Prof. Bart Meyns with the first Impella® patient at Belgium's Gasthuisberg University Hospital in Leuven

Pump Use

To date, the Impella® Circulatory Support System has been implanted more than 1100 times in 198 centers world wide. The figures include cases with the Impella® LD and the Impella® RD, that are surgically implanted via thoracotomy, as well as cases with the Impella® LP5.0, implanted via a cut-down of the femoral artery and the Impella® LP2.5 that is implanted percutaneously.*

Advantages

The minimal invasive catheter pumps can support the heart with up to 5.5 liters blood per minute. The fast surgical implantation as well as the possibility to implant the left heart support pumps either via a cut-down or percutaneously, eliminates the requirement for a thoracotomy for patients needing left heart support. Due to the pump design, the minimal blood damage and the necessary low anticoagulation the complication rate is very low. Furthermore, a priming of the system is not necessary, as the system deaerates itself during implantation. The Impella® Mobile Console facilitates patient transport in-house and to another hospital. The patient and pump data is automatically recorded enabling a better patient monitoring and data interpretation during and after the support.

Indications and Intended Use

The Impella® LP2.5 and the Impella® LP5.0 are mostly implanted in cardiology.

The Impella® LP2.5 was implanted in high risk interventions (63%), due to its easy percutaneous implantation and the hemodynamic support of up to 2.5 liters blood per minute.

50% of all cases of AMI and cardiogenic shock were assisted with the Impella® LP5.0 that provides an outstanding hemodynamic support of 5 liters blood per minute.

Valve Injury

Due to the extremely soft tip of the cannula respectively the pig-tail of the peripheral pumps, as well as the surface characteristics of the cannula itself which protrudes through the valve, valve injuries are not to be expected. This has been repeatedly substantiated in animal tests. Nor does data acquired thus far during the examination of human valves indicate that any morphological or functional impairments have occurred. No pump-induced increase in regurgitation has been observed in peri- or postoperative ultrasonic Doppler examinations.

Weaning and Explantation

At the first signs of recovery or after 3 to 4 days of maximum support, inotopic infusion weaning should occur. This dose should be the necessary one for vasoconstriction and/or right ventricular support, only.

The pump speed can be reduced by each power level, monitoring the patient's response after each reduction. If the patient tolerates the reduction of pump support without the need for increased inotropic support, the weaning procedure can be continued. Impella® LP 2.5

Due to the pump design and the pump position, the pump can remain implanted, running at the lowest possible speed (which is necessary to avoid a retrograde flow) until the patient is stable and does not need any kind of support.

Due to the pump design and the pump position, the pump can remain implanted, running at the lowest possible speed (which is necessary to avoid a retrograde flow) until the patient is stable and does not need any kind of support.

Bleeding

The coagulation times specified in the instructions for use (ACT > 160 s or aPTT > 55 s) have been validated. Based upon clinical experience gained to date, shorter coagulation times can be selected in the case of diffusely bleeding patients. Shorter coagulation times have not resulted in any pump-specific problems during the first postoperative phase.

Hemolysis

Due to pump design, low hemolysis and the low anticoagulation, to date almost or no complications have occurred.

The diagrams shows that the higher hemolysis value occurred temporarily and returned to base line within 24 hours.

Short time High Risk intervention with the Impella® LP2.5	Long term intervention with the Impella ® LD

Hemodynamics

Impella® LD, Impella® RD and Impella® LP5.0

• The Impella® ventricular unloading catheters have been used to increase MAP in patients who were hemodynamically instable.
• The PCWP was markedly reduced with the use of Impella®.
• The diagram shows a significantly increase of the cardiac output during the support with an Impella® system.
  

Impella® LP2.5

Impella technology may be used to significantly augment MAP for patients that are hemodynamically comprised.

The graph shows a clinically relevant major improvement over baseline in the cardiac output during the assistance with the Impella catheters.

The PCWP is significantly reduced with the use of the Impella® LP2.5 - active unloading of the left ventricle.

*All information is based upon the informal, voluntarily reported patient data base of Abiomed Europe GmbH. No liability assumed.