Left Bundle Branch Area Defibrillator (LBBAD): A First-in-Human Feasibility Study.

BACKGROUND: Left bundle branch area (LBBA) pacing is a promising pacing technique. LBBA implantable cardioverter-defibrillator (ICD) lead implantation reduces the number of leads in patients with both pacing and ICD indications, reducing cost and potentially increasing safety. LBBA positioning of ICD leads has not previously been described. OBJECTIVES: The goal of this study was to evaluate the safety and feasibility of implanting an LBBA ICD lead. METHODS: This prospective, single-center, feasibility study was conducted in patients with an ICD indication. LBBA ICD lead implantation was attempted. Acute pacing parameters and paced electrocardiography data were collected, and defibrillation testing was performed. RESULTS: LBBA defibrillator (LBBAD) implantation was attempted in 5 patients (mean age 57 ± 16.5 years; 20% female) and achieved in 3 (60%). Mean procedural and fluoroscopy duration were 170.0 ± 17.3 minutes and 28.8 ± 16.1 minutes, respectively. Left bundle capture was achieved in 2 patients (66%) and left septal capture in 1 patient. LBBA pacing exhibited a mean QRS duration and V6 R-wave peak time of 121.3 ± 8.3 milliseconds and 86.1 ± 10.0 milliseconds. In all 3 patients, defibrillation testing was successful with mean time to adequate shock delivery of 8.6 ± 2.6 seconds. Acute LBBA pacing threshold and R-wave amplitudes were 0.80 ± 0.60 V at 0.4 milliseconds and 7.0 ± 2.7 mV. No LBBA lead-related complications occurred. CONCLUSIONS: This first-in-human evaluation showed the feasibility of LBBAD implantation in a small cohort of patients. With current tools, implantation remains complex and time-consuming. Considering the feasibility reported and the potential benefits, further technological development in this field is warranted with evaluation of long-term safety and performance.

Non-invasive assessment of ventricular electrical heterogeneity to optimize left bundle branch area pacing.

BACKGROUND: Left bundle branch area pacing (LBBAP) is a novel therapeutic option for bradycardia and heart failure patients. ECG belt is a novel technology for assessment of ventricular electrical heterogeneity (VEH) using multi-electrode ECG. A metric of overall VEH based on standard deviation of activation times (SDAT) from all electrodes in the ECG belt has been previously shown to predict cardiac resynchronization therapy (CRT) response. The aim of the study is to evaluate non-invasive assessment of VEH using ECG belt to optimize LBBAP. METHODS: VEH from a 40-electrode ECG belt was characterized in 20 patients (male 15, EF 33 ± 13%, NYHA class 3.05 ± 0.6; CRT indication 18) during LBBAP (20) and LBBAP-Optimized CRT (LOT-CRT-7), anodal capture (16), NS-LBBP (18), S-LBBP (5), LVSP (9). In addition to SDAT, regional (LV/RV) VEH was assessed with average left ventricular activation times (LVAT), SDAT of left-sided (LV dispersion) and right-sided (RV dispersion) electrodes. Optimal LBBAP was determined based on maximal SDAT and QRS duration (d) change. RESULTS: All metrics were significantly reduced (p < 0.0001 for ECG belt metrics, p = 0.0027 for QRSd) during LBBAP and LOT-CRT compared to intrinsic. QRSd, SDAT, LVAT, and LV and RV dispersion during optimal LBBAP were significantly lower (133 ± 20/157 ± 24; 20.5 ± 7.5/38.6 ± 9; 44.4 ± 14.3/61.4 ± 21; 11.6 ± 11.6/29.5 ± 15; 21.1 ± 7.8/42.5 ± 9.3; p < 0.0001) compared to intrinsic rhythm. However, they were not significantly different among selective, non-selective, anodal, and LV septal captures. EF and NYHA class improved to 46 ± 11% and 1.9 ± 0.6 (p < 0.001). CONCLUSIONS: LBBAP significantly reduced overall and regional (RV/LV) VEH, irrespective of the mechanism of capture. Detailed assessment of electrical heterogeneity using ECG belt may add valuable insights on effects of LBBAP. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04583709.

Ventricular activation pattern assessment during right ventricular pacing: Ultra-high-frequency ECG study.

