Dornier HM3 Lithotripter Research Articles

Extracorporeal Shock Wave Lithotripsy for Mid and Lower Ureteral Stones

Concerns have been expressed by some in the United States that extracorporeal shock wave lithotripsy (SWL) for mid and lower ureteral stones could damage ovarian reproductive function, is difficult to perform with a Dornier HM3, and is not as effective as ureteroscopy. Seventy-nine patients with midureteral stones and 45 patients with lower ureteral stones were treated using Dornier HM3 and Medstone STS lithotripters. With the latter machine, the head and foot angle radiographs, the absence of the water-filled tub, and the easy prone positioning of the patient made the visualization and treatment of the mid and lower ureteral stones easier to perform. With single stones, the stone-free rate at 3 months was 77%, the retreatment rate was 2%, and the post-SWL secondary procedure rate was 15%. However, stone retrieval by ureteroscopy in the lower third of the ureter is a single procedure without the need for secondary or repeat treatments and, with reported stone-free rates of 83% to 93%, it is more efficient and less expensive than ESWL.

Efficacy of Second Generation Lithotriptors: A Multicenter Comparative Study of 2,206 Extracorporeal Shock Wave Lithotripsy Treatments with the Siemens Lithostar, Dornier HM4, Wolf Piezolith 2300, Direx Tripter X-1 and Breakstone Lithotriptors

Extracorporeal shock wave lithotripsy (ESWL*) has become the treatment of choice for urinary calculi. The good results of the first generation Dornier HM3 lithotriptor stimulated the development of second generation machines. A multicenter trial is presented involving the Siemens Lithostar, Dornier HM4, Wolf Piezolith 2300, Direx Trip ter X-1 and Breakstone lithotriptor to compare the therapeutic efficacy of second generation machines. Treatment results were best for calculi less than 2cm. in diameter. Although the second generation lithotriptors are comparable to each other, none of the machines provided a success rate comparable to that of the first generation unmodified Dornier HM3 lithotriptor. The 5 machines differed mainly in types of stones treated in relation to imaging system, use of anesthesia, use of auxiliary procedures and hospitalization but overall success rates were similar. We conclude that second generation ESWL is less effective than first generation ESWL.

Long-Term Followup after Extracorporeal Shock Wave Lithotripsy Treatment of Kidney Stones in Solitary Kidneys

A total of 64 treatments by the Dornier HM3 lithotriptor was performed on 52 solitary kidneys with stones. A slight increase but no significant variations in serum creatinine was noted in 15 patients without obstruction just after treatment (p >0.05). No significant increases in serum creatinine were found even at the short-term, mid-term and long-term followup. After 12 to 56 months hypertension developed in only 1 previously normotensive patient. Of 37 patients at midterm followup (12 to 24 months) 62% were stone-free, 24% had passable fragments, 8% had recurrent stones and 5% had regrowth of the residual fragments. At long-term followup (24 to 56 months) 50% of 26 patients were stone-free, 19% had dust or passable fragments, 19% had recurrences and 11% had regrowth of the residual fragments. The demonstrated effectiveness, small number of complications at the short-term followup, lack of sequelae at the long-term followup and relatively small number of recurrences confirm that extracorporeal lithotripsy is not only effective but also safe. It can be proposed as the treatment of first choice even when the stone is in a single remaining kidney.

Effect of Extracorporeal Shock Wave Lithotripsy on Renal Function and Body Height in Pediatric Patients

Although extracorporeal shock wave lithotripsy (ESWL*) is the preferred modality for treatment of most renal and upper ureteral calculi in adults, little is known about its effect on the pediatric population. We carefully followed 12 children 2.2 to 15.3 years old (mean age 9.4) treated with the Dornier HM3 lithotriptor. Effective renal plasma flow was obtained by quantitative 131iodine hippurate scan immediately preceding ESWL and at followup (range 74 to 238 weeks, mean 149). The treated kidney received an average of 1,702 shocks (range 1,000 to 2,200). Mean effective renal plasma flow increased in the treated kidney from 185 cc per minute before ESWL to 217 at followup (p = 0.016) and in the untreated kidney from 191 to 224 (p = 0.0013). Total effective renal plasma flow increased from 376 cc per minute before ESWL to 440 at followup (p = 0.0019). In the treated kidney mean and total effective renal plasma flow increased by 31 (expected 32) and 64 (expected 68) cc per minute, respectively, while in the nontreated kidney mean effective renal plasma flow increased by 33 (expected 36) cc per minute. None of the observed changes in effective renal plasma flow was significantly different from the expected changes using the paired t test at the 95% level. In addition, change in body height was evaluated using standard deviation scores. Mean body height (standard deviation) before ESWL was −0.39 (range −3.2 to 2.0) and at last followup it was −0.26 (range −2.6 to 2.4), which is not statistically significant (p = 0.37). Although these patients continue to be followed and caution is advised, this long-term study indicates that ESWL within the range of shocks delivered to this cohort does not statistically affect linear growth (body height) or renal function in the pediatric population.

