Right Ventricular Outflow Tract Dysfunction Research Articles

Clinical assessment of patient outcomes post percutaneous pulmonary valve implantation: Insights from a single tertiary centre

Background: Percutaneous pulmonary valve implantation (PPVI) has emerged as a promising treatment for congenital right ventricular outflow tract (RVOT) dysfunction and restoring conduit graft viability. Methods: This is a single-centre retrospective study of 41 patients (18 men, 23 women; mean age 26.1±10.2 years) who underwent PPVI between December 2007 and November 2014 and were evaluated for right ventricular pressures and exercise tolerance. Results: PPVI significantly reduced mean baseline RVOT gradients across different pathologies: stenosis (45 vs 18.4 mmHg), regurgitation (19.2 vs 7.6 mmHg), and mixed disease (32.5 vs 12 mmHg). Furthermore, mean right ventricular (RV) systolic pressures decreased from 61.6±2.3 to 41.9±2 mmHg (p<0.001), while RV diastolic pressures decreased by about 60% from 14.3±1.1 to 8.6±1.4 mmHg (p<0.001). Echocardiography revealed significant improvements in pulmonary and tricuspid valve velocities (p for trend<0.01). Additionally, there was a consistent reduction in the main pulmonary artery maximum pressure gradient measured pre-procedure. No significant changes were observed in PR, QRS, or QTc interval duration on follow-up electrocardiograms. Similarly, no changes were noted in cardiopulmonary exercise test performance during follow-up. Conclusion: The study highlights the effectiveness of PPVI using Medtronic Melody and Edwards SAPIEN valves in patients with various pulmonary diseases. Immediate improvements in right ventricular pressures and functional outcomes suggest that PPVI is a valuable treatment option for individuals with RVOT dysfunction. Multi-centre collaborations are crucial for further elucidating the long-term effects of PPVI on cardiac function, exercise tolerance, and quality of life in RVOT dysfunction.

Transcatheter pulmonary valve replacement after arterial switch operation.

Patients with d-transposition of the great arteries (d-TGA) who have undergone an arterial switch operation (ASO) can develop right ventricular outflow tract (RVOT) dysfunction with pulmonary regurgitation (PR) or stenosis. In these patients, treatment may include transcatheter pulmonary valve replacement (TPVR). Coronary compression is a contraindication occurring in 5% of typical TPVR cases. After ASO, there are various anatomical considerations that can confound TPVR, including potential coronary artery compression. Our goal is to understand feasibility of TPVR in patients following ASO. This was a retrospective multicenter cohort study of patients with RVOT dysfunction after ASO who underwent cardiac catheterization with intention to perform TPVR from 2008 to 2020. Across nine centers, 33 patients met inclusion criteria. TPVR was successful in 22 patients (66%), 19 receiving a Melody valve and 3 a SAPIEN valve. RVOT stenosis in isolation or with PR dictated need for TPVR in nearly all patients. One serious adverse event occurred with valve embolization. After TPVR, the RVOT peak gradient decreased from 43 to 9 mm Hg (p < 0.001); PR was trivial/none in all but one patient, in whom it was mild. Coronary compression prohibiting TPVR occurred in eight patients (24%) and two patients (6%) had severe aortic regurgitation from aortic root deformation precluding TPVR. Seven patients underwent RVOT reintervention a median of 5.3 years post-TPVR. TPVR in patients with d-TGA after ASO is feasible, but in this cohort, coronary compression or aortic root distortion precluded TPVR in one-third of patients. The rate of RVOT reintervention after TPVR was higher in this cohort of ASO patients than in prior studies.

