Transcatheter Pulmonary Valve Implantation Research Articles

Occurrence and Outcome of Infective Endocarditis after Surgical Compared to Transcatheter Pulmonary Valve Implantation in Congenital Heart Disease.

Background: Conflicting data exist on the occurrence and outcome of infective endocarditis (IE) after pulmonary valve implantation. Objectives: This study sought to assess the differences between transcatheter pulmonary valve implantation (TPVI) and surgical pulmonary valve replacement (SPVR). Methods: All patients ≥ 4 years who underwent isolated pulmonary valve replacement between 2005 and 2018 were analyzed based on the data of a major German health insurer (≈9.2 million insured subjects representative of the German population). The primary endpoint was a composite of IE occurrence and all-cause death. Results: Of 461 interventions (cases) in 413 patients (58.4% male, median age 18.9 years [IQR 12.3-33.4]), 34.4% underwent TPVI and 65.5% SPVR. IE was diagnosed in 8.0% of cases during a median follow-up of 3.5 years. Risk for IE and all-cause death was increased in patients with prior IE (p < 0.001), but not associated with age (p = 0.50), sex (p = 0.67) or complexity of disease (p = 0.59). While there was no difference in events over the entire observational time period (p = 0.22), the time dynamics varied between TPVI and SPVR: Within the first year, the risk for IE and all-cause death was lower after TPVI (Hazard Ratio (HR) 95% CI 0.19 (0.06-0.63; p = 0.006) but increased over time and exceeded that of SPVR in the long term (HR 10.07 (95% CI 3.41-29.76; p < 0.001). Conclusions: Patients with TPVI appear to be at lower risk for early but higher risk for late IE, resulting in no significant difference in the overall event rate compared to SPVR. The results highlight the importance of long-term specialized care and preventive measures after both interventions.

First pathological report of successful transcatheter pulmonary valve implantation in a client-owned dog

First pathological report of successful transcatheter pulmonary valve implantation in a client-owned dog

Patient Screening for Self-Expanding Percutaneous Pulmonary Valves Using Virtual Reality.

In recent years, self-expanding technology to treat pulmonary regurgitation in the native right ventricular outflow tract became Food and Drug Administration approved in the United States and is now routinely used. The current practice for selection of patients who are candidates for these devices includes screening for "anatomic fit," performed by each of the manufacturing companies. Our study aims to validate the use of virtual reality (VR) as a tool for local physician-led screening of patients. This retrospective study from Children's Hospital Colorado included patients who underwent pulmonary valve replacement and had screening for a Harmony TPV or Alterra Prestent performed between September 2020 and January 2022. The data from the commercial companies' dedicated analysis for self-expanding transcatheter pulmonary valve frames evaluation with perimeter analysis were collected. VR simulation was performed blinded by 2 congenital interventional cardiologists using Elucis VR software and an Oculus Quest 2 headset. Among the 27 evaluated cases, the use of a self-expandable valve was recommended by companies' dedicated analysis in 23 cases (85.2%), by VR assessment in 26 cases (96.3), and finally implanted in 25 cases (92.6%). Regarding the level of agreement, both modalities (manufacturer and VR) were good at screening-in patients who received a self-expanding valve (100% versus 96.1%). When it came to screening-out the patients, VR presented good capacity to accurately classify nonsuitable patients (50% versus 100%). Our institutional experience with VR transcatheter pulmonary valve implantation planning accurately predicted clinical outcomes. This paves the way for routine use of VR in patient selection for self-expanding valve technologies.

Transcatheter Pulmonary Valve Implantation in Repaired Tetralogy of Fallot and Anomalous Left Coronary Artery Origin

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.

Multicenter Experience for Early and Mid-Term Outcome of MyVal Transcatheter Pulmonary Valve Implantation.

