Transcatheter Pulmonary Valve Replacement Research Articles

OR13-6 | Clinical Outcomes of Transcatheter Pulmonary Valve Replacement Versus Surgical Pulmonary Valve Replacement: A Meta-Analysis

OR13-6 | Clinical Outcomes of Transcatheter Pulmonary Valve Replacement Versus Surgical Pulmonary Valve Replacement: A Meta-Analysis

Transcatheter Pulmonary Valve Replacement With the Harmony Valve in Patients Who Do Not Meet Recommended Oversizing Criteria on the Screening Perimeter Plot.

Anatomic selection for Harmony valve implant is determined with the aid of a screening report and perimeter plot (PP) that depicts the perimeter-derived radius along the right ventricular outflow tract (RVOT) and projects device oversizing. The PP provides an estimation of suitability for implant, but its sensitivity as a screening method is unknown. This study was performed to describe anatomic features and outcomes in patients who underwent Harmony TPV25 implant despite a PP that predicted inadequate oversizing. We reviewed RVOT anatomic features and measurements in patients who underwent transcatheter pulmonary valve replacement with the Harmony TPV25 device despite a PP that predicted inadequate oversizing. This study included 22 patients. There were no unsuccessful implants or adverse valve-related events. Anatomic features varied, but all patients fit into 1 of 3 anatomic types characterized by differences in RVOT dimensions. Type 1 patients (n=9) had a long RVOT with a choke point and a wide main pulmonary artery. Type 2 patients (n=6) had a short RVOT that was pyramidal in shape, with no choke point, and extensive main pulmonary artery lengthening/expansion during systole. Type 3 patients (n=7) had a short, bulbous main pulmonary artery with a choke point and an open pulmonary artery bifurcation. Transcatheter pulmonary valve replacement with the Harmony valve is feasible in some patients whose PP fit analysis predicts inadequate oversizing. All cases in this series fit into 1 of 3 anatomic patterns, which are not identified in the screening report. Implanters must review cases individually to assess the feasibility of the implant.

2024 Statement from Asia expert operators on transcatheter pulmonary valve replacement.

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.

Right ventricle to pulmonary artery conduit: a comparison of long-term graft-related events between bovine jugular vein conduit, aortic homograft, and porcine-valved conduits.

The optimal conduit for right ventricle to pulmonary artery (RV-PA) reconstruction does not exist. Reinterventions are common due to conduit stenosis and endocarditis. Tailoring conduit choice according to patients' characteristics could improve the outcomes. The study aimed to compare graft-related events (infective endocarditis, transcatheter pulmonary valve replacement (PVR), transcatheter conduit dilatation, surgical conduit replacement, and transcatheter pulmonary branch intervention for RV-PA reconstruction using bovine jugular vein, aortic homograft, and porcine-valved conduits. In a retrospective cohort study, 155 patients with 193 procedures that were done in King Faisal Specialist Hospital and Research Center-Jeddah (KFSHRC JED) for implanting RV-PA conduits from 1999 to 2021 were included. The patients were grouped according to the type of conduit into 3 groups; Group 1 (n=153) received bovine jugular vein (BJVs) grafts, Group 2 (n=29) received aortic homografts, Group 3 (n=11) received porcine-valved conduits. Factors associated with graft-related events were evaluated using stepwise Cox regression analysis. Patients with BJVs were significantly younger than those with porcine-valved conduits 3 (P=0.009). The weight of BJVs patients was significantly lower than homografts (P=0.002) and porcine-valved conduits patients 3 (P<0.001). The conduit size was as expected significantly lower in BJVs patients than patients who received porcine-valved conduits (P<0.001) and patients who received aortic homografts (P<0.001). There was no difference between Group 2 and 3 (P=0.084). Operative mortality occurred in 13 patients: 12 (7.84%) with BJV conduit and 1 (9.09%) with porcine valved conduit (P=0.351). Male gender [odds ratio (OR): 10.04; 95% confidence interval (CI): 1.28-78.86; P=0.028] and smaller conduit size (OR: 0.78; 95% CI: 0.61-0.99; P=0.048) were associated with increased operative mortality. Freedom from graft-related events at 5 and 10 years was 67% and 52% in BJVs patients, 74% and 36% in patients who received aortic homografts, and 53% in patients who received porcine-valved conduits. Factors associated with increased graft-related events were male gender (HR: 1.58; 95% CI: 1.004-2.50, P=0.048) and younger age (HR: 0.995; 95% CI: 0.991-0.999, P=0.041). RV-PA reconstruction was associated with low mortality, unrelated to the conduit type. Reinterventions for graft-related events were common. The durability and graft-related events might be comparable among BJV grafts, aortic homografts, and porcine-valved conduits. Factors associated with increased graft-related events in this study were male gender and younger age.

