Urolithiasis (2015) 43:387–396 DOI 10.1007/s00240-015-0818-9

INVITED REVIEW

Arguments for choosing extracorporeal shockwave lithotripsy for removal of urinary tract stones Hans‑Göran Tiselius1 · Christian G. Chaussy2,3,4 

Received: 9 August 2015 / Accepted: 14 August 2015 / Published online: 28 August 2015 © Springer-Verlag Berlin Heidelberg 2015

Abstract  At a time when there is an almost unlimited enthusiasm and preference among urologists for endoscopic stone removal, we have found it essential to meet some of the frequently presented arguments on why extracorporeal shockwave lithotripsy (SWL) should not be used. We have based our considerations in this brief article on our 30–35 years’ experience with the non-invasive or least invasive technique that SWL represents. Stone disintegration, requirement of repeated treatment sessions, the concern of residual fragments, complications and economic aspects are some points that are discussed. Keywords  Extracorporeal shockwave lithotripsy (ESWL) · Shockwave lithotripsy (SWL) · Residual fragments · Treatment sessions · Complications · Pain treatment · Results · Stone treatment index (STI) · Economy · Training

Introduction Despite the obvious advantages of the non-invasive mode of stone removal that are features of * Hans‑Göran Tiselius hans‑[email protected] Christian G. Chaussy [email protected] 1

Division of Urology, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden

2

University of Munich, Munich, Germany

3

University of Regensburg, Regensburg, Germany

4

Keck School of Medicine, USC, Los Angeles, USA





extracorporeal shockwave lithotripsy (SWL), there seems to be a current trend in favour of endourological methods. After more than 35 years with mainly successful SWL, it is surprising to encounter articles, congress programmes and reports with a generally negative attitude to this technique. Titles like “ESWL: Still a role” (30th annual EAU congress Madrid) or “Crossfire: Controversies in Urology: Shockwave lithotripsy should be retired” (AUA annual meeting 2015, New Orleans) are just two examples reflecting the contemporary opinion that SWL is an inferior method for stone removal when compared with modern endoscopic and invasive alternatives [1]. The popularity of different stone-removing procedures is usually well reflected in the annual number of publications. As is evident from the diagram in Fig.  1, there has been a dramatic increase in articles on endourological approaches during recent years. On the other hand, the annual number of SWL articles has remained surprisingly constant over the years but with two identifiable peaks. A closer look at the content of the articles, however, disclose that during the first peak period (~1989–1993) usefulness, achievements and advantages of SWL were in focus, whereas articles published during the second peak (~2006–2012) were dominated by reported shortcomings of SWL leading to claims that this method of stone removal should not be the first choice. Undoubtedly there has been a remarkable development of endoscopic instruments (fURS, RIRS, Ho-YAG laser) and this progress most certainly has been very attractive to surgically oriented urologists. Moreover, percutaneous surgery (PNL), with smaller and smaller instruments, has made it possible to apply this technique for removing smaller and smaller stones. But despite this development, it stands to reason that all endoscopic

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388

Urolithiasis (2015) 43:387–396 350

Number

300

PNL

250 URS/RIRS

200 150 100

SWL

50 0

1

3

5

7

9 11 13 15 17 19 21 23 25 27 29

Year

Fig. 1  Publications on PNL, URS/RIRS and SWL from 1985 until 2013

procedures still require both anaesthesia and operating theatres. When methods for active stone removal are discussed with colleagues, we have the impression that SWL often is considered as a boring form of treatment and we fear that with such an attitude insufficient focus is placed on all those factors that need to be continuously and carefully controlled to achieve an optimal treatment outcome [2–4]. A review of the literature also shows a considerable variation in treatment results. Accordingly stone-free rates between 32 and 90 % have been recorded for SWL of stones in the kidney and 34–97 % for stones in the ureter. Improper patient selection or poorly functioning lithotripters might have played a role in the less successful outcomes, but it can also be assumed that the procedure has not been carried out with sufficient care. This will be further discussed below, but let us initially consider and elucidate the most common arguments why endourological methods today so often are given priority over SWL.

