家庭监测系统在双腔起搏器植入患者中的多中心注册研究

目的:评价家庭监测系统(HM)在植入双腔起搏器患者中的临床应用。方法:连续入选2009-03至2010-12在全国97家医院植入德国Biotronic公司具有家庭监测功能的起搏器患者,共628例。应用远程无线家庭监测系统每日自动传输起搏器信息,特殊报警事件随时传送。所有信息进行分析,将异常报警事件分为两类:疾病相关事件和系统相关事件;前者主要包括房性和室性心律失常,植入后3个月、6个月对所有入选患者进行常规诊室随访。结果:628例患者中,13例患者一直没有信息传输(2.1%),其余615例患者有137例患者没有异常事件的报警(22.3%),其余478例(77.7%)均可见异常报警事件;HM发现异常事件的时间均早于3个月和6个月门诊随访时发现相应事件的时间。房颤事件中共141例记录到至少一次房颤发作,且6个月随访期间,房颤平均负荷逐渐而显著性降低(P<0.05)。结论:对于植入双腔起搏器的患者,HM是一项安全可靠的远程监测方法,可以早期发现疾病相关事件及起搏系统相关异常,特别是对房颤进行早期诊断与及时治疗,并可能给病人带来临床长远益处。     

全自动远程家庭监测系统在植入心律转复除颤器患者中的应用

目的 评价全自动远程家庭监测（HM）在植入心律转复除颤器（ICD）/心脏再同步治疗除颤器（CRT-D）患者中的应用.方法 随访23例植入了带有HM功能的ICD及CRT-D患者,分析HM所获得的日常信息和报警数据,观察其对系统相关事件、心律失常和心力衰竭（心衰）监测在内的临床相关事件的早期监测及临床干预的疗效.结果 对23例患者随访122～937（452.1±262.2）d,共接收报警信息1 991次,发现异常事件1 481次,其中96.4％是临床相关事件,1.5％为系统相关事件,无信息传输事件占2.1％.系统相关事件多为感知异常,其中发现左心室导线脱位1例.临床相关事件中心律失常报警事件占84.7％[室上性心律失常和心房颤动（房颤）事件较多],心衰报警事件占15.3％,以静息时心率升高及心脏再同步治疗心室起搏百分比降低为主.根据HM系统报警信息,电话联络患者65例次,优化参数11例次,指导调整药物治疗方案18例次,4例患者入院治疗.结论 对于植入ICD/CRT-D的患者,HM系统是一项必要的、安全可靠的远程监测方法,可以及时识别起搏系统相关异常、发现临床相关事件,可指导对患者进行早期临床干预,优化随访管理,提高患者生活质量.     

起搏器家庭监测功能对安置起搏器患者监测报警事件的观察

目的观察家庭监测(HM)功能对安置起搏器患者监测报警事件的应用。方法植入带有HM系统的双腔或三腔起搏器患者28例,随访15.71±9.73个月,记录系统传送的事件及返院随访的情况。结果 17例(61%)患者传送了报警事件。临床心血管事件报警8例,其中心房颤动报警最为多见,较常规随访提早发现32.2±19.0天。起搏系统报警事件14例(34次),其中以P波感知不良报警次数最多,为17次,较常规随访提早发现42.5±25.3天。结论 HM系统可在下一次常规随访前提早发现报警事件,有助于起搏器术后患者的实时监测和随访。     