Melody transcatheter pulmonary valve replacement: a single-center case series in Southeast Asia

BackgroundStudies of transcatheter pulmonary valve replacement (TPVR) with the Melody valve have demonstrated good clinical and hemodynamic outcomes. Our study analyzes the midterm clinical and hemodynamic outcomes for patients who underwent Melody valve implantation in Southeast Asia.MethodsPatients with circumferential conduits or bioprosthetic valves and experiencing post-operative right ventricular outflow tract (RVOT) dysfunction were recruited for Melody TPVR.ResultsOur cohort (n = 14) was evenly divided between pediatric and adult patients. The median age was 19 years (8–38 years), a male-to-female ratio of 6:1 with a median follow-up period of 48 months (16–79 months), and the smallest patient was an 8-year-old boy weighing 18 kg. All TPVR procedures were uneventful and successful with no immediate mortality or conduit rupture. The primary implant indication was combined stenosis and regurgitation. The average conduit diameter was 21 ± 2.3 mm. Concomitant pre-stenting was done in 71.4% of the patients without Melody valve stent fractures (MSFs). Implanted valve size included 22-mm (64.3%), 20-mm (14.3%), and 18-mm (21.4%). After TPVR, the mean gradient across the RVOT was significantly reduced from 41 mmHg (10–48 mmHg) to 16 mmHg (6–35 mmHg) at discharge, p < 0.01. Late follow-up infective endocarditis (IE) was diagnosed in 2 patients (14.3%). Overall freedom from IE was 86% at 79 months follow-up. Three patients (21.4%) developed progressive RVOT gradients.ConclusionFor patients in Southeast Asia with RVOT dysfunction, Melody TPVR outcomes are similar to those reported for patients in the US in terms of hemodynamic and clinical improvements. A pre-stenting strategy was adopted and no MSFs were observed. Post-implantation residual stenosis and progressive stenosis of the RVOT require long term monitoring and reintervention. Lastly, IE remained a concern despite vigorous prevention and peri-procedural bacterial endocarditis prophylaxis.

Finite element modeling with patient-specific geometry to assess clinical risks of percutaneous pulmonary valve implantation.

Percutaneous pulmonary valve implantation (PPVI) is a non-surgical treatment for right ventricular outflow tract (RVOT) dysfunction. During PPVI, a stented valve, delivered via catheter, replaces the dysfunctional pulmonary valve. Stent oversizing allows valve anchoring within the RVOT, but overexpansion can intrude on the surrounding structures. Potentially dangerous outcomes include aortic valve insufficiency (AVI) from aortic root (AR) distortion and myocardial ischemia from coronary artery (CA) compression. Currently, risks are evaluated via balloon angioplasty/sizing before stent deployment. Patient-specific finite element (FE) analysis frameworks can improve pre-procedural risk assessment, but current methods require hundreds of hours of high-performance computation. We created a simplified method to simulate the procedure using patient-specific FE models for accurate, efficient pre-procedural PPVI (using balloon expandable valves) risk assessment. The methodology was tested by retrospectively evaluating the clinical outcome of 12 PPVI candidates. Of 12 patients (median age 14.5 years) with dysfunctional RVOT, 7 had native RVOT and 5 had RV-PA conduits. Seven patients had undergone successful RVOT stent/valve placement, three had significant AVI on balloon testing, one had left CA compression, and one had both AVI and left CA compression. A model-calculated change of more than 20% in lumen diameter of the AR or coronary arteries correctly predicted aortic valve sufficiency and/or CA compression in all the patients. Agreement between FE results and clinical outcomes is excellent. Additionally, these models run in 2-6 min on a desktop computer, demonstrating potential use of FE analysis for pre-procedural risk assessment of PPVI in a clinically relevant timeframe.

Technical Recommendations for Computed Tomography Guidance of Intervention in the Right Ventricular Outflow Tract: Native RVOT, Conduits and Bioprosthetic Valves: A White Paper of the Society of Cardiovascular Computed Tomography (SCCT), Congenital Heart Surgeons' Society (CHSS), and Society for Cardiovascular Angiography & Interventions (SCAI).

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

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.

Technical Recommendations for Computed Tomography Guidance of Intervention in the Right Ventricular Outflow Tract: Native RVOT, Conduits, and Bioprosthetic Valves.

