钙调磷酸酶抑制剂和环磷酰胺对2型糖尿病患者中特发性膜性肾病的疗效和预后比较

  目的  比较不同初始治疗方案对2型糖尿病患者中特发性膜性肾病(idiopathic membranous nephropathy,IMN)的疗效及预后。  方法  回顾性收集并分析2004年1月至2015年4月在北京协和医院确诊的2型糖尿病合并IMN患者临床资料。根据初始治疗方案将患者分为环磷酰胺(cyclophosphamide,CTX)组、钙调磷酸酶抑制剂(calcineurin inhibitors,CNIs)组和其他治疗组。采用Kaplan-Meier生存分析和Cox多因素回归分析,观察不同治疗方案对患者总体缓解 (total remission,TR)率、完全缓解 (complete remission,CR)率、估算肾小球滤过率 (estimated glomerular filtration rate,eGFR)下降 ≥ 30%或进入终末期肾病 (end-stage renal disease,ESRD)、空腹血糖>8 mmol/L的影响。  结果  共纳入89例符合入选和排除标准的2型糖尿病合并IMN患者。多因素回归分析显示,CNIs组和CTX组在CR(HR=0.793,95% CI:0.315~1.999,P=0.623)、TR (HR=0.647,95% CI:0.334~1.252,P=0.196) 及空腹血糖>8 mmol/L(HR=1.709,95% CI:0.669~4.369,P=0.263)方面均无统计学差异。但CNIs组出现eGFR下降 ≥ 30%或进入ESRD的风险显著高于CTX组(HR=13.505,95% CI:1.512~120.665,P=0.020)。  结论  在2型糖尿病合并IMN患者中,CNIs与CTX作为初始治疗蛋白尿缓解率相当,但CNIs治疗后肾功能下降的风险显著增加。对此类患者需谨慎选择初始治疗方案。     

分子分型与老年乳腺癌患者预后的相关性:病例对照研究

  目的  通过分析老年乳腺癌分子分型特点, 明确分子分型与老年乳腺癌患者预后的相关性。  方法  回顾性收集北京协和医院乳腺外科2010年1月1日至2016年6月30日收治的老年乳腺癌患者的临床资料, 包括基本人口学特征、手术方式、病理信息、辅助治疗信息及预后。应用Kaplan-Meier和Cox比例风险回归模型分析分子分型与患者无病生存期和总生存期的相关性。  结果  共502例符合纳入和排除标准的患者入选本研究, 平均年龄(76.65±4.36)岁, 其中腔管型乳腺癌占79.88%(401/502), 人表皮生长因子受体-2(human epidermal growth factor receptor 2, Her-2)过表达型乳腺癌占7.77%(39/502), 三阴性乳腺癌占12.35%(62/502)。截至末次随访(2019年4月30日), 8.37%(42/502)的患者出现局部复发和/或远处转移, 50例患者去世, 其中11例死因与乳腺癌相关。生存分析提示, 分子分型与老年女性乳腺癌患者无病生存期(P < 0.001)及总生存期(P=0.040)均显著相关, 腔管B2型(HR=4.306, 95% CI:1.469~12.618, P=0.008)、Her-2过表达型(HR=3.729, 95% CI:1.418~9.809, P=0.008)和三阴性(HR=2.580, 95% CI:1.045~6.367, P=0.040)乳腺癌局部复发和/或远处转移风险均明显高于腔管A型; Her-2过表达型总生存期显著劣于腔管A型(HR=3.219, 95% CI:2.762~3.676, P=0.010)。  结论  老年女性乳腺癌患者的分子分型与无病生存期及总生存期显著相关, 腔管B2型、Her-2过表达型和三阴性老年女性乳腺癌局部复发及远处转移风险较高。     

输注血液制品与心脏术后结局相关性的系统分析

  目的  系统评价心脏围术期输血与术后近远期结局的关系。  方法  检索中英文文献数据库中1990年1月至2014年12月关于输血和心脏术后结局关系的回顾性病例对照研究, 使用RevMan 5.3软件, 应用Meta分析方法对所纳入文献的研究结果进行定量综合分析。  结果  本研究共纳入13项回顾性病例对照临床研究, 总样本量88 808例, 其中输血组42 991例, 未输血组45 817例。输血组和未输血组的各心脏术后结局指标差异均有统计学意义:30 d死亡率(OR=2.39, 95% CI:1.71~3.34, P < 0.000 01), 1年死亡率(OR=3.08, 95% CI:2.18~4.35, P < 0.000 01), 5年死亡率(OR=1.90, 95% CI:1.42~2.56, P < 0.0001), 缺血事件(OR=2.23, 95% CI:1.71~2.90, P < 0.000 01), 感染(OR=2.18, 95% CI:1.74~2.75, P < 0.000 01)。  结论  围术期输血与心脏手术后近远期死亡率和缺血事件、感染的发生具有明显相关性。     