家庭监测型心脏转复除颤器术后管理的安全性及有效性

目的探讨家庭监测（HM）功能在埋藏式心脏转复除颤器（ICD）患者随访中的作用及意义。方法分析15例行HM型ICD植入患者的临床资料,与术后传统诊室随访方式相对比,评价远程HM获得的起搏系统参数的可靠性,并分析不同类型的报警信息,通过电话指导或必要时诊室随访的方式进行处理。结果 15例出院前HM方法与同一时间诊室随访方法所测定的右室除颤电极感知数值（r=0.97,P〈0.01）、起搏阻抗数值（r=0.92,P〈0.01）及除颤阻抗数值（r=0.98,P〈0.01）有强相关性。随访（283.9±271.3）天,网上传输中观察到200次报警事件,其中临床相关事件共报警121次,较常规诊室随访提前发现临床事件（77.5±44.5）天,及时发现了电风暴,电极脱位和ICD误诊断,误放电等不良事件。12例（80%）通过电话远程调整治疗方案,3例（20%）提前诊室随访。结论 ICD患者通过HM功能进行术后随访是安全可靠的,通过HM可提前发现起搏系统异常及临床事件,利于及时调整治疗方案,优化术后的管理。     

氨基端脑钠素原对心脏再同步治疗远期疗效的预测价值

目的评价心脏再同步治疗（CRT）对血浆氨基端脑钠素原（NT-proBNP）的影响,以及NT—proBNP水平变化对CRT远期疗效的预测价值。方法44例首次植入CRT的心力衰竭患者入选,男性34例,女性10例,平均年龄（58±13）岁,心功能（3．3±0．5）级（NYHA分级）,QRS时限（150±14）ms。最初3个月随访期间,所有患者药物治疗稳定。分别在CRT植入术前和植入术后3个月时测定血浆NT-proBNP水平,同时在每次门诊随访时评估患者超声心动图和运动耐量的变化。结果平均随访（16．3±5．5）个月,11例为CRT无反应者（心功能无改善8例,心力衰竭再住院2例,心力衰竭死亡1例）。CRT反应者NT—proBNP水平明显降低[（1697．8±1279．8）fmol／ml对（1075．O±874．6）fmol/ml,P〈0．001],但CRT无反应者NT—proBNP水甲无明显改善【（1834．9±1159．9）fmol／ml对（1782．4±1070．4）fmol／ml,P=0．21]。取血浆NT—proBNP水平下降12．9％为预测CRT反应者和无反应者的最佳闽值点。结论心力衰竭患者接受CRT3个月后血浆NT—proBNP水平明显降低。血浆NT—proBNP可能是预测CRT远期疗效的有效指标。     

慢性心力衰竭患者心脏再同步治疗疗效观察

目的随访慢性心力衰竭患者心脏再同步治疗（CRT）的临床疗效。方法入选1999年至2008年行CRT的慢性心力衰竭患者,收集这些患者基线和最后一次临床资料。采集数据包括临床心功能评估,心脏超声学指标和体表心电图QRS时限宽度。结果95例患者行CRT治疗,分为早期组和近期组。早期组随访时间（57±17）个月,随访生存率为66．6％;近期组随访时间（18±10）个月,生存率为89．1％。两组患者CRT治疗后心功能显著提高,但自身状态下体表心电图QRS时限宽度变化差异无统计学意义。随访中患者药物治疗变化明显。结论中长期和短期随访均证实CRT治疗在一部分慢性心力衰竭患者中能提高心功能,但缺乏预测疗效的敏感指标。     

不同起始剂量华法林在老年非瓣膜性房颤缺血性脑卒中预防中的应用

目的探讨老年非瓣膜性房颤患者应用华法林抗凝治疗的合适方案,以及影响治疗的因素。方法把96例65岁以上非瓣膜性房颤患者随机分为普通（3．0mg／d）、低（1．5mg／d）起始剂量组,抗凝强度的目标——国际标准化比值（INR）为1．5～3．0。随访2年。在治疗前、治疗期间查凝血酶原时间（PT）和INR。治疗前和治疗1、2年做头颅CT检查。比较两组全程缺血性脑卒中事件（“事件”）和出血的发生率,并对年龄、华法林起始用量等9个因素进行Logistic回归分析,找出血并发症的影响因素。结果96例患者平均年龄（74．5±6．8）岁,两组在随访期内均未发生“事件”;INRmax平均INR、PTmax以及出血发生率差异无统计学意义。并发出血16例（16．7％）,严重出血2例（2．1％）。所有患者平均INR为（1．9±1．4）～（2．1±0．8）,INRmax中位数2．4;第1个月平均实际检测次数为（4．1±1．1）次。Logistic回归分析显示,首月实际INR监测次数是出血发生的独立影响因素（OR 0．38,95％CI 0．20-0．75,P=0．006）,与出血并发症呈负相关。结论低抗凝强度华法林治疗对高龄、南方非瓣膜性房颤患者预防脑栓塞是可行的。避免出血并发症,增加患者治疗依从性的重要措施是在治疗的第1个月严密监测INR,并调整用药剂量。     

