Author + information
- Received January 31, 2018
- Revision received February 27, 2018
- Accepted March 6, 2018
- Published online April 30, 2018.
- Nirav Patel, MDa,
- Rajat Kalra, MBChBb,
- Rajkumar Doshi, MBBS, MPHc,
- Navkaranbir S. Bajaj, MD, MPHa,d,
- Garima Arora, MDa and
- Pankaj Arora, MDa,e,∗ ()
- aDivision of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama
- bCardiovascular Division, University of Minnesota, Minneapolis, Minnesota
- cDepartment of Cardiology, North Shore University Hospital, Northwell Health, Manhasset, New York
- dDivision of Cardiovascular Medicine, and Department of Radiology, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
- eSection of Cardiology, Birmingham Veterans Affairs Medical Center, Birmingham, Alabama
- ↵∗Address for correspondence:
Dr. Pankaj Arora, Division of Cardiovascular Disease, University of Alabama at Birmingham, 1670 University Boulevard, Volker Hall B140, Birmingham, Alabama 35294-0019.
Objectives The purpose of this study was to compare trends of use, in-hospital mortality, and annual expenditures associated with orthotopic heart transplantation (OHT) and left ventricular assist device (LVAD) implantation. In view of the changing health care landscape, we assessed the impact of federal funding cuts on Medicare and Medicaid beneficiaries seeking these procedures.
Background Use and cost trends associated with OHT and LVAD are not well defined. Moreover, little is known about the economic contribution of Medicare and Medicaid for these procedures.
Methods Using the National Inpatient Sample from 2009 through 2014, the study identified index hospitalizations for OHT and LVAD. The aforementioned trends and inflation-adjusted cost analyses were performed.
Results A total of 28,765 hospitalizations associated with OHT or LVAD were identified. The number of index hospitalizations for OHT increased from 1,795 to 2,140, whereas the number of LVAD implants increased from 2,205 to 3,645 (ptrend <0.001 for both). Unadjusted in-hospital mortality declined significantly from 17% to 12% (ptrend = 0.013) but remained unchanged for OHT (4.5% and 6.6%, respectively; ptrend = 0.30). The annual expenditure increased from ∼$288 to $451 million for OHT and from ∼$400 to $800 million for LVAD during the study period. Overall, Medicare and Medicaid contributed to more than 50% of the costs associated with these hospitalizations.
Conclusions With increasing use and annual expenditure, OHT and LVAD account for more than 1 billion dollars of the health care budget. In-hospital mortality associated with LVAD has continued to decline but has remained higher than that with OHT. Medicare and Medicaid beneficiaries seeking these procedures would be adversely affected by the proposed cuts.
Heart failure (HF) has been diagnosed in more than 6.5 million Americans (1). The American College of Cardiology/American Heart Association (ACC/AHA) delineates 4 stages of HF, from stage A to stage D (2). Treatment of stage D (end-stage) HF hospitalizations with orthotopic heart transplantation (OHT) carries a Class I recommendation (2). Due to the limited availability of donor hearts, left ventricular assist devices (LVAD) have been suggested by ACC/AHA guidelines as Class IIa recommendation for treatment, either as a destination therapy or a bridge to OHT in end-stage HF patients (2).
Determination of use and cost associated with OHT and LVAD implantation in end-stage HF hospitalizations using data until 2008 suggested an upward trend nationally (3). However, recent trends of use, in-hospital mortality, and length of stay (LOS) and expenditure associated with OHT and LVAD implantation in the end-stage HF hospitalizations are lacking. This is particularly pertinent given that more than 8 million people will have HF by 2030 (4). Moreover, the recently proposed health care reforms have endorsed reducing federal spending on Medicare and Medicaid over the next decade (5,6).
We conducted a retrospective study to determine the aforementioned trends associated with OHT and LVAD implantation. Additionally, in view of the proposed Medicare and Medicaid cuts, we examined the costs associated with OHT and LVAD implantation stratified by different primary payers.
Our study population was derived from the National Inpatient Sample (NIS) (7,8). Details of the NIS have been published previously (8–10). A brief summary of the NIS has been described in Online Method 1.
