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Eur J Cardiothorac Surg 2004;26:S36-S38
© 2004 Elsevier Science NL
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a Cardiac Surgery, San Raffaele University Hospital, Via Olgettina 60, 20132 Milan, Italy
b Interventional Cardiology, San Raffaele University Hospital, Milan, Italy
* Corresponding author. Tel.: +39 02 26437109; fax: +39 02 26437125. (Email: ottavio.alfieri{at}hsr.it).
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Abstract |
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 Top Abstract 1. Introduction2. Techniques and technologies3. Current status4. Expectations for the...5. The role of...6. Key issuesAppendixReferences |
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Key Words: Mitral valve insufficiency • Mitral valve repair • Catheter-based interventions
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1. Introduction |
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TopAbstract1. Introduction2. Techniques and technologies3. Current status4. Expectations for the...5. The role of...6. Key issuesAppendixReferences |
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2. Techniques and technologies |
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TopAbstract1. Introduction2. Techniques and technologies3. Current status4. Expectations for the...5. The role of...6. Key issuesAppendixReferences |
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These two techniques, when combined, can restore a perfect mitral valve function in the great majority of patients presenting with mitral insufficiency [1]. The edge to edge repair can be carried out percutaneously either using a clip device [2] or a catheter-based suction-and-suture system, derived from a surgical instrument for beating-heart mitral leaflet approximation [3]. The percutaneous annuloplasty is feasible introducing a variety of ‘ad hoc’ devices into the coronary sinus, taking advantage of the close anatomical relationship between the posterior mitral annulus and the coronary sinus. More recently, a transventricular percutaneous approach has been developed, based on the placement of several almost-stapled-like anchors around the mitral annulus to reduce the diameter of the orifice. The current methods of percutaneous mitral valve repair and the Companies which have been developing the related technology are listed in Table 1 .
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3. Current status |
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TopAbstract1. Introduction2. Techniques and technologies3. Current status4. Expectations for the...5. The role of...6. Key issuesAppendixReferences |
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A wide spectrum of techniques are in the armamentarium of surgeons to effectively correct mitral incompetence. Excellent long-term (up to 30 years) results have been repeatedly and consistently reported in the literature. All the percutaneous mitral valve repair development programs are still in the pre-clinical phase, with the exception of the E-valve clip device which has been already utilized in humans to create a double orifice mitral valve [4].
As of mid-May 2004, 14 patients have been enrolled in a feasibility and safety study called EVEREST 1, with 80% acute efficacy in reducing mitral regurgitation (Jan Komtebedde, personal communication). Interim EVEREST 1 results have been presented at the American College of Cardiology meeting in mid-March 2004 by Ted Feldman [5]. The only reported adverse event was clip detachment from one leaflet in a patient who subsequently underwent uneventful mitral repair surgery.
A double orifice mitral valve therefore can be created safely using a percutaneous approach. The procedure is effective in consistently reducing mitral regurgitation in the great majority of patients. The duration of the procedure in the last cases has been less than two hours.
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4. Expectations for the future and drivers for change |
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TopAbstract1. Introduction2. Techniques and technologies3. Current status4. Expectations for the...5. The role of...6. Key issuesAppendixReferences |
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On the other hand, the scenario could evolve differently on the basis of other considerations. In contrast with percutaneous aortic valve replacement which will be limited, at least initially, to non-surgical or high risk candidates, percutaneous mitral valve repair could be targeting current surgical candidates, and the patient preference for a transcatheter approach could be relatively high.
Rapid advancements in mitral valve repair products in combination with improvements in imaging modalities could accelerate the adoption of the percutaneous techniques. A much less invasive procedure, as provided by catheter-based methods, might induce a radical change in indications and lead to correction of mitral insufficiency in a very early stage of the disease.
Finally, reduction rather than abolishment of mitral regurgitation can be considered an acceptable therapeutic goal in many patients, and this attitude will favour the percutaneous approach to mitral repair.
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5. The role of the cardiac surgeon |
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TopAbstract1. Introduction2. Techniques and technologies3. Current status4. Expectations for the...5. The role of...6. Key issuesAppendixReferences |
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No other specialist therefore can contribute to the development of percutaneous mitral repair techniques more and better than the cardiac surgeon. A specific training should be envisioned to create specialists prepared to run clinical percutaneous valve repair–replacement programs.
