five-year clinical experience with the dornier delta lithotriptor
TRANSCRIPT
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ADULT UROLOGY
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FIVE-YEAR CLINICAL EXPERIENCE WITH THE DORNIERDELTA LITHOTRIPTOR
WESLEY WHITE AND FREDERICK KLEIN
ABSTRACTbjectives. Multiple studies support the clinical value of extracorporeal shock wave lithotripsy (ESWL) in
he treatment of symptomatic urolithiasis. Although prior investigations have examined such efficacy amongeveral commercially available lithotriptors, no published data exist to support the efficacy of the Dornierelta lithotriptor.ethods. A retrospective review of 4621 patients with urolithiasis treated with the Dornier Delta lithotrip-
or from 1999 through 2004 was undertaken. Data were obtained regarding stone location, stone size,hockwave usage, total success rate, and complications.esults. From January 1, 1999 through December 31, 2004, 4621 patients with 7347 stones were treatedith the Dornier Delta lithotriptor. Of these stones, 74.38% were located in the kidney, and 25.62% wereonfined to the ureter. Of renal stones, 22.8% were in the renal pelvis, whereas upper, middle, and lowerole stones constituted 16.3%, 23.3%, and 37.6%, respectively. Of ureteral stones, 72.2% were in theroximal ureter, compared with 14.2% and 13.6% in the mid- and distal ureter, respectively. The majorityf stones were less than 1 cm (65.7%). The average number of shocks was 2037. Average shockwave
ntensity was 5.5 (out of 6). Average treatment time was 23.8 minutes. Of those patients that completedollow-up, 85.1% achieved total success, with 58.5% being stone free and 26.6% having fragments less than
mm. The efficiency quotient was 0.51.onclusions. Treatment of renal and/or ureteral stones in selected patients with the Dornier Delta litho-riptor is appropriate. The total success rate and efficiency quotient is consistent with that of other availableithotriptors. UROLOGY 68: 28–32, 2006. © 2006 Elsevier Inc.
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he use of shock waves for the treatment of re-nal and proximal ureteral stones was first dem-
nstrated to be successful in 1980 by Dr. Christianhaussy at the University of Munich.1 Since that
andmark introduction, extracorporeal shock waveithotripsy (ESWL) has become the standard foroninvasive treatment of renal and proximal ure-eral calculi. As the popularity, safety, and efficacyf ESWL have increased, so too have the numberf commercially available models. Advances haveome in the form of alternative shock wave sourcesnd power, as well as modifications pertaining tomaging, durability, size, and mobility. Although nu-
rom the Department of Urology, University of Tennessee Medi-al Center, Knoxville, and the Knoxville Area Stone Center, Knox-ille, Tennessee
Reprint requests: Wesley White, M.D., The University of Ten-essee Medical Center, Knoxville, Department of Urology, 1928lcoa Highway, Suite B-127, Knoxville, TN 37920. E-mail:[email protected]: May 23, 2005, accepted (with revisions): January
o0, 2006
© 2006 ELSEVIER INC.8 ALL RIGHTS RESERVED
erous studies have examined the treatment successith nearly all of these new and evolving models, noata exist to support the use of the Dornier Deltaithotriptor (Dornier MedTech, Marietta, Ga). Weeport our experience using the Dornier Delta athe University of Tennessee Medical Center andhe Knoxville Area Stone Center.
MATERIAL AND METHODS
From January 1, 1999 to December 31, 2004, 4621 patientsith 7347 symptomatic renal and ureteral stones were treatedith ESWL. All stones were diagnosed radiographically before
nitiation of treatment with abdominal plain films (KUB),tone protocol computed tomography (CT) (noncontrast CTith 3-mm axial slices), intravenous urography, retrogradeyelography, or some combination thereof. Confirmation oftone location and feasibility of treatment with lithotripsy waserformed preoperatively with KUB. Once a diagnosis of renal/reteral calculi was made, patients were advised of their treat-ent options, and consent was obtained for lithotripsy. All
atients were treated with the Dornier Delta lithotriptor, aobile, fully integrated, newest-generation lithotriptor with
n electromagnetic shockwave source and fully integrated flu-
roscopic (and optional ultrasonic) guidance. Treatment pa-0090-4295/06/$32.00doi:10.1016/j.urology.2006.01.031
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ameters were limited by the retrospective nature of this studynd were the preference of the operating surgeon.
