Melody Transcatheter Pulmonary Valve Research Articles

Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve.

We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial. As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a "real-world" environment. The 5-year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared. The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time-related outcomes and valve-related adverse events were compared between the two trials with Kaplan-Meier curves and log-rank testing. 167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p=.61) or any reintervention (p=.74) over time did not differ between trials. Freedom from stent fracture (p=.003) and transcatheter reintervention (p=.010) were longer in PAS, whereas freedom from explant (p=.020) and TPV endocarditis (p=.007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p=.056); the incidence of any particular event was low in both. Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices.

Early multicenter experience of Melody valve implantation in India.

Background :Transcatheter valves provide a safe and effective alternative to surgery for treating dysfunctional right ventricular outflow tracts (RVOTs). We present our early multicenter experience of percutaneous pulmonary valve implantation (PPVI) using Melody valve (Medtronic Inc., Minneapolis, MN).Methods :Patients with stenosed conduits or degenerated bioprosthetic valves in RVOT with combined stenosis and regurgitation were evaluated for suitability of Melody valve implantation. After undergoing an initial structured training, PPVI using Melody transcatheter pulmonary valve (TPV) was guided by an approved proctor. Conduits were serially dilated and prestented with careful coronary interrogation, and bioprosthetic valves were dilated with high-pressure balloons. Clinical and echocardiographic follow-up was performed at 6 monthly intervals.Results :Fifteen patients (three females) aged 23.1 ± 9.5 years in NYHA Class II-III underwent Melody TPV implantation in four Indian centers. The underlying anatomy comprised surgically implanted bioprosthetic valves for pulmonary regurgitation (n= 5), conduit repair for pulmonary atresia (n = 4), Rastelli repair (n = 3), truncus (n = 1), and Ross procedure (n = 2). Twelve patients had more than one previous surgery. Doppler gradient decreased from 74.2 ± 21.5 mmHg to 10.2 ± 4.5 mmHg after the PPVI. At a median follow-up of 14 months (1–39 months), all the patients were in NYHA Class I with echocardiographic gradients of 8 ± 5.7 mmHg with no evidence of pulmonary regurgitation. There were no major procedural adverse events or deaths.Conclusions :Our early experience shows encouraging results of the PPVI program in India with proctored case selection and meticulous planning. It also confirms the safety and efficacy of Melody TPV for treating dysfunctional RVOT in postoperative patients.

Percutaneous Pulmonary Valve Implantation.

Percutaneous pulmonary valve implantation (PPVI) is recognized as a feasible and low risk alternative to surgery to treat dysfunctional right ventricular outflow tract (RVOT) in usually pluri-operated patients. Evolving technology allowed to develop different kind of prosthesis and to go from an initial treatment exclusively of stenotic conduit to an actual approach extended also to wide native RVOT. The Melody transcatheter pulmonary valve (TPV) and the Edwards Sapien valve are nowadays the most commonly implanted prostheses. However, other devices have been developed to treat large RVOT (i.e., the Venus p-valve, the Medtronic Harmony TPV, the Alterra Adaptive Prestent, and the Pulsta valve). Indications for PPVI are the same as for surgical interventions on pulmonary valve, with limits related to the maximum diameter of the available percutaneous prosthesis. Therefore, an accurate preoperative evaluation is of paramount importance to select patients who could benefit from this procedure. The overall periprocedural mortality incidence is around 1.4%, while freedom from RVOT reintervention ranges from 100% at 4 months to 70% at 70 months, according to the different published studies.

P641 Severe pulmonary steno-insufficiency due to metastatic carcinoid tumor in a 57 years old patient treated with MTPV implantation: first experience

