Incidence, management, and prognosis of post-ischaemic ventricular septal defect: Insights from a 12-year tertiary centre experience.

Background: Among mechanical complications of acute myocardial infarction, ventricular septal defect (VSD) is uncommon but still serious. The evolution of emergency coronary revascularisation paradoxically decreased our knowledge of this disease, making it even rarer. Aim: To describe ischaemic VSD incidence, management, and associated in-hospital and 1-year outcomes over a 12-years period. Methods: A retrospective single-centre register of patients managed for ischaemic VSD between January 2009 and December 2020. Results: Ninety-seven patients were included representing 8 patients/ years and an incidence of 0.44% of ACS managed. The majority of the patients were 73-years-old males (n = 54, 56%) with STEMI presentation (n = 75, 79%) and already presented with Q necrosis on ECG (n = 70, 74%). Forty-nine (51%) patients underwent PCI, 60 (62%) inotrope/vasopressors infusion, and 70 (72%) acute mechanical circulatory support (IABP 62%, ECMO 13%, and Impella® 3%). VSD surgical repair was performed for 44 patients (45%) and 1 patient was transplanted. In-hospital mortality was 71%, and 86% at 1 year, without significant improvement over the decade. Surgery appears to be a protective factor [0.51 (0.28-0.94) p = 0.003], whereas age [1.06 (1.03-1.09), p < 0.001] and lactate [1.16 (1.09-1.23), p < 0.001] were linked to higher 1-year mortality. None of the patients that were managed medically survived 1 year. Conclusion: Post-ischaemic VSD is a rare but serious complication still associated with high mortality. Corrective surgery is associated with better survival, however, timing, patient selection, and a place for mechanical circulatory support need to be defined.

Prevalence, management, and outcomes of haemorrhagic events in left ventricular assist device recipients.

AIMS: Left ventricular assist devices (LVADs) have reduced the mortality of patients with advanced heart failure both as bridge-to-transplant and as destination therapy. However, LVADs are associated with various complications, including bleedings, which affect the prognosis. The aim of the study was to explore the prevalence, management, and outcomes of haemorrhagic adverse events in LVAD recipients. METHODS AND RESULTS: We conducted a retrospective, single-centre, cohort study including all patients who received an LVAD from January 2008 to December 2019 in our tertiary centre (Rangueil University Hospital, Toulouse, France). Bleeding events, death, and heart transplantation were collected from electronic medical files. Eighty-eight patients were included, and 43 (49%) presented at least one bleeding event. Gastrointestinal (GI) bleeding was the most frequent (n = 21, 24%), followed by epistaxis (n = 12, 14%) and intracranial haemorrhage (n = 9, 10%). Bleeding events were associated with increased mortality [hazard ratio (HR) 3.8, 95% confidence interval (CI) 1.5-9.3, P < 0.01], particularly in case of intracranial haemorrhage (HR 14.6, 95% CI 4.2-51.1, P < 0.0001). GI bleedings were associated with a trend towards increased mortality (HR 3.0, 95% CI 0.9-9.3, P = 0.05). Each bleeding episode multiplied the risk of death by 1.8 (95% CI 1.2-2.7, P < 0.01). Finally, only early bleedings (<9 months post-implantation) had an impact on mortality (HR 4.2, 95% CI 1.6-11.1, P < 0.01). Therapeutic management was mainly based on temporary interruption of anticoagulation and permanent interruption of antiplatelet therapy. Invasive management was rarely performed. CONCLUSIONS: Haemorrhagic events in LVAD recipients are frequent and associated with increased mortality. GI bleedings are the most frequent, and intracranial haemorrhages the most associated with mortality. Management remains empirical requiring more research.

Budget Impact Analysis of Impella CP® Utilization in the Management of Cardiogenic Shock in France: A Health Economic Analysis.

