The Melody™ TPV has been used as an alternative to surgical pulmonary valve replacement; limited medium-term follow-up data are available.

To report the follow-up data of all Melody™ TPVs implanted locally over a 15-year period (2006-2021).

Single-centre non-randomised prospective observational study of all implanted Melody™ valves in the pulmonary position.

234 Melody™ valves were implanted at a mean age of 20.8 ± 24.6y. Indications for valve implantation included: pulmonary stenosis (47.2%,) regurgitation (30.9%), and mixed pathology (21.9%). The implant zone substrate consisted of homograft in 52.6%, patched right ventricular outflow tract in 33.8%, and bioprostheses in 13.6% of the cases. Valve survival at 10 years was 89% and 72% at 15 years follow-up. Pulmonary stenosis and pulmonary and tricuspid valve regurgitation demonstrated no significant evolution over the 15-year follow-up. Over the study period, there were 7 deaths at a mean age of 54.2 ± 21.1y; none was valve related. Valve failure was observed in 22 cases (9.4%), mainly due to endocarditis 13/22 (59.0%). The overall incidence of endocarditis was 1.5% per patient-year and occurred in 10.2% (n = 24) of patients 2.7 ± 1.6y after TPV, mostly in younger men (median 18.3, range 8.1 - 49.5 y). Balloon dilatation to accommodate for somatic growth was successful in all 17 (7.3%) attempted cases.

The Melody™ valve had a low risk for valve failure with overall well-preserved valve function over up to 15 years of follow-up. Endocarditis remains a concern. The Melody™ valve is competitive with other surgical and percutaneous conduits.

Congenital heart disease (CHD) patients with pulmonary valve failure may undergo transcatheter pulmonary valve replacement (TPVR). Aspirin is often prescribed as long-term therapy after TPVR to prevent thromboembolic events (TE).

We aimed to examine the prevalence of aspirin resistance within the CHD TPVR population.

The VerifyNow point-of-care test quantifies platelet aggregation as Aspirin Reactivity Units (ARU). ARU values greater than 550 suggest aspirin resistance (AR). A retrospective chart review analyzed ARU test results from May 2022 through December 2023 in CHD patients following successful TPVR (n = 48). Lifelong TE history was collected. Association between AR and sex, race, and ethnicity was examined with Fisher's Exact test, and the Wilcoxon rank sum exact test analyzed associations between AR and age.

Three of 45 (6.67%) CHD TPVR aspirin-compliant patients (average age 33.14 years; range 0.74-77.86 years, 47% females) were AR. Interestingly, all AR patients were females, suggesting higher AR prevalence in females (p = 0.094). No significant associations were found between AR and age (p = 0.8), race (p = 0.077), or ethnicity (p = 0.2). No AR patients had a documented history of TE. Five of 42 (11.9%) aspirin sensitive patients had TE while taking aspirin, including two females (not on birth control at time of event) and three males.

AR is prevalent in CHD TPVR patients, but TE occurrence did not correlate with AR. However, AR exclusively in females and TE in aspirin sensitive patients, suggests need for further investigations on the most effective TE prophylaxis in this population.

Pulmonary insufficiency often follows the surgical repair of tetralogy of Fallot, leading to adverse outcomes. Young patients with short right ventricle-pulmonary artery conduits are at risk of pulmonary artery branch occlusion when a traditional Melody valve (Medtronic) is used. We report a novel case of a folded Melody valve implanted with a simultaneous stent in a pediatric patient to address challenges posed by a short right ventricle-pulmonary artery conduit.

Information on mid-term outcomes of percutaneous pulmonary valve replacement (PPVR) with the Edwards Sapien (ES) valve in the native right ventricular outflow tract (RVOT) are limited. This study assesses mid-term outcomes in 76 patients who underwent PPVR between 2016 and 2022, comparing native (40.8%) and non-native (59.2%) RVOTs. The primary endpoint was a composite of endocarditis, reinterventions, and cardiovascular death and secondary outcomes included prosthetic valve dysfunction (PVD), tricuspid regurgitation (TR), right ventricular ejection fraction (RVEF), and indexed ventricular volumes. The median patient age was 23.9 years. Pulmonary regurgitation was predominant in the native RVOT group (67.7%), while pulmonary stenosis or combined lesions were more common in the non-native group (90.9%). Procedural success was 98.7%. After a median follow-up of 3.3 years, there was no significant difference in freedom from the primary outcome between groups (87.1% native vs. 93.1% non-native, p = 0.875). Endocarditis and reinterventions occurred at 1.2 per 100 patient-years, and PVD at 3.19 per 100 patient-years, with no differences between groups. A 1-year reduction in ventricular volumes and TR was seen only in the non-native group, with no improvement in RVEF. Overall, PPVR with the ES valve demonstrates satisfactory mid-term outcomes in both native and non-native RVOTs.

