Late and early results in tune with Melody and Harmony transcatheter PVs

At SCAI 2020, researchers shared 10 years of data on a long-standing device and 6 months for a more recent arrival.

Two reports, covering two different pulmonary valves per catheter for separate but related indications, provide reassurance that an evolving field is heading in the right direction, with options extending to a wider population of patients with congenital heart disease .

Transcatheter pulmonary valves (TPV) placed in an existing dysfunctional right ventricular outlet (RVOT) or bioprosthetic pulmonary valve show good long-term results, according to the 10-year follow-up of the Experimental Device Exemption (IDE) Melody (Medtronic) test.

For the Harmony transcatheter pulmonary valve (Medtronic), 6-month data from the pivotal trial shows positive signs for a target that has proven to be more elusive: pulmonary regurgitation (RP) in patients who have undergone RVOT surgery for congenital heart disease but has not received a valve or prior conduit.

Both reports were published at the 2020 Virtual Meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).

Thomas K. Jones, MD (Seattle Children’s Hospital, WA), who presented the Melody IDE data, told TCTMD that in 2000, the device was the first transcatheter valve to be implanted in a human patient.

“One of the festive aspects of all of this is that [Melody] represents a new paradigm in cardiac treatment which has now [grown into] this explosive number of patients treated worldwide, in particular for aortic valve disease. But it all started with the congenital heart population in the treatment of pulmonary valve position, ”he commented. As such, “this is the first and only long-term study of catheter-based heart valves ever to be performed. Ten-year data is difficult to obtain, and forward-looking 10-year data is important. “

Christopher J. Petit, MD (Children’s Healthcare of Atlanta, GA), agreed that long-term follow-up is welcome. For clinicians who have implanted Melody valves over the years and have tracked their results, “there has always been a kind of understanding of how our patients are doing. But certainly overall to have this data and to have the entirety of all the initial 171 patients who were enrolled 10 years later, it’s very useful, ”he told TCTMD.

Melody IDE Trial

For the Melody IDE trial, researchers recruited 150 patients with a median age of 19 (47% were under 18). Half had originally been diagnosed with tetralogy of Fallot. Pulmonary insufficiency was the main indication for 53%, RVOT obstruction for 26% and a combination of the two for 21%.

By 10 years, 90% of these patients had survived. Most (73%) had no or traces of RP, while 25% and 3% had mild or moderate RP, respectively. An even higher percentage belonged to NYHA functional class I (78%), with 22% in class II. The absence of repeat surgery was 79% and the absence of reoperation by catheter was 72%.

The primary endpoint of the study was the absence of TPV dysfunction (reoperation, catheter reoperation, or hemodynamic dysfunction consisting of moderate or greater RA and / or mean RVOT gradient> 40 mm Hg). This was encountered by 54% of patients at 10 years.

“This compares quite favorably to experience with surgically implanted valves,” Jones said.

Older patients seem to do better, he said. Specifically, 65% of adults were free from TPV dysfunction at 10-year follow-up, compared to 47% of pediatric patients. This is because “they keep growing. So their somatic growth at some point exceeds the size of the valve they implanted, ”Jones said, adding that late endocarditis is also somewhat more common in children.

Overall, TPV-related endocarditis occurred in 19% of patients, representing an annualized event rate of 2% per patient-year. Major stent fractures increased only slightly between 5 and 10 years, from 15% to 16% of patients.

The Melody valve fulfills its design goal of extending the useful life of RVOT conduits and surgically implanted bioprosthetic valves and reducing the lifelong burden of repeat open heart operations, ”Jones concluded in his SCAI presentation.

Melody’s use has not been static – as therapy has matured over the decade, the need to introduce yourself has become better known, Jones told TCTMD. It has also become used in valve-in-valve interventions for tricuspid or mitral disease. And finally, he added, operators can use a hybrid surgical approach or, more rarely, surgical implantation to now allow even younger children to receive a Melody device.

Going forward, Medtronic is developing a next-generation balloon-expandable bioprosthetic TPV that will be available in larger sizes than Melody, which has an internal diameter of 20 or 22mm, he said.

“The big takeaways,” said Petit, “are that there’s a pretty decent reoperation rate at 10 years.” For patients under 22 years of age, 52% had not undergone reoperation; for patients 22 years of age or older, this rate was 74%. “And it’s not surprising,” he said, observing that stenosis and other issues can arise. Another key finding, Petit continued, is that the risk of endocarditis is not only “early, but constant.” And it is stable throughout these 10 years.

Harmony pivot test

John P. Cheatham, MD (Nationwide Children’s Hospital Heart Center, Phoenix, AZ), who presented the results of the pivotal Harmony trial, explained that among patients who initially undergo RVOT surgery, 75% do not receive a conduit. or bioprosthetic valve in time. These are the people who, as they develop PR over the years, are Harmony’s intended recipients. “It’s a larger population base that has this particular condition,” he said.

