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ADULT UROLOGY

ASSESSMENT OF STRICTURE FORMATION WITH THE


URETERAL ACCESS SHEATH
FERNANDO C. DELVECCHIO, BRIAN K. AUGE, RICARDO M. BRIZUELA, ALON Z. WEIZER,
ARI D. SILVERSTEIN, COSTAS D. LALLAS, PAUL K. PIETROW, DAVID M. ALBALA, AND
GLENN M. PREMINGER

ABSTRACT
Objectives. To analyze the long-term incidence of ureteral stricture formation in a series of patients in whom
a new-generation ureteral access sheath was used. A new generation of ureteral access sheaths has been
developed to facilitate ureteroscopic procedures. However, some have questioned their safety and whether
the device might cause significant ureteral trauma.
Methods. Between September 1999 and July 2001, 150 consecutive ureteroscopic procedures with
adjunctive use of an access sheath were performed. A retrospective chart review to April 2002 was done. Of
the 150 patients, 130 underwent ureteroscopy for ureteral stones. Patients who underwent endoureter-
otomy or treatment of transitional cell carcinoma were excluded from this analysis. Sixty-two patients had
follow-up greater than 3 months and were included in the analysis. Overall, 71 ureteroscopic procedures
were performed, with 9 patients undergoing multiple procedures. Ninety-two percent of the patients had
pathologic findings above the iliac vessels. The average patient age was 45.3 years (range 17 to 76), and
70% and 30% of the patients were male and female, respectively. The mean clinical follow-up was 332 days
(range 95 to 821), and follow-up imaging was performed within 3 months after ureteroscopy in all patients.
Results. The 10/12F access sheath was used in 8 ureteroscopic procedures (11.2%), the 12/14F access
sheath in 56 (78.9%), and the 14/16F access sheath in 7 (9.8%). One stricture was identified on follow-up
imaging of 71 procedures performed, for an incidence of 1.4%. The patient developed the stricture at the
ureteropelvic junction after multiple ureteroscopic procedures to manage recurrent struvite calculi. The
access sheath did not appear to be a contributing factor.
Conclusions. The results of our series indicate that the ureteral access sheath is safe and beneficial for
routine use to facilitate flexible ureteroscopy. However, awareness of the potential ischemic effects with the
use of unnecessarily large sheaths for long periods in patients at risk of ischemic injury should be considered.
We advocate the routine use of the device for most flexible ureteroscopic procedures proximal to the iliac
vessels. UROLOGY 61: 518–522, 2003. © 2003, Elsevier Science Inc.

T he downsizing of endoscopes and the develop-


ment of safer and more efficient intracorporeal
lithotriptors and lasers have expanded the indica-
teral stricture rates secondary to ureteroscopy from
approximately 10% in early series to single digit
figures in modern series.1–5 The development of
tions of ureteroscopy from a purely diagnostic tool ureteral strictures as a result of adjuncts used to
to a therapeutic device currently used for a wide facilitate the procedure (ie, the ureteral access
range of indications. Similarly, endoscopic exper- sheath) has recently been theorized.6 Therefore,
tise gained by urologic surgeons has played an we retrospectively analyzed the incidence of ure-
enormous role in significantly reducing the ure- teral strictures in a series of patients in whom a
new-generation ureteral access sheath was used to
From the Comprehensive Kidney Stone Center, Division of Urol- facilitate flexible ureteroscopy.
ogy, Department of Surgery, Duke University Medical Center,
Durham, North Carolina
Reprint requests: Glenn M. Preminger, M.D., Division of Urol- MATERIAL AND METHODS
ogy, Department of Surgery, Duke University Medical Center,
Box 3167, Room 1527D, White Zone, Durham, NC 27710 A total of 150 consecutive ureteroscopies with the use of a
Submitted: May 28, 2002, accepted (with revisions): October 7, new-generation ureteral access sheath (Applied Medical,
2002 Rancho Santa Margarita, Calif ) were performed. Sixty-two pa-

