Abstract
Background
Catheter ablation (CA) for ventricular tachycardia (VT) is an effective treatment for preventing VT recurrence. However, the optimal timing and outcomes of CA for VT during emergent admission remains unclear.
Methods and Results
We retrospectively investigated patients who underwent CA for VT after emergent admission between 2012 and 2021 using the Japanese Registry of All Cardiac and Vascular Diseases database. The clinical characteristics, complication and outcomes (primary outcome: in-hospital death; secondary outcome: emergent re-admission for VT within 30 days) were compared between the patients who underwent CA within (CA ≤3) and after (CA >3) the third day of admission. A total of 3,827 patients (787 patients had CA ≤3 days, and 3,040 patients had CA >3 days) was enrolled. Compared with the CA >3 days group, those with CA ≤3 were younger and had less comorbidities of underlying heart diseases and medications. After adjusting for baseline characteristics, CA ≤3 days or >3 days after emergent admission was not associated with in-hospital death and re-admission for VT. Furthermore, the emergent re-admission and overall complication rates were not significantly different between the 2 groups.
Conclusions
The clinical background differed substantially between patients who underwent CA within 3 days and those who underwent CA later during emergency hospitalization. An emergency CA for VT is not strongly recommended; however, it might be acceptable in cases with unavoidable circumstances.
Key Words: Catheter ablation, Diagnosis procedure combination database, Real-world data, Ventricular tachycardia
Catheter ablation (CA) for ventricular tachycardia (VT) is an effective treatment to prevent VT recurrence.1,2 Several multicenter randomized trials have shown that CA is superior to antiarrhythmic drug (AAD) therapy or an implantable cardioverter-defibrillator (ICD) alone in preventing recurrent VT or death due to ischemic heart diseases.3–5 Even in patients with ischemic heart diseases and ICD, sustained VT before ICD implantation was shown as an independent predictor of appropriate ICD therapy, suggesting significance of VT suppression.6 Furthermore, CA reduces VT recurrence in non-ischemic cardiomyopathy.7,8 Recent European Society of Cardiology and American Heart Association/American College of Cardiology/Heart Rhythm Society guidelines recommend attempting CA for VT refractory to AADs, regardless of underlying heart diseases.9,10
However, the clinical outcomes after CA for VT in patients with an emergent admission remain unclear. Generally, the earlier suppression of VT may have a beneficial effect on hemodynamic stabilization, but early CA for VT may lead to an increase in complications. Previous studies have demonstrated that rescue CA within 24 h for electrical storm with cardiogenic shock was associated with a higher proportion of ablation failure and electrical storm recurrence.11 Among high-risk patients with electrical storm, CA performed >48 h after admission is associated with lower 30-day mortality.12 However, previous reports were a single-center with small sample sizes, and few studies compared outcomes based on the duration from admission to CA. Thus, it remains unclear when CA for emergent VT should be performed. Therefore, this study aimed to assess the appropriate timing of CA for patients with emergent admission for VT using a larger cohort.
Methods
Data Source
We retrospectively analyzed the data of patients who underwent CA for VT after emergent admission using the Diagnosis Procedure Combination database of the Japanese Registry of All Cardiac and Vascular Diseases (JROAD-DPC), in which 403 hospitals participated between April 2012 and March 2021. The JROAD-DPC includes patient information, such as age, sex, main diagnosis, comorbidities, medications, devices, procedures, complications arising after admission, hospitalization period, and discharge status.13–16 Diagnoses are listed by detailed names, as well as by the International Classification of Diseases, 10th Revision (ICD-10) codes.
This study was approved by the institutional review board of the National Cerebral and Cardiovascular Center (R22025). The requirement for informed consent was waived, as personal information was not included in the database.
Study Population
Figure 1 shows a flowchart of this study. We enrolled patients from the JROAD-DPC who underwent CA and those with VT using the ICD-10 code I472 for ‘main diagnosis’, ‘admission-precipitating diagnosis’, ‘most resourceconsuming diagnosis’, and/or ‘second most resourceconsuming diagnosis’ (n=13,732). Subsequently, we excluded patients who: (1) were diagnosed with supraventricular arrhythmia and/or Wolff-Parkinson-White syndrome by the ICD-10 codes I48$, I471, and I456 for ‘main diagnosis’, ‘admission-precipitating diagnosis’, ‘most resourceconsuming diagnosis’, and/or ‘second most resourceconsuming diagnosis’ (n=570); (2) had CA for verapamil-sensitive VT (n=79) or non-sustained VT (n=2,429); (3) were discharged on March of each year (n=984) because the JROAD-DPC database collected data on an annual basis (from April to March); (4) had CA with planned admissions (n=5,823); and (5) were missing data (n=20).
