Pilarczyk Kevin, Boening Andreas, Jakob Heinz, Langebartels Georg, Markewitz Andreas, Haake Nils, Heringlake Matthias, Trummer Georg
Department of Thoracic and Cardiovascular Surgery, West German Heart Centre Essen, University Hospital Essen, Essen Germany
Department of Cardiovascular Surgery, Justus-Liebig University Gießen, Giessen, Germany.
Eur J Cardiothorac Surg. 2016 Jan;49(1):5-17. doi: 10.1093/ejcts/ezv258. Epub 2015 Aug 5.
In contrast to the results of previous studies, recent randomized controlled trials (RCTs) failed to show a benefit of prophylactic aortic counterpulsation in high-risk patients undergoing cardiac surgery. The present analysis aims to redefine the effects of this treatment modality in the light of this new evidence. MEDLINE, EMBASE, CENTRAL/CCTR, Google Scholar and reference lists of relevant articles were searched for full-text articles of RCTs in English or German. Assessments for eligibility, relevance, study validity and data extraction were performed by two reviewers independently using prespecified criteria. The primary outcome was hospital mortality. A total of nine eligible RCTs with 1171 patients were identified: 577 patients were treated preoperatively with intra-aortic balloon pump (IABP) and 594 patients served as controls. The pooled odds ratio (OR) for hospital mortality (22 hospital deaths in the intervention arm, 54 in the control group) was 0.381 (95% CI 0.230-0.629; P < 0.001). The pooled analyses of five RCTs including only patients undergoing isolated on-pump coronary artery bypass grafting (n[IABP] = 348, n[control] = 347) also showed a statistically significant improvement in mortality for preoperative IABP implantation (fixed-effects model: OR 0.267, 95% CI 0.129-0.552, P < 0.001). The pooled OR for hospital mortality from two randomized off-pump trials was 0.556 (fixed-effects model, 95% CI 0.207-1.493, P = 0.226). Preoperative aortic counterpulsation was associated with a significant reduction in low cardiac output syndrome (LCOS) in the total population (fixed-effects model: OR 0.330, 95% CI 0.214-0.508, P < 0.001) as well as in the subgroup of CAGB patients (fixed-effects model: OR 0.113, 95% CI 0.056-0.226, P < 0.001), whereas there was no benefit in the off-pump population (fixed-effects model: OR 0.555, 95% CI 0.209-1.474, P = 0.238). Preoperative IABP implantation was associated with a reduction of intensive care unit (ICU) stay in all investigated populations with a greater effect in the total population [fixed-effects model: standard mean difference (SMD) -0.931 ± 0.198, P < 0.001] as well as in the subgroup of CAGB patients (fixed-effects model: SMD -1.240 ± 0.156, P < 0.001), compared with the off-pump group (fixed-effects model: SMD -0.723 ± 0.128, P < 0.001). Despite contradictory results from recent trials, the present study confirms the findings of previous meta-analyses that prophylactic aortic counterpulsation reduces hospital mortality, incidence of LCOS and ICU requirement in high-risk patients undergoing on-pump cardiac surgery. However, owing to small sample sizes and the lack of a clear-cut definition of high-risk patients, an adequately powered, prospective RCT is necessary to find a definite answer to the question, if certain groups of patients undergoing cardiac surgery benefit from a prophylactic IABP insertion.
与以往研究结果相反,近期的随机对照试验(RCT)未能显示预防性主动脉反搏对接受心脏手术的高危患者有获益。本分析旨在根据这一新证据重新界定这种治疗方式的效果。检索了MEDLINE、EMBASE、CENTRAL/CCTR、谷歌学术以及相关文章的参考文献列表,以查找英文或德文的RCT全文文章。由两名审阅者独立使用预先设定的标准进行资格评估、相关性评估、研究有效性评估和数据提取。主要结局是医院死亡率。共确定了9项符合条件的RCT,涉及1171例患者:577例患者术前接受主动脉内球囊泵(IABP)治疗,594例患者作为对照。干预组有22例医院死亡,对照组有54例,医院死亡率的合并比值比(OR)为0.381(95%CI 0.230 - 0.629;P < 0.001)。仅纳入接受单纯体外循环冠状动脉旁路移植术患者的5项RCT的合并分析(n[IABP] = 348,n[对照] = 347)也显示,术前植入IABP可使死亡率有统计学意义的改善(固定效应模型:OR 0.267,95%CI 0.129 - 0.552,P < 0.001)。两项非体外循环随机试验的医院死亡率合并OR为0.556(固定效应模型,95%CI 0.207 - 1.493,P = 0.226)。术前主动脉反搏与总体人群中低心排血量综合征(LCOS)的显著降低相关(固定效应模型:OR 0.330,95%CI 0.214 - 0.508,P < 0.001),在冠状动脉旁路移植术(CAGB)患者亚组中也是如此(固定效应模型:OR 0.113,95%CI 0.056 - 0.226,P < 0.001),而在非体外循环人群中无获益(固定效应模型:OR 0.555,95%CI 0.209 - 1.474,P = 0.238)。术前植入IABP与所有研究人群中重症监护病房(ICU)住院时间的缩短相关,并在总体人群中效果更显著[固定效应模型:标准均数差(SMD) - 0.931 ± 0.198,P < 0.001],在CAGB患者亚组中也是如此(固定效应模型:SMD - 1.240 ± 0.156,P <