Melody Valve Research Articles

4D flow MRI to assess right ventricular outflow tract in patients undergoing transcatheter pulmonary valve replacement for severe pulmonary regurgitation

Magnetic resonance imaging (MRI) is essential to assess right ventricular enlargement and function as well as the severity of pulmonary regurgitation before pulmonary valve replacement. Transcatheter pulmonary valve replacement (TPVR) has emerged as an alternative to surgical replacement but limited by the size of the right ventricular outflow tract (RVOT). The aim of the study was to compare the measurements of native RVOT between different MRI imaging sequences and catheterization findings. Single-center retrospective study of patients who underwent TPVI for severe pulmonary regurgitation assessed by 4D flow MRI, without significant residual RVOT obstruction. Balloon calibration was used as the reference. Nine adult with repaired tetralogy of Fallot and one patient with Ross procedure were included (mean age: 43.9 ± 12.9). One patient had a too large RVOT to achieve a TPVR, 1 patient had TPVR with Edwards XT 29 mm valve, 7 patients had Melody valve implantation procedure. Mean RVOT measured 25.1 ± 3.0 mm by balloon calibration, 25.0 ± 3.2 mm and 22.5 ± 3.0 mm 4D flow MRI, in respectively in systole and diastole, 22.7 ± 2.4 mm in 2D SSFP MRI. Interventional angiograms dimensions were 26.7 ± 3.3 mm and 24.4 ± 1.3 mm respectively in systole and diastole. No statistical differences were found comparing different measurements dimensions. Good correlation was found between balloon calibration and MRI 4D flow in systole ( r = 0.794, P = 0.01), while no correlation existed between balloon calibration, 2D MRI and 4D flow MRI in diastole. Balloon calibration was also well correlated to angiograms measurements ( r = 0.881; P = 0.0002 and r = 0.775; P = 0.024, respectively). 4D flow MRI sequence allowing 3D measurement through the cardiac cycle, appears as an interesting technique to measure RVOT in daily practice and therefore to plan TPVI.

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)

Long-term outcomes of melody valve-in-valve implantation for bioprosthetic mitral valve dysfunction.

This study reports long-term outcomes percutaneous Melody valve (Medtronic, Minneapolis, Minnesota) valve-in-valve therapy in patients with prosthetic valve dysfunction. Repeat valve surgery is associated with high morbidity and mortality. Transcatheter mitral valve-in-valve is a promising alternative in patients at high-risk for cardiac surgery. We conducted a retrospective cohort analysis of 13 patients who underwent Melody valve-in-valve for bioprosthetic dysfunction from July 2011 to October 2013. Mean age was 74.4 years, 46% male, and STS score 13.5 ± 6.8%. All patients had NYHA class 3 or 4 symptoms with improvement to class 1 or 2 in 82% post procedure. Median follow-up was 4.5 years with longest follow-up of 5.5 years. Thirty-day mortality was 15.4% with 1-year mortality of 25% and no other reported deaths until 4.5 years. 76.9% of patients had mitral gradient of 5 mmHg or less immediately postprocedure. One patient required repeat valve procedure for structural deterioration at 4.4 years. At 1, 3, and 5 year follow-ups 75% of patients were NYHA class 1 or 2, mean gradients were 4.5 ± 0.6, 6.8 ± 0.5, and 7.5 ± 0.7, respectively. Using 4-point scale, mitral regurgitation postprocedure was 0.8 ± 0.6. At 1, 3, and 5 years this increased to 1.0 ± 1.1, 1.3 ± 1.3, and 2.5 ± 2.1, respectively. Melody valve-in-valve therapy was effective with 1-year symptomatic improvement. Prosthesis deterioration requiring repeat intervention was observed in one patient. Larger cohorts with multicenter registries are needed to determine the role of this percutaneous valve-in-valve therapy as valve technology and procedural techniques improve.

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.

Surgical Atrioventricular Valve Replacement With Melody Valve in Infants and Children.

