Pump Exchange; Explantation; Summary Of Clinical Experience - Abbott CentriMag Reference Manual

arterial pressure tracing will increase. Serial echocardiography to assess contractility and ejection fraction provides a good indication of
ventricular recovery. Decreased dependence on inotropic drugs is an important indicator of recovery.
Guidelines for weaning a patient from and termination of CentriMag system support include:
1. Final weaning and termination is preferentially done in an operating room.
Transesophageal echocardiography should be used continuously to assess ventricular function. Observe for ventricular dilation,
2.
septal shift, ejection fraction, and changes in inotropic drug requirements.
Decrease the flow rate by 0.5 LPM every 15-30 minutes until 2.0 LPM is reached.
3.
Increase anticoagulation to a target ACT > 300 seconds.
4.
5. Continue weaning as above until flow rate is 0.5 LPM.
Clamp the return tubing to terminate support, decrease the set speed to zero, and continue to carefully monitor the patient's
6.
hemodynamics and perfusion.
If the patient remains stable on low dose inotropic support, decannulate.
7.
8. Consider using an IABP and/or leaving the sternum unwired (skin closure only) for patients with marginal function following
decannulation.

Pump Exchange

Pump exchange may be necessary if the duration of support exceeds the indicated duration for use, if hemolysis is believed to be caused
by the pump, or if there are indications of thrombosis at the inlet or outlet of the pump or inside the pump. A pump may be exchanged
using the following procedure:
1. Using a sterile field and aseptic technique, a new pump or pump and circuit are primed as described in the Preparing for
CentriMag System Use section. Tubing connectors are placed at the patient ends of the tubing. It is always advisable to
change the pump as well as the tubing, rather than the pump alone.
CAUTION: Ensure that the patient is adequately pharmacologically supported before discontinuing CentriMag system
support, as the patient's arterial pressure may drop upon discontinuation of support.
Four tubing clamps are used to clamp the patient's existing drainage and return tubing.
2.
After the clamps are placed, the pump speed setting on the console is turned to zero.
3.
4. The existing tubing is cut at least 4-5 cm from the cannula-connector end.
The new tubing connectors are attached using a wet-wet connection while taking care to eliminate air at the junction as well as
5.
in the circuit. Secure these new connections with bands.
Ensure that the pump is securely inserted into the motor, and that the pin is screwed in.
6.
7. Turn the CentriMag system set speed to >1000 RPM, and remove clamps. Increase the set speed to achieve target flow.

Explantation

Before device removal, ensure adequate volume and anticoagulation levels, particularly if the pump is going to be run with low flow
(under 2 liters per minute) for any length of time. If available, use TEE to check for the presence of thrombi in the atria, ventricles,
and at the cannulation sites prior to weaning and device removal.
Explantation generally requires a repeat sternotomy. During decannulation, the surgeon should allow retrograde bleeding from the
cannulation site to remove any thrombus that may have formed at the cannula site. During periods when the heart is being
manipulated, the CentriMag system set speed should be reduced. If flow is compromised by manipulation of the heart, immediately
reduce the set speed or clamp the return tubing as necessary to prevent inflow obstruction and/or air entrainment.
CAUTION: Abrupt changes in the CentriMag system flow due to manipulation of the heart may result in air entrainment.

Summary of Clinical Experience

The clinical study experience for the CentriMag system includes four FDA-approved, prospective, non-randomized, multi-center,
unblended, controlled studies encompassing 95 patients. The clinical studies are:
1. Cardiogenic Shock Pilot Trial [CentriMag VAS Cardiogenic Shock Trial] (IDE G030052)
2. RVAS Pilot Study [CentriMag VAS: Use as an RVAS Following Implantation of a Commercially Approved LVAS] (IDE
G040029)
3. Pivotal Study [CentriMag VAS Failure to Wean (FTW) from Cardiopulmonary Bypass Trial] (IDE G030052/S21)
4. HDE PAS Study [CentriMag RVAS U.S. Post Approval Study (PAS)] (H070004)
Data from these clinical studies, together with the results of a comprehensive literature review and an analysis of global post-
market surveillance data, are the basis for the CentriMag system clinical experience overview. Because the pivotal study (IDE
G030052/S21) was the only study to strictly enroll and analyze outcomes for the study population reflected in the indication for
use in this PMA, it was the only one used to assess effectiveness of the device for this PMA. However, because adverse events
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