Abstract Funding Acknowledgements none Background Right side heart valve involvement is a well known phenomenon in metastatic carcinoid disease. In recent times bioprosthetic valves have been widely used for replacement of stenotic and regurgitant native heart valves. Melody Transcatheter Pulmonary Valve (MTPV, Medtronic, Minneapolis, MN, USA) has been approved for treatment of native pulmonary valves as well as failing biological prostheses and conduits. We present the first case to our knowledge of severe native pulmonary valve steno-insufficiency due to metastatic carcinoid syndrome treated with MTPV implantation. Case report A 57-year-old woman is known since 2007 for metastatic carcinoid syndrome treated with surgical resection followed by chemotherapy (tamoxifene, everolimus) and radiotherapy. For 2 years she has been known for tricuspid and pulmonary involvement, which aggravated progressively, leading to symptomatic right heart failure. She was therefore submitted for multimodality imaging evaluation (see picture) and right heart catheterization. Transthoracic echocardiogram, cardiac MRI and right heart catheterization confirmed severe pulmonary valve steno-insufficiency. Cardiopulmonary exercise testing revealed a severe limitation of aerobic exercise capacity (VO2 max 14.4 ml/min/kg). After heart team discussion it was decided to treat the patient in a 2 step approach, initially with implantation of a Melody valve in pulmonary position and subsequently with surgical repair of the tricuspid valve. Pulmonary valve was treated by placement of a 39 x 25 mm ANDRA stent and subsequent implantation of a 22 mm Melody valve. Before stenting, coronary angiography with simultaneous balloon inflation in RVOT was performed to exclude coronary artery compression. During the procedure the patient developed hypotension, which was treated effectively with Octeotride. Post-operative echocardiogram showed a significant reduction in pulmonary valve gradient and no significant residual regurgitation. Conclusions We treated effectively severe pulmonary steno-insufficiency due to metastatic carcinoid tumor with MTPV implantation. No complications occurred. Multimodality imaging is fundamental for patients selection and preoperative planning of prosthetic valve dimensions. Abstract P641 Figure. Multimodality imaging of PV

Three-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study.

The Harmony transcatheter pulmonary valve (TPV) was designed for treatment of postoperative pulmonary valve regurgitation in patients with repaired right ventricular outflow tracts. The Native TPV EFS (Early Feasibility Study) is a prospective, multicenter, nonrandomized feasibility study. Three-year outcomes are reported. Of 20 implanted patients, 17 completed 3-year follow-up (maximum: 4.1 years). There were no deaths and 2 early explants. One patient did not complete the 3-year visit. In patients with available 3-year echocardiographic data, 1 had a mild paravalvular leak and the rest had none/trace; 1 patient had mild pulmonary valve regurgitation and the remainder had none/trace. The 3-year mean right ventricular outflow tract echocardiographic gradient was 15.7±5.5 mm Hg. Radiographically, no late frame fractures or erosions were identified. At 2 years, 2 patients presented with an increased echocardiographic outflow gradient (1 mixed lesion with moderate/severe pulmonary valve regurgitation). Computed tomography scans identified neointimal tissue ingrowth within the stent frame in both patients, and they were treated successfully with a transcatheter valve-in-valve procedure (Melody TPV). Additional follow-up computed tomography scans performed at 3.2±0.5 years after implant were obtained in 16 patients and revealed luminal tissue thickening at the inflow and outflow portion of the frame with no significant alteration of the valve housing. Three-year results from the Native TPV EFS revealed stable Harmony TPV device position, good valve function in most, and the absence of moderate/severe paravalvular leak and significant late frame fractures. Two patients developed significant neointimal proliferation requiring valve-in-valve treatment, while all others had no clinically significant right ventricular outflow tract obstruction. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01762124.

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

To investigate whether age and valve size at implant contribute to outcomes after Melody transcatheter pulmonary valve replacement (TPVR). Patient age and valve size at implant contribute to longevity of surgical pulmonary valves. 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). 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%. 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. https://clinicaltrials.gov/ct2/show/NCT00740870 (NCT00740870), https://clinicaltrials.gov/ct2/show/NCT01186692 (NCT01186692), and https://clinicaltrials.gov/ct2/show/NCT00688571 (NCT00688571).

THE ELEPHANT IN THE CONDUIT: BACTEREMIA IN A PATIENT WITH TETRALOGY OF FALLOT AND A TRANSCATHETER PULMONARY VALVE REPLACEMENT

Endocarditis of the Melody (Medtronic, Minneapolis, MN) transcatheter pulmonary valve (TPV) has emerged as a potentially serious complication, challenging to diagnose and treat. A 53-year-old male with Tetralogy of Fallot and pulmonary atresia, right ventricle to pulmonary artery conduit in

Leaflet morphology classification of the Melody Transcatheter Pulmonary Valve.