Background Pediatric patients with atrioventricular valve disease have limited options for prosthetic valve replacement in sizes <15 mm. Based on successful experience with the stented bovine jugular vein graft (Melody valve) in the right ventricular outflow tract, the prosthesis has been modified for surgical valve replacement in pediatric patients with atrioventricular dysfunction with the intention of subsequent valve expansion in the catheterization laboratory as the child grows. Methods and Results A multicenter, retrospective cohort study was performed among patients who underwent atrioventricular valve replacement with Melody valve at 17 participating sites from North America and Europe, including 68 patients with either mitral (n=59) or tricuspid (n=9) replacement at a median age of 8 months (range, 3 days to 13 years). The median size at implantation was 14 mm (range, 9-24 mm). Immediately postoperatively, the valve was competent with low gradients in all patients. Fifteen patients died; 3 patients underwent transplantation. Nineteen patients required reoperation for adverse outcomes, including valve explantation (n=16), left ventricular outflow tract obstruction (n=1), permanent pacemaker implantation (n=1), and paravalvular leak repair (n=1). Twenty-five patients underwent 41 episodes of catheter-based balloon expansion, exhibiting a significant decrease in median gradient ( P<0.001) with no significant increase in grade of regurgitation. Twelve months after implantation, cumulative incidence analysis indicated that 55% of the patients would be expected to be free from death, heart transplantation, structural valve deterioration, or valve replacement. Conclusions The Melody valve is a feasible option for surgical atrioventricular valve replacement in patients with hypoplastic annuli. The prosthesis shows acceptable short-term function and is amenable to catheter-based enlargement as the child grows. However, patients remain at risk for mortality and structural valve deterioration, despite adequate early valvular function. Device design and implantation techniques must be refined to reduce complications and extend durability. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT02505074.

Up to 11 years of experience with the Melody valved stent in the right ventricular outflow tract.

The aim of the study was to report up to 11 years of follow-up after Melody valve implantation in the pulmonary position. This was a single-institution non-randomised prospective observational study of all Melody valves in the pulmonary position after discharge between 2006 and 2017 (n=188). Mean age was 19.4 years (SD 13.2). The indication was stenosis (45%), regurgitation (33%) and mixed (22%). Pre-stenting was performed in all except the initial four patients. In stenotic lesions the peak gradient was 36 mmHg PIG (SD 12.0) after 11 years and in regurgitant lesions the maximal regurgitation was 2/4. Stent fractures were observed in 8.6%; only one grade III fracture required redo PPVI. Surgical removal was carried out in seven (3.7%), redo PPVI in five (2.7%). Endocarditis was diagnosed in 19 (10.2%) patients at a median of 2.3 years (0.7-8.8) after Melody implantation. Three were surgically removed early because of persistent infection, 16 were sterilised; six required replacement (three surgical, three redo PPVI). There were no valve- or procedure-related deaths. The Melody valve shows a good preserved leaflet function up to 11 years after implantation. The main reason for graft failure was endocarditis, although in half of those patients no reintervention was needed. After pre-stenting, stent fractures led very exceptionally to reintervention.

Fever within 48 h after Melody implantation is a risk factor of late infective endocarditis

Fever following pulmonary valve implantation is known but its frequency and impact have been poorly described. The aim of this study was to analyze clinical and biological parameters of inflammation just after the Melody valve implantation, and to see if early onset of inflammation can predict the risk of late infective endocarditis (IE). We performed a retrospective study on patients with Melody valve implanted for dysfunctional RVOT in our unit between January 2008 and December 2016. All clinical and biological inflammatory parameters following Melody implantation were recorded. In total, 198 patients were included (median age = 22.8 [Q1–Q3: 15.4–31.5] years). Before the procedure, the RVOT statute of patients was: 74 (37.4%) pulmonary valved conduits, 57 (28.8%) natives (with or without valve), 50 (25.2%) homografts, and 17 (8.6%) valveless conduits. Within 48 h post procedure, 58 patients (29.3%) had fever [T > 37.9 °C] and 140 patients (70.7%) had no fever, 98 patients (49.5%) had a CRP >5 mg/L, and 61 patients (30.8%) had white blood cells (WBC) >10G/L. Fifty-five patients received large spectral antibiotic regimen waiting for results of blood culture. No patients were found to have early IE and antibiotics were stopped after a median duration of 2 [1–2] days. Length of stay was longer in patients with fever compared to those without fever ( P < 0.001). The median follow-up was 3.3 [1.3–5.3] years. Twenty-one patients developed IE (10.6%), with a median at 1.8 [0.3–3.5] years. At 5 years, freedom from IE was 87.2%. Fever within 48 h post procedure was a significative risk factor (HR = 6.1, IC95%[2.5–15.1], P < 0.001). At 5 years, freedom from IE was 88.5% for patients without fever and 67.7% patients with fever within 48 h post-procedure ( P < 0.001). Elevated post-procedural WBC ( P = 0.62), CRP level ( P = 0.90), and initial RVOT statute of patients ( P = 0.70) were not a risk factor for IE. Patients with fever within 48 hours after Melody valve implantation are at particular risk of IE in their life. The reasons might be related to a specific genetic profile. Further studies are needed to understand the causes behind.

