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INTRODUCTION: Infective Endocarditis (IE) has emerged to be one of the most impactful adverse complications post-transcatheter procedures, especially Transcatheter Pulmonary Valve Replacement (TPVR). We conducted a systematic review and meta-analysis with the aim of identifying the incidence of IE post-TPVR with the MELODY valve in the pediatric population. METHODS: A comprehensive literature search was performed across several prominent databases, including PubMed/MEDLINE, SCOPUS, and Science Direct. Studies compared the clinical outcomes of pediatric patients who received TPVR using the MELODY valve. Data extraction was done for variables like the total pediatric patient population that underwent TPVR with MELODY valve, mean age, the sex of the patients, the incidence rate of IE following the procedure, and the duration between the procedure and the occurrence of IE. Inverse Variance was used to estimate the incidence of IE in patients who underwent TPVR with respective 95% confidence interval (CI). RESULTS: In total, 4 studies with 414 pediatric patients who underwent TPVR using the MELODY valve were included in the study. The mean age of the study population was 12.7 ± 3.11 years. The pooled incidence of IE following TPVR with MELODY valve in the pediatric population was 17.70% (95% Cl 3.84-31.55; p<0.00001). Additionally, the mean length of duration to develop IE following TPVR with MELODY valve in the pediatric population was 2.18 years (95% Cl 0.35-4.01; p<0.00001). CONCLUSION: Our meta-analysis reveals that IE post-TPVR with MELODY valve in pediatric patients is a significant complication, clinically and statistically. Further research needs to be done to understand the risk factors and develop better management strategies.
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Tricuspid regurgitation (TR) is common after a heart transplant and is associated with worse clinical outcomes. The incidence ranges from 34% immediately after transplant to 20% by 10 years. Most patients can be managed medically; however, severe TR and symptomatic right heart failure warrant tricuspid valve replacement. The use of Melody transcatheter pulmonary valve in the tricuspid position is previously described. We report a unique case of posttransplant severe TR treated with surgical bioprosthetic tricuspid valve replacement who subsequently underwent successful transcatheter Melody valve placement in tricuspid position for progressive bioprosthetic valve stenosis with 11 years of follow-up.
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BACKGROUND: Studies of transcatheter pulmonary valve replacement (TPVR) with the Melody valve have demonstrated good clinical and hemodynamic outcomes. Our study analyzes the midterm clinical and hemodynamic outcomes for patients who underwent Melody valve implantation in Southeast Asia. METHODS: Patients with circumferential conduits or bioprosthetic valves and experiencing post-operative right ventricular outflow tract (RVOT) dysfunction were recruited for Melody TPVR. RESULTS: Our cohort (n = 14) was evenly divided between pediatric and adult patients. The median age was 19 years (8-38 years), a male-to-female ratio of 6:1 with a median follow-up period of 48 months (16-79 months), and the smallest patient was an 8-year-old boy weighing 18 kg. All TPVR procedures were uneventful and successful with no immediate mortality or conduit rupture. The primary implant indication was combined stenosis and regurgitation. The average conduit diameter was 21 ± 2.3 mm. Concomitant pre-stenting was done in 71.4% of the patients without Melody valve stent fractures (MSFs). Implanted valve size included 22-mm (64.3%), 20-mm (14.3%), and 18-mm (21.4%). After TPVR, the mean gradient across the RVOT was significantly reduced from 41 mmHg (10-48 mmHg) to 16 mmHg (6-35 mmHg) at discharge, p < 0.01. Late follow-up infective endocarditis (IE) was diagnosed in 2 patients (14.3%). Overall freedom from IE was 86% at 79 months follow-up. Three patients (21.4%) developed progressive RVOT gradients. CONCLUSION: For patients in Southeast Asia with RVOT dysfunction, Melody TPVR outcomes are similar to those reported for patients in the US in terms of hemodynamic and clinical improvements. A pre-stenting strategy was adopted and no MSFs were observed. Post-implantation residual stenosis and progressive stenosis of the RVOT require long term monitoring and reintervention. Lastly, IE remained a concern despite vigorous prevention and peri-procedural bacterial endocarditis prophylaxis.
