STRUCTURAL INTERVENTIONS

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 AorticCruz-Gonzales 2014Smolka 2016Davidavicius 2014Swaans 2021Werner 2018
Number of patients (number of PVL)33
(34)
49
(49)
7
(9)
7
(7)
10
(17)
Mitral/ Aortic PVL27 / 729 / 209 / 06 / 112/ 5
Mechanical/ Tissue32 / 130 / 194 / 34 / 34 / 6
Indication for PVL (% patients (N))Heart failure21.2% (7)89.8% (44)57.1% (4);14.2% (1)50% (5)
Hemolytic anemia3% (1)0%*0%42.9% (3)0%
Both75.7% (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-up90 d6 mo, 1y40 - 364 d;3 mo1y
COMPOSITE ENDPOINT
Technical success (overall)90.9%93.9%100%100%86%
Mitral92.3%89.7%100%100%NR
Aortic100%100%n/a100%NR
SAFETY ENDPOINTS
SurvivalIntra-procedural100%100%100%100%100%
30 d100%98%100%100%80%
Follow-up100%95.9%85.7%85.7%70%
Stroke (30 d)02%NR00
Conversion to surgery6%NR014.2%0
Bleeding/ vascular complications12%2%28.6%14.2%20%
EFFECTIVENESS ENDPOINTS
% patients with absent to moderate PVL regurgitation100%93.8%100%100%NR
% patients with reduction in NYHA class90.3%90.5%85.7%71.4%NR
HemolysisImprovedImprovedImprovedNSNR

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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