Author + information
- Received July 19, 2016
- Accepted July 29, 2016
- Published online November 14, 2016.
- Gino Gerosa, MDa,
- Laura Besola, MDa,
- Erica Manzan, MDa,
- Eleonora Bizzotto, MDa,
- Fabio Zucchetta, MDa,
- Demetrio Pittarello, MDb,
- Giuseppe Tarantini, MD, PhDa,
- David Meerkin, MDc and
- Andrea Colli, MD, PhDa,∗ ()
- aDepartment of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy
- bInstitute of Anesthesia, Department of Medicine, University of Padua, Italy
- cShaare Zedek Medical Center, Jerusalem, Israel
- ↵∗Reprint requests and correspondence:
Dr. Andrea Colli, Department of Cardiology, Thoracic and Vascular Sciences, University of Padua, via Giustiniani, 2, 35128 Padova, Italy.
Restrictive mitral valve annuloplasty with a rigid closed ring has evolved as a surgical alternative to mitral valve replacement (1–3) to correct functional mitral regurgitation (MR).
By reducing the anteroposterior annular diameter, mitral valve annuloplasty facilitates effective leaflet coaptation by directly reducing the MR as well as preventing further annular dilation that could lead to MR recurrence.
We present images of a first-in-human case of Implantation of the Amend transcatheter mitral valve repair system (ValCare Medical, Herzliya, Israel) to treat functional mitral incompetence under a compassionate use approval.
A 74-year-old woman presented with progressive dyspnea and New York Heart Association functional class III. Echocardiography demonstrated severe central MR (Figures 1A and 1B, Online Video 1) and an ejection fraction of 35%. Multislice computed tomography demonstrated an anteroposterior diameter of 30 mm (Figure 1C), compatible with a medium prosthesis (24.5 × 34.0 mm).
The procedure was performed under general anesthesia with standard transapical access, using guidance from transesophageal echocardiography (2D and 3D TEE) and fluoroscopy (Figures 2 and 3, Online Videos 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11). After introduction into the left ventricle, the 28-F Amend system was advanced through the mitral valve over a wire to the left atrium and the ring was unsheathed, where it adopted its closed D shape. The ring was then oriented appropriately to the annulus using the different adjustment tools achieving intimate contact with the posterior annulus and fixed to it with anchors. At this point the sheath was steered anteriorly toward the mitro-aortic continuity and again when good contact was achieved the anterior anchors were also deployed. The device was then released from the delivery system and retracted from the heart.
The patient was discharged home and at 3-month follow-up, she was asymptomatic (New York Heart Association functional class I) with mild MR, and stable ring position confirmed by multislice computed tomography (Figures 1D to 1F, Online Videos 12 and 13).
For supplemental videos and their legends, please see the online version of this article.
Dr. Meerkin is the Medical Director of Valcare Medical, Israel. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 19, 2016.
- Accepted July 29, 2016.
- American College of Cardiology Foundation
- Nishimura R.A.,
- Otto C.M.,
- Bonow R.O.,
- et al.
- Vahanian A.,
- Alfieri O.,
- Andreotti F.,
- et al.