Costs Before and After Left Ventricular Assist Device Implant and Preceding Heart Transplant: A Cohort Study

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Heart, Lung and Circulation (2019) xx, 1–10 1443-9506/04/$36.00 https://doi.org/10.1016/j.hlc.2019.08.008

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ORIGINAL ARTICLE

Costs Before and After Left Ventricular Assist Device Implant and Preceding Heart Transplant: A Cohort Study [TD$FIRSNAME]Roslyn[TD$FIRSNAME.] [TD$SURNAME]Prichard[TD$SURNAME.], BA a, [TD$FIRSNAME]Louise[TD$FIRSNAME.] [TD$SURNAME]Kershaw[TD$SURNAME.], MPH a, [TD$FIRSNAME]Stephen[TD$FIRSNAME.] [TD$SURNAME]Goodall[TD$SURNAME.], PhD b, [TD$FIRSNAME] Patricia[TD$FIRSNAME.] [TD$SURNAME]Davidson[TD$SURNAME.], PhD c,d, [TD$FIRSNAME]Phillip J.[TD$FIRSNAME.] [TD$SURNAME]Newton[TD$SURNAME.], PhD d, [TD$FIRSNAME]Sopany[TD$FIRSNAME.] [TD$SURNAME]Saing[TD$SURNAME.], MPH b, [TD$FIRSNAME] Christopher[TD$FIRSNAME.] [TD$SURNAME]Hayward[TD$SURNAME.], MD a* a

St Vincent’s Hospital, Sydney, NSW, Australia Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, NSW, Australia Johns Hopkins University, Baltimore, MD, USA d Q6 Faculty of Health, University of Technology Sydney, NSW, Australia Q5

b c

Received 19 July 2018; received in revised form 21 July 2019; accepted 12 August 2019; online published-ahead-of-print xxx

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Background

Up to 50% of heart transplant candidates require bridging with left ventricular assist devices (VAD). This study describes hospital activity and cost 1 year preceding and 1 year following VAD implant (pre-VAD) and for the year before transplant (pre-HTX). The sample comprises an Australian cohort and is the first study to investigate costs using both institutional and linked administrative data.

Methods

Institutional activity was established for 77 consecutive patients actively listed for transplant between 2009 and 2012. Costs were sourced from the institution or Australian refined diagnosis groups (arDRGs) and the National Efficient Price for admissions to other public and private institutions. Data from 25/77 VAD recipients were analysed and compared with data from 52/77 pre-transplant patients. Total and per day at risk costs were assessed, as well as totals per resource.

Results

Fifty per cent (50%) of the hospital costs in the pre-VAD year occurred during admission of VAD implant. Sixty-four per cent (64%) of costs in the pre-HTX and 38% in the pre-VAD period occurred outside the implanting centre. Costs in the year prior to VAD, $97,565 (IQR $86,907–$153,916), were significantly higher than costs accrued in the year prior to transplant, $40,250 ($13,493–$81,260), p < 0.0001. Once discharged, costs per day at risk for post-VAD patients approximated those from the pre-admission period, p = 0.16 and in the more clinically stable pre-HTX cohort, p = 0.08.

Conclusion

Compared with the year prior, VAD implant stabilised hospital cost in patients discharged home. A high proportion of the hospital costs in the pre-implant year occur outside the implanting centre and should be considered in economic models assessing the impact of VAD implant.

Keywords

Heart failure  Ventricular assist device  Cost

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*Corresponding author at: Heart Lung Clinic, St Vincent’s Hospital Sydney, 390 Victoria Street, Darlinghurst, Australia, Emails: [email protected], [email protected] © 2019 Published by Elsevier B.V. on behalf of Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ).

