Abstract
Background
Early 2021 data showed significant disparities in intravascular lithotripsy (IVL) access, with women, Black patients, and Medicaid beneficiaries less likely to receive treatment. We evaluated whether disparities persisted during rapid national expansion and whether they were associated with differential clinical outcomes.
Methods
Using 2021–2023 National Inpatient Sample data, we examined access disparities among 267,598 percutaneous coronary intervention patients and clinical outcomes among 9824 IVL recipients. Multivariable logistic regression predicted IVL use and mortality, adjusting for demographics, comorbidities, and hospital characteristics. Due to Healthcare Cost and Utilization Project restrictions, race/regional analyses were limited to 2021–2022; sex and insurance analyses included all years.
Results
IVL utilization increased from 0.55% in 2021 to 6.40% in 2023 (11.6-fold, P < 0.001). Females had 12% lower odds of receiving IVL (adjusted odds ratio [aOR] 0.88, 95% confidence interval [CI] 0.84–0.93), improved from the 35% gap in 2021. Race-based disparities were not statistically significant (Black aOR 0.93, 95% CI 0.80–1.08). Insurance disparities persisted with smaller effect sizes than earlier reports. Among IVL recipients, in-hospital mortality (4.2%) did not differ by sex, race, or insurance. Black patients experienced longer hospitalizations (8.2 vs 5.5 days; adjusted +2.2 days, P = 0.003).
Conclusions
Sex-based differences in IVL utilization narrowed substantially during the 11.6-fold expansion from 2021 to 2023, while race-based differences were no longer detectable within the study period. Insurance-related disparities persisted, although to a lesser extent. Comparable in-hospital mortality across demographic groups suggests that the remaining differences in access are more likely attributable to systemic barriers. The longer hospital length of stay observed among Black patients warrants further investigation into social determinants of health.
Keywords: Coronary calcification, health disparities, intravascular lithotripsy, percutaneous coronary intervention
Severe coronary artery calcification remains a major challenge in percutaneous coronary intervention (PCI), limiting stent delivery, expansion, and long-term patency.1–3 Traditional techniques for calcium modification, including rotational or orbital atherectomy, can facilitate stent deployment but are associated with procedural complexity, higher rates of complications such as coronary perforation and slow-flow phenomena compared with conventional balloon angioplasty, and variable efficacy in heavily calcified lesions.4 Intravascular lithotripsy (IVL) has emerged as a novel technology that delivers localized sonic pressure waves to disrupt calcified plaques, improving vessel compliance and facilitating optimal stent expansion while minimizing vessel injury.5–7 Early studies have demonstrated the safety and effectiveness of IVL in severely calcified coronary arteries, with low rates of major adverse events and high procedural success.5,6
Despite its clinical promise, the adoption of IVL in the United States has not been uniform. Prior work by Bahar et al documented significant disparities in IVL use during its first year of availability in 2021, with women, Black patients, and Medicaid beneficiaries substantially less likely to receive the therapy.8 These disparities reflect broader patterns observed in advanced cardiovascular interventions, where sex, race, and socioeconomic factors influence access to high-cost or novel technologies.9–11 Such patterns reflect structural inequities embedded within the US healthcare system, including differential insurance coverage, unequal reimbursement rates, and geographic maldistribution of resources. However, it remains unclear whether these early disparities have persisted as IVL adoption has expanded nationally or whether clinical outcomes are equitable once IVL is delivered.
Understanding these patterns is critical as IVL dissemination accelerates. Determining whether access disparities narrow over time and whether in-hospital outcomes are comparable across demographic groups can help distinguish systemic barriers from differences in clinical appropriateness. This information is essential for guiding health policy, institutional quality improvement, and equitable implementation of novel cardiovascular therapies.
To address these gaps, we leveraged the National Inpatient Sample (NIS) to examine trends in IVL utilization from 2021 to 2023. Our study had three primary objectives: (1) characterize temporal trends in IVL adoption during its rapid dissemination phase, (2) evaluate demographic and insurance-related disparities in IVL access, and (3) assess whether in-hospital outcomes differ across sex, race, and insurance groups among patients receiving IVL.
METHODS
Data for this study were drawn from the NIS, the largest publicly available all-payer inpatient database in the United States. Maintained by the Healthcare Cost and Utilization Project (HCUP), the NIS utilizes a stratified sampling design encompassing approximately 20% of all US hospital discharges and produces nationally representative estimates when applied with provided discharge weights. Available data elements include patient demographics, hospital characteristics, clinical diagnoses and procedures captured via the International Classification of Diseases, Tenth Revision, Clinical Modification and Procedure Coding System (ICD-10-CM/PCS), and resource utilization metrics such as length of stay (LOS), total charges, and discharge disposition.12 The NIS contains deidentified data and is exempt from institutional review board approval per HCUP policy.
