Oct. 19, 2015
FOR IMMEDIATE RELEASE
Contact: Beth Bales, 312-334-2316
bbales@vascularsociety.org
New study aligns with SVS efforts to gather better PAD data
Report provides more evidence that traditional, “open” surgery may be more durable than
endovascular procedures for peripheral arterial disease; leading association calls for caution,
more research
Oct. 19, 2016, CHICAGO, ILL. -- The last decade has seen a dramatic evolution in the treatment
of peripheral arterial disease (PAD), which can sometimes lead to leg amputation. Surgeons and
patients have overwhelmingly preferred less invasive endovascular procedures over
conventional open bypass surgery.
However a new study published online this month in by the American Heart Association in
Circulation, suggests that open, lower extremity bypass (LEB) surgeries may have better longterm outcomes than the less invasive peripheral endovascular intervention (PVI) for those with
symptomatic PAD.
The article, “The Contemporary Safety and Effectiveness of Lower Extremity Bypass Surgery and
Peripheral Endovascular Interventions in the Treatment of Symptomatic Peripheral Arterial
Disease,” was authored by Dr. Thomas Tsai of Kaiser Permanente, University of Colorado and
cohorts.
Based on a prospective registry of 1,800 cases within two Kaiser regional systems, the authors
report that while 30-day complications were lower after the less-invasive endovascular
procedures, long-term outcomes are significantly better after open surgeries. Patients who
underwent endovascular procedures were far more likely to need additional vascular
procedures within the first few years.
The Tsai study results run counter to prevailing wisdom, noted Dr. Bruce Perler, president of
the 5,300-member Society for Vascular Surgery, since it suggests that traditional open bypasses
offer better outcomes than less invasive treatments.
“The less invasive approach to treating arterial occlusive disease would be expected to be
associated with a lower rate of complications -- and this is obviously appealing to patients and
practitioners,” said Perler. “However, the implications of the higher rate of subsequent reinterventions should not be ignored.”
Trained vascular surgeons, Perler said, are capable of performing both endovascular and open
surgeries and can advise patients on the best course of action.
Perler pointed out that in addition to costing patients additional suffering, the need for
additional surgeries runs counter to the nation’s new era of value-based reimbursement,
longitudinal care emphasis and bundled Medicare payments.
“Will the lower rate of early complications be more than counterbalanced by a need for repeat
interventions and greater costs mid- and long-term?” he asked. “This is a question that
deserves more analysis.”
“The Tsai study highlights the huge and growing burden of secondary treatments and failures
due to recurrent disease,” said Dr. Michael Conte, co-chair of the Society for Vascular Surgery’s
practice guidelines for lower extremity arterial disease and co-editor of the Global Vascular
Guidelines writing group. He also is the immediate past chair of the PAD Council for the
American Heart Association.
“At least one re-intervention was required in 30 to 50 percent of critical limb ischemia patients
in the Tsai study,” Conte said. “For these patients, recurrent pain, non-healed wounds,
diminished function and multiple hospitalizations describe the true impact of vascular
treatment failure. Repeat procedures are burdensome on patients, and are consuming a large
fraction of PAD-related costs. Focusing on the factors that predict treatment failure within each
group might provide greater insight to improve procedure selection, such as who would be
better served by an open bypass first.”
He said the report provided a limited examination of clinical effectiveness. “It showed that longterm rates of mortality and limb loss are roughly similar for the two types of procedures, which
is not particularly surprising,” said Conte. “Patients were selected by their treating physicians
for one procedure versus another for complex reasons. The overwhelming majority of patients
with symptomatic PAD are at fairly low risk for limb loss, and one might expect that medical
management alone (including exercise, not studied by the investigators) might offer
comparable outcomes for death and mortality across a broad patient group such as this. But
those statistics don’t fully capture the impact of successful revascularization on patients’ lives.”
The Circulation findings are not totally surprising for SVS members, who tend to have long-term
relationships with patients and track their progress and any re-interventions. As an example, for
the treatment of asymptomatic PAD and claudication, the SVS just published best practice
clinical guidelines suggesting that invasive procedures performed for claudication, a chronic
non-limb threatening disability, should have a minimum effectiveness of at least two years on
average.
“Many such procedures are being done that fail to meet that minimal threshold,” noted Conte.
Vascular surgery researchers are working diligently to compile more and better data on the
outcomes of various procedures, with the SVS’s new Vascular Quality Initiative emerging as a
key repository of information.
“In the absence of prospective trials, administrative data sets and prospective registries can
provide important snapshots of contemporary practice and outcomes, with known limitations,”
Conte added. “Many studies such as this one have documented the rising use of peripheral
endovascular intervention (PVI) versus lower extremity bypass (LEB), a higher case complexity
and complication rate for LEB and greater durability for LEB.”
A significant number of procedures are being done that fail to meet the treatment goals of
patients, he said, meaning that the field needs to find better ways to predict clinical, rather
than technical success.
“In the meantime,” Conte added, “scientists and engineers should continue to work diligently
to improve the durability of vascular interventions, clearly still the Achilles’ heel of peripheral
revascularization.”
About SVS
The Society for Vascular Surgery® (SVS) is a not-for-profit professional medical society,
composed primarily of vascular surgeons, that seeks to advance excellence and innovation in
vascular health through education, advocacy, research, and public awareness. SVS is the
national advocate for more than 5,300 specialty-trained vascular surgeons and other medical
professionals who are dedicated to the prevention and cure of vascular disease. The Society is
at 633 N. St. Clair St., 22nd Floor, Chicago, Ill., 60611. Visit www.vascularweb.org or email Beth
Bales, content manager, at bbales@vascularsociety.org.