Second generation shock wave lithotripsy: experience with the Siemens Lithostar

In 1980, extracorporeal shock wave lithotripsy (ESWL) was incorporated as a nonsurgical method of stone removal in the cases of nephrolithiasis and rapidly found worldwide acceptance. Several devices commonly designated "second generation" lithotripters vs "first generation" Dornier HM3 are now under experimental or clinical trial. We report our clinical experience of ESWL using a Siemens Lithostar and compared it with that obtained using a Dornier HM3. One hundred patients were treated during the period of April through October, 1986 using an HM3, and 100 other patients were treated using a Lithostar from April to August, 1988. More cases were treated with a Lithostar than with a HM3. Nearly 10% of all patients treated by ESWL required additional therapeutic approaches (excepted ureteral stent) either with HM3 or Lithostar. However, in the cases of ureteral stone, with the Lithostar more cases required adjuvant procedures (TUL) than HM3. Significantly more shock waves were needed with Lithostar than HM3 for complete fragmentation of the same size of renal and ureteral stones. The stone-free rate during a one month period after ESWL was nearly the same for HM3 and Lithostar (HM3: 84.3%, Lithostar: 83.5%). Lithostar is a multifunctional lithotriptor which has most of the advantages required by the lithotripter.     

Extracorporeal shock wave lithotripsy for distal ureteral calculi: what a powerful machine can achieve

PURPOSE: We assessed the efficacy of extracorporeal shock wave lithotripsy (ESWL, Dornier Medical Systems, Inc., Marietta, Georgia) for distal ureteral calculi with the HM3 (Dornier Medical Systems, Inc.) lithotriptor. MATERIALS AND METHODS: A total of 585 consecutive patients with distal ureteral calculi were treated with ESWL using an unmodified HM3 lithotriptor. Of these patients 67 referred for treatment only for whom no followup was available were excluded from further analysis. The remaining 518 cases were followed until they were radiologically documented to be stone-free or considered treatment failures. Before ESWL additional procedures were performed in 144 patients, including stone push back, ureteral catheter or Double-J (Medical Engineering Corp., New York, New York) stent placement, percutaneous nephrostomy, ureteral endoscopic maneuvers or stone basket manipulation. A total of 374 patients needed no preliminary treatment before ESWL. RESULTS: Of the 518 patients 469 (91%) were successfully treated with 1 ESWL session, while 49 (9%) needed 2 or 3. Manipulation after ESWL was performed in 22 cases, including stent placement, percutaneous nephrostomy, ureteral endoscopic stone removal and a stone basket procedure. On day 1 after ESWL 327 patients (63%) were stone-free, 158 (30%) had less than 5 mm. fragments and 33 (7%) had more than 5 mm. fragments. At 3 months the stone-free rate increased to 97%. CONCLUSIONS: These data show that ESWL for distal ureteral calculi with the powerful unmodified HM3 lithotriptor has a high success rate with a low rate of minimally traumatic manipulations before and after intervention. Results in terms of the re-treatment and stone-free rates are superior to those of any other second or third generation lithotriptor and comparable to the results of the best ureteroscopic series.     

Extracorporeal shock wave lithotripsy using Dornier modified HM3 lithotripter comparison with the results by Dornier HM3 lithotripter

Ninety-four kidneys with renal stones less than or equal to 20 mm in diameter were treated by extracorporeal shock wave litotripsy (ESWL) using a Dornier modified HM3 lithotripter and the results were compared with those of 98 kidneys with similar size stones treated with a Dornier HM3 lithotripter. The Dornier modified HM3 lithotripter is equipped with a new type of shock wave generator with a reduced capacity for 30% less pressure peakes at the same voltage. It has an enlarged ellipsoid leading to a smaller focus and a reduced pressure per area at the shock wave entry into the skin. All treatments of modified HM3 litotripter series were performed under only intravenous analgosedation, without epidural anesthesia. The number of shock waves in the modified HM3 series ranged 900 to 6000, with the mean values of 2863 +/- 1234, which was 1.55 times as that in the Dornier HM3 series. Complete disintegration was achieved in 94 of 94 modified HM3 series kidneys and 98 of 98 kidneys of HM3 series. Complete removal of the stone was done at 72.6% in the modified HM3 series and at 70.4% in the HM3 series 3 months after ESWL. There were no severe complications in both modified HM3 series and HM3 series. Renal damage caused by ESWL was monitored by the level of urinary enzyme, N-acetyl-beta-glucosaminidase (NAG) and beta 2 microglobulin (beta 2MG) and the level of urinary protein. The levels of NAG, beta 2MG and urinary protein in the HM3 series were higher than those of the modified HM3 series.(ABSTRACT TRUNCATED AT 250 WORDS)     

