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.
NEW VERSION AVAILABLE
GET THE AMPLATZER PORTFOLIO APP
The Amplatzer Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.
MAT-2201630 v1.0 | Item approved for Global OUS use only.