IN.PACT AV Access Trial: Economic Evaluation of Drug-Coated Balloon Treatment for Dysfunctional Arteriovenous Fistulae Based on 12-Month Clinical Outcomes

PurposeTo study, from a U.S. payer’s perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae.Materials and MethodsCost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated.ResultsUsing the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48.ConclusionsEndovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness.     

紫杉醇药物涂层球囊成形术治疗症状性椎动脉开口处狭窄的疗效

目的 探讨紫杉醇药物涂层球囊（P-DCB）成形术治疗症状性椎动脉开口狭窄的安全性和有效性。方法 回顾性分析2017 年12月至2019年6月经P-DCB成形术治疗的43例症状性椎动脉开口处狭窄的临床资料。结果 所有病人均完成介入治疗，成功率为100%。术后即刻狭窄率[（12.03±2.15）%]较术前[（86.32±10.26）%]明显降低（P<0.05）。围手术期发生动脉夹层1例，无其他并发症。随访12~16个月，平均13.5个月；症状改善43例，无变化例，症状改善率为95.3%（41/43）；全部病人接受DSA或CTA随访，随访狭窄率[（16.1±3.12）%]与术后即刻无统计学差异（P>0.05）；5例发生再狭窄，再狭窄率为11.6%。结论 P-DCB成形术治疗椎动脉开口狭窄具有较好的临床疗效。     

Balloon Pulmonary Angioplasty for the Treatment of Nonoperable Chronic Thromboembolic Pulmonary Hypertension: Single-Center Experience with Low Initial Complication Rate

PurposeTo evaluate the safety and efficacy of balloon pulmonary angioplasty (BPA) for nonoperable chronic thromboembolic pulmonary hypertension (CTEPH) patients during the initial experience of a single center.MethodsA total of 18 CTEPH patients (5 with residual pulmonary hypertension after pulmonary endarterectomy) were treated with BPA during the period 2014–2018 and were retrospectively reviewed. Mean age was 61 ± 19 years; 55% were female; mean pulmonary artery pressure was 44 ± 12 mmHg; cardiac output was 4.3 ± 1.0 l/min; and pulmonary vascular resistance was 8.4 ± 3.6 WU. Patients were evaluated by New York Heart Association functional class, 6-minute walk distance, N-terminal pro b-type natriuretic peptide, echocardiography, right heart catheterization, and before and after completions of BPA.ResultsA total of 91 procedures were performed, with a median number of 4 BPA sessions per patient (range, 2–8). There were no deaths or major complications requiring extracorporeal support or (non)invasive ventilation. The most common complication was self-limiting hemoptysis (3%). According to Society of Interventional Radiology classification, 4 mild, 4 moderate, and 1 severe adverse events were noted. Invasive hemodynamics significantly improved, with a cardiac index increase of 15% (P = .0333), decrease of mean pulmonary artery pressure of 30% (P = .0013), and decrease of pulmonary vascular resistance of 45% (P = .0048). Stroke volume index (P = .0171) and pulmonary arterial compliance (P = .0004) were also significantly enhanced.ConclusionsBPA significantly improves cardiopulmonary hemodynamics with an acceptable safety profile. Further studies assessing the long-term efficacy of BPA are required.     

耳科手术护理配合标准作业程序的构建与应用

目的提高耳科疾病患者手术护理质量与效率。方法按时间段将耳科手术患者400例分为两组各200例;对照组按常规进行手术护理配合;观察组构建耳科手术护理配合标准作业程序(SOP),对护士进行专项培训后用于手术护理中。比较耳蜗植入、中耳手术、听神经瘤手术及咽鼓管球囊扩张4项手术的应用效果。结果观察组前3项手术时间显著短于对照组;手术医生满意度显著高于对照组,因手术器械仪器故障致手术中断率显著低于对照组(P0.05,P0.01)。结论构建的耳科手术护理配合SOP使手术护理规范化、标准化、同质化,有效提高了手术室护理工作效率及护理质量。     

Capsule endoscopy for small‐intestinal disorders: Current status

Small‐bowel capsule endoscopy (SBCE) is used widely because of its non‐invasive and patient‐friendly nature. SBCE can visualize entire small‐intestinal mucosa and facilitate detection of small‐intestinal abnormalities. In this review article, we focus on the current status of SBCE. Several platforms for SBCE are available worldwide. Third‐generation SBCE (PillCam^® SB3) has a high‐resolution camera equipped with an adaptive frame rate system. Several software modes have been developed to reduce the reading time for capsule endoscopy and to minimize the possibility of missing lesions. The main complication of SBCE is capsule retention. Thus, the main contraindication for SBCE is known or suspected gastrointestinal obstruction unless intestinal patency is proven. Possible indications for SBCE are obscure gastrointestinal bleeding, Crohn's disease, small‐intestinal polyps and tumors, and celiac disease. Colon capsule endoscopy (CCE) can observe inflamed colonic mucosa non‐invasively, and allows for the continuous and non‐invasive observation of the entire intestinal tract (pan‐endoscopy). Recently, application of CCE as pan‐enteric endoscopy for inflammatory bowel diseases (including Crohn's disease) has been reported. In the near future, reading for CE will be assisted by artificial intelligence, and reading CE videos for long periods will not be required.     

Cholecystectomy reduces subsequent cholangiocarcinoma risk in choledocholithiasis patients undergoing endoscopic intervention

BACKGROUNDCholangiocarcinoma is a disease with a high mortality rate. Our previous study revealed that cholelithiasis patients who undergo endoscopic sphincterotomy (ES)/endoscopic papillary balloon dilatation are at a higher risk for subsequent cholangiocarcinoma than cholelithiasis patients who undergo cholecystectomy.AIMTo clarify the relationship between recurrent biliary events and subsequent cholangiocarcinoma risk in choledocholithiasis patients.METHODSFrom one million random cases in the Taiwan National Health Insurance Research Database 2004–2011, we selected symptomatic choledocholithiasis patients older than 18 years who were admitted from January 2005 to December 2009 (study group). Cases for a control group were defined as individuals who had never been diagnosed with cholelithiasis, matched by sex and age in a 1:3 ratio. The study group was further divided into ES/endoscopic papillary balloon dilatation, both ES/endoscopic papillary balloon dilatation and cholecystectomy, and no intervention groups.RESULTSWe included 2096 choledocholithiasis patients without previous intervention or cholangiocarcinoma. A total of 12 (2.35%), 11 (0.74%), and 1 (1.00%) subsequent cholangiocarcinoma cases were diagnosed among 511 ES/endoscopic papillary balloon dilatation patients, 1485 patients with no intervention, and 100 ES/endoscopic papillary balloon dilatation and cholecystectomy patients, respectively. The incidence rates of recurrent biliary event were 527.79/1000 person-years and 286.69/1000 person-years in the subsequent cholangiocarcinoma and no cholangiocarcinoma group, showing a high correlation between subsequent cholangiocarcinoma risk and recurrent biliary events.CONCLUSIONCholedocholithiasis patients who undergo further cholecystectomy after ES/endoscopic papillary balloon dilatation have decreased subsequent cholangiocarcinoma risk due to reduced recurrent biliary events.