Figure 1.
Study flow chart. CA, catheter ablation; ICD-10, International Classification of Diseases, 10th Revision; JROAD-DPC, Diagnosis Procedure Combination of the Japanese Registry of All Cardiac and Vascular Diseases; VT, ventricular tachycardia; WPW, Wolff-Parkinson-White.
In total, 3,827 patients who underwent CA for VT of emergent admission were enrolled. Based on a previous study demonstrating that conducting a CA >48 h after admission is associated with reduced 30-day mortality,12 we selected 3 days as the cut-off point. We then divided all patients into 2 groups: those who underwent CA within 3 days of admission (CA ≤3 days group), and those who underwent CA after the third day of admission (CA >3 days group). ‘Day 1’ refers to the day of admission.
Outcomes
The primary outcomes were in-hospital mortality and emergent re-admission within 30 days of VT diagnosis, respectively. Although the JROAD-DPC data did not include VT recurrence evaluated by electrocardiography, we evaluated emergent re-admission with VT as a surrogate marker of VT recurrence. Secondary outcomes were newly required procedures and complications after CA. These included direct current cardioversion, AAD intravenous drip, intubation, intra-aortic balloon pump (IABP), percutaneous cardiopulmonary support, and transfusion. ICD implantation was also included as an outcome. Furthermore, complications attributed to CA were analyzed using ICD-10 diagnoses (coded for ‘complications arising after admission’) as follows: cardiac complications (cardiac tamponade: I319 and I971; myocardial infarction: I21$; vasospastic angina: I201; and complete atrioventricular block: I442), pulmonary complications (pneumothorax: J930, J931, J938, and J939; and hemothorax: J942), neurological complications (stroke: I63$), and vascular access complications (thigh hematoma: T810; pseudoaneurysm: I724; and arteriovenous fistula: I770).
Statistical Analysis
Categorical data were presented as counts and percentages. Continuous data were presented as median and interquartile range (IQR). The χ2 or Fisher’s exact tests were used to compare categorical data. The Wilcoxon rank-sum test was used to compare continuous data.
We performed multivariable logistic analysis to compare the outcomes between the CA ≤3 days and CA >3 days groups, adjusting for the following covariates: age, sex, coexistence of ischemic heart disease, supraventricular tachycardia, Charlson Comorbidity Index (CCI) without age, IABP before CA, percutaneous cardiopulmonary support before CA, intubation before CA, catecholamine use before CA, and AAD intravenous drip before CA. We also performed propensity score-matching analysis. Propensity scores were calculated using multivariable logistic regression models for the CA ≤3 days group. Age, sex, comorbid ischemic heart disease, non-ischemic cardiomyopathy, supraventricular tachycardia, CCI without age, IABP before CA, percutaneous cardiopulmonary support before CA, intubation before CA, catecholamine use before CA, and AAD intravenous drip use before CA were used as independent variables. Nearest neighbor matching was performed without replacement using a 1 : 1 ratio and a caliper of 0.2 standard deviations of the logit of the propensity score. The balance of each covariate between the 2 groups before and after matching was evaluated using standardized differences. Standardized differences with an absolute value of <0.1 were considered well balanced.
All tests were 2-sided, and values of P<0.05 were considered significant. All statistical analyses were performed using STATA 16.0 (StataCorp, College Station, TX, USA).
Results
Clinical Characteristics
The distribution of day of CA is shown in Figure 2. There were 787 patients in the CA ≤3 days group and the remaining 3,040 patients were in the CA >3 days group. The median interval from admission to CA was 1 day (IQR 1–2 days) in the CA ≤3 days group, and 8 days (IQR 5–13 days) in the CA >3 days group. Table 1 summarizes the differences in baseline characteristics between the CA ≤3 days and >3 days groups. Compared with the CA >3 days group, the CA ≤3 days group were significantly younger and had less ischemic heart disease, lower CCI without age, and received less mechanical circulatory support, catecholamine, and AAD intravenous drips before CA.
Figure 2.
