| Objectives: This study sought to identify the relative anatomical location of implantable cardiac device lead and tricuspid by using Real-time three -Dimensional echocardiography (RT-3DE) and to evaluate the factors that worsen Lead-induced tricuspid regurgitation (LITR) severity post-implantation. In addition, three -dimensional color Doppler echocardiographic quantification indices of tricuspid regurgitation were compared with conventional two-dimensional measures.Method: The subjects were a cohort of 128 consecutive patients who had cardiac devices implanted at the First Affiliated Hospital of Kunming Medical University Cardiovascular Department from October 2016 to March 2017. Conventional two-dimensional echocardiography (2DE) measures were performed before implantation and Real-time 3-Dimensional echocardiography were conducted to identify the relative anatomical location of implantable cardiac device lead and tricuspid. Comprehensive conventional two-dimensional and color Doppler measures was performed by an experienced sonographer using an GE Vivid E9 equipped with M5S and 4 V transducer and digital loops were stored and analyzed offline with Echo PAC software.TR severity was quantified based on vena contracta width (VCW),proximal isovelocity surface area radius (PISA) jet area/ right atrial area (JA/RAA)and three-Dimensional vena contracta area(3D VCA)according to published guidelines.Statistical significance was defined as p<0.05. Statistical analysis was performed using SPSS Statistics version 22.0.Results:1. October 2016 to March 2017,A total of 143 inpatients that had cardiac devices implanted were performed comprehensive 2DE and RT-3DE. Care was taken during offline analysis to optimally depict the course of the device lead at the level of the tricuspid valve leaflets, resulting in exclusion of 15 of 143 patients due to inadequate image quality. Eventually, we included in 128 patients (58 patients of male, 70 female,age 57.22± 15.93 years).Among them,77 patients with permanent pacemaker (PPM),32 patients with implantable cardioverter defibrillator (ICD) and 19 patients with cardiac resynchronization therapy (CRT). Right ventricular apical and non-apical pacing was 59 vs. 69 cases. Subjects were clarified into two groups based on the relative anatomical location of implantable cardiac device lead and tricuspid: Interfering lead group 49 patients (male 23 patients, age 58±15 years)vs. Noninterfering lead group 79 patients (male 35 patients,age 56± 16 years).The mean time between the RT-3DE examination and device lead placement was 57.21 ±29.42 months.2. In our study, the device leads position was evaluated at the tricuspid annular level using RT-3DE. Among the Interfering lead group: the lead impinged on the P leaflet in 10 patients, impinged on the S leaflet in 35 patients and impinged on the A leaflet in 4 patients; Among the Noninterfering lead group: the device leads were located in the commissure of two leaflets, the majority of the leads were in PS (n=37),6 leads were in AS and 5 leads were in AP, 24 patients showed device leads in the middle of the tricuspid orifice. The RT-3DE images were analyzed offline by two independent observers,The observers agreed on the lead position at the tricuspid annular level in 115 of 128, patients Disagreements were between S vs. SP (8 cases), P vs. SP (5 cases).The observation agreement and Kappa value was 89.8% and 0.802?respectively.3. Comparation of echocardiograms between pre-and post-implantation:Parameters were significantly increased after pacemaker procedures included RV end-diastolic or end-systolic area, RA mid-dimension, RV transverse or mid-dimension, tricuspid annular diameter and VCW had increased by 1.51 ±0.16cm2(p=0.001 ),1 . 16 ± 0.14cm2 (p=0.001 ),0.09 ± 0.04cm(p=0.030),0.27 ± 0.04cm(p=0.001),0.25 ± 0.03cm(p=0.001 ),0.07 ± 0.02cm(p=0.002) and 0.15 ± 0.02cm(p=0.001)respectively. Of note,RV fractional area change was worsen by 1.79 ± 0.59%(p=0.003).4. Comparation of echocardiograms between Interfering lead group and Noninterfering lead group: There were no significant intergroup differences on pre-implantation echocardiograms (p>0.05). On the post-implantation echocardiograms,in the Interfering lead group: the VCW was larger 0.46±0.21 vs. 0.27± 0.20 cm(p=0.001), as were the RV end-systolic area,RV fractional area change, RV Tei index and tricuspid annular diameter: 12.74±2.65 vs. 11.30±2.67cm2(p=0.004),41.42±9.63 vs. 46.81 ±9.52 cm2(p=0.006),46.12± 11.89 vs. 40.05± 12.09%(p=0.006),2.59+ 0.38 vs. 2.35 + 0.59 cm(p=:0.016),respectively; Of note, other conventional two-dimensional parameters, including LVEF, RA size were similar between Interfering lead group and Noninterfering lead group.5. TR worsening after device implantation: TR severity was quantified based on VCW according to published guidelines. 35% of patients had different grades of TR pre-implantation, 63 patients(49%) had worsening in TR severity by ?1 grade after device lead placement. Of note, 12 patients decreased TR severity by?1 grade.For bivariate analysis for post-implantation worsening in TR severity, the change of tricuspid annular diameter and RV transverse-dimension associated with the TR worsening after device lead implantation, r=0.204(p=0.021) and r=0.180(p=0.042),respectively. Similarly, the age of the device lead, the pre- implantation RA mid-dimension and lead-leaflet interference significantly associated with the TR worsening after device lead implantation. r=0.197(p=0.026), r=0.195(p=0.027),r=0.486(p=0.001),respectively. Using a univariable logistic regression analysis: the age of the device lead, pre-device RA mid-dimension and lead-leaflet interference are factors associated with TR worsening (p<0.05); Further, Using a multivariate stepwise logistic regression analysis, the presence of an interfering lead was the only factor associated with TR worsening OR=8.863 (95% CI: 3.639-21.585; p=0.001).6. Evaluation on 2DE/RT-3DE TR index: conventional two-dimensional TR measures including VCW, 2D EROA, and JA/RAA associated with 3D VCA: r=0.753(p<0.001), r=0.875(p<0.001), r=0.354(p<0.001), respectively. The Bland-Altman analysis showed that mean 3D VCA was similar to 2D EROA: the bias was(-0.09 ±0.15)cm2 and most patients fell within agreements zone ranged from(-0.39-0.21) cm2. In addition, ROC curves of 3D VCA was made for severe TR determination. The area under the curve for 3D VCA was 0.92 (95%CI:0.799 -0.923 ;p=0.001) demonstrating good accuracy of 3D color Doppler echocardiographic measures in the determination of severe TR defined by 2D EROA? 0.4cm2. The cutoff for 3D VCA was 0.55cm2 with sensitivity of 82% and specificity of 88% in predicting severe TR.Conclusions:1. RT-3DE can straightforward visualize tricuspid valves on one plane simultaneously,which facilitate identifying the relative anatomical location of implantable cardiac device lead and tricuspid ,as were the relationship between lead location and LITR.RT-3DE have the advantages of facilitation, visualization and good repeatability compared with conventional two-dimensional measures.2. Our study also aimed to explore the factors caused post-implantation worsening LITR, in bivariate analysis and logistic regression analysis: the change of tricuspid annular diameter and RV transverse-dimension, similarly, the age of the device lead pre-divce RA mid-dimension and lead-leaflet interference significantly associated with the TR worsening after device lead implantation. In addition, an interfering lead would dramatically increase the likelihood of worsening TR by a factor of 8.8.3. Finally, the aim of this study was to examine the utility and feasibility of directly measured 3D VCA compared with conventional two-dimensional TR measures including VCW,2D EROA,JA/RAA, it suggested that the cutoff for 3D VCA 0.55cm2 has good accuracy in determining severe TR. |
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