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Background: Transcatheter pulmonary valve replacement (TPVR) with the self-expanding Harmony valve (Medtronic) is an emerging treatment for patients with native or surgically repaired right ventricular outflow tract (RVOT) pulmonary regurgitation (PR). Limited data are available since U.S. Food and Drug Administration approval in 2021., Objectives: In this study, the authors sought to evaluate the safety and short-term effectiveness of self-expanding TPVR in a real-world experience., Methods: This was a multicenter registry study of consecutive patients with native RVOT PR who underwent TPVR through April 30, 2022, at 11 U.S., Centers: The primary outcome was a composite of hemodynamic dysfunction (PR greater than mild and RVOT mean gradient >30 mm Hg) and RVOT reintervention., Results: A total of 243 patients underwent TPVR at a median age of 31 years (Q1-Q3: 19-45 years). Cardiac diagnoses were tetralogy of Fallot (71%), valvular pulmonary stenosis (21%), and other (8%). Acute technical success was achieved in all but 1 case. Procedural serious adverse events occurred in 4% of cases, with no device embolization or death. Hospital length of stay was 1 day in 86% of patients. Ventricular arrhythmia prompting treatment occurred in 19% of cases. At a median follow-up of 13 months (Q1-Q3: 8-19 months), 98% of patients had acceptable hemodynamic function. Estimated freedom from the composite clinical outcome was 99% at 1 year and 96% at 2 years. Freedom from TPVR-related endocarditis was 98% at 1 year. Five patients died from COVID-19 (n = 1), unknown causes (n = 2), and bloodstream infection (n = 2)., Conclusions: In this large multicenter real-world experience, short-term clinical and hemodynamic outcomes of self-expanding TPVR therapy were excellent. Ongoing follow-up of this cohort will provide important insights into long-term outcomes., Competing Interests: Funding Support and Author Disclosures Dr Goldstein is a consultant, proctor, and investigator for Medtronic; is a consultant and investigator for Edwards Lifesciences; is a consultant and proctor for W.L. Gore and Associates; is a consultant and advisory board member for Mezzion Pharmaceuticals; and is a consultant for PECA Labs. Dr McElhinney is a consultant and proctor for Medtronic and Edwards Lifesciences. Dr Gillespie is a consultant and proctor for Medtronic and W.L. Gore and Associates. Dr Aboulhosn is a consultant, advisory board member, and proctor for Medtronic; and is a consultant and proctor for Edwards Lifesciences. Dr Levi is a consultant for Medtronic and Edwards Lifesciences. Dr Cabalka is a consultant and investigator for Medtronic and Edwards Lifesciences; and is a consultant for B. Braun. Dr Zampi is a consultant and proctor for Medtronic and W.L. Gore and Associates; and is on the data safety monitoring board for Encore Medical. Dr Balzer is a consultant and proctor for Medtronic, Edwards Lifesciences, and Abbott. Dr Law is a proctor for Medtronic, Edwards Lifesciences, and W.L. Gore and Associates. Dr Qureshi is a consultant and proctor for Medtronic, W.L. Gore and Associates, and B. Braun. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter pulmonary valve replacement (TPVR) has expanded and evolved since its initial commercial approval in the United States in 2010., Objectives: This study sought to characterize real-world practice, including patient selection, procedural outcomes, complications, and off-label usage., Methods: Characteristics and outcomes for patients undergoing balloon-expandable TPVR were collected from the American College of Cardiology National Cardiovascular Data Registry IMPACT (Improving Pediatric and Adult Congenital Treatment) Registry., Results: Between April 2016 and March 2021, 4,513 TPVR procedures were performed in patients with a median age of 19 years, 57% with a Melody (Medtronic Inc) and 43% with a SAPIEN (Edwards Lifesciences) valve. Most implanting centers performed <10 cases annually. One-third of transcatheter pulmonary valve implants were into homograft conduits, one-third were into bioprosthetic valves (BPVs), 25% were in native or patched right ventricular outflow tracts (RVOTs), and 6% were into Contegra (Medtronic Inc) conduits. Over the course of the study period, SAPIEN valve use grew from ∼25% to 60%, in large part because of implants in patients with a native/patched RVOT. Acute success was achieved in 95% of patients (95.7% in homografts, 96.2% in BPVs, 94.2% in native RVOTs, and 95.4% in Contegra conduits). Major adverse events occurred in 2.4% of procedures, more commonly in patients with a homograft (2.9%) or native RVOT (3.4%) than a prior BPV (1.4%; P = 0.004)., Conclusions: This study describes novel population data on the use and procedural outcomes of TPVR with balloon-expandable valves. Over time, there has been increasing use of TPVR to treat regurgitant native RVOT anatomy, with the SAPIEN valve more commonly used for this application., Competing Interests: Funding Support and Author Disclosures A portion of this work was supported by the National Institutes of Health (T32HL007604) to Dr Stefanescu Schmidt. The manuscript contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health. Dr Stefanescu Schmidt is an investigator for Occlutech. Dr Armstrong is a consultant and proctor for Medtronic and Edwards Lifesciences and an investigator for Edwards Lifescience. Dr Aboulhosn is a consultant and proctor for Medtronic and Edwards Lifesciences. Dr Jones is an investigator, consultant, proctor, and Clinical Event Committee member for Medtronic; and is an investigator and consultant for Edwards Lifesciences. Dr Levi is a consultant for Medtronic and Edwards Lifesciences. Dr McElhinney is a consultant and proctor for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: Fontan patients have variable exercise capacity. Contemporary understanding as to which factors predict high tolerance is limited., Methods: Records from the Ahmanson/University of California, Los Angeles Adult Congenital Heart Disease Center were reviewed for adult Fontan patients who underwent CPET. Patients were considered "high performers" if their maximum oxygen uptake (VO 2 max/kg)-predicted was greater than 80%. Cross-sectional clinical, hemodynamic, and liver biopsy data was gathered. High-performers were compared to control patients across these parameters via associations and regression., Results: A total of 195 adult patients were included; 27 patients were considered "high performers". They had lower body mass indices (BMI, p < 0.001), mean Fontan pressures (p = 0.026), and cardiac outputs (p = 0.013). High performers also had higher activity levels (p < 0.001), serum albumin levels (p = 0.003), non-invasive and invasive systemic arterial oxygen saturations (p < 0.001 and p = 0.004), lower New York Heart Association (NYHA) heart failure class (p = 0.002), and were younger at Fontan completion (p = 0.011). High performers had less severe liver fibrosis (p = 0.015). Simple regression found Fontan pressure, non-invasive O 2 saturation, albumin level, activity level, age at Fontan surgery, NYHA class, and BMI to predict significant changes in VO 2 max/kg %-predicted. These associations persisted in multiple regression for non-invasive O 2 saturation, NYHA class II, activity level, and BMI., Conclusions: Thin Fontan patients who exercise more had better exercise capacity, Fontan hemodynamic profiles, and less liver fibrosis., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Patients with repaired tetralogy of Fallot are at elevated risk for ventricular arrhythmia and sudden cardiac death. Over the past decade, the pathogenesis and natural history of ventricular tachycardia has become increasingly understood, and catheter ablation has emerged as an effective treatment modality. Concurrently, there has been great progress in the development of a versatile array of transcatheter valves that can be placed in the native right ventricular outflow tract for the treatment of long-standing pulmonary regurgitation. Although such valve platforms may eliminate the need for repeat cardiac operations, they may also impede catheter access to the myocardial substrates responsible for sustained macro-reentrant ventricular tachycardia. This manuscript provides the rationale and design of a recently devised multicenter study that will examine the clinical outcomes of a uniform, preemptive strategy to eliminate ventricular tachycardia substrates before transcatheter pulmonary valve implantation in patients with tetralogy of Fallot., Competing Interests: Declaration of Competing Interest Drs. Aboulhosn and Levi report a relation with Edwards Lifesciences Corp. that includes consulting or advisory and with Medtronic Inc. that includes consulting or advisory. The remaining authors have no competing interests to declare., (Published by Elsevier Inc.)