Transcatheter pulmonary valve implantation (TPVI) is a surgical alternative for correcting dysfunctional right ventricular outflow tract in previously operated patients. MyVal transcatheter heart valve (THV) (Meril Life Sciences, India), a new transcatheter valve designed for aortic position has recently been reported to be implanted in pulmonary position. Myval transcatheter valve were implanted in patients with stenosed dysfunctional conduits, severe regurgitation from transannular patch or dysfunctional surgical pulmonary valves(Bioprosthesis). Procedural details and post-TPVI follow-up were analysed. Myval TPVI was used in Fifty three patients with median age of 15years (IQR 12-19.5years). Almost sixty percent of the patients were male, with a median weight of 50kg (31-63kg). Prestenting was used in more than 80 percent of patients (n = 45 patients), while 6 patients had a prior surgical valve implantation. After Myval TPVI implantation, the peak instantaneous gradient across the RVOT decreased from a median of 23.5mmHg (IQR 10-53mmHg) pre-procedure to 10mmHg (IQR 5-16mmHg) post-procedure. The median fluoroscopy time for the procedure was 35min (IQR 23.5-44min). The large sizes-mainly the 29-mm and 32mm Myval (Navigator, Meril Life Sciences Pvt Ltd, India), were the most used size in 40% (n = 22) of the cases each. The median contrast volume used during the procedure was 247mL (IQR 120-300mL). Patients were followed for a median period of 360days (IQR 164-525days). At the last clinic follow-up, there was no tricuspid valve regurgitation. Moderate neo-pulmonary valve regurgitation was reported in three cases. Early experience of TPVI with MyVal is encouraging with procedural success in all patients and acceptable mid-term outcomes.

[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.

A Modified Technique for Transcatheter Pulmonary Valve Implantation of SAPIEN 3 Valves in Large Right Ventricular Outflow Tract: A Matched Comparison Study.

Percutaneous pulmonary valve implantation (PPVI) with a SAPIEN 3 valve is effective for treating treat right ventricle outflow (RVOT) dysfunction. A modified technique was developed without prestenting using a protective valve delivery method. We aimed to compare the procedural results of the modified technique group (MTG) to those of patients in a conventional technique group (CTG). We designed a matched before-after study. All consecutive PPVI with SAPIEN 3 performed in the MTG over 9 months were matched, based on the RVOT type and size, to consecutive procedures performed previously with SAPIEN 3. A total of 54 patients were included, equally distributed in the two groups. The sizes of the SAPIEN 3 valves were 23 mm (n = 9), 26 mm (n = 9), 29 mm (n = 36). The two groups were similar regarding demographic data, RVOT type, and pre-procedure hemodynamics. PPVI was performed in a single procedure in all patients of the MTG, whereas six (22.2%) patients of the CTG group underwent prestenting as a first step and valve implantation later (p = 0.02). The procedures were successful in all cases. Stent embolization was reported in two patients (7.4%) in the CTG, which were impacted in pulmonary arteries. In one case (3.7%), in the MTG, an unstable 29 mm SAPIEN 3 valve was stabilized with two stents and additional valve-in-valve implantation. The hemodynamics results were good in all cases, without significant differences between the two groups. The procedures' durations and fluoroscopy times were significantly reduced in the MTG (48.1 versus 82.6 min, p < 0.0001; 15.2 versus 29.8 min, p = 0.0002). During follow-up, neither stent fracture nor valve dysfunction was noticed in either group. PPVI without prestenting and with a protective delivery method of the SAPIEN 3 valve significantly reduces the procedure's complexity, the duration, and the irradiation while maintaining excellent hemodynamics results in selected cases.

Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry.

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. Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. 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. Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.

Role of Computed Tomography before Transcatheter Pulmonary Valve Implantation in Patients with Dysfunctional Native Right Ventricular Outflow Tract.

The most performed percutaneous valve replacement procedure is for the aortic valve. In recent years, there have been developments in percutaneous valve replacement methods for other valves, including the pulmonary valve. Computed tomography plays a crucial role in various stages of procedure planning and provides essential information regarding potential complications after the procedure. We present images documenting step by step how to evaluate cardiac computed tomography in the qualification procedure for transcatheter pulmonary valve implantation in patients with dysfunctional native right ventricular outflow tract.

