Institutional Volume and Initial Results for Endovascular Treatment for Chronic Occlusive Lower-Extremity Artery Disease: A Report From the Japanese Nationwide Registry

Abstract

Purpose:

Chronic total occlusion (CTO) remains as a major target for endovascular treatment (EVT) in improving symptomatic lower-extremity artery disease (LEAD). However, despite the technical demand and learning curve for the procedure, volume-outcome relationship of EVT targeted for CTO in symptomatic LEAD remains unclear.

Materials and Methods:

Data were obtained from a nationwide registry for EVT procedures limited to the Japanese Association of Cardiovascular Intervention and Therapeutics between January 2018 and December 2020 from 660 cardiovascular centers in Japan. In total, 96 099 patients underwent EVT for symptomatic LEAD, and 41 900 (43.6%) underwent CTO-targeted EVTs during the study period. Institutional volume was classified into quartiles. The association of institutional volumes with short-term outcomes was explored using the generalized linear mixed model using a logit link function, in which, interinstitution variability was used as a random effect.

Results:

The median institutional volume for all EVT cases per quartile was 29, 68, 125, and 299 cases/year for the first, second, third, and fourth quartiles, respectively. With each model analysis, the adjusted odds ratios (ORs) for technical success were significantly lower in patients who underwent EVT in institutions within the first quartile (<52 cases/year) than in the other quartiles (P < .01, respectively). On the contrary, the adjusted ORs for procedural complications were significantly higher in the first and second quartiles than in the third and fourth quartiles (P < .01, respectively).

Conclusion:

In contemporary Japanese EVT practice, a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions.

Clinical Impact

EVT for CTO lesions is still challenging for clinicians because of difficulties of wire/devise crossing or high procedural complications rate. Our study demonstrated that a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions. In contemporary Japanese practice, a higher institutional experience has better impacts on short-term clinical outcomes. Future research should determine the relationship between institutional volume and long-term clinical outcomes.

Keywords

institutional volume endovascular therapy chronic total occlusion lower-extremity artery disease

Introduction

Globally, more than 200 million people suffer from lower-extremity artery disease (LEAD). In Japan, the number of patients with LEAD is increasing owing to the advancing age or rising incidence of type 2 diabetes, chronic kidney disease, and hemodialysis. A number of endovascular treatments (EVTs) are performed for patients with LEAD worldwide because of their low invasiveness and fewer procedural complications than surgical intervention and technological advances.^1,2

For example, more than 40 000 EVT procedures are performed annually in more than 500 centers in Japan. Owing to the development of devices and the accumulation of experience, the success rate of EVT has gradually increased, although the success rate of noncomplex EVT, including nonsevere calcification or nonchronic total occlusion (CTO), is satisfactory.^3,4 On the contrary, complex EVT, in particular, the recanalization of CTO, remains technically challenging. In addition, EVT for CTO sometimes requires a complex procedure, which means that there may be an increased possibility of procedural complications.

Despite the high number of EVT procedures performed, the volume-outcome relationship of the intervention for CTO has not been reported. Previous studies have investigated the volume-outcome relationship for EVT using a nationwide database and have reported that treatment in high-volume institutions favorably impacts clinical outcomes, such as patency, critical in-hospital complications, and limb preservation.^5–7 However, these studies have not focused on CTO, which is widely considered as one of the most technically demanding type of lesion. The previous studies have included patient-level data more than a decade ago and may not fully reflect the contemporary practice pattern and advent of the endovascular device and techniques.

In this study, we conducted a comprehensive analysis using a current nationwide database to explore the association between institutional volume and short-term clinical outcomes after EVT for CTO in patients with symptomatic LEAD.

Materials and Methods

Registry Data

The Japanese Endovascular Therapy (J-EVT) registry is an ongoing nationwide EVT registry endorsed by the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) that was designed to record clinical characteristics and in-hospital outcomes of patients undergoing EVT. In January 2015, the J-EVT registry was incorporated into the National Clinical Data system, a nationwide prospective web-based registry linked to board certification. Since all hospitals must participate in the J-EVT registry for board certification application and renewal, the degree of data completeness is high. The registered data included clinical diagnosis, baseline patient characteristics, treated vessel territories, lesion morphology (e.g., CTO vs. non-CTO lesions), and short-term clinical outcomes, including procedural success and complications. The CVIT holds an annual meeting of data managers to secure appropriate data collection and performs random audits (20 institutions annually) to check the quality of abstracted data. Data analysis was performed in accordance with the Declaration of Helsinki guidelines and was approved by the ethics committee of the affiliated institution.