剖宫产切口瘢痕妊娠超声参数与手术中出血量的相关性

  目的  探讨剖宫产切口瘢痕妊娠二维、三维超声参数与手术中出血量的相关性, 分析影响手术出血量的独立危险因素。  方法  收集2011年11月至2013年1月北京协和医院临床确诊为剖宫产切口瘢痕妊娠、并接受手术治疗的35例患者, 术前进行二维及三维超声检查, 获得病灶最大径、病灶平均径、病灶植入瘢痕面积、植入体积及植入深度; 按有无胎心搏动、病灶类型、彩色多普勒血流分级及术前有/无甲氨蝶呤联合治疗进行分组。记录患者手术中出血量, 分析超声参数与出血量的相关性, 比较组间出血量差异; 将病灶按出血量进行分组, ≥ 200 ml组和 < 200 ml组, 应用Logistic回归分析影响出血量的独立危险因素。  结果  病灶最大径和病灶植入瘢痕面积与出血量存在线性关系(P=0.009和0.008)。病灶平均径、病灶植入体积、病灶植入深度与出血量无线性关系(P=0.017, 0.044和0.423)。有/无胎心搏动组间出血量(分别为23.38和13.47 ml)差异有统计学意义(P=0.004);病灶类型、彩色多普勒血流分级及术前有/无甲氨蝶呤联合治疗组间出血量差异无统计学意义(P=0.131, 0.044和0.047)。Logistic回归分析显示病灶植入瘢痕面积为影响手术中出血量的独立危险因素(P=0.007), 受试者工作特征曲线下面积为0.839(0.606~1.071)。  结论  剖宫产切口瘢痕妊娠病灶最大径、病灶植入瘢痕面积及有/无胎心搏动与手术中出血量密切相关, 其中病灶植入瘢痕面积是影响剖宫产切口瘢痕妊娠手术中出血量的独立危险因素, 本研究结果可为临床决策(包括是否手术及术式选择)提供重要参考依据。     

脑血流动力学及脑氧饱和度变化与感染性休克患者预后的相关性:前瞻性队列研究

  目的  探讨大脑中动脉血流动力学相关指标及脑氧饱和度变化与感染性休克患者预后的相关性。  方法  前瞻性收集2018年5月至2019年3月在中南大学湘雅医院重症医学科住院治疗的感染性休克患者临床资料, 根据28 d内是否死亡, 将患者分为死亡组和存活组。比较两组患者一般资料, 入重症监护室即刻和初始复苏治疗6 h后动脉和中心静脉血气指标, 重症心脏超声指标, 器官功能指标, Sepsis生物标志物指标, 液体复苏治疗6 h后大脑中动脉血流速度、灌注指数、动态脑血管自动调节功能[瞬时脑充血反应率(transient hyperemic response ratio, THRR)]以及脑氧饱和度变化。采用多因素Logistic回归, 分析影响感染性休克患者预后的危险因素。  结果  51例符合纳入和排除标准的感染休克患者入选本研究, 男性31例, 女性20例, 年龄(53±13)岁, 28 d死亡率为43%。死亡组的序贯性器官衰竭评分(sequential organ failure assessment, SOFA)(P=0.007)、入室急性生理和慢性健康状况评估(acute physiology and chronic health evaluation Ⅱ, APACHE Ⅱ)评分(P=0.026)以及高峰APACHE Ⅱ评分(P < 0.001)均高于存活组。初始复苏治疗6 h后, 死亡组的氧合指数低于存活组(P=0.047), 而中心静脉-动脉二氧化碳分压差(central venous-to-arterial carbon dioxide difference, Pcv-aCO₂)则高于存活组(P=0.044)。死亡组动态脑血管自动调节功能受损者(THRR < 1.09)多于存活组(P=0.025), 脑氧饱和度(regional cerebral oxygen saturation, rSO₂)均值低于存活组(P=0.031)且rSO₂均值< 60%者多于存活组(P=0.010)。多因素Logistic回归分析显示, 高峰APACHE Ⅱ评分(OR=1.099, 95% CI:1.009~1.196, P=0.030)、液体复苏治疗6 h后的Pcv-aCO₂(OR=1.320, 95% CI:1.001~1.742, P=0.050)、THRR < 1.09(OR=4.952, 95% CI:1.130~21.70, P=0.034)和rSO₂均值< 60%(OR=4.817, 95% CI:1.392~16.663, P=0.013)是预测感染性休克患者28 d内死亡的独立危险因素。  结论  感染性休克患者死亡率高, 脑血流动力学和rSO₂指标中动态脑血管自动调节功能障碍(THRR < 1.09)与rSO₂均值< 60%是28 d死亡率增加的独立预测因素。     