Experience with extracorporeal shock wave lithotripsy for urinary stone. Factors for requiring more than two ESWL treatments and its result

Extracorporeal shook wave lithotripsy (ESWL) was performed for the treatment of 1277 urolithiasis patients at Osaka City University Hospital from July, 1985 to December, 1988. A total of 1788 ESWL treatments were carried out using Dornier HM3 kidney lithotripter. 964 patients (75.5%) underwent only one ESWL treatment, while 313 patients (24.5%) more than two ESWL treatments. We retrospectively examined the factors for requiring more than two ESWL treatments. Not only stone number, size and location, but fragility were considered to be the main causes for requiring more than two ESWL treatments. According to component analysis of ureteral stones, which were hard and resistant to shock wave, calcium apatite content of these stones turned out to be high (p less than 0.001). As for fragility, the residual stones created by ESWL were more difficult to be disintegrated that the nontreated stones of the same size (p less than 0.05). "Fragility" of the stones before shock wave and residual stones after ESWL are considered to be a major problem in ESWL treatment of urinary stones to be solved in the years to come.     

Extracorporeal shock wave lithotripsy treatment of lower caliceal stones: an update on the use of a cobra catheter for direct irrigation

As the general experience with extracorporeal shock wave lithotripsy (ESWL) for renal calculi broadens, it is increasingly evident that the clearance of stone fragments in lower pole calices needs to be improved. The stone-free rate posttreatment for lower caliceal stones is consistently less than that for other upper tract locations. Utilization of a cystoscopically placed cobra catheter for directed irrigation during ESWL with a Dornier HM4 lithotripter resulted in an increase of our lower caliceal stone-free rate to 64% (29/45) at 1 month follow-up and 73% (33/45) at 3 months follow-up compared to 36% (15/42) of randomly selected controls at 1 month (p less than 0.007) and 54% (23/42) at 3 months (p < 0.070). Patients were included in the study if they had a solitary calculus, less than 2 cm in size, located in a normal lower pole calix and had no indwelling stent placed by the referring physician. The cobra catheter was positioned in the appropriate calix with fluoroscopic guidance under intravenous sedation. Statistical analysis was performed using Pearson's Chi-square test. We conclude that the pre-ESWL treatment placement of a cobra catheter into the lower pole calix and intermittent irrigation during the procedure is a useful adjunct in the successful treatment of lower caliceal calculi.     

Primary extracorporeal shock wave lithotripsy of staghorn renal calculi.

186 patients with partial and 55 patients with complete renal staghorn calculi were treated with primary extracorporeal shock wave lithotripsy (ESWL) at the Department of Urology, University of Würzburg Medical School. Partial staghorn calculi required an average of 1.4, complete staghorn calculi an average of 2.2 treatment sessions using the Dornier HM 3 lithotriptor. 55% of all patients and 46% of the patients with complete staghorn calculi were rendered stone-free within 1 year after ESWL. Pretreatment urinary tract infections present in 50.6% of all patients could be reduced to 22.5% 1 year after ESWL. The most frequent complications after ESWL were ureteral obstruction caused by 'steinstrasse' (41.4%), fever (38.4%), and renal colics (29.4%). Severe complications needing open operative procedures or blood transfusions did not occur. 50% of all patients underwent auxiliary procedures (e.g. insertion of indwelling ureteral stents: 25.3%, percutaneous nephrostomy: 20.3%, percutaneous nephrolithotripsy: 2.9%). Pretreatment insertion of an indwelling ureteral stent was found to reduce posttreatment complications as well as the need for percutaneous nephrostomy only in patients with partial staghorn calculi. The data presented in this study demonstrate that primary ESWL therapy can be safely and successfully performed in the majority of patients with renal staghorn calculi. In patients requiring complete removal of all stone fragments, a percutaneous lithotripsy can be performed following ESWL.     