We sought to describe the leaflet morphology variation in the Melody Transcatheter Pulmonary Valve (TPV) and evaluate associated outcomes. The Melody TPV is constructed from harvested bovine jugular venous valves which have been rigorously tested. Natural anatomic leaflet variations are seen in the Melody TPV but have not been evaluated. A Melody TPV leaflet morphology classification system was devised after reviewing a subset of photographed and implanted TPVs. All images were blindly reviewed by implanters and classified. Midterm hemodynamic outcomes and complications of the Melody TPVs were compared by leaflet morphology. Photographed Melody TPVs implanted between 2011 and 2016 (n = 62) were categorized into the following leaflet morphology types: A-symmetric trileaflet (47%); B-asymmetric trileaflet with a single small leaflet (32%); C-asymmetric trileaflet with a single large leaflet (16%); D-rudimentary leaflet with near bicuspid appearance (5%). Acceptable hemodynamic function at 6 months postimplantation was seen in 97.5% of valves. Over a median follow-up of 1.5 years (range 0-4.4 years), two TPVs (Type A) had > mild regurgitation. Nine TPVs developed complications (endocarditis, 3; stent fracture, 2; refractory arrhythmia, 1; conduit replacement, 2; death, 1), of which 6 required reintervention. There was no significant difference in outcomes based on Melody TPV leaflet morphology type. The Melody TPV can be classified into one of four categories based on leaflet morphology. Study outcomes were not associated with leaflet morphology. Further documentation and evaluation of Melody TPV morphology may lead to better understanding of this technology.

Endocarditis After Transcatheter Pulmonary Valve Replacement

BackgroundEndocarditis has emerged as one of the most concerning adverse outcomes in patients with congenital anomalies involving the right ventricular outflow tract (RVOT) and prosthetic valves. ObjectivesThe aim of this study was to evaluate rates and potential risk factors for endocarditis after transcatheter pulmonary valve replacement in the prospective Melody valve trials. MethodsAll patients in whom a transcatheter pulmonary valve (TPV) was implanted in the RVOT as part of 3 prospective multicenter studies comprised the analytic cohort. The diagnosis of endocarditis and involvement of the TPV were determined by the implanting investigator. ResultsA total of 309 patients underwent transcatheter pulmonary valve replacement (TPVR) and were discharged with a valve in place. The median follow-up duration was 5.1 years, and total observation until study exit was 1,660.3 patient-years. Endocarditis was diagnosed in 46 patients (median 3.1 years after TPVR), and a total of 35 patients were reported to have TPV-related endocarditis (34 at the initial diagnosis, 1 with a second episode). The annualized incidence rate of endocarditis was 3.1% per patient-year and of TPV-related endocarditis was 2.4% per patient-year. At 5 years post-TPVR, freedom from a diagnosis of endocarditis was 89% and freedom from TPV-related endocarditis was 92%. By multivariable analysis, age ≤12 years at implant (hazard ratio: 2.3; 95% confidence interval: 1.2 to 4.4; p = 0.011) and immediate post-implant peak gradient ≥15 mm Hg (2.7; 95% confidence interval: 1.4 to 4.9; p = 0.002) were associated with development of endocarditis and with development of TPV-related endocarditis (age ≤12 years: 2.8; 95% confidence interval: 1.3 to 5.7; p = 0.006; gradient ≥15 mm Hg: 2.6; 95% confidence interval: 1.3 to 5.2; p = 0.008). ConclusionsEndocarditis is an important adverse outcome following TVPR in children and adults with post-operative congenital heart disease involving the RVOT. Ongoing efforts to understand, prevent, and optimize management of this complication are paramount in making the best use of TPV therapy. (Melody Transcatheter Pulmonary Valve [TPV] Study: Post Approval Study of the Original Investigational Device Exemption [IDE] Cohort; NCT00740870; Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692; and Melody Transcatheter Pulmonary Valve [TPV] Post-Market Surveillance Study; NCT00688571)

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

This study describes procedural and 1-year outcomes of the 16 mm Melody PB1016 valve in patients with dysfunctional RVOT conduits. 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. 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. 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. 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. ClinicalTrials.gov Identifier: NCT02347189.

