scholarly journals Long-Term Outcomes After Melody Transcatheter Pulmonary Valve Replacement in the US Investigational Device Exemption Trial

2021 ◽  
Author(s):  
Thomas K. Jones ◽  
Doff B. McElhinney ◽  
Julie A. Vincent ◽  
William E. Hellenbrand ◽  
John P. Cheatham ◽  
...  
Keyword(s):  
Pulmonary Valve ◽  
Pulmonary Regurgitation ◽  
Right Ventricular Outflow Tract ◽  
Ventricular Outflow Tract ◽  
Complex Congenital Heart Disease ◽  
Stent Fracture ◽  
Unique Identifier ◽  
Investigational Device Exemption ◽  
Melody Valve ◽  
The Us

Background: The Melody valve was developed to extend the useful life of previously implanted right ventricular outflow tract (RVOT) conduits or bioprosthetic pulmonary valves, while preserving RV function and reducing the lifetime burden of surgery for patients with complex congenital heart disease. Methods: Enrollment for the US Investigational Device Exemption study of the Melody valve began in 2007. Extended follow-up was completed in 2020. The primary outcome was freedom from transcatheter pulmonary valve (TPV) dysfunction (freedom from reoperation, reintervention, moderate or severe pulmonary regurgitation, and/or mean RVOT gradient >40 mm Hg). Secondary end points included stent fracture, catheter reintervention, surgical conduit replacement, and death. Results: One hundred seventy-one subjects with RVOT conduit or bioprosthetic pulmonary valve dysfunction were enrolled. One hundred fifty underwent Melody TPV replacement. Median age was 19 years (Q1–Q3: 15–26). Median discharge mean RVOT Doppler gradient was 17 mm Hg (Q1–Q3: 12–22). The 149 patients implanted >24 hours were followed for a median of 8.4 years (Q1–Q3: 5.4–10.1). At 10 years, estimated freedom from mortality was 90%, from reoperation 79%, and from any reintervention 60%. Ten-year freedom from TPV dysfunction was 53% and was significantly shorter in children than in adults. Estimated freedom from TPV-related endocarditis was 81% at 10 years (95% CI, 69%–89%), with an annualized rate of 2.0% per patient-year. Conclusions: Ten-year outcomes from the Melody Investigational Device Exemption trial affirm the benefits of Melody TPV replacement in the lifetime management of patients with RVOT conduits and bioprosthetic pulmonary valves by providing sustained symptomatic and hemodynamic improvement in the majority of patients. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00740870.

Abstract 2611: Transcatheter Valve Insertion A Model Of Enlarged Right Ventricular Outflow Tracts

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Adeline Basquin ◽  
Younes Boudjemline
Keyword(s):  
Right Ventricular ◽  
Pulmonary Valve ◽  
Main Pulmonary Artery ◽  
Pulmonary Regurgitation ◽  
Right Ventricular Outflow Tract ◽  
Ventricular Outflow Tract ◽  
The Difference ◽  
Group 2 ◽  
Transcatheter Valve ◽  
Group B

Background: Transcatheter pulmonary valve insertion has recently emerged as an alternative to surgery. To extend the indications to patients with large right ventricular outflow tract (RVOT), we previously developed an intravascular device that reduces the diameter of the main pulmonary artery (MPA) allowing the insertion of available valved stents. We report its use in a model of animals with enlarged RVOT and pulmonary valve incompetence (PVI). Methods and Results: 33 sheep were included. They first underwent surgical MPA enlargement. We then intended to implant percutaneously a reducer followed by the insertion of a valve. Three animals died during interstage. The remaining were sacrificed acutely (group 1, n=6), after a mean follow-up of 1 (group 2, n=12) and 2 months (group 3, n=12). Animals from chronic groups were equally divided into 2 subgroups according to the difference between diameters of the device inserted and MPA (A: < 5-mm, B: ≥ 5-mm). Reducers were inserted successfully (n=30). One embolized after its insertion (Group 3A). A valved stent could be implanted in all animals but one which experienced a balloon ruptured during its inflation leading to incomplete expansion and death of the animal. Six animals had pulmonary regurgitation after valve insertion. Five of them (Group A, n=5; Group B, n=1) had downsizing of the reducer. Conclusion: Pulmonary valve insertion is possible through a transcatheter technique using a PA reducer. Oversizing of this device reduces the risk of embolisation and paraprosthetic leak.