Study Population

This study extracted EVT data for CTO in patients with symptomatic LEAD between January 2018 and December 2020. Overall, 96 099 patients had symptomatic LEAD and underwent EVT for aortoiliac (AI), femoropopliteal (FP), and/or below-knee (BK) lesions for chronic limb-threatening ischemia (CLTI) or AI and/or FP EVT for intermittent claudication. Of the total cases, 45 952 (47.8%) were targeted for CTO lesions. After excluding 4052 cases with no available data on institutional volume, the remaining 41 900 EVTs (43.6%) for CTO at 660 cardiovascular centers across Japan were included in this study.

Outcome Measures

We analyzed the association of institutional and operator volumes with technical success and procedural complications of all EVTs. We assessed the technical success rate and procedural complication rate according to the institutional volume. Procedural complications included in-hospital death (regardless of the cause), bleeding complications, emergency operations, distal embolization, vessel rupture, acute occlusion, contrast-induced nephropathy, cardiac shock, and other complications.

Definition

Definition of symptomatic LEAD included intermittent claudication and CLTI. CLTI included a broader and more heterogeneous group of patients with varying degrees of ischemia that may delay wound healing and increase the risk of amputation.⁸ Coronary artery disease was defined as a history of myocardial infarction or revascularization for stenotic coronary artery lesions, whereas cerebrovascular disease was defined as a history of cerebral infarction or hemorrhage with neurological symptoms sustained for ≥24 h. Technical success was defined as successful crossing of the lesion with the guidewire and residual stenosis of <30%. Bleeding complications were defined as access site and bleeding complications requiring transfusion.

Because of the calculation, EVT procedures within the first year of registration at each center were excluded. During the analysis, the institutional volume was categorized into quartiles.

Statistical Analysis

Data are presented as mean ± standard deviation or median (interquartile range, first to third quartile) for continuous variables and as frequencies (percentages) for categorical variables unless otherwise indicated. Statistical significance was set at P < .05, and 95% confidence intervals were reported where appropriate.

To explore the association of institutional and operator volumes with short-term outcomes, odds ratios were derived from a generalized linear mixed model in which the quartile of the hospital volume and that of the operator volume were entered as fixed effects, whereas the operator interinstitution and interoperator variabilities were entered as random effects. The association of institutional volumes (the second to fourth quartiles versus the first quartile) with short-term outcomes was explored using the generalized linear mixed model using a logit link function in which the interinstitution variability was used as a random effect. Four models were developed to reveal this association. The association was validated by supplementing the spline curve of the institutional volume for the outcomes with generalized additive mixed models using a logit link function, in which the interinstitution variability was entered as a random effect. All statistical analyses were performed using the R software (version 4.1.1; R Development Core Team, Vienna, Austria).

Results

The clinical characteristics stratified by institutional volume are summarized in Table 1. The median institutional volume for each CTO case was 99 (interquartile range, 52-194) cases/year. The median institutional volume for all EVT cases per quartile was 29, 68, 125, and 299 cases/year for the first, second, third, and fourth quartiles, respectively. The percentage of institutional volume for each CTO case per quartile was 48.8%, 49.4%, 51.3%, and 53.7%, for the first, second, third, and fourth quartiles, respectively. The operator volume for each CTO case per quartile was 7, 17, 26, and 63 cases/year, for the first, second, third, and fourth quartiles, respectively. Patients in the first quartile had a lower prevalence of diabetes, chronic kidney disease, hemodialysis, and CLTI, which reflected a lower prevalence of BK lesions compared to the patients in the other quartiles. The percentage of multilevel CTO was 5.1%, 6.4%, 6.6%, and 8.9%, for the first, second, third, and fourth quartiles, respectively.

Table 1.

Baseline Characteristics According to Institutional Volume of All EVT.