肺间质纤维化合并严重呼吸衰竭患者的机械通气策略

  目的  研究肺间质纤维化合并严重呼吸衰竭患者的机械通气策略。  方法  54例肺间质纤维化合并呼吸衰竭患者分为无创通气组(21例)和有创通气组(33例), 观察两组患者机械通气前后动脉血气的变化以及机械通气治疗期间出现的并发症, 计算两组患者死亡率及平均住院时间。  结果  两组患者接受机械通气治疗1 h后氧合均得到明显改善(P < 0.01)。无创通气组患者机械通气治疗期间并发症发生率为23.8%, 明显少于有创通气组的51.5%(P=0.043);无创通气组和有创通气组患者死亡率分别为90.5%和93.9%, 两组差异无统计学意义(P=0.636);无创通气组患者平均住院时间为(13.1±11.7)d, 明显少于有创通气组的(19.4±15.8)d(P=0.008)。  结论  对于肺间质纤维化合并严重呼吸衰竭患者, 无创正压通气和有创通气均难以改善预后, 但无创正压通气因并发症较少且住院时间短, 可尝试使用。     

重症医学科严重大出血患者预后危险因素

  目的  探讨影响重症医学科病房(Intensive Care Unit, ICU)严重大出血患者预后的危险因素。  方法  回顾性分析北京协和医院2013年1月至2015年12月全部收住ICU 24 h内输注红细胞(red blood cell, RBC)超过20 U的大出血患者的临床资料, 比较生存组与死亡组的差异, 并采用Logistic回归分析影响这些患者预后的危险因素。  结果  研究共纳入严重大出血患者141例, 生存组和死亡组患者分别为78例和63例, 住院死亡率44.7%。其中非手术相关大出血78例, 手术相关大出血63例。全部严重大出血患者死亡组ICU输RBC量(P=0.002)、非手术相关大出血患者的比例(P=0.002)以及来自急诊的大出血患者的比例(P=0.010)均显著高于生存组, 而来自手术科室患者的比例低于生存组(P=0.001), 输RBC前凝血功能, 肝、肾功能明显较生存组差(P均 < 0.05)。在非手术相关大出血患者中, 死亡组感染造成大出血患者的比例显著高于生存组(P=0.009), 而应激性溃疡导致大出血患者的比例(P=0.048)、输RBC前血小板水平(P=0.003)和采用手术止血措施的患者比例(P=0.039)均显著低于生存组。在手术相关大出血患者中, 死亡组ICU输RBC量显著多于生存组(P=0.019), 输RBC前基线肝、肾功能受损的比例显著高于生存组(P均 < 0.05)。Logistic回归分析显示患者凝血功能紊乱(P=0.014, OR=3.594)及入ICU后仍存在活动性大出血(P=0.025, OR=2.680)为全部严重大出血患者死亡危险因素。  结论  患者凝血功能紊乱及入ICU后仍存在活动性大出血是严重大出血患者的死亡危险因素。     

子宫下段受累可能为Ⅰ期内膜癌辅助放疗的不良预后因素

  目的  探讨子宫下段受累对Ⅰ期子宫内膜癌术后放疗患者的预后作用。  方法  回顾性分析1999年1月至2012年12月在北京协和医院进行术后放疗的Ⅰ期子宫内膜癌患者265例, 中位年龄53岁, 病理类型主要为子宫内膜样腺癌(226例, 85.3%)。根据病理结果是否有子宫下段受累分为两组:子宫下段受累组和子宫下段未受累组, 比较两组患者的预后因素和临床治疗结果, 并对其中的高危和高中危患者进行亚组分析。主要研究终点包括总生存率、无进展生存率、局部区域复发率、远处转移率和治疗失败率。使用Kaplan-Meier法统计生存率, 不同组间生存率的比较使用Log-rank检验, 使用Cox比例风险回归模型进行预后因素分析。  结果  所有Ⅰ期内膜癌患者的5年总生存率和无进展生存率分别为92.8%和89.7%, 5年局部区域复发率、远处转移率和治疗失败率分别为4.5%、6.4%和7.8%。单因素分析显示, 子宫下段受累是影响总生存率和无进展生存率的相关因素(P=0.015, 0.035)。Cox比例风险回归模型显示, 子宫下段受累组患者的总生存率和无进展生存率更低(P=0.041, RR=0.346, 95% CI:0.125~0.959; P=0.041, RR=0.411, 95% CI:0.175~0.963)。亚组单因素分析显示, 在高危和高中危患者中, 子宫下段受累是影响治疗失败率的相关因素(P=0.034)。  结论  子宫下段受累可能是影响Ⅰ期内膜癌辅助放疗患者总生存率和无进展生存率的不良预后因素; 在高危和高中危患者中, 子宫下段受累主要与治疗失败的发生相关。     

