Pulmonary Vein Intervention for Severe Pulmonary Vein Stenosis After Atrial Fibrillation Ablation　― A Retrospective Cohort Study ―

Abstract

Background: Pulmonary vein (PV) stenosis (PVS) is a serious complication of atrial fibrillation (AF) ablation. The objective of this study was to describe interventional treatments for PVS after AF ablation and long-term outcomes in Japanese patients.

Methods and Results: This multicenter retrospective observational study enrolled 30 patients (26 [87%] male; median age 55 years) with 56 severe PVS lesions from 43 PV interventional procedures. Twenty-seven (90%) patients had symptomatic PVS and 19 (63%) had a history of a single AF ablation. Of the 56 lesions, 41 (73%) were de novo lesions and 15 (27%) were retreated. Thirty-three (59%) lesions were treated with bare metal stents, 14 (25%) were treated with plain balloons, and 9 (16%) were treated with drug-coated balloons. All lesions were successfully treated without any systemic embolic event. Over a median follow-up of 584 days (interquartile range 265–1,165 days), restenosis rates at 1 and 2 years were 35% and 47%, respectively. Multivariate Cox regression analysis revealed devices <7 mm in diameter (hazard ratio [HR] 2.52; 95% confidence interval [CI] 1.04–6.0; P=0.040) and totally occluded lesions (HR 3.33; 95% CI 1.21–9.15; P=0.020) were independent risk factors for restenosis.

Conclusions: All PVS lesions were successfully enlarged by the PV intervention; however, restenosis developed in approximately half the lesions within 2 years.

Due to the aging population in Japan, the number of patients with atrial fibrillation (AF) is increasing rapidly.^1,2 Catheter ablation, mainly pulmonary vein (PV) isolation, is actively performed to maintain sinus rhythm.^3,4 However, severe PV stenosis has been reported (frequency 0.5–4.0%) as a serious complication of catheter ablation in the chronic phase, and can be fatal if not treated appropriately.^5–8 Percutaneous PV intervention is a treatment option for PV stenosis (PVS), but the diagnostic and treatment procedures have not yet been established due to the limited number of reported cases in Japan.⁹ The number of catheter ablation cases in Japan is increasing every year,² and PV intervention for PVS is predicted to increase in the future. The aim of the present study was to investigate and describe data on PV intervention for PVS from a multicenter registry, including patient background, interventional procedures, and long-term outcomes, to help establish optimal diagnostic and treatment procedures for this iatrogenic complication.

Methods

Study Patients

This multicenter retrospective observational study was conducted at 3 cardiovascular centers in Japan (Saga University Hospital, Kokura Memorial Hospital, and Saga-ken Medical Centre Koseikan). Thirty patients who were clinically indicated to undergo PV intervention for PVS or PV occlusion after AF ablation between 2010 and 2023 were enrolled in the study. Thirty paients with 56 lesions in 43 PV interventional procedures were analyzed retrospectively. PVS was defined as >75% stenosis or total occlusion evaluated by contrast-enhanced computed tomography (CT). The clinical indications for PV intervention were symptoms associated with PVS in 27 (90%) patients and abnormal chest radiograph findings due to PVS in 3 (10%) asymptomatic patients.

PV Intervention Procedure

Venous access was achieved through the femoral vein. Either a steerable sheath (Agilis; Abbott, St. Paul, MN, USA) or a non-steerable sheath (Swartz SL0, Abbott) was used for the transseptal approach and as a guiding catheter sheath for the PV intervention. The choice of plain old balloon angioplasty (POBA), stents, or drug-coated balloons (DCB), and whether to use intravascular ultrasound (IVUS) were left to the operators at each institute. In all cases, 0.014-inch guidewires were used. The “largest device diameter” was defined as the largest diameter of any device used for the lesion (either the treatment device or the device used for post-dilation).

Ethical Considerations

The study protocol was approved by the Ethics Committee of Saga University Hospital (Approval reference no. 20230211). This study was conducted in accordance with the principles of the Declaration of Helsinki.

Data Collection

The following data were collected: the clinical characteristics of the study patients, including medical history, AF ablation history, and presenting symptoms; the diagnostic process; PV intervention procedures; postprocedural management; and long-term restenosis, death, and surgical intervention. Follow-up data were obtained from clinic visits and hospital admission records.

