Urology

Shock Wave Lithotripsy for Stones in the Ureter

a report by

Dr Joseph N Macaluso, Jr
Managing Director, Urologic Institute of New Orleans

The treatment of ureteral stones has undergone significant change during the past 20 years. In 1975, the treatment of choice for ureteral stones was observation with spontaneous passage. Endourological intervention was limited to blind manipulation, with basket extraction rarely under fluoroscopic control. Open ureterolithotomy was the mainstay of therapy for difficult stones or stones in the upper ureter. By 1980, we had progressed to directvision, rigid ureteroscopy with basket extraction. Over the next several years, flexible ureteroscopy was added and fragmentation via laser or electrohydraulic lithotriptor supplemented basket extraction. Video endoscopy rounded out the enhancements to endourology. All of these exist today with extensively upgraded technology available. Endourologically assisted lithotripsy (with a ureteral catheter or a stent) made an early appearance shortly after the introduction of extracorporeal shock wave lithotripsy (ESWL) to the US during the 1984 Food and Drug Administration (FDA) trial. In-situ lithotripsy, already shown to be feasible during the early introduction of ESWL in Europe, is the latest addition to the urologic armamentarium for the treatment of ureteral stones. It can be argued that in-situ ESWL is the treatment of choice for the majority of patients with ureteral calculi in 2004. In an era when ureteroscopy in skilled hands is capable of successful extraction of ureteral stones in the vast majority of cases, why is lithotripsy necessary at all? Clearly, the drive of patients to embrace minimally invasive therapies is playing a role across the board in medicine today. Patients are much more willing to try a non-invasive therapy even if the statistical odds are not as great for success in the hope of avoiding an invasive procedure. Also, the advent of second- and third-generation lithotriptors, which are tubeless and equipped with advanced imaging systems, has made the visualization of ureteral stones much easier. Ureteroscopy, even in experienced hands, is clearly invasive. While stone extraction, when successful, is usually complete in the lower ureter, working in the

upper ureter above the iliac vessels is more difficult, requires greater skill and proficiency, and is not associated with as high a stone-free success rate. In many cases, a ureteral stent is required to be left in place after ureteroscopy that from the patients point of view may cause discomfort and require a second procedure to remove the stent. This is still true even if only a dangle system is employed for stent removal. For many reasons, patients and urologists have moved toward insitu lithotripsy as the first-line standard of therapy for most patients. From the earliest use of lithotripsy in Europe, the treatment of ureteral stones was considered. Chaussy and his associates in their early work proved that ESWL of calculi in the upper ureter was possible and that stone-free success could be obtained. Over time, it became clear that the unmodified Dornier HM-3 lithotriptor was quite capable of treating a wide range of ureteral calculi. Clearly, this was more easily accomplished in the upper or the perivesical ureter. The so-called middle ureter, lying over the bony pelvis, offered special challenges and was frequently referred to as the lithotripsy no mans land. Also, it became quite evident that both operator and technician proficiency were critical to success, since the positioning of patients in the standard gantry required time, patience, experience, and skill.Thus, the use of the original HM-3 for ureteral lithotripsy gradually began to expand. After treating the first patient with ESWL in February 1980, Chaussy and associates turned their attention to ureteral calculi, beginning in August of the same year. Early results with several patients were not encouraging. By 1981, however, Chaussy was able to report a 50% success rate with in-situ therapy of upperureteral calculi, using the HM-3 lithotriptor. By 1983, success rates had climbed to between 75% and 95%, depending on a number of factors peculiar to each stone treated. Decreased efficacy was noted when ureteral stones were impacted or associated with varying degrees of ureteral obstruction. It was postulated that the lack of an expansion chamber resulted in the inability of the stone particles to

Dr Joseph N Macaluso is Managing Director of the Urologic Institute of New Orleans. He is also President Elect of the Louisiana State University (LSU) Health Sciences Center Foundation and Chair of the Urology Advisory Board for Urology Domains a specialty-based website. Dr Macaluso has spoken in public many times on healthrelated topics, including many television appearances, and has written 45 publications and many more scientific abstracts. He has featured in the publication Best Doctors in America on more than one occasion. Dr Macaluso has served as a consultant to many companies including Boston Scientific Corporation, AstraZeneca Pharmaceuticals, Promethean Surgical, and Antigenics. He was awarded the Ambrose-Reed Prize in Socioeconomics in 1997. Dr Macaluso was appointed in 1992 to the American Urological Association Select Panel on Practise Parameters and Clinical Guidelines. He has served an unprecedented three terms as President of the American Lithotripsy Society and has been a member of various boards of directors including the LSU Medical Alumni Association and The Institute of Professional Education. Dr Macaluso is a board-certificated diplomate of the American Board of Urology and a Fellow of the American College of Surgeons.