腹腔手术后重症患者心肌损伤的危险因素

  目的  探讨腹腔手术后重症患者心肌损伤的发生情况及可能的危险因素。  方法  回顾性分析北京大学人民医院2017年1月至2019年1月腹腔手术后重症患者的一般临床资料及心肌损伤情况,收集并观察基础病史、术中(手术时间、是否急诊手术、术中出血＞800 ml和术中低血压等)及术后指标(改良氧合指数、血乳酸、急性肾损伤和术后24 h内使用升压药情况等)。根据术后是否发生心肌损伤,将患者分为心肌损伤组和非心肌损伤组,采用Logistic回归分析腹腔手术后重症患者心肌损伤的危险因素。  结果  在纳入的803例腹腔手术后重症患者中,心肌损伤发生率为17.2%(138/803),而急性心肌梗死发生率仅为0.9%(7/803)。单因素分析显示,慢性肾功能不全病史、手术时间、急诊手术、术中低血压、术后24 h内使用升压药、高APACHEⅡ评分及术后即刻急性肾损伤与术后重症患者心肌损伤相关(P＜0.05)。多因素回归分析显示,急诊手术(OR=3.14,95% CI:1.76~5.60,P＜0.001)、术后24 h内使用升压药(OR=2.26,95% CI:1.23~4.15,P=0.008)、APACHEⅡ评分(OR=1.05,95% CI:1.01~1.09,P=0.008)和术后急性肾损伤(OR=3.18,95% CI:1.78~5.69,P＜0.001)与腹腔手术后重症患者发生心肌损伤独立相关。  结论  重症患者腹腔手术后心肌损伤发生率高,急诊手术、术后24 h内使用升压药、高APACHEⅡ评分和术后急性肾损伤是导致腹腔手术后重症患者发生心肌损伤的独立危险因素。     

直肠癌术前容积调强与固定野调强技术的剂量学比较

  目的  比较对直肠癌术前患者应用固定野调强(fixed-field intensity-modulated radiotherapy, FF-IMRT)和容积调强(volumetric modulated arc therapy, VMAT)两种计划方式进行术前放射治疗的剂量学差异。  方法  选择15例直肠癌术前进行调强放疗的患者行CT模拟定位, 勾画靶区及危及器官, 对同一CT图像设计FF-IMRT计划和VMAT计划。评估靶区及危及器官的剂量分布。  结果  VMAT计划组和FF-IMRT计划组靶区覆盖度均能满足处方剂量要求。与FF-IMRT计划组相比, VMAT计划组计划靶区(planning target volume, PTV)105%覆盖度、Dmean及Dmax均增加(P=0.011, P=0.017, P=0.006), 适形度指数减低(P=0.008), 而均匀性指数差异无统计学意义(P=0.193)。与FF-IMRT计划组相比, VMAT计划组膀胱V₅₀增加约15%(P=0.009), Dmax平均值增加0.7 Gy(P=0.003);小肠V₃₀降低10%(P=0.004), Dmax平均值增加0.9 Gy(P=0.000);骨髓V₁₀、V₃₀、V₄₀分别降低2%、10%、10%(P=0.000, P=0.000, P=0.000), Dmean平均值降低1.7 Gy(P=0.000);左右股骨头D₅分别降低3.2 Gy、2.4 Gy(P=0.000, P=0.000);全身V₁₀、V₂₀、V₃₀、V₄₀也明显降低(P=0.003, P=0.000, P=0.000, P=0.004)。VMAT计划组较FF-IMRT计划组机器跳数(monitor units, MU)平均值减少50%(P=0.000)。  结论  直肠癌术前患者采用VMAT技术, 可以获得等同于或优于FF-IMRT计划的剂量分布, 患者治疗时间明显缩短, MU明显降低。     

Survival and Appropriate Device Interventions in Recipients of Cardioverter Defibrillators Implanted for the Primary Versus Secondary Prevention of Sudden Cardiac Death

