Res Jan C J, Bokern Marcel J J A, de Cock Carel C, van Loenhout Ton, Bronzwaer Patrick N A, Spierenburg Han A M
Department of Cardiology, Ba 579, Erasmus Medical Centre Rotterdam, PO Box 2040, 3000 CA Rotterdam, The Netherlands.
Europace. 2007 Oct;9(10):857-61. doi: 10.1093/europace/eum147. Epub 2007 Aug 7.
The BRIGHT study evaluated bifocal right ventricular (RV) (apex and outflow tract) pacing in a single, blind, randomized crossover study in patients eligible for cardiac resynchronization therapy (CRT). Forty-two patients were enrolled with the following characteristics: chronic drug refractory heart failure New York Heart Association (NYHA) class III-IV; ejection fraction (EF)<35%; QRS width >or= 120 ms; and a left bundle branch block. The aim of the study was to assess an improvement in left ventricular (LV) EF, 6 min walk test, Minnesota quality-of-life score, and NYHA classification. Methods and result Patients were randomized to receive either bifocal pacing or the control mode, each for a period of 3 months. Parameters were measured prior to randomization and after 3 months of control or bifocal pacing. Eight patients failed to make the 7 month follow-up, three patients died (one prior to randomization at the first month), five patients dropped out, and three patients refused further participation. One patient had a persistent lead problem, which was subsequently replaced with an LV lead, and one patient suffered with persistent atrial fibrillation. Compared with baseline, bifocal pacing improved EF from 26 +/- 12% to 36 +/- 11% (P < 0.0008), NYHA classification decreased from 2.8 +/- 0.4 to 2.3 +/- 0.7 (P < 0.007). Furthermore, the 6 min walk test improved from 372 +/- 129 m to 453 +/- 122 m (P < 0.05), and the Minnesota Living with Heart Failure scores decreased from 33 +/- 20 to 24 +/- 21 (P < 0.006). In the control group, no significant changes in any parameters were observed. Eight patients did not tolerate reprogramming from DDD BRIGHT to control pacing, with symptoms disappearing in all patients after reprogramming to bifocal pacing.
Bifocal RV pacing in patients with a classic indication for CRT shows improvement in all parameters.
BRIGHT研究在一项针对符合心脏再同步治疗（CRT）条件的患者的单盲、随机交叉研究中，评估了双焦点右心室（RV）（心尖和流出道）起搏情况。42例患者入组，其具有以下特征：慢性药物难治性心力衰竭，纽约心脏协会（NYHA）III-IV级；射血分数（EF）<35%；QRS波宽度≥120 ms；以及左束支传导阻滞。该研究的目的是评估左心室（LV）EF、6分钟步行试验、明尼苏达生活质量评分和NYHA分级的改善情况。方法与结果：患者被随机分为接受双焦点起搏或对照模式，每种模式持续3个月。在随机分组前以及对照或双焦点起搏3个月后测量参数。8例患者未能完成7个月的随访，3例患者死亡（1例在第1个月随机分组前死亡），5例患者退出，3例患者拒绝进一步参与。1例患者存在持续的导线问题，随后更换为左心室导线，1例患者患有持续性心房颤动。与基线相比，双焦点起搏使EF从26±12%提高到36±11%（P<0.0008），NYHA分级从2.8±0.4降至2.3±0.7（P<0.007）。此外，6分钟步行试验从372±129米提高到453±122米（P<0.05），明尼苏达心力衰竭生活评分从33±20降至24±21（P<0.006）。在对照组中，未观察到任何参数有显著变化。8例患者不能耐受从DDD BRIGHT重新程控为对照起搏，在重新程控为双焦点起搏后所有患者症状消失。
对于有CRT经典适应证的患者，双焦点右心室起搏可使所有参数得到改善。
