A cost effectiveness analysis of dialysis graft thrombosis treatment Yen-Ni Hung1, Po-Jen Ko2, Shiao-Chi Wu 3 1 Institute of Public Health, National Yang-Ming University 2 Division of Thoracic and Cardiovascular Surgery, Chang-Gung Memorial Hospital 3 Institute of Health and Welfare Policy, National Yang-Ming University Address correspondence to: Shiao-Chi Wu, No. 155, Sec. 2, Li-Nong St., Taipei 112, Taiwan 1 Abstract Objectives. To evaluate the necessity and effectiveness of different adjunctive therapies used with dialysis graft surgical thrombectomy.Method.We reviewed the records of 590 consecutive surgical dialysis graft thrombectomies performed in a medical center between Aug. 2001 and Aug. 2003. All cases underwent Fogarty thrombecotmies and were classified into four groups: ONLY group, those receiving surgical thrombectomies using Fogarty thrombectomy catheter alone (300 cases); ANGIO group, those receiving thrombectomies plus intraoperative angioplasties of graft outlets (110 cases); REVS group, those receiving thrombectomies plus graft outlet surgical revisions (126 cases) and SEQL group, those receiving thrombectomies plus sequential balloon angioplasties, over separate sessions (54 cases). Age, gender, graft age, co-morbidity and primary patency of the graft were also reviewed. Cost of each group was determined by the average time, professional labor, and materials used complete all the procedures. Results. Patient in all four groups had similar demographic characteristics and comorbidities (p>0.05). The mean primary patency of four groups are 1.99±4.02, 7.21±7.61, 8.35±9.53, 7.26±6.99 (months), respectively. The effectiveness (primary patency period ) of ONLY group was statistically inferior to that of the other three groups. Although the methods used to treat graft outlet stenosis in ANGIO, REVS, and SEQL groups were found to be equally effective, REVS group was found to be the most cost effective ( 2.76-2.94 USD/per patency day , with different salary level) ,the second cost effective was ONLY group (2.81-3.14 USD/per patency day) ,the third was group ANGIO group (3.13-3.27 USD/per patency daty) and SEQL group is the most expensive 3.16-3.37 USD/per patency day). Conclusion.Although cost-effectiveness of thrombectomy alone (ONLY group) was found to be similar to that of REVS group and cheaper than the modalities used for ANGIO and SEQL groups, it result in much more inferior outcome. Based on our findings, thrombectomy plus graft outlet surgical revision had the best primary patency and was most cost-effective. However, from patients’ aspect, it will be more covenient and less painstaking to be treated for all the medical problems surrounding graft outlet stenosis at one time. Considering the invasiveness, procedure time and the effectiveness of the procedures, intraoperative angioplasty of graft outlet is the most reasonable adjunct treatment of graft outlet stenosis associated with trombectomies. Key words: cost-effecctiveness analysis; vascular access; thrombectomy 2 Introduction The incidence rate of end stage renal disease(ESRD) of Taiwan is the highest in the world (384 persons/per million /per year), and the prevalence rate is the second highest(1,631/per million)(USRDS, 2006), just next to Japan.Care of patients with ESRD is resoruce intense, according to National Health Insurance statistics, ESRD patients spend 5.86% of total expenditure(Department of Health, 2005). About 93% of ESRD patients in Taiwan are under Hemodialysis(HD)(USRDS, 2006). Patient who choose HD need vascular access before initiation of dialysis.They may choose native arteiovenous fistula (AVF), a synthetic graft, or central venous catheter. In Taiwan, many choosing synthetic grafts for vascular access. A functional and patent dialysis access can ensure the effectiveness of renal replacement therapy. Neglect of dialysis access monitor and shortness of effective care may lead to complications such as dialysis access thrombosis, stenosis, infection, aneurysm, rupture or pseudoaneurysm and in turns give to large amount of extra medical expenses(Hakim & Himmelfarb, 1998). According to the literatures, some15.7~25% of admissions in dialysis patients are due to dialysis access related complications (Feldman, Kobrin, & Wasserstein, 1996; Hakim & Himmelfarb, 1998; Manns et al., 2005). The strategy of clinical intervention correlates highly to the quality of dialysis access care(Arnold, 2000; Beathard & Litchfield, 2004; Lee et al., 2002; Manns et al., 2005; Pisoni et al., 2002; Young et al., 2002). Different strategies of clinical intervention to cope with the complications may lead to different cost of medical care. To find a cost efficient strategy of treatment when coping with complications of dialysis access is so important for the payers, institutions and the government. 