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.

Intentional Fracture of Bioprosthetic Valve Frames in Patients Undergoing Valve-in-Valve Transcatheter Pulmonary Valve Replacement.

Percutaneous transcatheter pulmonary valve replacement (TPVR) has good clinical and hemodynamic outcomes in treating dysfunctional bioprosthetic valves (BPV) in the pulmonary position. Valve-in-valve therapy can further decrease the inner diameter (ID), potentially resulting in patient-prosthesis mismatch in patients with smaller BPVs. To evaluate feasibility and outcomes of intentional BPV fracture to enlarge the pulmonary valve orifice with TPVR, 37 patients from 13 centers who underwent TPVR with intended BPV fracture were evaluated. A control cohort (n=70) who underwent valve-in-valve TPVR without attempted fracture was evaluated. BPV was successfully fractured in 28 patients and stretched in 5 while fracture was unsuccessful in 4. A Melody valve was implanted in 25 patients with fractured/stretched frame and a Sapien (XT 3) valve in 8. Among patients whose BPV was fractured/stretched, the final ID was a median of 2 mm larger (0-6.5 mm) than the valve's true ID. The narrowest diameter after TPVR in controls was a median of 2 mm smaller ( P<0.001) than true ID. Right ventricular outflow tract gradient decreased from median 40 to 8 mm Hg in the fracture group. Cases with fracture/stretching were matched 1:1 (weight, true ID) to controls. Post-TPVR peak gradient was lower but not significant (8.3±5.2 versus 11.8±9.2 mm Hg; P=0.070). There were no fracture-related adverse events. Preliminary experience shows intentional fracture of BPV frame can be useful for achieving larger ID and better hemodynamics after valve-in-valve TPVR.

Pulmonary Regurgitation- Is the Future Percutaneous or Surgical?

For decades, surgical replacement of the pulmonary valve has been seen as the gold-standard technique. Until the advent of Medtronic's Melody valve, it was the only option. Whilst radical changes in surgical techniques have not been forthcoming, rapid and substantial developments in the techniques and available technology for percutaneous valves now cause us to ask if the gold-standard moniker now belongs in the cath lab. This manuscript explores the recent history and future of a revolution in this large area of congenital cardiac practice.

Infective Endocarditis After Melody Valve Implantation in the Pulmonary Position: A Systematic Review.

BackgroundInfective endocarditis (IE) after transcatheter pulmonary valve implantation (TPVI) in dysfunctioning right ventricular outflow tract conduits has evoked growing concerns. We aimed to investigate the incidence and the natural history of IE after TPVI with the Melody valve through a systematic review of published data.Methods and ResultsPubMed, EMBASE, and Web of Science databases were systematically searched for articles published until March 2017, reporting on IE after TPVI with the Melody valve. Nine studies (including 851 patients and 2060 patient‐years of follow‐up) were included in the analysis of the incidence of IE. The cumulative incidence of IE ranged from 3.2% to 25.0%, whereas the annualized incidence rate ranged from 1.3% to 9.1% per patient‐year. The median (interquartile range) time from TPVI to the onset of IE was 18.0 (9.0–30.4) months (range, 1.0–72.0 months). The most common findings were positive blood culture (93%), fever (89%), and new, significant, and/or progressive right ventricular outflow tract obstruction (79%); vegetations were detectable on echocardiography in only 34% of cases. Of 69 patients with IE after TPVI, 6 (8.7%) died and 35 (52%) underwent surgical and/or transcatheter reintervention. Death or reintervention was more common in patients with new/significant right ventricular outflow tract obstruction (69% versus 33%; P=0.042) and in patients with non‐streptococcal IE (73% versus 30%; P=0.001).ConclusionsThe incidence of IE after implantation of a Melody valve is significant, at least over the first 3 years after TPVI, and varies considerably between the studies. Although surgical/percutaneous reintervention is a common consequence, some patients can be managed medically, especially those with streptococcal infection and no right ventricular outflow tract obstruction.

