Hotline 24/7: 0909384389

Share links:

Strong 10-year performance for Melody transcatheter pulmonary valve

Ngày 21/05/2020 08:47 | Lượt xem: 863

A late-breaking clinical trial presented at the virtual Society for Cardiovascular Angiography and Interventions (SCAI) 2020 Scientific Sessions (14–16 May, Eastern Time) demonstrated strong long-term haemodynamic and safety outcomes for the Melody transcatheter pulmonary valve (Medtronic). Additionally, results from a second late-breaking trial—for the investigational Harmony transcatheter pulmonary valve (also Medtronic)—met its safety and efficacy endpoints for haemodynamic function at six months

The Melody transcatheter pulmonary valve 10-year outcomes trial studied 150 implanted patients ranging from age 7–53, with a median age of 19, and the primary indication for intervention was pulmonary regurgitation. The study assessed Melody’s long-term functionality, or transcatheter pulmonary valve dysfunction, which is defined as reoperation, catheter reintervention, or haemodynamic dysfunction (i.e. moderate or greater pulmonary regurgitation and/or mean RVOT gradient >40mmHg). The study’s safety outcomes included serious device-related adverse events, stent fracture, catheter reintervention, surgical conduit replacement, and mortality rate.

The 10-year data highlights:

• The study demonstrated sustained long-term function of Melody transcatheter pulmonary valve when compared to the historical control of surgical conduit
• The Melody transcatheter pulmonary valve demonstrated consistent haemodynamics through 10 years as measured by stable RVOT gradients
• Strong valve efficacy with 97% none/trace/mild pulmonary regurgitation at 10 years
• Annualized incidence of TPV-related endocarditis was 2% per patient-year, over the course of long-term follow-up
• Freedom from major stent fracture 84% at 10 years, steady after five years
• Freedom from any reintervention (surgical or catheter) was 61% at 10 years.

Thomas K Jones (Seattle Children’s, Seattle, USA) says: “Having long-term data is an important milestone especially for this paediatric patient population who are growing and changing so rapidly during a 10-year period. While the study reinforces the longevity, durability, and efficacy of the Melody transcatheter pulmonary valve, it will also serve as a study model for future evaluations of novel paediatric congenital heart disease technologies.”

As part of the Medtronic congenital heart disease programme, a press release reports, the safety and effectiveness of the Harmony transcatheter pulmonary valve is currently being evaluated for patients with right ventricular outflow tract (RVOT) malformations who require a correction to their structural malformation early in life and need a minimally invasive option to restore pulmonary valve function, and are without a conduit. Data presented at SCAI 2020 show:

• The study met its primary safety and effectiveness endpoints of freedom from procedure or device-related mortality and met its haemodynamic function target at six months
• 100% of patients experienced freedom from procedure-or device related mortality at 30 days
• Acceptable haemodynamic function at six months was achieved in 89% of the pivotal trial participants. For the pre-specified primary endpoint analysis, 91% of patients from both the EFS and pivotal trial achieved acceptable hemodynamic function, surpassing the performance target of 75%
• 84% of patients were free from device failure at six months
• At six months, 94% of patients had no, or mild pulmonary regurgitation and 97% had no or mild paravalvular leak.

John P Cheatham (Nationwide Children’s Hospital, Columbus, Ohio, USA), lead principal investigator, comments: “These pivotal data support the rationale for a potential new therapy designed specifically for the right ventricular outflow tract. If future study data continue to be strong, we are hopeful that Harmony may potentially impact this critical, hard-to-treat segment of patients, who have limited treatment choices with current transcatheter technologies.”

Source CardiovascularNews

Duc Tin Clinic

Tin tức liên quan

Enrolment reaches midway point in trial of Early Bird bleed monitoring system

Eight-fold increased risk of heart attack seen in patients with subclinical obstructive coronary atherosclerosis

ACC 2023: REVIVED-BCIS-2 results challenge “long-held beliefs” on myocardial viability testing prior to PCI

Blood pressure successfully cut in RADIANCE II ultrasound renal denervation trial

New data examine mortality rates and cardiac damage in early-stage aortic stenosis patients

SUPPORT CONSULTANT

CUSTOMER REVIEWS

• I am Nguyen Thanh Sang, born in 1990. Since the examination and treatment at the clinic Duc Tin, I am very grateful to the Doctor for explaining and sharing about my illness. During the treatment time in the clinic I was very caring staff of the clinic. Now my illness has improved in a good way. Expect more and more clinic to be able to save many patients.

  I sincerely thank you !. Tel: 0938303275

• Huynh Thi Muoi, born in 1940, was examined and treated at Duc Tin Clinic. I am very pleased about how to serve and care patients of the clinic. The doctor is committed to explaining and sharing with the patient.

  Huynh Thi Muoi sincerely thank you! Phone number: 0972868746

• As I said Duc Tin surgical clinin is where my family trust, hope to visit. Physicians caring, thoughtful, gentle to the patient. Nurses and staff clinic polite, cheerful and thoughtful. This clinic clean, sterile, so I would love to. Tel: +84949914060.

• The doctor is very caring, attentive and very gentle nurse, courteous, affable with me. The clinic is clean, comfortable, polite. I enjoyed this faith. Every visit I was very relieved disease. Tel: 0839820792.

• I was patient, had to clinics of Dr. Le Duc Tin. I see very conscientious doctor patient care, answer any questions and very dedicated staff from the receptionist to the children tested, nursing. Clinics very clean and spacious. I'm very satisfied. Tel: +841227880829.

Search

News

Customer support