3 Thrombosis is a major cause dialysis graft failure. Therefore, surgical thrombectomy is often used to treat dialysis graft failure in the medical center. However, more than 85% of the cases of dialysis graft thrombosis are caused by graft outlet stenosis(Aruny et al., 1999; Turmel-Rodrigues et al., 2000). If the underlying strictures of access is treated when doing the thrombectomy procedure, the patency of the access may be enhanced significantly(Besarab, Sullivan, Ross, & Moritz, 1995; "III. NKF-K/DOQI Clinical Practice Guidelines for Vascular Access: update 2000," 2001; Sands & Miranda, 1995; Turmel-Rodrigues et al., 2000). Our institution started adopting several different adjuct treatment modalities manage this problem since 2001. These adjunct theapies include intraoperative angioplasty of graft outlet, graft outlet surgical revision, and sequential balloon angioplasty done over separate sessions. This study evaluates the necessity and effectiveness of different adjunctive therapies used with dialysis graft surgical thrombectomy. Methods Setting The institution is a 2500 beds university affiliated teaching hospital. All cases of dialysis graft thrombosis treated in the institution are by vascular surgeons section using Fogarty thrombecotmies. Four vascular surgeons are responsible for the surgical care of dialysis access problems. Since this is a referred center, most of the patients treated were receiving dialysis therapy in the outside institution. Data collection Inclusion criteriae are all cases dialysis graft thrombectomy done in the institution. However, only one procedure (the fisrt one) of one patient during the study period were selected to be inculded. Procedures done under general anesthesia were excluded from the study. A senior vascular surgeon were responsible for 4 reviewing the medical records of 590 qualified surgical dialysis graft thrombectomies between 2001 and 2003. All these enrolled cases are classified into 4 groups according to the type of treatments. The variables regarding demographic data, medical condition and outcome (primary patency; time from dialysis access thrombectomy procedure to first intervention or occlusion.) were collected from chart and carefully reviewed. The medical expense for each group were calculated according to standard costs. Grouping All the dialysis graft thrombosis were treated by surgical thrombectomy in standard fashion to remove the thrombosis. According to the adjuvant therapy, the enrolled cases were classified into 4 groups. Surgical thrombectomy group(ONLY group), those receiving surgical thrombectomies using Fogarty thrombectomy catheter alone (300 cases); intraprocedure angioplasty group (ANGIO group), those receiving thrombectomies plus intraoperative angioplasties of graft outlets (110 cases); surgical revision group (REVS group), those receiving thrombectomies plus graft outlet surgical revisions (126 cases) and sequential balloon group (SEQL group), those receiving thrombectomies plus sequential balloon angioplasties, over separate sessions (54 cases). Evaluation of effectiveness and cost Effectiveness of treatment is measured in terms of duration of primary patency(months). We took the perspective of the health care provider and included ONLY group direct health care related cost. Societal costs were excluded. Direct cost include labor and material. Different treatment involved different type of professional labors and took different time to complete all medical procedures. Labor cost of each group was 5 determined by the average time of procedures , average salary of different type of professional labor, and materials used. The cost effectiveness of each group were examined in terms of the cost effectiveness ration (CE ratio), which is in this study, the total cost divided by the patency duration. The lower the CE ratio, the less cost needed to keep the graft open for a certain duration. Statistial analysis Demographic characteristics and comorbidities of four groups were tested using chi square and one-way ANOVA. Descriptive statistics were used to compare the primary patecy of four groups. Differences resulting in p< 0.05 were considered significant. The statistical analyses were perfomed using SPSS 14.0 for Windows. The CE ratios of 4 groups were calculated and analysed, too. Results The four patient groups exhibited similar demographic characteristics and comorbidities. (p>0.05)(Table 1) except for the graft age and history of previous thrombecomy. The graft age of ANGIO group is the oldest (22.19) and that of ONLY group is the youngest (13.28). Similarly, the rate of positive previous thrombectomy history is the highest among 4 groups and that of ONLY group is the lowest. Mean primary patency after the thrombectomy procedure in groups A, B, C and D was 1.99(SD, 4.02), 7.21(SD, 7.61), 8.35(SD, 9.53) and 7.26(SD, 6.99) months, respectively. The effectiveness in terms of primary patency period of ONLY group was statistically inferior to that of the other three groups. And the methods used to treat graft outlet stenosis in ANGIO, REVS and SEQL group were found to be equally 6 effective. The