Pašara Vedran, Ban Bruno, Prepolec Ivan, Nekić Andrija, Katić Zvonimir, Kardum Domagoj, Miličić Davor, Velagić Vedran
Department of Cardiovascular Diseases, University Hospital Centre Zagreb, 10000 Zagreb, Croatia.
School of Medicine, University of Zagreb, 10000 Zagreb, Croatia.
J Clin Med. 2025 Jun 21;14(13):4422. doi: 10.3390/jcm14134422.
Pulmonary vein isolation (PVI) is the standard treatment for atrial fibrillation (AF), but medium-term success rates remain suboptimal. Non-pulmonary vein triggers, particularly from the superior vena cava (SVC), contribute to AF recurrence. Empirical SVC isolation (SVCi) in addition to standard PVI may improve outcomes. This study evaluated the acute procedural efficacy and safety of PVI with adjunctive SVCi versus PVI alone in patients with paroxysmal AF (PAF). In this randomized, controlled, single-center study, 149 patients with PAF were assigned to either standard PVI ( = 74) or PVI with adjunctive empirical SVCi ( = 75) using a fourth-generation CB. Primary endpoints were acute procedural success and the incidence of procedure-related complications, particularly phrenic nerve injury (PNI) and sinus node dysfunction. Acute PVI was achieved in all patients; SVCi was successful in 84.9% of the PVI + SVCi group. Major complication rates were low and comparable between groups (0% vs. 2.6%, = 0.157). However, the overall complication rate was significantly higher in the PVI + SVCi group (50.6% vs. 6.8%, < 0.001), driven primarily by transient or impending right PNI (38.6% vs. 6.8%, < 0.001) and sinus node dysfunction. All PNI events resolved before the end of the procedure. Empirical SVCi using a fourth-generation CB is feasible and generally safe, but carries a higher risk of transient PNI and reversible sinus node dysfunction. Therefore, CB SVCi should be approached with caution. Further studies are needed to evaluate long-term outcomes and assess whether the potential benefits outweigh these procedural risks.
肺静脉隔离（PVI）是心房颤动（AF）的标准治疗方法，但中期成功率仍不尽人意。非肺静脉触发因素，尤其是来自上腔静脉（SVC）的触发因素，会导致房颤复发。在标准PVI的基础上进行经验性上腔静脉隔离（SVCi）可能会改善治疗效果。本研究评估了阵发性房颤（PAF）患者在辅助SVCi的情况下进行PVI与单独进行PVI相比的急性手术疗效和安全性。在这项随机、对照、单中心研究中，149例PAF患者被分配接受标准PVI（n = 74）或使用第四代冷冻球囊进行辅助经验性SVCi的PVI（n = 75）。主要终点是急性手术成功率和手术相关并发症的发生率，特别是膈神经损伤（PNI）和窦房结功能障碍。所有患者均实现了急性PVI；SVCi在PVI + SVCi组中的成功率为84.9%。主要并发症发生率较低，两组之间具有可比性（0%对2.6%，P = 0.157）。然而，PVI + SVCi组的总体并发症发生率显著更高（50.6%对6.8%，P < 0.001），主要是由短暂或即将发生的右侧PNI（38.6%对6.8%，P < 0.001）和窦房结功能障碍所致。所有PNI事件在手术结束前均得到缓解。使用第四代冷冻球囊进行经验性SVCi是可行的且总体安全，但存在短暂性PNI和可逆性窦房结功能障碍的较高风险。因此，应谨慎进行冷冻球囊SVCi。需要进一步研究来评估长期疗效，并评估潜在益处是否超过这些手术风险。
