Klop Idserd D G, Van Putte Bart P, Kloppenburg Geoffrey T L, Klautz Robert J M, Sprangers Mirjam A G, Nieuwkerk Pythia T, Klein Patrick
Department of Cardiothoracic Surgery, St Antonius Hospital, Nieuwegein, Netherlands.
Department of Cardiothoracic Surgery, AMC Heart Centre, Amsterdam University Medical Center, Amsterdam, Netherlands.
Interdiscip Cardiovasc Thorac Surg. 2024 May 2;38(5). doi: 10.1093/icvts/ivae083.
Surgical aortic valve replacement through conventional sternotomy yields excellent results. Minimally invasive techniques are deemed equally safe and serve as a viable and less traumatic alternative. However, it is unclear how both surgical techniques affect patient-reported outcomes. The objective of this trial is to compare postoperative cardiac-related quality of life and postoperative pain after upper hemisternotomy and conventional surgical aortic valve replacement.
In this single-centre, open-label, investigator-initiated randomized clinical trial, patients were randomized to upper hemisternotomy or conventional full median sternotomy. Patients unable to undergo randomization were monitored prospectively (registry group). Primary outcome was cardiac-specific quality of life, measured with the Kansas City Cardiomyopathy Questionnaire up to 1 year postoperatively.
Patients undergoing upper hemisternotomy had a significantly higher physical limitation domain score across all postoperative time points than patients undergoing conventional surgical aortic valve replacement (estimated mean difference 2.12 points; P = 0.014). Patients undergoing upper hemisternotomy were more likely to have a pain score <30 the first 2 days postoperatively than patients undergoing conventional surgical aortic valve replacement (odds ratio 2.63; P = 0.007). This was associated with reduced opioid analgesic intake. Postoperative surgical outcome did not differ between both groups.
Surgical aortic valve replacement through both conventional sternotomy and upper hemisternotomy resulted in clinically similar and important improvements in quality of life, with a small advantage for upper hemisternotomy, while there was no compromise in safety.
通过传统胸骨切开术进行外科主动脉瓣置换术效果极佳。微创技术被认为同样安全,是一种可行且创伤较小的替代方法。然而,尚不清楚这两种手术技术如何影响患者报告的结局。本试验的目的是比较上半胸骨切开术和传统外科主动脉瓣置换术后与心脏相关的生活质量及术后疼痛情况。
在这项单中心、开放标签、研究者发起的随机临床试验中,患者被随机分为上半胸骨切开术组或传统全正中胸骨切开术组。无法进行随机分组的患者进行前瞻性监测(登记组)。主要结局是心脏特异性生活质量,使用堪萨斯城心肌病问卷在术后1年内进行测量。
在上半胸骨切开术组的患者在所有术后时间点的身体限制领域得分均显著高于接受传统外科主动脉瓣置换术的患者(估计平均差异2.12分;P = 0.014)。上半胸骨切开术组的患者在术后前两天疼痛评分<30的可能性高于接受传统外科主动脉瓣置换术的患者(优势比2.63;P = 0.007)。这与阿片类镇痛药摄入量减少有关。两组术后手术结局无差异。
传统胸骨切开术和上半胸骨切开术进行外科主动脉瓣置换术在生活质量方面均带来了临床上相似且重要的改善,上半胸骨切开术略有优势,同时安全性并未降低。