Background: The Harmony transcatheter pulmonary valve (TPV) is the first U.S. Food and Drug Administration-approved device for severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT)., Objectives: One-year safety and effectiveness of the Harmony TPV were evaluated in patients from the Harmony Native Outflow Tract Early Feasibility Study, Harmony TPV Pivotal Study, and Continued Access Study, representing the largest cohort to date of Harmony TPV recipients., Methods: Eligible patients had severe PR by echocardiography or PR fraction ≥ 30% by cardiac magnetic resonance imaging and clinical indications for pulmonary valve replacement. The primary analysis included 87 patients who received a commercially available TPV22 (n = 42) or TPV25 (n = 45) device; 19 patients who received an early device iteration prior to its discontinuation were evaluated separately., Results: In the primary analysis, median patient age at treatment was 26 years (IQR: 18-37 years) in the TPV22 group and 29 years (IQR: 19-42 years) in the TPV25 group. At 1 year, there were no deaths; 98% of TPV22 and 91% of TPV25 patients were free from the composite of PR, stenosis, and reintervention (moderate or worse PR, mean RVOT gradient >40 mmHg, device-related RVOT reoperation, and catheter reintervention). Nonsustained ventricular tachycardia occurred in 16% of patients. Most patients had none/trace or mild PR (98% of TPV22 patients, 97% of TPV25 patients). Outcomes with the discontinued device are reported separately., Conclusions: The Harmony TPV device demonstrated favorable clinical and hemodynamic outcomes across studies and valve types through 1 year. Further follow-up will continue to assess long-term valve performance and durability., Competing Interests: Funding Support and Author Disclosures This study was supported by Medtronic. Dr Gillespie serves as a consultant for Medtronic; as an advisory board member and a consultant for Abbott; and as a consultant and principal investigator for W. L. Gore & Associates. Dr McElhinney serves as a proctor and consultant for Medtronic. Dr Jones is an investigator, a consultant, and a proctor for Medtronic; and is an investigator and a consultant for Edwards Lifesciences. Dr Levi serves as a consultant for Edwards Lifesciences and Medtronic. Dr Asnes is a consultant for Medtronic. Dr Gray receives research support as an investigator for Medtronic and Edwards Lifesciences. Dr Cabalka is an investigator and a consultant for Medtronic and Edwards Lifesciences. Dr Qureshi serves as a consultant for Medtronic and W.L. Gore & Associates. Dr Justino serves as a consultant for Abbott, Abiomed, Baylis Medtech, Chiesi USA, Edwards Lifesciences, Janssen Research and Development, Medtronic, and Pediastent; and is a cofounder of PolyVascular. Dr Benson serves as consultant for Medtronic. Mr Haugan is a full-time employee and shareholder of Medtronic. Dr Cheatham serves as a consultant, a principal investigator, a proctor, and an advisory board member for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: A favorable postnatal prognosis in cases of pulmonary atresia/critical stenosis with intact ventricular septum (PA/CS-IVS) is generally equated with the possibility of achieving biventricular (BV) repair. Identification of fetuses that will have postnatal univentricular (UV) circulation is key for prenatal counseling, optimization of perinatal care and decision-making regarding fetal therapy. We aimed to evaluate the accuracy of published models for predicting postnatal circulation in PA/CS-IVS using a large internationally derived validation cohort., Methods: This was a systematic review of published uni- and multiparametric models for the prediction of postnatal circulation based on echocardiographic findings at between 20 and 28 weeks of gestation. Models were externally validated using data from the International Fetal Cardiac Intervention Registry. Sensitivity, specificity, predictive values, area under the receiver-operating-characteristics curves (AUCs) and proportion of cases with true vs predicted outcome were calculated., Results: Eleven published studies that reported prognostic parameters of postnatal circulation were identified. Models varied widely in terms of the main outcome (UV (n = 3), non-BV (n = 3), BV (n = 3), right-ventricle-dependent coronary circulation (n = 1) or tricuspid valve size at birth (n = 1)) and in terms of the included predictors (single parameters only (n = 6), multiparametric score (n = 4) or both (n = 1)), and were developed on small sample sizes (range, 15-38). Nine models were validated externally given the availability of the required parameters in the validation cohort. Tricuspid valve diameter Z-score, tricuspid regurgitation, ratios between right and left cardiac structures and the presence of ventriculocoronary connections (VCC) were the most commonly evaluated parameters. Multiparametric models including up to four variables (ratios between right and left structures, right ventricular inflow duration, presence of VCC and tricuspid regurgitation) had the best performance (AUC, 0.80-0.89). Overall, the risk of UV outcome was underestimated and that of BV outcome was overestimated by most models., Conclusions: Current prenatal models for the prediction of postnatal outcome in PA/CS-IVS are heterogeneous. Multiparametric models for predicting UV and non-BV circulation perform well in identifying BV patients but have low sensitivity, underestimating the rate of fetuses that will ultimately have UV circulation. Until better discrimination can be achieved, fetal interventions may need to be limited to only those cases in which non-BV postnatal circulation is certain. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology., (© 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.)

Background: Recurrent laryngeal nerve injury leading to vocal cord paralysis is a known complication of cardiothoracic surgery. Its occurrence during interventional catheterisation procedures has been documented in case reports, but there have been no studies to determine an incidence., Objective: To establish the incidence of left recurrent laryngeal nerve injury leading to vocal cord paralysis after left pulmonary artery stenting, patent ductus arteriosus device closure and the combination of the procedures either consecutively or simultaneously., Methods: Members of the Congenital Cardiovascular Interventional Study Consortium were asked to perform a retrospective analysis to identify cases of recurrent laryngeal nerve injury after the aforementioned procedures. Twelve institutions participated in the analysis. They also contributed the total number of each procedure performed at their respective institutions for statistical purposes., Results: Of the 1337 patients who underwent left pulmonary artery stent placement, six patients (0.45%) had confirmed vocal cord paralysis. 4001 patients underwent patent ductus arteriosus device closure, and two patients (0.05%) developed left vocal cord paralysis. Patients who underwent both left pulmonary artery stent placement and patent ductus arteriosus device closure had the highest incidence of vocal cord paralysis which occurred in 4 of the 26 patients (15.4%). Overall, 92% of affected patients in our study population had resolution of symptoms., Conclusion: Recurrent laryngeal nerve injury is a rare complication of left pulmonary artery stent placement or patent ductus arteriosus device closure. However, the incidence is highest in patients undergoing both procedures either consecutively or simultaneously. Additional research is necessary to determine contributing factors that might reduce the risk of recurrent laryngeal nerve injury.

Transcatheter pulmonary valve replacement was first performed by Dr Philip Bonhoeffer, who implanted a Medtronic Melody valve in a human in 2000. Over the past 2 decades, there have been many advances in transcatheter pulmonary valve technology. This includes the use of the SAPIEN transcatheter heart valve in the pulmonary position, modifications and refinements to valve implantation procedures, and development of self-expanding valves and prestents to treat large diameter native or patched right ventricular outflow tracts. This article reviews the current transcatheter pulmonary valve technologies with a focus on valve design, screening process, implant procedure, and clinical outcomes., (© 2022 The Author(s).)

