Prognostic Survey of ECPELLA in Japanese Patients With Acute Myocardial Infarction and Cardiogenic Shock　― Findings From the Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD) ―

Abstract

Background: The short-term mortality associated with veno-arterial extracorporeal membrane oxygenation combined with the Impella device (termed ECPELLA) for acute myocardial infarction complicated by cardiogenic shock (AMI-CS) remains unclear.

Methods and Results: The Japanese Registry for Percutaneous Ventricular Assist Devices (J-PVAD) includes data on all patients treated with an Impella in Japan. We extracted data for 922 AMI-CS patients who underwent ECPELLA support and conducted an exploratory analysis focusing on 30-day mortality. The median age of patients was 69 years, and 83.8% were male. The overall 30-day mortality was 46.1%. Factors associated with mortality included age >80 years, in-hospital cardiac arrest, systolic blood pressure <90 mmHg, serum creatinine >1.5 mg/dL, and serum lactate >4.0 mmol/L. In patients aged >80 years with any of these factors, mortality was significantly higher than in those without, ranging from 57.5% to 64.9%. The J-PVAD score assigns 1 point per predictor, with a C-statistic of 0.620 (95% confidence interval 0.586–0.654). The 30-day mortality was 20.0% for a J-PVAD score of 0, increasing to 70.0% for a score of 5.

Conclusions: The J-PVAD data indicate high short-term mortality in AMI-CS patients treated with ECPELLA, particularly among older patients. Further studies are needed to validate this risk stratification in this patient subset.

Acute-phase mortality rates for patients with acute myocardial infarction (AMI) have improved in the era of percutaneous coronary intervention (PCI). However, when complicated by cardiogenic shock (CS), in-hospital mortality remains high, ranging from 30% to 50% internationally.^1,2 Mechanical circulatory support (MCS) is increasingly used to manage patients with AMI complicated by CS (AMI-CS).³ Although MCS devices enhance hemodynamic stability in these patients, they are also linked to complications that can impede recovery. Therefore, careful patient selection is crucial when using MCS for AMI-CS. Notably, previous studies have shown that advanced age, particularly >80 years, is significantly associated with higher mortality in CS patients on MCS.⁴ In addition, veno-arterial extracorporeal membrane oxygenation (VA-ECMO)-related medical expenses account for 6% of total hospital costs, highlighting the need for the more judicious use of VA-ECMO given the lack of proven mortality benefits and its impact on healthcare costs.⁵

Although clinical experience often suggests that VA-ECMO is highly effective in treating CS, evidence from several past randomized control trials does not support this.^6,7 The Extracorporeal life support (ECLS)-SHOCK trial did not include Impella in the early extracorporeal membrane oxygenation (ECMO) group, underscoring the need to evaluate treatment outcomes and real-world data on the combined use of Impella and ECMO (termed ECPELLA) in AMI-CS patients.⁷ In the Japanese Registry for Percutaneous Ventricular Assist Devices (J-PVAD), the 30-day survival rate for AMI-CS patients treated with ECPELLA between October 2017 and January 2020 was 45.7%.⁸ With an increasing number of patients in Japan receiving ECPELLA support, updating patient background and treatment outcomes for AMI-CS patients treated with ECPELLA is essential to improve their prognosis. Therefore, we conducted a survey to investigate the current use of ECPELLA in the clinical setting of AMI-CS in Japan and to explore short-term mortality outcomes.

Methods

Study Population

This study conducted a post hoc analysis of cases registered in J-PVAD, specifically focusing on those receiving ECPELLA support for the treatment of AMI between February 2020 and December 2022. The design of and patient enrollment in J-PVAD have been described previously.^8,9 The present study complies with the Declaration of Helsinki.

A flowchart of the patient selection process is shown in Figure 1. Of the 1,024 patients screened, the following were excluded: 10 patients who could not have an Impella inserted; 86 who did not undergo PCI; and 6 without data during the observation period. Thus, 922 patients were included in the present study. We conducted an exploratory investigation of the factors associated with short-term mortality in these patients.

Figure 1.

Flowchart showing patient selection. AMI-CS, acute myocardial infarction complicated with cardiogenic shock; J-PVAD, Japan Registry for Percutaneous Ventricular Assist Device; PCI, percutaneous coronary intervention; VA-ECMO, veno-arterial extracorporeal membrane oxygenation.