	Q1	Q2	Q3	Q4
No	9388	10371	10891	11250	P value
Institutional volume (all EVT) (cases/year) [A]	29 (19-39)	68 (58-79)	125 (108-144)	299 (228-448)	<.001
Institutional volume (CTO) (cases/year) [B]	13 (8-19)	33 (27-41)	62 (52-78)	172 (117-233)	<.001
B÷A×100 (%)	48.8 (39.4-57.9)	49.4 (42.3-56.2)	51.3 (43.7-57.7)	53.7 (47.2-63.5)	<.001
Operator volume (all EVT) (cases/year) [C]	14 (8-24)	32 (16-48)	48 (24-87)	120 (57-179)	<.001
(missing data)	1391 (14.8%)	1090 (10.5%)	1087 (10.0%)	761 (6.8%)	<.001
Operator volume (CTO) (cases/year) [D]	7 (4-13)	17 (8-26)	26 (12-46)	63 (30-113)	<.001
(missing data)	1391 (14.8%)	1090 (10.5%)	1087 (10.0%)	761 (6.8%)	<.001
D÷C×100 (%)	53.8 (42.9-66.7)	53.8 (42.9-64.9)	55.3 (45.1-64.7)	58.3 (50.0-68.4)	<.001
(missing data)	1391 (14.8%)	1090 (10.5%)	1087 (10.0%)	761 (6.8%)	<.001
Age (years)	74 ± 9	75 ± 10	75 ± 10	75 ± 10	<.001
Male, n (%)	6528 (69.5%)	7038 (67.9%)	7375 (67.7%)	7473 (66.4%)	<.001
Hypertension, n (%)	7167 (76.3%)	7942 (76.6%)	8299 (76.2%)	8475 (75.3%)	.15
Diabetes mellitus, n (%)	5173 (55.1%)	5842 (56.3%)	6360 (58.4%)	6695 (59.5%)	<.001
Dyslipidemia, n (%)	4816 (51.3%)	5222 (50.4%)	5335 (49.0%)	5174 (46.0%)	<.001
Coronary artery disease, n (%)	3506 (37.3%)	4025 (38.8%)	4251 (39.0%)	4330 (38.5%)	.073
Cerebrovascular disease, n (%)	1284 (13.7%)	1518 (14.6%)	1739 (16.0%)	1863 (16.6%)	<.001
Chronic respiratory disease, n (%)	504 (5.4%)	438 (4.2%)	446 (4.1%)	451 (4.0%)	<.001
Current smoking, n (%)	3237 (34.5%)	3573 (34.5%)	3449 (31.7%)	3471 (30.9%)	<.001
Chronic kidney disease, n (%)	3090 (32.9%)	4407 (42.5%)	5028 (46.2%)	5887 (52.3%)	<.001
Hemodialysis, n (%)	1865 (19.9%)	2647 (25.5%)	3337 (30.6%)	4680 (41.6%)	<.001
Critical limb-threatening ischemia, n (%)	4333 (46.2%)	5608 (54.1%)	6699 (61.5%)	8194 (72.8%)	<.001
ADL, n (%)
Ambulatory	6872 (73.2%)	7180 (69.2%)	7296 (67.0%)	6672 (59.3%)	.90
Wheel chair	2092 (22.3%)	2713 (26.2%)	3097 (28.4%)	3759 (33.4%)
Bed ridden	424 (4.5%)	478 (4.6%)	498 (4.6%)	819 (7.3%)
Lesion distribution of total occlusion, n (%)
Aorto-iliac	1973 (21.0%)	1817 (17.5%)	1605 (14.7%)	1113 (9.9%)	<.001
Femoropopliteal	5788 (61.7%)	5907 (57.0%)	5673 (52.1%)	4919 (43.7%)	<.001
Below the knee	2109 (22.5%)	3324 (32.1%)	4343 (39.9%)	6237 (55.4%)	<.001
Multilevel CTO	476 (5.1%)	664 (6.4%)	721 (6.6%)	1000 (8.9%)	<.001

Continuous data are presented as mean ± standard deviation and categorical data as the number (percentage).

Abbreviations: ADL, activity of daily life; CTO, chronic total occlusion; EVT, endovascular treatment.

