Hemodynamics, anatomy, and outcomes of quadricuspid aortic valves: Multimodality imaging assessment.

BACKGROUND:Quadricuspid aortic valve (QAV) is a rare congenital heart disease with a limited body of literature. This retrospective cohort study investigates QAV morphology, function, and clinical outcomes.METHODS:Echocardiography was used to assess valvular function. Morphological characteristics such as phenotypes, raphe, regurgitant orifice area (ROA), and aortic dilation (diameter >40 ​mm) were assessed by cardiac CT. Patients were followed up for the combined event of all-cause death and aortic valve replacement (AVR).RESULTS:Ninety QAV patients (screened from 322385 CT scans) were included (mean age 55.2 ​± ​13.6 years, 61.1 ​% male). Isolated significant aortic regurgitation (AR) was present in 75.6 ​% of patients. The cohort was dominated by type I (four equal leaflets, 37.8 ​%) and type II (3 larger and 1 smaller leaflets, 42.2 ​%) QAV. Fused raphe was present in 26.7 ​% of patients. ROACT was correlated with AR severity and aortic dilation (41.1 ​%, n ​= ​37). Among patients without AVR at baseline (n ​= ​60), one died and 17 underwent AVR during a median follow-up of 35.0 months (IQR:17.3-62.8). ROACT was associated with an increasing risk of combined event (as a categorical variable with a cut-off of 21.4 ​mm2, HR ​= ​4.25, 95%CI 1.49-12.17, p ​= ​0.007; as a continuous variable (per mm2 increment), HR ​= ​1.04, 95%CI 1.01-1.07, p ​= ​0.003). Additionally, ROACT had incremental prognostic value when added to the AR severity model (area under the receiver-operating characteristic curve increased from 86.8 to 88.4, p ​= ​0.004).CONCLUSION:QAV is characterized by variable anatomy, progressive AR, concomitant cusp fusion and aortic enlargement. ROACT may be a potential ancillary prognostic marker in patients with QAV.

Simultaneous percutaneous closure of aortic paravalvular leak and residual shunt of ventricular septal defect.

Favorable mid-term performance of fully biodegradable implantable device for ventricular septal defect closure.

Objectives:To assess the mid-term safety and efficacy of transthoracic perimembranous ventricular septal defect (Pm-VSD) closure using a new biodegradable device. Implantation entailed right subaxillary minithoracotomy under transesophageal echocardiography guidance.Methods:Between October 2019 and January 2020, 13 patients (males, 5; mean age, 3.6 ± 2.5 years) with Pm-VSDs underwent transthoracic device closures at Zhengzhou University Central China Fuwai Hospital as described previously. Delivery pathways were established by manipulating a hollow probe from right atrium through tricuspid valve to right ventricle and then through VSDs to left ventricle, whereupon installation took place.Results:All occluder implantations were successfully executed. Mean defect size was 4.1 ± 1.0 mm, and mean device waist size was 5.2 ± 1.1 mm. One patient (7.7%) with 1.5-mm residual shunt showed complete closure at discharge. There was 1 instance of postoperative incomplete right bundle branch block, which converted to complete right bundle branch block at month 1. During patient follow-up (mean, 24.6 ± 0.8 months), no device dislocations, new residual shunts, new valvular regurgitation, or detectable atrioventricular block ensued.Conclusions:Closure of Pm-VSDs using a novel, fully biodegradable occluder in the manner described has proven safe and effective at mid-term follow-up. Long-term safety and efficacy of this device must be further corroborated in a large patient cohort going forward.

In vitro bench testing using patient-specific 3D models for percutaneous pulmonary valve implantation with Venus P-valve.

