HLC 1572 No. of Pages 4
Heart, Lung and Circulation (2014) xx, 1–4 1443-9506/04/$36.00 http://dx.doi.org/10.1016/j.hlc.2014.03.027
ORIGINAL ARTICLE
Cost Benefit for Assessment of Intermediate Coronary Stenosis with Fractional Flow Reserve in Public and Private Sectors in Australia J.C. Murphy, MBBCh PhD a, P.S. Hansen, MBBS FRACP PhD b, R. Bhindi, MBBS PhD FRACP b, G.A. Figtree, MBBS PhD FRACP b, G.I.C. Nelson, MBBS FRACP PhD b, M.R. Ward, MBBS(Hons) FRACP PhD b* a
Royal North Shore Hospital University of Sydney
b
Received 10 April 2013; received in revised form 28 November 2013; accepted 22 March 2014; online published-ahead-of-print xxx
Background
Fractional Flow Reserve (FFR) is a proven technology for guiding percutaneous coronary intervention (PCI), but is not reimbursed despite the fact that it is frequently used to defer PCI.
Methods
Costs incurred with use of FFR were compared in both the public and private sectors with the costs that would have been incurred if the technology was not available using consecutive cases over a two year period in a public teaching hospital and its co-located private hospital.
Results
FFR was performed on 143 lesions in 120 patients. FFR was < 0.80 in 37 lesions in 34 patients and 25 underwent PCI while 11 had CABG. It was estimated that without FFR 78 lesions in 70 patients would have had PCI with 17 patients having CABG with 35 additional functional tests. Despite a cost of $A1200 per wire, FFR actually saved money. Mean savings in the public sector were $1200 per patient while in the private sector the savings were $5000 per patient.
Conclusions
FFR use saves money for the Federal Government in the public sector and for the Private Health Funds in the private sector. These financial benefits are seen in addition to the improved outcomes seen with this technology.
Keywords
Coronary intervention Fractional flow reserve Cost effectiveness Revascularisation Coronary artery bypass grafting
Introduction Fractional Flow Reserve (FFR) (where the functional significance of an indeterminate coronary stenosis is assessed by measuring the pressure drop across the stenosis during maximal hyperaemia) is widely accepted as an important tool in
modern interventional cardiology. When the FFR shows the stenosis is not haemodynamically significant, percutaneous coronary intervention (PCI) results in an excess of adverse outcomes [1], while when the stenosis is haemodynamically significant adverse events are prevented by PCI [2]. FFR can also predict graft occlusion early after CABG [3]. However,
*Corresponding author at: Department of Cardiology, Royal North Shore Hospital, St Leonards NSW 2065, Australia. Fax: +61 2 9906 7807., Email: [email protected] © 2014 Published by Elsevier Inc 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: Murphy JC, et al. Cost Benefit for Assessment of Intermediate Coronary Stenosis with Fractional Flow Reserve in Public and Private Sectors in Australia. Heart, Lung and Circulation (2014), http://dx.doi.org/ 10.1016/j.hlc.2014.03.027
HLC 1572 No. of Pages 4
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J.C. Murphy et al.
use of this technology in Australia has been low [4], hampered by lack of listing on the Medical Benefits Scheme and thus reimbursement by Private Health Funds. In addition, its use in the public sector may have been curtailed by some conflicting evidence on its cost-benefit in other health care systems [5–7]. We sought to define the ‘real world’ costs of treating intermediate coronary stenosis in the presence and absence of FFR assessment by using patients treated in our institution over a two year period using FFR, to compare costs incurred with predicted costs if the technology was not available.