心脏再同步治疗超反应的预测因子分析

目的 心脏再同步治疗（CRT）能明显改善患者临床症状,逆转心肌重构,称之为CRT超反应.本文主要分析CRT术后,患者超反应的预测因子.方法 采用回顾性研究,2005年1月至2010年6月共有124例随访资料完整的CRT或心脏再同步治疗除颤器（CRT-D）纳入分析,分为超反应组及其他反应组.并在CRT术后第6个月随访时,进行临床评估及超声心动图评价.心功能（NYHA分级）提高≥1级,左心室射血分数（LVEF） ≥0.45或增加2倍以上称为超反应.结果 两组患者在基线状态除QRS时限[（160.2±36.1）ms对（139.6±32.5）ms,P=0.01],完全左束支阻滞比例（95％对82％,P=0.02）、心力衰竭症状出现时间[（21.0±14.6）个月对（36.0±25.3）个月,P=0.02]差异有统计学意义外,其余参数在基线状态差异无统计学意义;有17％的患者出现超反应.6个月随访时超反应组与其他反应组在心功能分级、脑钠肽（BNP）、QRS时限、LVEF及因心力衰竭住院率方面有明显改善.结论 完全左柬支阻滞及心力衰竭症状出现较短的患者CRT反应较好.     

CRT术后极短期心功能改变与中长期反应性的相关性

目的 通过复查心脏再同步化治疗（cardiac resynchronization therapy，CRT）术后极短期内的心脏超声，评估双心室同步起搏的效果以及与CRT术后中长期反应的相关性。 方法 收集行CRT-P/D，术后平均5 d内（简称术后）复查了心脏彩超、心电图、脑钠尿肽前体（pro-BNP）等相关检查，且完成起搏器门诊首次随访（随访1，平均术后2个月）和二次随访（随访2，平均术后6个月），包括心脏彩超、心电图等辅助检查的18例患者。 结果 18例入选患者平均随访6个月时，4例（22%）为超反应，7例（39%）为无反应，11例（61%）为有反应（包括超反应）。CRT有反应和无反应组在性别、年龄、扩心病、心脏大小和心功能等方面均无统计学差异CRT有反应组术后左室射血分数（LVEF）与术前、随访1和随访2的LVEF均有显著差异（P<0.05或P<0.01）；而无反应组以上均无统计学差异。相关分析提示术后LVEF与随访1和随访2的LVEF值显著正相关，与体质量指数（BMI）呈负相关（均P<0.05）。 结论 术后极短期心功能LVEF值的变化与CRT术后中长期的反应性可能相关。     

心脏再同步治疗术后患者死亡原因分析

目的探讨心力衰竭患者心脏再同步治疗（CRT）术后的死亡原因及相关影响因素。方法对110例行CRT的心力衰竭患者[其中7例植入带有心脏再同步治疗除颤器（CRT—D）]进行长期随访,观察患者术后的转归情况,以及死亡患者的死亡原因、生存时间和相关影响因素。结果110例患者中有92例患者完成随访研究,随访1～132（48±28）个月,共死亡30例,死亡率为32．6％,5年生存率为66．9％±5．8％。24例为心脏性死亡,占总体死亡的80％,其中包括11例为心力衰竭恶化导致的死亡,13例为心脏性猝死（SCD）,其余6例为非心脏性死亡。14例行CRT的持续性心房颤动（房颤）患者中有8例死亡;71例行CRT的窦性心律患者中死亡22例;前组的中位生存时间短于后组（50比87,P=0．013）;7例植人CRT—D的患者均无死亡;3组患者的死亡率差异有统计学意义（P=0．01）。合并慢性肾功能衰竭的CRT患者死亡率（66．7％）较无肾功能不良者（20．6％）高（相对危险度：3．24,95％CI1．88～5．59,P〈0．001）。结论CRT患者的主要死亡原因是心脏性死亡,其中包括心力衰竭恶化和SCD。CRT—D和CRT两组患者之间的死亡率差异有统计学意义,接受CRT的窦性心律患者较持续性房颤患者有显著的生存获益。合并慢性肾功能衰竭的CRT患者预后较差。对于合并持续性房颤的CRT患者同时给予房室结消融有可能进一步提高生存率。     

