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In-hospital outcomes and cost comparison of femoropopliteal reopening strategies
Cardiovascular Revascularization Medicine 12 (2011) 292 – 298
In-hospital outcomes and cost comparison of femoropopliteal reopening strategies☆,☆☆ David M. Safley a,b,⁎, Jason B. Lindsey b , Katherine Robertus a , John A. House a , Elizabeth Mahoney a,b , Keith B. Allen a,b , David J. Cohen a,b a
Saint-Luke's Mid America Heart Institute, St. Luke's Hospital, Kansas City, MO 64111, USA b University of Missouri–Kansas City, Kansas City, MO, USA
Received 9 August 2010; received in revised form 2 December 2010; accepted 9 December 2010
Abstract
Purpose: Atherectomy has emerged as an alternative to percutaneous transluminal angioplasty (PTA) for endovascular reopening. Despite increasing use of atherectomy (and higher cost of atherectomy catheters compared with balloon catheters), few studies have compared outcomes and costs with other reopening strategies. Methods: We performed a retrospective cohort study involving all patients undergoing isolated femoropopliteal PTA (n=69) or atherectomy (n=92) at our institution from 1/2005 to 4/2006. The choice of reopening strategy was left to the treating physician, and no patients with relative contraindications to stent placement (specifically common femoral artery lesions) were included. Device and supply costs were calculated using the hospital resource-based accounting system, and other costs were calculated using the hospital micro-cost accounting system. Professional fees were calculated from the Medicare Fee Schedule. Results: Baseline characteristics were generally well matched. There were no significant differences in complications (vascular complications, urgent repeat reopening, death, myocardial infarction, or stroke) between groups (PTA 8.7% vs. atherectomy 5.4%, P=.53). PTA required more balloons (2.0±0.8 vs. 0.7±1.0, Pb.001) and stents (1.5±0.8 vs. 0.2±0.5, Pb.001), but fewer atherectomy catheters (0.0±0.0 vs. 1.2±0.4, Pb.001). Neither procedural supply costs (PTA $3137±1459 vs. atherectomy $3338±1505, P=.20) nor total costs differed between PTA and atherectomy patients ($10,945±4521 vs. $10,783±3857, P=.42). Conclusions: Initial outcomes and costs are comparable for femoropopliteal PTA and atherectomy. The choice of reopening strategy should therefore be based on operator experience and anatomic suitability. Further studies are required to determine whether there are differences in long-term outcomes or costs between these approaches. © 2011 Elsevier Inc. All rights reserved.
Keywords:
Angioplasty; Catheterization; Reopening; Endovascular; Cost analysis
☆ Funding: This study was funded by the Mid America Heart Institute Foundation. ☆☆ Conflict of Interest: Dr. Safley receives speaking honoraria from Abbott Vascular. Dr. Cohen receives research grant support from Cordis and Boston Scientific and consulting fees from Cordis and Medtronic. Dr. Allen, Dr. Lindsey, Dr. Mahoney, Ms. Robertus, and Mr. House have no relevant disclosures. ⁎ Corresponding author. Saint Luke's Mid America Heart Institute, 4401 Wornall Road, Kansas City, MO 64111, USA. Tel.: +1 816 932 5750; fax: +1 816 932 5798. E-mail address: [email protected] (D.M. Safley).
1553-8389/10/$ – see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.carrev.2010.12.003
1. Introduction Lower extremity peripheral arterial disease (PAD) is present in 10–20% of patients over age 55 [1–3]. Initial treatment includes cardiovascular risk factor modification for all patients as well as medication, smoking cessation, and exercise therapy to control symptoms of intermittent claudication (IC) [4]. For those unresponsive to conservative measures, reopening is indicated to relieve severe symptoms
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and for limb salvage [4]. Current reopening options include percutaneous transluminal angioplasty (PTA) with or without adjunctive stenting, atherectomy using either rotational or directional cutting systems [5,6], and lower extremity bypass surgery. Although PTA with stenting and bypass surgery are both highly effective therapies for aortoiliac disease, treatment of femoropopliteal disease is more problematic. Depending on patient and lesion characteristics, restenosis and reocclusion remain common after PTA (with or without stenting) [7–9] and long-term (3–5 years) primary and secondary graft primary patency rates after bypass surgery range from 57% to 90%, respectively [10–15]. In light of these limitations, there has been increasing interest in alternative reopening strategies. The Silverhawk device (ev3 Endovascular, Plymouth, MN, USA) is a directional atherectomy device commonly used for percutaneous endovascular reopening. Despite its increasing popularity, however, there are no studies comparing its short- or long-term outcomes with those of alternative approaches to femoropopliteal reopening. Moreover, its acquisition cost is approximately $1900 per device, and multiple devices may be required to complete a single procedure. Because of the cost of atherectomy devices and the possibility of higher procedural costs as compared with conventional endovascular reopening, we undertook the present study to evaluate in-hospital outcomes and costs of atherectomy compared to conventional PTA with bailout stenting for patients undergoing femoropopliteal reopening. 2. Methods 2.1. Patient population This study included all patients undergoing isolated femoropopliteal PTA or atherectomy at a single center between 1/2005 and 4/2006. Patients with common femoral artery lesions were excluded due to the relative contraindication to stent placement. If both PTA and atherectomy were used in a single patient, the treatment group assignment was determined based on the intended initial form of definitive therapy determined by detailed chart review. 2.2. Data sources and definitions Clinical data were obtained by detailed chart review using a standardized data collection instrument. Hypertension, hypercholesterolemia, diabetes mellitus, chronic renal insufficiency (defined as a serum creatinine level N1.5 mg/dl), coronary artery disease, and congestive heart failure were recorded as documented by the admitting physician. Rutherford class was obtained from the preprocedural history and physical or from the attending physician's assessment at the time of arteriography. Smoking was defined as current tobacco use at the time of admission. Laboratory data were obtained from preprocedural labora-