This study aimed to assess the outcomes of valve-in-valve implantation within previously placed bioprosthetic valves.

This single-center retrospective study included patients who underwent percutaneous valve-in-valve procedures between July 2014 and September 2023. These patients had previously received pulmonary bioprosthetic valves via surgical or transcatheter methods.

The study included 20 patients (13 males, 7 females; mean age: 20.4±7.1 years; range, 10.8 to 35.8 years). Preprocedural assessment revealed stenotic dysfunction in 12 patients, regurgitant dysfunction in two patients, and a combination of both in six patients. Following implantation, there was a notable improvement in invasive measurements; systolic right ventricular pressure decreased from 64.0±24.5 mmHg to 31.3±6.7 mmHg (p<0.001), right ventricular outflow tract gradient from 44.0±23.2 mmHg to 7.6±5.8 mmHg (p<0.001), and echocardiographic pulmonary regurgitation grade from 2.1±1.2 to 0.2±0.4 (p<0.001). The median time between initial bioprosthetic pulmonary valve placement and valve-in-valve procedure was 8.2 years (IQR, 6.2 to 9.9 years). The median follow-up duration was 24.8 months (IQR, 8.3 to 40.2 months). Only one patient required a repeat PPVI procedure 10 years after the valve-in-valve procedure, while no other patients required reintervention during the follow-up period.

Valve-in-valve implantation within previously placed bioprosthetic valves is a feasible and safe approach, offering symptom relief and eliminating the need for further surgical interventions.

Varying rates of nonsustained ventricular tachycardia (NSVT) have been reported early after transcatheter pulmonary valve replacement (TPVR) with the Harmony valve, but data regarding rhythm outcomes beyond hospital discharge are limited. This study aims to characterize ventricular arrhythmias after Harmony TPVR from implant through mid-term follow-up.

Ventricular arrhythmia data from postimplant telemetry and follow-up extended rhythm monitoring (ERM) were analyzed after Harmony TPVR.

Fifty-four patients with tetralogy of Fallot (n=39), valvar pulmonary stenosis (n=10), or pulmonary atresia with intact ventricular septum (n=5) were studied; 22% had prior NSVT and 24% were on prior rhythm medication. On postimplant telemetry, 27 patients (50%) had NSVT, including 1 who had torsade de pointes, but most had <5 episodes. Pre-TPVR NSVT or rhythm medications, diagnosis other than tetralogy, and substantial device contact with the myocardium were associated with more frequent NSVT on telemetry. Ten patients (19%) were started on a new antiarrhythmic medication. On discharge ERM, 37% of patients had NSVT, most with <5 episodes and only 13% with NSVT beyond 5 days post-discharge. On follow-up ERM, 14% of patients had a single episode of NSVT and 1 had 5 episodes. During follow-up, antiarrhythmic medications were discontinued in 8 of 10 patients and no patients died or had sustained ventricular tachycardia.

NSVT and ventricular ectopy were common early after TPVR but were infrequent in most cases and diminished rapidly after discharge. The incidence of NSVT on follow-up ERM was similar to preimplant incidence. Few patients had antiarrhythmic medications initiated, and most were discontinued on follow-up. There were no major arrhythmic events after discharge.

To describe the workflow and value of three-dimensional rotational angiography (3DRA) in percutaneous pulmonary valve implantation (PPVI).

3DRA offers visualization of the entire topography in the chest and may enhance safety and reduce the risk for complications in PPVI through improved pre-procedural planning and per-procedural guidance.

All PPVI procedures with the use of 3DRA performed between August 2011 and December 2022 were reviewed. Success rate, complications and radiation dose were assessed. Radiation dose of the latest 3DRA protocol was compared to historical 3DRA data.