Extracorporeal shock-wave lithotripsy (ESWL) monotherapy for stones in lower ureter

Extracorporeal shock-wave lithotripsy (ESWL) has been accepted as the method of choice for most upper urinary tract calculi. However, in cases of stones in the lower ureter, ureteroscopic procedures have generally been preferred. Using the Dornier HM3 lithotriptor with modifications in the patient's position, we were able to successfully treat 155 unselected cases of lower ureteral calculi. The average stone size was 9.6 mm (range 5–23 mm). One hundred forty-three patients had stones located below the lower margin of the sacroiliac joint. These patients were placed in a supine position. The stones were visualized radiologically without use of a ureteral catheter in 78 percent of the patients; in 22 percent a ureteral catheter was inserted prior to ESWL to aid in stone localization. In 145 patients (94 %) treatment was completed in one session; 10 patients (6%) required two sessions. Of the patients, 38 percent were free of stones one day after ESWL; 97 percent became stone free within three months, and only 3 patients required endoscopic manipulation, after ESWL. Twelve patients had stones in the midureter overlying the sacroileum. They were placed in the prone position, and the calculi were visualized with the aid of a ureteral catheter. All these patients became free of stones one month after treatment. There were no significant treatment-related complications except for bacteremia in 1 case. In view of the remarkable efficacy, negligible complication rate, and shorter hospital stay as compared to ureteroscopic stone manipulations, we recommend high energy ESWL as the primary monotherapy of mid and lower ureteral stones.

Extracorporeal Shock Wave Lithotripsy for Patients with Calcified Ipsilateral Renal Arterial or Abdominal Aortic Aneurysms

A total of 4 patients with renal or upper ureteral calculi associated with ipsilateral calcified renal arterial or abdominal aortic aneurysms underwent extracorporeal shock wave lithotripsy. One patient with a renal artery aneurysm had a solitary kidney. Linear distance from the calcified aneurysm to the stone, calculated by computerized and plain tomography, ranged between 4.6 and 6.5cm. (mean 5.3). Treatment was accomplished on an unmodified Dornier HM3 lithotriptor using 900 to 2,400 shock waves (mean 1,575) at 18kv. There were no complications of treatment and all 4 patients were discharged from the hospital within 24 hours, at which time radiographic examination revealed excellent stone comminution without change in the calcified aneurysm. With followup as long as 30 months, no adverse effects of therapy have become evident. We conclude that the presence of an ipsilateral calcified aneurysm may not necessarily preclude treatment of renal or upper ureteral calculi with extracorporeal shock wave lithotripsy, although further studies are required to help define the potential limits of such therapy in this setting.

Long-Term Follow-Up of Blood Pressure After Extracorporeal Shock Wave Lithotripsy

Thirty-five men and 33 women, mean age 45 years (range 15-67) treated with extracorporeal shock wave lithotripsy (SWL) for renal stones by a modified Dornier HM3 lithotripter, were followed in a 24- to 36-month prospective study to assess the risk of hypertension. No significant increase in the mean diastolic blood pressure was observed. No correlation was found between the hypertension incidence and the number of shock waves applied, the kilovoltage, urinary N-acetylglucosaminidase variations, or initial blood pressure. Among the normotensive group, three new cases of hypertension (diastolic pressure of ≥100 mm Hg) were observed (6%), which was not significantly greater than expected. Nevertheless, we believe that long-term surveillance is essential after SWL.

