Ventricular Outflow Tract Dysfunction Research Articles

Finite element modeling with patient-specific geometry to assess clinical risks of percutaneous pulmonary valve implantation.

Percutaneous pulmonary valve implantation (PPVI) is a non-surgical treatment for right ventricular outflow tract (RVOT) dysfunction. During PPVI, a stented valve, delivered via catheter, replaces the dysfunctional pulmonary valve. Stent oversizing allows valve anchoring within the RVOT, but overexpansion can intrude on the surrounding structures. Potentially dangerous outcomes include aortic valve insufficiency (AVI) from aortic root (AR) distortion and myocardial ischemia from coronary artery (CA) compression. Currently, risks are evaluated via balloon angioplasty/sizing before stent deployment. Patient-specific finite element (FE) analysis frameworks can improve pre-procedural risk assessment, but current methods require hundreds of hours of high-performance computation. We created a simplified method to simulate the procedure using patient-specific FE models for accurate, efficient pre-procedural PPVI (using balloon expandable valves) risk assessment. The methodology was tested by retrospectively evaluating the clinical outcome of 12 PPVI candidates. Of 12 patients (median age 14.5 years) with dysfunctional RVOT, 7 had native RVOT and 5 had RV-PA conduits. Seven patients had undergone successful RVOT stent/valve placement, three had significant AVI on balloon testing, one had left CA compression, and one had both AVI and left CA compression. A model-calculated change of more than 20% in lumen diameter of the AR or coronary arteries correctly predicted aortic valve sufficiency and/or CA compression in all the patients. Agreement between FE results and clinical outcomes is excellent. Additionally, these models run in 2-6 min on a desktop computer, demonstrating potential use of FE analysis for pre-procedural risk assessment of PPVI in a clinically relevant timeframe.

Safety and Efficacy of Percutaneous Pulmonary Valve Implantation: The Singapore Experience

Background: Right ventricular outflow tract (RVOT) dysfunction in adult congenital heart disease patients frequently requires repeated interventions. Percutaneous pulmonary valve implantation (PPVI) is being used increasingly to treat pulmonary stenosis (PS) and regurgitation (PR), improving symptoms, right ventricular haemodynamics and function and, indirectly, left ventricular filling and function. This article explores the authors’ early local experience with PPVI. Methods: Between 2017 and 2022, PPVI was attempted in 10 patients at a single tertiary centre, including six with PS and four with PR. Patients underwent multimodality imaging and dental clearance. PPVI was then performed. Patients were continued on lifelong single antiplatelet therapy and dental hygiene was reinforced. Results: Overall, there was an 80% success rate of Melody PPVI in the 10 adult congenital heart disease (ACHD) patients (mean age 35.8 ± 13.7 years; 60% male), with significant improvements in RVOT pathology, right ventricle function and pulmonary pressures. Melody PPVI was cancelled in one patient due to risk of coronary compression, and an Edwards S3 PPVI was implanted in another patient instead due to a large RVOT size causing stent embolisation. Two patients experienced complications of bleeding and stent fracture, both of which were conservatively managed and had good long-term outcomes. Conclusion: The authors present their early local experience with PPVI in ACHD patients at a single tertiary centre. PPVI has proven to be safe and efficacious, improving PS and PR, right and left ventricle function and pulmonary pressures. Nonetheless, precautions must be taken to minimise complications such as coronary compression, access site bleeding, device embolisation and stent fracture.

Patients' and physicians' needs, experiences and preferences in the treatment of right ventricular outflow tract dysfunction

Background: patients with congenital heart defects, developing right ventricular outflow tract (rVoT) dysfunction, can face repeated open chest interventions over their lifetime. repeating surgery increases difficulties and procedural risks, and exposes patients to burdensome and long recovery times that may induce them to postpone the treatment, with possible severe and irreversible consequences for their health. The percutaneous procedure was introduced to delay the need for open chest surgery. uncertainties still exist regarding the lifelong consequences that may result from adopting different treatment strategies. current decisions on treatment depend on patients’ clinical needs, but also on physicians’ experience and opinion, patients’ preferences, and procedural costs. The objective is to identify which treatment characteristics influence decisions on how to treat patients with rVoT dysfunction. Methods: a literature review was conducted, followed by a discussion with a panel of experts. Ten treatment characteristics, potentially relevant for treatment, were identified and rated in a survey, according to the importance assigned to each characteristic by specialist physicians, patients and/or their caregivers. Results: while some characteristics appear to be more important (risk of severe complications associated with intervention delays) or less important (scar) to both physicians and patients/caregivers, other characteristics are rated differently in importance depending on subjects consulted, e.g., risk of complications during the months post intervention was among the most important characteristics for patients/caregivers, but the fifth most important characteristic for physicians. Conclusions: to optimize benefits and efficiency of the treatment strategies, perceptions and opinions from the different subjects involved, together with patients’ clinical needs and overall costs, should be considered in decision-making....