Safety and Feasibility of Melody Transcatheter Pulmonary Valve Replacement in the Native Right Ventricular Outflow Tract: A Multicenter Pediatric Heart Network Scholar Study

ObjectivesThis study sought to determine the safety and feasibility of transcatheter pulmonary valve replacement (TPVR) using the Melody valve in native (nonconduit) right ventricular outflow tracts (nRVOT), and to identify factors associated with successful TPVR. BackgroundThe Melody valve is Food and Drug Administration–approved for TPVR within right ventricle-to-pulmonary artery conduits and bioprosthetic pulmonary valves. However, most patients needing pulmonary valve replacement have nRVOT and TPVR has been adapted for this indication. MethodsIn this multicenter retrospective study of all patients presenting for nRVOT TPVR, we collected pre-procedural magnetic resonance imaging, echocardiography, and catheterization data, and evaluated procedural and early outcomes. ResultsOf 229 patients (age 21 ± 15 years from 11 centers), 132 (58%) had successful TPVR. In the remaining 97, TPVR was not performed, most often because of prohibitively large nRVOT (n = 67) or compression of the aortic root or coronary arteries (n = 18). There were no deaths and 5 (4%) serious complications, including pre-stent embolization requiring surgery in 4 patients, and arrhythmia in 1. Higher pre-catheterization echocardiographic RVOT gradient was associated with TPVR success (p = 0.001) and larger center volume approached significance (p = 0.08). Magnetic resonance imaging anterior-posterior and lateral RVOT diameters were smaller in implanted versus nonimplanted patients (18.0 ± 3.6 mm vs. 20.1 ± 3.5 mm; p = 0.005; 18.4 ± 4.3 mm vs. 21.5 ± 3.8 mm; p = 0.002). ConclusionsTPVR in the nRVOT was feasible and safe. However, nearly half the patients presenting for catheterization did not undergo TPV implantation, mainly because of prohibitively large nRVOT size. Improved understanding of magnetic resonance imaging data and availability of larger devices may improve the success rate for nRVOT TPVR.

Transcatheter pulmonary valve replacement using the melody valve for treatment of dysfunctional surgical bioprostheses: A multicenter study

BackgroundStented bioprosthetic valves (BPVs) are commonly used for surgical pulmonary valve (PV) replacement in postoperative congenital heart disease, but develop structural failure in a time-related fashion. The Melody transcatheter PV (TPV) (Medtronic, Minneapolis, Minn) has been used to treat BPV dysfunction, but there have been few studies in this population. MethodsWe performed a retrospective, multicenter study to evaluate Melody valve function in patients who underwent TPV replacement (TPVR) into a dysfunctional pulmonary BPV. ResultsOne hundred patients who underwent TPVR at 10 centers between January 2010 and June 2015 were enrolled. The median patient age was 22 years (range, 5-79 years), and 32 patients were age <18 years. The underlying diagnosis was tetralogy of Fallot in 80 patients, and moderate or severe pulmonary regurgitation (PR) was present in 84%. The TPV was implanted into various types of BPVs, with a median size of 23 mm (range, 19-33 mm). At hospital discharge, PR was mild or less in all but 1 patient, and the mean Doppler right ventricular outflow tract (RVOT) gradient was reduced from a mean of 29.3 ± 12.0 mm Hg to 16.2 ± 6.9 mm Hg (median, 29 mm Hg to 16 mm Hg; P < .001). During follow-up (median, 12.4 months), no patients underwent reintervention on the TPV. Endocarditis was diagnosed in 1 patient who was managed medically without intervention. The mean RVOT gradient at the most recent follow-up was ≤35 mm Hg in all patients, and was similar to that at early postimplantation. PR was more than mild in only 1 patient. Hemodynamic outcomes did not differ between patients with small BPVs (≤23 mm) and those with large BPVs (≥25 mm). ConclusionsTPVR restores competence and relieves the obstruction of dysfunctional surgical BPVs, with excellent early results in both small and large BPVs, highlighting the potential for TPVR to extend the life of existing BPVs in adults and children. Collaboration between surgeons and cardiologists is important to determine the optimal lifetime management, combining surgical PV replacement and TPVR in this population.

Multicenter Experience Evaluating Transcatheter Pulmonary Valve Replacement in Bovine Jugular Vein (Contegra) Right Ventricle to Pulmonary Artery Conduits.

