Table 6.
Studies Reporting Clinical Outcomes as Efficacy End Points
| Author (y) | Study Design | Study Population | Follow‐Up Time | Efficacy End Point | Results |
|---|---|---|---|---|---|
| Cabanas‐Grandío (2020)24 | 2‐arm, multicenter cohort study | One hundred six patients (64 patients implanted with TVP and 42 patients implanted with LP). The choice of TVP or LP was based on clinical criteria and operator availability. | 6 mo | Quality of life evaluated by the SF‐36 questionnaire | LP is associated with significantly higher scores on physical function (63 vs 42; P<0.001), physical role (64 vs 36; P=0.004), and mental health (75 vs 65; P=0.017) compared with TVP. LP is also associated with lower discomfort and physical restrictions compared with TVP. Hazard/odds ratio not reported. |
| Tjong (2018)32 |
Prospective, multicenter, single‐arm cohort study |
Seven hundred twenty patients. Number of patients who completed the SF‐36 questionnaire at baseline, 3, and 12 mo was 702, 681, and 635, respectively. | 3 and 12 mo | Health‐related quality of life evaluated using the SF‐36 questionnaire | Health‐related quality of life was improved at 3 and 12 mo after LP implantation (mental component score improved by 28.4% at 3 mo and 26.9% at 12 mo; increases in physical component score were 26.8% and 25.3%, respectively). At 3 mo, most patient were satisfied with the treatment. |
| Beurskens (2019)25 | Retrospective, 2‐arm, single‐center cohort study | Fifty‐six consecutive patients underwent LP implantations, but only 53 patients (28 Nanostim and 25 Micra) with quality echocardiography images were included. | 12 mo | Tricuspid valve regurgitation grade evaluated by echocardiography | Tricuspid valve regurgitation worsened in 23 (43%) patients but comparable to that (38%) in those with TVP (P=0.39) and was unrelated to pacing rates. Hazard/odds ratio not reported. |
| Salaun (2018)26 | Single‐arm, single‐center cohort study | Twenty‐nine consecutive patients implanted with LP, but only 23 were included for analysis (14 with Nanostim and 9 with Micra). Three patients were excluded because of lack of echocardiography images, and 3 refused to participate. | 2 mo | Right ventricular and tricuspid valve function evaluated by echocardiography | No significant change in right ventricular function was observed. One patient experienced significantly deteriorating tricuspid valve regurgitation that was related to pulmonary hypertension caused by chronic obstructive lung disease. |
LP indicates leadless pacemaker; SF‐36, Short Form‐36; and TVP, transvenous pacemaker.