By PATRICK RYAN, MD, FACS, Founder, Nashville Vascular & Vein Institute
Is Open Vascular Surgery Still Necessary?
Vascular Surgery has changed dramatically in the past two decades. The specialty itself is young and small. We are fewer that 4,000 physicians in the U.S.
The first fellowships started in the late 60’s and early 70’s as non-certificated “further training” programs following a general surgery residency. Emphasis at that time was on developing surgeons who were more facile technically in the precise technique required in vascular surgery and … perhaps more importantly … familiar with the natural history of patients with peripheral atherosclerosis in general.
The endovascular revolution started with the first endovascular abdominal aortic aneurysm repair by Juan Parodi and Julio Palmaz in Buenos Aires, Argentina in September 1990. Dr. Parodi’s self-funded, hand-made revolutionary graft quickly spread to the U.S. when he assisted Frank Veith in performing an endo-AAA repair in New York City. The first FDA approved device for endo-AAA repair was released in the late 90’s, and endo-AAA repair is now the preferred first choice for AAA repair worldwide.
Dr. Parodi’s revolutionary procedure had a profound effect on the practice of vascular surgery. Often led by our colleagues in cardiology whose skills in wire-based intervention were already established, vascular surgeons, and the programs training them, quickly rushed into the development of endovascular treatments for peripheral arterial disease. Procedures used at first mostly included angioplasty of larger arteries of the pelvis and thigh. Poor long-term results led to the development of stents tailored to these arteries, improving long-term patency. As with stenting in the coronary arteries, the development of the P2Y12 inhibitor, clopidogrel, greatly decreased the early restenosis and occlusion that occurred when stents were placed in smaller arteries.
The fast pace of changes in the endovascular realm continued through the 2000’s and 2010’s with development of atherectomy (cutting out atherosclerosis from an artery), drug coated balloons and stents, and even the use of stem cell autotransplant into critically ischemic legs. The enthusiasm for these minimally invasive procedures continues unabated today by specialists in vascular surgery, cardiology, radiology, neurosurgery and others. So that begs the question: Do we even need open surgery any more?
Multiple studies have looked at this question. Unfortunately, most of them are observational, industry-sponsored, or just small. A direct, head-to-head, controlled, randomized comparison of endovascular versus open surgery has not been reported, yet. The BEST-CLI trial is underway which aims to compare the two strategies, but its results are years away, and many believe that the trial design is faulty and will not provide an answer to the open vs. endo question. So, what is does an interventionalist do? How do we decide the best way to treat the patient with PVD? There are some studies that help guide us.
In most cases, the choice of how to treat a patient first starts with the specialty of the proceduralist. Non-vascular surgeon physicians have a natural, understandable and proper propensity to attempt an endovascular approach first because the open approach is not part of that specialty. My colleagues in cardiology, radiology and neurosurgery do amazing work in the peripheral realm and nationally have been responsible for many of the advances in endovascular intervention. One need not look far to see remarkable case reports of opening arteries almost from the top of the head to the little toe!
One can easily argue that the pace of advancement in endovascular surgery was in many ways driven by my friends in the cath lab and radiology. Fortunately, a rising tide has lifted all boats, and the care of vascular patients has improved across all specialties. But if we have all this fancy equipment in the lab, and these patients are going home the same day, why do we need to do surgery at all? The answer is complicated, and we are far from being in agreement across specialties.
Numerous studies have been reported trying to answer this question. None are conclusive, but there is a growing consensus among vascular surgeons of the following strategy. For lower extremity disease, the endovascular-first approach is preferable in cases of single-level chronic total occlusions (iliac, femoral, tibial) in good risk patients. However, the aortic, iliac and leg bypass are in many cases the best option in good operative candidates with reasonable life expectancy who have multilevel disease. There are numerous reports of (and I have ample experience in) patients who have poor outcomes after an overly aggressive attempt at limb salvage or claudication treatment after endovascular intervention. A 50 percent one-year mortality for leg amputation makes the complication one to be avoided at all costs. Unfortunately, using an endovascular-only or endo-first approach can lead to just this result. So, how can you, as a referring physician, decide how to get your patient the best result? Let me suggest an approach.
Choose a vascular expert who has specific training and experience in the treatment of peripheral vascular surgery. These days that includes all vascular surgeons and many cardiologists, radiologists and even neurosurgeons (particularly in carotid disease). Ask your consultants if they ever refer patients they cannot treat or on whom a procedure fails to a surgeon. If they respond that they never refer PVD patients to a surgeon, then I would argue (and so would 99 percent of the Society for Vascular Surgery) that this could be a warning sign. Furthermore, remember that claudication is a benign process in literally 95 percent of patients over five years. Most claudicants should be treated with medication, smoking cessation and exercise therapy at first. Exceptions are for people whose lifestyles are severely affected (i.e. they cannot work due to claudication) or worsening symptoms despite best medical therapy. For a half-mile claudicant, the potential benefits of intervention DO NOT outweigh the potential risk of intervention. Finally, every single vascular patient should be on a relatively high dose of a statin and aspirin and potentially an ACE/ARB for risk reduction, regardless of cholesterol levels.
Is surgery still necessary for the treatment of PVD? Absolutely, it is. However, it is much, much less common than it used to be and for very good reasons. The specialist who practices evidenced-based treatment for PVD will be able to fix most of their patients with wire-based interventions. But, there are times that a patient will just need an operation.
Patrick Ryan, MD, FACS, is a board certified vascular surgeon practicing in Nashville. He specializes in minimally invasive and open vascular surgery and has a particular interest in critical limb ischemia, aneurysm disease and carotid disease. Ryan is the founder of Nashville Vein & Vascular Institute. For more information, go online to nvavi.com.