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Adult: Mechanical Circulatory Support| Volume 158, ISSUE 2, P466-475.e4, August 2019

In-hospital mortality in older patients after ventricular assist device implantation: A national cohort study

Open ArchivePublished:November 15, 2018DOI:https://doi.org/10.1016/j.jtcvs.2018.10.142

      Abstract

      Objectives

      To assess baseline patient characteristics and identify factors associated with in-hospital mortality after ventricular assist device (VAD) placement.

      Methods

      Cross-sectional study using the National Inpatient Sample database from January 2010 to December 2014. Analyses were performed with sample weights provided by the National Inpatient Sample, which are reported ± the standard error of the mean.

      Results

      Weighted samples yielded 15,021 ± 1111 patients who received a VAD. The mean age at time of implantation was 56.6 years. Most recipients were white (59.9%) and male (75.0%). Among older patients, in-hospital mortality increased from 17.2% to 48.2% when 1 or more high-risk interventions (cardiac surgery, prolonged mechanical ventilation, hemodialysis, or extracorporeal membrane oxygenation) preceded VAD placement (P < .001). In comparison, in-hospital mortality in younger patients increased from 11.1% to 29.4% when 1 or more of these same procedures preceded VAD placement. The mortality difference associated with these procedures was 19% greater in older patients compared with younger patients (95% confidence interval [CI], 9%-28%). In-hospital mortality among VAD recipients was associated with age older than 65 years (odds ratio [OR], 1.76; 95% CI, 1.29-2.40), female sex (OR, 1.27; 95% CI, 0.97-1.67), and at least 1 high-risk intervention preceding VAD (OR, 5.52; 95% CI, 4.27-7.13).

      Conclusions

      Older patients who underwent 1 or more intensive treatments before VAD placement had a nearly 50% inpatient mortality and were unlikely to receive a cardiac transplantation. Refining patient selection might help better align VAD with those most likely to benefit.

      Graphical abstract

      Key Words

      Abbreviations and Acronyms:

      AHRQ (Agency for Healthcare Research and Quality), CI (confidence interval), ECMO (extracorporeal membrane oxygenation), ICD-9 (International Classification of Diseases, Ninth Revision), ICD-9-PCS (International Classification of Diseases, Ninth Revision, Procedural Coding System), IABP (intra-aortic balloon pump), INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support), LVAD (left ventricular assist device), NIS (National Inpatient Sample), OR (odds ratio), VAD (ventricular assist device)
      Figure thumbnail fx2
      In-hospital mortality in older patients after VAD implantation: a national cohort study.
      Older adults who undergo intensive treatments before VAD implantation have a 48.2% inpatient mortality.
      We assessed outcomes after VAD placement in older adults. Older adults who underwent intensive treatments (cardiac surgery, mechanical ventilation, hemodialysis, or ECMO) before VAD implantation had a 48.2% mortality rate and are unlikely to receive cardiac transplantation. Refining patient selection might help better align treatment with those most likely to benefit.
      See Commentaries on pages 476 and 478.
      Ventricular assist devices (VADs) have emerged as an alternative to transplantation for the >250,000 patients in the United States with end-stage heart failure.
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      • et al.
      Heart disease and stroke statistics-2018 update: a report from the American Heart Association [erratum in 2018;137:e493].
      Improved technology has made VAD, and especially left VAD (LVAD), implantation a treatment option for an increasing number of patients, particularly in older adults who are unlikely to receive a heart transplantation.
      • Butler C.R.
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      Mechanical circulatory support for elderly heart failure patients.
      The proportion of LVADs placed as destination therapy increased from 14.7% in 2006 to 49.7% of all LVAD placements in 2014.
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      At the same time, the number of heart transplantations has remained stable and relatively uncommon in older adults. Currently, only 15% of heart transplantations are performed in adults older than the age of 65 and less than 2% in adults older than the age of 70 years.
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      Compared with medical management, VADs improve quality of life, symptoms, and longevity in younger and older patients.
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      Ventricular assist device implant in the elderly is associated with increased, but respectable risk: a multi-institutional study.
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      • Stevenson L.W.
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      • et al.
      Seventh INTERMACS annual report: 15,000 patients and counting.
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      However, adverse outcomes such as stroke, gastrointestinal bleeding, early mortality, and rehospitalization are more common among older patients.
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      • et al.
      Ventricular assist device implant in the elderly is associated with increased, but respectable risk: a multi-institutional study.
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      • et al.
      Ventricular assist device therapy in older patients with heart failure: characteristics and outcomes.
      Furthermore, increased frailty and comorbidities might attenuate the benefit of VAD therapy. VAD therapy requires substantial caregiving, which might be more challenging when the primary caregiver is another older adult. The decision to implant a VAD involves complex trade-offs, and can exert a great effect on patients and families.
      • McIlvennan C.K.
      • Allen L.A.
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      • Brieke A.
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      • Matlock D.D.
      Decision making for destination therapy left ventricular assist devices: “There was no choice” versus “I thought about it an awful lot”.
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      • Mueller L.A.
      • Mueller P.S.
      • Swetz K.M.
      Choices for patients “without a choice”: interviews with patients who received a left ventricular assist device as destination therapy.
      The expense is also significant, with a mean procedure cost of $234,808 in 2011, which is most often paid for by Medicaid and Medicare plans.
      • Shah N.
      • Agarwal V.
      • Patel N.
      • Deshmukh A.
      • Chothani A.
      • Garg J.
      • et al.
      National trends in utilization, mortality, complications, and cost of care after left ventricular assist device implantation from 2005 to 2011.
      An improved understanding of VAD implantation, including hospital outcomes might identify opportunities to optimize patient selection and thereby improve quality by lowering mortality, minimizing unnecessary suffering, increasing access, and reducing cost.
      Previous studies have shown increased risk of early mortality after VAD implantation in patients older than the age of 65 years.
      • Shah N.
      • Chothani A.
      • Agarwal V.
      • Deshmukh A.
      • Patel N.
      • Garg J.
      • et al.
      Impact of annual hospital volume on outcomes after left ventricular assist device (LVAD) implantation in the contemporary era.
      In addition, patients who require hemodialysis, intubation, or who undergo same-admission cardiac surgery before VAD placement have an increased risk of early mortality.
      • Kirklin J.K.
      • Naftel D.C.
      • Pagani F.D.
      • Kormos R.L.
      • Stevenson L.W.
      • Blume E.D.
      • et al.
      Seventh INTERMACS annual report: 15,000 patients and counting.
      • Sheetz K.H.
      • Krell R.W.
      • Englesbe M.J.
      • Birkmeyer J.D.
      • Campbell Jr., D.A.
      • Ghaferi A.A.
      The importance of the first complication: understanding failure to rescue after emergent surgery in the elderly.
      We hypothesized that in older patients, intensive treatments before VAD placement would result in a greater increase of in-hospital mortality compared with younger patients. We used the National Inpatient Sample (NIS) to compare younger and older patients receiving VADs over a 5-year period (2010-2014). Specifically, we analyzed: (1) demographic and clinical characteristics; (2) differences in hospital course, mortality, and disposition; and (3) temporal trends in the number of VADs placed. We captured and compared the effects of intensive treatments before VAD placement. These treatments included prolonged intubation (>96 hours), hemodialysis, intra-aortic balloon pump (IABP), same-admission cardiac surgery, and extracorporeal membrane oxygenation (ECMO).

