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J Thorac Cardiovasc Surg 2007;133:209
© 2007 The American Association for Thoracic Surgery
Evolving Technology |
Dr. Klodell. Thank you for those questions. Concerning the right heart function, we didn’t present that data. The right heart function is evaluated by echo. There has not been any significant change in right heart function. The right heart pressures were also monitored perioperatively in the bulk of the patients and implantation of the device did not have any deleterious effects.
As far as the shape of the apex, to which you alluded, many of these patients have quite spherical hearts with elevated sphericity indices. One of the tricks of deployment is a little bit of apical traction with that suction cup to try and elongate the apex. thereby making the device deploy a little easier.
As to your third question, as far as fibrosis is concerned, we don’t have any information regarding humans yet, but in the animal model at least, the degree of reaction and fibrosis to the nitinol based device has been much less than the other support device, and it is hoped that that will translate into humans as well.
Dr S. Gideon (Beer Sheba, Israel). Did you have any bleeding complications due to erosion of epicardial blood vessels?
Dr Klodell. No, sir, to date there have been no bleeding complications, with the exception of the epicardial laceration from the introducer that I mentioned. None of the treated patients who have had a successful implant have subsequently had any bleeding complications.
Dr P. Kurlansky (Miami, Fla). I was wondering if you could help us to understand the device a little better. From the graph that you showed us, this is an extremely compliant material; therefore, it doesn’t seem as though there is passive restraint. It would seem that in fact this would have a lot of give to it, but it would also be, as it were, "hugging" the heart. If you can kind of explain to us a little better the physiology of what is going on or perhaps even the mechanics of what is going on with the device, because it doesn’t seem to be the same as the other sort of passive restraint device that is attempting to be on the market. Thank you.
Dr Klodell. I think that is a great question: Basically, what are the differences between this device and the CorCap device? First of all, this device is implanted completely differently. This is a minimal access, a 9- to 10-cm thoracotomy incision, and the pericardium is left intact. This is in contrast to how the other the device is implanted via sternotomy. And the sizing of this device, to which you alluded, is a little different. This device is sized based on MRI and echo data preoperatively. Currently, there are 12 sizes, so the device is selected based on the size of the heart you are going to put it on. Because nitinol has elasticity that when exposed to body temperature tends to constrict a little bit, it conforms very nicely to the heart. As opposed to the other device, which is a passive device that only prevents dilation, this actually has some elasticity to it; although it is very compliant, it also has elasticity to it. So there is a constant pressure on the ventricle that is probably along the order of 4 mm or so of magnitude, and what that is going to do long term is unclear at this time. I will share with you that the Magdeberg Germany group has submitted an abstract to the Heart Failure Society in which, hopefully, we will be hearing then that the elasticity feature may contribute to cardiac resynchronization.
Dr J. Puskas (Atlanta, Ga). Dr. Klodell, you had 2 out of 10 in this original series die of device related deaths and 1 of 10 aborted due to epicardial tear. Tell us about evaluation preoperatively for epicardial and pericardial adhesions. How can we avoid the difficulties inserting these?
Dr Klodell. Very good question. Thank you. Just to be clear, it was 1 epicardial laceration out of 21 patients and 2 patients out of the 21 that we presented today.
The preoperative evaluation, the things that we have learned from the U.S. patients so far is that patients who have an ischemic etiology frequently will have some pericardial adhesions. That can be problematic, certainly. Any patients who have epicardial LV leads and things like that should be excluded. We didn’t have time to cover in too much detail the operative approach, but one thing that has been very useful is when the introducer is inserted into the pericardial space to use a thoracoscope through the introducer to look at the heart and to try and make sure there are not adhesions there. When there are adhesions, at least in the European experience and in our experience in a couple of patients, those adhesions can be taken down under direct vision using the thoracoscope. But I do think that as far as the one patient that was aborted is concerned, preoperative nutrition status and overall qualitative assessment of the patient probably would have deterred that implant, and that is something to learn for the future: these need to be the same kind of relatively healthy patients who you would feel comfortable putting on bypass for a cardiac operation.
Related Article
J. Thorac. Cardiovasc. Surg. 2007 133: 204-209.
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