Abstract
Objective:
To describe the incidence and predictors of acute limb ischemia (ALI) in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS).
Methods:
Patients with index hospitalizations for AMI complicated by cardiogenic shock from 2016 to 2019 in the US National Readmission Database were identified. We evaluated the incidence of ALI and its associated mortality, length of stay, and cost of hospitalization. We used multivariable logistic regression to determine independent predictors of ALI in this population.
Results:
A total of 84,615 patients had AMI complicated by cardiogenic shock and 1302 (1.54%) developed ALI. The rates of ALI increased from 1.29% in 2016 to 1.66% in 2019 (P ≤ .002). The use of microaxial mechanical circulatory support increased from 2.25% in 2016 to 13.36% in 2019 (P = .0001). The major predictors of ALI included peripheral arterial disease (odds ratio [OR], 7.34; 95% confidence interval [CI], 6.12–8.81), venoarterial extracorporeal membrane oxygenation (OR, 4.40; 95% CI, 3.19–6.07), and microaxial mechanical circulatory support (OR, 3.12; 95% CI, 2.74–3.55). ALI in patients with cardiogenic shock was associated higher mortality (39.20% vs 33.53%; P ≤ .0001).
Conclusions:
This nationwide observational study shows that ALI is an important complication of AMI with cardiogenic shock. This complication is associated with higher mortality. In addition to peripheral artery disease, the use of mechanical circulatory devices was associated with significantly higher rates of ALI.
Keywords: Mechanical circulatory support (MCS), Peripheral artery disease (PAD), Amputation, Venoarterial extracorporeal membrane oxygenation (VA-ECMO)
Every year roughly 350,000 people in the United States will have an acute myocardial infarction (AMI).1 In patients presenting with AMI, cardiogenic shock (CS) is an ominous complication that occurs in 5% to 10% of cases and has a mortality rate as high as 50%.2,3 These mortality rates have been noted despite adjunctive therapies like an intra-aortic balloon pump (IABP). To improve these outcomes operators have been using larger bore mechanical circulatory support (MCS) devices like the microaxial MCS (Impella, Abiomed, Danvers, MA) and venoarterial extracorporeal membrane oxygenation (VA-ECMO). Early studies have shown that we may be able to decrease mortality of CS with the use of MCS devices.4–6
There has been a nationwide increase in use of an MCS device in the treatment of patients with CS.7 The use of these circulatory support devices requires placement of large-bore cannula (≤24F) in the arteries of the extremities, which may increase the risks of acute limb ischemia (ALI). However, the rates of ALI in these patients have not been well studied and most studies have focused on bleeding complications rather than ischemic ones.8–12 This study aims to describe the incidence, temporal trends, and the predictors of ALI in patients with AMI complicated by CS.
METHODS
Data source
All data were derived from the Nationwide Readmissions Database (NRD) for 2016 to 2019. The NRD includes all-payer hospital inpatient stays developed by the Agency for Healthcare Research and Quality. The hospital stay that is recorded is that of the index admission. The weighted NRD contains data from approximately 36 million yearly discharges, and the unweighted estimates approximate 18 million yearly discharges in the United States. The NRD is a compilation of the State Inpatient Databases of 30 states and represents roughly 60% of all US hospitalizations.13
Study population
We identified patients with a principal discharge diagnosis of AMI. AMI included both ST elevation myocardial infarction using the International Classification of Diseases, Tenth Revision, Clinical Modification/Procedure Coding System (ICD-10-CM) code I21- and non-ST elevation myocardial infarction ICD-10-CM code I214. Among these patients, the presence of CS was identified with an ICD-10-CM code R57- and ALI complication was identified with ICD-10-CM code I74-.
Ethics statement.
This study was deemed to be exempt from institutional review board assessment because it was conducted using the NRD, a publicly available database that contains only deidentified patient information.
Patient and hospital characteristics
Demographic characteristics including primary expected payer and hospital characteristics were obtained from the NRD. Charlson Comorbidity Index was used to assess the severity of comorbid conditions.14 The following ICD-10 procedure codes were used to identify the use of microaxial MCS (Impella Implantation) treatment (ICD 10 PCS code 02HA3-, 02HA4-), IABP (ICD 10 PCS code 5A0211- 5A1522-), and VA-ECMO (ICD 10 PCS code 5A1522G). The 306 patients who had both VA-ECMO and microaxial MCS devices implanted were excluded. All other variables and comorbidities were defined using the Healthcare Cost and Utilization Project Clinical Classification Software and ICD-10 codes. All codes are listed in Supplementary Table I (online only).
