希氏束起搏和右心室起搏的长期有效性和安全性比较的荟萃分析

A comparison in long-term efficacy and safety of His-bundle pacing and right ventricular pacing:a Meta-analysis

目的系统评价希氏束起搏(HBP)和右心室起搏(RVP)应用于有起搏器植入指征的患者的长期有效性和安全性。方法应用计算机检索和手工检索2000年至2019年3月30日数据库PubMed、The Cochrane Library、Web of Science中关于HBP的临床研究,采用Cochrane风险偏倚评估工具评价随机对照实验的研究质量,采用纽卡斯尔-渥太华量表(NOS)评价观察性研究的研究质量,采用STATA 12.0进行数据分析。结果最终纳入临床试验6项,包括交叉试验3项,观察性研究3项,共包含希氏束起搏组582例,右心室起搏组622例。荟萃分析结果提示,随访时间大于3个月,与RVP组相比,HBP组起搏QRS显著变窄,差异有统计学意义(WMD=-49.13,95%CI:-59.70^-38.56,P<0.01);起搏阈值显著升高,差异有统计学意义(WMD=1.15,95%CI:1.02~1.28,P<0.01);感知显著降低,差异有统计学意义(WMD=-6.67,95%CI:-7.89^-5.45,P<0.01);阻抗显著降低,差异有统计学意义(WMD=-85.08,95%CI:-165.61^-4.56,P=0.04)。与RVP组相比,HBP组左室射血分数显著提高,差异有统计学意义(WMD=4.06%,95%CI:2.22~5.89,P<0.01);肺动脉压力显著降低,差异有统计学意义(WMD=-4.17,95%CI:-7.27^-1.07,P<0.01);电极相关并发症显著升高,差异有统计学意义(RR=3.30,95%CI:1.63^-6.65,P<0.01);HBP组心衰住院率、全因死亡率减低,但无统计学差异。结论与RVP相比,长期HBP能显著缩短起搏QRS,提高左室射血分数,减少心衰住院率和全因死亡率。但HBP有起搏参数不理想、电极相关并发症发生率高等缺点。以上结论仍需更多大型随机对照试验的验证。

Objective To review systematically the long-term efficacy and safety of His-bundle pacing(HBP)and right ventricular pacing(RVP)in patients with indications of pacemaker implantation.Methods The databases of PubMed,The Cochrane Library and Web of Science were retrieved by computer and manual searching from 2000 to Mar.30,2019 for collecting HBP-related clinical randomized controlled trials(RCT).The quality of the RCT was reviewed by using Cochrane risk bias assessing tool,quality of observing studies was reviewed by using Newcastle-Ottawa Scale(NOS),and data was analyzed by using STATA 12.0 software.Results There were finally 6 RCT collected,including 3 cross-over trials and 3 observational studies.There were 582 cases in HBP group and 622 in RVP group.The results of Meta-analysis showed that follow-up duration was more than 3 months.Compared with RVP group,in HBP group pacemaking QRS was significantly narrower(WMD=-49.13,95%CI:-59.70^-38.56,P<0.01),pacemaking threshold increased significantly(WMD=1.15,95%CI:1.02~1.28,P<0.01),R wave sensing decreased significantly(WMD=-6.67,95%CI:-7.89^-5.45,P<0.01),and lead impedance decreased significantly(WMD=-85.08,95%CI:-165.61^-4.56,P=0.04).Compared with RVP group,in HBP group LVEF increased significantly(WMD=4.06%,95%CI:2.22~5.89,P<0.01),pulmonary arterial pressure decreased significantly(WMD=-4.17,95%CI:-7.27^-1.07,P<0.01),and electrode-related complications increased significantly(RR=3.30,95%CI:1.63^-6.65,P<0.01).The heart failure hospitalization rate and all-cause mortality decreased in HBP group but there was no statistical difference between 2 groups.Conclusion Compared with RVP,long-term HBP can significantly shorten pacemaking QRS,increase LVEF and reduce heart failure hospitalization rate and all-cause mortality.But HBP has disadvantages including unsatisfactory pacemaking parameters and higher incidence rate of electrode-related complications.The conclusion needs to be verified by more large-scale RCT.