Point/Counterpoint: Endo first for the treatment of infrainguinal PAD?
What about inadequate autogenous conduit? Even my counterpoint opponent has published a documented 20% risk of absent or inadequate ipsilateral greater saphenous vein.3 While he and his colleagues have documented excellent results using contralateral greater saphenous vein, there is still an inevitable morbidity and, yes, even a mortality risk associated with contralateral leg vein harvest. While in a good cardiac risk patient this may be negligible, we are again facing an ever more complex and medically ill patient population to subject to vascular treatment. It is in this setting that many vascular surgeons move to prosthetic conduits for the treatment of the patient’s vascular disease. While this may provide a short-term fix for the conduit problem, in the long term the risk of sudden, uncompensated failure of limb perfusion by prosthetic graft failure may often result in a higher risk procedure at a time when the patient may be older and more severely limited. Endovascular treatment is clearly a reasonable alternative in patients where autogenous conduit is not readily available.
While this debate will inevitably continue as long as practitioners have bias toward either open or endovascular management of vascular disease, one thing is for certain: We will continue to extend the limits of treatment to ever more ill and complex patients. While we have been very successful at performing fewer and fewer morbid interventions for limb-threatening vascular disease, these patients continue to be increasingly challenging to manage.
As the overall population continues to age, the need for less invasive treatment of limb-threatening vascular disease will continue to grow. And, yes, I agree that vascular surgeons in the role of interventionalist or surgeon are the leadership for the management of CLI in the future.
Dr. Meier is professor and chief of vascular surgery at the University of Cincinnati.
References
1. J. Vasc. Surg. 1998;27:256-63; discussion 264-6
3. J. Vasc. Surg. 2002:35:1085-92
No: A selective approach remains the key.
By Dr. MICHAEL S. CONTE
Recently the term “pandemic” has been applied to the growing global impact of peripheral artery disease (PAD), currently estimated to afflict more than 200 million individuals.1 The term “critical limb ischemia” (CLI), connoting the most advanced stage of PAD with imminent limb threat, is inadequately defined2 but likely encompasses 1%-3% of PAD. Aging of the global population and the increasing prevalence of diabetes are fueling increases in CLI and its impact on public health. While traditionally treated largely by vascular surgeons plying the open bypass trade, the ongoing development and market dispersion of catheter-based technologies for CLI has led to major secular changes.
Recent estimates suggest that upward of 5 billion dollars are spent annually on CLI in the Medicare population.3, 4 Increasing volumes and costs associated with revascularizations for CLI are a major driver, yet recent data suggest that regional spending in the United States is widely disparate and not directly associated with amputation rates.5 Thus defining effectiveness and value in CLI care has become a major challenge to the vascular community.
In current everyday practice, clinicians are faced with making treatment choices for CLI patients based on limited data and lots of anecdote. While the “open vs. endo” debate goes on, in many ways it has become less broadly relevant as the sophisticated clinician recognizes the real challenge lies in defining which approach to apply first in the right patient, at the right time. The only randomized, controlled trial (RCT) done in the field, the BASIL trial,6 is more than a decade old. However its findings remain important. For patients with “severe limb ischemia” likely to survive for at least 2 years, open bypass surgery offered better outcomes over angioplasty as an initial strategy.7 Moreover, the finding in BASIL that patients undergoing bypass after prior failed angioplasty did poorly,8 suggesting “no free lunch” for endovascular failures, has since been confirmed in other large registry studies.9
Simply stated, failure matters in CLI. And although endovascular techniques have continued to improve, the growing epidemic of restenosis shows no signs of abating.10 As in the case of percutaneous coronary intervention (PCI), we will know when endo results are meaningfully improved in PAD when the procedure volume curves actually flatten, not continue to grow geometrically.
So, in selecting the optimal strategy for CLI today, let’s focus on what we seem to know and try to apply an evidence-based mentality. We know that open bypass surgery is an effective and versatile treatment, but one that carries real morbidity (10%-20%) and some mortality (1%-3%). Among many large studies, the PREVENT III multicenter trial provides benchmark data on perioperative and 1-year outcomes.11