PPVI was successful in 95 of 102 procedures. Seven procedures were aborted due to coronary compression after balloon testing (n = 3), main pulmonary artery (MPA) oversize (n = 3) and not passing of a Melody valve through a calcified Melody valve in situ (n = 1). PPVI was attempted in 61 homografts, 19 native right ventricular outflow tracts (including transannular patch), 4 previously implanted Melody valves, 2 in previously implanted Sapien valves and 16 in other bioprosthetic valves. A Melody valve was implanted in 43, a Sapien valve in 49 and a Pulsta valve in 1 patient. In 2 patients a Melody as well as a Sapien valve were subsequently implanted. Mean total dose area product (DAP) was 11813 mGycm2 and 179 mGycm2/kg for all attempted PPVI's. For successful PPVI 9835 mGycm2 and 174 mGycm2/kg. After optimizing the 3DRA protocols the mean dose reduced from 12677 mGycm2 to 8551 mGycm2 (200 mGycm2/kg to 163 mGycm2/kg). Four patients experienced one or more complications. There were no deaths peri-procedural or during follow-up. Complications were; need for cardiopulmonary resuscitation (n = 2), MPA paravasation (n = 1), valve dysfunction (n = 2).

The use of rotational angiography for the guidance of PPVI results in a high success rate, low number of complications with the use of a low amount of radiation.

Delivery systems are crucially important for the implantation of medical devices in patients with congenital heart disease. However, very little data is available comparing the advantages and disadvantages of the various delivery systems.

This article describes the delivery systems and methods used for delivery of atrial septal occluder devices, ventricular septal occluder devices, devices to occlude patent arterial ducts, and transcatheter pulmonary valves. Delivery systems are compared relating to prepping and loading, positioning of the delivery sheath/catheter, deployment, ability to recapture and reposition, as well as device release.

For most ASD/VSD/PDA occluder devices, the basic delivery mechanism has changed very little over the preceding 20 years. Future modifications may focus on meaningful modifications to the cable systems that reduce stiffness and improve angulation at the connection to the device. Over the next 5-10 years, it is expected to see significant changes to delivery systems used for transcatheter pulmonary valve implantation, that result in improvements in the ability to recapture and reposition self-expandable transcatheter valves during the deployment process, combined with kink resistant sheaths that facilitate easy tracking across often complex right ventricular outflow tracts.

This study aims to assess the early to mid-term clinical efficacy of expanded polytetrafluoroethylene (ePTFE) trileaflet valved conduits in pediatric right ventricular outflow tract reconstruction for congenital heart disease.

We conducted a retrospective analysis of pediatric patients who underwent right ventricular outflow tract (RVOT) reconstruction using ePTFE trileaflet valved conduits at two cardiac centers in China, between January 2017 and June 2023. The main assessment criterion was the functionality of the prosthetic pulmonary valve conduit.

A total of 162 pediatric patients were included, with follow-up periods ranging from 0.1 to 5 years post-discharge, and a median follow-up duration of 1 year (interquartile range: 1, 2). Three patients (1.9%) required re-operation due to conduit obstruction. During follow-up, pulmonary valve flow velocities were recorded as <3 m/s in 134 patients (82.7%), between 3 and 4 m/s in 24 patients (14.8%), and >4 m/s in 4 patient (2.5%). Mild pulmonary valve regurgitation was noted in 148 patients (91.4%), and moderate pulmonary valve regurgitation was noted in 14 patients (8.6%), with no instances of more than moderate pulmonary valve regurgitation.

The ePTFE trileaflet valved conduit, known for its accessibility and simplicity in manufacturing, demonstrates favorable early to mid-term clinical outcomes in pediatric RVOT reconstruction.

Patients with d-transposition of the great arteries (d-TGA) who have undergone an arterial switch operation (ASO) can develop right ventricular outflow tract (RVOT) dysfunction with pulmonary regurgitation (PR) or stenosis. In these patients, treatment may include transcatheter pulmonary valve replacement (TPVR). Coronary compression is a contraindication occurring in 5% of typical TPVR cases. After ASO, there are various anatomical considerations that can confound TPVR, including potential coronary artery compression. Our goal is to understand feasibility of TPVR in patients following ASO.