Study end points and outcomes
The primary end point of the study was the rate of ALI during the index admission in patients whose principal discharge diagnosis was AMI complicated by CS. Our secondary end points included all-cause 30-day mortality, inpatient length of stay, total charges for hospitalization, and procedural interventions, which included extremity angioplasty, extremity bypass surgery, amputation, extremity endarterectomy, and extremity thrombectomy. We also assessed the predictors of ALI in this cohort. The variables we included as possible predictors of ALI were peripheral artery disease (PAD), VA-ECMO, microaxial MCS devices, postprocedural hemorrhage, thrombophilia, cerebrovascular accident, bleeding, sepsis, congestive heart failure, acute kidney injury, chronic obstructive pulmonary disease, sex (female), IABP, atrial fibrillation, and coronary artery bypass grafting.
As a part of the sensitivity analysis, a propensity score matching analysis was used to evaluate the effects of microaxial MCS devices and VA-ECMO implantation independently on the rates of ALI. The Pearson χ2 test was used to compare the implanted treated group and nontreated group. Falsification end point analyses were performed to access for any residual confounders. The prespecified hypothesis of this study was that the use of large-bore MCS devices such as microaxial MCS devices would be associated with increased risk of ALI in patients with AMI complicated by CS (Supplementary Table II, online only). As falsification end points, we chose upper extremity fracture (ICD10- CM S42-) and ulcerative colitis (ICD10-CM K51-) because they are not likely to be causally related to microaxial MCS device implantation (Supplementary Table III, online only).
Statistical analyses
The Pearson χ2 test was used for all categorical variables and the Student t test was used for all continuous variables when comparing the baseline characteristics of patients with and without ALI. The Cochrane-Armitage test was used to evaluate the trends of ALI incidence over time from 2016 to 2019. A univariate logistic regression analysis was used to determine the predictors associated with ALI. (Supplementary Table IV, online only). Only those variables with statistical significance (P < .05) and deemed to be clinically relevant by expert opinion were considered candidates for the multivariate model. Those covariates that were not statistically significant (P > .05) were then removed from the model. The final model included both clinically and statistically significant variables. Multivariate Cox regression was used to determine the independent predictors of ALI in patients with AMI complicated by CS. Multivariate Cox regression was also done on both falsification end points. Stata MP 17.0 (Stata Corp LLC., College Station, TX) was used for analysis.
RESULTS
A total of 1,283,586 hospitalizations were identified as having a principal discharge diagnosis of AMI and 84,615 (6.59%) of them developed CS. Among the patients with CS, 1302 (1.54%) developed ALI. ALI required amputation in 32 patients (2.46%) (Fig 1). In patients who developed ALI, the amputation-free survival was 66.37% compared with 60.52% in those without ALI at the time of discharge. There was a statistically significant increase in rate of ALI over the study period, with a rate of 1.29% in 2016, 1.50% in 2017, 1.66% in 2018, and 1.68% in 2019 (P = .025). The rate of ALI also increased in patients with an MCS device with a rate of 3.6% in 2016, 4.21% in 2017, 4.22% in 2018, and 4.55% in 2019 (P = .17). The rates of cardiogenic shock increased from 20,445 in 2016 to 21,477 in 2017, to 22,142 in 2018, and to 23,459 in 2019. The rates of IABP placement increased in the study from 8727 in 2016 to 10,490 in 2019. The rates of ALI in patients with an MCS device was significantly higher than in patients without an MCS device (1.54% vs 4.33%; P = .0001) (Fig 2). The baseline characteristics of the patients are shown in Table I.
Fig 1.
Flow diagram indicating the patient population as AMI complicated by cardiogenic shock (CS) followed by ALI and amputation as subgroups. ALI, acute limb ischemia; AMI, acute myocardial ischemia.
Fig 2.
