Innovative solutions from UCC’s cardiac surgeons
5.04.2019
dr Maciej Brzeziński
The first polish clamp of left atrial appendage is being used for patients with atrial fibrillation. The authors of the project are prof. Jan Rogowski and dr Maciej Brzeziński from The Department of Cardiac and Vascular Surgery of Medical University of Gdańsk supported by scientists from The Technical University of Gdansk.
The clamp for closing the left atrial appendage has its own name “atriclamp” – a combination of heart atrium and clamping. It is a clamp used for closing something that we do not really need. A good comparison here would be an appendix which sometimes has to be removed operationally. Similar holds for the left atrial appendage. It is a natural creation which evolved at some stage of development however, it is not well understood for what it should serve.
– When an arrhythmia occurs, there might be unwanted blood clotting complications. The micro-thromboses are formed, which in turn might evolve into a large thrombus that is visible with the naked eye. This, in turn, could directly threaten our life, and certainly our health and fitness – explains dr Brzeziński. More and more often brain vascular events such as strokes are caused by embolic material that migrates from the left atrium. Not all of them, of course, have to come from here but for the majority of cases this structure is responsible for that. The method that has been recognized for years is a closure, or the better word here will be “turning off”, of the left atrial appendage which is performed as an additional or an independent procedure.
The left atrial appendage can be “turned off” in many ways, for instance by placing in it a kind of plug. One can simply sew up or use staplers (tools resembling a paper stapler). Unfortunately, the disadvantage of this procedure is the lack of reposition. Another method which could be applied is a clamp that can be compared to a flexible safety-pin loop. Nevertheless, it requires carrying the appendage through the loop, which means more manipulation of this structure. In a situation where there are already some small thrombus in the appendage that cannot be seen in echocardiography, they could be released during that maneuvering.
The clamp of left atrial appendage invented by scientists from the Medical University of Gdańsk outperforms other devices of this form as it allows reposition at any time: it can be pulled up, removed, and does not require threading. It is placed just like a clip on the side of the base of the left atrial appendage.
The device is placed intraoperatively under the control of a very precise tool which is the eye of the surgeon. – Our clamp is produced with the use of 3D printing from a special polyamide powder. This allows us to already mention that our device will be price competitive in comparison to other devices of this type on the market – adds dr Brzeziński.
It is worth mentioning that the results of research on other devices used for closing the left atrial appendage, in particular, mentioned cork, are ambiguous. This is due to these results that the idea to create something that would be effectively generated.
The clamp, as a device not bearing the “CE” mark yet, cannot be widely used. In March 2018, the Office for Registration of Medicinal Products, Devices, and Biocidal Products authorized a clinical trial which is currently in progress and for which a group of 30 patients has been selected. From the 10th of August this year. it has been implanted (currently in four patients). If everything goes well, the next step will be planning multi-center medical trials – this is also the requirement to register and receive the “CE” mark. Then, the device can be introduced into medical markets.
The project has been already recognized by the jury of the Golden Scalpel competition.
Photo: Sylwia Mierzewska, UCC