A long-term restenosis event was defined as the recurrence of PVS with symptoms or abnormal chest radiograph findings or >75% stenosis or total occlusion on follow-up examinations. The lesions were evaluated by follow-up contrast-enhanced CT.

Statistical Analysis

Patient, procedure, and lesion-specific variables were analyzed. Categorical variables are presented as percentages, and the significance of differences in categorical variables between approaches was analyzed using Chi-squared statistics. Continuous variables are presented as the median with interquartile range (IQR) and were compared using the Mann-Whitney U test. The Kaplan-Meier method was used to estimate restenosis event proportions, with the significance of differences between groups evaluated using the log-rank test. To evaluate risk factors for restenosis, univariable Cox proportional hazard regression analysis was performed to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). Multivariate Cox regression analyses were also performed using variables with P<0.20 in the univariate analysis. All statistical inferences were made using 2-sided P values at a 5% significance level. Statistical analyses were performed using R version 4.3.2 (R Foundation for Statistical Computing, Vienna, Austria).

Results

Patient Characteristics

We enrolled 30 patients with 56 lesions in 43 PV interventional procedures. Patient background, history of previous AF ablation, and the diagnostic process are presented in Table 1. Of the 30 patients in this study, 26 (87%) were men. The median age was 55 years (IQR 46–65 years). The left atrial diameter evaluated by transthoracic echocardiography just before PV intervention was 34.0 mm (IQR: 32.0–39.1 mm). Only 3 (7%) patients had recurrent AF at the time of diagnosis of PVS. Before the PV intervention, 25 (83%) patients were on an anticoagulant and 16 (53%) were on antiplatelet therapy. Symptoms were present in 27 (90%) patients. The symptoms in most patients were hemoptysis or dyspnea on exertion (Figure 1). Three (10%) patients were asymptomatic but had abnormal chest radiographs that appeared to be caused by PVS; this was considered as an indication for PV intervention. Symptoms developed a median of 5 months (IQR 4–9 months) after the last AF ablation procedure. Nineteen (63%) patients had a history of a single AF ablation, whereas the remaining patients had undergone ≥2 sessions. In 28 (93%) patients, the most recent ablation performed was radiofrequency ablation (RFA). No patients were treated with high-power and short-duration RFA. The median delay between the onset of symptoms and the diagnosis of PVS was 1 month (IQR 1–3 months).

Table 1.

Patient Characteristics (n=30)

Male sex	26 (87)
Age (years)	55 [46–65]
Chronic heart failure	3 (10)
Chronic kidney disease (eGFR <60 mL/min/1.73 m2)	11 (37)
Coronary disease	1 (3)
Hypertension	12 (40)
Dyslipidemia	7 (23)
Diabetes	0 (0)
History of smoking	10 (33)
History of stroke	0 (0)
Symptomatic at diagnosis	27 (90)
EF (%)	62.5 [60.0–66.4]
LAD (mm)	34.0 [32.0–39.1]
AF recurrence	2 (7)
Antithrombotic drug before the procedure
Anticoagulant therapy	25 (83)
Antiplatelet therapy	16 (53)
No. prior AF ablations
1	19 (63)
2	10 (33)
3	0 (0)
4	1 (3)
Most recent AF ablation
Radiofrequency ablation	28 (93)
Cryoablation	2 (7)
Time from ablation to symptom onset (months)	5 [4–9]
Time from symptom onset to diagnosis (months)	1 [1–3]
Contrast CT as diagnostic tool	30 (100)

Categorical variables are presented as n (%) and continuous variables are presented as the median [interquartile range]. AF, atrial fibrillation; CT, computed tomography; EF, ejection fraction; eGFR, estimated glomerular filtration rate; LAD, left atrial diameter.

Figure 1.

Chief complaints of patients with severe pulmonary vein stenosis at diagnosis.

Procedure-Related Information

Procedural data are presented in Table 2. Of the 43 procedures in total, 29 (67%) were initial treatments for de novo lesions, 10 (23%) were second treatments for restenosis, and 4 (9%) were third treatments for restenosis. Steerable (Agilis) and non-steerable (Swartz SL0) sheaths were used in 38 (88%) and 5 (12%) procedures, respectively. Eleven (26%) procedures required treatment of ≥2 branches in the same session.

Table 2.

