Akodad Mariama, Labour Jessica, Nogue Erika, Delseny Delphine, Macia Jean-Christophe, Gervasoni Richard, Lattuca Benoit, Nagot Nicolas, Roubille François, Cayla Guillaume, Leclercq Florence
Department of Cardiology, CHU Montpellier, Univ Montpellier, Montpellier, France.
PhyMedExp, Uni Montpellier, INSERM, CNRS, France.
Int J Cardiol Heart Vasc. 2022 Jan 18;39:100951. doi: 10.1016/j.ijcha.2021.100951. eCollection 2022 Apr.
Vascular and bleeding events remain the main complications after balloon aortic valvuloplasty (BAV). While BAV is usually performed with per procedural heparin injection, BAV performed without heparin may reduce hemorrhagic events. We aimed to determine whether vascular and bleeding complications may be reduced with BAV performed without heparin.
This randomized, double-blind, placebo-controlled study was conducted from January 2013 to September 2016. Patients were randomly assigned to placebo or intravenous unfractionated heparin (UH) 50 IU/kg bolus during the procedure. The primary endpoint included major vascular, bleeding and ischemic complications (stroke, transient ischemic attack, myocardial infarction) according to VARC-2 criteria.
Among 89 randomized patients, 82 completed the study (n = 39 in the UH group and n = 43 in the placebo group). At baseline, diabetes, sex male and renal failure were more frequent in the UH group and peripheral artery disease was more frequent in the placebo group. The primary endpoint was achieved in 7 patients (8.5%), 1 in the placebo group (2.3%) versus 6 in the UH group (15.4%). After adjustment on diabetes, sex, renal failure, peripheral artery disease, percutaneous closure device and chronic obstructive pulmonary disease, UH utilization was associated with a significant risk of major vascular, bleeding and ischemic complications (primary endpoint) (OR: 11.9; 95%CI: 1.2-117.2; p = 0.03). Hospitalization length was lower in the placebo group compared to the UH group (p = 0.03).
BAV without per procedural UH was associated with a reduction of major VC and bleeding events without increasing the ischemic risk and with a shorter hospitalization length.
血管及出血事件仍是球囊主动脉瓣成形术（BAV）后的主要并发症。虽然BAV通常在手术过程中注射肝素，但不使用肝素进行BAV可能会减少出血事件。我们旨在确定不使用肝素进行BAV是否可减少血管及出血并发症。
本随机、双盲、安慰剂对照研究于2013年1月至2016年9月进行。患者在手术过程中被随机分配至安慰剂组或静脉注射普通肝素（UH）50 IU/kg推注组。主要终点包括根据VARC-2标准定义的主要血管、出血及缺血并发症（中风、短暂性脑缺血发作、心肌梗死）。
89例随机分组的患者中，82例完成了研究（UH组39例，安慰剂组43例）。基线时，UH组糖尿病、男性性别及肾衰竭更为常见，而安慰剂组外周动脉疾病更为常见。7例患者（8.5%）达到主要终点，安慰剂组1例（2.3%），UH组6例（15.4%）。在对糖尿病、性别、肾衰竭、外周动脉疾病、经皮闭合装置及慢性阻塞性肺疾病进行校正后，使用UH与主要血管、出血及缺血并发症（主要终点）的显著风险相关（OR：11.9；95%CI：1.2 - 117.2；p = 0.03）。安慰剂组的住院时间低于UH组（p = 0.03）。
不进行术中UH注射的BAV与主要血管及出血事件减少相关，未增加缺血风险且住院时间更短。