Annual rates of acute limb ischemia (ALI) in acute myocardial ischemia (AMI) complicated by patients with CS with and without mechanical circulatory support (MCS) use from 2016 to 2019 (P = .0001).
Table I.
Basic characteristics of patients with and without acute limb ischemia (ALI)
| Basic characteristics | No ALI | ALI | Total | P value |
|---|---|---|---|---|
| Age, years | 68.70 | 65.55 | 68.66 | <.0001 |
| Female sex | 28,627 (34.36) | 530 (40.71) | 29,157 (34.46) | <.0001 |
| PAD | 1323 (1.59) | 155 (11.9) | 1478 (1.75) | <.0001 |
| VA-ECMO | 615 (0.74) | 45 (3.46) | 660 (0.78) | <.0001 |
| Microaxial MCS | 8418 (10.10) | 366 (28.11) | 8784 (10.38) | <.0001 |
| Cerebral vascular accident | 2676 (3.21) | 112 (8.60) | 2788 (3.29) | <.0001 |
| Postprocedure hemorrhage | 1439 (1.73) | 67 (5.15) | 1506 (1.78) | <.0001 |
| Thrombophilia | 3567 (4.28) | 137 (10.52) | 3704 (4.38) | <.0001 |
| Bleeding | 5363 (6.44) | 174 (13.36) | 5537 (6.54) | <.0001 |
| Sepsis | 9628 (11.56) | 268 (20.58) | 9896 (11.70) | <.0001 |
| IABP alone | 29,259 (35.12) | 440 (33.79) | 29,699 (35.10) | .32 |
| Congestive heart failure | 51,221 (61.48) | 986 (75.73) | 52,207 (61.70) | <.0001 |
| COPD | 10,943 (13.13) | 206 (15.82) | 11,149 (13.18) | .004 |
| CABG | 6116 (7.34) | 79 (6.07) | 6195 (7.32) | .08 |
| Acute kidney injury | 42,903 (51.5) | 855 (65.67) | 43,758 (51.71) | <.0001 |
| Atrial fibrillation | 23,570 (28.29) | 371 (28.49) | 23,941 (28.29) | .871 |
| Pulmonary embolism | 895 (1.07) | 23 (1.77) | 918 (1.08) | .017 |
| Complete heart block | 5991 (7.19) | 99 (7.60) | 6090 (7.20) | .567 |
| PCI | 11,341 (13.61) | 173 (13.29) | 11,514 (13.61) | .734 |
ALI, Acute limb ischemia; CABG, coronary artery bypass graft; COPD, chronic obstructive pulmonary disease; IABP, intra-aortic balloon pump; MCS, mechanical circulatory support device; PAD, peripheral artery disease; PCI, percutaneous coronary intervention; VA-ECMO, venoarterial extracorporeal membrane oxygenation.
Values are number (%).
Comparison of the basic characteristics of patients with AMI complicated by cardiogenic shock who developed ALI versus the characteristics of patients who did not develop ALI.
There was a marked increase in the use of MCS devices in patients with AMI complicated by CS with a rate of 2.19% in 2016, 10.67% in 2017 14.38% in 2018, and 16.09% in 2019 (P = .0001). MCS device implantation increased six-fold from 2016 to 2019. The use of MCS devices was significantly higher in patients who developed ALI then those who did not (11.16% vs 31.57%; P = .0001). The use of MCS devices also increase significantly over the study period with a rate of 6.27% in 2016, 30.77% in 2017, 36.34% in 2018, and 44.74% in 2019 (P = .0001). No significant association was noted between the incidence of ALI and the use of IABP (P = .32) (Fig 3).
Fig 3.
Year-on-year increase in the rates of mechanical circulatory support (MCS) use both among patients with acute myocardial ischemia (AMI) complicated by cardiogenic shock (CS) (Cochran-Armitage trend test, P = .0001) and those patients additionally complicated by acute limb ischemia (ALI) (Cochran-Armitage trend test, P = .0001). The rates of MCS use are higher in patients who develop ALI.
Predictors of ALI.
Based on the multivariate cox regression, PAD, microaxial MCS device implantation and VA-ECMO were found to be major predictors of ALI in these patients. PAD was associated with an odds ratio (OR) of 7.34 (95% confidence interval [CI], 6.12–8.81; P = .0001). Microaxial MCS device implantation was associated with an OR of 3.12 (95% CI, 2.74–3.55; P = .0001). VA-ECMO was associated with an OR of 4.40 (95% CI, 3.19–6.07; P = .0001) (Fig 4).
