Increased Risk of New-Onset Hypertension After Shock Wave Lithotripsy in UrolithiasisNovelty and Significance
A Nationwide Cohort Study
Although shock wave lithotripsy is minimally invasive, earlier studies argued that it may increase patients’ subsequent risk of hypertension and diabetes mellitus. This study evaluated the association between shock wave lithotripsy and new-onset hypertension or diabetes mellitus. The Taiwanese National Health Insurance Research Database was used to identify 20 219 patients aged 18 to 65 years who underwent the first stone surgical treatment (shock wave lithotripsy or ureterorenoscopic lithotripsy) between January 1999 and December 2011. A Cox proportional model was applied to evaluate associations. Time-varying Cox models were applied to evaluate the association between the number of shock wave lithotripsy sessions and the incidence of hypertension or diabetes mellitus. After a median follow-up of 74.9 and 82.6 months, 2028 and 688 patients developed hypertension in the shock wave lithotripsy and ureterorenoscopic lithotripsy groups, respectively. Patients who underwent shock wave lithotripsy had a higher probability of developing hypertension than patients who underwent ureterorenoscopic lithotripsy, with a hazard ratio of 1.20 (95% confidence interval, 1.10–1.31) after adjusting for covariates. The risk increased as the number of shock wave lithotripsy sessions increased. However, the diabetes mellitus risk was similar in the shock wave lithotripsy and ureterorenoscopic lithotripsy groups. Furthermore, the hazard ratio did not increase as the number of shock wave lithotripsy sessions increased. Shock wave lithotripsy consistently increased the incidence of hypertension on long-term follow-up. Therefore, alternatives to urolithiasis treatment (eg, endoscopic surgery or medical expulsion therapy) could avoid the hypertension risk. Furthermore, avoiding multiple sessions of shock wave lithotripsy could also evade the hypertension risk.
Urolithiasis is a common urologic problem, and its prevalence has increased globally in the past 2 decades.1 Studies have shown associations between urolithiasis and hypertension, diabetes mellitus, obesity, insulin resistance, and metabolic syndrome.2,3 In addition, patients undergoing urolithiasis have a higher long-term risk of developing cardiovascular disease and osteoporosis than the general population.4–6
Shock wave lithotripsy (SWL) was introduced to the clinical setting for stone management in 19827 and became the first-line treatment for uncomplicated renal and proximal ureteral stones. Accompanied by endoscopic surgery, stone treatment is easier and more convenient for patients and causes less morbidity than the open surgical approach. Although SWL is easy to perform, it is a special form of renal trauma, and earlier studies argued that early-onset hypertension would develop after SWL treatment.8–13 In 2006, Krambeck et al14 performed a retrospective, hospital-based study. They found that patients receiving SWL for renal and proximal ureteral stones had an increased risk of developing hypertension and diabetes mellitus after 19 years as compared with patients who received conservative treatment. Nevertheless, subsequent studies (hospital-based and database studies) showed conflicting results on the long-term side effects of SWL.15–18 Because patients with urolithiasis have a higher prevalence of hypertension and diabetes mellitus than the general population, it is difficult to prove that the development of hypertension or diabetes mellitus after SWL is because of SWL and not the stone itself.
A suitable comparison group with a large cohort and long-term follow-up is needed to evaluate the outcomes of SWL in patients undergoing urolithiasis. Moreover, the high recurrence and retreatment rates in patients undergoing urolithiasis should be considered. Taiwan has a high prevalence and recurrence rate of urolithiasis.19 After the Taiwan National Health Insurance program was established in 1995,20 comprehensive medical and surgical stone treatments were reimbursed and recorded in all clinical settings. SWL and ureterorenoscopic lithotripsy (URSL) are first-line surgical treatments for urolithiasis, and ≈100 000 and 30 000 procedures, respectively, are performed annually in Taiwan.21 Percutaneous nephrolithotripsy (PCNL) and open stone surgeries are usually reserved for patients with a large stone burden or those who underwent failed first-line surgical treatment. Hence, patients treated with SWL and URSL share similar characteristics and are more suitable for comparison with each other.
