Beating-Heart Mitral Valve Repair Using a Novel ePTFE Cordal Implantation Device
James S. GammieKrzysztof BartuśAndrzej GackowskiMichael N. DʼAmbraPiotr SzymańskiAgata BilewskaMariusz KuśmierczykBogusław KapelakJolanta Rzucidło-ResilNeil MoatAlison DuncanRashmi YadevS.A. LiveseyPaul DiproseGino GerosaAugusto D’OnofrioDemetrio PitterelloPaolo DentiGiovanni La CannaMichele De BonisOttavio AlfieriJudy HungPiotr Kołsut
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Key result
Beating-heart ePTFE cord implantation reduces MR to moderate or less in ~90% at 30 days.
- 95% CI 73-98
- P<0.001
- n=30
Why the study?
Conventional mitral valve operations require cardiopulmonary bypass and cardiac arrest, leading to significant perioperative disability and risks of morbidity and mortality.
Does ePTFE cordal implantation using a novel transesophageal echocardiographic-guided device successfully and safely reduce severe degenerative mitral regurgitation on the beating heart?
Key Points
- To evaluate the safety and performance of a transesophageal echocardiography-guided device designed to implant artificial ePTFE cords on mitral leaflets in the beating heart.
- Conducted a prospective multicenter study in N=30 consecutive patients with severe degenerative mitral regurgitation across 6 clinical sites in 3 countries (NCT02768870).
- Implanted artificial ePTFE cords on prolapsed mitral leaflets in the beating heart via a small left thoracotomy under transesophageal echocardiographic guidance using a mitral valve repair system.
- The primary endpoint of cord implantation with MR reduction to moderate or less was met in 27 of 30 patients (90%; 95% CI: 73% to 98%; p < 0.001 versus the 58% performance goal), while 3 patients required conversion to open surgery.
- At 1 month, MR was mild or less in 89% (24 of 27) and 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 reverse cardiac remodeling at 6 months included significant reductions in left ventricular end-diastolic volume (161 ± 36 ml to 122 ± 30 ml; p < 0.001) and left atrial volume (106 ± 36 ml to 69 ± 24 ml; p < 0.001).
Study Design
Type
Observational (n=30)
Multicenter
Yes
Structured PICO
Does ePTFE cordal implantation using a novel transesophageal echocardiographic-guided device successfully and safely reduce severe degenerative mitral regurgitation on the beating heart?
P
Population
30 adults (mean age 61, 77% male) with severe degenerative mitral regurgitation due to isolated posterior leaflet prolapse, treated at 6 European centers with beating-heart repair and followed for 6 months.
I
Intervention
Transesophageal echocardiographic-guided beating-heart mitral valve repair using the Harpoon mitral valve repair system (MVRS) to implant artificial expanded polytetrafluoroethylene (ePTFE) cords on mitral leaflets via small left thoracotomy.
O
Outcome
Successful implantation of 1 or more ePTFE artificial cords on the MV, with subsequent reduction of MR from severe to moderate or less at the conclusion of and 30 days after the procedure.composite
Main Result
p-value: p=<0.001
Limitations
- Early in the clinical experience with the technology
- Small sample size
- Suboptimal echocardiographic imaging equipment used in early procedural cases
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
MMMichael MackCardiac surgeon, Baylor Scott & White Health
“This was a low-risk patient population with isolated P2 prolapse that if treated surgically has a >95% successful repair rate in valve reference centers. In this series, by 6 months post-procedure, only 22 of 30 (73%) of patients had mild or lesser degree MR without conversion to surgery.”
“The Harpoon device was found to be remarkably safe and effective. The device allowed the surgeons to precisely and effectively reduce the degree of mitral regurgitation (MR) without using an open-heart procedure. There were no deaths. Only one patient needed a blood transfusion, and there were no strokes, no need for pacemakers, no readmission to the ICU, and no reintubations.”
“We believe the impact of this device for patients will be less invasive therapy for MR, it's going to be safer, [increase] the potential for faster recovery, [and lead to] improved quality of life. We believe for physicians this is going to demystify mitral valve repair and it's going to turn the low-volume mitral valve surgeon into a high-quality mitral valve repair surgeon.”
Implication
A novel beating-heart transesophageal echocardiographic-guided ePTFE cordal implantation device safely reduced mitral regurgitation to moderate or less in 90% of selected patients with isolated posterior leaflet prolapse.
Abstract
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 cm 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).
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Cite This Study
Gammie et al. (2017) conducted an observational in Severe degenerative mitral regurgitation (n=30). Mitral valve repair system (MVRS) ePTFE cordal implantation was evaluated on Successful implantation of cords with mitral regurgitation reduction to moderate or less at 30 days (95% CI 73-98, p=<0.001). The beating-heart transesophageal echocardiographic-guided device successfully implanted ePTFE cords and reduced mitral regurgitation to moderate or less in 90% of patients at 30 days.
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