Procedural Data (n=43)

Treatment number
Initial treatment	29 (67)
Second treatment	10 (23)
Third treatment	4 (9)
Guiding sheath
Agilis series	38 (88)
SL series	5 (12)
Guidewire
0.014 inch	43 (100)
Two or more branches treated	11 (26)
Acute procedural success	43 (100)
Procedural complications	3 (7)

Data are presented as n (%).

In all cases, the lesions were enlarged and the procedure was successfully completed. Complications occurred in 3 patients: transient hypotension due to diffuse coronary spasm immediately after revascularization in 1 patient; worsening of respiratory status, possibly due to ventilation-perfusion imbalance caused by revascularization during the procedure in 1 patient; and pericardial effusion observed the day after the procedure, possibly due to vessel injury caused by the balloon or wire in 1 patient. All 3 patients with complications were discharged without the need for additional invasive treatment. Cerebral infarction, the most concerning complication, did not occur in any patient.

Lesion and Treatment Data

PVS lesions and treatment data are presented in Table 3. Of the 56 PVS, 41 (73%) lesions were de novo lesions and 15 (27%) were retreated lesions. Forty-eight (86%) lesions were on the left side and 8 (14%) were on the right. Twenty-nine (52%) lesions were in the left inferior (LI) PV, and 17 (30%) were in the left superior (LS) PV. Thirty-four (61%) lesions were totally occluded and 22 (39%) showed non-occlusive stenosis.

Table 3.

Lesion and Treatment Data

Lesions (n=56)
De novo or restenosis
De novo	41 (73)
Restenosis	15 (27)
Lesion site
RS PV	3 (5)
RM PV	1 (2)
RI PV	4 (7)
LS PV	17 (30)
LM PV	2 (4)
LI PV	29 (52)
Lesion morphology
Totally occluded	34 (61)
Non-occlusive	22 (39)
Treatment (n=56)
BMS	33 (59)
DCB	9 (16)
POBA	14 (25)
IVUS use	19 (34)
Stent diameter (mm; n=33)
5	1 (3)
6	2 (6)
7	15 (46)
8	14 (42)
9	1 (3)
Largest device diameter (mm; n=56)
4–6	13 (23)
7–9	26 (46)
10–12	17 (30)

Categorical variables are presented as n (%). BMS, bare metal stent; DCB, drug-coated balloon; IVUS, intravascular ultrasound; LI, left inferior; LM, left middle; LS, left superior; POBA, plain old balloon angioplasty; PV, pulmonary vein; RI, right inferior; RM, right middle; RS, right superior.

Thirty-three (59%) lesions were treated with bare metal stents (BMS), 14 (25%) were treated with POBA, and 9 (16%) were treated with a DCB. Information for the lesions treated with a DCB are presented in Supplementary Table 1. In most cases with BMS treatment (91%), a BMS of ≥7 mm was implanted. In 43 (77%) lesions, the diameter of the largest device used for each lesion was ≥7 mm.

The use of IVUS was left to the operators’ discretion, and IVUS was performed in 19 (34%) lesions. Among the 41 de novo lesions, IVUS was used in 13 (32%) lesions and there was a trend towards smaller largest device diameters in cases using IVUS, although the difference was not statistically significant (Figure 2).

Figure 2.

Differences in the diameter of the largest device used for de novo lesions during pulmonary vein intervention according to the use of intravascular ultrasound (IVUS). The boxes show the interquartile range, with the median value indicated by the horizontal line; whiskers show the range.

Postprocedural Management

Data on postprocedural management are presented in Supplementary Table 2. Postoperatively, all patients received antiplatelet or anticoagulant medications. Most (82%) patients received 2 antiplatelet agents or a combination of antiplatelet and anticoagulant therapy. Only 3 (7%) patients were treated with triple therapy (a combination of dual antiplatelet therapy and anticoagulation). In approximately half the patients (49%), antithrombotic therapy was reduced within 6 months. All patients continued on at least an antiplatelet or an anticoagulant during the follow-up period.

Prognosis

The median duration of follow-up was 584 days (IQR 265–1,165 days). None of the patients died or required lung resection during the follow-up period. During follow-up, restenosis was confirmed in 24 of 56 lesions. The restenosis rates were 35% at 1 year and 47% at 2 years (Figure 3A). There were no significant differences in the restenosis rate between the de novo and retreated lesions (Figure 3B). The restenosis rate was significantly lower for a device diameter ≥7 mm and a non-occlusive lesion (Figure 3C,D).