BACKGROUND:Due to the wide variety of morphology, size, and dynamics, selecting an optimal valve size and location poses great difficulty in percutaneous pulmonary valve implantation (PPVI). This study aimed to report our experience with in vitro bench testing using patient-specific three-dimensional (3D)-printed models for planning PPVI with the Venus P-valve.METHODS:Patient-specific 3D soft models were generated using PolyJet printing with a compliant synthetic material in 15 patients scheduled to undergo PPVI between July 2018 and July 2020 in Central China Fuwai Hospital of Zhengzhou University.RESULTS:3D model bench testing altered treatment strategy in all patients (100%). One patient was referred for surgery because testing revealed that even the largest Venus P-valve would not anchor properly. In the remaining 14 patients, valve size and/or implantation location was altered to avoid valve migration and/or compression coronary artery. In four patients, it was decided to change the point anchoring because of inverted cone-shaped right ventricular outflow tract (RVOT) (n = 2) or risk of compression coronary artery (n = 2). Concerning sizing, we found that an oversize of 2-5 mm suffices. Anchoring of the valve was dictated by the flaring of the in- and outflow portion in the pulmonary artery. PPVI was successful in all 14 patients (absence of valve migration, no coronary compression, and none-to-mild residual pulmonary regurgitation [PR]). The diameter of the Venus P-valve in the 3D simulation group was significantly smaller than that of the conventional planning group (36 [2] vs. 32 [4], Z = -3.77, P <0.001).CONCLUSIONS:In vitro testing indicated no need to oversize the Venus P-valve to the degree recommended by the balloon-sizing technique, as 2-5 mm sufficed.

Percutaneous closure of ventricular septal rupture after myocardial infarction: A retrospective study of 81 cases.

OBJECTIVE:To investigate the efficacy and safety of percutaneous closure of ventricular septal rupture (VSR) after acute myocardial infarction (AMI).METHODS:This retrospective study included 81 patients who underwent transcatheter closure for postinfarction VSR. We analyzed clinical data from hospitalization and the 30-day follow-up, compared clinical data from the survival and death groups, and explored the best closure time and the safety and efficacy of occlusion. The risk factors for death at 30 days were analyzed by logistic regression.RESULTS:C-reactive protein (CRP), white blood cell counts, N-terminal pro brain natriuretic peptide (NT-ProBNP), and aspartate aminotransferase were higher in the death group than in the survival group (p < .01), with a higher rate of application of vasoactive drugs, and a shorter time from AMI to operation (p < .05). At 30 days postocclusion, 19 patients (23.5%) had died. The mortality rate was significantly lower for operation performed 3 weeks after AMI than for operation performed within 3 weeks of AMI (12.5% vs. 48%, p < .001). Devices were successfully implanted in 76 patients, with 16 (21.1%) operation-related complications and 12 (15.8%) valve injuries. Cardiac function improved significantly (p < .001) at discharge (N = 66) and 30 days after procedure (N = 62). Qp/Qs and pulmonary artery systolic pressure decreased significantly, while aortic systolic pressure increased significantly (p < .001). Additionally, EF and LVDd improved (p < .05) after occlusion. Increases in CRP and NT-ProBNP were risk factors for death at 30 days after closure (p < .05).CONCLUSION:Percutaneous VSR closure can be a valuable treatment option for suitable patients with VSR.

[Effect and prognosis of new type of re-dilated stent in the treatment of pulmonary artery bifurcation stenosis].

the early and med-term follow-up results and technical points of new re-dilated stent in the treatment of pulmonary artery bifurcation opening stenosis, and explore its feasibility and advantages. From March 2019 to October 2020, 10 children [5 males, mean age (7±3) years], mean weight 18.75(13.35,23.05) kg with pulmonary artery bifurcation opening stenosis were treated with new re-dilated stents in the Central China Fuwai Hospital. Including 5 cases of tetralogy of Fallot, 4 cases of pulmonary atresia, 1 case of anomalous origin of coronary artery, all children were given new re-dilated stent implantation. Echocardiography, chest X-ray and electrocardiogram were performed 1 day, 3, 6, 12 months after intervention. Pulmonary artery CTA was performed after 6 or 12 months to evaluate the results, including restenosis, malposition and rupture. A total of 16 stents were implanted in 10 children, 5 cases had simultaneous stenosis of bifurcation openings of pulmonary arteries, and 1 stent was implanted in each of the left and right pulmonary artery openings. The pressure of right ventricular and gradient was significantly decreased immediately after intervention, from preoperative (38-80) mmHg(1 mmHg=0.133 kPa) to postoperative (0-22) mmHg, only one patient's pressure gradient is over 20 mmHg (22 mmHg), and all cases discharged successfully. Stent restenosis, malposition, fracture and other abnormalities were not observed in follow-up. Stents implantation for patients with pulmonary artery bifurcation opening stenosis is very more difficult. A good strategy can ensure that the intervention is safe and effective. It not only avoids the risk of repeated surgery, but also achieves good med-term follow-up results.

