Leadless pacemakers are considered a low-risk alternative to single-lead pacemakers (SL-PPMs). In 2021, the FDA issued a warning regarding leadless pacemakers because of increased morbidity and mortality from perforation. Clinical outcome data is limited. The National Readmissions Database (NRD) is a nationally representative annualized sample of US hospitalizations that may shed insight on patient selection and procedural risks from leadless pacemaker implantation.
Determine patient selection, adverse events and mortality rates related to leadless pacemakers versus SL-PPM using the NRD.
NRD data was analyzed from January 2016 to December 2019. ICD-10 and ICD-CM 10 coding was used to identify patients and adverse outcomes. Predictors of mortality and cardiac perforation were determined by multivariable regression.
Distribution of age and gender were similar between both groups. Patients receiving single-chamber leadless pacemakers were more likely to be dialysis dependent, have diabetes and obstructive sleep apnea. Mortality was higher in leadless pacemakers (5.3% vs. 1.9%, p < 0.001) with a higher incidence of adverse outcomes. A multivariable regression model found that dialysis dependence and pulmonary hypertension increased the risk for mortality in leadless pacemakers while obstructive sleep apnea and diabetes were associated with lower risk. Leadless pacemakers had an adjusted odds ratio of 2.74 and 2.92 for death and perforation respectively.
Mortality rates were higher in patients receiving leadless pacemakers with a higher incidence of adverse outcomes in patients with dialysis dependence and pulmonary hypertension. Clinical benefits may be offset by increased risk of procedural mortality and adverse outcomes.

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