Follow-up of transcatheter pulmonary valve replacement (TPVR) with the Melody valve has demonstrated good short-term and long-term outcomes, but there are no published studies focused on valve performance in the Contegra bovine jugular vein conduit. This is a retrospective, multicenter study of the short- and intermediate-term outcomes of Melody TPVR within the Contegra conduit in the right ventricle to pulmonary artery position. Data from 13 centers were included in the analysis. During the study period, 136 patients underwent 139 catheterizations for attempted Melody TPVR with a median follow-up of 3 years (1 day to 9.1 years). Of the 136 patients, 117 underwent successful Melody TPVR. Two patients underwent a second Melody TPVR. The majority of patients underwent placement of ≥1 stents before transcatheter pulmonary valve implantation. There was a significant reduction in peak conduit pressure gradient acutely after transcatheter pulmonary valve implantation (39 versus 10 mm Hg; P<0.001). At most recent follow-up, the maximum pulmonary valve gradient by echocardiogram remained significantly reduced relative to prevalve implant measurements (65.9 versus 27.3 mm Hg; P<0.001). The incidence of Melody transcatheter pulmonary valve stent fracture (3.4%) and infectious endocarditis (4.3%) were both low. Serious adverse events occurred in 3 patients. Melody TPVR in Contegra conduits is safe and effective and can be performed in a wide range of conduit sizes with preserved valve function and low incidence of stent fracture and endocarditis.

Outcomes Following Melody Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract Dysfunction in Repaired Congenital Heart Disease: First Reported Australian Single Centre Experience

Transcatheter pulmonary valve implantation (TPVI) with the Melody® transcatheter pulmonary valve (TPV) has demonstrated good haemodynamic and clinical outcomes in the treatment of right ventricular outflow tract (RVOT) conduit dysfunction in patients with repaired congenital heart disease CHD. We present the first Australian single centre experience of patients treated with Melody TPV. A prospective, observational registry was developed to monitor clinical and haemodynamic outcomes in patients with RVOT dysfunction treated with the Melody TPV (Medtronic Inc, Minneapolis, United States). Seventeen patients underwent TPVI with Melody TPV at The Prince Charles Hospital between January 2009 and February 2016 with a median (range) age of 34 (R: 15-60). Fifteen (88%) were NYHA Class 2 dyspnoea and 11 (59%) had corrected Tetralogy of Fallot. Indication for TPVI was stenosis in eight (47%), regurgitation in two (12%) and mixed dysfunction in seven (41%). Device implantation was successful in all patients. Peak RVOT gradient was significantly reduced and there was no significant regurgitation post procedure. There was one (6%) major procedural adverse event and two (12%) major adverse events at last recorded follow-up. There were no patient deaths. Follow-up cardiac magnetic resonance imaging revealed a significant reduction in indexed right ventricular end diastolic volume. This study confirms the safety and effectiveness of TPVI with Melody TPV for RVOT dysfunction in repaired CHD.

Melody valve implantation within freestyle stentless porcine aortic heterograft.

The Melody transcatheter pulmonary valve has been implanted successfully worldwide since its first implant in 2000. The vast majority of these valves have been implanted in pulmonary homografts. In our institution, the most common valve used for pulmonary valve replacement is the Medtronic Freestyle stentless porcine aortic heterograft. We describe our experience implanting the Melody valve within the Freestyle heterograft. Retrospective chart review was performed. Between June 2012 and June 2015, 19 Melody valves were placed within Freestyle heterografts. The most common indication for intervention was pulmonary stenosis. Following pre-stent and Melody valve implantation, right ventricle-to-pulmonary artery gradient decreased from 38.1 ± 12.1 to 10 ± 4.7 mm Hg (P < 0.001), and right ventricular pressure decreased from 61.7 ± 17.8 to 35.6 ± 10.2 mm Hg (P < 0.001). Two procedural adverse events occurred. At median follow-up of 24 months (range 2-48 months), no patients had mean right ventricular outflow tract gradients >30 mm Hg or worse than mild insufficiency. No valve reinterventions have been necessary and no episodes of endocarditis have been observed. The Melody valve can be implanted successfully within a stentless aortic bioprosthesis with good short- and intermediate-term longevity. © 2016 Wiley Periodicals, Inc.

