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Transcatheter mitral valve therapy at ‘event horizon’

Key clinical point: Transcatheter mitral valve repair and replacement technology has reached a critical point that requires cardiac surgeons to assume their place in a multidisciplinary team.

Major finding: One transcatheter device is commercially available in the United States and more than 25 companies have devices in development.

Data source: Review of 22 published reports on transcatheter mitral valve technology.

Disclosures: Dr. Badhwar disclosed he is an uncompensated member of the Abbott Vascular advisory board. Coauthor Vinod Thourani, MD, disclosed relationships with Edwards Lifesciences, Medtronic Cardiovascular, Abbott Vascular, St. Jude Medical, Mitralign and AtriCure. Coauthor Michael Mack, MD, serves on the Edwards Lifesciences steering committee Partner Trial, and is an uncompensated co-principal investigator of the Abbott Vascular Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy Trial.

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‘Clarion call’ for MR treatment

Channeling Bob Dylan’s “The Times They Are A-Changin’” in his invited commentary, W. Randolph Chitwood Jr., MD, of East Carolina University in Greenville, N.C., called Dr. Badhwar’s expert opinion “the clarion call for cardiac surgeons to become engaged in this rapidly evolving parade.”

Dr. W. Randolph Chitwood Jr.

The evidence supporting the safety and efficacy of transcatheter aortic valve replacement (TAVR) is already strong, Dr. Chitwood noted. “It seems reasonable to suspect that the evolving pathway for the development of transcatheter mitral valve replacement (TMVR) could recapitulate the success of TAVR, with each generation having improved results,” he said (J Thorac Cardiovasc Surg. 2016;152:336-7).

Cardiac surgeons need to develop alternate access platforms and acquire the skills to use the new generation of transcatheter mitral devices, Dr. Chitwood said. The expert opinion “should encourage cardiac surgeons to become members of a heart team,” he said. “Guidewire skills are at the pinnacle of necessity to remain a player in this new world.”

Dr. Chitwood’s advice to colleagues: “Then you better start swimming or you’ll sink like a stone, For the times they are a-changin’.”

Dr. Chitwood disclosed he is a consultant to Direct Flow Medical and co-principal investigator for the Edwards Lifesciences Transform Trial.


 

FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY

References

As investigational transcatheter mitral valve therapies continue to explode onto the scene, cardiac surgeons must act now to seize and assert their place in the multidisciplinary team with interventional, imaging, and heart failure colleagues to deliver these treatments to people with complex mitral valve regurgitation, an expert opinion report in the August issue of the Journal of Thoracic and Cardiovascular Surgery states (J Thorac Cardiovasc Surg. 2016;152:330-6).

“There is a growing population of patients with primary and secondary mitral regurgitation underserved by surgical therapy because of comorbid risk,” Vinay Badhwar, MD, of West Virginia University and his colleagues said. “This has led to a tremendous activity of device development.”

Dr. Vinay Badhwar

Dr. Vinay Badhwar

With more than 25 different transcatheter mitral valve devices in development (MitraClip, Abbott Vascular, is the only FDA-approved transcatheter for primary mitral regurgitation [MR]), cardiac surgeons will soon have the tools to offer transcatheter mitral valve repair (TMVr) and transcatheter mitral valve replacement (TMVR) to more complex patients who have MR along with other health problems. Today about half of those patients do not get surgery because they are too frail, Dr. Badhwar and his colleagues said.

The authors used the astrophysical phrase “event horizon” to define the current state of transcatheter mitral valve therapies – “a point of no return.” They expect surgery to remain the treatment of choice for MR for the next 10 years. “However, as our patient cohorts become increasingly more complex and transcatheter mitral therapies more facile, the day when this will become a daily clinical reality will soon be upon us,” Dr. Badhwar and his colleagues said.

The multidisciplinary team approach will be integral in achieving the full potential of transcatheter mitral valve replacement or repair, Dr. Badhwar and his coauthors said. While surgery is the most effective treatment for primary MR, cardiac surgeons are challenged to introduce transcatheter treatments in patients who have other health problems. “The best way to adjudicate innovative surgical and interventional mitral therapies is through a robust collaboration within a well-functioning heart team that includes not only a cardiac surgeon and interventional cardiologist but also an imaging specialist,” the authors said.

The time to reach out to those other specialties is now, before those investigational devices start emerging from the development pipeline, Dr. Badhwar and his colleagues said. “This will soon enable the team-based mitral specialist to be facile in safely transitioning patients from open mitral surgery to TMVr or TMVR as most appropriate for durable long-term outcomes.”

Dr. Badhwar disclosed he is an uncompensated member of the Abbott Vascular advisory board. Coauthor Vinod Thourani, MD, disclosed relationships with Edwards Lifesciences, Medtronic Cardiovascular, Abbott Vascular, St. Jude Medical, Mitralign, and AtriCure. Coauthor Michael Mack, MD, serves on the Edwards Lifesciences steering committee Partner Trial and is an uncompensated co-principal investigator of the Abbott Vascular Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy Trial.

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