Fig 4.
The strongest predictors of development of acute limb ischemia (ALI) in acute myocardial infarction (AMI) with mechanical circulatory support (MCS) were history of peripheral artery disease (PAD), venoarterial extra-corporeal membrane oxygenation (VA-ECMO) cannulation, and microaxial MCS implantation. COPD, chronic obstructive pulmonary disease; OR, odds ratio.
Mortality and resource use.
Patients who developed ALI had a mortality rate of 39.20% compared with 33.53% in patients who did not develop ALI (P = .0001). The length of stay for patients with ALI was significantly longer than in those without ALI (17.96 ± 18.51 vs 9.81 ± 11.50; P = .0001). Total charges of an admission for AMI complicated by CS were $260,738. If the patient also developed ALI, the cost of hospitalization increased by more than double to $540,617. The rate of amputation was significantly higher in patients with ALI than those without ALI (2.46% vs 0.12%; P = .0001). The most common treatment for ALI was anticoagulation alone followed by angioplasty and thrombectomy, which was performed in 15.67% and 11.90% of patients, respectively (Table II).
Table II.
In-hospital outcomes and resource utilization in patients with and without acute limb ischemia (ALI)
| In-hospital outcomes | No ALI | ALI | Total | P value |
|---|---|---|---|---|
| Lower extremity bypass surgery | 78 (0.09) | 28 (2.15) | 106 (0.13) | <.0001 |
| Lower extremity angioplasty | 568 (0.68) | 204 (15.67) | 772 (0.91) | <.0001 |
| Lower extremity thrombectomy | 132 (0.16) | 155 (11.90) | 287 (0.34) | <.0001 |
| Lower extremity amputation | 98 (0.12) | 32 (2.46) | 130 (0.15) | <.0001 |
| Peripheral arterial endarterectomy | 17 (0.02) | 18 (1.38) | 35 (0.04) | <.0001 |
| Death | 27,924 (33.53) | 510 (39.20) | 28,434 (33.62) | <.0001 |
| Total charges, $ | 260,738 ± 314873 | 540,617 ± 612,308 | 107,981 ± 136,834 | |
| Length of stay, days | 9.81 ± 11.50 | 17.96 ± 18.51 | 4.71 ± 5.84 | <.0001 |
| 30-Day readmission | 1272 (1.53%) | 18 (1.38%) | 1290 (1.52%) | <.0001 |
Values are number (%) or mean ± standard deviation.
Comparing the in-hospital procedural outcomes, death rates, hospital expenses, length of stay and 30-day readmission rate of patients with and without ALI.
Sensitivity analysis.
Patients with bleeding and sepsis are more likely to have ALI. Therefore, bleeding and sepsis may be confounding factors when accessing the association of MCS devices on the ALI rate. To address this factor, we performed propensity matching between patients with and without microaxial MCS device as well as between patients with and without VA-ECMO. Of patients with microaxial MCS device implanted, 4.17% of patients developed ALI compared with 1.21% in the group that did not have a microaxial MCS device implanted (P = .0001). Of Patients who had VA-ECMO, 6.82% of patients developed ALI compared with 1.36% (P= 0.0001). As part of the falsification end point analysis, a multivariate cox regression was done for ulcerative colitis and upper extremity fracture. Only the variable for female had a significant relationship for ulcerative colitis (P = .033) and upper extremity fracture (P = .001). No other variables had a significant relationship with ulcerative colitis or upper extremity fracture.
DISCUSSION
To our knowledge, this nationwide study is the first to show that ALI is not an uncommon complication in patients with AMI with CS, and that the rate of this complication has been increasing in contemporary practice. The rates of ALI in general population are 9 to 16 cases per 100,000 persons per year in the lower extremity and 1 to 3 cases per 100,000 persons per year in the upper extremity.15 With an incidence of 1.53%, this finding represents at least an 81-fold increase in the rate of ALI in patients with AMI complicated by CS.