BACKGROUND: Right ventricular (RV) pacing causes delayed activation of remote ventricular segments. We used the ultra-high-frequency ECG (UHF-ECG) to describe ventricular depolarization when pacing different RV locations. METHODS: In 51 patients, temporary pacing was performed at the RV septum (mSp); further subclassified as right ventricular inflow tract (RVIT) and right ventricular outflow tract (RVOT) for septal inflow and outflow positions (below or above the plane of His bundle in right anterior oblique), apex, anterior lateral wall, and at the basal RV septum with nonselective His bundle or RBB capture (nsHBorRBBp). The timings of UHF-ECG electrical activations were quantified as left ventricular lateral wall delay (LVLWd; V8 activation delay) and RV lateral wall delay (RVLWd; V1 activation delay). RESULTS: The LVLWd was shortest for nsHBorRBBp (11 ms [95% confidence interval = 5-17]), followed by the RVIT (19 ms [11-26]) and the RVOT (33 ms [27-40]; p < .01 between all of them), although the QRSd for the latter two were the same (153 ms (148-158) vs. 153 ms (148-158); p = .99). RV apical capture not only had a longer LVLWd (34 ms (26-43) compared to mSp (27 ms (20-34), p < .05), but its RVLWd (17 ms (9-25) was also the longest compared to other RV pacing sites (mean values for nsHBorRBBp, mSp, anterior and lateral wall captures being below 6 ms), p < .001 compared to each of them. CONCLUSION: RVIT pacing produces better ventricular synchrony compared to other RV pacing locations with myocardial capture. However, UHF-ECG ventricular dysynchrony seen during RVIT pacing is increased compared to concomitant capture of basal septal myocytes and His bundle or proximal right bundle branch.

The Mitral Coaptation to Ventricular Septal Space: Two- and Three-Dimensional Transesophageal Echocardiographic Assessment.

OBJECTIVES: To assess the dimensions and changes in the CSEPT (space between the ventricular septum and mitral coaptation point) before and after cardiopulmonary bypass (CPB) and to compare patients with and without aortic valve stenosis (AS) undergoing cardiac surgery. DESIGN: Retrospective review of intraoperative transesophageal echocardiographic examinations. SETTING: Single academic medical center. PARTICIPANTS: The study comprised 91 elective cardiac surgical patients-30 with AS scheduled for aortic valve replacement and 61 without AS (non-AS). INTERVENTIONS: Two- and 3-dimensional (2D and 3D) analysis of the CSEPT before and after CPB. MEASUREMENTS AND MAIN RESULTS: Assessment of the CSEPT distances and areas was performed using 2D and 3D imaging before and after CPB. Two-dimensional measures of CSEPT distances were performed using midesophageal 5-chamber and long-axis windows. Three-dimensional measures were performed offline using multiplanar reconstruction. The CSEPT space was smaller after CPB (p < 0.01). Before and after CPB, the midesophageal 5-chamber and long-axis windows were similar to each other, and both were larger than the pre-CPB 3D CSEPT distance. Patients with AS had smaller before and after CPB distances and areas compared with non-AS patients (p < 0.05). The change in CSEPT area in AS patients was 24%. CONCLUSIONS: The CSEPT space is smaller after CPB and more so for patients with AS undergoing aortic valve replacement. Two-dimensional CEPT distances vary compared with 3D CSEPT distances. Additional study using Doppler analysis will elucidate the added value of 3D assessment of the CSEPT space.

Comprehensive Functional Echocardiographic Assessment of Transposition of the Great Arteries: From Fetus to Newborn.

To improve the understanding of the pathophysiology of transposition of the great arteries with intact ventricular septum (TGA/IVS) and the cardiac remodeling occurring from fetal to neonatal life, we performed a morphometric and functional echocardiographic assessment in fetuses and newborns. This was a prospective case-control study performed in a tertiary referral center, which included fetuses and newborns with a diagnosis of TGA/IVS between 2011 and 2018. Morphometry and systolic and diastolic function parameters were compared with age and body surface-matched healthy controls. Twenty-one TGA/IVS patients were included during the study period and morphometric and functional echocardiographic data were recorded. TGA/IVS patients showed morphometric and functional changes of increased overall volume and output, predominantly in the aortic component from fetus to newborn, probably due to compensatory mechanisms secondary to brain hypoxia.

Importance of Preoperative Computed Tomography Assessment of the Membranous Septal Anatomy in Patients Undergoing Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve.

