ABSTRACT

Background Patients with severe aortic stenosis (AS) who are managed medically have a poor prognosis. No contemporary studies have examined the costs and resource utilization associated with medical management for severe AS.

Methods We used data from the Optum Market Clarity Database, which links electronic health records (EHR) with claims cost and utilization data, to identify patients with documented severe AS between 2016 and 2020 who did not undergo aortic valve replacement (AVR) within one year following diagnosis. To adjust for comorbidities that may have influenced treatment decisions, medically managed patients were matched 1:1 with similar patients who underwent AVR. Outcomes included healthcare resource utilization and costs during the 4-year period following the initial diagnosis of severe AS. Unadjusted Fine and Gray competing risk models were used to estimate resource utilization, and the Bang/Tsiatis method was used to quantify utilization and cost outcomes while accounting for censoring.

Results Over the study period, 6,892 patients presented with newly diagnosed severe AS, of which 3334 (48%) were managed medically and 2812 (41%) were able to be propensity matched with patients who underwent AVR. Over 4 years of follow-up, these patients experienced an average of 1.99 hospitalizations—1.33 of which were related to a cardiovascular condition. Total healthcare-related costs (including hospitalizations, outpatient care, and pharmacy services) were $126,638/patient, of which $56,032 were related to inpatient care, $31,603 were related to outpatient care, and $21,160 were for pharmacy services.

Conclusions In contemporary practice, despite the availability of effective treatment, many patients with documented severe AS do not undergo AVR within the first year after diagnosis. These patients with severe AS who are managed medically experience high health-care related resource utilization and costs. Further research is needed to identify factors associated with lack of timely valve replacement and to address barriers to care for these patients.

Clinical Perspective What is new?

What are the clinical implications?

Medically-managed patients with severe aortic stenosis are frail, elderly, with multiple comorbid conditions and have high resource utilization and costs.

Further research is needed to identify patients who may benefit from aortic valve replacement.

Competing Interest Statement

Shannon M.E. Murphy, MA and Christin Thompson, Ph.D. are employees and shareholders of Edwards Lifesciences. David J. Cohen, MD, MSc?Research grant support from Edwards Lifesciences, Abbott, Boston Scientific, and Philips; Consulting income from Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic

Funding Statement

The study was funded by Edwards Lifesciences. Drs. Vohra and Cohen did not receive compensation for their time and effort on this study.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

As this was a noninterventional, retrospective, observational study that collected de-identified data for patients who met eligibility criteria, informed consent was not required from patients under an institutional review board exemption status. All aspects of this study were conducted in compliance with the Health Insurance Portability and Accountability Act of 1996 regulations and the act's Omnibus Rule of 2013.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

he data that support the findings of this study are available from the corresponding author upon reasonable request.

Nonstandard Abbreviations and AcronymsAVRaortic valve replacementASaortic stenosisACCAmerican College of CardiologyAHAAmerican Heart Association