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Medium term follow-up after percutaneous pulmonary valve replacement with the Melody® valve.

ABSTRACT: Data on long term function of the Melody valve are scarce. Patients and methods: single institution; results of percutaneous pulmonary valve implantation (PPVI) from 2006 to 2014. The function of the valved conduit was analyzed by Doppler echocardiography. Annual Chest X-ray after implant and permanent screening for events (e.g. Endocarditis).112 Melody valves were implanted in 111 patients; mean age 19.3 years (4.5-81.6). No pre-stenting of the RVOT was performed (n = 4) at first. In the next 107 patients pre-stenting was always performed. In 82 patients 1 pre-stent, 18 patients 2, in 6 patients 3 stents and 1 patient 4 stents were used. The Melody stent was dilated up to 24 mm (n = 4), 22 mm (n = 72), 20 mm (n = 28) and 18 mm (n = 6). When stenotic, the Doppler gradient reduced from 67.0 mm Hg (SD 13.9) to 18.9 mm Hg (SD 10.4) (p < 0.001); pulmonary regurgitation (PR) was reduced from median 3.5/4 (range 0-4/4) to none or trivial (p < 0.001). There was no significant change in RVOT peak velocity at 5 years (p = 0.122) nor PR (p = 0.835). Type 1 stent fractures were observed in 1/4 non-pre-stented patients and in 5/107 pre-stented (p < 0.05). Endocarditis occurred in 8/112 valves; freedom of endocarditis was 85% at 5 years. In 2 patients early surgical replacement was necessary. Six were sterilized with antibiotic treatment; 2 patients required re-stenting and re-PPVI due to residual gradient.Adequate pre-stenting of the RVOT before PPVI nearly abolishes or delays stent fracture. Cusp function is well preserved in mid-term follow-up; endocarditis is a threat.

SUBMITTER: Cools B

PROVIDER: S-EPMC5497227 | biostudies-other | 2015 Jun

REPOSITORIES: biostudies-other

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Project description:BackgroundTranscatheter pulmonary valve placement is an emerging therapy for pulmonary regurgitation and right ventricular outflow tract obstruction in selected patients. The Melody valve was recently approved in the United States for placement in dysfunctional right ventricular outflow tract conduits.Methods and resultsFrom January 2007 to August 2009, 136 patients (median age, 19 years) underwent catheterization for intended Melody valve implantation at 5 centers. Implantation was attempted in 124 patients; in the other 12, transcatheter pulmonary valve placement was not attempted because of the risk of coronary artery compression (n=6) or other clinical or protocol contraindications. There was 1 death from intracranial hemorrhage after coronary artery dissection, and 1 valve was explanted after conduit rupture. The median peak right ventricular outflow tract gradient was 37 mm Hg before implantation and 12 mm Hg immediately after implantation. Before implantation, pulmonary regurgitation was moderate or severe in 92 patients (81% with data); no patient had more than mild pulmonary regurgitation early after implantation or during follow-up (>or=1 year in 65 patients). Freedom from diagnosis of stent fracture was 77.8+/-4.3% at 14 months. Freedom from Melody valve dysfunction or reintervention was 93.5+/-2.4% at 1 year. A higher right ventricular outflow tract gradient at discharge (P=0.003) and younger age (P=0.01) were associated with shorter freedom from dysfunction.ConclusionsIn this updated report from the multicenter US Melody valve trial, we demonstrated an ongoing high rate of procedural success and encouraging short-term valve function. All reinterventions in this series were for right ventricular outflow tract obstruction, highlighting the importance of patient selection, adequate relief of obstruction, and measures to prevent and manage stent fracture. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00740870.

Project description:BackgroundIn China, where Rheumatic heart disease is still prevalent, two thirds of valve replacements are in mitral position. Before a valve replacement operation is conducted, most patients have reached Class III/IV heart function under the New York Heart Association (NYHA) classification system. As the background to this disease is quite different to that of degenerated cases, which are more prevalent in Western countries, the development of an artificial heart valve that is suitable for local patients is very significant for China. In this medium long-term clinical follow-up study, a data analysis was conducted of domestic heart valve production for mitral replacement.MethodsA total of 288 patients who underwent mitral valve replacements from 2005 to 2015 at 2 cardiac surgery centres (i.e., The Affiliated Hospital of Qingdao University, and The First People's Hospital of Yulin) were evaluated. All implanted bioprostheses were BalMedic® bovine pericardial bioprosthetic valves, which had been granted marketing approval by the China Food and Drug Administration (CFDA) in 2003. Double valve cases that involved both aortic and mitral replacements were not included in the study. On average, patients were aged 54.5±10.8 (range, 11 to 77 years) before the procedure. The mean follow-up period was 7.2±2.6 years. The study examined the overall survival (OS) curve, and different age group results. To gain further insights into the functions of the valves, the OS curve and the age group results for the reoperation-free and structural valve deterioration (SVD)-free rates are also presented.ResultsThe 10-year OS rate was 65.6%, the 10-year reoperation-free rate was 76.3%, and the 10-year SVD-free rate was 58.0%. In relation to the age group results, younger patients had higher survival rates, while older patients had higher reoperation-free rates and SVD-free rates.ConclusionsIn relation to the medium long-term clinical follow-up results, the durability performance of the BalMedic® bovine pericardial valve in the mitral position was satisfactory, especially among patients whose heart function was worse than that of Western sufferers. Survival rate, reoperation-free rate and SVD-free rate were used for the comprehensive analysis.

Project description:BackgroundFunctional mitral regurgitation (FMR) is a bad prognosis condition despite optimal medical treatment. Nowadays there is an open debate about the surgical versus percutaneous treatment. The main objective of this study is to evaluate the mid-term follow up clinical outcomes of patients with FMR treated with MitraClip® system, according to their left ventricular ejection fraction (LVEF).MethodsData was obtained from two experienced centers in transcatheter mitral valve repair (TMVR). All consecutive cases of severe FMR undergoing TMVR in both centers with the same inclusion criteria were included prospectively in this study and followed-up. Periodical follow-ups with clinical and echocardiographic evaluation were scheduled from the baseline procedure, at 3 months and then yearly.ResultsFrom October 2015 to October 2019, a total of 119 patients with FMR at 2 centers in Spain underwent TMVR with the MitraClip® procedure and were included in this study. The mean age was 73.8±8.9 years old and 32 patients (26.9%) were female. A 39.5% of cases [47] had a LVEF ≤30% (group 1) and 60.5% (72 cases) had a LVEF >30% (group 2). There was a similar distribution in cardiovascular risk factors, age and other diseases. All MitraClip® implantations were elective and procedural success was achieved in 110 patients (92.4%) with a similar distribution between the groups. There were no differences in procedural time and the number of implanted clips. The median follow-up was 22.6 months (IQR, 11.43-34.98 months). The primary combined endpoint occurred in the 41.6% of the global cohort, 57.5% in group 1 and 30.99% in group 2 (P=0.036). LVEF was associated to the main event in the multivariate analysis (HR 2.09, 95% CI: 1.12-3.89; P=0.02).ConclusionsThe MitraClip edge-to-edge technique is a safe and effective procedure for the treatment of FMR. In this study, patients with LVEF >30% treated with Mitraclip presented better clinical cardiovascular outcomes than those with a LVEF ≤30%. Regardless clinical outcomes, at the end of the follow-up, there was a sustained reduction in MR grades and an important improvement in NYHA functional class.

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Medium term follow-up after percutaneous pulmonary valve replacement with the Melody® valve.

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