Please cite this article in press as: Prichard R, et al. Costs Before and After Left Ventricular Assist Device Implant and Preceding Heart Transplant: A Cohort Study. Heart, Lung and Circulation (2019), https://doi.org/10.1016/j.hlc.2019.08.008

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Introduction

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Heart failure (HF) is prevalent in Australia [1], and while 17 Q9 heart transplant is only available to a small subset of 18 advanced HF patients, many of these patients require 19 Q10 mechanical circulatory support with ventricular assist devi20 ces (VADs), involving a significant one-off cost. VAD ther21 Q11 apy has demonstrated significant improvements in survival 22 and quality of life (QoL) [2,3] but outcomes vary, and 23 complications of therapy can result in frequent rehospital24 isations, with increased cost and impairment of quality of 25 life [4–7]. Commonly, the costs of care are concentrated in 26 the implanting centre during the first year following surgery 27 [8–12], but VAD patients are often referred for assessment 28 after a period of progressive deterioration while managed 29 outside the transplant centre [13]. Thus, when assessing the 30 comparative costs of VAD therapy, attention must be paid 31 to this period leading up to implant, where considerable 32 accelerating cost, de-conditioning and worsening prognosis 33 are reflected in increasingly frequent and prolonged hospi34 talisations [14,15]. This period leading up to intervention with VAD therapy 35 could also offer the opportunity to identify patients who 36 may benefit from pro-active, pre-conditioning or ‘‘pre37 habilitation” programs which incorporate multidisciplinary 38 nutritional, psychological, and behavioural interventions 39 [16,17]. However, in resource constrained systems, these 40 interventions require careful patient screening, targeting 41 and multidisciplinary decision-making, and although 42 efforts are being made to attribute costs for such processes 43 at the patient level [18], much of the decision-making and 44 patient preparatory activity currently generated during this 45 period is not clearly reflected in costing and re-imbursement 46 strategies. 47 Four quaternary hospitals perform adult heart transplants 48 and implant VADs in Australia and while it is now possible 49 to access VAD therapy through the private system the per50 ceived need for co-location with quaternary transplant ser51 vices remains a limiting factor with few VADs yet to be 52 implanted privately. Australia’s universal health care system 53 is funded by both federal and state governments and rigor54 ous appraisal of new technology or changing indications for 55 existing technology proposed for public funding is under56 taken through the Medical Services Advisory Committee 57 using the best available evidence [19]. 58 Q12 No cost effectiveness models exist for cf-VAD therapy 59 using Australian data and this study sets out to establish a 60 dataset of patient level activity and cost, for an Australian 61 cohort of heart failure (HF) patients listed for transplant. 62 Through semi-structured clinician interviews and detailed 63 file reviews, we identify and cost a model of care that incor64 porates multidisciplinary team input in the year leading up 65 to implant or transplant, and following VAD implant. By 66 using linked administrative data to capture activity and cost 67 in hospitals external to the implanting centre, our study 68 highlights the potential for cost stabilisation following 69 VAD implant in selected HF patients.

Materials and Methods Ethics approval was obtained from the implanting hospital and New South Wales (NSW) Ministry of Health research ethics committees (HREC/13/CIPHS/51). One hundred (100) consecutive patients enrolled onto the heart transplant list between July 2009 and June 2012 were screened. Inclusion and exclusion criteria are described in Figure 1 with excluded patients including those with complex congenital conditions, receiving investigational devices, BiVADs or listed for repeat transplantation. The final sample included 77 patients, 25 of whom received a single left VAD implant. All received the HeartWare HVAD1 (Heartware Inc. Framingham, MA, USA) representing a 20% sample of patients enrolled onto heart transplant waitlist Australia-wide. A micro-costing, patient level approach was undertaken to capture institutional activity and cost. Semi-structured clinician interviews verified medical and nursing activity identified in the manual reviews, established additional un-documented activity and reported estimated time required for each activity. Fourteen (14) resource groups in addition to medical and nursing care were identified and costed as described in the published methodology for this study [20]. Data extraction used predefined date ranges to capture activity in the: 1 1 year prior to transplant or death (pre-HTX). 2 1 year prior to VAD implant (pre-VAD). 3 VAD. The VAD cohort data (25/77) were further examined to extract activity and cost in the periods prior to, during and following the implanting admission (index admission). 1 Prior to the index admission (pre-admission). 2 During index admission prior to implant (pre-implantation).