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Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Hemodinámica , Diseño de Prótesis , Válvula Pulmonar , Recuperación de la Función , Humanos , Masculino , Niño , Femenino , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Adolescente , Válvula Pulmonar/cirugía , Válvula Pulmonar/fisiopatología , Válvula Pulmonar/diagnóstico por imagen , Resultado del Tratamiento , Adulto Joven , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/efectos adversos , Factores de Tiempo , Adulto , Insuficiencia de la Válvula Pulmonar/cirugía , Insuficiencia de la Válvula Pulmonar/fisiopatología , Insuficiencia de la Válvula Pulmonar/etiología , Insuficiencia de la Válvula Pulmonar/diagnóstico por imagen , Bioprótesis , Estenosis de la Válvula Pulmonar/cirugía , Estenosis de la Válvula Pulmonar/fisiopatología , Estenosis de la Válvula Pulmonar/diagnóstico por imagen , Estudios Retrospectivos , Factores de Riesgo , Asia SudorientalRESUMEN
Infective endocarditis (IE) remains a serious disease that is associated with significant morbidity and mortality, and despite the significant advances that have been made in understanding the disease process in past decades, its incidence appears to be on the rise recently. Endocarditis in children is no longer a rare occurrence. This appeared to be related to a combination of the improved survival of children with congenital heart diseases (CHDs), increase use of intracardiac protheses, and catheter-related interventions. The American Heart Association (AHA) 2007 guidelines reduced the recommendations for use of prophylactic antibiotics in those with CHDs which occurred despite the noticeable increase in endocarditis incidence around that time. In general, the recommendations for managing children with IE are derived from the adults' guidelines, and the evidence-base is lacking in many clinical scenarios. Understanding the epidemiology, clinical presentations, microbiology, and outcomes of different management strategies for endocarditis is needed to have a clear and optimal plan for these children. In the current narrative review, we discuss IE in the pediatric population in terms of etiology, predisposing factors, and different treatment strategies for this unique population.
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Options for atrioventricular (AV) valve replacement in small pediatric patients are very limited. The Melody valve has shown reasonable short-term outcomes. This study was aimed at identifying predictors of valve failure following AV valve replacement with a Melody valve at a single-center. 26 patients underwent 37 AV valve replacements with 31/37 (84%) of valves placed in the systemic AV valve position. Median age at procedure was 17 months (IQR 4-33) and weight was 8.5 kg (IQR 6.25-12.85). Median balloon size for valve implant was 20 mm (IQR 18-22). Repeat intervention occurred in 21 cases (57%) with repeat surgery in all but one. Median freedom from re-intervention was 31 months; 19% were free from re-intervention at 60 months. Age < 12 months weight < 10 kg and BSA < 0.4 m2 were all significant risk factors for early valve failure (p = 0.003, p 0.017, p 0.025, respectively). Valve longevity was greatest with balloon inflation to diameter 1.20-1.35 times the patient's expected annular diameter (Z0), relative to both smaller or larger balloons (p = 0.038). In patients less than 12 months of age, patients with single ventricle physiology had an increased risk of early valve failure (p = 0.004).
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OBJECTIVES: Surgical management of mitral valve disease is challenging in infants <1 year old. We aimed at reviewing the French experience with Melody mitral valve replacement in critically ill infants. METHODS: A retrospective cohort study reporting the French experience with Melody mitral valve replacement. RESULTS: Seven symptomatic infants [complete atrioventricular septal defect (n = 4, Down syndrome: n = 3), hammock valve (n = 3)] underwent Melody mitral valve replacement [age: 3 months (28 days to 8 months), weight: 4.3 kg (3.2-6.4 kg)] because of severe mitral valve regurgitation (6) or mixed valve disease (1) and 14 mm (11-16 mm) mitral valve annulus. In 2 patients whose valve was felt irreparable, Melody mitral valve replacement was performed straightaway. The others underwent 2 (1-3) previous attempts of valve repair; 3 were on extracorporeal membrane oxygenation. Melody mitral valve replacement led to competent valve and low gradient [3 mmHg, (1-4 mmHg)]. One patient died 3 days post-implant from extracorporeal membrane oxygenation-related stroke. Of the 6 discharged home patients, 3 (50%) were readmitted for a definite diagnosis (1) or high suspicion (2) of infective endocarditis, of which 2 died. Over the follow-up, 1 underwent balloon expansions of the valve at 9- and 16-months post-implant, and mechanical mitral valve replacement at 2 years; another is currently planned for transcatheter Melody valve dilation. CONCLUSIONS: Melody mitral valve replacement may be considered in selected infants with small mitral valve annulus as an alternative to mechanical mitral valve replacement. Our experience highlights a high-risk of late infective endocarditis that deserves further consideration.
