Amplatzer™ Valvular Plug III CLINICAL DATA
Paravalvular leaks (PVLs) are a common and challenging problem around the world.1 The Amplatzer™ Valvular Plug III is specially designed to provide an effective solution to this key issue, improving quality of life and longevity for an increasing number of patients.2-5
CLINICALLY PROVEN OUTCOMES
Clinical studies continue to show that the Amplatzer™ Valvular Plug III, formerly known as AVP III, is a highly effective solution in closing PVL near mechanical surgical valves.1-3
93%
Up to 93% of PVL reduced
to moderate or less.2,4
90%
Up to 90% of patients report one-class NYHA classification improvement.1,2,5,6
A SOLUTION THAT HAS RECEIVED CLOSE ATTENTION2,4,7-9— AND STRONGLY POSITIVE REVIEWS.10
OVERALL - Mitral and Aortic | Cruz-Gonzales 2014 | Smolka 2016 | Davidavicius 2014 | Swaans 2021 | Werner 2018 | |
---|---|---|---|---|---|---|
Number of patients (number of PVL) | 33 (34) | 49 (49) | 7 (9) | 7 (7) | 10 (17) | |
Mitral/ Aortic PVL | 27 / 7 | 29 / 20 | 9 / 0 | 6 / 1 | 12/ 5 | |
Mechanical/ Tissue | 32 / 1 | 30 / 19 | 4 / 3 | 4 / 3 | 4 / 6 | |
Indication for PVL (% patients (N)) | Heart failure | 21.2% (7) | 89.8% (44) | 57.1% (4); | 14.2% (1) | 50% (5) |
Hemolytic anemia | 3% (1) | 0%* | 0% | 42.9% (3) | 0% | |
Both | 75.7% (25) | 10.2% | 42.9% (3) | 42.9% (3) | 50% (5) | |
Access (TA:transapical, TS: transseptal, TF: transfemoral) | Mitral: TF, TS Aortic: TF | Mitral: TS,TA Aortic: TF | Mitral: TA Aortic: n/a | Mitral: TA Aortic: TA | Mitral: TS,TA Aortic: TF | |
Follow-up | 90 d | 6 mo, 1y | 40 - 364 d; | 3 mo | 1y | |
COMPOSITE ENDPOINT | ||||||
Technical success (overall) | 90.9% | 93.9% | 100% | 100% | 86% | |
Mitral | 92.3% | 89.7% | 100% | 100% | NR | |
Aortic | 100% | 100% | n/a | 100% | NR | |
SAFETY ENDPOINTS | ||||||
Survival | Intra-procedural | 100% | 100% | 100% | 100% | 100% |
30 d | 100% | 98% | 100% | 100% | 80% | |
Follow-up | 100% | 95.9% | 85.7% | 85.7% | 70% | |
Stroke (30 d) | 0 | 2% | NR | 0 | 0 | |
Conversion to surgery | 6% | NR | 0 | 14.2% | 0 | |
Bleeding/ vascular complications | 12% | 2% | 28.6% | 14.2% | 20% | |
EFFECTIVENESS ENDPOINTS | ||||||
% patients with absent to moderate PVL regurgitation | 100% | 93.8% | 100% | 100% | NR | |
% patients with reduction in NYHA class | 90.3% | 90.5% | 85.7% | 71.4% | NR | |
Hemolysis | Improved | Improved | Improved | NS | NR |
NR: Data not reported in the article. NS: Not significant. n/a: Not applicable.
Range instead of total was provided for follow-up > 30d as the follow-up durations differ greatly between studies.
Results from clinical studies are not directly comparable. Information provided for educational purposes only.
*In Smolka 2016, small PVL causing significant hemolysis but no heart failure symptoms were an exclusion criteria; therefore, patients with hemolytic anemia only were not included. Total percentages may underrepresent the actual population with hemolytic anemia only and overrepresent the population with heart failure only.
MAT-2201630 v1.0 | Item approved for Global OUS use only.