Figure 1 Exclusions table. Abbreviations: TAH, total artificial heart; C Pulse, extraaortic counter pulsation device; AHF, advanced heart failure; HTX, heart transplant; NSW, New South Wales; ACT, Australian Capital Territory.

Please cite this article in press as: Prichard R, et al. Costs Before and After Left Ventricular Assist Device Implant and Preceding Heart Transplant: A Cohort Study. Heart, Lung and Circulation (2019), https://doi.org/10.1016/j.hlc.2019.08.008

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3 During index admission after implant (post-implantation). 4 After first discharge to the end of first year (post-discharge).

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Medical and Nursing Activity

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Detailed manual paper and electronic file reviews identified over 10,000 dated, documented activities for 17/77 randomly selected patients in detailed file reviews (DFRs). During this phase all documented activity was coded and added to a cumulative database until a definitive set of lower cost, higher frequency activity was established as applicable to all patients in specific clinical environments (ICU, Ward). Higher cost/less frequent or predictable medical and nursing activities identified in the DFRs were then manually identified for the remaining 60 patients in short file reviews. The shorter reviews generated another 1,005 records of higher cost or infrequent activity with initiation date and duration data. Clinician interviews (n = 12) provided estimates of the time required for each of the activities. The resource intensive process of manual activity data extraction was expedited through this process while maintaining the robustness of a patient level dataset. Indirect cost, including non-clinical activities not distributed at the patient level—for example cleaning, engineering, finance, human resources and administrative support—were

107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125

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applied using a fractional marginal mark-up technique used by the hospital finance department [21], adding 21% to all costs excluding the cost of the VAD pump itself.

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Linked Administrative Data

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Linked administrative emergency and admitted patient data (EDDC and APDC), capturing statewide public and private admissions and emergency presentations, were obtained from the NSW Ministry of Health using linkage services from the Centre for Health Record Linkage [22]. These files yielded 1,984 admission records, and 705 emergency presentations related to the 77 patients. Each APDC unit record contains an admission specific Australian refined diagnosis related code (ArDRGs) with a cost weight derived from length of stay, and factors contributing to case complexity. Cost weights used in this study included emergency costs where presentation led to admission, and were multiplied by the national weighted activity unit (NWAU), to generate cost data for each unit record. Emergency department (ED) presentations that did not result in admissions were identified in the EDDC records and costed using the national average cost of an ED presentation multiplied by the cost weight specific for the urgency and disposition coded for each EDDC unit record [23–25]. Total costs for each patient included all institutional costs collected from the micro-costed institutional patient level

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Table 1 Demographics and clinical indicators. Pre HTX*

Pre VAD*,^

VAD^

p values **

^^

NS

NS

Patients

52

25

Age

51 (10)

47 (14)

Female

30%

28%

31%

NS

NS

BMI IHD

25.5 (6) 14%

25.2 (4.4) 28%

23.9 (6.4)

NS NS

NS NS

Creatinine

114 (38)

122 (55)

107 (53)

NS

NS

eGFR<60

55%

48%

52%

NS

NS

Albumin

43 (8)*

37 (6)*,^

42 (7)^

0.003*

Cardiac output Cardiac Index

*

3.6 (1.4)

*

1.8 (0.6) 20 (7)

*

MPAP Intermacs score

33 (9)

*

NYHA 4

21%

PAWP

23

*,^

3.3 (1.1)

*,^

1.7 (0.5) *,^

4.7 (1.2)

^

^

2.6 (0.6)

0.01^ <0.0001^

*

0.48

<0.0001^

*

0.48

<0.0001

38 (7) 96% 1 or 2

22 (9)

^

100%

20.00%

<0.0001*

<0.0001^

26 (2)