BACKGROUND: Cardiac conduction disturbance (CD) is the most frequent complication following transcatheter aortic valve replacement (TAVR). This study examined whether the anatomy of the membranous septum (MS) could provide useful information about the risk of CD following TAVR with a balloon-expandable valve (BEV).Methods and Results:Among 132 consecutive patients, 106 (mean age, 85.6±5.1 years; 75 females) were included in the study. Using preoperative CT and angiography, MS length and implantation depth (ID) were assessed. The MS length minus the prosthesis ID was calculated (∆MSID). Correlation between CD, defined as new-onset left-bundle branch block (LBBB) or the need for permanent pacemaker (PPM) within 1 week after the procedure, and MS length were evaluated. A total of 19 patients (18%) developed CD following TAVR. MS length was significantly shorter in these patients than in those without CD (5.3±1.3 vs. 6.6±1.4; P<0.001), and was the important predictor of CD (odds ratio [OR]: 0.43, 95% confidence interval [CI]: 0.27-0.69, P<0.001). When considering the pre- and postprocedural parameters, the ∆MSID was smaller in patients with CD (-1.7±1.5 vs. 0.8±1.9, P<0.001), and emerged as the important predictor of CD (OR: 0.47, 95% CI: 0.33-0.69, P<0.001). CONCLUSIONS: Short MS is associated with an increased risk of CD after TAVR with BEV.

Magnetic Resonance Imaging in Assessment of Cardiac Remodeling in Rats with Experimental Arterial Hypertension.

Magnetic resonance imaging was employed to examine the morphofunctional status of myocardium in Wistar rats with multifactor cardiovasorenal model of arterial hypertension. In 3 months after the onset of experiment, the rats demonstrated a pronounced hypertrophy in left ventricular myocardium mostly due to thickening of the posterior and lateral walls against the background of relatively stable thickness of ventricular septum. The left ventricular endsystolic volume markedly increased in parallel with moderate increase of the end-diastolic volume. The standard calculated indices were used for precise assessment of the type of remodeling of individual myocardial structures. The study showed that multifactor arterial hypertension model was characterized by domination of hypertrophic mode of the left ventricular remodeling, whereas the concentric variant was observed more rarely by 2.5 times. The greatest alterations were observed in the posterior and lateral walls of the left ventricle, which could result from the hemodynamic effects of hypervolemic arterial hypertension.

Should the septum be included in the assessment of right ventricular longitudinal strain? An ultrasound two-dimensional speckle-tracking stress study.

Right ventricular longitudinal strain (RVLS) by 2D speckle-tracking echocardiography (2D-STE) is a useful parameter for assessing systolic function. However, the exact method to perform it is not well defined as some authors evaluate only free wall (FW) segments while others include all six RV segments. To compare the assessment of RVLS at rest and during exercise by these two approaches. Echocardiography was performed on 80 healthy subjects at rest and during exercise. The analysis consisted of standard and 2D-STE assessment of RV global and segmental strain tracing only RVFW and also tracing all six RV segments. At rest, RVLS could be assessed in 78 (feasibility 97.5%) subjects by both methods. However, during exercise, RVLS by RVFW method was feasible in 67 (83.8%) as compared to 74 (92.5%) by RV6S approach. Both at rest and during exercise, RVLS values by the two methods showed excellent correlation (r = > 0.90). However, RVLS values assessed by RV6S were lower (absolute values) than those by RVFW approach (RV6S vs. RVFW; rest: - 27.0 ± 3.9 vs. - 9.5 ± 3.9, p < 0.001 and exercise: - 30.7 ± 5.2 vs. - 33.3 ± 5.1, p < 0.001). Furthermore, basal strain was higher and apical strain lower (absolute values) by RV6S approach. At rest, reproducibility for RVLS was excellent and similar for the two methods. However, during exercise, reproducibility for RVFW method was poorer, especially at the apex. The two currently described methods for RVLS assessment by 2D-STE demonstrated excellent agreement. However, the RV6S approach seemed to be more feasible and reproducible, particularly during exercise. Moreover, global and segmental strain values are different with both methods and should not be interchanged.

