Johnston Stephen S, Johnson Barbara H, Chakke Divya, Roy Sanjoy, Grange Philippe, Pollack Esther
MedTech Epidemiology and Real-World Data Sciences, Johnson & Johnson, New Brunswick, NJ, USA.
Analytics, Mu Sigma, Bangalore, India.
Med Devices (Auckl). 2022 Sep 2;15:317-328. doi: 10.2147/MDER.S372629. eCollection 2022.
To compare outcomes of non-donor patients undergoing radical nephrectomy using fixed-height gripping surface (FHGS) vs variable-height Tri-Staple™ (VHTS) reloads for transection of the renal vessels.
Using the Premier Healthcare Database of US hospital discharge records, we selected non-donor patients undergoing inpatient radical nephrectomy with dates of admission between 1 October 2015, and 31 December 2020 (first=index admission). The primary outcome was in-hospital hemostasis-related complications (hemorrhage, acute posthemorrhagic anemia, and/or procedure to control bleeding) during the index admission. Secondary outcomes included index admission intraoperative injury, blood transfusion, conversion from minimally invasive to open surgery, total hospital costs, length of stay (LOS), discharge status, and mortality as well as 30-day all-cause inpatient readmission. We used stable balancing weights to balance the FHGS and VHTS groups on numerous patient, procedure, and hospital/provider characteristics, allowing a maximum post-weighting standardized mean difference ≤0.01 for all covariates; we also exactly matched the groups on laterality (right vs left kidney) and intended surgical approach (open, laparoscopic, robotic). We used bivariate multilevel mixed-effects generalized linear models accounting for hospital-level clustering to compare the study outcomes between the FHGS and VHTS groups.
After weighting, the FHGS and VHTS groups comprised 2952 and 795 patients, respectively. The observed incidence proportion of the primary outcome of hemostasis-related complications during the index admission was similar between the groups (8.6% for FHGS vs 9.0% for VHTS, difference 0.4% [95% CI -3.2% to 2.5%], =0.808). Differences between the FHGS and VHTS groups were not statistically significant for any of the secondary outcomes.
Endoscopic surgical staplers have become common for transection of the renal vessels during radical nephrectomy, with FHGS and VHTS being the predominant reload types. In this retrospective study of 3747 non-donor patients undergoing radical nephrectomy, use of FHGS vs VHTS reloads was associated with similar clinical and economic outcomes.
比较接受根治性肾切除术的非供体患者使用固定高度夹持面（FHGS）与可变高度三联吻合器（VHTS）钉仓进行肾血管横断的手术效果。
利用美国医院出院记录的Premier医疗数据库，我们选取了2015年10月1日至2020年12月31日期间接受住院根治性肾切除术的非供体患者（首次=索引入院）。主要结局是索引入院期间与止血相关的院内并发症（出血、急性出血后贫血和/或控制出血的手术）。次要结局包括索引入院时的术中损伤、输血、从微创手术转为开放手术、总住院费用、住院时间（LOS）、出院状态和死亡率以及30天全因住院再入院率。我们使用稳定的平衡权重，在众多患者、手术和医院/提供者特征方面平衡FHGS组和VHTS组，使所有协变量的加权后标准化平均差异最大≤0.01；我们还在肾侧别（右肾与左肾）和预期手术方式（开放、腹腔镜、机器人手术）方面对两组进行了精确匹配。我们使用考虑医院层面聚类的双变量多级混合效应广义线性模型来比较FHGS组和VHTS组的研究结局。
加权后，FHGS组和VHTS组分别包括2952例和795例患者。两组在索引入院期间与止血相关并发症这一主要结局的观察发病率相似（FHGS组为8.6%，VHTS组为9.0%，差异为0.4%[95%CI -3.2%至2.5%]，P=0.808）。FHGS组和VHTS组在任何次要结局方面的差异均无统计学意义。
在根治性肾切除术中，内镜手术吻合器已成为肾血管横断的常用工具，FHGS和VHTS是主要的钉仓类型。在这项对3747例接受根治性肾切除术的非供体患者的回顾性研究中，使用FHGS与VHTS钉仓的临床和经济结局相似。