This was a retrospective multicenter cohort study of patients with RVOT dysfunction after ASO who underwent cardiac catheterization with intention to perform TPVR from 2008 to 2020.

Across nine centers, 33 patients met inclusion criteria. TPVR was successful in 22 patients (66%), 19 receiving a Melody valve and 3 a SAPIEN valve. RVOT stenosis in isolation or with PR dictated need for TPVR in nearly all patients. One serious adverse event occurred with valve embolization. After TPVR, the RVOT peak gradient decreased from 43 to 9 mm Hg (p < 0.001); PR was trivial/none in all but one patient, in whom it was mild. Coronary compression prohibiting TPVR occurred in eight patients (24%) and two patients (6%) had severe aortic regurgitation from aortic root deformation precluding TPVR. Seven patients underwent RVOT reintervention a median of 5.3 years post-TPVR.

TPVR in patients with d-TGA after ASO is feasible, but in this cohort, coronary compression or aortic root distortion precluded TPVR in one-third of patients. The rate of RVOT reintervention after TPVR was higher in this cohort of ASO patients than in prior studies.

Over the last 2 decades, experience with transcatheter pulmonary valve replacement (TPVR) has grown significantly and has become an effective and reliable way of treating pulmonary valve regurgitation, right ventricular outflow (RVOT) obstruction, and dysfunctional bioprosthetic valves and conduits. With the introduction of self-expanding valves and prestents, dilated native RVOT can be addressed with the transcatheter approach. In this article, the authors review the current practices, technical challenges, and outcomes of TPVR.

Studies of transcatheter pulmonary valve replacement (TPVR) with the Melody valve have demonstrated good clinical and hemodynamic outcomes. Our study analyzes the midterm clinical and hemodynamic outcomes for patients who underwent Melody valve implantation in Southeast Asia.

Patients with circumferential conduits or bioprosthetic valves and experiencing post-operative right ventricular outflow tract (RVOT) dysfunction were recruited for Melody TPVR.

Our cohort (n = 14) was evenly divided between pediatric and adult patients. The median age was 19 years (8-38 years), a male-to-female ratio of 6:1 with a median follow-up period of 48 months (16-79 months), and the smallest patient was an 8-year-old boy weighing 18 kg. All TPVR procedures were uneventful and successful with no immediate mortality or conduit rupture. The primary implant indication was combined stenosis and regurgitation. The average conduit diameter was 21 ± 2.3 mm. Concomitant pre-stenting was done in 71.4% of the patients without Melody valve stent fractures (MSFs). Implanted valve size included 22-mm (64.3%), 20-mm (14.3%), and 18-mm (21.4%). After TPVR, the mean gradient across the RVOT was significantly reduced from 41 mmHg (10-48 mmHg) to 16 mmHg (6-35 mmHg) at discharge, p < 0.01. Late follow-up infective endocarditis (IE) was diagnosed in 2 patients (14.3%). Overall freedom from IE was 86% at 79 months follow-up. Three patients (21.4%) developed progressive RVOT gradients.

For patients in Southeast Asia with RVOT dysfunction, Melody TPVR outcomes are similar to those reported for patients in the US in terms of hemodynamic and clinical improvements. A pre-stenting strategy was adopted and no MSFs were observed. Post-implantation residual stenosis and progressive stenosis of the RVOT require long term monitoring and reintervention. Lastly, IE remained a concern despite vigorous prevention and peri-procedural bacterial endocarditis prophylaxis.

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.

In this study, the authors sought to evaluate the safety and short-term effectiveness of self-expanding TPVR in a real-world experience.

This was a multicenter registry study of consecutive patients with native RVOT PR who underwent TPVR through April 30, 2022, at 11 U.S.

The primary outcome was a composite of hemodynamic dysfunction (PR greater than mild and RVOT mean gradient >30 mm Hg) and RVOT reintervention.

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).

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.

Pulsta valve is increasingly used for percutaneous pulmonary valve implantation (PPVI) in patients with a large native right ventricular outflow tract (RVOT). This study aims to elucidate the outcomes of Pulsta valve implantation within the native RVOT and assess its adaptability to various native main pulmonary artery (PA) anatomies.

A multicenter retrospective study included 182 patients with moderate to severe pulmonary regurgitation in the native RVOT who underwent PPVI with Pulsta valves® between February 2016 and August 2023 at five Korean and Taiwanese tertiary referral centers.

