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Appropriateness of Prescription and Safety of Wearable Cardioverter Defibrillators: A Single-center Experience

机译:穿戴式心脏复律除颤器的处方和安全性的适当性:单中心经验

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Introduction Wearable cardioverter defibrillators (WCD) are recommended for patients with a high risk of sudden cardiac death (SCD) secondary to arrhythmia that have not qualified for placement of an implantable cardiac defibrillator (ICD). This study provides insights into a single-center experience with WCD in terms of its usage and safety. Materials and methods We studied all patients that were prescribed a WCD in the Fairview Hospital in Cleveland Clinic Health System, from January 2014 to June 2016. Institutional Review Board of the Cleveland Clinic approved the study. A retrospective chart review was performed to collect data regarding demographics and baseline comorbidities including age, gender, history of hypertension, diabetes, coronary artery disease, and chronic kidney disease. The patients that were lost to follow up in our electronic medical record (EMR) were excluded. Ejection fraction (EF) at the time of diagnosis and follow-up was recorded. The primary outcome was?ICD placement at follow up focusing on appropriate use while the secondary outcome was delivery of shock (appropriate or inappropriate) focusing on efficacy and safety of the device. Patients were stratified based on ICD placement. Statistical Package for the Social Sciences (SPSS), version 23 (IBM Corp., NY, USA) was used for the statistical analysis. Results We identified 73 patients with WCD placement. After the exclusion of 23/73 (31.5%) patients due to loss of follow-up, 50 patients were included in the study (n=50). Clinical characteristics showed 66% patients were males, 76% had hypertension, 40% had diabetes, 34% had chronic kidney disease, 56% patient had a New York Heart Association functional status of II and 34% were on anti-arrhythmic medication. Indication for WCD use was ischemic cardiomyopathy in 23/50 (46%) patients and non-ischemic cardiomyopathy in 27/50 (54%) patients. No ICD was placed in 39/50 (78%) patients and ICD was placed in 11/50 (22%) patients at end time of follow up. Mean age was 59.9 years (95% confidence interval (CI), 55.9 - 63.9 years) in the group with no ICD placement and 63.5 years (95% CI, 56.5 - 70.6 years) in the group with ICD placement. Mean EF in the group with no ICD placement at the time of diagnosis was 25.8% (95% CI, 23.8% - 27.9%) which improved by 18.8% to a mean EF of 44.6% (41.1% - 48.1%) at the follow-up. Mean EF in the group with ICD placement was 32.7% (95% CI, 27.6% - 37.9%) which reduced by 4.1% to mean EF of 28.6% (95% CI, 12.2% - 44.9%) which was statistically significant (p0.0001). Patients who had no ICD placement were followed for an average of 162 days and with ICD placement for 78 days. There was no difference between ischemic or nonischemic groups in getting the ICD. There were no shocks delivered whether appropriate or inappropriate in our population. Conclusion Almost a quarter of the patients that were prescribed WCD in our center ended up with an implanted device which demonstrates appropriate use. Equally important was the observed safety of WCDs as a treatment modality with no inappropriate shocks recorded in the followed cohort.
机译:简介对于不适合植入式心脏除颤器(ICD)放置的心律失常继发性心律失常(SCD)高风险的患者,建议使用可穿戴式心脏复律除颤器(WCD)。这项研究就WCD的使用和安全性提供了对WCD单中心体验的见解。材料和方法我们研究了2014年1月至2016年6月在克利夫兰诊所医疗系统Fairview医院开出WCD的所有患者。克利夫兰诊所机构审查委员会批准了该研究。进行回顾性图表审查以收集有关人口统计学和基线合并症的数据,包括年龄,性别,高血压病史,糖尿病,冠状动脉疾病和慢性肾脏疾病。在我们的电子病历(EMR)中失去随访的患者被排除在外。记录诊断和随访时的射血分数(EF)。主要结果是随访时ICD放置,重点是适当的使用,次要结果是电击(适当或不适当)的递送,重点是设备的功效和安全性。根据ICD的位置对患者进行分层。统计分析使用社会科学统计软件包(SPSS),版本23(IBM Corp.,NY,美国)。结果我们确定了73例WCD植入患者。在由于失去随访而排除23/73(31.5%)位患者后,该研究纳入了50位患者(n = 50)。临床特征显示66%的患者为男性,76%的患者为高血压,40%的患者为糖尿病,34%的患者为慢性肾脏疾病,56%的患者的纽约心脏协会功能状态> II和34%的患者接受抗心律失常药物治疗。使用WCD的适应症是23/50(46%)患者为缺血性心肌病,而27/50(54%)患者为非缺血性心肌病。在随访结束时,未将ICD放置在39/50(78%)患者中,将ICD放置在11/50(22%)患者中。无ICD放置组的平均年龄为59.9岁(95%置信区间(CI),55.9-63.9岁),有ICD放置组的平均年龄为63.5岁(95%CI,56.5-70.6岁)。诊断时未放置ICD的组的平均EF为25.8%(95%CI,23.8%-27.9%),其后提高了18.8%,至随后的平均EF为44.6%(41.1%-48.1%) -向上。植入ICD的组的平均EF为32.7%(95%CI,27.6%-37.9%),降低了4.1%,平均EF为28.6%(95%CI,12.2%-44.9%),具有统计学意义(p <0.0001)。无ICD放置的患者平均随访162天,ICD放置78天。缺血性或非缺血性组在获得ICD方面没有差异。在我们的人口中,无论适当还是不适当,都没有造成任何震惊。结论在我们中心,将近四分之一的接受WCD处方的患者最终都植入了可正确使用的器械。同样重要的是,观察到的WCD作为治疗方式的安全性,随后的队列中未记录任何不适当的电击。

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