© 2003, ELSEVIER SCIENCE INC. 0090-4295/03/$30.00


518 ALL RIGHTS RESERVED doi:10.1016/S0090-4265(02)02433-0
no evidence of stricture) were scheduled for repeat imaging 12
TABLE I. Patient characteristics to 15 months after this first follow-up study. Asymptomatic
Characteristic % patients with residual radiopaque stone burden were subse-
quently followed up with plain abdominal radiography and
Ureteroscopic procedures (n) 71 tomography, and contrasted imaging studies were obtained in
Mean age (yr) 45.3 (17–76) symptomatic patients. All patients had an imaging study per-
Gender (M/F) (n) 43/19 70/30 formed within the first 3 months after surgery. The long-term
Preoperative stent 20 28 clinical follow-up ranged between 95 and 821 days (mean
Preoperative obstruction 51 72 332).
Postoperative stent 62 87
Balloon dilation 6 8.4 RESULTS
Follow-up (days)
Range 95–821 — Sixty-two patients undergoing 71 ureteroscopic
Mean 331.7 — procedures with the aid of the ureteral access
KEY: M/F ⫽ male/female. sheath and with complete follow-up longer than 3
months were identified for analysis. A 10/12F ac-
cess sheath was used in 8 (11.2%), a 12/14F access
tients were identified with complete follow-up and were ret- sheath in 56 (78.9%), and a 14/16F access sheath in
rospectively enrolled for analysis (Table I). The average pa- 7 (9.8%). Twenty patients (32.2%) had a stent
tient age was 45.3 years (range 17 to 76), and 70% of the placed preoperatively, none of whom required bal-
patients were male. Ninety-two percent of the patients had
renal or proximal ureteral pathologic findings managed intra-
loon dilation of the ureteral orifice at the time of
corporeally with a 7.5F flexible ureteroscope. The ureteral surgery. Balloon dilation to 18F was necessary in
access sheath was used to facilitate treatment of distal ureteral 6 cases (8.4%) to facilitate passage of the access
stones in 5 patients early in our experience. However, its use sheath. A postoperative stent was positioned at
for calculi in this location was abandoned thereafter, because the conclusion of 62 ureteroscopic procedures
it proved to be too difficult to stabilize the sheath within the
distal ureter. All patients with stones above the iliac vessels
(87.3%) and maintained for 3 to 5 days.
were treated with a flexible ureteroscope, and no attempt was An asymptomatic stricture occurred in only one
made to use a semirigid endoscope through the access sheath. renal unit of 71 ureteroscopic procedures (1.4%).
Overall, 71 ureteroscopic procedures were performed, with 9 This patient was a T6 paraplegic with recurrent
patients having multiple procedures. The stone size was be- struvite calculi who developed a left ureteropelvic
tween 6 and 25 mm in diameter (mean size 10.7). The mean
operative time was 42 minutes.
junction stricture 3 months after his second uret-
The indications for ureteroscopy were renal or ureteral cal- eroscopy. His last ureteroscopy was performed us-
culus disease. Patients with pre-existing ureteral stricture dis- ing a 12/14F ureteral access sheath that was placed
ease or with upper tract transitional cell carcinoma were ex- just above the iliac vessels, well below the stricture
cluded from the study series, because subsequent stricture site. No balloon dilation was required, and a ure-
formation in this group of patients could be related to their
primary disease and therefore could bias our results.
teral stent was left indwelling for 7 days after the
The ureteral access sheath used, available in three different procedure. The patient had undergone two prior
diameters (10/12F, 12/14F, and 14/16F) and variable lengths percutaneous nephrolithotomies with ureteral
(20, 28, 35, or 55 cm), is a soft, malleable, hydrophilic, two- catheterization, one shock wave lithotripsy, and
piece device with a removable inner tapered obturator and an two ureteroscopic procedures, one for a proximal
outer working sheath. The sheath size is chosen on the basis of
patient size, gender, and position of the pathologic findings
and one for a distal ureteral stone.
within the collecting system. The access sheath was used in The overall stone free rate for 71 ureteroscopic
patients with large stone burdens in whom multiple re-entry procedures was 77.4%. When stratified by loca-
into the collecting system for stone fragment clearance was tion, the stone free rate was 81% for renal stones,
anticipated; it was also used as a ureteral dilator. The access 72% for proximal and mid-ureteral stones, and
sheath is placed directly over a safety guidewire with fluoro-
scopic guidance.7 The tip of the access sheath is placed just
100% for distal stones. Considering residual frag-
below the stone during treatment of ureteral stones and at the ments less than 4 mm, the overall success rate
ureteropelvic junction for management of renal calculi. All was 90.3%, and the renal and proximal/mid suc-
stones were fragmented with a 200-␮m holmium laser fiber cess rate approached 95% and 86%, respectively
using power settings of 0.6 J at 6 Hz.8 A nitinol basket or (Table II).
grasper was used in 39% of patients with ureteral calculi to
remove stone fragments (after laser fragmentation) through
the access sheath. Moreover, the nitinol devices were used in COMMENT
62% of patients with renal calculi to reposition stones within
the collecting system and remove fragments after laser litho- Technological advancements leading to the de-
tripsy.9 velopment of the flexible actively deflectable
The initial follow-up evaluation consisted of intravenous ureteroscope have revolutionized intracorporeal
urography with renal tomography or spiral computed tomog- access to the proximal ureter and intrarenal col-
raphy to determine stricture rates and stone-free status. There-
after, additional imaging was tailored to the individual patient lecting system. Reports of complications from the
on the basis of the findings from the initial study. Patients with early use of large-caliber, rigid instruments de-
a normal imaging study (ie, no evidence of residual stones and scribed minor injuries such as ureteral perforation,