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tories—typically performed within 1 week of reopening. The last measurement of ankle brachial index (ABI), duplex imaging, or computed tomography angiograms (CTA) were reviewed and assessed for lesion severity. If maximal estimated lesion severity was provided, it was averaged for the group, and the most severe measurement was used in a composite comparison if multiple evaluations were available. Outside angiograms were included as an assessment of lesion severity only if there were no noninvasive evaluations available. Qualitative assessments of mild, moderate, or severe stenosis were recorded if there was no estimate of lesion severity provided. Noninvasive studies were considered normal with ABI of 0.9 or greater or reported stenosis of 0%, mildly abnormal with ABI of 0.70–0.89 or reported stenosis of 1–69%, moderately abnormal with ABI of 0.40–0.69 or a reported stenosis of 70–90%, and severe disease was defined as ABI under 0.40 or maximum estimated stenosis of N90%. In-hospital outcomes were assessed from hospital records and discharge summaries. Lesion length, percent stenosis, and reference vessel diameter were obtained from review of diagnostic angiograms and procedural reports. Complications included vascular-related, urgent repeat reopening, death, myocardial infarction, or stroke. Vascular complications were defined as bleeding requiring transfusion or intervention to repair vascular damage (i.e., thrombin injection or surgical repair of pseudoaneurysm). Technical success was defined as successful endovascular treatment of the lesion with b40% residual stenosis (by visual estimate), and procedural success was defined as technical success with no in-hospital complications (as defined above). The protocol was approved by the local institutional review board. Since our goal was to focus on complications and resource utilization that was directly attributable to the reopening procedures, we reviewed the hospital course for each patient and excluded those resources that were not directly attributable to the reopening procedures or their complications (e.g., preprocedure hospital days for another condition). Preprocedure hospital days were considered part of the reopening procedure if they were required to allow for hydration, laboratory assessment, and noninvasive testing. Postprocedure hospital days were considered procedure related if complications from the procedure led to testing or treatment prolonging the hospitalization. 2.3. Cost methodology Total costs included supply costs, other procedural costs, non–procedure-related hospital costs, and physician fees assessed in constant 2005 US dollars. Procedure-related supply costs, including balloons, stents and atherectomy devices, contrast dye, and guide wires, were obtained directly from the hospital's cardiovascular laboratory accounting system. Interventional suite costs (excluding relevant supply costs) were based on room costs to the
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hospital as well as direct labor and other nonlabor costs. Nonprocedural hospital costs included room and ancillary costs, such as histology, specimen procurement, and nutrition, in addition to specific department costs (laboratory, radiology, pharmacy). These costs were based on direct costs obtained from the hospital accounting system. Physician costs were derived by applying 2005 Medicare Relative Value Unit-based rates to current procedural terminology codes for each procedure. 2.3.1. Statistical analysis Demographic and clinical data are presented as mean±S.D. for continuous variables and proportions for categorical variables. Data were compared by ANOVA for continuous variables and χ2 or Fisher's Exact Test, where appropriate, for categorical variables. Cost data are presented as mean±S.D. with selected data reported as median and interquartile range. P values for the difference in mean costs between treatment groups were obtained using bootstrap resampling [16]. All P values are two-tailed, and Pb.05 was considered significant. All analyses were performed using SAS version 9.1 (SAS Institute, Cary, NC, USA). 3. Results 3.1. Patient population Between 1/2005 and 4/2006, a total of 161 eligible isolated femoropopliteal reopening procedures were performed. The intended treatment strategy was PTA in 69 patients and atherectomy in 92. Table 1 displays baseline demographic and clinical characteristics for the two groups. There were few differences between the PTA and atherectomy groups. Overall, the mean age was 68 years, 61% were male and 93% were Caucasian. There were similar rates of hypertension, hypercholesterolemia, diabetes mellitus, active smoking, chronic renal failure, and congestive heart Table 1 Baseline characteristics
Age, years Male, % Caucasian, % Hypertension, % Hyperlipidemia, % Diabetes mellitus, % Insulin-requiring, % Tobacco use, % Renal insufficiency, % Serum creatinine, mg/dl Coronary artery disease, % Congestive heart failure, % Prior LE revascularization, % Bilateral PAD, % Initial stenosis, %
PTA (n=69)
ATH (n=92)
P value
67.3±22.0 60.9 92.8 92.8 98.6 40.6 18.8 23.2 11.6 1.4±1.1 82.6 18.8 52.2 75.4 84.7±14.6
68.6±13.6 58.7 92.4 90.2 94.6 38.0 16.5 29.3 4.3 1.2±0.8 67.4 10.9 57.6 76.1 83.5±14.5
.65 .78 .62 .57 .24 .74 .70 .38 .08 .36 .03 .15 .49 .92 .45
ATH=atherectomy; LE=lower extremity.