Repeated treatment sessions and stone disintegration The need for repeated SWL sessions for adequate stone disintegration is frequently emphasized in the literature [5]. It is easy, therefore, to gain the impression that when SWL is selected, several treatment sessions are more or less the rule. This is a misconception that can be best illustrated by the carefully evaluated treatment results in a series comprising 598 consecutively treated patients with ureteral stones [6]. For these stones, with a mean (SD) surface area of 42 (34) mm2 and following an average of 1.3 sessions, the observed stone-free rate was 97 %. Of these patients, 76.3 % required only one SWL session and it needs to be emphasized that for stones in the distal ureter, as many as 83.6 % were satisfactorily treated with one session.

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Fig. 2  Large renal stone composed of COM, successfully disintegrated with four SWL sessions

The larger stone burden in the kidney is usually associated with more treatment sessions. This is, however, not a treatment failure, but an expected consequence of the physical laws that determine the shockwave effect. In a similarly carefully evaluated series of 420 patients, consecutively treated with SWL for stones in the kidney, 64 % were considered adequately treated with only one session. Some of the kidneys had stones with quite large volumes (only staghorn stones were excluded). The mean (SD) stone surface area was 94 (172) mm2. Following an average of 1.49 sessions as many as 96 % of the stones were considered to be satisfactorily disintegrated [7] and a similar rate of stone disintegration has been frequently reported [8–11]. In the EAU guidelines [12], it is recommended that invasive procedures should be used for so-called SWLresistant stones, that is stones composed of calcium oxalate monohydrate (COM), brushite or cystine. It is obvious that such a restriction will significantly reduce the usefulness of SWL. The problems in this regard are that details of stone composition are usually unknown before the treatment and even if known or assumed in terms of radiological density or Hounsfield units [13, 14], stones composed of COM are very common [15– 17]. The relative hardness of different stone crystals is reflected by their hardness factors: (COM) 1.3, calcium oxalate dihydrate (COD) 1.0, hydroxyapatite (HAP) 1.1, octacalcium phosphate (OCP) 1.1, whitlockite 1.1, brushite 2.2 MAP 1.0, carbonate apatite 1.3, cystine 2.4 and uric acid 1.0 [18]. Stones with a high hardness index, calculated from the relative occurrence of different crystal types, will require a larger total amount of energy for disintegration and such stones usually need

Urolithiasis (2015) 43:387–396

repeated treatment sessions. But with acceptance of repeated treatment sessions, almost all stones can be disintegrated with SWL. Figure 2 shows a very large stone composed of COM in a patient who refused any invasive treatment. That stone was completely disintegrated with four SWL sessions and the kidney rendered stone-free. We do not consider this stone as a recommended indication for SWL but present it here just as example showing the capacity of SWL when invasive methods need to be excluded. The bottom line is that although repeated sessions often are necessary to achieve a good overall treatment result with SWL, a large proportion of patients can be adequately treated with only one session.

Residual fragments Despite the obvious disintegrating capacity of SWL, it is important to realize that the presence of residual fragments in the kidney is both an annoying finding and a matter of future concern. Residual fragments therefore are considered as a treatment failure. That residual fragments are commonly encountered in patients treated with SWL for renal stones, is a consequence of intra-renal anatomical conditions rather than insufficient disintegration. Isolated small fragments or collections of well-disintegrated stone material are usually found in the lower calyces. It stands to reason that residual fragments that originate from infection, brushite and cystine stones need to be cleared as completely as possible because of the high risk of recurrence of such stones [19]. For residual fragments from calcium stones (COM, COD, and calcium phosphate stones other than brushite), the need for immediate fragment clearance is debatable and it is doubtful whether extensive surgery for this purpose is really beneficial for the patients [10, 20]. In a previously presented series of patients with calcium stone residual fragments with a mean (SD) followup of 5.3 (1.5) years, 50 % displayed either decreased stone volume or no/minimal progress. New stone formation obviously without relation to residual fragments was recorded in 12 %. Asymptomatic growth or consolidation was recorded in 26 %, and in 12 % of these patients new stone-removal procedures were necessary [7, 19]. A small fraction of fragments accordingly will develop into symptomatic stones requiring new stone-removing procedures. In a recent more than 5-year follow-up of 140 patients, it was shown that after 7 years the need for repeated stoneremoval procedures was 20 %, corresponding to approximately 3 % per year. Although the aim always should be to accomplish clearance of fragments as completely as possible, the course of residual calcium stone fragments is difficult to predict.