Outcome and right ventricle remodelling after valve replacement for pulmonic stenosis

Heart ◽  
2021 ◽  
pp. heartjnl-2021-320121
Author(s):  
Emilie Laflamme ◽  
Rachel M Wald ◽  
S Lucy Roche ◽  
Candice K Silversides ◽  
Sara A Thorne ◽  
...  
Keyword(s):  
Right Ventricle ◽  
Valve Replacement ◽  
Pulmonary Valve ◽  
Pulmonary Regurgitation ◽  
Right Ventricular Outflow Tract ◽  
Ventricular Outflow Tract ◽  
Cardiovascular Death ◽  
Older Age ◽  
Supraventricular Arrhythmia ◽  
Systolic Volume

BackgroundComplications and need for reinterventions are frequent in patients with pulmonary valve stenosis (PVS). Pulmonary regurgitation is common, but no data are available on outcome after pulmonary valve replacement (PVR).MethodsWe performed a retrospective analysis of 215 patients with PVS who underwent surgical valvotomy or balloon valvuloplasty. Incidence and predictors of reinterventions and complications were identified. Right ventricle (RV) remodelling after PVR was also assessed.ResultsAfter a median follow-up of 38.6 (30.9–49.4) years, 93% of the patients were asymptomatic. Thirty-nine patients (18%) had at least one PVR. Associated right ventricular outflow tract (RVOT) intervention and the presence of an associated defect were independent predictors of reintervention (OR: 4.1 (95% CI 1.5 to 10.8) and OR: 3.6 (95% CI 1.9 to 6.9), respectively). Cardiovascular death occurred in 2 patients, and 29 patients (14%) had supraventricular arrhythmia. Older age at the time of first intervention and the presence of an associated defect were independent predictors of complications (OR: 1.0 (95% CI 1.0 to 1.1) and OR: 2.1 (95% CI 1.1 to 4.2), respectively). In 16 patients, cardiac magnetic resonance before and after PVR was available. The optimal cut-off values for RV volume normalisation were 193 mL/m2 for RV end-diastolic volume indexed(sensitivity 80%, specificity 64%) and 100 mL/m2 for RV end-systolic volume indexed(sensitivity 80%, specificity 56%).ConclusionsPrevious RVOT intervention, presence of an associated defect and older age at the time of first repair were predictors of outcome. More data are needed to guide timing of PVR, and extrapolation of tetralogy of Fallot guidelines to this population is unlikely to be appropriate.

scholarly journals Tissue Valve Replacement for Severe Calcified Pulmonary Stenosis: First time in BSMMU

2014 ◽  
Vol 9 (1) ◽  
pp. 54-55
Author(s):  
Rezwanul Haque Bulbul ◽  
Omar Sadeque Khan ◽  
Mohammad Samir Azam Sunny ◽  
Swadesh Ranjan Sarker ◽  
Mostafa Nuruzzaman
Keyword(s):  
Valve Replacement ◽  
Pulmonary Valve ◽  
Pulmonary Stenosis ◽  
Pulmonary Regurgitation ◽  
Right Ventricular Outflow Tract ◽  
Ventricular Outflow Tract ◽  
Pulmonary Valve Replacement ◽  
Tissue Valve ◽  
Biventricular Failure ◽  
First Time

Pulmonary valve replacement for pulmonary regurgitation is a common practise. Pulmonary stenosis relief or after release of right ventricular outflow tract obstruction, progressive pulmonary regurgitation leading to biventricular failure is a big problem. If early pulmonary valve replacement done by homograft or tissue valve then we can overcome this problem. In our case report we have done pulmonary valve replacement by Edward life science Tissue valve for calcified pulmonary valve. And our patient showed a good response after valve replacement. DOI: http://dx.doi.org/10.3329/uhj.v9i1.19514 University Heart Journal Vol. 9, No. 1, January 2013; 54-55

Abstract 3083: Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients with Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: Procedural and 6-Month Results from the U.S. Feasibility Trial

