Midterm Results Comparing Perventricular Device Closure with Surgical Repair for Isolated Congenital Ventricular Septal Defects: A Systematic Review and Meta-Analysis.

Background: This systematic review and meta-analysis aimed at comparing the midterm outcomes of perventricular device closure (PDC) with conventional surgical repair (CSR) for VSD. Methods: PubMed, Cochrane Library, and Web of Science databases were searched from January 1, 2005, to October 15, 2020, for English or Chinese language studies comparing outcomes of PDC with CSR for VSD. The midterm results were assessed as a primary outcome. A systematic review and meta-analysis was performed under the frequentist frame with risk ratio (RR) and 95% confidence interval (CI). Results: A total of 4381 patients (PDC = 2016, CSR = 2365) from 15 studies were included. The pooled estimates of success rate favored the CSR compared with the PDC (RR, 0.97; 95% CI, 0.96 to 0.99; p = 0.001). No significant differences in minor complications or severe complications were found between the PDC and CSR (RR, 0.79; 95% CI, 0.50 to 1.23; p = 0.29; RR, 1.43; 95% CI, 0.74 to 2.75; p = 0.29). The pooled estimates of residual shunts favored the PDC compared with the CSR (RR, 9.07; 95% CI, 4.77 to 17.24; p < 0.001), the pooled estimates of aortic regurgitation favored the CSR compared with the PDC (RR, 1.59; 95% CI, 1.05 to 2.39; p = 0.03). Conclusions: PDC is a safe and effective procedure with less surgical injury and shorter perioperative hospital stay. However, aortic regurgitation is a concern during follow-up.

A review of the therapeutic management of multiple ventricular septal defects.

BACKGROUND AND AIM: We showed in our anatomical review, ventricular septal defects existing as multiple entities can be considered in terms of three major subsets. We address here the diagnostic challenges, associated anomalies, the role and techniques of surgical instead of interventional closure, and the outcomes, including reinterventions, for each subset. METHODS: We reviewed 80 published investigations, noting radiographic findings, and the results of clinical imaging elucidating the location, number, size of septal defects, associated anomalies, and the effect of severe pulmonary hypertension. RESULTS: Overall, perioperative mortality for treatment of residual multiple defects has been cited to be between 0% and 14.2%, with morbidity estimated between 6% and 13%. Perioperative mortality is twice as high for perimembranous compared to muscular defects, with the need for reoperation being over four times higher. Perventricular hybrid approaches are useful for the closure of high anterior or apical defects. Overall, the results have been unsatisfactory. Pooled data reveals incidences between 2.8% and 45% for device-related adverse events. Currently, however, outcomes cannot be assessed on the basis of the different anatomical subsets. CONCLUSIONS: We have addressed the approaches, and the results, of therapeutic treatment in terms of coexisting discrete defects, the Swiss-cheese septum, and the arrangement in which a solitary apical muscular defect gives the impression of multiple defects when viewed from the right ventricular aspect. Treatment should vary according to the specific combination of defects.

Hybrid Subxiphoid Perventricular Approach as an Alternative Access in Neonates and Small Children Undergoing Complex Congenital Heart Interventions.

The hybrid subxiphoid perventricular approach provides direct access through the heart and may alleviate the technical limitations of complex percutaneous interventions particularly in infants with low body weight. We present the outcomes from a tertiary cardiology center using this approach. We performed a retrospective review of all patients less than 15 kg who underwent a hybrid perventricular approach via a small subxiphoid incision. Medical records were reviewed to obtain clinical, demographic and outcome data. Seventeen patients underwent 18 hybrid perventricular procedures using a subxiphoid approach. Median age at time of procedure was 4.6 months (IQR = 1.6 to 18 months) and median weight was 6.2 kgs (IQR = 3.4 to 8.6 kgs). Six patients underwent hybrid pulmonary valve replacement (PVR), 5 patients underwent pulmonary outflow stenting, and 5 infants underwent hybrid ventricular septal defect (VSD) device closure. One patient with a single ventricle who did not tolerate a percutaneous approach underwent left pulmonary artery (LPA) stenting for severe LPA coarctation with subsequent right ventricular outflow tract (RVOT) stenting. One further patient underwent implantation of a larger diameter stent for pulmonary artery bifurcation stenosis. Procedure success rate was 89% with two of the VSD cases reverted to open surgical repair. There were no intra-procedural complications; however, one patient died within 72 h. Minor adverse events occurred in 2 patients including a wound infection in one patient with an immunodeficiency syndrome. Hybrid subxiphoid perventricular approach provides an excellent alternative access to the heart especially in low birth weight infants to prevent hemodynamic instability or in small children requiring large delivery sheaths.