Study population
We identified adult patients (≥18 years) hospitalized between 2021 and 2023 who underwent PCI, defined by ICD-10-PCS codes starting with 0270–0273. IVL was identified using coronary artery–specific fragmentation codes (02F03ZZ–02F33ZZ), which were implemented on October 1, 2021. All procedure fields were queried to ensure comprehensive capture of both PCI and IVL procedures.
The study utilized two analytic cohorts. The PCI-inclusive cohort (2021–2023) comprised all PCI hospitalizations regardless of IVL use and was used to analyze disparities in IVL access. The IVL-treated cohort was restricted to hospitalizations where IVL was performed during the index PCI and served as the primary group for outcome analyses.
Outcomes and covariates
The primary clinical outcome was in-hospital mortality, determined using the discharge disposition indicator. The secondary outcome included LOS as the key resource utilization measure, analyzed as a continuous variable measured in days.
Patient-level demographic and socioeconomic variables were defined according to standard NIS conventions, including age, sex, primary payer (Medicare, Medicaid, private, self-pay, or other), and median household income quartile by ZIP code. Race and ethnicity were included as covariates to evaluate whether demographic differences persisted after accounting for clinical and hospital-level factors. Race/ethnicity was categorized into six groups: White, Black, Hispanic, Asian/Pacific Islander, Native American, and Other. Notably, race data were unavailable for 2023 hospitalizations and were treated as missing for that period.
Clinical covariates included presentation with acute myocardial infarction (AMI), elective admission status, weekend admission, and comorbidity burden quantified using the Elixhauser comorbidity score, a validated composite measure consistent with NIS research standards. Hospital-level characteristics included bed size, teaching status, and geographic region. All analyses incorporated discharge-level weights and stratification variables to ensure nationally representative measures.
Statistical analyses
Statistical analyses were conducted in accordance with established methodological standards for HCUP database research.12 We accounted for the complex survey design of the NIS by incorporating discharge-level weights, hospital-level clustering, and stratification to generate nationally representative estimates. Population characteristics and outcomes were compared using survey-weighted proportions, means, and regression models as appropriate. All tests were two-sided with a significance threshold of P < 0.05. Analyses were performed using Stata Statistical Software, version 19 (StataCorp LLC, College Station, Texas).
IVL utilization and access
Among PCI hospitalizations from 2021 to 2023, temporal trends in IVL utilization were assessed using survey-weighted proportions stratified by calendar year. To examine access disparities, we employed survey-weighted logistic regression models with IVL use as the dependent variable. Following the methodology of Bahar et al, we utilized a sequential modeling approach. Initial crude associations were assessed via survey-weighted contingency tables, followed by multivariable models adjusting for age, insurance type, comorbidity burden (Elixhauser score), hospital characteristics (bed size, teaching status), and clinical factors (AMI status, elective/weekend admission, and income quartile).
Due to the absence of race and hospital region variables in the 2023 NIS per HCUP restrictions, modeling strategies were tailored by data availability: analyses of sex and insurance status utilized the full 2021–2023 period, while race- and regional- based analyses were restricted to the 2021–2022 subset. Models evaluating race additionally adjusted for geographic region.
Outcomes among IVL-treated patients
We evaluated clinical outcomes exclusively within the IVL-treated cohort to assess potential disparities in postprocedural care. In-hospital mortality was analyzed across sex, race/ethnicity, and insurance groups using survey-weighted logistic regression. Length of stay was modeled as a continuous outcome via survey-weighted linear regression. Multivariable models adjusted for age, sex, comorbidity burden (Elixhauser score), AMI status, and hospitalization year. Analyses evaluating race/ethnicity and hospital region were restricted to the 2021–2022 subset.
To further delineate disparities, subgroup analyses directly compared Black and White patients, estimating both absolute and relative differences in LOS. These analyses were specifically designed to decouple disparities in access to IVL from differences in clinical outcomes once the technology was utilized.
RESULTS
Population characteristics and temporal adoption
Between 2021 and 2023, an estimated 1,337,990 weighted PCI procedures were performed in the United States (representing 267,598 unweighted hospitalizations). The study population had a mean age of 65 years and a mean Elixhauser comorbidity score of 3.5, encompassing a diverse range of payer types and racial/ethnic groups. Baseline characteristics of PCI patients are shown in Table 1.
Table 1.