Modified technique for Melody valve implantation in the mitral position

Modified technique for Melody valve implantation in the mitral position

French national survey on infective endocarditis and the Melody™ valve in percutaneous pulmonary valve implantation

Percutaneous pulmonary valve implantation (PPVI) is a routine treatment for dysfunctional right ventricular outflow tract. Infective endocarditis (IE) is a major concern. To report French experience with the Melody™ valve (Medtronic Inc., Minneapolis, MN, USA). All patients who underwent PPVI were recorded in a multicentre French national survey. Demographic and procedural data were collected from patients with IE. Bacterial identification, diagnostic tools and outcome were recorded. Forty-five cases of IE were diagnosed in 43 patients. The cumulative IE incidence was 11.8% (95% confidence interval [CI] 8.5-15.9). The annualized IE incidence was 3.6% (95% CI 0-4.8). Freedom from IE was 96.3% and 85.8% at 12 months and 60 months, respectively. IE incidence did not change during the study period. The mean interval between PPVI and IE was 2.6±2.1 years (range, 5 days to 7.3 years). Fifteen patients with IE required intravenous antibiotics only. Seven patients had early interventional cardiac catheterization to relieve severe right ventricular outflow tract obstruction. Twenty-four patients had surgical valve replacement (six urgently; nine semi-urgently; nine electively). Staphylococcus aureus IE required surgery in all but one patient. Three patients died before any treatment. Three additional patients died, giving a mortality rate of 14%. Global survival in the total cohort of patients who received a Melody valve was excellent (96.5% at 5 years). When comparing survival curves between the IE and non-IE groups, death and cardiovascular events were statistically significantly higher in the IE group (log-rank P<0.0001). Melody valve IE is a severe complication following PPVI. The annualized IE incidence in this cohort was similar to rates reported in other studies. With rapid diagnosis and adequate treatment, outcome has improved, and unfavourable outcome is mainly associated with S. aureus.

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

ObjectivesThis study sought to evaluate the safety, feasibility, and outcomes of transcatheter pulmonary valve replacement (TPVR) in conduits ≤16 mm in diameter. BackgroundThe Melody valve (Medtronic, Minneapolis, Minnesota) is approved for the treatment of dysfunctional right ventricular outflow tract (RVOT) conduits ≥16 mm in diameter at the time of implant. Limited data are available regarding the use of this device in smaller conduits. MethodsThe study retrospectively evaluated patients from 9 centers who underwent percutaneous TPVR into a conduit that was ≤16 mm in diameter at the time of implant, and reported procedural characteristics and outcomes. ResultsA total of 140 patients were included and 117 patients (78%; median age and weight 11 years of age and 35 kg, respectively) underwent successful TPVR. The median original conduit diameter was 15 (range: 9 to 16) mm, and the median narrowest conduit diameter was 11 (range: 4 to 23) mm. Conduits were enlarged to a median diameter of 19 mm (29% larger than the implanted diameter), with no difference between conduits. There was significant hemodynamic improvement post-implant, with a residual peak RVOT pressure gradient of 7 mm Hg (p < 0.001) and no significant pulmonary regurgitation. During a median follow-up of 2.0 years, freedom from RVOT reintervention was 97% and 89% at 2 and 4 years, respectively, and there were no deaths and 5 cases of endocarditis (incidence rate 2.0% per patient-year). ConclusionsIn 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.

Transcatheter valve replacement in congenital heart disease: the present and the future

### Learning objectives Survival into adulthood for patients with congenital heart disease (CHD) is expected in those that have access to specialty care. Many of them will need multiple valve...