*,^

*

<0.0001^

14 (4)

^

<0.0001^

*

0.0001

NYHA 3

62%

0%

4.00%

<0.0001

0.31^

NYHA 2

16%

0%

36.00%

0.04

0.001^

NYHA 1

0%

0%

24.00%

NS

0.01^

unknown

1%

0%

16.00%

*

Abbreviations: BMI, body mass index; IHD, ischaemic heart disease; eGFR, estimated glomerular filtration rate; PAWP, pulmonary arterial wedge pressure; MPAP, mean pulmonary arterial pressure; NYHA, New York Heart Association functional classification; NS, not significant. *

indicates comparison between pre htx and pre vad.

^

indicates comparison between pre vad and vad.

Please cite this article in press as: Prichard R, et al. Costs Before and After Left Ventricular Assist Device Implant and Preceding Heart Transplant: A Cohort Study. Heart, Lung and Circulation (2019), https://doi.org/10.1016/j.hlc.2019.08.008

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data, and NWAU derived cost from other public and private hospitals throughout NSW, with all emergency presentations. Totals per resource and patient per diem costs are reported, with censoring at transplant or death in the year following VAD implant. Median and interquartile range are reported for non-parametric data. Some averages are reported to increase the usefulness of the cost output for planning purposes. Per day at risk calculations took the total cost for each patient and divided by days in the cohort prior to death, implant, transplant or 365 days. Wilcoxon rank sum tests were used to compare paired data with Mann Whitney tests used for non-paired comparisons, while Chi squared and Fisher’s exact tests were used to compare proportional data. A p value of 0.05 or less was considered significant. Statistical analyses were carried out using Prism 7 for Windows Version 7.03 statistical software (Graphpad Software, La Jolla, CA, USA).

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Results

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Patients and Outcomes

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Pre-VAD patients had significantly worse haemodynamics, functional status and albumin levels than pre-HTX

patients reflecting worse clinical status and prognosis (Table 1). Eleven (11) of the 25 VAD patients were transferred emergently from outlying hospitals to St Vincent’s Hospital (Sydney, NSW) prior to implant, three patients were supported on extra corporeal membrane oxygenation (ECMO), 14 required intra-aortic balloon pumps, and six were intubated and ventilated in the year prior to implant. Using the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACs) scoring system which grades the most severe Class 4 New York Heart Association (NYHA) patients on a scale of 1 to 7 [26], eight of the VAD patients were scored at the most severe Level 1, and 17 at Level 2. Two (2) deaths occurred during the VAD admission (at days 21 and 73) but clinical condition significantly improved in the surviving 23/25 as reflected in functional status (NYHA score), cardiac index, pulmonary arterial wedge pressure, mean pulmonary pressure and albumin levels (Table 1). The 23 surviving VAD patients were supported for an average of 284 days in the first year. Two more patients died at day 63 and 427 while 19 went on to receive transplants (8 during the first year and 11 thereafter), and two remained supported on VAD at the end of the observation period (30/ 6/14). Fourteen (14) patients were supported for more than a

Table 2 Pre transplant, pre and post VAD year days in cohort and costs per resource. HF Pre HTX

HF Pre VAD

VAD year 1

Number of patients

52

25

25

Days in Cohort (med IQR)

365 (365–365)

365 (365–365)

365 (202–365)

Days in Cohort (Av SD)

365 (0)

365 (0)

284 (109)

Cost (med IQR)

$40,250 (13,493–81,260)

$97,565 (88,769–147,209)

$288,921 (210,856–401,339)

Cost (Av SD) Per diem Cost (med IQR)

$59,478 (75,659) $110 (37–223)

$120,902 (63,935) $267 (238–422)

$311,197 (113,136) $1,118 (603–1,689)

Per diem Cost (Av SD) Per Resource (med IQR)

$163 (207) HF pre HTX*

$331(175) HF Pre VAD^

$1,822(2,749) VAD year 1

Medical Nursing

$418 (0–4,395) $176 (0–2,104)