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

Preliminary experience of transcatheter pulmonary valve replacement using domestic balloon-expandable valve

Objectives: To evaluate the feasibility and preliminary clinical results of transcatheter pulmonary valve replacement (TPVR) with the domestically-produced balloon-expandable Prizvalve system. Methods: This is a prospective single-center observational study. Patients with postoperative right ventricular outflow tract (RVOT) dysfunction, who were admitted to West China Hospital of Sichuan University from September 2021 to March 2023 and deemed anatomically suitable for TPVR with balloon-expandable valve, were included. Clinical, imaging, procedural and follow-up data were analyzed. The immediate procedural results were evaluated by clinical implant success rate, which is defined as successful valve implantation with echocardiography-assessed pulmonary regurgitation<moderate and peak trans-pulmonary pressure gradient<40 mmHg (1 mmHg=0.133 kPa). Results: A total of 5 patients were included, with 4 males, aged 14 to 37 years. The initial diagnosis included Tetralogy of Fallot (2 cases), truncus arteriosus (1 case), pulmonary atresia (1 case) and subaortic stenosis (1 case, prior Ross procedure). Four patients underwent RVOT reconstruction with homograft or artificial conduit, and one patient was treated with trans-annular patch technique. The indications of TPVR included RVOT obstruction and regurgitation (3 cases), isolated obstruction (1 case), and isolated regurgitation (1 case). Of the 4 patients with varying severity of ROVT obstruction, the average preprocedural peak jet velocity of RVOT was 3.5 m/s, and the average peak pressure gradient was 50.0 mmHg. Except for one patient, who had previously been implanted with a covered Cheatham-Platinum (CP) stent due to severe stenosis of the main pulmonary artery, other patients underwent pre-stenting with a covered CP stent before TPVR. Clinical implant success was achieved in all of the 5 patients, and there was no serious periprocedural complications. The average trans-pulmonary peak jet velocity and peak pressure gradient derived from postprocedural echocardiography was 2.3 m/s and 21.2 mmHg, respectively. All patients experienced significant symptom relief after the procedure. All patients completed 3-month follow-up, and 4 completed 6-month follow-up. There was no case of infectious endocarditis during follow-up. All patients were graded as NYHA functional class one at the latest follow-up. Conclusions: TPVR using the domestically-produced balloon-expandable Prizvalve system is safe and feasible for the treatment of patients with post-surgical RVOT dysfunction and suitable landing-zone anatomy. The safety, effectiveness, and long-term valve durability of the Prizvalve system deserve further research.

Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial)

Significant pulmonary regurgitation (PR) and pulmonary stenosis are common after surgical repair of some congenital heart defects. This prospective, single-arm, multicenter trial enrolled patients who underwent transcatheter heart valve (THV) implantation with a SAPIEN 3 valve to treat dysfunctional right ventricular outflow tract (RVOT) conduits or pulmonic surgical valves (≥ moderate PR and/or mean RVOT gradient ≥35mm Hg). The primary end point was a nonhierarchical composite of THV dysfunction at 1year comprising RVOT reintervention, ≥ moderate total PR, and mean RVOT gradient >40mm Hg. A performance goal of <25% of upper confidence interval (CI) was prespecified for the primary end point, using a 95% exact binomial CI. Patients (n=58) were enrolled between July 5, 2016 and July 17, 2018, with mean age of 32years. Prestenting was performed in 53.4%. At discharge, the device success was 98.1% (single valve without explant, < moderate PR, gradient <35mm Hg). At 30days, there were no major adjudicated adverse clinical events. At 1year, the primary end point composite was 4.3% (95% CI 0.5 to 14.5). The composite components were 0% (0 of 56) RVOT reintervention, 2.1% (1 of 47) ≥ moderatePR, and 2.1% (1 of 48) mean RVOT gradient >40mm Hg. No mortality, endocarditis, thrombosis, or stent fracture were reported at 1year. In conclusion, the SAPIEN 3 THV was safe and effective in patients with dysfunctional RVOT conduits or previously implanted valves in the pulmonic position to 1 year. Clinical trial registration: NCT02744677; https://clinicaltrials.gov/ct2/show/NCT02744677.

Transcatheter pulmonary valve replacement in congenital heart diseases.

Surgical repair of a variety of congenital heart diseases involves repair of the right ventricular outflow tract (RVOT) with valved or non-valved conduit to connect the right ventricle (RV) to the pulmonary artery (PA) or just patch enlargement of the native RVOT. With time, this RV-PA conduit will degenerate with deterioration of function, either causing pulmonary stenosis or pulmonary regurgitation. This RVOT dysfunction may result in RV dilation, RV dysfunction, and eventual RV failure and arrhythmias. Multiple surgical pulmonary valve replacement (PVR) is often required throughout the patient's lifetime. Patients are subjected to increased risks with each additional cardiac operation. Transcatheter PVR (TPVR) has been developed over the past two decades as a valuable non-surgical alternative to restore the RVOT and RV function, and hence reduce patients' lifetime risks related to surgery. This article will discuss the long-term results of TPVR which are demonstrated to be comparable to surgical results and the latest development of large pulmonary valves which will allow TPVR to be performed on native or larger RVOT.