UROLOGY 61 (3), 2003 519


does the access sheath facilitate repeated insertion
TABLE II. Ureteroscopy performed with the
and withdrawal of the endoscope, it also protects
aid of the ureteral access sheath
the ureteral orifice and wall from trauma they
SFR/Patients (%) might otherwise sustain while advancing the in-
Stone Patients URS
Location (n) (n) Abs AbsⴙRel strument through the native ureter. Moreover, the
Kidney 21 24 17 (81) 20 (95) ability to irrigate the intrarenal collecting system
Proximal-mid 36 42 26 (72) 31 (86) continuously has resulted in improved clearance of
Distal 5 5 5 (100) 5 (100) renal stones compared with our series of patients
Total 62 71 48 (77.4) 56 (90.3) before the routine use of the access sheath.29 A
KEY: URS ⫽ ureteroscopic procedure; SFR ⫽ stone free rate; Abs ⫽ absolute stone recent report from our institution demonstrates
free rate; Abs⫹Rel ⫽ absolute stone free rate plus residual stones ⬍4 mm in size.
that the ureteral access sheath reduces both oper-
ative time and costs and obviates the need for rou-
tine balloon dilation in most patients undergoing
mucosal injury, and urinary extravasation.10 –13 flexible ureteroscopy.7
However, major complications occurred in more Recently, concerns have been raised as to the
than 10% of cases, including ureteral avulsion, long-term safety of the ureteral access sheath with
complete obstruction, vesicoureteral reflux, and regard to stricture formation secondary to pres-
ureteral stricture.12,14 –17 Stricture rates ranged sure-induced ischemia. However, no clinical stud-
from 2% to 10%, with prior ureteral surgery and ies have been performed to explore the potential
ureteral or pelvic radiation therapy cited as nega- trauma induced by the ureteral access sheath. This
tive influences on ureteral blood flow, contributing current review of ureteroscopic procedures using
to poor healing and scar formation.4,15,18 Uretero- the ureteral access sheath demonstrated a stricture
scopes used early on to perform retrograde endo- rate of only 1.4%, consistent with modern series of
pyelotomy were large-caliber scopes (9 to 12F), flexible ureteroscopy without the assistance of the
and, although used successfully, these endoscopes access sheath. A review of the operative notes from
were associated with a stricture rate of 20%.19,20 the 1 patient who developed a ureteral stricture
As the ureteroscope diameter decreased to 7.5F failed to disclose intraoperative complications that
and 6.5F, and the malleability of semirigid endo- could account for the problem. It is likely that re-
scopes and actively deflectable flexible uretero- peated ureteral manipulation during percutaneous
scopes has improved, so too have the complication and retrograde procedures rather than the use of
rates secondary to ureteroscopy decreased.21–23 the access sheath may have placed this patient at
Strictures are now rare, comprising 1% to 2% of all higher risk of stricture formation.
complications in large series.23–25 It could be argued that imaging follow-up studies
Because repeated insertion and withdrawal of a within 3 months of ureteroscopy is not long
ureteroscope increases the likelihood of ureteral enough to capture all potential strictures. How-
damage, adjuncts to prevent ureteral injury have ever, several reports have indicated that failure of
been sought. The concept of a ureteral access the ureteroscopic incision of secondary uteropel-
sheath is not new. In the early 1970s, Takayasu and vic junction obstruction or incision of benign ure-
Aso26 described the use of a “guide tube” or prim- teral strictures occurs within 1.5 to 4.5 months
itive access sheath as an aid to ureteroscopy. Early postoperatively. Furthermore, strictures related to
devices designed to aid ureteroscope insertion and impacted stones were detected at a mean of 2.6
stability involved a cystoscopic sheath for uretero- months after stone extraction.22,30 These data sug-
scope passage. A peel-away ureteral and renal ac- gest that although long-term follow-up is war-
cess system was developed in the mid-1980s. This ranted, if the access sheath had caused significant
access system involved the use of sequential rigid ureteral injury, most sheath-induced traumatic
dilators and a peel-away outer sheath that required strictures should have been apparent during the
multiple steps before ureteroscope insertion. Al- follow-up period.
though these devices improved stone fragmenta- Despite the apparent safety of the ureteral access
tion and stone removal and facilitated other uret- sheath, patient factors may contribute to ureteral
eroscopic procedures, its use contributed to injury during ureteroscopy with or without the use
perforation in up to 30% of cases.27,28 of the access sheath. These factors include prior
The new-generation ureteral access sheath is a ureteral or retroperitoneal surgery, retroperitoneal
two-piece hydrophilic-coated device of varying radiotherapy, severe peripheral vascular disease,
lengths and diameters designed to facilitate flexible and collagen vascular disorders affecting small to
and semirigid ureteroscopy. During the current medium-size blood vessels. Animal studies at our
study, the access sheath was used primarily during institution investigating the effects of the access
flexible ureteroscopic procedures and not in con- sheath on ureteral blood flow failed to demonstrate
junction with semirigid ureteroscopes.7 Not only acute ischemic damage based on blood flow mea-