Background: Implantable cardioverter-defibrillators (ICD) implanted after an episode of ventricular tachyarrhythmia (VTA) or in patients at high risk of VTA lower the long-term mortality. Comparisons of the clinical outcomes of the two indications are scarce.
Methods: The study enrolled 360 consecutive ICD recipients. The device was implanted for secondary prevention in 150 patients, whose mean age was 60 ± 14 years, and mean left ventricular ejection fraction (LVEF) was 40 ± 16%, and for primary prevention in 210 patients, whose mean age was 61 ± 11 years, and mean LVEF was 31 ± 13%. All-cause mortality and time to first appropriate ICD therapy were measured.
Results: The two study groups were similar with respect to age and prevalence of coronary artery disease. Mean LVEF was higher in the secondary prevention group (P = 0.001). Cox regression analysis revealed a significantly shorter time to first appropriate ICD therapy in the secondary prevention group (HR = 0.51, 95% CI = 0.30 – 0.87, P = 0.01). Over a mean follow-up of 37 ± 19 months, the all-cause mortality in the overall population was 12.7%, and was similar in both subgroups (HR = 0.99, 95% CI = 0.55–1.77, P = 0.97).
Conclusions: The long-term mortality in this unselected population of ICD recipients was low. Patients treated for secondary prevention received earlier appropriate ICD therapy than patients treated for primary prevention. Long-term mortality was similar in both groups. The higher VT incidence of VTA was effectively treated by the ICD and was not associated with a higher mortality.     

Predictors of Appropriate Implantable Cardioverter Defibrillator (ICD) Therapy in Primary Prevention Patients with Ischemic and Nonischemic Cardiomyopathy

Background: We sought to assess predictors of appropriate implantable cardioverter defibrillator (ICD) therapy in patients receiving primary prevention ICDs. Methods: Four hundred twenty‐one consecutive patients (ischemic and nonischemic) undergoing primary prevention ICD implantation were studied. Patients were grouped based on the presence/absence of appropriate ICD therapy. Summary data and stored electrograms from ICDs were reviewed to determine appropriateness of therapy. Predictors of therapy were assessed by both univariate and multivariate Cox regression analysis. Results: Of 421 primary prevention patients undergoing ICD implantation, 79 (19%) had received appropriate ICD therapies. By univariate comparison, nonsustained ventricular tachycardia (NSVT), male sex, left ventricle diastolic diameter (LVDD), and hypertension were all significant predictors for ICD therapy over a mean follow‐up time of 751 ± 493 days (P ≤ 0.05). The use ofβ‐blockers was found to be a negative predictor. In the ischemic cardiomyopathy (ICM) population, 55 (17%) patients received ICD therapy and this was predicted by NSVT, hypertension, LVDD, and left atrial diameter.β‐blockers were protective. In the nonischemic dilated cardiomyopathy (NIDCM) population, 24 (23%) received appropriate therapies, which were predicted by NSVT, male sex, dual chamber device, lack of biventricular device, and lack ofβ‐blockers. By multivariate analysis, NSVT, hypertension, and lack ofβ‐blockers were significant for ICM, while NSVT and absence ofβ‐blockers were predictive for NIDCM. Ejection fraction, New York Heart Association class, and QRS width were not significantly different between therapy and no‐therapy groups in any population. Conclusions: ICD‐delivered therapy occurred in 19% of primary prevention patients with both ischemic and dilated cardiomyopathy and was predicted by NSVT and a lack ofβ‐blocker use. (PACE 2010; 33:320–329)     

Are Nonsustained Ventricular Tachycardias Predictive of Major Arrhythmias in Patients with Dilated Cardiomyopathy on Optimal Medical Treatment?