Methods Patients We collected data on two consecutive years of FFR use from January 1st 2010 to December 31st 2011 in the co-located cardiac catheterisation laboratories of the Royal North Shore Hospital and North Shore Private Hospital. The medical records from all patients in whom FFR was performed were examined to determine the clinical setting of FFR use (acute coronary syndrome or stable elective admission), the age and sex of the patient, whether functional non-invasive testing had been performed prior to coronary angiography and its result, FFR performed (lesion site and results) and subsequent revascularisation performed. Where the FFR was < 0.80 and PCI was the chosen form of revascularisation this was performed in the same sitting as FFR. The costs associated with treatment of the patient in the absence of FFR was determined according to the following (based on our practice before the availability of FFR):
1. If the patient had an acute coronary syndrome with a possible culprit lesion being interrogated and the angiographic stenosis was > 50% by quantitative coronary angiography then in the absence of FFR the lesion would be stented during the same procedure. 2. If the patient had an acute coronary syndrome and the lesion being interrogated was a non-culprit lesion, with the culprit already stented then the patient would be sent for outpatient functional imaging (stress sestaMIBI or stress echocardiography). 3. If the patient was clinically stable and prior non-invasive functional imaging had suggested ischaemia in the territory supplied by the lesion under interrogation (or with positive stress ECG and there was only one possible lesion to explain positive test), in the absence of FFR the lesion would be stented. 4. If the patient was clinically stable and functional testing had not been performed then the patient would be sent for stress sestaMIBI or stress echocardiography. 5. Results from functional imaging would reflect the results of the FFR and revascularisation would subsequently be performed according to these results. 6. Stress sestaMIBI and stress echocardiography would be ordered equally often (half each; consistent with the pattern of functional testing in those who had had sestaMIBI or stress echo before angiography in this cohort). 7. Stents in the public sector would be 70% DES, 30% BMS while in the private sector there would be 90% DES and 10% BMS (based on recent trends). 8. Clopidogrel treatment for one year was added after stenting when the patient was clinically stable and had
Table 1a Costs in Private Sector. ITEM
FFR
FFR COST
NO FFR
NO FFR COST
($)
(n)
($)
(n)
($)
38218*
6100
0
0
52
38246/38241*
7280
95
691600
0
0
14000 14420
0 25
0 360500
68 0
952000 0
38246/38306* 38246/38306/38241*
317200
38306/38243*
13150
0
0
10
131500
CABG
19000
11
209000
17
323000
O/N STAY
1259
25
31475
78
98202
DAYSTAY
751
95
71345
52
39052
DES
3750
24
90000
79
296250
BMS
2000
3
6000
8
16000
PW MIBI/SE
1345 600
120 0
159900 0
0 35
0 21000
CLOPIDOGREL
1000
49
49000
78
TOTAL *
COST
1668820
78000 2272204
MBS item numbers attached to theatre fees: 38218 diagnostic angiography, 38246 diagnostic angiography and coronary intervention/FFR, 38241 FFR 38306 stent placement, 38243 coronary invention without diagnostic angiography; CABG coronary artery bypass grafting; O/N overnight; DES drug-eluting stent; BMS bare metal stent; PW pressure wire; MIBI/SE stress sestaMIBI scanning or stress echocardiography.
Please cite this article in press as: Murphy JC, et al. Cost Benefit for Assessment of Intermediate Coronary Stenosis with Fractional Flow Reserve in Public and Private Sectors in Australia. Heart, Lung and Circulation (2014), http://dx.doi.org/ 10.1016/j.hlc.2014.03.027
HLC 1572 No. of Pages 4
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Cost effectiveness of FFR
Table 1b Costs in the public sector. ITEM
PRESSURE WIRE
COST
FFR
FFR COST
NO FFR
NO FFR COST
($)
(n)
($)
(n)
($)
1425
120
169500
0
AD HOC PCI POST FFR
400
25
10000
0
0
AD HOC PCI ALONE
600
0
0
68
40800
PCI ON RETURN
800
0
0
10
8000
O/N STAY
600
25
15000
78
46800
18000
11
198000
17
306000
1800
19
109800
61
109800
600 600
8 0
15600 0
26 35
15600 21000
1000
49
49000
78
CABG DES BMS MIBI/SE CLOPIDOGREL TOTAL
0
78000
480500
626000
PCI percutaneous coronary intervention, FFR fractional flow reserve, CABG coronary artery bypass grafting, DES drug-eluting stent, BMS bare metal stent, MIBI/ SE stress sestaMIBI or stress echocardiography.
not had any other coronary stents within the previous 12 months. 9. After PCI the patient stayed overnight while after FFR alone the patient was discharged the same day.