Transcatheter pulmonary valve implantation: A cross-sectional US experience

More than a decade ago Bonhoeffer et al. [ [1] Bonhoeffer P. Boudjemline Y. Saliba Z. Merckx J. Aggoun Y. Bonnet D. Acar P. Le Bidois J. Sidi D. Kachaner J. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. Lancet. Oct 21 2000; 356: 1403-1405 Abstract Full Text Full Text PDF PubMed Scopus (821) Google Scholar ] demonstrated implantation of transcatheter pulmonary valve (TPV) in a RVOT (Right Ventricular Outflow Tract) conduit with a device comprising a balloon-expandable stent with mounted bovine jugular venous valve. US food and Drug Administration (FDA) approved modified version of the original device, the Melody valve (Medtronic Inc, Minneapolis, Minnesota) in 2010 after the original Investigational Device Exemption (IDE #G050186) trial [ [2] Zahn E.M. Hellenbrand W.E. Lock J.E. McElhinney D.B. Implantation of the Melody transcatheter pulmonary valve in patients with a dysfunctional right ventricular outflow tract conduit early results from the U.S. Clinical trial. J. Am. Coll. Cardiol. 2009; 54: 1722-1729 Abstract Full Text Full Text PDF PubMed Scopus (255) Google Scholar ]. The results of this study and its continuing study done by McElhinney et al. [ [3] McElhinney D.B. Hellenbrand W.E. Zahn E.M. Jones T.K. Cheatham J.P. Lock J.E. Vincent J.A. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. 2010; 122: 507-516 Crossref PubMed Scopus (454) Google Scholar ] demonstrated substantial clinical improvement in patients who underwent Melody TPV implantation procedure, which were similar to previously reported cohort study data on non-surgically approached transcutaneous pulmonary valve implantation [ 4 Vezmar M. Chaturvedi R. Lee K.J. Almeida C. Manlhiot C. McCrindle B.W. Horlick E.M. Benson L.N. Percutaneous pulmonary valve implantation in the young 2-year follow-up. JACC Cardiovasc. Interv. 2010; 3: 439-448 Abstract Full Text Full Text PDF PubMed Scopus (74) Google Scholar , 5 Eicken A. Ewert P. Hager A. Peters B. Fratz S. Kuehne T. Busch R. Hess J. Berger F. Percutaneous pulmonary valve implantation: two-centre experience with more than 100 patients. Eur. Heart J. 2011; 32: 1260-1265 Crossref PubMed Scopus (226) Google Scholar , 6 Lurz P. Coats L. Khambadkone S. Nordmeyer J. Boudjemline Y. Schievano S. Muthurangu V. Lee T.Y. Parenzan G. Derrick G. Cullen S. Walker F. Tsang V. Deanfield J. Taylor A.M. Bonhoeffer P. Percutaneous pulmonary valve implantation: impact of evolving technology and learning curve on clinical outcome. Circulation. 2008; 117: 1964-1972 Crossref PubMed Scopus (395) Google Scholar ].

The Utility of Intracardiac Echocardiography Following Melody™ Transcatheter Pulmonary Valve Implantation.

The aim of this study was to determine the utility of intracardiac echocardiography (ICE) in assessing Melody™ transcatheter pulmonary valve (TPV) function immediately following valve implantation. ICE is used increasingly in percutaneous cardiac interventions. At our center, ICE is routinely utilized to evaluate valve function following Melody TPV implantation, but the utility of this practice remains unclear. A retrospective review of all Melody valves placed in the right ventricular outflow tract from April 2010 to September 2013 was performed. The clinical utility of ICE was described, along with the relationship between ICE data and traditional hemodynamic/angiographic data. ICE was performed in 54 cases and provided excellent Melody TPV visualization with no complications. ICE did not change clinical management but did provide supplemental information in two cases. In one case, angiography showed severe catheter-related Melody insufficiency. Subsequent ICE confirmed no insufficiency and prevented the need for additional angiography. In the second case, ICE allowed characterization of the mechanism of a residual gradient. ICE did not detect any clinically significant paravalvar leaks or valvar insufficiency not seen by angiography. The peak catheterization gradient was more closely approximated by the mean ICE gradient (median difference -7.4% between measurements) than by the peak ICE gradient (median difference 58.3%; p<0.0001). ICE provides excellent and safe visualization following Melody TPV implantation but did not provide new clinical information impacting management in this series. Selective use of ICE in cases with more than expected valve insufficiency or larger than expected residual gradients may streamline use while maintaining optimal clinical outcomes.

One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study.