Our study population was identified by using the International Classification of Diseases-9th Revision-Clinical Modification (ICD-9-CM) diagnosis and procedures codes from 2009 through 2014. ICD procedure codes 37.51 (heart transplantation) and 37.66 (insertion of implantable heart assist system) were used to identify index hospitalizations for OHT and LVAD implantation, respectively (3,11). All hospitalizations among adults ≥18 years of age were included in our study. To identify true index hospitalization costs, all hospitalizations where 1) OHT and LVAD implantation; 2) biventricular assist devices; and 3) combined heart-lung transplantations occurred during the same admission were removed. The final study cohort consisted of 2 groups: those who underwent OHT and those with LVAD implantation (Figure 1) from 2009 to 2014. We used the Elixhauser index to classify comorbidities for our study (12). Comorbidities not identified by the Elixhauser index were identified using appropriate ICD-9-CM diagnostic codes (Online Table 1). Severity of comorbid conditions was defined using the Deyo modification of Charlson’s comorbidity index (CCI) (12), which contains 17 weighted comorbid conditions with a score ranging from 0 to 33 (Online Table 2). A higher score corresponds to a greater burden of comorbid conditions at baseline before the procedure (12). Appropriate weights (i.e., trend and discharge weights) provided by the Agency for Healthcare Research and Quality/Healthcare Cost and Utilization Project (AHRQ/HCUP) were used to generate national estimates from the 20% stratified sample.
To estimate the cost of index hospitalizations associated with OHT and LVAD implantation, we merged NIS data with cost-to-charge ratio files available from AHRQ/HCUP (3). A detailed description of the cost calculations has been described in Online Method 2.
Primary outcomes were used (measured as the number of index hospitalizations for OHT and LVAD implantation) and in-hospital mortality from 2009 through 2014. Additionally, the trends of LOS and mean cost for index hospitalization associated with OHT and LVAD implantation were examined. The secondary outcome was annual expenditure associated with the aforementioned hospitalizations during the study period.
SAS version 9.4 software (SAS Institute Inc., Cary, North Carolina) was used for statistical analyses. Temporal trends for total number of OHT and LVAD implantation procedures were analyzed from 2009 to 2014. In-hospital mortality was calculated by using the number of hospital deaths divided by OHT or LVAD implantation procedure for the given year. Temporal trends of LOS were examined by using the median length of hospitalization, and the trends of CCI were analyzed by using the CCI categories. All trend tests were performed using the Jonckheere-Terpstra trend test, and a p value of <0.05 was considered significant. All analyses in the study were performed according to recommended AHRQ/HCUP weighting (13) and in agreement with the best research practices, summarized in a methodological statement for conducting research using the NIS database (14).
A total of 28,765 index hospitalizations associated with OHT or LVAD implantation were identified between 2009 and 2014 (Figure 1). Among these hospitalizations, 11,435 were for OHT, and 17,330 were for LVAD implantation (Table 1). The mean age of OHT hospitalizations was lower than that of LVAD hospitalizations (53 vs. 56 years of age, respectively). A higher proportion of men underwent OHT and LVAD implantation than women (74.1% were women, and 76.8% were men) (Table 1). Race distribution was similar among hospitalizations associated with OHT and LVAD implantation (Table 1). The prevalence of comorbidities with CCI of ≥3 was higher in hospitalizations associated with LVAD implantation compared to OHT (55.4% vs. 45.7%, respectively) (Table 1). Of the 11,435 OHT hospitalizations, nearly 15% had a history of LVAD implantation (Table 1).
Hospitalizations associated with OHT were more likely funded by private insurance (46.1%), and LVAD implantation hospitalizations were more likely to be funded by Medicare (47.7%) (Table 1). The southern United States, consisting of 17 states and District of Columbia (Online Table 3), had the most index hospitalizations (37%) for OHT and LVAD implantation. The median length of hospitalization (21.0 days vs. 28.0 days, respectively), and the mean cost of hospitalization ($181,497 vs. $224,684, respectively) was lower in OHT hospitalizations than in LVAD hospitalizations (Table 1).
OHT index hospitalizations
The annual number of OHT hospitalizations increased by 19% from 2009 through 2014 (Figure 2A) (1,795 in 2009 vs. 2,140 in 2014; ptrend <0.001). Rates of unadjusted in-hospital mortality were unchanged for those undergoing OHT (4.5% in 2009 to 6.6% in 2014, ptrend = 0.30) (Figure 2A). The median LOS for OHT hospitalizations increased from 20 days in 2009 to 23 days in 2014 (ptrend = 0.04) (Online Figure 1). The percentage of hospitalizations for OHT with CCI ≥3 increased significantly from 2009 to 2014 (45% vs. 51%, respectively; ptrend = 0.03) (Figure 3A). Correspondingly, the mean cost of index hospitalization associated with OHT hospitalizations increased substantially from 2009 through 2014 (∼$160,000 vs. ∼$211,000, respectively; a relative increase of ∼32%) (Figure 3A). With increased use and rising hospitalization cost of OHT, the nationwide annual expenditure associated with OHT hospitalizations also increased from ∼$288 to ∼$451 million from 2009 to 2014 (Figure 3A).