Producing and Testing Prototype Tissue-Engineered 3D Tri-Leaflet Valved Stents on Biodegradable Poly-ε-Caprolactone Scaffolds.

Transcatheter pulmonary valve replacement is a minimally-invasive alternative treatment for right ventricular outflow tract dysfunction and has been rapidly evolving over the past years. Heart valve prostheses currently available still have major limitations. Therefore, one of the significant challenges for the future is the roll out of transcatheter tissue engineered pulmonary valve replacement to more patients. In the present study, biodegradable poly-ε-caprolactone (PCL) nanofiber scaffolds in the form of a 3D leaflet matrix were successfully seeded with human endothelial colony-forming cells (ECFCs), human induced pluripotent stem cell-derived MSCs (hMSCs), and porcine MSCs (pMSCs) for three weeks for the generation of 3D tissue-engineered tri-leaflet valved stent grafts. The cell adhesion, proliferation, and distribution of these 3D heart leaflets was analyzed using fluorescence microscopy and scanning electron microscopy (SEM). All cell lineages were able to increase the overgrown leaflet area within the three-week timeframe. While hMSCs showed a consistent growth rate over the course of three weeks, ECFSs showed almost no increase between days 7 and 14 until a growth spurt appeared between days 14 and 21. More than 90% of heart valve leaflets were covered with cells after the full three-week culturing cycle in nearly all leaflet areas, regardless of which cell type was used. This study shows that seeded biodegradable PCL nanofiber scaffolds incorporated in nitinol or biodegradable stents will offer a new therapeutic option in the future.

Preliminary experience of transcatheter pulmonary valve replacement using domestic balloon-expandable valve

Objectives: To evaluate the feasibility and preliminary clinical results of transcatheter pulmonary valve replacement (TPVR) with the domestically-produced balloon-expandable Prizvalve system. Methods: This is a prospective single-center observational study. Patients with postoperative right ventricular outflow tract (RVOT) dysfunction, who were admitted to West China Hospital of Sichuan University from September 2021 to March 2023 and deemed anatomically suitable for TPVR with balloon-expandable valve, were included. Clinical, imaging, procedural and follow-up data were analyzed. The immediate procedural results were evaluated by clinical implant success rate, which is defined as successful valve implantation with echocardiography-assessed pulmonary regurgitation<moderate and peak trans-pulmonary pressure gradient<40 mmHg (1 mmHg=0.133 kPa). Results: A total of 5 patients were included, with 4 males, aged 14 to 37 years. The initial diagnosis included Tetralogy of Fallot (2 cases), truncus arteriosus (1 case), pulmonary atresia (1 case) and subaortic stenosis (1 case, prior Ross procedure). Four patients underwent RVOT reconstruction with homograft or artificial conduit, and one patient was treated with trans-annular patch technique. The indications of TPVR included RVOT obstruction and regurgitation (3 cases), isolated obstruction (1 case), and isolated regurgitation (1 case). Of the 4 patients with varying severity of ROVT obstruction, the average preprocedural peak jet velocity of RVOT was 3.5 m/s, and the average peak pressure gradient was 50.0 mmHg. Except for one patient, who had previously been implanted with a covered Cheatham-Platinum (CP) stent due to severe stenosis of the main pulmonary artery, other patients underwent pre-stenting with a covered CP stent before TPVR. Clinical implant success was achieved in all of the 5 patients, and there was no serious periprocedural complications. The average trans-pulmonary peak jet velocity and peak pressure gradient derived from postprocedural echocardiography was 2.3 m/s and 21.2 mmHg, respectively. All patients experienced significant symptom relief after the procedure. All patients completed 3-month follow-up, and 4 completed 6-month follow-up. There was no case of infectious endocarditis during follow-up. All patients were graded as NYHA functional class one at the latest follow-up. Conclusions: TPVR using the domestically-produced balloon-expandable Prizvalve system is safe and feasible for the treatment of patients with post-surgical RVOT dysfunction and suitable landing-zone anatomy. The safety, effectiveness, and long-term valve durability of the Prizvalve system deserve further research.