We investigated the association between SWL and new-onset hypertension and diabetes mellitus by comparing patients who underwent SWL and URSL in a population-based cohort study with long-term follow-up. With long-term follow-up, stone retreatment could be fully assessed.
The longitudinal health insurance database 2000, a data subset randomly sampled from the Taiwan NHIRD (National Health Insurance Research Database) between 1996 and 2013, was used for the analysis. The longitudinal health insurance database 2000 contains 1 000 000 beneficiaries who are randomly selected from the ≈23.75 million people who were recorded in the 2000 registry of the NHIRD. There was no significant difference in the sex distribution compared with the population in the original NHIRD.22
The potential study subjects were patients who received SWL or URSL as the first stone surgical treatment. The first stone surgical treatment date was defined as the index date. We used a new user design and recruited those with an index date between January 1, 1999, and December 31, 2011, to exclude prevalent cases (1996–1998 was the wash-out period), ensuring that every patient had at least 2 years of follow-up. We only included patients aged between 18 and 65 years because children are seldom treated with URSL and older people have more comorbidities and a greater risk of death.
We then compared SWL and URSL in terms of the risk of new-onset hypertension. We excluded patients with a history of hypertension before surgical treatment, patients who were treated with both SWL and URSL to avoid contamination between groups, and those with <3 months of follow-up (including new-onset hypertension). We applied similar criteria to investigate diabetes mellitus.
Hypertension or history of diabetes mellitus was defined as at least 2 outpatient claims or 1 inpatient claim of hypertension/diabetes mellitus or prescription of hypertension/diabetes mellitus medication for hypertension/diabetes mellitus within 1 year before the index date because we only wanted to recruit normotensive patients and those with normal glucose levels. The incidence of new-onset hypertension or diabetes mellitus was defined as a diagnosis of hypertension after the index date with administration of antihypertensive medication for >90 days or a diagnosis of diabetes mellitus with administration of antidiabetic medication for >30 days in 1 year, respectively. Therefore, patients with borderline hypertension or high glucose were excluded. The antihypertensive and antidiabetic medications in this study included angiotensin-converting enzyme inhibitors, calcium channel blockers, angiotensin II antagonists, α-blockers, β-blockers, diuretics, insulin, sulfonylureas, meglitinides, biguanides, thiazolidinediones, α-glucosidase inhibitors, and D-phenylalanines (Table S1 in the online-only Data Supplement).
The demographic and clinical characteristics of patients were described using mean±SD. Student t test or ANOVA was used for continuous variables, and χ2 tests were used for categorical variables. The associations between different surgical treatments and hypertension/diabetes mellitus were analyzed using Kaplan–Meier survival curves and log-rank tests. Multivariable Cox proportional hazards models were further conducted to estimate adjusted associations. The proportional hazards assumption was evaluated by plotting the Kaplan–Meier survival curves for the investigated covariates against follow-up time. Study entry was defined as the index date. In the models estimating the hazard ratio (HR) of hypertension and diabetes mellitus, observations were censored on December 31, 2013, the date patients developed hypertension/diabetes mellitus, received PCNL or open stone surgery, or loss of follow-up, whichever occurred first. The characteristics that were adjusted in the multivariable Cox proportional hazards models included sex, age, hyperlipidemia, gout, chronic kidney disease, index year, D’Hoore Charlson comorbidity index score, monthly income, region, and diabetes mellitus or hypertension. We further used a time-varying Cox model to estimate the association between the number of SWL treatment sessions and new-onset hypertension or diabetes mellitus. The number of SWL sessions was used as a time-varying variable in the study group. The variables were enumerated as 1, 2, 3, 4, and ≧5 after the first, second, third, fourth, and fifth SWL sessions, respectively. Because multiple treatment sessions may have been due to either residual or recurrent stones, a longer interval to the second event implied a recurrent stone. We stratified patients with a second event into 3 groups according to the time to the second event to determine the hypertension risk in these subgroups. We further performed a subgroup analysis investigating the possible interaction between the hypertension or diabetes mellitus risk and sex or age.