Bio-Chimney Technique for Narrow Mitral Annulus in Adults

Narrow mitral annulus is a common situation faced in adult patients. Choice of prosthetic valve in such cases is unclear. There are reported experiences with supra-annular mitral valve, Manouguian technique, "chimney technique" with mechanical valve and Melody valve, the latter two being in children. We report a novel "bio-chimney" technique in which a bioprosthetic valve of a size appropriate for the patient is sutured to a polyester vascular graft, which is then implanted to the native narrow mitral annulus in an adult patient, with promising initial results.

Bilateral branch pulmonary artery valve implantation in repaired tetralogy of fallot.

Transcatheter, bilateral branch pulmonary artery (PA) valve implantation is a novel treatment for patients with severe pulmonary insufficiency and oversized right ventricle (RV) outflow tract. There is scarce data on efficacy and safety of this approach. This was a retrospective study of 8 patients with repaired tetralogy of fallot (TOF) who underwent bilateral branch PA valve implantation. Demographics, echocardiography, cardiac catheterization, and axial imaging data were reviewed. Variables were compared by a paired sample t-test. All patients were adult sized (weight 43-99 kg) with oversized RV outflow tract not suitable for conventional transcatheter pulmonary valve implantation. Staged bare metal PA stenting followed by valve implantation (interval 3-5 months) was technically successful in 7 patients with one stent embolization. In another patient, proximal stent migration prevented placement of bilateral pulmonary valve stents. There were a total of 14 valved branch PA stents placed (Melody valve n = 9, Sapien XT n = 2, Sapien 3 n = 3). In the 7 patients undergoing successful branch pulmonary valve placement, at median follow up of 10 months (range 3 months to 6 years), 13 (93%) valves had none/trivial insufficiency on echocardiography. Prevalve and postvalve implantation cardiac magnetic resonance imaging in five patients showed significant reduction of indexed RV end-diastolic volume (152 ± 27 to 105 ± 15 mL/m2 , P < .001). Transcatheter, bilateral branch PA valve implantation was technically feasible with satisfactory efficacy and safety in patients with repaired TOF, severe pulmonary insufficiency, and oversized RV outflow tracts. Elimination of pulmonary insufficiency with this method resulted in reduced RV end-diastolic volume. This approach can be offered as an alternative to surgery, particularly in patients considered high risk for standard surgical placement and who are not candidates for the newer self-expanding valve prosthesis for placement in RV outflow tracts larger than 30 mm diameter.

Safety and efficacy of Sapien 3 valve for percutaneous pulmonary valve implantation

Efficacy of Sapien XT valve has been reported for percutaneous pulmonary valve implantation (PPVI). Implantation is complex given the rigidity and the of the Novaflex ® delivery system. Sapien 3 valve is the latest evolution of Edwards valves with a more flexible Commander ® delivery system. We report our results of off-label use of Sapien 3 for PPVI. Between September 2016 and April 2017, 16 procedures were performed with the Sapien 3 and compared to 26 procedures performed with the Sapien XT between January 2015 and July 2016. Sapien 3 were implanted in 16 patients [26 years old (23–38)]. Conduit were native patched valves ( n = 6), bioprosthesis ( n = 4), tube ( n = 4), homograft ( n = 1) and Melody valve ( n = 1). All patients had pulmonary prestenting (Andrastent XXL, n = 12; eV3 LDmax, n = 4). Valve implantation was performed during a second procedure in 5 cases. Valve diameters were 23 ( n = 3), 26 ( n = 4) and 29 mm ( n = 9). Valves were successfully implanted in all cases. After procedure, one patient had minor pulmonary valve regurgitation. Peak-to-peak gradient across the valves was ≤ 15 mmHg in 14 cases. Two patients had minor valve mismatch. Nor valve dysfunction nor infective endocarditis was reported during follow-up. Procedure duration, fluoroscopy time, dose-length product and kerma were lower with Sapien 3 compared to Sapien XT procedures (0.002, 0.01, 0.006, and 0.007 respectively). Sapien 3 valve implantation in pulmonary position with the Commander delivery system is efficient and faster. However, the lack of valve covering onto the delivery system remains an issue.

Melody valve implantation pre-procedural planning using custom-made 3D printed model of the region of interest.

Melody valve implantation pre-procedural planning using custom-made 3D printed model of the region of interest.

Melody valve implantation through a recanalized occluded femoral vein.

Melody valve implantation through a recanalized occluded femoral vein.