Impact of pulmonary stenosis on right ventricular global longitudinal strain in repaired tetralogy of Fallot patients post transcatheter pulmonary valve replacement.

Mixed pulmonary disease with pulmonary regurgitation (PR) and stenosis (PS) in repaired tetralogy of Fallot (rTOF) can negatively impact ventricular health. Myocardial strain has been shown to be more sensitive at detecting occult ventricular dysfunction compared to right ventricular ejection fraction (RV EF). We hypothesize that rTOF patients with predominant PS will have lower RV global longitudinal strain (RV GLS) prior to and post-transcatheter pulmonary valve replacement (TPVR). A retrospective cohort of rTOF patients who underwent cardiac magnetic resonance (CMR) and cardiac catheterization for right ventricular pressure (RVSP) measurement were analyzed at three time points: before valve implantation, at discharge and within 18 months post-TPVR. Patients were dichotomized into three groups based on RVSP: 0%-49%, 50%-74%, and >75%. RV GLS and left ventricular (LV) GLS by speckle tracking echocardiography (STE) were obtained from the apical 4-chamber using TomTec software (TOMTEC IS, Germany). Forty-eight patients were included. Every 14.3% increase in preimplantation RVSP above 28% was associated with an absolute magnitude 1% lower RV GLS (p=.001). Preimplantation RVSP when 75% or higher had 3.36% worse RV GLS than the lowest bin (p=.014). Overall, average RV strain magnitude was higher when preimplantation RVSP was less than 50% and had greater improvement over the three time points. Higher post implantation RVSP correlated with lower strain magnitude. Patients with significant PS (>50%) may benefit from earlier PVR and not depend solely on RV size and EF. Myocardial strain may be a more sensitive marker of function; however, larger, prospective studies are needed.

Modern possibilities for transcatheter pulmonary valve replacement

The literature review is devoted to transcatheter pulmonary valve replacement. The authors summarize the indications, clinical data and current capabilities of transcatheter pulmonary valve replacement. The authors also overviewed modern valves for transcatheter pulmonary artery replacement. Effectiveness of transcatheter pulmonary valve implantation has been substantiated. Various studies comparing the outcomes of different valve systems for endovascular implantation were analyzed. The authors concluded the prospects for transcatheter pulmonary valve implantation.

Growth of the right ventricular outflow tract in repaired tetralogy of Fallot: A longitudinal CMR study.

Many patients with repaired tetralogy of Fallot require pulmonary valve replacement (PVR) due to significant pulmonary regurgitation (PR). Transcatheter PVR (TPVR) is an equally effective and less invasive alternative to surgical PVR but many native right ventricular outflow tracts (RVOTs) are too large for TPVR at time of referral. Understanding the rate of growth of the RVOT may help optimize timing of referral. This study aims to examine the longitudinal growth of the native RVOT over time in repaired tetralogy of Fallot (TOF). A retrospective review of serial cardiac MRI cardiovascular magnetic resonance (CMR) data from 121 patients with repaired TOF and a native RVOT (median age at first CMR 14.7 years, average interval between the first and last CMR of 8.1 years) was performed to measure serial changes in RVOT diameter, cross-sectional area, perimeter-derived diameter, and length. All parameters of RVOT size continued to grow with increasing age but growth was more rapid in the decade after TOF repair (for minimum systolic diameter, mean increase of 5.7mm per 10 years up to year 12, subsequently 2.3mm per 10 years). The RVOT was larger with a transannular patch and in patients without pulmonary stenosis (p<0.001 for both), but this was not associated with rate of growth. More rapid RVOT enlargement was noted in patients with larger right ventricular end-diastolic volume (RVEDV), higher PR fraction, and greater rates of increases in RVEDV and PR (p<0.001 for all) CONCLUSIONS: in patients with repaired TOF, using serial CMR data, we found that RVOT size increased progressively at all ages, but the rate was more rapid in the first decade after repair. More rapid RVOT enlargement was noted in patients with a larger RV, more PR, and greater rates of increases in RV size and PR severity. These results may be important in considering timing of referral for transcatheter pulmonary valves, in planning transcatheter and surgical valve replacement, and in designing future valves for the native RVOT.

Application of Speckle Tracking Echocardiography for Evaluating Ventricular Function after Transcatheter Pulmonary Valve Replacement.

