Intra-Aortic Balloon Pump Support in Patients with Acute Myocardial Infarction with Ventricular Septal Rupture

Abstract

Background: An intra-aortic balloon pump (IABP) is the device most frequently used as a bridge to surgical repair in cases of myocardial infarction. However, robust evidence of IABP support for patients with postinfarction ventricular septal rupture (VSR) remains lacking. This study was aimed at assessing the effect of IABP support on 30-day prognosis in patients with acute myocardial infarction (AMI) complicated by VSR.

Methods: Retrospective data for patients with VSR after AMI at Fuwai Hospital between April 2002 and August 2020 were analyzed. Patients were initially stratified into two groups according to IABP implantation. The Kaplan-Meier method was used to determine the cumulative incidence of 30-day all-cause mortality. Multivariate logistic regression was used to evaluate the independent risk factors for 30-day mortality.

Results: A total of 92 patients (mean age of 67.8 ± 8.3 years; 46.7% male) were included, 59 of whom underwent IABP implantation. Patients with rather than without IABP treatment were younger, were more often male, and had a higher body mass index and lower mean blood pressure at the onset of VSR. At 30 days, all-cause death occurred in 21 patients in the IABP group (35.59%) and 31 patients in the group without IABP (93.94%). After adjustment for age, sex, left atrial diameter, left ventricular diameter, perforation diameter and ventricular aneurysm, IABP support was found to be an independent protective predictor of 30-day all-cause mortality (hazard ratio: 0.22; 95% confidence interval: 0.12 to 0.42; P < 0.001).

Conclusions: IABP support was associated with lower 30-day mortality in patients with VSR after AMI. Patients with postinfarction VSR with hemodynamic instability or cardiogenic shock could receive IABP treatment as a bridge to surgical repair.

Main article text

Introduction

Ventricular septal rupture is an uncommon but catastrophic complication of acute myocardial infarction (AMI). Despite the use of reperfusion therapy, mortality in the acute phase of ventricular septal rupture (VSR) remains high [1]. The optimal timing and mortality for VSR surgery remain controversial, and better outcomes have been reported with delayed surgery. Mechanical circulatory support (MCS) strategies now offer new opportunities to achieve hemodynamic stabilization in patients in more critical condition, thus allowing for delayed surgery and potentially contributing to improved survival [2]. An intra-aortic balloon pump (IABP) is the most frequently used device as a bridge to surgical repair and is recommended by guidelines (class IIa, level C) in cases of mechanical complications of myocardial infarction [3]. The cornerstone of treatment of VSR is afterload reduction to increase effective left ventricle stroke volume by decreasing left-to-right shunting. IABP can decrease the left-to-right shunt by decreasing the afterload, increasing the coronary flow, and diminishing ventricular wall stress and oxygen demand. MCS has been demonstrated to be an effective therapeutic option that can improve clinical outcomes [4]. However, robust evidence regarding IABP support for patients with postinfarction VSR and CS remains lacking. The purpose of the present study was to examine the effects of IABP support on 30-day prognosis in patients with AMI complicated by VSR.

Methods

Study Populations

The inclusion criteria were consecutive patients admitted to the cardiac care unit of Fuwai Hospital for AMI between April 2002 and August 2020, who had echocardiography-demonstrated evidence of VSR and who received a recommendation for IABP support, according to the 2023 European Society of Cardiology guidelines [3]. Eligible patients were selected among those with evidence of hemodynamic instability and signs of inadequate hypoperfusion, such as cool, clammy skin; oliguria; altered sensation; or other evidence of elevated left ventricular filling pressure with clinical signs of pulmonary congestion. For these patients, IABP support was indicated to maintain a systolic blood pressure greater than 90 mmHg. The onset of recorded vital signs was used to determine the clinical hemodynamics for each patient. The exclusion criteria were 1) VSR secondary to the presence of congenital heart disease, and 2) serious infection. One patient with free wall rupture and 24 patients without an indication for IABP implantation, because of stable hemodynamics, were excluded. Clinical characteristics, echocardiographic features and surgical repair of VSR were recorded. The protocol for this retrospective study was approved by the Ethics Committee of Fuwai Hospital (approval number: 2021-1422) and was conducted in accordance with the principles of the Declaration of Helsinki. Patients were initially stratified into two groups according to the presence or absence of IABP treatment. The study flowchart is shown in Figure 1.