Zinc (Zn) and Zn alloys have been studied as potential materials for bioresorbable stents (BRSs) in the last decade due to their favorable biodegradability and biocompatibility. However, most Zn alloys lack the necessary combination of strength, ductility, fatigue resistance, corrosion rate (CR), and thermal stability needed for such applications. In this study, nanoparticles made of tungsten carbide (WC) were successfully incorporated into Zn alloyed with 0.5 wt % magnesium (Mg) and evaluated for their suitability for BRS applications. Specifically, the resulting Zn-0.5Mg-WC nanocomposite's microstructure, mechanical properties, in vitro CR, and thermal stability were evaluated. The Zn-0.5Mg-WC nanocomposite had excellent mechanical strength [ultimate tensile strength (UTS) > 250 MPa], elongation to failure (>30%), and a suitable in vitro CR (∼0.02 mm/y) for this clinical application. Moreover, the Zn-0.5Mg-WC nanocomposite survived 10 million cycles of tensile loading (stress ratio, R = 0.053) when the maximum stress was 80% of the yield stress. Its ductility was also retained during a 90-day thermal stability study, indicating an excellent shelf life. Stent prototypes were fabricated using this composition and were successfully deployed during bench testing without fracture. These results show that the Zn-0.5Mg-WC nanocomposite is a promising material for BRS applications. In vivo studies are underway to validate both biocompatibility, stent function, and degradation.

Background: Transcatheter pulmonary valve (TPV) replacement (TPVR) has become the standard therapy for postoperative pulmonary outflow tract dysfunction in patients with a prosthetic conduit/valve, but there is limited information about risk factors for death or reintervention after this procedure., Objectives: This study sought to evaluate mid- and long-term outcomes after TPVR in a large multicenter cohort., Methods: International registry focused on time-related outcomes after TPVR., Results: Investigators submitted data for 2,476 patients who underwent TPVR and were followed up for 8,475 patient-years. A total of 95 patients died after TPVR, most commonly from heart failure (n = 24). The cumulative incidence of death was 8.9% (95% CI: 6.9%-11.5%) 8 years after TPVR. On multivariable analysis, age at TPVR (HR: 1.04 per year; 95% CI: 1.03-1.06 per year; P < 0.001), a prosthetic valve in other positions (HR: 2.1; 95% CI: 1.2-3.7; P = 0.014), and an existing transvenous pacemaker/implantable cardioverter-defibrillator (HR: 2.1; 95% CI: 1.3-3.4; P = 0.004) were associated with death. A total of 258 patients underwent TPV reintervention. At 8 years, the cumulative incidence of any TPV reintervention was 25.1% (95% CI: 21.8%-28.5%) and of surgical TPV reintervention was 14.4% (95% CI: 11.9%-17.2%). Risk factors for surgical reintervention included age (0.95 per year [95% CI: 0.93-0.97 per year]; P < 0.001), prior endocarditis (2.5 [95% CI: 1.4-4.3]; P = 0.001), TPVR into a stented bioprosthetic valve (1.7 [95% CI: 1.2-2.5]; P = 0.007), and postimplant gradient (1.4 per 10 mm Hg [95% CI: 1.2-1.7 per 10 mm Hg]: P < 0.001)., Conclusions: These findings support the conclusion that survival and freedom from reintervention or surgery after TPVR are generally comparable to outcomes of surgical conduit/valve replacement across a wide age range., Competing Interests: Funding Support and Author Disclosures Dr McElhinney has served as a consultant for Medtronic. Dr Levi has served as a consultant for Edwards and Medtronic. Dr Goldstein has served as a consultant for Medtronic. Dr Shahanavaz has served as a consultant for Edwards and Medtronic. Dr Qureshi has served as a consultant for Edwards, Medtronic, W.L. Gore and Associates, and Abiomed Inc. Dr Cabalka has served as a consultant for Medtronic. Dr Torres has served as a proctor for Edwards. Dr Morray has served as a consultant for Medtronic. Dr Armstrong has served as a consultant for Edwards and Medtronic; and has received research grants from Edwards. Dr Aboulhosn has served as a consultant for Edwards and Medtronic; and has received research grants from Edwards. Dr Berger has served as a consultant for Medtronic. Dr Sondergaard has served as a consultant for and received research grants from Edwards and Medtronic. Dr Schranz has served as a consultant for Medtronic. Dr Jones has served as a consultant for and received research grants from Edwards and Medtronic. Dr Cheatham has served as a consultant for Medtronic and NuMED. Dr Schubert has served as a proctor for Abbott, Edwards, Gore, Lifetech, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Cor triatriatum sinister (CTS) is a rare congenital cardiac anomaly representing <0.1% of all congenital cardiac malformations. It is characterized by the presence of a left atrial (LA) membrane that leads to left ventricular inflow obstruction. Uncorrected, obstructed CTS may have significant sequelae such as pulmonary hypertension or arrhythmias. Transcatheter balloon decompression has been described as a successful alternative to surgical resection of the obstructing membrane. Our review of the literature revealed no reported cases utilizing radiofrequency (RF) energy to perforate the CTS membrane prior to balloon decompression. This manuscript describes two patients with CTS who were treated successfully with a transcatheter technique using RF energy to perforate the obstructing membrane prior to balloon angioplasty and decompression of the LA., (© 2021 Wiley Periodicals LLC.)

Background: Endocarditis has emerged as one of the most impactful adverse events after transcatheter pulmonary valve replacement (TPVR), but there is limited information about risk factors for and outcomes of this complication., Objectives: The purpose of this study was to evaluate risk factors for and outcomes of endocarditis in a large multicenter cohort., Methods: The authors established an international registry focused on characterizing endocarditis after TPVR, including the incidence, risk factors, characteristics, and outcomes., Results: Investigators submitted data for 2,476 patients who underwent TPVR between July 2005 and March 2020 and were followed for 8,475 patient-years. In total, 182 patients were diagnosed with endocarditis a median of 2.7 years after TPVR, for a cumulative incidence of 9.5% (95% CI: 7.9%-11.1%) at 5 years and 16.9% (95% CI: 14.2%-19.8%) at 8 years (accounting for competing risks: death, heart transplant, and explant) and an annualized incidence of 2.2 per 100 patient-years. Staphylococcus aureus and Viridans group Streptococcus species together accounted for 56% of cases. Multivariable analysis confirmed that younger age, a previous history of endocarditis, and a higher residual gradient were risk factors for endocarditis, but transcatheter pulmonary valve type was not. Overall, right ventricular outflow tract (RVOT) reintervention was less often to treat endocarditis than for other reasons, but valve explant was more often caused by endocarditis. Endocarditis was severe in 44% of patients, and 12 patients (6.6%) died, nearly all of whom were infected with Staphylococcus aureus., Conclusions: The incidence of endocarditis in this multicenter registry was constant over time and consistent with prior smaller studies. The findings of this study, along with ongoing efforts to understand and mitigate risk, will be critical to improve the lifetime management of patients with heart disease involving the RVOT. Although endocarditis can be a serious adverse outcome, TPVR remains an important tool in the management of RVOT dysfunction., Competing Interests: Funding Support and Author Disclosures Drs McElhinney, Morray, Goldstein, Cabalka, Berger, and Schranz have served as consultants for Medtronic. Drs Aboulhosn and Levi have served as consultants for Edwards and Medtronic; and has received research grants from Edwards. Dr Qureshi has served as a consultant for Edwards, Medtronic, W.L. Gore and Associates, and Abiomed Inc. Dr Torres has served as a proctor for Edwards. Dr Shahanavaz has served as a consultant for Edwards and Medtronic. Dr Armstrong has served as a consultant for Edwards and Medtronic; and has received research grants from Edwards. Dr Sondergaard has served as a consultant for Edwards and Medtronic; and has received research grants from Edwards and Medtronic. Dr Jones has served as a consultant for Edwards and Medtronic; and has received research grants from Edwards and Medtronic. Dr Cheatham has served as a consultant for Medtronic and NuMED. Dr Schubert has served as a proctor for Abbott, Edwards, Gore, Lifetech, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: A large-diameter, intravascular, self-expanding stent system capable of continued expansion during somatic and vascular growth was modeled with finite element analysis (FEA), manufactured and tested in an animal model., Background: Children can quickly outgrow intravascular stents. If a stent could expand after implantation in arteries this would be ideal for use in pediatric patients., Methods: Computer-aided design and FEA were used to design and manufacture large-diameter, self-expanding nitinol stents with both high and low chronic outward force (COF). Four distinct stents with similar designs but with variable lengths and strut thicknesses were manufactured. Fourteen of these stents were implanted in the abdominal aortas or iliac arteries of four juvenile swine., Results: All animals survived without complication to their designated time points of harvest (90 or 180-days), and all stents expanded to greater diameters than the adjacent non-stented artery. Luminal diameter growth was 34-49% and 20-23% for stented and non-stented segments, respectively. Histologic examination revealed variable degrees of the internal elastic lamina and/or medial disruption with a mean injury score ranging from 0.70 ± 0.56 to 1.23 ± 0.21 and low COF stents implanted in smaller arteries having a larger injury score. Inflammatory responses and stenosis formation were minimal and ranged from 0.50 ± 0.71 to 3.00 ± 0.00 and 5.52 ± 1.05% to 14.68 ± 9.12%, respectively. The stent's COF did not correlate with vessel expansion or vascular injury., Conclusions: Self-expanding stents can mirror and even exceed somatic growth. Although longer-term testing is needed, it may be possible to custom tailor self-expanding stents to expand after arterial implantation in pediatric patients., (© 2021 Wiley Periodicals LLC.)