Figure 3.

Prognosis of long-term restenosis in patients undergoing pulmonary vein intervention for severe pulmonary vein stenosis after atrial fibrillation ablation: (A) all lesions; (B) de novo vs. retreatment groups; (C) largest device diameter ≥7 vs. <7 mm; and (D) lesion morphology, totally occluded vs. non-occlusive groups. *P<0.05.

Univariate and multivariate Cox regression analyses of risk factors for restenosis are presented in Table 4. Devices <7 mm in diameter and totally occluded lesions were identified as independent risk factors for restenosis.

Table 4.

Predictors of Restenosis During the Study Period

	Univariate		Multivariate
	HR (95% CI)	P value	HR (95% CI)	P value
Largest device diameter (<7 vs. ≥7 mm)	2.59 (1.10–6.10)	0.029*	2.52 (1.04–6.01)	0.040*
Lesion morphology (totally occluded vs. non-occluded)	2.57 (1.01–6.55)	0.048*	3.33 (1.21–9.15)	0.020*
Used device (BMS or DCB vs. POBA)	0.53 (0.22–1.25)	0.147	0.47 (0.19–1.19)	0.117
Reduction of antithrombotic therapy within 6 months	0.68 (0.30–1.53)	0.353	–
IVUS use	1.24 (0.47–3.19)	0.660	–
Lesion site (superior vs. inferior)	0.82 (0.35–1.93)	0.657	–
Male sex	0.82 (0.30–2.21)	0.693	–
De novo vs. retreatment	0.87 (0.34–2.21)	0.767	–

*P<0.05. CI, confidence interval; HR, hazard ratio. Other abbreviations as in Table 3.

A typical case of BMS restenosis after PV intervention is shown in Figure 4. This patient, a 57-year-old man, presented with hemoptysis 5 months after his second RFA. Contrast-enhanced CT revealed PV occlusion in the LS and LI PVs, and a PV intervention was performed. A 7-mm×19-mm BMS at the ostium of the LS PV and a 5-mm×19-mm BMS at the ostium of the LI PV were placed. Contrast-enhanced CT immediately after implantation confirmed that both stents were open. However, 8 months after treatment, hemoptysis recurred and contrast-enhanced CT showed occlusion of the 5-mm BMS at the LI PV ostium. Malapposition of the BMS in the LS PV was confirmed on short-axis CT images.

Figure 4.

A typical case of bare metal stent (BMS) restenosis after pulmonary vein (PV) intervention. Five months after atrial fibrillation ablation in a 57-year-old man with PV stenosis, a 7-mm×19-mm BMS was placed at the ostium of the left superior (LS) PV and a 5-mm×19-mm BMS was placed at the ostium of the left inferior (LI) PV. Contrast-enhanced computed tomography (CT) immediately after implantation confirmed that both stents were open. However, 8 months after treatment, hemoptysis recurred and contrast-enhanced CT showed occlusion of the 5-mm BMS at the LI PV ostium. Malapposition of the BMS in the LS PV was observed. Pink arrowheads indicate the occluded LI PV; the yellow arrow indicates the position of the short axis at the site of stent malapposition.

Discussion

Major Findings

We retrospectively investigated and described the patient characteristics and long-term outcomes of Japanese patients who underwent PV intervention for severe PVS. In the present cohort, severe PVS was more common in relatively young men, with symptoms appearing within 6 months of the last ablation, and many patients presented with complaints of hemoptysis or dyspnea on exertion. Although all patients underwent successful intervention, approximately half experienced restenosis within 2 years. Restenosis rates were higher for lesions treated with devices <7 mm in diameter and totally occluded lesions.

Diagnosis of PVS After AF Ablation

PVS during the chronic phase of AF ablation can be a serious complication if not treated appropriately. Unfortunately, PVS is not typically diagnosed promptly because of the small number of cases and lack of awareness among clinicians.¹⁰ PVS may be treated as a respiratory disease, mostly pneumonia, because the primary symptoms of PVS are hemoptysis and cough or because of abnormal findings noted on radiography. In our cohort, there was also a 1- to 3-month delay from symptom onset to definitive diagnosis. In the 3 centers participating in this study with experience in PVS diagnosis, all cases were diagnosed using contrast-enhanced CT scans, underscoring the importance of this imaging modality when PVS is suspected after AF ablation.