But what’s been difficult, Cheatham told TCTMD, is being able to design a TPV that can handle the anatomical variations between patients – resulting from the different RVOT surgeries they had at a young age and how they healed – as well as the dynamic shape and movement of the right ventricle. The first iteration of Harmony was implanted in a patient in 2009; since then, however, its design has evolved in order to meet these “engineering challenges,” Cheatham said.

In their pivotal trial, Cheatham et al include data on three Harmony generations: the initial 22mm valve used in an early feasibility study; a later 25mm version which is shorter in length, has larger diameters on its inlet and outlet ends, and is designed to treat a wider range of patients; and the most recent 25mm version which has been modified to make stakeout more predictable.

“Severe RP after surgical correction of RVOT abnormalities remains an important hemodynamic abnormality and a challenge to correct using transcatheter technologies,” Cheatham told viewers at SCAI.

Six-month data is available for 38 patients (of the original 40) given the first two Harmony models, and 1-month data is available for 10 who received the last model.

Of the total 50 patients (median age 28 years, 38% female), 92% were initially diagnosed with tetralogy of Fallot, 6% with pulmonary stenosis, and 2% with pulmonary atresia with intact ventricular septum. Pulmonary regurgitation was severe for 94% and moderate for 6%.

At 30 days, the primary safety endpoint for freedom from procedure or device-related mortality was 100%. Efficacy was defined as the absence of valve interventions plus an average RVOT gradient ≤ 40 mm Hg and a PR

The most common adverse events were ventricular tachycardia (18%), minor paravalvular leakage (10%), minor hemorrhage (10%), and premature ventricular beats (8%).

“We are very satisfied with the results so far. It certainly hit its safety rating and the effectiveness it needed to achieve, ”Cheatham told TCTMD. This Harmony data is currently being submitted to the United States Food and Drug Administration for pre-market approval, he said. A continuous access study on the 22 mm and more recent 25 mm versions is in progress.

Currently, the only two TPVs approved by the FDA are Melody and Sapien XT (Edwards Lifesciences).


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Medtronic’s Melody and Harmony Transcatheter Lung Valves Show Gains in Congenital Heart Disease

Medtronic provided new data from two clinical trials evaluating the long-term safety and short-term performance of its pulmonary valve catheter replacement therapies for children with congenital heart disease.

Presented virtually as late-breaking studies at the Society for Cardiovascular Angiography and Interventions Scientific Session, 10-year data showed sustained function and stable hemodynamics with the company’s Melody valve compared to a group historical witness using a surgically implanted conduit. In addition, 97% of patients experienced mild, trace or no pulmonary regurgitation after a decade.

“Having long-term data is an important step, especially for this pediatric patient population that grows and changes so rapidly over a 10-year period,” said Thomas Jones, director of cardiac catheterization at Seattle Children’s, in a statement.

According to Medtronic, congenital heart disease is the most common type of birth defect in the United States, affecting approximately 40,000 infants each year. About 22% have structural defects in the part of the right ventricle that helps connect the heart to the lungs, and typically undergo open heart surgery to help increase blood flow.

Many patients can have a tube implanted early in life, but once that conduit is no longer functional, the Melody Transcatheter Valve is designed as a method to help delay further procedures. In the 10-year study, 61% of implanted patients did not require additional surgery or reoperation through a catheter.

RELATED: FDA Approves Medtronic Transcatheter Valve to Treat Patients With Congenital Heart Disease

Meanwhile, a new study of Medtronic’s experimental Harmony valve, designed for patients who have received a transannular patch, with significantly deformed parts of their right ventricle, has met its criteria for safety and efficacy at six months.

The 50 treated patients experienced no procedure- or device-related mortality after one month, with acceptable hemodynamic function at six months maintained in 89% of participants. At the same time, 94% of patients had mild or no pulmonary regurgitation, while 97% had mild or no paravalvular leakage.

“These crucial data support the rationale for a potential new therapy designed specifically for the right ventricular outflow pathway,” said principal investigator John Cheatham, professor emeritus of pediatric cardiology at Nationwide Children’s Hospital. “If the data from future studies continues to be strong, we hope that Harmony has the potential to impact this critical and difficult-to-treat segment of patients, who have limited treatment choices with current transcatheter technologies. .


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Medtronic touts positive results from Melody and Harmony POS

Medtronic (NYSE: MDT) today announced the results of two successful clinical trials for its transcatheter pulmonary valve (TPV) therapies Melody and Harmony.

The Fridley, Minnesota-based medical tech giant virtually presented its 10-year results at the 2020 Society for Cardiovascular Angiography & Interventions (SCAI) science sessions. Melody demonstrated strong hemodynamic and long-term safety results, while the pivotal investigational Harmony TPV trial met the safety and efficacy endpoints for hemodynamic function at six months, according to a release from hurry.

Melody TPV has demonstrated constant hemodynamics for 10 years with high valve efficiency with 97% pulmonary failure / trace / mild pulmonary regurgitation. The annualized incidence of TPV-related endocarditis was 2% per patient-year, while no major stent fracture was 84% ​​at 10 years and no reoperation was 61%.