All preoperative, operative, and postoperative data were re-orded at the time of treatment and during the postoperativevaluation. These data were subsequently forwarded and storedt the Knoxville Area Stone Center with a Microsoft Accessatabase (Microsoft, Redmond, Wash). Treating physiciansere asked to provide documentation of preoperative stone
ize and location, to record pertinent operative details, includ-ng the number of shocks used, shockwave intensity, and
ethod of anesthesia, and to document success of treatmentostoperatively on the basis of radiographic evidence, as wells any intraoperative and/or postoperative complications. Pa-ients were seen postoperatively to determine operative suc-ess, defined for the purposes of this study as a stone burdeness than 4 mm. Stone presence on post-treatment CT scansnd/or KUB films was based on radiology reports. These dataere subsequently submitted to the centralized aforemen-
ioned database for collection and review. An audit of patientharts was thereafter performed to confirm the veracity of dataeporting. Unconfirmed data were removed. Thereafter, aomparative efficiency quotient (EQ � [% stone free/(100% �
retreatment � % auxiliary procedures)] � 100) was ren-ered as originally reported by Denstedt et al.2
RESULTS
Of the 7347 stones treated between January 1,999 and December 31, 2004, 4824 stones (65.6%)ere less than 1 cm, whereas 2172 stones (29.6%)ere 1 to 2 cm. Stones measuring greater than 2 cmumbered 351 (4.8%), of which 26 were staghornalculi (0.20% of total stones). Stones located in theidney represented 74.38% of all stones, whereasreteral stones accounted for 25.62%. Of all pa-ients, 78.7% (4684) had single stones, and 20.9%1246) had multiple stones. Data were further sub-ategorized according to stone location and sizeTable I).Patients were treated with the Dornier Delta
ithotriptor exclusively. The supine position wassed in the vast majority of cases. General anesthe-ia was used in 99.4% of patients. The remaining.6% were treated under epidural/spinal anesthe-ia, local, and monitored anesthesia care sedation,r some combination thereof. Stone presence andocation were subsequently confirmed fluoroscop-cally (average length of fluoroscopic exposure to-aled 1.9 minutes). The average number of shockssed was 2037, at an average shockwave intensityf 5.5 (maximum of 6). The average treatment timeas 23.8 minutes.Of all the patients (5954), 96.3% (5735) completedstandard aftercare course, defined as follow-up ap-ointments and post-ESWL imaging (CT or KUB)ithin 90 days of the date of treatment. The re-aining 219 patients (3.7%) were lost to follow-upithin 90 days. Again, treatment success was de-ned as being either stone free or with evidence oftone fragments measuring less than 4 mm on ra-iographs within 90 days of the date of treatment.
bdominal plain films were used in 88% of patients aROLOGY 68 (1), 2006
o determine postoperative success. Patients whoere not stone free and who did not have frag-ents less than 4 mm were deemed treatment fail-res. These patients were subsequently retreated,reated with alternative means, or watched conser-atively.Of the 5735 patients who completed the required
ftercare, 58.5% (3356) were stone free, whereas6.6% (1525) exhibited stone fragments measur-ng less than 4 mm, translating to a total successate of 85.1%. A further analysis of total successased on stone location and size was undertaken,evealing greater success with stones measuringess than 1 cm (total success rate of 87.2%) andmong all ureteral stones, regardless of stone sizeTable II). Retreatment and/or alternative treat-ents were recommended for all aftercare patientsho exhibited residual stones measuring greater
han 4 mm and/or those with symptomatic residualtones. Postprocedure interventions accounted for4.89% of all patients (854); nearly half of theseere retreatments with lithotripsy (Table III). Treat-ent complications were rare and consistent with
hose reported in the literature. Complications areisted in Table IV. Given these data, and using theforementioned formula for EQ, an EQ of 0.51 wasendered.
COMMENT
The Dornier HM3 lithotriptor is well established
TABLE I. Size and location of stones
ocation Size (mm) NumberPercentage ofTotal Stones
enal pelvis �10 632 8.611–20 444 6.0�20 172 2.3
pper pole �10 717 9.811–20 136 1.9�20 34 0.5
iddle pole �10 1063 14.511–20 178 2.4�20 32 0.4
ower pole �10 1614 22.011–20 381 5.2�20 62 0.8
pper ureter �10 1096 14.911–20 221 3.0�20 41 0.6
iddle ureter �10 214 2.911–20 46 0.6�20 7 0.1
ower ureter �10 229 3.111–20 25 0.3�20 3 0.0
igures based on total patients.