Background: To evaluate the role of nonsustained ventricular tachycardias (NSVT) for the prediction of major ventricular arrhythmias (MVA) in patients with idiopathic dilated cardiomyopathy (DCM) after optimization of medical treatment.
Methods and Results: Three hundred nineteen consecutive DCM patients were evaluated after adequate stabilization on optimal angiotensin-converting enzyme (ACE) inhibitor (88%) and β-blocker (82%) therapy. Frequency, length, and rate of NSVT at 24-hour Holter monitoring were analyzed to assess their values in predicting MVA (unexpected sudden death, SVT, ventricular fibrillation, and appropriate implantable cardioverter defibrillator interventions). During follow-up (median 96 months, 1^st–3^rd interquartile range 52–130), MVA incidence was low, and not statistically different between patients with and without NSVT (3 and 2 per 100 patient-years, respectively, P = nonsignificant [NS] at log-rank analysis). At multivariable analysis, the number of NSVT was predictive of MVA only if left ventricular ejection fraction (LVEF) was >0.35 (two NSVT/day vs no NSVT/day: hazard ratio [HR] 5.3, 95% confidence interval [CI] 1.59–17.85 in LVEF >0.35 vs HR 0.93, 95% CI 0.3–2.81 in LVEF ≤0.35). Consequently, in patients with LVEF ≤0.35, MVA incidence rates were similar regardless of NSVT (3.6 and 4.1 patient-years, respectively, in those with and without NSVT, P = NS), while in patients with LVEF >0.35, MVA incidence (3.1 per 100 patient-years vs 0.9 per 100 patient-years, P = 0.003) was significantly higher when NSVT were present.
Conclusions: After medical stabilization, NSVT did not increase the risk of MVA in patients with DCM and LVEF ≤0.35. Conversely, the number and length of NSVT runs were significantly related to the occurrence of MVA in the patients with LVEF >0.35.     

Left Ventricular Ejection Fraction and Absence of ACE Inhibitor/Angiotensin II Receptor Blocker Predicts Appropriate Defibrillator Therapy in the Primary Prevention Population

Introduction: Implantable cardioverter defibrillators (ICD) significantly reduce mortality in patients with left ventricular (LV) dysfunction. However, little is known of the predictors of appropriate device activation in the primary prevention population. The aim of the present study was to determine predictors of appropriate device therapy in patients receiving ICDs for primary prevention. Methods & Results: One hundred twenty‐six patients with a left ventricular ejection fraction (LVEF) of < 35% and no prior documented ventricular arrhythmias underwent ICD implantation. The ICD implanted was single chamber in 60 (48%), dual chamber in 10 (8%), and biventricular in 56 (44%) patients and programmed with a single ventricular fibrillation (VF) zone at >180 beats per minute. Mean age was 58 ± 13 years and mean LVEF was 23 ± 7%. Fifty‐two percent had ischemic cardiomyopathy and 66% were New York Heart Association heart failure class II/III. During a mean follow‐up period of 589 ± 353 days, 17 (13%) patients received appropriate device therapy and three (4%) received inappropriate shocks. Appropriate ICD therapy was associated with reduced LVEF (mean 19.9% vs 23.7%, P = 0.02) and the patients were less likely to have received angiotensin‐converting enzyme inhibitor (ACEI) or angiotensin II receptor blockers (AIIRB) (65% vs 90%, P = 0.04). Multivariate analysis revealed lack of ACEI/AIIRB (odds ratio [OR]= 0.06, 95% confidence interval [CI]= 0.01–0.37, P = <0.01) and lower LVEF (OR = 0.88, 95% CI 0.79–0.98, P = 0.02) predicted appropriate device activation. There was no difference in transplant‐free survival between the appropriate therapy and no/inappropriate therapy groups, LVEF <20% and LVEF >20% group, and lack of ACEI/AIIRB and ACEI/AIIRB group. Conclusion: Appropriate device activation occurred in 13% of patients in a primary prevention population. LVEF and absence of ACEI/AIIRB predicted appropriate ICD therapy. (PACE 2010; 33:696–704)     

Ventricular Proarrhythmic Effects of Atrial Fibrillation are Modulated by Depolarization and Repolarization Anomalies in Patients with Left Ventricular Dysfunction

Background: Atrial fibrillation (AF) may have a ventricular proarrhythmic effect, particularly in the setting of heart failure. We assessed whether AF predicts appropriate implantable cardioverter-defibrillator (ICD) shocks in patients with left ventricular dysfunction and explored modulators of risk.
Methods and Results: A retrospective cohort study was conducted on 215 consecutive patients with ICDs for primary prevention having a left ventricular ejection fraction ≤ 35%. Mean age at ICD implantation was 61.0 ± 9.7 years and 17% were women. Overall, 22 patients (10.2%) experienced appropriate ICD shocks over a follow-up of 1.3 ± 0.7 years, corresponding to an actuarial event-rate of 5.8% per year. In univariate analysis, AF was associated with a 3.6-fold increased risk of appropriate shocks (P = 0.0037). Annual rates of appropriate ICD shocks in patients with and without AF were 12.9% and 3.5%, respectively (P = 0.0200). In multivariate stepwise Cox regression analyses controlling for baseline imbalances, demographic parameters, underlying heart disease, and therapy, history of AF independently predicted appropriate shocks (hazard ratio 2.7, P = 0.0278). Prolonged QRS duration (>130 ms) and QTc (>440 ms) modulated the effect of AF on appropriate shocks. Patients with both AF and QRS > 130 ms were more than five times more likely to receive an appropriate ICD shock (hazard ratio 5.4, P = 0.0396). Patients with AF and QTc > 440 ms experienced a greater than 12-fold increased risk of appropriate shocks (hazard ratio 12.7, P = 0.0177).
Conclusion: In prophylactic ICD recipients with left ventricular dysfunction, AF is associated with increased risk for ventricular tachyarrhythmias, particularly when combined with conduction and/or repolarization abnormalities.     