      Methods

      Data Source

      We used the NIS, which is the largest publicly available all-payer inpatient health care database in the United States, yielding national estimates of diagnoses, procedure utilization, and outcomes for hospital inpatient stays from a 20% stratified sample of US hospitals and is part of the Healthcare Quality and Utilization Project.
      • HCUP
      NIS overview.
      The database contains a nationally representative sample from more than 7 million hospitalizations annually. Applying sample weights provided by the NIS, the database projects estimates for more than 36 million hospitalizations annually. The NIS provides data on patient demographic characteristics, in-hospital clinical outcomes, hospital characteristics, and hospital charges. Federal hospitals are not included in the NIS. Quality control and validation of the NIS are performed by the Agency for Healthcare Research and Quality (AHRQ). For all demographic variables, except race/ethnicity, there is <1% missing data. Missing race/ethnicity was categorized as “unknown” in our results. Data from the NIS has been used to describe patterns of health care usage and outcomes of major procedures.
      • Kumar G.
      • Kumar N.
      • Taneja A.
      • Kaleekal T.
      • Tarima S.
      • McGinley E.
      • et al.
      Nationwide trends of severe sepsis in the 21st century (2000-2007).
      • Deshmukh A.
      • Kumar G.
      • Kumar N.
      • Nanchal R.
      • Gobal F.
      • Sakhuja A.
      • et al.
      Effect of joint national committee VII report on hospitalizations for hypertensive emergencies in the United States.
      In addition, data from the NIS has been previously validated in the study of VAD and congestive heart failure.
      • Shah N.
      • Agarwal V.
      • Patel N.
      • Deshmukh A.
      • Chothani A.
      • Garg J.
      • et al.
      National trends in utilization, mortality, complications, and cost of care after left ventricular assist device implantation from 2005 to 2011.
      The database was provided with deidentified patient information and thus deemed exempt from institutional review by the Human Research Committee at Partners HealthCare.

      Study Sample and Primary Outcomes

      We included all individuals ≥18 years old who received a VAD during a hospitalization between January 1, 2010 and December 31, 2014. VAD was defined by the International Classification of Diseases, Ninth Revision, Procedural Coding System (ICD-9-PCS) code for VAD placement (37.66). This code is specific to implantation of a durable VAD and excludes temporary procedures such as pulsation balloons and percutaneous external heart assist devices as well as total internal biventricular heart replacement. This code has been stable in its usage throughout the study period. Use of this ICD-9-PCS code to identify patients who received a VAD has been previously validated in several studies.
      • Shah N.
      • Agarwal V.
      • Patel N.
      • Deshmukh A.
      • Chothani A.
      • Garg J.
      • et al.
      National trends in utilization, mortality, complications, and cost of care after left ventricular assist device implantation from 2005 to 2011.
      • Lampropulos J.F.
      • Kim N.
      • Wang Y.
      • Desai M.M.
      • Barreto-Filho J.A.
      • Dodson J.A.
      • et al.
      Trends in left ventricular assist device use and outcomes among Medicare beneficiaries, 2004-2011.
      We excluded patients who underwent a heart transplantation (ICD-9-PCS code 37.51) or combined heart-lung transplantation (ICD-9-PCS code 37.51) during same admission as VAD placement. The primary outcome of this study was in-hospital mortality. Secondary outcomes included length of hospital stay and hospital charges.

      Covariates

      Demographic covariates included age, sex, race/ethnicity, primary insurance type, and median income quartile on the basis of zip code. Race/ethnicity was reclassified as non-Hispanic white, non-Hispanic black, other (Hispanic, Asian, and Native American), and unknown. Other covariates included type of admission and geographic region (Northeast, Midwest, South, and West). Comorbidities were defined using International Classification of Diseases, Ninth Revision, Clinical Modification codes and the Elixhauser comorbidity index. The Elixhauser Index used in this study is a well validated indicator of comorbidities and was designed specifically to measure hospital charges, length of stay, and in-hospital mortality, which were the primary and secondary outcomes of this study. Furthermore, the Elixhauser Index was developed and validated using AHRQ data using the same variables that are reported in the NIS database (also maintained by AHRQ).
      • Elixhauser A.
      • Steiner C.
      • Harris D.R.
      • Coffey R.M.
      Comorbidity measures for use with administrative data.
      In this study, Elixhauser comorbidities were generated from International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes using AHRQ Comorbidity Software.
      • HCUP
      Elixhauser Comorbidity Software, Version 3.7.

      Age Stratification

      Previous reports focusing on in-hospital factors associated with mortality after VAD placement have dichotomized at the age of 65 years.
      • Shah N.
      • Chothani A.
      • Agarwal V.
      • Deshmukh A.
      • Patel N.
      • Garg J.
      • et al.
      Impact of annual hospital volume on outcomes after left ventricular assist device (LVAD) implantation in the contemporary era.
      To determine the validity of dichotomization, we treated age as a continuous variable and used a logistic regression model to plot age against probability of in-hospital mortality after VAD implantation (Figure 1). We determined that mortality risk as a function of age is relatively stable until the age of 65 years, at which point it begins to dramatically increase. Because of the previous categorization of age within the literature and the findings in our regression we chose to categorize age into younger (18-65) and older (>65) categories.
      Figure thumbnail gr1
      Figure 1Plot of predicted probability of death after ventricular assist device placement in a logistic regression model with age as a continuous variable. Bars around central line represent upper and lower limits of 95% confidence intervals.

      In-Hospital Treatments

      Circulatory support and co-therapy were identified using ICD-9 codes listed in Table E1. All hospital charges were adjusted for inflation with reference to 2014 US dollars, using the latest Consumer Price Index data (http://www.usinflationcalculator.com).
      VAD surgery date and admission date were used to determine intensive procedures or treatments that occurred 1 hospital day before VAD placement. A 1 hospital day cutoff was used to ensure invasive treatments directly related to the VAD implantation (eg, mechanical ventilation during surgery) were not included in the analysis. Inpatient intensive procedures or treatments received during admission before VAD implantation were identified using ICD-9 procedure codes. These included IABP, cardiac surgery, mechanical ventilation, hemodialysis, and ECMO. In the case of cardiac surgery, we identified surgeries on the basis of ICD-9 procedure codes, which are listed in Table E1. We included open and endovascular procedures involving the valves and septa, coronary vessels, cardiotomy, pericardiotomy, and ascending aorta.

