Abstract Background Transcatheter closure of ventricular septal defects (VSDs) presents technical challenges in patients with complex anatomies and residual post-surgical defects. This study aimed to evaluate the feasibility, safety, and early outcomes of percutaneous VSD closure using a range of occlusion devices in a heterogeneous patient population. Methods This was a retrospective single-centre observational study of patients who underwent percutaneous VSD closure between 2017 and 2024 at a tertiary congenital cardiac centre. Results Twenty patients were included (12 females, 8 males) with a median age of 5.5 years (range 6 months–72.9 years) and median body weight of 18 kg (range 6.4–127 kg). Native VSDs were present in 14 patients and residual post-surgical defects in 6. Defect types included perimembranous (n = 13; including 3 Gerbode defects) and muscular (n = 7). Procedural success was achieved in 95% (19/20). Immediate complete occlusion occurred in 65% (13/20), while 7 patients had small residual shunts that remained haemodynamically insignificant at 1-year follow-up. Complications included one case of transient haemolysis and one case of ventricular ectopy requiring surgical device retrieval. No cases of complete heart block, device embolisation, or significant valve injury were observed during follow-up. Conclusion Percutaneous VSD closure using a range of occlusion devices is feasible and safe across different anatomies and age groups, with high procedural success and low complication rates at one-year follow-up.
INTRODUCTION:Transcatheter interventions are becoming increasingly used to address postoperative residual lesions after Norwood procedure with Sano shunt. METHODS:This is a single-centre retrospective review of the outcome of all cases with Sano shunt at our institution over a 6-years period (2017-2023) who underwent transcatheter interventions. RESULTS:Thirteen out of the total 34 patients (38%) needed transcatheter interventions. The most common interventions were left pulmonary artery balloon angioplasty (n = 6), balloon angioplasty of aortic recoarctation (n = 6), and Sano shunt stenting (n = 5). Left pulmonary artery size improved from 3 [IQR; 2-5] mm to 4.9 [IQR; 2.7-7.3] mm post-intervention (p-value = 0.068), and gradient from 28 [IQR; 25-33] mmHg to 11 [IQR; 10-13] mmHg (p-value = 0.109). Balloon angioplasty of aortic recoarctation improved vessel size from 6.7 [IQR; 4-9] mm to 9.5 [IQR; 7-13] mm (p-value = 0.066), and reduced peak-to-peak gradient from 22.3 [IQR; 10-39] mmHg to 7.6 [IQR; 4-14] mmHg (p-value = 0.109). Finally, Stenting of Sano shunt resulted in increased shunt size from 3.4 [IQR; 3.1-3.6] mm to 5.5 [IQR; 4.2-6] mm (p-value = 0.066), and improvement of the oxygen saturation from 71.3 [IQR; 69-74] % to 85.3 [IQR; 83-89] % (p-value = 0.066). There was one procedure-related death. CONCLUSION:Transcatheter intervention for patients post Sano shunt is feasible with good results, improving haemodynamics and oxygenation of the patients and thereby allowing them to come on the proper time for the second stage palliation.
Children with single-ventricle physiology palliated with the Fontan circulation are prone to late complications, including atrioventricular valve (AVV) dysfunction. We present the case of a 9-year-old boy with left atrial isomerism, unbalanced atrioventricular septal defect, and an extracardiac Fontan who developed severe stenosis of a previously implanted bioprosthetic Magna Mitral Ease atrioventricular (AV) valve leading to Fontan circulation failure. On presentation with AVV stenosis, both surgical and catheter-based interventions were deemed high risk due to multiple previous sternotomies and complex anatomy. Cardiac transplant was not considered, as he did not meet the criteria for listing. A hybrid surgical-transcatheter approach was undertaken, allowing safe deployment of a Myval Octacor valve under direct vision. The procedure was successful, improving hemodynamic status with gradient reduced to 2.5 mmHg with no regurgitation. This case illustrates the feasibility of a novel hybrid atrioventricular valve-in-valve implantation in a Fontan patient, offering an alternative when conventional surgical or transcatheter approaches are unsuitable.