Definitions and Endpoints

CS was defined as: (1) prolonged hypotension (systolic blood pressure [SBP] ≤90 mmHg) lasting at least 30 min or a cardiac index of ≤2.2 L/min/m², despite adequate fluid replacement, to differentiate it from hypovolemia and septic shock; or (2) a condition requiring the use of intravenous vasoactive inotropes and/or MCS to SBP ≥90 mmHg. The primary endpoint was 30-day mortality after device implantation, defined as death from any cause within 30 days after Impella implantation.

Statistical Analysis

Continuous variables are presented as the median with interquartile range (IQR), whereas categorical variables are presented as counts and percentages. Logistic regression analysis was performed to identify patient background characteristics associated with 30-day mortality. A multivariate logistic regression model was constructed to identify predictors of 30-day mortality. The multivariate model included fundamental background variables, well-established prognostic factors for AMI-CS patients,^10–15 and prognostic factors reported in previous studies using J-PVAD data.⁸ Based on these considerations, 8 factors were selected: age, in-hospital cardiac arrest (IHCA), SBP <90 mmHg, creatinine (Cre) >1.5 mg/dL, albumin <3.0 g/dL, lactate >4.0 mmol/L, left ventricular ejection fraction (LVEF) <40%, and the frequency of VA-ECMO use before Impella implantation (ECMO first). To address missing data, multiple imputation was performed using R version 4.2.3 (R Foundation for Statistical Computing, Vienna, Austria), with the “mice” package (version 3.16.0) used for the imputations.

Mortality at 30 days was compared between groups with and without the factors listed above, focusing on factors that were significant in the multivariate analysis. In addition, exploratory comparisons of mortality rates by age and combinations of these factors were conducted. Between-group differences in these variables were analyzed using Chi-squared or Fisher’s exact tests.

The J-PVAD score was developed using the selected variables and the strength of association determined by β coefficients, as described previously.^16,17 The model’s performance was evaluated using the area under the curve (AUC) and its 95% confidence interval (CI). To ensure the internal validity of the J-PVAD score, bootstrapping with 200 iterations was performed using R version 4.2.3. The “boot” package (version 1.3-30) was used for resampling, and the AUC and its 95% CI were calculated for each bootstrap sample to assess the model’s consistency across different iterations. In addition to bootstrapping, the Hosmer-Lemeshow test was conducted to evaluate the goodness-of-fit of the novel scoring system. The 30-day mortality rate by score was tested using a Chi-squared test. These analyses were conducted using SPSS Statistics 19.0 (SPSS Inc., Chicago, IL, USA). Significance was set at P<0.05 for all statistical analyses.

Results

Study Population

The clinical characteristics of the 922 patients who received ECPELLA support are presented in Table 1. The median age was 69.0 years (IQR 59.0–76.0 years), with 11.1% of patients being aged >80 years, and 83.8% were male. The rate of out-of-hospital cardiac arrests and IHCAs was 37.2% and 55.0%, respectively. The median SBP was 81.0 mmHg (IQR 60.0–100.0 mmHg), with 61.1% of patients having an SBP <90 mmHg. The median Cr level was 1.2 mg/dL (IQR 1.0–1.6 mg/dL), with 29.1% of patients having Cre >1.5 mg/dL. The median lactate level was 8.5 mg/dL (IQR 4.7–13.0 mg/dL), with 80.0% of patients having lactate >4.0 mmol/L. The median LVEF was 20.0% (IQR 15.0–30.0%), with 82.4% of patients having LVEF <40.0%. Of the Impella device types used, 3.4% were Impella 2.5, 94.9% were Impella CP, 1.2% were Impella 5.0, and 0.5% were Impella 5.5. The median number of Impella insertions per facility was 8.0 (IQR 5.0–13.0). Regarding the timing of VA-ECMO use, 70.7% of patients received ECMO before Impella implantation (ECMO first).

Table 1.

