Author + information
- Received December 23, 2014
- Accepted January 15, 2015
- Published online May 1, 2015.
- Azeem Latib, MB ChB∗,†∗ (, )
- Matteo Montorfano, MD†,
- Eustachio Agricola, MD∗,
- Alessandro Castiglioni, MD‡,
- Andrea Blasio, MD‡,
- Fabrizio Monaco, MD§,
- Pietro Spagnolo, MD‖,
- Ottavio Alfieri, MD‡ and
- Antonio Colombo, MD∗,†
- ∗Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy
- †Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy
- ‡Department of Cardiothoracic Surgery, San Raffaele Scientific Institute, Milan, Italy
- §Department of Cardiac Anesthesia, San Raffaele Scientific Institute, Milan, Italy
- ‖Centre for Cardiovascular Prevention, San Raffaele Scientific Institute, Milan, Italy
- ↵∗Reprint requests and correspondence:
Dr. Azeem Latib, EMO-GVM Centro Cuore Columbus, Via Buonarroti 48, 20145 Milan.
Recurrent mitral regurgitation (MR) may occur after mitral annuloplasty and reoperation may be associated with significant morbidity and mortality. Recently, transcatheter mitral valve-in-ring procedures via the transvenous, transatrial, and transapical routes have been shown to be a feasible alternative in selected high-risk patients and associated with good short-term outcomes (1). However, there are still numerous procedural challenges that can occur such as device malpositioning, valve stability and anchoring, paravalvular leak, and left ventricular outflow tract (LVOT) obstruction. Until now, only balloon-expandable valves have been used for this indication with the limitation that this is a one-shot procedure. We report the first-in-human implantation of a fully repositionable and retrievable transcatheter valve in the mitral position.
A 76-year-old woman with chronic atrial fibrillation presented with recurrent episodes of heart failure. She had previously undergone surgical mitral valve repair (edge-to-edge plus annuloplasty with a St. Jude Seguin 34-mm ring) and coronary artery bypass grafting (left internal mammary artery to left anterior descending artery and a saphenous vein graft to the first diagonal). Echocardiography demonstrated severe central MR without evidence of the previous edge-to-edge repair (Figures 1A to 1C) and an ejection fraction of 34%. Multislice computed tomography (MSCT) demonstrated a perimeter-derived diameter of 27.4 mm (Figures 2A to 2C) compatible with a 29-mm prosthesis. Our multidisciplinary heart team agreed that a transcatheter procedure was indicated. In view of the radiolucent semirigid mitral ring that could potentially make accurate positioning challenging, implantation with a fully retrievable and repositionable valve was deemed to be advantageous with the option to reposition or fully retrieve the valve if the result was suboptimal.
The procedure was performed with the patient under general anesthesia in a hybrid operating room with standard transapical access (Figure 3, Online Videos 3, 4, and 5). After crossing the mitral valve and placing a stiff wire in the right inferior pulmonary vein, a 22-F sheath was inserted into the left ventricle (LV). The Direct Flow Medical (DFM) transcatheter valve system (Direct Flow Medical Inc., Santa Rosa, California) was inserted in the left atrium, the valve was unsheathed, and the non-metallic double ring valve was inflated in the left atrium. The ventricular ring was deflated, and the prosthesis pulled toward the LV until the ventricular ring was within the LV and the inflated atrial ring was parallel to the mitral annulus. Inflation of the ventricular ring confirmed symmetrical expansion and sealing with no residual MR on ventriculography. The valve was deliberately positioned more atrially to take advantage of the larger 31-mm proximal ring for sealing and to prevent LVOT obstruction. During valve positioning, the patient was stable because there was a functional valve across the native mitral valve. Transesophageal echocardiography confirmed the absence of central and paravalvular MR, a mean transprosthetic gradient of 2 mm Hg and no evidence of LVOT obstruction (Figures 1D to 1F, Online Video 1). The valve was fixed in position by the polymer exchange and detached as previously described (2). The patient was discharged on day 5. At 9-month follow-up, she was asymptomatic (New York Heart Association functional class I) with no residual paravalvular leak, a stable transprosthetic gradient of 4 mm Hg, and stable valve position confirmed by MSCT (Figures 2F to 2I, Online Video 2).
This is the first-ever case of a nonballoon-expandable valve being implanted in the mitral position. The principal advantage of having a fully repositionable and retrievable valve is that it allowed for the treatment of a radiolucent annuloplasty ring in a controlled and safe manner. The non-metallic conformable structure and rings of the DFM valve may be particularly advantageous in the mitral position to ensure sealing of the D-shaped annulus, with excellent hemodynamics, as evidenced by the follow-up computed tomography. This case is sufficiently encouraging to warrant further evaluation of the DFM valve for transcatheter mitral valve-in-ring implantation.
For accompanying videos and their legends, please see the online version of this article.
Dr. Latib is a consultant for Direct Flow Medical; and on the advisory board of Medtronic. Dr. Montorfano is a proctor for Edwards Lifesciences. Dr. Colombo is a minor shareholder in Direct Flow Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 23, 2014.
- Accepted January 15, 2015.
- 2015 American College of Cardiology Foundation