Pulsta valve implantation was successful in 179 out of 182 patients (98.4%) with an average age of 26.7 ± 11.0 years. The median follow-up duration was 29 months. Baseline assessments revealed enlarged right ventricle (RV) volume (mean indexed RV end-diastolic volume: 163.1 (interquartile range, IQR: 152.0-180.3 mL/m²), which significantly decreased to 123.6(IQR: 106.6-137.5 mL/m2  after 1 year. The main PA types were classified as pyramidal (3.8%), straight (38.5%), reverse pyramidal (13.2%), convex (26.4%), and concave (18.1%) shapes. Pulsta valve placement was adapted, with distal main PA for pyramidal shapes and proximal or mid-PA for reverse pyramidal shapes. Two patients experienced Pulsta valve embolization to RV, requiring surgical removal, and one patient encountered valve migration to the distal main PA, necessitating surgical fixation.

Customized valve insertion sites are pivotal in self-expandable PPVI considering diverse native RVOT shape. The rather soft and compact structure of the Pulsta valve has characteristics to are adaptable to diverse native RVOT geometries.

Transcatheter pulmonary valve replacement (TPVR), also known as percutaneous pulmonary valve implantation, refers to a minimally invasive technique that replaces the pulmonary valve by delivering an artificial pulmonary prosthesis through a catheter into the diseased pulmonary valve under the guidance of X-ray and/or echocardiogram while the heart is still beating not arrested. In recent years, TPVR has achieved remarkable progress in device development, evidence-based medicine proof and clinical experience. To update the knowledge of TPVR in a timely fashion, and according to the latest research and further facilitate the standardized and healthy development of TPVR in Asia, we have updated this consensus statement. After systematical review of the relevant literature with an in-depth analysis of eight main issues, we finally established eight core viewpoints, including indication recommendation, device selection, perioperative evaluation, procedure precautions, and prevention and treatment of complications.

Transcatheter pulmonary valve replacement (TPVR) has expanded and evolved since its initial commercial approval in the United States in 2010.

This study sought to characterize real-world practice, including patient selection, procedural outcomes, complications, and off-label usage.

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.

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).

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.

This consensus document for the performance of Cardiovascular Computed Tomography (CCT) to guide intervention in the right ventricular outflow tract (RVOT) in patients with congenital disease (CHD) was developed collaboratively by pediatric and adult interventionalists, surgeons and cardiac imagers with expertise specific to this patient subset. The document summarizes definitions of RVOT dysfunction as assessed by multi-modality imaging techniques and reviews existing consensus statements and guideline documents pertaining to indications for intervention. In the context of this background information, recommendations for CCT scan acquisition and a standardized approach for reporting prior to surgical or transcatheter pulmonary valve replacement are proposed and presented. It is the first Imaging for Intervention collaboration for CHD patients and encompasses imaging and reporting recommendations prior to both surgical and percutaneous pulmonary valve replacement.

To determine the safety and feasibility of over-expansion of right ventricle to pulmonary artery conduits during transcatheter pulmonary valve placement.

Transcatheter pulmonary valve placement is an alternative to surgical pulmonary valve replacement. Traditionally, it was thought to be unsafe to expand a conduit to >110% of its original size.

This retrospective cohort study from two centers includes patients with right ventricle to pulmonary artery conduits with attempted transcatheter pulmonary valve placement from 2010 to 2017. Demographic, procedural, echocardiographic and follow-up data, and complications were evaluated in control and overdilation (to >110% original conduit size) groups.

One hundred and seventy-two patients (51 overdilation and 121 control) had attempted transcatheter pulmonary valve placement (98% successful). The overdilation group was younger (11.2 versus 16.7 years, p < 0.001) with smaller conduits (15 versus 22 mm, p < 0.001); however, the final valve size was not significantly different (19.7 versus 20.2 mm, p = 0.2). Baseline peak echocardiographic gradient was no different (51.8 versus 55.6 mmHg, p = 0.3). Procedural complications were more frequent in overdilation (18%) than control (7%) groups (most successfully addressed during the procedure). One patient from each group required urgent surgical intervention, with no procedural mortality. Follow-up echocardiographic peak gradients were similar (24.1 versus 26 mmHg, p = 0.5).