Transcatheter pulmonary valve implantation in clinical practice: A nationwide survey of cardiological implanting and non-implanting physicians

AimTranscatheter Pulmonary Valve Implantation (TPVI), when feasible, is the first-line approach to pulmonary valve replacement. Our aim was to obtain a picture of current TPVI practice in Italy. MethodsAfter conducting a literature review on TPVI, online surveys were devised by an Advisory Board of 10 experts from the three Italian reference centers for congenital heart diseases and sent electronically to physicians working either in implanting center or in referral non-implanting cardiologic centers. ResultsApproximately 450 physicians across Italy were invited to contribute. 82 (18%) physicians answered. EchoColorDoppler, electrocardiogram and cardiac magnetic resonance were considered the first line approach to monitor these patients, before and after TPVI.For non-implanting centers, reasons for non-referral of patients for PVR were: paucisymptomatic disease (67%) and patients’ poor adherence to disease management programs (41%), but also the lack of connections with specialized centers (33%). For implanters, the main reasons for refraining from TPVI were: high risk for coronary compression (67% first rank), the need for concomitant cardiac surgical procedures (39% first rank) and the unsuitable anatomy of the conduit (39% first rank). The availability of new larger valves of a self-expandable nature was indicated as a key technological development for expanding the cohort of patients currently eligible for TPVI. ConclusionsDespite a non-invasive imaging protocol for the follow up and selection of patients candidate to TPVI is well implemented in Italy, there is still a lack in connections between non-implanting and implanting centers.

Rationale and Design of the Multicenter Catheter Ablation of Ventricular Tachycardia Before Transcatheter Pulmonary Valve Replacement in Repaired Tetralogy of Fallot Study

Patients with repaired tetralogy of Fallot are at elevated risk for ventricular arrhythmia and sudden cardiac death. Over the past decade, the pathogenesis and natural history of ventricular tachycardia has become increasingly understood, and catheter ablation has emerged as an effective treatment modality. Concurrently, there has been great progress in the development of a versatile array of transcatheter valves that can be placed in the native right ventricular outflow tract for the treatment of long-standing pulmonary regurgitation. Although such valve platforms may eliminate the need for repeat cardiac operations, they may also impede catheter access to the myocardial substrates responsible for sustained macro-reentrant ventricular tachycardia. This manuscript provides the rationale and design of a recently devised multicenter study that will examine the clinical outcomes of a uniform, preemptive strategy to eliminate ventricular tachycardia substrates before transcatheter pulmonary valve implantation in patients with tetralogy of Fallot.

Infective Endocarditis Risk with Melody versus Sapien Valves Following Transcatheter Pulmonary Valve Implantation: A Systematic Review and Meta-Analysis of Prospective Cohort Studies.

Transcatheter pulmonary valve implantation (TPVI) is an effective non-surgical treatment method for patients with right ventricle outflow tract dysfunction. The Medtronic Melody and the Edwards Sapien are the two valves approved for use in TPVI. Since TPVI patients are typically younger, even a modest annual incidence of infective endocarditis (IE) is significant. Several previous studies have shown a growing risk of IE after TPVI. There is uncertainty regarding the overall incidence of IE and differences in the risk of IE between the valves. A systematic search was conducted in the MEDLINE, EMBASE, PubMed, and Cochrane databases from inception to 1 January 2023 using the search terms 'pulmonary valve implantation', 'TPVI', or 'PPVI'. The primary outcome was the pooled incidence of IE following TPVI in Melody and Sapien valves and the difference in incidence between Sapien and Melody valves. Fixed effect and random effect models were used depending on the valve. Meta-regression with random effects was conducted to test the difference in the incidence of IE between the two valves. A total of 22 studies (including 10 Melody valve studies, 8 Sapien valve studies, and 4 studies that included both valves (572 patients that used the Sapien valve and 1395 patients that used the Melody valve)) were used for the final analysis. Zero IE incidence following TPVI was reported by eight studies (66.7%) that utilized Sapien valves compared to two studies (14.3%) that utilized Melody valves. The pooled incidence of IE following TPVI with Sapien valves was 2.1% (95% CI: 0.9% to 5.13%) compared to 8.5% (95% CI: 4.8% to 15.2%) following TPVI with Melody valves. Results of meta-regression indicated that the Sapien valve had a 79.6% (95% CI: 24.2% to 94.4%, p = 0.019; R2 = 34.4) lower risk of IE incidence compared to the Melody valve. The risk of IE following TPVI differs significantly. A prudent valve choice in favor of Sapien valves to lower the risk of post-TPVI endocarditis may be beneficial.