This study included 150 implanted patients aged 7 to 53 years, with a median age of 19 years and the main indication for intervention being pulmonary regurgitation.

Medtronic is promoting the Melody Transcatheter Valve as the first of its kind to be implanted in humans anywhere in the world and to achieve FDA approval. In 2017, it won an expanded indication for implantation in patients with failed surgical bioprosthetic pulmonary heart valves, making it the first TPV to achieve this indication.

“Having long-term data is an important step, especially for this pediatric patient population that grows and changes so rapidly over a ten-year period,” said Seattle Children’s director of cardiac catheterization. , Dr. Thomas Jones. “Although the study enhances the longevity, durability and efficacy of Melody TPV, it will also serve as a study model for future evaluations of new pediatric congenital heart disease technologies. “

Harmony TPV results revealed that 100% of patients experienced no procedure or device-related mortality at 30 days and that acceptable hemodynamic function at six months was observed in 89% of participants in the test, exceeding the performance target by 75%.

At six months, 94% of patients had no or mild pulmonary regurgitation and 97% had no or slight paravalvular leakage, the statement said.

The trial included 50 patients at 12 sites in the United States, Canada and Japan. Harmony TPV is designed for patients with right ventricular outflow tract (RVOT) abnormalities who develop severe pulmonary regurgitation when a previous repair fails. It is not yet approved for anything other than experimental use in the United States.

“As these latest studies show, we are constantly building our body of new, short and long term research around innovative and minimally invasive TPV solutions for patients with coronary artery disease,” said Sandra Lesenfants, Vice President and Director General of the Structural Heart Division of Medtronic. said in the press release. “This Harmony data demonstrates our commitment to generating new therapies and expanding our Congenital Heart Disease program to support a lifetime of care this patient population needs. “


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Melody Investment Advisors acquires Uniti wireless towers

NEW YORK, May 11, 2020 / PRNewswire / – Melody Investment Advisors (“Melody”), an alternative asset manager focused on communications infrastructure, today announced the acquisition of 90% of Uniti Towers, the wireless tower business of Uniti Group Real Estate Investment Trust Inc. (“Uniti”) (NASDAQ: UNIT). Purchase totals approximately $ 220 million in cash and includes over 500 US-based tours. Melody Investment Advisors will finance the purchase from Melody Communications Infrastructure Fund II.

Through an investment in a subsidiary of Melody, Uniti will retain a 10% stake in the tower business and will receive an additional earn-out from Melody for each additional pipeline tower completed in 2020. Additionally, as part of the transaction , Melody and Uniti will establish a strategic relationship to collaborate on integrated solutions for wireless operators requiring tower, fiber optic and small cell infrastructure. The transaction is subject to various closing conditions and is expected to be finalized by the end of the second quarter of 2020.

The acquisition strengthens Melody’s position as the primary owner and operator of wireless infrastructure assets. With the addition of the Uniti towers, Melody and its affiliates now own and market more than 4,000 towers, land leases, and structural and roof leases, including pipeline sites. Melody and its affiliates are one of the top five independent owners of national wireless infrastructure assets and one of the largest private telecommunications owners in the United States.

“As the transition to 5G continues, communications infrastructure is one of the most dynamic, stable and critical segments of the economy. We are delighted with the addition of these tours to our expanding portfolio and the benefits they will bring to our operating partners. and to our investors ”, declared Omar Jaffrey, Managing Partner and Founder of Melody Investment Advisors. “We look forward to working with Uniti as we continue to grow and invest in our wireless infrastructure platform while seeking further growth through acquisitions. ”

“We are delighted to continue to grow our portfolio of assets,” said Chester dawes, COO and CFO of Melody Investment Advisors. “We are well funded and positioned to capitalize on other tower construction, acquisitions and financing solutions in our sectors.”

Melody Investment Advisors focuses on communications infrastructure transactions ranging from $ 50 million To $ 1 billion or more. Melody’s investment objective includes telecommunications easements, wireless towers, data centers, fiber optics and other critical elements of the communications infrastructure.

About Melody Investment Advisors
Melody Investment Advisors is an alternative asset manager specializing in communication infrastructures. The company invests directly in assets and also seeks to provide innovative financing solutions to complex problems for the world’s leading communications companies. With its subsidiaries, the Melody team has deployed over more than $ 1 billion capital in this sector over the past six years. To learn more about Melody Investment Advisors, visit https://www.melodyinvestmentadvisors.com/

About Uniti
Uniti, an internally managed real estate investment trust, is engaged in the acquisition and construction of critical communications infrastructure and is a leading provider of wireless infrastructure solutions for the communications industry. From March 31, 2020, Uniti has 6.3 million kilometers of fiber optics, approximately 700 wireless towers and other communications real estate across United States. Additional information about Uniti is available on its website at www.uniti.com.

SOURCE Melody Investment Advisors

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