A percutaneous valve procedure requires the expertise of different specialists (cardiac surgeon, interventional cardiologist, echocardiographist and anaesthesiologist) working in close cooperation.
The companies which are involved in the pioneering phase of percutaneous valve repair–replacement technology are certainly aware that successful clinical programs will depend on optimal cooperation among different specialists. A new opportunity for cardiac surgeons can be foreseen.
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6. Key issues |
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TopAbstract1. Introduction2. Techniques and technologies3. Current status4. Expectations for the...5. The role of...6. Key issuesAppendixReferences |
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Appendix |
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TopAbstract1. Introduction2. Techniques and technologies3. Current status4. Expectations for the...5. The role of...6. Key issuesAppendixReferences |
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Mr B. Keogh (Birmingham, UK): There is quite good evidence that having even a relatively small amount of residual mitral regurgitation after a standard conventional mitral valve repair impairs your long-term survival, and therefore it strikes me that an important area that we need to understand is exactly how much residual mitral regurgitation should be allowed in the patient's interests.
Dr Alfieri : Don't forget that these are the very first patients which have been treated percutaneously. So we can expect improvements. For instance, I was told, that the last cases were treated with two clips instead of one and apparently results have been better. Is that true?
Dr Cosgrove : They are better, yes.
Dr Alfieri : They are better. So, there is room for improvement.
Dr J. Vaage (Oslo, Norway): Thank you very much for a very interesting presentation. I become a little bit worried when we are talking about the involvement of the cardiac surgeon, because the scenario you are speaking about, I can see the cardiac surgeon being involved in the discussion initially, then he is some kind of bystander and waiting for complications and perhaps helping with the access. After a short time, the cardiologist or interventional cardiologist will start doing a combined sinoplasty and edge-to-edge plasty, and after some more years he will not even consult the cardiac surgeon before doing this. So actually, unless the cardiac surgeon himself will do it, then this is a loss of surgery.
And my final comment is I would like the chairmen to ask the group if people had a mitral insufficiency grade 3+, would you like to have an operation with a perfect result or having such a procedure done and end up with 1.7?
Dr L. Bockeria (Moscow, Russia): We have first to discuss what kind of patients we choose and then discuss, because this is not a very good proposal I guess. Though, if you insist, we can show hands up. Do we? I think that we have to have in mind what kind of patients we are talking about. If we have a patient in pregnancy with symptomatic mitral stenoses for example, probably we will do percutaneous mitral valve repair, but I don't think that is reasonable to discuss mitral comissurotomy by catheter approach for all patients.
Dr Vaage : My point is just that with percutaneous intervention, a lot of people, probably also including surgeons, will accept a less than perfect result.
Dr Alfieri : Your view is a little bit pessimistic, because I think that cardiac surgeons could be perfectly involved in this. We started, in Milano a training for cardiac surgeons in interventional cardiology. The key issue is to have a very good cooperation with collegues, to create groups which are disease- and procedure-oriented.
Interventional cardiologists have the coronary patient on the table, but a valve patient is sent, at the moment, to the cardiac surgeon by the general cardiologist. If the surgeon is able to do also the procedure with a catheter, he can choose the best treatment for the patient, because he has the entire therapeuthic armamentarium.
Dr S. Hagl (Heidelberg, Germany): Otto (Ottavio Alfieri), you speculated that we are talking about a large number of patients who can be treated by this method. I have very little experience with your technique in surgery, but normally what we see is a certain pathology which is, let's say, ideal for this type of repair; that means a big annulus and big leaflets. But in most other cases where you have rupture of the chordae or other pathologies, I think it is probably not the right technique to use. So what pathology do you suggest from your standpoint is ideal for this type of treatment?
Dr Alfieri : I can tell you by experience that if you combine annuloplasty and the edge to edge repair, the great majority of patients with mitral insufficiency can be treated. Of course, there are many other alternative techniques which are absolutely excellent, but from the point of view of the effectiveness of treatment, I can really guarantee that most of the patients with mitral insufficiency can be treated with these two techniques together.
Dr Hagl : And what is the risk of creating a mitral stenosis in those cases?
Dr Alfieri : Very small, and, of course, this can be checked out immediately by echo. The clip device is nice because you can put the clip, make your assessments, and if you are not pleased, you can relieve it and put it again.
