• Determinants of high device cost in current percutaneous coronary interventions

    Abstract

    Background

    Percutaneous coronary interventions (PCI), especially medical devices, consume large amounts of medical resources. It is important to know which type of lesions requires high device costs among current PCI. The purpose of this study was to investigate the association between lesion characteristics and medical device costs in current PCI.

    Methods

    We identified 593 coronary artery lesions in our PCI database between January 1, 2015 and December 31, 2015. The total PCI cost was calculated for each lesion. The highest quartile (Q1) of total PCI costs was defined as the highest cost group, whereas the other quartiles (Q2, Q3, Q4) were defined as the low-intermediate cost group.

    Results

    The mean PCI cost in the highest cost and low-intermediate cost groups was ¥1,032,943 ± 211,912 and ¥532,547 ± 112,127, respectively. In a multivariate logistic regression analysis, lesion length (10 mm increase: OR 2.93, 95% CI 2.25–3.82, < 0.001), left main lesion (OR 2.96, 95% CI 1.02–8.60, = 0.046), moderate to severe calcification (OR 16.43, 95% CI 7.97–33.88, < 0.001), chronic total occlusion (CTO) (OR 5.83, 95% CI 2.07–16.39, = 0.001), and bifurcation (OR 2.01, 95% CI 1.08–3.75, = 0.027) were significantly associated with the highest cost group.

    Conclusions

    Lesion characteristics including CTO, diffuse long lesion, calcification, and bifurcation were significantly associated with the highest device cost. Non-CTO complex lesions including bifurcation and calcification as well as CTO lesions require higher PCI device costs than non-complex lesions.

    Highlights

     

    •  

      Percutaneous coronary interventions (PCI) consume large amounts of medical resources, especially medical devices.

    •  

      The purpose of this study was to investigate the association between lesion characteristics and device cost in current PCI.

    •  

      Non-CTO complex lesions as well as CTO lesions require higher PCI device cost than non-complex lesions.

     

    Introduction

    Percutaneous coronary interventions (PCI) are widely performed for patients with coronary artery disease. Although PCI were originally restricted to non-complex lesions [  ], current PCI are used for more complex lesions, such as left main coronary artery disease, severe calcified lesions, and chronic total occlusion (CTO). The results of recent clinical trials support PCI for left main coronary artery disease with a low or intermediate SYNTAX score [  ]. Furthermore, the current success rate for CTO PCI has increased up to 80% in the USA as well as in Japan [  ,  ]. Therefore, lesions that were not treated with PCI in 2000s are now frequently managed by PCI.

    On the other hand, PCI, especially medical devices, consume large amounts of medical resources [  ]. Since the cost of medical devices per coronary lesion is closely associated with the total cost for patients with coronary artery disease, it is important to know which type of lesions requires high device costs among current PCI. The purpose of this study was to investigate the association between lesion characteristics and medical device costs in current PCI.

    Methods

    Coronary stenosis

    We identified coronary artery lesions in our PCI database between January 1, 2015 and December 31, 2015. Consecutive lesions that were treated with PCI in our medical center were included in the present study. We excluded lesions when more than two lesions were treated simultaneously. We also excluded unsuccessful PCI cases, because the device cost in an unsuccessful case would not reflect the true device cost if the case was treated successfully. This study was approved by the Institutional Review Board of Saitama Medical Center, Jichi Medical University.

    Angiographic analysis

    Angiograms were reviewed by an experienced cardiologist (KH). Off-line, computer-based software QAngio XA ver.7.3 (MEDIS Imaging Systems, Leiden, Netherland) was used for quantitative coronary angiographic analysis. All study lesions were analyzed based on 11 characteristics (lesion length, eccentricity, proximal bend, lesion angle, border irregularity, calcification, total occlusion <3 months, total occlusion ≥3 months, ostial lesion, bifurcation lesion, and thrombus).

    PCI procedures

    PCI was performed with standard conventional techniques. The choice of components such as guide wire, balloon, and stent was left at the discretion of the interventional cardiologists at our cardiology center. Intravascular ultrasound (IVUS) was routinely used for almost all lesions.

