causes of mortality table

The Insertion of Impella 5.0™ in the Right Subclavian Artery for Treatment of Acute Decompensated Heart Failure

December 9, 2016

Key Takeaways

  • In this study, all patients were in cardiogenic shock and on at least 2 pressors.
  • Using the right subclavian artery, heart failure patients experienced an improvement in end organ function and hemodynamic stability. The device was placed via cutdown through an 8 mm vascular graft.
  • A survival-to-discharge rate of 62.5% and bridge-to-success rate of 70.8% were reported for patients receiving Impella 5.0™ support using the right subclavian artery.

A recent retrospective review published in The Ochsner Journal reveals advantages to using the right subclavian artery (RSA) for the insertion of Impella 5.0™ in the management of acute decompensated heart failure (ADHF). This synopsis provides a brief overview of how this technique may benefit end organ function in ADHF patients while improving left ventricular unloading and time to recovery.

As an exacerbated form of cardiac dysfunction, ADHF comprises a significant proportion of money spent on HF care.1 The use of minimally invasive left ventricular assist devices (LVADs), like Impella 5.0™, can be used for ADHF patients to provide hemodynamic support.

Although Impella® is often inserted via the femoral artery, this retrospective review of 24 patients with ADHF examined the benefits of inserting the device via a cutdown through the RSA.2 As usual for device placement, transesophageal echocardiography and fluoroscopy were used to position the device.

Table 1. Causes of Mortalitya
causes of mortality table
aData from Bansal A, Bhama JK, Patel R, et al2

Patients experienced a significant improvement in both hemodynamics and end organ function, as assessed by the Model for End-Stage Liver Disease (MELD) score. The authors also point out that Impella® provided a survival-to-discharge rate of 62.5% and bridge-to-success rate of 70.8%.

Six patients recovered, 9 patients received permanent LVAD support, 2 required heart transplantation, and 7 patients died. Mortality was attributable to a number of different causes, including pneumonia, shock, and ventricular arrhythmia, among others (Table 1).a

References:

  1. Joseph SM, Cedars AM, Ewald GA, Geltman EM, and Mann DL. Acute Decompensated Heart Failure: Contemporary Medical Management. Tex Heart Inst J. 2009;36(6):510-520.
  2. Bansal A, Bhama JK, Patel R, et al. Using the Minimally Invasive Impella 5.0 via the Right Subclavian Artery Cutdown for Acute on Chronic Decompensated Heart Failure as a Bridge to Decision. Ochsner J. 2016;16(3):210-216.

Impella® Device — Indication & Safety Information

INDICATIONS FOR USE

Protected PCI

The Impella 2.5® and Impella CP® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 and Impella CP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Cardiogenic Shock

The Impella 2.5®, Impella CP®, Impella 5.0®, and Impella LD® Catheters, in conjunction with the Automated Impella Controller (collectively, “Impella® System Therapy”), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5 and Impella CP, and ≤ 6 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.

Important Risk Information for Impella devices

CONTRAINDICATIONS

The Impella 2.5, Impella CP, Impella 5.0 and Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade*

* This condition is a contraindication for the cardiogenic shock indication only.

POTENTIAL ADVERSE EVENTS

Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit http://www.abiomed.com/important-safety-information to learn more.

Right-Side Support – Indication & Safety Info.

INDICATIONS FOR USE

The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Important Risk Information for Impella RP

CONTRAINDICATIONS

The Impella RP System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device. Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve. Mural thrombus of the right atrium or vena cava. Anatomic conditions precluding insertion of the pump. Presence of a vena cava filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter.

POTENTIAL ADVERSE EVENTS

The potential adverse effects (eg, complications) associated with the use of the Impella RP System: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia.

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP®. Visit http://www.abiomed.com/impella/impella-rp to learn more.

General Indication and Safety Information

To learn more about the Impella platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/

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