$13,543 (9,704–18,040) $9,592 (7,078–15,511)

$34,511 (19,845–64,565) $38,374 (27,095–73,815)

Consumables

$10 (0–333)

$3,745 (2,464–6,109)

$10,063 (4,039–28,615)

Imaging

$461 (95–1,117)

$1,606 (896–2,967)

$4,041 (2,816–6,005)

Allied health

$208 (88–406)

$609 (231–1,764)

$3,397 (1,939–6,845)

Theatre and catheter lab

$0 (0–590)

$0 (0–1,964)

$9,874 (7,982–17,564)

Pharmacy

$0 (0–170)

$3,278 (764–6,449)

$1,763 (681–6,155)

Blood

$0 (0–0)

$0 (0–757)

$7,875 (3,483–16,508)

Emergency Rehabilitation

$0 (0–746) $0 (0–0)

$0 (0–1,801) $0 (0–0)

$724 (0–1,448) $0 (0–4,874)

Outpatient care

$5,882 (4,392–6,413)

$2,803 (1,316–4,943)

$6,739 (3,194–9,053)

Pathology

$1,047 (546–1,859)

$4,564 (3,181–6,523)

$11,461 (6,833–14,987)

Indirect

$2,159 (1,462–4,585)

$11,101 (6,892–15,654)

$31,657 (18,276–52,435)

VAD pump

$0 (0–0)

$0 (0–0)

$103,000 (103,000–103,000)

Other hospitals

$21,746 (1,456–41,996)

$32,981 (15,339–56,637)

$0 (0–2,697)

Abbreviations: HF Pre-HTX, heart failure before transplant; HF Pre-VAD, heart failure before ventricular assist device; Med IQR, median interquartile range; Av SD, average standard deviation; VAD, ventricular assist device.

Please cite this article in press as: Prichard R, et al. Costs Before and After Left Ventricular Assist Device Implant and Preceding Heart Transplant: A Cohort Study. Heart, Lung and Circulation (2019), https://doi.org/10.1016/j.hlc.2019.08.008

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year with median days on support in this group of 528 days from the date of first discharge (IQR 432–810). Six (6) of the 52 pre-HTX cohort died while waiting for transplant, 42 received transplants and 4 remained alive on the list at the end of the study period (Figure 1). Notably only 4/77 patients received care exclusively at the implanting centre during the 2 years examined.

Costs in the Year Preceding Implant and Transplant The pre-VAD patients were significantly more unwell and more costly than the pre-HTX group, with per patient median total costs of $97,565 (IQR $88,769–$147,209) compared with $40,250 (IQR $13,493–$81,260) for the pre-HTX group, p < 0.0001. Median Post-VAD cost including the cost of the VAD pump was $288,921 ($210,856–$401,339). Table 2 reports total and per diem costs and per resource costs accrued in the year preceding transplant death or VAD implant (pre-HTX, pre-VAD) and the year following VAD implant (VAD).

Table 3 divides the pre-VAD year at the implant date showing per diem costs in the two periods prior to implant (pre-admission, and pre-implant) and the two periods after implant (post implant and post admission). Per diem cost for the days at risk before the admission, (pre-admission $134, $65–$233), increase dramatically during the VAD admission prior to implant (pre-imp $2,050 $1,524–$2,572), reflecting the intensive clinical inpatient activity generated during this acute phase of deterioration and decision-making. After first discharge home (post admission), the 23 surviving VAD patients per diem costs at a median $103 ($65–$486), approximate those in the pre-admission period (p = 0.16) suggesting cost stabilisation in a patient cohort at high risk of deterioration and death. Per diem costs after first discharge home were also no longer statistically different from per diem costs accrued in the pre-HTX HF group at $110 per day (p = 0.08) (Figure 2 and Table 3). Total and per diem results presented in Figure 3 show the proportional contribution of each resource category during various phases in the care pathway. Of note is the small proportion of total costs attributable to allied health care (1% before and 2% after VAD implant), and the concentration

