SAN DIEGO (March 24, 2014)—Individuals suffering from spinal fractures—
caused by osteoporosis or weakened bones—now have another option to reduce
pain, restore function and improve quality of life, according to a study of 300
patients treated with a new type of vertebral augmentation. Results of a randomized,
controlled multicenter trial on a new implant treatment for vertebral compression
fractures are being reported for the first time at the Society of Interventional
Radiology’s 39th Annual Scientific Meeting.
Made of medical polymer, the implant is designed to treat painful and
debilitating vertebral compression fractures, which cause the bones in the spine to
collapse and, left untreated, can lead to pain and a condition called kyphosis (or a
curvature of the spine). Recently cleared by the U.S. Food and Drug Administration
(FDA), the implant provides a new treatment alternative to vertebroplasty and
kyphoplasty, the current standards of care. The implant was shown to meet or
exceed the performance of kyphoplasty on every measure studied.
“This the first new method of treating these painful fractures in a decade, which
is great news for patients because it not only helps restore quality of life, but it also
was shown to outperform our most-used treatment in important ways,” said Sean M.
Tutton, M.D., FSIR, lead author of the study and professor of radiology, medicine
and surgery at Medical College of Wisconsin in Milwaukee. “This Level 1 trial,
which provides the highest quality and most reliable data, is one of the largest to
date to compare a new treatment for vertebral compression fractures to standard of
care—and the results match or exceed those of the current treatment,” said Tutton.
“This research also adds to the growing body of evidence supporting the efficacy
and safety of these treatments,” he added.
“Interventional radiologists are leading the way in providing minimally invasive
treatment innovations for the spine, including developing new technologies that
show significant patient benefits,” said SIR President Scott C. Goodwin, M.D.,
FSIR. The Society recently published a multisociety position statement on vertebral
augmentation, discussing current and future technologies and noting that augmentation is a safe, effective and
durable treatment in appropriate patients, added Goodwin, Hasso Brothers’ Professor and chair of radiological
services at the University of California Irvine (UCI) School of Medicine.
Kiva System as a Vertebral Augmentation Treatment—A Safety and Effectiveness Trial (KAST) was a study
conducted with FDA approval in which 153 patients with one or two painful osteoporotic vertebral compression
fractures received the new implant and 147 had balloon kyphoplasty. Patients were treated at one of 21 centers in
the United States, Canada, Belgium, France and Germany and were followed for one year. Results of the study
confirmed that the implant provided essentially the same amount of pain relief and improvement in daily function
based on accepted measures for pain and function (visual analogue score, VAS; Oswestry Disability Index, ODI)
and safety. Researchers also found patients who had the implant were more likely to benefit from a reduction in
the angle of the kyphosis and less likely to have the bone cement leak. Moreover, the study showed a clinically
important trend in that the implant patients were less likely to suffer a fracture in adjacent vertebra. This latter
finding is despite the fact that the 153 patients who received the implant had higher risk predictors for future
fractures.
There are approximately 700,000 osteoporosis-related vertebral compression fractures in the United
States every year, which is only expected to continue growing as the population ages, said Tutton. Treatment options include pain medications and bed rest, or now one of three image-guided minimally
invasive treatments often performed by an interventional radiologist or interventional neuroradiologist:
vertebroplasty, balloon kyphoplasty and the placement of this new implant. The implant is designed to
provide structural support to the vertebral body and a reservoir to direct and contain bone cement. “We are
moving away from traditional vertebroplasty or balloon-based vertebral augmentation, which relies solely
on the administration of bone cement. This new approach allows the treating doctor to deliver a much more
predictable supportive structure into the vertebrae,” said Tutton.
More information about the Society of Interventional Radiology, finding an interventional radiologist
in your area and minimally invasive treatments can be found online at www.SIRweb.org.
Abstract 238: “KAST Study: The Kiva® System as a Vertebral Augmentation Treatment—A Safety and
Effectiveness Trial,” S.M. Tutton, M.D., FSIR, Medical College of Wisconsin, Milwaukee; R. Pflugmacher,
M.D., Universitätsklinikum Bonn, Germany; M. Davidian, M.D., Radiological Associates of Sacramento,
Calif.; D. Beall, M.D., Clinical Radiology of Oklahoma, Edmond; F.R. Facchini, M.D., FSIR, Vascular and
Interventional Radiology Associates, Hinsdale, Ill.; C. Nutting Jr. DO, FSIR, Radiology Imaging
Associates, Greenwood Village, Col.; J. Hierholzer, M.D., Klinikum Ernst von Bergmann gGmbH,
Potsdam, Germany; D. Nguyen, M.D., Radiology, Penn State Hershey Medical Center, Pa.; R. Smith,
M.D., radiology, Toronto Western Hospital, Ontario, Canada; F. Schils, Saint Joseph, Liege, Belgium; J.
Rappaport, M.D., Sierra Regional Spine Institute, Reno, Nev.; P. Jarzem, M.D., Montreal General
Hospital, Quebec, Canada; D.F. Kallmes, M.D., Mayo Clinic, Rochester, Minn.; J.A. Stone, Mayo Clinic
Jacksonville, Jacksonville, Fla.; F. Komlos, El Camino Hospital, Mountain View, Calif.; J. Zucherman,
M.D., St. Mary’s Spine Center, San Francisco, Calif.; E. Kerr, M.D., Spine Institute of Louisiana,
Shreveport; M. Alonzo, M.D., North Shore University Health System, Evanston, Ill.; H. Deramond, M.D.,
Radiology, CHU Amiens, France; S.R. Garfin, M.D., Orthopedics, UC San Diego. SIR Annual Scientific
Meeting, March 22–27. This abstract can be found at www.SIRmeeting.org
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About the Society of Interventional Radiology
Interventional radiologists are physicians who specialize in minimally invasive, targeted treatments.
They offer the most in-depth knowledge of the least invasive treatments available coupled with diagnostic
and clinical experience across all specialties. Using X-ray, MRI and other imaging to advance a catheter in
the body, such as in an artery, they treat disease at the source internally. As the inventors of angioplasty and
the catheter-delivered stent, which were first used in the legs to treat peripheral arterial disease,
interventional radiologists pioneered minimally invasive modern medicine. Many conditions that once
required surgery can be treated less invasively by interventional radiologists. Interventional radiology
treatments offer less risk, less pain and less recovery time compared to open surgery. Visit
www.SIRweb.org. Follow SIR on Facebookand Twitter and use #SIR2014 to keep up with news from SIR
2014.
Local interviews and medical illustrations are available by contacting SIR’s communications
department staff: Ellen Acconcia, SIR manager, website and communications, eacconcia@SIRweb.org,
(703) 460-5582, or Maryann Verrillo, SIR director of communications and public relations,
mverrillo@SIRweb.org, (703) 460-5572.