Background Characteristics of Patients Receiving ECPELLA Support (n=922)

Age (years)	69.0 [59.0–76.0]
Age ≤60 years	264/922 (28.6)
Age 60> or ≤80 years	556/922 (60.3)
Age >80 years	102/922 (11.1)
Male sex	773/922 (83.8)
BMI (kg/m2)	24.3 [21.7–26.8]
Hypertension	552/922 (59.9)
Dyslipidemia	394/922 (42.7)
Diabetes	395/922 (42.8)
Prior MI	143/922 (15.5)
History of HF	108/922 (11.7)
Prior stroke/TIA	73/922 (7.9)
OHCA	343/922 (37.2)
IHCA	507/922 (55.0)
SBP (mmHg)	81.0 [60.0–100.0]
SBP <90 mmHg)	563/922 (61.1)
DBP (mmHg)	56.0 [37.0–71.0]
Heart rate (beats/min)	90.0 [67.0–110.0]
Creatinine (mg/dL)	1.2 [1.0–1.6]
Creatinine >1.5 mg/dL	264/907 (29.1)
Albumin (g/dL)	3.5 [2.9–3.9]
Albumin <3.0 g/dL	227/858 (26.5)
Lactate (mmol/L)	8.5 [4.7–13.0]
Lactate >4.0 mmol/L	585/731 (80.0)
LVEF (%)	20.0 [15.0–30.0]
LVEF <40%	300/364 (82.4)
Catecholamine use at initiation of Impella support
Epinephrine	278/922 (30.2)
Dobutamine	215/922 (23.3)
Norepinephrine	439/922 (47.6)
Dopamine	82/922 (8.9)
Any catecholamine	763/922 (82.8)
≥2 catecholamines	216/922 (23.4)
Devise type of first Impella
Impella 2.5	31/922 (3.4)
Impella CP	875/922 (94.9)
Impella 5.0	11/922 (1.2)
Impella 5.5	5/922 (0.5)
Total support duration (days)	5.2 [2.3–8.8]
Shock to first Impella support (h)	2.3 [1.4–4.0]
Shock to first Impella support <6 h	786/916 (85.8)
No. Impella insertions at the facility	8.0 [5.0–13.0]
ECMO first before Impella implantation	652/922 (70.7)
Use of pulmonary artery catheter	631/922 (68.4)

Data are expressed as the number of subjects, n/N (%), or as the median [interquartile range]. BMI, body mass index; DBP, diastolic blood pressure; ECMO, extracorporeal membrane oxygenation; HF, heart failure; IHCA, in-hospital cardiac arrest; LVEF, left ventricular ejection fraction; MI, myocardial infarction; OHCA, out-of-hospital cardiac arrest; SBP, systolic blood pressure; TIA, transient ischemic attack.

Factors Associated With the Primary Endpoint

Table 2 presents the patient characteristics associated with 30-day mortality. Significant factors identified in the multivariate analysis were age >80 years, IHCA, SBP <90 mmHg, Cre >1.5 mg/dL, and lactate >4 mmol/L.

Table 2.

Logistic Regression Analysis of Factors Associated With 30-Day Mortality

Variables	Univariate		Multivariate
	OR (95% CI)	P value	OR (95% CI)	P value
Age ≤60 years	–		–
Age 60> or ≤80 years	1.30 (0.97–1.75)	0.085	1.29 (0.95–1.76)	0.10
Age >80 years	1.86 (1.17–2.95)	0.009	1.83 (1.14–2.96)	0.013
Male sex	1.16 (0.82–1.66)	0.40
Body mass index	1.03 (1.00–1.05)	0.075
Hypertension	1.09 (0.83–1.42)	0.54
Dyslipidemia	0.77 (0.59–1.00)	0.051
Diabetes	0.82 (0.63–1.07)	0.14
Prior MI	0.85 (0.59–1.22)	0.37
History of HF	1.25 (0.83–1.86)	0.28
Prior stroke/TIA	0.80 (0.49–1.30)	0.37
OHCA	1.25 (0.96–1.63)	0.10
IHCA	1.59 (1.23–2.07)	<0.001	1.53 (1.15–2.03)	0.003
SBP <90 mmHg	1.36 (1.04–1.77)	0.026	1.33 (1.01–1.76)	0.043
Creatinine >1.5 mg/dL	1.83 (1.37–2.44)	<0.001	1.78 (1.32–2.39)	<0.001
Albumin <3.0 g/dL	1.40 (1.04–1.88)	0.024	1.15 (0.85–1.57)	0.36
Lactate >4.0 mmol/L	1.74 (1.25–2.44)	0.001	1.56 (1.10–2.21)	0.012
LVEF <40%	1.56 (1.09–2.23)	0.016	1.44 (0.99–2.09)	0.057
Any catecholamine	1.38 (0.97–1.95)	0.073
≥2 catecholamines	1.04 (0.76–1.41)	0.82
No. Impella insertions at the facility	1.00 (0.98–1.00)	0.91
Shock to first Impella support <6 h	0.87 (0.61–1.24)	0.45
ECMO first before Impella implantation	1.48 (1.11–1.98)	0.008	1.24 (0.90–1.70)	0.20
Use of pulmonary artery catheter	0.79 (0.60–1.04)	0.092