Albumin-Based Zn (II)-Quercetin Enzyme Mimic Scavenging ROS for Protection against Cardiotoxicity Induced by Doxorubicin.

Doxorubicin (DOX) is a chemotherapeutic agent that can cause cardiotoxicity leading to progressive, chronic, life-threatening cardiomyopathy, called DOX-induced cardiomyopathy (DIC). DIC is a fatal cardiomyopathy with a worse prognosis compared to other cardiomyopathies and limits the use of DOX in malignancies due to its cardiotoxicity. DIC has been proven to be associated with reactive oxygen species (ROS)-induced side effect damage in cardiac myocytes. Currently, scavenging of reactive oxygen species is a practical strategy to reduce chemotherapy-associated DIC. Although quercetin has already been reported to have superior antioxidant activity, its clinical application is severely limited due to its rapid degradation and poor tissue absorption. Herein, we reported the preparation of a novel enzyme mimic via coordinated albumin, Zinc Ion (Zn2+) and quercetin. The enzyme mimics were capable of simultaneously increasing the biocompatibility and efficiently overcame the drawbacks of free quercetin, and were achieved by long circulation in vivo. Most importantly, these quercetin-based enzyme mimics had no effect on the antioxidant activity of quercetin. These beneficial therapeutic properties, together with high drug-carrying capacity and redox stimuli, will significantly improve quercetin's alleviation of chemotherapeutic cardiotoxicity without causing significant side effects. Therefore, nanoparticles of albumin-based Zn (II)-Quercetin have a promising clinical application as an effective agent for mitigating the cardiotoxicity of chemotherapy.

First hybrid implantations of novel Salus-Valves in patients with severe pulmonary regurgitation: A case series.

With the increasing age of patients after right ventricular outflow tract (RVOT) reconstruction, progressive pulmonary valve (PV) dysfunction can result in different degrees of right heart insufficiency, and PV replacement is frequently needed during follow-up. The traditional redo thoracotomy is difficult and associated with higher risks when compared to transcatheter implantations. Herein, we report the advantages and describe the outcomes of the first hybrid implantations of the novel Salus-Valves (Balance Medical, Beijing, China) from the sub-xiphoid approach in five patients (mean age of 22.6 years) with severe pulmonary regurgitation (PR) after RVOT reconstruction.

Comparison between Cardiac CTA and Echocardiography for Assessment of Ventricular Septal Rupture Diameter and Its Effect on Transcatheter Closure.

Objective:This study is aimed at comparing cardiac computed tomographic angiography (CTA) with echocardiography in the assessment of ventricular septal perforation diameter.Methods:A total of 44 ventricular septal rupture (VSR) patients undertaking transcatheter occlusion were included and randomly divided into the CTA group and echocardiography group with a 1 : 1 ratio. Clinical data, operation-related data, and 30 d follow-up data were collected and analyzed.Results:Incidence of closure failure, occluder displacement, poor occluder molding, and occluder waist diameter shrinkage between the two groups were not statistically different. The mean residual shunt volume in the echocardiography group (4.2 (3.1, 5.9) mm) was significantly higher than that in the CTA group (2.1 (0, 4.0) mm) with a p value of 0.005. However, no significant differences were found in all-cause mortality and incidence of operative complications within 30 days after surgery. Within the CTA group, the correlation was strongest between postoperative occluder diameter and long diameter measured by CTA with a correlation coefficient of 0.799 and p < 0.001, followed by the correlation between postoperative occluder diameter and mean diameter measured by CTA with a correlation coefficient of 0.740 and p < 0.001. The diameter measured by echocardiography was not correlated to postoperative occlude diameter.Conclusion:Assessment of VSR diameter by cardiac CTA is more accurate than by echocardiography.