Hybrid perventricular muscular ventricular septal defect closure using the new multi-functional occluder.

The hybrid perventricular approach for the closure of trabecular ventricular septal defects is an attractive treatment modality for small children. Worldwide experience has shown that procedure success is influenced by the defect anatomical accessibility, operators' expertise, and device technical features. In May 2018, a new promising device, the KONAR-Multi-functional™ ventricular septal defect occluder (Lifetech, Shenzhen, China), obtained CE-marking for septal defect transcatheter closure after the first-in-man implantation in 2013. Herein, this is the first report of successful perventricular closure of ventricular septal defect using this new device in a child with significant co-morbidities.

Comparisons of perventricular device closure, conventional surgical repair, and transcatheter device closure in patients with perimembranous ventricular septal defects: a network meta-analysis.

BACKGROUND: Treatments for perimembranous ventricular septal defects (pmVSD) mainly include conventional surgical repair (CSR), transcatheter device closure (TDC), and perventricular device closure (PDC). We aimed to perform a network meta-analysis to compare the three approaches in patients with pmVSD. METHODS: We searched for comparative studies on device closure and conventional repair for pmVSD to April 2020. A network meta-analysis was performed under the frequentist frame with risk ratio and 95% confidence interval. The main outcome was the procedural success rate. Additional outcomes were postoperative complications, including residual shunt, intra-cardiac conduction block, valvular insufficiency, incision infection, and pericardial effusion. RESULTS: Twenty-four studies of 8113 patients were included in the comparisons. The pooled estimates of success rate favored the CSR compared with the PDC. No significant differences of success rate were found in the TDC versus CSR and the PDC versus TDC. The pooled estimates of incidences of the residual shunt, new tricuspid regurgitation, incision infection, and pericardial effusion favored the PDC compared with the CSR. There were no significant differences between the PDC and TDC approaches in all outcomes except new aortic regurgitation. CONCLUSION: The PDC technique not only reduces the risk of significant complications compared with the CSR, but also produces not inferior results compared with the TDC in selected pmVSD patients. PROSPERO REGISTRATION NUMBER: CRD42019125257.

Hybrid procedure of right ventricle outflow tract stenting in small infants with pulmonary atresia and ventricular septal defect: early and mid-term results from a single centre.

IntroductionPulmonary atresia, ventricular septal defect, major aorto-pulmonary collateral arteries, and pulmonary arteries hypoplasia are rare and complex congenital defects that require early interventions to relieve cyanosis and enhance the growth of native pulmonary arteries. The treatment of these patients is still controversial. Surgical techniques require cardiopulmonary bypass which is poorly tolerated by small infants. Percutaneous techniques such as radiofrequency perforation can be challenging. The hybrid technique consists of perventricular stenting of the right ventricle outflow tract through medial sternotomy, to restore native pulmonary flow. METHODS: We retrospectively reviewed the cardiovascular database of our centre in order to analyse our experience in hybrid procedure. We detected six patients who underwent hybrid first approach between November 2007 and December 2015. We report our early results and mid-term outcomes. RESULTS: Median age at the procedure was 26 days, median weight was 3150 g, and median Nakata index was 52 mm2/m2. All procedures were successful except for one: this patient underwent a surgical shunt. No immediate and early deaths or major complications occurred and oxygen saturation levels increased in all the patients. Patients were followed up for a period of 12-103 months, and four of them underwent a procedure of unifocalisation at the mean age of 12.5 months. CONCLUSIONS: We reported data from the largest series of patients who underwent this hybrid procedure. Our experience demonstrated encouraging results to expand the use of this approach to bridge high-risk patients with diminutive pulmonary arteries to a second step of surgical repair.

