Danker Walter, Aggarwal Jyoti, Kelkar Sneha S, Marston Xiaocong L, Gao Xin, Johnston Stephen S
Ethicon Inc., Somerville, NJ, USA.
OPEN Health, Bethesda, MD, USA.
Clinicoecon Outcomes Res. 2022 Mar 10;14:129-138. doi: 10.2147/CEOR.S338672. eCollection 2022.
Topical hemostatic agents are an option for controlling bleeding during cardiovascular surgery. Previous studies comparing topical hemostatic agents in cardiovascular surgery predate the 2012 reformulation of Surgiflo, which had been re-engineered to increase paste viscosity and thus be more adherent to the bleeding surface.
To compare clinical and economic outcomes in patients receiving the current formulation of Surgiflo vs Floseal during cardiovascular surgeries.
A retrospective analysis was conducted using the Premier Healthcare Database. Eligible patients had an inpatient cardiovascular surgery between 1/1/2013 and 6/1/2018, were ≥18 years old and received the current formulation of Surgiflo or Floseal during surgery. Propensity score matching was performed, with exact matching on the surgery year and surgery type (aortic, coronary artery bypass grafting, valve, or other). Descriptive analysis and generalized estimating equations models compared outcomes between the Surgiflo and Floseal groups.
The matched sample included 5768 patients in each group (mean age: 66.5 years; 66.3% male). In the matched sample, rates of any documented bleeding event were similar in Surgiflo and Floseal groups (6.9% vs 7.2%; P = 0.576). Differences in transfusion rates between patients receiving Surgiflo vs Floseal varied by operational definition and timing of measurement but did not differ by >2 percentage points. Compared to Floseal, patients who received Surgiflo experienced longer surgery duration (306.0 vs 299.4 minutes), lower hospitalization cost ($44,146 vs $46,812), and lower odds of readmission at 30, 60, and 90 days post-discharge (all P < 0.05). Inpatient mortality and LOS were comparable between Surgiflo and Floseal (all P > 0.05).
In this large study of real-world clinical and economic outcomes after cardiovascular surgery involving the current formulation of Surgiflo vs Floseal, Surgiflo was associated with mostly similar clinical outcomes as compared with Floseal. Differences in selected economic/resource use outcomes were also observed, for which root-cause analysis in future research would be informative.
局部止血剂是控制心血管手术出血的一种选择。以往比较心血管手术中局部止血剂的研究早于2012年Surgiflo的重新配方，该产品经过重新设计以提高糊剂粘度，从而更能粘附于出血表面。
比较心血管手术中接受当前配方的Surgiflo与Floseal的患者的临床和经济结局。
使用Premier医疗数据库进行回顾性分析。符合条件的患者在2013年1月1日至2018年6月1日期间接受住院心血管手术，年龄≥18岁，且在手术期间接受了当前配方的Surgiflo或Floseal。进行倾向得分匹配，在手术年份和手术类型（主动脉、冠状动脉搭桥术、瓣膜或其他）上进行精确匹配。描述性分析和广义估计方程模型比较了Surgiflo组和Floseal组的结局。
匹配样本每组包括5768名患者（平均年龄：66.5岁；66.3%为男性）。在匹配样本中，Surgiflo组和Floseal组任何记录的出血事件发生率相似（6.9%对7.2%；P = 0.576）。接受Surgiflo与Floseal的患者输血率差异因操作定义和测量时间而异，但差异不超过2个百分点。与Floseal相比，接受Surgiflo的患者手术时间更长（306.0对299.4分钟），住院费用更低（44,146美元对46,812美元），出院后30、60和90天再次入院的几率更低（所有P < 0.05）。Surgiflo和Floseal的住院死亡率和住院时间相当（所有P > 0.05）。
在这项关于心血管手术后涉及当前配方的Surgiflo与Floseal的现实世界临床和经济结局的大型研究中，与Floseal相比，Surgiflo的临床结局大多相似。还观察到选定的经济/资源使用结局存在差异，未来研究中的根本原因分析将有助于了解情况。