failure. Patients undergoing PTA were more likely to have documented coronary artery disease (82.6% vs. 67.4%, P=.03) and also tended to have more baseline renal insufficiency (11.6% vs. 4.3%, P=.08). Over one-half of patients had undergone at least one prior lower extremity reopening procedure (52% PTA vs. 58% atherectomy, P=.49). The majority of these were prior endovascular reopening (76.4% among PTA patients and 94.2% among atherectomy patients). A minority of patients (14.7% PTA and 0 atherectomy) had both prior PTA and surgery, while 8.8% of PTA and 5.8% of atherectomy patients had undergone prior lower extremity bypass surgery (P=.005 for difference in type of prior reopening between groups). Symptomatic status was obtained for 100% of patients. The average Rutherford class was 2.7±1.1 among PTA patients and 2.3±1.1 among those undergoing atherectomy. Claudication (Rutherford Class 1–3) was the indication for reopening in 88.3% of PTA and in 91.3% of atherectomy patients, while critical limb ischemia was the indication in 10.1% and 6.6%, respectively (P=.08). Ankle brachial indices were available in 42% of patients overall (38% PTA and 45% atherectomy, P=.38) and were 0.6±0.1 for PTA and 0.6±0.2 for atherectomy (P=.85). CTA was obtained in 38% of patients (47% PTA and 32% atherectomy, P=.06), with maximal lesion severity of 84.7±25.8% for PTA and 88.6±12.5% for atherectomy (P=.46). Duplex imaging was available in 35% of cases (36% PTA and 35% atherectomy, P=.85). The maximal estimated stenosis was 74.0±9.9% for PTA and 72.2±16.5% for atherectomy (P=.63). Overall, noninvasive evaluation (duplex and/or CTA imaging and/or ABI) was available in 91.9% of patients (92.8% PTA and 91.3% atherectomy, P=.74). Studies were normal in 1.6% of PTA and 0% of atherectomy patients, mildly abnormal in 17.2% of PTA and 20.2% atherectomy, and moderately abnormal in 31.3% of PTA and 27.4% of atherectomy patients. Severe stenosis were detected in 50.0% of PTA and in 52.4% of atherectomy patients (P=.69 for severity comparison). There were an average of 2.0 vessel segments treated (proximal, mid, or distal SFA or popliteal artery) in the PTA group and 1.9 in the atherectomy group (P=.34). Below the knee, popliteal intervention was undertaken in 66% of popliteal lesions in the PTA group and in 55% of popliteal lesions in atherectomy patients (P=.49). Initial angiographic stenosis was 84.7±14.6% in the PTA patients and 83.5±14.5% in atherectomy patients (P=.45). The average lesion length was 84.2±51.0 mm for PTA and 71.1±44.6 for atherectomy (P=.03). The mean reference vessel diameter was 5.5±1.2 for PTA and 5.4±1.2 for atherectomy (P=.69). Occlusions were present in 29.1% of PTA and in 20.6% of atherectomy patients (P=.08). 3.1.1. Procedural outcomes and in-hospital complications Procedural outcomes were similar for both modes of reopening (Table 2). Technical success rates were high and similar for PTA and atherectomy (98.6% vs. 97.8%, P=.99). Additionally, there were no significant differences in
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Table 2 Procedural resource utilization and complications
Procedural details Technical success, % Procedural success, % Fluoroscopy time (min) Contrast volume (ml) Balloons used Stents used Atherectomy devices used Procedural costs ($) Room and ancillary Supplies Total procedural cost
PTA (n=69)
ATH (n=92)
P value
98.6 88.4 27.0±17.2 222±96 2.0±0.8 1.5±0.8 0.0±0.0
97.8 93.5 24.8±12.4 221±93 0.7±1.0 0.2±0.5 1.2±0.4
.99 .26 .36 .92 b.001 b.001 b.001
4259±1545 [4111] 3137±1459 [3138] 7396±2724 [7050]
4218±1636 [1488] 3338±1505 [2532] 7556±3014 [6158]
.43 .20 .36
Values are mean±S.D. unless otherwise noted. Values in brackets represent medians. Indirect CV laboratory costs included in procedural costs.
procedural success rates (technical success with no complications) between PTA and atherectomy (88.4% vs. 93.5%, P=.26). Residual stenosis was lower following PTA (7.5±13.1% vs. 12.3±11.9%, P=.02). Procedural complication rates were not different between the two groups. Overall in-hospital complication rates were similar for both groups (Table 3). Although not statistically significant, bleeding events were twice as common in PTA patients (8.7% vs. 4.3%), while urgent repeat procedures were required in two atherectomy patients (2.2%) and no PTA patients (P=NS for both comparisons). One atherectomy patient was sent urgently to the operating room for surgical repair of the arteriotomy due to uncontrolled hemorrhage and the other urgent procedure was a PTA performed later on the same day of the index procedure due to sudden occlusion of the vessel at the site of atherectomy due to dissection that was not appreciated at the time of the index procedure. There were no in-hospital deaths in either group. There were three patients with residual stenosis N40% after the index procedure. One underwent no further reopening procedure as a decision was
made to accept the procedural outcome and treat with conservative measures thereafter, while the second patient underwent another attempt at percutaneous reopening that was also unsuccessful. Ultimately, a decision was made to treat conservatively in that case as well. The third patient was referred for urgent surgical repair of the arteriotomy site and treated conservatively thereafter. 3.1.2. Procedural resource utilization and costs Measures of procedural resource utilization and cost are summarized in Table 2. On average, 1.2±0.4 atherectomy devices were used per procedure. Some of these patients also had balloon dilatation and stent placement (average use 0.7±1.0 and 0.2±0.5, respectively). Compared with atherectomy, PTA procedures required substantially more balloons (2.0±0.8, Pb.001) and stents (1.5±0.8, Pb.001). Fluoroscopy time (PTA 27±17 min vs. atherectomy 25±12 min, P=.36) and contrast volume (222±96 vs. 221±93 ml, P=.92) were similar for the two strategies. Overall procedural costs were comparable for
Table 3 Hospital resource utilization and costs
Length of stay, days Procedural complications Overall complications, % Bleeding, % Urgent repeat reopening, % Death/MI/stroke, % Procedural costs ($) Nonprocedural costs ($) Pharmacy Laboratory Radiology Room and ancillary Total Total hospital Professional fees ($) Total costs ($)
PTA (n=69)
ATH (n=92)
P value
1.3±1.6 [1]
1.2±0.7 [1]
.75
8.7 8.7 0.0 0.0 7396±2724 [7050]
5.4 4.3 2.2 0.0 7556±3014 [6158]
.53 .33 .51 — .36
284±434 [203] 75±219 [0] 6±32 [0] 2291±2880 [1488] 2655±3441 [1721] 10,052±4472 [9018] 893±279 [908] 10,945±4521 [9877]
284±539 [166] 65±149 [0] 3±149 [0] 1995±1491 [1486] 2347±2057 [1715] 9903±3754 [8120] 880±242 [806] 10,783±3857 [9064]
.50 .40 .24 .23 .27 .43 .38 .42
MI, Myocardial infarction. Indirect CV laboratory costs are included in procedural costs for interventional arm. Numbers in brackets represent median values.