Single ventricle hearts palliated with the Fontan operation present complications later in life as a result of increased venous pressures and abnormal ventricle function. Wave intensity analysis uses measurements of blood velocity and pressure to represent arterial hemodynamics as summations of energy waves. This methodology could potentially be a useful tool in assessment of Fontan patients. The clinical value of wave intensity parameters was utilized to evaluate the functional performance of the single ventricle in Fontan patients. A retrospective analysis of invasive hemodynamic data was retrospectively obtained from routine cardiac catheterization of patients with Fontan circulation (n = 20) and comparison to those with biventricular circulation (n = 10) who presented to the catheterization laboratory for closure of small patent ductus arteriosus (PDAs). Wave intensity analysis and wave energy flux was calculated using aortic pressure waveforms and echocardiography aortic Doppler measurements as previously described. Significant differences were seen in the peak forward compression wave (p = 0.013), early systolic energy flux (p = 0.005) and the systolic and diastolic ratio (p = 0.006) in Fontan patients versus controls. Within the Fontan group, there was a positive correlation (0.54, p = 0.02) between the wave speed and pulmonary vascular resistance. Early systolic energy flux was a potential individual indicator of a Fontan patients heart failure classification (AUC = 0.71). Wave intensity analysis could be a useful tool in screening Fontan patients and predicting clinical outcomes and Fontan failure. Future prospective analyses of Fontan hemodynamics and WIA are needed.

Transcatheter closure of large apical muscular ventricular septal defects (VSDs) can be performed via transfemoral or hybrid approach. A very large apical muscular VSD was closed via a hybrid approach. A strategy for deployment of a right ventricular stay suture was utilized to minimize the risk of device embolization without the use of bypass and without externalization of a portion of the device., (© 2020 Wiley Periodicals LLC.)

Objectives: To determine over-dilation potential of commercially available covered stents., Background: Covered stents including the Atrium iCast, Gore VBX, and Lifestream stents (LS) can treat ruptures, dissections, and aneurysms in small vessels. Especially in growing patients, stents often require serial dilations beyond their implant or nominal diameters. Tolerance of serial dilations is clinically important information for interventionalists., Methods: Serial dilations of 5-12 mm iCast, VBX, and LS covered stents were performed in 1-2 mm increments (up to 20 mm). With each dilation, foreshortening and recoil were measured, and stent strut and covering integrity were assessed. High-pressure balloons were used to expand the stents until they fractured or could not be further expanded., Results: The 5-8 mm LS tolerated dilation to 14.5-16 mm. The 10-12 mm LS stents tolerated dilation to 18 mm and fractured on the 20 mm balloon. LS stents foreshortened 35%-45% on average after 8 mm of over-dilation and had 5%-10% recoil on <6 mm over-dilation. All iCast stents tolerated dilation to 12-13 mm and required fracture for dilation to >14 mm. ICast stents foreshortened 19%-29% at maximum dilation, with 3-6% recoil on <2 mm over-dilation, and < 3% thereafter. VBX stents over-dilated to 2.9-4.7 mm above nominal, foreshortening 40%-50% after 4-6 mm of over-dilation before collapsing into a ring. VBX stent recoil was <2.5% on all dilations., Conclusions: LS stents had the greatest over-dilation potential. VBX stents had the least recoil but tended to foreshorten significantly 3-4 mm above nominal. Regardless of nominal size, all iCast stents (including the 5 mm) tolerated dilation to a maximum of 12-13 mm., (© 2020 Wiley Periodicals LLC.)

Background: There are limited published data focused on outcomes of transcatheter pulmonary valve replacement (TPVR) with either a Sapien XT or Sapien 3 (S3) valve., Objectives: This study sought to report short-term outcomes in a large cohort of patients who underwent TPVR with either a Sapien XT or S3 valve., Methods: Data were entered retrospectively into a multicenter registry for patients who underwent attempted TPVR with a Sapien XT or S3 valve. Patient-related, procedural, and short-term outcomes data were characterized overall and according to type of right ventricular outflow tract (RVOT) anatomy., Results: Twenty-three centers enrolled a total of 774 patients: 397 (51%) with a native/patched RVOT; 183 (24%) with a conduit; and 194 (25%) with a bioprosthetic valve. The S3 was used in 78% of patients, and the XT was used in 22%, with most patients receiving a 29-mm (39%) or 26-mm (34%) valve. The implant was technically successful in 754 (97.4%) patients. Serious adverse events were reported in 67 patients (10%), with no difference between RVOT anatomy groups. Fourteen patients underwent urgent surgery. Nine patients had a second valve implanted. Among patients with available data, tricuspid valve injury was documented in 11 (1.7%), and 9 others (1.3%) had new moderate or severe regurgitation 2 grades higher than pre-implantation, for 20 (3.0%) total patients with tricuspid valve complications. Valve function at discharge was excellent in most patients, but 58 (8.5%) had moderate or greater pulmonary regurgitation or maximum Doppler gradients >40 mm Hg. During limited follow-up (n = 349; median: 12 months), 9 patients were diagnosed with endocarditis, and 17 additional patients underwent surgical valve replacement or valve-in-valve TPVR., Conclusions: Acute outcomes after TPVR with balloon-expandable valves were generally excellent in all types of RVOT. Additional data and longer follow-up will be necessary to gain insight into these issues., Competing Interests: Author Disclosures This study received funding from Edwards Lifesciences, Inc., to support data management and analysis, but there was no direct participation by employees of Edwards Lifesciences, Inc. Drs. Aboulhosn, Asnes, and Torres have served as proctors for Edwards Lifesciences. Dr. Balzer has served as a proctor for Edwards Lifesciences and Medtronic. Drs. Berman and Zahn have served as a proctor and consultant for Edwards Lifesciences, Abbott, and Medtronic. Dr. Gillespie has served as a consultant for Medtronic. Dr. Goldstein has served as a consultant for Medtronic; has served as a consultant and proctor for W.L. Gore & Associates; and has served on the PECA Labs Advisory Board. Dr. Levi has served as a consultant and proctor for Edwards Lifesciences. Dr. McElhinney has served as a consultant and proctor for Medtronic. Dr. Morgan has served as a consultant and proctor for Edwards Lifesciences; and has served as a consultant for Medtronic. Dr. Murray has served as a consultant for Medtronic and Abbott. Dr. Shahanavaz has served as a proctor for Edwards Lifesciences and Medtronic. Dr. Sathanandam has served as a proctor and consultant for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: For patients with combined tricuspid and pulmonary valve disease, operative intervention carries high mortality risk. Published reports of combined transcatheter tricuspid and pulmonary valve replacement have been limited to single cases., Methods: A retrospective chart review was performed including all patients undergoing combined transcatheter tricuspid and pulmonary valve replacement at the Ahmanson/UCLA Adult Congenital Heart Disease Center., Results: Combined transcatheter tricuspid and pulmonary valve replacement was undertaken in five adult patients (median age: 46 years; range: 24-64 years). Three had congenital heart disease and two had carcinoid syndrome. Four patients had previous surgical tricuspid valve replacement and one had a surgical incomplete annuloplasty ring. Four patients had previous surgical pulmonary valve replacement and one had a right ventricle-to-pulmonary artery homograft conduit. Two patients underwent Medtronic Melody valve implantation in both tricuspid and pulmonary positions and three underwent Edwards Sapien S3 implantation in both tricuspid and pulmonary positions. Valve implantation was successful in all. Follow-up ranged from 0.9 to 3.0 years. One patient underwent redo transcatheter tricuspid valve replacement 12 months after the first transcatheter intervention for progressive regurgitation of a Melody valve. This patient died 2.5 years after combined valve placement of complications from refractory heart failure. The remaining patients were alive and free of valve reintervention at follow-up., Conclusions: Combined transcatheter tricuspid and pulmonary valve replacement can be performed successfully, with an acceptable complication rate. This strategy is a feasible option for appropriately selected patients.