Figure 1

Flowchart of Patient Selection.

Definitions

AMI can be diagnosed on the basis of clinical evidence, including acute myocardial ischemia; an increase and/or decrease in cardiac troponin levels with at least one value above the 99^th percentile upper range limit; and electrocardiographic evidence of >2 mm ST-segment elevation in the precordial leads or >1 mm ST-segment elevation in the limb leads [5]. All patients underwent echocardiographic confirmation of VSR through transthoracic methods during hospital admission. Diagnosis of VSR was defined by a disruption in the ventricular septum with evidence of left-to-right shunt on color Doppler imaging. Left ventricular ejection fraction (LVEF) was calculated with biplane Simpson’s method.

IABP

IABP implantation was performed via the femoral artery. A 7 or 7.5 F balloon catheter (Arrow, Datascope Corp, Oakland, NJ, USA), of 30 or 40 cc, in accordance with the patient’s height and weight, was implanted into the descending aorta and connected to a Datascope pump CS100/CS300 (Datascope, USA). The balloon size was selected according to the patient’s height (30, 40 or 50 cc). Correct positioning of the balloon catheter was identified through chest X-ray. All IABPs were inserted by a cardiologist experienced with the percutaneous insertion technique.

Endpoints

The 30-day mortality (all-cause death) after VSR diagnosis in patients with or without IABP treatment was analyzed and compared.

Statistical Analysis

Continuous variables are summarized as the mean ± standard deviation. Categorical variables are expressed as percentages. Student’s t-test was used for the comparison of continuous variables, or rank sum tests were used when necessary. The chi-square test was used to compare categorical variables. To determine predictors of 30-day mortality, we performed univariate logistic regression on the baseline variables. Multivariate logistic regression was used to assess the effects of the selected parameters on IABP use in VSR patients. Factors associated with IABP use in the multivariate model as well as other factors known to be associated with death were selected and included in the model in a stepwise fashion to adjust the influence of IABP on 30-day mortality. The results are presented as odds ratios (ORs) and 95% confidence intervals (CIs). Interaction analyses, including LVEF and renal function, and their potential interactions with confounders, were performed to evaluate the relationships of these factors with IABP use and mortality. Follow-up mortality was analyzed with the Kaplan-Meier method. A two-sided P-value <0.05 was considered significant. For all calculations, SAS version 9.4 (SAS Institute, Cary, North Carolina) was used.

Results

Baseline Characteristics

A total of 92 patients with VSR after AMI between April 2002 and August 2020 treated at the cardiac care unit of Fuwai Hospital who met the inclusion criteria were included in the analysis. Baseline clinical characteristics are shown in Table 1. An IABP was used in 59 patients (64.1%). Compared with patients without IABP treatment, patients in the IABP group tended to be younger, were more likely to be current smokers and male, and had a higher body mass index (BMI) and lower mean blood pressure at the onset of VSR (all P < 0.05). The characteristic distributions of other demographics and clinical comorbidities were balanced between groups.

Table 1

Baseline Demographic and Clinical Characteristics of the Study Participants.