Because the stone severity, which may be associated with hypertension and diabetes mellitus, was not recorded in the NHIRD, we assigned patients to a large stone group (those receiving PCNL or open surgery) and compared the risk of new-onset hypertension and diabetes mellitus between the SWL and large stone groups. In addition, we also chose chronic obstructive pulmonary disease as a negative outcome because there is no evidence that chronic obstructive pulmonary disease is associated with stone disease or SWL. We also conducted a nested case–control study to test the association between SWL sessions for new-onset hypertension and diabetes mellitus (online-only Data Supplement).
Analyses were performed using SAS software, version 9.4 (SAS Institute, Cary, NC). A 2-sided P<0.05 was considered statistically significant. This study was approved by the Institutional Review Board of the National Taiwan University Hospital. The need for informed consent was waived because of the anonymous nature of the data.
In the longitudinal health insurance database 2000, we found 20 219 patients aged between 18 and 65 years who first received a surgical treatment of SWL or URSL between 1999 and 2011. We further excluded 3897, 3598, and 279 patients because of a history of hypertension before treatment, received SWL and URSL, or follow-up <3 months, respectively. There were 9025 and 3420 patients remaining in the SWL and URSL groups, respectively, and these patients formed our study cohort to assess the risk of new-onset hypertension. Applying similar criteria, we included 347 patients in the large stone group for the sensitivity analysis (Figure 1A). Regarding the risk of diabetes mellitus, 10,145, 3,879, and 472 patients were included in the SWL, URSL, and large stone groups, respectively (Figure 1B).
Table 1 illustrates the demographic data of patients in the SWL, URSL, and large stone groups. Regarding the cohort for studying new-onset hypertension, the SWL and URSL groups were similar in terms of mean age (42.6 versus 42.9 years; P=0.18), prevalence of hyperlipidemia (4.9% versus 4.4%; P=0.34), diabetes mellitus (4.8% versus 4.6%; P=0.73), Charlson comorbidity index score (P=0.32), and gout (3.9% versus 4.2%; P=0.43). However, women (25.9% versus 24.0%; P=0.04) and patients with a history of urinary tract infection (5.6% versus 3.3%; P<0.01) or renal disease (2.7% versus 1.5%; P<0.001) were more common in the URSL group than in the SWL group. SWL was more commonly used for people with a higher income (P<0.01) and those who lived in metropolitan areas (58.6% versus 51.4%; P<0.001) than in those with a lower income or those who lived in rural regions. However, the baseline characteristics in the large stone group differed from those of the SWL and URSL groups. The patients in the large stone group were older and predominantly women compared with those in the SWL and URSL groups. The prevalence of urinary tract infection, diabetes mellitus, hyperlipidemia, chronic kidney disease, and gout was also higher in the large stone group than in the SWL and URSL groups. The demographic data for studying new-onset diabetes mellitus were similar to those of the cohort that was used for studying new-onset hypertension (Table 1).
After a median follow-up of 74.9 and 82.6 months, 2028 and 688 patients developed hypertension in the SWL and URSL groups, with an incidence rate of 33.5 and 28.3 per 1000 person-years, respectively. The median onset period was 55.2 and 57.2 months in the SWL and URSL groups, respectively (Table 2). The cumulative risk probability of new-onset hypertension was higher in the SWL group than in the URSL group (log-rank test; P<0.001; Figure 2A).
After adjusting for age, sex, diabetes mellitus, gout, hyperlipidemia, renal disease, calendar year, Charlson comorbidity index score, region, and monthly income, we found that the SWL group had a higher probability of new-onset hypertension than the URSL group, with an HR of 1.20 (95% confidence interval [CI], 1.10–1.31). Among 9025 patients, 1612, 649, 279, and 420 received 2, 3, 4, and 5 or more SWL sessions, respectively. After adjusting for covariates, we discovered that the risk of new-onset hypertension increased as the number of SWL sessions increased with an HR of 1.10 (95% CI, 1.00–1.20), 1.30 (95% CI, 1.15–1.48), 1.55 (95% CI, 1.31–1.85), 1.70 (95% CI, 1.32–2.19), and 2.00 (95% CI, 1.63–2.45) in 1, 2, 3, 4, and 5 or more SWL sessions, respectively (Table 3). Regarding the time to the second event, we found that the risk of new-onset hypertension was 1.38 (95% CI, 1.21–1.58), 1.64 (95% CI, 1.40–1.93), and 1.43 (95% CI, 1.21–1.69) for the <3 months, 3 to 24 months, and >24 months groups, respectively. In subgroup analysis, the risk of new-onset hypertension was not different for age (P for interaction=0.59) or sex (P for interaction=0.70; Table S2).