Assessment of Subclinical Cardiac Alterations and Atrial Electromechanical Delay by Tissue Doppler Echocardiography in Patients with Nonfunctioning Adrenal Incidentaloma / Avaliação de Alterações Cardíacas Subclínicas e Atraso Eletromecânico Atrial por Ecocardiografia com Doppler Tecidual em Pacientes com Incidentaloma Adrenal Não Funcionante

Abstract Background: Majority of the incidentally discovered adrenal masses, called adrenal incidentaloma (AI), are nonfunctioning adrenal adenomas. The appropriate management of AI is still a matter debate, so it is necessary to investigate their associated morbidity. However, data regarding morphological and functional cardiac alterations are limited in this group. Objective: In this study, we aimed to assess cardiac structural and functional characteristics and atrial conduction properties in patients with nonfunctioning AI. Methods: Thirty patients with nonfunctioning AI and 46 properly matched control subjects were included in the study. After hormonal and biochemical analysis, all participants underwent transthoracic echocardiography to obtain systolic and diastolic parameters of both ventricles, in addition to atrial conduction times by tissue Doppler echocardiography. Data were analyzed with Statistical Package for the Social Sciences (SPSS, Chicago, IL, United States) statistics, version 17.0 for Windows. P < 0.05 was considered statistically significant. Results: Left ventricular (LV) mass index and LV myocardial performance index were significantly increased in AI group. Among atrial conduction times, both intra- and interatrial electromechanical delays were significantly prolonged in patients with nonfunctioning AI. Other laboratory and echocardiographic findings were similar between groups. Conclusion: Our study revealed that intra- and inter-atrial conduction times were prolonged, and LV mass index was increased in patients with nonfunctioning AI. These findings may be markers of subclinical cardiac involvement and tendency to cardiovascular complications. Close follow-up is necessary for individuals with nonfunctioning AI for their increased cardiovascular risk.

Resumo Fundamento: A maioria das massas adrenais descobertas incidentalmente, denominadas incidentaloma adrenal (IA), são adenomas adrenais não funcionantes. O manejo adequado da IA ainda é um tema de debate, e por isso é necessário investigar suas morbidades associadas. Entretanto, dados referentes a alterações cardíacas morfológicas e funcionais são limitados nesse grupo. Objetivo: Neste estudo, objetivamos avaliar as características estruturais e funcionais cardíacas e as propriedades de condução atrial em pacientes com IA não funcionante. Métodos: Trinta pacientes com IA não funcionante e 46 controles adequadamente pareados foram incluídos no estudo. Após análise hormonal e bioquímica, todos os participantes foram submetidos a ecocardiograma transtorácico para obtenção de parâmetros sistólicos e diastólicos de ambos os ventrículos, além dos tempos de condução atrial pelo ecocardiograma com Doppler tecidual. Os dados foram analisados com o Statistical Package for the Social Sciences (SPSS, Chicago, IL, Estados Unidos), versão 17.0 para Windows. P < 0,05 foi considerado estatisticamente significativo. Resultados: O índice de massa do ventrículo esquerdo (VE) e o índice de desempenho miocárdico do VE foram significativamente aumentados no grupo IA. Entre os tempos de condução atrial, os atrasos eletromecânicos intra- e interatriais foram significativamente prolongados em pacientes com IA não funcionante. Outros achados laboratoriais e ecocardiográficos foram semelhantes entre os grupos. Conclusão: Nosso estudo revelou que os tempos de condução intra- e interatrial estavam prolongados e o índice de massa do VE estava aumentado em pacientes com IA não funcionante. Esses achados podem ser marcadores de envolvimento cardíaco subclínico e de tendência a complicações cardiovasculares. Um acompanhamento rigoroso é necessário para indivíduos com IA não funcionante, devido ao aumento do risco cardiovascular.

Assessment of Subclinical Cardiac Alterations and Atrial Electromechanical Delay by Tissue Doppler Echocardiography in Patients with Nonfunctioning Adrenal Incidentaloma.

BACKGROUND: Majority of the incidentally discovered adrenal masses, called adrenal incidentaloma (AI), are nonfunctioning adrenal adenomas. The appropriate management of AI is still a matter debate, so it is necessary to investigate their associated morbidity. However, data regarding morphological and functional cardiac alterations are limited in this group. OBJECTIVE: In this study, we aimed to assess cardiac structural and functional characteristics and atrial conduction properties in patients with nonfunctioning AI. METHODS: Thirty patients with nonfunctioning AI and 46 properly matched control subjects were included in the study. After hormonal and biochemical analysis, all participants underwent transthoracic echocardiography to obtain systolic and diastolic parameters of both ventricles, in addition to atrial conduction times by tissue Doppler echocardiography. Data were analyzed with Statistical Package for the Social Sciences (SPSS, Chicago, IL, United States) statistics, version 17.0 for Windows. P < 0.05 was considered statistically significant. RESULTS: Left ventricular (LV) mass index and LV myocardial performance index were significantly increased in AI group. Among atrial conduction times, both intra- and interatrial electromechanical delays were significantly prolonged in patients with nonfunctioning AI. Other laboratory and echocardiographic findings were similar between groups. CONCLUSION: Our study revealed that intra- and inter-atrial conduction times were prolonged, and LV mass index was increased in patients with nonfunctioning AI. These findings may be markers of subclinical cardiac involvement and tendency to cardiovascular complications. Close follow-up is necessary for individuals with nonfunctioning AI for their increased cardiovascular risk.