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the PTA and atherectomy strategies ($7396±2724 vs. $7556±3014, P=.36). 3.1.3. Hospital resource utilization and costs Total costs for the index hospitalization, according to cost category, are summarized in Table 3 and Fig. 1. Examination of the individual cost components demonstrated no significant differences in length of stay or in any other components of hospital care for the two percutaneous reopening techniques. As a result, total hospital costs were virtually identical for the PTA and atherectomy groups ($10,052±4472 vs. $9903±3754; 95% CI for difference $1512 less to $1113 more; P=.43). Total costs for the hospitalization (including physician services) were also similar ($10,945±4521 vs. $10,783±3857; 95% CI for difference $1532 less to $1114 more; P=.42). 4. Discussion Despite increasing use of percutaneous intervention as a first-line reopening strategy for femoropopliteal PAD, there are few data comparing rates of technical success, clinical complications, and cost with alternative approaches to this common and costly condition. In this single-center observational study, we found no significant differences in rates of technical success or major clinical complications among patients undergoing PTA or atherectomy for symptomatic femoropopliteal PAD. Despite the high cost of the atherectomy device, both procedural and total hospital costs were virtually identical for the two alternative approaches to endovascular reopening. The similarity in total costs was a somewhat unexpected finding given the higher acquisition cost of atherectomy catheters (currently ∼$1900 per device) compared with PTA balloons (∼$350 per device) and self-expanding stents (∼$1300 per device). To our knowledge, this is the first study to directly compare the results of Silverhawk atherectomy with those of
Fig. 1. Comparison of total in-hospital costs and the major components of cost for PTA vs. atherectomy.
PTA for reopening of femoropopliteal PAD. Several findings of this comparison are noteworthy. First, both approaches had similar rates of both technical and overall procedural success. For the individual strategies of PTA or atherectomy, our results were largely comparable to those reported from single-center or multicenter single-device studies [11,17–21]. On the other hand, it is apparent that, in order to achieve technical success, PTA is more likely to require adjunctive stenting to treat unacceptable residual stenosis or significant dissection. In our study, adjunctive stenting was performed in 86% of PTA procedures as compared with 13% of atherectomy procedures. These differences in adjunctive device use led to significant shifts in resource utilization patterns that tended to offset the cost of the atherectomy devices (an average of $2391/procedure), such that total procedural costs and overall hospital costs were similar for the two approaches. Assuming (in the absence of contravening data) that longterm clinical outcomes are also similar for the two endovascular strategies, these findings thus suggest that the choice between PTA or atherectomy as initial reopening strategies for patients with symptomatic femoropopliteal PAD should be based on anatomic considerations and operator experience, more than on clinical or economic factors. There are currently limited comparative data regarding long-term outcomes of PTA and atherectomy and no data whatsoever from contemporary practice comparing liberal use of provisional stenting and current atherectomy devices. One small trial that compared PTA and directional atherectomy reported lower 2-year patency and clinical success for atherectomy [6]. The only other published study examining femoropopliteal PTA vs. extraction atherectomy found no difference in patency rates at 6 months [22]. Neither of these prior studies was performed with the current Silverhawk device. Considering the high cost of endovascular reopening and the high prevalence of PAD, there is substantial clinical and economic justification for well-designed, adequately powered clinical trials comparing alternative approaches to femoropopliteal reopening. Although our study directly compared the two most common endovascular approaches to femoropopliteal reopening, it should be recognized that a third possible approach—surgical bypass grafting—was not included in our analysis. Although it would have been technically feasible to perform such a comparison, we believed that profound differences in the anatomic extent of disease for patients undergoing surgical vs. percutaneous reopening in contemporary practice would preclude valid comparisons, even using sophisticated risk-adjustment strategies. Of note, Hunink et al. [23] have previously used a decision-analytic model to address the issue of surgical vs. endovascular reopening and found that, for patients with femoropopliteal disease, the strategy of initial PTA was associated with lower lifetime costs and greater quality-adjusted life expectancy than bypass surgery. Moreover, according to their model, initial PTA was the economically dominant strategy as long
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as its 5-year patency rate was at least 30%. Atherectomy was not evaluated, however. Given that the initial difference in cost between PTA and bypass surgery in their study was N$5000 and that PTA results have improved with the availability of bailout stenting, it seems likely that their results would remain valid in contemporary practice.
[3]
[4]
4.1. Limitations Our results should be considered in light of several important limitations. This was a nonrandomized, retrospective study, and there may be unmeasured confounding between the treatment groups. Given the single-center nature of the study, the extrapolation of our cost data to other settings is uncertain. The small sample size limits statistical power to detect differences between groups. Alternative devices are available for the treatment of lower extremity atherosclerosis, including lasers, rotational and orbital atherectomy devices, and combination rheolytic thrombectomy with atherectomy. However, the present findings cannot be extended to these since they were not evaluated in the current study. The lack of long-term follow-up prevents long-term cost comparisons and cost-effectiveness analysis. Finally, the current study does not assess quality of life after reopening, which will be critical in future assessment of the treatment of PAD, as the vast majority of femoropopliteal reopening procedures are performed to relieve lifestyle-limiting IC. 5. Conclusions For patients undergoing endovascular femoropopliteal reopening, initial clinical outcomes and costs appear to be comparable for PTA and atherectomy. These findings thus suggest that, in the absence of compelling differences in long-term outcomes or quality of life, the choice between PTA vs. atherectomy as the initial reopening strategies for patients with symptomatic femoropopliteal disease should be based on anatomic considerations and operator experience, more than on clinical or economic factors. Future randomized studies are warranted to determine long-term outcomes and cost-effectiveness of these two procedures.
[5]
[6]
[7]
[8]
[9]
[10]
[11] [12]
[13]
[14]
Acknowledgments The authors would like to thank Dena McDonnell for assistance in the data collection for this manuscript and Joseph Murphy for editorial assistance.
