Basic Data Underlying Clinical Decision-Making in Endovascular Therapy
Endovascular Intervention for Treatment of Claudication: Is It Cost-Effective?

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Background

Treatment of claudication with endovascular intervention (EVI), a procedure designed to enhance quality of life, is on the rise despite being expensive. We examined clinical outcomes and costs for treatment of claudication with EVI.

Methods

Records of all EVI performed at a University Health Center during a single year were reviewed for functional capacity, Trans-Atlantic Inter-Society Council (TASC) classification, procedure, reintervention, and financial data. Sustained clinical success (SCS) (improvement without target extremity revascularization [TER]) and secondary sustained clinical success (SSCS) (improvement with TER) were tracked over 2 years follow-up.

Results

There were 77 patients (90 limbs). Mean follow-up was 14.8 ± 7.7 months (1-30). Procedural success was 94%. Two-year SCS and SSCS were found to be 28 ± 9% and 49 ± 11%, respectively. SCS differed significantly from TASC (p = 0.02), whereas SSCS did not (p = 0.33). Mean time to reintervention was 11.7 ± 6.6 months. Two-year TER-free rate (65 ± 7%) did not differ significantly by procedure (p = 0.26), the artery treated (p = 0.24), or TASC (p = 0.18). Two-year costs for EVI were $13,886, differing significantly by TASC (p = 0.017) and by the artery treated (p < 0.001). Estimated cost for a 3-month trial of supervised exercise and pharmacotherapy was $1,376, and the maintenance cost over a 2 year follow-up period was $6,602.

Conclusions

TER was necessary in more than one-third of limbs to maintain 2-year SSCS in 49% of patients. EVI was twice as expensive as estimated 2-year costs for supervised exercise and pharmacotherapy, and 10 times more costlier than a 3-month trial. Mandating a trial of conservative therapy before EVI merits consideration.

Introduction

Percutaneous revascularization is minimally invasive, carries nominal risk, and consequently has gained popularity in the management of peripheral arterial disease (PAD). Although reasonable midterm outcomes for treatment of claudication with endovascular intervention (EVI) have been reported,1, 2 clinical benefit from more conservative management, such as exercise3 or pharmacotherapy,4 has also been demonstrated. Moreover, conflicting results on the cost-effectiveness of EVI have also been reported. Some have indicated that EVI for claudication is cost-effective,5, 6 whereas others have found it expensive,7 and still some have favored supervised exercise (SE) on the basis that EVI is significantly more expensive than exercise but does not confer significantly greater improvement in physical functioning.8 Although the relative benefit and cost-effectiveness of EVI for treatment of claudication have yet to be unequivocally established, an unmistakable trend toward management with EVI has evolved. In New York State alone, hospitalization for the treatment of claudication increased 76% during the period 2001-2006 and the number of EVI performed more than doubled (unpublished data). This may indicate that Trans-Atlantic Inter-Society Council (TASC II) recommendations to reserve infra-inguinal EVI for cases that fail “best” medical management9 may not be universally implemented as a standard of practice. Several practitioners across diverse specialties currently perform EVI. Differences in ideology as well as accessibility of care such as payor reimbursed supervised exercise programs make it likely that conservative therapy is implemented with varying degrees of rigor and that thresholds for intervention differ.

PAD occurs in 15% of elderly Americans,9 representing a major health concern for the United States. According to the recent Medicare data (unpublished), the incidence of PAD is rising and is likely to continue as the baby boom generation ages. The shear increase in the number of individuals seeking treatment compounded by enthusiasm to use this new but potentially costly technology will undoubtedly add fiscal strain. Funding of health care has become a highly politicized national concern. Reform is imminent and the concept of value-based insurance is gaining momentum. It is imperative that the most efficacious, cost-efficient management be identified and implemented. The purpose of this study was to examine clinical outcomes and insurer cost for treatment of claudication with EVI.

Section snippets

Design

This is a retrospective review of all percutaneous EVIs performed for lifestyle-limiting claudication during a single year within two adult acute care hospitals of a consolidated, university-affiliated, tertiary health care system. Although EVI of the iliac vessels for treatment of claudication is generally considered as an accepted practice, infra-inguinal procedures remain under scrutiny.9 To accurately capture efficacy and cost effectiveness of all EVIs used to treat claudication, iliac and

Results

A total of 77 patients (90 limbs) were treated for lifestyle-limiting claudication. This represented one-third of all EVI performed during the study period. Among the patients, 62% (48) were men. The mean age at the time of intervention was 64.5 ± 11.0 years. The percent of patients smoking at the time of intervention was found to be 57%. Pre-intervention ABI was 0.65 ± 0.21 at rest. Rutherford classification was severe (65%), moderate (23%), and mild (12%). The majority of limbs treated for

Discussion

Developments in endovascular technology have advanced rapidly as has enthusiasm to perform EVI. The potential to improve QOL with minimally invasive technique is alluring, offering an attractive alternative to previous management strategies despite lack of thorough evaluation and proven outcome. Endovascular interventions are performed by a vast number of physicians across diversified specialty fields. Lack of cross-specialty universal standards for intervention has resulted in more liberal

Limitations

Generalization of results may be limited as the sample size of this study was small. Moreover, because of the retrospective design, we were unable to use validated tools commonly used to evaluate QOL outcomes such as the Medical Outcomes Study-8 Health Survey or Walking Impairment Questionnaire. Although these tools work well in controlled randomized prospective trials, they are cumbersome to implement into clinical practice as intense diligence is required to ensure patient completion at

Conclusions

As the potential for nationalized health care becomes more imminent, the consensus of physicians who perform EVI must be proactive in directing its future, keeping in mind its efficacy and costs. Universal standards that address patient selection criteria, protocols of care, and methods for reporting outcomes need to be developed. The Claudication: Exercise Vs. Endoluminal Revascularization study, a 5-year randomized controlled trial sponsored by the National Institute of Health is underway.18

References (18)

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