Incremental value of live/real time three-dimensional transesophageal echocardiography in the assessment of ventricular septal rupture following acute myocardial infarction.

Ventricular septal rupture is a serious complication following acute myocardial infarctions and is associated with a significant mortality rate. Classically, two-dimensional transthoracic echocardiography has been used to diagnose this complication and visualize its location. Two-dimensional transesophageal echocardiography has supplemented the transthoracic approach by providing more accurate assessment of the defect size and in guiding closure both percutaneously and intraoperatively. This modality, however, is limited to two-dimensional views only, and a greater breadth of information is instead available through the use of three-dimensional transesophageal echocardiography. We present a series of 11 patients in which live/real time three-dimensional transesophageal echocardiography offered incremental benefits over two-dimensional imaging alone.

Native T1 mapping and extracellular volume fraction measurement for assessment of right ventricular insertion point and septal fibrosis in chronic thromboembolic pulmonary hypertension.

OBJECTIVES: The aim of this study was to assess septal and right ventricular insertion point (RVIP) fibrosis in patients with chronic thromboembolic pulmonary hypertension (CTEPH) via native T1 mapping and extracellular volume fraction (ECV) determination and to analyze correlations with functional parameters. METHODS: Imaging was performed at 1.5 Tesla in 24 patients diagnosed with CTEPH and 24 controls. T1 values were measured within the septal myocardium, the upper and lower RVIP, and the lateral wall at basal short axis section. RESULTS: The mean septal native T1 values were 1012.8 ms ± 50.5 in the CTEPH group and 956.9 ms ± 24.4 in controls (p < 0.001), upper RIVP 1050.8 ms ± 64.2 vs. 965.3 ms ± 37.1 (p < 0.001), and lower RVIP 1084.4 ms ± 93.1 vs. 959.8 ms ± 40.4 (p < 0.001). The corresponding mean ECV values were also significantly increased in the CTEPH group (p < 0.001). Native septal T1 showed a strong negative correlation with right ventricular ejection fraction (k = -0.92; p = 0.01). CONCLUSIONS: We conclude that native T1 mapping and ECV assessment enable visualization and quantification of septal fibrosis in CTEPH patients. The results also correlate well with right ventricular ejection fraction. Therefore, these parameters might be useful for prognosis and as therapy-monitoring tool in the future. KEY POINTS: • Septal native T1 and ECV values are significantly higher in CTEPH patients. • Native T1 and ECV values are elevated even in absence of LGE. • These techniques therefore enable an improved quantification of septal fibrosis in CTEPH. • Native T1 values also correlate well with right ventricular EF and PA-pressure. • Prognosis and therapy-monitoring might be assessable in the future with these parameters.

Fetal cardiac interventricular septum: volume assessment by 3D/4D ultrasound using spatio-temporal image correlation (STIC) and virtual organ computer-aided analysis (VOCAL).

OBJECTIVE: To determine reference values for fetal interventricular septum (IVS) volume by 3D/4D ultrasound using spatio-temporal image correlation (STIC) and virtual organ computer-aided analysis (VOCAL). METHODS: A prospective cross-sectional study was conducted on 200 consecutive normal low-risk pregnant women at a gestational age ranging from 18w0d to 33w6d. The volume data sets of the fetal heart were acquired by applying STIC to a four-chamber plane. IVS volume was calculated offline using VOCAL with rotation of 30° (six planes). To assess the correlation of fetal IVS volume as a function of gestational age (GA), Pearson's correlation coefficient (r) and polynomial regression models with adjustments through the coefficient of determination (R(2)) were calculated. The intra-class coefficient (ICC) was used to evaluate intra- and inter-observer reproducibility. RESULTS: A good correlation between GA and fetal IVS volume (r = 0.827) was observed. The mean fetal IVS volume ranged from 0.13 ± 0.03 cm(3) (0.08-0.18 cm(3)) at 18wd0 of gestation to 1.33 ± 0.37 cm(3) (0.41-1.98 cm(3)) at 33w6d. The best correlation between fetal IVS volume and GA was exponential: fetal IVS volume = 0.11e(0.139×GA) (R(2 )= 0.785). A good intra- and inter-observer reliability were observed, with ICC = 0.999 and 0.991, respectively. CONCLUSIONS: Reference values for fetal IVS volume using STIC and VOCAL by 3D/4D ultrasound between 18w0d and 33w6d of gestation were determined and showed to be reliable and concordant.