Costs We have endeavoured to include only those costs which would be unique to either management pathway. The cost of each item is shown in Table 1. In the public sector, costs were estimated by the added cost of each piece of extra equipment (averaged where multiple brands were available) and that of an overnight stay. The cost of FFR immediately after angiography was equivalent to the cost of the wire and the cost of a guiding catheter. Follow-on PCI after FFR was the cost of one pre-dilatation balloon, one post-dilatation balloon, one stent and one inflation device. The cost of PCI when returning after functional testing was the sum of sheath, guiding wire, guiding catheter, one intracoronary wire, one inflation device, one pre-dilatation and one postdilatation balloon and one stent. In the private sector the only equipment billed to the health funds is stents with all other equipment absorbed into the theatre fees. Therefore private sector costs included one stent with the added costs of theatre fees, physician procedural fees and accommodation fees. Theatre fees were those billed by North Shore Private Hospital and proceduralist fees were direct-billing Medibank Private (largest health fund) fees. In both sectors the cost of functional imaging was the average of bulk-billed stress sestaMIBI and stress echo ($A600) while the cost of Clopidogrel treatment for one year was rounded to $1000.
Results One hundred and twenty patients had FFR performed on 143 lesions in our co-located cardiac catheterisation laboratories
over the two-year period. This included 80 males and 40 females with a mean (SD) age of 66.5 (10.2) years. Fifty patents had an acute coronary syndrome (43 with troponin elevation) while 59 had stable coronary disease with 11 having follow-up angiography of non-culprit lesions after STEMI where functional testing was expected to be unreliable (eg paced or LBBB) or was equivocal. Of the 59 patients with stable symptoms 51 had had a functional test prior to angiography while four had coronary computed tomographic angiography (CCTA) alone. The four patients with no functional test or CCTA included one with severe aortic stenosis undergoing assessment for transcutaneous aortic valve implantation and one with symptoms consistent with restenosis (who had FFR positive restenosis). The vessel under interrogation was the Left Anterior Descending or diagonal in 83, Right Coronary Artery or posterior WITH FFR 11 CABG
WITHOUT FFR
5
59 SAP 12 42
25 PCI
84 MED RX
10
12
5
33
4 50 NSTEMI/UAP
9
29
78 PCI
17
10
3
1
1
17 CABG
36 13
3 11 POST MI
5
35 MIBI/SE
25
25 MED RX
Figure 1 Fate of 120 patients with and without FFR according to mode of presentation. CABG coronary artery bypass grafting; PCI percutaneous coronary intervention, MED RX medical therapy; SAP stable angina pectoris; NSTEMI/UAP non-STelevation myocardial infarction/unstable angina pectoris; POST MI post myocardial infarction; MIBI/SE sestaMIBI scanning or stress echocardiography.
Please cite this article in press as: Murphy JC, et al. Cost Benefit for Assessment of Intermediate Coronary Stenosis with Fractional Flow Reserve in Public and Private Sectors in Australia. Heart, Lung and Circulation (2014), http://dx.doi.org/ 10.1016/j.hlc.2014.03.027
HLC 1572 No. of Pages 4
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J.C. Murphy et al.
descending in 30, Circumflex or marginal in 18, left main coronary artery in five, Intermediate in five and vein graft in two. FFR was 0.80 in 37 lesions in 34 patients which resulted in 27 PCI in 25 patients and CABG in 11 patients. In the absence of FFR measurement there would have been 68 ad hoc PCI performed with 17 CABG and 35 patients sent for MIBI or stress echo of whom 10 would have come back for stenting (this data is represented in Figure 1). In the public sector costs incurred were $A480,500, but without FFR this would have been $A626,000 representing a saving of $A145,500. In the private sector costs incurred were $A1668,820 but without FFR this would have been $A2,272,204 a saving of $A603,384.
