The Impact of Charlson Comorbidity Index on De Novo Cardiac Implantable Electronic Device Procedural Outcomes in the United States

Abstract Background There is limited evidence on the differences in procedural outcomes between sexes after de novo cardiac implantable electronic device implantation (CIED). Furthermore, it is unclear whether any sex-based disparities have changed over the years. Purpose To compare procedural outcomes of de novo CIED implantation between sexes and study the trends of these outcomes over a 11-year period in a nationally representative sample. Methods Using the National Inpatient Sample, all hospitalisations between 2004 and 2014 for de novo CIED implantation were included, stratified by sex. Multivariable logistic regression was performed to 1) examine the association between sex and in-hospital complications of CIED implantation, expressed as odds ratios (OR) with 95% confidence intervals (CI), and 2) analyse trends of in-hospital outcomes by assessing the interaction term between time (years) and sex as covariates. Results Out of 2,815,613 hospitalisations for de novo CIED implantation, 41.9% were performed on women. Women were associated with increased adjusted odds of major adverse cardiovascular events (composite of mortality, thoracic and cardiac complications; OR 1.17 95% CI 1.16, 1.19), procedure-related bleeding (OR 1.13 95% CI 1.12, 1.15), and local complications (thoracic: OR 1.42 95% CI 1.40, 1.44, cardiac: OR 1.44 95% CI 1.38, 1.50). (p<0.001 for all) Notably, there was no difference in odds of all-cause mortality between sexes (OR women: 0.96 95% CI 0.94, 1.00). The odds of adverse complications in the overall CIED cohort were persistently raised in women throughout the study period, whereas similar odds of all-cause mortality across the sexes were observed throughout the study period (see Figure). Conclusion In a national cohort of CIED implantations we demonstrate that women are at a persistently higher risk of procedure-related adverse events other than mortality compared to men. This trend is concerning and warrants further work on procedural techniques to neutralise these sex disparities. Trends of odds of complications in women Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This work constitutes part of a PhD for MOM that is supported by Medtronic Ltd. Medtronic Ltd. was not involved in the conceptualization, design, conduct, analysis, or interpretation of the current study.

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Reduced Risk of Reoperations With Modern Deep Brain Stimulator Systems: Big Data Analysis From a United States Claims Database

Frontiers in Neurology ◽

10.3389/fneur.2021.785280 ◽

2021 ◽

Vol 12 ◽

Author(s):

Chengyuan Wu ◽

Sean J. Nagel ◽

Rahul Agarwal ◽

Monika Pötter-Nerger ◽

Wolfgang Hamel ◽

...

Keyword(s):

United States ◽

Risk Reduction ◽

De Novo ◽

The United States ◽

Secondary Outcome ◽

Administrative Claims ◽

Complication Rates ◽

Claims Database ◽

The Impact ◽

Deep Brain

Objective: There have been significant improvements in the design and manufacturing of deep brain stimulation (DBS) systems, but no study has considered the impact of modern systems on complications. We sought to compare the relative occurrence of reoperations after de novo implantation of modern and traditional DBS systems in patients with Parkinson's disease (PD) or essential tremor (ET) in the United States.Design: Retrospective, contemporaneous cohort study.Setting: Multicenter data from the United States Centers for Medicare and Medicaid Services administrative claims database between 2016 and 2018.Participants: This population-based sample consisted of 5,998 patients implanted with a DBS system, of which 3,869 patients had a de novo implant and primary diagnosis of PD or ET. Follow-up of 3 months was available for 3,810 patients, 12 months for 3,561 patients, and 24 months for 1,812 patients.Intervention: Implantation of a modern directional (MD) or traditional omnidirectional (TO) DBS system.Primary and Secondary Outcome Measures: We hypothesized that MD systems would impact complication rates. Reoperation rate was the primary outcome. Associated diagnoses, patient characteristics, and implanting center details served as covariates. Kaplan–Meier analysis was performed to compare rates of event-free survival and regression models were used to determine covariate influences.Results: Patients implanted with modern systems were 36% less likely to require reoperation, largely due to differences in acute reoperations and intracranial lead reoperations. Risk reduction persisted while accounting for practice differences and implanting center experience. Risk reduction was more pronounced in patients with PD.Conclusions: In the first multicenter analysis of device-related complications including modern DBS systems, we found that modern systems are associated with lower reoperation rates. This risk profile should be carefully considered during device selection for patients undergoing DBS for PD or ET. Prospective studies are needed to further investigate underlying causes.

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