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Outpatient Surgery for Vesicoureteral Reflux: Endoscopic Injection vs Extravesical Ureteral Reimplantation
Opposing Views
Outpatient Surgery for Vesicoureteral Reflux: Endoscopic Injection vs Extravesical Ureteral Reimplantation ENDOSCOPIC INJECTION “Doctor, What Would You Do For Your Child?”
ENDOSCOPIC injection to correct vesicoureteral reflux (VUR) is an established procedure with a 3-decade track record. O’Donnell and Puri are credited with advancing the STING (subureteral Teflon® injection) procedure,1 while Stenberg and Läckgren were the first to substitute dextranomer hyaluronic acid co-polymer (Deflux®) for polytef paste, reporting excellent, sustained long-term clinical results.2 These authors contributed invaluable information to our understanding of endoscopic surgery and to numerous concepts regarding the pathophysiology and management of VUR in general. Since my first case of endoscopic injection for VUR in 2001 (following Food and Drug Administration approval of Deflux), I have had only 1 parent request open ureteral reimplantation. Initially, as an “inexperienced injector,” I quoted a success rate of 50% to parents since I really had no prior experience with the injection of materials for VUR. I was pleasantly surprised when after my first 20 cases my success rate was 60%! I was even more pleased after the next 50 cases when this success rate increased to 74%. Since the only true reported risk of the procedure was persistent VUR, we took a more aggressive approach to injection by standardizing a purely intraluminal ureteral floor injection, known as the hydrodistention implantation technique (HIT). This maneuver resulted in an 89% cure rate compared to 74% rate with the standard STING.3 Our goal was to achieve a success rate of 95% which would be comparable to open reimplantation, and thus support the option of avoiding a post-injection voiding cystourethrogram (VCUG). We modified the method further to involve tandem proximal and distal intraluminal injections, hypothesizing that this would coapt the ureteral tunnel and orifice to the point whereby ureteral hydrodistention ceased to occur (Double HIT). We evaluated 336 patients treated with the Double HIT and achieved a ureteral success 0022-5347/11/1865-1764/0 THE JOURNAL OF UROLOGY® © 2011 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
1764
www.jurology.com
AND
RESEARCH, INC.
rate of 92% after a single treatment with no increased risk of obstruction.4 These patients were followed for 3 years and only 5% went on to open surgery and another 5% had a second injection. It is important to note that we always considered success as no VUR after 1 treatment. The main question that remained after treating patients with the Double HIT was the durability of a successful outcome. Did we really have to bring patients back for VCUG when they had normal studies at 3 months, particularly if they had no further febrile urinary tract infections (UTIs) while off antibiotic prophylaxis? A few recent studies, including the Swedish Reflux Study, have shown high (20%) recurrence rates after the STING procedure.5 The initial endoscopic success rate in that study was also poor, likely due to the fact that there were multiple surgeons using various methods and volumes of injection. We recently completed a study of 30 patients with grades II to IV reflux who underwent a delayed VCUG 1 year after the Double HIT and the cure rate was 93%.6 Consequently, we have achieved the success that we had desired, and no longer routinely obtain postoperative VCUG in patients with primary grades II to IV reflux, reserving the study for those with post-injection recurrent febrile UTIs. This risk of clinical VUR recurrence in patients initially cured radiographically is about 4%. After more than 10 years of proven success in the United States and more than 25 years in Europe, endoscopic injection has earned its place as a primary surgical approach to VUR worldwide, with many opting to perform open surgery as either a salvage procedure after failed injection or because of surgeon’s choice, and frankly, one’s bias. Despite this trend towards minimally invasive surgery for VUR, urologists should continue to offer the procedure with which they are most comfortable and which provides the best clinical results. The outpatient extravesical ureteral reimplantation may be a step in the right direction but will likely fall short when the risks and benefits of the 2 procedures are compared. How can one really argue an open operVol. 186, 1764-1767, November 2011 Printed in U.S.A. DOI:10.1016/j.juro.2011.08.024
OPPOSING VIEWS
