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Purpose: Pre-stenting of the right ventricular outflow tract (RVOT) is commonly performed before percutaneous pulmonary valve implantation (PPVI), to relieve obstruction, prevent valved stent fractures, and provide a landing zone. This study aimed to evaluate the biomechanical characteristics of the stents currently used to perform pre-stenting of the RVOT. Methods: We assessed five commercially available stents: Cheatham-Platinum Stent ("CP Stent"), AndraStent XL, AndraStent XXL, Optimus XL, and Optimus XXL. Following stent deployment at nominal pressure, radial and longitudinal elastic recoils and radial resistance were measured. The bending stiffness of the stents crimped onto the balloons was also evaluated. Results: Three samples were tested for each stent. Our study showed no significant difference between the stent platforms in terms of radial elastic recoil, which was relatively low (< 10%). The longitudinal elastic recoil was also low for all the devices (< 5%). Significant differences were observed in radial resistance (P < 0.001). CP Stent and AndraStent XL exhibited the highest radial resistances. The bending stiffnesses of the stents crimped on their balloons were significantly different (P < 0.00001). Optimus XL and XXL were more flexible than the other stents. Conclusion: This study highlights the significant differences between the stents currently used in RVOT pre-stenting. Stents with good radial resistance are preferred, especially for calcified vessels, and flexibility is crucial for tortuous vessels. We proposed an algorithm for selecting the most suitable stent according to the need for radial force and flexibility, which will help inform clinicians considering RVOT revalvulation. [ABSTRACT FROM AUTHOR]

Structured abstract: Objectives: To describe the workflow and value of three-dimensional rotational angiography (3DRA) in percutaneous pulmonary valve implantation (PPVI). Background: 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. Methods: 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. Results: 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). Conclusions: 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.

Abstract Background Percutaneous pulmonary valve implantation has become an attractive method of dysfunctional right ventricle outflow tract treatment. Case presentation We describe a unique case of a 20-year-old Caucasian male patient with a complex cyanotic heart defect, namely pulmonary atresia, with congenitally corrected transposition of the great arteries and ventricular septal defect after Rastelli-like surgery at the age of 5 years with homograft use. At the age of 20 years, the patient needed percutaneous pulmonary valve implantation owing to homograft dysfunction. Despite unusual course of the coronary arteries, balloon testing in the landing zone of the right ventricle outflow tract excluded potential coronary artery compression. Then, after presentation, a Melody valve was implanted successfully in the pulmonary valve position. The 8-year follow-up was uneventful. Conclusion This is likely the first description of a percutaneous pulmonary valve implantation in such anatomy. Such a procedure is feasible; however, it requires exceptional caution owing to the anomalous coronary arteries course, which can be the reason for their compression.

Assessment of the right ventricular outflow tract and pulmonary arteries (RVOT) for percutaneous pulmonary valve implantation (PPVI) uses discrete measurements (diameters and lengths) from medical images. This multi-centre study identified the 3D RVOT shape features prevalent in patients late after surgical repair of congenital heart disease (CHD). A 3D RVOT statistical shape model (SSM) was computed from 81 retrospectively selected CHD patients (14.7 ± 6.8 years) who required pulmonary valve replacement late after surgical repair. A principal component analysis identified prevalent shape features (modes) within the population which were compared with standard geometric measurements (diameter, length and surface area) and between sub-groups of diagnosis, RVOT type and dysfunction. Shape mode 1 and 2 represented RVOT size and curvature and tapering and length, respectively. Shape modes 3–5 related to branch pulmonary artery calibre, conical vs. bulbous RVOTs and RVOT curvature, respectively. Tetralogy of Fallot, transannular patch type and regurgitant RVOTs were larger and straighter while conduit and stenotic types were longer and more cylindrical than other subgroups. This SSM analysed the main 3D shape features present in a population of RVOTs, exploiting the wide 3D anatomical information provided by routine imaging. This morphological information may have implications for PPVI patient selection and device design.

Background: Percutaneous pulmonary valve implantation has become an attractive method of dysfunctional right ventricle outflow tract treatment. Case presentation: We describe a unique case of a 20-year-old Caucasian male patient with a complex cyanotic heart defect, namely pulmonary atresia, with congenitally corrected transposition of the great arteries and ventricular septal defect after Rastelli-like surgery at the age of 5 years with homograft use. At the age of 20 years, the patient needed percutaneous pulmonary valve implantation owing to homograft dysfunction. Despite unusual course of the coronary arteries, balloon testing in the landing zone of the right ventricle outflow tract excluded potential coronary artery compression. Then, after presentation, a Melody valve was implanted successfully in the pulmonary valve position. The 8-year follow-up was uneventful. Conclusion: This is likely the first description of a percutaneous pulmonary valve implantation in such anatomy. Such a procedure is feasible; however, it requires exceptional caution owing to the anomalous coronary arteries course, which can be the reason for their compression. [ABSTRACT FROM AUTHOR]

Background and Aims Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. Methods Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. Results Data for 840 consecutive patients treated in 2014–2021 at a median age of 29.2 (19.0–41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%–99.2%] of patients. Median follow-up was 20.3 (7.1–38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P =.009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%–1.0%), 0.9% (0.2%–1.6%), and 3.8% (0.0%–8.4%); pulmonary valve replacement, 0.4% (0.0%–0.8%), 1.3% (0.2%–2.4%), and 8.0% (1.2%–14.8%); and pulmonary valve thrombosis, 0.4% (0.0%–0.9%), 0.7% (0.0%–1.3%), and 0.7% (0.0%–1.3%), respectively. Conclusions Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs. [ABSTRACT FROM AUTHOR]

We describe a rare and extremely challenging case of transcatheter pulmonary valve implantation in repaired tetralogy of Fallot and anomalous origin of the left main coronary artery from the right coronary sinus. Procedural planning based on advanced multimodality imaging and 3-dimensional technology proved to be the key to procedural success.