    Total PCI cost

    We calculated the total PCI cost for each lesion. The total PCI cost was defined as the sum of all reimbursement device prices, as previously described [  ]. We included the prices of the guiding catheter, guidewire, balloon catheter, micro catheter, imaging devices, rotational atherectomy devices, bare-metal stent, and drug-eluting stent. However, we did not include procedure fees for PCI, staff fees and catheter laboratory charges. The reimbursement price for each device is strictly set by the Ministry of Health, Labor, and Welfare in Japan. The reimbursement price that was used in the present study is shown in Table 1 

    Table 1
    The reimbursement price for all devices.
    Device typeReimbursement price
    Bare metal stent ¥169,000
    Drug eluting stent ¥261,000
    Guiding catheter ¥16,600
    Balloon catheter (general) ¥67,300
    Balloon catheter (non-slip element) ¥128,000
    Balloon catheter (drug coating) ¥170,000
    Guide wire (for general) ¥17,100
    Guide wire (for complex) ¥20,600
    Micro catheter ¥44,000
    Penetration catheter ¥43,400
    Intravascular ultrasound ¥109,000
    Optical frequency domain imaging ¥145,000
    Rotablator ¥218,000

     

    Statistical analysis

    Data are presented as percentages for categorical variables and the mean ± SD for continuous variables. The total PCI cost was calculated for each lesion. The highest quartile (Q1) of total PCI costs was defined as the highest cost group, whereas the combination of the other quartiles (Q2, Q3, Q4) was defined as the low-intermediate cost group. Continuous variables were compared between the highest cost group and the low-intermediate cost group with an unpaired Student's -test, whereas categorical variables were compared with a χ test. We performed multivariate logistic regression analysis to find determinants of the highest cost; the highest cost group was used as a dependent variable. Variables that showed a significant difference in comparisons between the highest cost group and low-intermediate cost group were used as independent variables. Because PCI cost is significantly higher in CTO PCI than in non-CTO PCI [  ,  ], we also performed comparisons between the highest cost and low-intermediate cost groups and multivariate logistic regression analysis after excluding CTO cases. The odds ratios (OR) and the 95% confidence intervals (95% CI) were calculated. We also developed a multiple regression analysis. In this model, the device cost was used as a dependent variable. The beta coefficient for each independent variable was calculated. The analyses were performed with statistical software, SPSS 24/Windows (SPSS, Chicago, IL). A value <0.05 was considered significant.

    Results

    Between January 1, 2015 and December 31, 2015, there were 636 lesions treated with PCI. We excluded 13 lesions (11 CTO lesions and 2 non-CTO lesions) for which PCI was unsuccessful. We excluded an additional 30 lesions, because multiple lesions were treated simultaneously. Thus, a total of 593 lesions were included in the analysis ( Fig. 1 ). The mean PCI cost was ¥657,435 ± 259,915 ( Fig. 2 ). Since the cutoff value for the highest quartile (Q1) of total PCI costs was ¥798,001, the lesions that required ≥¥798,001 were assigned to the highest cost group, whereas the other lesions (Q2–Q4) were assigned to the low-intermediate cost group. 

    Fig. 1
    Study flow chart.
    Abbreviations: PCI, percutaneous coronary interventions; CTO, chronic total occlusion.
    Fig. 2
    Overall distribution of device costs.

     

    The lesion and procedure characteristics are shown in Table 2 . The mean PCI cost in the highest cost group and low-intermediate cost group was ¥1,032,943 ± 211,912 and ¥532,547 ± 112,127, respectively. The prevalence of acute coronary syndrome (ACS) was significantly lower in the highest cost group (23.0%) than in the low-intermediate cost group (40.4%) ( < 0.001). A radial approach was less frequently used in the highest cost group (10.8%) than in the low-intermediate cost group (50.6%), whereas a femoral approach was predominantly used in the highest cost group (84.5%). 

