Author + information
- Received October 12, 2017
- Revision received October 24, 2017
- Accepted October 25, 2017
- Published online January 1, 2018.
- James S. Gammie, MDa,∗ (, )
- Krzysztof Bartus, MD, PhDb,
- Andrzej Gackowski, MD, PhDb,
- Michael N. D’Ambra, MDc,
- Piotr Szymanski, MD, PhDd,
- Agata Bilewska, MD, PhDd,
- Mariusz Kusmierczyk, MD, PhDd,
- Boguslaw Kapelak, MD, PhDb,
- Jolanta Rzucidlo-Resil, MDb,
- Neil Moat, MBBSe,
- Alison Duncan, MBBS, PhDe,
- Rashmi Yadev, MBBS, PhDe,
- Steve Livesey, MBChBf,
- Paul Diprose, MBChBf,
- Gino Gerosa, MD, PhDg,
- Augusto D’Onofrio, MDg,
- Demetrio Pitterello, MDg,
- Paolo Denti, MDh,
- Giovanni La Canna, MDh,
- Michele De Bonis, MDh,
- Ottavio Alfieri, MD, PhDh,
- Judy Hung, MDi and
- Piotr Kolsut, MD, PhDd
- aDivision of Cardiac Surgery, University of Maryland School of Medicine, Baltimore, Maryland
- bJagiellonian University John Paul II Hospital, Krakow Poland
- cBrigham and Women’s Hospital, Boston, Massachusetts
- dInstitute of Cardiology, Warsaw, Poland
- eRoyal Brompton and Harefield National Health Service Foundation Trust, London, United Kingdom
- fUniversity Hospital Southampton National Health Service Foundation Trust, United Kingdom
- gPadova University Hospital, Padova, Italy
- hOspedale San Raffaele, Milan, Italy
- iMassachusetts General Hospital, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. James S. Gammie, Division of Cardiac Surgery, University of Maryland School of Medicine, 110 South Paca Street, 7th Floor, Baltimore, Maryland 21201.
Background Conventional mitral valve (MV) operations allow direct anatomic assessment and repair on an arrested heart, but require cardiopulmonary bypass, aortic cross-clamping, sternotomy or thoracotomy, and cardioplegic cardiac arrest, and are associated with significant perioperative disability, and risks of morbidity and mortality.
Objectives This study evaluated safety and performance of 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 a mitral valve repair system (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 1 month, MR was mild or less in 89% (24 of 27) and was moderate in 11% (3 of 27). At 6 months, MR was mild or less in 85 % (22 of 26), moderate in 8% (2 of 26), and severe in 8% (2 of 26). Favorable cardiac remodeling at 6 months included decreases in end-diastolic (161 ± 36 ml to 122 ± 30 ml; p < 0.001) and left atrial volumes (106 ± 36 ml to 69 ± 24 ml; p < 0.001). The anterior-posterior mitral annular dimension decreased from 34.7 ± 5.8 mm to 28.2 ± 5.1 mm; p < 0.001 as did the mitral annular area (10.0 ± 2.7 cm2 vs. 6.9 ± 2.0 cm2; p < 0.0001).
Conclusions MVRS ePTFE cordal implantation can reduce the invasiveness and morbidity of conventional MV surgery. The device’s safety profile is promising and prospective trials comparing the outcomes of the MVRS to conventional MV repair surgery are warranted. (CE Mark Study for the Harpoon Medical Device [TRACER]; NCT02768870)
This research was funded by Harpoon Medical, Inc. Dr. Gammie had equity interest in Harpoon Medical Inc; and is a consultant for Edwards Lifesciences. Dr. Bartus is a consultant for Harpoon Medical Inc. Dr. D'Onofrio is a proctor for Edwards Lifesciences and Symetis. Dr. Denti is a consultant for 4Tech, Saturn, InnovHeart, and Abbott. Drs. Gammie, D’Ambra, Gackowski, and Bartus have ownership of stock and/or options to purchase stock in Harpoon Medical, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 12, 2017.
- Revision received October 24, 2017.
- Accepted October 25, 2017.
- 2018 American College of Cardiology Foundation
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