BackgroundPercutaneous pulmonary valve implantation (PPVI) has emerged as a less invasive alternative for treating severe pulmonary regurgitation after tetralogy of Fallot (TOF) repair in patients with a native right ventricular outflow tract (RVOT). However, the success of PPVI depends on precise patient-specific valve sizing, the avoidance of oversizing complications, and optimal valve performance. In recent years, innovative adaptations of commercially available cardiovascular mock loops have been used to test conduits in the pulmonary position. These models are instrumental in facilitating accurate pulmonic valve sizing, mitigating the risk of oversizing, and providing insight into the valve performance before implantation. This study explored the utilization of custom-modified mock loops to implant patient-specific 3D-printed pulmonary artery geometries, thereby advancing PPVI planning and execution.Material and MethodsPatient-specific 3D-printed pulmonary artery geometries of five patients who underwent PPVI using Pulsta transcatheter heart valve (THV) ® were tested in a modified ViVitro pulse duplicator system®. Various valve sizes were subjected to 10 cycles of testing at different cardiac output levels. The transpulmonary systolic and regurgitation fractions of the valves were also recorded and compared.ResultsA total of 39 experiments were conducted using five different patient geometries and several different valve sizes (26, 28, 30, and 32 mm) at 3, 4, and 5 L/min cardiac output at heart rates of 70 beats per minute (bpm) and 60/40 systolic/diastolic ratios. The pressure gradients and regurgitation fractions of the tested valve sizes in the models were found to be similar to the pressure gradients and regurgitation fractions of valves used in real procedures. However, in two patients, different valve sizes showed better hemodynamic values than the actual implanted valves.DiscussionThe use of 3D printing technology, electromagnetic flow meters, and the custom-modified ViVitro pulse duplicator system® in conjunction with patient-specific pulmonary artery models has enabled a comprehensive assessment of percutaneous pulmonic valve implantation performance. This approach allows for accurate valve sizing, minimization of oversizing risks, and valuable insights into hemodynamic behavior before implantation. The data obtained from this experimental setup will contribute to advancing PPVI procedures and offer potential benefits in improving patient outcomes and safety.

The implantation of percutaneous balloon expandable valves in native or patched right ventricular outflow tracts (nRVOT) is a challenging technique due to the diversity of anatomies and shapes, the large sizes, and the distensibility of the nRVOT, for which specific techniques have been developed. We present a single center experience with balloon expandable percutaneous pulmonary valves in nRVOT, describing the techniques used, complications observed, and a short-mid term follow-up.. This is a single center descriptive study of patients who underwent a percutaneous pulmonary valve implantation in a nRVOT with a balloon expandable pulmonary valve in our center between September 2012 and June 2022.. We implanted successfully 45 valves in 46 patients (20 Sapien and 25 Melody). Tetralogy of Fallot or pulmonary atresia with VSD were the main congenital heart disease (n = 32). All were pre-stented, 18 in a one step procedure. We used a Dryseal sheath in 13/21 Sapien. In 6 patients we used the anchoring technique, 5 with a very large nRVOT and one pyramidal nRVOT. In the 3.5 year follow-up 7 patients developed endocarditis and 3 required a valve redilation, no fractures were observed. PPVI of native RVOT with balloon expandable valves is feasible in a number of selected anatomies, including large or pyramidal nRVOT, using specific techniques, (presenting, LPA anchoring). [ABSTRACT FROM AUTHOR]

Background Pulmonary valve replacement in patients with congenital heart diseases and heart failure is challenging. Case summary Here, we describe a case of a patient who had surgical fallot repair with chronic heart failure. Investigations found severe biventricular dysfunction and enlargement due to chronic pulmonary regurgitation. The right ventricle outflow tract was tortuous and large with a diameter of 35 mm. Percutaneous pulmonary valve implantation (PPVI) was done after a challenging pre-stenting. A 32 mm Myval valve over-sized to 35 mm was used for PPVI, which yielded a good result. Discussion A 32 mm Myval valve is effective at extending the possibilities of PPVI in a large and tortuous right ventricle outflow tract not accessible for the other valves. [ABSTRACT FROM AUTHOR]

Performance of cardiovascular magnetic resonance (CMR) in the planning phase of percutaneous pulmonary valve implantation (PPVI) is needed for the accurate delineation of the right ventricular outflow tract (RVOT), coronary anatomy and the quantification of right ventricular (RV) volume overload in patients with significant pulmonary regurgitation (PR). This helps to find the correct timings for the intervention and prevention of PPVI-related complications such as coronary artery compression, device embolization and stent fractures. A defined CMR study protocol should be set for all PPVI candidates to reduce acquisition times and acquire essential sequences that are determinants for PPVI success. For correct RVOT sizing, contrast-free whole-heart sequences, preferably at end-systole, should be adopted in the pediatric population thanks to their high reproducibility and concordance with invasive angiographic data. When CMR is not feasible or contraindicated, cardiac computed tomography (CCT) may be performed for high-resolution cardiac imaging and eventually the acquisition of complementary functional data. The aim of this review is to underline the role of CMR and advanced multimodality imaging in the context of pre-procedural planning of PPVI concerning its current and potential future applications. [ABSTRACT FROM AUTHOR]

During percutaneous pulmonary valve implantation, it is challenging to advance the delivery system loaded with a stent-valve through the right ventricular outflow tract. An extra-stiff wire can provide enough supporting and stable positioning to prevent the displacement of the guide wire in stent-valve delivery. In the 2 cases reported here, we used a snare to trap the extra-stiff wire and a large sheath to support the snare; thus, the extra-stiff wire was pulled to the distal end and provided strong support for the advancement of the delivery system. After 8 months of follow-up, the patients were in good condition with excellent valve function. We named this novel, efficient technique the “parallel anchor sheath snare” technique. This report highlights a novel delivery strategy for patients with tortuous right ventricular outflow tracts in percutaneous pulmonary valve implantation. [ABSTRACT FROM AUTHOR]

Carcinoid heart disease is an important complication of neuroendocrine tumors that may lead to significant morbidity and mortality. Right-sided heart valve involvement with consequent valve dysfunction is one of the common manifestations. Patients often have multiple, significant comorbidities with advanced metastatic disease and, as such, may not be suitable for surgical valve replacement due to excessive risk. Transcatheter valve replacement using balloon-expandable valves has been the mainstay of management for these patients, particularly with stenotic lesions but there is limited experience in patients with pulmonary regurgitation and dilated pulmonary arteries outside the dimensions that would be suitable for these valves. We report three successful cases of percutaneous pulmonary valve implantation with the VenusP-valve, a large self-expanding valve platform, and highlight the technical aspects and challenges specific to treatment of pulmonary regurgitation in patients with carcinoid heart disease. Percutaneous pulmonary valve implantation, using the VenusP-valve, may be considered an effective treatment in this patient group., (© 2024 Wiley Periodicals LLC.)