Long-term outcomes of transcatheter pulmonary valve implantation with melody and SAPIEN valves

BackgroundTranscatheter pulmonary valve implantation (TPVI) is effective for treating right ventricle outflow tract (RVOT) dysfunction. Factors associated with long-term valve durability remain to be investigated. MethodsConsecutive patients successfully treated by TPVI with Melody valves (n = 32) and SAPIEN valves (n = 182) between 2008 and 2020 at a single tertiary centre were included prospectively and monitored. ResultsThe 214 patients had a median age of 28 years (range, 10–81). The RVOT was a patched native pulmonary artery in 96 (44.8%) patients. Median follow-up was 2.8 years (range, 3 months–11.4 years). Secondary pulmonary valve replacement (sPVR) was performed in 23 cases (10.7%), due to stenosis (n = 22, 95.7%) or severe regurgitation (n = 1, 4.3%), yielding an incidence of 7.6/100 patient-years with melody valves and 1.3/100 patient-years with SAPIEN valves (P = 0.06). The 5- and 10-year sPVR-freedom rates were 78.1% and 50.4% with Melody vs. 94.3% and 82.2% with SAPIEN, respectively (P = 0.06). The incidence of infective endocarditis (IE) was 5.5/100 patient-years with Melody and 0.2/100 patient-years with SAPIEN (P < 0.0001). Factors associated with sPVR by univariate analysis were RV obstruction before TPVI (P = 0.04), transpulmonary maximal velocity > 2.7 m/s after TPVI (p = 0.0005), valve diameter ≤ 22 mm (P < 0.003), IE (P < 0.0001), and age < 25 years at TPVI (P = 0.04). By multivariate analysis adjusted for IE occurrence, transpulmonary maximal velocity remained associated with sPVR. ConclusionsTPVI is effective for treating RVOT dysfunction. Incidence of sPVR is higher in patients with residual RV obstruction or IE. IE add a substantial risk of TPVI graft failure and is mainly linked to the Melody valve. Social media abstractTranscatheter pulmonary valve implantation is effective for treating right ventricular outflow tract dysfunction in patients with congenital heart diseases. Incidence of secondary valve replacement is higher in patients with residual obstruction or infective endocarditis.

Clinical presentation of ventricular arrhythmias in patients with repaired Tetralogy of Fallot

BackgroundMany studies have investigated ventricular arrhythmias (VA) risk factors in patients with repaired Tetralogy of Fallot (TOF), but none have evaluated the clinical presentation of VA before and after pulmonary valve replacement (PVR). ObjectivesThis study examines the current VA prevalence and clinical presentation in patients with repaired TOF before and after PVR. MethodsRetrospective analysis performed on adult patients with repaired TOF from 1995 to 2021. Medical and surgical history, ECG, transthoracic echocardiogram, cardiac magnetic resonance imaging (MRI), cardiopulmonary exercise test (CPET) and 24-hour ECG Holter were evaluated. ResultsBefore PVR (154 patients, mean age 26 ± 11 years) 3.2 % of patients experienced sustained ventricular tachycardia (VT). Patients with VT were older at repair, presented more frequently with arrhythmic symptoms, QRS duration ≥180 ms, right ventricular outflow tract (RVOT) dysfunction with right ventricular (RV) dysfunction and complex premature ventricular complexes (PVC). All presented with monomorphic and hemodynamically tolerated VT, were referred after the VT episode and presented with longstanding RVOT dysfunction. After PVR (analysis performed on 85 patients, mean age 35 ± 13 years, mean follow-up 9 ± 1 years) VA incidence was not significantly different (6 %, equal to 0.7 % per year, p = .52). Two patients presented with resuscitated ventricular fibrillation (VF) related to short coupled PVC, while the others experienced monomorphic VT related to the development of a new hemodynamic lesion, all these patients received PVR after longstanding RVOT dysfunction with RV dysfunction. ConclusionCurrently the incidence of VA in patients with repaired TOF is low. Patients with VA are older at repair and more frequently present with longstanding RVOT dysfunction with RV dysfunction. While monomorphic VT are usually hemodynamically tolerated and rarely recurs after hemodynamic lesions resolution, VF related to short coupled PVC rarely can occur after PVR.

Infective endocarditis after transcatheter approach versus surgical pulmonary valve replacement: A meta-analysis.