[15]
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In-hospital outcomes and cost comparison of femoropopliteal reopening strategies☆,☆☆ David M. Safley a,b,⁎, Jason B. Lindsey b , Katherine Robertus a , John A. House a , Elizabeth Mahoney a,b , Keith B. Allen a,b , David J. Cohen a,b a
Saint-Luke's Mid America Heart Institute, St. Luke's Hospital, Kansas City, MO 64111, USA b University of Missouri–Kansas City, Kansas City, MO, USA
Received 9 August 2010; received in revised form 2 December 2010; accepted 9 December 2010
Abstract
Purpose: Atherectomy has emerged as an alternative to percutaneous transluminal angioplasty (PTA) for endovascular reopening. Despite increasing use of atherectomy (and higher cost of atherectomy catheters compared with balloon catheters), few studies have compared outcomes and costs with other reopening strategies. Methods: We performed a retrospective cohort study involving all patients undergoing isolated femoropopliteal PTA (n=69) or atherectomy (n=92) at our institution from 1/2005 to 4/2006. The choice of reopening strategy was left to the treating physician, and no patients with relative contraindications to stent placement (specifically common femoral artery lesions) were included. Device and supply costs were calculated using the hospital resource-based accounting system, and other costs were calculated using the hospital micro-cost accounting system. Professional fees were calculated from the Medicare Fee Schedule. Results: Baseline characteristics were generally well matched. There were no significant differences in complications (vascular complications, urgent repeat reopening, death, myocardial infarction, or stroke) between groups (PTA 8.7% vs. atherectomy 5.4%, P=.53). PTA required more balloons (2.0±0.8 vs. 0.7±1.0, Pb.001) and stents (1.5±0.8 vs. 0.2±0.5, Pb.001), but fewer atherectomy catheters (0.0±0.0 vs. 1.2±0.4, Pb.001). Neither procedural supply costs (PTA $3137±1459 vs. atherectomy $3338±1505, P=.20) nor total costs differed between PTA and atherectomy patients ($10,945±4521 vs. $10,783±3857, P=.42). Conclusions: Initial outcomes and costs are comparable for femoropopliteal PTA and atherectomy. The choice of reopening strategy should therefore be based on operator experience and anatomic suitability. Further studies are required to determine whether there are differences in long-term outcomes or costs between these approaches. © 2011 Elsevier Inc. All rights reserved.
Keywords:
Angioplasty; Catheterization; Reopening; Endovascular; Cost analysis
☆ Funding: This study was funded by the Mid America Heart Institute Foundation. ☆☆ Conflict of Interest: Dr. Safley receives speaking honoraria from Abbott Vascular. Dr. Cohen receives research grant support from Cordis and Boston Scientific and consulting fees from Cordis and Medtronic. Dr. Allen, Dr. Lindsey, Dr. Mahoney, Ms. Robertus, and Mr. House have no relevant disclosures. ⁎ Corresponding author. Saint Luke's Mid America Heart Institute, 4401 Wornall Road, Kansas City, MO 64111, USA. Tel.: +1 816 932 5750; fax: +1 816 932 5798. E-mail address: [email protected] (D.M. Safley).
1553-8389/10/$ – see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.carrev.2010.12.003
1. Introduction Lower extremity peripheral arterial disease (PAD) is present in 10–20% of patients over age 55 [1–3]. Initial treatment includes cardiovascular risk factor modification for all patients as well as medication, smoking cessation, and exercise therapy to control symptoms of intermittent claudication (IC) [4]. For those unresponsive to conservative measures, reopening is indicated to relieve severe symptoms
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and for limb salvage [4]. Current reopening options include percutaneous transluminal angioplasty (PTA) with or without adjunctive stenting, atherectomy using either rotational or directional cutting systems [5,6], and lower extremity bypass surgery. Although PTA with stenting and bypass surgery are both highly effective therapies for aortoiliac disease, treatment of femoropopliteal disease is more problematic. Depending on patient and lesion characteristics, restenosis and reocclusion remain common after PTA (with or without stenting) [7–9] and long-term (3–5 years) primary and secondary graft primary patency rates after bypass surgery range from 57% to 90%, respectively [10–15]. In light of these limitations, there has been increasing interest in alternative reopening strategies. The Silverhawk device (ev3 Endovascular, Plymouth, MN, USA) is a directional atherectomy device commonly used for percutaneous endovascular reopening. Despite its increasing popularity, however, there are no studies comparing its short- or long-term outcomes with those of alternative approaches to femoropopliteal reopening. Moreover, its acquisition cost is approximately $1900 per device, and multiple devices may be required to complete a single procedure. Because of the cost of atherectomy devices and the possibility of higher procedural costs as compared with conventional endovascular reopening, we undertook the present study to evaluate in-hospital outcomes and costs of atherectomy compared to conventional PTA with bailout stenting for patients undergoing femoropopliteal reopening. 2. Methods 2.1. Patient population This study included all patients undergoing isolated femoropopliteal PTA or atherectomy at a single center between 1/2005 and 4/2006. Patients with common femoral artery lesions were excluded due to the relative contraindication to stent placement. If both PTA and atherectomy were used in a single patient, the treatment group assignment was determined based on the intended initial form of definitive therapy determined by detailed chart review. 2.2. Data sources and definitions Clinical data were obtained by detailed chart review using a standardized data collection instrument. Hypertension, hypercholesterolemia, diabetes mellitus, chronic renal insufficiency (defined as a serum creatinine level N1.5 mg/dl), coronary artery disease, and congestive heart failure were recorded as documented by the admitting physician. Rutherford class was obtained from the preprocedural history and physical or from the attending physician's assessment at the time of arteriography. Smoking was defined as current tobacco use at the time of admission. Laboratory data were obtained from preprocedural labora-
