CHOICE-CLOSURE: a randomized trial of plug-based versus suture-based large-bore vascular closure

Reported from TCT 2021

Why this study: the rationale/objective?

• TAVI is most performed through the transfemoral access route, which is typically obtained and closed percutaneously.
• Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce.
• Authors sought to assess the comparative performance of a pure plug-based (MANTA 18 Fr) and a primary suture-based (ProGlide) VCD strategy in a randomized multicenter trial of patients undergoing transfemoral TAVI.

How was it executed: the methodology?

• Investigator-initiated, randomized, controlled, open-label study, conducted in 3 German university centres.
• Indication: patients with severe aortic valve stenosis, qualified to TAVI using transfemoral approach
• 1:1 randomization to MANTA 18 Fr based technique or ProGlide-based technique
• The primary endpoint: the rate of access-site or access-related major and minor vascular complications according to the VARC-2 criteria during index hospitalization.
• Single additional device added to the suture-based technique was not considered a device failure.

What is the main result?

Baseline characteristics:

• Population of 258 patients in each study group
• Age 80.7 ± 5.7 vs. 80.4 ± 6.5 years, p = 0.703
• Femoral artery size: 7.8 ± 1.6 vs. 7.8 ± 1.7 mm, p = 0.724
• Severe calcification of iliofemoral arteries: 23.7 % vs. 22.7 %, NS

Procedural details:

• Ultrasound-guided puncture was used in 18.2 % of patients
• Protamine administered in 99 % of patients
• Additional VCD used in 95.2 % of suture-based group patients

Clinical outcomes:

• The primary endpoint occurred in 19.4 % of the pure plug-based group and 12.0 % of the primary suture-based group (RR: 1.61, 95 % CI: 1.07-2.44, p = 0.029).
• Access-site or access-related bleeding occurred in 11.6 % vs. 7.4 % (RR: 1.58, 95 % CI: 0.91-2.73, p = 0.133)
• Device failure occurred in 4.7 % vs. 5.4 % (RR: 0.86, 95 % CI: 0.40-1.82, p = 0.841) in the respective groups.
• Time to haemostasis was 80 [32, 180] vs. 240 [174, 316] seconds, p < 0.001) in the groups.

Source: courtesy of Radoslaw Parma

Source: courtesy of Radoslaw Parma

Critical reading

The CHOICE-CLOSURE RCT showed that, among patients undergoing percutaneous access site closure during transfemoral TAVI, a vascular closure device strategy using the plug-based MANTA technique with no additional devices is associated with a higher rate of access-site or access-related vascular complications, but a shorter time to haemostasis compared to a primary suture-based strategy using the double ProGlide technique complemented by a small plug.

• The primary endpoint rates in the current study were twice as high in both arms when compared the previous RCT by van Wiechen et al, which used ultrasound-guided puncture and similar endpoint definitions (https://doi.org/10.1016/j.jcin.2020.09.052).
• Operator VCD experience was high, with the cumulative operator experience with the MANTA device was well beyond several hundred cases
• Low ultrasound-guided puncture rate may have influenced the high rate of primary and secondary endpoints.
• No predefined anatomical or clinical factor identified a subgroup in which MANTA 18 Fr VCD would be superior to suture-based approach
• The 95.2 % of additional VCD use in the suture-based group point to the study comparison of a single MANTA 18 Fr VCD vs. 3 combined VCD approach (mostly 2 ProGlides + 1 AngioSeal).
• The results of this trial do not apply to the smaller 14 French MANTA device or the use of a single ProGlide device for vascular closure.

Relevance for clinical practice

Based on the CHOICE-CLOSURE study results, patients undergoing transfemoral TAVI may experience lower number of in-hospital and 30-day access-related vascular complications when using primarily suture-based techniques in comparison to MANTA 18 Fr approach.

The use of ultrasound-guidance for femoral artery puncture may lower the number of observed complications. MANTA collagen plug-based device may come useful as a bailout strategy when the suture-based strategy fails.

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Author

Radoslaw Parma

@parma

Interventional cardiologist / Cardiologist

Katowice, Poland

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