s the gold standard against which all other com-
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ercially available lithotriptors are measured. Itsntroduction in 1984 marked the beginning of shock-ave lithotripsy as an efficient and safe means of
reating urinary calculi in the United States. Sincets introduction, lithotriptors have evolved in termsf shockwave source, power, mobility, safety, andase of use. Although each lithotriptor might yieldew advantages as compared with the HM3, thesedvances are tempered, in most cases, by reducedfficacy. As such, urologists must weigh the ben-
TABLE II. Fragmentation according to st
tone Location
Total Number of Stones
nPercentage ofTotal Stones
ll StonesDistal ureter 277 3.5Mid ureter 287 3.7Upper ureter 1449 18.5Renal pelvis 1304 16.6Lower calyx 2191 27.9Middle calyx 1385 17.7Upper calyx 949 12.1Total 7842 100
tones �1 cmDistal ureter 228 4.4Mid ureter 198 3.8Upper ureter 1016 19.7Renal pelvis 501 9.8Lower calyx 1486 28.8Middle calyx 1031 20.0Upper calyx 693 13.5Total/average 5153 100
tones �1 cmDistal ureter 49 1.8Mid ureter 89 3.3Upper ureter 433 16.1Renal pelvis 803 29.9Lower calyx 705 26.2Middle calyx 354 13.2Upper calyx 256 9.5Total 2689 100
TABLE III. Post-treatment procedures
rocedureNumberof Cases
Percentageof TotalPatients
Percentageof Post-
TreatmentPatients
otal 854 14.89 100epeat ESWL 413 7.2 48.36tent placement 166 2.89 19.44reteroscopy 163 2.84 19.09ercutaneousnephrolithotomy 16 0.28 1.87reterolithotomy 5 0.09 0.59ther 91 1.59 10.66
EY: ESWL � extracorporeal shock wave lithotripsy.
fits of improved mobility, decreased cost, and s
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reater flexibility against the risk of decreased totaluccess.Numerous studies have examined the efficiency
f commercially available lithotriptors since com-etition was introduced in the 1980s. Early data byhaussy et al.1 suggested stone-free rates amongatients treated by the Dornier HM3 as high as 70%.hese data were confirmed in a large series by thenited States Cooperative Study, which cited a
location and size (based on total stones)Fragments 0–4 mm Stone Free
PercentageTotal Success n
PercentageStone Free
5 88.4 188 67.90 80.1 182 63.41 85.6 963 66.54 78.5 760 58.30 83.1 1261 57.66 84.9 842 60.81 84.4 550 60.07 83.4 4746 60.5
2 88.6 155 67.98 84.8 128 64.63 88.9 704 69.38 85.4 325 64.89 86.7 878 59.10 87.3 634 61.55 87.3 406 58.65 87.2 3230 62.7
3 87.6 33 67.32 69.7 54 60.78 78.1 259 59.86 74.2 435 54.21 75.3 383 54.36 80.0 208 58.86 76.5 144 56.32 75.9 1516 56.4
TABLE IV. Treatment complications
omplication Patients (n)Percentage ofTotal (5735)
nemia 9 0.16R visit 49 0.85ever 32 0.56ematoma 15 0.26ospital admission 45 0.78bstruction 41 0.71ther 69 1.20teinstrasse 94 1.64ransfusion 1 0.02TI 20 0.35otal 375 6.54
EY: ER � emergency room; UTI � urinary tract infection.
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tone-free rate of 77.4%, with a retreatment rate
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f 16% and post-ESWL procedure rate of 8%.3
ass4 subsequently examined first-generation (Dor-ier HM3) and second-generation lithotriptorsMedstone STS) in a large, comparative study. Al-hough his data proffered no statistical significanceetween the two machines in terms of stone-freeates, his comments regarding the conveniencend continued efficacy of second-generation litho-riptors were well received. Teichman et al.5 there-fter collected comparative data for not only first-nd second-generation lithotriptors as a group butlso for each lithotriptor individually. Recently,akada et al.6 at the University of Wisconsin re-orted data on a newest-generation lithotriptor,he Dornier Doli S. In the latter two studies, eachithotriptor was compared on the basis of the afore-
entioned EQ. Available data regarding successates and EQs for commercial lithotriptors are foundn Table V.
Our center examined the success of the Dornierelta lithotriptor among 4621 patients. As stated,ur stone-free rate totaled approximately 59% withn EQ of 0.51. These results are consistent withhose from previous studies of other lithotriptorssee Table V). Of particular note, our analysis ofuccess based on stone size and location revealedppreciably greater success among stones measur-ng less than 1 cm (stone-free rate of 62.7%) thanmong stones larger than 1 cm (stone free rate of6.4%), regardless of stone location. Although ure-eral stones also seemed to fragment better regard-ess of stone size, the limited number of treatedtones in the middle and distal ureter preclude anytatements of statistical significance. Given theelta’s success in fragmenting stones smaller thancm, regardless of stone location, coupled with its
TABLE V. Co
odel of Lithotriptor Reference
ornier HM3 Drach et al.3
Cass4
odulith SL20 Liston et al.7
Kohrmann et al.8
ithostar C Elabbady et al.9
El-Damanhoury et al.10
Mobley et al.11
edstone 1050ST Lipson et al.12
edstone STS Thomas and Cass13
Cass4
conolith Simon14
ornier Doli Lippert and Koser15
ornier Doli S Nakada et al.6
ornier Delta Present study
EY: EQ � efficiency quotient.
