Author + information
- Received October 12, 2017
- Revision received October 24, 2017
- Accepted October 25, 2017
- Published online November 1, 2017.
- James S. Gammie, MD1,∗ (, )
- Krzysztof Bartus, MD, PhD2,
- Andrzej Gackowski, MD, PhD2,
- Michael N. D’Ambra, MD;3,
- Piotr Szymanski, MD, PhD4,
- Agata Bilewska, MD, PhD4,
- Mariusz Kusmierczyk, MD, PhD4,
- Boguslaw Kapelak, MD, PhD2,
- Jolanta Rzucidlo-Resil, MD2,
- Neil Moat, Mr., MBBS, FRCS5,
- Alison Duncan, Dr., MBBS, PhD5,
- Rashmi Yadev, Ms., MBBS, PhD, FRCS (CTh)5,
- Steve Livesey, Mr., FRCS6,
- Paul Diprose, Dr., FRCA6,
- Gino Gerosa, MD, PhD7,
- Augusto D’Onofrio, MD7,
- Demetrio Pitterello, MD7,
- Paolo Denti, MD8,
- Giovanni La Canna, MD8,
- Michele De Bonis, MD, FESC, FAHA8,
- Ottavio Alfieri, MD, PhD8,
- Judy Hung, MD9 and
- Piotr Kolsut, MD, PhD4
- 1Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore, MD, USA
- 2Jagiellonian University John Paul II Hospital, Krakow, Poland
- 3Brigham and Women’s Hospital, Boston, MA, USA
- 4Institute of Cardiology, Warsaw, Poland
- 5The Royal Brompton & Harefield NHS Foundation Trust, London, UK
- 6University Hospital Southampton NHS Foundation Trust UK
- 7Padova University Hospital, Padova, Italy
- 8Ospedale San Raffaele, Milan, Italy
- 9Massachusetts General Hospital, Boston, MA, USA
- ↵∗Correspondence: James S. Gammie, MD Division of Cardiac Surgery University of Maryland School of Medicine 110 S. Paca Street, 7th Floor Baltimore, MD 21201 Telephone: 410 328 5842 Fax 410 328 2750.
Background We evaluated safety and performance of the Harpoon Mitral Valve Repair System (H-MVRS), a transesophageal echocardiographic-guided device designed to implant artificial expanded polytetrafluoroethylene (ePTFE) cords on mitral leaflets in the beating heart.
Methods In a prospective multicenter study, 30 consecutive patients with severe degenerative mitral regurgitation (MR) were treated with H-MVRS via small left thoracotomy. The primary (30 day) endpoint was successful implantation of cords with MR reduction to moderate or less.
Results The primary endpoint was met in 27 of 30 patients (90 %). Three patients required conversion to open mitral surgery. There were no deaths, strokes, or permanent pacemaker implantations. At one month, MR was mild or less in 89 % (24/27) and was moderate in 11% (3/27). At 6 months, MR was mild or less in 85 % (22/26), moderate in 8% (2/26), and severe in 8% (2/26). Favorable cardiac remodeling at six months included decreases in end-diastolic (161 ± 36 to 122 ± 30 ml, p <0.001) and left atrial volumes (106 ± 36 to 69 ± 24 ml, p <0.001). The anterior-posterior mitral annular dimension decreased from 34.7 ± 5.8 to 28.2 ± 5.1 mm, p <0.001 as did the mitral annular area (10.0 ± 2.7 vs 6.9 ± 2.0 cm2, p<0.0001).
Conclusions H-MVRS ePTFE cordal implantation can reduce the invasiveness and morbidity of conventional mitral valve surgery. The safety profile of the device is promising and prospective trials comparing the outcomes of H-MVRS to conventional mitral valve repair surgery are warranted.
Funding Sources: Funding for this study was provided by Harpoon Medical, Inc.
Conflict of Interest Disclosures: Drs. Gammie, D’Ambra, Gackowski and Bartus have ownership of stock and/or options to purchase stock in Harpoon Medical, Inc. The remaining authors have nothing to disclose.
Clinical Trial Registration https://clinicaltrials.gov/ct2/show/NCT02768870?term=NCT02768870&rank=1
- Received October 12, 2017.
- Revision received October 24, 2017.
- Accepted October 25, 2017.