    Table 2
    The lesion characteristics between the highest cost and the low-intermediate cost groups including CTO lesions.
     All 
    (n = 593)
    Highest cost group 
    (n = 148)
    Low-intermediate cost group 
    (n = 445)
    value
    Patient characteristics
    Age, y 70.2 ± 9.9 70.9 ± 10.6 69.9 ± 9.7 0.159
    Male sex, n (%) 445 (75.0) 121 (81.1) 335 (75.3) 0.148
     
    Lesion and procedure characteristics
    Stenosis site       <0.001
    Right coronary artery, n (%) 190 (32.0) 42 (28.4) 148 (33.3)  
    Left main trunk, n (%) 32 (5.4) 20 (13.5) 12 (2.7)  
    Left anterior descending artery, n (%) 272 (45.9) 72 (48.6) 200 (45.0)  
    Left circumflex artery, n (%) 93 (15.7) 13 (8.8) 80 (18.0)  
    Bypass graft, n (%) 6 (1.0) 1 (0.7) 5 (1.1)  
    Reason for PCI       <0.001
    PCI to the culprit of ACS, n (%) 214 (36.1) 34 (23.0) 180 (40.4)  
    PCI to the stable lesions, n (%) 379 (63.9) 114 (77.0) 265 (59.6)  
    Approach site       <0.001
    Radial, n (%) 241 (40.6) 16 (10.8) 225 (50.6)  
    Brachial, n (%) 31 (5.2) 7 (4.7) 24 (5.4)  
    Femoral, n (%) 321 (54.1) 125 (84.5) 196 (44.0)  
    Lesion length, mm 22.2 ± 16.6 39.2 ± 21.0 16.5 ± 9.7 <0.001
    Eccentricity, n (%) 78 (13.2) 15 (10.1) 63 (14.2) 0.210
    Proximal bend       <0.001
    Mild (120–180°), n (%) 448 (75.5) 131 (88.5) 317 (71.2)  
    Moderate (90–120°), n (%) 129 (21.8) 15 (10.1) 114 (25.6)  
    Severe (<90°), n (%) 16 (2.7) 2 (1.4) 14 (3.1)  
    Lesion angle       <0.001
    Mild (135–180°), n (%) 500 (84.3) 103 (69.6) 397 (89.2)  
    Moderate (90–135°), n (%) 75 (12.7) 34 (23.0) 41 (9.2)  
    Severe (<90°), n (%) 18 (3.0) 11 (7.4) 7 (1.6)  
    Border irregularity, n (%) 19 (3.2) 5 (3.4) 14 (3.1) 0.889
    Moderate to severe calcification, n (%) 95 (16.0) 71 (48.0) 24 (5.4) <0.001
    Total occlusion <3 months, n (%) 80 (13.5) 14 (9.5) 66 (14.8) 0.097
    Total occlusion ≥3 months, n (%) 39 (6.6) 29 (19.6) 10 (2.2) <0.001
    Ostial lesion, n (%) 63 (10.6) 27 (18.2) 36 (8.1) 0.001
    Bifurcation lesion, n (%) 171 (28.8) 75 (50.7) 96 (21.6) <0.001
    Thrombus, n (%) 34 (5.7) 4 (2.7) 30 (6.7) 0.067
    Abbreviations: PCI, percutaneous coronary interventions; ACS, acute coronary syndrome.

     

    The results of the multivariate logistic regression analysis for the highest cost group (Q1) are shown in Table 3 . Lesion length (10 mm increase: OR 2.93, 95% CI 2.25–3.82, < 0.001), left main lesion (OR 2.96, 95% CI 1.02–8.60, = 0.046), femoral approach (OR 2.60, 95% CI 1.30–5.20, = 0.007), moderate to severe calcification (OR 16.43, 95% CI 7.97–33.88, < 0.001), CTO (OR 5.83, 95% CI 2.07–16.39, = 0.001), and bifurcation (OR 2.01, 95% CI 1.08–3.75, = 0.027) were significantly associated with the highest cost group, while moderate to severe lesion angle (OR 0.33, 95% CI 0.13–0.83, = 0.019) was inversely associated with the highest cost group. Because CTO, diffuse long lesion, calcification, and bifurcation lesions were significantly associated with the highest cost group, we added the direct comparisons of total device cost among CTO vs. non-CTO, diffuse long lesions vs. non-diffuse long lesions, moderate to severe calcified lesions vs. non-calcified lesions, and bifurcation lesions vs. non-bifurcation lesions in Fig. 3 . The results of the multiple regression analysis are shown in Table 4 