Changes in Renal Function after Extracorporeal Shock Wave Lithotripsy in Patients with Solitary Functioning Kidneys: Long-Term Follow-Up

Nine of twelve consecutive patients with a solitary functioning kidney treated for renal stone by extracorporeal shock wave lithotripsy (SWL) with the modified Dornier HM3 lithotripter were evaluated before and 20 months (range 12-24 months) after treatment by detailed renal cortical and tubular function tests. Urinary excretion of the renal tubular enzymes N-acetyl-β-glucosaminidase (NAG), alkaline phosphatase (ALP), and kallikrein and of albumin and β2-microglobulin was unchanged. Clearances of creatinine (CCr), inulin (CIN) and para-aminohippuric acid (CPAH) and filtration fraction (FF) were constant, as were serum levels of creatinine, urea, and β2-microglobulin. In seven of the nine patients, however, CIN was decreased at follow-up by a mean of 15% (range 5% to 54%), and CPAH was decreased by a mean of 30% (range 3% to 58%) in six of the nine patients. Plasma renin activity (PRA) and serum aldosterone were stable, and no patient developed new-onset hypertension.

Extracorporeal shock-wave lithotripsy for distal ureteric calculi.

The results of 67 consecutive patients referred to the New South Wales Lithotripter Centre with distal ureteric calculi were evaluated. All these patients were treated on the Dornier HM3 Lithotripter. Distal ureteric calculi were classified as those at, or distal to, the proximal margin of the sacro-iliac joint. Eleven patients with stones overlying the sacro-iliac joint were treated in the prone position, while 56 patients with stones distal to the sacro-iliac joint, were treated in the saddle (astride) position. Of the 64 patients in whom follow-up was available, 44 (69%) were rendered totally stone free by extracorporeal shock-wave lithotripsy (ESWL). Lithotripsy has proved an effective treatment for distal ureteric calculi and has rendered 69% of patients stone free with minimal morbidity. Stones overlying the sacro-iliac joint can be successfully treated in the prone position.

Cellular Effects of Piezoelectric Versus Electrohydraulic High Energy Shock Waves

High energy shock waves produced by a piezoelectric lithotripter, (EDAP LT.01) and an electro-hydraulic lithotripter, (Dornier HM3) were examined for their effects on Chinese hamster ovary cells in suspension. The EDAP caused acute lactate dehydrogenase release, consistent with severe membrane disruption in a proportion of cells, with the remaining proportion of cells replicating normally as measured by clonogenic assay. Similarly, the Dornier also caused lactate dehydrogenase release. However, a significant proportion of cells which remained “viable” after Dornier treatment, (intact to lactate dehydrogenase), did not replicate by clonogenic assay.The Dornier HM3 lithotripter has been reported to produce free radicals in aqueous solution. In the current investigation, we could not detect significant free radical formation from the EDAP LT.01. Chinese hamster ovary cell killing by the Dornier HM3 was significantly augmented by radiosensitizers, 5-iodo-2-deoxyuridine or buthionine sulfoximine, while radioprotectors cysteamine and WR-1065 had no protective effect. EDAP cell killing was not influenced by either radioprotectors or radiosensitizers.The mechanism of in vitro cytotoxicity differs between piezoelectric and electrohydraulic high energy shock wave delivery.

The effect of isolated high-energy shock wave treatments on subsequent bacterial growth.

To determine whether high-energy shock waves possess bactericidal potential, ATCC strains of Escherichia coli, Streptococcus faecalis, Pseudomonas aeruginosa and Staphylococcus aureus were suspended in solution at concentrations approximating 10(6) bacteria per milliliter, placed in polypropylene cryovials, and immersed in the water bath of a Dornier HM3 lithotriptor. Each cryovial was then fluoroscopically guided to the epicenter of the f2 focal point and 2000 shocks at 20 kV applied. Suspensions were then serially diluted and colony counts obtained. The procedure was then repeated with 4000 shocks at 20 kV from the Dornier HM3 and 4000 shocks at intensity level 4 from a Wolff Piezolith 2200 shock wave lithotriptor. Comparison of shock-wave-treated and sham-treated bacterial suspensions revealed no significant difference in bacterial growth according to the colony count technique. We conclude that high-energy shock waves, whether generated by spark gap or piezoelectric array, do not possess significant bactericidal activity.