Sustained polymorphic arrhythmias induced by programmed ventricular stimulation have prognostic value in patients receiving defibrillators

BACKGROUND: Patients with ischemic cardiomyopathy (ICM) who have monomorphic ventricular tachycardia (VT) induced by programmed ventricular stimulation (PVS) are at increased risk of sudden cardiac death (SCD). Among a primary prevention population, the prognostic significance of induced polymorphic ventricular arrhythmias is unknown. METHODS: A total of 105 consecutive patients who received an implantable cardioverter-defibrillator (ICD) for primary prevention of SCD in the setting of ICM and non-sustained VT were retrospectively evaluated. Seventy-five patients (group I) had induction of monomorphic VT and 30 patients (group II) had a sustained ventricular arrhythmia other than monomorphic VT (ventricular flutter, ventricular fibrillation, and polymorphic VT) induced during PVS. RESULTS: Baseline characteristics were similar between group I and group II except for ejection fraction (25% vs. 31%, P = 0.0001) and QRS duration (123 milliseconds vs. 109 milliseconds, P = 0.04). Sixteen of 75 (21.3%) patients in group I and 6 of 30 (20%) patients in group II received appropriate ICD therapy (P = 0.88). Survival free from ICD therapy was similar between groups (P = 0.54). There was a trend toward increased all-cause mortality among patients in group I by Kaplan-Meier analysis (P = 0.08). However, when adjusted for age, EF, and QRS duration mortality was similar (P = 0.45). CONCLUSIONS: There is no difference in rates of appropriate ICD discharge or mortality between patients dichotomized by type of rhythm induced during PVS. These results suggest that patients in this population who have inducible VF or sustained polymorphic VT have similar rates of subsequent clinical ventricular tachyarrhythmias as those with inducible monomorphic VT.     

Implantable Cardioverter Defibrillator Events in Patients with Asymptomatic Nonsustained Ventricular Tachycardia:

Primary prevention trials have demonstrated that patients with coronary disease, reduced left ventricular function, and nonsustained ventricular tachycardia (NSVT) have improved survival with implantable cardioverter defibrillator (ICD) therapy, presumably secondary to effective termination of life-threatening arrhythmias. However, stored intracardiac electrograms were not always available and specific arrhythmias leading to ICD therapy were not always known. We examined the occurrence of ICD events in 51 consecutive patients who match the described patient profile to determine the frequency of appropriate and inappropriate ICD therapy. ICD detections were noted in 18 (35%) patients during a median follow-up period of 13.1 months. Appropriate therapy for sustained ventricular tachycardia (VT)/ventricular fibrillation (VF) occurred in 11 (22%) patients, with appropriate shocks in 8 (16%) patients and appropriate antitachycardia pacing (ATP) in 4 (8%) patients. The time to first appropriate therapy occurred at a mean of 17 +/- 12 months (median 18 months, range 3-36 months). Inappropriate therapy occurred in 5 (10%) patients with inappropriate shocks in 4 patients and inappropriate ATP in 2 patients. Inappropriate therapy was delivered for supraventricular arrhythmias (SVAs) in 4 patients and for T wave oversensing in 1 patient. The reason for shock therapy was unknown in 1 patient (2%) due to ICD malfunction. The mean arrhythmia rate leading to appropriate therapy for VT/VF was 232 +/- 72 beats/min (range 181-400 beats/min), and the mean rate leading to inappropriate therapy for SVT was 168 +/- 10 beats/min (range 160-180 beats/min). Patients with coronary disease and asymptomatic NSVT commonly receive appropriate defibrillator therapy. These results support the need for ICD implantation for primary prevention, with attention to careful programming of the detection rate to prevent inappropriate therapy.     

