NEW YORK – Combined transcatheter mitral valve interventions with the potential to have results as good as cardiac surgery are beginning to emerge in Europe, where cardiac surgeons are also getting early experience with newer transcatheter systems that offer alternatives to existing mitral valve treatments, said Dr. Francesco Maisano.
Surgeons in Europe are investigating for mitral valve repair, as alternatives to the MitraClip (Abbott Vascular) percutaneous mitral valve system, and developers of these devices have met their share of challenges, Dr. Maisano of the University Hospital Zurich (Switzerland) said at the 2015 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.
“This list was much longer in the past, but some of the companies have lost their way in the past few years,” he said. “This is because it is difficult to pursue such a tremendous effort of doing a transcatheter repair that is competing with a device that has been commercially available.”
The NeoChord system (NeoChord) has been approved in Europe and has been implanted in about 200 patients so far. It is implanted through a small (2-3–inch) left thoracotomy and deploys implantation of multiple neochordae. “This is slowly getting into practice,” Dr. Maisano said. “The main problem with this technology is that it still is a hybrid procedure; it requires general anesthesia. It’s still doubtful what the role will be for this procedure in the spectrum of mitral interventions.”
The Carillon Mitral Contour System (Cardiac Dimension Inc.) is “the only coronary sinus annuloplasty technology that survived in these years,” he said. The device is in clinical trials in Europe and Australia. However, he noted, efficacy with the device “doesn’t happen at the implant, but it happens over time.” Group outcomes data is pending. “Enthusiasm around coronary sinus annuloplasty never took, so a lot of physicians are still reluctant to embrace this technology,” he said. Nonetheless, in some patients the device has show results ”as good as other procedures.”
Meanwhile, three other percutaneous systems that aim to reproduce surgical annuloplasty are in development: the Mitralign (Mitralign), a percutaneous system that selectively plicates the annulus using pledget sutures; the Accucinch (Guided Delivery Systems) which completes a full-seal annuloplasty using suture-connected mitral anchors; and Cardioband (ValtechCardio), which can perform surgery-like annuloplasty without sutures. Dr. Maisano said Mitralign is hopeful to get CE-mark approval possibly as early as this year, and the Cardioband has been implanted in 42 patients in Europe with an average 22% reduction in septal dimensions – “good outcomes in terms of reduction of mitral regurgitation and improvement of symptoms,” he said.
Helping to advance the development of percutaneous procedures and the promise of combining those procedures to replicate surgery is the integration of multimodal imaging in the cardiac suite, Dr. Maisano said.
“There are many problems to be solved” in pursuing combined percutaneous procedures to replicate surgical results, he said. “It’s not easy from a regulatory standpoint or from an economical standpoint, but there is the potential to simulate what is done today in surgery-associated procedures. This is something that is happening in Europe, which is land of freedom in terms of utilizing devices.”
He related the story of a patient in whom he implanted two mitral valve clips and then, to stop leakage, used a vascular plug to fill the gap in the subcommissure. European cardiac surgeons have pondered or attempted transcatheter aortic implantation (TAVI) in combination with other procedures, including left atrial appendage closure (LAAC) and mitral clip insertion in varied combinations. “This is still feasible and something that is getting done more in Europe in experienced centers,” Dr. Maisano said. Although feasibility, safety, and efficacy of such approaches need to be proved in larger series, combination therapy will evolve in the future, in an attempt to reproduce surgical standards, he said.
Findings were presented on behalf of the European Society of Cardiology. Dr. Maisano is a consultant for Abbott Vascular and ValtechCardio, among other companies. He receives royalties from Edwards Lifesciences.