    Table 3
    Multivariate logistic regression analysis for the highest cost including CTO.
    Independent variablesDependent variable: Highest cost
    Odds ratio95% confidence intervalvalue
    Lesion length (10 mm increase) 2.93 2.25–3.82 <0.001
    Left main lesion 2.96 1.02–8.60 0.046
    Indication (stable disease) 0.88 0.45–1.72 0.706
    Femoral approach 2.60 1.30–5.20 0.007
    Moderate to severe proximal bend 0.54 0.24–1.24 0.146
    Moderate to severe lesion angle 0.33 0.13–0.83 0.019
    Moderate to severe calcification 16.43 7.97–33.88 <0.001
    CTO lesion 5.83 2.07–16.39 0.001
    Ostial lesion 1.68 0.68–4.11 0.259
    Bifurcation lesion 2.01 1.08–3.75 0.027
    Abbreviations: CTO, chronic total occlusion.
    Fig. 3
    Direct comparison of total device costs for CTO vs. non-CTO, diffuse long lesions vs. non-diffuse long lesions, moderate to severe calcified lesions vs. non-calcified lesions, and bifurcation lesions vs. non-bifurcation lesions. Panel A: Total device cost was significantly greater for CTO lesions (¥959,303 ± 272,721) than for non-CTO lesions (¥636,184 ± 245,623) ( < 0.001). Panel B: Total device cost was significantly greater for diffuse long (≥20 mm) lesions (¥834,861 ± 291,013) than for non-diffuse long lesions (¥544,216 ± 154,368) ( < 0.001). Panel C: Total device cost was significantly greater for moderate to severe calcified lesions (¥989,189 ± 265,949) than for non-calcified lesions (¥594,148 ± 205,038) ( < 0.001). Panel D: Total device cost was significantly greater for bifurcation lesions (¥782,697 ± 265,266) than for non-bifurcation lesions (¥606,677 ± 240,054) ( < 0.001).
    Table 4
    Multiple regression model to predict the higher costs.
    R square = 0.702 ( < 0.001)Beta coefficientvalue
    Left main trunk stenosis (vs. others) 0.057 0.021
    PCI to the stable lesions (vs. ACS) −0.026 0.298
    Femoral approach (vs. others) 0.079 0.002
    Lesion length (mm) 0.53 <0.001
    Eccentric lesion (vs. non-eccentric) 0.042 0.07
    Moderate to severe proximal bend (<120°) (vs. mild) −0.042 0.079
    Moderate to severe lesion angle (<135°) (vs. mild) −0.061 0.024
    Border irregular lesion (vs. smooth lesion) −0.044 0.06
    Moderate to severe calcification (vs. mild or none) 0.398 <0.001
    Total occlusion ≥3 months (vs. others) 0.146 <0.001
    Ostial lesion (vs. others) 0.064 0.008
    Bifurcation lesion (vs. others) 0.097 <0.001
    Thrombus, n (%) −0.005 0.844

     

    From 593 lesions, we excluded 39 CTO lesions to investigate determinants of the highest cost without CTO, which are known to be associated with high cost [  ,  ] ( Fig. 1 ). The mean cost of non-CTO 554 lesions was 636,184 ± 245,623. Since the cutoff value for the highest quartile (Q1) of total PCI costs was ¥756,101, the lesions that required ≥¥756,101 were assigned to the highest cost group (Q1), whereas the other lesions (Q2–Q4) were assigned to the low-intermediate cost group. The lesion and procedure characteristics are shown in Table 5 

    Table 5
    The lesion characteristics between the highest cost and the low-intermediate cost groups excluding CTO lesions.
     All 
    (n = 554)
    Highest cost group 
    (n = 134)
    Low-intermediate cost group 
    (n = 420)
    value
    Patient characteristics
    Age, y 70.6 ± 9.8 72.5 ± 10.1 70.1 ± 9.7 0.003
    Male sex, n (%) 422 (76.2) 107 (79.9) 315 (75.0) 0.251
     