Discussion In this study we show that contemporary use of FFR measurement in the cardiac catheterisation lab saves money in the public sector and in the private sector. These savings are seen over and above the improved patient care and outcomes which would have occurred with the better triage of patients for revascularisation. This highlights the need for reimbursement for this technology in Australia, whose uptake has been low [4]. Cost-effectiveness studies using FFR have resulted in mixed conclusions. In the FAME study, where all lesions were stented in the control arm while those in the FFR arm had to have FFR 0.80 or less, the strategy was cost-saving in 90% of cases, but this assumes a universal stenting strategy in the absence of FFR [5]. Given the increase in adverse outcomes in this study, universal stenting of lesions with angiographic stenosis > 50% cannot be justified on clinical let alone economic grounds. In contrast, a study from Canada alleged that FFR increased costs as they assumed that intermediate lesions would be left alone to see how they went clinically [6]. However, the authors ignored the costs of repeat procedures in the patients with ongoing symptoms and the cost of clopidogrel. In addition, the results of functional testing prior to angiography were not used in decision-making to perform intervention. Lastly an analysis in the Australian system from Brisbane, which resulted in reduction in revascularisation as occurred in our study, failed to factor in the reduced expenditure involved in further hospital stay, outpatient functional imaging and the added drug cost of clopidogrel [7] which we have included. In our study we have attempted to include all costs unique to each management pathway and to analyse the data from an Australian public and private health perspective. Several limitations of our study should be mentioned. Firstly, the balance of costs relies very heavily on the patient and lesion subset to which it applies. In general, FFR was used by our interventionalists to try to justify avoidance of revascularisation in patients where there was true clinical equipoise and no functional data to direct decision-making, or where a false positive functional test was suspected on the basis of angiography. This economic analysis would
therefore not apply to any angiographic stenosis, and use should be reserved for indeterminate stenosis (50-70%) or stenosis where a false positive non-invasive functional test is suspected. In addition if less stable patients had had functional testing prior to angiography this may have altered our analysis but the main reason for FFR in stable patients was distrust of functional testing. In contrast this paper has not included the cost of clinical events avoided by the use of FFR as suggested by the FAME economic analysis [5] and has ignored hidden costs in the public sector associated with PCI such as salaries, overheads and ancillary costs (as used in previous costings of PCI [8]) as they would not be incurred specifically by one treatment strategy over another. Secondly, while the balance of costs is strongly in favour of FFR in our study this is somewhat dependent on the cost of both pressure wire and stents and the balance of drug-eluting and bare metal stents used. However, as our avoidance of revascularisation was so high in our study with 70% being treated medically after FFR, these costs and ratios would have to alter radically to abrogate the economic benefits of FFR. For example if the percentage of drug-eluting stents reduced to 50% and the cost to $A1600 (as in Victoria) then the savings per patient in the public sector reduce to $A1000. In addition the savings in the public system are to the State system which funds public hospitals and only indirectly to the Federal Government which provides most of the State Government monies. The savings in the private system are both to the Federal Government and to the health funds. In conclusion we have found significant cost savings with our current use of FFR and propose that the wire should be reimbursed as soon as possible to promote better patient care and reduced health expenditure.
References [1] Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van’ t Veer M, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med 2009;360:213–24. [2] De Bruyne B, Pijls NHJ, Kalesan B, Barbato E, Tonino PAL, Piroth Z, et al. Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease. N Engl J Med 2012;367:991–1001. [3] Botman CJ, Schonberger J, Koolen S, Penn O, Botman H, Dib N, et al. Does stenosis severity of native vessels influence bypass graft patency? A prospective fractional flow reserve-guided study. Ann Thorac Surg 2007;83:2093–7. [4] Harper RW, Ko BS. A new algorithm for the management of stable coronary disease incorporating CT coronary angiography and fractional flow reserve: How we can improve outcomes and reduce costs. Med J Aust 2011;194:186–9. [5] Fearon WF, Bornschein B, Tonino PA, Gothe RM, Bruyne BD, Pijls NH, et al. Economic evaluation of fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. Circulation 2010;122:2545–50. [6] Hoole SP, Seddon MD, Poulter RS, Mancini GB, Wood DA, Saw J. Fame comes at a cost: a Canadian analysis of procedural costs in use of pressure wire to guide multivessel percutaneous coronary intervention. Can J Cardiol 2011;27:262. [7] Trivedi S, Aroney CN, Walters DL, Bett JH. Measurement of myocardial fractional flow reserve is a cost-effective way to identify coronary artery lesions of indeterminate severity that warrant revascularisation. Heart Lung Circ 2005;14:239–41. [8] Harper RW, Sampson KD, See PL, Kealey JL, Meredith IT. Costs, charges and revenues for elective coronary angioplasty and stenting: the public versus the private system. Med J Aust 2000;173:296–300.