C48 TEN–YEARS, SINGLE–CENTER EXPERIENCE WITH MELODY TPV IMPLANTATION: EARLY OUTCOMES AND MID–TERM FOLLOW–UP

Abstract Objectives Melody TPV is the first percutaneous valvular bio–prosthesis approved for trans–catheter pulmonary valve implantation (TPVI). We describe our ten–years experience about Melody TPV implantation in patients with congenital heart disease (CHD). Methods This is an observational retrospective single–center study. All patients undergone Melody TPV implantation were included. The early outcomes analyzed were: procedural failure, death of patient, life–threating adverse events. The long–term outcomes analyzed during follow–up were: infective endocarditis, trans–catheter redo–procedure, and surgical redo–procedure. Results From 2012 to 2022, 39 patients were evaluated in our catheterization laboratory for TPVI with Melody TPV. Mean age and weight were 21,31±11,58 (range 8–66) years and 57,5±16,24 (range 23–96) kilograms. The patients were affected by the following CHD: tetralogy of Fallot (22 pts, 56,4%), pulmonary atresia with ventricular septal defect (VSD) (4 pts, 10,3%), aortic stenosis s/p Ross surgery (4 pts, 10,3%), transposition of the great arteries with VSD and PS (3 pts, 7,7%), pulmonary stenosis (PS) (2 pts, 5,1%), truncus arteriosus (2 pts, 5,1%), double outlet right ventricle (1 pt, 2,5%), Ebstein’s anomaly (1 pt, 2,5%) In 4 cases (10,3%), the procedure failed because of coronary compression during balloon RVOT interrogation. One patient (2,5%) died due to post–procedural septic shock. In the other 34 patients (87,2%), the Melody TPV was implanted effectively. No life–threating adverse events were recorded. In 3 cases, the Melody TPV was implanted off–label: in tricuspid position (one case) and in “small conduits” (&amp;lt;16 mm) (two cases). The mean follow–up was 4,41±2,82 years. During follow–up, 5 patients (14,7%) developed an infective endocarditis, 7 patients (20,6%) required a trans–catheter procedure (6 Melody balloon dilation and 1 Melody valve–in–valve), and 2 patients (5,9%) underwent surgical Melody TPV replacement. Conclusion Trans–catheter Melody TPV implantation is effective to deal RVOT dysfunction. At a mid–term follow–up, the most of the implanted Melody TPV worked properly and only a few patients required surgical valve replacement.

Clinical experience of reoperative right ventricular outflow tract reconstruction with valved conduits: risk factors for conduit failure in long-term follow-up.