total cost per treatment of ONLY group (surgical thrombectomy ONLY group without any additional cost and time spent for adjuvant therapy) is the lowest (168.0-187.5 US dollars). While the total cost of REVS group, thrombectomy followed by surgical revision of graft, is the highest (691.9-737.5 US dollars). The CE ratio of 4 groups was 2.81-3.14, 3.13-3.27, 2.76-2.94 and 3.16-3.37 (dollars/day) respectively. That is, when we take into consideration the result of each treatment in terms of primary patency, we found that REVS group is the most cost-effective. It took ONLY group 2.76-2.94 dollars in terms of procedure cost to maintain per patency day. 7 Discussion Dialysis graft failure in hemodialysis patients is a common clinical problem encountered by vascular surgeons. Venous stenosis is known to be the most common contributing cause of thrombosis in dialysis grafts. According to K/DOQI guidelines for vascular access,("Clinical practice guidelines for vascular access," 2006) intraprocedure image study during thrombectomy of dialysis grafts should be performed to detect any anatomic stenotic lesion. Although numerous of papers had stated that address the underlying graft outlet stenosis is pertinent to the primary patency of dialysis graft thrombectomy, to save procedure time and expense, many surgeons in Taiwan still treat the graft thrombosis with ONLY group surgical thrombectomy without any adjuvant treatment to the underlying lesion. Different treatment modalities for preventing graft outlet stenosis have been proposed to enhance the results of thrombectomy. Surgical revision (patch angioplasty or jump graft revision) has long been considered an effective, reliable and straightforward way of surgically treating the outlet stricture of thrombosed graft. (Etheredge, Haid, Maeser, Sicard, & Anderson, 1983; Schwartz, McBrayer, Sloan, Meneses, & Ennis, 1995; Wellington, 1983) Transuluminal balloon angioplasty has also been used for treating underlying dialysis graft stenosis with satisfactory results. Angioplasty treatment can be performed in a combined fashion (Anain, Shenoy, O'Brien-Irr, Harris, & Dryjski, 2001; Ko, Liu, Hsieh, Chu, & Lin, 2003) during thrombectomy or in a separate session after the surgery.(Maya & Allon, 2006; McCutcheon, Weatherford, Maxwell, Hamann, & Stiles, 2003; Smith, Cragg, Castaneda, & Hunter, 1989) Some reports suggest that surgical revision is superior to transluminal balloon angioplasty in terms of long term patency in treating graft outlet lesions.(Brooks, Sigley, May, & Mack, 1987; Huber, Buhler, & Seeger, 2004) 8 Conversely, other reports indicate that angioplasty results are not inferior to those of revision.(Bitar, Yang, & Badosa, 1997; McCutcheon et al., 2003) Other newly developed endovascular methods such as stenting with nitinal stents or covered stents have shown promising results and may offer effective alternative adjuvant therapies (Lombardi, Dougherty, Veitia, Somal, & Calligaro, 2002; Naoum, Irwin, & Hunter, 2006; Sreenarasimhaiah, Margassery, Martin, & Bander, 2005). This study analyzed 4 different type of practice of graft thrombosis treatment. We found that, in terms of effectiveness, ONLY group (surgical thrombectomy ONLY group) yielded the worst results. This outcome again confirms that surgical thrombectomy alone is inadequate for treating thrombosed dialysis grafts. Adjuvant therapy is pertinent to the effectiveness of dialysis declotting procedure. ANGIO, REVS and SEQL groups yielded similar primary patency rates statistically. This observation suggests that adjuvant therapies for treating the underlying stenosis produce similar results. Cost of human resources is the major part of medical expense in the dialysis graft thrombosis treatments. According to our study, the total cost per procedure of ONLY group is the least expensive among 4 groups. It was obviously that surgical thrombectomy ONLY group yields the lowest cost per every procedure. Unfortunately, according to our study and the literatures, the result of pure surgical thrombectomy does not last long. The primary patency of ONLY group was inferior to all the other 3 group significantly. ANGIO, REVS and SEQL groups yields the similar primary patency. However, in terms of CE ratio, REVS group (adjuvant therapy with surgical revision) was the most cost-effective group. (Lowest CE ratio). It seems that with the adjuvant treatment of revision, although the operation wound is bigger and the operation time is longer, the treatment can maintain the graft patent at lowest cost. 9 The opportunity cost, including loss of work days, cost of traveling…etc, was not taken into consideration in this review. The treatment of graft stenosis was performed by interventionist in a different session and venue \ following the surgical thrombectomy. Thus from the view point of the patient, the fashion of treatment in SEQL group increase the commute time and waiting time. In spite of the similar effectiveness of treatment (primary patency) and CEratio, we think that the treatment of SEQL group is more inconvenient for the patients and medical personnel. Both ANGIO and REVS groups yield similar patency rate and reasonable CE ratio in this review. Although the surgical revision needs a bigger wound and more procedure time, the low cost may offset the shortcomings of invasiveness. Surgeons may choose the type of adjuvant procedure based on their techniques and preference. The true cost of procedure includes direct and indirect costs, such as operation room, equipment and other supplies. Owing to the difficulty in acquiring the exact amount of indirect expense of procedure, the indirect cost was not calculated and analyzed in the review. This may lead to the underestimation of cost in this review; especially in SEQL group (the procedure was split into 2 parts and held in separate venues). The total procedure time of REVS and SEQL groups were similar, considering the CE ratio of 2 groups, REVS group seems better than SEQL group in terms of cost-effectiveness. Comparing ANGIO and REVS group, although the CE ratio of REVS group is better than group, the procedure time of revision group was longer (25 more minutes per procedure) than REVS group. In addition, balloon angioplasty as an adjuvant therapy decreased the invasiveness (degree of pain, length of wound…etc) in contrast to the revision group. Thus, choosing the method of REVS group (concomitant balloon angioplasty) to treat the dialysis graft outlet thrombosis during thrombectomy procedure will be a reasonable choice. As for the inferiority of primary patency in 10 ONLY group, We don’t suggest surgical thrombectomy ONLY group to treat the graft thrombosis. From the view point of government or health insurance institutions, the treatment with relative low CE ratio should be encouraged. Not ONLY group we can control the medical expense on dialysis graft thrombectomy, but also can enhance the quality of care in dialysis graft problems. Conclusion Although cost-effectiveness of thrombectomy alone (ONLY group) was found to be similar to that of REVS group and cheaper than the modalities used for ANGIO groups and SEQL, it result in much more inferior outcome. Based on our findings, thrombectomy plus graft outlet surgical revision (REVS group) had the best primary patency and was most cost-effective. However, from patients’ aspect, it will be more covenient and less painstaking to be treated for all the medical problems surrounding graft outlet stenosis at one time. Considering the invasiveness, procedure time and the effectiveness of the procedures, intraoperative angioplasty of graft outlet is the most reasonable adjunct treatment of graft outlet stenosis associated with trombectomies. 11 Talbe 1 Demographic data and risk factors of 4 groups ONLY (n=300) ANGIO (n=110) REVS (n=126) SEQL (n=54) P value 64.39(12.84) 128(42.7) 13.28(12.79) 63.74(14.20) 51(46.4) 22.19(14.84) 64.13(11.49) 45(35.7) 14.59(12.84) 59.91(14.35) 23(42.6) 17.57(14.40) *** Previous-thrombecto 178(59.3) 86(78.2) 87(69.0) 41(75.9) ** my(%) Comorbidity no. (%) DM(%) Hypertension(%) Heart dis. (%) Other (%) Primary patency(SD) 134(44.7) 142(47.3) 79(26.3) 41(13.7) 1.99(4.02) 45(40.9) 62(56.4) 24(21.8) 9(8.2) 7.21(7.61) 48(38.1) 62(49.2) 25(19.8) 14(11.1) 8.35(9.53) 25(46.3) 31(57.4) 16(29.8) 4(7.4) 7.26(6.99) *** Mean age-y(SD) Male sex (%) Graft age(SD) * P<0.05, **p <0.005, *** p<0.0005 Table 2 Standard of procedure time,type of professional labor, and material of 4 groups ONLY ANGIO REVS SEQL Labor Physician 30min*1 45min*1 70min*1 Nurse 30min*2 45min*2 70min*2 Technician Material Forgarty 1. Forgarty 1. Forgarty thrombectomy thrombectomy thrombect catheter catheter omy 2. Non-compliant catheter 70min*1 30min*2 40min*1 1. Forgarty thrombectomy catheter 2. Non-compliant angioplasty 2. Prosthetic balloon graft catheter guidewire 3. Contrast medium * 50ml 4. Pressure gauge angioplasty balloon catheter guidewire 3. Contrast medium * 50ml 4. Pressure gauge 12 Table 3 cost effectiveness analysis ONLY Cost a Labor cost b Material Total cost Effectiveness Patency duration (months) Patency duration (days) Cost effectiveness ratio c ANGIO REVS SEQL 18.0-37.5 27.0-56.3 41.9-87.5 38.3-83.9 150.0 650.0 650.0 650.0 168.0-187.5 677.0-706.3 691.9-737.5 688.3-733.9 1.99 59.7 2.81-3.14 7.21 216.3 3.13-3.27 a Cost is caculated in US dallors. physician’s cost caculate with different salary level c CE ratio=Total cost/ patency duration (days) b 13 8.35 250.5 2.76-2.94 7.26 217.8 3.16-3.37 References Anain, P., Shenoy, S., O'Brien-Irr, M., Harris, L. M., & Dryjski, M. (2001). Balloon angioplasty for arteriovenous graft stenosis. J Endovasc Ther, 8(2), 167-172. Arnold, W. P. (2000). Improvement in hemodialysis vascular access outcomes in a dedicated access center. Semin Dial, 13(6), 359-363. Aruny, J. E., Lewis, C. A., Cardella, J. F., Cole, P. E., Davis, A., Drooz, A. T., et al. (1999). 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