Acute and midterm results following perventricular device closure of muscular ventricular septal defects: A multicenter PICES investigation.

OBJECTIVES: To describe acute and mid-term results of hybrid perventricular device closure of muscular ventricular septal defects (mVSDs). BACKGROUND: Perventricular device closure of mVSDs can mitigate technical limitations of percutaneous closure and need for cardiopulmonary bypass or ventriculotomy with a surgical approach. METHODS: This is a multicenter retrospective cohort study of patients undergoing hybrid perventricular mVSD device closure from 1/2004 to 1/2014. Procedural details, adverse events, outcomes, and follow-up data were collected. Patients were divided into two groups: (1) simple (mVSD closure alone) and (2) complex (mVSD closure with concomitant cardiac surgery). RESULTS: Forty-seven patients (60% female) underwent perventricular mVSD device closure at a median age of 5.2 months (IQR 1.8-8.9) and weight of 5.1 kg (IQR 4.0-6.9). Procedural success was 91% [100% (n = 22) simple and 84% (n = 21/25) complex]. Adverse events occurred in 19% (9/47) [9% (2/22) simple and 28% (7/25) complex]. Hospital length of stay (LOS) was shorter in the simple vs. complex group (4 vs. 14 days, P < 0.01). At mid-term follow-up of 19.2 months (IQR 2.3-43) 90% of pts had complete mVSD closure; none developed late heart block, increased atrioventricular (AV) valve insufficiency or ventricular dysfunction. CONCLUSIONS: Perventricular device closure of simple mVSD was associated with a high rate of procedural success, few adverse events, and short hospital LOS. Procedural adverse events were associated with the presence of concomitant complex surgery. Residual mVSD, AV valve insufficiency, or ventricular dysfunction were uncommon at mid-term follow-up. © 2017 Wiley Periodicals, Inc.

Perventricular device closure of doubly committed sub-arterial ventricular septal defects via a left infra-axillary approach.

BACKGROUND: This study sought to evaluate the feasibility, safety, and efficacy of perventricular device closure of a doubly committed sub-arterial ventricular septal defect (dcVSD) through a left infra-axillary approach. METHOD: Forty-five patients, with a dcVSD of less than 8 mm in diameter, were enrolled in this study. The pericardium was exposed and opened through a left infra-axillary mini-incision. Two parallel purse-string sutures were placed on the right ventricle outflow tract and under transesophageal echocardiography guidance, a delivery sheath loaded with the device was inserted into the right ventricle and advanced through the defect into the left ventricle. The device, connected to a delivery cable, was then deployed. RESULTS: Forty-one patients achieved successful device closure. In four patients, the device failed to occlude the VSD due to device dislodgement, device-related aortic regurgitation, and residual shunts, and open surgical repair was required. The mean dcVSD diameter was 4.5 ± 1.0 mm (range, 3.0-8.0 mm). The implanted device size was 6.0 ± 1.5 mm (range, 4-10 mm). All patients were implanted with an eccentric device. The mean intracardiac manipulation time was 20.9 ± 7.1 min (range, 9-45 min). The procedure time was 62.5 ± 19.5 min (range 34-105 min). There were no severe adverse events. CONCLUSIONS: Perventricular device closure of a dcVSD through a left infra-axillary approach is feasible, safe, and efficacious in selected patients with dcVSD.

Echocardiography-guided percutaneous per-ventricular laser ablation of ventricular septum: in vivo study in a canine model.