New-Onset Diabetes Mellitus
Regarding new-onset diabetes mellitus, after a median follow-up of 82.7 and 88 months, 1021 and 420 patients in the SWL and URSL groups, respectively, developed diabetes mellitus, with an incidence of 13.9 and 14.5 per 1000 person-years. The median onset period was 57.6 and 62.4 months in the SWL and URSL groups, respectively (Table 2). The SWL group had a similar probability of new-onset diabetes mellitus to that of the URSL group (Figure 2B; log-rank test P=0.48).
After adjusting for age, sex, hypertension, gout, hyperlipidemia, renal disease, Charlson comorbidity index score, calendar year, monthly income, and region, we found that the risk of new-onset diabetes mellitus was also similar in the SWL and URSL groups (HR, 0.95; 95% CI, 0.85–1.06). Among the 10 145 SWL patients, 1841, 755, 342, and 520 received 2, 3, 4, and 5 or more SWL sessions, respectively. The risk of new-onset diabetes mellitus did not increase significantly as the number of SWL sessions increased with an HR of 0.91 (95% CI, 0.80–1.03), 1.00 (95% CI, 0.84–1.19), 1.01 (95% CI, 0.79–1.30), 1.11 (95% CI, 0.79–1.57), and 1.17 (95% CI, 0.88–1.55) in 1, 2, 3, 4, and 5 or more SWL sessions, respectively (Table 3). In subgroup analysis, the risk of new-onset diabetes mellitus was not different in different age (P for interaction=0.79) or sex (P for interaction=0.76; Table S2).
Compared with large stone group, the risk of new-onset hypertension was similar in patients treated with SWL and patients who had large stones treated without SWL (HR, 1.18; 95% CI, 0.83–1.68). However, the risk of new-onset hypertension increased significantly in patients treated with SWL if they received ≥3 SWL sessions. In the large stone group, patients who were treated with SWL had a higher HR of new-onset hypertension than patients not treated with SWL (HR, 1.51; 95% CI, 0.98–2.34). The risk of new-onset diabetes mellitus was similar in the SWL and large stone groups without SWL (HR, 1.07; 95% CI, 0.73–1.58) and the large stone group treated with or without SWL (Table S3).
The risk of developing chronic obstructive pulmonary disease was similar in the SWL and URSL groups regardless of the crude rate, adjusted HR, or the number of treatment sessions (Tables S4–S6; Figure S2).
The nested case–control study also confirmed the association between SWL sessions and new-onset hypertension (Mantel–Haenszel test and signed-rank test; P<0.001). SWL treatment sessions were not associated with new-onset diabetes mellitus (Mantel–Haenszel test, P=0.69 and signed-rank test, P=0.54; Tables S7 and S8).
In our study, patients with urolithiasis had a 20% increased risk of developing hypertension after SWL compared with patients undergoing URSL. The risk increased as the number of SWL treatment sessions increased. The risk consistently increased even up to 14 years. However, SWL did not increase the risk of new-onset diabetes mellitus compared with URSL.
Two prospective randomized controlled trials failed to show an increased risk of new-onset hypertension after SWL in asymptomatic renal calculi patients. However, these 2 studies focused on a limited number of cases with 2 years of follow-up and only 1 SWL session.11,13
After Krambeck et al14 demonstrated the association between SWL and the long-term risk of hypertension and diabetes mellitus, a similar retrospective hospital-based study compared 772 patients treated with SWL for kidney and ureteropelvic junction stones with 505 patients treated with SWL for ureter stones with a mean follow-up of 17 years.15 There was no difference in new-onset hypertension and diabetes mellitus for the 2 groups after adjusting for age, sex, body mass index, and number of shock waves. However, the response rate was only 30%, and recurrent treatment in their cohort was not considered.