Home monitoring remote control of pacemaker and implantable cardioverter defibrillator patients in clinical practice: impact on medical management and health-care resource utilization.

AIMS: To evaluate the impact of Home Monitoringtrade mark(HM) remote control on patient medical treatment and on health-care resource utilization. METHODS AND RESULTS: One hundred and seventeen patients received HM pacemakers or defibrillators. A pacing expert nurse consulted daily the website and submitted critical cases to physician. During a mean follow-up of 227 +/- 128 days, 25,210 messages were received (23,545 daily messages and 1665 alert events) resulting in 90.7% of HM supervised days. Fifty-nine minutes/week for the nurse and 12 min/week for the physician were spent for HM data analysis during 267 web-connections. The mean connection time per patient was 115 +/- 60 s. The nurse submitted to the physician 133 critical cases in 56 patients. The diagnosis were atrial fibrillation (47%), ventricular tachyarrhythmias (9%), inappropriate implantable cardioverter defibrillator intervention (4%), unsustained ventricular tachycardia (7%), device suboptimal programming (23%), and impending heart failure (10%). Sixty-six unplanned follow-up in 43 patients led to drug therapy change (44%), device reprogramming (18%), diagnosis confirmation without further intervention (24%), no confirmation (6%), further diagnostic tests (9%). CONCLUSION: HM technology allowed optimization of medical treatment and device programming with low consumption of health-care resource.     

家庭监护系统在植入心律转复除颤器患者随访中的应用价值

目的 了解家庭监护系统在植入心律转复除颤器（ICD）患者随访中的应用价值.方法 纳入2010年6月～2012年6月置入带有家庭监护系统（HM）的ICD患者30例,通过HM网站收集的患者各项测试参数及黄色和红色报警记录,分析心律失常事件监测和治疗的准确性和及时性,并与门诊随访结果进行比较.结果 随访334～1078（637.83±217.134）天,累计9例患者报告室性心律失常事件发生,1例患者曾出现误识别及误放电治疗.HM系统反应时间随事件严重程度逐渐缩短.同时,与门诊随访相比,HM系统在网络通畅的前提下,可以做到全覆盖随访.共收到黄色报警258次,红色报警5次,通过与患者及时进行电话联系,及时治疗,减少并避免ICD事件再次发生.30例患者中报告死亡3例,均为非心源性死亡.结论 通过HM系统使用,可以对ICD置入患者的恶性心律失常事件进行有效监控,避免ICD事件的再次发生和治疗,提高ICD使用安全性.     

具备家庭监测功能起搏器临床应用

目的观察家庭监测(HM)起搏器在临床中的应用。方法 4例患者,2例因病窦综合征安置双腔起搏器,2例因心力衰竭安置了三腔起搏器,4台起搏器均带有HM功能,通过远程监测观察起搏系统及心律失常事件。结果在病例1中,发现阻抗的变化,及时发现电极导线问题,并予更换;在病例2中,发现模式转换及心律失常事件,并帮助判断药物治疗的有效性;在病例3中,监测右室起搏比例,帮助判断药物控制心室率的情况;在病例4中,监测各种心律失常事件和心脏再同步化治疗比例,发现了阵发性心房颤动,并及时给予治疗。结论 HM能很好实现远程监测。     