Objectives: We aimed to evaluate the utility of computed tomography angiography (CTA) for coronary compression (CC) prediction in patients with congenital heart disease undergoing balloon-expandable transcatheter pulmonary valve replacement (TPVR)., Background: Coronary compression is a serious complication of TPVR, but the value of preprocedural CTAs to assess CC risk is largely unexplored., Methods: In all, 586 patients underwent TPVR between January 2009 and July 2018. Adults with a pre-TPVR CTA and children with a CTA performed less than one year prior to TPVR were included. Patients with poor CTA image quality or with aborted cases due to reasons other than CC were excluded. Sixty-six patients were finally included. Cardiac anatomy was assessed via multiplanar reconstruction of CTAs., Results: Coronary compression occurred in 9 (14%) of the 66 patients who underwent TPVR. Most CC cases (seven of nine) occurred in patients with conduits. Proximity of the right ventricular outflow tract (RVOT) landing zone to the coronary arteries and to the chest wall was a significant risk factor for compression ( P < .001 and P = .019, respectively). Compression risk increased significantly if patients had an RVOT to coronary artery distance of ≤3 mm ( P < .001) and an RVOT to chest wall distance of ≤8 mm ( P = .026). Anomalous course of coronary arteries was another significant univariate risk factor ( P = .003)., Conclusions: Right ventricular outflow tract landing zone distance of ≤3 mm to a coronary artery, landing zone distance of ≤8 mm to the chest wall, and anomalous coronary arteries are associated with increased CC risk. Electrocardiogram gating may not be necessary if coronary arteries are opacified on CTAs. Larger studies are needed to explore and confirm these coronary artery compression risk factors.

Congenital interventional cardiology has seen rapid growth in recent decades due to the expansion of available medical devices. Percutaneous interventions have become standard of care for many common congenital conditions. Unfortunately, patients with congenital heart disease often require multiple interventions throughout their lifespan. The availability of transcatheter devices that are biodegradable, biocompatible, durable, scalable, and can be delivered in the smallest sized patients will rely on continued advances in engineering. The development pipeline for these devices will require contributions of many individuals in academia and industry including experts in material science and tissue engineering. Advances in tissue engineering, bioresorbable technology, and even new nanotechnologies and nitinol fabrication techniques which may have an impact on the field of transcatheter congenital device in the next decade are summarized in this review. This review highlights recent advances in the engineering of transcatheter-based therapies and discusses future opportunities for engineering of transcatheter devices.

Objectives: We sought to delineate the risk factors for infective endocarditis (IE) in patients undergoing transcatheter pulmonary valve replacement (TCPVR)., Background: Despite the therapeutic benefits of TCPVR for treatment of dysfunctional right ventricular outflow tracts, IE is a major complication of the approach. Specific hemodynamic gradients and patient immune status as predisposing factors for IE are largely unexplored., Methods: We performed a retrospective review of patients who had undergone TCPVR at UCLA between October 2010 and October 2017. Cases of IE were diagnosed based on the modified Duke criteria., Results: Two hundred and thirty-five cases of TCPVR were performed with a mean follow-up of 2.6 years (range 0.0-8.0 years). Sixteen distinct IE events developed in 13 patients (Melody™ n = 12, SAPIEN n = 1), with a median time from implant to IE of 3.3 years (range 2.0-7.2 years). Univariate Cox regression showed that immunocompromised status was significantly associated with the development of IE hazard ratios (HR 5.43 [1.80-16.4], p = .003). Kaplan-Meier curves show that the 5-year freedom from IE among immunocompetent patients was 87% (95% CI 78-96%) versus 64% (95% CI 39-89%) among immunocompromised patients (log-rank p = .02). Postimplant right ventricular systolic pressure was higher among immunocompromised patients (p = .03). The risk of IE post-TCPVR in immunocompromised patients with residual pulmonary stenosis was 43%., Conclusions: Among the risk factors examined in this study, immunocompromised status was the most significant predictor of IE development post-TCPVR. Patients with the lowest risk of IE are those with competent immune systems, without a history of IE, and with minimal residual pulmonary valve gradients post-TCPVR., (© 2019 Wiley Periodicals, Inc.)

Objective: We examined the atrial tachyarrhythmia (AT) burden among patients with congenital heart disease (CHD) following transcatheter (TC-) or surgical (S-) pulmonary valve replacement (PVR)., Design/setting: This was a retrospective observational study of patients who underwent PVR from 2010 to 2016 at UCLA Medical Center., Patients: Patients of all ages who had prior surgical repair for CHD were included. Patients with a history of congenitally corrected transposition of the great arteries, underwent a hybrid PVR procedure, or had permanent atrial fibrillation (AF) without a concomitant ablation were excluded., Outcome Measures: The primary outcome was a time-to-event analysis of sustained AT. Sustained ATs were defined as focal AT, intra-atrial reentrant tachycardia/atrial flutter, or AF lasting at least 30 seconds or terminating with cardioversion or antitachycardia pacing., Results: Two hundred ninety-seven patients (TC-PVR, n = 168 and S-PVR, n = 129) were included. During a median follow-up of 1.2 years, nine events occurred in TC-PVR group (5%) vs 23 events in S-PVR group (18%). In the propensity adjusted models, the following factors were associated with significant risk of AT after PVR: history of AT, age at valve implantation, severe right atrial enlargement, and S-PVR. In the secondary analysis, TC-PVR was associated with lower adjusted risk of AT events in the postoperative epoch (first 30 days), adjusted IRR 0.31 (0.14-0.97), P = .03, but similar risk in the short-term epoch, adjusted IRR 0.64 (0.14-2.94), P = .57., Conclusion: There was an increased risk of AT in the first 30 days following S-PVR compared to TC-PVR. Additional factors associated with risk of AT events after PVR were a history of AT, age at valve implantation, and severe right atrial enlargement., (© 2019 Wiley Periodicals, Inc.)