    Lesion and procedure characteristics
    Stenosis site       <0.001
    Right coronary artery, n (%) 172 (31.0) 30 (22.4) 142 (33.8)  
    Left main trunk, n (%) 29 (5.2) 19 (14.2) 10 (2.4)  
    Left anterior descending artery, n (%) 261 (47.1) 75 (56.0) 186 (44.3)  
    Left circumflex artery, n (%) 86 (15.5) 9 (6.7) 77 (18.3)  
    Bypass graft, n (%) 6 (1.1) 1 (0.7) 5 (1.2)  
    Reason for PCI       0.001
    PCI to the culprit of ACS, n (%) 214 (38.6) 35 (26.1) 179 (42.6)  
    PCI to the stable lesions, n (%) 340 (61.4) 99 (73.9) 241 (57.4)  
    Approach site       <0.001
    Radial, n (%) 240 (43.3) 17 (12.7) 223 (53.1)  
    Brachial, n (%) 31 (5.6) 9 (6.7) 22 (5.2)  
    Femoral, n (%) 283 (51.1) 108 (80.6) 175 (41.7)  
    Lesion length, mm 20.5 ± 14.5 33.9 ± 18.6 16.3 ± 9.7 <0.001
    Eccentricity, n (%) 77 (13.9) 17 (12.7) 60 (14.3) 0.641
    Proximal bend       <0.001
    Mild (120–180°), n (%) 419 (75.6) 122 (91.0) 297 (70.7)  
    Moderate (90–120°), n (%) 120 (21.7) 10 (7.5) 110 (26.2)  
    Severe (<90°), n (%) 15 (2.7) 2 (1.5) 13 (3.1)  
    Lesion angle       <0.001
    Mild (135–180°), n (%) 478 (86.3) 102 (76.1) 376 (89.5)  
    Moderate (90–135°), n (%) 65 (11.7) 27 (20.1) 38 (9.0)  
    Severe (<90°), n (%) 11 (2.0) 5 (3.7) 6 (1.4)  
    Border irregularity, n (%) 17 (3.1) 3 (2.2) 14 (3.3) 0.522
    Moderate to severe calcification, n (%) 94 (17.0) 81 (60.4) 13 (3.1) <0.001
    Total occlusion <3 months, n (%) 80 (14.4) 14 (10.4) 66 (15.7) 0.131
    Ostial lesion, n (%) 59 (10.6) 28 (20.9) 31 (7.4) <0.001
    Bifurcation lesion, n (%) 158 (28.5) 73 (54.5) 85 (20.2) <0.001
    Thrombus, n (%) 34 (6.1) 4 (3.0) 30 (7.1) 0.081

     

    The mean PCI costs in the highest cost and low-intermediate cost groups were ¥996,793 ± 213,277 and ¥521,133 ± 101,637, respectively. The results of the multivariate logistic regression analysis for the highest cost group (Q1) are shown in Table 6 . Lesion length (10 mm increase: OR 2.70, 95% CI 2.04–3.56, < 0.001), femoral approach (OR 2.56, 95% CI 1.29–5.06, = 0.007), moderate to severe calcification (OR 32.02, 95% CI 14.19–72.29, < 0.001), and bifurcation (OR 2.56, 95% CI 1.31–5.00, = 0.006) were significantly associated with the highest cost group. 

    Table 6
    Multivariate logistic regression analysis for the highest cost excluding CTO.
    Independent variablesDependent variable: Highest cost
    Odds ratio95% confidence intervalvalue
    Age (1 year increase) 1.02 0.98–1.05 0.334
    Lesion length (10 mm increase) 2.70 2.04–3.56 <0.001
    Left main lesion 2.19 0.69–6.99 0.185
    Indication (stable disease) 1.21 0.62–2.35 0.575
    Femoral approach 2.56 1.29–5.06 0.007
    Moderate to severe proximal bend 0.52 0.21–1.29 0.157
    Moderate to severe lesion angle 0.35 0.12–0.99 0.047
    Moderate to severe calcification 32.02 14.19–72.29 <0.001
    Ostial lesions 2.37 0.94–5.98 0.069
    Bifurcation lesions 2.56 1.31–5.00 0.006

     

    Discussion

    We investigated the association between the PCI device cost and lesion characteristics in 593 lesions including CTO and in 554 lesions excluding CTO. Lesion characteristics including diffuse long lesion, calcification, bifurcation, especially left main coronary artery disease, and CTO were significantly associated with the highest device cost. The association between the highest device cost and lesion characteristics such as diffuse long lesion, calcification and bifurcation remained significant even after excluding CTO lesions. Our results suggest that non-CTO complex lesions including calcification as well as CTO lesions require higher PCI device costs than non-complex lesions.