      Statistical Analysis

      All analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC). Frequencies, proportions, and 95% confidence intervals (CIs) were calculated and weighted to reflect national estimates using inverse sampling weights provided by the NIS. Trend weights were used for 2010-2011 NIS data to adjust for the redesign in 2012. χ2 Tests were used to compare the demographic and clinical characteristics. Continuous variables, such as length of stay and hospital charges, were compared using Wilcoxon rank sum test. Multivariable logistic regression was used to identify associations with in-hospital mortality. We used a model that included all patient demographic characteristics, hospital factors, and comorbidities measured using the Elixhauser comorbidity index. To avoid collinearity we combined preimplantation interventions with significant clinical overlap into a single high-risk intervention variable. Difference-in-difference analysis was used to compare the effects of preoperative interventions on mortality in older and younger patients. Finally, χ2 tests and Wilcoxon rank sum tests were used to compare temporal trends of VAD use, in-hospital mortality, and hospital charges from 2010 to 2014. A 2-tailed P < .05 was considered to indicate statistical significance.

      Results

      Study Population

      Results are expressed as weighted samples ± the standard error of the mean. We identified 15,021 ± 1111 episodes of VAD implantation. The demographic characteristics, clinical characteristics, and hospital course of patients receiving a VAD are presented in Table 1. Most of the recipients were white (59.9%) and male (75.0%). The average score on the Elixhauser Comorbidity Index was 3.60 ± 0.07. Individual components of the Elixhauser Comorbidity Index are listed in Table E2. More than half of the patient population presented through the emergency department (65.1%) and a large percentage were covered either through Medicare (48.5%) or private insurance (36.1%). Overall, mortality was 12.9%; however, nearly half were able to be discharged home without services, or home with additional home care (49.8%). The average length of stay was 33.2 ± 0.68 days for patients who were alive at discharge and 39.0 ± 1.89 days for those who died in-hospital. Similarly, mean hospital charges were $767,431 ± $21,0.23 for patients alive at discharge and $1,037,622 ± $49,259 for those who died in-hospital. Finally, the most common preoperative procedure was IABP, which was performed in approximately 1 in 5 patients. Other major preoperative interventions including prolonged mechanical ventilation, ECMO, hemodialysis, and same-admission cardiac surgery occurred in <10% of the study population.
      Table 1Patient characteristics
      Overall (n = 15,021 ± 1111)Ages 18-65 years (n = 10,790 ± 782)Ages > 65 years (n = 4231 ± 329)P value
      ValueSEValueSEValueSE
      Mean age, y56.60.27
      Male sex, n (%)11,481 (76.4)8277919 (73.4)5933562 (84.2)286<.001
      Elixhauser index, mean3.610.073.530.083.80.10<.001
      Emergency department admission, n (%)9778 (65.1)7067155 (66.4)5182623 (62.1)235.03
      Race, n (%)
       Non-Hispanic white8995 (59.9)6965930 (55.0)4943065 (72.4)260<.001
       Black3227 (21.5)2792847 (26.4)252380 (9.0)49
       Other
      Includes Hispanic, Asian or Pacific Islander, Native American, and other.
      1754 (11.7)2221324 (12.3)163430 (10.2)74
       Unknown1045 (6.9)168689 (6.4)116356 (8.4)65
      Primary payer, n (%)
       Medicare7282 (48.5)5293684 (34.1)2953598 (85.0)283<.001
       Medicaid1666 (11.1)1541636 (15.2)15130 (0.7)12
       Private insurance5426 (36.1)4154895 (45.4)377530 (12.5)65
       Other
      Includes self-pay, no charge, and other.
      523 (3.5)79461 (4.3)7162 (1.5)19
      Household income quartile, n (%)
       First (highest income)4078 (27.1)3432212 (20.9)2321154 (27.8)140<.001
       Second3659 (24.4)2892440 (23.0)2041215 (29.3)112
       Third3655 (24.3)2852760 (26.0)237900 (21.7)83
       Fourth (lowest income)3366 (22.4)3323196 (30.1)276883 (21.3)100
      Hospital region, n (%)
       Northeast3009 (20.0)4672046 (19.0)328962 (22.7)180.01
       Midwest3812 (25.4)5562740 (25.4)4261072 (25.3)151
       South6063 (40.4)6704576 (42.4)5121487 (35.1)186
       West2137 (14.2)3681428 (13.2)248709 (16.8)136
      Discharge disposition, n (%)
       Home3902 (26.0)3643185 (29.5)297716 (16.9)95<.001
       Home care3573 (23.8)3942112 (19.6)2651462 (34.6)166
       Health care facility5608 (37.3)4574284 (39.7)3631323 (31.3)140
       Died1933 (12.9)1751204 (11.1)120729 (17.2)81
      Mean length of stay, d
       Alive at discharge33.20.6833.30.7233.21.01.94
       Died39.01.8941.92.4434.32.42.03
      Mean hospital charges, USD
       Alive at discharge767,43121,023761,35421,367784,15528,579.52
       Died1,037,62249,2591,065,77764,374991,54758,889.39
      Interventions before VAD implantation, n (%)
       IABP3278 (21.8)3322343 (22.8)220935 (19.5)112.07
       Cardiac surgery
      Includes 5 major groups of surgeries operations on valves and septa, vessels of heart, cardiotomy and pericardiotomy, pericardiotomy and excision of lesion of heart, and major aortic dissection or aneurysm repair.
      557 (3.7)86392 (3.6)52165 (3.9)34.62
       Mechanical ventilation1250 (8.3)151969 (9.0)104281 (6.6)47<.001
       ECMO526 (3.5)82431 (4.0)6195 (2.2)21<.001
       Hemodialysis575 (3.8)96332 (3.2)52243 (5.1)44.01
      SE, Standard error of the mean of the weighted sample; VAD, ventricular assist device; IABP, intra-aortic balloon pump; ECMO, extracorporeal membrane oxygenation.
      Includes Hispanic, Asian or Pacific Islander, Native American, and other.
      Includes self-pay, no charge, and other.
      Includes 5 major groups of surgeries operations on valves and septa, vessels of heart, cardiotomy and pericardiotomy, pericardiotomy and excision of lesion of heart, and major aortic dissection or aneurysm repair.

