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• W4387338439 abstract "This study compares clinical outcomes between leadless pacemakers (leadless-VVI) and transvenous ventricular pacemakers (transvenous-VVI) in subgroups of patients at higher risk of pacemaker complications. This study is based on the Micra Coverage with Evidence Development (CED) Study. Patients from the Micra CED study were considered in a high-risk subgroup if they had a diagnosis of chronic kidney disease Stages 4-5 (CKD45), end-stage renal disease (ESRD), malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) 12 months prior to pacemaker implant. A pre-specified set of complications and reinterventions were identified using diagnosis and procedure codes. Competing risks models were used to compare reinterventions and complications between leadless-VVI and transvenous-VVI patients within each subgroup; results were adjusted for multiple comparisons. Post-hoc analyses of a composite outcome of reinterventions and device complications and a comparison of outcomes by the number of high-risk comorbidities were conducted. Out of 27,991 patients, 9,858 leadless-VVI and 12,157 transvenous-VVI patients have at least one high-risk comorbidity. Compared to transvenous-VVI patients, leadless-VVI patients in four subgroups (Malignancy, HR 0.68, [0.48-0.95]; Diabetes, HR 0.69, [0.53-0.89]; TVD, HR 0.60 [0.44-0.82]; COPD, HR 0.73, [0.55-0.98]) had fewer complications, in three subgroups (Diabetes, HR 0.58, [0.37-0.89]; TVD, HR 0.46 [0.28-0.76]; COPD, HR 0.51, [0.29-0.90]) had fewer reinterventions, and in four subgroups (Malignancy, HR 0.52, [0.32-0.83]; Diabetes, HR 0.52, [0.35-0.77]; TVD, HR 0.44 [0.28-0.70]; COPD, HR 0.55, [0.34-0.89]) had lower rates of the combined outcome. Leadless-VVI patients that have 0, 1, and 2 high-risk comorbidities have between 30% and 45% fewer chronic complications than transvenous-VVI patients (0 comorbidities, HR 0.55, [0.39 – 0.78]; 1 comorbidity, HR 0.57, CI [0.43 – 0.76]; 2 comorbidities, HR 0.70, CI [0.51 – 0.95]). At all levels of the number of comorbidities, leadless-VVI patients have fewer reinterventions than transvenous-VVI patients (0 comorbidities, HR 0.47, CI [0.29 – 0.75]; 1 comorbidity, HR 0.61, CI [0.40 – 0.94]; 2 comorbidities, HR 0.53, CI [0.30 – 0.93]; >2 comorbidities, HR 0.54, CI [0.31 – 0.95]). In a real-world study, leadless pacemaker patients had lower 2-year complications and reinterventions rates compared with transvenous-VVI pacing in several high-risk subgroups." @default.
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• W4387338439 date "2023-10-01" @default.
• W4387338439 modified "2023-10-06" @default.
• W4387338439 title "2-YEAR OUTCOMES OF LEADLESS VS. TRANSVENOUS SINGLE CHAMBER VENTRICULAR PACEMAKER IN HIGH-RISK SUBGROUPS" @default.
• W4387338439 doi "https://doi.org/10.1016/j.cjca.2023.06.062" @default.
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