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
Up to 93% of PVL reduced
to moderate or less.2,4
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|
|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|
|Follow-up||90 d||6 mo, 1y||40 - 364 d;||3 mo||1y|
|Technical success (overall)||90.9%||93.9%||100%||100%||86%|
|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%|
|% 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|
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.
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MAT-2201630 v1.0 | Item approved for Global OUS use only.