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separate, despite fragmentation and, thus, subsequent shock waves were rendered less effective in achieving further fragmentation. On the basis of work by Chaussy, Schmiedt, Jocham, and others from 1980 to 1985, several fundamental principles of ESWL therapy for ureteral calculi were developed. In the case of the HM-3, the stone would ideally be situated above the iliac crest.There would be no urinary tract infection present. There would be a definable expansion chamber present, as confirmed by the fact that the IVP did not show a narrow stone bed and contrast passed around the stone. By using these criteria for selecting patients to augment with ureteral catheters or stents, overall stone-free success could be pushed to more than 95% for most patients. Over time, it became clear that the best results with insitu therapy occurred in the upper ureter and, preferably, the renal pelvis. Therefore, the concept of manipulation of ureteral stones into a more favorable treatment position the so-called push bang technique came into favor. By using this method, actual stone fragmentation rates approaching 100% could be obtained, with stone-free rates as high as 98% being reported. However, this technique had the obvious drawback of requiring an invasive endourological procedure, and therefore automatically increased the secondary procedure rate for ESWL by a factor of two. This clearly was not an ideal solution, despite the final success rates. Also, the question was raised that if manipulation of stones was to be undertaken anyway, why did the urologist not simply ureteroscope the patient and remove the stone? This logic was particularly true when applied to lower-third calculi. Subsequently, the introduction of tubeless lithotriptors (Medstone, Storz, Siemens Lithostar, Dornier MFL 5000 and others) led to a significant change in imaging. Stones throughout the ureter could now be visualized for therapy regardless of their position in the ureter. This in turn led to a resurgence of enthusiasm for in-situ lithotripsy. By their very nature, ureteral stones are liable to cause problems for their human hosts. Many factors play a role in determining the difficulty that a ureteral stone will cause for a patient. Clearly, early data showed that size was a factor. Ureteral stones greater than 1cm in diameter were much less amenable to in-situ ESWL. Stones smaller than 1cm in diameter proved to be successfully treatable at a much higher rate. Initially, stones in the upper ureter were more amenable to therapy, but the advent of secondgeneration lithotriptors has made the entire ureter accessible for treatment.

Stone composition, which influences the concept of stone fragility first discussed by Dretler, is critical. Uric acid, cystine, and calcium oxalate monohydrate stones are all very hard, with significant fragility thresholds. This is clearly not the case with calcium oxalate dihydrate, calcium phosphate, and magnesium ammonium phosphate stones. The presence of an obstruction will also influence the expected success rate associated with in-situ ESWL. Obstruction is usually associated with considerable inflammation of the ureteral wall with associated edema. Over time, this process leads to impaction of the ureteral calculus at the point of obstruction. Impaction reduces the size of the natural expansion chamber around the ureteral stone to zero. This directly affects positive outcomes with in-situ therapy and is one indication for consideration of stone manipulation prior to treatment (ESWL with bypass). Despite the fact that upper ureteral calculi were more easily treated with ESWL, attempts at treatment of lower-third or distal stones were made quickly. Chaussy and Fuchs showed in their early reports that the positioning of patients in the gantry of the HM-3 lithotriptor was basically the rate-limiting step in the treatment equation. Their data indicated that distal ureteral calculi could be successfully fractured in almost 100% of cases if the stone could be positioned. Multiple presenters at multiple meetings during the early years of lithotripsy addressed the issue of gantry modifications, leading to enhanced results and extended usefulness of the HM-3 lithotriptor. These reports, such as those by Miller and associates from Ulm, Germany, showed clearly that modified gantries would allow for the positioning of stones over the bony pelvis.Again, data from Miller and others showed clearly that if stones could be positioned they could be treated and that success rates would approach more than 95% in most cases. Clearly, as with stones in the upper ureter, stone sizes greater than 1cm and the presence of impaction are related to a decreased success rate. In fact, most series have shown that these two factors account for the majority of in-situ ESWL failures, with stone composition accounting for the remainder. Numerous investigators have commented on the subject of treating distal ureteral calculi in women of child-bearing age. Some centers have excluded women older than 40 years of age from ESWL of the lower ureter because of the theoretical possibility of either a teratogenic effect or damage to the ovary as a result of scarring or tubal obstruction caused by hemorrhage. Many centers give informed consent but do not