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To illustrate the need for future active stone removal, theoretical prediction was carried out in 100 patients treated for calcium renal stones with SWL and 100 patients with PNL [21]. In these two groups of patients, stone-free rates after surgery were set to 57 and 80 %, respectively. The previously observed course of stone fragments mentioned above was used to predict the need for new stone removal during a 7-year period. It is also understood that in these patients, the risk of new stone formation will be approximately 50 % also when the kidneys are rendered stone-free. During the 7-year period, approximately 18 patients in the SWL group and 15 in the PNL group can be expected to require new active stone removal. That theoretical outcome reflects only a small difference for the development of symptomatic residuals between the two treatment alternatives. Despite the observations referred to above, it seems justified to add methods for fragment elimination whenever possible. In our opinion, such methods should be non-invasive to maintain, as far as ever possible, the non-touch character of stone removal. There are several reports with good results of inversion therapy [22–26]. SWL in Trendelenburg position has showed variable but occasionally promising results [27], although there so far are no lithotripters that allow a sufficient steep angle for that purpose. We are convinced, however, that further development and standardization of DIVE. with fragment elimination (E) accomplished by inversion therapy (I) during high diuresis (D) and vibration (V) efforts, might enable non-invasive fragment elimination in a significant number of patients. For patients with residual fragments, it is also essential to identify risk factors of stone formation and provide adequate recurrence prevention [28]. In the EAU guideline document, it is recommended that lower calyx stones with a diameter exceeding 10 mm should be primarily treated with endoscopic methods [12]. Even smaller stones should be excluded from SWL in cases of unfavourable anatomy. Although some differences in fragment clearance have been observed as the result of steep outflow angles, long calyx necks and narrow calyces or other geometrical features [29–32], this information is not easily obtained from standard NCCT examinations. The reasons why fragments usually are encountered in the lower calyx are that a majority of stones are located there at the time of treatment. But, moreover, fragments ending up in the lower calyces might come from stones located in other parts of the kidney [19]. The data presented in Fig. 3 were recorded in a large group of SWL-treated patients in Sweden. When the literature is consulted for recommendations on stone removal it is easy to draw the erroneous conclusion that all patients become stone-free if they are treated with endourological methods. Although this possibly might

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6%

4%

66%

Percent stone-free patients

24%

100

n=4601

n=3670

n=2475

n=497

n=210

80 60

74

82

88

76

93

SWL Ureteral stone

URS Ureteral stone

RIRS Renal stone

PNL Renal stone

40 20

SWL Renal stone

Fig. 4  Average stone-free rates reported in publications on comparative studies with different methods of stone removal

Fig. 3  Approximate location of renal stones that following SWL gave rise to fragments eventually encountered in the lower calyces (observation from patients treated in Sweden)

be the outcome in the hands of experts, reports show that residuals were encountered in 8–50 % following RIRS and in up to 57 % after PNL [33, 34]. Also following URS in the CROES global study [35] between 5 and 17 % had residuals. This result should be compared with the occurrence of 10–68 % of residuals in patients treated for renal stones with SWL. The conclusion is that whichever method is used for stone removal, residual fragments cannot be avoided. When the results recorded in patients included in comparative studies between non-invasive and invasive methods were considered [36–62], it is evident from Fig. 4 that apart from smaller differences between SWL and RIRS/ URS the best result was achieved with PNL. How extensive clearance of residual calcium stone fragments should be in asymptomatic patients will certainly remain a matter of debate. For a significant number of patients, however, it might be sufficient to follow-up with or without medical recurrence preventive measures.