Clinical experience with extracorporeal shock wave lithotripsy MFL-5000 for urinary stone

A Dornier MFL 5000, a new generation extracorporeal shock wave lithotripter, was installed in our hospital and the first Japanese clinical experience has been collected between July and November in 1989. We report our experience with the first 35 patients with 45 stones who were treated in 42 treatments using ESWL. We followed up 3 weeks. No invasive anesthesia was performed except 2 cases of epidural anesthesia. A double J catheter was installed in 2 patients, a ureteral catheter in 4 patients, and PNL was performed in 2 patients before ESWL. We did not use a PNL or a TUL in the postoperative treatment. In the 3 week followed up period, 29 patients (82.9%) were completely free from stone fragments. No serious complications were observed after ESWL. We conclude that the DORNIER MFL 5000 is effective for renal and ureteral stones without serious complications.     

The future of ESWL

With the introduction of the Dornier HM3 lithotripter, the successful history of extracorporeal shock wave lithotripsy (ESWL) for noninvasive treatment of urinary stones began about 25 years ago. The development of newer lithotripters has not been able to improve clinical efficacy because the shock wave parameters specifically responsible for stone disintegration or tissue trauma and pain induction have not yet been identified. Actual research in lithotripter technology deals with modification of the focal point. The evolution of endoscopic procedures, ureterorenoscopy, and percutaneous nephrolithotomy took longer but was more successful in terms of clinical efficacy. Nowadays, ESWL or an endoscopic procedure is offered as a reasonable option for most urinary stone cases. Therefore, economic aspects and the surgeon's expertise will become greater factors when a procedure is chosen. ESWL, with or without anaesthesia, will be an inherent part of future treatment modalities for urinary stones.     

In situ extracorporeal shock wave lithotripsy for obstructing ureteral stones with acute renal colic.

In situ (no instrumentation) extracorporeal shock wave lithotripsy (ESWL*) was used to treat 49 patients with obstructing ureteral stones causing acute renal colic. Ureteral obstruction was diagnosed on the delayed films of an excretory urogram and was classified as severe (dilatation above and no contrast medium seen below the stone) in 17 patients and partial (dilatation above and contrast medium seen below the stone) in 32. Upper third ureteral stones were present in 41 patients (obstruction severe in 15 and partial in 26) and lower third ureteral stones were present in 8 (obstruction severe in 2 and partial in 6). ESWL was performed within 14 days of the onset of the acute renal colic because of persistent pain with an unmodified Dornier HM3 lithotriptor in 17 patients and a Medstone STS device in 32. With single stones the stone-free rate at 3 months, the repeat ESWL rate and the secondary procedure (stone basketing) rate were 92%, 6% and 8%, respectively, with severe obstruction, and 78%, 6% and 6%, respectively, with partial obstruction. No urinary drainage procedures for sepsis were required after ESWL. Obstructing ureteral stones, which presented mainly in the upper third of the ureter, were successfully treated with in situ ESWL without the need for either bypassing the stone with a ureteral stent or for pushing the stone back into the kidney before treatment with ESWL.     

Extracorporeal shock wave lithotripsy for upper urinary tract stone using piezoelectric lithotripter (Piezolith 2200)

The results of clinical trial using the second generation extracorporeal shock wave lithotripter (Piezolith 2200, Wolf, West Germany) were presented. The treatments were performed between December 1987 and March 1988 at the University of Tokyo. In total 59 ESWL sessions were carried out on 32 patients with 48 upper urinary tract stones. The treatment could be performed without anesthesia or analgesic agent in every case. A double-J ureteral stent was indwelling in 6 patients with ureteral stones or large stones before ESWL treatment, and transurethral lithotripsy (TUL) was performed in two patients after the treatment. On the X-ray film obtained three weeks after the final ESWL treatment, 13 cases (40.6%) were completely free from stone fragments, while 9 cases (28.2%) had stone fragments less than or equal to 5 mm. Others had fragments greater than 5 mm. ESWL using this device was clinically useful in 71.9% in the three weeks follow-up period. No serious complication was observed after treatment except macroscopic hematuria for a few days in all cases, pyrexia in 4 cases (12.5%) and flank pain in 7 cases (21.9%). There were slight and transient changes in the laboratory data after the treatment, but these changes were milder than those with spark gap lithotripters. It is concluded that Piezolith 2200 is useful in the management of patients with upper urinary tract stones, and it is applicable more safely than the first generation lithotripters.     

