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EXCOR® Adult

Berlin Heart is your partner during the entire VAD therapy: from choosing the right system, through implantation, to postoperative management for your patients.

EXCOR® Adult

Bridging therapy for severe heart failure

EXCOR® Adult is a mechanical, pulsatile heart support system. (Ventricular Assist Device, VAD). The paracorporeal VAD is used for the short to long-term support of the left and/or right ventricular pumping function. It is indicated in seriously ill adults suffering life-threatening heart failure, after all conservative therapeutic options have been exhausted.

Berlin Heart offers a comprehensive service plan for this system. Our Clinical Affairs Team supports you for the entire duration of the VAD therapy: starting with product training, consultation for patient selection, on to implantation, postoperative care, and system instruction for treating personnel. If you have any questions, you can contact our experts at any time via the 24-hour hotline.

If you have any questions, you can contact our experts at any time via the
24-hour hotline.

Benefits

The EXCOR® Adult offers the following benefits:

  • Restoration of the blood perfusion required for supplying the organs in cases of heart failure
  • Excellent long-term results, even after use over many years
  • Broad range of application: bridging until transplantation or until myocardial recovery
  • Support as an LVAD, RVAD and BVAD
  • Compatible pumps and cannulae for all body sizes and varying anatomical conditions
  • CARMEDA® BioActive Surface* coating for improved hemocompatibility
  • Use of biocompatible materials
  • Transparent materials to monitor the blood-carrying components
  • Functional safety thanks to redundant design of the main drive components

Components

A system of harmonized components

The EXCOR® Adult system comprises components that optimally match one another and have proven successful in practice:

Silicone Cannulae

Our EXCOR® cannulae are made by hand from the purest medical silicone. In order to optimally supply patients, the cannula range includes cannulae of various types and sizes with the following features:

  • Proven biocompatibility with an unlimited product life
  • Customization to diverse anatomical Customization to diverse anatomical conditions thanks to various diameters, lengths, angles and tip styles
  • Arterial and/or atrial cannulae with flexible metal reinforcement for adaptation to the individual anatomy
  • Velour-coated suture ring, developed for a fast and safe anastomosis
  • Good ingrowth of the cannula to the transcutaneous exit site thanks to the velour sheathing

Blood pumps

The EXCOR® Adult range includes blood pumps of various sizes, which are optimally suited to patients’ needs. Our blood pumps boast the following features:

  • Different sizes available: 50, 60 and 80 ml pump volumes
  • Transparent polyurethane casing allows for visual inspection: pump filling and any deposits can be detected
  • Flexible triple-layer membrane for a high degree of safety; graphite powder between the membrane layers minimizes friction
  • Ultra-smooth, flow-optimized blood contact surfaces with Carmeda® BioActive Surface* coating for the best possible blood compatibility
  • Safe de-airing through a de-airing port
  • Valves at the inflow and outflow section guarantee that the blood flows in the right direction
  • Selection of blood pumps with tri-leaflet valve made from polyurethane or blood pumps with bileaflet valve made of carbon

Stationary driving unit Ikus

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:

  • Pump rate, operating mode, driving pressure variable within wide limits
  • Biventricular operation in synchronous mode, asynchronous mode or with independent control of the pumps
  • Laptop with permanently installed monitor program for system configuration and monitoring
  • High degree of safety due to multiple redundancy
  • Automatic 30-minute battery power supply in the event of mains power failure
  • Patient transport within the hospital while in battery operation
  • Acoustic and visual alarms
  • Plain text messages in the monitor program
  • Comprehensive system status information at a glance

Mobile Driving System Excor

The mobilization of the patient is important for his/her well-being and the success of the therapy. With the Excor mobile, mobilized patients can move freely and can usually be discharged home. The mobile driving unit offers a high degree of safety and user-friendly handling:

  • Can be used for 60 ml and 80 ml EXCOR® blood pumps
  • Optimal operating point within pre-set limits
  • Synchronous pump with simultaneous pressure build-up comparable to native heart contractions
  • Lightweight
  • Acoustic and visual alarms in the event of faults
  • Two rechargeable batteries and two additional backup rechargeable batteries for several hours of mains-free operation
  • Clear display on each battery: charge level is displayed
  • Emergency batteries in the drives for additional safety
  • Modular construction allows the patient to replace components

 

Postoperative Management

Wound management

The cannulae of the paracorporeal EXCOR® VAD are diverted below the rib cage and through the thorax. Depending on the form of therapy, up to four individual wounds will form 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.

During the patient’s stay in the hospital, nursing personnel will be in charge of wound care. If the patient is transferred, e.g. to a rehab clinic, this responsibility will pass on to the personnel at the new facility. If a patient on EXCOR® VAD is discharged to home, wound care can be assumed by a family member – if there is a willingness to do so – or by an outpatient nurse.

Anticoagulation

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. Once the patient is clinically stable, oral therapy with vitamin K antagonists or low molecular weight heparin should be used. The antiaggregation therapy is conducted with a combination of acetylsalicylic acid (ASA) and Dipyridamole.

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.

Pump inspection

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 identified 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.

System handling

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 and back into the patient's circulation. With a suction presure, 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.

Driving units

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 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 every patient in such a manner that the blood flows through the VAD as gently as possible. The typical rectangular curve progression presented on the laptop is formed through the compressor technology used, with which the alternating pressures are generated.

Excor mobile

With a stable hemodynamic status and a blood pump size of at least 60 ml, adolescent and adult patients can use the Excor mobil driving unit during the postoperative course of therapy. Secured onto a caddy, the system has the size of a carry-on suitcase and can be used in both interior and exterior environments. If clinically justifiable, patients on Excor mobil can be discharged to rehabilitation and further on to their home environment. With the four exchangeable batteries it is possible to pursue activities independently of a mains power supply.

The filling and emptying pressures of Excor mobil adjust during operation in accordance with the changing hemodynamic conditions, within the limits specified by the attending physician. Safety is of utmost importance, especially among VAD patients in outpatient care. Thanks to the system’s modular design, individual components can be replaced in cases of fault.

Case Reports

The following case reports show interesting case studies on our EXCOR® Adult system.

Video

See how EXCOR® Adult works


The use of EXCOR® VAD for adults, RVAD-support, EXCOR® blood pumps with bileaflet valves, EXCOR® graft adapter cannulas, Excor mobile and EXCOR® Active is not FDA-approved.

*CARMEDA® is a trademark of Carmeda AB