Variability of Holter electrocardiographic findings in patients fulfilling the noninvasive MADIT criteria. Multicenter Automatic Defibrillator Implantation Trial

In the MADIT study, a selected group of postinfarction patients with asymptomatic nonsustained ventricular tachycardia (NSVT) has been shown to benefit from prophylactic ICD treatment. The present study analyzed the variability of NSVT in a patient population fulfilling the non-invasive MADIT criteria. Three consecutive Holter ECGs were performed in weekly intervals in 68 postinfarction patients with an LVEF < or = 0.35. Patients with NSVT underwent programmed ventricular stimulation (PVS); patients were implanted with an ICD if sustained VT or VF was inducible. If NSVT was found in at least two recordings, the arrhythmia was defined as reproducible. In 28 (41%) of the 68 patients, NSVT was found in at least one recording. Seventeen patients revealed NSVT in the first, the remaining 11 in the second registration; no patient had NSVT only in the third Holter. Of the patients with NSVT, 50% had only one, 39% had two, and 11% had three positive recordings. Thus, reproducible NSVT was found in only 50% of the patients with NSVT. Predictors for reproducibility were LVEF > 0.27, NYHA Class I, absence of digitalis therapy, and > 2 NSVT per 24-hour period. Reproducible NSVT was not associated with risk factors such as elevated mean heart rate, reduced heart rate variability, late potentials, or inducibility of sustained VT during PVS. During 17 +/- 9 months of follow-up, seven (10%) patients experienced arrhythmic events: two without and five with previously documented NSVT. In the latter patients, first occurrence of NSVT was consistently in the first Holter; only two of them had reproducible NSVT. In postinfarction patients, the risk factor NSVT exhibits marked spontaneous variability, especially in those with a low number of NSVT per 24-hour period, LVEF < 0.27 or NYHA III, which limits its clinical value as a selection criterion for PVS. Reproducibility of NSVT itself does not seem to be an independent risk factor.     

Safety and effectiveness of primary prevention cardioverter defibrillators in octogenarians

Background: Implantable cardioverter‐defibrillators (ICDs) reduce the rate of sudden cardiac death (SCD) in patients with cardiomyopathy and reduced left ventricular systolic function. It is unclear if this benefit extends to the very elderly patient population. Methods: Patients who underwent initial ICD implantation at age 80 or older between January 1995 and April 2010 for primary SCD prevention were identified. Clinical data were collected from the medical record, including periprocedural complications, device type, and therapies delivered. Results: Three‐hundred eighty patients were identified; 84 patients met eligibility criteria. The mean age was 82.68 years; mean follow‐up was 34 months. Mean left ventricular ejection fraction was 28.1%. Mortality during follow‐up was 17.9%. One‐ and 5‐year survival estimates were 100% and 60%, respectively. Periprocedural complications occurred in 9.4% of patients; serious complications occurred in 4.8% with no periprocedural deaths. Device therapies occurred in 11.9% (n = 10) of patients (9.5% appropriate, n = 8; 2.4% inappropriate, n = 2). Cardiac resynchronization therapy‐defibrillator (CRT‐D) implantation was associated with prolonged median survival and decreased risk of death (hazard ratio 0.212; 95% confidence interval 0.048?.942, P = 0.042) compared to ICD alone. Conclusions: Implantation of primary prevention ICDs in patients 80 years of age or older was associated with a low risk of serious complications and a 5‐year survival estimate of 60%. Inappropriate therapies after implantation were uncommon. CRT‐D implantation was associated with a decreased risk of death compared to ICD alone. These data suggest that, in selected patients in this age group, ICD implantation is safe and effective. (PACE 2011; 34:900–906)     

Time to First Shock in Implantable Cardioverter Defibrillator (ICD) Patients with Chagas Cardiomyopathy

The time to first ICD shock has been extensively studied in patients with coronary artery disease (CAD). However, there are no published data on ICD shocks in patients with Chagas cardiomyopathy (ChC). The occurrence of the first appropriate ICD shock during the first 6 months of follow-up in 20 patients with ChC (group 1) and 35 CAD patients (group 2) was analyzed retrospectively. All patients had received a third-generation pectoral ICD for ventricular tachycardia or fibrillation (VT/VF). Indications for ICD implantation were refractoriness to drug therapy or noninducibility of VT/VF at EPS in cardiac arrest survivors. Results: The mean age, left ventricular ejection fraction (LVEF), and sex in groups I and II were 57.4 ± 7 years versus 64 ± 9 (P < 0.01), 30.9%± 10% versus 32.9%± 10% (P = NS), and 10 men versus 31 women (P < 0.005), respectively. Six months after ICD implantation, 85% (17/20) group I patients received appropriate ICD shocks versus 51 % (18/35) in group 2, a statistically significant difference (P < 0.02, RR: 1.65, OR: 5.35). Conclusions: The incidence of appropriate ICD shocks within the first 6 months postimplantation was significantly higher in ChC patients than in CAD patients. ChC patients were younger and more often women than CAD patients.