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多传感器植入式除颤器算法在心房颤动存在时进行心力衰竭监测的性能。

Performance of a multi-sensor implantable defibrillator algorithm for heart failure monitoring in the presence of atrial fibrillation.

机构信息

Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy.

Cardiology Department, University of Ferrara, S. Anna University Hospital, Ferrara, Italy.

出版信息

Europace. 2023 Aug 2;25(9). doi: 10.1093/europace/euad261.

Abstract

AIMS

The HeartLogic Index combines data from multiple implantable cardioverter defibrillators (ICDs) sensors and has been shown to accurately stratify patients at risk of heart failure (HF) events. We evaluated and compared the performance of this algorithm during sinus rhythm and during long-lasting atrial fibrillation (AF).

METHODS AND RESULTS

HeartLogic was activated in 568 ICD patients from 26 centres. We found periods of ≥30 consecutive days with an atrial high-rate episode (AHRE) burden <1 h/day and periods with an AHRE burden ≥20 h/day. We then identified patients who met both criteria during the follow-up (AHRE group, n = 53), to allow pairwise comparison of periods. For control purposes, we identified patients with an AHRE burden <1 h throughout their follow-up and implemented 2:1 propensity score matching vs. the AHRE group (matched non-AHRE group, n = 106). In the AHRE group, the rate of alerts was 1.2 [95% confidence interval (CI): 1.0-1.5]/patient-year during periods with an AHRE burden <1 h/day and 2.0 (95% CI: 1.5-2.6)/patient-year during periods with an AHRE-burden ≥20 h/day (P = 0.004). The rate of HF hospitalizations was 0.34 (95% CI: 0.15-0.69)/patient-year during IN-alert periods and 0.06 (95% CI: 0.02-0.14)/patient-year during OUT-of-alert periods (P < 0.001). The IN/OUT-of-alert state incidence rate ratio of HF hospitalizations was 8.59 (95% CI: 1.67-55.31) during periods with an AHRE burden <1 h/day and 2.70 (95% CI: 1.01-28.33) during periods with an AHRE burden ≥20 h/day. In the matched non-AHRE group, the rate of HF hospitalizations was 0.29 (95% CI: 0.12-0.60)/patient-year during IN-alert periods and 0.04 (95% CI: 0.02-0.08)/patient-year during OUT-of-alert periods (P < 0.001). The incidence rate ratio was 7.11 (95% CI: 2.19-22.44).

CONCLUSION

Patients received more alerts during periods of AF. The ability of the algorithm to identify increased risk of HF events was confirmed during AF, despite a lower IN/OUT-of-alert incidence rate ratio in comparison with non-AF periods and non-AF patients.

CLINICAL TRIAL REGISTRATION

http://clinicaltrials.gov/Identifier: NCT02275637.

摘要

目的

HeartLogic 指数结合了多个植入式心脏复律除颤器(ICD)传感器的数据,已被证明可准确分层心力衰竭(HF)事件风险患者。我们评估并比较了该算法在窦性节律和持续性心房颤动(AF)期间的性能。

方法和结果

在来自 26 个中心的 568 例 ICD 患者中激活了 HeartLogic。我们发现≥30 天的连续高心房率事件(AHRE)负担<1 小时/天和 AHRE 负担≥20 小时/天的时期。然后,我们在随访期间确定符合这两个标准的患者(AHRE 组,n=53),以允许对时期进行配对比较。出于对照目的,我们确定了在整个随访期间 AHRE 负担<1 小时的患者,并实施了 2:1 的倾向评分匹配与 AHRE 组(匹配的非-AHRE 组,n=106)。在 AHRE 组中,在 AHRE 负担<1 小时/天的时期,警报发生率为 1.2[95%置信区间(CI):1.0-1.5]/患者年,而在 AHRE 负担≥20 小时/天的时期,警报发生率为 2.0(95%CI:1.5-2.6)/患者年(P=0.004)。在 IN-警报期间,HF 住院的发生率为 0.34(95%CI:0.15-0.69)/患者年,而在 OUT-警报期间,HF 住院的发生率为 0.06(95%CI:0.02-0.14)/患者年(P<0.001)。在 AHRE 负担<1 小时/天的时期,HF 住院的 IN/OUT-警报状态发生率比为 8.59(95%CI:1.67-55.31),而在 AHRE 负担≥20 小时/天的时期,该比值为 2.70(95%CI:1.01-28.33)。在匹配的非-AHRE 组中,在 IN-警报期间,HF 住院的发生率为 0.29(95%CI:0.12-0.60)/患者年,而在 OUT-警报期间,HF 住院的发生率为 0.04(95%CI:0.02-0.08)/患者年(P<0.001)。发病率比为 7.11(95%CI:2.19-22.44)。

结论

在 AF 期间,患者接收到更多的警报。尽管与非 AF 期和非 AF 患者相比,该算法识别 HF 事件风险增加的能力的 IN/OUT-警报发生率比值较低,但在 AF 期间仍能确认其识别 HF 事件的能力。

临床试验注册

http://clinicaltrials.gov/标识符:NCT02275637。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8471/10498140/08671827a655/euad261_ga1.jpg

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