      Relation of Age and Mortality

      In stratified analysis, all differences between the age groups were statistically significant (Table 1). Compared with patients ages 18-65 years, older VAD recipients were more likely to be white (72.4% vs 55.0%; P < .001) and male (84.2% vs 73.4%; P < .001). Older VAD recipients had a higher Elixhauser index score (3.80 vs 3.53; P < .001). Regional utilization differences also existed, with a higher proportion of older patients receiving a VAD in the West (16.8% vs 13.2%; P < .001) and Northeast (22.7% vs 19.0%; P < .001). Patients ages 18-65 years were more likely to have been admitted through the emergency department (66.4% vs 62.1%; P = .03). The mean length of stay was >30 days in both groups. Patients ages 18-65 years who died in-hospital had a longer mean length of stay than patients older than 65 years who died in-hospital (41.9 vs 34.3 days; P = .03). Total hospital charges were similar in both groups. In both age groups, a significant proportion of patients underwent invasive treatments before VAD placement, which included IABP, cardiac surgery, mechanical ventilation >96 hours, ECMO, and hemodialysis. Among these treatments patients between the ages of 18 and 65 years tended to have a high rate of prolonged mechanical ventilation (9.0% vs 6.6%; P < .001) and use of ECMO (4.0% vs 2.2%; P < .001). Conversely, those aged 18-65 years had a significantly lower rate of hemodialysis (3.2% vs 5.1%; P = .01).

      Preoperative Interventions and Mortality

      In-hospital mortality for patients older than 65 years was significantly higher than in patients ages 18-65 years (17.2% vs 11.1%; P < .001). In-hospital mortality among patients who received intensive procedures/treatments during the index admission before VAD implantation surgery, stratified according to age, is shown in Table 2 and Figure 2. The 4 procedures/treatments most highly correlated with inpatient mortality were same-admission cardiac surgery, hemodialysis, mechanical ventilation, and ECMO. Among patients older than 65 years, 649 ± 83 (15.3%) had at least 1 of these procedures, before VAD implantation. Of these patients, 313 ± 52 (48.2%) died during hospitalization. For patients ages 18-65 years, 1694 ± 169 (15.7%) had 1 of these 4 procedures before VAD implantation. Of these patients, 498 ± 65 (29.4%) died during hospitalization. Although having 1 of these procedures increased mortality in younger and older patients, there was a significantly greater increase in mortality in patients older than 65 years.
      Table 2Difference-in-difference analysis of mortality according to intervention in patients before receipt of VAD
      Ages 18-65 yearsAge older than 65 yearsMortality difference (95% CI)
      Died (% receiving treatment)SEDied (% receiving treatment)SE
      IABP350 (15.0)48150 (16.2)311.0% (−5.0-7.0)
      Cardiac surgery
      Includes 5 major groups of surgeries: operations on valves and septa, vessels of heart, cardiotomy and pericardiotomy, pericardiotomy and excision of lesion of heart, and major aortic dissection or aneurysm repair.
      76 (19.5)1968 (41.1)2022% (5.0-39)
      Mechanical ventilation263 (27.1)40113 (40.1)2413% (1.0-26)
      ECMO183 (42.4)3450 (52.4)1610% (−15-34)
      Hemodialysis159 (47.8)33173 (71.1)3423% (4.0-42)
      At least 1 intervention excluding IABP
      High-risk intervention defined by cardiac surgery, mechanical ventilation (>96 hours), ECMO, or hemodialysis before VAD placement, all of which are associated with high in-hospital mortality.
      498 (29.4)65313 (48.2)5219% (9.0-28)
      Baseline in-hospital mortality after VAD implantation1204 (11.1)120729 (17.2)816.1% (+5.3-7.1)
      Mortality difference is the change in mortality between each age group in those who received the indicated treatment. SE, Standard error of the mean; CI, confidence interval; IABP, intra-aortic balloon pump; ECMO, extracorporeal membrane oxygenation; VAD, ventricular assist device.
      Includes 5 major groups of surgeries: operations on valves and septa, vessels of heart, cardiotomy and pericardiotomy, pericardiotomy and excision of lesion of heart, and major aortic dissection or aneurysm repair.
      High-risk intervention defined by cardiac surgery, mechanical ventilation (>96 hours), ECMO, or hemodialysis before VAD placement, all of which are associated with high in-hospital mortality.
      Figure thumbnail gr2
      Figure 2In-hospital mortality for patients who received intensive treatments before ventricular assist device placement. Examined treatments included intra-aortic balloon pump (IABP), cardiac surgery, mechanical ventilation >96 hours, extracorporeal membrane oxygenation (ECMO), and hemodialysis.
      In our multivariable logistic regression model the 4 highest risk interventions (same-admission cardiac surgery, hemodialysis, mechanical ventilation >96 hours, and ECMO) were combined into a high-risk treatment category to avoid collinearity. These high-risk treatments were associated with increased in-hospital mortality (odds ratio [OR], 5.52; 95% CI, 4.27-7.13). Univariate analysis is reported separately in Table E3. Age older than 65 years was also associated with increased in-hospital mortality (OR, 1.77; 95% CI, 1.29-2.40; Table 3). However, we did not see a significant interaction effect between age older than 65 years and high-risk treatments in multivariate analysis (P = .24). Elective admission (as opposed to admission through the emergency department) was associated with lower odds of mortality (OR, 0.75; 95% CI, 0.57-0.98). In multivariate regression, IABP was not associated with a significant change in overall mortality (OR, 0.91; 95% CI, 0.69-1.20). Because of the categorization of age we performed a sensitivity analysis using age as a continuous variable. There were no changes to the major trends and minimal change in the reported ORs.
      Table 3Multivariate analysis of in-hospital mortality after the VAD procedure and sensitivity analysis using age as a continuous variable
      Age dichotomizedAge as a continuous variable
      Age > 65 years1.77 (1.29-2.40)
      Female sex1.27 (0.96-1.67)1.30 (0.99-1.17)
      Race
       WhiteReferenceReference
       Black1.02 (0.73-1.43)1.09 (0.79-1.52)
       Other
      Includes Hispanic, Asian or Pacific Islander, Native American, and other.
      1.15 (0.80-1.65)1.17 (0.81-1.68)
       Unknown1.41 (0.90-2.20)1.42 (0.90-2.23)
      Primary payer
       MedicareReferenceReference
       Medicaid0.98 (0.63-1.53)1.12 (0.72-1.72)
       Private0.91 (0.67-1.23)0.99 (0.75-1.31)
       Other
      Includes self-pay, no charge, and other.
      1.22 (0.68-2.20)1.33 (0.74-2.38)
      Hospital region
       MidwestReferenceReference
       Northeast0.97 (0.66-1.43)0.97 (0.65-1.43)
       West1.06 (0.76-1.49)1.06 (0.75-1.50)
       South0.84 (0.54-1.32)0.81 (0.65-1.43)
      Household income1.12 (1.00-1.25)1.10 (0.99-1.23)
      Elective admission0.75 (0.57-0.98)0.72 (0.55-0.96)
      Year of implantation0.95 (0.88-1.03)0.94 (0.87-1.02)
      Elixhauser score1.01 (0.95-1.08)1.01 (0.95-1.09)
      IABP before VAD placement0.91 (0.69-1.20)0.92 (0.70-1.22)
      High-risk intervention before VAD placement
      Includes vasopressors, intra-aortic balloon pump, extracorporeal membrane oxygenation, hemodialysis, mechanical ventilation, and same admission cardiac surgery before VAD placement.
      5.52 (4.27-7.13)5.65 (4.35-7.34)
      Because of the nonlinear relationship of age and mortality age and age2 were included in the continuous model. The results of mortality as a plot of age against the probability of in-hospital mortality is shown in Figure 1. Data are presented as OR (95% CI). IABP, Intra-aortic balloon pump; VAD, ventricular assist device.
      Includes Hispanic, Asian or Pacific Islander, Native American, and other.
      Includes self-pay, no charge, and other.
      Includes vasopressors, intra-aortic balloon pump, extracorporeal membrane oxygenation, hemodialysis, mechanical ventilation, and same admission cardiac surgery before VAD placement.

