Basic Data Underlying Clinical Decision-Making in Endovascular TherapyEndovascular Intervention for Treatment of Claudication: Is It Cost-Effective?
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treatment of claudication increased 76% during the period 2001-2006 and the number of EVI performed more than doubled (unpublished data).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 According to the recent Medicare data (unpublished), the incidence of PAD is rising and is likely to continue as the baby boom generation ages.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
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Cited by (12)
Improved Adherence to a Stepped-care Model Reduces Costs of Intermittent Claudication Treatment in The Netherlands
2017, European Journal of Vascular and Endovascular SurgeryCitation Excerpt :Treatment strategies for peripheral arterial disease (PAD) are well described in international guidelines recommending supervised exercise therapy (SET) as first line treatment for patients with intermittent claudication (IC).1–3 The advocated treatment strategy for IC may be incorporated into a so called stepped care model (SCM), which aims initially to refer patients to a SET program and restrict revascularisation to those not responding to SET.4–6 Despite the overwhelming evidence supporting the effectiveness of SET, these programs are often not fully reimbursed.7–15
Significant savings with a stepped care model for treatment of patients with intermittent claudication
2014, European Journal of Vascular and Endovascular SurgeryCitation Excerpt :This theoretical approach strives to initially refer all IC patients to a SET program and restrict revascularization to those who do not respond to SET. Several cost-effectiveness analyses have been performed supporting such a SET first treatment strategy.13,16–20 However, no study has been performed to investigate the overall economic consequences of SCM implementation nationwide.
Endovascular treatment for intermittent claudication in patients with peripheral arterial disease: A systematic review
2014, Annals of Vascular SurgeryCitation Excerpt :SET includes programmed exercise plans that are performed under supervision.1 EVT directly improves the narrowing of arteries and has been proven to bring about lasting regression of the ischemic conditions in a significant number of patients.2 However, whether EVT can bring functional benefit to patients, especially compared to SET, is still controversial.
Medical Treatment of Peripheral Artery Disease
2013, Vascular Medicine: A Companion to Braunwald's Heart Disease: Second EditionComments regarding 'walking performance and health-related quality of life after surgical or endovascular invasive versus non-invasive treatment for intermittent claudication - A prospective randomised trial'
2011, European Journal of Vascular and Endovascular Surgery