BACKGROUND:Transcatheter pulmonary valve implantation has emerged as a minimally invasive and preferred therapeutic option for patients with dysfunction of previously repaired right ventricular outflow tracts. The Myval™ Octacor valve is a new device designed for this purpose, though limited reports exist regarding its use in the pulmonary position. AIMS:To report the immediate and short-term outcomes of percutaneous pulmonary valve implantation using the Myval™ Octacor valve in patients with severe right ventricular-pulmonary artery conduit or pulmonary valve bioprosthesis dysfunction. METHODS:This was a single-centre retrospective review of data obtained from case files. RESULTS:The Myval™ Octacor valve was used in ten patients with a mean age of 34.5 ± 7.4 years. The median procedure duration and fluoroscopy time were 146 minutes and 30.5 minutes, respectively. The median Z-score for valves used was -0.5. The median right ventricular systolic pressure decreased from 68.5 mmHg pre-procedure to 33 mmHg post-procedure. The median peak instantaneous gradient across the right ventricular outflow tract or conduit decreased from 30 mmHg to 6.5 mmHg. There were no reported incidences of frame fracture, conduit rupture, device embolisation, or endocarditis. CONCLUSION:This is the first UK experience of using the new-generation Myval™ Octacor valve in percutaneous pulmonary valve implantation. The results demonstrate the valve's safety and clinical efficacy, with favourable outcomes in terms of procedural success, haemodynamic improvement, and echocardiographic findings.
BACKGROUND AND AIMS Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. METHODS Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. RESULTS Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively. CONCLUSIONS Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.
BACKGROUND:There are limited studies with medium-term follow-up following percutaneous pulmonary valve implantation and no studies with a gender-specific analysis. AIMS:To report clinical outcomes up to five years following percutaneous pulmonary valve implantation using the two most common balloon expandable valves in a mixed population of paediatric and adult patients with an age and gender-specific analysis. METHODS:This was a single-centre retrospective observation study. Relevant data were obtained retrospectively from the case files. Age and gender- specific analysis was performed using SPSS. RESULTS:Totally, 58 patients (13 children, 45 adults) underwent percutaneous pulmonary valve implantation. Statistically significant reduction in median right ventricular outflow tract flow velocity following valve implantation was maintained for the whole five years in adults but not in children. There were no gender-specific differences despite the study being adequately powered. Independent of valve type used, there was significant reduction of the right ventricular outflow tract flow velocity in the immediate post valve implantation period (Edwards P = 0.001, Melody P = 0.013). There was a significant negative correlation between implanted valve Z-score and subsequent right ventricular outflow tract gradient during the first two years following valve implantation. CONCLUSION:Gender does not significantly affect valve function following percutaneous pulmonary valve implantation. It is important to consider patients' age and body surface area in relation to existing right ventricular outflow tract size during decisions for percutaneous pulmonary valve implantation.
With the use of percutaneous pulmonary valve implantation rising globally, more clinicians are contemplating the balloon valve fracture of pre-existing bioprosthesis before valve deployment to avoid patient-bioprosthesis mismatch. However, such interventions often encounter limitations attributed to the material and construction of the pre-existing valve, leading to variable success rates. While the Trifecta valve has been widely recognized for its resistance to balloon fracture in earlier studies, recent reports have highlighted instances of success using serial high-pressure balloons (>5 mm of the labeled valve size) and exceeding pressures greater than manufacturer recommendations to achieve such results prior to percutaneous pulmonary valve implantation. By utilizing the aforementioned techniques, we attempted four cases of balloon valve fracture in our centre between January 2020 and January 2023. Regrettably, the outcomes were unsuccessful in all cases, and we conclude that balloon valve fracture of the Trifecta valve remains unpredictable even with the use of Cheathamplatinum stents. However, the risk remains low, and clinicians should consider further refining this technique to encourage reproducibility of the procedure.
We report successful off-label usage of the Edwards SAPIEN 3 Ultra valve in two cases of transcatheter tricuspid valve-in-valve implantation. Patients had previous tricuspid valve replacements for different conditions and became progressively symptomatic in recent years. Deployment was performed with Edwards eSheath and GORE DrySeal sheath, resulting in no major complications or valvular leaks during short-term follow-up.
