To the TandemHeart team at&#160;LifeSparc.

This procedure and protocol have been approved by the institutional review board and the United States Food and Drug Administration (FDA).
1. Patient criteria
<ol>
	<li>Include patients with CS stage B and above as defined by the SCAI consensus statement1.</li>
	<li>Include as bridge to transplant or durable left ventricular assist system in stage D heart failure.</li>
	<li>Include as bridge to recovery in AMI complicated by CS.</li>
	<li>Exclude contra-indication to ...

Hemodynamics of LAFAB&#160;device: 
The hemodynamic profile of the LAFAB device is distinct from other pVADs. By draining blood directly from the LA&#160;and returning it to the femoral artery, the device bypasses the LV completely. In doing so, it reduces LV end diastolic volume and pressure, contributing to improved LV geometry, and thereby effecting a decrease in LV stroke work. However, by returning the blood back into the iliac artery/descending aorta, afterload increases. This...

Cardiogenic shock (CS) is a state of tissue hypoperfusion with or without concomitant hypotension, in which the heart is unable to deliver sufficient blood and oxygen to meet the body&#39;s demands, resulting in organ failure. It is classified into stages A to E by the Society of Cardiovascular Angiography and Interventions (SCAI): stage A - patients at risk for CS; stage B - patients at beginning stage of CS with hypotension or tachycardia without hypoperfusion; stage C - classic CS with cold and wet phenotype requiring inotropes/vasopressors or mechanical support to maintain perfusion; stage D - deteriorating on current medical or mechanical support requiring escalation to more advanced devices; and stage E - includes patients with circulatory collapse and refractory arrhythmias who are actively experiencing cardiac arrest with ongoing cardiopulmonary resuscitation1. The most common causes of CS are acute MI (AMI) representing 81% of cases in a recently reported analysis2, and acute decompensated heart failure (ADHF). CS is classically characterized by congestion and impaired perfusion, manifested by elevated filling pressures (pulmonary capillary wedge pressure [PCWP], left ventricular end-diastolic pressure [LVEDP], central venous pressure [CVP], and right ventricular end-diastolic pressure [RVEDP]), decreased cardiac output (CO), cardiac index (CI), cardiac power output (CPO), and end-organ malfunction3. In the past, the only available treatments for AMI complicated by CS were early revascularization and medical management with inotropes and/or vasopressors4. More recently, with the advent of mechanical circulatory support (MCS) devices and the recognition that escalation of vasopressors is associated with increased mortality, there has been a paradigm shift in the treatment of both AMI and ADHF related CS5,6.
In the current era of percutaneous ventricular assist devices (pVAD), there are a number of MCS device platforms/configurations available, which provide univentricular or biventricular circulatory and ventricular support with and without oxygenation capability7. Despite steady increases in the use of pVADs to treat both AMI and ADHF CS, mortality rates have remained largely unchanged5. With emerging evidence for possible clinical benefits to early unloading of the left ventricle (LV) in AMI8 and early use of MCS in AMI CS9, the use of MCS continues to increase.
The Left Atrial to Femoral Artery Bypass (LAFAB) MCS device bypasses the LV by draining blood from the left atrium (LA) and returning it to the systemic arterial circulation via the femoral artery (Figure 1). It is supported by an external centrifugal pump that offers 2.5-5.0 liters per minute (L/m) flow (new generation pump, designated as LifeSPARC, capable of up to 8 L/m flow) depending on the size of the cannulas. Once the blood is extracted from the LA via the transseptal venous cannula, it passes through the external centrifugal pump which recirculates the blood back into the patient&#39;s body via the arterial cannula placed in the femoral artery.
<img alt="Figure 1" class="xfigimg" src="/files/ftp_upload/62140/62140fig01.jpg" /> 
Figure 1: LAFAB setup. Image courtesy of TandemLife, a wholly owned subsidiary of LivaNova US Inc. <a href="https://www.jove.com/files/ftp_upload/62140/62140fig01large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr >
			<td >For LAFAB (TandemHeart)</td>
			<td ></td>
			<td ></td>
			<td></td>
		</tr>
		<tr >
			<td >Factory Supplied Equipment for circuit connections.</td>
			<td >TandemLife</td>
			<td ></td>
			<td></td>
		</tr>
		<tr >
			<td >ProtekSolo 15 Fr or 17 Fr Arterial Cannula&#160;</td>
			<td >TandemLife</td>
			<td ></td>
			<td></td>
		</tr>
		<tr >
			<td >ProtekSolo 62 cm or 72 cm Transseptal Cannula&#160;</td>
			<td >TandemLife</td>
			<td ></td>
			<td></td>
		</tr>
		<tr >
			<td >TandemHeart Controller&#160;</td>
			<td >TandemLife</td>
			<td ></td>
			<td>For adjusting flows/RPM</td>
		</tr>
		<tr >
			<td >TandemHeart Pump&#160;</td>
			<td >LifeSPARC</td>
			<td ></td>
			<td>Centrifugal pump</td>
		</tr>
		<tr >
			<td >For RAPAB (ProtekDuo)</td>
			<td ></td>
			<td ></td>
			<td></td>
		</tr>
		<tr >
			<td >Factory Supplied Equipment to complete the circuit.&#160;</td>
			<td >TandemLife</td>
			<td ></td>
			<td></td>
		</tr>
		<tr >
			<td >ProtekDuo&#160; 29 Fr or 31 Fr Dual Lumen Cannula&#160;</td>
			<td >TandemLife</td>
			<td ></td>
			<td></td>
		</tr>
		<tr >
			<td >TandemHeart Controller&#160;</td>
			<td >TandemLife</td>
			<td ></td>
			<td>For adjusting flows/RPM</td>
		</tr>
		<tr >
			<td >TandemHeart Pump&#160;</td>
			<td >LifeSPARC</td>
			<td ></td>
			<td>Centrifugal pump</td>
		</tr>
	</tbody>
</table>