Please cite this article in press as: Murphy JC, et al. Cost Benefit for Assessment of Intermediate Coronary Stenosis with Fractional Flow Reserve in Public and Private Sectors in Australia. Heart, Lung and Circulation (2014), http://dx.doi.org/ 10.1016/j.hlc.2014.03.027
Heart, Lung and Circulation (2014) xx, 1–4 1443-9506/04/$36.00 http://dx.doi.org/10.1016/j.hlc.2014.03.027
ORIGINAL ARTICLE
Cost Benefit for Assessment of Intermediate Coronary Stenosis with Fractional Flow Reserve in Public and Private Sectors in Australia J.C. Murphy, MBBCh PhD a, P.S. Hansen, MBBS FRACP PhD b, R. Bhindi, MBBS PhD FRACP b, G.A. Figtree, MBBS PhD FRACP b, G.I.C. Nelson, MBBS FRACP PhD b, M.R. Ward, MBBS(Hons) FRACP PhD b* a
Royal North Shore Hospital University of Sydney
b
Received 10 April 2013; received in revised form 28 November 2013; accepted 22 March 2014; online published-ahead-of-print xxx
Background
Fractional Flow Reserve (FFR) is a proven technology for guiding percutaneous coronary intervention (PCI), but is not reimbursed despite the fact that it is frequently used to defer PCI.
Methods
Costs incurred with use of FFR were compared in both the public and private sectors with the costs that would have been incurred if the technology was not available using consecutive cases over a two year period in a public teaching hospital and its co-located private hospital.
Results
FFR was performed on 143 lesions in 120 patients. FFR was < 0.80 in 37 lesions in 34 patients and 25 underwent PCI while 11 had CABG. It was estimated that without FFR 78 lesions in 70 patients would have had PCI with 17 patients having CABG with 35 additional functional tests. Despite a cost of $A1200 per wire, FFR actually saved money. Mean savings in the public sector were $1200 per patient while in the private sector the savings were $5000 per patient.
Conclusions
FFR use saves money for the Federal Government in the public sector and for the Private Health Funds in the private sector. These financial benefits are seen in addition to the improved outcomes seen with this technology.
Keywords
Coronary intervention Fractional flow reserve Cost effectiveness Revascularisation Coronary artery bypass grafting
Introduction Fractional Flow Reserve (FFR) (where the functional significance of an indeterminate coronary stenosis is assessed by measuring the pressure drop across the stenosis during maximal hyperaemia) is widely accepted as an important tool in
modern interventional cardiology. When the FFR shows the stenosis is not haemodynamically significant, percutaneous coronary intervention (PCI) results in an excess of adverse outcomes [1], while when the stenosis is haemodynamically significant adverse events are prevented by PCI [2]. FFR can also predict graft occlusion early after CABG [3]. However,
*Corresponding author at: Department of Cardiology, Royal North Shore Hospital, St Leonards NSW 2065, Australia. Fax: +61 2 9906 7807., Email: [email protected] © 2014 Published by Elsevier Inc 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: Murphy JC, et al. Cost Benefit for Assessment of Intermediate Coronary Stenosis with Fractional Flow Reserve in Public and Private Sectors in Australia. Heart, Lung and Circulation (2014), http://dx.doi.org/ 10.1016/j.hlc.2014.03.027
HLC 1572 No. of Pages 4
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J.C. Murphy et al.
use of this technology in Australia has been low [4], hampered by lack of listing on the Medical Benefits Scheme and thus reimbursement by Private Health Funds. In addition, its use in the public sector may have been curtailed by some conflicting evidence on its cost-benefit in other health care systems [5–7]. We sought to define the ‘real world’ costs of treating intermediate coronary stenosis in the presence and absence of FFR assessment by using patients treated in our institution over a two year period using FFR, to compare costs incurred with predicted costs if the technology was not available.