Minimally-invasive-perventricular-device-occlusion versus surgical-closure for treating perimembranous-ventricular-septal-defect: 3-year outcomes of a multicenter randomized clinical trial.

BACKGROUND:Minimally-invasive-perventricular-device-occlusion (MIPDO) combined superiority of surgical-repair and percutaneous-device-closure in treating perimembranous-ventricular-septal-defect (pmVSD). This study was to evaluate the efficacy and safety of MIPDO for treating pmVSD, comparing with surgical-repair.METHODS:Patients aged ≥3 months with isolated pmVSDs were randomized to undergo either surgical or MIPDO procedure, with the median follow-up time of 49 months. The primary outcome was the rate of complete pmVSD closure at discharge. The secondary outcomes included the adverse events during hospitalization and follow-up, chest tube output volume, blood transfusion volume, procedural duration, ventilation time, hospitalization duration and hospitalization cost. Also, perioperative cardiac performance and systemic conditions were evaluated.RESULTS:Of the 313 patients (9 months to 42 years old; median, 4 years old) with pmVSDs recruited from 3 centers, 100 were finally enrolled and randomly allocated 1:1 into two groups. The non-inferiority (non-inferiority margin -8.0%) of MIPDO to surgical closure regarding efficacy was shown in both intention-to-treat (0, 95% CI: -0.055 to 0.055) and per-protocol populations (0.02, 95% CI: -0.018 to 0.058). Although the rate of adverse events was similar between groups, the MIPDO group showed superiority in procedural duration, ventilation time, chest tube output volume, postoperative hospitalization time and hospitalization cost compared with surgical group (P<0.05). Moreover, MIPDO method showed comparable perioperative cardiac performance with milder change of systemic condition.CONCLUSIONS:In patients with pmVSDs, MIPDO method showed non-inferiority to surgical closure in efficacy for both intention-to-treat and per-protocol population with easier perioperative recovery, economic benefit and promising outcomes.

Hemodynamics, anatomy, and outcomes of quadricuspid aortic valves: Multimodality imaging assessment.

BACKGROUND:Quadricuspid aortic valve (QAV) is a rare congenital heart disease with a limited body of literature. This retrospective cohort study investigates QAV morphology, function, and clinical outcomes.METHODS:Echocardiography was used to assess valvular function. Morphological characteristics such as phenotypes, raphe, regurgitant orifice area (ROA), and aortic dilation (diameter >40 ​mm) were assessed by cardiac CT. Patients were followed up for the combined event of all-cause death and aortic valve replacement (AVR).RESULTS:Ninety QAV patients (screened from 322385 CT scans) were included (mean age 55.2 ​± ​13.6 years, 61.1 ​% male). Isolated significant aortic regurgitation (AR) was present in 75.6 ​% of patients. The cohort was dominated by type I (four equal leaflets, 37.8 ​%) and type II (3 larger and 1 smaller leaflets, 42.2 ​%) QAV. Fused raphe was present in 26.7 ​% of patients. ROACT was correlated with AR severity and aortic dilation (41.1 ​%, n ​= ​37). Among patients without AVR at baseline (n ​= ​60), one died and 17 underwent AVR during a median follow-up of 35.0 months (IQR:17.3-62.8). ROACT was associated with an increasing risk of combined event (as a categorical variable with a cut-off of 21.4 ​mm2, HR ​= ​4.25, 95%CI 1.49-12.17, p ​= ​0.007; as a continuous variable (per mm2 increment), HR ​= ​1.04, 95%CI 1.01-1.07, p ​= ​0.003). Additionally, ROACT had incremental prognostic value when added to the AR severity model (area under the receiver-operating characteristic curve increased from 86.8 to 88.4, p ​= ​0.004).CONCLUSION:QAV is characterized by variable anatomy, progressive AR, concomitant cusp fusion and aortic enlargement. ROACT may be a potential ancillary prognostic marker in patients with QAV.

Simultaneous percutaneous closure of aortic paravalvular leak and residual shunt of ventricular septal defect.