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tories—typically performed within 1 week of reopening. The last measurement of ankle brachial index (ABI), duplex imaging, or computed tomography angiograms (CTA) were reviewed and assessed for lesion severity. If maximal estimated lesion severity was provided, it was averaged for the group, and the most severe measurement was used in a composite comparison if multiple evaluations were available. Outside angiograms were included as an assessment of lesion severity only if there were no noninvasive evaluations available. Qualitative assessments of mild, moderate, or severe stenosis were recorded if there was no estimate of lesion severity provided. Noninvasive studies were considered normal with ABI of 0.9 or greater or reported stenosis of 0%, mildly abnormal with ABI of 0.70–0.89 or reported stenosis of 1–69%, moderately abnormal with ABI of 0.40–0.69 or a reported stenosis of 70–90%, and severe disease was defined as ABI under 0.40 or maximum estimated stenosis of N90%. In-hospital outcomes were assessed from hospital records and discharge summaries. Lesion length, percent stenosis, and reference vessel diameter were obtained from review of diagnostic angiograms and procedural reports. Complications included vascular-related, urgent repeat reopening, death, myocardial infarction, or stroke. Vascular complications were defined as bleeding requiring transfusion or intervention to repair vascular damage (i.e., thrombin injection or surgical repair of pseudoaneurysm). Technical success was defined as successful endovascular treatment of the lesion with b40% residual stenosis (by visual estimate), and procedural success was defined as technical success with no in-hospital complications (as defined above). The protocol was approved by the local institutional review board. Since our goal was to focus on complications and resource utilization that was directly attributable to the reopening procedures, we reviewed the hospital course for each patient and excluded those resources that were not directly attributable to the reopening procedures or their complications (e.g., preprocedure hospital days for another condition). Preprocedure hospital days were considered part of the reopening procedure if they were required to allow for hydration, laboratory assessment, and noninvasive testing. Postprocedure hospital days were considered procedure related if complications from the procedure led to testing or treatment prolonging the hospitalization. 2.3. Cost methodology Total costs included supply costs, other procedural costs, non–procedure-related hospital costs, and physician fees assessed in constant 2005 US dollars. Procedure-related supply costs, including balloons, stents and atherectomy devices, contrast dye, and guide wires, were obtained directly from the hospital's cardiovascular laboratory accounting system. Interventional suite costs (excluding relevant supply costs) were based on room costs to the
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hospital as well as direct labor and other nonlabor costs. Nonprocedural hospital costs included room and ancillary costs, such as histology, specimen procurement, and nutrition, in addition to specific department costs (laboratory, radiology, pharmacy). These costs were based on direct costs obtained from the hospital accounting system. Physician costs were derived by applying 2005 Medicare Relative Value Unit-based rates to current procedural terminology codes for each procedure. 2.3.1. Statistical analysis Demographic and clinical data are presented as mean±S.D. for continuous variables and proportions for categorical variables. Data were compared by ANOVA for continuous variables and χ2 or Fisher's Exact Test, where appropriate, for categorical variables. Cost data are presented as mean±S.D. with selected data reported as median and interquartile range. P values for the difference in mean costs between treatment groups were obtained using bootstrap resampling [16]. All P values are two-tailed, and Pb.05 was considered significant. All analyses were performed using SAS version 9.1 (SAS Institute, Cary, NC, USA). 3. Results 3.1. Patient population Between 1/2005 and 4/2006, a total of 161 eligible isolated femoropopliteal reopening procedures were performed. The intended treatment strategy was PTA in 69 patients and atherectomy in 92. Table 1 displays baseline demographic and clinical characteristics for the two groups. There were few differences between the PTA and atherectomy groups. Overall, the mean age was 68 years, 61% were male and 93% were Caucasian. There were similar rates of hypertension, hypercholesterolemia, diabetes mellitus, active smoking, chronic renal failure, and congestive heart Table 1 Baseline characteristics
Age, years Male, % Caucasian, % Hypertension, % Hyperlipidemia, % Diabetes mellitus, % Insulin-requiring, % Tobacco use, % Renal insufficiency, % Serum creatinine, mg/dl Coronary artery disease, % Congestive heart failure, % Prior LE revascularization, % Bilateral PAD, % Initial stenosis, %
PTA (n=69)
ATH (n=92)
P value
67.3±22.0 60.9 92.8 92.8 98.6 40.6 18.8 23.2 11.6 1.4±1.1 82.6 18.8 52.2 75.4 84.7±14.6
68.6±13.6 58.7 92.4 90.2 94.6 38.0 16.5 29.3 4.3 1.2±0.8 67.4 10.9 57.6 76.1 83.5±14.5
.65 .78 .62 .57 .24 .74 .70 .38 .08 .36 .03 .15 .49 .92 .45
ATH=atherectomy; LE=lower extremity.
