Clinique Pasteur, 45 Avenue de Lombez BP 27617, 31076 Toulouse Cedex 3, France.
Medtronic, Inc., Minneapolis, MN, USA.
Europace. 2023 Mar 30;25(3):1041-1050. doi: 10.1093/europace/euad016.
This study compares clinical outcomes between leadless pacemakers (leadless-VVI) and transvenous ventricular pacemakers (transvenous ventricular permanent-VVI) in subgroups of patients at higher risk of pacemaker complications.
This study is based on the Micra Coverage with Evidence Development (CED) study. Patients from the Micra CED study were considered in a high-risk subgroup if they had a diagnosis of chronic kidney disease Stages 4-5 (CKD45), end-stage renal disease, malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) 12 months prior to pacemaker implant. A pre-specified set of complications and reinterventions were identified using diagnosis and procedure codes. Competing risks models were used to compare reinterventions and complications between leadless-VVI and transvenous-VVI patients within each subgroup; results were adjusted for multiple comparisons. A post hoc comparison of a composite outcome of reinterventions and device complications was conducted. Out of 27 991 patients, 9858 leadless-VVI and 12 157 transvenous-VVI patients have at least one high-risk comorbidity. Compared to transvenous-VVI patients, leadless-VVI patients in four subgroups [malignancy, HR 0.68 (0.48-0.95); diabetes, HR 0.69 (0.53-0.89); TVD, HR 0.60 (0.44-0.82); COPD, HR 0.73 (0.55-0.98)] had fewer complications, in three subgroups [diabetes, HR 0.58 (0.37-0.89); TVD, HR 0.46 (0.28-0.76); COPD, HR 0.51 (0.29-0.90)) had fewer reinterventions, and in four subgroups (malignancy, HR 0.52 (0.32-0.83); diabetes, HR 0.52 (0.35-0.77); TVD, HR 0.44 (0.28-0.70); COPD, HR 0.55 (0.34-0.89)] had lower rates of the combined outcome.
In a real-world study, leadless pacemaker patients had lower 2-year complications and reinterventions rates compared with transvenous-VVI pacing in several high-risk subgroups.
ClinicalTrials.gov ID NCT03039712.
本研究旨在比较无导线起搏器（无导线-VVI）与经静脉心室起搏器（经静脉心室永久-VVI）在更高起搏器并发症风险亚组患者中的临床结局。
本研究基于 Micra 覆盖范围的证据开发（CED）研究。如果患者在起搏器植入前 12 个月患有慢性肾脏病 4-5 期（CKD45）、终末期肾病、恶性肿瘤、糖尿病、三尖瓣疾病（TVD）或慢性阻塞性肺疾病（COPD），则认为他们来自 Micra CED 研究的高危亚组。使用诊断和程序代码确定了一组预先规定的并发症和再介入。在每个亚组内，使用竞争风险模型比较无导线-VVI 和经静脉-VVI 患者之间的再介入和并发症；结果经过多次比较的调整。对再介入和设备并发症的复合结果进行了事后比较。在 27991 例患者中，9858 例无导线-VVI 和 12157 例经静脉-VVI 患者至少有一种高危合并症。与经静脉-VVI 患者相比，四个亚组中的无导线-VVI 患者[恶性肿瘤，HR 0.68（0.48-0.95）；糖尿病，HR 0.69（0.53-0.89）；TVD，HR 0.60（0.44-0.82）；COPD，HR 0.73（0.55-0.98）]并发症较少，三个亚组中[糖尿病，HR 0.58（0.37-0.89）；TVD，HR 0.46（0.28-0.76）；COPD，HR 0.51（0.29-0.90））再介入较少，四个亚组（恶性肿瘤，HR 0.52（0.32-0.83）；糖尿病，HR 0.52（0.35-0.77）；TVD，HR 0.44（0.28-0.70）；COPD，HR 0.55（0.34-0.89）]的复合结局发生率较低。
在一项真实世界的研究中，与经静脉心室永久-VVI 起搏相比，无导线起搏器患者在多个高危亚组中的 2 年并发症和再介入率较低。
ClinicalTrials.gov 标识符 NCT03039712。
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