August 2013
Structural heart disease 15 Transcatheter Valve News
The “huge paradox” of percutaneous mitral valve repair
At EuroPCR (21–24 May, Paris, France), Carlos E Ruiz (Structural and Congenital Heart Disease Program, North Shore Long Island Jewish Health System and Lenox Hill Heart and Vascular Institute of New York, New York, USA) outlined the reasons why there are substantial more transcatheter aortic valve implantation (TAVI) procedures than there are percutaneous mitral valve repair procedures even though the technologies were developed within months of each other
R
uiz said: “To date, since the tech- nology was first developed, more than 100,000 TAVI procedures have been performed. However, even though the technology for percutaneous mitral valve repair was developed around the same time as TAVI, far fewer—less than 10,000—mitral valve repair proce- dures have been performed. To me, this is a huge paradox, given the fact that the mitral valve market for mitral regurgita- tion is four times the size of the aortic valve market.””
He added that one reason for this
difference in procedure rates was that both aortic and pulmonary valves were basically non-cardiac and belonged to the vascular structures (aorta and pulmonary arteries), whereas the mitral and tricuspid were true cardiac structures and that one of their functions was to work as a valve. Ruiz commented: “The mitral valve is more than just a valve. Its valvular func- tion is just one part of its very complex, interconnected components.” He further explained that a problem with the designs of current mitral valve prostheses (as used in surgical replacement) is that they are based on a “borrowed concept form
outflow valve designs. They function only as a valve and lack most of the other sup- port functions that the native mitral valve has.” Similarly, percutaneous technologies for the management of mitral regurgita- tion may need to repair/replace all of the mechanisms of action of the mitral valve rather than just the valvular function. Another issue with mitral valve repair, Ruiz, reported, was the “huge heterogene- ity” of mitral valve disease and that how many patients were poor candidates for mitral valve repair. He said: “If you look at the spectrum of mitral valve patholo- gies, only a small percentage of them are suitable for management with replacement or repair. This is supported by data from the Society of Thoracic Surgeons (STS). Only 5.6% of patients in a STS database of isolated mitral valve surgeries met the eligibility criteria for mitral valve repair (STS score of 12) and of these, only 15% actually underwent the procedure—the remaining 85% underwent mitral valve replacement.”
Ruiz also commented that identifying the cause—degenerative or functional— of the mitral regurgitation was also important. He said: “There is no therapy
MitraClip will provide some clini- cal benefit for very high- risk symptomatic patients with mitral regurgitation ≥3+
Carlos Ruiz
to slow down the progress of degenerative mitral regurgitation; you can treat the mitral insufficiency in these patients but not its cause. On the other hand, we do have lot of therapies that can slow down the progress of functional mitral regurgitation because the insufficiency is not a primary pathology of the valve; its primary pathology is mostly from the ventricle and targeting the ventricle may slow down the process. So, there is a big difference between these entities.” He added that surgical mitral valve repair seemed to be more effective for degenerative mitral regurgitation than it was for functional regurgitation, stating that one study showed freedom from reoperation rate was 94% at 10 years in patients with degenerative mitral regurgitation but another study had shown rate of mitral valve repair failure to be 65% at five years in patients with functional regurgitation. According Ruiz, the reason why several percutaneous
devices for managing mitral regurgitation have “come and gone” over the years may be because they have: “Targeted the effects of mitral regurgitation rather than the mechanisms of regurgitation.” Of the percutaneous devices that have been developed, Ruiz said that the MitraClip (Abbott Vascular) was the only one to show clinical benefit. However, he added that a recent study had shown that after four years, outcome data was in fa- vour of surgical mitral valve repair rather than the MitraClip. He said: “MitraClip will provide some clinical benefit for very high-risk symptomatic patients with mitral regurgitation ≥3+. It should not be an op- tion for good surgical candidates.” Summarising his talk, Ruiz said: “Proper technology selection, based on the mechanistic cause of the mitral regur- gitation and underlying pathology will be preferable, making the case for a patient- specific device(s) planning approach to mitral valve repair/replacement.”
High procedural success rate with JenaValve in real-world data
J
enaValve Technology has announced the 30-day results of its post-market registry (JUPITER), which is evaluating the five-year long-term safety
and effectiveness of its second-generation transapical, transcatheter aortic valve implantation (TAVI) system in 180 elderly high-risk patients, at EuroPCR (21–24 May, Paris, France).
According to a press release, the 30-day results of the
first half of the patients enrolled in the JUPITER registry showed that JenaValve was associated with a high procedural success rates and excellent clinical. In 88 patients with a mean logistic EuroSCORE of 24.9%, the procedural success rate was 95.5%. Major adverse events such as major stroke (0.0%) or
spontaneous myocardial infarction (1.3%) were very low and represent the safety of the JenaValve TAVI system. The press release also reported that excellent haemodynamics and very low paravalvular leakage confirm the advantages of the system; 97.6% of the patients had a paravalvular leakage ≤mild, severe paravalvular leakage did not occur (0%). The data were presented by Stephan Ensminger, from the Heart and Diabetes Center NRW in Bad Oeynhausen, Germany, on behalf of the registry investigators. He said: “The JUPITER registry confirms the excellent performance and safety of this 2nd generation TAVI system in a real world clinical use.”
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