Extracorporeal shock wave lithotripsy of staghorn stones in solitary kidney

Extracorporeal shock wave lithotripsy (ESWL) has been established as noninvasive treatment of choice for the great majority of upper urinary tract stones. However the management of staghorn stones in solitary kidney still deserves special consideration. We reviewed retrospectively 11 patients with staghorn stones in solitary kidney treated mainly with the Dornier HM-3 lithotripter during the period between December 1984 and December 1989 at the Sagamidai Hospital. The contralateral kidneys of the 8 patients were nephrectomized or nonfunctioning due to stone disease and those of 3 patients were nephrectomized due to tuberculosis. They were consisted of 6 males and 5 females with average ages of 60.0 years and 48.6 years respectively. The size of the stones ranged from 30 x 30 mm to 85 x 40 mm in KUB. ESWL was the first treatment for all the cases except for one patient a cystine stone. In that patient, ESWL was preceded by percutaneous nephrolithotripsy (PNL). In three patients the treatment was successfully by ESWL alone without any obvious complication. In 6 patients percutaneous nephrostomy was required and in two patients PNL was performed as an auxiliary procedure. Seven patients developed high fever (over 38.5 degrees C) and two of them became septic during the course of treatment. In five patients serum creatinine elevated over 2.0 mg/dl, but returned to within normal limits postoperatively. Extracorporeal shock wave lithotripsy can play a major role in the patient of the staghorn stones in solitary kidney.(ABSTRACT TRUNCATED AT 250 WORDS)

Proliferative Glomerulopathy Following Extracorporeal Shock Wave Lithotripsy in the Pig

Histopathologic changes after extracorporeal shock wave lithotripsy (ESWL) were studied in kidneys from four groups of nine pigs treated with an EDAP LT-01 (five pigs/group) or Dornier HM3 (four pigs/group) lithotripter, and sacrificed at time zero, 48hours, one week and one month. Treatment dosages increased consistently within each group. Samples from primary treatment area and opposite control kidney were processed routinely for light, immunofluorescence, and electron microscopy. Tubulointerstitial changes included hemorrhages at zero and 48hours and scars at one week and one month with both lithotripters. Glomerular mesangial cell proliferation started by 48hours and increased over one month in treated and control samples. Electron microscopy showed mesangial deposits and phagolysosomes. Immunofluorescence showed trace IgG, zero IgM, and 1−2+ C3. The conclusions were: 1) Mesangial cell proliferation associated with deposits of C3 and phagocytosis of cellular debris starts by 48hours post ESWL and increases thereafter, with both Dornier and EDAP lithotripters. 2) The pathogenesis appears to involve phagocytosis of circulating cellular debris and red blood cell fragments presumed to derive from breakdown of the hematoma caused by the lithotripsy.

Lithotripter wave propagation. II. Computational results.

The results of modeling the field of a Dornier HM-3 lithotripter are presented. Water path versus a variety of tissue path results are compared. The possible significance of the modeled results for the design and use of lithotripters is considered. [Work supported by NIH.]

Analgesia in Anesthesia-Free Extracorporeal Shock Wave Lithotripsy: A Standardized Protocol

We treated 101 patients at our stone facility with the Dornier HM3 lithotriptor modified with the anesthesia-free design upgrade. A protocol designed by our anesthesiologists consisting of intravenous and intramuscular injections for sedation was used without any general or regional anesthesia required. Pre-medication with intramuscular meperidine and promethazine, and oral diazepam was sufficient sedation in 43 patients, while 37 required additional intravenous meperidine and/or midazolam during the procedure, 16 were treated with intraprocedural medication alone and 5 required no medication at all. Care before, during and after the procedure was rendered by the urology staff for patients in American Society of Anesthesiologists risk category I or II. Treatment was successfully completed in all patients without complications. We compared this group to the 99 patients treated consecutively before the modification. Voltage used, number of shocks and stone burden were comparable in the 2 groups but average treatment time was prolonged with the upgraded equipment (39.2 versus 27.1 minutes) to a significant degree (p <0.001).