Krambeck et al17 also performed a registry-based retrospective cohort study using a health claim database to compare patients with urolithiasis treated with and without SWL, having a median follow-up of 103 months.18 No difference in the incidence of hypertension and diabetes mellitus between the 2 groups was found. In their cohort, only a small portion (8%) of the population received SWL treatment, and only 15% of patients received ≥2 sessions; furthermore, other surgical treatment in the non-SWL group was not differentiated. With a low treatment rate and a small number of SWL cases, they could not estimate the relationship between SWL treatment sessions and new-onset hypertension. Moreover, because only a cohort from a single community was studied, it was difficult to generalize the results.
In contrast, a questionnaire-based retrospective cohort study that comprised 1758 patients with urolithiasis treated with SWL showed an increase in the risk of new-onset hypertension compared with matched controls using the National Health and Nutritional Examination Survey database with a median of 6 years of follow-up. However, the response rate was only 30%, and the control group was the general population.16
Similar to our results, Denburg et al23 conducted a retrospective cohort study to assess the risk of incident hypertension after exposure to SWL and URSL. SWL in the kidney was associated with incident hypertension while URSL was not. When stratifying SWL by the kidney and ureter, only SWL of the kidney was related to incident hypertension.
Handa et al24 designed a juvenile pig model to demonstrate the effects of shock waves on the development of metabolic syndrome. An increased risk of early-onset hypertension was found, but there were no signs of worsening glucose tolerance after shock wave treatment compared with sham therapy.
The pathophysiologic mechanism of the interaction between hypertension and nephrolithiasis is unclear. Several hypotheses have been proposed, such as hypercalciuria, insulin resistance, chronic kidney disease, and inflammatory oxidative stress in patients with urolithiasis and hypertension.3 Empirical studies showed that nephrolithiasis increases the risk of subsequent hypertension. However, whether hypertension induces nephrolithiasis is unclear.25,26
There are 2 possible mechanisms for increased new-onset hypertension after SWL. First, shock wave is a special form of renal trauma with high incidences of intrarenal and subscapular bleeding and intrarenal ischemia, which cause nephron loss with interstitial fibrosis in the focal zone.27,28 In addition, vasoconstriction with decreased renal blood flow and release of a vasoconstrictive substance might also account for hypertension after SWL.29 Second, SWL has a low stone-free rate and increased recurrent stone formation.30 Because nephrolithiasis will induce hypertension, new-onset hypertension may be attributed to recurrent stone formation in SWL-treated patients. Our data also showed that patients with recurrent stones had higher risk of new-onset hypertension.
Regarding diabetes mellitus, the pancreas is an exocrine and endocrine organ that secretes digested enzymes and insulin, respectively. Although overt pancreatitis with digested enzyme increases after SWL were noted, it does not necessarily lead to islet cell injury in the endocrine system.31 Although SWL is a standard treatment for pancreatic duct stones, no studies have shown new-onset diabetes mellitus after SWL in patients with pancreatic duct stones although the follow-up period was relatively short.32
SWL and URSL are the first-line treatments in Taiwan. Taiwan’s National Health Insurance program will reimburse providers for SWL if renal stones (symptomatic or asymptomatic) are 0.5 to 2 cm or ureter stones are <1.5 cm and patients do not have a urinary tract infection. Up to 5 sessions are allowed per year.33 Open surgery or PCNL is usually reserved for large renal stones (>2 cm) or ureter stones that cannot be removed by URSL. Hence, the large stone group comprised patients with more severe stone diseases. New-onset hypertension was higher in the SWL group than in the large stone group if there were ≥3 SWL treatment sessions, and the risk was also higher for patients in the large stone group who received SWL than for patients without SWL. SWL treatment may increase the risk of new-onset hypertension but not stone severity. In contrast, the risk of new-onset diabetes mellitus was not different between the SWL and large stone groups and SWL and non-SWL in the large stone group. New-onset diabetes mellitus is evidently not associated with SWL.