Favorable mid-term performance of fully biodegradable implantable device for ventricular septal defect closure.

Objectives:To assess the mid-term safety and efficacy of transthoracic perimembranous ventricular septal defect (Pm-VSD) closure using a new biodegradable device. Implantation entailed right subaxillary minithoracotomy under transesophageal echocardiography guidance.Methods:Between October 2019 and January 2020, 13 patients (males, 5; mean age, 3.6 ± 2.5 years) with Pm-VSDs underwent transthoracic device closures at Zhengzhou University Central China Fuwai Hospital as described previously. Delivery pathways were established by manipulating a hollow probe from right atrium through tricuspid valve to right ventricle and then through VSDs to left ventricle, whereupon installation took place.Results:All occluder implantations were successfully executed. Mean defect size was 4.1 ± 1.0 mm, and mean device waist size was 5.2 ± 1.1 mm. One patient (7.7%) with 1.5-mm residual shunt showed complete closure at discharge. There was 1 instance of postoperative incomplete right bundle branch block, which converted to complete right bundle branch block at month 1. During patient follow-up (mean, 24.6 ± 0.8 months), no device dislocations, new residual shunts, new valvular regurgitation, or detectable atrioventricular block ensued.Conclusions:Closure of Pm-VSDs using a novel, fully biodegradable occluder in the manner described has proven safe and effective at mid-term follow-up. Long-term safety and efficacy of this device must be further corroborated in a large patient cohort going forward.

In vitro bench testing using patient-specific 3D models for percutaneous pulmonary valve implantation with Venus P-valve.

BACKGROUND:Due to the wide variety of morphology, size, and dynamics, selecting an optimal valve size and location poses great difficulty in percutaneous pulmonary valve implantation (PPVI). This study aimed to report our experience with in vitro bench testing using patient-specific three-dimensional (3D)-printed models for planning PPVI with the Venus P-valve.METHODS:Patient-specific 3D soft models were generated using PolyJet printing with a compliant synthetic material in 15 patients scheduled to undergo PPVI between July 2018 and July 2020 in Central China Fuwai Hospital of Zhengzhou University.RESULTS:3D model bench testing altered treatment strategy in all patients (100%). One patient was referred for surgery because testing revealed that even the largest Venus P-valve would not anchor properly. In the remaining 14 patients, valve size and/or implantation location was altered to avoid valve migration and/or compression coronary artery. In four patients, it was decided to change the point anchoring because of inverted cone-shaped right ventricular outflow tract (RVOT) (n = 2) or risk of compression coronary artery (n = 2). Concerning sizing, we found that an oversize of 2-5 mm suffices. Anchoring of the valve was dictated by the flaring of the in- and outflow portion in the pulmonary artery. PPVI was successful in all 14 patients (absence of valve migration, no coronary compression, and none-to-mild residual pulmonary regurgitation [PR]). The diameter of the Venus P-valve in the 3D simulation group was significantly smaller than that of the conventional planning group (36 [2] vs. 32 [4], Z = -3.77, P <0.001).CONCLUSIONS:In vitro testing indicated no need to oversize the Venus P-valve to the degree recommended by the balloon-sizing technique, as 2-5 mm sufficed.

Percutaneous closure of ventricular septal rupture after myocardial infarction: A retrospective study of 81 cases.

