Why is CABG being carried out
GOPCABE (German Off Pump CABg in Elderly)
Coronary bypass surgery has been the gold standard for treating complex coronary heart disease for over 40 years. It is the only method to ensure a life advantage for the patient and is therefore carried out from both a symptomatic and a prognostic point of view. Technically, this operation can either be performed with the help of the heart-lung machine (on pump), or on the beating heart without the heart-lung machine (off pump). Due to its lower invasiveness, off pump surgery is said to bring better results in terms of stroke rate, inflammatory reactions and overall survival. However, none of the studies to date have come to a clear conclusion. There are only a few studies, especially in older patients. Here, however, the potential advantage of off pump surgery should become apparent, as this patient population is usually characterized by higher comorbidities. The study recently ended and the results have been published. It was found that there was no significant advantage of the off-pump surgery in the patient population of over 75-year-olds. Regarding the study results, however, it must be said that the detailed follow-up analyzes for the study are not yet complete and that certain subpopulations who experience a particularly high risk from the operation were not included in the study.
CABACS (Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis)
Every year more than 50,000 isolated coronary bypass operations (CABG) are performed in Germany. In patients without carotid stenosis (CAS), the risk of stroke or death with CABG is around 2-3%. However, carotid stenosis is present in 6-8% of patients who receive bypass. This is associated with a significantly increased risk of suffering a stroke or of dying postoperatively. The treatment of these patients is a controversial topic in Germany. Some surgeons synchronously perform a carotid endarterectomy (CEA) to reduce the increased risk. However, previous studies in this area show neither an advantage nor a disadvantage of the concurrent endarterectomy. However, these studies often have weaknesses with regard to the lack of randomization and certain design disadvantages, so that the current CABACS study aims to investigate the safety of bypass surgery alone versus bypass surgery plus carotid endarterectomy in patients with asymptomatic atherosclerotic stenosis of the carotid.
Cardioplegia enables interventions with the heart-lung machine and heart transplants in cardiac surgery. There are currently a large number of solutions, but all of them show little or no differences in cardioprotection. The differences between blood cardioplegia and crystalloid cardioplegia are also small. A further development of a crystalloid cardioplegia solution shows clear advantages in animal models for organ transplantation with significantly improved organ protection and improved function in reducing hypoxic and ischemic damage. These results suggest that the same improvement in cardioprotection compared to conventional solutions can also be expected in patients. Therefore, this prospective multicenter phase III study should show that Custodiol-N is at least comparable or superior to an established HTK cardioplegic solution (Custodiol).
PARI (prosthesis-annulus relation as a predictor of the hemodynamics of an aortic valve prosthesis)
Aortic valve replacement is one of the most common cardiac surgery procedures performed. In contrast to mechanical prostheses, the proportion of biological aortic valve prostheses has increased significantly recently. The hemodynamic properties of the implanted prostheses influence the survival rate and the quality of life of the patient. If the opening area of the prosthesis is still insufficient for the patient, a “patient-prosthesis mismatch” (PPM) occurs, as was first described by Rahimtoola in 1987. Pibarot and Dumesnil defined PPM as the quotient of the effective opening area (EOA) divided by the body surface. Virtually all studies that have examined the effect of prosthesis size on mortality have used this concept. The results are very heterogeneous. For various reasons, however, it is conceivable that the previous methods for calculating PPM are incorrect. We have now developed a new method for determining the hemodynamic relevance of implanted aortic valve prostheses depending on the anatomical conditions of each individual patient and are investigating this in the PARI study we are conducting.
CADENCE MIS (A randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially available aortic bioprostheses in subjects undergoing surgiCal aortic valve replacement using Minimally InvaSive techniques.)
Minimally invasive interventions are associated with a lower invasive burden for the patient and are therefore increasingly carried out despite the higher demands on the surgical skills of the surgeon. The Edwards Intuity valves were developed to facilitate the installation of aortic valves and thus also to shorten the operating time. The aim of this randomized, multicenter study is to investigate how ischemia time (XCT) and cardiopulmonary bypass time (CPBT) for the Edwards Intuity valves behave between the minimally invasive technique (hemi-sternotomy or right thoracotomy) and the current standard of the full sternotomy. Furthermore, it will be investigated what benefit patients have with these new valves in the course of two years after the procedure.
Magna-Mitral (Carpentier-Edwards Perimount Magna Mitral Bioprsotheses)
Heart valve diseases are life-threatening diseases that affect millions of people around the world. This leads to the repair or replacement of the valves in around 250,000 cases each year. Stenosis or a leak in the mitral valve caused by various diseases lead to restricted blood flow or mitral regurgitation.
Diseased heart valves are usually treated by surgical repair or replacement, with repair being preferred. If repair is not possible, the mitral valve can be replaced with a mechanical valve (made of synthetic material) or a biological valve (made of biological material).
The aim of this study is to evaluate the long-term safety and efficiency of the Magna mitral valves in patients receiving mitral valve replacement under cardiopulmonary bypass. This is a prospective, single-arm, multicenter study conducted in the United States, Canada, and Europe that will monitor patients for at least eight years.
PROSE (Prospective Randomized On-X / St. Jude Medical Evaluation)
When using mechanical heart valves to replace defective valves, there is an increased risk of thrombosis. This is countered by the administration of anticoagulants, which, however, entail an increased risk of bleeding. Therefore, attempts are being made to reduce the risk of thrombosis through an appropriate design and surface finish of valves. The aim of this study is to investigate whether thromboembolic complications can be reduced with a new generation of mechanical valves compared to the previous generation of mechanical valves.
Trifecta Durability Study
Heart valve disease results in approximately 93,000 procedures and 20,000 deaths each year in the United States alone. Diseases of the aortic valve make up the main part (63%). The most common cause of diseases of the aortic valve are degenerative calcification processes that limit the mobility of the valve leaflets. This disease begins at the base of the leaflets, progresses to the free end, and leads to a reduction in the opening area of the valve. Other causes are congenital changes and rheumatic fever. The reduction in the opening area leads to a reduction in the ejection capacity of the heart. Patients with aortic stenosis can remain symptom-free for a long period of time. If symptoms such as chest pain (angina), shortness of breath (dyspnoea), heart murmurs, exhaustion and heart failure appear, the mean survival without treatment drops to about two years. Aortic valve replacement appears to be the only effective treatment for this condition. Two types of valves are currently available for valve replacement: mechanical valves (made of synthetic material) or biological valves (made of biological material). Biological valves are less durable than mechanical valves, but do not increase the risk of thrombus formation. Therefore attempts are made to improve the service life of biological valves. In this study, the long-term durability of the Trifecta valve is therefore to be investigated.
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