Valve Tech Roundup – Transcath heart valves getting safer, seeing expanded use
Abbott (NYSE:ABT) today released 30-day data from a study of its Portico transcatheter aortic valve replacement, touting excellent clinical outcomes and low rates of death, disabling stroke and paravalvular leak.
The real-world, multicenter, prospective, single-arm Portico I study aimed to explore the safety and efficacy of the Portico valve with independent adjudication of clinical events and independent echocardiography core-lab analysis.
Investigators in the study will follow patients through to five years in a real-world setting after their treatment with the Portico, Abbott said.
“Patients with severe aortic stenosis require timely treatment to reduce symptoms and improve clinical outcomes and quality of life. These new data reinforce that treatment with the Portico valve is safe in a real-world setting – with robust clinical results – and confirm that Portico is an excellent solution for patients at increased risk for surgery,” principal investigator Dr. Francesco Maisano of Zürich, Switzerland’s Universitäts Spital said in a prepared statement.
A total of 941 patients have been treated so far in the trial at 61 centers across the EU, Canada and Australia.
At 30 days post-implant, patients showed “excellent hemodynamic performance” of 8.6 mm Hg and an effective orifice area of 1.8 cm2. A total of 96.2% of patients experienced none-to-mild paravalvular leak, with the percentage of patients in NYHA class III/IV dropping from 64% to 13.1%. Mean improvements on the six-minute walk test were reported at 26 meters, and no severe aortic regurgitation or leaks were reported.
“When developing the Portico valve, our goal was to provide physicians with new offerings that would improve deliverability, placement accuracy and performance when replacing a diseased or damaged aortic heart valve using a minimally invasive therapy. The findings of the Portico I real-world study corroborate those from our previous clinical trials, which showed that Portico is a life-saving valve that improves quality of life and helps patients resume their day-to-day activities,” Abbott structural heart biz VP Michael Dale said in a press release.
Edwards Lifesciences (NYSE:EW) today released 30-day data from a registry study of its Sapien 3 valve in intermediate-risk patients, touting positive patient outcomes and consistent results with previous trials of the device.
The study examined outcomes from 1,956 intermediate-risk patients that were part of the STS/ACC TVT registry as compared to 652 patients in the Partner II S3i study and 652 patients in the Sapien 3 intermediate-risk continued access program at 30 days, Edwards said. All patients in the trial were treated through a transfemoral access procedure, the company added.
Rates of all-cause mortality across the S3i, S3iCAP and TVT Registry IR trials were 0.9%, 0.9% and 0.8%, respectively, while rates of all stroke were 2%, 2.3% and 2.2%, respectively. Data from the TVT Registry also showed a low rate of moderate to severe paravalvulare leak and a two-day average length of stay.
“We are very pleased that, as the Sapien 3 valve therapy was introduced and utilized by a broader number of U.S. clinicians in a real-world environment, the excellent patient outcomes reported from earlier clinical trials were preserved. Even as more hospitals offered transcatheter aortic valve replacement with the Sapien 3 valve, the procedure was generalizable and effective. These registry data are an important indication that, moving from a rigorously controlled environment of a clinical trial, to continued access and then to a commercial environment, positive patient results can be maintained when hospitals offer broader access to patients in need,” Edwards transcath heart valves corp VP Larry Wood said in a prepared statement.
“These data comparing real-world outcomes with clinical study results in intermediate-risk patients treated with the Edwards Sapien 3 transcatheter heart valve demonstrated comparably positive outcomes including high survival rates and low rates of stroke,” Dr. E. Tuzcu of the Cleveland Clinic Abu Dhabi said in a press release.
Medtronic (NYSE:MDT) today presented one-year outcomes from a registry study of its Evolut R transcatheter aortic valve replacement system in the global real-world patient population, touting excellent hemodynamic performance and low rates of disabling stroke.
In the study, investigators examined data from more than 1,000 patients selected based on advanced age and heart team assessment and treated at 53 sites across 20 countries.
Results from the trial indicated an 8.9% rate of all-cause mortality and a 2.1% rate of disabling stroke at one year. Cardiovascular mortality was reported at 6.9% at one year, with the rate of all stroke at 3.4%.
There were no reported cases of severe paravalvular leakage, with a 1.2% rate of moderate PVL and 21.1% rate of mild PVL.
The company also reported sustained positive hemodynamic performance with 1.9 cm2 EOAs and a mean gradient of 8.1 mmHg. Rates of pacemaker implantation post-procedure were 19.7% at one year, Medtronic reported.