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Tzelves L. et al., 2021: Shockwave Lithotripsy Complications According to Modified Clavien-Dindo Grading System. A Systematic Review and Meta-regression Analysis in a Sample of 115 Randomized Controlled Trials

Tzelves L, Geraghty R, Mourmouris P, Chatzikrachtis N, Karavitakis M, Somani B, Skolarikos A.
2nd Department of Urology, National and Kapodistian University of Athens, Athens, Greece.
Department of Urology, The Newcastle upon Tyne Hospitals NHS Foundation, Newcastle upon Tyne, UK.
Department of Urology, University Hospital Southampton NHS Trust, Southampton, UK.
2nd Department of Urology, National and Kapodistian University of Athens, Athens, Greece.

Abstract

Context: Shockwave lithotripsy (SWL) shows clear associated benefits for urolithiasis patients. Objective: To identify and classify SWL complications according to modified ClavienDindo grading system while assessing the effect of different patient characteristics, stone parameters, types of lithotripters, and lithotripsy techniques. Evidence acquisition: Literature was reviewed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Evidence synthesis: We analyzed the results of 115 randomized trials including 17 827 patients, of whom 16.06%, 2.07%, 2.23%, 1.32%, 0.85%, 0.16%, and 0% suffered from Clavien I, II, III, IIIa, IIIb, IV, and V complications, respectively. In total, 18.43% of patients suffered from Clavien I–II and 2.48% from Clavien III–IV complications. In studies with >100 treated patients, Clavien I, III, and IV complication rates and need for auxiliary procedure rates were lower than in studies with smaller sample size. Electrohydraulic lithotripters led to a higher rate of Clavien IIIb and IV complications than electromagnetic lithotripters. Clavien I–II complications were increased by 14.3% in patients with multiple and complicated stones. Hematuria was increased by 8.29% in patients who underwent intravenous urography preoperatively and had longer duration of SWL. Pain occurrence was increased by 14.79% in patients with more than one stone at the time of SWL and by 3.21% in those who were managed with a piezoelectric lithotripter. Conclusions: SWL should not be considered an uneventful procedure, as in 2.5% of cases an intervention or Clavien III–V complication will be observed. Low-volume centers, treatment of multiple or complex stones, a long-lasting SWL session, and electrohydraulic lithotripters are associated with higher rates of complications. Patient summary: We analyze the occurrence of shockwave lithotripsy (SWL) complications in 17 000 patients. In centers with larger caseloads, complications were less common. The type of lithotripter is associated with complications. An increased number of treated stones, complex stones, and increased SWL duration were associated with a higher incidence of pain and hematuria.

Eur Urol Focus. 2021 Nov 27:S2405-4569(21)00293-5. doi: 10.1016/j.euf.2021.11.002. Online ahead of print. PMID: 34848163. Review.

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Comments 1

Hans-Göran Tiselius on Thursday, 21 April 2022 10:30

The occurrence of complications was examined in 115 RCTs and classified according to the modified Clavien-Dindo system. Some specific notations are summarized below:

1. Macroscopic hematuria was discovered in 17.25% of the patients. To me, macroscopic hematuria in most cases is not a complication but an expected consequence of stone disintegration. Routine use of bladder catheter and diuresis during SWL early taught me that if there was no hematuria, the conclusion was that there was no stone disintegration either.
2. The occurrence of steinstrasse was 4.07%, some of which were classified as Grade IIIb a complication that required treatment with URS. In my experience almost no patient with steinstrasse requires URS. Steinstrasse was either successfully removed with repeated SWL, without or with insertion of a stent or a ureteral catheter, always with local anesthesia only. Sometimes a percutaneous nephrostomy catheter was necessary to decrease the intrarenal pressure.
3. Sepsis and hematoma (Grade II-III) were the most serious complications (0.15-1.44%).
4. Pain occurred in 12.18%, but it is difficult to make a correct interpretation of this symptom.
5. Importantly, there were no deaths among the 17 827 patients treated with SWL!

One important lesson was that in studies with more than 100 treated patients, auxiliary procedures and Clavien III and IV complications were fewer than in studies with less than 100 patients. An observation that emphasizes the value of experience. With infrequent use of SWL it is likely that the method is not appropriately handled, and the risk of complications increases.

The unexpected overall relatively high level of complications is to a large extent explained by reported macroscopic hematuria; to me a desired complication!!

One important remark in the article related to COVID-19 is that “SWL represents a great choice for patients with stone disease because there is no need for anesthesia and intubation, procedures that increase the transmission of virus greatly. Nor is there a need of in-hospital stay. Moreover, SWL was accompanied by a low frequency of emergency visits, 3.5% compared with 7.7% for URS.

Although complications can occur after SWL most of them are less serious and can be managed in an easy and non-invasive way.

Hans-Göran Tiselius

The occurrence of complications was examined in 115 RCTs and classified according to the modified Clavien-Dindo system. Some specific notations are summarized below: 1. Macroscopic hematuria was discovered in 17.25% of the patients. To me, macroscopic hematuria in most cases is not a complication but an expected consequence of stone disintegration. Routine use of bladder catheter and diuresis during SWL early taught me that if there was no hematuria, the conclusion was that there was no stone disintegration either. 2. The occurrence of steinstrasse was 4.07%, some of which were classified as Grade IIIb a complication that required treatment with URS. In my experience almost no patient with steinstrasse requires URS. Steinstrasse was either successfully removed with repeated SWL, without or with insertion of a stent or a ureteral catheter, always with local anesthesia only. Sometimes a percutaneous nephrostomy catheter was necessary to decrease the intrarenal pressure. 3. Sepsis and hematoma (Grade II-III) were the most serious complications (0.15-1.44%). 4. Pain occurred in 12.18%, but it is difficult to make a correct interpretation of this symptom. 5. Importantly, there were no deaths among the 17 827 patients treated with SWL! One important lesson was that in studies with more than 100 treated patients, auxiliary procedures and Clavien III and IV complications were fewer than in studies with less than 100 patients. An observation that emphasizes the value of experience. With infrequent use of SWL it is likely that the method is not appropriately handled, and the risk of complications increases. The unexpected overall relatively high level of complications is to a large extent explained by reported macroscopic hematuria; to me a desired complication!! One important remark in the article related to COVID-19 is that “SWL represents a great choice for patients with stone disease because there is no need for anesthesia and intubation, procedures that increase the transmission of virus greatly. Nor is there a need of in-hospital stay. Moreover, SWL was accompanied by a low frequency of emergency visits, 3.5% compared with 7.7% for URS. Although complications can occur after SWL most of them are less serious and can be managed in an easy and non-invasive way. Hans-Göran Tiselius
Friday, 14 June 2024