Anesthesia-free in situ extracorporeal shock wave lithotripsy of ureteral stones

Stones in the proximal, mid and distal ureter in 375 consecutive patients were treated with extracorporeal shock wave lithotripsy (ESWL) in a technically unmodified Dornier HM3 lithotriptor without regional or general anesthesia. Adequate followup was available in 162 patients with proximal, 62 with mid and 146 with distal ureteral stones. The fraction of patients with stone-free ureters within 3 months after ESWL was 96, 97 and 97%, respectively. Of all patients only 13 (3.6%) had residual stones or fragments in the ureter after 3 months. The average number of ESWL sessions was 1.34 for all patients, and 1.36, 1.45 and 1.38 for those with proximal, mid and distal ureteral stones, respectively. A ureteral catheter with saline irrigation was used whenever it was possible to insert a ureteral catheter. Only 15 stones were pushed up to the kidney during catheterization and all other stones were treated in situ. There were more retreatments in patients in whom the stone had not been bypassed by a catheter at the initial ESWL session. During at least 1 treatment session 238 patients had a ureteral catheter with the tip above the stone. Approximately half of all patients were treated after only premedication with pethidine and diazepam, and cutaneous half of all patients were treated after only premedication with pethidine and diazepam, and cutaneous anesthesia with an anesthetic cream containing lidocaine-prilocaine (for proximal and mid ureteral stones). Small supplements of pethidine and diazepam were given to the other patients during the ESWL session. In situ ESWL of ureteral stones as described is a convenient, efficient and attractive procedure that, applied in a consequent manner, theoretically might result in a successful outcome in up to 98% of the patients.     

Extracorporeal shock wave lithotripsy monotherapy of 'stoned' internal ureteral stent in children. Case report

A case of ESWL treatment, as monotherapy, of a 'stoned' ureteral stent in a 12-year-old boy was described. Two years previously, the patient had pyelolithotomy with staghorn stone removal, and double-J stent was left indwelling intraoperatively. The patient was lost for follow-up for 2 years, when he had multiple stone formation adherent to the whole length of the stent. Four ESWL sessions were required before the stent was freed for removal.     

Outcome and safety of extracorporeal shock wave lithotripsy as first-line therapy of lower pole nephrolithiasis

INTRODUCTION: The aim of this study is to assess the efficiency of extracorporeal shock wave lithotripsy (ESWL) as initial therapy for isolated lower pole kidney stones smaller than 20 mm. PATIENTS AND METHODS: During a 24-month period 116 patients with previously untreated single stones under 20 mm in diameter were treated with a Dornier lithotripter S. They were analyzed with regard to stone site and size, number of ESWL sessions, auxiliary measures, retreatment rates, complications and the time taken for stone clearance. RESULTS: 76 patients (65.5%) became stone free, 50 of them (43.1%) within 3 months after ESWL. Depending on stone size the stone-free rates were 67.1% for patients with a stone diameter of <10 mm (59 of 88 patients), and 60.7% for stone diameters between 10 and 20 mm (17 of 28 patients). Complications during and after treatment were rare, i.e. the necessity of ureteral stent insertion due to colic (n = 10), endoscopic stone removal (n = 2), acute pyelonephritis (n = 1), stonestreet (n = 1) and 1 case of hematoma not requiring intervention. The recurrence rate during follow-up (13.2-36.9, mean 25.0 months) was low: 16 patients (13.8%) had recurrent or persistent stones, and 74 patients (63.8%) had no evidence of urolithiasis. CONCLUSIONS: ESWL is a safe and efficient first-line therapy for treatment of isolated small lower pole kidney stones with acceptable stone-free rates, low morbidity, few complications and a low stone recurrence rate.     