Assessment of the right ventricular outflow tract and pulmonary arteries (RVOT) for percutaneous pulmonary valve implantation (PPVI) uses discrete measurements (diameters and lengths) from medical images. This multi-centre study identified the 3D RVOT shape features prevalent in patients late after surgical repair of congenital heart disease (CHD). A 3D RVOT statistical shape model (SSM) was computed from 81 retrospectively selected CHD patients (14.7 ± 6.8 years) who required pulmonary valve replacement late after surgical repair. A principal component analysis identified prevalent shape features (modes) within the population which were compared with standard geometric measurements (diameter, length and surface area) and between sub-groups of diagnosis, RVOT type and dysfunction. Shape mode 1 and 2 represented RVOT size and curvature and tapering and length, respectively. Shape modes 3-5 related to branch pulmonary artery calibre, conical vs. bulbous RVOTs and RVOT curvature, respectively. Tetralogy of Fallot, transannular patch type and regurgitant RVOTs were larger and straighter while conduit and stenotic types were longer and more cylindrical than other subgroups. This SSM analysed the main 3D shape features present in a population of RVOTs, exploiting the wide 3D anatomical information provided by routine imaging. This morphological information may have implications for PPVI patient selection and device design.

Performance of cardiovascular magnetic resonance (CMR) in the planning phase of percutaneous pulmonary valve implantation (PPVI) is needed for the accurate delineation of the right ventricular outflow tract (RVOT), coronary anatomy and the quantification of right ventricular (RV) volume overload in patients with significant pulmonary regurgitation (PR). This helps to find the correct timings for the intervention and prevention of PPVI-related complications such as coronary artery compression, device embolization and stent fractures. A defined CMR study protocol should be set for all PPVI candidates to reduce acquisition times and acquire essential sequences that are determinants for PPVI success. For correct RVOT sizing, contrast-free whole-heart sequences, preferably at end-systole, should be adopted in the pediatric population thanks to their high reproducibility and concordance with invasive angiographic data. When CMR is not feasible or contraindicated, cardiac computed tomography (CCT) may be performed for high-resolution cardiac imaging and eventually the acquisition of complementary functional data. The aim of this review is to underline the role of CMR and advanced multimodality imaging in the context of pre-procedural planning of PPVI concerning its current and potential future applications.

Open in new tab Download slide Open in new tab Download slide OBJECTIVES Since percutaneous pulmonary valve implantation (PPVI) was introduced to prolong the lifetime of surgically placed right ventricular to pulmonary artery conduits, valve technology has evolved and the indications for PPVI expanded to native and larger right ventricular outflow tracts. We explore how indications, patient populations and outcomes compare to surgical pulmonary valve replacement (PVR). METHODS This is a retrospective cohort study of PPVI and PVR procedures between 1998 and 2020 at a single UK centre. One hundred and twenty-eight patients underwent PPVI and 365 patients PVR. Primary outcome measures were survival, infective endocarditis and reintervention. RESULTS The most common indication for PVR was replacement of the native pulmonary valve for pulmonary regurgitation whereas PPVI was more commonly used to treat pulmonary stenosis in a previously placed bioprosthetic conduit or valve. Treatment indications for PPVI expanded over the study to include the native right ventricular outflow tract. Survival was similar for PPVI and PVR (92% PPVI and 96.8% PVR at 5 years; 85.8% PPVI and 95.1% PVR at 10 years). Preprocedural New York Heart Association class 3 and 4 was the most important predictor of poor outcome. Annualized infective endocarditis rate was significantly higher for the Melody PPVI (0.024 vs 0.0024/person/year for PVR, P  < 0.05). Both groups showed significant symptomatic improvement postprocedure with remodelling of ventricular volumes and improvement in cardiac output. Long-term follow-up for PVR showed half of patients will need replacement at 10–15 years post-index procedure. CONCLUSIONS An increasing number of patients requiring PVR can now be treated percutaneously. A lifetime strategy for re-valving should be considered at the first valve implant. [ABSTRACT FROM AUTHOR]

Background : Balloon-expandable pulmonary valves are usually not suitable for dilated native outflow tracts. Methods : Indian Venus P-valve registry was retrospectively analyzed for efficacy, complications, and midterm outcomes. Straight valve was used in prestented conduits in patients with right ventricular pressure above two-thirds systemic pressure and/or right ventricular dysfunction. Flared valve 1–4 mm larger than balloon waist was used in native outflow in symptomatic patients, large ventricular volumes, and ventricular dysfunction. Objectives : A self-expanding porcine pericardial Venus P-valve is available in straight and flared designs.. Results : Twenty-nine patients were included. Straight valve was successful in all seven conduits, reducing gradients significantly, including one patient with left pulmonary artery (LPA) stent. Flared valve was successfully implanted in 20 out of 22 native outflow tracts. Sharp edges of the older design contributed to two failures. Complications included two migrations with one needing surgery, endocarditis in one, insignificant wire-frame fractures in three, and groin vascular complication in one patient. There were no deaths or valve-related reinterventions at a mean follow-up of 47.8 ± 24.5 months (1–85 months). Modifications of technique succeeded in three patients with narrow LPA. There was significant improvement in symptoms, right ventricular volume, and pulmonary regurgitant fraction. Conclusion : Straight and flared Venus P-valves are safe and effective in appropriate outflow tracts. Straight valve is an alternative to balloon-expandable valves in stenosed conduits. Flared valve is suitable for large outflows up to 34 mm, including patients with LPA stenosis. Recent design modifications may correct previous technical failures. Studies should focus on durability and late complications.