use of a percutaneous ventricular assist device/left atrium to femoral artery bypass system for cardiogenic shock

The left atrial to femoral artery bypass (LAFAB) system is a mechanical circulatory support (MCS) device used in cardiogenic shock (CS) that bypasses the left ventricle by draining blood from the left atrium (LA) and returning it to the systemic arterial circulation via the femoral artery. It can provide flows ranging from 2.5-5 L/min depending on the size of the cannula. Here, we discuss the mechanism of action of LAFAB, available clinical data, indications for its use in cardiogenic shock, steps of implantation, post-procedural care, and complications associated with the use of this device and their management.
We also provide a brief video of the procedural component of device therapy, including the pre-placement preparation, percutaneous placement of the device via transseptal puncture under echocardiographic guidance and the post-operative management of device parameters.

Clinical applications of LAFAB device 
The technique and feasibility of a percutaneous trans-atrial left ventricular bypass system were first described in the 1960s by Dennis et al.11,12. However transseptal puncture was not initially widely adopted due to complications with the septostomy technique. Over the last decade, with advancements in the field of percutaneous interventions, operators have accumulated experience with atrial septostom...

Watch this Scientific Journal Video about Use of a Percutaneous Ventricular Assist Device/Left Atrium to Femoral Artery Bypass System for Cardiogenic Shock at JoVE.com

Use of a Percutaneous Ventricular Assist Device/Left Atrium to Femoral Artery Bypass System for Cardiogenic Shock

The following article describes the stepwise procedure for placement of a device (e.g., Tandemheart) in cardiogenic shock (CS) that is a percutaneous left ventricular assist device (pLVAD) and a left atrial to femoral artery bypass (LAFAB) system that bypasses and supports the left ventricle (LV) in CS.

The left atrial to femoral artery bypass (LAFAB) system is a mechanical circulatory support (MCS) device used in cardiogenic shock (CS) that bypasses the ...