Over-expansion of right ventricle to pulmonary artery conduits during transcatheter pulmonary valve placement can be performed successfully. Procedural complications are more frequent with conduit overdilation, but there was no difference in the rate of life-threatening complications. There was no difference in valve function at most recent follow-up, and no difference in rate of reintervention. The long-term outcomes of transcatheter pulmonary valve placement with conduit over-expansion requires further study.

This consensus document for the performance of cardiovascular computed tomography (CCT) to guide intervention in the right ventricular outflow tract (RVOT) in patients with congenital heart disease (CHD) was developed collaboratively by pediatric and adult interventionalists, surgeons, and cardiac imagers with expertise specific to this patient subset. The document summarizes definitions of RVOT dysfunction as assessed by multimodality imaging techniques and reviews existing consensus statements and guideline documents pertaining to indications for intervention. In the context of this background information, recommendations for CCT scan acquisition and a standardized approach for reporting prior to surgical or transcatheter pulmonary valve replacement are proposed and presented. It is the first Imaging for Intervention collaboration for CHD patients and encompasses imaging and reporting recommendations prior to both surgical and percutaneous pulmonary valve replacement.

This consensus document for the performance of cardiovascular computed tomography (CCT) to guide intervention in the right ventricular outflow tract (RVOT) in patients with congenital disease (CHD) was developed collaboratively by pediatric and adult interventionalists, surgeons and cardiac imagers with expertise specific to this patient subset. The document summarizes definitions of RVOT dysfunction as assessed by multi-modality imaging techniques and reviews existing consensus statements and guideline documents pertaining to indications for intervention. In the context of this background information, recommendations for CCT scan acquisition and a standardized approach for reporting prior to surgical or transcatheter pulmonary valve replacement are proposed and presented. It is the first Imaging for Intervention collaboration for CHD patients and encompasses imaging and reporting recommendations prior to both surgical and percutaneous pulmonary valve replacement.

Congenital heart diseases (CHDs) frequently impact the right ventricular outflow tract, resulting in a significant incidence of pulmonary valve replacement in the pediatric population. While contemporary pediatric pulmonary valve replacements (PPVRs) allow satisfactory patient survival, their biocompatibility and durability remain suboptimal and repeat operations are commonplace, especially for very young patients. This places enormous physical, financial, and psychological burdens on patients and their parents, highlighting an urgent clinical need for better PPVRs. An important reason for the clinical failure of PPVRs is biofouling, which instigates various adverse biological responses such as thrombosis and infection, promoting research into various antifouling chemistries that may find utility in PPVR materials. Another significant contributor is the inevitability of somatic growth in pediatric patients, causing structural discrepancies between the patient and PPVR, stimulating the development of various growth-accommodating heart valve prototypes. This review offers an interdisciplinary perspective on these challenges by exploring clinical experiences, physiological understandings, and bioengineering technologies that may contribute to device development. It thus aims to provide an insight into the design requirements of next-generation PPVRs to advance clinical outcomes and promote patient quality of life.

Pulmonary stenosis (PS) is mainly a congenital defect that accounts for 7-12% of congenital heart diseases (CHD). It can be isolated or, more frequently, associated with other congenital defects (25-30%) involving anomalies of the pulmonary vascular tree. For the diagnosis of PS an integrated approach with echocardiography, cardiac computed tomography and cardiac magnetic resonance (CMR) is of paramount importance for the planning of the interventional treatment. In recent years, transcatheter approaches for the treatment of PS have increased however, meaning surgery is a possible option for complicated cases with anatomy not suitable for percutaneous treatment. The present review aims to summarize current knowledge regarding diagnosis and treatment of PS.

Mitral valve replacement using a Melody valve is a promising solution to the challenge of surgical mitral valve replacement in infants with a hypoplastic annulus. We report the creation of a landing zone in the mitral valve annulus using a Cheatham-Platinum (CP)-covered stent that facilitates Melody valve placement, helps prevent paravalvular leak, minimizes left ventricular outflow tract obstruction, and allows for potential future dilation of the valve.