Background In this meta-analysis, we aimed to assess the risk of infective endocarditis in transcatheter versus surgical pulmonary valve replacement patients. Methods We systematically searched PubMed, Cochrane, EMBASE, Scopus, and Web of Science for the studies that reported the event rate of infective endocarditis in both transcatheter and surgical pulmonary valve replacement between December 2012 and December 2021. Random-effects model was used in the meta-analysis. Results Fifteen comparison groups with 4,706 patients were included. The mean follow-up was 38.5±3.7 months. Patients with transcatheter pulmonary valve replacement had a higher risk of infective endocarditis than patients receiving surgically replaced valves (OR 2.68, 95% CI: 1.83-3.93, p<0.00001). The calculated absolute risk difference was 0.03 (95% CI: 0.01-0.05), indicating that if 1,000 patients received a surgical valve replacement, 30 cases of infective endocarditis would be prevented. A meta-regression of follow-up time on the incidence of infective endocarditis was not statistically significant (p=0.753). Conclusion Although transcatheter pulmonary valve replacement is a feasible alternative to surgical replacement in severe right ventricular outflow tract dysfunction, the higher incidence of infective endocarditis in transcatheter replacement remains a significant concern. Regarding this analysis, surgical treatment of right ventricular outflow tract dysfunction is still a viable option in patients with prohibitive risk.

Pre- and Postprocedure Imaging of Transcatheter Pulmonary Valve Implantation.

Transcatheter pulmonary valve replacement (TPVR) is a minimally invasive procedure for treatment of right ventricular outflow tract (RVOT) dysfunction in surgically repaired congenital heart diseases. TPVR is performed in these patients to avoid the high risk and complexity of repeat surgeries. Several TPVR devices are now available to be placed in the right ventricle (RV) to pulmonary artery (PA) conduit, native RVOT, or surgical bioprosthetic valves. Imaging is used before TPVR to determine patient eligibility and optimal timing, which is critical to avoid irreversible RV dilatation and failure. Imaging is also required for evaluation of contraindications, particularly proximity of the RVOT to the left main coronary artery and its branches. Cross-sectional imaging provides details of the complex anatomy in which the TPVR device will be positioned and measurements of the RVOT, RV-PA conduit, or PA. Echocardiography is the first-line imaging modality for evaluation of the RVOT or conduit to determine the need for intervention, although its utility is limited by the complex RVOT morphology and altered anatomy after surgery. CT and MRI provide complementary information for TPVR, including patient eligibility, assessment of contraindications, and key measurements of the RVOT and PA, which are necessary for procedure planning. TPVR, performed using a cardiac catheterization procedure, includes a sizing step in which a balloon is expanded in the RVOT, which also allows assessment of the risk for extrinsic coronary artery compression. Follow-up imaging with CT and MRI is used for evaluation of postprocedure remodeling and valve function and to monitor complications. ©RSNA, 2022 Online supplemental material is available for this article.

Transcatheter Pulmonary Valve Replacement from Autologous Pericardium with a Self-Expandable Nitinol Stent in an Adult Sheep Model.

Transcatheter pulmonary valve replacement has been established as a viable alternative approach for patients suffering from right ventricular outflow tract or bioprosthetic valve dysfunction, with excellent early and late clinical outcomes. However, clinical challenges such as stented heart valve deterioration, coronary occlusion, endocarditis, and other complications must be addressed for lifetime application, particularly in pediatric patients. To facilitate the development of a lifelong solution for patients, transcatheter autologous pulmonary valve replacement was performed in an adult sheep model. The autologous pericardium was harvested from the sheep via left anterolateral minithoracotomy under general anesthesia with ventilation. The pericardium was placed on a 3D shaping heart valve model for non-toxic cross-linking for 2 days and 21 h. Intracardiac echocardiography (ICE) and angiography were performed to assess the position, morphology, function, and dimensions of the native pulmonary valve (NPV). After trimming, the crosslinked pericardium was sewn onto a self-expandable Nitinol stent and crimped into a self-designed delivery system. The autologous pulmonary valve (APV) was implanted at the NPV position via left jugular vein catheterization. ICE and angiography were repeated to evaluate the position, morphology, function, and dimensions of the APV. An APV was successfully implanted insheep J. In this paper, sheep J was selected to obtain representative results. A 30 mm APV with a Nitinol stent was accurately implanted at the NPV position without any significant hemodynamic change. There was no paravalvular leak, no new pulmonary valve insufficiency, or stented pulmonary valve migration. This study demonstrated the feasibility and safety, in a long-time follow-up, of developing an APV for implantation at the NPV position with a self-expandable Nitinol stent via jugular vein catheterization in an adult sheep model.

