The Ohio State University Columbus OH USA.
Medical University of South Carolina Charleston SC USA.
J Am Heart Assoc. 2024 Oct 15;13(20):e035501. doi: 10.1161/JAHA.124.035501. Epub 2024 Oct 11.
Diagnostic variables from insertable cardiac monitors may be useful in identifying patients at increased risk of heart failure (HF) events. High-risk alerts must be coupled with interventions to improve outcomes. We aim to assess the safety of a predefined protocolized intervention pathway activated by insertable cardiac monitor high-risk alerts.
ALLEVIATE-HF (Algorithm Using LINQ Sensors for Evaluation and Treatment of Heart Failure) Phase 1 was a randomized interventional study enrolling patients with New York Heart Association class II/III and a recent HF event. A HF risk score based on insertable cardiac monitor diagnostics, including impedance, respiration rate, atrial fibrillation burden, heart rate during atrial fibrillation, heart rate variability, and activity duration, was calculated. A protocolized intervention pathway was activated when high-risk scores were detected that involved physician-prescribed nurse-implemented uptitration of diuretic for 4 days, unless safety rule-out conditions were met. Interventions could be repeated if high-risk scores persisted and did not require worsening symptoms. In total, 59 patients were randomized (mean age 68.2±11.8 years; 59.3% male); 67.8% with ejection fraction ≥50%. The mean follow-up was 11.8±8.1 months. Overall, 146 high-risk scores were recorded in 33 patients and 118 interventions occurred in 75 (51.4%) high-risk alerts that did not meet safety rule-out criteria. There were no serious adverse events and 13 adverse events related to interventions. In patients with symptoms at intervention initiation, symptoms resolved in 37 interventions (80%) and worsened in 8 (17%). In asymptomatic patients, symptoms developed in 3 interventions (7%).
A personalized medication intervention based on insertable cardiac monitor risk score can be safely instituted in patients with HF, irrespective of symptoms.
URL: https://www.clinicaltrials.gov; Unique Identifier: NCT04452149.
可植入式心脏监测器的诊断变量可能有助于识别心力衰竭（HF）事件风险增加的患者。高危警报必须与干预措施相结合，以改善结果。我们旨在评估由可植入式心脏监测器高危警报触发的预设协议化干预途径的安全性。
ALLEVIATE-HF（基于 LINQ 传感器的心力衰竭评估和治疗算法）是一项随机干预研究，纳入纽约心脏协会（NYHA）心功能 II/III 级和近期 HF 事件的患者。根据可植入式心脏监测器的诊断结果（包括阻抗、呼吸率、房颤负担、房颤期间的心率、心率变异性和活动持续时间）计算 HF 风险评分。当检测到高危评分时，会激活协议化干预途径，包括医生开处方、护士实施利尿剂滴定 4 天，除非符合安全排除标准。如果高危评分持续存在且没有恶化症状，则可以重复干预。共有 59 名患者随机分组（平均年龄 68.2±11.8 岁；59.3%为男性；50.4%为女性）；67.8%射血分数≥50%。平均随访时间为 11.8±8.1 个月。总的来说，在 33 名患者中记录了 146 次高危评分，在 75 次（51.4%）不符合安全排除标准的高危警报中进行了 118 次干预。无严重不良事件，13 例与干预相关的不良事件。在干预开始时出现症状的患者中，37 次干预（80%）症状缓解，8 次（17%）症状恶化。在无症状患者中，3 次干预（7%）出现症状。
可植入式心脏监测器风险评分的个性化药物干预措施可安全用于 HF 患者，无论症状如何。
