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EHRA 24: Venous Vascular Closure Vs Manual Compression: Style-AF

Published: 16 Apr 2024

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EHRA 24 - We are joined onsite by Dr Roland Tilz (University Heart Center, DE) to discuss the findings of the Style-AF study (NCT05563142).

This prospective, randomized, controlled study aims to compare the safety and efficacy of the Perclose ProStyle suture-medicated closure device to manual compression for the treatment of hemostasis after single-shot-device pulmonary vein isolation (PVI). 125 patients were enrolled in the trial, who were randomized in a 1:1 ratio to either recieve the ProStyle closure device, or manual compression with a figure-of-eight stitch. The primary outcome endpoint of the study were time to hemostasis, and the primary safety endpoint was the total number of major complications. 

Findings of the study were positive, with the ProStyle device resulting in a significantly faster time to ambulation with no difference in terms of complication between both groups. In terms of secondary endpoints, time to discharge eligibility and hemostasis was significantly shorter in the vascular closure arm, and patient satisfaction found to be higher.

Interview Questions:

  1. What is the reasoning behind this study?
  2. Could you tell us a bit more about the ProStyle Closure Device?
  3. What was the study design and patient population?
  4. What were your key findings revealed at EHRA 24?
  5. What questions remain?
  6. What are your key take-home messages?
  7. What are the next steps?

Recorded on-site at EHRA in Berlin, 2024.

Transcript

"Hello, everybody. My name is Professor Roland Tilz. I'm the director of the Department of Rhythmology at the University Hospital in Lubeck. Today, I'm going to summarize the results of the STYLE AF study, which was presented as a late-breaking clinical trial at EHRA 2024.

What is the reasoning behind this study?

So the background of the study is that same-day discharge AF ablation is getting increasingly more popular. Vascular access management is critical for same-day discharge. In addition, vascular access complications are by far the most common complications in patients undergoing AF ablation. So we wanted to evaluate whether a vascular closure device is more effective and at least as safe as a traditional approach using a figure of eight suture.

Could you tell us a bit more about the ProStyle Closure Device?

The pro style closure device is a device that allows for immediate hemostasis after sheath removal, so you can use it for venous access as well as for arterial access, and as soon as you deploy it, you achieve immediate hemostasis so you do not need to manually compress the groin.

What was the study design and patient population?

The STYLE AF study is a multicenter, randomized study which enrolled 125 patients. Patients undergoing single-shot AF ablation with a maximum of two sheaths were eligible. Patients were randomized into an intervention arm which was venous closure using the pro style device, and the usual treatment arm which was manual compression with a figure of eight stitch. The primary endpoint of the study was time to hemostasis and the primary safety endpoint was the total number of major complications.

What were your key findings revealed at EHRA 24?

So I'm very happy that the study was positive. The pro style device resulted in a significantly faster time to ambulation and there was no difference in terms of complication between both groups. There were no major complications in both arms in terms of secondary endpoints. The study was also in favor of the pro style device as compared to the figure of eight arm. The time to discharge eligibility and the time to hemostasis was significantly shorter in the vascular closure arm. In addition, patient satisfaction was significantly higher in the vascular closure arm as compared to the control arm.

What Questions Remain, What are your Key Take-Home Messages, and What are the Next Steps

We need to transfer this data into our everyday practice and now we need to confirm that we can treat more patients if we use the vascular closure device because we can discharge them earlier and add an additional procedure in the evening or can close the wake-up room earlier. In addition, we need scientific evidence that the vascular closure device is a more effective approach as compared to a traditional approach in patients undergoing same-day discharge. We already prepared the next study which is the SHAZAM AF study which is comparing exactly this so same discharge using pro style device on one side with inpatient AF ablation using figure of eight stitch.

If you use the vascular closure device, you have a faster time to ambulation, you have a faster time to hemostasis, you have a faster time to discharge eligibility, and you have a higher patient satisfaction. So it is the perfect approach for same-day discharge procedures. The next steps are randomized study the SHAZAM AF trial, which is going to confirm the superiority of vascular closure device for same-day AF ablation as compared to a conventional approach using an inpatient approach.”

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