Centre for Cardiovascular Telemedicine and Department of Cardiology and Angiology, Charité Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany.
Int J Cardiol. 2012 Nov 29;161(3):143-50. doi: 10.1016/j.ijcard.2011.09.007. Epub 2011 Oct 8.
Meta-analyses have suggested that remote telemedical management (RTM) positively affects clinical outcomes in chronic HF patients. The results of two recent randomised RTM trials do not corroborate these results. We aim to report prospectively defined and exploratory subgroup analyses for the TIM-HF trial and to identify a patient profile that could potentially benefit from RTM for further investigation in randomised clinical trials.
In TIM-HF, 710 stable chronic HF patients, in NYHA class II or III with a history of HF decompensation within 2 years previously or a LVEF ≤ 25% were randomly assigned (1:1) to RTM or usual care. The primary outcome was total death and secondary outcomes included days lost due to death or HF hospitalisation and a composite of cardiovascular death and HF hospitalisation. Twelve subgroups were prospectively defined and patient profiling was investigated for the subgroup with a prior history of HF decompensation, an LVEF ≥ 25% and a PHQ-9 score<10.
The subgroup treatment effects were significant for total mortality for the PHQ-9 subgroup only (p for interaction<0.027). For the outcome 'number of days lost due to hospitalisation for HF or death', the subgroup treatment effects were significant (p for interaction<0.05) for patients with a prior HF decompensation or an ICD implant or a PHQ score of <10 and for the patient-profiling subgroup.
Telemedicine management may not be appropriate for all HF patients. Future research needs to investigate which HF population may benefit from this intervention.
荟萃分析表明,远程远程医疗管理(RTM)对慢性 HF 患者的临床结局有积极影响。最近两项随机 RTM 试验的结果并不支持这些结果。我们旨在报告 TIM-HF 试验的前瞻性定义和探索性亚组分析,并确定可能从 RTM 中受益的患者特征,以便在随机临床试验中进一步研究。
在 TIM-HF 中,710 名稳定的慢性 HF 患者,NYHA 分级 II 或 III 级,在 2 年内有 HF 失代偿史或 LVEF≤25%,随机分为 RTM 组或常规护理组(1:1)。主要结局是总死亡率,次要结局包括因死亡或 HF 住院而失去的天数以及心血管死亡和 HF 住院的复合结局。定义了 12 个亚组,并对有 HF 失代偿史、LVEF≥25%和 PHQ-9 评分<10 的亚组进行了患者分析。
仅 PHQ-9 亚组的总死亡率亚组治疗效果显著(交互作用 p 值<0.027)。对于因 HF 住院或死亡而失去的天数这一结局,对于有 HF 失代偿史、ICD 植入或 PHQ 评分<10 的患者以及患者特征亚组,亚组治疗效果显著(交互作用 p 值<0.05)。
远程医疗管理可能并不适合所有 HF 患者。未来的研究需要调查哪些 HF 人群可能受益于这种干预。