Abstract
Background
Pacemaker (PM) lead interference with tricuspid valve (TV) function is an important determinant of hemodynamic compromise and is associated with substantial morbidity and mortality. Lead-related TV regurgitation (TR) can potentially be mitigated by leadless pacemaker (LP) therapy by eliminating the presence of a transvalvular lead.
Purpose
This large multicenter study aimed to evaluate the impact of LP therapy on TV function in comparison with an age –, sex, and follow-up duration -matched cohort of transvenous single-chamber (VVI) and dual-chamber (DDD) PM recipients.
Methods
Leadless, and transvenous VVI and DDD-PM recipients who underwent an echocardiographic study prior to the procedure and 15±6 months thereafter between January 2013 and September 2018 at two tertiary centers in the Netherlands were included. We used the data of a prospectively acquired population that comprised consecutive patients who underwent LP implantation who were 1:1 matched to transvenous VVI-PM and DDD-PM patients.
Results
A total of 198 patients (129 males, age 79±8.2 years) were included, of whom 66 were implanted with a LP (two models: Nanostim, Micra LP), and 66 with a transvenous VVI and 66 with DDD-PM. In the total cohort, the Wilcoxon signed-rank test revealed that TR severity was graded more severe in 87 (44%), equally in 104 (53%), and less severe in 7 (4%) patients (p<0.001) compared with baseline echocardiographic findings. Worsening TR was observed in 28 (42%) of the LP (p<0.001) and 34 (52%) of transvenous VVI-PM (p<0.001), and 25 (38%) of the DDD-PM recipients (p<0.01). Binary logistic regression analysis showed that LP recipients were equally prone to increasing TV dysfunction compared with transvenous PMs (p=0.42). Septal position of the leadless intracardiac device (odds ratio 3.6, p=0.03) was associated with worsening TR. In the total cohort, 30 (15%) patients had heart failure hospitalization during the follow-up period.
Conclusions
TR is a malignant disease which can result in high rates of heart failure hospitalization. This study revealed an unexpected high proportion of patients with worsening TR following LP therapy, yet it was comparable to conventional PM systems. The mechanical impact of the LP near the TV apparatus is the most likely cause of this phenomenon since the septal positioning of the device was associated with increasing TV incompetence. The general consensus was that LP therapy mitigates the risk for TV dyfunction due to the circumvention of transvalvular leads. Therefore, the current results are highly clinically relevant as the contradict expected performance of the LP approach.