Transapical beating heart mitral valve repair with the NeoChord system: early outcomes of a single-center experience.

Wróbel, Krzysztof; Kurnicka, Katarzyna; Zygier, Marcin; Zieliński, Dariusz; Dyk, Wojciech; Wojdyga, Ryszard; Juraszyński, Zbigniew; Pruszczyk, Piotr; Biederman, Andrzej

doi:10.5114/wiitm.2019.82738

Cited by 4 publications

(7 citation statements)

References 25 publications

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“…One advantage of the NeoChord procedure compared to technologies such as the MitraClip which create a fixed coaptation point, is that it does not create any barriers to MV re-repair if necessary, making it more appealing for early-stage disease treatment in younger patients. In our study, four (30%) of the patients who required reintervention were re-repaired rather than requiring MV replacement confirming what shown by other groups (16). Moreover, two out of four were re-repaired through re-NeoChord procedure.…”

Section: Discussionsupporting

confidence: 89%

Transapical off-pump echo-guided mitral valve repair with neochordae implantation mid-term outcomes

Gerosa

Nadali

Longinotti

et al. 2021

Ann Cardiothorac Surg

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Background: The NeoChord echo-guided transapical beating heart repair is a promising early-stage minimally invasive surgical procedure for degenerative mitral valve (MV) regurgitation (DMR) correction. The technique has been improved since its inception following procedure standardization, patient selection optimization, and learning curve stabilization. We hereby present the mid-term clinical results through three years of our large single center experience. Methods: All consecutive patients with severe symptomatic DMR due to prolapse or flail of one or both mitral leaflets that underwent the NeoChord procedure between November 2013 and June 2019 were included. Patients were categorized according to MV anatomy; Type A isolated central posterior leaflet prolapse and/or flail, Type B posterior multi-segment prolapse and/or flail, Type C anterior and/or bi-leaflet prolapse or flail, Type D paracommissural prolapse and/or flail and/or significant leaflet and/or annular calcifications. Patients underwent clinical and echocardiographic follow-up at one, three, six, twelve months and yearly thereafter. Clinical outcomes and the composite primary endpoint (patient success) were defined according to Mitral Valve Academic Research Consortium (MVARC) criteria. Mitral regurgitation (MR) severity was graded as absent, mild, moderate and severe according to American Society of Echocardiography (ASE) and European Society of Cardiology (ESC) guidelines. Results: Two hundred and three patients were included; median follow-up was 24 months [interquartile range (IQR), 9-36]. Median age was 64 years (IQR, 54-74 years), median Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) was 0.60% (IQR, 0.32-1.44%). There were 106 Type A patients (52.2%), 68 Type B (33.5%), 16 Type C (7.9%), and 13 Type D (6.4%). Kaplan-Meier estimate of survival was 99.0%±0.7% at one and two years and 94.0%±2.9% at three years. At one-year follow-up patient success was 91.2%±2.0% and 111 patients (74%) presented a residual MR mild or less (1+). At three-year follow-up patient success was 81.2%±3.8% and 32 patients (64%) had a residual MR mild or less (1+). Patient success was significantly different according to anatomical type (P=0.001). Echocardiographic analysis showed a significant acute left ventricle and left atrial reverse remodeling that was maintained up to three years. Conclusions: The NeoChord echo-guided transapical beating heart repair procedure demonstrated good clinical outcomes and echocardiographic results up to three-year follow-up.

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Section: Discussionsupporting

confidence: 89%

Transapical off-pump echo-guided mitral valve repair with neochordae implantation mid-term outcomes

Gerosa

Nadali

Longinotti

et al. 2021

Ann Cardiothorac Surg

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“…Colli et al 11 Overlap of included patients with Colli et al 12 Colli et al 13 Overlap of included patients with Colli et al 12 Colli et al 14 Overlap of included patients with Colli et al 12 Colli et al 15 Overlap of included patients with Colli et al 12 Colli et al 16 Overlap of included patients with Colli et al 12 Colli et al 17 Overlap of included patients with Colli et al 12 Kurnicka et al 6 Overlap of included patients with Colli et al 12 Rucinskas et al 18 Overlap of included patients with Colli et al 12 Samalavicius et al 19 Overlap of included patients with Colli et al 12 Wrobel et al 7 Overlap of included patients with Colli et al 12 Seeburger et al 20 Overlap of included patients with Colli et al 12 and Kiefer et al 21 Kavakli et al 22 Overlap of included patients with Kavakli et al 23…”