Clinical application of extracorporeal shock wave lithotripsy to 5 solitary kidney patients with upper urinary tract stones

We performed extracorporeal shock wave lithotripsy (ESWL) to 5 solitary kidney patients with upper urinary tract stones (4 kidneys and 1 lower ureter) using the EDAP lithotripter LT-01 and achieved 4 complete and 1 well results. The size of stones ranged from 8 mm to staghorn and trials were 1 to 10 units. We could accomplish perfect crushing and abortion of stones in the 4 renal stone patients without any adjuvant systems as ureteral stent but nephrostomy was needed in the 1 lower ureteral stone patient developed anuria. The values of blood pressure, hematology, blood chemical constituents and urine excretion enzymes at a month after the last ESWL were not so changed compared with those of preoperation and also excretory urogram showed favorable findings. In this series decreased renal functions by ESWL were not observed. We confirmed ESWL was an effective and a safe method even in the cases of solitary kidney patients and monotherapy without any adjuvants was possible.     

A prospective randomised trial comparing the modified HM3 with the MODULITH® SLX-F2 lithotripter

Background

The relative efficacy of first- versus last-generation lithotripters is unknown.

Objectives

To compare the clinical effectiveness and complications of the modified Dornier HM3 lithotripter (Dornier MedTech, Wessling, Germany) to the MODULITH^® SLX-F2 lithotripter (Storz Medical AG, Tägerwilen, Switzerland) for extracorporeal shock wave lithotripsy (ESWL).

Design, setting and participants

We conducted a prospective, randomised, single-institution trial that included elective and emergency patients.

Interventions

Shock wave treatments were performed under anaesthesia.

Measurements

Stone disintegration, residual fragments, collecting system dilatation, colic pain, and possible kidney haematoma were evaluated 1 d and 3 mo after ESWL. Complications, ESWL retreatments, and adjuvant procedures were documented.

Results and limitations

Patients treated with the HM3 lithotripter (n = 405) required fewer shock waves and shorter fluoroscopy times than patients treated with the MODULITH^® SLX-F2 lithotripter (n = 415). For solitary kidney stones, the HM3 lithotripter produced a slightly higher stone-free rate (p = 0.06) on day 1; stone-free rates were not significantly different at 3 mo (HM3: 74% vs MODULITH^® SLX-F2: 67%; p = 0.36). For solitary ureteral stones, the stone-free rate was higher at 3 mo with the HM3 lithotripter (HM3: 90% vs MODULITH^® SLX-F2: 81%; p = 0.05). For solitary lower calyx stones, stone-free rates were equal at 3 mo (63%). In patients with multiple stones, the HM3 lithotripter's stone-free rate was higher at 3 mo (HM3: 64% vs MODULITH^® SLX-F2: 44%; p = 0.003). Overall, HM3 lithotripter led to fewer secondary treatments (HM3: 11% vs MODULITH^® SLX-F2: 19%; p = 0.001) and fewer kidney haematomas (HM3: 1% vs. MODULITH^® SLX-F2: 3%; p = 0.02).

Conclusions

The modified HM3 lithotripter required fewer shock waves and shorter fluoroscopy times, showed higher stone-free rates for solitary ureteral stones and multiple stones, and led to fewer kidney haematomas and fewer secondary treatments than the MODULITH^® SLX-F2 lithotripter. In patients with a solitary kidney and solitary lower calyx stones, results were comparable for both lithotripters.     

Extracorporeal shock wave lithotripsy (ESWL) in the management of complex biliary tract stone disease.

The use of extracorporeal shock wave lithotripsy (ESWL) in the management of ten patients with complex biliary tract stones is described. General or epidural anesthesia was used in all cases, and stone fragmentation was performed, using an unmodified Dornier HM3 waterbath lithotripter (Dornier Medical Systems Inc., Marietta, GA). In all cases, biliary drainage was established before the procedure to allow contrast visualization during and after the procedure, as well as to ensure free drainage of the common bile duct. Indications for ESWL included failure of basket extraction (4 cases), unfavorable anatomy (duodenal diverticulum, previous Billroth II reconstruction, hepatic duct stone, gallbladder stone, cystic duct remnant stone), and immaturity of the T-tube tract (2 cases). Cholangitis was the presenting diagnosis in four cases. Fragmentation of the stones was successful in all patients; in two cases, two ESWL sessions were needed for stone disruption. Morbidity was minimal (there was a minor elevation of LDH and transaminases and asymptomatic hemobilia and hematuria); pancreatitis did not occur. After ESWL, hospital stays ranged from 1 to 13 days (mean of 5.3 days). ESWL can be a valuable adjunct in the management of patients with complex biliary stones.     