      Temporal Trends in Heart Transplantation and VAD Placement According to Age

      The number of VAD implantations per year in patients ages 18-65 years increased from 1808 ± 459 in 2010 to 2560 ± 317 in 2014 (Figure 3). The number of VAD implantations per year in patients older than 65 years more than doubled with 532 ± 143 in 2010 to 1100 ± 120 in 2014. In-hospital mortality during this period did not significantly change on the basis of age. The rate of heart transplantations declined steadily with age. Of nearly 10,000 heart transplantations, only 1515 (15.1%) were performed in individuals older than the age of 65 years (Figure 4). By the age of 71 years, this number decreased to 229 (2.2%), indicating that most of the 2025 ± 198 patients with a VAD older than the age of 71 years were unlikely to receive heart transplantation.
      Figure thumbnail gr3
      Figure 3Ventricular assist device implantation and in-hospital mortality between 2010 and 2014 for those aged 18-65 years and those older than 65 years.
      Figure thumbnail gr4
      Figure 4Distribution of ventricular assist device (VAD) placement and heart transplantation stratified according to age. After the age of 70 years the opportunity for heart transplantation is exceptionally rare.

      Discussion

      The objective of this study was to analyze the baseline demographic characteristics and characteristics of patients receiving VADs and determine the effect of preimplantation interventions on in-hospital mortality. We found that in-hospital mortality after VAD placement begins to rapidly increase in patients older than the age of 65 years. Although previous studies have reported increasing age to be a risk factor for early mortality,
      • Kirklin J.K.
      • Naftel D.C.
      • Pagani F.D.
      • Kormos R.L.
      • Stevenson L.W.
      • Blume E.D.
      • et al.
      Seventh INTERMACS annual report: 15,000 patients and counting.
      • Shah N.
      • Chothani A.
      • Agarwal V.
      • Deshmukh A.
      • Patel N.
      • Garg J.
      • et al.
      Impact of annual hospital volume on outcomes after left ventricular assist device (LVAD) implantation in the contemporary era.
      • Lampropulos J.F.
      • Kim N.
      • Wang Y.
      • Desai M.M.
      • Barreto-Filho J.A.
      • Dodson J.A.
      • et al.
      Trends in left ventricular assist device use and outcomes among Medicare beneficiaries, 2004-2011.
      our study shows an explanation for this finding. Intensive procedures before VAD placement resulted in a nearly 50% in-patient mortality in older patients. Finally, this work confirmed a low rate of cardiac transplantations in patients older than the age of 65 years, indicating that most VAD placements in this older age group was destination therapy rather than a bridge to transplantation (Graphical Abstract). The high rate of in-patient mortality in older adults who have intensive procedures before VAD placement, coupled with the unlikelihood of cardiac transplantation, is an important distinction and deserves recognition by clinicians and discussion with patients (Video 1).
      Figure thumbnail fx3
      Video 1The second author (Brooks Udelsman, MD) presenting a short summary of the study, highlighting the central findings and conclusions. Video available at: https://www.jtcvs.org/article/S0022-5223(18)32962-3/fulltext.
      The dichotomization of age in epidemiologic studies has the potential to bias analysis and requires ample clinical justification.
      • Chen H.
      • Cohen P.
      • Chen S.
      Biased odds ratios from dichotomization of age.
      Although age has been dichotomized in previous studies focusing on VAD placement,
      • Kim J.H.
      • Singh R.
      • Pagani F.D.
      • Desai S.S.
      • Haglund N.A.
      • Dunlay S.M.
      • et al.
      Ventricular assist device therapy in older patients with heart failure: characteristics and outcomes.
      • Shah N.
      • Chothani A.
      • Agarwal V.
      • Deshmukh A.
      • Patel N.
      • Garg J.
      • et al.
      Impact of annual hospital volume on outcomes after left ventricular assist device (LVAD) implantation in the contemporary era.
      we chose to further validate this decision. Using linear regression, we showed an exponential increase of in-hospital mortality after VAD placement in individuals older than the age of 65 years. Clinically, the age of 65 years represents the time point at which the rate of cardiac transplantation begins to decline. Although in younger patients high-risk VAD placement might be attempted to bridge the patient to cardiac transplantation, in older patients transplantation is unlikely and VADs must often be considered destination therapy.
      Previous studies have shown similar short-term mortality between younger and older VAD recipients. The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) report showed 30-day survival of 93% for VAD patients aged 70 years or older.
      • Kirklin J.K.
      • Naftel D.C.
      • Pagani F.D.
      • Kormos R.L.
      • Stevenson L.W.
      • Blume E.D.
      • et al.
      Seventh INTERMACS annual report: 15,000 patients and counting.
      Likewise, a single-center study reported by Adamson and colleagues
      • Adamson R.M.
      • Stahovich M.
      • Chillcott S.
      • Baradarian S.
      • Chammas J.
      • Jaski B.
      • et al.
      Clinical strategies and outcomes in advanced heart failure patients older than 70 years of age receiving the HeartMate II left ventricular assist device.
      showed a 30-day survival of 97% for patients older than 70 years.
      • Adamson R.M.
      • Stahovich M.
      • Chillcott S.
      • Baradarian S.
      • Chammas J.
      • Jaski B.
      • et al.
      Clinical strategies and outcomes in advanced heart failure patients older than 70 years of age receiving the HeartMate II left ventricular assist device.
      In our study 17.2% of patients aged older than 65 years died in the hospital after VAD implantation. The discrepancy in short-term mortality might in part be explained by differences in measurement. A subset of patients captured in the NIS died >30 days after VAD implantation, but while still in-hospital. The high mortality identified in our study could also stem from differences in cohort selection and study periods. INTERMACS collects data from sites approved by the registry, which currently includes 127 centers. In our study, a cohort was extracted on the basis of a weighted sample of hospitals participating in the NIS, which in 2011 included approximately 1000 centers and is the single largest all-payer publicly available database in the United States. The inclusion of hospitals outside of INTERMACS helps explain the higher overall number of VAD placements seen in this study compared with recent reports using the INTERMACS registry. The INTERMACS registry reports a 1-year mortality rate of 20% in patients after LVAD implantation. Other multi-institutional studies have shown a 1-year mortality of 25% in patients aged 70 years and older compared with 16% in patients aged 60-69 years.