Table 3 Year Pre and Post VAD showing the implant admission split at date of surgery. Year prior to Implant Pre admission

Year following implant Pre implant

Post implant

Post admission

Number of patients

25

25

25

23

Days in Cohort (med IQR) Days in Cohort (Av SD)

343 (332–355) 342 (12.2)

22 (1033) 23 (12)

31 (26–70) 53 (47)

296 (178334) 251 (96)

Cost (med IQR)

$44,050 (22,398–79,145)

$42,587 (20,566–79,014)

$209,474 (181,036–303,897)

$32,189 (20,508–88,952)

Cost (Av SD)

$65,706 (65,086)

$55,258 (48,489)

$256,125 (99,372)

$59,856 (62,609)

Per diem cost (med IQR)

$134(65–233)

$2,050 (1,524–2,572)

$6,089 (4,531–8,420)

$ 103 (65–486)

Per diem cost (Av SD)

$190 (186)

$2,576 (2,082)

$6,507 (2,979)

289 (310)

Medical Nursing

$544 (0–5,040) $145 (0–5,413)

$11,762 (5,152–16,431) $7,033 (3,781–11,981)

$25,674 (16,343–39,207) $27,549 (20,435–41,267)

$4,092 (1,674–14,497) $4,704 (1,529–19,036)

Consumables

$0 (0–1,105)

$2,465 (1,515–4,109)

$8,094 (3,557–25,155)

$664 (88–2,931)

Imaging

$266 (0–1,663)

$886 (511–1,466)

$2,506 (1,377–3,141)

$1,428 (862–3,128)

Allied health

$0 (0–388)

$281 (15–591)

$2,469 (1,696–5,473)

$394 (111–1,547)

Theatre and catheter lab

$0 (0–1,117)

$0 (0–411)

$9,152 (6,928–12,942)

$1,034 (0–2,780)

Pharmacy

$1,539 (0–2,820)

$2,474 (221–3,432)

$962 (544–2,712)

$59.2 (9.82–1,213)

Blood

$0 (0–0)

$0 (0–303)

$6,967 (3,029–14,539)

$0 (0–0)

Emergency Rehabilitation

$0 (0–1,801) $0 (0–0)

$0 (0–0) $0 (0–0)

$0 (0–0) $0 (0–4,874)

$724 (0–1,448) $0 (0–0)

Out patient care

$473 (0–3,718)

$473 (0–2,596)

$0 (0–0)

$7,152 (3,318–8,950)

Pathology

$687 (17.5–2,420)

$3,356 (1,686–4,604)

$6,638 (4,936–9,750)

$3,468 (1,634–5,388)

Indirect costs

$1372 (460–7,165)

$6,425 (3,440–11,574)

$18,479 (13,543–34,866)

$3,856 (3,123–13,253)

VAD pump

$0 (0–0)

$0 (0–0)

$103,000 (103,000–103,000)

$0 (0–0)

Other hospitals

$26,451 (8,892–44,970)

$0 (0–14,799)

$0 (05,272)

0 (0–2,568)

Costs per resource med (IQR)

Abbreviations: VAD, ventricular assist device; med IQR, median interquartile range; Av SD, average standard deviation.

Please cite this article in press as: Prichard R, et al. Costs Before and After Left Ventricular Assist Device Implant and Preceding Heart Transplant: A Cohort Study. Heart, Lung and Circulation (2019), https://doi.org/10.1016/j.hlc.2019.08.008

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Figure 2 Cost per day at risk. Total cost per patient per day at risk in the year prior to transplant (Pre transplant), prior to VAD implant admission (Pre vad admission) and after first discharge home (Post discharge home). Abbreviation: VAD, ventricular assist device.

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of costs on the implanting centre post implant. The majority of the costs in the pre-HTX year occur outside the transplanting hospital (Figure 3 other hospitals), while postVAD costs are borne extensively by the VAD-implanting hospital.