Utility of ureteral stent for stone street after extracorporeal shock wave lithotripsy

We reviewed the records of the 530 patients with urinary stones (renal stones: 243; ureter stones 287) who received extracorporeal shock wave lithotripsy (ESWL) (MFL5000; Dornier), from January 1995 to July 2002, retrospectively and determined whether the ureteral stent affected the incidence rate of stone street (SS). We also assessed the effect of ureteral stent on the subsequent management for SS. Forty patients (7.5%) developed SS. Twenty patients were inserted a ureteral stent prior to ESWL (stent group), and 20 patients were performed ESWL without a ureteral stent (in situ group). In the stent group, the most common (80.0%) location for SS was in the upper third ureter, while in the in situ group, SS mostly developed in the distal third ureter (60.0%). The incidence of SS did not differ significantly between the two groups when the size of renal and ureter stones was below 30 and 20 mm, respectively. When the renal stones were larger than above 30 mm, the incidence of SS in the stent group was significantly higher than that in the in situ group. SS disappeared spontaneously with stone passage in 10 of the patients in in situ group, but in only 1 patient in the stent group. In the stent group, 15 patients were treated for SS by removal of ureteral stent regardless of stone diameter. We conclude that ESWL should be performed without a ureteral stent when the stone diameter is below 20 mm. When the ureteral stent is thought to interfere with the delivery of stone fragments, the decision to remove it should be made as soon as possible.     

Extracorporeal shock wave lithotripsy for large renal stones. To what size is extracorporeal shock wave lithotripsy alone feasible?

The complications after extracorporeal shock wave lithotripsy (ESWL) for large renal calculi could be reduced by insertion of ureteral stents. In a prospective study, the critical stone size for ESWL combined with ureteral stenting was looked for. Sixty consecutive patients entered the study, 17 patients suffered from renal calculi with a length of greater than 4 cm and a width of greater than 3 cm (group 1), and in 43 patients the calculi measured between 4 x 3 and 2.5 x 1.5 cm2 (group 2). ESWL was performed with the Dornier apparatus HM-3. A ureteral stent was placed immediately before ESWL. In group 1 with very large stones, significantly more obstructive problems were encountered. Three months after ESWL, only 6 of 14 (43%) were free of stones or with stone material likely to discharge spontaneously. In group 2, a success rate of 25 of 29 (86%) was noticed, which was considered satisfactory. For most stones greater than 4 x 3 cm2 the combination of percutaneous nephrolithotomy and ESWL seems to be the preferred treatment.     

Extracorporeal shockwave lithotripsy of distal ureteral calculi

To date, the use of extracorporeal shockwave lithotripsy (ESWL) has been limited to renal calculi and ureteral calculi above the pelvic brim. Modifying the position of the patient on the support of the Dornier lithotripter HM3, we were able to localize and treat distal ureteral calculi. Until April 1986, 43 patients with stones in the lower ureter underwent contact-free lithotripsy. Treatment was successful in 39 patients (90%), 2 of these requiring 2 sessions. In 4 patients treatment failed and stone removal was accomplished using ureteroscopy or open surgery. No complications or adverse side effects were encountered in the whole series. ESWL is now the method of choice for the treatment of distal ureteral calculi in our department.     

Extracorporeal lithotripsy as the primary procedure in the treatment of large kidney calculi

Extracorporeal shock wave lithotripsy (ESWL) as primary treatment for large renal stones has been evaluated in this clinical study of 55 patients. Patients were treated using the Dornier HM-3 lithotripter. Twenty-one (38%) patients presented with a stone burden greater than 4 centimeters. Nineteen patients had "steinstrasse", of which 8 had to undergo a secondary procedure. Sixteen (29%) patients had no residual stone, 5 had clinically non significant stones and 34 had clinically significant stones. Out of the 15 patients who underwent a second ESWL, only 2 were rendered stone-free. In this study, ESWL was not found to be a satisfactory treatment for large renal stones.