One of the major obstacles preventing successful percutaneous pulmonary valve implantation (PPVI) is related to the close proximity of coronary artery branches to the expected landing zone. The aim of this study was to assess the frequency of coronary artery anomalies (CAAs) especially those associated with major coronary branches crossing the right ventricular outflow tract (RVOT) and to describe their relevance for the feasibility of percutaneous pulmonary valve implantation (PPVI). In our retrospective single-center study 90 patients were evaluated who underwent invasive testing for PPVI in our institution from 1/2010 to 1/2020. CAAs were identified in seven patients (8%) associated with major branches crossing the RVOT due to origin of the left anterior descending (LAD) or a single coronary artery from the right aortic sinus. In 5/7 patients with CAAs balloon testing of the RVOT and selective coronary angiographies revealed a sufficiently large landing zone distal to the coronary artery branch. While unfavorable RVOT dimensions prevented PPVI in one, PPVI was performed successfully in the remaining four patients. The relatively short landing zone required application of the "folded" melody technique in two patients. All patients are doing well (mean follow-up 3 years). CAAs associated with major coronary branches crossing the RVOT can be expected in about 8% of patients who are potential candidates for PPVI. Since the LAD crossed the RVOT below the plane of the pulmonary valve successful distal implantation of the valve was possible in 4/7 patients. Therefore these coronary anomalies should not be considered as primary contraindications for PPVI. [ABSTRACT FROM AUTHOR]

Background: Balloon-expandable pulmonary valves are usually not suitable for dilated native outflow tracts. Methods: Indian Venus P-valve registry was retrospectively analyzed for efficacy, complications, and midterm outcomes. Straight valve was used in prestented conduits in patients with right ventricular pressure above two-thirds systemic pressure and/or right ventricular dysfunction. Flared valve 1-4 mm larger than balloon waist was used in native outflow in symptomatic patients, large ventricular volumes, and ventricular dysfunction. Objectives: A self-expanding porcine pericardial Venus P-valve is available in straight and flared designs.. Results: Twenty-nine patients were included. Straight valve was successful in all seven conduits, reducing gradients significantly, including one patient with left pulmonary artery (LPA) stent. Flared valve was successfully implanted in 20 out of 22 native outflow tracts. Sharp edges of the older design contributed to two failures. Complications included two migrations with one needing surgery, endocarditis in one, insignificant wire-frame fractures in three, and groin vascular complication in one patient. There were no deaths or valve-related reinterventions at a mean follow-up of 47.8 ± 24.5 months (1-85 months). Modifications of technique succeeded in three patients with narrow LPA. There was significant improvement in symptoms, right ventricular volume, and pulmonary regurgitant fraction. Conclusion: Straight and flared Venus P-valves are safe and effective in appropriate outflow tracts. Straight valve is an alternative to balloon-expandable valves in stenosed conduits. Flared valve is suitable for large outflows up to 34 mm, including patients with LPA stenosis. Recent design modifications may correct previous technical failures. Studies should focus on durability and late complications. [ABSTRACT FROM AUTHOR]

Introduction: Percutaneous pulmonary valve replacement (PPVI) continues to gather pace in pediatric and adult congenital practice. This is fueled by an expanding repertoire of devices, techniques and equipment to suit the heterogenous anatomical landscape of patients with lesions of the right ventricular outflow tract (RVOT). Contrast-induced nephropathy is a real risk for teenagers and adults with congenital heart disease (CHD). Aim: To present a series of patients who underwent PPVI without formal RVOT angiography and propose case selection criteria for patients who may safely benefit from this approach. Material and methods: We retrospectively collected PPVI data from the preceding 2 years at our institution identifying patients who had been listed as suitable for consideration for contrast-free PPVI from our multidisciplinary team (MDT) meeting based on predefined criteria. Demographic, clinical, imaging and hemodynamic data were collected. Data were analyzed using SPSS. Results: Twenty-one patients were identified. All patients had a technically successful implantation with improvements seen in invasive and echocardiographic hemodynamic measurements. 90% of patients had a bio-prosthetic valve (BPV) in situ prior to PPVI. One patient had a complication which may have been recognized earlier with post-intervention RVOT contrast injection. Conclusions: Zero-contrast PPVI is technically feasible and the suitability criteria for those who might benefit are potentially straightforward. The advent of fusion and 3D imaging in cardiac catheterization laboratories is likely to expand our capacity to perform more procedures with less contrast. Patients with bio-prosthetic valves in the pulmonary position may benefit from contrast-free percutaneous pulmonary valve implantation. [ABSTRACT FROM AUTHOR]

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We describe our experience with aortic root distortion in transcatheter pulmonary valve implantation (TPVI). Aortic root distortion (AD) can be observed with balloon angioplasty of the right ventricular outflow tract (RVOT), but its long-term significance is unknown. This has been a common finding in our institution, though not fully appreciated in our early experience. Retrospective review of procedural angiograms prior to TPVI and follow up imaging was performed. Between June 2012 and October 2017, 47 patients underwent catheterization to attempt TPVI. Five patients had coronary compression which precluded TPVI (one with significant AD as well). Four patients had significant AD and did not receive TPVI. Of the remaining 38 successful TPVI, 20 had adequate imaging to assess the aortic root. Four patients had severe AD, 7 had mild AD, and 9 with no AD. Severity of AI did not correlate with degree of AD. Median follow up after TPVI was 46 months (IQR 21–67). Of the 4 patients with severe AD who received TPVI, 1 has new mild AI with 78 months follow up. Of the 18 patients who received TPVI without adequate arch imaging, 2 patients have new mild AI with 86 and 75 months follow up. AD during RVOT angioplasty is a relatively common finding. In our early experience, some patients who were retrospectively identified to have severe AD received TPVI. These patients have done well, though further data is needed before considering severe AD a benign finding. [ABSTRACT FROM AUTHOR]