Objectives: To report the results of the Nit-Occlud PDA prospective postapproval study (PAS) along with a comparison to the results of the pivotal and continued access trials., Background: The Nit-Occlud PDA (PFM Medical, Cologne, Germany), a nitinol coil patent ductus arteriosus (PDA) occluder, was approved by the Food and Drug Administration in 2013., Methods: The PAS enrolled a total of 184 subjects greater than 6 months of age, weighing at least 5 kg, with PDAs less than 4 mm by angiography at 11 centers. Patients were followed prospectively at 2 months, 12 months, and 24 months postprocedure. These outcomes were compared to the 357 subjects enrolled in the pivotal and continued access protocols. Efficacy and safety data were reported., Results: Among 184 subjects enrolled for the PAS between 2014 and 2017, 180 (97.8%) had successful device implantation. After 12 months, 98.7% (150/152) had trivial or no residual shunt by echocardiography and two subjects had only small residual shunts. There were three device embolizations that were all retrieved by snare without clinical consequence. Together with the pivotal and continued access study, 97.4% (449/461) had complete echocardiographic closure at 12 months in 541 enrolled subjects. The composite success was 94.4%. There were no mortalities and no serious device-related adverse events., Conclusions: The Nit-Occlud PDA is a safe and effective device for closure of a small to moderate sized PDA. There were no serious device-related adverse events in a large cohort of three clinical trials., (© 2018 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

Objectives: This study describes procedural and 1-year outcomes of the 16 mm Melody PB1016 valve in patients with dysfunctional RVOT conduits., Background: The Melody PB1016 is a standard Melody valve produced from a 16 mm bovine jugular vein and is intended for deployment up to 20 mm., Methods: This is a prospective, non-randomized, multicenter study of the procedural and short-term outcomes of Melody PB1016 TPV replacement within dysfunctional RVOT conduits. Data from eight centers were included in the analysis., Results: During the study period, 39 patients underwent attempted Melody TPVR. Of the 39 patients, 30 underwent successful Melody TPVR. The majority of patients underwent placement of one or more stents prior to TPVR. There was a significant reduction in peak conduit pressure gradient following TPVR (38 mmHg vs. 11 mmHg, P < 0.001). There were three cases of confined conduit tears successfully treated with covered stents or the valve itself. Repeat catheterization was performed in one patient for early re-obstruction that was successfully treated with balloon valvuloplasty. At recent follow-up, there were no cases of more than mild valve regurgitation and the mean pulmonary valve gradient by echocardiogram remained reduced relative to pre-TPVR implant measurements (33.5 mmHg vs. 15.2 mmHg). There were no cases of valve stent fracture or endocarditis reported at the 1-year follow-up., Conclusions: Our analysis of TPVR with the PB1016 valve in RVOT conduits showed it to be safe and effective and can be performed in a wide range of conduit sizes with preserved valve function. ClinicalTrials.gov Identifier: NCT02347189., (© 2018 Wiley Periodicals, Inc.)

Objectives: To describe a multicenter experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards SAPIEN S3 valve without the use of a prior stent ("pre-stenting")., Background: The SAPIEN S3 and XT valves have durable cobalt-chromium stent frames which may allow for TPVR in large diameter dysfunctional right ventricular outflow tracts (RVOTs) without pre-stenting the landing zone., Methods: A retrospective review was performed of all patients with Congenital Heart Disease and dysfunctional RVOT who underwent TPVR using the SAPIEN valve without the use of a pre-stent. Imaging data, procedural elements, and clinical follow-up data were collected to evaluate short and intermediate-term results., Results: Fifty-seven patients underwent percutaneous placement of the SAPIEN valve in the pulmonary position without the use of pre-stenting. The anatomical substrate varied: native RVOTs (n = 41), conduits (n = 10), and bioprosthetic valves (n = 6). There were no cases in which the valve could not be implanted and no cases of valve embolization or misplacement. On follow-up (range 1 month to 2.2 years, median 5.3 months), no patients had significant obstruction or regurgitation around the valve. There were no frame fractures. There were no procedural deaths. Major complications included severe aortic compression (n = 1) requiring surgical explantation and tricuspid valve injury requiring surgical intervention (n = 2)., Conclusions: This limited multi-institutional experience demonstrates that the SAPIEN valve can be used for TPVR without the use of a pre-stent without medium-term risk of frame fracture, paravalvar leak, or embolization. Longer term follow-up is required to fully assess this method., (© 2018 Wiley Periodicals, Inc.)

Patients with dysfunctional right ventricular outflow tracks comprise a large portion of patients with severe congenital heart disease. Transcatheter pulmonary valve replacement in patients with dysfunctional right ventricular outflow tracks is feasible, safe, and efficacious. This article reviews current transcatheter valve replacement technology for dysfunctional right ventricular outflow tract and pulmonary valvular disease and its applications to patients with congenital heart disease. Discussed are the approach and preprocedural planning, current options, and applications of transcatheter pulmonary valve therapy. Also considered are future directions in this field as the technologies begin to develop further., (Copyright © 2018 Elsevier Inc. All rights reserved.)

This article describes current devices and indications for transcatheter device closure of atrial septal defect (TC-ASD) and patent foramen ovale in children and young adults. TC-ASD has a proven record of efficacy and safety, but device erosion raises questions about the relative safety of TC-ASD versus operative open heart surgical ASD closure. New devices for ASD closure with properties to reduce risk of erosion are being developed. Recent studies demonstrating superiority of patent foramen ovale device closure over medical therapy for cryptogenic stroke may lead to changes in practice for structural/interventional cardiologists. Care should be taken in extrapolating data to children and younger adults., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: Comparative ventricular arrhythmia (VA) outcomes following transcatheter (TC-PVR) or surgical pulmonary valve replacement (S-PVR) have not been evaluated. We sought to compare differences in VAs among patients with congenital heart disease (CHD) following TC-PVR or S-PVR., Methods: Patients with repaired CHD who underwent TC-PVR or S-PVR at the UCLA Medical Center from 2010 to 2016 were analysed retrospectively. Patients who underwent hybrid TC-PVR or had a diagnosis of congenitally corrected transposition of the great arteries were excluded. Patients were screened for a composite of non-intraoperative VA (the primary outcome variable), defined as symptomatic/recurrent non-sustained ventricular tachycardia (VT) requiring therapy, sustained VT or ventricular fibrillation. VA epochs were classified as 0-1 month (short-term), 1-12 months (mid-term) and ≥1 year (late-term)., Results: Three hundred and two patients (TC-PVR, n=172 and S-PVR, n=130) were included. TC-PVR relative to S-PVR was associated with fewer clinically significant VAs in the first 30 days after valve implant (adjusted HR 0.20, p=0.002), but similar mid-term and late-term risks (adjusted HR 0.72, p=0.62 and adjusted HR 0.47, p=0.26, respectively). In propensity-adjusted models, S-PVR, patient age at PVR and native right ventricular outflow tract (RVOT) (vs bioprosthetic/conduit outflow tract) were independent predictors of early VA after pulmonary valve implantation (p<0.05 for all)., Conclusion: Compared with S-PVR, TC-PVR was associated with reduced short-term but comparable mid-term and late-term VA burdens. Risk factors for VA after PVR included a surgical approach, valve implantation into a native RVOT and older age at PVR., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: This study sought to evaluate the safety, feasibility, and outcomes of transcatheter pulmonary valve replacement (TPVR) in conduits ≤16 mm in diameter., Background: The Melody valve (Medtronic, Minneapolis, Minnesota) is approved for the treatment of dysfunctional right ventricular outflow tract (RVOT) conduits ≥16 mm in diameter at the time of implant. Limited data are available regarding the use of this device in smaller conduits., Methods: The study retrospectively evaluated patients from 9 centers who underwent percutaneous TPVR into a conduit that was ≤16 mm in diameter at the time of implant, and reported procedural characteristics and outcomes., Results: A total of 140 patients were included and 117 patients (78%; median age and weight 11 years of age and 35 kg, respectively) underwent successful TPVR. The median original conduit diameter was 15 (range: 9 to 16) mm, and the median narrowest conduit diameter was 11 (range: 4 to 23) mm. Conduits were enlarged to a median diameter of 19 mm (29% larger than the implanted diameter), with no difference between conduits. There was significant hemodynamic improvement post-implant, with a residual peak RVOT pressure gradient of 7 mm Hg (p < 0.001) and no significant pulmonary regurgitation. During a median follow-up of 2.0 years, freedom from RVOT reintervention was 97% and 89% at 2 and 4 years, respectively, and there were no deaths and 5 cases of endocarditis (incidence rate 2.0% per patient-year)., Conclusions: In this preliminary experience, TPVR with the Melody valve into expandable small diameter conduits was feasible and safe, with favorable early and long-term procedural and hemodynamic outcomes., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To provide a comparison of the outcome of infective endocarditis (IE) in patients undergoing transcatheter pulmonary valve replacement (TPVR) versus surgical pulmonary valve replacement (SPVR)., Background: Although TPVR is thought to be associated with a higher risk of IE than SPVR, there is paucity of data to support this., Methods: Patients who underwent TPVR or SPVR at UCLA between October 2010 and September 2016 were included and retrospectively analyzed., Results: Three hundred forty-two patients underwent PVR at UCLA including 134 SPVR and 208 TPVR. Patients undergoing TPVR were more likely to have had a history of endocarditis than those undergoing SPVR (5.3% vs. 0.7%, P = 0.03) and a right ventricle to pulmonary artery (RV to PA) conduit (37% vs. 17%, P = 0.0001). Two SPVR and seven TPVR patients developed IE with a 4-year freedom from endocarditis of 94.0% in the SPVR versus 84% in the TPVR group (P = 0.13). In patients who underwent TPVR and developed endocarditis, the mean gradient across the RVOT prior to intervention was higher (28.1 ± 4.5 vs. 17.4 ± 0.6 mmHg, P = 0.02) and were more likely to have a conduit (71% vs. 36%, P = 0.049)., Conclusions: In this study, patients undergoing TPVR were not at a higher risk of IE than patients undergoing SPVR. TPVR patients were more likely to have had a prior history of IE and RV-PA conduit. The patients at highest risk were those with stenotic RV to PA conduits who were treated with TPVR., (© 2017 Wiley Periodicals, Inc.)