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 .

Clinical presentation of ventricular arrhythmias in patients with repaired Tetralogy of Fallot

BackgroundMany studies have investigated ventricular arrhythmias (VA) risk factors in patients with repaired Tetralogy of Fallot (TOF), but none have evaluated the clinical presentation of VA before and after pulmonary valve replacement (PVR). ObjectivesThis study examines the current VA prevalence and clinical presentation in patients with repaired TOF before and after PVR. MethodsRetrospective analysis performed on adult patients with repaired TOF from 1995 to 2021. Medical and surgical history, ECG, transthoracic echocardiogram, cardiac magnetic resonance imaging (MRI), cardiopulmonary exercise test (CPET) and 24-hour ECG Holter were evaluated. ResultsBefore PVR (154 patients, mean age 26 ± 11 years) 3.2 % of patients experienced sustained ventricular tachycardia (VT). Patients with VT were older at repair, presented more frequently with arrhythmic symptoms, QRS duration ≥180 ms, right ventricular outflow tract (RVOT) dysfunction with right ventricular (RV) dysfunction and complex premature ventricular complexes (PVC). All presented with monomorphic and hemodynamically tolerated VT, were referred after the VT episode and presented with longstanding RVOT dysfunction. After PVR (analysis performed on 85 patients, mean age 35 ± 13 years, mean follow-up 9 ± 1 years) VA incidence was not significantly different (6 %, equal to 0.7 % per year, p = .52). Two patients presented with resuscitated ventricular fibrillation (VF) related to short coupled PVC, while the others experienced monomorphic VT related to the development of a new hemodynamic lesion, all these patients received PVR after longstanding RVOT dysfunction with RV dysfunction. ConclusionCurrently the incidence of VA in patients with repaired TOF is low. Patients with VA are older at repair and more frequently present with longstanding RVOT dysfunction with RV dysfunction. While monomorphic VT are usually hemodynamically tolerated and rarely recurs after hemodynamic lesions resolution, VF related to short coupled PVC rarely can occur after PVR.

ТРАНСКАТЕТЕРНАЯ ИМПЛАНТАЦИЯ КЛАПАНА ЛЕГОЧНОЙ АРТЕРИИ ПОСЛЕ ХИРУРГИЧЕСКОЙ КОРРЕКЦИИ ПУТЕЙ ОТТОКА ПРАВОГО ЖЕЛУДОЧКА: ОПЫТ ОДНОГО ЦЕНТРА

Transcatheter pulmonary valve implantation (TPVI) is a relatively new method of treating patients with right ventricular outflow tract (RVOT) dysfunction after surgical treatment of congenital heart defects. Since its introduction in 2000 by Bonhoeffer, more than ten thousand of such procedures have been performed worldwide. Currently two types of valves are available in the Republic of Belarus: Melody TPVMedtronic and Edwards Sapien. TPVI is safe and effective in the majority of patients with RVOT dysfunction and in some selected patients with patched RVOT. The low complication rate and the reduced number of open-chest re-interventions over a patient’s lifetime are among the main advantages of the procedure. The article presents a literature review, and summarizes the experience and results of TPVI performed on 24 patients in the Republican Centre of Pediatric Surgery.

A New Solution for Stenting Large Right Ventricular Outflow Tracts Before Transcatheter Pulmonary Valve Replacement.