Real-time magnetic resonance assessment of septal curvature accurately tracks acute hemodynamic changes in pediatric pulmonary hypertension.

BACKGROUND: This study assesses the relationship between septal curvature and mean pulmonary artery pressure and indexed pulmonary vascular resistance in children with pulmonary hypertension. We hypothesized that septal curvature could be used to estimate right ventricular afterload and track acute changes in pulmonary hemodynamics. METHODS AND RESULTS: Fifty patients with a median age of 6.7 years (range, 0.45-16.5 years) underwent combined cardiac catheterization and cardiovascular magnetic resonance. The majority had idiopathic pulmonary arterial hypertension (n=30); the remaining patients had pulmonary hypertension associated with repaired congenital heart disease (n=17) or lung disease (n=3). Mean pulmonary artery pressure and pulmonary vascular resistance were acquired at baseline and during vasodilation. Septal curvature was measured using real-time cardiovascular magnetic resonance. There was a strong correlation between mean pulmonary artery pressure and SCmin at baseline and during vasodilator testing (r=-0.81 and -0.85, respectively; P<0.01). A strong linear relationship also existed between pulmonary vascular resistance and minimum septal curvature indexed to cardiac output both at baseline and during vasodilator testing (r=-0.88 and -0.87, respectively; P<0.01). Change in septal curvature metrics moderately correlated with absolute change in mean pulmonary artery pressure and pulmonary vascular resistance, respectively (r=0.58 and -0.74; P<0.01). Septal curvature metrics were able to identify vasoresponders with a sensitivity of 83% (95% confidence interval, 0.36-0.99) and a specificity of 91% (95% confidence interval, 0.77-0.97), using the Sitbon criteria. Idiopathic pulmonary arterial hypertension subgroup analysis revealed 3 responders with ΔSCmin values of 0.523, 0.551, and 0.568. If the middle value of 0.551 is taken as a cutoff, the approximate sensitivity would be 67% and the specificity would be 93%. CONCLUSIONS: Septal curvature metrics are able to estimate right ventricular afterload and track acute changes in pulmonary hemodynamics during vasodilator testing. This suggests that septal curvature could be used for continuing assessment of load in pulmonary hypertension.

Transcatheter versus surgical closure of perimembranous ventricular septal defects in children: a randomized controlled trial.

OBJECTIVES: The objective of this study was to evaluate the safety and efficacy of the surgical versus transcatheter approach to correct perimembranous ventricular septal defects (pmVSDs) in a prospective, randomized, controlled clinical trial. BACKGROUND: pmVSD is a common congenital heart disease in children. Surgical closure of pmVSD is a well-established therapy but requires open-heart surgery with cardiopulmonary bypass. Although the transcatheter approach is associated with significant incidence of complete atrioventricular block, it may provide a less invasive alternative. Critical comparison of the safety and efficacy of the 2 interventions necessitates a prospective, randomized, controlled trial. METHODS: Between January 2009 and July 2010, 229 children with pmVSD were randomly assigned to surgical or transcatheter intervention. Clinical, laboratory, procedural, and follow-up data over a 2-year period were compared. RESULTS: Neither group had mortality or major complications. However, statistical analysis of the 2 groups demonstrated significant differences (p < 0.001) in minor adverse events (32 vs. 7), quantity of blood transfused, duration of the procedure, median hospital stay, median intensive care unit stay, median hospitalization cost, and median blood loss. During a median follow-up of 2 years, the left ventricular end-diastolic dimension of both groups returned to normal and there was no difference in closure rate, adverse events, and complications between groups. CONCLUSIONS: Transcatheter device closure and surgical repair are effective interventions with excellent midterm results for treating pmVSD in children. Transcatheter device closure has a lower incidence of myocardial injury, less blood transfused, faster recovery, shorter hospital stay, and lower medical expenses. (Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects; NCT00890799).