Surgical myectomy and ethanol ablation are established intervention strategies for left ventricular outflow obstruction in hypertrophic cardiomyopathy. Safety and efficacy limitations of these interventions call for a minimally invasive, potentially safer, and more efficacious strategy. In this study, we aimed to evaluate the feasibility of echocardiography-guided percutaneous per-ventricular laser ablation of a ventricular septum in a canine model. Six domestic dogs were chosen for the study. A 21G needle was inserted into the right ventricle with its tip reaching the targeted basal to mid-septum, after which laser ablation was performed as follows: 1-W laser for 3 min (180 J) at the basal segment and 5 min (300 J) at middle segment of the septum, respectively. Echocardiography, blood chemistry tests, and pathology examination were performed to assess the results of laser ablation. No death or major complications, i.e., tamponade, pericardial effusion, or ventricular fibrillation, occurred. The laser-ablated areas were well demarcated in the results of the pathological examination. The diameters of the ablated regions were 4.42 ± 0.57 and 5.28 ± 0.83 mm for 3 and 5 min ablation, respectively. Pre-ablation and post-ablation, cardiac enzymes were found to increase significantly while no significant differences were found among M-mode, 2D (LVEF), pulsed-wave (PW) Doppler, and tissue Doppler imaging (TDI) measurements. Contrast echocardiography confirmed the perfusion defects in the ablated regions. Microscopically, the ablated myocardium showed coagulative changes and a sparse distribution of disappearing nuclei and an increase in eosinophil number were observed. Our study suggests that percutaneous and per-ventricular laser ablation of the septum is feasible, potentially safe and efficacious, and warrants further investigation and validation.

Hybrid approach for pulmonary atresia with intact ventricular septum: early single center results and comparison to the standard surgical approach.

OBJECTIVES: To examine acute and mid-term patient outcomes following the hybrid approach to pulmonary atresia with intact ventricular septum (PA-IVS) compared with the standard surgical approach. BACKGROUND: A subset of PA-IVS patients with the prospect of biventricular circulation typically undergo surgical or transcatheter right ventricular (RV) outflow tract opening. A recently described hybrid procedure, involving perventricular pulmonary valve perforation, was shown to be safe and effective in single-center series. METHODS: A single-center retrospective review of all patient with PA-IVS who underwent either surgical or hybrid RV decompression between January 2002 and December 2011 was completed and acute and mid-term patient outcomes were compared between the surgical and hybrid cohorts. Additionally, a systematic literature review was completed to compare a transcatheter cohort to the hybrid cohort. RESULTS: Seven patients with PA-IVS underwent a hybrid procedure; the procedure was technically successful in all attempts, and none required CPB. No patients required surgical re-intervention prior to hospital discharge, and none died during the study period. Surgical RV decompression was performed in 17 patients with a median CPB time of 80 min. Patient outcomes were nearly identical between cohorts. By systematic review, the transcatheter approach has a procedural success of 75-95% but up to 75% of patients require operation in the neonatal period. CONCLUSIONS: The hybrid approach is a safe and feasible alternative to the standard surgical and transcatheter approaches to PA-IVS. Acute and mid-term patient outcomes are comparable with those treated with a standard surgical approach and neonatal CPB is completely avoided.

Perventricular device closure of the ventricular septal defects in children-first experience in the United Arab Emirates.