Contribution of remote monitoring to the early diagnosis of implantable cardioverter-defibrillator shocks in the patient with cardiac resynchronisation therapy

We present the case of a 68-year-old man with coronary artery disease and a history of recurrent myocardial infarctions, having left ventricular ejection fraction 25% in NYHA functional class III. The patient received a biventricular cardioverter-defibrillator (ICD) Biotronik Lumax 340 HF-T in November 2008 from the primary prophylactic indication. Remote monitoring using the Biotronik Home Monitoring? (HM) system was activated since device implantation. Up to April 2012 the patient received five shocks including 3 appropriate VF therapies and 2 inappropriate ICD shocks (due to T-wave oversensing and atrial flutter degenerating to VF after ATPs). All arrhythmic events were promptly detected by the HM system with a rapid consequent pharmacological and non-pharmacological intervention (radiofrequency catheter ablation of atrial arrhythmia and reprogramming the device). This case points out that prophylactic ICD implantation is a justifiable method for the prevention of arrhythmic death in high-risk patients and HM significantly helps in the early recognition of inappropriate ICD therapy.     

Risk stratification following myocardial infarction in the thrombolytic era: a two-step strategy using noninvasive and invasive methods

Objectives. We prospectively performed a two-step risk assessment in patients in the early phase after acute myocardial infarction (MI).Background. Noninvasive methods like Holter electrocardiographic monitoring (HM) and determination of the left ventricular ejection fraction (EF) as well as the invasive technique of programmed ventricular stimulation (PVS) have been used to identify patients in the late phase after MI as candidates for prophylactic implantation of a cardioverter/defibrillator. However, it is unclear whether these results can be transferred to patients following acute MI.Methods. A series of 657 patients with acute MI (≤75 years) underwent HM and EF. If one of the two methods yielded abnormal findings (HM ≥20 ventricular ectopic beats/h/≥10 ventricular pairs/day/ventricular tachycardia; EF ≤40%), PVS was done (abnormal PVS: induction of monomorphic ventricular tachycardia, duration >10 s, cycle length ≥230 ms).Results. Of 657 patients, 304 (46%) had either an abnormal HM or EF. The PVS performed in 146 of 304 patients was abnormal in 22. During a mean follow-up of 37 months, there were 106 (16%) deaths, being sudden in 24 (3.6%), nonsudden cardiac in 45 (6.8%). The incidence of arrhythmic events (sudden cardiac death, symptomatic ventricular tachycardia, cardiac arrest) was 18% (4/22) with an abnormal PVS and only 4% (5/124) with a normal PVS (odds ratio 4.0, p = 0.032).Conclusions. The rate of arrhythmic events is low in post-MI patients in the 1990s. Nevertheless, a two-step risk stratification is helpful in selecting candidates for a defibrillator trial aiming at primary prevention of sudden cardiac death after MI.     

Comparison of autotriggered memory loop recorders versus standard loop recorders versus 24-hour Holter monitors for arrhythmia detection

To determine the relative yields of Holter monitoring (HM), memory loop recording (MLR), and autotriggered MLR (AT-MLR), we retrospectively interrogated the very large database of Lifewatch (a Card Guard company and a commercial monitoring company) and compared the results obtained by each method. From among a total database of approximately 100,000 patients, records of 1,800 patients from 2003 were randomly selected and examined, 600 from each of the 3 different monitoring groups. Each session of MLR and AT-MLR was applied for 30 days. For each patient we determined the symptomatic and asymptomatic events that were documented, including those that met predefined immediate physician notification criteria and the time to first notification event. The groups were identical in age and symptoms that necessitated monitoring; fewer women had HM. Information on the type of underlying structural heart disease, if present, and medications taken, if any, was not available to us in this database. The AT-MLR approach provided a higher yield of diagnostic events (e.g., 37, 108, and 216 total patients who had events; 37, 212, and 524 total events; and 6.2%, 17%, and 36% with a diagnostic yield for HM, MLR, and AT-MLR, respectively) and an earlier diagnosis. AT-MLR was also the most effective technique for capturing asymptomatic significant events, such as atrial fibrillation (52 with AT-MLR vs 1 for standard MLR). AT-MLR detected more than half as many asymptomatic episodes of atrial fibrillation (n = 52) as the total number of symptomatic episodes detected by patient activated recording (n = 94), thus confirming the common presence of asymptomatic atrial fibrillation. AT-MLR provided electrocardiographic documentation of tachyarrhythmias (n = 392) more often than MLR (n = 47) or HM (n = 44) and bradyarrhythmias/pauses/atrioventricular block (n = 38) more often than MLR (n = 13) or HM (n = 18). Thus, MLR and AT-MLR provide a diagnosis more often than does HM, thus confirming the benefit of prolonged monitoring. Further, the higher yield of AT-MLR versus MLR demonstrates the significantly enhanced benefit of autotriggered programmable recording.     