Methods Patients We collected data on two consecutive years of FFR use from January 1st 2010 to December 31st 2011 in the co-located cardiac catheterisation laboratories of the Royal North Shore Hospital and North Shore Private Hospital. The medical records from all patients in whom FFR was performed were examined to determine the clinical setting of FFR use (acute coronary syndrome or stable elective admission), the age and sex of the patient, whether functional non-invasive testing had been performed prior to coronary angiography and its result, FFR performed (lesion site and results) and subsequent revascularisation performed. Where the FFR was < 0.80 and PCI was the chosen form of revascularisation this was performed in the same sitting as FFR. The costs associated with treatment of the patient in the absence of FFR was determined according to the following (based on our practice before the availability of FFR):
1. If the patient had an acute coronary syndrome with a possible culprit lesion being interrogated and the angiographic stenosis was > 50% by quantitative coronary angiography then in the absence of FFR the lesion would be stented during the same procedure. 2. If the patient had an acute coronary syndrome and the lesion being interrogated was a non-culprit lesion, with the culprit already stented then the patient would be sent for outpatient functional imaging (stress sestaMIBI or stress echocardiography). 3. If the patient was clinically stable and prior non-invasive functional imaging had suggested ischaemia in the territory supplied by the lesion under interrogation (or with positive stress ECG and there was only one possible lesion to explain positive test), in the absence of FFR the lesion would be stented. 4. If the patient was clinically stable and functional testing had not been performed then the patient would be sent for stress sestaMIBI or stress echocardiography. 5. Results from functional imaging would reflect the results of the FFR and revascularisation would subsequently be performed according to these results. 6. Stress sestaMIBI and stress echocardiography would be ordered equally often (half each; consistent with the pattern of functional testing in those who had had sestaMIBI or stress echo before angiography in this cohort). 7. Stents in the public sector would be 70% DES, 30% BMS while in the private sector there would be 90% DES and 10% BMS (based on recent trends). 8. Clopidogrel treatment for one year was added after stenting when the patient was clinically stable and had
Table 1a Costs in Private Sector. ITEM
FFR
FFR COST
NO FFR
NO FFR COST
($)
(n)
($)
(n)
($)
38218*
6100
0
0
52
38246/38241*
7280
95
691600
0
0
14000 14420
0 25
0 360500
68 0
952000 0
38246/38306* 38246/38306/38241*
317200
38306/38243*
13150
0
0
10
131500
CABG
19000
11
209000
17
323000
O/N STAY
1259
25
31475
78
98202
DAYSTAY
751
95
71345
52
39052
DES
3750
24
90000
79
296250
BMS
2000
3
6000
8
16000
PW MIBI/SE
1345 600
120 0
159900 0
0 35
0 21000
CLOPIDOGREL
1000
49
49000
78
TOTAL *
COST
1668820
78000 2272204
MBS item numbers attached to theatre fees: 38218 diagnostic angiography, 38246 diagnostic angiography and coronary intervention/FFR, 38241 FFR 38306 stent placement, 38243 coronary invention without diagnostic angiography; CABG coronary artery bypass grafting; O/N overnight; DES drug-eluting stent; BMS bare metal stent; PW pressure wire; MIBI/SE stress sestaMIBI scanning or stress echocardiography.
