Author + information
- Received March 28, 2019
- Revision received June 11, 2019
- Accepted July 2, 2019
- Published online September 9, 2019.
- Paul Sorajja, MDa,∗ (, )@psorajja,
- Mario Gössl, MDa,
- Vasilis Babaliaros, MDb,
- David Rizik, MDc,
- Lenard Conradi, MDd,
- Richard Bae, MDa,
- Robert F. Burke, MDc,
- Ulrich Schäfer, MDd,
- John C. Lisko, MDb,
- Robert D. Riley, MDc,
- Robert Guyton, MDb,
- Nicolas Dumonteil, MDe,
- Pierre Berthoumieu, MDe,
- Didier Tchetche, MDe,
- Philipp Blanke, MDf,
- João L. Cavalcante, MDa and
- Benjamin Sun, MDa
- aValve Science Center, Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota
- bEmory Structural Heart and Valve Center, Atlanta, Georgia
- cHonorHealth, Phoenix, Arizona
- dUniversity Heart Center, Hamburg, Germany
- eClinique Pasteur, Toulouse, France
- fDepartment of Radiology, St. Paul’s Hospital and University of British Columbia, Vancouver, British Columbia, Canada
- ↵∗Address for correspondence:
Dr. Paul Sorajja, Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, 920 East 28th Street, Suite 200, Minneapolis, Minneapolis 55407.
Background Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak.
Objectives The objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis.
Methods Nine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy.
Results Device implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up.
Conclusions Transcatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted.
Dr. Sorajja has been a consultant and served on Speakers Bureaus for Abbott Vascular, Medtronic, Boston Scientific, Edwards Lifesciences, Admedus, and Gore; and has received research support from Abbott Vascular, Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Gössl has been a consultant and served on the Speakers Bureau and a Subject Eligibility Committee for Abbott Vascular. Dr. Babaliaros has been a consultant for Edwards Lifesciences and Abbott Vascular; and holds equity in Transmural Systems. Dr. Rizik has served on Advisory Boards for Abbott Vascular, Cordis/Cardinal, Biotronik, and Boston Scientific; has received grant or research support from Abbott Vascular and Boston Scientific; and has received licensing fees from Boston Scientific. Dr. Conradi has been a consultant for Edwards Lifesciences, Boston Scientific, and Abbott Vascular; has served on Speakers Bureaus for Edwards Lifesciences, Boston Scientific, Abbott Vascular, Neovasc Medical, and Medtronic; and has been a proctor for Neovasc Medical. Dr. Bae has served on a Speakers Bureau for Abbott Vascular. Dr. Burke has been a proctor for Abbott Vascular. Dr. Schäfer has been a consultant and served on Speakers Bureaus for Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Gore, and New Valve Technology; and has received research support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and New Valve Technology. Dr. Guyton has served as an unpaid consultant for Edwards Lifesciences. Dr. Dumonteil has been a consultant for Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Tchetche has been a consultant for Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Blanke has been a consultant to Tendyne/Abbott Vascular, Edwards Lifesciences, Neovasc, Gore, and Circle Cardiovascular Imaging; and his institution has provided computed tomography core lab services for Tendyne/Abbott Vascular, Edwards Lifesciences, Medtronic, and Neovasc. Dr. Cavalcante has received research grants and support from Abbott Vascular, Siemens, Medtronic, and Circle Cardiovascular Imaging; and has been a consultant and served on Speakers Bureaus for Siemens and Medtronic. Dr. Sun has been a consultant for Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received March 28, 2019.
- Revision received June 11, 2019.
- Accepted July 2, 2019.
- 2019 American College of Cardiology Foundation
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