Transcatheter Pulmonary Valve Replacement With the Melody Valve in Small Diameter Expandable Right Ventricular Outflow Tract Conduits

Shahanavaz, Shabana; Qureshi, Athar M.; Levi, Daniel S.; Boudjemline, Younès; Peng, Lynn F.; Martin, Mary Hunt; Bauser‐Heaton, Holly; Keeshan, Britton; Asnes, Jeremy D.; Jones, Thomas K.; Justino, Henri; Aboulhosn, Jamil; Gray, Robert G.; Nguyen, Hoang H.; Balzer, David T.; McElhinney, Doff B.

doi:10.1016/j.jcin.2018.01.239

Cited by 38 publications

(15 citation statements)

References 22 publications

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“…There are a growing number of studies of TPVR in smaller patients with smaller conduits and bioprosthetic valves. These studies have demonstrated the ability to expand small diameter conduits up to 18, 20 and even 22 mm with similar technical success rates and adverse event profiles to studies in larger patients . In this current analysis, three patients with nominal conduit diameters <16 mm were successfully implanted and all were dilated to greater than 120% of the original conduit size and implanted with 18 mm or 20 mm delivery systems.…”

Section: Discussionmentioning

confidence: 80%

“…These studies have demonstrated the ability to expand small diameter conduits up to 18, 20 and even 22 mm with similar technical success rates and adverse event profiles to studies in larger patients. [15][16][17] In this current analysis, three patients with nominal conduit diameters <16 mm were successfully implanted and all were dilated to greater than 120% of the original conduit size and implanted with 18 mm or 20 mm delivery systems. If this practice continues to grow, it will be important to have a complementary valve option that functions well in smaller conduits and bioprosthetic valves.…”

Section: Discussionmentioning

confidence: 99%

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Implantation of the Melody transcatheter pulmonary valve PB1016 in patients with dysfunctional right ventricular outflow tract conduits

Morray

Jones

Coe

et al. 2018

Cathet Cardio Intervent

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Objectives This study describes procedural and 1‐year outcomes of the 16 mm Melody PB1016 valve in patients with dysfunctional RVOT conduits. Background The Melody PB1016 is a standard Melody valve produced from a 16 mm bovine jugular vein and is intended for deployment up to 20 mm. Methods This is a prospective, non‐randomized, multicenter study of the procedural and short‐term outcomes of Melody PB1016 TPV replacement within dysfunctional RVOT conduits. Data from eight centers were included in the analysis. Results During the study period, 39 patients underwent attempted Melody TPVR. Of the 39 patients, 30 underwent successful Melody TPVR. The majority of patients underwent placement of one or more stents prior to TPVR. There was a significant reduction in peak conduit pressure gradient following TPVR (38 mmHg vs. 11 mmHg, P < 0.001). There were three cases of confined conduit tears successfully treated with covered stents or the valve itself. Repeat catheterization was performed in one patient for early re‐obstruction that was successfully treated with balloon valvuloplasty. At recent follow‐up, there were no cases of more than mild valve regurgitation and the mean pulmonary valve gradient by echocardiogram remained reduced relative to pre‐TPVR implant measurements (33.5 mmHg vs. 15.2 mmHg). There were no cases of valve stent fracture or endocarditis reported at the 1‐year follow‐up. Conclusions Our analysis of TPVR with the PB1016 valve in RVOT conduits showed it to be safe and effective and can be performed in a wide range of conduit sizes with preserved valve function. https://ClinicalTrials.gov Identifier: NCT02347189.

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Section: Discussionmentioning

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Implantation of the Melody transcatheter pulmonary valve PB1016 in patients with dysfunctional right ventricular outflow tract conduits

Morray

Jones

Coe

et al. 2018

Cathet Cardio Intervent

Self Cite

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“…Young age at time of RVOT conduit or BPV implantation is associated with earlier reintervention in many studies, but little is known about the relationship between age and outcomes after TPVR. This study compared pediatric patients with adults who underwent Melody TPVR in three multicenter prospective trials.…”

Section: Discussionmentioning

confidence: 99%

Association between patient age at implant and outcomes after transcatheter pulmonary valve replacement in the multicenter Melody valve trials

