In Print at Last, Early Cardioband Results Show Safety, Feasibility at 6 Months
Early results with percutaneous mitral annulus repair have been presented time and again at medical meetings over the last 2 years. Now, 6-month outcomes in the first 31 patients have finally appeared in print.
Writing in the October 10, 2016, issue of JACC: Cardiovascular Interventions, Georg Nickenig, MD (Heart Center Bonn, Germany), and colleagues say that percutaneous delivery of the Cardioband system (Valtech Cardio) is safe and feasible and associated with improved heart failure symptoms at 6 months in patients with functional mitral regurgitation (FMR).
Asked to explain what, precisely, these early results convey about the device given the low patient numbers and short follow-up to date, Nickenig highlighted the demonstration of “feasibility, great efficacy, and safety” with no procedural deaths and no recurrence of mitral regurgitation at 12 months.
TCTMD has previously described the incremental gains with the Cardioband, with most of these reports coming from the same group presenting updates at no fewer than four different meetings: 6-month results in 24 patients, 35 patients, and 40 patients, and 12-month results in six patients and then 50 patients. The band is delivered transfemorally with transseptal puncture, then positioned and deployed supra-annularly using repositionable screws to anchor the ring in place. After deployment, a second sizing tool is used to reshape and cinch the device until the desired degree of annular resizing is achieved.
This week’s report included 31 patients, mean age 72, predominantly male, with moderate-to-severe FMR, symptomatic heart failure, and depressed LV function. Cinching of the implanted device resulted in annular septolateral dimension reductions of greater than 30%, on average, out to 6 months. Heart failure class, exercise capacity, quality of life, and mitral regurgitation severity were all significantly improved from baseline to 6 months.
There were no periprocedural deaths, but three patients died within the first six months (9.6%), one from hemorrhagic stroke, one from multiorgan failure, and one from sepsis following elective open heart surgery. Ten patients required rehospitalization for heart failure within 6 months.
In an email to TCTMD, Nickenig said he believes the Cardioband may be a suitable approach for all patients with mitral annular dilation, which essentially means all patients with FMR, with the exception of patients with severe leaflet tethering.
But before the therapy can be used in a wider patient population, he said, “We need to treat more patients with less selection; this is underway.” At the same time, he continued, “we need to roll out the procedural technique to more centers—this also is being realized currently. Ultimately, we need to know whether we reduce morbidity and mortality, but this is also uncertain for mitral surgery [and the] mitral clip.”
Many Unknowns—And Not Just for the Cardioband
In an accompanying editorial, Steven F. Bolling, MD (University of Michigan, Ann Arbor), points out that numerous nonrandomized trials of mitral surgery for FMR have failed to show a mortality benefit for surgical annuloplasty procedures, although they have hinted that a full rigid ring is better than a partial flexible ring. “The Cardioband,” Bolling notes, “would be considered a partial, flexible band.”
To this point, Nickenig countered that “the data are as they are. We obviously do not need a rigid ring. The Cardioband is flexible but is stabilized by a wire inside. And the Cardioband is fixed by 6-mm long anchors from which we know after the procedure that each of them adheres tightly to the annulus. The big advantage is that we can evaluate this while doing the procedure since it is a beating heart procedure with real-time control,” something not possible in open heart surgery.
A larger question, and one raised by Bolling, is just how much FMR needs to be reduced, or abolished, for survival and heart failure symptoms to improve. There is also the question of durability. In surgical studies, Bolling notes, significant FMR begins to recur at around 6 months and does not stabilize for 12 to 24 months. “Unfortunately,” he writes, “what is the ‘standard’ for FMR, and whether this will be different for percutaneous FMR approaches, remains unclear.”
Speaking with TCTMD, Bolling said that overall he is “very upbeat and optimistic” about percutaneous mitral valve interventions. “I think this is a very dynamic time for mitral valve therapies, and this device is one of the first. Technically, it’s a tour de force. But what we’ve learned from the surgical field is that the mitral valve is far more complex than the aortic valve and we can’t forget the lessons we’ve learned from surgery.”
Ethically, he points out, surgery is typically not “permitted” until a patient’s condition has worsened and in some cases, surgery exacts “too big of a price” in these very sick patients.
“Now imagine you have a patient with heart failure and class 1 or 2 mitral regurgitation, and you could make that magically go away [using a low-risk intervention]?” he asked. That’s where he believes percutaneous mitral therapies will one day play an important role.
“I think this [preliminary Cardioband data] is a really fantastic series,” he said. “Everyone is excited about this technology, and there will be more to come. It’s an exciting time.”
- Nickenig G, Hammerstingl C, Schueler R, et al. Transcatheter mitral annuloplasty in chronic functional mitral regurgitation: 6-month results with the Cardioband percutaneous mitral repair system. J Am Coll Cardiol Intv. 2016;9:2039-2047.
- Bolling SF. Percutaneous mitral repair: a potential “standard” for functional mitral regurgitation? J Am Coll Cardiol Intv. 2016;9:2048-2049.
- Nickenig reports not relevant conflicts of interest.
- Bolling reports working as a consultant for Edwards, Millipede Sorin, Medtronic, and Abbott Vascular; and receiving IP/royalty from Edwards and Millipede.
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