Multipulse Biowave is the new technology being used by Schiller (Basel, Switzerland) to reduce the quantity of energy needed for defibrillation to a point where the risk of injuring heart tissue is virtually eliminated.
The biphasic waveform used in the Schiller FRED range of semi-automatic defibrillators is pulsed at high frequency, leading to a much-reduced amount of energy applied to the patient together with improved effectiveness. With a defibrillation threshold of about 60 joules (less than one-third of the usual monophasic pulse of 200 joules) and a maximal applied energy of 180 joules, the waveform has a reserve of effective energy ratio of three before it should be considered potentially harmful. The company says that this opens up new perspectives for improved chances of survival after out-of-hospital cardiac arrest.
Philips Medical Systems (Best, the Netherlands) has added specially designed external defibrillation pads with an attenuator to reduce the energy delivered to an appropriate level for pediatric use. Developed for use with the Heartstream FR2 automatic external defibrillator (AED), they can be used on children and infants younger than 8 years of age with the electric shock level in line with American Heart Association (Dallas, Texas) recommendations. The pediatric pad connector is represented by a pink teddy bear for quick identification of the correct pads to be used on pediatric patients. The FR2 pediatric pads are already available in Europe.
Artema (Albertslund, Denmark) has added an external pacing option to its Cardio-Aid 200 AED, which also offers manual, synchronized and internal defibrillation options. The unit can provide fixed or demand pacing with each delivered pace pulse monitored by an independent security system and clear visual indication on an ECG display.
Metrax (Rottweil, Germany) has launched its Defi-Monitor DM110/DM330 semi-automatic defibrillator to add to the Primedic Handyscan lightweight compact ultrasound scanner for mobile emergency use, while the Marquette Responder 3000 from Marquette Hellige (Freiburg, Germany) features automatic energy sequencing and lead sensing/ switching, as well as automated integral battery conditioning.
ECG unit with infrared interface
Infrared interfaces of the Cardiette portable ECG units from H&C Medical Devices (Seste St. Giovanni, Italy) enable these next-generation units to communicate with a PC in wireless mode. Depending on the optional software installed on the computer, real-time ECG acquisitions can be performed or electrocardiograms saved on the hard disk.
The new Prima ECG recorder is very small and light in weight, having the dimensions of a palm-size PC. The unit from Remco Italia Cardioline (Vignate, Italy) has been specifically designed as a mobile cardiovascular device for daily use and about 100 ECG tests can be acquired and stored on an internal flash memory for downloading. In addition to digital ECG, the basic palm-sized multipurpose unit from Cardioline also can be programmed for use as a Holter recorder, trans-telephonic ECG transmitter or for use in a stress testing system.
Biodegradable stents on the horizon
A stent that will resorb fully in about six months is under development at the Biomat Clinical Research Center (Aachen, Germany) by Dr. Ruediger Blindt and his group. He said that animal trials have shown partial absorption after two to four months.
The stent is produced from bioresorbable poly D.L-lactide using a low-temperature molding technique which permits the incorporation of temperature-sensitive antiprolliferative additives that may help to reduce restenosis, said Blindt, who also works at University Hospital RWTH in Aachen. Preliminary animal trials using paclitaxil have shown positive results in reducing restinosis, but Blindt said that human trials will not be before late 2002.
Myocor trials encouraging to date
The Myosplint device from Myocor (Minneapolis, Minnesota) has been used in European Phase I safety trials on 14 patients to date, with encouraging results in patients with late-stage heart failure. Another Phase I trial in the United States is now under way on an additional 10 patients, with the clinical trial under the control of the Cleveland Clinic Foundation (Cleveland, Ohio) and the University of Michigan Health System (Ann Arbor, Michigan).
The Myosplint implantable device is designed to change the size and shape of the left ventricle and to reduce cardiac wall stress to improve heart function. In the procedure, three sets of two specially designed pads rest on either side on the outside of the heart, connected by a high-strength tension member. They are placed down the length of the left ventricle and are used to pull the walls of the heart closer together, reshaping and reducing the volume of the left ventricle by a precalculated amount.
Tri-leaflet valve trials to start this year
Tri-leaflet Medical (Triflo; Aachen, Germany) is developing a new three-leaflet mechanical heart valve that should provide improved flow and occluder dynamics according to Ulrich Steinseifer, research director at Triflo. The new valve, which should start clinical trials before the end of this year, is designed to operate similarly to a biological aortic valve with three symmetrically placed leaflets so as to be anatomically correct.
Tri-leaflet Medical also has joint R&D agreements in the cardiology sector with the University of Minnesota (Duluth, Minnesota) and the Texas Heart Institute (Dallas, Texas)
Integrated imaging workflow
Agfa (Mechelen, Belgium) has developed, in close collaboration with the cardiology team at Brigham and Women's Hospital (Boston, Massachusetts), the XA3000 Impax system, which comprises an integrated digital server, workstation and archives designed specifically by and for cardiologists.
The system is designed to enable rapid retrieval of patient records and images on demand for different modalities both inside and outside cardiology and including ultrasound, computed tomography, magnetic resonance and nuclear medicine. The possibility to integrate and view simultaneously images from more than one modality provides substantial advantages in time saving and data accessibility.
Dr. Jeffrey Popma, director of interventional cardiology at the hospital, said, "Our CCU [cardiac care unit] and cardiac catheterization laboratory are separated by 14 floors. [In addition] our cardiac surgeons' offices are also half-a-mile from the cath labs. It is now very convenient for us to obtain immediate surgical consultation in order to define the best pathway for clinical care."
Crannburn updates Tomcat system
The Tomcat comprehensive information system for managing the administrative and clinical needs of an entire cardiology department has been significantly improved with added features. The software can now be linked to HIS and to a wide range of clinical equipment and can link to DICOM-compatible digital image storage systems for viewing still and moving images.
Crannburn Software (Belfast, Northern Ireland) has worked in conjunction with cardiologists, technicians and administrative personnel from several major hospitals to ensure a user-friendly system. Enhanced coronary anatomy diagrams have been included to record lesions, stents, grafts and vessels. The system automatically converts these diagrams into text for inclusion in the procedure report alongside the diagram.