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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.
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Procedimientos Quirúrgicos Cardíacos , Estenosis de la Válvula Pulmonar , Válvula Pulmonar , Transposición de los Grandes Vasos , Humanos , Masculino , Preescolar , Adulto Joven , Adulto , Transposición Congénitamente Corregida de las Grandes Arterias , Transposición de los Grandes Vasos/complicaciones , Transposición de los Grandes Vasos/cirugía , Válvula Pulmonar/diagnóstico por imagen , Válvula Pulmonar/cirugía , Estenosis de la Válvula Pulmonar/complicaciones , Estenosis de la Válvula Pulmonar/diagnóstico por imagen , Estenosis de la Válvula Pulmonar/cirugía , Resultado del TratamientoRESUMEN
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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A common feature of congenital heart disease is the presence of right ventricular outflow tract (RVOT) obstruction that can range from mild to severe and can lead to atresia of the pulmonary valve, in extreme conditions. RVOT abnormalities can frequently be corrected surgically or via interventional means. However, most of these patients will ultimately develop pulmonary valve insufficiency and eventual right ventricular dilation, which will require a pulmonary valve replacement at some point in their life to mitigate the detrimental effects of pulmonary valve regurgitation (PVR) on the right ventricle (RV). The evolution from the studies done by Philip Bonhoeffer to implant a pulmonary valve via transcatheter means, have provided a bedrock for transcatheter pulmonary valve replacement (TPVR). Yet, several areas of unmet need for a demographic of patients still exist. Here, we discuss the clinical unmet needs in children under 20 Kg and expand the use of hybrid and other TPVR approaches along with the current indications and contraindications for pulmonary valve replacement. The constraints and limitations from commercially available pulmonary valves will be discussed from a clinical standpoint. Finally, we explore the use of hybrid and periventricular delivery of transcatheter pulmonary valves in younger patients.
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Cardiopatías Congénitas , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Pulmonar , Válvula Pulmonar , Obstrucción del Flujo de Salida Ventricular Derecho , Niño , Humanos , Válvula Pulmonar/cirugía , Diseño de Prótesis , Cateterismo Cardíaco , Resultado del Tratamiento , Insuficiencia de la Válvula Pulmonar/cirugía , Cardiopatías Congénitas/cirugía , Estudios RetrospectivosRESUMEN
Mitral valve replacement using a Melody valve is a promising solution to the challenge of surgical mitral valve replacement in infants with a hypoplastic annulus. We report the creation of a landing zone in the mitral valve annulus using a Cheatham-Platinum (CP)-covered stent that facilitates Melody valve placement, helps prevent paravalvular leak, minimizes left ventricular outflow tract obstruction, and allows for potential future dilation of the valve.
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Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Lactante , Humanos , Válvula Mitral/cirugía , Platino (Metal) , Diseño de Prótesis , Catéteres , Cateterismo Cardíaco , Stents , Politetrafluoroetileno , Resultado del TratamientoRESUMEN
We report a successful percutaneous tricuspid valve implantation followed by a percutaneous pulmonary valve implantation in a young child with Ebstein's anomaly of tricuspid valve and pulmonary stenosis who was previously treated surgically at 1 year of age with tricuspid ring annuloplasty and a transannular outflow patch. This article shows the feasibility of sequential implantation of two valves in young patients with severe tricuspid and pulmonary valve insufficiency.
