Author + information
- Mohamad Lazkani, MD,
- Divya Ratan Verma, MD,
- George Gellert, MD,
- Michael Morris, MD,
- Kenith Fang, MD and
- Ashish Pershad, MD∗ ()
- ↵∗Division of Interventional Cardiology, 1300 North 12th Street, #407, Banner University Medical Center, Phoenix, Arizona 85006
Guerrero et al. (1) describe an early multicenter global experience of valve replacement in mitral annular calcification (MAC) with the Sapien (Edwards Lifesciences Corporation, Irvine, California) family of transcatheter heart valves (THV) for inoperable patients with mitral disease and heavy MAC (1). The 29.7% procedure-related mortality is sobering, and as suggested by the authors, may even be underestimated due to self-reporting from sites participating in the registry, missing data, and lack of clinical event adjudication.
There has been a proliferation of off-label use of the Sapien valve in the native mitral position. Our experience has also been suboptimal with 2 cases of embolization of the THV into the left atrium—1 occurring a few hours after the procedure and another occurring a few weeks after the procedure.
Conceivable reasons for high procedural mortality have been attributed to patient comorbidities, late treatment in natural history of the disease (the COHORT C patient), and operator learning curves. However, it is more likely unpredictable outcomes are due to: 1) inability to predict left ventricular outflow tract obstruction (LVOT); 2) degree and distribution of mitral annular and leaflet calcification necessary for valve anchoring being unclear; 3) algorithms for prosthesis sizing for seal in the D shaped mitral annulus being unknown; and 4) foreshortening of the device in the left atrium being unpredictable.
We disagree with the authors, that early results in this registry are similar to dedicated mitral valve therapies. This registry included very experienced Sapien-transcatheter aortic valve replacement sites and operators. The inexperience is not device related but with the pathology being treated. In contrast, all dedicated mitral devices are currently first-generation devices and the worldwide experience with them is limited. The FORTIS and CardiAQ (Edwards Lifesciences) devices have similar high 30-day mortality rates. The FORTIS program has been voluntarily suspended by Edwards Lifesciences (2,3). The 30-day mortality with the first-generation TIARA (Neovasc, Inc., British Columbia, Canada) device was 18% (4). The Tendyne (Tendyne Holdings, Inc., Roseville, Minnesota) program in their early data reported a 4.3% LVOT, 4.3% severe mitral regurgitation rate, and 0% cardiac mortality (5).
The results from this registry call into question if these procedures should be undertaken outside the purview of a prospective clinical trial such as the MITRAL trial (NCT02370511). We urge the investigators of the MITRAL trial to be inclusive in their endeavor for a solution to this clinical conundrum.
Please note: Drs. Gellert, Fang, and Pershad have served as proctors for Edwards Lifesciences. Dr. Gellert has served as a consultant for Abbott Vascular, Medtronic, Edwards Lifesciences, Philips, and Siemens. Dr. Pershad has served on the Speakers Bureau for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- 2016 American College of Cardiology Foundation
- Guerrero M.,
- Dvir D.,
- Himbert D.
- ↵Hermann H. CardiAQ-Edwards TMVR: design highlights and clinical update. Paper presented at: Transcatheter Valve Therapies 2016; June 16–18, 2016; Chicago, IL.
- ↵Rodés-Cabau J. FORTIS: design highlights and clinical update. Paper presented at: Transcatheter Valve Therapies 2016; June 16–18, 2016; Chicago, IL.
- ↵Leon M. Tiara: design features and highlights. Paper presented at: Transcatheter Valve Therapies 2016; June 16–18, 2016; Chicago, IL.
- ↵Moat N. Tendyne: design features and clinical update. Paper presented at: Transcatheter Valve Therapies 2016; June 16–18, 2016; Chicago, IL.