Pulmonary regurgitation usually leads to right heart dilatation and eventually right heart dysfunction, which is associated with a poor prognosis. Transcatheter pulmonary valve replacement is a developing treatment for pulmonary valve dysfunction that can take the place of traditional surgery and make up for the shortcomings of a large injury. Echocardiography plays a significant role in assessing ventricular function; however, conventional echocardiographic parameters have several limitations. Speckle tracking echocardiography has been regarded as a more accurate tool for quantifying cardiac function than conventional echocardiography. Therefore, the aim of this review was to summarize the application of speckle tracking echocardiography for evaluating right and left ventricular functions in patients after transcatheter pulmonary valve replacement.

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

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

Current status of transcatheter intervention for complex right ventricular outflow tract abnormalities.

Various transcatheter interventions for the right ventricular outflow tract (RVOT) have been introduced and developed in recent decades. Transcatheter pulmonary valve perforation was first introduced in the 1990s. Radiofrequency wire perforation has been the approach of choice for membranous pulmonary atresia in newborns, with high success rates, although complication rates remain relatively common. Stenting of the RVOT is a novel palliative treatment that may improve hemodynamics in neonatal patients with reduced pulmonary blood flow and RVOT obstruction. Whether this option is superior to other surgical palliative strategies or early primary repair of tetralogy of Fallot remains unclear. Transcatheter pulmonary valve replacement has been one of the biggest innovations in the last two decades. With the success of the Melody and SAPIEN valves, this technique has evolved into the gold standard therapy for RVOT abnormalities with excellent procedural safety and efficacy. Challenges remain in managing the wide heterogeneity of postoperative lesions seen in RVOT, and various technical modifications, such as pre-stenting, valve ring modification, or development of self-expanding systems, have been made. Recent large studies have revealed outcomes comparable to those of surgery, with less morbidity. Further experience and multicenter studies and registries to compare the outcomes of various strategies are necessary, with the ultimate goal of a single-step, minimally invasive approach offering the best longer-term anatomical and physiological results.

Neurocognitive function and health-related quality of life in adolescents and young adults with CHD with pulmonary valve dysfunction.

Neurocognitive impairment and quality of life are two important long-term challenges for patients with complex CHD. The impact of re-interventions during adolescence and young adulthood on neurocognition and quality of life is not well understood. In this prospective longitudinal multi-institutional study, patients 13-30 years old with severe CHD referred for surgical or transcatheter pulmonary valve replacement were enrolled. Clinical characteristics were collected, and executive function and quality of life were assessed prior to the planned pulmonary re-intervention. These results were compared to normative data and were compared between treatment strategies. Among 68 patients enrolled from 2016 to 2020, a nearly equal proportion were referred for surgical and transcatheter pulmonary valve replacement (53% versus 47%). Tetralogy of Fallot was the most common diagnosis (59%) and pulmonary re-intervention indications included stenosis (25%), insufficiency (40%), and mixed disease (35%). There were no substantial differences between patients referred for surgical and transcatheter therapy. Executive functioning deficits were evident in 19-31% of patients and quality of life was universally lower compared to normative sample data. However, measures of executive function and quality of life did not differ between the surgical and transcatheter patients. In this patient group, impairments in neurocognitive function and quality of life are common and can be significant. Given similar baseline characteristics, comparing changes in neurocognitive outcomes and quality of life after surgical versus transcatheter pulmonary valve replacement will offer unique insights into how treatment approaches impact these important long-term patient outcomes.

Intentional Bioprosthetic Valve Ring Fracture Causing Coronary Artery Compression During Transcatheter Pulmonary Valve Replacement

Intentional Bioprosthetic Valve Ring Fracture Causing Coronary Artery Compression During Transcatheter Pulmonary Valve Replacement

Abstract 17910: Is Implantation of a Larger Edwards Sapien Transcatheter Pulmonary Valve Associated With Early Valve Failure? A Different Type of Patient-Prosthesis Mismatch