OHT hospitalizations cost subgroup analysis
To assess the effect of LVAD explantation on the cost, the mean cost of OHT stratified by LVAD explantation during the same hospitalization was examined. The mean cost of OHT hospitalizations with concurrent LVAD explantation was $201,848, whereas the cost for those without LVAD explantation was $174,793 during the study period.
LVAD implantation index hospitalizations
Overall, the annual number of hospitalizations associated with LVAD implantation increased substantially from 2009 to 2014 (2,205 vs. 3,645 per year, respectively; a relative increase of ∼65%; ptrend <0.001) (Figure 2B). This paralleled the U.S. Food and Drug Administration’s (FDA) approval of HeartMate II as a bridge to transplantation in April 2008 and approval of HeartMate II as a destination therapy in January 2010 (Figure 2B). Rates of in-hospital mortality decreased significantly from ∼17% to ∼12% (ptrend = 0.013) during this period (Figure 3B). The median LOS for LVAD hospitalization also decreased significantly from 34 days in 2009 to 28 days in 2014 (ptrend <0.001) (Online Figure S1). The percentage of hospitalizations associated with LVAD implantation with CCI ≥3 increased significantly from 2009 to 2014 (44% vs. 61%, respectively; p <0.001) (Figure 3B). The mean cost of index hospitalization associated with LVAD implantation remained stable during the study period (∼$214,000 vs. $229,000, respectively; a relative increase of 7%) (Figure 3B). However, there was a consistent rise in nationwide annual expenditure associated with increasing use of LVAD from ∼$400 to $800 million. (Figure 3B).
Total and annual expenditure stratified by primary payers
Among OHT and LVAD implantation index hospitalizations from 2009 through 2014, ∼44% were for Medicare beneficiaries, and ∼11% were for Medicaid beneficiaries. Therefore, among different primary payers, Medicare and Medicaid jointly shared more than 50% of the economic burden of the index hospitalizations associated with these procedures (Figure 4A). From 2009 to 2014, Medicare expended ∼$770 million and ∼$1.8 billion, respectively, toward OHT and LVAD implantation hospitalizations, and Medicaid contributed ∼$215 million toward OHT and ∼$452 million to LVAD implantation (Figure 4A). The number of Medicare and Medicaid dollars spent on OHT and LVAD increased from ∼$380 million in 2009 to ∼$725 million in 2014 (Figure 4B).
Our analyses have highlighted important trends of use, in-hospital mortality, LOS, and expenditures associated with OHT and LVAD implantation. We noted steady increases in the rates of OHT hospitalizations from 2009 to 2014. There was no change in the rates of in-hospital mortality, but a significant trend toward increasing LOS was noted with index OHT hospitalizations. Similar to OHT, there was also a rise in the rates of hospitalizations associated with LVAD implantation. However, this was accompanied with a significant decline in the rates of in-hospital mortality and LOS during the study period. During the study period, the mean cost of index hospitalization for OHT increased by ∼32%, whereas the mean cost of index hospitalization associated with LVAD implantation increased by ∼7%. There was an accompanying rise in the nationwide annual expenditure from ∼$688 million to ∼$1.25 billion from 2009 to 2014, corresponding to the increasing uses and rising costs of OHT and LVAD implantations. Compared to 2009, a higher proportion of individuals with at least 3 or more comorbidities underwent OHT and LVAD implantation in 2014. Among Medicare and Medicaid beneficiaries, we noted a nearly 2-fold change in the annual expenditure associated with OHT and LVAD implantation from 2009 to 2014.