Dr F. Beyersdorf (Freiburg, Germany): I think this is a very good example of what we have to do in the near future, and that means that we have to look more exact to the long-term results of what we are doing, because if I have the choice of having an operation once with a heart–lung machine and a normal, perfect reconstruction of my mitral valve, and I am sure that this will last for the next whatever, 10, 20 years, or if I am asked if I have something stuck in my groin and then they do in my coronary sinus something and I am not sure what is going on the next year, then there is no question for me what I would like to have. I mean, I would like to have one procedure and then I am healthy and that is it.
And you see that same question comes up when we are talking about reconstruction of bileaflet aortic valves. I mean, this can be done. But I don't know of any data what is going on in 10 or 15 years, and the same is true for all the other discussions which we had. I think the patients would like to know what chances do I have to have another procedure done and what are the risks of a second or maybe even third procedure, and this could be an argument for the treatment we are offering. What do you think?
This has nothing to do with your procedure because it is completely new. We don't know the results at all. This is fine and it is a new approach, but I think that in general, I cannot just imagine somebody who is agreeing to have a second and third procedure done.
Dr Alfieri : I agree that the strength of surgery at the moment is to offer a long-lasting procedure.
Dr G. Buckberg (Los Angeles, CA, USA): We have traditionally looked at the mitral valve through the atrium, but really the valve is an atrio ventricular complex. My first question is, should we be dealing with mitral insufficiency relative to physiology or relative to the form of the valve and it's ventricular components? My concept of ‘form’ means that if you look at several aspects of valve function, including the annulus, the ventricular wall size and shape as well as it's blood supply, and papillary muscle displacement. This concept of form may be especially important in patients with dilated ventricles that have alteration of these form related factors, and need ventricular restoration, but are without physiologic evidence of mitral insufficiency. Normally, they are tested at rest, without exercise, so that dynamic insufficiency related to structural change can be missed. During restoration, we can modify the annulus, shape of the ventricle, and papillary muscle width between the base of these muscles... I think our approach may have to be broadened from not just looking at what we see at rest, but recognize that insufficiency stems from distortion of the form of the ventricular components that can produce regurgitation as physiology changes. These alterations are independent of alterations that happen during the operation from loading and anesthesia, so the decision is not made by inducing changes by pressure of flow, but rather by anatomy as it alters ventricular form. This altered configuration can be changed surgically, and I am interested to hear some discussion of this ‘form related concept ‘ for the future.
Dr Alfieri : The target population for percutaneous interventions is not the patient with an excessively dilated ventricle and cardiomyopathy. I tend to think that the candidate can be a patient in the early stage of the disease where the ventricle is not excessively dilated.
Dr J. Revuelta (Santander, Spain): I am sure that this technique will be a success. There is a lot of expectation among cardiologists, every cardiologist asking if the technique is already there. But, Otto, I have been following very carefully your experience and doing cases, and I am happy with the technique because I learned two things from you and later from the Stanford animal studies. One is that one single suture is dangerous; it should be a running suture. Second, without annuloplasty, we must expect very high diastolic stress of the leaflet, which will result in failure.
So now when we have scientific evidence in our hands, we put this scientific evidence in a drawer and give the technique to the cardiologists, because, believe it or not, this is not for surgeons. When something is a clip and a catheter, it is for cardiology. It probably will be in our hands for one month or less than that.
Dr Alfieri : But why? If you have in your hands all the possibilities of treating a mitral valve, why should the patients go to somebody who only has one possibility, the clip?
Dr Revuelta : Because the patient will appear in our out-patient clinic. In other words, they already have the clip in place. We are not getting the patient before that.
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Footnotes |
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Presented at the EACTS Symposium for the Future of Cardiac Surgery, Frankfurt, Germany, July 1–2, 2004. |
References |
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TopAbstract1. Introduction2. Techniques and technologies3. Current status4. Expectations for the...5. The role of...6. Key issuesAppendixReferences |
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This article has been cited by other articles:
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  L. R. Croft, J. H. Jimenez, R. C. Gorman, J. H. Gorman III, and A. P. Yoganathan Efficacy of the Edge-to-Edge Repair in the Setting of a Dilated Ventricle: An In Vitro Study Ann. Thorac. Surg., November 1, 2007; 84(5): 1578 - 1584. [Abstract] [Full Text] [PDF]
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