Association of the US Department of Justice Investigation of Implantable Cardioverter-Defibrillators and Devices Not Meeting the Medicare National Coverage Determination, 2007-2015

Desai, Nihar R.; Bourdillon, Paul M; Parzynski, Craig S.; Brindis, Ralph G.; Spatz, Erica S.; Masters, Claire; Minges, Karl E.; Peterson, Pamela N.; Oetgen, William J.; Buxton, Alfred E.; Zipes, Douglas P.; Curtis, Jeptha P.

doi:10.1001/jama.2018.8151

Cited by 16 publications

(9 citation statements)

References 25 publications

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“…Despite initial enthusiasm for LVAD therapy in end stage HF patients, and dramatic improvements in clinical outcomes, clinical use has plateaued at levels far less than previously forecasted [ 9 ]. Our findings offer a potential explanation for this finding—unlike in the case of other therapeutics where real-world use is expanded beyond the population studied in the clinical trial, treatment with LVADs appears to be quite conservative considering the number of patients who are inferred to benefit from this intervention [ 10 – 12 ]. The causes of this behavior are unclear and might result from several factors such as patient preferences, lack of knowledge among most physicians about the therapy, and misunderstandings regarding candidacy [ 13 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure

et al. 2020

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Importance Patient outcomes in heart failure clinical trials are generally better than those observed in real-world settings. This may be related to stricter inclusion and exclusion criteria in clinical trials. Objective We study sought to characterize the clinical implications of differences between patients in clinical trials and those in a real-world registry of patients receiving left ventricular assist devices (LVADs). Design, setting, and participants This retrospective cohort study included all patients in INTERMACS (the Interagency Registry for Mechanically Assisted Circulatory Support) who were implanted with an axial flow LVAD from 2010 to 2015 to allow for equivalent comparisons. Main outcomes and measures Differences in patient characteristics and 2-year rates of adverse outcomes with those reported in the ENDURANCE and MOMENTUM 3 clinical trials. Survival analyses were used to assess the relationships between prespecified patient factors and clinical outcomes. Results Of the 10,937 LVAD recipients identified in INTERMACS between 2010–2015, 44% met at least 1 clinical trial exclusion criterion. The 2-year incidence of stroke and death amongst LVAD recipients in INTERMACS and the landmark clinical trials differed significantly (P<0.04, both). Nevertheless, patients who would have been excluded from the clinical trials did not have dramatically different 2-year mortality outcomes in INTERMACS [2y survival estimate: 66.4%, 95% CI (64.9–67.9%) versus 71.9%, 95% CI (70.6–73.1%)]. Clinical interventions driving a significantly increased risk of death were relatively rare (<5% of implants) and included mechanical ventilation, ECMO, severe thrombocytopenia, and dialysis. Conclusions and relevance Most exclusion criteria used in LVAD clinical trials did not afford a substantially greater risk to patients in the real-world setting. In the relatively infrequent cases of end stage renal disease, thrombocytopenia, respiratory failure, and need for ECMO, the risks and benefits of LVAD therapy need careful weighting and further study.

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Section: Discussionmentioning

confidence: 99%

Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure

et al. 2020

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“…It was recently reported that the number of ICDs implanted in the US has fallen significantly since the announcement of the results of the DOJ investigation and repayment process. 4 I take this as a hopeful sign that cardiologists are following the guidelines and implanting these devices appropriately.…”

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confidence: 98%

Sloppy, Greedy, or Overworked?

Alpert

2018

The American Journal of Medicine

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“…Firstly, clinical practice is not static as shown by the substantial decrease in the number of primary prevention ICDs and the proportion of devices not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria following the announcement of a US Department of Justice investigation into ICD use in 2010 [13] . There are also some important limitations of the SHaRe registry itself including the risk of inclusion bias, missing data and a relatively short follow-up period.…”

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confidence: 99%

Sudden cardiac death in hypertrophic cardiomyopathy: time to change the narrative

Elliott

2021

European Heart Journal

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Association of the US Department of Justice Investigation of Implantable Cardioverter-Defibrillators and Devices Not Meeting the Medicare National Coverage Determination, 2007-2015

Cited by 16 publications

References 25 publications

Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure

Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure

Sloppy, Greedy, or Overworked?

Sudden cardiac death in hypertrophic cardiomyopathy: time to change the narrative

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