm); these stents consisted of an elastic mesh woven from stainless cobalt-based alloy filaments. The stent was mounted on a 7F delivery catheter.5 A follow-up report of 40 patients with 54 ureters obstructed by malignancy demonstrated a 49% reintervention rate, with a Kaplan-Meier estimation of only a 31% patency rate at 12 months.6 Much of the problem with these stents was secondary to ingrowth of hyperplastic urothelium and subsequent obstruction. The mean follow-up was 10.5 months, and the survival rate at 12 and 24 months was 40% and 22%, respectively. Concerns about metal ureteral stents include biocompatibility, hyperplastic tissue response, and encrustation. Newer expandable stents constructed of Nitinol may be more biocompatible than their predecessors.7 To avoid hyperplastic tissue ingrowth and to provide a biocompatible device, a stent was made of a specially treated nickelcobaltchromiummolybdenum material. To answer concerns about encrustation, we compared the encrustation potential of the Resonance metal stent with that of silicone

and polyurethane stents in an in-vivo rabbit model.8 These studies demonstrated no increased risk of encrustation in the severe environment of the hypercalciuric rabbit bladder. To date, we are uncertain of the means of drainage, as these studies have yet to be completed; however, we hypothesize that drainage occurs solely by capillary action along the metal coils of the stent. Studies in this regard are planned for the near future. With regard to acceptable stent dwelling time, this has yet to be determined. In Europe, the stent is approved to remain in situ for 12 months. In England, these stents have been left in place for as long as 11 months without complications. There have been no reports to date of stent fracture or inability to remove the stent secondary to encrustation. We plan to leave the present stent in place for at least 6 months.

CONCLUSION
A novel 6F unfenestrated metal stent was able to provide long-term drainage in a patient with malignant ureteral obstruction who had failed prior placement of single as well as double ureteral stents. Use of this stent may allow patients with malignant ureteral obstruction to avoid the discomfort and disfigurement associated with placement of a chronic nephrostomy tube for the final months/years of their lives.

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FIG. 4. Prone left antegrade nephrostogram and Whitaker test 11 days after Resonance stent placement. (A) Scout image. (B) Contrast flowing down stent and (C) filling bladder.

C B

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FIG. 5. The Resonance metal stent, a composite of nonmagnetic nickelcobaltchromiummolybdenum. Stent is continuous coil with inner safety wire welded to both ends that prevents elastic elongation, especially during removal.

ACKNOWLEDGMENT
This study was supported in part by an unrestricted education/research grant from Cook Urological, Inc., Spencer, IN.

REFERENCES
1. Docimo SG, DeWolf WC. High failure rate of indwelling ureteral stents in patients with extrinsic obstruction: Experience at 2 institutions. J Urol 1989;142:277. 2. Chung SY, Stein RJ, Landsittel D, Davies BJ, Cuellar DC, Hrebinko RL, Tarin T, Averch TD. 15-year experience with the management of extrinsic ureteral obstruction with indwelling ureteral stents. J Urol 2004;172:592. 3. Russo P. Urologic emergencies in the cancer patient. Semin Oncol 2000;27:284. 4. Liu JS, Hrebinko RL. The use of two ipsilateral ureteral stents for relief of ureteral obstruction from extrinsic compression. J Urol 1998;159:179.

5. Lugmayr H, Pauer W. Self-expanding metallic stents in malignant ureteral stenosis. Dtsch Med Wochenschr 1991;116:573. 6. Lugmayr HF, Pauer W. Wallstents for the treatment of extrinsic malignant ureteral obstruction: Midterm results. Radiology 1996; 198:105. 7. Trueba Arguinarena FJ, Fernandez del Busto E. Self-expanding polytetrafluoroethylene covered Nitinol stents for the treatment of ureteral stenosis: Preliminary report. J Urol 2004;172:620. 8. Borin JF, Tyson D, Sala LG, Abdelshehid CA, Le T, Nguyen A, McDougall EM, Clayman RV. Encrustation of biomaterials in an in-vivo rabbit model [abstract]. J Endourol 2005;19:A284.

Address reprint requests to: Ralph V. Clayman, M.D. Dept. of Urology University of California, Irvine 101 The City Drive Building 55, 3rd Floor Orange, CA 92612 E-mail: rclayman@uci.edu