Due to the presence of missing values in the continuous variables of creatinine, albumin, lactate, LVEF, and shock to first Impella support, multiple imputation was used to handle the missing data. The multivariate analysis was adjusted for age >80 years, IHCA, SBP <90 mmHg, creatinine >1.5 mg/dL, albumin <3.0 g/dL, lactate >4.0 mmol/L, LVEF <40%, and ECMO first before Impella implantation. CI, confidence interval; OR, odds ratio. Other abbreviations as in Table 1.

Exploratory Analysis Focusing on 30-Day Mortality

The 30-day mortality rate for the entire AMI-CS cohort treated with ECPELLA was 46.1%. Figure 2 shows comparisons of 30-day mortality rates for variables significantly associated with mortality. The 30-day mortality rate increased significantly with age: 40.5% for patients aged ≤60 years vs. 46.9% for those aged >60 and ≤80 years and 55.9% for those aged >80 years (Figure 2A; P=0.025). In addition, 30-day mortality was significantly higher in patients with than without IHCA (51.3% vs. 39.8%; P=0.001; Figure 2B), in those with SBP <90 than ≥90 mmHg (49.0% vs. 41.5%; P=0.026; Figure 2C), in those with Cre >1.5 than ≤1.5 mg/dL (56.7% vs. 41.7%; P<0.001; Figure 2D), and in those with lactate >4.0 than ≤4.0 mmol/L (48.8% vs. 35.3%; P=0.001; Figure 2E).

Figure 2.

Thirty-day mortality rate according to (A) age, (B), in-hospital cardiac arrest (IHCA), (C) systolic blood pressure (SBP), (D) creatinine (Cre), and (E) lactate.

Figure 3 shows 30-day mortality based on the combination of age >80 years and other significant factors, namely IHCA, SBP <90 mmHg, Cre >1.5 mg/dL, and lactate >4.0 mmol/L. Thirty-day mortality was significantly higher in patients with both age >80 years and each of these factors (Figure 3). In particular, the highest 30-day mortality rate was 64.9% in patients aged >80 years with Cre >1.5 mg/dL.

Figure 3.

Thirty-day mortality rate according to the combination of age (in years) with (A) in-hospital cardiac arrest (IHCA), (B) systolic blood pressure (SBP; in mmHg), (C) creatinine (Cre; in mg/dL), and (D) lactate (in mmol/L).

A simplified version of the multivariable model was used to create the prognostic risk score, referred to as the J-PVAD score (Table 3). The J-PVAD score assigns 1 point for each category in the model, with the total score ranging from 0 to 5. Higher J-PVAD scores were associated with increased 30-day mortality, with a 70.0% mortality rate for a J-PVAD score of 5 (Figure 4). The C-statistic for the J-PVAD score was 0.620 (95% CI 0.586–0.654). To ensure the internal validity of the J-PVAD score, we used a bootstrap method with 200 iterations. The mean AUC from the bootstrap samples was 0.619 (95% CI 0.582–0.652), closely mirroring the results from the original dataset. The Hosmer-Lemeshow test for the J-PVAD score yielded a P value of 0.93, suggesting that the J-PVAD score is internally valid and that the model’s performance is consistent across different sample iterations.

Table 3.

Logistic Regression Analysis of Risk Factors and Score Assignment

	OR (95% CI)	β coefficient	J-PVAD score (points)
Age >80 years	1.83 (1.14–2.96)	0.607	1
IHCA	1.53 (1.15–2.03)	0.425	1
SBP <90 mmHg	1.33 (1.01–1.76)	0.287	1
Creatinine >1.5 mg/dL	1.78 (1.32–2.39)	0.574	1
Lactate >4.0 mmol/L	1.56 (1.10–2.21)	0.447	1

J-PVAD, Japanese Registry for Percutaneous Ventricular Assist Device. Other abbreviations as in Tables 1,2.

