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EXCOR® Pediatric
Berlin Heart is your partner during the entire VAD therapy: from choosing the right system, through implantation, to postoperative management for your patients.
The EXCOR® Pediatric system comprises the following components, that optimally match with one another and have proven successful in practice:
Our EXCOR® cannulae are made by hand from the purest medical silicone. In order to optimally supply patients, the cannula range includes various types and sizes of cannulae with the following features:
The EXCOR® Pediatric range includes blood pumps of various sizes, which are optimally suited to patients’ needs. From newborns to adolescents, patients of all ages can thus be supplied. Our blood pumps boast the following features:
The EXCOR® blood pumps are connected to the heart or the vessels near the heart using cannulae. Following implantation, they are initially operated by the stationary pneumatic driving unit Ikus. Individual parameter settings are recorded on the driving unit for each patient in order to generate a pulsatile movement of the blood pump membrane. In this manner, support of the heart function can be achieved. Following mobilization, there is an option – for patients who are supplied with a 60 ml blood pump – to switch to the driving system Excor mobil.
The Ikus driving unit is designed specifically for stationary use with EXCOR® blood pumps. As a high-performing all-rounder, the Ikus covers all areas of application:
The mobilization of young patients is important to their well-being. For adolescents with a weight starting at approximately 40 to 50 kg, the use of blood pumps starting at 60 ml can be considered. A battery-supplied Excor mobil driving unit can be used with these blood pumps. It enables mobility over several hours independent of the mains current.
The cannulae of the paracorporeal EXCOR® VAD are diverted below the rib cage out of the thorax. Depending on the form of therapy, up to four individual wounds can result from this procedure around the cannula transcutaneous exit sites and must be cared for as per antiseptic standards during the entire course of therapy. The more thorough the wound care, the lower the risk of wound healing disorders.
The dressing does not only ensure sterile wound closure. It is also used to immobilize the cannulae at the transcutaneous exit site, thereby promoting the wound healing. In addition, the dressing has a strain-relieving effect on the cannulae. This also fosters the healing process.
In the earlier postoperative phase, the change of wound dressing is conducted daily. If healing progresses normally, the interval for changing dressings can be expanded to twice a week. If the appearance of the transcutaneous exit site changes (e.g. circumferential skin reddening, skin secretions, etc.), wound care will be adapted accordingly.
Anticoagulation therapy is still a challenge for VAD patients: coagulation must be managed by medication in such a manner that no deposits are formed in the VAD, and no severe bleeding complications are experienced by the patient.
Anticoagulation therapy is initiated 24 hours after implantation at the earliest with administration of heparin. If possible, a switch should be made to oral therapy with vitamin-K-antagonists as early as possible. The antiaggregation therapy is conducted with a combination of acetylsalicylic acid (ASA) and Dipyridamole and Clopidogrel, if required.
The choice and dosage of medications administered postoperatively is closely monitored. The monitoring includes thrombelastography (e.g. Rotem®) as well as control of platelet function with the aid of aggregometry (e.g. Multiplate™). Anticoagulation is PTT- and/or INR-controlled
The blood circulation is mechanically supported by a VAD. This means that the blood comes into contact with non-biological surfaces such as silicone or metal. The blood reacts to such contact as it does with an open wound: it coagulates, whereby the artificial surface is covered with a biological film. In order to prevent this, the patient receives a medication-based anticoagulation therapy. The blood is analyzed at regular intervals in order to control whether the platelet inhibition is effective.
Regular control of the EXCOR® blood pump and of the visible part of the cannulae is equally important. This control is conducted several times a day with the aid of a mirror and a flashlight. The blood-carrying part of the blood pump can be inspected through the transparent polyurethane housing. If small fibrin deposits are observed during the pump control, the anticoagulation therapy is adjusted. If a thrombus-like formation is already present, the blood pump is replaced.
The membrane, which alternates continuously between pump filling and pump emptying, can be easily checked through the also transparent housing for the air side of the blood pump. It is possible to tell, based on the membrane movement, whether the drive parameters have been optimally set or whether optimization is necessary.
The EXCOR® VAD is a pneumatic ventricular assist device. A triple-layer membrane serves to separate the blood and air sides of the blood pump. The membrane is curved and can be set in motion through alternating pressures. The pressures originate from a driving system and are channeled into the pump via a tube.
If positive pressure is applied on the membrane, it ejects the blood out of the blood chamber back into the patient's circulation. With a suction pressure, the blood pump fills again with blood. Valves in the inflow and outflow stubs ensure that the blood can only circulate in one direction.
The blood pumps differ in the size of their stroke volumes, i.e. the volume of blood displaced with each stroke. The pump rate setting determines how often the membrane moves in one minute. The rate should be chosen in such a way that the resulting blood flow meets the patient's requirements.
The Ikus is a powerful stationary driving system for operation of the EXCOR® blood pumps. The system offers a variety of setting options to optimally support patients of all ages and weights at any time during their EXCOR® therapy.
All control-relevant system components are designed redundantly in order to offer a maximum of safety. Although conceived as a stationary driving system, battery operation allows for a patient on the system to move within hospital premises.
The settings can be reviewed and optimized at any time, if needed, via a laptop integrated in the driving system. The filling (diastole) and emptying (systole) pressures are individually set for each patient in such a manner that the blood flows through the VAD as gently as possible. The typical rectangular curve progression that is presented on the laptop is formed through the compressor technology used, with which the alternating pressures are generated.
The access to some or all shown products may be restricted due to country-specific regulatory approvals. IKUS and EXCOR® Active are/is intended for professional healthcare facility environments only.
The use of EXCOR® VAD for adults, RVAD-support, EXCOR® Blood pumps with bileaflet valves, EXCOR® Venous Cannula, EXCOR® Arterial Cannula for Graft, Caddy quattro kit as well as Excor mobile is not FDA approved. EXCOR® Active is an investigational device approved for pediatric use in a clinical study under IDE# G200252 approved by the FDA.
*CARMEDA® is a trademark of Carmeda AB