Complications No surgical procedure, non-invasive or minimally invasive, is without complications or side effects. From the patient’s perspective, however, it should be of interest to know that the complication risk with SWL is lower than that with RIRS and PNL when renal stones are treated. To illustrate this aspect, it might suffice to show some representative

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data on complications associated with stone removal. Whereas the complication rates between 3 and 38 % (average 20 % in ~17000 patients) and 8 and 30 % (average 21 % in 312 patients) were recorded in patients treated with RIRS and PNL, respectively, complications following SWL were seen in between 6 and 10 % in our own 1018 patients referred to above [6, 7]. Also URS for ureteral stone removal was associated with complications between 6 and 12 % in the CROES global study of ureteroscopy [33, 35]. Re-admittance was common and even repeated treatments were required in 2.4–4.6 % of the patients. The complications recorded in our own 1018 stone patients referred to above were 10 % for renal stones and 7 % for ureteral stones. When those patients were excluded in whom pain after the treatment was considered as a complication, the corresponding levels were not greater than 6 and 3 %, for renal and ureteral stones, respectively. The most dreaded complications seen with SWL are subcapsular hematoma and septicaemia [63, 64]. Although these unfortunate and serious side effects cannot be avoided completely, their occurrence can be reduced by strictly applying pretreatment and treatment principles as outlined in Table 1 [2, 3]. The third most common side effect is obstruction by accumulated fragments in the ureter (steinstrasse). Insertion of a stent before treating large renal stones might alleviate that problem. Search for long-term side effects of SWL has been extensively carried out, but so far both hypertension and diabetes mellitus [65] apparently can be excluded as consequences of SWL. Neither is reduced renal function, a common sequela of SWL [66]. Although it recently has been suggested that an increased frequency of brushite stones would be caused by SWL [67], this effect is yet unproven. In one recently published experimental study, it was shown that SWL resulted in discrete increments in urine pH [68] and

Urolithiasis (2015) 43:387–396 Table 1  This is a brief summary of factors that need to be taken into account before, during and after SWL

391 Before SWL Measure blood pressure. If the patient is hypertensive: postpone treatment until the patient is adequately treated Stop treatment with salicylates (aspirin) 7–10 days before SWL Stop warfarin treatment 5 days before SWL and add low molecular heparin as bridging therapy after SWL Identify bacteriuria or infection history and give appropriate antibiotics Insert an internal stent when stone surface >200 mm2 During SWL Make sure that the transmission medium is applied in sufficient amount and free of air bubbles Identify the stone and place it in SWL focus Make sure that there is no interference between the shockwave path and skeleton or intestinal gas Use the collimators to reduce the X-ray aperture Apply a belt to reduce respiratory movements ECG recording and intravenous port Oxygen supply on mask or via nose catheter Adequate pain relief Select appropriate sw frequency and sw power Apply ramping strategy To facilitate judgment of disintegration, high diuresis and bladder catheter might be a useful adjunct Avoid overtreatment After SWL

Diclofenac twice daily during 7 days Alpha receptor antagonists up to 4 weeks High diuresis For lower calyx stones: consider inversion therapy (DIVE: diuresis inversion, vibration, elimination) Apply appropriate follow-up regimen For patients with residual fragments: consider risk evaluation and recurrence preventive measures

For further details, the reader is referred to references [2, 3]

that such an effect might be associated with increased risk of converting CaOx stone disease to CaP stone disease. It is likely that the acidification system in the kidney is very sensitive to various forms of trauma or pressure, because increased formation of brushite stones has been observed both in paediatric stone formers [69] and also after other forms of stone removal than SWL [70]. The increased occurrence of brushite stones, although still at a low level, might be an effect of current regimens for prevention of recurrence [71, 72]. Only further extensive and long-term studies will show whether or not this rather infrequent stone type is found more commonly in patients treated by SWL than in patients treated by other means of stone removal.