Reconstruction of right ventricular outflow tract in patients with congenital heart disease in various age groups remains a controversial issue. Currently, a little is known about the fate of secondary and subsequent conduit. The aim of the study was to determine risk factors of conduit failure, evaluate long-term conduit survival, find out which type of conduit should be preferred in case of reoperations. We performed a retrospective analysis of a total of 249 records of valved conduit secondary and subsequent replacement in right ventricular outflow tract in 197 patients. Median follow-up was 5.7years. The study endpoints were defined as conduit explants; balloon dilatation of the graft (excluding balloon dilatation of left/right pulmonary artery), transcatheter pulmonary valve implantation; heart transplantation or death of the patient. There were total of 21 deaths (11% mortality) among 197 patients during the follow-up, 2 patients underwent heart transplant, in 23 implanted conduits pulmonary angioplasty or/including transcatheter pulmonary valve implantation was afterwards performed due to graft failure, conduit had to be explanted in 46 cases. After 28years follow-up, freedom from graft failure after 5years was 77%, 48% after 10years and 21% after 15years. Reoperative right ventricular outflow tract reconstruction demonstrates good mid-term and acceptable long-term outcomes regardless of the type of conduit implanted. Worse long-term graft survival of secondary and further conduits is associated with younger age of the recipient at implantation, small size of the conduit, younger age of donor and male donor in case of allograft implantation.

Clinical outcomes of handmade polytetrafluoroethylene trileaflet-valved conduit used for pulmonary valve replacement.

To mitigate the shortage of homograft sources, the use of handmade trileaflet expanded polytetrafluoroethylene valves in pulmonary valve replacement has shown excellent results from multicentre studies conducted in Japan. However, world-wide data outside Japan are relatively insufficient. This study presents the long-term results of a single surgeon's use of flipped-back trileaflet method in a 10-year case series. We have developed an efficient way to make a trileaflet-valved conduit utilizing flipped-back method for pulmonary valve replacement and have employed the technique since 2011. Retrospective data were studied between October 2010 and January 2020. Echocardiography, electrocardiogram, Pro-Brain Natriuretic Peptide and Magnetic Resonance Imaging data were analysed. Fifty-five patients were reviewed and median follow-up duration was 2.9 years. The majority of diagnoses was Tetralogy of Fallot (n = 41), and these patients subsequently underwent secondary pulmonary valve replacement at a median age of 15.6 years. Survival was 92.7% with the longest follow-up period being 10 years. There was no need for reoperation, and freedom from reintervention was 98.0% at 10 years. There were 4 deaths (3 in-hospital and 1 outpatient). One patient eventually received transcatheter pulmonary valve implantation. Postoperative echocardiography showed mild or less pulmonary stenosis and pulmonary regurgitation degree in 92.2% and 92.0% of patients, respectively. Comparable magnetic resonance imaging data (n = 25) showed significant reduction in right ventricular volumes but not in ejection fractions. Our series showed satisfactory long-term function of handmade flipped-back trileaflet-valved conduit used in our patients. The simple design is efficiently reproducible without complex fabrication process.

Long-term outcomes following transcatheter pulmonary valve implantation with the SAPIEN 3 valve: An international multicentre registry

Long-term outcomes following transcatheter pulmonary valve implantation with the SAPIEN 3 valve: An international multicentre registry

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

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

Long-term outcomes following transcatheter pulmonary valve implantation with the sapien 3 valve: an international multicentre registry