Stryker Frame Gantry Modification for Extracorporeal Shock Wave Lithotripsy to Circumvent Positioning Problems

From July 1986 through December 1989, 45 patients with renal or biliary calculi were treated on a Dornier HM3* lithotriptor using a Stryker frame gantry modification. The modification was necessary due to inability to position the patients in the standard gantry. The situations that required nonstandard positioning techniques included stones in the distal or mid ureter, renal transplant, gallbladder or common bile duct, and unusual body habitus, such as myelomeningocele, bilateral lower extremity amputations and children with stones. Positioning with adequate focus of the shock wave was achieved in 87% of the patients and fragmentation was achieved in 89%. The Stryker frame gantry modification is an excellent method to circumvent positioning problems with the Dornier HM3 lithotriptor, extending lithotripsy capability to patients who might otherwise not be candidates.

Extracorporeal Shockwave Lithotripsy or Extracorporeal Piezoelectric Lithotripsy? Comparison of Costs and Results

One thousand patients with renal stones up to 3 cm in diameter were divided equally into 2 groups matched for age, sex and stone size. One group was treated on the Dornier HM3 lithotriptor and the other on the EDAP LT01. The results showed that for stones less than 1 cm both lithotriptors were equally effective, with a stone-free rate of 87.5% for the Dornier and 90.4% for the EDAP at 3 months. The success rate fell more steeply for the EDAP machine, however, to become 77.2 and 42.5% respectively as the stone size increased to 3 cm. Treatment time was longer on the EDAP lithotriptor and more sessions were required but patients preferred it to the Dornier. Running costs per patient were higher on the EDAP.

Extracorporeal Lithotripsy

Retained or recurrent bile duct stones can be successfully removed in up to 80% to 85% of patients with the use of percutaneous or endoscopic techniques. However, problems related to difficult biliary access, large stones, and biliary strictures may decrease the success rate of this approach. We evaluated the safety and efficacy of extracorporeal shock-wave lithotripsy (ESWL) in 16 patients with complicated biliary stones treated prospectively over a 24-month period. Successful stone fragmentation was achieved in 15 patients (94%) using a Dornier HM3 lithotripter (average of 2290 shocks at 22 kV). Three patients (19%) required a second ESWL treatment. Biliary clearance of stone fragments was spontaneous in seven (43%) of the patients and required additional treatment in eight (57%) of the patients. Complications from ESWL were minor and included transient hematuria and ecchymoses at the skin entry site. Extracorporeal shock-wave lithotripsy failed in one patient (6%) with a biliary stricture and surgery was required. At hospital discharge, all patients were asymptomatic and stone free. Treatment with ESWL appears to be a safe and effective adjunct for selected patients with complex biliary stone disease.

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⁎⁎Dornier Medical Systems, Inc., Marietta, Georgia.) 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 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.

Comparison of Alfentanil and Ketamine Infusions in Combination with Midazolam for Outpatient Lithotripsy

Sixty unpremedicated outpatients undergoing elective extracorporeal shock wave lithotripsy using an unmodified Dornier HM-3 lithotriptor were randomly assigned to receive an intravenous infusion of either alfentanil or ketamine as an adjuvant to midazolam for sedation and analgesia. Although both drug regimens allowed the maximal number of shock waves and energy level, the alfentanil group had significantly better calculi fragmentation (78% vs. 50% of patients with fragments less than 2 mm). Ketamine infusion provided superior intraoperative cardiorespiratory stability; however, it was associated with more disruptive movements (22 vs. 5) and dreaming (35% vs. 5%) during the procedure (P less than 0.05). Postoperatively, confusion also occurred more frequently in the ketamine-treated patients (31% vs. 5%, P less than 0.05). Alfentanil infusion was associated with more episodes of hemoglobin oxygen desaturation to less than 90% (12 vs. 2, P less than 0.05), itching (23% vs. 4%, P less than 0.05), and ability to recall intraoperative events (45% vs. 12%, P less than 0.05). The incidence of postoperative nausea was decreased (not significantly) in the alfentanil group (32% vs. 54%). The mean anesthesia time was similar in both groups; however, discharge times (means +/- standard deviations) were shorter in the alfentanil group (142 +/- 42 min vs. 161 +/- 31 min, P = 0.05). These data suggest that although both techniques proved effective for anesthesia in outpatients undergoing immersion lithotripsy, alfentanil is superior to ketamine as part of a sedative-analgesic technique because of the improved recovery profile and calculi fragmentation.