Percutaneous Mitral Valve Leaflet Repair for Mitral Regurgitation - Not Why, But Who?

Published date : 25 October 2012
Article date : 25 October 2012

The debate surrounding percutaneous mitral valve leaflet repair for mitral regurgitation is not dissimilar to the TAVI debate, explored in our September journal.  The key differences are that, by comparison, TAVI procedures have accelerated and the procedure has generated greater media coverage on patient selection and outcomes for those outside high-risk and inoperable categories.  

Nevertheless, a debate prevails on percutaneous mitral valve leaflet repair for mitral regurgitation as an alternative to valve surgery, for non-traditional patient cohorts. Percutaneous mitral valve leaflet repair is effective and less traumatic for patients and there are several medical devices at various stages of development. The catheter-based MitraClip Mitral Valve Repair System from Abbott Vascular is one of the only percutaneous devices for which there is any significant clinical-trial data. More than 3000 patients have been treated with the device (the majority in Europe) in various trials. Post-procedure recovery is typically one to three days.  

However, the National Institute for Health and Clinical Excellence (NICE) (1) published its reservations in 2010 (IPG309) concluding that the data was insufficient for its routine recommendation and that the device procedure should only be used in the context of research. NICE advised that patient selection and treatment must be undertaken by specialist units that include an interventional cardiologist with expertise in echocardiography and a cardiac surgeon. NICE were to review their guidance on publication of further evidence. 

Comment

 

Which Medical Device invited Dr. Douglas Muir, a site editor and respected UK Consultant Interventional Cardiologist for a view. He said, "The comparison and contrast with TAVI is an interesting one. What is the reason that percutaneous mitral valve technologies have failed to take off in the way that TAVI has? Are the technologies for mitral repair simply less effective or are the trial data less compelling?"
 
Dr. Muir went on to say, "One possible difference lies in the natural history of the conditions being treated. There is no question that the target for TAVI - severe symptomatic aortic stenosis - has a dismal prognosis when left untreated with almost all patients dying within 3 years of symptom onset. By contrast, many patients with mitral regurgitation (the target for mitral valve technologies) may live for many years, albeit with limiting symptoms. Therefore it may be inherently more difficult to prove efficacy for mitral valve technologies when the condition to be treated is rather more indolent in some patients.
 
A second difference is the approach to reducing the regurgitation. With TAVI, all devices aim to implant a new valve prosthesis, which mimics the native valve function, or at least that of a surgically replaced valve. Mitral technologies have looked at mimicking annuloplasty rings by coronary sinus reduction systems such as the Carillon device, or recreating the “Alfieri stitch” with the MitraClip. Most experienced mitral valve surgeons will use a variety of simultaneous techniques to restore valve function rather than just concentrating on a single mechanism as the percutaneous technologies do. 
 
In addition, each percutaneous device seems to have significant limitations, such as circumflex coronary artery compression with the coronary sinus devices or need for multiple devices with MitraClip. In addition, the technical expertise to correctly select and implant the MitraClip may surpass the skills needed for TAVI."
 
He concluded, "It seems inevitable that percutaneous mitral technologies will develop further and become part of our therapeutic armamentarium, but whether the current techniques will prove to be the way forward remains to be seen. Earlier in 2012, the first ever percutaneous mitral valve replacement, the CardiaQ, was implanted. This technology appears much more “TAVI-like” and it’s evolution will be of great interest over the coming few years."
 

Questions

 

A visit to YouTube demonstrates how the procedure is less invasive, most certainly from a patient’s perspective. Will this factor alone (as may have been the case with TAVI) result in patients outside the traditional criteria, lobbying for or accepting a procedure which is potentially higher-risk, more costly and which offers less certain long-term outcomes than gold standard surgery? 

Furthermore, in industrialised countries, in particular, should governments intervene with campaigns that educate patients to resist pseudo ‘quick-fixes’ and prioritise slower post-surgery recovery for a better outcome, in the longer-term? Looking ahead, could the economics of percutaneous mitral valve repair/replacement herald a groundswell from the health economists for continuation of valve surgery for patients outside the high-risk category? 

The European Association of Cardio Thoracic Surgery annual meeting takes place this month (27-31 October). One of the areas that the programme will address is percutaneous mitral valve repair for mitral regurgitation.  

 

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(1) NICE IPG309 Percutaneous mitral valve leaflet repair for mitral regurgitation.

 

 
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