BACKGROUND: Ventricular septal defect (VSD) is the most common congenital cardiac malformation, accounting for approximately 30% of congenital heart defects. Conventional surgical repair using cardiopulmonary bypass is invasive and associated with morbidities and prolonged hospital stay. With the advent of interventional approaches and availability of different occluding devices, the technique of perventricular device closure is evolving and being implemented successfully in larger groups of patients. We present herein, our initial experience of perventricular device closure for the ventricular septal defects in children to assess risks and benefits. METHODS: From March, 2023 to February, 2024, we have performed perventricular closure of ventricular septal defects in 13 children, under guidance of transesophageal echocardiography without cardiopulmonary bypass support. The median age at operation was 2 year (range 1.3-10 years) with the median body weight 11 kg (range 8.7-16.6 kg). Sixty-nine percent were males. The ventricular septal defect sizes ranged from 2.7 to 6 mm (mean 4.7 mm). Seven defects were perimembranous, four sub-aortic and two were muscular. One patient also underwent pulmonary artery de-banding with pulmonary artery balloon angioplasty and other one patent ductus arteriosus ligation, concomitantly. For defect closure, we used ventricular septal defect occlusion device (MemoPart™, Lepu Medical Technology Company, China) through a 3-cm skin incision in the lower- third of the sternum. The device sizes ranged from 5 to 8 mm (mean 6.9+-1.8 mm) and all patients except for two required symmetrical devices. RESULTS: All patients underwent device closure successfully. The procedural duration ranged between 32 and 52 min. None of the patients required cardiopulmonary bypass. The mean ventilation time and intensive care unit stay was 3 and 24 h, respectively. None of the patients required inotropic support or blood transfusions. Moreover, no patients developed any arrhythmias including heart block. The average length of hospital stay was 4.4 days. At the latest follow up, there were no residual shunts, conduction disturbances, device dislodgement or major aortic or tricuspid valve complications seen in any patients. There was no mortality. CONCLUSIONS: Perventricular device closure of ventricular septal defects is a less invasive, extremely safe and effective method in children. It is associated with very fast recovery, shorter hospitalization time and better cosmetic incision. Moreover, it avoids cardiopulmonary bypass. The modifications and refinements in the design, material and implantation techniques will help in expanding the indications and prevent complications in the long-term.

Electroencephalographic Patterns on Follow-Up Visits in Extremely Premature Infants With Periventricular Leukomalacia: An Observational Study.

BACKGROUND: Periventricular leukomalacia (PVL) is a common brain injury in premature infants, and epilepsy remains a significant complication. One concerning electroencephalographic (EEG) pattern found is developmental and/or epileptic encephalopathy with spike-and-wave activation in sleep (DEE-SWAS). This pattern is associated with persistent neuropsychological and motor deficits, even without a diagnosis of epilepsy. The purpose of this study is to identify the relationships between various PVL grades and EEG patterns in this population on follow-up visits, especially the occurrence of DEE-SWAS pattern on EEG. METHODS: This is a retrospective study of <36 weeks gestational age newborns who were followed in the neurodevelopmental clinic at Corewell Health East/Corewell Health Children's Hospital in Royal Oak, Michigan, between 2020 and 2022. Patients' demographics along with prematurity complications, diagnostic head ultrasound (HUS), and EEG studies were reviewed and graded. EEG studies are usually ordered when seizures were suspected. RESULTS: A total of 155 newborns met the inclusion criteria. Twenty-six patients had PVL. Nine patients had grade 2 to 3 PVL based on HUS review. EEG was performed on 15 patients with PVL at a mean age of 22 months. More severe PVL grades were significantly associated with worse EEG patterns (P = 0.005). Five patients had DEE-SWAS pattern on EEG, all of whom had grade 2 or 3 PVL. Epilepsy was eventually diagnosed in three infants with PVL. CONCLUSIONS: EEG can help identify important abnormal electrographic patterns in premature infants with PVL early in life; this might give a window of opportunity to intervene early and improve long-term developmental outcomes in this population.

Hybrid perventricular device closure of doubly committed subarterial ventricular septal defects: mid-term results.

BACKGROUND: Doubly committed Subarterial ventricular septal defect (VSD) is a specific anatomic type of VSD located just beneath the aortic valve. The purpose of this study was to evaluate the safety and feasibility of using minimal invasive perventricular device closure in managing this type of VSD. METHODS: During Dec 2008 and Aug 2010, 34 Pediatric patients with doubly committed subarterial VSD who met the inclusion criteria for device closure were enrolled in this study. Perventricular closure was attempted using a unique design eccentric device under the guidance of real-time transesophageal echocardiography. Complications such as residual shunt, valve regurgitation, arrhythmias were all recorded in postoperative period and during follow-up. RESULT: Perventricular device closure was successfully done in 28 patients (82%). 6 patients converted to open surgical repair due to residual shunt >3mm (1 patient), more than mild degree aortic regurgitation (3 patients) and device mal-position (2 patients). Complete closure rate was achieved in 93% at discharge and 100% during 20 months follow-up. No severe complications such as device embolism, significant arrhythmias and noticeable valve regurgitation were noted during follow-up. Procedure induced trivial grade aortic valve regurgitation was noted in five (18%) patients after procedure while only one (4%) persisted during midterm follow-up. CONCLUSION: Perventricular closure of doubly committed subarterial VSDs appears to be a safe and effective minimally invasive technique with good mid-term outcomes.