Please cite this article in press as: Murphy JC, et al. Cost Benefit for Assessment of Intermediate Coronary Stenosis with Fractional Flow Reserve in Public and Private Sectors in Australia. Heart, Lung and Circulation (2014), http://dx.doi.org/ 10.1016/j.hlc.2014.03.027
HLC 1572 No. of Pages 4
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Cost effectiveness of FFR
Table 1b Costs in the public sector. ITEM
PRESSURE WIRE
COST
FFR
FFR COST
NO FFR
NO FFR COST
($)
(n)
($)
(n)
($)
1425
120
169500
0
AD HOC PCI POST FFR
400
25
10000
0
0
AD HOC PCI ALONE
600
0
0
68
40800
PCI ON RETURN
800
0
0
10
8000
O/N STAY
600
25
15000
78
46800
18000
11
198000
17
306000
1800
19
109800
61
109800
600 600
8 0
15600 0
26 35
15600 21000
1000
49
49000
78
CABG DES BMS MIBI/SE CLOPIDOGREL TOTAL
0
78000
480500
626000
PCI percutaneous coronary intervention, FFR fractional flow reserve, CABG coronary artery bypass grafting, DES drug-eluting stent, BMS bare metal stent, MIBI/ SE stress sestaMIBI or stress echocardiography.
not had any other coronary stents within the previous 12 months. 9. After PCI the patient stayed overnight while after FFR alone the patient was discharged the same day.
Costs We have endeavoured to include only those costs which would be unique to either management pathway. The cost of each item is shown in Table 1. In the public sector, costs were estimated by the added cost of each piece of extra equipment (averaged where multiple brands were available) and that of an overnight stay. The cost of FFR immediately after angiography was equivalent to the cost of the wire and the cost of a guiding catheter. Follow-on PCI after FFR was the cost of one pre-dilatation balloon, one post-dilatation balloon, one stent and one inflation device. The cost of PCI when returning after functional testing was the sum of sheath, guiding wire, guiding catheter, one intracoronary wire, one inflation device, one pre-dilatation and one postdilatation balloon and one stent. In the private sector the only equipment billed to the health funds is stents with all other equipment absorbed into the theatre fees. Therefore private sector costs included one stent with the added costs of theatre fees, physician procedural fees and accommodation fees. Theatre fees were those billed by North Shore Private Hospital and proceduralist fees were direct-billing Medibank Private (largest health fund) fees. In both sectors the cost of functional imaging was the average of bulk-billed stress sestaMIBI and stress echo ($A600) while the cost of Clopidogrel treatment for one year was rounded to $1000.
Results One hundred and twenty patients had FFR performed on 143 lesions in our co-located cardiac catheterisation laboratories
over the two-year period. This included 80 males and 40 females with a mean (SD) age of 66.5 (10.2) years. Fifty patents had an acute coronary syndrome (43 with troponin elevation) while 59 had stable coronary disease with 11 having follow-up angiography of non-culprit lesions after STEMI where functional testing was expected to be unreliable (eg paced or LBBB) or was equivocal. Of the 59 patients with stable symptoms 51 had had a functional test prior to angiography while four had coronary computed tomographic angiography (CCTA) alone. The four patients with no functional test or CCTA included one with severe aortic stenosis undergoing assessment for transcutaneous aortic valve implantation and one with symptoms consistent with restenosis (who had FFR positive restenosis). The vessel under interrogation was the Left Anterior Descending or diagonal in 83, Right Coronary Artery or posterior WITH FFR 11 CABG
WITHOUT FFR
5
59 SAP 12 42
25 PCI
84 MED RX
10
12
5
33
4 50 NSTEMI/UAP
9
29
78 PCI
17
10
3
1
1
17 CABG
36 13
3 11 POST MI
5
35 MIBI/SE
25
25 MED RX
Figure 1 Fate of 120 patients with and without FFR according to mode of presentation. CABG coronary artery bypass grafting; PCI percutaneous coronary intervention, MED RX medical therapy; SAP stable angina pectoris; NSTEMI/UAP non-STelevation myocardial infarction/unstable angina pectoris; POST MI post myocardial infarction; MIBI/SE sestaMIBI scanning or stress echocardiography.
