Aim. To make the first clinical experience evaluation of the new biological closed support ring for mitral valve.Methods. 26 patients (16 men, 10 women, mean age 55 [49; 62] years) with dysplastic mitral insufficiency were implanted “NEORING” biological ring for the first time from March 2020 to June 2021. The etiological factor of the defect formation in all cases was the connective tissue dysplasia. The mean functional class of heart failure before surgery was 2 [2; 3] according to NYHA, the effective regurgitant orifice (ERO) was 0.4 [0.3; 0.5], vena contracta was 0.7 [0.6; 0.8]. Ten patients received rings of 28 mm diameter, ten patients – 30 mm, six patients – 32 mm.Results. No significant adverse events such as death from any causes, strokes, myocardial infarction, cardiac complications, bleeding, and return of regurgitation or failure of plastic surgery requiring reoperation, infective endocarditis after the intervention were observed. In two cases a permanent pacemaker was implanted due to sinus node dysfunction. At discharge all patients had no regurgitation (ERO 0), medium transvalvular gradient was 4.0 [3.0; 5.3] mm Hg. All the patients were assigned to NYHA functional class I heart failure after the surgery.Conclusion. New biological support ring “NEORING” (“NeoKor”, Kemerovo) use in the middle age group of patients showed high hemodynamic efficiency, the absence of specific complications in the early stages after the surgery. It is planned to expand the clinical material on the use of the biological ring, as well as to evaluate the long-term results in the format of a prospective, randomized trial and compare the new device with the existing ones.

Highlights. For the first time, as part of a prospective randomized study, a comparative assessment of the mid-term results of mitral valve annuloplasty using a new biological NeoRing ring (CJSC NeoKor, Kemerovo) and a RIGID ring (CJSC NPP MedInzh, Penza) in patients with connective tissue dysplasia was carried out. Predictors of the conversion of sinus rhythm to atrial fibrillation and residual mitral insufficiency in the medium-term follow-up period were determined.Aim. To analysis and compare mid-term results of mitral valve annuloplasty conducted using NeoRing и RIGID rings.Methods. From November 2019 to March 2022, 62 patients with mitral valve (MV) dysplasia underwent MV annuloplasty using NeoRing semi-rigid rings (CJSC NeoKor, Kemerovo, n = 31) and rigid RIGID rings (CJSC NPP MedInzh, Penza, n = 31). There were no differences between the groups at baseline.Results. Two deaths were registered during inpatient treatment in the RIGID group. Both devices showed a satisfactory outcome during inpatient treatment in the form of restoration of MV function (p<0.001) and the frequency of detected maximum residual mitral regurgitation (MR) up to grade 1 in the NeoRing group 9.7% and in the RIGID group 29%, respectively, no statistically significant intergroup differences were noted (p = 0.292). After 12 months, freedom from ≥2 grade MR in the NeoRing group was 93.5% and 77.4% in the RIGID group (p = 0.147). In the RIGID group, patients had higher values of the transvalvular mitral diastolic gradient – PAV 3.70 [3.00–4.40] mm Hg vs. NeoRing group 2.3 [2.05–2.85] mmHg (p<0.001), as well as a higher transvalvular flow rate – VAV 79 [71–94] cm/sec vs. 70 [64–79] cm/sec (p = 0.017). The analysis of the achievement of composite primary endpoint (recurrence of ≥2 grade MR, MACCE, new onset arrhythmias, reoperations) by the device was carried out. The composite endpoint rate in the RIGID group was 3.067 times higher compared to the NeoRing group, odds differences were statistically significant (p = 0.037, 95% CI: 1.053–8.934).Conclusion. The outcome of MV annuloplasty conducted using rigid and semi-rigid rings revealed no significant differences in long-term survival and recurrence of MR between groups. Given the statistically significant difference in achieving the combined endpoint, lower inpatient and long-term indicators of transmitral pressure gradient, and a positive effect on cardiac chambers reverse remodeling, it was concluded that the use of semi-rigid NeoRing rings for MV annuloplasty when performing valvepreserving operations for connective tissue dysplasia is preferable.

В данной работе проведена оценка эффективности применения новых полужестких биологических опорных колец «НеоКор» при коррекции вторичной недостаточности трикуспидального клапана. Выполнен анализ госпитального периода 310 случаев хирургического лечения пациентов с приобретенными пороками левых отделов сердца с сочетанной вторичной недостаточностью трикуспидального клапана. Статистически значимые различия получены для таких показателей, как снижение систолического давления в легочной артерии с 50 (41; 60) до 33 (28; 38) мм рт.ст. [МЕ (Q1; Q3), p<0,001], снижение степени трикуспидальной регургитации с 2,7±0,8 до 0,4±0,6 (р<0,05). Эхокардиографические показатели гемодинамики трикуспидального клапана после аннулопластики следующие: медиана скорости кровотока составила 63 (50; 72) см/с, медиана диастолического градиента 2 (1,5; 2,7) мм рт.ст. При использовании колец 32, 34 и 36-го размера -2,1 (1,7; 2,8), 1,9 (1,4; 2,6) и 1,3 (1,2; 2,1) мм рт.ст. соответственно. Таким образом, применение новых биологических опорных колец для аннулопластики трикуспидального клапана производства ЗАО «НеоКор» (г. Кемерово) приводит к значимому снижению степени регургитации при невысоком градиенте давления и отсутствию специфических осложнений.Финансирование. Исследование не имело спонсорской поддержки.