Section: Cause Of Exclusionmentioning

confidence: 99%

“…It has gained increasing recognition as a feasible, safe, and effective procedure with minor complications and excellent outcome. 6,7 While the device is approved for clinical use in European countries, it is not yet approved in the United States. Currently, there are two ongoing studies evaluating the performance of the procedure in Germany (ClinicalTrials.gov identifier: NCT04190602) and in the United States (ClinicalTrials.gov identifier: NCT02803957) with expected completion dates at 2027 and 2025, respectively.…”

Section: Introductionmentioning

confidence: 99%

“…The latter technique entails the implantation of artificial chordae on a beating heart under transesophageal echocardiographic guidance. It has gained increasing recognition as a feasible, safe, and effective procedure with minor complications and excellent outcome 6,7 . While the device is approved for clinical use in European countries, it is not yet approved in the United States.…”

Section: Introductionmentioning

confidence: 99%

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Transapical off‐pump mitral valve repair with NeoChord implantation: A systematic review

et al. 2021

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Introduction: Mitral valve repair (MVr) is the gold standard for the treatment of degenerative mitral valve regurgitation (MR). The recently introduced NeoChord DS1000 has gained increasing recognition as a feasible, potentially safe, and effective procedure with minor complications and promising outcomes. This study aims to conduct a systematic review of the published literature that discusses the technical feasibility and outcome of transapical off-pump MVr with NeoChord DS1000 device implantation in the treatment of degenerative MR. Methods: This review was performed according to the PRISMA statement. Databases searched in this review included Pubmed, Web of Science, Scopus, and Cochrane databases for systematic reviews. All English articles on humans reporting isolated MVr using NeoChord DS1000 device were included provided that basic preoperative data, operative specifications, and postoperative mortality and morbidity were reported. Results: This review included six studies comprised 249 patients who had NeoChord mitral procedure. Almost all patients included had severe MR (243/249, 97.6%). Operative success was achieved in 241 out of the 249 patients (96.8%). No intraoperative mortality was reported. Intraoperative arrhythmia was reported in six patients (2.4%) and significant bleeding was reported in eight patients (3.2%). Conclusion: Awaiting more evidence, NeoChord mitral procedure appears to be a promising procedure that can be considered in selected cases.

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“…In selected patients, this technique has been considered as a feasible and effective option with promising short-and mid-term outcomes. [7][8][9][10] A novel ePTFE chordal implantation device, E-Chord (Med-Zenith Medical, Beijing, China), was recently developed in China. This study reports the initial results of this device in porcine model.…”

mentioning

confidence: 99%

Feasibility Study of a Novel Transapical Chordal Implantation System in a Porcine Model

Lu,

Chen,

Yin

et al. 2024

Int. Heart J.

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Transapical beating-heart mitral repair with chordal implantation system has been considered as an alternative treatment for degenerative mitral regurgitation. This study aimed to assess the feasibility and safety of the E-Chord system (Med-Zenith Medical, Beijing, China) for transapical beating-heart mitral valve repair in a porcine model. Artificial chordae were transapically implanted on the mitral valves of 12 anesthetized pigs under epicardial echocardiographic guidance and secured outside the left ventricular apex. The study endpoints included procedural success, device durability, and tissue response to the device. The procedural success rate was 100% (12/12). All animals were implanted with E-Chord in the anterior and posterior leaflets, respectively, and survived uneventfully until euthanized as planned. During the 180-day follow-up, no animal had significant mitral valve dysfunction. The gross observation showed no evidence of anchor detachment and chordal rupture, and there was no obvious damage or changes to mitral leaflets. Microscopic evaluation revealed that the endothelialization of anchor and chordae was completed 90 days after implantation and there was no evidence of chordal rupture, thrombosis, or infection during the 180-day follow-up. The E-Chord system was found to be feasible and safe for heart-beating mitral chordal implantation in a porcine model. The findings of this study suggest that the E-Chord system may be a potential alternative for the treatment of degenerative mitral regurgitation in humans.

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Transapical beating heart mitral valve repair with the NeoChord system: early outcomes of a single-center experience.

Cited by 4 publications

References 25 publications

Transapical off-pump echo-guided mitral valve repair with neochordae implantation mid-term outcomes

Transapical off-pump echo-guided mitral valve repair with neochordae implantation mid-term outcomes

Transapical off‐pump mitral valve repair with NeoChord implantation: A systematic review

Feasibility Study of a Novel Transapical Chordal Implantation System in a Porcine Model

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