Characteristics	All (n = 92)	Patients with IABP (n = 59)	Patients without IABP (n = 33)	P value
Mean age, yr	67.8 ± 8.3	65.9 ± 7.8	71.2 ± 8.0	0.01
Male	43 (46.7%)	33 (55.9%)	10 (30.3%)	0.02
BMI, kg/m2	24.3 ± 3.3	25.2 ± 3.2	22.8 ± 3.1	<0.001
Time from infarction to the defect, days	3.8 ± 3.8	3.8 ± 4.1	3.0 ± 3.1	0.56
Emergency intervention	12 (13.0%)	8 (13.6%)	4 (12.1%)	0.84
Current smoker	44 (47.8%)	33 (55.9%)	11 (33.3%)	0.04
Hypertension	56 (60.9%)	33 (55.9%)	23 (69.7%)	0.19
Diabetes mellitus	24 (26.1%)	12 (20.3%)	12 (36.4%)	0.09
Prior stroke	21 (22.8%)	14 (23.7%)	7 (21.2%)	0.78
Chronic renal insufficiency	22 (23.9%)	15 (25.4%)	7 (21.2%)	0.65
Creatinine, μmol/L	135 ± 58.8	137.1 ± 66.7	130.7 ± 39.4	0.62
Mean blood pressure at the onset of VSR, mmHg	73.4 ± 10.8	70.4 ± 9.4	78.9 ± 11.1	<0.001
Heart rate at the onset of VSR, beats/min	102.6 ± 16.9	103.7 ± 16.1	100.6 ± 18.3	0.38
Killip class IV	86 (93.5%)	55 (93.2%)	31 (93.9%)	0.89
Left atrial diameter, mm	36.9 ± 5.1	37.1 ± 4.9	36.6 ± 5.6	0.59
Left ventricular diameter, mm	51.6 ± 5.8	52.2 ± 5.8	50.5 ± 5.7	0.19
LVEF, %	46.9 ± 10.0	46.0 ± 9.9	48.4 ± 10.1	0.39
Perforation size, mm	13.7 ± 6.1	14.8 ± 6.5	11.8 ± 4.7	0.03
Pulmonary artery systolic pressure, mmHg	31.6 ± 6.2	31.4 ± 6.4	31.9 ± 6.5	0.88
Transseptal blood flow velocity, m/s	3.88 ± 0.23	3.86 ± 0.26	3.9 ± 0.19	0.21
VSR location in anterior	75 (81.5%)	48 (81.4%)	27 (81.8%)	0.96
Combined ventricular aneurysm	40 (43.5%)	29 (49.2%)	11 (33.3%)	0.14

Abbreviations: BMI, body mass index; LVEF, left ventricular ejection fraction.

Echocardiographic Characteristics

Echocardiographic characteristics at the onset of VSR are presented in Table 1. The perforation size, measured by transthoracic echocardiography, was significantly larger in the IABP support group than the group without IABP treatment (14.8 ± 6.5 vs. 11.8 ± 4.7 mm, P = 0.03). The diameter of the left atrium and left ventricle, level of LVEF and prevalence of combined ventricular aneurysm did not differ between groups (all P > 0.05).

Clinical Outcomes

The overall 30-day mortality in patients with AMI after VSR was 56.5%. Twenty-one patients in the IABP support group (35.59%) and 31 patients in the group without IABP treatment (93.94%) died (Table 2). Preoperative mortality in the IABP support group was lower than that in the group without IABP treatment (33.9% versus 90.9%). Univariate analysis demonstrated that IABP insertion was a protective factor against 30-day mortality in patients with VSR (HR 0.18, 95% CI 0.10–0.32, P < 0.0001), as shown in Table 3. Other factors, such as age, sex, left atrial diameter, left ventricular diameter, perforation size and ventricular aneurysm, were also significantly associated with 30-day mortality in the univariate analysis (Table 3, Figure 2). The association between IABP treatment and 30-day mortality remained significant after adjustment for age and sex (HR 0.20, 95% CI 0.11–0.36, P < 0.001) (Table 4). After additionally controlling for age, sex, left atrial diameter, left ventricular diameter, perforation diameter and ventricular aneurysm, we determined that the association remained significant for IABP treatment (HR 0.22, 95% CI 0.12–0.42, P < 0.001) (Table 4). Kaplan-Meier analysis (Figure 3) indicated that the death rates at 30 days were significantly lower in the IABP group than the no-IABP group (35.6% versus 93.9%, P < 0.001). All discharged patients were alive at the end of the study. Complications after IABP included two cases of ischemic cerebral infarction, one case of lower limb vascular ischemia and two cases of bleeding at the puncture site. All five patients recovered after suitable therapy (such as neurological drug therapy, removal of the IABP and contralateral insertion, and bandage hemostasis).