Procedural success was achieved in 39 359 patients (93.9 %), and procedural complications were observed in 1076 patients (2.6%). The proportions of technical success and procedural complications according to institutional volume in their respective quartiles are shown in Table 2. The percentage of technical success ranged from 91.3% to 95.6% and that of procedural complications ranged from 1.4% to 3.4%. Bleeding was one of the most common procedural complications. There was an increasing trend in technical success and a declining trend in procedural complications from the first to the fourth quartile (both P < .01).

Table 2.

Technical Success and Procedural Complications According-Institutional Volume for All EVTs.

	Q1	Q2	Q3	Q4	P value
	Estimated	Estimated	Estimated	Estimated	P value
Technical success	91.3% (90.7%-91.8%)	93.3% (92.8%-93.8%)	95.1% (94.7%-95.5%)	95.6% (95.2%-96.0%)	<.001
Procedural complications	3.3% (3.0%-3.7%)	3.4% (3.0%-3.7%)	2.4% (2.1%-2.7%)	1.4% (1.2%-1.6%)	<.001
In-hospital death	0.3% (0.2%-0.4%)	0.3% (0.2%-0.5%)	0.3% (0.2%-0.4%)	0.2% (0.1%-0.2%)
Bleeding complications	1.1% (0.9%-1.3%)	1.0% (0.8%-1.2%)	0.6% (0.5%-0.8%)	0.4% (0.3%-0.5%)
Emergency operation	0.1% (0.1%-0.2%)	0.1% (0.1%-0.2%)	0.0% (0.0%-0.1%)	0.0% (0.0%-0.1%)
Distal embolization	0.4% (0.3%-0.6%)	0.5% (0.3%-0.6%)	0.2% (0.1%-0.3%)	0.3% (0.2%-0.4%)
Vessel rupture	0.6% (0.5%-0.8%)	0.6% (0.4%-0.7%)	0.4% (0.3%-0.6%)	0.4% (0.3%-0.5%)
Acute occlusion	0.4% (0.3%-0.5%)	0.2% (0.2%-0.4%)	0.2% (0.1%-0.3%)	0.2% (0.1%-0.3%)
Contrast induced nephropathy	0.0% (0.0%-0.1%)	0.1% (0.0%-0.2%)	0.1% (0.0%-0.1%)	0.0% (0.0%-0.0%)
Cardiac shock	0.0% (0.0%-0.0%)	0.0% (0.0%-0.1%)	0.0% (0.0%-0.1%)	0.0% (0.0%-0.0%)
Other complications	0.7% (0.6%-0.9%)	1.0% (0.8%-1.2%)	0.7% (0.5%-0.8%)	0.3% (0.2%-0.4%)

Estimated means or proportions (95% confidence interval) after multiple imputation.

Abbreviation: EVT, endovascular treatment.

The association of institutional and operator volumes with technical success and procedural complications of all EVTs is presented in Figure 1A. Institutional volume but not operator volume was significantly correlated with technical success and procedural complications. After adjusting for baseline differences using the generalized linear mixed model with a logit link function, the adjusted odds ratios (ORs) for technical success according to institutional volume in the first quartile were generally lower than those in the other quartiles in all analysis models (Figure 1B). The adjusted ORs for procedural complications were significantly higher in the first quartile and 86 in the third and fourth quartiles, although there was no significant difference between the first and second quartiles (Figure 1C).

A spline relationship was demonstrated using the generalized additive mixed models shown in Figure 2. The predictive probability of technical success tends to increase with increasing institutional volume (Figure 2A). On the contrary, a reverse trend was observed between institutional volume and procedural complications (Figure 2B).

Technical success and procedural complications and their adjusted ORs according to the institutional volume of all EVTs for CTO are presented in Supplementary Table 1 and 2. The same trends were observed in the analyses of institutional volume limited to CTO cases. Additional analyses of the correlation between institutional volume and technical success or procedural complications were performed by lesion level. In AI-level analyses for an institutional volume, technical success was significantly higher in the higher institutional volume; however, procedural complications did not follow the same trend (Supplementary Table 3 and 4). In FP-level analyses for the institutional volume of all EVTs, technical success and procedural complications were significantly associated with better outcomes (Supplementary Table 5 and 6). In BK-level analyses for the institutional volume of all EVTs, technical success was significantly higher in the higher institutional volume, but procedural complications were not (Supplementary Table 7 and 8).