520 UROLOGY 61 (3), 2003


surements and histopathologic changes. However, lowing for repeated atraumatic ureteral reentry.
this study demonstrated that ureteral blood flow Moreover, all of the advantages of the ureteral ac-
decreased more rapidly, more profoundly, and cess sheath are achieved with a significant decrease
took longer to return to baseline values, when us- in operative time and costs. Additional studies are
ing a large caliber 14/16F ureteral access sheath.6 warranted to evaluate the impact of using the larg-
We would therefore recommend using the smallest est access sheath in patients at high risk of ischemic
diameter access sheath that will allow the operator ureteral injury, because the 14/16F sheath was
to efficiently and effectively perform the proce- used in less than 10% of our patient population.
dure. We commonly use the smaller 10/12F and The current series demonstrates the safety of the
12/14F access sheaths, reserving the 14/16F sheath ureteral access sheath during ureteroscopic stone
for those individuals who have undergone preop- manipulation. Therefore, we advocate the routine
erative ureteral stent placement, with a subse- use of the ureteral access sheath for flexible uret-
quently dilated ureter. eroscopic procedures above the iliac vessels.
Because our facility is a tertiary care center, many
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UROLOGY 61 (3), 2003 521


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24. Abdel-Razzak OM, and Bagley DH: Clinical experience © 2003, ELSEVIER SCIENCE INC.
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25. Elashry OM, Elbahnasy AM, Rao GS, et al: Flexible REPLY BY THE AUTHORS
ureteroscopy: Washington University experience with the
9.3F and 7.5F flexible ureteroscopes. J Urol 157: 2074 –2080, The percutaneous approach remains our first choice for the
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29. Weizer AZ, Auge BK, Silverstein AD, et al: Routine report provides additional evidence to support previously per-
post-operative imaging is important following ureteroscopic formed studies, which validate the safety of the access sheath.2
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we believe that postureteroscopic imaging is an important ad-
junct to uncover silent obstruction.3
Flexible ureteroscopy can be performed safely and effi-
ciently without a ureteral access sheath. Yet, we believe that
EDITORIAL COMMENT the combination of advantages afforded by this new genera-
tion of access sheaths supports our recommendation to use a
The goal of this retrospective study was to determine ureteral access sheath routinely during flexible ureteroscopic
whether the use of ureteral access sheaths increases postoper- procedures.
ative ureteral stricture formation. This is a relevant question,
given the popularization of retrograde approaches to signifi- REFERENCES
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ment, and (b) clinical assessment only thereafter. It is inter- metric determination of ureteral blood flow after ureteral ac-
esting to note a relatively short mean operative time (42 min- cess sheath placement. J Endourol 16: 583–590, 2002.
utes). How many passages of the ureteroscope were 3. Weizer AZ, Auge BK, Silverstein AD, et al: Routine post-
necessary? We think most urologists agree that ureteral access operative imaging is important after ureteroscopic stone ma-
sheaths are safe, when properly used, and ultimately this study nipulation. J Urol 168: 46 –50, 2002.
raises the issue of whether they are necessary. Developments
such as hydrophilic coatings and the ability to place the sheath Fernando C. Delvecchio, M.D.,
without multiple, sequential dilations have likely reduced Glenn M. Preminger, M.D.
complications due to shear forces. We continue to perform Duke University Medical Center
retrograde ureteroscopy and renoscopy routinely without an Durham, North Carolina
access sheath or ureteral dilation, simply being careful during
manipulation and also selecting those patients with lower
stone burden and therefore requiring fewer passages. Despite doi:10.1016/S0090-4295(02)02435-4
the advances in ureteroscopic lithotripsy such as the holmium © 2003, ELSEVIER SCIENCE INC.
laser, our preference is to still manage large upper urinary tract ALL RIGHTS RESERVED

522 UROLOGY 61 (3), 2003

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