Pulmonary Artery Pseudoaneurysm After Transcatheter Pulmonary Valve Replacement, a Novel Approach for Complication Management

Transcatheter pulmonary valve replacement (TPVR) using the SAPIEN 3 (Edwards Lifesciences) transcatheter heart valve is increasingly used to treat patients with right ventricular outflow tract (RVOT) dysfunction. Yet, TPVR in patients with calcified RVOT homografts remains challenging and carries a high risk of complications. We present a case of a dysfunctional 24-mm calcified RVOT homograft in a patient with a history of truncus arteriosus and hypoplastic branch pulmonary arteries.

E-40 | Demographic Features and Cost Analysis of Patients Undergoing Percutaneous Pulmonary Valve Implantation (PPVI), an Insight from the National Inpatient Sample (NIS) Database

BackgroundPercutaneous Pulmonary Valve Implantation (PPVI) was initially developed as an alternative to surgical management in patients with Right Ventricular Outflow Tract (RVOT) dysfunction, including stenosis or regurgitation. We present the first ever demographic analysis of patients from the National Inpatient Sample Database (NIS), undergoing PPVI including supplementation, repair or revision of stenotic valve conduits.MethodsNIS CORE datasets from 2012–2017 were used to extrapolate data for patients undergoing above procedures. Data was analyzed using SAS Analytics.ResultsOf the 37,559,346 cases recorded between 2012 to 2017, 463 met the inclusion criteria, including 291(62.9%) males and 172 (37.2%) females. Majority of the patients were white (60.1%), however, Hispanics were disproportionately represented as compared to their demographic distribution. The most common co-morbidities were diabetes (5.2%) and pulmonary diseases (5.8%). The mean age at admission was 24.9 years with an average length of stay of 3 days. Co-existing valvular disorders were present in only less than 10 cases. Mortality was also low, <=10 cases. Mean cost of inpatient stay was 53,794$ with a maximum of 456,788$. Data is illustrated in Table 1 and Table 2.ConclusionsDisclosuresM. S. Khan Nothing to disclose. A. Baqi Nothing to disclose. M. Al-Dabbas Nothing to disclose. J. Shah Nothing to disclose. W. Ullah Nothing to disclose. A. Khan Nothing to disclose. T. Mir Nothing to disclose. M. Z. Khan Nothing to disclose. F. Salman Nothing to disclose. K. H. Changal Nothing to disclose. M. Ahsan Nothing to disclose. S. S. Ali Nothing to disclose. H. Singh Nothing to disclose. BackgroundPercutaneous Pulmonary Valve Implantation (PPVI) was initially developed as an alternative to surgical management in patients with Right Ventricular Outflow Tract (RVOT) dysfunction, including stenosis or regurgitation. We present the first ever demographic analysis of patients from the National Inpatient Sample Database (NIS), undergoing PPVI including supplementation, repair or revision of stenotic valve conduits. Percutaneous Pulmonary Valve Implantation (PPVI) was initially developed as an alternative to surgical management in patients with Right Ventricular Outflow Tract (RVOT) dysfunction, including stenosis or regurgitation. We present the first ever demographic analysis of patients from the National Inpatient Sample Database (NIS), undergoing PPVI including supplementation, repair or revision of stenotic valve conduits. MethodsNIS CORE datasets from 2012–2017 were used to extrapolate data for patients undergoing above procedures. Data was analyzed using SAS Analytics. NIS CORE datasets from 2012–2017 were used to extrapolate data for patients undergoing above procedures. Data was analyzed using SAS Analytics. ResultsOf the 37,559,346 cases recorded between 2012 to 2017, 463 met the inclusion criteria, including 291(62.9%) males and 172 (37.2%) females. Majority of the patients were white (60.1%), however, Hispanics were disproportionately represented as compared to their demographic distribution. The most common co-morbidities were diabetes (5.2%) and pulmonary diseases (5.8%). The mean age at admission was 24.9 years with an average length of stay of 3 days. Co-existing valvular disorders were present in only less than 10 cases. Mortality was also low, <=10 cases. Mean cost of inpatient stay was 53,794$ with a maximum of 456,788$. Data is illustrated in Table 1 and Table 2. Of the 37,559,346 cases recorded between 2012 to 2017, 463 met the inclusion criteria, including 291(62.9%) males and 172 (37.2%) females. Majority of the patients were white (60.1%), however, Hispanics were disproportionately represented as compared to their demographic distribution. The most common co-morbidities were diabetes (5.2%) and pulmonary diseases (5.8%). The mean age at admission was 24.9 years with an average length of stay of 3 days. Co-existing valvular disorders were present in only less than 10 cases. Mortality was also low, <=10 cases. Mean cost of inpatient stay was 53,794$ with a maximum of 456,788$. Data is illustrated in Table 1 and Table 2. Conclusions DisclosuresM. S. Khan Nothing to disclose. A. Baqi Nothing to disclose. M. Al-Dabbas Nothing to disclose. J. Shah Nothing to disclose. W. Ullah Nothing to disclose. A. Khan Nothing to disclose. T. Mir Nothing to disclose. M. Z. Khan Nothing to disclose. F. Salman Nothing to disclose. K. H. Changal Nothing to disclose. M. Ahsan Nothing to disclose. S. S. Ali Nothing to disclose. H. Singh Nothing to disclose. M. S. Khan Nothing to disclose. A. Baqi Nothing to disclose. M. Al-Dabbas Nothing to disclose. J. Shah Nothing to disclose. W. Ullah Nothing to disclose. A. Khan Nothing to disclose. T. Mir Nothing to disclose. M. Z. Khan Nothing to disclose. F. Salman Nothing to disclose. K. H. Changal Nothing to disclose. M. Ahsan Nothing to disclose. S. S. Ali Nothing to disclose. H. Singh Nothing to disclose.