The distribution of catheter ablation dates. The horizontal axis represents the days of admission to ablation. Day 1 refers to the date of admission. Red columns show the catheter ablation ≤3 days group.
Table 1.
Baseline Characteristics Between Patients Who Underwent CA ≤3 Days and >3 Days After Admission
| CA ≤3 days (n=787) |
CA >3 days (n=3,040) |
P value | |
|---|---|---|---|
| Age (yearssssssssssssss) | 65 [54–73] | 67 [56–74] | 0.024 |
| Female | 206 (26) | 725 (24) | 0.190 |
| Underlying heart diseases | |||
| IHD | 261 (33) | 1,176 (39) | 0.004 |
| NICM† | 79 (10) | 412 (14) | 0.008 |
| DCM | 44 (6) | 302 (10) | <0.001 |
| HCM | 36 (5) | 111 (4) | 0.25 |
| Sarcoidosis | 25 (3) | 119 (4) | 0.40 |
| Valvular diseases | 24 (3) | 80 (3) | 0.54 |
| Supraventricular arrhythmia | 122 (16) | 546 (18) | 0.11 |
| CCI without age | 1 [0–2] | 1 [1–2] | <0.001 |
| MCS before CA | 7 (0.9) | 71 (2.3) | 0.010 |
| IABP | 5 (0.6) | 67 (2.2) | 0.003 |
| PCPS | 3 (0.4) | 19 (0.6) | 0.60 |
| Intubation before CA | 33 (4.2) | 340 (11.2) | <0.001 |
| Catecholamine use before CA | 28 (3.6) | 311 (10.2) | <0.001 |
| AAD div before CA | 190 (24.1) | 1,462 (48.1) | <0.001 |
| Amiodarone | 121 (15.4) | 1,019 (33.5) | <0.001 |
| Lidocaine | 43 (5.5) | 341 (11.2) | <0.001 |
| Nifekalant | 42 (5.3) | 292 (9.6) | <0.001 |
| Pilsicainide | 7 (0.9) | 61 (2.0) | 0.034 |
| Flecainide | 2 (0.3) | 9 (0.3) | >0.99 |
| Landiolol | 12 (1.5) | 113 (3.7) | 0.001 |
†NICM includes DCM and HCM. Data are presented as n (%), or median [IQR]. AADs, antiarrhythmic drugs; CA, catheter ablation; CCI, Charlson Comorbidity Index; DCM, dilated cardiomyopathy; HCM, hypertrophic cardiomyopathy; IABP, intra-aortic balloon pump; IHD, ischemic heart disease; MCS, mechanical circulatory support; NICM, non-ischemic cardiomyopathy; PCPS, percutaneous cardiopulmonary support.
Acute Outcomes After CA for VT
Table 2 shows the acute outcomes after CA. The in-hospital mortality rate was 2.3%, and no significant difference was observed in in-hospital death between the CA ≤3 days and CA >3 days groups (2.7% vs. 2.2%; P=0.44). The rate of direct current cardioversion performed was significantly higher in the CA ≤3 days group compared with the CA >3 days group, and use of some AADs (amiodarone, lidocaine, pilsicainide, and flecainide) after CA was larger in the CA ≤3 days group. Use of intubation and IABP after CA were significantly higher in the CA ≤3 days group than that in the CA >3 days group. Conversely, the ICD implantation rate during the index admission was significantly lower in the CA ≤3 days group than that in the CA >3 days group (15.4% vs. 22.1%; P<0.001). Overall complication rates showed no difference between the 2 groups (3.8% vs. 4.1%; P=0.77).
Table 2.