Transventricular balloon dilation and stenting of the RVOT in small infants with tetralogy of fallot with pulmonary atresia.

INTRODUCTION: The management of small infants with tetralogy of Fallot (TOF) with pulmonary atresia (PA) and hypoplastic pulmonary arteries can be very challenging. METHODS: In three small infants (weight range 2,200-3,600 g, pulmonary trunk 2.0-3.2 mm), initial palliation consisted of sternotomy, transventricular puncture of the right ventricular outflow tract and atretic pulmonary valve, followed by balloon dilation (n = 1) or stent deployment (n = 2) from the right ventricle into the pulmonary trunk (stent diameter 5-6 mm, length 16 mm). RESULTS: The procedure resulted in adequate palliation with good anterograde flow to the pulmonary arteries and near normal saturations in all three patients (>92%); there was no associated morbidity. Additional transvenous stenting was required in all patients because of progressive muscular infundibular stenosis after a median of 3 months. Two patients evolved to full repair at the age of 5 months and one patient with multiple hilar stenoses requires additional percutaneous procedures through the stented RV outflow tract. CONCLUSION: Transventricular balloon dilation and stenting of the RVOT through medial sternotomy as initial palliation strategy appears a safe and well tolerated alternative treatment in small infants with TOF with PA and a hypoplastic pulmonary trunk.

Update on percutaneous and perventricular device closure of congenital ventricular septal defect.

INTRODUCTION: Ventricular septal defect is the most common congenital heart defect. Surgical repair has been standard therapy for symptomatic ventricular septal defects since the 1950s. Catheter-based device closure of ventricular septal defects emerged in the 1980s and has become a safe and effective alternative in select patients. AREAS COVERED: This review focuses on patient selection and procedural techniques for device closure of ventricular septal defects, including percutaneous and hybrid perventricular approaches. The available devices used for these procedures and outcomes of their use are reviewed. EXPERT OPINION: Percutaneous and perventricular device closure of ventricular septal defects is safe and effective in select patients. However, the majority of ventricular septal defects requiring closure continue to be managed with conventional surgery. Further development and investigation of transcatheter and hybrid surgical approaches for closing ventricular septal defects is required.

Comparison of perventricular and percutaneous ultrasound-guided device closure of perimembranous ventricular septal defects.

Background: Ultrasound-guided percutaneous device closure of perimembranous ventricular septal defects (PmVSD) is a minimally invasive recent treatment approach. Perventricular PmVSD device closure is an emerging radiation-free intervention, yet it comes with certain limitations. No studies compared both of these treatment approaches. Methods: We performed a retrospective institutional data comparison of percutaneous (PCP Group, n = 138) and perventricular (PVP Group, n = 67) ultrasound-guided device closure procedures in 205 patients with PmVSD between March 2017 and December 2022. Results: Patients of the PCP and PVP groups had a median age of 4.9 years (IQR, 3.1-14.0) and 5.3 years (IQR, 3.4-13.1) respectively. The median PmVSD diameter in the PCP Group was 4.0 mm (IQR, 3.3-5.3) and 5.2 mm (IQR, 4.0-7.0) in the PVP Group (p = 0.001). There was no significant difference in success rates between the PCP and PVP Groups (intention-to-treat population, 88.4% vs. 92.5%, p = 0.36; as-treated population, 88.4% vs. 89.3%, p = 0.84). 5/8 failed percutaneous cases that were shifted to the perventricular approach were successful. Compared to the PVP Group, patients of the PCP group experienced a significant decrease in ventilation time, drainage volume, and postoperative hospital stay (p < 0.001). The median follow-up period was 24 months (IQR, 6-42) for the PCP group and 61 months (IQR, 53-65) for the PVP group. The overall severe adverse event rate was 0% in the PCP group and 3.0% in the PVP group. Conclusions: Perventricular and percutaneous ultrasound-guided device closure of PmVSD are both effective and safe treatment options. The percutaneous approach offers less trauma and faster recovery and may be the preferred approach in selected patients.