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Procedimientos Quirúrgicos Cardíacos , Anomalía de Ebstein , Válvula Pulmonar , Insuficiencia de la Válvula Tricúspide , Humanos , Anomalía de Ebstein/cirugía , Válvula Pulmonar/diagnóstico por imagen , Válvula Pulmonar/cirugía , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Válvula Tricúspide/anomalías , Insuficiencia de la Válvula Tricúspide/diagnóstico , Insuficiencia de la Válvula Tricúspide/cirugía , LactanteRESUMEN
Advancements in transcatheter interventions have revolutionized the treatment of adult congenital heart disease. We present a case of a 32-year-old male with a history of tetralogy of Fallot with pulmonary atresia diagnosed with Bartonella spp. culture-negative infective endocarditis (IE) of his Melody valve, necessitating Melody valve replacement.
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OBJECTIVES: The aim of this study was to compare the immediate and midterm echocardiographic performance of the Melody (Medtronic Inc) and Sapien (Edwards Lifesciences Inc) valves after transcatheter pulmonary valve replacement (TPVR) in native and conduit right ventricular outflow tracts (RVOTs). BACKGROUND: TPVR is now a common procedure, but limited data exist comparing postimplantation echocardiographic findings between Melody and Sapien valves. METHODS: This was a single-institution retrospective cohort study of all patients who underwent successful TPVR from 2011 to 2020. Patient demographics, procedural details, and immediate and midterm echocardiographic findings were collected and compared between valve types using the Wilcoxon rank sum, chi-square, or Fisher exact test as appropriate. Subgroups were analyzed individually and were adjusted for multiple comparisons using the Bonferroni method. RESULTS: A total of 328 patients underwent successful TPVR (Melody: n = 202, Sapien: n = 126). The groups had a similar baseline age, weight, and diagnosis. The most common indications for TPVR were pulmonary stenosis (32.2%) or mixed disease (46%) in the Melody group and pulmonary insufficiency in the Sapien group (52.4%) (P < 0.001). Sapien valves were more often placed in native RVOTs (43.7% vs 18.8%; P < 0.001). The discharge and follow-up mean and peak Doppler gradients were similar between the Melody and Sapien groups. Valves implanted in native RVOTs had significantly lower postimplantation gradients at each follow-up period. CONCLUSIONS: Echocardiographic performance after TPVR was generally acceptable and similar when comparing Melody and Sapien valves despite differences in the indication and anatomy in each group. The peak and mean gradients were lower in transcatheter valves implanted in native RVOTs compared with those implanted in conduits or bioprosthetic valves.
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Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Válvula Pulmonar , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/métodos , Ecocardiografía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Diseño de Prótesis , Válvula Pulmonar/diagnóstico por imagen , Válvula Pulmonar/cirugía , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
A Melody valve was successfully placed across a very stenotic right-sided component of a common atrioventricular valve because of ongoing troublesome arrhythmias in a young woman with an unbalanced atrioventricular septal defect, a very dilated right atrium and a hypoplastic right ventricle. Four years later, she remains well.
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Defectos de los Tabiques Cardíacos , Estenosis de la Válvula Tricúspide , Constricción Patológica , Femenino , Defectos de los Tabiques Cardíacos/cirugía , Válvulas Cardíacas , HumanosRESUMEN
Guidelines for management of Melody transcatheter pulmonary valve (TPV) infective endocarditis (IE) are lacking. We aimed to identify factors associated with surgical valve removal versus antimicrobial therapy in Melody TPV IE. Multicenter retrospective analysis of all patients receiving Melody TPV from 10/2010 to 3/2019 was performed to identify cases of IE. Surgical explants versus non-surgical cases were compared. Of the 663 Melody TPV implants, there were 66 cases of IE in 59 patients (59/663, 8.8%). 39/66 (59%) were treated with IV antimicrobials and 27/66(41%) underwent valve explantation. 26/59 patients (44%) were treated medically without explantation or recurrence with average follow-up time of 3.5 years (range:1-9). 32% of Streptococcus cases, 53% of MSSA, and all MRSA cases were explanted. 2 of the 4 deaths had MSSA. CART analysis demonstrated two important parameters associated with explantation: a peak echo gradient ≥ 47 mmHg at IE diagnosis(OR 10.6, p < 0.001) and a peak echo gradient increase of > 24 mmHg compared to baseline (OR 6.7, p = 0.01). Rates of explantation varied by institution (27 to 64%). In our multicenter experience, 44% of patients with Melody IE were successfully medically treated without valve explantation or recurrence. The degree of valve stenosis at time of IE diagnosis was strongly associated with explantation. Rates of explantation varied significantly among the institutions.