There are several possible explanations for the increase in OHT and LVAD implantation from 2009 to 2014. Advancements in the medical management of HF have likely led to greater numbers of hospitalizations with end-stage HF who have survived to OHT and LVAD implantation (15). There is also evidence to suggest that LVAD implantation is being sought earlier in the course of decompensated end-stage HF, before the onset of severe cardiogenic shock (11). Rapid improvements in LVAD technology (such as FDA approval of HeartMate II and HeartWare devices), decreases in procedure-related complications, and a possible decrease in availability of donor hearts may all play a role in increasing the numbers of candidates for LVAD implantation (3,16,17). Correspondingly, the nationwide estimated expenditure associated with OHT and LVAD implantation nearly doubled from 2009 to 2014 in this study cohort.
There are also several possible explanations for the rates of in-hospital mortality that we noted in our investigation. The rate of in-hospital mortality among hospitalizations for OHT remained unchanged from 2009 to 2014. This is similar to previously reported results (3,18). The refinement of candidate selection, improved surgical expertise, and improved perioperative management may be possible factors in the improved survival rates after LVAD implantation (17,19). Survival rates will probably continue to improve with the advent of more contemporary therapies, such as the recent FDA approval of the HeartMate III LVAD device (20). Previous studies have also described a similar trend of declining in-hospital mortality associated with LVAD implantation (3,11).
Advancement in medical management of HF and the availability of LVAD as a bridge to transplantation has allowed end-stage HF hospitalizations seeking OHT to survive longer to get transplantation. Hence, individuals with higher comorbidity burden (i.e., CCI ≥3) are getting OHT, and they may have a higher incidence of periprocedural complications leading to increased LOS. Increased amounts of periprocedural complications and LOS may also explain the increasing mean cost for index hospitalization associated with OHT. Similar to OHT hospitalizations, more individuals with CCI ≥3 are getting LVAD implantation, which has likely led to a higher mean cost of index LVAD hospitalization. However, this has been balanced by an accompanying decrease in the median LOS for index LVAD hospitalizations. Thus, the mean cost per LVAD implantation has remained remarkably stable at approximately ∼$200,000 (11). The annual expenditure for OHT and LVAD implantation nearly doubled from 2009 to 2014 in this study cohort. This suggests that there has been a rapid rise in the number of procedures being sought.
Medicare’s and Medicaid’s roles in funding ∼55% of OHT and LVAD implantation index hospitalizations is of great public health importance. After implementation of the Affordable Care Act (ACA), more hospitalizations with end-stage HF have had access to health insurance (i.e., funding status), which is mandatory for OHT (21,22). Despite this, the American Senate has recently passed the Tax Cuts and Jobs Act of 2017, which proposes cuts in federal spending especially to the Medicare, Medicaid, and ACA programs over the next 10 years (5,23,24). The Center on Budget and Policy Priorities (CBPP) and Congressional Budget Office (CBO) estimate that Medicaid and ACA beneficiaries will be affected the most by the proposed cuts, followed by Medicare beneficiaries, due to short- and long-term projected reductions in health care funding (5,23,25).
A newer projection from CBPP and CBO for Medicare estimates a ∼$473 billion reduction in net federal spending over the next decade (6,23,25). The proposed 9% in Medicare cuts will likely be compensated for by increasing insurance premiums for Medicare beneficiaries (6,25). Additionally, the Centers for Medicare and Medicaid services have already proposed ∼5% reimbursement reductions for LVAD implantation starting from October 1, 2017 (26–29). Taken collectively, Medicare beneficiaries seeking LVAD implantation for end-stage HF may face significant financial burden due to the aforementioned policy changes.
Furthermore, CBPP and CBO estimate a further ∼$1.3 trillion proposed cut (∼29% cuts) of net federal spending on Medicaid and ACA over the course of 10 years (5,6,23). These reductions will be primarily driven by major cuts in Medicaid funding through block design, which mandates locking the annual federal funding for every state (5). This suggests that the 33 American states that implemented ACA and expanded their Medicaid program may have their federal funding swiftly siphoned away to other causes (30). The future of the Medicaid funding for these states is therefore uncertain. The CBO also estimated that nearly 13 million individuals (including 5 million Medicaid beneficiaries) will lose their health care coverage over the period of the next 10 years (5,24). Our suspicion is that these recurring themes of imbalance in political policy will likely widen the extensive and pre-existing disparities in health care coverage when it comes to end-stage HF therapy, such as LVAD and OHT implantation.