Navigation guidance for ventricular septal defect closure in heart phantoms.

PURPOSE: Transesophageal echocardiography (TEE) is the preferred imaging modality in a hybrid procedure used to close ventricular septal defects (VSDs). However, the limited field of view of TEE hinders the maneuvering of surgical instruments inside the beating heart. This study evaluates the accuracy of a method that aims to support navigation guidance in the hybrid procedure. METHODS: A cardiologist maneuvered a needle to puncture the patient's heart and to access a VSD, guided by information displayed in a virtual environment. The information displayed included a model of the patient's heart and a virtual needle that reproduced the position and orientation of the real needle in real time. The physical and the virtual worlds were calibrated with a landmark registration and an iterative closest point algorithms, using an electromagnetic measurement system (EMS). For experiments, we developed a setup that included heart phantoms representing the patient's heart. RESULTS: Experimental results from two pediatric cases studied suggested that the information provided for guidance was accurate enough when the landmark registration algorithm was fed with coordinates of seven points clearly identified on the surfaces of the physical and virtual hearts. Indeed, with a registration error of 2.28 mm RMS, it was possible to successfully access two VSDs (6.2 mm and 6.3 mm in diameter) in all the attempts with a needle (5 attempts) and a guidewire (7 attempts). CONCLUSION: We found that information provided in a virtual environment facilitates guidance in the hybrid procedure for VSD closure. A clear identification of anatomical details in the heart surfaces is key to the accuracy of the procedure.

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.

Long-term outcomes after conventional surgical repair versus perventricular device occlusion for doubly committed subarterial ventricular septal defects: a propensity score matched study.

OBJECTIVES: This study aimed to investigate the long-term outcomes of perventricular device occlusion and surgical repair for doubly committed subarterial ventricular septal defect using propensity score matched analysis because previous comparative studies were limited by differences in the baseline characteristics. METHODS: We reviewed inpatients with isolated doubly committed subarterial ventricular septal defect aged <18 years who underwent surgical repair or device occlusion between January 2011 and December 2017. Propensity score matching was used to assemble a cohort of patients with similar baseline characteristics. RESULTS: A total of 336 patients underwent surgical repair; 99 underwent device occlusion. After matching, the repair group included 164 patients, whereas the device group had 91 patients. There were no significant differences in the baseline characteristics. The median follow-up periods were 46 and 58 months for the device and repair groups, respectively. No significant difference was noted in the rates of cumulative adverse events in the 2 groups (7.9% vs 5.5%; P = 0.61). The repair group required longer periods of hospitalization (P = 0.002) and mechanical ventilation (P = 0.016). No grade 3 or higher valvular regurgitation or high-degree atrioventricular block events were observed. All patients were in sinus rhythm at the last follow-up examination. CONCLUSIONS: In selected patients with doubly committed subarterial ventricular septal defect, compared with conventional repair, perventricular device occlusion has comparable efficacy and safety, less invasiveness in terms of time in the hospital and on mechanical ventilation and avoidance of cardiopulmonary bypass.

Indications and results for hybrid interventions in patients with congenital heart disease.

A hybrid therapy or procedure is a new treatment modality that develops by combining therapies from different subspecialties. In congenital heart disease, a growing number of such procedures have been described in recent decades, as a result of increasing collaboration between surgeons and interventionalists. The ideas behind these therapies include enabling the performance of procedures of different complexity in a less invasive manner, shortening procedural times, avoiding cardiopulmonary bypass, facilitating vascular access and decreasing the number of complications associated with more invasive approaches. Over the years, hybrid therapy has gained a place as a widely accepted therapeutic option for the management of several conditions in high-risk patients with congenital heart disease.