This study sought to confirm that the short-term hemodynamic effectiveness of the Melody transcatheter pulmonary valve (TPV) (Medtronic, Inc., Minneapolis, Minnesota) achieved by real-world providers is equivalent to thehistorical results established in the initial 5-center Investigational Device Exemption trial. TPV replacement has been used to treat right ventricular outflow tract (RVOT) conduit dysfunction for >10 years. The Melody TPV received U.S. Food and Drug Administration approval in 2010 as a Humanitarian Use Device. Patients with dysfunctional RVOT conduits were entered in this prospective, nonrandomized study at 10 centers. The primary endpoint was acceptable hemodynamic function at 6 months post-implantation, defined as a composite of RVOT echocardiographic mean gradient≤30 mmHg, pulmonary regurgitation less than moderate as measured by echocardiography, and freedom from conduit reintervention and reoperation. Cardiac catheterization was performed in 120 patients for potential implantation of the Melody TPV; of these, 100 patients were implanted, with a 98.0% procedural success rate. There were no procedure-related deaths. Acceptable hemodynamic function at 6 months was achieved in 96.7% of patients with evaluable data (87.9% of the entire implanted cohort), with results maintained through 1 year. No patient had moderate or severe pulmonary regurgitation after implantation. No patient required catheter reintervention in the first year after implantation, and 2 patients required reoperation for conduit replacement. The rate of freedom from TPV dysfunction was 96.9% at 1 year. This first prospective, real-world experience with the Melody TPV in the United States demonstrates continued high procedural success, excellent short-term TPV function, and low reintervention and reoperation rates at1year. (Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692).

Use and performance of the Melody Transcatheter Pulmonary Valve in native and postsurgical, nonconduit right ventricular outflow tracts.

Melody Transcatheter Pulmonary Valve (TPV) replacement therapy represents an important advance in congenital cardiovascular interventions. The off-label extension of the Melody TPV to patients with nonconduit outflow tracts (right ventricular outflow tract [RVOT]) has the potential to vastly expand the population of patients eligible to benefit from nonsurgical restoration of RVOT function. However, knowledge on the performance of the Melody TPV in this setting is limited. This is a multicenter, retrospective review of the Melody TPV when placed in nonconduit RVOTs, in which at least a portion of the circumference was composed of native tissue. Five centers contributed data on 31 patients. The median age at implantation was 24 years (range, 7-66). At a median follow-up of 15 months, all patients were alive. No patient had greater than mild TPV insufficiency, and the median maximum instantaneous gradients across the RVOT was 23 mm Hg. Stent fracture occurred in 32%. Eight patients developed more than mild TPV obstruction, of whom 6 were associated with identified stent fracture. Three patients developed blood stream infections. There were 5 reinterventions in 3 patients, including 3 repeat TPV implantations and 2 TPV explantations. Melody TPV implantation is feasible in selected patients with RVOTs comprised solely or predominantly native tissue and has the potential to expand the population of patients eligible to benefit from nonsurgical restoration of RVOT function. In early follow-up, valve competency seems preserved. The dominant mechanism of valve dysfunction seems to be related to stent fracture with recurrent obstruction. Additional data are necessary to better understand how to safely expand TPV therapy to this population.

Feasibility and Short-Term Outcomes of Percutaneous Transcatheter Pulmonary Valve Replacement in Small (&lt;30 kg) Children With Dysfunctional Right Ventricular Outflow Tract Conduits

In 2010, the Melody transcatheter pulmonary valve (TPV) received Food and Drug Administration approval for treatment of dysfunctional right ventricular outflow tract conduits in patients ≥30 kg. Limited data are available regarding use of this device in smaller patients. We evaluated technical and short-term clinical outcomes of 25 patients <30 kg (10 patients <20 kg) who underwent TPV replacement for treatment of conduit dysfunction at 3 centers. Median age and weight were 8.0 years (3.4-14.4) and 21.4 kg (13.8-29.0). The median conduit diameter at the time of surgical implant was 17 mm (12-23). Two patients did not undergo TPV implant (risk of coronary compression in 1; inability to advance the delivery sheath beyond the common femoral vein in 1). After successful TPV implant, the peak conduit gradient fell from 29±16 to 9±6 mm Hg (P<0.001), and all but 2 patients had no/trivial regurgitation (down from moderate or severe preimplant in 20). TPV implant was via the femoral vein in 17 patients, the right internal jugular vein in 4, and the left subclavian vein in 2 patients. At a median follow-up of 16 months, 1 patient underwent conduit replacement for recurrent conduit stenosis, 2 developed stent fracture requiring a second TPV, and 2 developed bacterial endocarditis treated with antibiotics, 1 of whom then underwent conduit replacement. The average Melody valve mean Doppler gradient and conduit regurgitation were unchanged from early postimplant. Percutaneous TPV replacement can be performed in small children with good procedural and early hemodynamic results in the majority of patients.