Abstract Background Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract dysfunction related to congenital heart disease. Long-term outcomes following TPVI with the new-generation SAPIEN 3 valve are not well documented. Purpose We investigated mid-term outcomes in a large cohort of patients who underwent TPVI using the SAPIEN 3 valve. Methods We retrospectively analysed data from a multicentre observational registry of patients who underwent TPVI with SAPIEN 3 in 30 centres in 12 countries from Europe, the Middle East, and Canada. Patient-related, procedural, and mid-term-outcome data were assessed. Results We obtained data for 713 patients treated in 2014–2021. Number of procedures performed among centres varied from 1 to 190 with a median of 15. Median age was 29.4-year-old [19.0–42.8]. The most common underlying diagnosis was cono-truncal defect (68.9%), with a native or patched right-ventricular outflow tract, a bioprosthetic valve, a homograft and a conduit, in 50.8%, 19.6%, 16.5% and 13.2% patients, respectively. Pre-stenting was performed in 74.8% patients. The 20-mm, 23-mm, 26-mm, and 29-mm valves were used in 0.4%, 28.2%, 31.2%, and 40.2% of patients, respectively. Valve implantation was successful in 98.6% patients. Life-threatening peri-procedural adverse events occurred in 3.7% patients, including 0.6% peri-procedural death. Median follow-up was 1.4 years (maximum, 5.9 years; 1160 patient-years), At last follow-up, pulmonary regurgitation grade 2, 3 and 4 was noted in 6.9%, 0.9% and 0.0% patients, respectively. Median maximal gradient at last follow-up was 18 mmHg. Six patients experienced infective endocarditis (0.5 per 100 patient-years) of whom 1 died and 2 required pulmonary valve replacement. Nine patients (0.8 per 100 patient-years) had secondary pulmonary valve replacement (including 2 by valve-in-valve TPVI; 7 patients had 23-mm and 2 had 26-mm valves). Four patients experienced pulmonary valve thrombosis (0.6 per 100 patient-year) of whom one died and 3 resolved under anticoagulation therapy. Cumulative incidences of infective endocarditis, secondary pulmonary valve replacement and valve thrombosis were 0.7%, 1.3% and 1.3%; 0.4%, 1.3% and 4.6%; 0.5%, 0.5% and 0.8% at 1, 3 and 5 years after TPVI respectively. Conclusion TPVI with the SAPIEN 3 valve was feasible and safe in a wide range of patients with congenital heart defects, most of whom had large native right-ventricular outflow tracts. Mid-term outcomes were favourable. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): The study is promoted and financially supported by a Research grant of the Groupe Hospitalier Paris Saint Joseph

Long-term outcomes following transcatheter pulmonary valve implantation with the SAPIEN 3 valve: An international multicentre registry

Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract dysfunction related to congenital heart disease. We investigated long-term outcomes following TPVI with the new-generation SAPIEN 3. We retrospectively analysed data from a multicentre observational registry of patients who underwent TPVI with SAPIEN 3 in 30 centres in 12 countries from Europe, the Middle East, and Canada. We obtained data for 713 patients treated in 2014–2021 (Median age 29.4-year-old). The most common underlying diagnosis was cono-truncal defect (68.9%), with a native or patched right-ventricular outflow tract, a bioprosthetic valve, a homograft and a conduit, in 50.8%, 19.6%, 16.5% and 13.2% patients, respectively. Pre-stenting was performed in 74.8% patients. The 20-mm, 23-mm, 26-mm, and 29-mm valves were used in 0.4%, 28.2%, 31.2%, and 40.2% of patients, respectively. Valve implantation was successful in 98.6% patients. Life-threatening peri-procedural adverse events occurred in 3.7% patients, including 0.6% peri-procedural death. Median follow-up was 1.4 years (maximum, 5.9 years; 1160 patient-years). Six patients experienced infective endocarditis (0.5 per 100 patient-years) of whom 1 died and 2 required pulmonary valve replacement. Nine patients (0.8 per 100 patient-years) had secondary pulmonary valve replacement (including 2 by valve-in-valve TPVI; 7 patients had 23-mm and 2 had 26-mm valves). Four patients experienced pulmonary valve thrombosis (0.6 per 100 patient-year) of whom one died and 3 resolved under anticoagulation therapy. Cumulative incidences of infective endocarditis, secondary pulmonary valve replacement and valve thrombosis were 0.7%, 1.3% and 1.3%; 0.4%, 1.3% and 4.6%; 0.5%, 0.5% and 0.8% at 1, 3 and 5 years after TPVI respectively ( Fig. 1 ). TPVI with the SAPIEN 3 valve was feasible and safe in a wide range of patients with congenital heart defects, most of whom had large native right-ventricular outflow tracts. Mid-term outcomes were favourable. Clinicaltrials.gov identifier: NCT05264181 .

Pre- and Postprocedure Imaging of Transcatheter Pulmonary Valve Implantation.

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