ation with minimal hospitalization vs a quick, outpatient scar-free procedure? Perhaps a concealed umbilical single port approach would be more appealing. Most importantly, open surgery in general does not seem to offer any real clinical benefit to the patient over endoscopic injection. If successes are comparable, wouldn’t most parents prefer the least morbid approach for their child? Today, with vast experience and a proven, teachable and reproducible technique, the early and longterm radiographic (93% for grades I to IV reflux) and clinical success (5% febrile UTI) of endoscopic injection is essentially no different than that seen after open surgery.4 As a result, the main difference between the 2 approaches appears to be the presence of a small but permanent surgical scar, longer recovery at home and increased time away from work for the parent(s), pain, wound infection, bleeding and risk of urinary retention after open bilateral extravesical reimplantation surgery. Surgeons who contend that this is not a significant risk need only care for a patient who experiences prolonged urinary retention requiring catheterization to experience some degree of angst when performing bilateral extravesical reimplantation, even with minimal dissection. When given the option of any potential for pain, scarring or risk of complication such as urinary retention vs painless and scar-free surgery, teenage girls typically prefer the latter. Extravesical reimplantation may have an advantage over endoscopic reflux correction but those occasions are infrequent (less than 5%). One occasion would be as a salvage procedure after failed endoscopic injection when moderate to high grade VUR persists unilaterally. Another would be the child in whom the injection was difficult, often requiring multiple injection sites and high injected volume. In these infrequent instances I advise against a second
1765
endoscopic injection. Finally, the extravesical approach is ideal for megaureter repair that requires ureteral tapering and possible stenting. Such a patient should not be sent home on the day of surgery. Other reasons to perform open extravesical ureteral reimplantation benefit the surgeon and not the patient, better reimbursement and a teaching opportunity for residents. As pediatric urologists, we should continue to strive towards a highly successful outpatient procedure that would apply to a variety of clinical scenarios. Laparoscopic, robotic and vesicoscopic antireflux surgery has been performed with a good deal of success. These percutaneous approaches require relatively lengthy procedures and leave several small scars often in areas that are not concealed and they may or may not fade with time. Parents clearly prefer endoscopic injection over open surgery. Given the option of an outpatient, painless, 20-minute procedure that can be performed bilaterally, without risk of urinary retention, without leaving a scar, without need for pain medication and with the same or better clinical results as open surgery, why would they not prefer it? It is clear that a randomized study to standardize the method of injection and evaluate radiographic success, incidence of postoperative UTI and quality of life is needed to determine the best surgical method to correct VUR. For most of us, I believe, endoscopic injection passes the “what would you do for your child?” question that we so often encounter when counseling families regarding the surgical management of VUR. Andrew J. Kirsch Division of Pediatric Urology Emory University School of Medicine Children’s Healthcare of Atlanta Atlanta, Georgia
REFERENCES 1. O’Donnell B and Puri P: Treatment of vesicoureteric reflux by endoscopic injection of Teflon. Br Med J 1984; 289: 7. 2. Stenberg A and Läckgren G: Treatment of vesicoureteral reflux in children using stabilized nonanimal hyaluronic acid/dextranomer gel (NASHA/ DX): a long-term observational study. J Pediatr Urol 2007; 3: 80.
3. Kirsch AJ, Perez-Brayfield M, Smith EA et al: The modified STING procedure to correct vesicoureteral reflux: improved results with submucosal implantation within the intramural ureter. J Urol 2004; 171: 2413. 4. Kaye JD, Srinivasan AK, Delaney C et al: Clinical and radiographic results of endoscopic injection for vesicoureteral reflux: defining measures of success. J Pediatr Urol 2011; Epub ahead of print.
EXTRAVESICAL URETERAL REIMPLANTATION DURING the last decade the STING and its iteration HIT procedures for VUR using dextranomer/hyaluronic acid copolymer have gained favor due in part to uniform outpatient discharge compared to open
5. Holmdahl G, Brandström P, Läckgren G et al: The Swedish Reflux Trial in Children: II. Vesicoureteral reflux outcome. J Urol 2010; 184: 280. 6. Kalisvaart J, Cuda S, Srinivasan A et al: Intermediate-long-term follow-up indicates low risk of recurrence after Double HIT endoscopic treatment for primary vesicoureteral reflux (VUR). Unpublished data.
and laparoscopic ureteral reimplantation. Although an excellent treatment option, it has been touted as possibly replacing ureteral reimplantation as the gold standard because it is 1) minimally invasive, 2) an outpatient operation, 3) associated with mini-
Outpatient Surgery for Vesicoureteral Reflux: Endoscopic Injection vs Extravesical Ureteral Reimplantation ENDOSCOPIC INJECTION “Doctor, What Would You Do For Your Child?”