Acute Outcomes After CA for Ventricular Tachycardia
| Total (n=3,827) |
CA ≤3 days (n=787) |
CA >3 days (n=3,040) |
P value | |
|---|---|---|---|---|
| In-hospital death | 88 (2.3) | 21 (2.7) | 67 (2.2) | 0.44 |
| DC after CA | 424 (11.1) | 107 (13.6)* | 317 (10.4)* | 0.012* |
| AAD iv after CA | ||||
| Amiodarone | 341 (8.9) | 117 (14.9)* | 224 (7.4)* | <0.001* |
| Lidocaine | 96 (2.5) | 29 (3.7)* | 67 (2.2)* | 0.018* |
| Nifekalant | 136 (3.6) | 36 (4.6) | 100 (3.3) | 0.083 |
| Pilsicainide | 23 (0.6) | 10 (1.3)* | 13 (0.4)* | 0.006* |
| Flecainide | 8 (0.2) | 5 (0.6)* | 3 (0.1)* | 0.003* |
| Landiolol | 42 (1.1) | 9 (1.1) | 33 (1.1) | 0.89 |
| Novel ICD implantation during hospitalization |
794 (21) | 121 (15.4)* | 673 (22.1)* | <0.001* |
| All complication | 153 (4.0) | 30 (3.8) | 123 (4.1) | 0.77 |
| Cardiac tamponade | 54 (1.4) | 12 (1.5) | 42 (1.4) | 0.76 |
| Myocardial infarction | 28 (0.7) | 5 (0.6) | 23 (0.8) | 0.72 |
| Vasospastic angina | 11 (0.3) | 4 (0.5) | 7 (0.2) | 0.19 |
| CAVB | 12 (0.3) | 2 (0.3) | 10 (0.3) | 0.74 |
| Pneumothorax | 2 (0.05) | 0 (0.0) | 2 (0.07) | 0.47 |
| Hemothorax | 2 (0.05) | 0 (0.0) | 2 (0.07) | 0.47 |
| Stroke | 33 (0.9) | 6 (0.8) | 27 (0.9) | 0.73 |
| Thigh hematoma | 6 (0.2) | 0 (0.0) | 6 (0.2) | 0.21 |
| Pseudoaneurysm | 8 (0.2) | 2 (0.3) | 6 (0.2) | 0.76 |
| Arteriovenous fistula | 1 (0.03) | 0 (0.0) | 1 (0.03) | 0.61 |
| Intubation after CA | 210 (5.5) | 68 (8.6)* | 142 (4.7)* | <0.001* |
| IABP after CA | 69 (1.8) | 25 (3.2)* | 44 (1.5)* | 0.001* |
| PCPS after CA | 29 (0.8) | 10 (1.3) | 19 (0.6) | 0.063 |
| IMPELLA® after CA | 7 (0.2) | 3 (0.4) | 4 (0.1) | 0.14 |
| Transfusion after CA | 178 (4.7) | 39 (5.0) | 139 (4.6) | 0.65 |
*Statistically significant (P<0.05). Data are presented as n (%), or median [IQR]. CAVB, complete atrioventricular block; DC, direct current cardioversion; ICD, implantable cardioverter-defibrillator. Other abbreviations as in Table 1.
Table 3 shows re-admission rates within 30 days after CA for VT. The overall re-admission for VT was 10.7%, and the emergent re-admission rate for VT was 7.1%. However, in comparison between the CA ≤3 days and CA >3 days groups, the rate of emergent re-admission for VT within 30 days and that leading to the second CA was similar between the 2 groups (6.1% vs 7.3%; P=0.25, and 2.7% vs. 2.2%; P=0.39, respectively).
Table 3.
Re-Admission After CA for Ventricular Tachycardia
| Total (n=3,739) |
CA ≤3 days (n=766) |
CA >3 days (n=2,973) |
P value | |
|---|---|---|---|---|
| Re-admission for VT in 30 days | 400 (10.7) | 72 (9.4) | 328 (11.0) | 0.19 |
| Emergent re-admission for VT in 30 days | 265 (7.1) | 47 (6.1) | 218 (7.3) | 0.25 |
| Re-admission for VT in 30 days leading to CA | 87 (2.3) | 21 (2.7) | 66 (2.2) | 0.39 |
Data are presented as n (%). CA, catheter ablation; VT, ventricular tachycardia.
Multivariable Analysis for Acute Outcomes After CA for VT
Table 4 shows the multivariable logistic analysis for in-hospital death and emergent re-admission for recurrent VT within 30 days. Older age, the absence of ischemic heart disease and supraventricular arrhythmia, higher CCI without age, and intubation, catecholamine use, and AAD intravenous injection before CA were associated with in-hospital mortality. CA ≤3 days was also associated with in-hospital mortality (odds ratio [OR] 2.37 [1.37–4.11]; P=0.002). In contrast, only older age and higher CCI without age were associated with emergent re-admission for VT within 30 days.
Table 4.