Background: 4D Multiphase Steady State Imaging with Contrast (MUSIC) acquires high-resolution volumetric images of the beating heart during uninterrupted ventilation. We aim to evaluate the diagnostic performance and clinical impact of 4D MUSIC in a cohort of neonates and infants with congenital heart disease (CHD)., Methods: Forty consecutive neonates and infants with CHD (age range 2 days to 2 years, weight 1 to 13 kg) underwent 3.0 T CMR with ferumoxytol enhancement (FE) at a single institution. Independently, two readers graded the diagnostic image quality of intra-cardiac structures and related vascular segments on FE-MUSIC and breath held FE-CMRA images using a four-point scale. Correlation of the CMR findings with surgery and other imaging modalities was performed in all patients. Clinical impact was evaluated in consensus with referring surgeons and cardiologists. One point was given for each of five key outcome measures: 1) change in overall management, 2) change in surgical approach, 3) reduction in the need for diagnostic catheterization, 4) improved assessment of risk-to-benefit for planned intervention and discussion with parents, 5) accurate pre-procedural roadmap., Results: All FE-CMR studies were completed successfully, safely and without adverse events. On a four-point scale, the average FE-MUSIC image quality scores were >3.5 for intra-cardiac structures and >3.0 for coronary arteries. Intra-cardiac morphology and vascular anatomy were well visualized with good interobserver agreement (r = 0.46). Correspondence between the findings on MUSIC, surgery, correlative imaging and autopsy was excellent. The average clinical impact score was 4.2 ± 0.9. In five patients with discordant findings on echo/MUSIC (n = 5) and catheter angiography/MUSIC (n = 1), findings on FE-MUSIC were shown to be accurate at autopsy (n = 1) and surgery (n = 4). The decision to undertake biventricular vs univentricular repair was amended in 2 patients based on FE-MUSIC findings. Plans for surgical approaches which would have involved circulatory arrest were amended in two of 28 surgical cases. In all 28 cases requiring procedural intervention, FE-MUSIC provided accurate dynamic 3D roadmaps and more confident risk-to-benefit assessments for proposed interventions., Conclusions: FE-MUSIC CMR has high clinical impact by providing accurate, high quality, simple and safe dynamic 3D imaging of cardiac and vascular anatomy in neonates and infants with CHD. The findings influenced patient management in a positive manner.

Sputter-deposited thin film nitinol constructs with various micropatterns were fabricated to evaluate their effect on the vessel wall in vivo when used as a covering for commercially available stents. Thin film nitinol constructs were used to cover stents and deployed in non-diseased swine arteries. Swine were sacrificed after approximately four weeks and the thin film nitinol-covered stents were removed for histopathologic evaluation. Histopathology revealed differences in neointimal thickness that correlated with the thin film nitinol micropattern. Devices covered with thin film nitinol with a lateral × vertical length = 20 × 40 µm diamond pattern had minimal neointimal growth with well-organized cell architecture and little evidence of ongoing inflammation. Devices covered with thin film nitinol with smaller fenestrations exhibited a relatively thick neointimal layer with inflammation and larger fenestrations showed migration of inflammatory and smooth muscle cells through the micro fenestrations. This "proof-of-concept" study suggests that there may be an ideal thin film nitinol porosity and pore geometry to encourage endothelialization and incorporation of the device into the vessel wall. Future work will be needed to determine the optimal pore size and geometry to minimize neointimal proliferation and in-stent stenosis.

Objectives: This study sought to describe the results of transcatheter tricuspid valve-in-ring (TVIR) implantation for treatment of tricuspid regurgitation (TR)., Background: Off-label use of transcatheter valves within surgically placed tricuspid annuloplasty prostheses has only been described in small reports. An international multicenter registry was developed to collect data on TVIR implantation., Methods: Data were collected from 13 sites on 22 patients (5 to 69 years of age) with TR who underwent catheterization with the intent to perform TVIR implantation., Results: TVIR implantation was performed in 20 patients (91%). Most patients were severely impaired (86% in New York Heart Association functional class III or IV); TR was severe in 86%. A Sapien valve (Edwards Lifesciences, Irvine, California) was implanted in 17 patients and a Melody valve (Medtronic, Minneapolis, Minnesota) in 3. There were no procedural deaths. There was 1 valve embolization requiring retrieval and placement of second TVIR implant and 1 valve malposition with severe paravalvular regurgitation requiring a second TVIR implantation. Over a median follow-up of 12 months, 1 patient died and 2 underwent repeat TVIR implantation, 1 of whom subsequently underwent surgical valve replacement. Significant paravalvular leak (PVL) was treated at the time of TVIR implantation in 4 patients: 3 underwent device occlusion and 1 received a second TVIR implant. On follow-up echocardiography, 15 patients had PVL (75%), the majority of which (n = 10) were trivial or mild and did not require treatment. PVL intervention was performed in 3 patients during follow-up. Functional capacity improved in most patients (70%)., Conclusions: TVIR implantation using commercially available transcatheter prostheses is technically feasible and clinically effective in reducing TR. Paravalvular regurgitation is common and may necessitate further interventions., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aims to evaluate the safety and efficacy of transcatheter fenestrated ASD closure and to summarize the literature regarding the published techniques and outcomes of transcatheter partial ASD closure., Background: Patients with left ventricular diastolic dysfunction (LVDD) or right ventricular (RV) dysfunction and/or pulmonary hypertension (PHT) may suffer untoward consequences of complete closure of an ostium secundum atrial septal defect (ASD). Therefore, for patients that fall under these categories we suggest partial occlusion of the defect, which may be better tolerated than complete defect closure., Methods and Patients: After obtaining IRB approval, a search for patients that have undergone percutaneous ASD closure was performed in the Ahmanson/UCLA Adult Congenital Heart Disease Center database to identify which patients received a fenestrated ASD closure device., Results: Eight consecutive patients ranging between 22 and 83 years of age (mean 48 years) with PHT and/or LVDD or RV dysfunction who underwent fenestrated transcatheter ASD closure at UCLA were identified. None of the subjects experienced complications related to the procedure. Postprocedure clinical evaluation showed improvement in symptoms and exercise capacity. Available follow-up transthoracic echocardiography data (mean 4 months, range 0-20 months) demonstrated patent fenestrations in four of eight patients. None of the patients had thromboembolic or infectious complications and there were no device migrations, erosions or embolizations., Conclusions: Partial ASD occlusion in patients with diastolic dysfunction or RV dysfunction and/or PHT is safe and may be better tolerated than complete ASD closure in selected patients., (© 2016 Wiley Periodicals, Inc.)

