Interventional procedure overview of off-pump minimal access mitral valve repair by artificial chordae insertion to treat mitral regurgitation
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Appendix B: Other relevant studies
Other potentially relevant studies that were not included in the main evidence summary (tables 2 and 3) are listed in table 5 below.
Study | Number of people and follow up | Direction of conclusions | Reason study was not included in main evidence summary |
|---|---|---|---|
Brown A, Jefferson HL, Fatehi Hassanabad A, Noss C, Webb N, Fedak PW, Kent WD, Adams C. (2023) Echocardiographic and clinical outcomes following beating heart NeoChord DS1000 mitral valve repair: a single centre case series. Frontiers in Cardiovascular Medicine.10:1160979. | Prospective case series n=10 Follow-up: 6 weeks | All patients had severe chronic MR and normal left ventricular function. At 1 month follow-up echocardiography, MR was graded from trivial to moderate and left ventricular inner diameter dimensions decreased from an average of 5.4 ± 0.4 cm to 4.6 ± 0.3 cm. The early surgical outcomes suggest this approach is feasible, safe, and effective in reducing MR. | Larger and more relevant studies included in the summary of the key evidence. |
Colli A, Besola L, Bizzotto E, Fiocco A, Denas G, Bellu R, Pradegan N, Nadali M, Gregio A, Pittarello D, Gerosa G. (2019) Mechanisms of recurrent regurgitation after transapical off-pump mitral valve repair with neochord implantation. European Journal of Cardio-Thoracic Surgery. 56(3):479-87. | Retrospective case series n=52 | Possible mechanisms of recurrent MR were identified as: patient selection (17%), technical issues (29%), progression of baseline disease (15%), left ventricle reverse remodelling (2%), excessive over-tensioning (36%) and posterior mitral leaflet curling (31%). The mechanisms of recurrent MR after the NeoChord procedure can be used to formulate prevention strategies. | Studies with more relevant outcomes included in the summary of key evidence. |
Gonçalves-Teixeira P, Costa S, Martins D, Neves P, Ribeiro J. (2021) Transapical off-pump mitral valve repair with NeoChord™ implantation: An early single-center Portuguese experience. Revista portuguesa de cardiologia. 40(12):933-41. | Prospective case series n=18 Median follow up: 194 days | Successful repair, defined by none, trace or mild mitral regurgitation, by implantation of two to four neochordae,was achieved in all 18 patients. No major complications arose intra-procedurally In selected patients, minimally invasive mitral valve repair using the NeoChord system is safe, effective and reproducible. | Larger and more relevant studies included in the summary of the key evidence. |
Manzan E, Azzolina D, Gregori D, Bizzotto E, Colli A, Gerosa G. (2021) Combining echocardiographic and anatomic variables to predict outcomes of mitral valve repair with the NeoChord procedure. Annals of cardiothoracic surgery. 10(1):122. | Prospective case series n=91 Follow up: 2 years | A nomogram was developed to predict the probability of mild or less MR at follow-up. NeoChord mitral valve repair prediction tool would be helpful in clinical decision-making and in the identification of patients who may benefit from a ringless mitral valve repair using the NeoChord procedure. | Studies with more relevant outcomes included in the summary of key evidence. |
Gammie JS, Bartus K, Gackowski A, D'Ambra MN, Szymanski P, Bilewska A, Kusmierczyk M, Kapelak B, Rzucidlo-Resil J, Moat N, Duncan A. (2018) Beating-heart mitral valve repair using a novel ePTFE cordal implantation device: a prospective trial. Journal of the American College of Cardiology. 71(1):25-36. | Prospective multicentre case series n=30 Follow up: 6 months | At 1 month, MR was mild or less in 89% and was moderate in 11%. At 6 months, MR was mild or less in 85 %, moderate in 8%, and severe in 8%. MVRS ePTFE cordal implantation can reduce the invasiveness and morbidity of conventional MV surgery. The device's safety profile is promising. | Harpoon system used, device has been discontinued. Studies with NeoChord DS1000 included in the summary of key evidence. |
Gammie JS, Wilson P, Bartus K, Gackowski A, Hung J, D'Ambra MN, Kolsut P, Bittle GJ, Szymanski P, Sadowski J, Kapelak B. (2016) Transapical beating-heart mitral valve repair with an expanded polytetrafluoroethylene cordal implantation device: initial clinical experience. Circulation. 134(3):189-97. | Prospective feasibility trial n=11 Mean follow up: 186 days | Eleven patients with posterior leaflet prolapse and severe MR were treated with 100% procedural success. Immediate postprocedural mean MR grade was trace. At 1 month, the mean MR grade was mild with significant decreases in end-diastolic volume This MV repair technique demonstrates a significant reduction in MR with favourable left ventricular and left atrial reverse remodelling. This approach has the potential to decrease invasiveness and surgical morbidity | Harpoon system used, device has been discontinued. Studies with NeoChord DS1000 included in the summary of key evidence |
Gammie JS, Bartus K, Gackowski A, Szymanski P, Bilewska A, Kusmierczyk M, Kapelak B, Rzucidlo-Resil J, Duncan A, Yadav R, Livesey S. (2021) Safety and performance of a novel transventricular beating heart mitral valve repair system: 1-year outcomes. European Journal of Cardio-Thoracic Surgery. 59(1):199-206. | Prospective multicentre case-series n=62 Follow up: 1 year | 95% of people achieved technical success. At 1 year, 98% of the patients with HARPOON cords were in New York Heart Association class I or II, and mitral regurgitation was none/trace in 52%, mild in 23%, moderate in 23% and severe in 2%. | Harpoon system used, device has been discontinued. Studies with NeoChord DS1000 included in the summary of key evidence. |
Vairo A, Gaiero L, Marro M, Russo C, Bolognesi M, Soro P, Gallone G, Fioravanti F, Desalvo P, D'Ascenzo F, Alunni G. (2023) New echocardiographic parameters predicting successful trans-ventricular beating-heart mitral valve repair with neochordae at 3 years: Monocentric retrospective study. Journal of Clinical Medicine. 12(5):1748. | Retrospective case series n=72 Median follow up: 34 months | At follow-up, MR > moderate was found in 24.6% of people. Annular dysfunction parameters were the best predictors of procedural success: 3D early-systolic annulus area, 3D early-systolic annulus circumference, and 3D annulus area fractional change. | Studies with more relevant outcomes included in the summary of key evidence. |
Wang S, Meng X, Hu S, Sievert H, Xie Y, Hu X, Sun Y, Luo Z, Zhou H, Zhang G, Pan X. (2022) Initial experiences of transapical beating‐heart mitral valve repair with a novel artificial chordal implantation device. Journal of Cardiac Surgery. 37(5):1242-9. | Prospective feasibility trial n=10 Follow up: 1 year | MR reduced from severe to none or trace in five patients, and mild in five patients before discharge. The safety and efficacy endpoint were achieved in all patients at 1‐month follow‐up. At 1‐year follow‐ up, six patients had mild MR, three patients had moderate MR, one patient had recurrence of severe MR and underwent surgical repair. | Mitralstitch system used, device not used in the UK. Studies with NeoChord DS1000 included in the summary of key evidence. |
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