In our study, the hypertension risk increased as the number of SWL sessions increased. Hence, if patients are not stone free after a reasonable number of SWL sessions, retrograde intrarenal surgery should be considered, which is less damaging to the kidney parenchyma.
Several studies showed an association between urolithiasis and cardiovascular disease, metabolic syndrome, osteoporosis, and fracture.4,34 In addition, associations among hyperuricemia, hypertension, and urolithiasis are well documented.3,35 Urolithiasis is thought to be a manifestation of metabolic disorders. Finding and correcting underlying metabolic disturbance to prevent stone recurrence might avoid these events. We should not only treat the stone itself but also prevent stone recurrence.
Strengths and Limitations
The strength of our study is the long follow-up period (median follow-up: 7 years) with the largest cohort reported in the literature. Moreover, we used long-term treatment with hypertensive medications to define new-onset hypertension. Earlier retrospective registry studies also addressed the association between new-onset hypertension and SWL; however, whether the new-onset hypertension is transient, borderline, or long-term needing medication was unclear. Our study confirmed the association between SWL and hypertension and showed that the risk of new-onset hypertension consistently increased even up to 14 years with a need for medication. Moreover, our studies proved that SWL will not increase the risk of diabetes mellitus. Furthermore, we evaluated the full medical records of patients undergoing SWL, including the number of SWL treatment sessions, and a comparable group–URSL patients–was used because the indications for stone treatment and patient characteristics were similar between these groups. In addition, we used a time-varying Cox model to estimate the risk in a dose-responsive manner and corroborated our results with those of a nested case–control study. We also chose a group of patients with severe stone disease (treated with PCNL or open surgery) for sensitivity analysis and chronic obstructive pulmonary disease for a negative outcome. Because this was a national population-based study, there was no selection bias and generalizability was warranted.
However, this study has 3 limitations. First, the NHIRD lacks laboratory and physical examination data, such as body mass index, which is correlated with hypertension. Other surrogates, such as hyperlipidemia and diabetes mellitus, were used to adjust the risk. Second, we did not differentiate kidney and ureter stones in the SWL group. The treatment was mixed as the number of SWL treatment sessions increased; only 38% of treatment was in the kidney in the first session, and 62% of all treatments were SWL of the kidney. Furthermore, SWL of proximal ureter stones may cause renal injury. Hence, it is difficult to differentiate whether kidney injury developed in a single patient. However, the unmeasured confounder would nullify the results. Third, we lack data on stone severity (stone size, numbers) for adjustment. Hence, we used patients with severe stone disease who received PCNL or open stone surgery for the sensitivity analysis.
Our study showed that SWL consistently increased new-onset hypertension in the long term. Moreover, the risk increased as the number of SWL sessions increased. Therefore, alternative treatment for urolithiasis, such as endoscopic surgery or medical expulsion therapy, is suggested to avoid the risk of new-onset hypertension. In addition, avoiding multiple SWL treatment sessions is crucial to evade the new-onset hypertension risk.
We thank Editage (www.editage.com) for English language editing. We also thank Jou-Wei Lin for statistics analysis and methodology.
The online-only Data Supplement is available with this article at http://hyper.ahajournals.org/lookup/suppl/doi:10.1161/HYPERTENSIONAHA.117.09669/-/DC1.
- Received May 7, 2017.
- Revision received May 15, 2017.
- Accepted July 29, 2017.
- © 2017 American Heart Association, Inc.
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Novelty and Significance
What Is New?
Shock wave lithotripsy (SWL) consistently increased the risk of new-onset hypertension but not that of new-onset diabetes mellitus.
What Is Relevant?
SWL increased the risk of new-onset hypertension by 20%.
The risk increased as the number of SWL sessions increased.
There was no difference in the risk of new-onset diabetes mellitus between SWL and ureterorenoscopic lithotripsy.
SWL for urolithiasis increased new-onset hypertension in the long term. The risk increased as the number of SWL sessions increased. Therefore, alternative treatment for urolithiasis, such as endoscopic surgery or medical expulsion, may avoid the new-onset hypertension risk. Avoiding multiple SWL treatment sessions is crucial to evade the new-onset hypertension risk.