OBJECTIVE:To investigate the efficacy and safety of percutaneous closure of ventricular septal rupture (VSR) after acute myocardial infarction (AMI).METHODS:This retrospective study included 81 patients who underwent transcatheter closure for postinfarction VSR. We analyzed clinical data from hospitalization and the 30-day follow-up, compared clinical data from the survival and death groups, and explored the best closure time and the safety and efficacy of occlusion. The risk factors for death at 30 days were analyzed by logistic regression.RESULTS:C-reactive protein (CRP), white blood cell counts, N-terminal pro brain natriuretic peptide (NT-ProBNP), and aspartate aminotransferase were higher in the death group than in the survival group (p < .01), with a higher rate of application of vasoactive drugs, and a shorter time from AMI to operation (p < .05). At 30 days postocclusion, 19 patients (23.5%) had died. The mortality rate was significantly lower for operation performed 3 weeks after AMI than for operation performed within 3 weeks of AMI (12.5% vs. 48%, p < .001). Devices were successfully implanted in 76 patients, with 16 (21.1%) operation-related complications and 12 (15.8%) valve injuries. Cardiac function improved significantly (p < .001) at discharge (N = 66) and 30 days after procedure (N = 62). Qp/Qs and pulmonary artery systolic pressure decreased significantly, while aortic systolic pressure increased significantly (p < .001). Additionally, EF and LVDd improved (p < .05) after occlusion. Increases in CRP and NT-ProBNP were risk factors for death at 30 days after closure (p < .05).CONCLUSION:Percutaneous VSR closure can be a valuable treatment option for suitable patients with VSR.

[Effect and prognosis of new type of re-dilated stent in the treatment of pulmonary artery bifurcation stenosis].

the early and med-term follow-up results and technical points of new re-dilated stent in the treatment of pulmonary artery bifurcation opening stenosis, and explore its feasibility and advantages. From March 2019 to October 2020, 10 children [5 males, mean age (7±3) years], mean weight 18.75(13.35,23.05) kg with pulmonary artery bifurcation opening stenosis were treated with new re-dilated stents in the Central China Fuwai Hospital. Including 5 cases of tetralogy of Fallot, 4 cases of pulmonary atresia, 1 case of anomalous origin of coronary artery, all children were given new re-dilated stent implantation. Echocardiography, chest X-ray and electrocardiogram were performed 1 day, 3, 6, 12 months after intervention. Pulmonary artery CTA was performed after 6 or 12 months to evaluate the results, including restenosis, malposition and rupture. A total of 16 stents were implanted in 10 children, 5 cases had simultaneous stenosis of bifurcation openings of pulmonary arteries, and 1 stent was implanted in each of the left and right pulmonary artery openings. The pressure of right ventricular and gradient was significantly decreased immediately after intervention, from preoperative (38-80) mmHg(1 mmHg=0.133 kPa) to postoperative (0-22) mmHg, only one patient's pressure gradient is over 20 mmHg (22 mmHg), and all cases discharged successfully. Stent restenosis, malposition, fracture and other abnormalities were not observed in follow-up. Stents implantation for patients with pulmonary artery bifurcation opening stenosis is very more difficult. A good strategy can ensure that the intervention is safe and effective. It not only avoids the risk of repeated surgery, but also achieves good med-term follow-up results.

Albumin-Based Zn (II)-Quercetin Enzyme Mimic Scavenging ROS for Protection against Cardiotoxicity Induced by Doxorubicin.

Doxorubicin (DOX) is a chemotherapeutic agent that can cause cardiotoxicity leading to progressive, chronic, life-threatening cardiomyopathy, called DOX-induced cardiomyopathy (DIC). DIC is a fatal cardiomyopathy with a worse prognosis compared to other cardiomyopathies and limits the use of DOX in malignancies due to its cardiotoxicity. DIC has been proven to be associated with reactive oxygen species (ROS)-induced side effect damage in cardiac myocytes. Currently, scavenging of reactive oxygen species is a practical strategy to reduce chemotherapy-associated DIC. Although quercetin has already been reported to have superior antioxidant activity, its clinical application is severely limited due to its rapid degradation and poor tissue absorption. Herein, we reported the preparation of a novel enzyme mimic via coordinated albumin, Zinc Ion (Zn2+) and quercetin. The enzyme mimics were capable of simultaneously increasing the biocompatibility and efficiently overcame the drawbacks of free quercetin, and were achieved by long circulation in vivo. Most importantly, these quercetin-based enzyme mimics had no effect on the antioxidant activity of quercetin. These beneficial therapeutic properties, together with high drug-carrying capacity and redox stimuli, will significantly improve quercetin's alleviation of chemotherapeutic cardiotoxicity without causing significant side effects. Therefore, nanoparticles of albumin-based Zn (II)-Quercetin have a promising clinical application as an effective agent for mitigating the cardiotoxicity of chemotherapy.

