The STYLE-AF Study: Implications on Clinical Practice and Future Directions

Interview With Sorin Ștefan Popescu, MD, and Roland Richard Tilz, MD 

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EP LAB DIGEST. 2024;24(10):Online Only.

Interview by Jodie Elrod  

In this interview, EP Lab Digest speaks with Sorin Ștefan Popescu, MD, and Roland Richard Tilz, MD, about their research comparing the safety and efficacy of a venous vascular closure system to the standard of care (figure-of-8 suture and manual compression) following atrial fibrillation (AF) ablation. 

Can you summarize the key objectives of the STYLE-AF study and the main research questions it aimed to address?

Firstly, we would like to thank you for inviting us and for the opportunity to discuss the results of the STYLE-AF study, which was presented during the Late Breaking Clinical Trials session of the European Heart Rhythm Association (EHRA) Congress 2024 in Berlin and published in EP Europace in April 2024.¹ 

The primary objective of the study was to compare the safety and efficacy of venous vascular closure systems to the current gold standard, figure-of-8 suture and manual compression, in achieving hemostasis following catheter-based pulmonary vein isolation.

We aimed to investigate whether the use of a venous vascular closure system could improve the safety profile of catheter-based ablation for atrial fibrillation (AF), considering that puncture site-related complications are among the most frequent following such procedures. Additionally, we aimed to explore whether the use of these systems could lead to a shorter time to ambulation, thereby increasing patient comfort and satisfaction, and facilitating early postprocedural discharge.

What were the primary differences in outcomes between the venous vascular closure system and the figure-of-8 suture methods for closure following AF ablation?

Firstly, patients undergoing hemostasis through venous closure systems experienced a significantly shorter time to ambulation, meaning they could stand and walk earlier after the procedure. This also led to a shorter time to discharge eligibility, which could potentially translate in the future to shorter hospitalization durations and a higher rate of same-day discharge (SDD) procedures. However, due to the study design and the specifics of the German health care system, we did not evaluate SDD implementation as part of this study.

Additionally, the study demonstrated a lower rate of minor vascular access-related complications in the intervention group, while no major complications were reported in either group. This finding suggests an improved safety profile for venous closure systems, with the potential to significantly reduce the incidence of the most common complications following AF ablations.

Another notable finding was the higher satisfaction reported by patients regarding bed rest duration, which was significantly better in the intervention group. A trend towards greater comfort was also observed in this group.

How did the STYLE-AF study design ensure a robust comparison between the 2 closure methods? 

This is indeed a very important question. The STYLE-AF study was a multicenter, prospective, randomized controlled trial, where patients were randomized in a 1:1 fashion to undergo hemostasis either through a venous closure system or via figure-of-8 sutures and manual compression. Due to the study design, the risk of bias was minimal, ensuring a fair comparison between the study groups. Additionally, the study was adequately powered based on the primary efficacy endpoint, and the sample size was subsequently increased to allow for a device-based subanalysis. Moreover, the study was conducted in 3 tertiary electrophysiological centers in Germany, all highly experienced in running clinical trials and supported by dedicated onsite research departments. This led to high-quality data and strict adherence to the study protocol.

All study parameters were clearly defined in the study protocol to ensure a homogeneous implementation across centers and among study physicians. The decision regarding ambulation, which might otherwise be considered subjective, was based on clear, predefined criteria to enhance objectivity and reduce inter-physician variability.

Another key aspect was the rigorous documentation of all vascular adverse events. As noted in the manuscript, this meticulous documentation resulted in a high rate of minor vascular complications, demonstrating that even complications that might otherwise go unnoticed were thoroughly recorded.

What implications do the study’s findings have for clinical practice in terms of choosing a closure technique post ablation? Are there specific patient populations that might benefit more from one method over the other?

Thank you for this very important question! The study demonstrated that the use of venous closure systems leads to a significantly shorter time to ambulation, less than half compared to the control group. This finding can have major implications for patients, hospital infrastructure, and health care resource utilization. Firstly, the shorter bed rest can lead to increased patient comfort and satisfaction, which was also shown in the STYLE-AF study. The fact that patients could stand and walk after a median of 109 minutes can be translated into a reduced need for hospital beds for postprocedural monitoring, less crowding in postoperative facilities, and shorter working hours for personnel in this area. As mentioned earlier, the reduced time to ambulation also has the potential to facilitate the implementation of SDD protocols, thereby improving health care resource utilization, such as beds on the ward and personnel, which can then be allocated to other patients. Considering that AF is the most common arrhythmia in adults, and with its incidence expected to increase significantly, these aspects are highly relevant for the field of interventional electrophysiology, which must manage health care resources efficiently to ensure high-quality treatment for all patients in need.

Another important finding is the significant reduction in minor vascular complications following AF ablation, which are one of the most common causes of prolonged hospitalization. This aspect can also lead to increased patient comfort and facilitate early postprocedural discharge. 

Based on our experience, all patients undergoing interventional electrophysiological procedures could benefit from venous closure systems. However, the STYLE-AF study only investigated the use of vascular closure systems in patients undergoing interventions with up to 2 vascular access points. Whether these results can be extended to patients with more than 2 vascular punctures remains to be proven. It is also important to consider the economic aspects of implementing this technique. Nonetheless, the higher cost of the devices might be offset by the changes in postprocedural workflow, as discussed. 

In light of the STYLE-AF study results, what further research is necessary to build on these findings? Are there additional aspects of venous closure techniques that need to be explored?

As the number of procedures performed worldwide continues to grow, it is crucial to use health care resources as efficiently as possible to ensure we can provide high-quality treatment to all patients. For this reason, assessing the economic impact of the routine implementation of this protocol on health care resources is essential. At the Department of Rhythmology of the University Heart Centre Lübeck, we are currently working on a subanalysis of the economic impact of the routine use of venous closure systems following AF ablation and expect the first results by the end of the year.

As previously mentioned, one of the major advantages of this approach is the facilitation of SDD catheter ablation for AF. While SDD procedures are widely performed in countries such as England and the United States, there are no randomized data assessing the safety and efficacy of this approach. Therefore, the next step is to conduct a randomized controlled trial to evaluate this protocol and provide new evidence for its routine implementation. To address this, we will soon begin enrolling the first patients in the SHAZAM-AF study, a randomized controlled trial assessing the safety and efficacy of SDD catheter ablation for AF.

Reference

1.     Tilz RR, Marcel Feher, Julia Vogler, et al. Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study. EP Europace. 2024;26(5):euae105. doi:10.1093/europace/euae105