failure. Patients undergoing PTA were more likely to have documented coronary artery disease (82.6% vs. 67.4%, P=.03) and also tended to have more baseline renal insufficiency (11.6% vs. 4.3%, P=.08). Over one-half of patients had undergone at least one prior lower extremity reopening procedure (52% PTA vs. 58% atherectomy, P=.49). The majority of these were prior endovascular reopening (76.4% among PTA patients and 94.2% among atherectomy patients). A minority of patients (14.7% PTA and 0 atherectomy) had both prior PTA and surgery, while 8.8% of PTA and 5.8% of atherectomy patients had undergone prior lower extremity bypass surgery (P=.005 for difference in type of prior reopening between groups). Symptomatic status was obtained for 100% of patients. The average Rutherford class was 2.7±1.1 among PTA patients and 2.3±1.1 among those undergoing atherectomy. Claudication (Rutherford Class 1–3) was the indication for reopening in 88.3% of PTA and in 91.3% of atherectomy patients, while critical limb ischemia was the indication in 10.1% and 6.6%, respectively (P=.08). Ankle brachial indices were available in 42% of patients overall (38% PTA and 45% atherectomy, P=.38) and were 0.6±0.1 for PTA and 0.6±0.2 for atherectomy (P=.85). CTA was obtained in 38% of patients (47% PTA and 32% atherectomy, P=.06), with maximal lesion severity of 84.7±25.8% for PTA and 88.6±12.5% for atherectomy (P=.46). Duplex imaging was available in 35% of cases (36% PTA and 35% atherectomy, P=.85). The maximal estimated stenosis was 74.0±9.9% for PTA and 72.2±16.5% for atherectomy (P=.63). Overall, noninvasive evaluation (duplex and/or CTA imaging and/or ABI) was available in 91.9% of patients (92.8% PTA and 91.3% atherectomy, P=.74). Studies were normal in 1.6% of PTA and 0% of atherectomy patients, mildly abnormal in 17.2% of PTA and 20.2% atherectomy, and moderately abnormal in 31.3% of PTA and 27.4% of atherectomy patients. Severe stenosis were detected in 50.0% of PTA and in 52.4% of atherectomy patients (P=.69 for severity comparison). There were an average of 2.0 vessel segments treated (proximal, mid, or distal SFA or popliteal artery) in the PTA group and 1.9 in the atherectomy group (P=.34). Below the knee, popliteal intervention was undertaken in 66% of popliteal lesions in the PTA group and in 55% of popliteal lesions in atherectomy patients (P=.49). Initial angiographic stenosis was 84.7±14.6% in the PTA patients and 83.5±14.5% in atherectomy patients (P=.45). The average lesion length was 84.2±51.0 mm for PTA and 71.1±44.6 for atherectomy (P=.03). The mean reference vessel diameter was 5.5±1.2 for PTA and 5.4±1.2 for atherectomy (P=.69). Occlusions were present in 29.1% of PTA and in 20.6% of atherectomy patients (P=.08). 3.1.1. Procedural outcomes and in-hospital complications Procedural outcomes were similar for both modes of reopening (Table 2). Technical success rates were high and similar for PTA and atherectomy (98.6% vs. 97.8%, P=.99). Additionally, there were no significant differences in
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Table 2 Procedural resource utilization and complications
Procedural details Technical success, % Procedural success, % Fluoroscopy time (min) Contrast volume (ml) Balloons used Stents used Atherectomy devices used Procedural costs ($) Room and ancillary Supplies Total procedural cost
PTA (n=69)
ATH (n=92)
P value
98.6 88.4 27.0±17.2 222±96 2.0±0.8 1.5±0.8 0.0±0.0
97.8 93.5 24.8±12.4 221±93 0.7±1.0 0.2±0.5 1.2±0.4
.99 .26 .36 .92 b.001 b.001 b.001
4259±1545 [4111] 3137±1459 [3138] 7396±2724 [7050]
4218±1636 [1488] 3338±1505 [2532] 7556±3014 [6158]
.43 .20 .36
Values are mean±S.D. unless otherwise noted. Values in brackets represent medians. Indirect CV laboratory costs included in procedural costs.
procedural success rates (technical success with no complications) between PTA and atherectomy (88.4% vs. 93.5%, P=.26). Residual stenosis was lower following PTA (7.5±13.1% vs. 12.3±11.9%, P=.02). Procedural complication rates were not different between the two groups. Overall in-hospital complication rates were similar for both groups (Table 3). Although not statistically significant, bleeding events were twice as common in PTA patients (8.7% vs. 4.3%), while urgent repeat procedures were required in two atherectomy patients (2.2%) and no PTA patients (P=NS for both comparisons). One atherectomy patient was sent urgently to the operating room for surgical repair of the arteriotomy due to uncontrolled hemorrhage and the other urgent procedure was a PTA performed later on the same day of the index procedure due to sudden occlusion of the vessel at the site of atherectomy due to dissection that was not appreciated at the time of the index procedure. There were no in-hospital deaths in either group. There were three patients with residual stenosis N40% after the index procedure. One underwent no further reopening procedure as a decision was
made to accept the procedural outcome and treat with conservative measures thereafter, while the second patient underwent another attempt at percutaneous reopening that was also unsuccessful. Ultimately, a decision was made to treat conservatively in that case as well. The third patient was referred for urgent surgical repair of the arteriotomy site and treated conservatively thereafter. 3.1.2. Procedural resource utilization and costs Measures of procedural resource utilization and cost are summarized in Table 2. On average, 1.2±0.4 atherectomy devices were used per procedure. Some of these patients also had balloon dilatation and stent placement (average use 0.7±1.0 and 0.2±0.5, respectively). Compared with atherectomy, PTA procedures required substantially more balloons (2.0±0.8, Pb.001) and stents (1.5±0.8, Pb.001). Fluoroscopy time (PTA 27±17 min vs. atherectomy 25±12 min, P=.36) and contrast volume (222±96 vs. 221±93 ml, P=.92) were similar for the two strategies. Overall procedural costs were comparable for
Table 3 Hospital resource utilization and costs
Length of stay, days Procedural complications Overall complications, % Bleeding, % Urgent repeat reopening, % Death/MI/stroke, % Procedural costs ($) Nonprocedural costs ($) Pharmacy Laboratory Radiology Room and ancillary Total Total hospital Professional fees ($) Total costs ($)
PTA (n=69)
ATH (n=92)
P value
1.3±1.6 [1]
1.2±0.7 [1]
.75
8.7 8.7 0.0 0.0 7396±2724 [7050]
5.4 4.3 2.2 0.0 7556±3014 [6158]
.53 .33 .51 — .36
284±434 [203] 75±219 [0] 6±32 [0] 2291±2880 [1488] 2655±3441 [1721] 10,052±4472 [9018] 893±279 [908] 10,945±4521 [9877]
284±539 [166] 65±149 [0] 3±149 [0] 1995±1491 [1486] 2347±2057 [1715] 9903±3754 [8120] 880±242 [806] 10,783±3857 [9064]
.50 .40 .24 .23 .27 .43 .38 .42
MI, Myocardial infarction. Indirect CV laboratory costs are included in procedural costs for interventional arm. Numbers in brackets represent median values.