      • Kim J.H.
      • Singh R.
      • Pagani F.D.
      • Desai S.S.
      • Haglund N.A.
      • Dunlay S.M.
      • et al.
      Ventricular assist device therapy in older patients with heart failure: characteristics and outcomes.
      Both are higher than the in-hospital mortality reported in this study, but compare well if our data are projected out.
      The number of patients older than age 65 years with heart failure is expected to increase to 3.9 million by the year 2030. However, the availability of donor hearts remains stable; thus, we expect the utilization of VADs to increase.
      • Heidenreich P.A.
      • Albert N.M.
      • Allen L.A.
      • Bluemke D.A.
      • Butler J.
      • Fonarow G.C.
      • et al.
      Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association.
      • Miller L.W.
      • Guglin M.
      • Rogers J.
      Cost of ventricular assist devices: can we afford the progress?.
      Although VADs offer a more readily available method of cardiovascular support than heart transplantation, they are associated with significant morbidity, caregiver burden, and complicated end of life care.
      • Ottenberg A.L.
      • Cook K.E.
      • Topazian R.J.
      • Mueller L.A.
      • Mueller P.S.
      • Swetz K.M.
      Choices for patients “without a choice”: interviews with patients who received a left ventricular assist device as destination therapy.
      • Dunlay S.M.
      • Strand J.J.
      • Wordingham S.E.
      • Stulak J.M.
      • Luckhardt A.J.
      • Swetz K.M.
      Dying with a left ventricular assist device as destination therapy.
      • McIlvennan C.K.
      • Jones J.
      • Allen L.A.
      • Swetz K.M.
      • Nowels C.
      • Matlock D.D.
      Bereaved caregiver perspectives on the end-of-life experience of patients with a left ventricular assist device.
      • Swetz K.M.
      • Ottenberg A.L.
      • Freeman M.R.
      • Mueller P.S.
      Palliative care and end-of-life issues in patients treated with left ventricular assist devices as destination therapy.
      These challenges place further importance on optimizing patient selection and the shared decision-making process before VAD implantation.
      The decision to proceed with VAD placement remains a difficult challenge for clinicians. In particular, compared with heart transplantation, the criteria for VAD patient selection are less well defined.
      • Feldman D.
      • Pamboukian S.V.
      • Teuteberg J.J.
      • Birks E.
      • Lietz K.
      • Moore S.A.
      • et al.
      The 2013 International Society for Heart and Lung Transplantation guidelines for mechanical circulatory support: executive summary.
      • Mehra M.R.
      • Canter C.E.
      • Hannan M.M.
      • Semigran M.J.
      • Uber P.A.
      • Baran D.A.
      • et al.
      The 2016 International Society for Heart Lung Transplantation listing criteria for heart transplantation: a 10-year update.
      Several risk-assessment tools use clinical and laboratory variables to predict postoperative complications, mortality, and functional outcome.
      • Miller L.W.
      • Guglin M.
      Patient selection for ventricular assist devices: a moving target.
      • Cowger J.
      • Sundareswaran K.
      • Rogers J.G.
      • Park S.J.
      • Pagani F.D.
      • Bhat G.
      • et al.
      70 the HeartMate II risk score: predicting survival in candidates for left ventricular assist device support.
      • Porepa L.F.
      • Starling R.C.
      Destination therapy with left ventricular assist devices: for whom and when?.
      • Lietz K.
      • Long J.W.
      • Kfoury A.G.
      • Slaughter M.S.
      • Silver M.A.
      • Milano C.A.
      • et al.
      Outcomes of left ventricular assist device implantation as destination therapy in the post-REMATCH era: implications for patient selection.
      Increasingly, measures of frailty are used as a predictor for heightened risk of adverse outcomes.
      • Flint K.M.
      • Matlock D.D.
      • Lindenfeld J.
      • Allen L.A.
      Frailty and the selection of patients for destination therapy left ventricular assist device.
      • Hiesinger W.
      • Boyd J.H.
      • Woo Y.J.
      Ventricular assist device implantation in the elderly.
      • Shah R.
      • Attwood K.
      • Arya S.
      • Hall D.E.
      • Johanning J.M.
      • Gabriel E.
      • et al.
      Association of frailty with failure to rescue after low-risk and high-risk inpatient surgery.
      Our study further suggests that the intensity of the immediate medical care should be included in the risk assessment of VAD surgery. Not surprisingly, intensive procedures such as cardiac surgery, ECMO, mechanical ventilation, or hemodialysis before VAD implantation were associated with high in-hospital mortality. This is true for older and younger patients, yet the increase is substantially higher in patients older than the age of 65 years. In our study, we found that nearly 50% of older patients who had 1 or more intensive procedures before VAD placement died in the hospital. In contrast, IABP had only a minor effect on in-hospital mortality in younger patients and in patients older than 65 years of age it had no significant effect on in-hospital mortality.
      Finally, equitable access to this treatment remains a concern.
      • Joyce D.L.
      • Conte J.V.
      • Russell S.D.
      • Joyce L.D.
      • Chang D.C.
      Disparities in access to left ventricular assist device therapy.
      Older VAD recipients were overwhelmingly white and male. Historical evidence shows decreased access to evidence-based treatment for women and minority patients.
      • Dunlay S.M.
      • Roger V.R.
      Gender differences in the pathophysiology, clinical presentation, and outcomes of ischemic heart failure.
      • Davis A.M.
      • Vinci L.M.
      • Okwuosa T.M.
      • Chase A.R.
      • Huang E.S.
      Cardiovascular health disparities: a systematic review of health care interventions.
      Further analysis on access will enable us to address potential disparities and cost considerations as VAD becomes more common.