Rationale and design of a prospective study of the efficacy of a remote monitoring system used in implantable cardioverter defibrillator follow-up: the Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) study

Increased implantable cardioverter defibrillator (ICD) implant volumes (and product advisories/recalls) pose management challenges. Most device interrogations at 3- to 6-month routine follow-up visits are "nonactionable," that is, require no clinically significant reprogramming, lead revision, or initiation or up-titration of antiarrhythmic medications. Conversely, implanted devices collect important diagnostic data (eg, atrial fibrillation onset, system integrity) that remain concealed between device interrogations. Remote monitoring may resolve some of these challenges, but has not been studied in a large-scale clinical trial. Home Monitoring (HM) uses automatic (without patient intervention) data and electrogram transmissions with rapid (<24 hours) event notification of significant (including silent) events. The Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) is a multicenter, prospective, randomized study enrolling 1000 ICD patients designed to test whether HM can safely reduce the number of scheduled nonactionable office device interrogations by 50% and provide early detection and notification of cardiac and/or device problems. After enrollment, TRUST patients are randomized 2:1 to either HM or to control (ie, HM off) arms and are seen for an in-office follow-up 3 months postimplant. At subsequent 3-month intervals, control patients have conventional office visits, whereas in HM, patient data are remotely retrieved and evaluated. In HM patients, early notification may automatically occur between periodic checks for compromised system integrity (battery, lead parameters, high-voltage circuitry) or arrhythmia occurrence (eg, atrial fibrillation, ventricular arrhythmia). All study patients will have a final office visit 15 months after implant. The results of TRUST may confirm the role of remote monitoring as an intensive surveillance mechanism for device management.     

Prediction of life-threatening arrhythmia in patients after myocardial infarction by late potentials, ejection fraction and Holter monitoring.

In order to compare the prognostic significance of late potentials (LPs) on signal-averaged electrocardiogram (SA-ECG), left ventricular ejection fraction (EF) and 24-hour Holter monitoring (HM) following myocardial infarction, a prospective study on 60 patients (age 61.7 +/- 8.02 years old) just after acute myocardial infarction (AMI) was done. LPs, EF and HM were performed in all patients. Coronary arteriography had been done in 25 patients. The results showed that LPs were associated with a slightly higher incidence of life-threatening arrhythmia (34.8%) than HM (28.6%) and EF (25%). During the follow-up period (10 +/- 6 months), 9 patients had serious ventricular arrhythmic events, among whom 3 had sudden death due to ventricular fibrillation. The event rate in patients with abnormal LPs was higher than in patients with normal LPs (p = 0.01, odds ratio = 19.2). The study showed that there was no correlation between abnormal LPs and sex, age, number of narrowed coronary arteries, ventricular aneurysm, location of myocardial infarction, or EF alone. But there was a correlation between abnormal LPs and high grade ventricular ectopic activity detected by HM (r = 0.62899, p = 0.024). In addition, the combination of abnormal values of LPs, EF and HM could predict sustained ventricular tachycardia or sudden death in the first year after myocardial infarction with very high sensitivity (100%) as well as high specificity (p = 0.0009, odds ratio = 19).