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the PTA and atherectomy strategies ($7396±2724 vs. $7556±3014, P=.36). 3.1.3. Hospital resource utilization and costs Total costs for the index hospitalization, according to cost category, are summarized in Table 3 and Fig. 1. Examination of the individual cost components demonstrated no significant differences in length of stay or in any other components of hospital care for the two percutaneous reopening techniques. As a result, total hospital costs were virtually identical for the PTA and atherectomy groups ($10,052±4472 vs. $9903±3754; 95% CI for difference $1512 less to $1113 more; P=.43). Total costs for the hospitalization (including physician services) were also similar ($10,945±4521 vs. $10,783±3857; 95% CI for difference $1532 less to $1114 more; P=.42). 4. Discussion Despite increasing use of percutaneous intervention as a first-line reopening strategy for femoropopliteal PAD, there are few data comparing rates of technical success, clinical complications, and cost with alternative approaches to this common and costly condition. In this single-center observational study, we found no significant differences in rates of technical success or major clinical complications among patients undergoing PTA or atherectomy for symptomatic femoropopliteal PAD. Despite the high cost of the atherectomy device, both procedural and total hospital costs were virtually identical for the two alternative approaches to endovascular reopening. The similarity in total costs was a somewhat unexpected finding given the higher acquisition cost of atherectomy catheters (currently ∼$1900 per device) compared with PTA balloons (∼$350 per device) and self-expanding stents (∼$1300 per device). To our knowledge, this is the first study to directly compare the results of Silverhawk atherectomy with those of
Fig. 1. Comparison of total in-hospital costs and the major components of cost for PTA vs. atherectomy.
PTA for reopening of femoropopliteal PAD. Several findings of this comparison are noteworthy. First, both approaches had similar rates of both technical and overall procedural success. For the individual strategies of PTA or atherectomy, our results were largely comparable to those reported from single-center or multicenter single-device studies [11,17–21]. On the other hand, it is apparent that, in order to achieve technical success, PTA is more likely to require adjunctive stenting to treat unacceptable residual stenosis or significant dissection. In our study, adjunctive stenting was performed in 86% of PTA procedures as compared with 13% of atherectomy procedures. These differences in adjunctive device use led to significant shifts in resource utilization patterns that tended to offset the cost of the atherectomy devices (an average of $2391/procedure), such that total procedural costs and overall hospital costs were similar for the two approaches. Assuming (in the absence of contravening data) that longterm clinical outcomes are also similar for the two endovascular strategies, these findings thus suggest that the choice between PTA or atherectomy as initial reopening strategies for patients with symptomatic femoropopliteal PAD should be based on anatomic considerations and operator experience, more than on clinical or economic factors. There are currently limited comparative data regarding long-term outcomes of PTA and atherectomy and no data whatsoever from contemporary practice comparing liberal use of provisional stenting and current atherectomy devices. One small trial that compared PTA and directional atherectomy reported lower 2-year patency and clinical success for atherectomy [6]. The only other published study examining femoropopliteal PTA vs. extraction atherectomy found no difference in patency rates at 6 months [22]. Neither of these prior studies was performed with the current Silverhawk device. Considering the high cost of endovascular reopening and the high prevalence of PAD, there is substantial clinical and economic justification for well-designed, adequately powered clinical trials comparing alternative approaches to femoropopliteal reopening. Although our study directly compared the two most common endovascular approaches to femoropopliteal reopening, it should be recognized that a third possible approach—surgical bypass grafting—was not included in our analysis. Although it would have been technically feasible to perform such a comparison, we believed that profound differences in the anatomic extent of disease for patients undergoing surgical vs. percutaneous reopening in contemporary practice would preclude valid comparisons, even using sophisticated risk-adjustment strategies. Of note, Hunink et al. [23] have previously used a decision-analytic model to address the issue of surgical vs. endovascular reopening and found that, for patients with femoropopliteal disease, the strategy of initial PTA was associated with lower lifetime costs and greater quality-adjusted life expectancy than bypass surgery. Moreover, according to their model, initial PTA was the economically dominant strategy as long
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as its 5-year patency rate was at least 30%. Atherectomy was not evaluated, however. Given that the initial difference in cost between PTA and bypass surgery in their study was N$5000 and that PTA results have improved with the availability of bailout stenting, it seems likely that their results would remain valid in contemporary practice.
[3]
[4]
4.1. Limitations Our results should be considered in light of several important limitations. This was a nonrandomized, retrospective study, and there may be unmeasured confounding between the treatment groups. Given the single-center nature of the study, the extrapolation of our cost data to other settings is uncertain. The small sample size limits statistical power to detect differences between groups. Alternative devices are available for the treatment of lower extremity atherosclerosis, including lasers, rotational and orbital atherectomy devices, and combination rheolytic thrombectomy with atherectomy. However, the present findings cannot be extended to these since they were not evaluated in the current study. The lack of long-term follow-up prevents long-term cost comparisons and cost-effectiveness analysis. Finally, the current study does not assess quality of life after reopening, which will be critical in future assessment of the treatment of PAD, as the vast majority of femoropopliteal reopening procedures are performed to relieve lifestyle-limiting IC. 5. Conclusions For patients undergoing endovascular femoropopliteal reopening, initial clinical outcomes and costs appear to be comparable for PTA and atherectomy. These findings thus suggest that, in the absence of compelling differences in long-term outcomes or quality of life, the choice between PTA vs. atherectomy as the initial reopening strategies for patients with symptomatic femoropopliteal disease should be based on anatomic considerations and operator experience, more than on clinical or economic factors. Future randomized studies are warranted to determine long-term outcomes and cost-effectiveness of these two procedures.
[5]
[6]
[7]
[8]
[9]
[10]
[11] [12]
[13]
[14]
Acknowledgments The authors would like to thank Dena McDonnell for assistance in the data collection for this manuscript and Joseph Murphy for editorial assistance.
[15]
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