Early trends in leadless pacemaker implantation: Evaluating nationwide in-hospital outcomes

Association between frailty and in-hospital outcomes in patients undergoing leadless pacemaker implantation: A nationwide analysis

“… 16 However, 2 previous studies based on national registries in the United States have found that the leadless pacemaker group had a higher rate of certain complications such as vascular complications, bleeding, venous thromboembolism, thrombus formation in the device, and pericardial complications. 14 , 17 Likewise, both studies reported higher in-hospital all-cause mortality in the leadless pacemaker group, probably attributed to the higher proportion of comorbidities in these patients. It is important to acknowledge that the use of large introducer sheaths in leadless pacemaker implantation may increase the risk of vascular and pericardial complications.…”

“… 12 , 13 A previous study highlighted patient-related characteristics, such as sex and race, as well as comorbidities like heart failure, coronary artery disease, and peripheral artery disease; cardiogenic shock; and device infection, all of which were associated with an increased risk of all-cause mortality during hospitalization. 14 Our study focused on investigating the role of frailty as a predictor of in-hospital mortality following the procedure, independently of other well-established prognostic factors. The results demonstrated that frailty indeed emerged as a significant and robust predictor of in-hospital mortality.…”

Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

“…However, a contemporary prospective propensity-matched analysis also demonstrated that the rate of complication in a TPM cohort was 4.9% vs. 0.9% in a LPM cohort, during 800 days of follow-up and after excluding the pacemaker advisory-related complications [ 24 ]. Furthermore, in real-world practice, Micra implantation ( n = 16,825) is associated with a lower complication rate of 8.6%, which is lower than the 11.2% of contemporary TPM implantation ( n = 564,100) [ 25 ]. A continuous enrollment study and contemporaneous comparison of the Micra and TPMs in the Micra Coverage with Evidence Development (CED) study observed that the Micra implantation was associated with 23% fewer and 31% fewer complications compared with TPMs over 6 months [ 26 ] and 2 years [ 9 ], respectively, indicating that the fewer LPM complications were due to a time-dependent effect, which was also manifested by the improved LPM complication rates from the 6 month follow-up to the 2 year follow-up, and the similar 30 day adjusted complication rate of LPMs to that of TPMs [ 26 ].…”

“…In contrast, the more frequent incidences of cardiac perforation and pericardial effusion in LPMs than TPMs and the relatively high incidence of vascular complications in LPMs are short-term complications, both of which form a non-conclusive picture of the complications encountered with LPMs vs. TPMs. The discrepancies of the complication percentages between studies are partly because some studies only report complications requiring reinterventions [ 24 ], while some studies describe all complications [ 25 ].…”

“…The Manufacturer and User Facility Device Experience (MAUDE) report also estimated a 1% incidence of cardiac tamponade, and more than three times the cardiac tamponade of the Micra compared with the TPM ventricular lead [ 28 ]. In a real-world setting, 1.3% of LPM recipients suffered from cardiac effusion or perforation [ 18 ], and the figure was significantly higher than that of TPM recipients [ 25 ]. Similarly, as for Aveir VR implantation, the rate of cardiac tamponade was 1.5% (3/200) in the LEADLESS II-phase 2 IDE study [ 12 ].…”