The introduction of transcatheter pulmonary valve implantation (TPVI) has greatly benefited the management of right ventricular outflow tract dysfunction. Infective endocarditis (IE) is a feared complication of TPVI that affects valve durability and patient outcomes. Current recommendations provide only limited guidance on the management of IE after TPVI (TPVI-IE). This article, by a group of experts in congenital heart disease in children and adults, interventional cardiology, infectious diseases including IE, and microbiology, provides a comprehensive review of the current evidence on TPVI-IE, including its incidence, risk factors, causative organisms, diagnosis, and treatment. The incidence of TPVI-IE varies from 13–91/1000 person-years for Melody valves to 8–17/1000 person-years for SAPIEN valves. Risk factors include history of IE, DiGeorge syndrome, immunosuppression, male sex, high residual transpulmonary gradient and portal of bacteria entry. Staphylococci and streptococci are the most common culprits, whereas Staphylococcus aureus is associated with the most severe disease. In addition to the modified Duke criteria, a high residual gradient warrants a strong suspicion. Imaging studies are helpful for the diagnosis. Intravenous antibiotics guided by blood culture results are the mainstay of treatment. Invasive re-intervention may be required. TPVI-IE in patients with congenital heart disease exhibits several distinctive features. Whether specific valve types are associated with a higher risk of TPVI-IE requires further investigation. Patient and parent education regarding IE prevention may have a role to play and should be offered to all patients.
Percutaneous pulmonary valve implantation (PPVI) is safe and effective for treating right ventricle outflow tract (RVOT) dysfunction in patients with congenital heart disease. The Melody valve (Medtronic, Minneapolis, MN) used in the majority of cases has produced good outcomes despite a 2–4/100 patient-years incidence of infective endocarditis (IE). SAPIEN valves (Edwards Life Sciences, Irvine, CA) have been used in the pulmonary position since 2006. IE on SAPIEN valves has rarely been reported, and information on presentations and outcomes are therefore scant. We aim to report features of IE on SAPIEN valves after PPVI. We report 8 cases of IE on SAPIEN 3 valves in a retrospective multicenter cohort (EUROPULMS3, NCT05264181) of more than 700 patients. Two cases of IE after PPVI with SAPIEN XT valves were also identified. The 10 IE cases occurred in 8 males and 2 females aged 12 to 40 y. Five patients had surgical bioprostheses. Prestenting was performed in a single patient, with a homograft. No patients had genetic abnormalities. An increased residual gradient was present in 2 patients, consistent with the large diameters of the SAPIEN valves. Three patients had a history of IE or mediastinitis and 4 had identified portals of entry. In 8 patients, IE occurred early, within 6 months after PPVI. Some cases were diagnosed within a few days after the procedure. The main causative organisms were gram-positive bacteria. Of the three severely ill patients, two had Staphylococcus aureus and one Staphylococcus epidermidis. A patient with Enterococcus faecalis IE within a few days after PPVI had no history of gastrointestinal-tract symptoms. Two patients had negative blood cultures, including one whose samples were collected during antibiotic therapy. According to the modified Duke criteria, the diagnosis of IE was definite in 9 patients and possible in 1 patient. Six patients had a favorable outcome without relapses or recurrences after medical management only. Four patients were managed surgically, and two of them died of postoperative septic shock. IE on SAPIEN valves is a rare but severe complication that affects valve durability and patient outcomes. Further larger studies are needed to identify risk factors.