Prestenting right ventricular outflow tracts (RVOTs) before transcatheter pulmonary valve replacement (TPVR) is essential. Optimus-XXL (AndraTec GmbH, Koblenz, Germany) is a new extra-large, balloon-expandable cobalt-chrome stent with promising technologies. From June 2020 to November 2020, 15 patients with congenital heart disease, dysfunctional RVOTs and target TPVR diameter ≥ 23 mm received Optimus-XXL stents before proceeding to TPVR using the SAPIEN valve (Edwards Lifesciences, Irvine, CA). Standard safety and outcomes were prospectively assessed. Patients' median age and weight were 25.8 years (range: 10.5-63.1 years) and 58 kg (range: 43.8-101 kg), respectively. Underlying diagnosis was tetralogy of Fallot (66.7%), and RVOTs were patched (80%). Fifteen bare-metal stents were implanted using femoral (n= 14) and jugular approaches (n= 1). One conduit rupture was immediately controlled with a covered Optimus-XXL. Median stent length was 43 mm (range: 33-57 mm), and median target expansion diameter was 28 mm (range: 23-30 mm). Two procedural incidents occurred during stent delivery and were percutaneously treated. Stent stability was documented during TPVRs immediately performed in 14 patients. Median stent shortening was 13.7%, and median percentage of intended stent expansion was 95.9%. There was no stent fracture on the short-term follow-up (median: 4.5 months). We report the first implantations of Optimus-XXL stents in dysfunctional RVOTs with excellent preliminary results. Optimus-XXL should be considered as a valuable adjunct in the armamentarium for routine and complex TPVR procedures.

An evaluation of patient outcomes following transcatheter pulmonary valve implantation: a meta-analysis

Abstract Background Transcatheter pulmonary valve implantation has emerged as an effective alternative to surgery in patients with congenital Right Ventricular Outflow Tract Dysfunction (RVOT). There is demonstrable evidence that Percutaneous Pulmonary Valve Implantation (PPVI) effectively restores conduit graft viability with a consequent improvement in right ventricular pressures. Aim The objective of this study was to perform a meta-analysis of all previously published studies examining the outcome of PPVI and the associated early and late peri-procedural factors in patients with RVOT dysfunction. Data from procedures performed within our own centre have also been included. Methodology We performed a meta-analysis of all observational studies investigating early and late outcomes following PPVI. Risk ratios and risk differences were pooled in a random-effects model. The I2 statistic was used to quantify heterogeneity between studies. We searched EMBASE, MEDLINE, CINAHL, PsychInfo and Cochrane databases from their inception until 2021. Studies were included if they reported any comparative data regarding study endpoints. Primary endpoint was mean RVOT gradient. Secondary end points include pulmonary regurgitation fraction, left and right ventricular end-diastolic and systolic volume indexes, and left ventricular ejection fraction. Complication rates were considered a safety endpoint. Results A total of 23 studies with 1501 participants enrolled were included in the final meta-analysis. The RVOT gradient decreased significantly [weighted mean difference (WMD) = −20.32 mmHg; 95% confidence interval (CI): −22.15, −19.11; p&amp;lt;0.001]. Mean right ventricular (RV) systolic pressures fell significantly [(WMD)= −18.4 mmHg; 95% CI: −16.4, −20.2; p&amp;lt;0.001) and RV diastolic pressures decreased significantly [(WMD) = −6.3 mmHg, 95% CI: −4.3, −8.9; p&amp;lt;0.001). Pulmonary regurgitation fraction (PRF) also decreased notably (WMD = −24.38%, 95% CI: −28.27, −17.32; p&amp;lt;0.001).The incidence of infective endocarditis was 1.8% (95% CI: 0.7–3.8). Conclusion PPVI is an effective and safe strategy in relieving right ventricular remodelling and improving haemodynamic and clinical outcomes in patients with RVOT dysfunction. Multi-centre collaborations are essential to further determine the long-term effects of PPVI on cardiac function, exercise tolerance and quality of life in RVOT dysfunction. Funding Acknowledgement Type of funding sources: None.

Favorable Atrial Remodeling After Percutaneous Pulmonary Valve Implantation and Its Association With Changes in Exercise Capacity and Right Ventricular Function.