INTRODUCTION: Early detection and treatment of cardiogenic shock (CS) is crucial to avoid irreparable multiorgan damage and mortality. Impella CP® is a novel temporary mechanical circulatory support (MCS) device associated with greater hemodynamic support and significantly fewer device-related complications compared with other MCS devices, e.g., intra-aortic balloon pumps (IABP) and venoarterial extracorporeal membrane oxygenation (VA-ECMO). The present study evaluated the budget impact of introducing Impella CP versus IABP and VA-ECMO in patients with CS following an acute myocardial infarction (MI) in France. METHODS: A budget impact model was developed to compare the cost of introducing Impella CP with continuing IABP and VA-ECMO treatment from a Mandatory Health Insurance (MHI) perspective in France over a 5-year time horizon, with 700 patients with refractory CS assumed to be eligible for treatment per year. Costs associated with Impella CP and device-related complications for all interventions were captured and clinical input data were based on published sources. Scenario analyses were performed around key parameters. RESULTS: Introducing Impella CP was associated with cumulative cost savings of EUR 2.7 million over 5 years, versus continuing current clinical practice with IABP and VA-ECMO. Cost savings were achieved in every year of the analysis and driven by the lower incidence of device-related complications with Impella CP, with estimated 5-year cost savings of EUR 22.4 million due to avoidance of complications. Total cost savings of more than EUR 250,000 were projected in the first year of the analysis, which increased as the market share of Impella CP was increased. Scenario analyses indicated that the findings of the analysis were robust. CONCLUSION: Treatment with Impella CP in adult patients aged less than 75 years in a state of refractory CS following an MI was projected to lead to substantial cost savings from an MHI perspective in France, compared with continuing current clinical practice.

Pump flow setting and assessment of unloading in clinical practice.

The rationale for mechanical circulatory support (MCS) in cardiogenic shock is to restore cardiac output in selected patients when critically low or in case of refractory cardiac arrest. Furthermore, an MCS device that moves blood from either the left atrium or the left ventricle to the systemic circulation will potentially unload the ventricle. These devices are used alone or in combination with venoarterial extracorporeal membrane oxygenation (VA-ECMO). If a left-sided Impella device is used, it should be run at the highest possible performance level during treatment while avoiding suction events. When combined with VA-ECMO, the Impella device should be run at a lower performance level, ensuring sufficient left ventricular emptying but avoiding suction. Continuous monitoring is pivotal and patients managed outside the catheterization laboratory should be monitored with an arterial line, a central venous catheter, frequent use of pulmonary artery catheters and regular imaging by transthoracic echocardiogram.

Budget Impact Associated with the Introduction of the Impella 5.0® Mechanical Circulatory Support Device for Cardiogenic Shock in France.

AIM: Cardiogenic shock (CS), if not diagnosed and treated rapidly, can lead to irreversible multiorgan damage and death. An economic analysis was conducted to determine the budget impact of the introduction of Impella 5.0®, a mechanical circulatory support (MCS) device that directly unloads the left ventricle, into clinical practice in patients with left ventricular CS in France. METHODS: A budget impact model was developed to compare the cost of Impella 5.0 with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) from the perspective of the French national healthcare insurer. Costs associated with Impella 5.0, plus complication-related costs for VA-ECMO or Impella 5.0 from 2019 were included and clinical input data relating to complication rates and time spent on device were sourced from published literature. Extensive scenario and one-way deterministic sensitivity analyses were performed to explore the influence of uncertainty around key input parameters. RESULTS: Over a time horizon of 5 years, the introduction of Impella 5.0 was associated with cumulative savings of EUR 4.3 million. The results were driven by the lower risk of device-related complications associated with Impella 5.0. Savings were apparent from Year 1 onwards, with savings in excess of EUR 375,000 projected in Year 1 alone. On a per-patient level, in Year 1, estimated savings with the introduction of Impella 5.0 totaled EUR 616 per patient. Sensitivity analyses showed that the findings of the analysis were robust. CONCLUSION: The Impella 5.0 device was associated with cumulative cost savings in excess of EUR 4 million over a 5-year period compared with current practice. Projected savings were driven by a lower rate of device-related complications with Impella 5.0 compared with VA-ECMO.