Objective: Percutaneous pulmonary valve implantation (PPVI) into right ventricle-to-pulmonary artery conduits is increasingly being performed, but a few options are available for patients with a dilated native right ventricular outflow tract (RVOT), among which is the off-label use of Edwards SAPIEN® valves. This study reviews the results of the SAPIEN XT and SAPIEN 3 (S3) valve implantations in the pulmonary position in patients with a dilated native RVOT. Methods: Between January 2015 and March 2020, PPVI procedures were performed on 129 patients. Among them, 103 (80%) had dilated native RVOT, 86 of whom were eligible for PPVI prestenting and valve implantation. Retrospective analysis was performed on 84 patients who have undergone successful PPVI implantation using the SAPIEN XT or S3 valves with dilated native RVOT. Results: The procedural success rate was 84/86 (98%). The median age was 18.7 years (8-46 years), and the median weight was 57 kg (22-102 kg). The primary underlying diagnosis was tetralogy of Fallot (n=77/84). Stenting was performed simultaneously with valve implantation in 50/84 (60%) cases-six of which were hybrid procedures-whereas prestenting was performed 3 to 14 weeks earlier in 34/84 cases. Before valve implantation, the median right anterior oblique and lateral diameters of the stents were 26 mm (20-32 mm) and 28 mm (21-32 mm). Valve sizes were 26 mm (n=13) and 29 mm (n=64) for XT and 29 mm (n=7) for S3. In 59 patients, an additional 1-5 ml (median 2 ml) volume was added to the valves' balloons for stabilization. In all hybrid procedures, the stent and valve were implanted in the same session. During follow-ups of 1 to 59 months (median 14 months), no deaths were reported, 3 patients developed tricuspid regurgitation secondary to the procedure, and valves continued to function in all patients. Conclusion: The Edwards SAPIEN XT and S3 valves may be an alternative to PPVI in patients with dilated native RVOT. [ABSTRACT FROM AUTHOR]

Background: 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., Methods: 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., Results: 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/m 2  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., Conclusions: 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., (© 2024 Wiley Periodicals LLC.)

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., (© 2024 Wiley Periodicals LLC.)

Background : Pathophysiological differences in relief of pulmonary stenosis (PS) as opposed to pulmonary regurgitation (PR) by percutaneous pulmonary valve implantation (PPVI) remain elusive, but might impact current assessment of procedural success and ultimately indications. Methods : Invasive pressure measurements, cardiac magnetic resonance imaging and cardiopulmonary exercise testing were performed before pre-stenting (BMS), after BMS and after PPVI in patients with either PS or PR. Results : In PS (n = 14), BMS reduced the right ventricular (RV) to systemic pressure ratio (0.8 ± 0.2 vs. 0.4 ± 0.1%; p <.01), improved RF EF (53 ± 14 vs. 59 ± 12%; p =.01) but introduced free PR (PR fraction post 39 ± 12%; p <.01) with no changes in effective RV stroke volume (SV). PPVI eliminated PR (PR fraction 5 ± 3%; p <.01) and improved effective RV SV (p <.01) with no changes in RV EF (p =.47). Peak VO2 improved significantly after BMS, with no changes following PPVI (26 ± 9 vs. 30 ± 11 vs. 31 ± 10 ml/kg*min). In PR (n = 14), BMS exaggerated PR (PR fraction post 47 ± 10) with reduction in effective RV SV (pre 43 ± 9 vs. post 38 ± 8 ml/m2; p =.01), which improved after PPVI (post PPVI 49 ± 9 ml/m2; p <.01), secondary to elimination of PR (PR fraction 5 ± 4%; p <.01). RV EF (pre 53 ± 11 vs. post 53 ± 9 vs. post PPVI 50 ± 9%) and Peak VO2 (pre 22 ± 7 vs. post 21 ± 7 vs. post PPVI 23 ± 7 ml/kg*min) remained unchanged. Conclusions : Exercise capacity in patients with right ventricular outflow tract dysfunction is primarily afterload-dependent. • Exercise capacity in patients with RVOT dysfunction is primarily afterload-dependent. • Restoration of the valve function might not improve RV EF and exercise capacity. • These results support treating PR before a decline in exercise capacity and RV EF. [ABSTRACT FROM AUTHOR]

Interventional cardiology has made extraordinary advances over recent years, but most are still limited to addressing single intracardiac or valvular lesions. This debate considers whether complete interventional repair of more complex congenital defects might become achievable. Tetralogy of Fallot (ToF) is probably the first candidate where complete interventional repair might be achieved—given that various components of the defect have already been successfully addressed—albeit as either a palliative intervention (RVOT stenting) or to address the sequelae of standard surgery (percutaneous PVR). This article considers the challenges that would need to be overcome in terms of the morphology of the condition, the age limitations, and the necessary technological advancements that would be required—while setting these against the benchmark of current surgical outcomes and the parallel progress that is being developed in surgical correction. While complete interventional repair of ToF may still be beyond current techniques, a hybrid approach between surgeons and intentional cardiologists can strive to create a life-long paradigm of care that minimizes the need for surgery and focuses on the maintenance of a healthy right ventricle, such that patients born with ToF can achieve normal life expectancy. [ABSTRACT FROM AUTHOR]