Introduction: Transcatheter pulmonary valve replacement (TPVR) is an alternative option to address failing native and bioprosthetic pulmonary valves (BPV). TPVR has expanded to implantation in native right ventricular outflow tracts (nRVOT) and progressively smaller patients. We aim to define the relationship between valve-to-patient size ratio and early development of pulmonary insufficiency (PI). Methods: This single-center retrospective cohort study identified patients who underwent TPVR with a Sapien valve between 2014 and 2021. We collected demographic, anatomic, and pre- and post-TPVR echo data. Echo data were collected at four post-TPVR time points: prior to discharge, short-term (1-9 months), mid-term (9-18 months), and most recent study. The primary outcome was development of moderate or severe PI by mid-term follow-up. Valve size-to-body surface area (BSA) ratio was evaluated for correlation with the development of moderate or severe PI. Results: The cohort consisted of 187 patients; 79 (42.2%) underwent TPVR within the nRVOT (Table). Compared to patients with TPVR in a conduit or BPV, patients with a nRVOT were younger, had lower weight, and lower BSA. Moderate or severe PI post-TPVR was more common in patients in the nRVOT group (P-value &lt; 0.001), occurring in 9 (11.5%) by mid-term follow-up, compared to 2 (1.9%) in a conduit or BPV. In the subset of patients with TPVR within the nRVOT, the development of moderate or severe PI was associated with a larger valve size-BSA ratio (OR=1.13, 95% CI: 1.03, 1.26, P-value=0.012). Conclusions: Development of moderate or severe PI following TPVR with a Sapien valve was rare in this cohort. Patients receiving a Sapien TPVR within the nRVOT with a large valve size-to-BSA ratio were more likely to develop early PI. The increased risk of early valve failure in these patients should inform counseling regarding expected longevity of the valve and may guide valve choice as more transcatheter valve options become available.

Abstract 15800: Evaluating the Correlation Between Right Ventricular Outflow Tract Dimensions and Arrhythmia Risk Following Self-Expanding Transcatheter Pulmonary Valve Replacement

Introduction: The introduction of self-expanding valves has allowed for an expanded range of patients who can be treated with transcutaneous pulmonary valve replacement (TPVR). Though major complications are rare, ventricular tachycardia has been reported following self-expanding valve placement prompting investigation of potential risk factors. Hypothesis: Significant variation in valve dimensions within the right ventricular outflow tract (RVOT) throughout the cardiac cycle is postulated as a cause for increased arrhythmia risk. We hypothesized that greater dynamic variation of the valve in the RVOT correlates to higher ventricular arrythmia risk. Methods: A single center review was performed of patients who underwent TPVR with either Harmony TPV or Alterra Pre-stent with subsequent placement of 29mm Sapien valve between 2019 and 2023. Using post-procedural 3D rotational angiography, minimum (systole) and maximum (diastole) diameters (mm), perimeter (mm) and cross-sectional area (mm 2 ) of the valve frame were measured in two locations: closest to the branch pulmonary artery bifurcation and the RV cavity. Results: Twenty-eight patients were included (14 Harmony TPV, 14 Alterra). Higher frequency of ventricular arrythmia was seen in patients with congenital pulmonary stenosis ( p =0.004). Higher ventricular arrythmia rate was associated with larger diastolic diameter (34.1 vs 33.2mm, p =0.04), mean perimeter (118.3 vs 108.6mm, p =0.03) and area (1124.5 vs 926.2mm 2 , p =0.03) of the valve frame closest to the RV cavity. Conclusions: Increased movement of the valve frame close to the RV cavity may correlate with a higher ventricular arrythmia risk due to increased contact with the native RVOT throughout the cardiac cycle. Future studies should focus on more accurate, mathematical methodology to better understand whether the complex interaction between self-expanding valves and the native RVOT is a determinant for post-procedural ventricular arrythmia.

Risk of Infective Endocarditis Post-transcatheter Pulmonary Valve Replacement Versus Surgical Pulmonary Valve Replacement: A Systematic Review.

Pulmonary valve replacement (PVR) is the most common cardiac operation in adult patients with congenital heart disease (ACHD). It can improve right ventricular outflow tract (RVOT) obstruction, typically due to pulmonary valve stenosis or regurgitation. PVR can be performed surgically (open-heart) and through a transcatheter (percutaneous) method, which is minimally invasive and is associated with shorter hospitalization stays. However, following PVR, infectious endocarditis (IE) can complicate the recovery process and increase mortality in the long term. IEis a rare but deadly multi-organ system condition caused by microorganisms traversing the bloodstream from a specific entry point. It can have many presentations, such as splinter hemorrhages, fevers, and vegetation on valves that lead to stroke consequences. This paper aims to evaluate the differences in the rate, etiology, manifestations, treatment, and outcomes of IE following surgical and transcatheter PVR, as the goal is to perform a procedure with few complications. In both approaches, Staphylococcusaureus was the most common microorganism that affected the valves, followed by Streptococcus viridians. Research has shown that surgical pulmonary valve replacement (SPVR) has a decreased risk of IE following surgery compared to TPVR. However, TPVR is preferred due to the reduced overall risk and complications of the procedure. Despite this, the consensus on mortality rates does differ. Future research should consider the type of valves used for transcatheter pulmonary valve replacement (TPVR), such as Melody valves versus Edward Sapien valves, as their IE rates vary significantly.