First hybrid implantations of novel Salus-Valves in patients with severe pulmonary regurgitation: A case series.

With the increasing age of patients after right ventricular outflow tract (RVOT) reconstruction, progressive pulmonary valve (PV) dysfunction can result in different degrees of right heart insufficiency, and PV replacement is frequently needed during follow-up. The traditional redo thoracotomy is difficult and associated with higher risks when compared to transcatheter implantations. Herein, we report the advantages and describe the outcomes of the first hybrid implantations of the novel Salus-Valves (Balance Medical, Beijing, China) from the sub-xiphoid approach in five patients (mean age of 22.6 years) with severe pulmonary regurgitation (PR) after RVOT reconstruction.

Comparison between Cardiac CTA and Echocardiography for Assessment of Ventricular Septal Rupture Diameter and Its Effect on Transcatheter Closure.

Objective:This study is aimed at comparing cardiac computed tomographic angiography (CTA) with echocardiography in the assessment of ventricular septal perforation diameter.Methods:A total of 44 ventricular septal rupture (VSR) patients undertaking transcatheter occlusion were included and randomly divided into the CTA group and echocardiography group with a 1 : 1 ratio. Clinical data, operation-related data, and 30 d follow-up data were collected and analyzed.Results:Incidence of closure failure, occluder displacement, poor occluder molding, and occluder waist diameter shrinkage between the two groups were not statistically different. The mean residual shunt volume in the echocardiography group (4.2 (3.1, 5.9) mm) was significantly higher than that in the CTA group (2.1 (0, 4.0) mm) with a p value of 0.005. However, no significant differences were found in all-cause mortality and incidence of operative complications within 30 days after surgery. Within the CTA group, the correlation was strongest between postoperative occluder diameter and long diameter measured by CTA with a correlation coefficient of 0.799 and p < 0.001, followed by the correlation between postoperative occluder diameter and mean diameter measured by CTA with a correlation coefficient of 0.740 and p < 0.001. The diameter measured by echocardiography was not correlated to postoperative occlude diameter.Conclusion:Assessment of VSR diameter by cardiac CTA is more accurate than by echocardiography.

Minimally-invasive-perventricular-device-occlusion versus surgical-closure for treating perimembranous-ventricular-septal-defect: 3-year outcomes of a multicenter randomized clinical trial.

BACKGROUND:Minimally-invasive-perventricular-device-occlusion (MIPDO) combined superiority of surgical-repair and percutaneous-device-closure in treating perimembranous-ventricular-septal-defect (pmVSD). This study was to evaluate the efficacy and safety of MIPDO for treating pmVSD, comparing with surgical-repair.METHODS:Patients aged ≥3 months with isolated pmVSDs were randomized to undergo either surgical or MIPDO procedure, with the median follow-up time of 49 months. The primary outcome was the rate of complete pmVSD closure at discharge. The secondary outcomes included the adverse events during hospitalization and follow-up, chest tube output volume, blood transfusion volume, procedural duration, ventilation time, hospitalization duration and hospitalization cost. Also, perioperative cardiac performance and systemic conditions were evaluated.RESULTS:Of the 313 patients (9 months to 42 years old; median, 4 years old) with pmVSDs recruited from 3 centers, 100 were finally enrolled and randomly allocated 1:1 into two groups. The non-inferiority (non-inferiority margin -8.0%) of MIPDO to surgical closure regarding efficacy was shown in both intention-to-treat (0, 95% CI: -0.055 to 0.055) and per-protocol populations (0.02, 95% CI: -0.018 to 0.058). Although the rate of adverse events was similar between groups, the MIPDO group showed superiority in procedural duration, ventilation time, chest tube output volume, postoperative hospitalization time and hospitalization cost compared with surgical group (P<0.05). Moreover, MIPDO method showed comparable perioperative cardiac performance with milder change of systemic condition.CONCLUSIONS:In patients with pmVSDs, MIPDO method showed non-inferiority to surgical closure in efficacy for both intention-to-treat and per-protocol population with easier perioperative recovery, economic benefit and promising outcomes.