Healthcare cost and utilization before and after the development of significant tricuspid regurgitation by age, sex and race

A total of 79,046 patients with sTR were included in the analysis at index and Year -1 (Figure 1). Most (99.4%) patients met sTR criteria by having a TR diagnosis and 3 or more clinical findings while only 0.5% of patients entered via physician note of severity alone (Supplementary Table 1B). Chronic kidney disease, liver disease and edema were present in ≥90% of patients, whereas few patients had a record of ascites (16.7%), weight loss (7.8%), right heart dysfunction (0.1%) or fatigue (0.1%). Over half (56.8%) of patients had a TR diagnosis for at least 3 years prior to reaching sTR status, and 86.9% had a TR diagnosis at any time before the index encounter.

The results of this retrospective longitudinal analysis of multipayer data in the Optum Market Clarity database showed healthcare costs and utilization increased in the years leading up to and following sTR status. Cardiovascular hospitalizations were the primary driver of inpatient costs, but outpatient cardiac specialist care represented only a small proportion of total outpatient visits. There were also significant differences across demographic subgroups in terms of disease burden and healthcare utilization trends which impacted overall costs. Together, these data provide important insights into the clinical trajectory of TR, associated healthcare utilization patterns and demographic differences along the care pathway in patients with significant TR.

The findings of our analysis are consistent with past literature reporting the substantial impact of HFH in TR patients [1], and worsening TR severity with development of characteristic symptoms [7,14]. The current study illustrates a rising burden of costs associated with progression of TR and the development of clinically sTR. Nearly 87% of patients had a diagnosis of TR prior to the index encounter, many of them up to 3 years prior, consistent with progression of valvular heart disease that is often seen in clinical practice. Most patients in this study had additional valvular heart disease pathologies, with a predominance of mitral regurgitation (75%). Further, approximately two-thirds of patients were diagnosed with congestive heart failure before or at the time of meeting criteria for sTR, a finding frequently encountered clinically in the setting of hypervolemia that accompanies heart failure exacerbations. The presence of heart failure in patients with sTR has been shown to increase their healthcare utilization and costs compared with sTR patients without heart failure [15].

We observed a high intensity of care in the sTR cohort across all demographic groups. Increased medical care needs were identified leading up to sTR, with continued increases in costs and utilization once patients entered sTR status. Mean total costs more than tripled from Year -3 to Year +1 in the study, and cardiovascular-related inpatient hospitalization was a primary driver of increased cost associated with sTR. More than 50% of hospitalizations were urgent/emergent, and there were relatively low rates of outpatient cardiac specialist visits, suggesting patient cohorts with limited access to cardiac specialty care or those with frailty are underserved with regards to outpatient specialty access. More research is needed on whether improving outpatient specialty care for those patients with TR disease progression may be one avenue to avoid disruptive and expensive inpatient admissions.

Examining TR progression by age, sex and race/ethnicity revealed variable relationships between total healthcare costs and three utilization measures (HFHs, days in the hospital and outpatient visits to cardiac specialists). Specifically, by age, patients under 80 years had higher costs, equal HFHs, more days in the hospital and fewer outpatient cardiac specialist visits compared with those 80 years and over. By sex, male patients experienced higher costs, higher HFHs, more days in the hospital, and more outpatient cardiac specialist visits than female patients. By race/ethnicity, nonWhite patients had higher costs, more HFHs, more days in the hospital and fewer cardiac specialist visits compared with White patients. These results suggest that one mechanism of reducing costs may be via increased access to outpatient cardiac specialist visits, particularly among older and nonWhite patients, thereby reducing HFHs and days in the hospital. Further prospective work is needed to more comprehensively elucidate these relationships.

Understanding real-world patterns of TR progression to significant status may support clinical decision-making. For instance, older and more frail patients who may not be eligible for surgery are still at risk of hospitalization for heart failure and may benefit from minimally invasive transcatheter approaches [16]. Also, a consensus on risk stratification for patients to aid with clinical decision-making when faced with a patient with progressive TR is lacking. Treating patients before the development of severe right ventricular dysfunction and associated clinical symptomatology and heart failure risk may reduce heart failure related hospital admissions and associated costs. However, little guidance is presently available to consistently define and assess right ventricular dysfunction to help determine appropriate timing of intervention [17,18].

There are study limitations, including a lack of quality-of-life metrics and further clinical details, including specific cardiac testing results. Proxy definitions were required for disease severity as echocardiogram data is limited to small subset of patients in the Optum Market Clarity database. These proxy definitions are not intended to replicate TR severity classifications used in physician guidelines [19]. Valve disease has been found to be under-reported in community-based screening studies [20], and patients without a record of TR diagnosis would be missed by our proxy query. The study was observational and descriptive in nature, meaning that causal relationships between observed events cannot be assumed. Patients were not required to be enrolled during measurement Year -2 and Year -3 to be included in the study and therefore subject analysis across time periods was not conducted. Future trend research might evaluate the change in slope across demographic groups leading up to a sTR status. This study compares complete (pre years) to annualized (post year) costs; the accuracy of annualized costs diminishes with fewer months of available data and prior published work has found an absolute error between actual annual costs and annualized costs of $2700 for Medicare patients [21]. Additionally, annualizing costs may introduce bias by including patients with increased medical complexities and high short-term costs (but less than 12 months of follow-up) compared with patients who have all 12 months of follow-up available in the database. Finally, trends may be confounded by age, sex and race/ethnicity representativeness within each demographic category. A regression model adjusting for these differences would be relevant in future analyses assessing cost and clinical events in this population.

Annual costs before sTR increase over time and continue to increase as clinical disease progresses. Higher costs among Black patients as well as those 50–79 years old, were associated with more HFHs and an increased number of hospital days. Increasing recognition of TR progression in patients at high risk of sTR development, in addition to research on improved outpatient cardiac specialty access, may be an important means to reduce HFH duration as well as overall costs.

The authors thank D Frame for her assistance in writing the manuscript.

The present analysis and manuscript was supported by Edwards Lifesciences.

D Cork, F Medina, P Gaba, R Yeh and C Barker report administrative support, article publishing charges, statistical analysis and writing assistance were provided by Edwards Lifesciences Corportion. L Kemp, A Dratch, R Horn, S Murphy and S Mollenkopf report financial support was provided by Edwards Lifesciences Corporation. L Kemp, A Dratch, R Horn, S Murphy and S Mollenkopf report a relationship with Edwards Lifesciences Corporation that includes: employment. R Yeh reports the following relationships: Abbott Vascular Inc, Boston Scientific, Edwards Lifesciences, Elixir Medical and Medtronic relationships include: consulting and research grants; JenaValve and Siemens relationships that include: research grants; CathWorks, FastWave, Magenta Medical and Shockwave relationships that include: consulting. C Barker reports relationships with Alleviant, Boston Scientific, Edwards Lifesciences Corporation and Medtronic that include: consulting. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

The authors certify that this manuscript reports the secondary analysis of clinical data that have been shared with them, and that the use of this shared data is in accordance with the terms (if any) agreed upon their receipt.

This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit https://creativecommons.org/licenses/by-nc-nd/4.0/