exibility (mobile and fully integrated) and com- t
ROLOGY 68 (1), 2006
etitive price, its seems to be pragmatic and justi-ed to recommend its use in commercial practice.Although the volume of patients in this study
rovides considerable statistical power, some con-iderations and limitations should be noted. First,he study’s retrospective nature affords potentialonfounders, primarily an inability to control forhe lithotripsy technician and surgeon, and poten-ial arbitrary nature of data collection. As stated, anudit of our data was undertaken to minimize in-ccuracies. Second, our study failed to examine frag-entation and stone-free rates based exclusively
n stone composition. Further, although an analy-is of success based on stone size and location waserformed, we did not examine the size, location,nd nature of those stones that failed to fragmentuccessfully on initial lithotripsy but were success-ully fragmented on subsequent lithotripsy. Theseata would be of benefit in proving the Delta’serit as a noninvasive treatment that is highly ef-
ective, albeit with multiple treatments (ie, treat-ng large stones “noninvasively”). Moreover, weid not examine what percentage of patients whoequired post-treatment procedures were amonghose with not clinically insignificant stones ofess than 4 mm who were otherwise consideredreatment successes. Third, we chose to calculatehe EQ and success rate excluding those patientsho required stent placement. Other studies haveeemed this group of patients as treatment suc-esses. Next, the majority of patients seen postop-ratively were evaluated with KUB, a modality withnherent diagnostic limitations. However, the costssociated with postlithotripsy CT scans is prohib-tive and, as such, it is rarely used. Finally, we arencertain as to the reliability of the EQ in objec-
arative data
Patients (n)Percentage Stone
Free Overall EQ
1840 77 0.672402 70 0.64500 78 0.57549 91 0.67319 63 0.56
3278 64 0.5719,962 76 0.64
50 46 0.4081 68 0.60
2934 72 0.67500 75 0.56103 57 0.36270 74 0.65
4621 59 0.51
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onvenient tool, the vagaries of objective data re-orting and the lack of standard outcome reportingeasures limit its ultimate accuracy as a compara-
ive instrument.
CONCLUSIONS
The Dornier Delta lithotriptor is effective in treat-ng ureteral and renal calculi. Our data from aarge, single-center series of patients with singlend multiple stones show treatment success ratesnd morbidity comparable to those with other ma-hines, including the Dornier HM3. Given the ma-hine’s mobility, ease of use, and convenience, theornier Delta seems to be an appropriate and ef-
ective tool for treating high volumes of urinaryalculi.
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xperience with extracorporeally induced destruction of kid-ey stones by shock waves. J Urol 127: 417–420, 1982.
2. Denstedt JD, Clayman RV, and Preminger GM: Effi-iency quotient as a means of comparing lithotriptors. J En-ourol 4(suppl): 100, 1990.
3. Drach GW, Dretler S, Fair W, et al: Report of the Unitedtates Cooperative Study of Extracorporeal Shock Wave Lith-tripsy. J Urol 135: 1127–1133, 1986.
4. Cass AS: Comparison of first generation (DornierM3) and second generation (Medstone STS) lithotriptors:
reatment results with 13,864 renal and ureteral calculi. J Urol
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5. Teichman JMH, Portis AJ, Cecconi PP, et al: In vitroomparison of shock wave lithotripsy machines. J Urol 164:259–1264, 2000.
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2: 410–415, 2003.7. Liston TG, Montgomery BSI, Bultitude MI, et al: Extra-
orporeal shock wave lithotripsy with the Storz ModulithL20: the first 500 patients. Br J Urol 69: 465–469, 1992.
8. Kohrmann KU, Rassweiler JJ, Manning M, et al: Thelinical introduction of a third generation lithotripter: Modu-ith SL20. J Urol 153: 1379–1383, 1995.
9. Elabbady A, Mathes G, Morehouse DD, et al: Safety andffectiveness of Lithostar shock tube C in the treatment ofrinary calculi. J Endourol 9: 225–231, 1995.10. El-Damanhoury H, Scharfe T, Ruth J, et al: Extracorpo-
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12. Lipson SB, Ross LS, and Sonda LP: Initial clinical trialsith a tubless lithotripter. J Urol 143: 10–12, 1990.13. Thomas R, and Cass AS: Extracorporeal shock wave
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ave lithotripsy patients using a low-cost unit: the “Econolith.”Endourol 9: 215–218, 1995.15. Lippert C-M, and Koser MF: A modified shock wave
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2(suppl): S173, 1998.UROLOGY 68 (1), 2006