Outcomes of leadless pacemaker in chronic kidney disease patients: real-world data from the i-LEAPER registry

Abstract

Abstract Background Chronic kidney disease (CKD) represents a major risk factor for patients requiring transvenous pacemaker (TV-PM), resulting in a high rate of operative complications and PM-related infection rate (21.9% and 12.5%, respectively), with both complications parallels to severity of CKD. Moreover, TV leads represent an important concern for end-stage CKD patients, often needing vascular access patency for renal replacement therapy. In this setting leadless pacemakers (LPMs) represent an attractive alternative to TV-PM for their lower device-related infection rate and the absence of TV leads. To date, limited data on LPM safety and efficacy profile in CKD patients are available. Purpose to assess operative and long-term safety and efficacy of LPMs implantation in patients with different stages of CKD in the real-world setting. Methods Consecutive patients who underwent LPM implantation in 12 European centers joining the i-LEAPER registry were retrospectively enrolled. CKD stage was assessed according to CKD-EPI equation for eGFR. Patients with CKD stage G3a/b (N=245) and stage G4/G5 (N=67) were compared with patients with normal kidney function (NKF) (N=867). Primary safety endpoint was LPM-related major complications rate at implant and during follow-up (FU). Additionally, the rate of patients showing sub-optimal electrical performance (pacing threshold [PT] >1V@0.24ms) was compared between groups. Results 1179 patients were enrolled and followed for a median of 33 [IQR 24-47] months. When compared with the NKF group, patients with CKD stage G3a/b and stage G4/G5 showed a higher burden of cardiovascular comorbidities (Table 1). The choice of a LPM was mainly due to vascular concern in the CKD stage G4/G5 group, while a perceived highest infective risk was reported in CKD stage G3a/b group (Table 1). Major complication rate at implant and during FU did not differ between groups, regardless of renal impairment stage (Table 2). All-cause mortality incidence resulted higher in CKD stage G4/G5 group when compared with NKF group (17.9% vs 6.8%; HR 4.24; 95%CI 4.25-7.94, p<0.001) (Figure A). The rate of patients with PT>V1@0.24ms during FU did not differ between groups, not exceeding 13.8%, and therefore remaining consistent with historical data for LPM (Figure B). Conclusion In the real-world setting, LPM showed a remarkable safety and efficacy profile in CKD patients regardless of renal impairment stage that was comparable to NKF population. LPM should be considered as first choice in CKD patients requiring a PM.