Rego Alfredo, Cheung Patricia C, Harris William J, Brady Kevin M, Newman Jeffrey, Still Robert
South Florida Heart & Lung Institute, 3650 NW 82nd Ave, Doral, FL, 33166, USA.
Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA, USA.
J Cardiothorac Surg. 2019 Mar 15;14(1):61. doi: 10.1186/s13019-019-0871-5.
A prospective, multi-center study (RECON) was conducted to evaluate the clinical outcomes of pericardial closure using a decellularized extracellular matrix (ECM) graft derived from porcine small intestinal submucosa.
Patients indicated for open cardiac surgery with pericardial closure using ECM were eligible for the RECON study cohort. Postoperative complications and readmission of the RECON patients were compared to the patient cohort in the Nationwide Readmissions Database (NRD). Inverse probability of treatment weighting was used to control the differences in patient demographics, comorbidities, and risk factors.
A total of 1420 patients at 42 centers were enrolled, including 923 coronary artery bypass grafting (CABG) surgeries and 436 valve surgeries. Significantly fewer valve surgery patients in the RECON cohort experienced pleural effusion (3.1% vs. 13.0%; p < 0.05) and pericardial effusion (1.5% vs. 2.6%; p < 0.05) than in the NRD cohort. CABG patients in the RECON cohort were less likely to suffer bleeding (1.2% vs. 2.9%; p < 0.05) and pericardial effusion (0.2% vs. 2.2%, p < 0.05) than those in the NRD cohort. The 30-day all-cause hospital readmission rate was significantly lower among RECON patients than NRD patients following both valve surgery (HR: 0.34; p < 0.05) and CABG surgery (HR: 0.42; p < 0.05). In the RECON study, 14.4% of CABG patients and 27.0% of valve patients had postoperative atrial fibrillation as compared to previously reported risks, which generally ranges from 20 to 30% after CABG and from 35 to 50% after valve surgery.
Pericardial closure with ECM following cardiac surgery is associated with a reduction in the proportion of patients with pleural effusion, pericardial effusion, and 30-day readmission compared to a nationwide database.
NCT02073331 , Registered on February 27, 2014.
开展了一项前瞻性多中心研究（RECON），以评估使用源自猪小肠黏膜下层的脱细胞细胞外基质（ECM）移植物进行心包闭合术的临床疗效。
因心脏直视手术需用心包闭合术且使用ECM的患者符合RECON研究队列的入选标准。将RECON患者的术后并发症和再次入院情况与全国再入院数据库（NRD）中的患者队列进行比较。采用治疗权重逆概率法来控制患者人口统计学、合并症和危险因素方面的差异。
42个中心共纳入1420例患者，其中包括923例冠状动脉旁路移植术（CABG）和436例瓣膜手术。与NRD队列相比，RECON队列中瓣膜手术患者发生胸腔积液（3.1%对13.0%；p<0.05）和心包积液（1.5%对2.6%；p<0.05）的比例显著更低。与NRD队列中的CABG患者相比，RECON队列中的CABG患者发生出血（1.2%对2.9%；p<0.05）和心包积液（0.2%对2.2%，p<0.05）的可能性更小。在瓣膜手术（HR：0.34；p<0.05）和CABG手术（HR：0.42；p<0.05）后，RECON患者的30天全因住院再入院率均显著低于NRD患者。在RECON研究中，CABG患者和瓣膜手术患者术后发生心房颤动的比例分别为14.4%和27.0%，与之前报道的风险相比，CABG术后的风险一般在20%至30%之间，瓣膜手术后的风险在35%至50%之间。
与全国性数据库相比，心脏手术后用心包闭合术使用ECM与胸腔积液、心包积液患者比例降低以及30天再入院率降低相关。
NCT02073331，于2014年2月27日注册。
