Impact of Obesity on Haemostasis Using Venous Vascular Closure Systems Versus Figure-of-Eight Suture Following Atrial Fibrillation Ablation: A Subanalysis of the randomized STYLE-AF Study

S. Ș. Popescu (Lübeck)1, M. Feher (Leipzig)2, J. Vogler (Hamburg)3, K. Bode (Leipzig)2, A. I. Duta (Lübeck)1, A. Ortolan (Lübeck)1, M. L. Delgado Lopez (Lübeck)1, M. Küchler (Lübeck)1, J. Wenzel (Lübeck)1, R. Mamaev (Lübeck)1, S. Hatahet (Lübeck)1, E. Lian (Kiel)4, P. Sommer (Bad Oeynhausen)5, M. Braun (Bad Oeynhausen)5, V. Sciacca (Bad Oeynhausen)5, T. Demming (Kiel)4, V. Maslova (Kiel)4, C. Eitel (Lübeck)1, C.-H. Heeger (Hamburg)6, K.-H. Kuck (Pfäffikon SZ)7, R. R. Tilz (Lübeck)1
1Universitätsklinikum Schleswig-Holstein Klinik für Rhythmologie Lübeck, Deutschland; 2Herzzentrum Leipzig - Universität Leipzig Rhythmologie Leipzig, Deutschland; 3Asklepios Klinik St. Georg Kardiologie & internistische Intensivmedizin Hamburg, Deutschland; 4Universitätsklinikum Schleswig-Holstein Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische Intensivmedizin Kiel, Deutschland; 5Herz- und Diabeteszentrum NRW Klinik für Elektrophysiologie/ Rhythmologie Bad Oeynhausen, Deutschland; 6Asklepios Klinik Altona Kardiologie und Internistische Intensivmedizin Hamburg, Deutschland; 7Cardiance Clinic Pfäffikon SZ, Schweiz

Background

Venous vascular closure systems (VCS) are increasingly adopted in interventional electrophysiology to shorten time to ambulation (TTA), alleviate patient discomfort, and minimize vascular complications compared with manual compression or figure-of-eight (F8) suture. Obesity is a recognised risk factor for vascular complications. However, its impact on haemostasis outcomes with and without VCS remains unclear.

Purpose

To assess the impact of obesity on haemostasis following atrial fibrillation (AF) ablation using either a VCS or an F8 suture. 

Methods

The STYLE-AF study randomized 125 patients undergoing catheter ablation for AF (≤2 venous access sites) to haemostasis with either a suture-based VCS or an F8 suture, followed by manual compression. Patients were followed for 30 days post-procedure. This subanalysis compared patients with and without obesity (body mass index ≥30 kg/m²) regarding baseline and procedural data, TTA, complications and comfort.

Results

A total of 47 patients (37.6%) presented obesity. Patients with obesity were younger (61.9 ± 11.4 vs. 68.5 ± 11.2 years; p=0.002) and more frequently had arterial hypertension and non-paroxysmal AF.

Cryoenergy was the predominant energy source (85.1% of those with obesity vs. 76.9% of those without), followed by pulsed field ablation (12.8% vs. 17.9%). Two venous access sites were used in most patients (89.4% vs. 82.1%). VCS use was more frequent in patients with obesity (63.8% vs. 42.3%; p=0.027). Procedure and fluoroscopy times were similar, although patients with obesity required higher radiation doses and heparin amounts.

Median TTA did not differ between patients with and without obesity (240 [100–299.5] vs. 240 [88–288] min; p=0.434), irrespective of haemostasis methods.

On the day of the procedure, vascular complications occurred in 19.1% vs. 16.7% (p=0.810) of patients with and without obesity. Vascular complications on the day of procedure and the following day occurred in 29.4% vs. 37.8% (p=0.767) of patients with and without obesity treated with F8, and in 23.3% vs. 18.2% (p=0.758) of those treated with VCS. VCS use showed a trend toward fewer vascular complications in patients without obesity (OR 0.366, 95% CI 0.125–1.067; p=0.066) but not in those with obesity (OR 0.730, 95% CI 0.191–2.799; p=0.647). No major vascular complications occurred. 

There was a trend toward lower satisfaction regarding the bedrest time in patients with obesity. In patients treated with VCS, satisfaction was significantly lower in those with obesity compared with those without.

Conclusions

TTA was comparable between patients with and without obesity. The relative benefit of VCS in reducing vascular complications appeared less pronounced among patients with obesity. In patients without obesity, the incidence of vascular complications on the day of procedure and the following day was more than twice as high with the F8 compared with VCS. Satisfaction among VCS recipients was lower in patients with obesity.