Percutaneous Left-Ventricular Support With the Impella-2.5–Assist Device in Acute Cardiogenic Shock

Abstract

Background-Acute cardiogenic shock after myocardial infarction is associated with high in-hospital mortality attributable to persisting low-cardiac output. The Impella-EUROSHOCK-registry evaluates the safety and efficacy of the Impella-2.5-percutaneous left-ventricular assist device in patients with cardiogenic shock after acute myocardial infarction. Methods and Results-This multicenter registry retrospectively included 120 patients (63.6±12.2 years; 81.7% male) with cardiogenic shock from acute myocardial infarction receiving temporary circulatory support with the Impella-2.5-percutaneous left-ventricular assist device. The primary end point evaluated mortality at 30 days. The secondary end point analyzed the change of plasma lactate after the institution of hemodynamic support, and the rate of early major adverse cardiac and cerebrovascular events as well as long-term survival. Thirty-day mortality was 64.2% in the study population. After Impella-2.5-percutaneous left-ventricular assist device implantation, lactate levels decreased from 5.8±5.0 mmol/L to 4.7±5.4 mmol/L (P=0.28) and 2.5±2.6 mmol/L (P=0.023) at 24 and 48 hours, respectively. Early major adverse cardiac and cerebrovascular events were reported in 18 (15%) patients. Major bleeding at the vascular access site, hemolysis, and pericardial tamponade occurred in 34 (28.6%), 9 (7.5%), and 2 (1.7%) patients, respectively. The parameters of age >65 and lactate level >3.8 mmol/L at admission were identified as predictors of 30-day mortality. After 317±526 days of follow-up, survival was 28.3%. Conclusions-In patients with acute cardiogenic shock from acute myocardial infarction, Impella 2.5-treatment is feasible and results in a reduction of lactate levels, suggesting improved organ perfusion. However, 30-day mortality remains high in these patients. This likely reflects the last-resort character of Impella-2.5-application in selected patients with a poor hemodynamic profile and a greater imminent risk of death. Carefully conducted randomized controlled trials are necessary to evaluate the efficacy of Impella-2.5-support in this high-risk patient group. (Circ Heart Fail. 2013;6:23-30.)Key Words: cardiogenic shock ■ Impella-2.5-device ■ mechanical circulatory support ■ percutaneous left-ventricular assist device

The management of patients with cardiogenic shock

“…The TandemHeart (Cardiac Assist, USA) is a percutaneously or surgically implanted by-pass from the left atrium to the femoral artery via centrifugal continuous flow pump. Both systems may be implanted by interventional cardiologists prior to or after PCI; however, TandemHeart requires the operator to be skilled in transseptal puncture because the by-pass is implanted via the femoral vein through the interatrial septum at an activated clotting time of over 400 s. Despite encouraging results, bleeding complications, in-hospital, and long-term mortality still remain unacceptably high in this population [44]. This is best summarised in a meta-analysis by Cheng et al, with a conclusion that despite better haemodynamic profile mortality does not decrease significantly [45].…”

Role of New Therapies in Reducing Mortality and Major Morbidity in Patients with Systolic Heart Failure

“…As a result, newer pumps are smaller and have no bearings (resulting in less mechanical wear and tear and greater durability than older models). Though generally introduced by thoracotomy and requiring a transcutaneous connection to an external generator, newer iterations are sufficiently slim such that they can be introduced percutaneously (the Impella device) via the femoral or axillary artery in the cardiac catheterization lab [29,30]. Such percutaneously introduced devices have less pumping capacity than the more conventional models.…”

“…LVADs enhance total cardiac output by adding to that of the damaged native heart, potentially allowing myocardial recovery, particularly in patients with cardiogenic shock [30][31][32][33][34].…”

2015 SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in cardiovascular care (Endorsed by the American heart assocation, the cardiological society of India, and sociedad latino Americana de cardiologia intervencion; Affirmation of value by the canadian association of interventional cardiology–association canadienne de cardiologie d'intervention)

“…The most commonly reported complications of Impella placement are limb ischemia, vascular injury, and bleeding requiring blood transfusion [55]. Vascular complications common to all transfemoral procedures such as hematoma, pseudoaneurysm, and arterialvenous fistula, and retroperitoneal hemorrhage can occur with any mechanical support device.…”

“…Hemolysis due to mechanical erythrocyte shearing has been reported within the first 24 h of use in 5-10% of patients, and may respond to repositioning the device [55]. Persistent hemolysis associated with acute kidney injury is an indication for device removal.…”