ENDOSCOPIC injection to correct vesicoureteral reflux (VUR) is an established procedure with a 3-decade track record. O’Donnell and Puri are credited with advancing the STING (subureteral Teflon® injection) procedure,1 while Stenberg and Läckgren were the first to substitute dextranomer hyaluronic acid co-polymer (Deflux®) for polytef paste, reporting excellent, sustained long-term clinical results.2 These authors contributed invaluable information to our understanding of endoscopic surgery and to numerous concepts regarding the pathophysiology and management of VUR in general. Since my first case of endoscopic injection for VUR in 2001 (following Food and Drug Administration approval of Deflux), I have had only 1 parent request open ureteral reimplantation. Initially, as an “inexperienced injector,” I quoted a success rate of 50% to parents since I really had no prior experience with the injection of materials for VUR. I was pleasantly surprised when after my first 20 cases my success rate was 60%! I was even more pleased after the next 50 cases when this success rate increased to 74%. Since the only true reported risk of the procedure was persistent VUR, we took a more aggressive approach to injection by standardizing a purely intraluminal ureteral floor injection, known as the hydrodistention implantation technique (HIT). This maneuver resulted in an 89% cure rate compared to 74% rate with the standard STING.3 Our goal was to achieve a success rate of 95% which would be comparable to open reimplantation, and thus support the option of avoiding a post-injection voiding cystourethrogram (VCUG). We modified the method further to involve tandem proximal and distal intraluminal injections, hypothesizing that this would coapt the ureteral tunnel and orifice to the point whereby ureteral hydrodistention ceased to occur (Double HIT). We evaluated 336 patients treated with the Double HIT and achieved a ureteral success 0022-5347/11/1865-1764/0 THE JOURNAL OF UROLOGY® © 2011 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
1764
www.jurology.com
AND
RESEARCH, INC.
rate of 92% after a single treatment with no increased risk of obstruction.4 These patients were followed for 3 years and only 5% went on to open surgery and another 5% had a second injection. It is important to note that we always considered success as no VUR after 1 treatment. The main question that remained after treating patients with the Double HIT was the durability of a successful outcome. Did we really have to bring patients back for VCUG when they had normal studies at 3 months, particularly if they had no further febrile urinary tract infections (UTIs) while off antibiotic prophylaxis? A few recent studies, including the Swedish Reflux Study, have shown high (20%) recurrence rates after the STING procedure.5 The initial endoscopic success rate in that study was also poor, likely due to the fact that there were multiple surgeons using various methods and volumes of injection. We recently completed a study of 30 patients with grades II to IV reflux who underwent a delayed VCUG 1 year after the Double HIT and the cure rate was 93%.6 Consequently, we have achieved the success that we had desired, and no longer routinely obtain postoperative VCUG in patients with primary grades II to IV reflux, reserving the study for those with post-injection recurrent febrile UTIs. This risk of clinical VUR recurrence in patients initially cured radiographically is about 4%. After more than 10 years of proven success in the United States and more than 25 years in Europe, endoscopic injection has earned its place as a primary surgical approach to VUR worldwide, with many opting to perform open surgery as either a salvage procedure after failed injection or because of surgeon’s choice, and frankly, one’s bias. Despite this trend towards minimally invasive surgery for VUR, urologists should continue to offer the procedure with which they are most comfortable and which provides the best clinical results. The outpatient extravesical ureteral reimplantation may be a step in the right direction but will likely fall short when the risks and benefits of the 2 procedures are compared. How can one really argue an open operVol. 186, 1764-1767, November 2011 Printed in U.S.A. DOI:10.1016/j.juro.2011.08.024
OPPOSING VIEWS
