Transcatheter pulmonary valve replacement confers favorable 1-year outcomes, 100% survival
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ATLANTA — A speaker reported 100% 1-year survival and high freedom from pulmonary regurgitation, stenosis and reintervention in patients who underwent transcatheter pulmonary valve replacement.
Presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions, the finding of the Harmony TPV clinical study indicated that transcatheter pulmonary valve (TPV) replacement using 22 mm and 25 mm valves (Harmony, Medtronic) reduced severe pulmonary regurgitation to none or trace regurgitation in approximately 92% of patients.
“As a pediatric cardiologist, we’ve sort of morphed into calling ourselves congenital cardiologists because we treat patients with congenital heart disease, whether they’re kids or adults,” Daniel S. Levi, MD, FSCAI, interventional pediatric cardiologist at Mattel Children’s Hospital at UCLA, said during a press conference. “One of the things that we’ve really needed, as a group of doctors that treats a relatively small market, is self-expanding valves that can act as pulmonary valve replacers for patients with large outflow tracts. Patients that we can’t just put a Melody or a Sapien valve in.”
The present analysis assessed the 1-year outcomes in patients who underwent TPV replacement to treat severe pulmonary regurgitation in the Harmony early feasibility, pivotal trial and continued access studies. The trials tested three self-expanding valves: a 22 mm diameter valve; a prototype 25 mm valve that was discontinued due to unpredictable deployment; and a modified 25 mm valve.
“The first iteration of the harmony valve is the TPV22 valve, which just like all the Harmony valves, has a nitinol frame covered in polyester with a porcine pericardial valve that was 22 mm. We quickly realized that this valve would not be able to treat a large majority of the patients that were just too big for it. This valve was a little too long and not quite fat enough,” Levi said during the press conference. “Now we have what's called the modified TPV25, which is the commercialized version. The modified TPV25 and the TPV22 valves are both FDA-approved.”
In the Harmony trials, 44 patients received the 22 mm self-expanding valve; 45 received the prototype 25 mm valve; and 19 received the modified 25 mm valve (mean age, 29 years; 38% women; median follow-up, 2.1 years).
Overall, 81.6% of the overall cohort had an original diagnosis of tetralogy of Fallot, and 96.3% were diagnosed with severe pulmonary regurgitation by echocardiography.
All patients who received the 22 mm and modified 25 mm valves were free from explant at 24 hours, while two prototype 25 mm valves were explanted.
Two 22 mm valves were also eventually explanted during longer follow-up.
Four reinterventions were conducted: two patients who received prototype 25 mm valves underwent right ventricular outflow tract (RVOT) stent placement and implantation of another TPV; and two patients who received modified 25 mm valves had another TPV valve implanted, one also underwent RVOT stent placement.
All patients were free from all-cause mortality, endocarditis and sustained ventricular tachycardia through 1 year.
At 1 year, approximately 92% of patients were free or had only trace pulmonary regurgitation, as confirmed by core lab echocardiogram, and 93% were free from paravalvular leak.
Mean RVOT gradient at 1 year was 13.6 mm Hg, compared with 8.8 mm Hg before implant.
The rate of freedom from all of severe pulmonary regurgitation, mean RVOT gradient more than 40 mm Hg, device-related RVOT reoperation and catheter reintervention were as follows:
- 95.1% of patients who received the 22 mm valve;
- 73.3% of patients who received the prototype 25 mm valve; and
- 89.7% of patients who received the modified 25 mm valve.
At 1 year, there was one case of major stent fracture, in a patient who received the 22 mm valve.
“I’m not going stand here and tell you this is favorable clinical data ... it speaks for itself. But it’s important that we continue to follow all these patients; it’s important for us to make sure that they’re not having long-term arrhythmias; the mortality is zero, which it needs to be. The valve leaflets themselves are performing well,” Levi said during the press conference. “There have been a couple of explants, but again, all of the explants were in the prototype valve. There has been one modified TPV25 valve that had significant stenosis, but that was re-valved and it didn’t need to be removed surgically. ... This is hopefully the first of many abstracts looking at this data and we will continue to follow these valves to 10 years.”
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Levi DS, et al. Featured Clinical Research: Part 1. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 19-22, 2022; Atlanta.
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