LONDON, UK — New results from high-risk patients treated with the Lotus transcatheter aortic valve (Boston Scientific) outside of North America support the positive early results from this so-called "second-generation," fully retrievable and repositionable transcatheter device, investigators report.
The new data come as the first aortic-valve-stenosis patients are being treated with the Lotus in the US, where the trial needed prior to FDA approval of the device, REPRISE III , is now getting under way.
Thirty-day results for REPRISE II (the "primary device performance end point") were reported at TCT 2013 in San Francisco, as reported by heartwire .
REPRISE II: 12 Months
Earlier this month, at TCT 2014 , Dr Ian Meredith (Monash University, Melbourne, Australia) presented 12-month results for REPRISE II, the 120-patient trial conducted at centers in Europe and Australia to support CE Mark approval in Europe. CE Mark was granted in October 2013.
The new 12-month results show low rates of all-cause death (10.9%), cardiovascular death (6.7%), disabling stroke (3.4%), and nondisabling stroke (5.9%). Also of note, paravalvular regurgitation was very uncommon, with no moderate or severe paravalvular leak and trace or mild regurgitation seen in just 13.7% of treated patients.
Patients who had baseline STS scores of 8% or higher or were deemed at high surgical risk due to frailty or other comorbidities also demonstrated significant improvements in NYHA heart-failure class from baseline over the 12-month follow-up.
Extension Data from REPRISE II
Meredith also had new data for the PCR London Valves 2014 meeting, which wraps up today in the UK. This time it was 30-day results from a preplanned "extension" to the original REPRISE II cohort, made up of an additional 130 patients.
In the preplanned pooled analysis of all 250 patients (extension group combined with the original 120 patients in REPRISE II), investigators say the 30-day results echo those of the initial REPRISE II patients in terms of both echocardiographic parameters and clinical events.
Of note, device deployment was successful in all but two patients, both of whom experienced intraprocedural complications. In all of the 85 patients in whom it was attempted, valve repositioning was successful. Valve retrieval was successful in all but one of the 13 patients in whom this was attempted. In the single case designated as unsuccessful, retraction of the valve into the sheath was incomplete but it was successfully removed. This patient was successfully treated with the Lotus valve 42 days later.
In all, 11 of 249 patients died in the first 30 days (one patient withdrew consent).
Next Steps
All eyes following the progress of this transcatheter device can turn next to the RESPOND registry, the European postmarket study designed as a 1000-patient, single-arm study evaluating 30-day and one-year mortality among patients treated with the 23-mm, 25-mm, and 27-mm sizes. Of note, REPRISE II included only the 23- and 27-mm devices, something Meredith has previously described as a key shortcoming of the trial, since it left physicians with such limited options for correctly sizing the device.
Meanwhile, REPRISE III, in the US, which will also use the same three valve sizes as RESPOND, is an open-label, randomized comparison between Lotus and CoreValve (Medtronic), with a primary safety end point of 30 days and a primary effectiveness end point of one year.
Meredith disclosed "significant" consultant fees/honoraria/speaker's bureau payments from Boston Scientific.
Heartwire from Medscape © 2014 Medscape, LLC
Cite this: New Lotus TAVR Data Positive in Europe as US REPRISE III Launches - Medscape - Sep 30, 2014.
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