| BackgroundSudden cardiac death(SCD)is the most commonly cause of cardiac death.According to an epidemiological survey on the incidence of SCD in China,the annual incidence of SCD in China is estimated to be 41.8/100,000,accounting for 9.5%of the total mortality.With a population of 1.33 billion,the approximate annual incidence of SCD in China is about 500,000,more than that in the United States.Although early cardiopulmonary resuscitation,and effective cardioverter/defibrillation treatment can save some cardiac arrest patients life,the proportion of patients with cardiac arrest out hospital timely received cardiopulmonary resuscitation treatment is less.Therefore,the survival rate of cardiac arrest out hospital is still low,about less than 5%.SCD has becoming a serious social problem in the world.Implantable cardioverter defibrillators(ICDs)can effectively prevent SCD in high risk patients,such as those with arrhythmic cardiomyopathy and heart failure(HF).As ICDs run more complex programs than other common pacemakers,intensive clinical follow-up at a 3 to 6 month intervals is recommended after ICD implantation.This intensive clinical follow-up is associated with enhanced medical workload and financial burden to patients.Moreover,between clinic visit adverse events can occur in patients with ICDs.ICDs with Remote Monitoring(RM)were designed to allow patients to be monitored between clinic visits.ICDs with RM are typically equipped with a micro-antenna and a transmitter located close to the patient collects data regarding the characteristics of ICDs.This data is transmitted to a central database periodically or on demand by communication network,and subsequently sent to physicians by internet,short message,telephone or fax.Physicians can thus respond immediately to take steps to reduce adverse clinical events.Indeed,some clinical trials have evaluated the potential benefits of RM indicating that they can reduce total in-clinic follow-ups without increasing adverse events.Moreover,one registry study reported that ICDs with RM were associated with further reduced mortality when compared to conventional ICDs.However,subsequent pilot randomized controlled trials and meta-analyses produced conflicting data,and did not support the potential benefits of RM on mortality.Nevertheless,a subgroup meta-analysis of three previously published RCTs showed a reduction in all-cause mortality in patients using Home Monitoring(HM)systems with daily automatic transmission.HM systems are one of the five types of RM systems currently used,and that can automatically transfer information daily.Currently,some randomized controlled studies have investigated the influence of ICDs with daily automatic transmission RM systems on clinical outcome,however their results were inconsistent.Therefore,we carried out an updated meta-analysis to explore the influence of ICDs with daily automatic transmission RM systems on clinical end points including mortality,hospitalization,in-clinic follow-up times,and cost of follow-up.MethodsWe sought relevant articles in these databases included PubMed,EMBASE,Clinicaltrials.gov Websites,Google Scholar,Baidu Scholar,CNKI,Wanfang Data,Weipu paper check system.We also performed manual searches of the reference lists of each study and review article to identify additional relevant articles.No language restrictions were enforced.The last database searching was performed on May 30,2018.Only randomized studies that used ICDs with daily automatic transmission RM systems in the intervention group were included.In the intervention group,the daily automatic transmission RM systems should be applied after implantation.ICD didn’t use daily automatic transmission RM systems in the control(conventional)group.Study quality was assessed using the Modified Jadad score which comprises had four items,including randomization(0–2 points),concealment of allocation(0–2 points),double blinding(0–2 points),withdrawals and dropouts(0–1 points).Higher scores indicate better quality.Data were pooled and analyzed using RevMan5.2 statistical software.Statistical heterogeneity was evaluated using the I~2 statistic.The effect size was presented as the risk ratio(RR)and its 95%confidence interval(CI)for categorized variables and mean difference(MD),and the corresponding 95%confidence interval for continuous variables.For publication bias evaluation,funnel plots were used.ResultsStudy SelectionA total of 3698 records were identified,six randomized trials met the inclusion criteria.These 6 studies enrolled 3185 patients,and the final analysis included 2973 patients data(1736 in the intervention group,1237 in the conventional group).The mean follow-up duration were 1.0 to 3.06 years.In patients enrolled in the meta-analysis,1992(67%)patients implanted with ICDs primary as a preventative measure,515(19.6%)had a history of atrial fibrillation,and 2233(81.8%)had a history of heart failure.The qualities of the included studies were fairly good based on the Modified Jadad score(mean grade 4.3).The major adverse events(MAEs)Three trials(TRUST,IN-TIME,and ECOST studies)set MAE as primary or secondary end point,and the pooled results showed that ICDs applied daily automatic transmission RM systems were significantly associated with fewer MAEs(RR,0.84;95%CI,0.71 to1.00;P=0.05),than conventional ICDs.All-cause mortality and cardiovascular mortalityAll-cause mortality was reported in five trials.No statistically significant difference was detected in the all-cause mortality between intervention and conventional groups(RR0.80;95%CI,0.62 to 1.04;P=0.09).However,cardiovascular mortality was significantly lower in the intervention group(RR 0.60;95%CI,0.37 to 0.98;P=0.04).HospitalizationFour studies reported cardiac related hospitalization rates.The pooled results(including2312 patients)revealed a lower rate of hospitalization in the intervention group(RR0.80;95%CI,0.60 to 1.05;P=0.11).ICD shock therapiesThe total occurrence of ICD shock therapies did not differ statistically between the two groups(RR 0.79;95%CI,0.60 to 1.04;P=0.09).However,the proportion of inappropriate shocks delivered was significantly lower in the intervention group than the conventional group(RR 0.49;95%CI,0.28 to 0.86;P=0.01),while the rate of appropriate shocks did not significant differ between the two groups(RR 1.30;95%CI,0.88 to 1.92,P=0.20).The total in-clinic follow-up per patient and costs due to in-clinic follow-upThe pooled analysis showed the intervention group had significantly reduced times of in-clinic follow-up(MD,-1.11;95%CI,-1.41 to-0.82;P﹤0.00001,and scheduled in-clinic follow-up times(MD,-1.62;95%CI,-2.13 to-1.11;P﹤0.00001),despite the unscheduled in-clinic follow-up times increased(MD,0.18;95%CI,0.08 to0.28;P=0.0003)as compared with the conventional group.Furthermore,the costs due to in-clinic follow-up had significant decline in the intervention group(MD,-0.75;95%CI,-1.38 to-0.12;P=0.02).ConclusionICDs with daily automatic transmission RM systems may reduce inappropriate shocks and cardiovascular mortality in patients treated with ICDs,reduce total in-clinic follow-up times and medical expenses.ICD with daily automatic transmission RM systems should be applied in patients with implanted ICDs. |
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