    Penetration of CTO PCI is still significantly less than non-CTO PCI [  ,  ], partly because of high costs and low success rates [  ,  ,  ]. The present study also showed that the highest device cost was significantly associated with CTO PCI. Although a large UK registry including 14,439 CTO PCI showed a strong association between successful CTO PCI and overall mortality [  ], some registries could not show a benefit of CTO PCI [  ]. Therefore, the benefit of CTO PCI has not been established. When we consider an indication for CTO PCI, we should take into account the high device cost as well as the overall clinical benefit.

    The main reason why diffuse long lesions required the highest cost would be that multiple drug-eluting stent (DES) tends to be used for diffuse long lesions. Because DES is the most expensive device among current PCI, the number of DES used in a PCI is more closely associated with the total device cost than the number of guidewires or balloons. As the longest length of current DES in Japan is 38 mm, a diffuse long lesion >38 mm requires at least 2 DES. On the other hand, although the device cost is more expensive for DES than bare-metal stent (BMS) [  ], a recent meta-analysis revealed that second-generation or newer DES were less costly than BMS, because of less long-term adverse events with DES than with BMS [  ,  ]. Moreover, we recently showed better mid-term clinical outcomes in complete full-metal jacket strategy than in incomplete full-metal jacket strategy for diffuse long right coronary artery lesions [  ]. We should try to reduce the number of DES for diffuse long lesions without compromising the long-term clinical benefits.

    Bifurcation lesions, particularly left main bifurcation lesions, require complex techniques and additional devices such as guidewires for the side branch, double lumen catheters for re-cross via stent strut, and balloons for the kissing balloon technique or proximal optimization technique. We preferred the single stent technique rather than the 2 stent technique unless the circumflex artery had a severe flow disturbance, because of concern for stent thrombosis with the 2 stent technique [  ]. Furthermore, complex bifurcation treatment requires imaging devices, such as intravascular ultrasound or optical coherent tomography [  ,  ].

    A severe calcified lesion might require a rotational atherectomy (RA) system, including Rotablator (Boston Scientific, Natick, MA, USA) and RotaWire (Boston Scientific) [  ,  ]. Since stent delivery could be difficult in the case of severe calcified lesions, additional guidewires for the buddy wire technique [  ] or penetration catheters such as GuideLiner (Vascular Solutions, Minneapolis, MN, USA) might be used. Furthermore, direct coronary stenting without antecedent balloon dilatation, which should reduce the device costs, is rarely indicated for severe calcified lesions [  ]. A calcified lesion would require pre-dilatation devices, even when the RA is not indicated.

    Study limitations

    Because this study was a single-center, retrospective study, there was a risk of patient selection bias. Another bias is operator bias, because this study represents the clinical practice of interventional cardiologists at a single center. We examined total device cost, but did not include medication cost or the salary of the staff. Finally, the total PCI cost was calculated by the reimbursement price set by the Ministry of Health, Labor, and Welfare in Japan, which may not apply to other health care systems. Indeed, we previously analyzed the association between the total device cost and lesion characteristics with different prices, such as drug-eluting stent, ¥345,000 (the present study used ¥261,000), bare-metal stent, ¥230,000 (the present study used ¥169,000), and balloon, ¥100,000 (the present study used ¥67,300) [  ].

    Conclusions

    Lesion characteristics including CTO, diffuse long lesion, calcification, and bifurcation were significantly associated with the highest device costs. Non-CTO complex lesions including bifurcation and calcification as well as CTO lesions require higher PCI device costs than non-complex lesions. It will be important for interventional cardiologists to be aware of the association between lesion characteristics and device costs, because medical resources, including the healthcare expenditure of the national budget, are limited.

    Author bio

    Cardiovascular Revascularization Medicine, 2018-07-01, Volume 19, Issue 5, Pages 607-612, Copyright © 2017

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