The adjusted ORs for technical success of AI lesions in the first quartile were significantly lower than those in the third and fourth quartiles and there was a difference in the adjusted ORs for procedural complications only in superiority in the fourth quartile (Supplementary Table 9 and 10). Although the adjusted ORs for the technical success of FP lesions increased significantly with increasing institutional volume, only the fourth quartile was associated with significant reduction in procedural complications (Supplementary Table 11 and 12).

The adjusted ORs for technical success in the first quartile were significantly lower those in the third and fourth quartiles. On the other hand, the adjusted ORs for procedural complications were significantly higher in the first quartile than in the third and fourth quartiles (Supplementary Table 13). The adjusted ORs for technical success in the first quartile were significantly lower than those in the second and third quartiles, and the adjusted ORs for procedural complications in the first quartile were significantly lower than those in the third and fourth quartiles (Supplementary Table 14).

Discussion

In our analysis, using a nationwide database between 2018 and 2020, we evaluated and compared the current trends, technical success, and procedural complications of EVT focusing on CTO. This study has 2 important findings. First, a higher institutional volume was significantly and independently associated with a higher technical success rate of EVT for CTO regardless of operator volume. Second, there was an observed progressive reduction in the incidence of procedural complications at higher institutional volumes.

Several studies have investigated the volume-outcome relationship for percutaneous coronary intervention and have reported that treatment in higher-volume institutions favorably impacts short-term adverse outcomes.^9–13 Consistent with these reports, our current data also indicate that EVT in a higher institutional volume has statistically favorable outcomes in terms of technical success and procedural complications for CTO. Moreover, subanalyses by lesion level showed a similar tendency. In contrast to previous J-EVT registry reports, our analysis focused on only CTO procedures and presented a variation of ORs, which was supported by 4 models adjusted for the variables.^6,14 In our study, we also analyzed the association between operator volume and short-term outcomes and demonstrated that institutional volume was more significant factor than operator volume in terms of short-term outcomes. A previous report has suggested an association between operator procedural volume and improving outcomes for CLTI.¹⁵ However, the study period (2003-2007) was earlier than that of our study, which was registered from 2018 to 2020, and a larger number of EVT cases were analyzed in our study. In addition, several explanations for no relationship between operator volume and short-term outcomes exist. First, it is natural that operator volume increases as the number of EVT cases increases. Although total operator experience could not be calculated from the J-EVT registry, there should be experienced operators at higher-level institutional hospitals, resulting in a higher technical success rate and lower procedural complications. Second, the recent advancement in intervention devices or techniques has standardized catheter procedures and the differences between operator volume and short-term outcomes might have been decreasing. Third, the recent intervention fields expand from the coronary field to the structural field and the operator volume of only EVT procedures do not reflect all experiences.¹⁶ Fourth, live demonstrations and conferences focused on EVT techniques are frequently held in Japan. Finally, the higher-volume centers have experienced multiple CTO cases, as demonstrated in Table 1; therefore, the risk prediction or approach for procedural complications, including co-medical staff, has been well explored and studied.

Despite a significant increase in the technical success rate in higher institutional hospitals, it should be noted that there was a success rate of 90% or more, even in lower institutional hospitals. This is because of device progress, experience accumulation, and education such as live demonstrations or academic conferences. To fill the gap in the institutional technical success rate, a continuation of education is desired. In addition, the proctoring system may be effective in increasing technical success and decreasing procedural complications in EVT, as demonstrated in previous studies of coronary intervention.^17,18

A previous report indicated that perioperative complications in AI interventions were independently associated with major adverse cardiac events, whereas other reports demonstrated that perioperative complications in FP and BK interventions were independently associated with major adverse limb events.^19–21

Considering these findings, the prevention of perioperative complications should be mandatory for clinicians involved in the intervention. Ideally, all EVT procedures, including CTO, should be performed at high institutional centers to prevent perioperative complications. However, this could not be achieved because of hospital’s geographic problems.

