Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w
Plug-Based versus Suture-Based Vascular Closure Device after Transfemoral Transcatheter Aortic Valve Implantation: A Randomized Controlled Trial
K. Kneizeh1, A. Milzi2, F. Vogt2, K. Witte2, N. Marx2, M. Lehrke2, J. Schröder2, für die Studiengruppe: TAVI Aachen
1MED1, Uniklinik RWTH Aachen, Aachen; 2Med. Klinik I - Kardiologie, Angiologie und Internistische Intensivmedizin, Uniklinik RWTH Aachen, Aachen;

Objectives : 

Our study sought to evaluate the efficacy and safety of collagen-plug-based MANTA as compared to suture-based Prostar XL as widely used vascular closure devices (VCD) during TF-TAVI.

Background: 

Large-bore access-related complications are associated with worse outcome of TF-TAVI. Thus, the use of VCDs plays a central role. However, there is still no consensus when or whether to use a suture-based or a collagen-plug-based VCD.
Methods : 
In this randomized controlled single-center trial patients undergoing TF-TAVI were randomized to either a collagen-plug-based VCD via MANTA (Teleflex,PA,USA) or a suture-based closure using Prostar XL (Abbott,CA,USA). The primary endpoint combined major vascular complications, life-threatening and major bleeding. Secondary endpoints consisted mainly of device failure, hemostasis in angiogram, preparation time and the need for rescue stent-graft implantation or surgery. Access-site related complication were assessed strictly according to the Valve Academic Research Consortium-2 definitions. 

Results : 

A total of 250 patients eligible for TF-TAVI were included between January 2020 and March 2021. Mean age was 80 years. 50.4% were female. The frequency of major vascular complications was comparable for both techniques [5(3.9%) for MANTA vs. 4(3.2%) for Prostar XL;p=0.84]. Life-threatening and major bleedings were not significantly different between MANTA and Prostar [2(1.6%) vs. 0%;p=0.16 and 2(1.6)% vs. 5(4%); p=0.46)]. Device failure happened equally in both groups [6(4.8%) vs. 6(4.8%);p=0.99]. Furthermore, immediate hemostasis in angiogram occurred without a statistical difference between both VCDs [112(88%) vs. 110(90.3%);p=0.55]. However, the preparation time was significantly shorter in the plug-based group [(2.1±1.3) vs.(6.0±1.4) minutes;p=<0.001].  

Conclusions : 

Efficacy and safety of plug-based technique for large-bore percutaneous access-site closure are comparable to the those of suture-based closure. Plug-based closure required markedly a shorter time of preparation. 

Table 1 : Basic Characteristics 

 

MANTA

Prostar XL

p-value 

Age (yrs)

80.3±6.3

80.6±7.0

0.75

Male sex (n,%)

63(50.4)

59(48.0)

0.70

BMI (kg/m²)

27.3±5.6

26.8±4.3

0.44

T2DM (n,%)

48(38.4)

45(36.6)

0.76

Hypertension (n,%)

94(75.2)

93(75.6%)

0.94

GFR (ml/min/1.73 m²)

59.4±17.8

59.6±20.5

0.93

PAD (n,%)

18(14.6)

13(10.7)

0.34

STS (%)

3.8±3.1

3.7±3.4

0.96

Baseline Hb (g/dl)

12.2±1.8

12.4±1.7

0.50

Anticoagulation regime

 

 

 

ASS (n,%)

55(44.0)

56(46.3)

0.72

DAPT (n,%)

16(12.8)

19(15.7)

0.51

Anticoagulation (n,%)

16(12.8)

19(15.7)

0.55

Double therapy (n, %)

6(4.8)

9(7.4)

0.39

Anticoagulation + DAPT (n,%)

6(4.8)

4(3.3)

0.55
 

 

 

 

Calcification in CFA

 

 

0.70

  No calcification (n,%)

38(30.4)

30(24.2)

 

  0-30° (n,%)

59(47.2)

66(53.2)

 

  30-60° (n,%)

18(14.4)

19(15.3)

 

  >60° (n,%)

10(8.0)

9(7.3)

 

CFA diameter (mm)

8.0±1.1

7.9±1.3

0.42

SFAR

0.71±0.10

0.73±0.11

0.14


Table 2 : In-hospital outcomes 

 

MANTA

Prostar XL

p-value 

Primary outcomes 

 

 

 

Major vascular complications (n,%)

5(3.9)

4(3.2)

0.84

Life-threatening bleeding (n,%)

2(1.6)

0(0)

0.16

Major bleeding (n,%)

2(1.6)

5(4.0)

0.46

Death (n,%)

1(0.8)

2(1.6)

0.56

Secondary outcomes 

 

 

 

Device failure (n,%)

6(4.8)

6(4.8)

0.99

Immediate hemostasis in angiogram (n,%)

110(88.0)

112(90.3)

0.55

Stent implantation (n,%)

8(6.4)

7(5.6)

0.80

Manual compression (n,%)

16(12.8)

14(11.3)

0.71

Preparation time (min)

2.1±1.3

6.0±1.4

<0.001

Hemoglobin after TAVI (g/dl)

10.6±1.5

10.9±1.5

0.23

Transfusion (units)

0.3±1.5

0.2±0.6

0.59

 
https://dgk.org/kongress_programme/jt2023/aV1231.html