3D-engineered personalized airway stent (custom GINA stent): Introduction and performance evaluation in pigs

Enlarged left atrium (LA) is a risk factor for ablation failure after atrial fibrillation (AF) surgery. It predisposes patients to thromboembolic events, even in successful ablation; therefore, concomitant resection of the LA wall during surgical ablation was introduced. This study examined the clinical impacts of LA reduction in patients undergoing concomitant ablation for AF. This study enrolled 1484 patients with enlarged LA (≥50 mm) who underwent surgical AF ablation during major cardiac surgery between January 2001 and August 2018. Among them, 876 (59%) patients underwent concomitant LA reduction (Reduction group), whereas in the remaining 608 (41%), the LA wall was unresected (Preservation group). The primary outcome of interest was overall stroke. The secondary outcomes were overall mortality, late recurrence of AF, early postoperative complications and postoperative echocardiographic parameters. Outcomes were compared after adjusting baseline characteristics with inverse probability of treatment weighting (IPTW) using propensity score. The median follow-up was 60.1 months. After IPTW adjustment, long-term mortality (P = 0.250) and AF-free rates (P = 0.196) did not significantly differ between groups. However, the Reduction group showed a decreased risk of stroke (hazard ratio 0.54; 95% confidence interval 0.32–0.90; P = 0.018). Early postoperative complications rate such as mortality or reoperation for bleeding, was not significantly different between the 2 groups. The Reduction group showed smaller LA diameter (50.6 ± 8.0 mm vs 53.6 ± 8.9 mm; P < 0.001) on follow-up echocardiography. LA reduction effectively decreased LA size and appeared to decrease the stroke risk in patients with enlarged LA undergoing ablation for AF.