BackgroundRight atrial (RA) dilatation and impaired right ventricular (RV) filling are common in patients with RV outflow tract dysfunction. We aimed to study potential correlations between atrial function with clinically relevant hemodynamic parameters and to assess the predictive impact of atrial performance on the recovery of exercise capacity and RV pump function after percutaneous pulmonary valve implantation (PPVI).Methods and ResultsAltogether, 105 patients with right ventricular outflow tract dysfunction (median age at PPVI, 19.2 years; range, 6.2–53.4 years) who underwent cardiac magnetic resonance imaging before and 6 months after PPVI were included. RA and left atrial maximal and minimal volumes as well as atrial passive and active emptying function were assessed from axial cine slices. RA emptying function was inversely related to invasive RV end‐diastolic pressure, and RA passive emptying correlated significantly with peak oxygen uptake. After PPVI, a significant decrease in RA minimum volume was observed, whereas RA passive emptying function improved, and RA active emptying function decreased significantly. Patients with predominant right ventricular outflow tract stenosis showed more favorable changes in RA active and left atrial passive emptying than those with primary volume overload. None of the RA and left atrial emptying parameters was predictive for recovery of peak oxygen uptake or RV ejection fraction.ConclusionsIn patients with right ventricular outflow tract dysfunction, impaired RA emptying assessed by cardiac magnetic resonance imaging was associated with increased RV filling pressures and lower exercise capacity. PPVI leads to a reduction in RA size and improved passive RA emptying function. However, RA function was not associated with improved exercise performance and RV pump function.

Edwards SAPIEN XT Transcatheter Pulmonary Valve Implantation: 5-year follow-up in a French Registry

This study sought to investigate patient intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve. The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short-term follow-up has been reported. From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve-reintervention and freedom from infective endocarditis at last follow-up, respectively. The primary efficacy outcome was met for 87,1% patients after a mean follow-up of 55 ± 21 months, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8–95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular insufficiency was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient-year (95% CI 0.01–2.00%). At 5 years freedom from infective endocarditis was 98.4% (95% CI 89.1–99.8%) ( Fig. 1 ). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube-graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35. This study confirms the mid-term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit-risk balance.

Multicenter Study of Endocarditis After Transcatheter Pulmonary Valve Replacement

BackgroundEndocarditis has emerged as one of the most impactful adverse events after transcatheter pulmonary valve replacement (TPVR), but there is limited information about risk factors for and outcomes of this complication. ObjectivesThe purpose of this study was to evaluate risk factors for and outcomes of endocarditis in a large multicenter cohort. MethodsThe authors established an international registry focused on characterizing endocarditis after TPVR, including the incidence, risk factors, characteristics, and outcomes. ResultsInvestigators submitted data for 2,476 patients who underwent TPVR between July 2005 and March 2020 and were followed for 8,475 patient-years. In total, 182 patients were diagnosed with endocarditis a median of 2.7 years after TPVR, for a cumulative incidence of 9.5% (95% CI: 7.9%-11.1%) at 5 years and 16.9% (95% CI: 14.2%-19.8%) at 8 years (accounting for competing risks: death, heart transplant, and explant) and an annualized incidence of 2.2 per 100 patient-years. Staphylococcus aureus and Viridans group Streptococcus species together accounted for 56% of cases. Multivariable analysis confirmed that younger age, a previous history of endocarditis, and a higher residual gradient were risk factors for endocarditis, but transcatheter pulmonary valve type was not. Overall, right ventricular outflow tract (RVOT) reintervention was less often to treat endocarditis than for other reasons, but valve explant was more often caused by endocarditis. Endocarditis was severe in 44% of patients, and 12 patients (6.6%) died, nearly all of whom were infected with Staphylococcus aureus. ConclusionsThe incidence of endocarditis in this multicenter registry was constant over time and consistent with prior smaller studies. The findings of this study, along with ongoing efforts to understand and mitigate risk, will be critical to improve the lifetime management of patients with heart disease involving the RVOT. Although endocarditis can be a serious adverse outcome, TPVR remains an important tool in the management of RVOT dysfunction.

Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5‐year follow‐up in a French Registry

This study sought to investigate patient intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve. The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short-term follow-up has been reported. From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve-reintervention and freedom from infective endocarditis at last follow-up, respectively. The primary efficacy outcome was met for 87.1% patients after a mean follow-up of 4.6 ± 1.8 years, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8-95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular regurgitation was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient-year (95% CI 0.01-2.00%). At 5 years, freedom from infective endocarditis was 98.4% (95% CI 89.1-99.8%). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube-graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35. This study documents the mid-term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit-risk balance.