Baseline characteristics of PCI patients by IVL use, 2021 to 2023
| Characteristic | No IVL | IVL | P value |
|---|---|---|---|
| Total, N (weighted) | 1,288,915 | 49,075 | — |
| Demographics | |||
| Age, years (mean ± SD) | 65 ± 12 | 65 ± 11 | 0.32 |
| Female, % | 32.3 | 34.0 | <0.001 |
| Race/ethnicity, % (2021–2022 only) | |||
| White | 73.2 | 75.7 | 0.005 |
| Black | 11.8 | 9.7 | |
| Hispanic | 9.6 | 8.2 | |
| Asian/Pacific Islander | 4.2 | 4.5 | |
| Native American | 1.2 | 1.9 | |
| Primary payer, % | |||
| Medicare | 59.8 | 83.1 | <0.001 |
| Medicaid | 9.6 | 4.8 | |
| Private | 27.3 | 14.2 | |
| Self-pay/Other | 3.3 | 2.9 | |
| Clinical characteristics | |||
| Elixhauser score (mean ± SD) | 3.4 ± 2.1 | 4.1 ± 2.3 | <0.001 |
| Acute myocardial infarction, % | 48.7 | 32.1 | <0.001 |
| Elective admission, % | 18.3 | 36.8 | <0.001 |
| Year, % | |||
| 2021 | 34.2 | 5.0 | <0.001 |
| 2022 | 32.4 | 35.1 | |
| 2023 | 33.4 | 59.9 |
IVL indicates intravascular lithotripsy; PCI, percutaneous coronary intervention; SD, standard deviation. Continuous variables presented as mean ± SD. Categorical variables presented as percentages. P values from survey-weighted chi-square tests or t-tests as appropriate. Race/ethnicity data unavailable for 2023 per HCUP policy.
Intravascular lithotripsy was utilized in 3.67% of all cases (n = 49,075 weighted; 9824 unweighted), with rapid temporal expansion observed across the study period. Utilization rates rose from 0.55% in 2021 to 3.97% in 2022, reaching 6.40% by 2023—representing an 11.6-fold increase (Table 2). A design-based F-test confirmed that this adoption trajectory was statistically significant (F1.74,9163.66 = 690.14, P < 0.001).
Table 2.
Temporal trends in IVL utilization, 2021 to 2023
| Characteristic | 2021 | 2022 | 2023 |
|---|---|---|---|
| IVL utilization rate, % | 0.55 | 3.97 | 6.40 |
| Total PCI procedures (unweighted) | 88,692 | 86,899 | 92,007 |
| Total IVL procedures (unweighted) | 488 | 3452 | 5884 |
IVL indicates intravascular lithotripsy; PCI, percutaneous coronary intervention. P for trend <0.001.
Disparities in IVL access
Sex-based disparities
In the full 2021–2023 cohort, women had modestly lower adjusted odds of receiving IVL compared to men (adjusted odds ratio [aOR] 0.88; 95% confidence interval [CI], 0.84–0.93; P < 0.001), representing a substantially attenuated difference in utilization compared to earlier reports.
Race and regional disparities
Among hospitalizations with available race data (2021–2022), no statistically significant differences in IVL utilization were observed across racial and ethnic groups after multivariable adjustment. Compared to White patients, adjusted odds ratios were as follows: Black, 0.93 (95% CI, 0.80–1.08; P = 0.33); Hispanic, 0.95 (95% CI, 0.80–1.13; P = 0.56); Asian/Pacific Islander, 1.08 (95% CI, 0.90–1.31; P = 0.40); and Native American, 1.02 (95% CI, 0.82–1.28; P = 0.86).
Regional analysis revealed marked geographic variation
Patients in the West had nearly twofold higher odds of receiving IVL compared to those in the Northeast (aOR 1.93; 95% CI, 1.16–3.22; P = 0.01), while the Midwest and South showed no significant differences (P = 0.37 and P = 0.16, respectively).
Insurance-based disparities
Socioeconomic status, represented by primary insurance type, was a significant determinant of access. Unadjusted utilization was highest among Medicare patients (5.1%), while rates were notably lower for private insurance (1.92%), Medicaid (1.82%), and self-pay patients (1.26%; P <0.001). After multivariable adjustment, Medicaid, private insurance, and self-pay patients all had significantly lower odds of receiving IVL compared with Medicare patients (Medicaid aOR 0.67, 95% CI 0.60–0.75; private aOR 0.70, 95% CI 0.65–0.76; self-pay aOR 0.55, 95% CI 0.45–0.67; P <0.001 for all). Adjusted odds ratios for IVL use by sex, race, and insurance are presented in Table 3.
Table 3.