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Discussion

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This study presents 20% of the Australian VAD and pretransplant cohort over this period, and is important in health delivery planning, demonstrating when and where the burden of costs occur in this critically unwell population. Heart

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transplant and VAD implantation are the only treatment options that offer improved survival for end stage HF patients receiving optimal medical management, and while transplant numbers are limited by the availability of donor organs, access to VAD therapy depends on the willingness of policy makers and health care funders to pay for it. Up to half those on heart transplant waiting lists will require bridging VAD implants [27] and extended waiting periods can blur the lines between bridging to transplant, bridging to candidature and destination VAD therapy. This investigation supports the current practice of VAD implant as an important bridge for critically ill patients

Please cite this article in press as: Prichard R, et al. Costs Before and After Left Ventricular Assist Device Implant and Preceding Heart Transplant: A Cohort Study. Heart, Lung and Circulation (2019), https://doi.org/10.1016/j.hlc.2019.08.008

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Figure 3 Total proportional resource use over each time period.

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awaiting heart transplant and demonstrates both survival and stabilisation in per diem costs. Recent studies examining VAD and mechanical support costs and hospitalisation during the first postoperative year [8–12], have focussed on comparison with transplant. This is important as it highlights the high costs of transplant medicine and the reducing costs of mechanical support. Once transplanted, a recent metaanalysis of cost effectiveness studies including 1,083 BTT VAD patients, found these patients face no significant difference in the incidence of postoperative adverse events, overall long-term survival, or cost compared with medically managed patients [28]. Our study focusses attention, instead, on the pre-surgical year where patients and clinicians must weigh the likelihood of organ transplant against the trajectory of clinical decline and attempt to pick the ‘sweet spot’ where the benefits of VAD therapy outweigh the costs of delaying access to transplant. The additional cost of VAD therapy to the health system is currently capped through restricted VAD implant reimbursement, but the cost of the pre-implant period and of any subsequent adverse outcomes can carry significant cost risks for the institution. Institutional costs build rapidly during the period prior to implant and there is a clear potential to reduce cost in the year prior, and in the pre-implant period of the VAD admission, by identifying and implanting VAD recipients earlier. This would serve the dual purpose of reducing the accumulating organ damage accrued as patients deteriorate and the costs associated with prolonged acute care hospitalisation. However, the shared decision-making process during this period is complex. Earlier implant may reduce preoperative

deconditioning but lengthen the time that the patient is exposed to the potential complications of VAD therapy. The ROADMAP study demonstrated that implanting earlier in ambulant non-inotrope dependant patients did not improve survival over optimally medically managed HF patients, and at the same time introduced a significant burden of adverse events with concomitant increases in rates of hospitalisation [28]. These findings are echoed in the Eighth Intermacs report examining the impact of adverse events for VAD patients [6]. Earlier implant may reduce preoperative deconditioning but lengthen the time that the patient is exposed to the potential complications of VAD therapy, and this must be carefully weighed up by the surgical team. In addition, patients already listed for transplant face the prospect of de-listing for at least 3 months during their post implant recovery. Selecting and preparing the patients most likely to benefit and least likely to experience the more debilitating complications of VAD therapy involves the multidisciplinary team in complex rounds of testing, treatment discussions and shared decision-making [29–31]. Optimising patients clinically, physically and emotionally in this period, may involve temporary mechanical support and inotropy, screening for and addressing frailty, and tailoring patient education and preparation around cognitive and or social deficits or disability. While our implant admission (A10Z) costs are similar to those for the 20 VAD patients reported by Marasco et al. -$268,438 ($219,620–$388,326) vs $259,903 ($216,144–$290,451) [8], the variations apparent in post-VAD outcomes and cost in both studies, highlights the need for careful patient selection and management to prevent or mitigate the cost and