Approximately 50% of OHT recipients survive up to 10 years with continued improvement in the survival rates (31). Studies have shown that hospitalizations receiving LVAD as bridge to transplantation have 1-year survival rates similar to those with OHT (32), and these survival rates are approaching 80% in hospitalizations receiving LVAD as destination therapy (33). The aforementioned survival rates are far superior to survival rates of the medical management alone (34,35). Previous cost-effectiveness analyses have shown that these procedures not only improve survival but are a good use of resources (36).
We strongly support the preservation of funding for Medicare and Medicaid beneficiaries seeking these procedures for end-stage HF. Alternative solutions involve grassroots education campaigns and wider coverage of health care for hospitalizations with stages A to C HF to prevent progression to stage D. This essentially involves better access to medical care through preservation of federally funded Medicare and Medicaid programs. Hence, the strategy to reduce costs associated with OHT and LVAD is improvement in general HF care, which we hope will ultimately reduce the need for these procedures.
Retrospective studies have well-recognized limitations. The National Inpatient Sample is based on ICD-9-CM codes which are prone to coding errors, misinterpretation of procedure volume, and underreporting of comorbid conditions (3,11). Moreover, we have used discharge and trend weights to represent national estimates. Hence, the numbers may not reflect the actual numbers of OHT and LVAD implantation but are at least a valid approximation (3). Additionally, we do not have information for the proportion of hospitalizations “eligible” for OHT and LVAD implantation procedures. The lack of other key baseline data such as procedural indications and being unable to differentiate between the types of implanted device (LVAD) are also notable limitations to our data. The cost analyses in our study were limited to hospital claims for in-patient services and did not include the cost of organ acquisition. Similarly, little information can be extrapolated about the financial burden that the follow-up care, hospitalizations, and complications that OHT and LVAD implantation pose from this data set. However, the use of a retrospective analysis in this investigation affords us the opportunity to access a large group of hospitalizations for procedures that are done relatively infrequently.
The use of OHT and LVAD implantation continues to increase for end-stage HF with a corresponding rise in annual expenditure during the study period. In-hospital mortality associated with LVAD implantation is declining but has remained higher than OHT. With rising use and mean costs for OHT and LVAD implantation, the 2 procedures annually account for ∼$1.25 billion of the annual health care budget. Medicare and Medicaid beneficiaries with end-stage HF seeking these procedures will be drastically affected by the proposed cuts.
COMPETENCY IN MEDICAL KNOWLEDGE: With the increasing prevalence of end-stage HF, the recent trends in hospitalization, in-hospital mortality, and expenditure associated with OHT and LVAD implantation are not known. Additionally, in view of the recent health care policy reforms, we assessed the impact of proposed cuts on Medicare and Medicaid spending for beneficiaries seeking OHT and LVAD implantation.
TRANSLATIONAL OUTLOOK 1: Rates of hospitalizations associated with OHT and LVAD implantation have increased from 2009 to 2014. Rates of in-hospital mortality associated with OHT have remained steady but continue to decline among hospitalizations associated with LVAD implantation during the study period. With increasing utilization, there was an accompanying rise in the nationwide annual expenditure from ∼$688 million to ∼$1.25 billion from 2009 to 2014.
TRANSLATIONAL OUTLOOK 2: Medicare has contributed ∼$2.6 billion toward OHT and LVAD implantation from 2009 through 2014. Among Medicaid beneficiaries, the total expenditure associated with OHT and LVAD implantation was ∼$667 million from 2009 through 2014. Medicare beneficiaries may face difficult economic challenges if the proposed Medicare cuts are approved. States which have expanded the Medicaid coverage with the Affordable Care Act may be disproportionately affected if the proposed Medicaid cuts are carried out.
Dr. Arora is supported by a Walter B. Frommeyer Jr. Fellowship in Investigative Medicine through the University of Alabama. Dr. Patel is supported by U.S. National Institutes of Health (NIH) grant 1T32HL129948-01A1. Dr. Bajaj is supported by NIH grant 5T32HL094301-07. All other authors have reported that they have no relationships with industry relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- Affordable Care Act
- Agency for Healthcare Research and Quality
- Deyo modification of the Charlson Comorbidity Index
- Healthcare Cost and Utilization Project
- heart failure
- International Classification of Diseases-9th Revision-Clinical Modification
- length of stay
- left ventricular assist devices
- National Inpatient Sample
- orthotopic heart transplantation
- U.S. Food and Drug Administration
- Received January 31, 2018.
- Revision received February 27, 2018.
- Accepted March 6, 2018.
- 2018 American College of Cardiology Foundation
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