Mechanism of PVS After AF Ablation

Although the exact pathophysiological mechanism remains unclear, the ablation site (more distal parts of the PVs), a high-power setting during radiofrequency application, and multiple sessions are thought to be associated with the development of PVS.¹¹ The PVS patients in our cohort were 10 years younger than Japanese AF ablation patients reported in The Japanese Catheter Ablation Registry (mean [±SD] age 67±11 years).² In addition, based on the left atrial diameter evaluated by transthoracic echocardiography, the left atrial remodeling in our cohort was less advanced than that in general AF ablation cases.^13–15 PVS after AF ablation has been reported, even in pediatric cases.¹² Younger patients generally have less advanced structural remodeling.^13,14 These data suggest that patients with less advanced structural remodeling of the atria and PVs are more likely to develop PVS, possibly due to smaller PV diameters, a higher amount of myocardial mass,^13,14 more severe inflammation, and the subsequent fibrotic process of the ablation lesions, resulting in shrinkage of the PV.

One of the findings of this study was that most cases of PVS occurred after RFA, with a small number of cases after cryoablation. It has been reported that the incidence of PVS after cryoablation in Japanese patients is very low (0.07%).¹⁵ A recent study showed that the incidence of symptomatic PVS after RFA using conventional power setting is 0.2%, and that this increased up to 0.8% when high power and short duration were used; however, no symptomatic PVS was observed after cryoablation.¹⁶ The reason why cryoablation has a lower frequency of PVS than RFA is still unclear. Anatomically, in the immediate vicinity of each of the PVs, muscle fibers leave the main fascicle and turn around the opening of these veins, forming a sphincter-like structure. Some of these circular fibers extend to the PV, forming the myocardial sleeves,¹⁷ which are the targets of the electrical PV isolation procedure. We speculate that the narrower width of ablation lesions in the case of RFA compared with cryoablation may result in a higher amount of residual circular fibers in the PVs, causing PVS due to shrinkage of the circular fibers in the manner of a ring following fibrotic changes. Conversely, cryoablation may potentially prevent PVS because the width of the ablation lesions is wider, resulting in fewer residual circular fibers in the PVs. Furthermore, in RFA, inaccurate geometry and geometry shifts in 3-dimensional mapping sometimes occur due to inadequate respiratory management and body movements associated with sedation and pain. This is particularly important in patients with a smaller left atrium and smaller PVs, where inadvertent ablation of the distal PV may be the cause of PVS. Thus, RFA, especially for relatively young male patients with a small left atrium and smaller PVs, may have a higher risk of PVS than cryoablation. More than half the patients in our cohort developed severe PVS after the first ablation, suggesting that any patient who undergoes AF ablation should be followed up bearing in mind the possibility of PVS in the chronic phase.

Device Options and Long-Term Restenosis

Device options for PV interventions in PVS include POBA, stents, and DCB. Previous comparative studies have shown that BMS reduce long-term restenosis better than POBA.^10,18–21 Drug-eluting stents (DES) are the standard of care in coronary arteries, but it is unclear whether DES are more beneficial than BMS for PVS interventions.^22–24 A BMS was primarily used in our cohort data. However, stenotic PV lesions are anatomically unsuitable for stenting because the distal portion of the lesion is heavily branched, resulting in a large difference between the ostial and distal diameters of the vessel. Furthermore, the lack of available devices to overcome these anatomic problems and properly expand the stent makes the procedure difficult. Therefore, POBA may have to be selected in some cases when stenting is not suitable. A DCB is a new potential option for PV interventions. In our study, a DCB was used to treat a small number of de novo lesions. Although the literature regarding the use of a DCB in PV interventions is limited to case reports and adequate long-term results have not been demonstrated,^25–28 our data showed comparable outcomes to BMS.

Whether using a stent or balloon dilation, the diameter of the device is reported to be an important factor in long-term patency.^21,29 Our cohort data also showed a trend towards lower restenosis rates in patients with devices ≥7 mm in diameter and in patients with a BMS or DCB. However, it should be kept in mind that it is not clear whether this result is due to the choice of larger-diameter devices or BMS, or because originally larger vessels have a better outcome.