Please cite this article in press as: Murphy JC, et al. Cost Benefit for Assessment of Intermediate Coronary Stenosis with Fractional Flow Reserve in Public and Private Sectors in Australia. Heart, Lung and Circulation (2014), http://dx.doi.org/ 10.1016/j.hlc.2014.03.027
HLC 1572 No. of Pages 4
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J.C. Murphy et al.
descending in 30, Circumflex or marginal in 18, left main coronary artery in five, Intermediate in five and vein graft in two. FFR was 0.80 in 37 lesions in 34 patients which resulted in 27 PCI in 25 patients and CABG in 11 patients. In the absence of FFR measurement there would have been 68 ad hoc PCI performed with 17 CABG and 35 patients sent for MIBI or stress echo of whom 10 would have come back for stenting (this data is represented in Figure 1). In the public sector costs incurred were $A480,500, but without FFR this would have been $A626,000 representing a saving of $A145,500. In the private sector costs incurred were $A1668,820 but without FFR this would have been $A2,272,204 a saving of $A603,384.
Discussion In this study we show that contemporary use of FFR measurement in the cardiac catheterisation lab saves money in the public sector and in the private sector. These savings are seen over and above the improved patient care and outcomes which would have occurred with the better triage of patients for revascularisation. This highlights the need for reimbursement for this technology in Australia, whose uptake has been low [4]. Cost-effectiveness studies using FFR have resulted in mixed conclusions. In the FAME study, where all lesions were stented in the control arm while those in the FFR arm had to have FFR 0.80 or less, the strategy was cost-saving in 90% of cases, but this assumes a universal stenting strategy in the absence of FFR [5]. Given the increase in adverse outcomes in this study, universal stenting of lesions with angiographic stenosis > 50% cannot be justified on clinical let alone economic grounds. In contrast, a study from Canada alleged that FFR increased costs as they assumed that intermediate lesions would be left alone to see how they went clinically [6]. However, the authors ignored the costs of repeat procedures in the patients with ongoing symptoms and the cost of clopidogrel. In addition, the results of functional testing prior to angiography were not used in decision-making to perform intervention. Lastly an analysis in the Australian system from Brisbane, which resulted in reduction in revascularisation as occurred in our study, failed to factor in the reduced expenditure involved in further hospital stay, outpatient functional imaging and the added drug cost of clopidogrel [7] which we have included. In our study we have attempted to include all costs unique to each management pathway and to analyse the data from an Australian public and private health perspective. Several limitations of our study should be mentioned. Firstly, the balance of costs relies very heavily on the patient and lesion subset to which it applies. In general, FFR was used by our interventionalists to try to justify avoidance of revascularisation in patients where there was true clinical equipoise and no functional data to direct decision-making, or where a false positive functional test was suspected on the basis of angiography. This economic analysis would
therefore not apply to any angiographic stenosis, and use should be reserved for indeterminate stenosis (50-70%) or stenosis where a false positive non-invasive functional test is suspected. In addition if less stable patients had had functional testing prior to angiography this may have altered our analysis but the main reason for FFR in stable patients was distrust of functional testing. In contrast this paper has not included the cost of clinical events avoided by the use of FFR as suggested by the FAME economic analysis [5] and has ignored hidden costs in the public sector associated with PCI such as salaries, overheads and ancillary costs (as used in previous costings of PCI [8]) as they would not be incurred specifically by one treatment strategy over another. Secondly, while the balance of costs is strongly in favour of FFR in our study this is somewhat dependent on the cost of both pressure wire and stents and the balance of drug-eluting and bare metal stents used. However, as our avoidance of revascularisation was so high in our study with 70% being treated medically after FFR, these costs and ratios would have to alter radically to abrogate the economic benefits of FFR. For example if the percentage of drug-eluting stents reduced to 50% and the cost to $A1600 (as in Victoria) then the savings per patient in the public sector reduce to $A1000. In addition the savings in the public system are to the State system which funds public hospitals and only indirectly to the Federal Government which provides most of the State Government monies. The savings in the private system are both to the Federal Government and to the health funds. In conclusion we have found significant cost savings with our current use of FFR and propose that the wire should be reimbursed as soon as possible to promote better patient care and reduced health expenditure.
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Please cite this article in press as: Murphy JC, et al. Cost Benefit for Assessment of Intermediate Coronary Stenosis with Fractional Flow Reserve in Public and Private Sectors in Australia. Heart, Lung and Circulation (2014), http://dx.doi.org/ 10.1016/j.hlc.2014.03.027