Figure 4.

Japan Registry for Percutaneous Ventricular Assist Device (J-PVAD) score and 30-day mortality. Cre, creatinine; IHCA, in-hospital cardiac arrest; SBP, systolic blood pressure.

Adverse Events During ECPELLA Support

Adverse events observed in ECPELLA patients within 30 days were hemolysis (13.4% of patients), hemorrhage/hematoma (33.3%), peripheral ischemia (6.3%), stroke (8.8%), thrombosis (1.5%), sepsis (6.0%), renal failure (12.0%), and ventricular arrhythmia (6.0%; Table 4).

Table 4.

Adverse Events During ECPELLA Support (n=922 Patients)

Hemolysis	124/922 (13.4)
Hemorrhage/hematoma	307/921 (33.3)
Peripheral ischemia	58/922 (6.3)
Stroke	81/922 (8.8)
Thrombosis	14/922 (1.5)
Sepsis	55/922 (6.0)
Renal failure	111/922 (12.0)
Ventricular arrhythmia	55/922 (6.0)

Data are expressed as the number of subjects, n/N (%).

Discussion

In this post hoc analysis of J-PVAD, we explored the use of ECPELLA in AMI-CS patients. Compared with results previously reported from this registry for the period October 2017–January 2020,⁸ the present study (covering the period February 2020–December 2022) showed a numerically higher proportion of patients with SBP <90 mmHg. In addition, the primary Impella device type was Impella CP, and the use of Impella 5.5 was introduced (Supplementary Table 1). In the present study, 30-day mortality decreased numerically to 46.1% (vs. 54.3% in the earlier study⁸), but the frequency of adverse events, namely hemolysis, hemorrhage/hematoma, peripheral ischemia, stroke, and thrombosis, increased numerically. This trend is similar to that observed in the DanGer Shock trial, a randomized control trial reported in 2024, in which Impella CP improved 180-day mortality compared with standard care alone, suggesting that the increase in survival may have contributed to a higher occurrence of adverse events.¹⁸ In the present study, 55.0% of patients had IHCA, 61.1% had SBP <90 mmHg, 80.0% had lactate >4.0 mmol/L, and 82.8% required the use of any catecholamine, which aligns with the recently released Society for Cardiovascular Angiography and Interventions (SCAI) classification Stage C and above.¹⁹

In the present study, the presence of age >80 years, IHCA, SBP <90 mmHg, Cre >1.5 mg/dL, and lactate >4.0 mmol/L was associated with higher 30-day mortality. Patients aged >80 years had the highest 30-day mortality, consistent with previous reports in CS patients on MCS, which reported mortality as high as 81.8% for CS patients aged >80 years requiring MCS.⁴ Furthermore, older patients with CS have a higher mortality despite having a similar shock severity based on the SCAI shock stage.¹⁰ These results suggest that the indications for the use of MCS in patients aged >80 years require careful consideration of benefits and risks. An even more thorough discussion is necessary for the use of ECPELLA, given its higher risk of complications.

A previous study reported that in CS patients with cardiac arrest (66% due to AMI), ECPELLA significantly improved 30-day mortality compared with ECMO–intra-aortic balloon pump (28.6% vs. 75.6%).¹² However, in the present study, the 30-day mortality rate for ECPELLA patients with IHCA was 51.3%, which remains unacceptably high. Specifically, in patients aged >80 years with IHCA, the 30-day mortality rate was extremely high at 60.4%.

Many studies have reported that SBP <90 mmHg, Cre >1.5 mg/dL, and lactate >4.0 mmol/L have are factors associated with a poor prognosis in AMI-CS,^11,20 and we also found that these factors were associated with 30-day mortality. The 30-day mortality rate was extremely high particularly in patients aged >80 years with these factors, 60.9% for those with SBP <90 mmHg, 64.9% for those with Cre >1.5 mg/dL, and 57.5% for those with lactate >4.0 mmol/L.