Tissue Engineered Transcatheter Pulmonary Valved Stent Implantation: Current State and Future Prospect.

Patients with the complex congenital heart disease (CHD) are usually associated with right ventricular outflow tract dysfunction and typically require multiple surgical interventions during their lives to relieve the right ventricular outflow tract abnormality. Transcatheter pulmonary valve replacement was used as a non-surgical, less invasive alternative treatment for right ventricular outflow tract dysfunction and has been rapidly developing over the past years. Despite the current favorable results of transcatheter pulmonary valve replacement, many patients eligible for pulmonary valve replacement are still not candidates for transcatheter pulmonary valve replacement. Therefore, one of the significant future challenges is to expand transcatheter pulmonary valve replacement to a broader patient population. This review describes the limitations and problems of existing techniques and focuses on decellularized tissue engineering for pulmonary valve stenting.

ТРАНСКАТЕТЕРНАЯ ИМПЛАНТАЦИЯ КЛАПАНА ЛЕГОЧНОЙ АРТЕРИИ ПОСЛЕ ХИРУРГИЧЕСКОЙ КОРРЕКЦИИ ПУТЕЙ ОТТОКА ПРАВОГО ЖЕЛУДОЧКА: ОПЫТ ОДНОГО ЦЕНТРА

Transcatheter pulmonary valve implantation (TPVI) is a relatively new method of treating patients with right ventricular outflow tract (RVOT) dysfunction after surgical treatment of congenital heart defects. Since its introduction in 2000 by Bonhoeffer, more than ten thousand of such procedures have been performed worldwide. Currently two types of valves are available in the Republic of Belarus: Melody TPVMedtronic and Edwards Sapien. TPVI is safe and effective in the majority of patients with RVOT dysfunction and in some selected patients with patched RVOT. The low complication rate and the reduced number of open-chest re-interventions over a patient’s lifetime are among the main advantages of the procedure. The article presents a literature review, and summarizes the experience and results of TPVI performed on 24 patients in the Republican Centre of Pediatric Surgery.

First experiences with Myval Transcatheter Heart Valve System in the treatment of severe pulmonary regurgitation in native right ventricular outflow tract and conduit dysfunction

The rate of morbidity and mortality related to pulmonary regurgitation and pulmonary stenosis are big concerns after the surgery for CHD. Percutaneous pulmonary valve implantation has been established as a less invasive technique compared to surgery with promising results according to long-term follow-up of the patients. There are only two approved valve options for percutaneous pulmonary valve implantation until now, which are Melody (Medtronic, Minneapolis, Minn, USA) and Sapien (Edwards Lifesciences, Irvine, Ca, USA). Both valves have limitations and do not cover entire patient population. Therefore, the cardiologists need more options to improve outcomes with fewer complications in a such promising area. Herein, we present a case series applying for pulmonary position in conduits and native right ventricular outflow tract of a new transcatheter valve system Myval ® which is designed for transcatheter aortic valve implantation procedures. This is the first patient series in which the use of Myvalv in dysfunctional right ventricular outflow tracts is described, after surgical repair of CHD.

