Biventricular resynchronization to stimulate left and right ventricles of the heart has been the subject of a number of European trials, the first of which, PATH-CHF, showed significant improvements in hemodynamic status. In addition, Angelo Auricchio, the study leader at the Magdeburg University Hospital (Magdeburg, Germany), said that several patients scheduled for heart transplantation experienced levels of improvement which enabled them to be removed from the transplant waiting list.
Follow-up data from a 103-patient Canadian and European clinical trial showed improvements in patients' quality of life, exercise time and reduced fatigue at one month were maintained one year later.
The trial, which used the InSync pacemaker-like device from Medtronic (Minneapolis, Minnesota), was coordinated by Daniel Gras of the Institut Parisien de Rythmologie et de Stimulation Cardiaque (Paris), who reported that heart function in patients, all in Class III or Class IV functionally, improved on average by one or two functional classes, enabling them to participate in most daily activities.
The InSync system has been commercially available outside the United States since 1998. U.S. clinical trials are under way on the InSync, which includes two endocardial leads placed in the right atrium and right ventricle, and a third lead placed transvenously on the outside of the left ventricle. Medtronic also has a U.S. clinical trial under way using the InSync ICD, a defibrillator version of the system. Separately, Medtronic has reported the CE-marking of the Reveal Plus insertable loop recorder, designed to diagnose the cause of suspected heart-related symptoms.
St. Jude Medical's (St. Paul, Minnesota) CHF device, Frontier, has already been submitted for European approval, with European launch planned for mid-year. Guidant (Indianapolis, Indiana) already markets in Europe a full product line of implantable devices for treating heart failure, including the Contak CD for bioventricular pacing and cardioversion defibrillation back-up, a Contak TR pacemaker and the Easytrak lead system.
Cardiac ultrasound software
EchoTech (Hallbergmoos, Germany) has launched in Europe 3-D software solutions providing display and quantification of dynamic 3-D (4-D) images, contrast densitometry calculations, and stress echo upgrades. A dynamic 3-D freehand acquisition uses a standard TEE ultrasound probe with an electromagnetic sensor. The system, which is designed as an add-on for any cardiac ultrasound system, requires only a standard PC platform using MS Windows NT/98.
MedCom (Darmstadt, Germany) also has developed a 4-D cardiac ultrasound software package for use with a standard PC and MS Windows NT/98. An ultrafast 3-D/4-D visualization algorithm enables a 3-D display of the beating heart in real time. Potential applications include on-line assessments during surgery, estimation of regurgitation jets, quantification of mitral valve insufficiencies, and judgment of wall motions.
Emergency testing to speed diagnosis
A recent Danish study showed that performing a panel of rapid cardiac biochemical tests on emergency room chest-pain patients could improve acute myocardial infarct (AMI) case detection by 20%.
Birgit Jurlander and her group at the Copenhagen University Hospital (Copenhagen, Denmark) measured three cardiac biochemical markers, creatine kinase-MB (CK-MB), myoglobin, and troponin T in 155 patients with suspected AMI.
Results showed that in patients without ECG ST segment elevation (which would normally rule out AMI), combined analysis of two of the three tests identified another 20% of acute AMI patients with poor prognosis. Combination of results from the three marker tests correctly identified 85% of patients as having AMI or not. One-year event-free survival for patients with two of three negative tests on admission was excellent at 96%.
Axis-Shield (Dundee, Scotland) has signed a deal with Bayer Diagnostics (Munich, Germany) to put its cardiac markers, homocysteine and Activated Factor X11 (AFT) onto two of Bayer's immunoassay platforms. Bayer will add the two assays to existing cardiac menus on the Advia Centaur and ACS-180 immunoassay analyzers. The Centaur analyzer cardiac menu already includes CK-MB, troponin I, and myoglobin.
The SmartScan mobile diagnosis system from Thermamed (Bad Oyenhausen, Germany) is designed to provide fast and safe diagnosis at the accident scene by detecting brain hemorrhages and hemorrhagic stroke syndromes. Using the combined action of a laser diode and a detector, the SmartScan system also can be used to monitor patients under observation, under intensive care, and after neurosurgery.
UK launches new heart disease initiative
The British government has unveiled a 10-year plan to reform and modernize its coronary heart disease (CHD) services within the National Health Service. Another $80 million will be allocated to CHD services, with a target of reducing the incidence of coronary disease and stroke by 40% by 2010.
Among the measures to be taken are the installation of 700 external defibrillators in public places like airports, main railroad stations, and soccer stadiums to help heart attack victims (see Market Updates, page 12). Numbers of heart operations are to be increased, and a number of new fast-track chest pain clinics are to be opened to ensure that patients with suspected angina can be seen by a cardiologist within two weeks of urgent referral by their general practitioner.
Jules Dussek, president of the UK Society of Cardiothoracic Surgeons, said the number of bypass procedures in the UK last year fell by 600 to 2,5083, despite the government's pledge to improve cardiac services. Dussek said the problem was not caused by a shortage of surgeons, but by an insufficient number of intensive care and post-operational recovery beds. His criticism came shortly after the government's announcement of its 10-year modernization program.
German reimbursement cuts
Interim health care legislation, introduced at the beginning of last year, was intended to be the first step in a major reform of Germany's social health insurance system. The Healthcare Reform 2000 law is battling its way through the two German parliaments, the Bundestag and the Bundesrat. If it does not survive as planned, the government has drawn up alternatives to provide for continuing budget restrictions and other spending controls, including continuing reductions in hospital cardiac reimbursements (surgery down by about 22% and DRG rates by around 23% from 1998 levels).
Balloon angioplasty reimbursement is currently fixed at a maximum of $1,150. There were an estimated 150,000 angioplasty procedures last year, with the total expected to rise again this year in spite of reimbursement restrictions. Diagnostic catheterization procedures were in excess of 500,000 in Germany last year.
Spanish surgeons urge more funding
A group of Spanish cardiovascular surgeons from a number of major hospitals has called for increased investment to enable more operations to reduce substantial waiting lists. According to the group, numbers of operations at 400 per 1 million inhabitants are almost 40% lower than a European Union average of 638 per million. Per-capita spending on heart surgery at $1,250 is only half the level of expenditure in neighboring France.
Intuitive system in mitral valve repair
Surgeons at the Deutsches Herzzentrum (Berlin, Germany) have successfully carried out the endoscopic repair of a leaking mitral valve using the da Vinci computer-assisted surgery system developed by Intuitive Surgical (Mountain View, California). The entire procedure was performed endoscopically using four ports – a 12 mm port for the endoscope, two 10 mm ports for the robotically controlled instruments, and a fourth port for suturing and the insertion of a flexible atrial retractor secured to the left atrium.