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preclude ESWL as an option for women of childbearing age. Exposure times to X-ray during pelvic ESWL have been shown by Rassweiler and Eisenberger to be approximately the same as for the endourologic procedures used to treat distal stones. Thus, X-ray exposure per se is not a factor in women of childbearing age when considering in-situ lithotripsy as a therapy option. The advent of the Siemens Lithostar marked a new era in lithotripsy. The Siemens unit was a tubeless lithotriptor with realtime fluoroscopy capability that extended the anatomic range of treatment options over the entire urinary tract. It also employed a new energy source to power the electromagnetic generation of shock waves.This was accomplished through the use of an acoustic membrane and lens system, which resulted in repetitive shock waves of moderate intensity (180to 380-bar pressure), with no need to replace electrodes, and with a functional life for each membrane of more than 100,000 shocks. Thus, an era was ushered in when phrases such as anesthesia-free lithotripsy became popular. Clearly, the power requirements of the Siemens Lithostar were such that most patients could be treated with minimal urologist-supervised intravenous sedation. European success with the low-energy model of therapy encouraged American centers to try this new technology. Results published by Mobley, Jenkins, Jordan, and associates from Fayetteville, North Carolina, on almost 20,000 patients treated with the Lithostar show clearly the efficacy of this unit in the treatment of all types of stones. They report success in 89.5% and a total absence of stones in 83.5% of over 5,000 patients followed for three months subsequent to their having undergone ESWL of the ureteral calculi. Piezoelectric lithotripsy, which employs electrically stimulated ceramic crystals to create a shock wave effect, was initially employed in Europe as the first genuinely anesthesia-free lithotripsy treatment. Despite reported success and enthusiasm for these units in the late 1980s and early 1990s, they have not caught on in the US. These units achieve anesthesia-free status through the use of extremely small F2 focal points. Thus, the area of actual treatment is quite small. Surprisingly, these units generally deliver a significant amount of energy to the F2 focus (high energy density), but the focal point size is clinically insufficient and results in a poor efficacy from the first treatment. The large number of shock waves required for therapy and the increased number of sessions needed to achieve acceptable stone-free rates has caused a general lack of interest in the deployment of units using this technological approach. The Storz lithotriptor has generated great interest recently due to its fine focussing capability, as well as its high power density within the focal zone at higherpower settings. The unit is very operator-friendly and highly efficient in fragmentation in all cases, especially with ureteral stones. As with all units, casual overtreatment, either with too high a power setting or too many shocks, should be avoided. The Medstone lithotriptor has had a colorful and chequered path toward clinical usefulness. It is the only American-made lithotriptor. It was the second lithotriptor available after the HM-3, but technical and business problems delayed its general acceptance until the late 1980s. Despite this stuttering start, a significant number of Medstone units are now operating in the US. The Medstone is a tubeless lithotriptor that initially employed hard-copy X-ray localization. This made for superior imaging, but delayed treatment time due to film processing requirements. Beginning in the early 1990s, Medstone introduced a computer-driven x-ray digitization process for films. This technique greatly decreases processing time and allows for a rapid repositioning of patients after films are taken.The energy source for the Medstone is an in-line spark gap electrode which allows for the generation of HM-3-like F2 focal pressures (up to 1,200- or greater-bar pressure). The focal point created by the Medstone is larger and more generous than that of the HM-3, making targeting easier. Medstone was the first lithotriptor to employ PC-type computer interaction with the treating urologist and this unit is unquestionably very user-friendly. Data reported by Cass and associates in Minnesota and by Thomas, Macaluso, and associates in New Orleans has confirmed the ease of use and success of the Medstone in the treatment of ureteral calculi, particularly in the bony pelvis and lower-third ureter. Beginning in 1990, the American Urological Association (AUA) commissioned several study groups to create guidelines for the treatment of a variety of urologic disorders using the literature-based review method. To that end, the AUA Nephrolithiasis Guidelines Panel was born (comprising Segura, Preminger, Assimos, Dretler, Kahn, Lingeman, Macaluso, and McCollough) and has functioned since that time. The Panel has tackled a number of subjects. First in line was the treatment of staghorn calculi, about which the committee reported in 1994. The panel completed its second report on guidelines for the treatment of ureteral calculi and it was presented at the AUA annual meeting in Orlando, Florida, May 1996. One point that became clear