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We describe a rare and extremely challenging case of transcatheter pulmonary valve implantation in repaired tetralogy of Fallot and anomalous origin of the left main coronary artery from the right coronary sinus. Procedural planning based on advanced multimodality imaging and 3-dimensional technology proved to be the key to procedural success., Competing Interests: This work was supported by IRCCS Policlinico San Donato, a clinical research hospital partially funded by the Italian Ministry of Health, and was supported in part by Ricerca Corrente from the Italian Ministry of Health. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Background: Percutaneous pulmonary valve implantation (PPVI) has emerged as a less invasive alternative for treating severe pulmonary regurgitation after tetralogy of Fallot (TOF) repair in patients with a native right ventricular outflow tract (RVOT). However, the success of PPVI depends on precise patient-specific valve sizing, the avoidance of oversizing complications, and optimal valve performance. In recent years, innovative adaptations of commercially available cardiovascular mock loops have been used to test conduits in the pulmonary position. These models are instrumental in facilitating accurate pulmonic valve sizing, mitigating the risk of oversizing, and providing insight into the valve performance before implantation. This study explored the utilization of custom-modified mock loops to implant patient-specific 3D-printed pulmonary artery geometries, thereby advancing PPVI planning and execution., Material and Methods: Patient-specific 3D-printed pulmonary artery geometries of five patients who underwent PPVI using Pulsta transcatheter heart valve (THV) ® were tested in a modified ViVitro pulse duplicator system®. Various valve sizes were subjected to 10 cycles of testing at different cardiac output levels. The transpulmonary systolic and regurgitation fractions of the valves were also recorded and compared., Results: A total of 39 experiments were conducted using five different patient geometries and several different valve sizes (26, 28, 30, and 32 mm) at 3, 4, and 5 L/min cardiac output at heart rates of 70 beats per minute (bpm) and 60/40 systolic/diastolic ratios. The pressure gradients and regurgitation fractions of the tested valve sizes in the models were found to be similar to the pressure gradients and regurgitation fractions of valves used in real procedures. However, in two patients, different valve sizes showed better hemodynamic values than the actual implanted valves., Discussion: The use of 3D printing technology, electromagnetic flow meters, and the custom-modified ViVitro pulse duplicator system® in conjunction with patient-specific pulmonary artery models has enabled a comprehensive assessment of percutaneous pulmonic valve implantation performance. This approach allows for accurate valve sizing, minimization of oversizing risks, and valuable insights into hemodynamic behavior before implantation. The data obtained from this experimental setup will contribute to advancing PPVI procedures and offer potential benefits in improving patient outcomes and safety., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Odemis, AKA, Ali, Gumus and Pekkan.)

• In a non pre-selected cohort, percutanous pulmonary valve implantation (PPVI) could be performed in 80/382 patients (20.9%). • A large right ventricular outflow tract, small patient size, and coronary compression were the major obstacles. • Future device developments may expand the indication pool for PPVI. Percutaneous pulmonary valve implantation (PPVI) numbers are rising but are still minor compared to surgery due to several contraindications. We sought to analyze the impact of PPVI compared to standard surgery in an unselected cohort with dysfunctional right ventricular outflow tract (RVOT). Reasons for PPVI failure and possible contraindications were explored. Between 2010 and 2015 all consecutive patients who underwent surgery or intervention for a dysfunctional RVOT were investigated. A total of 382 cases was identified – 246 patients underwent successful valve insertion: 166 surgeries (166/246 = 67.4%) with 55/166 homografts (33.1%), 106 Contegra® grafts (63.8%), 5 Hancock valves (3.0%). Overall, 70/246 patients presented a priori with an enlarged RVOT > 28 mm (28.5%) not appropriate for PPVI and 14/246 (5.7%) had additional defects necessitating surgery. Some 31/246 patients had surgery for initial repair of congenital defects or were too small (<20 kg) for PPVI (12.6%). 80 underwent successful PPVI (32.5% of 246 valves implanted) [51 Edwards Sapien® valves (63.7%), 29 Melody valves (36.3%)]. The RVOT was too large for PPVI in 22/246 patients (8.9%). A total 20/246 patients (8.1%) showed coronary compression after balloon interrogation. In 4/246 patients PPVI was not possible due to technical issues (1.4%). PPVI could be performed successfully in 80/382 patients (20.9%). An enlarged RVOT, small patient size, and coronary compression were the major obstacles for interventional management. Future developments for larger RVOTs and smaller body weight may expand the indication for PPVI. [ABSTRACT FROM AUTHOR]

• Currently 2 types of percutaneous pulmonary valves are available for implantation. • Melody® valve (Medtronic, Dublin, Ireland) and Sapien™ valves (Edwards Lifesciences, Irvine, CA, USA). • There is still no consensus in the guidelines which type of valve is better suited. • Using Melody® valves carries a substantially higher risk of developing infective endocarditis. Interventional percutaneous pulmonary valve implantation (PPVI) was first reported in 2000. Today, two different valves are certified for this procedure [i.e. Medtronic Melody® valve (Medtronic, Dublin, Ireland) and Edwards Sapien™ valve (Edwards Lifesciences, Irvine, CA, USA)]. For a decade, studies have reported an increasing risk of infective endocarditis (IE) after PPVI; as patients for PPVI are usually younger, even a low annual incidence of IE is important. However, the overall incidence and potential differences between the valves remain unclear. A systematic literature search was performed in the databases Medline, Cochrane Library, and Embase including the clinical trials register. The aim was to summarize and compare the cumulative incidence of IE after PPVI. Using a sensitivity analysis we set the incidence rates of the two valve types in ratio with a normal population. A total of 967 publications were identified searching for "pulmonary valve implantation," "PPVI," and 47 publications were used for final analysis. A total 3616 patients with Melody® valves and 501 with Sapien™ valves were included. IE after PPVI occurred in 214 patients with Melody® valves and in 5 patients only with Sapien™ valves. The pooled incidence for Melody® and Sapien™ valves was 4.9% (95% CI: 3.6–6.2) and 1.3% (95% CI: 0.3–2.3), respectively. Chi-square test was significant. The sensitivity analysis showed that the incidence rate ratio was 252.1 (95% CI: 187.6–338.6) for Melody® valves and for Sapien™ valves 2.7 (95% CI: 0.8–9.2). At present, there is an important difference for the risk of IE after PPVI. To reduce the risk of post PPVI endocarditis, a careful valve selection in favor of the Sapien™ valves seems to be beneficial. [ABSTRACT FROM AUTHOR]