Multivariable predictors of IVL use
| Variable | Adjusted OR | 95% CI | P value |
|---|---|---|---|
| Model A: All years (2021–2023) | |||
| Female (ref: Male) | 0.88 | 0.84–0.93 | <0.001 |
| Insurance (ref: Medicare) | |||
| Medicaid | 0.67 | 0.60–0.75 | <0.001 |
| Private | 0.70 | 0.65–0.76 | <0.001 |
| Self-pay | 0.55 | 0.45–0.67 | <0.001 |
| Model B: 2021–2022 only (with race and region) | |||
| Race/ethnicity (ref: White) | |||
| Black | 0.93 | 0.80–1.08 | 0.33 |
| Hispanic | 0.95 | 0.80–1.13 | 0.56 |
| Asian/Pacific Islander | 1.08 | 0.90–1.31 | 0.40 |
| Native American | 1.02 | 0.82–1.28 | 0.86 |
| Hospital region (ref: Northeast) | |||
| West | 1.93 | 1.16–3.22 | 0.01 |
CI indicates confidence interval; IVL, intravascular lithotripsy; OR, odds ratio. Model A adjusted for age, insurance, Elixhauser comorbidity score, hospital bed size, teaching status, acute myocardial infarction, elective admission, weekend admission, and income quartile. Model B additionally adjusted for race/ethnicity and hospital region. Only selected variables shown; full models available upon request.
Outcomes among IVL-treated patients
The IVL-treated cohort included 49,075 weighted hospitalizations. Overall in-hospital mortality was 4.2%. Analysis of this subgroup revealed equitable clinical outcomes, with adjusted mortality models showing no statistically significant differences by sex, race/ethnicity, or insurance status (P > 0.05 for all).
However, resource utilization patterns diverged. While unadjusted mean LOS varied by payer—ranging from 3.68 days for no charge to 6.51 days for Medicaid—these differences were attenuated in adjusted models. Medicaid patients showed a nonsignificant LOS increase of 0.77 days compared to Medicare (P = 0.10), with similar nonsignificant findings for private insurance and self-pay status.
In contrast, a stark racial disparity in LOS was evident. In the 2021–2022 subset, Black patients experienced a 50% longer unadjusted mean LOS compared to White patients (8.2 vs 5.5 days; difference of 2.7 days). After multivariable adjustment for age, sex, comorbidity burden, AMI status, hospital region, and year, Black patients continued to have significantly longer hospitalizations, with an adjusted additional stay of 2.17 days (95% CI, 0.75–3.60; P = 0.003). Clinical factors remained important drivers of hospitalization duration; each additional Elixhauser comorbidity point was associated with 1.16 additional days in LOS (95% CI, 1.04–1.29; P < 0.001), and the presence of AMI was associated with an additional 1.37 days (95% CI, 0.93–1.81; P < 0.001). Clinical outcomes stratified by demographic groups are shown in Table 4.
Table 4.
Clinical outcomes among IVL recipients by demographics
| Outcome | Overall | Male | Female | P value |
|---|---|---|---|---|
| In-hospital mortality, % | 4.2 | 3.8 | 4.9 | NS |
| White | Black | P value | ||
| Length of stay, days (mean) | 5.5 | 8.2 | — | <0.001 |
| Adjusted difference, days | — | +2.17 | — | 0.003 |
| 95% CI | — | 0.75–3.60 | — | — |
CI indicates confidence interval; IVL, intravascular lithotripsy; NS, not significant. Mortality analyses adjusted for age, Elixhauser comorbidity score, acute myocardial infarction, and year. Length of stay analyses (2021–2022 only) adjusted for age, sex, Elixhauser score, acute myocardial infarction, hospital region, and year. P values from adjusted models.
DISCUSSION
In this nationally representative analysis of 267,598 PCI hospitalizations from 2021 to 2023, IVL utilization increased 11.6-fold, rising from 0.55% in 2021 to 6.40% in 2023. After multivariable adjustment, sex-based differences in IVL utilization were reduced and race-based differences were no longer detected during the study period, while Medicaid beneficiaries remained substantially less likely to receive IVL. Among 9824 patients who underwent IVL, in-hospital mortality was similar across demographic groups, although Black patients had longer hospitalizations than White patients.
These findings extend prior work by Bahar et al, who reported marked early adoption disparities during IVL’s initial clinical year, including 35% lower adjusted odds of receiving IVL among women, 34% lower adjusted odds among Black patients, and 80% lower odds among Medicaid beneficiaries compared with their respective reference groups.8 In contrast, our findings suggest attenuation of sex- and race-based differences during broader national dissemination, whereas insurance-based disparities persisted.