An evaluation of patient outcomes following transcatheter pulmonary valve implantation: a meta-analysis

Abstract Background Transcatheter pulmonary valve implantation has emerged as an effective alternative to surgery in patients with congenital Right Ventricular Outflow Tract Dysfunction (RVOT). There is demonstrable evidence that Percutaneous Pulmonary Valve Implantation (PPVI) effectively restores conduit graft viability with a consequent improvement in right ventricular pressures. Aim The objective of this study was to perform a meta-analysis of all previously published studies examining the outcome of PPVI and the associated early and late peri-procedural factors in patients with RVOT dysfunction. Data from procedures performed within our own centre have also been included. Methodology We performed a meta-analysis of all observational studies investigating early and late outcomes following PPVI. Risk ratios and risk differences were pooled in a random-effects model. The I2 statistic was used to quantify heterogeneity between studies. We searched EMBASE, MEDLINE, CINAHL, PsychInfo and Cochrane databases from their inception until 2021. Studies were included if they reported any comparative data regarding study endpoints. Primary endpoint was mean RVOT gradient. Secondary end points include pulmonary regurgitation fraction, left and right ventricular end-diastolic and systolic volume indexes, and left ventricular ejection fraction. Complication rates were considered a safety endpoint. Results A total of 23 studies with 1501 participants enrolled were included in the final meta-analysis. The RVOT gradient decreased significantly [weighted mean difference (WMD) = −20.32 mmHg; 95% confidence interval (CI): −22.15, −19.11; p&amp;lt;0.001]. Mean right ventricular (RV) systolic pressures fell significantly [(WMD)= −18.4 mmHg; 95% CI: −16.4, −20.2; p&amp;lt;0.001) and RV diastolic pressures decreased significantly [(WMD) = −6.3 mmHg, 95% CI: −4.3, −8.9; p&amp;lt;0.001). Pulmonary regurgitation fraction (PRF) also decreased notably (WMD = −24.38%, 95% CI: −28.27, −17.32; p&amp;lt;0.001).The incidence of infective endocarditis was 1.8% (95% CI: 0.7–3.8). Conclusion PPVI is an effective and safe strategy in relieving right ventricular remodelling and improving haemodynamic and clinical outcomes in patients with RVOT dysfunction. Multi-centre collaborations are essential to further determine the long-term effects of PPVI on cardiac function, exercise tolerance and quality of life in RVOT dysfunction. Funding Acknowledgement Type of funding sources: None.

Percutaneous pulmonary valve implantation in children and adults with 5 years follow up: single centre experience

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&amp;lt;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&amp;lt;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.

Favorable Atrial Remodeling After Percutaneous Pulmonary Valve Implantation and Its Association With Changes in Exercise Capacity and Right Ventricular Function.

BackgroundRight atrial (RA) dilatation and impaired right ventricular (RV) filling are common in patients with RV outflow tract dysfunction. We aimed to study potential correlations between atrial function with clinically relevant hemodynamic parameters and to assess the predictive impact of atrial performance on the recovery of exercise capacity and RV pump function after percutaneous pulmonary valve implantation (PPVI).Methods and ResultsAltogether, 105 patients with right ventricular outflow tract dysfunction (median age at PPVI, 19.2 years; range, 6.2–53.4 years) who underwent cardiac magnetic resonance imaging before and 6 months after PPVI were included. RA and left atrial maximal and minimal volumes as well as atrial passive and active emptying function were assessed from axial cine slices. RA emptying function was inversely related to invasive RV end‐diastolic pressure, and RA passive emptying correlated significantly with peak oxygen uptake. After PPVI, a significant decrease in RA minimum volume was observed, whereas RA passive emptying function improved, and RA active emptying function decreased significantly. Patients with predominant right ventricular outflow tract stenosis showed more favorable changes in RA active and left atrial passive emptying than those with primary volume overload. None of the RA and left atrial emptying parameters was predictive for recovery of peak oxygen uptake or RV ejection fraction.ConclusionsIn patients with right ventricular outflow tract dysfunction, impaired RA emptying assessed by cardiac magnetic resonance imaging was associated with increased RV filling pressures and lower exercise capacity. PPVI leads to a reduction in RA size and improved passive RA emptying function. However, RA function was not associated with improved exercise performance and RV pump function.