Structural interventions play a crucial role in the management of adult congenital heart disease (ACHD). In recent years, this field has seen significant advancements in catheter-based procedures despite limited investment from industry and lack of device development specific to this population. Because each patient is unique in their anatomy, pathophysiology, and surgical repair, many devices are used off-label with a "best fit" strategy. Therefore, continuous innovation is needed to adapt what is available to ACHD and to increase collaboration with industry and regulatory bodies to develop dedicated equipment. These innovations will further advance the field and offer this growing population less invasive options with fewer complications and faster recovery times. In this article, we summarize some of the contemporary structural interventions performed in adults with congenital defects and present cases performed at Houston Methodist to better illustrate them. We aim to offer a greater understanding of the field and stimulate interest in this rapidly growing specialty.

Prestenting of the landing zone for transcatheter pulmonary valve replacement (TPVR) with a balloon-expandable valve can dilate a stenotic right ventricular outflow tract (RVOT), prevent paravalvar leak (PVL), and protect against conduit tear. Simultaneous stenting (SS) with the Melody valve has been described, but to our knowledge, SS with a SAPIEN valve has not been reported. We report our experience with this novel technique.

A retrospective chart review of patients who underwent TPVR at Rady Children's hospital and UCSD Medical Center was performed. Patients were included if they had underwent SAPIEN TPVR with SS. Rationale for stent choice was a bare metal stent to relieve long-segment stenosis and covered stents to prevent PVL or to protect against conduit tear.

A total of 17 cases were identified. The majority of RVOTs were transannular patches (n = 9, 56%), with a minimum diameter of 19.6 ± 5.2 mm, and the most common valve placed was an Edwards SAPIEN 26.0 mm (n = 10, 59%). All SAPIEN valves placed were of the S3 generation. The procedure was successful in all patients, with no conduit tears. Minor complications occurred in 3 patients (17.6%).

Simultaneous stent deployment with a SAPIEN TPVR is an alternative 1-step technique for patients who require prestenting. SS simplifies the procedure, has low complication rates, and offers the benefits of a longer landing zone and decreased PVL.

In the sheep model with pathophysiologic changes similar to patients with repaired TOF, severe PR leads to fibrotic changes in the RV. Pulmonary valve replacement reverses these fibrotic changes. Early valve replacement led to a quick RV recovery, and in time there was no difference in outcome between early and late valve replacement. These data support the benefit of valve replacement for RV function and suggest that there is a margin in the timing of the surgery. The fibrotic changes correlated well with the circulating biomarker PICP, which can have an added value in the clinical follow-up of patients with repaired TOF.

This study sought to investigate the characteristics, morbidity (including the rate of infective endocarditis and valve replacement) and mortality of individuals undergoing percutaneous pulmonary valve implantation in Australia and New Zealand since the procedure has been performed.

The outcomes of percutaneous pulmonary valve implantation in Australia and New Zealand have not been evaluated. Recent international data, including patients from New Zealand, suggests the rate of infective endocarditis is not insignificant.

A retrospective multi-site cohort study was undertaken via medical record review at the centres where percutaneous pulmonary valve implantation has been performed. All procedures performed from 2009-March 2018 were included. Individuals were identified from local institution databases. Data was collected and analysed including demographics, details at the time of intervention, haemodynamic outcome, post procedure morbidity and mortality. Multi-site ethics approval was obtained.

One hundred and seventy-nine (179) patients attended the cardiac catheter laboratory for planned percutaneous pulmonary valve implantation. Of these patients, 172 underwent successful implantation. Tetralogy of Fallot and pulmonary atresia were the most common diagnoses. The median age at procedure was 19 years (range 3-60 yrs). There was a significant improvement in the acute haemodynamics in patients undergoing percutaneous pulmonary valve implantation for stenosis. Seven (7) patients (3.9%) experienced a major procedural/early post procedure complication (death, conversion to open procedure, cardiac arrest), including two deaths. The annualised rates of infective endocarditis and valve replacement were 4.6% and 3.8% respectively. There was one death related to infective endocarditis in follow-up.

Percutaneous pulmonary valve replacement is a relatively safe method of rehabilitating the right ventricular outflow tract.

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.