The aim of this study was to report long-term outcomes after percutaneous pulmonary valve implantation (PPVI). Excellent short- and mid-term results after PPVI for right ventricular outflow tract (RVOT) dysfunction have been reported. Data on long-term results after PPVI are scarce. All 226 patients treated with PPVI at a single institution were prospectively enrolled in a database and included in the study. Follow-up information regarding outcomes was collected. Risk-factor analysis for death and reinterventions was performed. Follow-up data (up to 11 years) were available in 96% of the patients. At the end of the study period, 219 patients (92.8%) still lived with the initially implanted valve. Seven patients died, 2 of them from procedure-related complications. Seventeen patients (7.2%) needed valve replacement surgically (n = 11) or percutaneously (n = 6) for infectious endocarditis (n = 10) or valve degeneration (n = 7). In the remaining patients, the valves retained excellent function, and right ventricular dimensions and exercise capacity improved. A post-interventional RVOT gradient >15 mm Hg was a risk factor for death (hazard ratio: 7.57; 95% confidence interval: 1.26 to 45.38; p = 0.027) and for valve failure (hazard ratio: 3.76; 95% confidence interval: 1.43 to 9.93; p = 0.007). The best outcome was achieved with RVOT pre-stenting and a post-interventional gradient <15 mm Hg, resulting in an estimated event-free survival rate of 88% at 10 years. Patients after PPVI have excellent long-term outcomes. Right ventricular volumes, function, and exercise capacity improve significantly. A residual RVOT gradient <15 mm Hg was associated with the best outcome. [ABSTRACT FROM AUTHOR]

Right ventricle to pulmonary artery (RV-PA) conduits have been used for the surgical repair of congenital heart defects. These conduits frequently become stenosed or develop insufficiency with time, necessitating reoperations. Percutanous pulmonary valve implantation (PPVI) can delay the need for repeated surgeries in patients with congenital heart defects and degenerated RV-PA conduits. We presented our first experience with PPVI and described in detail the procedural methods and the considerations that are needed for this intervention to be successful. Immediate and short-term clinical outcomes of our patients were reported. Good haemodynamic results were obtained, both angiographically and on echocardiography. PPVI provides an excellent alternative to repeat open-heart surgery for patients with congenital heart defects and degenerated RV-PA conduits. This represents a paradigm shift in the management of congenital heart disease, which is traditionally managed by open-heart surgery. [ABSTRACT FROM AUTHOR]

Background: Coronary compression (CC) is a life threatening complication that can occur during percutaneous pulmonary valve implantation (PPVI). We describe our experience using cardiac CT prior to PPVI to identify patients at high CC-risk due to a close relationship between the coronary arteries and pulmonary trunk (PT).Methods: A retrospective evaluation of candidates for PPVI who underwent CT prior to the procedure was done. Measurements of PT were performed using double oblique reconstructed images, with special attention to the stenotic tract of the PT. The analysis of coronary arteries included detection of anomalies of origin and course and assessment of their relationship with the PT, measuring the minimum distance between the coronary artery and the intended site of the future percutaneous valve implantation.Results: CT analysis was performed for 52 patients. Thirty patients underwent PPVI after CT and 22 didn't. In 6/22 cases the reason not to receive a PPVI was high CC-risk detected at CT. In 6 other patients CT detected an intermediate CC-risk but the test balloon performed during angiography prior to valve placement was safe and the patients successfully underwent the procedure. None of the patients deemed as no CC-risk at CT had CC during PPVI.Conclusion: CT can detect patients with high and intermediate CC-risk and therefore may identify which patients are unlikely to undergo successful PPVI and those who need a careful analysis with balloon testing. CT can also rule out CC-risk identifying those patients in which balloon inflation testing could be omitted. [ABSTRACT FROM AUTHOR]

Between 12/2011 and 7/2018, percutaneous pulmonary valve implantation (PPVI) was performed in 23 patients (8 women, 15 men). In 22 patients, the Melody TPV (Medtronic) valve was used. The Sapien valve (Edwards Lifescience) was implanted in one patient. The median age at implantation was 19.0 years (IQR 15.4-27.1). The median follow-up duration was 2.6 years (IQR 1.1-4.5, maximum 5.9 years). There was no death during the whole follow-up period. PPVI resulted in an immediate improvement in the right ventricle to aortic pressure ratio and in a decrease in the right ventricle to pulmonary artery pressure gradient, p < 0.001. Echocardiographic measurements showed a decrease in the systolic pressure gradient over the right ventricular outflow tract, p < 0.001. Similarly, the degree of pulmonary regurgitation improved, p < 0.001. During the follow-up period none of the patients needed another revalvulation procedure. PPVI is an effective strategy for right ventricular outflow tract revalvulation with excellent mid-term results. [ABSTRACT FROM AUTHOR]

Background Infective endocarditis (IE) after transcatheter pulmonary valve implantation (TPVI) in dysfunctioning right ventricular outflow tract conduits has evoked growing concerns. We aimed to investigate the incidence and the natural history of IE after TPVI with the Melody valve through a systematic review of published data. Methods and Results PubMed, EMBASE, and Web of Science databases were systematically searched for articles published until March 2017, reporting on IE after TPVI with the Melody valve. Nine studies (including 851 patients and 2060 patient‐years of follow‐up) were included in the analysis of the incidence of IE. The cumulative incidence of IE ranged from 3.2% to 25.0%, whereas the annualized incidence rate ranged from 1.3% to 9.1% per patient‐year. The median (interquartile range) time from TPVI to the onset of IE was 18.0 (9.0–30.4) months (range, 1.0–72.0 months). The most common findings were positive blood culture (93%), fever (89%), and new, significant, and/or progressive right ventricular outflow tract obstruction (79%); vegetations were detectable on echocardiography in only 34% of cases. Of 69 patients with IE after TPVI, 6 (8.7%) died and 35 (52%) underwent surgical and/or transcatheter reintervention. Death or reintervention was more common in patients with new/significant right ventricular outflow tract obstruction (69% versus 33%; P=0.042) and in patients with non‐streptococcal IE (73% versus 30%; P=0.001). Conclusions The incidence of IE after implantation of a Melody valve is significant, at least over the first 3 years after TPVI, and varies considerably between the studies. Although surgical/percutaneous reintervention is a common consequence, some patients can be managed medically, especially those with streptococcal infection and no right ventricular outflow tract obstruction.