In this analysis, we observed an increase in the proportion of bleeding complications and vessel rupture among all procedural complications at lower institutional centers; thus, to reduce all procedural complications, we should focus on these 2 complications. As one of the countermeasures, the use of intravascular ultrasound (IVUS) could be the key to preventing vessel rupture because IVUS tells us the accurate vessel size or lesion morphology, with which we could use optimal size balloons or stents.^22–24 On the contrary, another countermeasure to bleeding complications is the use of ultrasound guidance for common femoral artery (CFA) puncture. Previous reports have shown that ultrasound-guided CFA puncture may potentially protect against access site complications.^25,26 In addition, the use of a micropuncture needle for CFA puncture may be recommended to reduce access site complications.²⁷ We have shown that the volume-outcome relationship between recanalization of CTO and initial results still exists currently. Our study demonstrated significant institutional heterogeneity in the treatment of CTO in patients with symptomatic LEAD. However, these are yet to be comprehensively and systematically evaluated in the near future using the latest database.

Study Limitations

Several important limitations are inherent to large administrative databases. First, this was a retrospective observational study, which might be subject to traditional biases of observational studies, such as selection bias. Second, long-term follow-up data were not available in this database. Further investigation is needed to evaluate the relationship between institutional volume and long-term outcomes. Third, this study only included Japanese patients. Thus, our results might not apply to patients from other countries. Fourth, there might be some institutions where some patients are not registered for various reasons, leading to underestimation of our analyses and the possibility of selection bias. Fifth, no data about the number of operators per hospital might not exclude an operator skills-dependent bias. Sixth, sub-analysis for lesion level may have reduced the statistical power due to the reduced number of cases. Finally, this database did not include patients who underwent endovascular procedures performed by vascular surgeons and interventional radiologists who did not belong to our affiliated institution.

Conclusion

In contemporary Japanese EVT practice, a higher institutional volume but not operator volume is significantly associated with higher technical success and lower procedural complications after EVT in patients with symptomatic LEAD.

Supplemental Material

sj-docx-1-jet-10.1177_15266028231161242 – Supplemental material for Institutional Volume and Initial Results for Endovascular Treatment for Chronic Occlusive Lower-Extremity Artery Disease: A Report From the Japanese Nationwide Registry

Supplemental material, sj-docx-1-jet-10.1177_15266028231161242 for Institutional Volume and Initial Results for Endovascular Treatment for Chronic Occlusive Lower-Extremity Artery Disease: A Report From the Japanese Nationwide Registry by Takahiro Tokuda, Mitsuyoshi Takahara, Osamu Iida, Shun Kohsaka, Yoshimitsu Soga, Yasuhiro Oba, Keisuke Hirano, Toshiro Shinke, Tetsuya Amano and Yuji Ikari in Journal of Endovascular Therapy

Supplemental Material

sj-docx-2-jet-10.1177_15266028231161242 – Supplemental material for Institutional Volume and Initial Results for Endovascular Treatment for Chronic Occlusive Lower-Extremity Artery Disease: A Report From the Japanese Nationwide Registry

Supplemental material, sj-docx-2-jet-10.1177_15266028231161242 for Institutional Volume and Initial Results for Endovascular Treatment for Chronic Occlusive Lower-Extremity Artery Disease: A Report From the Japanese Nationwide Registry by Takahiro Tokuda, Mitsuyoshi Takahara, Osamu Iida, Shun Kohsaka, Yoshimitsu Soga, Yasuhiro Oba, Keisuke Hirano, Toshiro Shinke, Tetsuya Amano and Yuji Ikari in Journal of Endovascular Therapy

Supplemental Material

sj-docx-3-jet-10.1177_15266028231161242 – Supplemental material for Institutional Volume and Initial Results for Endovascular Treatment for Chronic Occlusive Lower-Extremity Artery Disease: A Report From the Japanese Nationwide Registry

Supplemental material, sj-docx-3-jet-10.1177_15266028231161242 for Institutional Volume and Initial Results for Endovascular Treatment for Chronic Occlusive Lower-Extremity Artery Disease: A Report From the Japanese Nationwide Registry by Takahiro Tokuda, Mitsuyoshi Takahara, Osamu Iida, Shun Kohsaka, Yoshimitsu Soga, Yasuhiro Oba, Keisuke Hirano, Toshiro Shinke, Tetsuya Amano and Yuji Ikari in Journal of Endovascular Therapy

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Takahiro Tokuda

Osamu Iida

Yoshimitsu Soga

Supplemental Material

Supplemental material for this article is available online.

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