      Limitation

      The findings of this study should be interpreted within the limitations of study design. First, clinical data such as INTERMACS profile, laboratory data, medications, and echocardiography data were not available, limiting our ability to study granular clinical characteristics. The data represent a cross-sectional assessment of device implantation; longitudinal clinical outcomes might offer a more comprehensive understanding of differences in clinical outcomes between patients ages 18-65 years versus patients older than 65 years. For example, we are unable determine readmission rates or long-term complications such as pump thrombosis. In our analysis, we used sample weights that are projected from NIS collected data. This method is designed to help study relatively rare events, such as VAD placement, and to identify national trends. This method has been validated several times, including in the study of VAD and congestive heart disease.
      • Shah N.
      • Agarwal V.
      • Patel N.
      • Deshmukh A.
      • Chothani A.
      • Garg J.
      • et al.
      National trends in utilization, mortality, complications, and cost of care after left ventricular assist device implantation from 2005 to 2011.
      • Kumar G.
      • Kumar N.
      • Taneja A.
      • Kaleekal T.
      • Tarima S.
      • McGinley E.
      • et al.
      Nationwide trends of severe sepsis in the 21st century (2000-2007).
      • Deshmukh A.
      • Kumar G.
      • Kumar N.
      • Nanchal R.
      • Gobal F.
      • Sakhuja A.
      • et al.
      Effect of joint national committee VII report on hospitalizations for hypertensive emergencies in the United States.
      Although most VADs are left-sided, it is not possible to identify the number of right VADs implanted in this study. On the basis of INTERMACS data from this time period there were only 116 right-sided VADs placed between 2006 and 2014.
      • Kirklin J.K.
      • Naftel D.C.
      • Pagani F.D.
      • Kormos R.L.
      • Stevenson L.W.
      • Blume E.D.
      • et al.
      Seventh INTERMACS annual report: 15,000 patients and counting.
      Although it is unlikely that all of these right VADs were implanted during our study period of 2010-2014, if they were they would only represent 0.8% of the study population. It is also not possible to identify the type or model of VAD device implanted. Furthermore, NIS data do not distinguish between VADs that were used for destination therapy versus bridge to transplantation because there are no administrative codes for that distinction.
      We analyzed the frequency of heart transplantations in the NIS database and determined that only 229 patients older than 70 years received a heart transplantation between 2010 and 2014; thus, most VADs for patients older than 70 years were for destination therapy. We chose to investigate outcomes of patients between the years of 2010 and 2014, because this represents a period of relatively stability in administrative coding and allowed for more robust analysis. However, the field advances rapidly. Although data in this study are recent, it is possible they do not perfectly reflect contemporary trends. Finally, we are limited in ascertainment of true cost of hospital care accrued during the index admission; our study only used hospital charges as a proxy measure.

      Conclusions

      In this nationally representative cohort, older patients who underwent major procedures during the hospitalization before VAD implantation had high in-hospital mortality (48.2%) and a low likelihood of cardiac transplantation. Future efforts to improve patient selection might help better align destination VAD implantation with those most likely to benefit.

      Conflict of Interest Statement

      Authors have nothing to disclose with regard to commercial support.
      The authors thank Dr Steven Worthington for help with statistical analyses. The authors also thank the Institute for Quantitative Social Science at Harvard University for providing access to cluster computing.