Introduction: Data on long term function of the Melody valve are scarce. Patients and methods: single institution; results of percutaneous pulmonary valve implantation (PPVI) from 2006 to 2014. The function of the valved conduit was analyzed by Doppler echocardiography. Annual Chest X-ray after implant and permanent screening for events (e.g. Endocarditis). Results: 112 Melody valves were implanted in 111 patients; mean age 19.3 years (4.5–81.6). No pre-stenting of the RVOT was performed (n = 4) at first. In the next 107 patients pre-stenting was always performed. In 82 patients 1 pre-stent, 18 patients 2, in 6 patients 3 stents and 1 patient 4 stents were used. The Melody stent was dilated up to 24 mm (n = 4), 22 mm (n = 72), 20 mm (n = 28) and 18 mm (n = 6). When stenotic, the Doppler gradient reduced from 67.0 mm Hg (SD 13.9) to 18.9 mm Hg (SD 10.4) (p

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. IE is 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, Staphylococcus  aureus 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., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Slouha et al.)

Abstract Objectives The aim of this study was to describe and analyze data from patients treated in France with the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position. Background The Edwards SAPIEN valve has recently been introduced for percutaneous pulmonary valve implantation (PPVI). Methods From April 2011 to May 2017, 71 patients undergoing PPVI were consecutively included. Results The median age at PPVI was 26.8 years (range 12.8 to 70.1 years). Primary underlying diagnoses were conotruncal malformations (common arterial trunk, tetralogy of Fallot and variants; n = 45), Ross procedure (n = 18), and other diagnoses (n = 8). PPVI indication was pure stenosis in 33.8% of patients, pure regurgitation in 28.1%, and mixed lesions in 38.1%. PPVI was successfully implemented in 68 patients (95.8%). Pre-stenting of the right ventricular outflow tract was performed in 70 patients (98.6%). Early major complications occurred in 4 subjects (5.6%), including 1 death, 1 coronary compression, and 2 pulmonary valve embolizations. Three of the 4 major complications occurred in the first 15 operated patients. No significant regurgitation was recorded after the procedure. Transpulmonary gradient was significantly reduced from 34.5 to 10.5 mm Hg (p < 0.0001). No patient died during a 1-month follow-up period. At 1-year follow-up, the death rate was 2.9%, and 3 patients had undergone surgical reintervention (44%). Conclusions Early results with the Edwards SAPIEN valve in the pulmonary position demonstrate an ongoing high rate of procedural success. Graphical abstract [ABSTRACT FROM AUTHOR]

Introduction: Until recently, two-dimensional (2D) angiography was the mainstay of guidance for percutaneous pulmonary valve implantation (PPVI). Recent advances in fusion software have enabled direct fusion of pre-intervention imaging, magnetic resonance imaging (MRI) or computed tomography (CT) scans, to create a reliable three-dimensional (3D) roadmap for procedural guidance. Aim: To report initial two-center experience with direct 2D-3D image fusion for live guidance of PPVI with MRI- and CT-derived 3D roadmaps. Material and methods: We performed a prospective study on PPVIs guided with the new fusion imaging platform introduced in the last quarter of 2015. Results: 3D guidance with an MRI- (n = 14) or CT- (n = 8) derived roadmap was utilized during 22 catheterizations for right ventricular outflow tract balloon sizing (n = 7) or PPVI (n = 15). Successful 2D-3D registration was performed in all but 1 patient. Six (27%) patients required intra-procedural readjustment of the 3D roadmap due to distortion of the anatomy after introduction of a stiff wire. Twenty-one (95%) interventions were successful in the application of 3D imaging. Patients in the CT group received less contrast volume and had a shorter procedural time, though the differences were not statistically significant. Those in the MRI group had significantly lower weight adjusted radiation exposure. Conclusions: With intuitive segmentation and direct 2D-3D fusion of MRI or CT datasets, VesselNavigator facilitates PPVI. Our initial data show that utilization of CT-derived roadmaps may lead to less contrast exposure and shorter procedural time, whereas application of MRI datasets may lead to lower radiation exposure. [ABSTRACT FROM AUTHOR]

Background Guidelines allow percutaneous pulmonary valve implantation (PPVI) in conduits above 16 mm diameter. Balloon dilatation of a conduit to a diameter > 110% of the original implant size is also not recommended. We analyzed patients undergoing PPVI in such conditions. Methods and results Nine patients (May 2008–July 2016) from 8 institutions underwent PPVI in conduits < 16 mm diameter. Five patients with 16–18 mm conduit diameter underwent PPVI after over-expansion of the conduit > 110%. Mean age and weight of the 14 patients was 12.1 (7.7 to 16) years and 44.9 (19 to 83) kg. Median conduit diameter at PPVI was 12 (10 to 17) mm. Median systolic right ventricular pressure was 70 (40 to 94) mm Hg. Procedure was successful in all cases. A confined conduit rupture occurred in 7 patients (50%) and was treated with covered stent in 6. One patient experienced dislocation of 2 pulmonary artery stents that were parked distally. The post-implantation median systolic right ventricular pressure was 36 (28 to 51) mm Hg. A fistula between right-ventricle outflow and aorta was found in one patient, secondary to undiagnosed conduit rupture. This was closed surgically. After a median follow-up of 20.16 (6.95 to 103.61) months, all the patients are asymptomatic with no significant RVOT stenosis. Conclusions PPVI is feasible in small conduits but rate of ruptures is high. Although such ruptures remain contained and can be managed with covered stents in our experience, careful selection of patients and high level of expertise are necessary. More studies are needed to better assess the risk of PPVI in this population. [ABSTRACT FROM AUTHOR]