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during the analysis and debate undertaken by the panel was a consensus that, from a patients perspective, a secondary intervention (ureteral catheter, stent, etc.) should be viewed as a complication. Thus, in evaluating any non-invasive therapy or in situ therapy, a careful understanding of the secondary procedure rate or prepatory procedure rate is necessary. Certainly, this concept is of significance in a proper assessment of in situ SWL or in any analysis of ureteroscopy or other minimally invasive stone therapies. Lithotripsy is among the safest and best-tolerated procedures currently available in medicine. Still, complications can occur and contraindications do exist. Historically, bleeding disorders and the use of anticoagulants have been absolute contraindications for treatment by lithotripsy. In some cases, bleeding disorders can be controlled before operation and anticoagulants can be safely reversed in the short term, to allow for successful, event-free lithotripsy. Pregnancy was and remains an absolute contraindication for lithotripsy in any anatomical location. Serum pregnancy tests should be routine for all women of childbearing age, prior to performing ESWL. Patients with chronic renal disease due to infection (recurrent pyelonephritis) or chronic renal failure requiring dialysis are known to have an increased tissue fragility with an increased risk of peri-renal hematoma formation. Care should be taken when treating these patients. Patients with pacemakers may be safely treated after consultation with their cardiologist to determine the type of pacemaker and any special programming requirements that might exist. Treatment of females of child-bearing age is a controversial subject. There appears to be nothing in the literature or the clinical reports of many meetings to suggest any definitive link between ESWL of the lower ureter and damage to the reproductive organs or ova. Despite this, policies on treatment of females younger than 40 years of age vary from center to center and are likely to continue to do so until this issue is resolved. Clearly, ESWL of ureteral stones can be performed safely and efficaciously in most instances. Machine type plays a role in determining the extent to which one can consider ureteral stones for treatment. ESWL offers many advantages for treatment of stones in the ureter. It is non-invasive and can be performed under intravenous sedation. All the evidence shows that ESWL is capable of fragmenting the vast majority of stones into passable fragments (smaller than 4mm in diameter). Lithotripsy is a same-day or outpatient

procedure in almost all centers and is repeatable if needed to treat complex or difficult stones. Lithotripsy does have disadvantages when viewed in a broad context. It may, in some instances of difficult stones, require associated invasive procedures, such as stone manipulation or ureteral catheter/stent placement. From the patients perspective, this is clearly a disadvantage. Comparatively, ESWL is expensive when viewed in terms of technology cost but only in comparison with ureteroscopy. New lithotriptors currently sell for between US$450,000 and US$750,000. This is clearly a greater initial capital expense than even a top-line complete ureteroscopy and video system (which would probably cost between US$35,000 and US$50,0000). Used lithotriptors may vary in price from less than US$100,000 to more than US$300,000, depending on the machine in question and its condition. Despite relatively high success rates that are machine-variable, ESWL may fail to sufficiently break the stone being treated, or to break a stone at all. In either case, a second ESWL or alternative ureteroscopic procedure will be required. The future of ESWL in the treatment of all stones will be dominated by factors heretofore not generally considered among clinical urologists. Data relating to outcomes (hopefully correlating with the efficacy of the treatment) will become increasingly important. Patient preference and satisfaction will be factored into new balance sheets, which will be used to help patients arrive at informed decisions about a choice of therapy for their particular clinical problem. Variances in reimbursement will have a negative effect on technology implementation across the board. Clearly, a real working knowledge of the service costs (meaning the procedural costs) will be essential if lithotripsy units are to survive and provide high-quality, innovative therapy in the future. Most lithotripsy centers know their profit margin, but not their real costs on a per-unit basis. As markets consolidate, an increase in global and regional contracting is likely to occur. Centers that are prepared to deal with these trends will prosper. Others will not fare as well. By its very nature, contracting may lead to high volume and thus ancillary factors, such as the ability of the center in question to offer a wide range of stone diseaserelated services, will become paramount. Diagnostic imaging and advanced endourological capabilities, open technique experience, and medical management abilities will all be assessed. A focus on stone occurrence prevention will be demanded. The reappearance of the true stone center may be the final result. A version of this article including bibliographical references can be found in the Reference Section on the CD-ROM accompanying this business briefing.

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