The attenuation in sex-based differences is an important finding but may not fully reflect inequitable access, as the lower use of IVL among women may in part be explained by the lower coronary calcium burden generally observed in women undergoing PCI—a recognized clinical difference in lesion morphology.13 Nevertheless, residual differences in access cannot be excluded after accounting for measured covariates. More broadly, these temporal changes align with established diffusion patterns in cardiovascular innovation, in which early adoption is concentrated in high-volume, resource-rich centers and becomes more equitable as technologies diffuse into routine practice.14–17
Prior studies demonstrate similar patterns of differential adoption across sociodemographic groups. Consistent with this pattern, Lee et al found that those with a higher area-level social deprivation, as measured by the Area Deprivation Index, had 8% to 10% lower odds of receiving calcium modification therapy.18 Similarly, we observed nearly twofold higher odds of IVL use in the West compared to the Northeast, likely reflecting geographic concentration of high-volume academic and early adopting centers in Western metropolitan areas, as well as potentially favorable regional reimbursement environments. However, the NIS does not allow granular center-level analysis, and this hypothesis warrants further investigation.
Perhaps the most concerning finding is the persistence of insurance-based disparities across multiple payer groups. After multivariable adjustment, Medicaid, private insurance, and self-pay patients all had significantly lower odds of receiving IVL compared with Medicare patients, with self-pay patients facing the largest deficit. This observation extends the initial findings reported by Bahar et al, who identified early signals of socioeconomic barriers during IVL's first year of clinical use.8 By incorporating data through 2023, our findings suggest that these disparities have not meaningfully narrowed as the technology matured and disseminated nationally. In the US healthcare system, disparities in access to novel technologies often persist through mechanisms related to reimbursement and institutional financial constraints.11,18,19 IVL catheters represent a high-cost disposable device, and the concentration of IVL use among older Medicare-eligible patients with calcific disease likely reflects both clinical selection and the favorable reimbursement environment that Medicare provides. The persistence of access gaps across non-Medicare payers suggests that passive diffusion alone may be insufficient to eliminate structural inequities, and that policy-level interventions targeting reimbursement equity may be required.18,19
Among patients who received IVL, in-hospital outcomes were otherwise broadly similar across demographic groups. Mortality rates did not differ significantly by sex, race, or insurance status; however, because in-hospital mortality is a blunt metric for a lesion-preparation device primarily designed to optimize stent expansion and long-term patency rather than prevent acute death, these findings should be interpreted as supportive, rather than definitive, evidence that access barriers reflect systemic factors. Longer-term outcomes including target lesion revascularization and restenosis, which are beyond the scope of NIS data, would provide more granular insight.
Notably, Black patients experienced longer hospitalizations after IVL compared with White patients, a difference exceeding 2 days after adjustment. This disparity in LOS likely reflects a confluence of factors including social determinants of health such as housing instability, limited postdischarge support, and transportation barriers, as well as potential differences in disease severity at presentation, delays in procedural decision-making, and variation in postprocedural care pathways. These findings underscore the need to address social determinants of health alongside procedural access in equity-focused quality improvement efforts.17,20
This study has several limitations. As a retrospective analysis of administrative data, it lacks detailed clinical and angiographic information, including calcium severity, lesion characteristics, and procedural complexity, limiting assessment of procedural appropriateness. Misclassification related to ICD-10 coding is possible, although the specificity of IVL fragmentation codes likely minimizes this concern. Race and regional data were unavailable for 2023, limiting race-and regional-based analyses to approximately 40% of the cohort. Additionally, race and ethnicity are subject to administrative misclassification and lack granularity across subgroups. The NIS does not capture longitudinal outcomes or repeat hospitalizations, and ZIP code income is an imperfect proxy for socioeconomic status. Finally, unmeasured confounding related to disease severity and physician decision-making may persist.
In conclusion, sex-based differences in IVL utilization narrowed substantially during rapid national expansion from 2021 to 2023, while race-based differences were no longer detectable. Among patients receiving IVL, in-hospital outcomes were similar across demographic groups, although mortality is a limited endpoint for this technology. These findings should be interpreted as supportive, rather than definitive, evidence that remaining access barriers are driven by systemic factors. Ongoing monitoring of adoption patterns, particularly during early diffusion phases, along with policy-level interventions addressing reimbursement, may be required to ensure equitable implementation.
ACKNOWLEDGMENTS
The authors used ChatGPT-5.5 (OpenAI, San Francisco, CA) to improve the readability and clarity of the manuscript. All content, analysis, and interpretation remain the responsibility of the authors.
Disclosure statement/Funding
The authors report no funding or conflicts of interest.
DISCLOSURE STATEMENT
The authors report no funding or conflicts of interest.
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