Regarding the timing of VA-ECMO or Impella activation for CS, observational studies have reported that the earlier use of both VA-ECMO and Impella is associated with better prognosis.^13,14 Specifically, in the context of simultaneous use of ECMO and Impella (ECPELLA), earlier activation of Impella for left ventricular unloading is linked to lower 30-day mortality compared with delayed left ventricular unloading.²¹ Early active left ventricular unloading with Impella may reduce infarct size by limiting reperfusion injury in patients with AMI without CS and mitigate the increase in left ventricular afterload caused by VA-ECMO.²² In the present study, receiving ECMO first before Impella implantation was associated with higher 30-day mortality in univariate analysis. However, in the multivariate logistic regression analysis, this effect was attenuated by other factors, indicating the need for further investigation to determine whether Impella first or ECMO first is the better approach. We compared patient backgrounds between the Impella first and ECMO first groups (Supplementary Table 2). The ECMO first group had a significantly higher frequency of out-of-hospital cardiac arrest, IHCA, albumin <3.0 g/dL, lactate >4.0 mmol/L, and LVEF <40% than the the Impella first group, suggesting that more critically ill patients, who required selection of ECMO first, were included in this group.

A recent meta-analysis found that in patients requiring VA-ECMO, the concomitant use of Impella was associated with an increased risk of major bleeding and hemolysis compared with the use of an intra-aortic balloon pump with VA-ECMO, but short-term mortality was comparable between the 2 groups.²³ In a recent retrospective study, the addition of Impella to VA-ECMO for patients with CS was associated with lower all-cause 30-day mortality, reduced inotrope use, and comparable safety profiles compared with VA-ECMO alone.²⁴ The combination of Impella with VA-ECMO improves hemodynamics by increasing cardiac power output and oxygen supply while decreasing oxygen demand, leading to overall better outcomes than VA-ECMO alone.²⁵ These studies suggest that the appropriate use of ECPELLA in selected cases may improve the prognosis of AMI-CS patients and that risk stratification in ECPELLA patients is needed. There has been no registry in Japan that has included a sufficient number of ECPELLA patients, so scoring has not been conducted. However, in the present study, we developed a new score, the J-PVAD score. Although the C-statistic of the J-PVAD score is not high, a gradual increase in mortality risk was observed with higher scores. The components of this score can be quickly assessed at the initial treatment stage and evaluated before the introduction of ECPELLA, making the J-PVAD score potentially useful for risk stratification and aiding in the appropriate use of ECPELLA in these patients.

Study Limitations

Our study has several limitations. First, we did not establish causation. As an observational study involving a highly challenging patient population of CS patients treated with both Impella and VA-ECMO, unmeasured confounding factors may have influenced the results, even after adjusting for several confounders. In particular, confounding by the indication and timing of MCS use may have affected the outcomes. The decision to use Impella or VA-ECMO depended on the patient’s hemodynamics and condition at the time. In some cases, VA-ECMO was initiated first when left ventricular support with Impella alone was insufficient. The decisions regarding Impella and VA-ECMO implantation during the follow-up period were at the discretion of the attending physicians. Second, the J-PVAD score was not prospectively validated with external data. Although the Hosmer-Lemeshow test results suggest a good fit for the model, and the internal validation analysis confirms the score’s reliability, the AUC is not exceptionally high. However, progressive increases in the J-PVAD score are associated with increases in the 30-day mortality rate, indicating the potential utility of the J-PVAD score in clinical practice.

Conclusions

This study conducted an exploratory analysis of short-term mortality in AMI patients with CS who underwent both Impella implantation and VA-ECMO in a real-world setting. The J-PVAD findings indicate that AMI patients treated with ECPELLA have a high short-term mortality, particularly those aged >80 years. Further prospective studies are needed to establish strict selection criteria for AMI-CS patients to maximize the benefits of ECPELLA.

Acknowledgments

The authors acknowledge using OpenAI’s ChatGPT to enhance the English expression of this paper. Special thanks to Mr. John Martin for his help with English language editing a draft of this paper.

Sources of Funding

This study was funded, in part, by the Japan Abiomed Post-Market Surveillance Program.

Disclosures

None.

IRB Information

This study was approved by the Graduate School of Medicine/Faculty of Medicine, Osaka University Ethics Committee (Approval no. 17232).

Data Availability

The deidentified participant data will not be shared.

Supplementary Files

Please find supplementary file(s);

https://doi.org/10.1253/circj.CJ-24-0522

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