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Doff B McElhinney ◽  
William E Hellenbrand ◽  
James E Lock ◽  
Thomas K Jones ◽  
John P Cheatham ◽  
...  
Keyword(s):  
Pulmonary Valve ◽  
Nyha Class ◽  
Right Ventricular Outflow Tract ◽  
Ventricular Outflow Tract ◽  
Class I ◽  
Feasibility Trial ◽  
Stent Fracture ◽  
Valve Placement ◽  
Procedural Success

RVOT conduit dysfunction can now be treated with transcatheter pulmonary valve placement (TPV). We report procedural and 6-mo outcomes of the prospective multicenter U.S. feasibility trial for TPV using the Melody valved stent. Outcomes included safety, procedural success and short-term effectiveness. Entry criteria included: weight ≥30 kg, RVOT conduit ≥16mm when implanted, and ≥moderate RVOT obstruction (RVOTO; mean gradient ≥40mmHg if NYHA class I, ≥35mmHg if higher) and/or regurgitation (PR; severe if class I, moderate if higher) by echo. Exercise testing, MRI, and chest CT were performed before catheterization (cath). The cath and TPV protocol was standardized, including high pressure balloon angioplasty when needed and balloon sizing of the conduit prior to TPV. In this 5-center study, 58 pts (median age 18 yrs) were enrolled and underwent cath from 1/07–5/08. The mean RVOT gradient on echo was 28±11mmHg and PR was severe or moderate in all but 5 pts. 5 pts were excluded at cath due to risk of coronary compression (2) or other predefined anatomic/hemodynamic factors (3). A Melody was implanted in the RVOT conduit in the other 53 pts. The peak RVOT gradient at cath was reduced from 36±16 to 15±7mmHg (p<0.001) and all pts had no/trivial PR. There were no deaths. In 1 pt, TPV was complicated by conduit rupture, which was managed surgically. Non-surgical complications included atrial tachycardia (1) and PA perforation by a guidewire (1). In 30 pts with 6-mo follow-up data, PR was none (29) or trivial (1) by echo, and mean RVOT gradient was 20±8mmHg, unchanged from discharge (19±8mmHg, p=0.9 by paired analysis). On 6-mo MRI (n=26), median PR fraction was 0%, down from 29% pre-TPV (p<0.001). 1 pt had a second Melody placed 3 mo after TPV for stent fracture and recurrent RVOTO. 8 other pts had stent fractures. There were no other adverse events through 6-mo follow-up, but 2 pts had a second Melody placed for stent fracture with RVOTO ~1 yr post-TPV. In this prospective multicenter study, TPV was safe and technically successful overall, with encouraging acute and 6-mo outcomes. Stent fracture with recurrent RVOTO, observed in ~10% of pts, may be overcome by pre-TPV RVOT angioplasty with or without stent implantation.

First experiences with Myval Transcatheter Heart Valve System in the treatment of severe pulmonary regurgitation in native right ventricular outflow tract and conduit dysfunction

2021 ◽  
pp. 1-7
Author(s):  
Ender Odemis ◽  
Irem Yenidogan
Keyword(s):  
Right Ventricular ◽  
Pulmonary Valve ◽  
Pulmonary Regurgitation ◽  
Right Ventricular Outflow Tract ◽  
Ventricular Outflow Tract ◽  
Outflow Tract ◽  
Valve System ◽  
Percutaneous Pulmonary Valve Implantation ◽  
Valve Implantation ◽  
Percutaneous Pulmonary Valve

Abstract The rate of morbidity and mortality related to pulmonary regurgitation and pulmonary stenosis are big concerns after the surgery for CHD. Percutaneous pulmonary valve implantation has been established as a less invasive technique compared to surgery with promising results according to long-term follow-up of the patients. There are only two approved valve options for percutaneous pulmonary valve implantation until now, which are Melody (Medtronic, Minneapolis, Minn, USA) and Sapien (Edwards Lifesciences, Irvine, Ca, USA). Both valves have limitations and do not cover entire patient population. Therefore, the cardiologists need more options to improve outcomes with fewer complications in a such promising area. Herein, we present a case series applying for pulmonary position in conduits and native right ventricular outflow tract of a new transcatheter valve system Myval ® which is designed for transcatheter aortic valve implantation procedures. This is the first patient series in which the use of Myvalv in dysfunctional right ventricular outflow tracts is described, after surgical repair of CHD.

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