Please cite this article in press as: Prichard R, et al. Costs Before and After Left Ventricular Assist Device Implant and Preceding Heart Transplant: A Cohort Study. Heart, Lung and Circulation (2019), https://doi.org/10.1016/j.hlc.2019.08.008

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A high proportion of activity and cost in the pre-VAD and pre-transplant year occurs outside the implanting hospital and it is important that future cost effectiveness analyses include these costs in model inputs. Our data suggests that VAD implant can stabilise accelerating per diem costs in a high cost, clinically unstable cohort of HF patients, but there remains considerable heterogeneity in post implant costs pointing to less favourable outcomes for some patients who may benefit from increased resourcing of improved candidate identification, optimisation of clinical status and focussed pre-habilitation activity.

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Conflicts of Interest and Source of Funding

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QoL impacts of VAD complications. Stroke, right heart failure, bleeding and infection remain the most serious VAD adverse events contributing to poorer QoL and increased mortality [6], and careful ongoing management of blood pressure, anticoagulation, bleeding and drive line infection risk is required to mitigate the occurrence and severity of these events [32–36]. The cost effectiveness literature examining VAD therapy is emerging from European and North American data where the health services and transparency around patient level costs of care, vary widely [37], and few report VAD therapy to be cost-effective, using currently accepted thresholds, outside specific situations where longer periods of support or pre-existing co morbidities may generate more costeffective outcomes [38,39]. Ventricular assist device therapy in Australia is currently publicly funded where a patient is eligible, or likely to become eligible, for subsequent heart transplant. The effect that the limit on the reimbursable supply of VADs may have on clinical decision-making is not clear, but it could plausibly contribute to delayed VAD implant. Appropriately resourcing pre-implant, screening and optimisation of clinical status, as well as post implant management, must be prioritised in programs to ensure the right patients are equitably offered timely implants and receive optimal pre and post implant care. In our study allied health expenditure was low throughout the patient journey (Figure 3), representing an opportunity to increase resource for screening and targeted ‘pre-habilitation’ programs that are increasingly providing improved patient outcomes for cardiac and oncology surgical patients [16,40,41].

Acknowledgments

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Limitations

The authors thank St Vincent’s Hospital, Sydney finance department, Melita Howes and Lai Mun Balnave, who provided assistance and advice throughout this project. Data linkage services were provided by The Centre for Health Record Linkage and the New South Wales Ministry of Health, gave access to unit files from the admitted patient and emergency department data collections (APDC/ EDDC) relevant to the cohort

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The study took a micro-costing, patient level approach where possible with greater attention focussed on medical and nursing activity within the implanting hospital, however, study resources did not allow testing of clinician activity time estimates against actual practice. The difficulty of establishing a true comparator cohort for VAD implant is also apparent in this observational study with the pre-HTX group, while still in the advanced stages of HF, not as acutely unwell as those requiring mechanical support to survive until transplant. Additionally, because of the nature of the data linkage achieved, we were unable to undertake an ad hoc analysis of the post transplant costs and outcomes for our cohort. Admissions which may have occurred elsewhere in Australia, expose the study to a potential cost shortfall of between 3 and 5% [13,42], and the study is insufficiently powered to make conclusions about the predictors for high cost poorer outcomes. However, with only four implanting institutions in Australia, it provides a suitable sample of transplant and VAD activity over the observed period. In spite of these limitations, this study provides a rigorous costing study in a defined cohort which is important in developing policy and funding models.

This investigator initiated study (CH) was supported by Heartware Incorporated (now Medtronic) who provided salary support to enable study set-up and data collection, by the National Health and Medical Research Council (R.P. NHMRC post graduate scholarship APP1133337) and by an Australian Government research training program (RTP) scholarship. None of the other authors have a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.

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Please cite this article in press as: Prichard R, et al. Costs Before and After Left Ventricular Assist Device Implant and Preceding Heart Transplant: A Cohort Study. Heart, Lung and Circulation (2019), https://doi.org/10.1016/j.hlc.2019.08.008