Gold Michael R, Adler Stuart, Fauchier Laurent, Haffajee Charles, Ip John, Kainz Walter, Kawasaki Raymond, Prakash Atul, Táborský Milos, Waller Theodore, Wilson Vance, Li Shelby, Hoffmann Ellen
Medical University of South Carolina, Charleston, South Carolina 29425, USA.
Heart Rhythm. 2009 Mar;6(3):295-301. doi: 10.1016/j.hrthm.2008.11.033. Epub 2008 Dec 6.
The role of atrial-based pacing algorithms in preventing atrial fibrillation (AF) remains controversial. The inconsistent results noted in previous trials may be due in part to differences in endpoints, pacing algorithms, and study design. SAFARI, a worldwide, prospective, randomized clinical trial, was designed to address these issues and to evaluate the safety and efficacy of a suite of prevention pacing therapies (PPTs) among patients with paroxysmal AF.
Patients who met standard pacemaker indications and documented symptomatic AF were implanted with a pacemaker (Vitatron Selection 9000). At 4 months, only patients with documented AF despite dual-chamber pacing were randomized to PPTs ON or PPTs OFF and followed for 6 months. Incidence of permanent AF and change in AF burden were compared between the two groups. Among the 555 patients enrolled, 240 had AF burden at 4 months and were randomized. The risk of developing permanent AF was similar in both groups (0 in the PPTs ON group vs. 3 in the OFF group). However, there was a significant reduction in AF burden between baseline and 10-month follow-up in the ON group compared with the OFF group (median decrease of 0.08 hours/day vs no change, P = .03).
Among patients with paroxysmal AF and standard bradycardia indications, PPTs are safe and associated with less AF burden compared with conventional pacing.
基于心房的起搏算法在预防心房颤动（AF）中的作用仍存在争议。先前试验中结果不一致可能部分归因于终点、起搏算法和研究设计的差异。SAFARI是一项全球性、前瞻性、随机临床试验，旨在解决这些问题，并评估一套预防起搏疗法（PPTs）对阵发性AF患者的安全性和有效性。
符合标准起搏器适应证且记录有症状性AF的患者植入起搏器（Vitatron Selection 9000）。4个月时，仅那些尽管进行了双腔起搏仍记录有AF的患者被随机分为PPTs开启组或PPTs关闭组，并随访6个月。比较两组永久性AF的发生率和AF负荷的变化。在纳入的555例患者中，240例在4个月时有AF负荷并被随机分组。两组发生永久性AF的风险相似（PPTs开启组为0例，关闭组为3例）。然而，与关闭组相比，开启组在基线至10个月随访期间AF负荷有显著降低（中位数每天减少0.08小时 vs 无变化，P = .03）。
在阵发性AF和标准心动过缓适应证的患者中，与传统起搏相比，PPTs是安全的且与较低的AF负荷相关。