Patients with refractory heart failure due to chronic progressive cardiac myopathy (CM) may require mechanical circulatory support as a bridge to transplantation. A few patients can be weaned from support devices if recovery can be achieved. The identification of these patients is of great importance as recovery may be missed if the heart is unloaded by the ventricular assist device (VAD). Testing the load-bearing capacity of the supported left ventricle (LV) by temporarily and gradually reducing mechanical support during cardiac exercise can help identify responders and potentially aid the recovery process. An exercise training protocol was used in 3 patients (8 months, 18 months and 8 years old) with histological CM findings and myocarditis. They were monitored regularly using clinical information and functional imaging with VAD support. Echocardiographic examination included both conventional real-time 3D echocardiography (RT3DE) and speckle tracking (ST). A daily temporary reduction in pump rate (phase A) was followed by a permanent reduction in rate (phase B). Finally, pump stops of up to 30 min were performed once a week (phase C). The final decision on explantation was based on at least three pump stops. Two patients were weaned and successfully removed from the VAD. One of them was diagnosed with acute viral myocarditis. The other had chronic myocarditis with dilated myopathy and mild interstitial fibrosis. The noninvasive assessment of cardiac output and strain under different loading conditions during VAD therapy is feasible and helps identify candidates for weaning despite severe histological findings. The presented protocol, which incorporates new echocardiographic techniques for determining volume and deformation, can be of great help in positively guiding the process of individual recovery, which may be essential for selecting and increasing the number of patients to be weaned from VAD.
Abstract Introduction Percutaneous pulmonary valve implantation (PPVI) is an established alternative to the surgical approach to treat right ventricular outflow tract (RVOT) dysfunction in patients with congenital heart diseases. Previous reports have found favourable long term outcomes with low rates of complications. Aim To report clinical outcomes up to 5 years following PPVI in a mixed population of paediatric and adult patients with CHD from a single centre in UK and compare it with national and international standards. Methods Single-centre retrospective study of patients referred for PPVI between January 2013 and June 2020. Clinical data (demographics, echocardiography, MRI scan, invasive haemodynamic and cardiopulmonary exercise test data) were retrieved from case notes and electronic database (Heartsuite) before and after PPVI (follow up (FU) at 1, 6, 12 months and then annually until 5 years). For comparison the patient population was divided as following: pulmonary stenosis (PS), mixed pulmonary valve disease (mPD) or pulmonary regurgitation (PR). Medtronic Melody or Edwards Sapien (S3, XT and Ultra) valves were used. Statistical analysis was performed using SPSS (median and interquartile range (IQR) for demographics and Wilcoxon signed rank test for comparisons). Statistical significance was set at P<0.05. Results 63 patients were referred for PPVI (adults 54 patients and children 9 patients). 18 patients (29%) were deemed unsuitable for PPVI due to mismatch between RVOT size and the largest available valve in the market or coronaries being in close proximity to RVOT. 45 patients underwent a PPVI and their background demographics and clinical outcomes are shown in Table 1. One patient had perioperative severe PR and underwent conduit change on the next day. There was significant reduction in median RVOT velocity following PPVI in all patients with previous PS or mPD [median (IQR), 4.1 (0.5) vs. 2.8 (1.0) m/sec, (P<0.001) and this result remained up to 5 years (4.1 (0.5) vs. 2.8 (1.1), P=0.012). Independent of the valve type used there was significant reduction of the RVOT velocity in the immediate post-PPVI period [Edwards (P=0.001, Melody (P=0.013)], (Figure 1). No patient had clinically significant PR (PR≥moderate) following PPVI (mild PR=6/45) and this persisted up to 5 years FU. There was reduction in MRI measured median RV volumes following the PPVI in patients with pulmonary regurgitation which was approaching statistical significance (end diastolic volume 194 (110) vs. 142 (80), P=0.051 and end systolic volume 113 (117) vs. 95 (56)ml/m2, P=0.061, N=5). Two adults died from non-cardiac reasons during FU. No patients required reintervention. Conclusion PPVI remains an alternative to surgery with a high success and low complication rates. RVOT velocity and PR at five years follow up remain in levels not requiring any further intervention and this was accompanied by improvement of NYHA status. Funding Acknowledgement Type of funding sources: None.
The surgical placement of the Melody®valve in the mitral position in infants and young children was first reported in 2012. Since then, there have only been a limited number of technically oriented reports describing catheter techniques to tackle valve-related issues such as valve adjustment for somatic growth or the management of haemodynamically significant paravalvar regurgitation. We present a case study where severe paravalvar leaks were tackled using a hybrid approach and large low-pressure balloons in a child who had previously undergone Melody® valve implantation in the mitral position. The technical outcome remains very good at 18 months follow-up and the patient remains symptom-free.
