What is the clinical evidence from this study?

Study design: Cohort. Population: Acute myocardial infarction related ventricular septal rupture (AMI-VSR) (n=261). Intervention: Levosimendan vs. Control. Primary outcome: 90-day mortality (propensity-matched) (p=0.539).

May 3, 2022Open Access

The evaluation of levosimendan in patients with acute myocardial infarction related ventricular septal rupture undergoing cardiac surgery: a prospective observational cohort study with propensity score analysis

ZLZeshi LiUtrecht University KWKuo WangChildren's Hospital of Chongqing Medical University TPTuo PanChinese Academy of Medical Sciences & Peking Union Medical College

Key Result

Levosimendan did not significantly reduce 90-day mortality (30.19% vs 37.74%, p=0.539) or postoperative complications compared to control in patients with AMI-related ventricular septal rupture.

Study Design

Type

Cohort (n=261)

Multicenter

Yes

Structured PICO

Does levosimendan improve 90-day survival and reduce postoperative complications in patients with acute myocardial infarction related ventricular septal rupture undergoing cardiac surgery?

Population

261 patients with acute myocardial infarction related ventricular septal rupture (AMI-VSR) diagnosed by echocardiography with low ejection fraction (≤35%) and scheduled for concomitant coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB). Mean age ~58, ~63% male, based in two tertiary hospitals in China.

Intervention

Levosimendan initiated immediately after cardiopulmonary bypass (loading dose 6 μg/kg in the first hour, followed by maintenance dose 0.1 μg/kg/min) and maintained during the postoperative 3 days.

Comparator

Standard treatment strategy without levosimendan.

Outcome

90-day mortality and postoperative complications (postoperative stroke, low cardiac output syndrome needing mechanical circulatory support, acute kidney injury ≥ stage III, postoperative infection or septic shock, new developed atrial fibrillation or ventricular arrhythmias).hard clinical

A low-dose infusion of levosimendan did not significantly improve 90-day survival or reduce postoperative complications in patients undergoing surgical repair for AMI-related ventricular septal rupture.

Main Result

Absolute Event Rate: 30.19% vs 37.74%

p-value: p=0.539

Limitations

Potential biases inherent to observational cohort studies despite propensity score matching.
Hidden bias attributed to latent variables might still remain after matching.
Propensity score matching removed a large number of patients, potentially increasing statistical error.
Did not systematically collect cardiac output data, which could mask the real efficacy of levosimendan.
Recruited patients might not reflect well to the clinical reality due to the complicated condition of AMI-VSR.

Abstract

STUDY OBJECTIVE: The purpose of the present study was to evaluate the efficacy of levosimendan in patients with acute myocardial infarction related ventricular septal rupture (AMI-VSR) underwent cardiac surgery. DESIGN: Prospective observational cohort study with propensity score analysis. PATIENTS: There were 261 patients with AMI-VSR in our study. After 1:1 propensity matching, 106 patients (53 levosimendan and 53 control) were selected in the matched cohort. INTERVENTIONS: None. MEASUREMENTS: Patients who received levosimendan were assigned to the levosimendan group (n = 164). The patients who were not received were levosimendan assigned to the control group (n = 97). The levosimendan was initiated immediately after cardiopulmonary bypass. Then, it has been maintained during the postoperative 3 days. The poor outcomes were identified as follows: death and postoperative complications (postoperative stroke, low cardiac output syndromeneeded mechanical circulatory support after surgery, acute kidney injury (≥ stage III), postoperative infection or septic shock, new developed atrial fibrillation or ventricular arrhythmias). MAIN RESULTS: Before matching, the control group had more length of ICU stay (6.69 ± 3.90 d vs. 5.20 ± 2.24 d, p < 0.001) and longer mechanical ventilation time (23 h, IQR: 16-53 h vs. 16 h, IQR: 11-23 h, p < 0.001). Other postoperative outcomes have not shown significant differences between two groups. After matching, no significant difference was found between both groups for all postoperative outcomes. The Kaplan-Meier survivul estimate and log-rank test showed that the 90-day survival had no significant differences between two groups before and after matching. CONCLUSION: Our study found that a low-dose infusion of levosimendan in AMI-VSR patients underwent surgical repair did not associated with positively affect to postoperative outcomes.

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