期刊
HEART RHYTHM
卷 15, 期 9, 页码 1387-1393出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.hrthm.2018.04.027
关键词
Arrhythmia; Leadless pacemaker; Leadless pacing; Pacemakers; Pacing
资金
- personal Netherlands Heart Institute Research Fellowship from the Netherlands Heart Institute, Utrecht, The Netherlands
- Czech Republic governmental scientific grant [IG160501]
- St. Jude Medical/Abbott
- Boston Scientific
- St. Jude Medical/Abbot
- Biotronik
- Medtronic
BACKGROUND The recent introduction of leadless pacemakers (PMs) was aimed to eliminate transvenous lead- and pocket related complications. While the initial results with the leadless PMs seem promising, the nonrandomized nature, limited implant experience of operators, and short follow-up period of these studies preclude a simple comparison to transvenous PMs. OBJECTIVES The objective of this study was to provide a balanced comparison of leadless and transvenous single-chamber PM therapies through a propensity score-matched analysis. METHODS Leadless patients from 3 experienced leadless implant centers were propensity score-matched to VVI-R patients from a contemporary prospective multicenter transvenous PM registry. The primary outcome was device-related complications that required invasive intervention during mid-term follow-up. Separate analyses including and excluding PM advisory-related complications were performed. RESULTS A total of 635 patients were match-eligible (leadless: n = 254; transvenous: n = 381), of whom 440 patients (median age 78 years; interquartile range 70-84 years; 61% men) were successfully matched (leadless: n = 220 vs transvenous: n = 220). The complication rate at 800 days of follow-up was 0.90/0 (95% confidence interval [CI] 0%-2.2%) in the leadless group vs 4.70/0 (95% CI 1.8%-7.6%) in the transvenous group when excluding PM advisory-related complications (P =.02). When including these PM advisory-related complications, the complication rate at 800 days increased to 10.9% (95% CI 4.8%-16.5%) in the leadless group vs 4.7% (95% CI 1.8%-7.6%) in the transvenous group (P =.063). CONCLUSION This study reveals favorable complication rates for leadless compared to transvenous single-chamber pacing therapy at mid-term follow-up in a propensity score-matched cohort. When including PM advisory-related complications, this advantage is no longer observed.
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