In terms of lesion morphology, totally occluded lesions had high restenosis rates. Previous reports have also shown that occluded lesions tend to have a higher restenosis rate compared with severely stenotic lesions.^30,31 The event rate is particularly high for occluded lesions treated with POBA, suggesting that more attention should be paid to the choice of treatment device and management during the chronic phase for totally occluded lesions.

In PV intervention, IVUS is expected to facilitate optimal stent diameter selection and postimplantation optimization.³² Previous studies on PV interventions have reported PV perforation as a procedural complication.^10,18,19,23 IVUS reduces the risk of vascular injury by providing the operators with an accurate vessel diameter and avoiding overdilation due to device mismatch. Therefore, IVUS may improve procedural safety. However, in our study, the diameter of the largest device selected for de novo lesions in cases where IVUS was used was smaller, which may reduce the long-term patency rate. The reason for analyzing the impact of IVUS use on device diameter only for de novo lesions is that device selection for retreated lesions is largely influenced not only by the IVUS findings, but also by the device diameter used in the previous treatment. Further studies are required to determine whether IVUS can be used to select optimal device size.

Previous studies have shown high restenosis rates, and the optimal treatment has not been established.^10,18–21 In our cohort, approximately half the patients had restenosis within 2 years. Despite the high restenosis rate, there were no deaths in our cohort, and some patients remained asymptomatic after re-occlusion. The challenge for PV intervention is to find treatment options with better long-term outcomes, because the current basic goal for PV intervention is to alleviate symptoms, even temporarily, until collateral blood circulation develops and the symptoms disappear.

Postoperative Management

Postoperative antithrombotic regimens have also not been established.²⁹ Many patients are on direct oral anticoagulants after AF ablation, and the addition of dual antiplatelet therapy, which is usually administered after the intervention, would result in a triple-drug regimen and could cause significant bleeding. However, it has been reported that the rate of restenosis in the chronic phase was lower in patients treated with triple therapy.³³ In the present cohort, only 1 patient received triple therapy. It is unclear whether these data are applicable to the Japanese population, which has a high incidence of bleeding events.^34,35

Acute Embolic Events

Regarding acute embolic events during or after PV intervention, PV thrombosis in a patient who underwent surgical lobectomy for PV obstruction after RFA has been reported.³⁶ This suggests that the thrombus may be the cause of systemic embolism during PV intervention. However, to the best of our knowledge, there have been no reports of systemic embolism due to intrinsic emboli, although there have been reports of stent dislodgement-related embolic stroke or embolic stroke related to the other complications.²¹ In our study, there were no systemic embolisms, including strokes. PV intervention in patients with symptomatic PV stenosis should not be withheld because of an undue concern for procedure-related embolism.

Study Limitations

Our study has several limitations that warrant mention. First, although data were collected from multiple centers, the number of patients with PVS after AF ablation was limited. Second, diagnostic procedures and treatment strategies are left to physicians at each institution and do not follow established protocols. Third, postoperative management is performed as per usual practice, and asymptomatic restenosis may be missed. Due to these limitations, our findings should be interpreted with caution.

Conclusions

We retrospectively investigated and described the procedural data and long-term outcomes in Japanese patients who underwent PV interventions for severe PVS. Although all lesions were successfully enlarged by PV intervention, approximately half the patients experienced restenosis within 2 years. Lesions treated with devices <7 mm in diameter and totally occluded lesions showed higher restenosis rates. There were no deaths and no surgical treatments performed during the study period. Given the increasing number of AF ablations in the future, we hope this study will raise awareness of this important potential chronic complication.

Acknowledgments

The authors thank Editage (www.editage.jp) for English language editing.

Sources of Funding

This study did not receive any specific funding.

Disclosures

K.Y. and S.S. are also affiliated with the Department of Medical Engineering Cardiology, Saga University, which is sponsored by Fukuda Denshi Co., Ltd., Japan. K.N. is a member of Circulation Journal’s Editorial Team. The remaining authors have no disclosures to report regarding this manuscript.

IRB Information

This study was approved by the Ethics Committee of Saga University Hospital (Approval reference no. 20230211).

Data Availability

Deidentified participant data, including patient information and the statistical analysis plan, will be shared up to 36 months after the publication of this paper on a request basis for anyone under approval of the Research Ethics Committee of the Saga University Hospital. The data can be used for any kind of analysis and will be shared in Excel format via email.

Supplementary Files

Please find supplementary file(s);

https://doi.org/10.1253/circj.CJ-23-0892

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