Figure 2

Stratified Analyses of the Association Between IABP Insertion and 30-day Mortality, According to Baseline Characteristics. Note: The P value for interaction represents the likelihood of interaction between the variable and IABP insertion. Abbreviations: BMI, body mass index; LVEF, left ventricular ejection fraction.

Figure 3

Kaplan-Meier Curves for Patients with and Without IABP.

Table 2

In-Hospital Management and Outcomes.

Characteristics	All (n = 92)	Patients with IABP (n = 59)	Patients without IABP (n = 33)	P value
Surgical repair	30 (32.6%)	29 (49.2%)	1 (3.0%)	<0.001
Time from onset of the defect to surgery, days	20.0 ± 9.1	20.6 ± 8.6	1.0	<0.001
Preoperative mortality	50 (54.3%)	20 (33.9%)	30 (90.9%)	<0.001
30-Day mortality from onset of defect	52 (56.5%)	21 (35.6%)	31 (93.9%)	<0.001

Table 3

Univariable Logistic Regression for 30-day Mortality.

Characteristics	Statistics	Death	P value
IABP
No	33 (35.87%)	1
Yes	59 (64.13%)	0.18 (0.10, 0.32)	<0.0001
Sex
Male	43 (46.74%)	1
Female	49 (53.26%)	2.05 (1.16, 3.64)	0.014
Age	67.77 ± 8.25	1.07 (1.03, 1.11)	0.001
Emergency intervention
No	80 (86.96%)	1
Yes	12 (13.04%)	0.65 (0.26, 1.62)	0.353
Hypertension
No	36 (39.13%)	1
Yes	56 (60.87%)	1.13 (0.64, 2.00)	0.676
Diabetes mellitus
No	68 (73.91%)	1
Yes	24 (26.09%)	0.82 (0.43, 1.57)	0.557
Prior stroke
No	71 (77.17%)	1
Yes	21 (22.83%)	0.89 (0.46, 1.73)	0.732
Chronic renal insufficiency
No	70 (76.09%)	1
Yes	22 (23.91%)	1.71 (0.94, 3.08)	0.076
Current smoker
No	48 (52.17%)	1
Yes	44 (47.83%)	0.69 (0.39, 1.19)	0.179
Mean blood pressure, mmHg	73.41 ± 10.83	1.01 (0.98, 1.04)	0.549
Heart rate, beats/min	102.57 ± 16.90	1.01 (1.00, 1.03)	0.107
Time from infarction to the defect, days	3.52 ± 3.77	1.01 (0.94, 1.09)	0.824
BMI, kg/m2	24.34 ± 3.34	0.92 (0.84, 1.00)	0.064
Creatinine, μmol/L	135.00 ± 58.83	1.00 (1.00, 1.01)	0.252
Left atrial diameter, mm	36.94 ± 5.13	0.93 (0.87, 0.99)	0.019
Left ventricular diameter, mm	51.61 ± 5.76	0.92 (0.87, 0.97)	0.003
EF, %	46.88 ± 10.01	1.01 (0.98, 1.04)	0.514
Perforation size, mm	13.73 ± 6.08	0.91 (0.86, 0.96)	0.001
Combined ventricular aneurysm
No	52 (56.52%)	1
Yes	40 (43.48%)	0.38 (0.21, 0.69)	0.002

Abbreviations: BMI, body mass index; EF, ejection fraction.

Table 4

Association Between IABP and 30-Day Mortality in the Multiple Regression Model.