Armstrong

Berger

Jones

et al. 2019

Cathet Cardio Intervent

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Objectives To investigate whether age and valve size at implant contribute to outcomes after Melody transcatheter pulmonary valve replacement (TPVR). Background Patient age and valve size at implant contribute to longevity of surgical pulmonary valves. Methods All patients discharged with a Melody valve in the pulmonary position, as part of three prospective Melody valve multicenter studies, comprised the study cohort. Acute and time‐related outcomes were analyzed according to age: children (≤12 years), adolescents (13–18 years), young adults (19–29 years), and older adults (≥30 years). Results Successful Melody valve implantation occurred in 49 children, 107 adolescents, 96 young adults, and 57 older adults. Pediatric patients (≤18 years) were more likely to have TPVR for conduit stenosis than adults (62% vs. 44%); children had the smallest conduits. After TPVR, pediatric and adult patients had similar decreases in right ventricular (RV) size by MRI, but adults had improved percentage predicted peak VO2 (58% preimplant to 64% postimplant, p = .02) and FEV1 (69% pre to 71% post, p = .005). Younger age was associated with shorter freedom from RVOT dysfunction, reintervention, and explant. Children had the shortest freedom from endocarditis (p = .041), but all other groups had 5‐year freedom from endocarditis of ≥90%. Conclusions Younger age was associated with shorter time to RVOT dysfunction, reintervention, and explant after Melody TPVR. Patients ≥13 years of age were at low risk for endocarditis and explant to 5 years. A better understanding of time‐related outcomes by age will aid in the comparison of therapeutic options for TPVR candidates. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT00740870 (NCT00740870), https://clinicaltrials.gov/ct2/show/NCT01186692 (NCT01186692), and https://clinicaltrials.gov/ct2/show/NCT00688571 (NCT00688571).

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“…Currently, the available conduits ( Table 1 ) can meet the clinical needs in most countries, and re-thoracotomy for conduit replacement is no longer a high-risk operation for cardiac surgeons. Moreover, trans-catheter pulmonary valve replacement (TPVR) has been proven to be a safe and effective therapeutic for failed pulmonary conduits ( 34 ). Therefore, our current task is to improve the durability and prolong the life of the valved conduit for RVOT reconstruction.…”

Section: Historymentioning

confidence: 99%

Conduits for Right Ventricular Outflow Tract Reconstruction in Infants and Young Children

et al. 2021

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Purpose of Review: Right ventricular outflow tract (RVOT) reconstruction remains a challenge due to the lack of an ideal conduit. Data and experience are accumulating with each passing day. Therefore, it is necessary to review this topic from time to time. This is a 2021 update review focused on the history, evolution, and current situation of small-sized conduits (≤ 16 mm) for RVOT reconstruction in infants and young children.Recent Findings: Currently, the available small-sized (≤16 mm) conduits can meet most clinical needs. Homograft is still a reliable choice for infants and young children validated by a half-century clinical experience. As an alternative material, bovine jugular vein conduit (BJVC) has at least comparable durability with that of homograft. The performance of expanded polytetrafluoroethylene (ePTFE) is amazing in RVOT position according to limited published data. The past century has witnessed much progress in the materials for RVOT reconstruction. However, lack of growth potential is the dilemma for small-sized conduits. Tissue-engineering based on cell-free scaffolds is the most promising technology to obtain the ideal conduit.Summary: No conduit has proved to have lifelong durability in RVOT position. We are far from the ideal, but we are not in a state of emergency. In-depth clinical research as well as innovation in material science are needed to help improve the durability of the conduits used in infants and young children.

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Transcatheter Pulmonary Valve Replacement With the Melody Valve in Small Diameter Expandable Right Ventricular Outflow Tract Conduits

Abstract: In this preliminary experience, TPVR with the Melody valve into expandable small diameter conduits was feasible and safe, with favorable early and long-term procedural and hemodynamic outcomes.

Cited by 38 publications

References 22 publications

Implantation of the Melody transcatheter pulmonary valve PB1016 in patients with dysfunctional right ventricular outflow tract conduits

Implantation of the Melody transcatheter pulmonary valve PB1016 in patients with dysfunctional right ventricular outflow tract conduits

Association between patient age at implant and outcomes after transcatheter pulmonary valve replacement in the multicenter Melody valve trials

Conduits for Right Ventricular Outflow Tract Reconstruction in Infants and Young Children

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