Pain and discomfort Effective stone disintegration is usually associated with some kind of pain experience and it is necessary to give the patient some form of analgesia. Experience has shown,

however, that neither regional nor general anaesthesia is necessary [6]. Modern principles of pain treatment are safe and easy to learn by nurses. Accordingly, in the average patient, with exception of children, there is no need for an anaesthetist. Different kinds of pain treatment are possible, but intermittent administration of small doses of a combination of alfentanil and propofol have proven very successful [73]. The average doses recorded in more than 3000 SWL treatments (Karolinska University Hospital, Stockholm) were 0.9 mg of alfentanil and 74 mg of propofol. The need for adequate pain relief is important, because it is the course of stone disintegration that should determine the treatment strategy and not the reaction of the patient! Patient satisfaction is usually good and higher scores were given by patients treated with SWL than by those treated with URS [47] or RIRS [49] despite the lower stone-free rate associated with SWL. It is also our experience that SWL is not considered to be uncomfortable by the patients.

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It is usually difficult to discuss cost of surgical procedures in view of extensive differences in the health care budgets between different countries. In published studies on this subject, SWL did come out top with significantly lower cost when compared with that of endoscopic stone removal [37, 54, 74, 75]. In addition to the direct cost of the treatment, there are also other economic advantages associated with SWL inasmuch as this non-invasive treatment can be carried out in outpatient settings without need for an operating theatre. Consequently, the total urological budget can be better used for those patients who really require invasive surgery for their stone disease or any other urological disease. This should be another reason for choosing a non-invasive method.

Auxiliary procedures Whether treated with SWL or an endoscopic procedure, various auxiliary or adjunctive procedures might be necessary to complete the treatment. For SWL, it is important to emphasize that in accordance with following a policy of least invasive treatment, it should be possible to carry out any auxiliary procedures that are required without employing regional or general anaesthesia. This means that when URS or PNL occasionally do become necessary, these procedures cannot be defined as “auxiliary” but rather become essential and reflecting a failure of the primary treatment of the stone. The most commonly encountered auxiliary procedures associated with SWL are insertion and removal of internal stents, ureteral catheters, percutaneous nephrostomy catheters or chemolysis. The same auxiliary procedures are also applicable to endoscopic stone removal. In the 420 patients treated with SWL for renal stones, auxiliary procedures were applied in 22.4 % of cases [7]. In the 598 patients with ureteral stones, the corresponding use of auxiliary procedures was necessary in 19.3 % of cases [6].

before, during and after the SWL treatment. The most important of these factors have previously been discussed in detail [2, 3, 8, 76–78]; they are briefly summarized in Table 1. When a Japanese stone centre exposed their operators to a special training programme, treatment achievements were significantly improved [8, 79]. It also has been demonstrated that there is a learning curve [80]. That observation is not surprising, but if the operators never have the opportunity to follow up adequately the patients whom they have treated, how can there be any learning curve at all?

Considerations on treatment results As shown in Fig. 4, comparative studies between SWL and endoscopic surgery showed average stone-free rates ranging from 72 to 90 % (Fig. 4). Results of SWL, however, cannot be fully evaluated without also considering the advantages of the non-invasive character of SWL. To illustrate this aspect, we have combined the reported stone-free rates with the complexity of the stone situation in terms of stone surface area, hardness index, patients’ age and BMI (when this information was available), anatomical abnormalities, number of sessions, auxiliary procedures, complications and anaesthesiarequiring procedures in terms of a stone treatment index (STI), the details of which have been published earlier [81]. The average STI-level was higher (and better) for SWLtreated patients than for those treated with RIRS and URS, and only inferior to PNL (Fig. 5). The high STI with PNL is explained by the larger stone volumes treated with this method.

7 6 5

STI

Is SWL an expensive form of stone removal?