Development of Novel Sutureless Balloon Expandable Fetal Heart Valve Device Using Absorbable Polycaprolactone Leaflets.

Congenital heart disease (CHD) accounts for nearly one-third of all congenital defects, and patients often require repeated heart valve replacements throughout their lives, due to failed surgical repairs and lack of durability of bioprosthetic valve implants. This objective of this study is to develop and in vitro test a fetal transcatheter pulmonary valve replacement (FTPVR) using sutureless techniques to attach leaflets, as an option to correct congenital defects such as pulmonary atresia with intact ventricular septum (PA/IVS), in utero. A balloon expandable design was analyzed using computational simulations to identify areas of failure. Five manufactured valves were assembled using the unique sutureless approach and tested in the fetal right heart simulator (FRHS) to evaluate hemodynamic characteristics. Computational simulations showed that the commissural loads on the leaflet material were significantly reduced by changing the attachment techniques. Hemodynamic analysis showed an effective orifice area of 0.08 cm2, a mean transvalvular pressure gradient of 7.52mmHg, and a regurgitation fraction of 8.42%, calculated over 100 consecutive cardiac cycles. In conclusion, the FTPVR exhibited good hemodynamic characteristics, and studies with biodegradable stent materials are underway.

Use of Three-Dimensional Intracardiac Echocardiography Catheter in the Evaluation of Prosthetic Pulmonary Valves after Transcatheter Replacement

Transcatheter pulmonary valve replacement (TPVR) is commonly performed in patients with congenital heart disease as a safe alternative to replacement via open heart surgery. Intracardiac echocardiography (ICE) is a useful technique for evaluating multiple structures that are difficult to assess by other echocardiographic techniques, particularly the pulmonary valve. To our knowledge, the use of three-dimensional (3D) ICE catheters to evaluate prosthetic valves after TPVR has not been reported. Three-dimensional ICE catheters offer a comprehensive evaluation of transcatheter-deployed pulmonary valves through 3D, 3D color, xPlane, and multiplane reconstruction. The aim of this study is to demonstrate the feasibility of using 3D ICE catheters, outline their role in evaluating post-TPVR deployment success and complications, consider their additive value to two-dimensional ICE, and present our institutional experience with it in 50 cases of TPVR.

Treatment of Severe Pulmonary Regurgitation in Enlarged Native Right Ventricular Outflow Tracts: Transcatheter Pulmonary Valve Replacement with Three-Dimensional Printing Guidance.

Severe pulmonary regurgitation (PR) often occurs following a transannular patch repair of tetralogy of Fallot, resulting in an enlarged native right ventricular outflow tract (nRVOT) with varying shapes. We conducted a single-center study with eight patients having severe PR and enlarged nRVOT (diameters ≥ 29 mm). Transcatheter pulmonary valve replacement (TPVR) was performed using the self-expanding PT-Valve. Preoperative evaluation included echocardiography, computed tomography, and magnetic resonance imaging. A 3D-printed model of the nRVOT was used for preoperative assessment. Follow-up data were collected in 1-year follow-up. PT-Valve was successfully implanted in all patients, resulting in immediate improvement of severe PR. Pulmonary artery diastolic pressure increased significantly (p < 0.001). No deaths or coronary compression occurred during the procedure. Over a 1-year follow-up, no stent displacement or fracture occurred. Only two patients had trace paravalvular leaks. Magnetic resonance imaging revealed a reversal of right ventricular remodeling, with a significant reduction in right ventricular end-diastolic volume index (p < 0.001) and improved right ventricular ejection fraction (p < 0.001). All patients achieved primary endpoints. 3D printing-guided PT-Valve implantation in enlarged nRVOT for severe PR is safe and effective, expanding TPVR indications and offering potential treatment for a broader patient population.

Comparison of Cardiac Computed Tomography and Magnetic Resonance Angiography Measurements for Determination of Candidacy for Transcatheter Pulmonary Valve Replacement in Native or Postsurgical Right Ventricular Outflow Tracts

Comparison of Cardiac Computed Tomography and Magnetic Resonance Angiography Measurements for Determination of Candidacy for Transcatheter Pulmonary Valve Replacement in Native or Postsurgical Right Ventricular Outflow Tracts

Surgical or transcatheter pulmonary valve replacement, how to choose ?

Surgical or transcatheter pulmonary valve replacement, how to choose ?