Diagnostic performances of lung ultrasound associated with inferior vena cava assessment for the diagnosis of acute heart failure in elderly emergency patients: a diagnostic study.

BACKGROUND AND IMPORTANCE: Few studies are looking at the usefulness of lung ultrasound combined with inferior vena cava (ultrasound strategy) in the particularly challenging diagnosis of acute heart failure (AHF) in elderly dyspneic patients attending the emergency department (ED). OBJECTIVE, DESIGN, SETTINGS, AND PARTICIPANTS: This was a prospective diagnostic study conducted in two French EDs from December 2015 to March 2019, aimed to determine the accuracy of an ultrasound strategy for the diagnosis of AHF in the elderly. Patients aged 65 and older referred to the ED for dyspnea were screened for inclusion. INTERVENTION: An emergency physician, blinded to the first findings, performed chest ultrasound, and assessment of inferior vena cava (ultrasound strategy). OUTCOME MEASURE AND ANALYSIS: The primary endpoint was a final diagnosis of AHF, adjudicated by two independent experts after reviewing the entire medical record. The sensitivity and specificity of ultrasound and standard strategies were calculated. MAIN RESULTS: A total of 116 patients were included, mean age 84 years (SD 9). Among them, there were 76 (66%) cases of AHF and 51 (44%) cases of pneumonia. The ultrasound work up had a sensitivity of 82% [95% confidence interval (CI), 71-90] and a specificity of 68% (95% CI, 51-90] for AHF. The standard strategy had a sensitivity of 92% (95% CI, 84-97) and a specificity of 53% (95% CI, (36-68). CONCLUSIONS: In this prospective study, there was no statistically significant difference between point-of-care ultrasound and a combination of clinical, radiographic, and biological findings for the diagnosis of acute heart failure.

Feasibility and accuracy of gated blood pool SPECT equilibrium radionuclide ventriculography for the assessment of left and right ventricular volumes and function in patients with left ventricular assist devices.

BACKGROUND: Left ventricular assist devices (LVADs) require serial assessment of right and left ventricular (RV & LV) volumes and function. Because the RV is not assisted, its function is a critical determinant of the hemodynamic and contributes significantly to postoperative morbidity and mortality. We evaluated the feasibility and the accuracy of tomographic-equilibrium radionuclide ventriculography (t-ERV) for the assessment of patients with LVADs. METHODS: Twenty-four patients with LVAD underwent t-ERV. Because of the limited acoustic window, transthoracic echocardiography (TTE) was only feasible in 19 patients. Functional evaluation including six-minute walk test (6MWT) and peak oxygen consumption (POC) was performed in 18 patients. Nine patients underwent a cardiac multidetector computed tomography (MDCT). Eight patients underwent a second evaluation by ERV 4.3 ± 1.4 months later. RESULTS: Reliability between t-ERV and MDCT for LV end-diastolic volume, LV end-systolic volume, LV ejection fraction, RV end-diastolic volume, RV end-systolic volume, and RV ejection fraction (RVEF) was 0.900 (P = .001), 0.911 (P = .001), 0.765 (P = .021), 0.728 (P = .042), 0.875 (P = .004), and 0.781 (P = .023), respectively. There was no correlation between t-ERV and RV systolic parameters assessed by TTE. RVEF was correlated with POC (R = 0.521; P = .027). A cut-off value of 40% for RVEF measured by t-ERV could discriminate patients with poor functional status (P = .048 for NYHA stage; P = .016 for 6MWT and P = .007 for POC). CONCLUSION: t-ERV is a simple, reproducible, and an accurate technique for the assessment of RV function in patients with LVADs and warrants consideration in the evaluation and monitoring of symptomatic patients.