ation with minimal hospitalization vs a quick, outpatient scar-free procedure? Perhaps a concealed umbilical single port approach would be more appealing. Most importantly, open surgery in general does not seem to offer any real clinical benefit to the patient over endoscopic injection. If successes are comparable, wouldn’t most parents prefer the least morbid approach for their child? Today, with vast experience and a proven, teachable and reproducible technique, the early and longterm radiographic (93% for grades I to IV reflux) and clinical success (5% febrile UTI) of endoscopic injection is essentially no different than that seen after open surgery.4 As a result, the main difference between the 2 approaches appears to be the presence of a small but permanent surgical scar, longer recovery at home and increased time away from work for the parent(s), pain, wound infection, bleeding and risk of urinary retention after open bilateral extravesical reimplantation surgery. Surgeons who contend that this is not a significant risk need only care for a patient who experiences prolonged urinary retention requiring catheterization to experience some degree of angst when performing bilateral extravesical reimplantation, even with minimal dissection. When given the option of any potential for pain, scarring or risk of complication such as urinary retention vs painless and scar-free surgery, teenage girls typically prefer the latter. Extravesical reimplantation may have an advantage over endoscopic reflux correction but those occasions are infrequent (less than 5%). One occasion would be as a salvage procedure after failed endoscopic injection when moderate to high grade VUR persists unilaterally. Another would be the child in whom the injection was difficult, often requiring multiple injection sites and high injected volume. In these infrequent instances I advise against a second
1765
endoscopic injection. Finally, the extravesical approach is ideal for megaureter repair that requires ureteral tapering and possible stenting. Such a patient should not be sent home on the day of surgery. Other reasons to perform open extravesical ureteral reimplantation benefit the surgeon and not the patient, better reimbursement and a teaching opportunity for residents. As pediatric urologists, we should continue to strive towards a highly successful outpatient procedure that would apply to a variety of clinical scenarios. Laparoscopic, robotic and vesicoscopic antireflux surgery has been performed with a good deal of success. These percutaneous approaches require relatively lengthy procedures and leave several small scars often in areas that are not concealed and they may or may not fade with time. Parents clearly prefer endoscopic injection over open surgery. Given the option of an outpatient, painless, 20-minute procedure that can be performed bilaterally, without risk of urinary retention, without leaving a scar, without need for pain medication and with the same or better clinical results as open surgery, why would they not prefer it? It is clear that a randomized study to standardize the method of injection and evaluate radiographic success, incidence of postoperative UTI and quality of life is needed to determine the best surgical method to correct VUR. For most of us, I believe, endoscopic injection passes the “what would you do for your child?” question that we so often encounter when counseling families regarding the surgical management of VUR. Andrew J. Kirsch Division of Pediatric Urology Emory University School of Medicine Children’s Healthcare of Atlanta Atlanta, Georgia
REFERENCES 1. O’Donnell B and Puri P: Treatment of vesicoureteric reflux by endoscopic injection of Teflon. Br Med J 1984; 289: 7. 2. Stenberg A and Läckgren G: Treatment of vesicoureteral reflux in children using stabilized nonanimal hyaluronic acid/dextranomer gel (NASHA/ DX): a long-term observational study. J Pediatr Urol 2007; 3: 80.
3. Kirsch AJ, Perez-Brayfield M, Smith EA et al: The modified STING procedure to correct vesicoureteral reflux: improved results with submucosal implantation within the intramural ureter. J Urol 2004; 171: 2413. 4. Kaye JD, Srinivasan AK, Delaney C et al: Clinical and radiographic results of endoscopic injection for vesicoureteral reflux: defining measures of success. J Pediatr Urol 2011; Epub ahead of print.
EXTRAVESICAL URETERAL REIMPLANTATION DURING the last decade the STING and its iteration HIT procedures for VUR using dextranomer/hyaluronic acid copolymer have gained favor due in part to uniform outpatient discharge compared to open
5. Holmdahl G, Brandström P, Läckgren G et al: The Swedish Reflux Trial in Children: II. Vesicoureteral reflux outcome. J Urol 2010; 184: 280. 6. Kalisvaart J, Cuda S, Srinivasan A et al: Intermediate-long-term follow-up indicates low risk of recurrence after Double HIT endoscopic treatment for primary vesicoureteral reflux (VUR). Unpublished data.
and laparoscopic ureteral reimplantation. Although an excellent treatment option, it has been touted as possibly replacing ureteral reimplantation as the gold standard because it is 1) minimally invasive, 2) an outpatient operation, 3) associated with mini-