Multivariable Logistic Analysis for Acute Outcomes
| In-hospital death after CA | Emergent re-admission within 30 days after CA |
|||||
|---|---|---|---|---|---|---|
| OR | 95% CI | P value | OR | 95% CI | P value | |
| Age | 1.03* | 1.01–1.05* | 0.003* | 1.01* | 1.00–1.02* | 0.023* |
| Female | 1.53 | 0.89–2.63 | 0.12 | 0.80 | 0.58–1.12 | 0.19 |
| IHD | 0.55* | 0.34–0.89* | 0.015* | 1.05 | 0.80–1.38 | 0.71 |
| Supraventricular arrhythmia | 0.50* | 0.25–1.00* | 0.049* | 1.06 | 0.77–1.46 | 0.73 |
| CCI without age | 1.57* | 1.34–1.82* | <0.001* | 1.22* | 1.10–1.35* | 0.001* |
| IABP before CA | 2.22 | 0.92–5.35 | 0.075 | 1.60 | 0.57–4.51 | 0.37 |
| PCPS before CA | 3.02 | 0.96–9.46 | 0.058 | |||
| Intubation before CA | 2.21* | 1.23–3.96* | 0.008* | 1.01 | 0.64–1.61 | 0.95 |
| Catecholamine use before CA | 2.84* | 1.58–5.09* | <0.001* | 0.81 | 0.48–1.37 | 0.43 |
| AAD iv before CA | 1.90* | 1.13–3.19* | 0.016* | 0.99 | 0.76–1.29 | 0.93 |
| CA ≤3 days | 2.37* | 1.37–4.11* | 0.002* | 0.87 | 0.62–1.22 | 0.42 |
*Statistically significant (P<0.05). CI, confidence interval; OR, odds ratio; VT, ventricular tachycardia. Other abbreviations as in Table 1.
After propensity score-matching, 787 patients were included in each group. The maximum absolute value of the standardized differences was <0.1, indicating that the 2 groups were well balanced (Supplementary Table). In the propensity score-matched population, in-hospital mortality in the CA ≤3 days group was higher than that of the CA >3 days group; however, the difference was not statistically significant (OR 1.63 [0.81–3.28]; P=0.17). CA ≤3 days was not associated with emergent re-admission for VT in 30 days (OR 0.72 [0.46–1.06]; P=0.10; Figure 3).
Figure 3.
Comparison of primary outcomes between the catheter ablation ≤3 days and >3 days groups in the total cohort and the propensity score-matched cohort. CA, catheter ablation; CI, confidence interval; VT, ventricular tachycardia.
Discussion
The major findings of this study were as follows: (1) CA ≤3 days for VT with emergent admission did not decrease re-admission for VT within 30 days, but more intensive treatments after CA were necessary in patients with CA ≤3 days; and (2) CA ≤3 days was associated with increased in-hospital deaths in the total cohort, but not in the baseline characteristics-matched cohort. These findings suggest that an emergent CA for VT is not strongly recommended in any case; however, it might be acceptable in cases with unavoidable circumstances such as an electrical storm.
Timing of CA and Periprocedural Outcomes
In the CA ≤3 days group, more patients needed intensive intervention, such as direct current cardioversion, AAD intravenous infusion, intubation, and IABP after CA, than those in the CA >3 days group. Direct current cardioversion after CA suggests VT recurrence. A previous study reported that the achievement of non-inducibility was lower in CA performed within 2 days after admission than that performed more than 2 days after admission.12 From the JROAD-DPC database, we did not obtain the data on whether VT non-inducibility had been achieved after CA; there might be more unsuccessful CAs in the CA ≤3 days group and it might have affected the recurrence of VT. However, no difference in the complication rate corresponded to those of Jiménez et al., regardless of CA timing.12 These results suggest that CA ≤3 days would not increase complications that require additional treatment; however, this earlier timing would not contribute enough to suppress VT. Moreover, early CA (≤3 days) may have been performed due to more severe conditions, such as electrical storm, which could influence poorer outcomes. However, this could not be determined from the baseline characteristics.
Our results showed that the ICD implantation rate during the index hospitalization was significantly lower in the CA ≤3 days group. Although there were no data on whether ICD had already been implanted before the index hospitalization, we hypothesized that many patients in the CA ≤3 days group had already been implanted with an ICD due to a history of prior VT. If this is the case, part of the cause for ablation delay can be explained by the following situation: a patient experienced first VT at the index hospitalization, therefore an extra observation period was needed to judge whether VT was refractory to antiarrhythmic drugs.