Outcome	Unadjusted model		Model I		Model II
	OR (95% CI)	P value	OR (95% CI)	P value	OR (95% CI)	P value
IABP
Without	Reference		Reference		Reference
With	0.18 (0.10, 0.32)	<0.001	0.20 (0.11, 0.36)	<0.001	0.22 (0.12, 0.42)	<0.001

Model I: Adjusted for age and sex.

Model II: Adjusted for age, sex, left atrial diameter, left ventricular diameter, perforation diameter, combination with ventricular aneurysm.

Abbreviations: OR, odds ratio; CI, confidence interval.

Discussion

Major findings from the data analysis indicated that IABP use was associated with 1) a diminished 30-day risk of death in patients with AMI complicated by VSR, combined with hemodynamic instability or cardiogenic shock, and 2) enhanced opportunities for surgical treatment.

Mortality rates associated with post-MI VSR have not changed significantly over time and are particularly poor in the setting of coexisting CS, despite improvements in early diagnosis and management [6, 7]. The main cause of death in patients with AMI with VSR is “pump failure,” which results in hemodynamic instability. Therefore, the hemodynamic status of patients must urgently be improved to decrease early mortality. The afterload reduction can be considered an advantage of IABP, which decreases LV wall stress, thus facilitating contractility and increasing cardiac output, while decreasing left-to-right shunting [8]. Despite being the safest and most cost-efficient type of MCS, IABP use is often limited by insufficient hemodynamic support in patients in critical condition, particularly in the presence of a large VSR or infarction, as well as biventricular involvement [8]. The survival rate of patients with AMI complicated by VSR has increased with the rapid advancements in extracorporeal circulation technology, particularly when extracorporeal membrane oxygenation and IABP are implemented before surgery [4].

IABP is often considered in the early period of CS treatment, because of its advantages of relatively low cost, ease of implantation and low complication rates [9]. Preoperative IABP use has been demonstrated to effectively prevent complications in high risk patients undergoing coronary artery bypass grafting [10]. A retrospective analysis has suggested that preserved LVEF was associated with better prognosis in the surgical management of VSR complicating AMI but not IABP implantation [11]. A total of 92 patients with AMI with VSR with hemodynamic instability or CS were included in our study. Traditional medical treatment is not effective in these patients. IABP was used in 59 patients (64.1%). Compared with the control group, patients in the IABP group had lower 30-day mortality (35.59% vs. 93.94%). Our findings suggested that IABP remained a highly effective treatment for VSR with unstable hemodynamics. These results supplement, and are consistent with, previous research [4, 12].

Surgery is the definitive treatment for VSR, but the optimal timing is unclear. Research has indicated that 1) the risk of death increases with the early surgical repair of VSR, because the infarcted myocardium is very fragile in the early phase after AMI, and 2) surgical repair is very difficult, because it increases the risk of recurrent septal defects. A long period of time for the heart and different body systems is required to adapt to the hemodynamic consequences of a sudden left-to-right shunt. The optimal time for surgery appears to be after the maturation of VSR with scarring at the edges of the defect [13]. If pharmacologic therapy fails, IABP should be used [14, 15]. IABP support decreased 30-day mortality in patients with shock (61% vs. 100%, P = 0.04). The benefit of IABP support in the shock cohort was driven primarily by a decrease in preoperative mortality (11% vs. 88%, P < 0.001) [12]. Patients who survive early and undergo VSR repair surgery have favorable long-term prognosis; therefore, timely surgical treatment is necessary [14]. Transcatheter device closure has been proposed as an alternative treatment, but its operative mortality rate to date is as high as that traditionally reported of surgical repair; therefore, percutaneous treatment may be appropriate in selected cases, depending on the adequacy of local expertise [16]. A study by Kun et al. has indicated an overall in-hospital mortality rate of 47%, and refractory heart failure as the most common cause of death (n = 35). These findings suggest that early application of hemodynamic support is particularly important to improve in-hospital outcomes [7]. In previous studies, IABP has been found to increase diastolic coronary and systemic blood flow, and decrease afterload and myocardial work, and thus protect LV function and prevent low cardiac output [17]. Experimental and clinical studies have indicated that IABP confers a hemodynamic benefit as a result of afterload reduction and diastolic augmentation with improvements in coronary perfusion [18]. The use of a temporary MCS for bridging is a reasonable option for VSR, after consideration of the upfront surgical risks, and is supported by the latest European Society of Cardiology STEMI guidelines [19, 20]. Using IABP before surgery may increase cardiac output, decrease left-to-right shunting and improve coronary perfusion. The early survival rate is affected by preoperative CS; therefore, improving patients’ hemodynamic status before surgery is critical [21]. In addition, the implementation of preoperative mechanical circulatory support and delayed surgery may improve the prognosis of patients with VSR complicated by CS [22].