AIMS Multiple surgical revisions are often necessary in individuals with congenital heart defects affecting the RVOT or pulmonary valve. There are no multicentre data on the feasibility and safety of percutaneous pulmonary valve implantation (PPVI) using the SAPIEN 3 (S3) transcatheter heart valve. The aim of this study was to explore the short-term safety, feasibility, and haemodynamic outcomes of PPVI using the S3 transcatheter heart valve. METHODS AND RESULTS Pulmonic S3 is an observational registry of patients undergoing PPVI with the S3 valve across centres in Europe and Canada. Data for 82 patients (mean age 27.3 years) were obtained. The most common underlying diagnosis was tetralogy of Fallot (ToF) (58.5%), with 16.0% of patients having native RVOT anatomy; 90.2% received pre-stenting. Prosthesis dislodgement occurred in one patient and conduit perforation in another. Both were successfully resolved without the need for open surgery. Peak systolic gradient over the RVOT fell from 46.3 mmHg to 17.2 mmHg, moderate/severe pulmonary regurgitation from 86.3% to 0.0%, and NYHA ≥II from 86.0% to 15.2%. During follow-up, valve thrombosis was observed in two patients which resolved with adequate anticoagulation. No other procedural complications, endocarditis, stent fracture or death were reported within two years. CONCLUSIONS PPVI with the S3 valve appears feasible and safe in a wide range of patients with congenital heart defects, with good short-term haemodynamic and functional outcomes.
Despite the increasing use of percutaenous valves, little is known about valve performance after external chest compression. We report a case of a compressed pulmonary Edwards Sapien® XT valve after resuscitation. With the patient on ECMO, successful redilatation was performed with unimpaired postprocedural valve function. We aim to increase the awareness for valve distortion after external chest compression with increasing numbers of transcatheter valvulations. We suggest that immediate re‐evaluation of the implanted device via biplane fluoroscopy is mandatory after resuscitation in such cases.
Objective: A 6-month-old patient with massively impaired left ventricular function: EF 35% (ejection fraction) LVEDD (left ventricular end diastolic diameter) 44 mm–2 SD, VTI (velocity time integral) aortal < Pc 3, Speckle-tracking (ST) longitudinal strain (GLS) 4Ch -6.5%, 2Ch -6.4%). Biopsy revealed histological diagnosis of dilative cardiomyopathy, DD chronical myocarditis. Genetic testing was performed for known cardiomyopathy encoding genes. LVAD-Berlin Heart (BH, left ventricular assist device) implantation 2 days after Admission to hospital because of clinical deterioration. A weaning plan including cardiac muscle training was performed over 14 weeks.
AbstractIntroductionAlthough the right jugular vein approach for percutaneous pulmonary valve implantation is well described, there are no reports that describe a percutaneous pulmonary valve implantation through a left superior caval vein to coronary sinus pathway.CaseA 14-year-old female with tetralogy of Fallot, mesocardia, left superior caval vein draining into the coronary sinus, and hemiazygos continuation of the inferior caval vein underwent ventricular septal defect closure, with homograft insertion from the right ventricle to the pulmonary artery, patch augmentation of the left pulmonary artery, and creation of an atrial communication. Thereafter followed numerous catheterisations and interventions with stent implantation for stenosis of the left pulmonary artery and the homograft, as did device closure of the atrial communication. When she was a 12-year-old, the indications for a percutaneous pulmonary valve implantation were fulfilled and she underwent implantation of a 22 mm Melody® valve through the left superior caval vein. The extra-stiff exchange wire was pre-formed into a “U-spiral”-type configuration, according to the underlying anatomy, in order to provide a smooth route for the delivery of stents, to create the landing zone, and for the implantation of the Melody “ensemble”. The procedure was performed under deep sedation according to our standard protocol. The duration of the procedure was 172 min and the radiation time was 24.9 min.ConclusionOn the basis of this unique experience, percutaneous pulmonary valve implantation is safe and feasible even in patients with unusual anatomy. Crucial is the “U-spiral” shaped configuration of the guide wire.