      Appendix

      Table E1In-hospital intensive procedures and treatments
      DescriptionICD-9 code
      Intra-aortic balloon pump37.61
      Mechanical ventilation96.70, 96.71, 96.72
      Hemodialysis39.95
      ECMO37.62
      Invasive mechanical ventilation ≥96 hours96.72
      Cardiac surgery
       Operations on valves and septa of heart
      Closed heart valvotomy, unspecified valve35
      Closed heart valvotomy, aortic valve35.01
      Closed heart valvotomy, mitral valve35.02
      Closed heart valvotomy, pulmonary valve35.03
      Closed heart valvotomy, tricuspid valve35.04
      Endovascular replacement of aortic valve35.05
      Transapical replacement of aortic valve35.06
      Endovascular replacement of pulmonary valve35.07
      Transapical replacement of pulmonary valve35.08
      Endovascular replacement of unspecified heart valve35.09
      Open heart valvuloplasty without replacement, unspecified valve35.1
      Open heart valvuloplasty of aortic valve without replacement35.11
      Open heart valvuloplasty of mitral valve without replacement35.12
      Open heart valvuloplasty of pulmonary valve without replacement35.13
      Open heart valvuloplasty of tricuspid valve without replacement35.14
      Open and other replacement of unspecified heart valve35.2
      Open and other replacement of aortic valve with tissue graft35.21
      Open and other replacement of aortic valve35.22
      Open and other replacement of mitral valve with tissue graft35.23
      Open and other replacement of mitral valve35.24
      Open and other replacement of pulmonary valve with tissue graft35.25
      Open and other replacement of pulmonary valve35.26
      Open and other replacement of tricuspid valve with tissue graft35.27
      Open and other replacement of tricuspid valve35.28
      Operations on papillary muscle35.31
      Operations on chordae tendineae35.32
      Annuloplasty35.33
      Infundibulectomy35.34
      Operations on trabeculae carneae cordis35.35
      Operations on other structures adjacent to valves of heart35.39
      Enlargement of existing atrial septal defect35.41
      Creation of septal defect in heart35.42
      Repair of unspecified septal defect of heart with prosthesis35.5
      Repair of atrial septal defect with prosthesis, open technique35.51
      Repair of atrial septal defect with prosthesis, closed technique35.52
      Repair of ventricular septal defect with prosthesis, open technique35.53
      Repair of endocardial cushion defect with prosthesis35.54
      Repair of ventricular septal defect with prosthesis, closed technique35.55
      Repair of unspecified septal defect of heart with tissue graft35.6
      Repair of atrial septal defect with tissue graft35.61
      Repair of ventricular septal defect with tissue graft35.62
      Repair of endocardial cushion defect with tissue graft35.63
      Other and unspecified repair of unspecified septal defect of heart35.7
      Other and unspecified repair of atrial septal defect35.71
      Other and unspecified repair of ventricular septal defect35.72
      Other and unspecified repair of endocardial cushion defect35.73
      Total repair of tetralogy of Fallot35.81
      Total repair of total anomalous pulmonary venous connection35.82
      Total repair of truncus arteriosus35.83
      Total correction of transposition of great vessels, not elsewhere classified35.84
      Interatrial transposition of venous return35.91
      Creation of conduit between right ventricle and pulmonary artery35.92
      Creation of conduit between left ventricle and aorta35.93
      Creation of conduit between atrium and pulmonary artery35.94
      Revision of corrective procedure on heart35.95
      Percutaneous balloon valvuloplasty35.96
      Percutaneous mitral valve repair with implant35.97
      Other operations on septa of heart35.98
      Other operations on valves of heart35.99
       Operations on vessels of heart
      Open chest coronary artery angioplasty36.03
      Intracoronary artery thrombolytic infusion36.04
      Insertion of non–drug-eluting coronary artery stent(s)36.06
      Insertion of drug-eluting coronary artery stent(s)36.07
      Other removal of coronary artery obstruction36.09
      Aortocoronary bypass for heart revascularization, not otherwise specified36.1
      (Aorto)coronary bypass of 1 coronary artery36.11
      (Aorto)coronary bypass of 2 coronary arteries36.12
      (Aorto)coronary bypass of 3 coronary arteries36.13
      (Aorto)coronary bypass of 4 or more coronary arteries36.14
      Single internal mammary-coronary artery bypass36.15
      Double internal mammary-coronary artery bypass36.16
      Abdominal-coronary artery bypass36.17
      Other bypass anastomosis for heart revascularization36.19
      Heart revascularization by arterial implant36.2
      Open chest transmyocardial revascularization36.31
      Other transmyocardial revascularization36.32
      Endoscopic transmyocardial revascularization36.33
      Percutaneous transmyocardial revascularization36.34
      Other heart revascularization36.39
      Repair of aneurysm of coronary vessel36.91
      Other operations on vessels of heart36.99
       Cardiotomy and pericardiotomy
      Incision of heart, not otherwise specified37.1
      Cardiotomy37.11
      Pericardiotomy37.12
       Pericardiectomy and excision of lesion of heart
      Pericardiectomy37.31
      Excision of aneurysm of heart37.32
      Excision or destruction of other lesion or tissue of heart, open approach37.33
      Excision or destruction of other lesion or tissue of heart, endovascular approach37.34
      Partial ventriculectomy37.35
      Excision, destruction, or exclusion of left atrial appendage37.36
      Excision or destruction of other lesion or tissue of heart, thoracoscopic approach37.37
       Major aortic dissection or aneurysm repair
      Unspecified site441
      Ascending aorta441.01
      Thoracoabdominal441.03
      Ascending aorta aneurysm, ruptured441.1
      Ascending aorta aneurysm without mention of rupture441.2
      Thoracoabdominal aneurysm, ruptured441.6
      Thoracoabdominal aneurysm, without mention of rupture441.7
      Aortic aneurysm of unspecified site without mention of rupture441.9
      ICD-9, International Classification of Diseases, Ninth Revision; ECMO, extracorporeal membrane oxygenation.
      Table E2Individual components of Elixhauser comorbidity index
      Overall (n = 15,021 ± 1055)Ages 18-65 years (n = 10,790 ± 782)Age older than 65 years (n = 4231 ± 329)P value
      n (%)SEnSEnSE
      Congestive heart failure
      Note that the diagnosis of congestive heart failure and valvular heart disease are primary diagnoses for a large percentage of patients in this study and thus not readily captured by our Elixhauser comorbidity index. Because of the ubiquity of these diagnoses in the study population they are essentially dropped in this analysis.
      85 (0.6)3971 (0.7)3514 (0.3)8.24
      Valvular disease
      Note that the diagnosis of congestive heart failure and valvular heart disease are primary diagnoses for a large percentage of patients in this study and thus not readily captured by our Elixhauser comorbidity index. Because of the ubiquity of these diagnoses in the study population they are essentially dropped in this analysis.
      30 (0.2)1625 (0.2)155 (0.1)5.54
      Pulmonary circulation disorders44 (0.3)2139 (0.4)215 (0.1)5.29
      Peripheral vascular disorders1325 (8.8)121793 (7.4)90532 (12.6)61<.001
      Hypertension6628 (44.1)5184568 (42.3)3752060 (48.7)179.03
      Paralysis359 (2.4)47264 (2.5)4094 (2.2)21.71
      Other neurologic disorders783 (5.2)90521 (4.8)69261 (6.2)39.12
      Chronic pulmonary disease2715 (18.1)2411817 (16.8)178898 (21.2)98.02
      Diabetes, uncomplicated3928 (26.1)3012739 (25.4)2251188 (28.1)111.15
      Diabetes, complicated1085 (7.2)102722 (6.7)79363 (8.6)47.08
      Hypothyroidism1744 (11.6)1451108 (10.2)106636 (15.0)68<.001
      Chronic kidney disease5989 (39.9)4813905 (36.1)3302084 (49.2)189<.001
      Liver disease533 (3.5)62406 (3.8)52127 (3.0)27.31
      Peptic ulcer disease, excluding bleeding5 (0.03)55 (0.04)50 (0)01
      Acquired immune deficiency syndrome20 (0.13)1020 (0.19)100 (0)01
      Lymphoma167 (1.1)34109 (1.0)2658 (1.4)20.4
      Metastatic cancer35 (0.2)1320 (0.18)1015 (0.4)9.37
      Solid tumor without metastasis140 (0.9)3185 (0.8)2255 (1.3)19.22
      Rheumatoid arthritis/collagen vascular diseases178 (1.2)32114 (1.1)2564 (1.5)18.29
      Coagulopathy5778 (38.5)4824010 (37.2)3601768 (41.8)152.02
      Obesity2431 (16.2)1872058 (19.1)167373 (8.8)51<.001
      Weight loss4102 (27.3)3462721 (25.2)2501381 (32.6)130.002
      Fluid and electrolyte disorders9778 (65.1)7597192 (66.7)5772586 (61.1)215.007
      Blood loss anemia255 (1.7)44172 (1.6)3583 (2.0)22.49
      Deficiency anemias3169 (21.3)3152310 (21.4)242886 (20.9)96.76
      Alcohol use385 (2.6)50336 (3.1)4549 (1.1)17.003
      Drug abuse330 (2.2)49321 (3.0)489 (0.2)7<.001
      Psychoses483 (3.2)66389 (3.6)6194 (2.2)23.08
      Depression1639 (10.9)1531233 (11.4)119406 (9.6)57.14
      SE, Standard error of the mean.
      Note that the diagnosis of congestive heart failure and valvular heart disease are primary diagnoses for a large percentage of patients in this study and thus not readily captured by our Elixhauser comorbidity index. Because of the ubiquity of these diagnoses in the study population they are essentially dropped in this analysis.
      Table E3Univariate analysis for in-hospital mortality after the VAD procedure
      OR (95% CI)P value
      Age older than 65 years1.02 (1.01-1.04)<.001
      Female sex1.22 (0.94-1.59).14
      Race
       WhiteReference
       Black0.77 (0.58-1.03).08
       Other
      Includes Hispanic, Asian or Pacific Islander, Native American, and other.
      1.19 (0.86-1.64).29
       Unknown1.40 (0.96-2.06).08
      Primary payer
       MedicareReference
       Medicaid0.89 (0.63-1.72).52
       Private0.99 (0.75-1.31).34
       Other
      Includes self-pay, no charge, and other.
      1.33 (0.74-2.38).47
      Hospital region
       MidwestReference
       Northeast1.00 (0.72-1.40).99
       West0.88 (0.64-1.21).41
       South0.82 (0.53-1.26).37
      Household income1.16 (1.05-1.27).003
      Elective admission0.65 (0.50-0.85).002
      Year of implantation0.96 (0.88-1.05).35
      Elixhauser score1.02 (0.95-1.07).72
      IABP before VAD placement1.29 (1.00-1.66).05
      High-risk intervention before VAD placement
      Includes vasopressors, IABP, extracorporeal membrane oxygenation, hemodialysis, mechanical ventilation, and same admission cardiac surgery before VAD placement.
      5.50 (4.38-6.91)<.001
      Age × Age was used in addition to Age as a continuous variable because of the nonlinear relationship of age and mortality. OR, Odds ratio; CI, confidence interval; IABP, intra-aortic balloon pump; VAD, ventricular assist device.
      Includes Hispanic, Asian or Pacific Islander, Native American, and other.
      Includes self-pay, no charge, and other.
      Includes vasopressors, IABP, extracorporeal membrane oxygenation, hemodialysis, mechanical ventilation, and same admission cardiac surgery before VAD placement.

      Supplementary Data

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