Transcatheter procedures for heart valve repair or replacement represent a valid alternative for treating patients who are inoperable or at a high risk for open-heart surgery. The transcatheter approach has become predominant over surgical intervention for aortic valve disease, but it is also increasingly utilized for diseases of the 'other valves', that is the mitral and, to a lesser extent, tricuspid and pulmonary valve. Preprocedural imaging is essential for planning the transcatheter intervention and computed tomography has become the main imaging modality by providing information that can guide the type of treatment and choice of device as well as predict outcome and prevent complications. In particular, preprocedural computed tomography is useful for providing anatomic details and simulating the effects of device implantation using 3D models. Transcatheter mitral valve replacement is indicated for the treatment of mitral regurgitation, either primary or secondary, and computed tomography is crucial for the success of the procedure. It allows evaluating the mitral valve apparatus, the surrounding structures and the left heart chambers, identifying the best access route and the landing zone and myocardial shelf, and predicting obstruction of the left ventricular outflow tract, which is the most frequent postprocedural complication. Tricuspid valve regurgitation with or without stenosis and pulmonary valve stenosis and regurgitation can also be treated using a transcatheter approach. Computer tomography provides information on the tricuspid and pulmonary valve apparatus, the structures that are spatially related to it and may be affected by the procedure, the right heart chambers and the right ventricular outflow tract.

The majority of patients with congenital heart disease who have undergone open heart surgery during childhood are possible candidates for additional transcatheter or surgical interventions. One fifth of these conditions usually involve the right ventricular outflow tract (RVOT). Percutaneous pulmonary valve replacement (PPVR) has been widely established as an alternative, less invasive option to surgical pulmonary valve replacement (SPVR). The variability of RVOT anatomy and size, the relative course of the coronary arteries and the anatomy of the pulmonary artery branches are factors that determine the success of the intervention as well as the complication rates. Careful and reliable pre-interventional imaging warrants the selection of suitable candidates and minimizes the risk of complications. 2D and 3D fluoroscopy have been extensively used during pre- and peri-interventional assessment. Established imaging techniques such as Cardiovascular Magnetic Resonance (CMR) and Computed Tomography (CT), as well as newer techniques, such as fusion imaging, have proved to be efficient and reliable tools during pre-procedural planning in patients assessed for PPVR.

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.

Neonatal myocardial infarction is rare and is associated with a high mortality of 40% to 50%. We report our experience with neonatal myocardial infarction, including presentation, management, outcomes, and our current patient management algorithm.

We reviewed all infants admitted with a diagnosis of coronary artery thrombosis, coronary ischemia, or myocardial infarction between January 2015 and May 2021.

We identified 21 patients (median age, 1 [interquartile range (IQR), 0.25-9.00] day; weight, 3.2 [IQR, 2.9-3.7] kg). Presentation included respiratory distress (16), shock (3), and murmur (2). Regional wall motion abnormalities by echocardiogram were a key criterion for diagnosis and were present in all 21 with varying degrees of depressed left ventricular function (severe [8], moderate [6], mild [2], and low normal [5]). Ejection fraction ranged from 20% to 54% (median, 43% [IQR, 34%-51%]). Mitral regurgitation was present in 19 (90%), left atrial dilation in 15 (71%), and pulmonary hypertension in 18 (86%). ECG was abnormal in 19 (90%). Median troponin I was 0.18 (IQR, 0.12-0.56) ng/mL. Median BNP (B-type natriuretic peptide) was 2100 (IQR, 924-2325) pg/mL. Seventeen had documented coronary thrombosis by cardiac catheterization. Seventeen (81%) were treated with intracoronary tPA (tissue-type plasminogen activator) followed by systemic heparin, AT (antithrombin), and intravenous nitroglycerin, and 4 (19%) were treated with systemic heparin, AT, and intravenous nitroglycerin alone. Nineteen of 21 recovered. One died (also had infradiaphragmatic total anomalous pulmonary venous return). One patient required a ventricular assist device and later underwent heart transplant; this patient was diagnosed late at 5 weeks of age and did not respond to tPA. Nineteen of 21 (90%) regained normal left ventricular function (ejection fraction, 60%-74%; mean, 65% [IQR, 61%-67%]) at latest follow-up (median, 6.8 [IQR, 3.58-14.72] months). Two of 21 (10%) had residual trivial mitral regurgitation. After analysis of these results, we present our current algorithm, which developed and matured over time, to manage neonatal myocardial infarction.

We experienced a lower mortality rate for infants with neonatal infarction than that reported in the literature. We propose a post hoc algorithm that may lead to improvement in patient outcomes following coronary artery thrombus.