Perspectives

The present analysis was derived from an observational study and should be considered only hypothesis-generating. The obtained results support the routine use of IABP in patients with VSR with signs of CS or the need for medical support to maintain hemodynamic stability. IABP insertion was associated with diminished 30-day mortality. Surgery may decrease the preoperative mortality rate. In contrast, because death can still occur with IABP, a risk scale must be developed to aid in the selection of patients who would benefit from additional circulatory support. This personalized treatment process might increase the effectiveness of the devices used and improve the prognosis for difficult cases [23]. VSR is a rare but life-threatening condition often associated with CS with specific pathophysiology and hemodynamic characteristics. The optimal timing and modality of VSR surgery remain controversial, and delaying surgery has been reported to increase effectiveness. Currently, MCS strategies offer new possibilities to achieve hemodynamic stabilization, thus enabling surgery delay, even in critically ill patients, and potentially contributing to improved survival. Because of the low incidence of mechanical complications of myocardial infarction, the application of delayed surgical treatment and treatment with MCS is limited. The major prior studies have involved only a small number of patients but nevertheless highlight certain trends, MCS as a bridge to surgical repair in VSR is recommended [8].

Study Limitations

This analysis was a single-center retrospective observational study and is thus limited by the particular patient population at this center. The study period was long, which may have limited the number of statistical variables. Moreover, we lacked data regarding the time of IABP insertion (after insertion); thus, this important aspect was not analyzed. The trial protocol allowed for the insertion of a ventricular assist device based on the investigator’s clinical judgment and patient consent. It cannot be excluded that in some patients, IABP was not inserted due to an initially extremely poor clinical condition, or patients’ own treatment expectations were not optimistic, or insufficient family support. The optimal duration of mechanical circulatory support remains unknown. However, a balance appears to have been weighed between stabilizing the patient and avoiding serious complications of IABP. To validate the results of this study, prospective data collection from multiple centers is needed.

Conclusion

In this cohort of patients with AMI complicated with VSR, IABP support was associated with diminished 30-day mortality. Patients with postinfarction VSR with hemodynamic instability or cardiogenic shock could receive IABP treatment as a bridge to surgical repair.

Ethics Statement

The authors are accountable for all aspects of the work, including ensuring that any questions associated with the accuracy or integrity of any part of the work have been appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). The study was approved by the Ethics Committee of the Fuwai Hospital (No. 2021-1422). Because of the retrospective nature of the research, the requirement for informed consent was waived.

Author Contributions

X.-L. Luo performed the studies, participated in data collection, performed the statistical analysis and drafted the manuscript, under the supervision of J. Zhang and S. Qiao. H. Xu, J. Li, C. Guo, J. Yuan and Y. Ma participated in data collection and proofread the manuscript. All authors read and approved the final manuscript.

Acknowledgments

The authors thank the physicians at the cardiac care unit at Fuwai Hospital for performing the research and the patients enrolled in the study for their compliance with follow-up.

Conflict of Interest

The authors declare no potential conflict of interest.

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