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Endocarditis Bacteriana , Endocarditis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Pulmonar , Válvula Pulmonar , Cateterismo Cardíaco/efectos adversos , Endocarditis/etiología , Endocarditis/cirugía , Endocarditis Bacteriana/tratamiento farmacológico , Endocarditis Bacteriana/cirugía , Prótesis Valvulares Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Diseño de Prótesis , Válvula Pulmonar/cirugía , Insuficiencia de la Válvula Pulmonar/cirugía , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: Infants requiring mitral valve replacement have few viable options. Recently, stented bovine jugular vein graft (Melody) has been surgically implanted in such cases. Herein, we report our experience, elaborating on evolution of implantation technique, pitfalls, as well as long-term outcome (including late dilatability). METHODS: Seven Melody valves were implanted (2013-2019). The median patient age and weight were 6.7 (1.8-30.5) months and 5.8 (4.6-9.5) kg, respectively. The indications for implantation were mitral stenosis and/or regurgitation postatrioventricular septal defect (AVSD) repair (5), congenital mitral valve dysplasia (1), and Shone's complex (1). Operative technique involved shortening the valve and creating a neo-sewing ring at 2/3 (atrial)-1/3 (ventricular) junction. Implantation was followed by intraoperative balloon dilatation. RESULTS: Five out of seven patients survived the perioperative period (one death due to technical failure and the other due to acute respiratory distress syndrome postcardiopulmonary bypass). Two out of five medium-term survivors got transplanted (1) or died due to acute myeloid leukemia (1). No valves were replaced. The mean echo gradient at discharge was a median 4 (2-6) mmHg. None of the patients showed left ventricular outflow tract or pulmonary venous obstruction. Two Melody valves were dilated late (5 months and 3 years postoperatively), resulting in decreasing mean gradients from 6 to 1 and from 17 to 4 mmHg. At last follow-up, surviving Melody had a mean gradient of 4 (1-9) mmHg. CONCLUSIONS: Mitral valve replacement with a Melody valve is feasible in infants, is reproducible, shows good immediate results, and offers the possibility of later dilatation. This technique offers a better solution compared to the existing alternatives for infants requiring a prosthetic mitral valve.
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Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Resultado del TratamientoRESUMEN
This is a report of a rare complication during implantation of a Melody valve in an adult patient in whom the valve failed to expand due to balloon rupture. An 18-year-old patient was admitted with an increased right ventricular pressure and severe pulmonary regurgitation for scheduled cardiac catheterization. Angiography revealed a proximal stenosis of the left pulmonary artery (LPA). First, a prestenting was performed. Three months later he came back for planned percutaneous pulmonary valve implantation (PPVI). Because of the proximity of the right coronary artery (RCA) to the right ventricular outflow tract (RVOT) and thus a relatively short landing zone, the Melody valve had been doubly folded. During the inflation of the outer balloon, it ruptured. At this point, the Melody valve was still fixed to the inner balloon. A second catheter was placed through the Melody valve and successful valve implantation was possible. This procedure was difficult because to push the catheter through the partly inflated Melody valve, the inner balloon had to be slowly and simultaneously deflated. The final angiograms and pressure measurements showed a good functional result and absent pulmonary regurgitation. Open heart surgery could be avoided after incomplete Melody valve dilatation using the contralateral pulmonary artery as a safe rail.