Urolithiasis (2015) 43:387–396

4 3

How should SWL most efficiently be carried out? It is not uncommonly stated in the literature that in contrast to SWL, operator experience and skill is necessary for successful endoscopic surgery. Although the latter statement most certainly is true, it, undoubtedly, stands to reason that without operator skill and experience acceptable results will not follow after SWL. There are a number of factors that need to be carefully controlled

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2 1 0

SWL Renal stone

SWL Ureteral stone

URS Ureteral stone

RIRS Renal stone

PNL Renal stone

Fig. 5  Calculated stone treatment index (STI) based on information collected from the studies referred to in Fig. 4

Urolithiasis (2015) 43:387–396

393

Indications for SWL As discussed above, the restrictions determined by stone size, stone position, stone hardness and lower calyx geometry, apparently reduce the indications for primary SWL. Our experience is, however, that with a suitable lithotripter, a well-trained operator and carefully performed SWL, the range of indications for its use might not necessarily be that narrow. Possible indications for SWL are briefly summarized in Fig. 6.

Position and stone surface area

Without hard stone constituents

With hard stone constituents

Kidney <200 mm2 Kidney 200 - 300 mm2 Kidney 300-500 mm2 Kidney 500-700 mm2 Kidney >700 mm2 Staghorn Ureter <300 mm2 Fig. 6  Stone surface area calculated from the length (L) and width (W) of the stone (mm): L  ×  W  ×  π  × 0.25. Green suitable indication for SWL. Yellow possible indication provided repeated sessions can be accepted. Orange normally not an indication for SWL, but for these patients SWL might provide a solution if other treatment alternatives are excluded. Red no indication for primary SWL. For ureteral stones >300 mm2, individual consideration is recommended

Conclusions In the shadow of overenthusiastic reports of outstanding endourological results, SWL occasionally has become characterized as a second- or third-line treatment that can “be tried” for stone removal but in which few

urologists seem to trust. The SWL procedure is often described as boring and the major problem might be that it does not satisfy urologists’ surgical ambitions and satisfaction. It has to be initially stated that ureteroscopic and contact stone disintegration techniques have developed in a technically almost unbelievable way, but also that this treatment modality is still invasive and requires anaesthesia. There is no doubt that these methods achieve excellent results in expert hands, but far from all urologists master these techniques to the same level of perfection as is shown in publications from the hands of colleagues with special expertise and experience in this field. It can be assumed, therefore, that poor endoscopy results are not published, because the success is considered mainly and highly dependent on operator skill. As far as SWL is concerned, the general idea seems to be, that results are only machine dependent, whereas the importance of a skilled and experienced operator cannot be overemphasized. Urologists’ widespread lack of enthusiasm for SWL is one reason why this method in many places, has been more or less handed over to technicians, nurses or young residents, usually with no or only very limited education and training. With simple cases and straightforward treatment, everything probably works out smoothly. But when more complicated problems are encountered, there is no senior urologist that can assist and such patients are thus most likely treated with endourological procedures. As is the fact with endoscopic techniques, SWL should also be performed by a highly trained and experienced urologist who is involved in stone management in all its aspects. In this brief review, we have summarized some aspects on the usefulness of the non-invasive or least invasive stone removal. Based on more than 30 years of experience with SWL, it needs to be emphasized that optimal treatment results cannot be obtained without a continuous interaction between the operator and the stone. In case of apparently poor disintegration, the problem should be carefully analysed and the treatment strategy adjusted accordingly. By simply applying a fixed number of shockwaves according to a predetermined schedule, with sporadic control of the stone position, the treatment can best be described as an “attempt at stone disintegration”. We are, however, convinced that under optimal conditions SWL should be much more than just an “attempt”.

Compliance with ethical standards  There has been no funding neither for this report nor for the studies carried out by the authors and referred to in the review.

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394 All procedures performed in studies involving human participants, carried out by the authors and referred to in this review, were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Conflict of interest  Author HG Tiselius has functions as literature reviewer and medical advisor for Storz Medical AG. Author CG Chaussy is medical advisor for Dornier MedTech Europe GmbH.

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