Background: While the Melody valve is unable to be used for replacement of large pulmonary outflow tracts, the 29 mm Sapien XT transcatheter valve, designed specifically for aortic valve replacement, can potentially be used in these large native outflow tracts. Techniques to enable off-label use of the Sapien XT valve for large-diameter pulmonary and tricuspid valve replacement are described., Methods: Use of the Sapien valve for transcatheter pulmonary and tricuspid valve replacement using both the commercially available Novaflex+ system and using a novel flexible delivery system was reviewed. This customized flexible delivery platform was constructed using the Ensemble sheath and a 30 mm Nucleus balloon. This system was bench tested prior to its clinical use., Results: Ten patients had successful implantation of Sapien valves into native right ventricular outflow tracts (RVOTs) (n = 7) or tricuspid valves (n = 3). There was no stenosis or regurgitation after Sapien valve implantation. Several of the pulmonary valve replacement cases were extremely challenging due to the limited flexibility of the Novaflex system. The Sapien valve was crimped onto a 30 mm Nucleus balloon preloaded through an Ensemble sheath. This system was able to consistently deliver the Sapien valve safely in a bench model as well as in native RVOTs in two patients., Conclusion: The 29 mm Sapien XT valve allows for large-diameter transcatheter valve replacement in both the pulmonary and tricuspid positions. Initial results of new techniques to utilize a more flexible delivery platform are described that could obviate the need for the Novaflex system. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Background and Objective: Contralateral oblique (CLO) angle view has been a useful addition to standard views in fluoroscopically guided interlaminar epidural injections. Determination of the appropriate CLO angle is paramount in the usefulness of this technique. Using MRI laminar angle measurements as a pre-procedural guide for the intra-procedural fluoroscopic CLO angle has been proposed. The purpose of this study was to help determine if using axial MRI laminar measurements prior to a cervical or thoracic epidural steroid injection would be useful in predicting the appropriate fluoroscopic CLO angle., Study Design: A retrospective review was performed for patients who underwent cervical or thoracic interlaminar injections. In the performance of interlaminar injections, the authors had routinely determined the true fluoroscopic contra-lateral oblique angle after epidural access was confirmed, for use during any potential future injections. The fluoroscopic CLO angle measurements were obtained from a chart review and compared blindly to each patient's MRI axial laminar angle measurements., Results: 34 injections were included. Inter-rater reliability comparing the two authors' MRI angle measurements was considered fair, ICC = 0.395. Accuracy was only 57% comparing MRI laminar angle measurements to within five degrees of the true fluoroscopic CLO angle as determined during the injection procedure. Accuracy by ICC showed only fair agreement, 0.47 and 0.22, for the two authors., Conclusions: The findings of this study indicate fair inter-rater reliability in manual measurements of laminar angle on axial MRI images. MRI laminar angle measurements do not appear to be highly accurate in determining the appropriate fluoroscopic CLO angle., (© 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: This study sought to elucidate the optimal bioprosthetic valve (BPV) size prior to Melody valve implantation., Background: BPVs provide an ideal "landing zone" for future Melody valve insertion. To guide surgical choice of BPV size, it is important to understand which BPV size can serve consistently as substrates for Melody valve placements., Methods: A database of all patients who underwent Melody implantation at UCLA or Kaiser Permanente Los Angeles from 2010 to 2014 was analyzed retrospectively. Patients with an existing BPV were stratified into those with a valve diameter of ≥27 mm or <27 mm., Results: One hundred and sixty patients underwent catheterization with the intention to implant a Melody valve. Melody valve implantation was performed in the pulmonary position in 52 patients with prior BPVs. The immediate procedural success rate was 100%. Immediately post-Melody, the right ventricular to pulmonary artery gradient was significantly higher in the <27 mm group compared to the ≥27 mm group (14.3±3 vs. 8.6±6.8, P=0.006). There was a significantly shorter time from prior valve replacement to Melody implantation in the <27 mm group. There was one patient in whom transcatheter pulmonary valve implantation was aborted due to inadequate landing zone in the <27 mm group, and no patients in the ≥27 mm group (P=NS)., Conclusions: The results of this study indicate that 27 and 29 mm BPV provide a superior landing zone for Melody valve implantation with excellent immediate and intermediate term hemodynamic results when compared to smaller BPVs less than 27 mm., (© 2015 Wiley Periodicals, Inc.)

Objectives: To assess the frequency, anatomic characteristics, and associations of systemic to pulmonary venous collaterals in adult patients undergoing cardiac catheterization after a Fontan operation. Additionally, the embryologic basis for the presence of venous collaterals is reviewed., Methods: Cardiac catheterization data was reviewed for 66 adults with single ventricle physiology and a Fontan palliation., Results: There were a total of 66 patients that underwent catheterization between 2004 and 2014 at the Ahmanson/UCLA Adult Congenital Heart Disease Center. There were 24 males and 42 females. Systemic venous to pulmonary venous collaterals were present in 38 patients (58%), most commonly originating from the right brachiocephalic vein (35%), azygous vein (20%) and superior vena cava (13%). Trans-catheter interventional closure was performed in 27/38 (71%) of patients with venous collaterals. At baseline these patients had lower oxygen saturation when compared to those not requiring intervention, 85.6% ± 6.1% vs 89.9% ± 5.4%, p < 0.05. At 6 months, the ambulatory systemic saturation improved from 85.6% ± 6.1% to 91.8% ± 6.4%, p < 0.05. At two years follow-up, the ambulatory systemic saturation had decreased to 90.5% ± 4.1% (p < 0.05)., Conclusion: In adults with single ventricle physiology and prior Fontan surgery, systemic venous collaterals are common and can be percutaneously occluded at minimal risk with resultant improvement in systemic oxygen saturation on long term follow up. When evaluated from a developmental standpoint, 85% of collaterals are above the diaphragm and could be secondary to recanalization of the collateral veins, an embryological connection between systemic and pulmonary veins., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

A 57-year-old woman developed progressive calcific mitral and aortic valve disease with a porcelain aorta secondary to a history of radiation therapy. She was considered a very poor operative candidate and referred for transcatheter aortic valve replacement (TAVR). Four weeks after extensive coronary artery stenting, a TAVR was performed with a 23 mm Edwards SAPIEN valve (Edwards Life Sciences, Irvine, CA) through a transapical approach. Post-operatively, her symptoms of dyspnea persisted and worsened. She was found to have an acquired ventricular septal defect (VSD) measuring 8 mm by 5 mm by transesophageal echocardiogram and by a CT angiogram. Percutaneous VSD closure was accomplished with an 8 mm Muscular VSD Occluder (St. Jude Medical, St. Paul, MN) with elimination of her shunt, improvement of her dyspnea, and marked improvement in exercise tolerance., (© 2014 Wiley Periodicals, Inc.)