Timing of CA and In-Hospital Death
As there is still no consensus on the optimal timing for VT ablation, the time from admission to CA differs, even in cases of electrical storm.12 The present study showed that CA within the third day of admission may increase in-hospital death. The crude rates of in-hospital death did not differ between the CA ≤3 days and CA >3 days groups. However, multivariable logistic analysis showed that CA ≤3 days was an independent risk factor for in-hospital death. The propensity score-matched analysis showed the same trend, although the difference was not significant.
We assume that the reason for the higher in-hospital mortality in the CA ≤3 days group is hemodynamic decompensation during CA, based on the following 3 reasons. First, our results showed that the CA complication rate was not higher in the CA ≤3 days group compared with the >3 days group. This suggests that complications arising directly from CA did not affect the increase in in-hospital mortality. Although we did not have data on the causes of in-hospital death in our study, heart failure and recurrent arrhythmia have been reported as major causes of death related to ventricular arrhythmia storms.17 Hemodynamic decompensation leading to heart failure could be a cause of in-hospital death.
Second, a previous study has suggested that acute hemodynamic decompensation during CA is associated with postprocedural mortality.18 Acute hemodynamic decompensation can occur by hypotension owing to recurrent VT or cardiac stunning due to repeated ICD shocks and can be caused by anesthesia and programmed ventricular stimulation during the CA procedure. In the very early phase of emergent admission, patients tend to be hemodynamically unstable, and physicians have difficulty predicting future hemodynamics. Cardiac stunning recovers over time; therefore, patients who have just been admitted are more likely to present with cardiac stunning than late-phase patients.
Last, acute hemodynamic decompensation causes discontinuation of the CA procedure; a previous study suggested that unstable patient conditions reduce CA success.19 CA performed too early could lead to an unsuccessful procedure and cause recurrent fatal arrhythmia.20
Timing of CA and Outcomes After Discharge
According to the present study, the rate of emergent re-admission for VT in 30 days was not significantly different between the CA ≤3 days and CA >3 days groups. A previous study reported that one of the main causes of re-admission after CA for VT was recurrent VT,21 which is associated with an elevated risk of subsequent mortality.20 Based on these results, we hypothesized that once a patient successfully recovers enough to be discharged, the timing of CA would not affect the subsequent prognosis. For higher survival rates, achievement of VT suppression in the first CA is important.
Appropriate Timing of CA
The present study demonstrated that early CA within the third day of admission was not superior to later CA. Thus, delaying the timing of CA to stabilize a patient’s condition, including hemodynamic status, should be considered. Previous studies have shown that mechanical circulatory support, especially if induced pre-emptively, could achieve an effective CA strategy by stabilizing hemodynamics during the procedure and allowing more time for VT activation mapping, leading to successful CA and better survival.22,23 Therefore, practitioners should consider waiting several days between admission and CA in order to confirm that the patient will not experience hemodynamic collapse during the procedure.
Study Limitations
This study has some limitations. The DPC data are based on medical claims, thus some DPC disease names may not always be the true diagnosis, and approximately half of the patients’ underlying heart diseases were unknown. Moreover, the true reason why emergent CA for VT had to be performed – such as whether it was due to an electrical storm – was unknown. Patients who had to undergo early CA might have more severe conditions, such as electrical storm. Moreover, in this study, we could not consider the end-point of CA, especially regarding VT inducibility after treatment, because detailed information about the CA procedure could not be obtained from the JROAD-DPC database.
Conclusions
The clinical background differed substantially between patients who underwent CA within 3 days and those who underwent CA later during emergency hospitalization. An emergency CA for VT is not strongly recommended; however, it might be acceptable in cases with unavoidable circumstances.
Disclosures
K.M. received funding/grants from Medtronic, Biosense Webster, Abbott, and Boston, and honoraria/speakers’ bureaus from Medtronic, Biosense Webster, Abbott and Boston outside of the submitted work, and is affiliated with a department endowed by Medtronic outside of the submitted work.
IRB Information
This study was approved by the institutional review board of the National Cerebral and Cardiovascular Center (R22025). The requirement for informed consent was waived, as personal information was not included in the database.
Supplementary Files
Supplementary Table.
Acknowledgments
The authors are grateful for the contributions of all investigators and data managers involved in the JROAD-DPC study.
Funding Statement
Sources of Funding: This study was supported by a National Cerebral and Cardiovascular Center research grant (21-4-4 for A.T.).
Data Availability
The deidentified participant data will not be shared.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Supplementary Table.
Data Availability Statement
The deidentified participant data will not be shared.