Longitudinal Outcomes Associated With Non-Evidence-Based Implantable Cardioverter-Defibrillators Among Medicare Beneficiaries (From the National Cardiovascular Data Registry)

Primary prevention implantable cardioverter-defibrillators (ICDs) in patients with recent myocardial infarction or coronary revascularization and those with newly diagnosed or severe heart failure (HF) are considered non-evidence-based, as defined by pivotal randomized clinical trials. Although non-...

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Veröffentlicht in:The American journal of cardiology 2021-09, Vol.155, p.64-71
Hauptverfasser: Daimee, Usama A., Aslam, Faisal, Parzynski, Craig S., Desai, Nihar R., Curtis, Jeptha P.
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container_start_page 64
container_title The American journal of cardiology
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creator Daimee, Usama A.
Aslam, Faisal
Parzynski, Craig S.
Desai, Nihar R.
Curtis, Jeptha P.
description Primary prevention implantable cardioverter-defibrillators (ICDs) in patients with recent myocardial infarction or coronary revascularization and those with newly diagnosed or severe heart failure (HF) are considered non-evidence-based, as defined by pivotal randomized clinical trials. Although non-evidence-based ICDs have been associated previously with greater risk of in-hospital adverse events, longitudinal outcomes are not known. We used Medicare-linked data from the National Cardiovascular Data Registry's ICD Registry to identify patients discharged alive following first-time primary prevention ICD implantations performed between 2010 and 2013. We compared longitudinal outcomes, including all-cause mortality and all-cause hospital readmission among patients receiving non-evidence-based versus evidence-based ICDs, up to 4.75 years after implantation, using multivariable time-to-event analyses. Of 71,666 ICD implantations, 9,609 (13.4%) were classified as non-evidence-based. Compared to patients receiving evidence-based ICDs, non-evidence-based ICD recipients had greater mortality risk at 90 days (HR = 1.44, CI: 1.37 – 1.52, p
doi_str_mv 10.1016/j.amjcard.2021.06.020
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Although non-evidence-based ICDs have been associated previously with greater risk of in-hospital adverse events, longitudinal outcomes are not known. We used Medicare-linked data from the National Cardiovascular Data Registry's ICD Registry to identify patients discharged alive following first-time primary prevention ICD implantations performed between 2010 and 2013. We compared longitudinal outcomes, including all-cause mortality and all-cause hospital readmission among patients receiving non-evidence-based versus evidence-based ICDs, up to 4.75 years after implantation, using multivariable time-to-event analyses. Of 71,666 ICD implantations, 9,609 (13.4%) were classified as non-evidence-based. Compared to patients receiving evidence-based ICDs, non-evidence-based ICD recipients had greater mortality risk at 90 days (HR = 1.44, CI: 1.37 – 1.52, p &lt;0.0001) and at 1 year (HR = 1.19, CI: 1.15 – 1.24, p &lt;0.0001), but similar mortality risk at 3 years (HR = 1.03, CI: 0.98 – 1.08, p = 0.2630). Risk of all-cause hospitalization was higher in patients with non-evidence-based ICDs at 90 days (HR = 1.17, CI: 1.14 – 1.20, p &lt;0.0001), but the difference diminished at 1 year (HR = 1.04, CI 1.00 – 1.07, p = 0.0272) and at 3 years (HR = 0.94, CI: 0.90 – 0.99, p = 0.0105). In conclusion, among patients undergoing primary prevention ICD implantations between 2010 and 2013, those with non-evidence-based ICDs were at increased risk of mortality and readmission during longitudinal follow-up. 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Although non-evidence-based ICDs have been associated previously with greater risk of in-hospital adverse events, longitudinal outcomes are not known. We used Medicare-linked data from the National Cardiovascular Data Registry's ICD Registry to identify patients discharged alive following first-time primary prevention ICD implantations performed between 2010 and 2013. We compared longitudinal outcomes, including all-cause mortality and all-cause hospital readmission among patients receiving non-evidence-based versus evidence-based ICDs, up to 4.75 years after implantation, using multivariable time-to-event analyses. Of 71,666 ICD implantations, 9,609 (13.4%) were classified as non-evidence-based. Compared to patients receiving evidence-based ICDs, non-evidence-based ICD recipients had greater mortality risk at 90 days (HR = 1.44, CI: 1.37 – 1.52, p &lt;0.0001) and at 1 year (HR = 1.19, CI: 1.15 – 1.24, p &lt;0.0001), but similar mortality risk at 3 years (HR = 1.03, CI: 0.98 – 1.08, p = 0.2630). Risk of all-cause hospitalization was higher in patients with non-evidence-based ICDs at 90 days (HR = 1.17, CI: 1.14 – 1.20, p &lt;0.0001), but the difference diminished at 1 year (HR = 1.04, CI 1.00 – 1.07, p = 0.0272) and at 3 years (HR = 0.94, CI: 0.90 – 0.99, p = 0.0105). In conclusion, among patients undergoing primary prevention ICD implantations between 2010 and 2013, those with non-evidence-based ICDs were at increased risk of mortality and readmission during longitudinal follow-up. 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Although non-evidence-based ICDs have been associated previously with greater risk of in-hospital adverse events, longitudinal outcomes are not known. We used Medicare-linked data from the National Cardiovascular Data Registry's ICD Registry to identify patients discharged alive following first-time primary prevention ICD implantations performed between 2010 and 2013. We compared longitudinal outcomes, including all-cause mortality and all-cause hospital readmission among patients receiving non-evidence-based versus evidence-based ICDs, up to 4.75 years after implantation, using multivariable time-to-event analyses. Of 71,666 ICD implantations, 9,609 (13.4%) were classified as non-evidence-based. Compared to patients receiving evidence-based ICDs, non-evidence-based ICD recipients had greater mortality risk at 90 days (HR = 1.44, CI: 1.37 – 1.52, p &lt;0.0001) and at 1 year (HR = 1.19, CI: 1.15 – 1.24, p &lt;0.0001), but similar mortality risk at 3 years (HR = 1.03, CI: 0.98 – 1.08, p = 0.2630). Risk of all-cause hospitalization was higher in patients with non-evidence-based ICDs at 90 days (HR = 1.17, CI: 1.14 – 1.20, p &lt;0.0001), but the difference diminished at 1 year (HR = 1.04, CI 1.00 – 1.07, p = 0.0272) and at 3 years (HR = 0.94, CI: 0.90 – 0.99, p = 0.0105). In conclusion, among patients undergoing primary prevention ICD implantations between 2010 and 2013, those with non-evidence-based ICDs were at increased risk of mortality and readmission during longitudinal follow-up. Differences in the risk of mortality and hospitalization were highest in the first year following device implantation.</abstract><cop>New York</cop><pub>Elsevier Inc</pub><doi>10.1016/j.amjcard.2021.06.020</doi><tpages>8</tpages></addata></record>
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subjects Adverse events
Cerebrovascular disease
Clinical trials
Congestive heart failure
Defibrillators
Disease prevention
Government programs
Hospitalization
Implantation
Medicare
Mortality
Myocardial infarction
Patients
Prevention
Risk
Transplants & implants
title Longitudinal Outcomes Associated With Non-Evidence-Based Implantable Cardioverter-Defibrillators Among Medicare Beneficiaries (From the National Cardiovascular Data Registry)
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