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@#Objective To summarize and analyze the preliminary clinical outcomes of the KokaclipTM transcatheter edge-to-edge mitral valve repair system for severe degenerative mitral regurgitation (DMR). Methods This study was a single-arm, prospective, single-group target value clinical trial that enrolled patients who underwent the KokaclipTM transcatheter edge-to-edge repair (TEER) system for DMR in the Department of Heart Surgery of Guangdong Provincial People's Hospital, Guangdong Cardiovascular Institute from June 2022 to January 2023. Differences in the grade of mitral regurgitation (MR) during the perioperative and follow-up periods were compared, and the incidences of adverse events such as all-cause death, thoracotomy conversion, reoperation, and severe recurrence of MR during the study period were investigated. Results The enrolled patient population consisted of 14 (50.0%) females with a mean age of 70.9±5.4 years. Twenty-eight (100.0%) patients were preoperatively diagnosed with typeⅡ DMR, with a prolapse width of 12.5 (11.0, 16.1) mm, a degree of regurgitation 4+ leading to pulmonary venous reflux, and a New York Heart Association cardiac function class≥Ⅲ. All patients completed the TEER procedure successfully, with immediate postoperative improvement of MR to 0, 1+, and 2+ grade in 2 (7.1%), 21 (75.0%), and 5 (17.9%) patients, respectively. Mitral valve gradient was 2.5 (2.0, 3.0) mm Hg. Deaths, thoracotomy conversion, or device complications such as unileaflet clamping, clip dislodgement, or leaflet injury were negative. Twenty-eight (100.0%) patients completed at least 3-month postoperative follow-up with a median follow-up time of 5.9 (3.6, 6.8) months, during which patients had a mean MR grade of 1.0+ (1.0+, 2.0+) grade and a significant improvement from preoperative values (P<0.001). There was no recurrence of ≥3+ regurgitation, pulmonary venous reflux, reoperation, new-onset mitral stenosis, or major adverse cardiovascular events. Twenty-two (78.6%) patients’ cardiac function improved to classⅠorⅡ. Conclusion The domestic KokaclipTM TEER system has shown excellent preliminary clinical results in selected DMR patients with a high safety profile and significant improvement in MR. Additional large sample volume, prospective, multicenter studies, and long-term follow-up are expected to validate the effectiveness of this system in the future.
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Objective:To investigate the effect of instantaneous flow rate on the consistency of diagnostic accuracy of severe degenerative mitral regurgitation (DMR) using proximal isovelocity surface area (PISA).Methods:From June 2019 to June 2021, 75 patients with DMR who underwent echocardiography in Department of Echocardiography of Zhongshan Hospital, Fudan University were prospectively enrolled. The instantaneous flow rate of DMR during the systolic phase was calculated using M-mode PISA(PISA M-mode), and a time-integrated curve was plotted. Regurgitant volume (RVol) and effective regurgitant orifice area (EROA) were calculated by traditional PISA (PISA max), pair PISA (PISA pair), and PISA M-mode, respectively. RVol acquired from cardiac magnetic resonance (CMR) volumetric method in 22 patients of the enrolled patients. The correlation and consistency of RVol acquired between the three PISA methods and CMR were compared. Agreement of diagnostic accuracy of severe mitral regurgitation (sMR) acquired between the three PISA methods and multi-parameter algorithm by American Society of Echocardiography (ASE) was analyzed using Cohen′s Kappa analysis. Results:The curve of instantaneous flow rate of DMR showed unimodal pattern with the peak at mid-late systolic phase. The correlation of RVol acquired between PISA methods and CMR was moderate for PISA max and PISA pair ( r=0.77, 0.80, both P<0.001), whereas PISA M-mode presented strong correlation with CMR ( r=0.87, P<0.001). RVol acquired from PISA max was larger than that of CMR[(69.1±37.1) ml vs (49.0±29.0)ml, P=0.002]. Both PISA max and PISA pair were shown moderate agreement of diagnostic accuracy of sMR with ASE multi-parameters algorithm (RVol: κ=0.496, 0.525, both P<0.001; EROA: κ=0.570, 0.578, both P<0.001), while PISA M-mode presented strong agreement (RVol: κ=0.867 and EROA: κ=0.802, both P<0.001). Conclusions:Based on the unimodal pattern of instantaneous flow rate in patients with DMR, PISA max may significantly overestimate RVol, exposing a significant proportion of patients with DMR to unnecessary MR surgery. PISA M-mode presents better correlation and consistency with CMR on the quantification of RVol compared with PISA max and PISA pair, and may improve the diagnostic accuracy of quantification of sMR using PISA.
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Objective:To quantitatively analyze the static geometric structure and dynamic changes of the mitral annulus(MA) in patients with degenerative mitral regurgitation (DMR) by three-dimensional transthoracic echocardiography.Methods:Thirty-five patients with DMR (both mitral valve prolapse and Barlow) were collected as DMR group in Yunnan Fuwai Cardiovascular Disease Hospital from August 2019 to March 2021, and 42 healthy volunteers were selected as control group during the same period. The mitral annulus area (MAA), mitral annulus perimeter (MAP), mitral annulus anterolateral-posteromedial diameter (DALPM), anteroposterior diameter (DAP), non-planar angle (NPA), mitral annulus height (AH), and the ratio of height to intercommissural diameter (AHCWR) were measured during the late-diastole, early-systole, mid-systole and late-systole, and the systolic change fractions of the above parameters were calculated. The differences of static structure and dynamic change of MA between the two groups were compared, and the characteristics of dynamic change of MA in the whole cardiac cycle were analyzed.Results:Static structure: MAA, MAP, DAP and DALPM in DMR group were higher than those in control group during the whole cardiac cycle, and the differences were statistically significant (all P<0.05). Compared with the control group, the saddle structure in DMR group were flattened in the middle and late contraction stages (AHCWR: 0.17±0.01 vs 0.21±0.01 and 0.15±0.01 vs 0.23±0.01, both P<0.05), while the saddle structure was relatively preserved in the rest of the contraction stage. Dynamic changes: Presystole contraction (MAA, MAP, DAP, DALPM decreased, all P<0.05) were appeared durng the late-diastole and early-systole in the control group, and saddle shape deepened (NPA decreased, AH and AHCWR increased, all P<0.05). Compared with the control group, presystole MA contraction and saddle deepening disappeared in DMR group (there were no significant differences in all MA parameters between late-diastole and early-systole, all P>0.05). The systolic dynamic changes were weaker and impaired when compared with the control group, which showed that the systolic change scores of DALPM, NPA and AHCWR were lower than those of the control group (all P<0.05). There were no statistical differences in the 4 time phases of MA parameters except DAP (all P>0.05). Conclusions:The saddle-shape structure of MA in normal subjects is obvious, and the dynamic change of MA in the cardiac cycle is significant, with obvious contraction before contraction and saddle-shape deepening. The saddle structure of DMR patient is flattened in the middle and late systolic period, and the MA kinetic energy of DMR patient is weakened throughout the cardiac cycle, the contraction phenomenon disappeared before contraction, and the dynamic change of systolic period is impaired to varying degrees.