The strongest predictor of the development of ALI was found to be a history of PAD with a seven-fold increased risk of developing ALI. This finding is consistent with the findings of the prior studies that have shown that PAD with ankle-brachial index of less than 0.8 or prior revascularization are at increased risk of ALI as well as mortality.16,17
MCS devices like the Impella or VA-ECMO cannulation were also significantly associated with the development of ALI. Contemporary rates of ALI in patients with CS are not known; however, they were previously thought to range from 0.9% to 3.0%.12,18–21 Prior studies looking at ALI have attributed this complication to bleeding or thrombosis or embolization related to the use of thrombolytics and left ventricular or atrial thrombus formation. In this study, we suggest that an MCS device is associated with an increased risk of ALI, even after accounting for bleeding. The large-bore cannulas used in these types of mechanical support are likely the reason for this observation. Unlike IABP, which usually uses a 7.5F to 8.0F canula, VA-ECMO and microaxial MCS device have a cannula size of 22F to 24F and 13F to 14F, respectively. To date there has not been evidence that conclusive MCS devices provide a mortality benefit in patients with AMI complicated by CS.22,23 Considering these findings, we believe that implantation of a large-bore MCS devices should be avoided in patients with PAD in favor of IABP if possible. The use of anterograde cannulas should be standard practice in patients with PAD receiving a large-bore MCS device. There should be consideration of early decannulation and removal, particularly in patients with PAD.
Our study showed that short-term mortality continues to be high in patients with AMI with CS, particularly if they develop ALI. From 2004 to 2015, AMI-associated mortality complicated by CS was 30.1% as compared with the mortality of 33.53% in our study.12,24 As expected, these patients with ALI also consumed significantly more health care resources in the forms of longer length of stay and higher hospital charges. They also had a markedly increased risk of amputation compared with those who did not develop ALI.
Limitations.
Our study had several limitations. Because this is a retrospective observational study, we cannot eliminate the possibility of selection bias. Although rigorous sensitivity analyses with propensity matching were performed, unmeasured confounders could still influence the results. The NRD is an administrative dataset and, therefore, has all the shortcomings of claims-based databases. One such short coming was the inability to accurately identify fasciotomy as a procedural outcome. This database only provides information up to 30 days of the index hospitalization and, therefore, lacks longer term follow-up and outcomes. The NRD does not provide information related to race or ethnicity, which are, therefore, not reported. The NRD does not provide granular data on procedural characteristic like type of balloon or stent used, operator experience, complexity of lesion, or drugs prescribed that influence outcomes. Only discharge information of 30 states in the United States are included in the NRD. Some of these limitations are mitigated by the size of the dataset and the validated codes that were used. Validated codes for ALI include thrombosis, emboli, and procedural outcomes as part of the definition. Because one of the major causes of ALI in this population was large-bore cannulas, we were not able to use these validated codes for ALI.
CONCLUSIONS
In contemporary practice ALI is not an uncommon complication of AMI complicated by CS and is associated with high in-hospital mortality and amputation rates. Patients with preexisting PAD who are treated with large bore MCS devices are at the highest risk of developing this complication. This risk should be weighed when deciding which type of MCS to use, particularly in patients with PAD or in cases which could be stabilized by using IABP.
Supplementary Material
ARTICLE HIGHLIGHTS.
Type of Research: Multicenter retrospective analysis of prospectively collected registry data from the National Readmission Database
Key Findings: The incidence of acute limb ischemia (ALI) was 1.54% of 84,615 patients with acute myocardial infarction with cardiogenic shock. Patients who developed ALI had higher mortality (39.20% vs 33.53%). Major predictors of ALI were venoarterial extracorporeal membrane oxygenation (odds ratio, 4.40) and microaxial mechanical circulatory support (odds ratio, 3.12).
Take Home Message: ALI is a frequent complication of acute myocardial infarction with cardiogenic shock that is associated with high mortality. In addition to peripheral artery disease, the use of mechanical circulatory support devices was associated with significantly higher rates of ALI.
Acknowledgments
R.B. receives research support from the NHLBI.
Footnotes
Presented at the Annual Scientific Sessions of the American Heart Association, Boston, MA, November 13-15, 2021.
Author conflict of interest: R.B. has equity interest in Thrombolex Inc.
The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.
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