#81: Care Process Measures and Outcomes of Percutaneous Pulmonary Valve Implantation-associated Infective Endocarditis

Abstract Background Percutaneous pulmonary valve implantation (PPVI) is being increasingly used as a minimally invasive corrective procedure for right ventricular outflow tract (RVOT) dysfunction. Ten-year survival following PPVI is estimated at over 90% due to the durability of the various bioprosthetic valves. However, infective endocarditis (IE) remains a potential complication of such valves with significant morbidity and mortality. We evaluated the presenting symptoms, clinical features, pathogens, and outcomes of patients with IE following PPVI to identify opportunities to improve early diagnosis and management. Methods A convenience sample of patients at a large Pediatric Cardiology practice in Northern Virginia was queried for PPVI and IE from January 1, 2016, to June 30, 2019. Manual chart review was done to extract clinical points of interest and descriptive analyses were performed. Patients were classified as having IE per modified Duke’s criteria. Results We identified 14 patients who underwent PPVI. Five of these patients (36%) developed IE. All IE patients had underlying Tetralogy of Fallot and none had previous episodes of IE. 60% of patients with IE were male with a median age of 26 years old (IQR 20–30). Four IE patients had a Melody valve and 1 had a SAPIEN valve. The median elapsed time between PPVI and IE diagnosis was 128 days (IQR 32–391) with a median duration of illness prior to the diagnosis of IE of 6 days (IQR 5–9). All IE patients had to present fever. 40% of IE patients had to present chest pain and 20% had presenting musculoskeletal pain. All IE patients had an elevated initial C-reactive protein (CRP) with a median value of 13.1 mg/dL (IQR 12.5–15.2). The median initial white blood cell count was 9.3 × 103/μL (IQR 8.1–10.3). The median duration of bacteremia was 1 day (IQR 1–2). A pathogen was recovered in all five IE patients with different organisms amongst the patients: coagulase-negative Staphylococcus species were recovered in patients who developed IE within 60 days from PPVI (Staphylococcus lugdunensis and Staphylococcus epidermidis) whereas coagulase-negative Staphylococcus species and oral commensal organisms were found in IE patients beyond 60 days from PPVI (Staphylococcus sanguinis, Gamella haemolysans, and Neisseria elongata). The initial echocardiogram did not show vegetations in any of the patients and 40% went on to have sternotomy with valve replacement. There were no deaths. Conclusions With an increase in PPVI, clinicians should have a high index of suspicion for IE in patients with underlying Tetralogy of Fallot who present with fever and elevated CRP, regardless of elapsed time from PPVI or valve type. Empiric antimicrobial therapy for suspected IE following PPVI should remain broad with other possible pathogens beyond coagulase-negative Staphylococcus species.

Abstract 16466: Greater Body Mass Index Predicts Valve Function Following Transcatheter Pulmonary Valve Replacement in Adults With Tetralogy of Fallot

Introduction: After the initial surgical repair of tetralogy of Fallot (rTOF), right ventricular outflow tract dysfunction is common, with pulmonary stenosis (PS), regurgitation, or both. Obese adults with rTOF have worse biventricular systolic function, and greater post-operative pulmonary valve replacement morbidity than non-obese patients. Transcatheter PVR (TPVR) is used increasingly, though no studies have examined the impact of body mass index (BMI) on morbidity and hemodynamics in adults with rTOF and subsequent TPVR. Hypothesis: BMI affects outcomes of transcatheter PVR in adults with TOF. Methods: This was a 10 yr, single center, retrospective review of adults (&gt;18 yo) with rTOF who underwent TPVR. The cohort was split into 2 groups based on BMI at time of TPVR. Group A (Grp A): normal and overweight (BMI &lt;30), group B (Grp B): obese (BMI ≥30). Pre and post-TPVR echocardiogram, cardiac MRI, and catheterization data were reviewed. Results: There were 81 adults, 42 (52%) normal, 18 (22%) overweight (Grp A) and 21 (26%) obese (Grp B). Mean follow up was 6.4 + 3.1 yrs. With most recent post-TPVR echocardiogram, there was no significant difference in LV or RV size and function across groups. Compared to Grp A, Grp B patients were more likely to develop any degree of PS (mild, moderate, or severe) following TPVR (69% vs 94%, respectively, p = 0.032). An ROC curve analysis demonstrated BMI ≥ 26.3 had a low sensitivity (45%), but good specificity (89%) for predicting PS post TPVR. There was no difference between groups requiring re- intervention for PVR. Conclusion: This is the first study to show greater BMI affects valve function in adults with rTOF following TPVR. BMI &gt;26 was associated with a greater risk of PS in follow up echocardiograms after TPVR. Obesity is an epidemic in the US and patient prosthesis mismatch may be an issue when considering TPVR. Further studies are indicated to determine the long-term effects of BMI on TPVR and the need for re-intervention in adults with TOF.