RF-TVA™ FAQ

How do spine fractures affect my patients’ overall health?
In addition to lasting pain, clinical studies have documented other important health concerns that are linked to having a vertebral compression fracture:

  • Impaired function and decreased mobility1
  • Increased depression, anxiety, and dependence on others2
  • Patients with a fracture in the mid back (thoracic region) experience a 9% decrease in lung function3
  • Having one spine fracture increases a patient's risk of having another fracture by 20%4
  • Female patients with a spine fracture experience a 23% increase in mortality4
What should patients know about spine fracture treatments?
Multiple treatments are available: non-operative care, invasive spine surgery, and minimally invasive procedures, such as vertebroplasty, conventional balloon kyphoplasty, and Radiofrequency-Targeted Vertebral Augmentation™ (RF-TVA™).

Evaluating each patient one-on-one to determine the best course of care is critically important. Non-operative care, while seemingly benign, is not without patient risks. And despite the controversy created by several NEJM publications, there is ample clinical evidence showing that vertebroplasty and vertebral augmentation are clinically appropriate when performed on the appropriate patient population. RF-TVA™ (formerly RF Kyphoplasty) has been clinically proven to provide rapid and lasting back pain relief.

Is RF-TVA right for my patients?
Patients with coagulation disorders, severe pulmonary insufficiency, or sensitivity to any of the components found in the bone cement are not qualified to undergo RF-TVA treatment. Please consult your patients to determine if RF-TVA is right for them and to discuss other potential concerns, including their current physical condition, age of the fracture, a treatment timetable, and RF-TVA (RF Kyphoplasty) risks and complications.

How will my patients benefit from of RF-TVA?
Benefits experienced during RF-TVA (RF Kyphoplasty) recovery can include:

  • Significant, immediate and lasting back pain relief5-15
  • Significant improvement in mobility and quality of life5-9
  • Return to daily activities soon after procedure5,7

What risks are associated with RF-TVA?
As with most surgical procedures, serious adverse events can occur, some of which can be fatal. RF-TVA is designed to minimize risks as much as possible and avoid complications. However, potential serious adverse events that can occur include:

  • Myocardial infarction (heart attack)
  • Pulmonary embolism (cement leakage that migrates to the lungs)
  • Cerebrovascular accident (stroke)
  • Cardiac arrest (heart stops beating)
  • Paralysis or muscle weakness
  • Death

A prescription is required. Consult your patients to determine if this procedure is right for them and to discuss these and other potential concerns, including their current physical condition, age of the fracture, a treatment timetable, and RF-TVA (RF Kyphoplasty) risks and complications.

What should my patients expect during the procedure?
RF-TVA is typically an outpatient procedure but may be done on an inpatient basis, depending on the patient’s physical condition. The procedure usually requires sedation, local anesthesia and a small incision to access the vertebra. The entire procedure takes, on average, 30 to 40 minutes to complete.5,6,14,16-18

What should my patients expect following the procedure?
A small band-aid is placed over the incision following treatment. The patient will then spend several hours in the recovery room, after which time he or she will be able to return home.

References

  1. Silverman SL. The Clinical Consequences of Vertebral Compression Fracture, Bone. 1992;13 Suppl 2:S27-31.
  2. Gold D. The Clinical Impact of Vertebral Fractures. Bone. 1996;18:1855-1895.
  3. Schlaich C. Reduced Pulmonary Function in Patients with Spinal Osteoporotic Fractures. Osteoporosis Int 1998;8:261-267.
  4. Kado D, Browner W, et al. Vertebral Fractures and Mortality. Arch Inter Med. 1999;159:1215-1220.
  5. Murphy K. Radiofrequency Kyphoplasty: A Novel Approach to Minimally Invasive Treatment of Vertebral Compression Fractures in The Comprehensive Treatment of the Aging Spine: Minimally Invasive and Advanced Techniques edited by Yue JJ, Guyer R, Johnson JP, Khoo LT, Hochschuler H, and Hochschuler SH. Elsevier. Pg 248-252.
  6. Elgeti F and Gebauer B. Radiofrequency Kyphoplasty for the Treatment of Osteoporotic and Neoplastic Vertebral Body Fractures: Preliminary Experience and Clinical Results after 6 Months. J Mimer Stoffwechs. 2011;18 Suppl 1:S5-9.
  7. Licht A and Kramer W. Radiofrequency-Kyphoplasty in the Treatment of Vertebral Body Compression Fractures. Eurospine 2010.
  8. Pflugmacher R, Randau T, Kabir K, and Wirtz DC. Radiofrequency (RF) Kyphoplasty in treatment of osteolytic vertebral fractures. IOF 2010.
  9. Miko L, Szikora I, Grohs J, and Murphy K. Initial Clinical Experience with Radio-Frequency Based Vertebral Augmentation in Treatment of Vertebral Compression Fractures. SIR 2009.
  10. Sewall L, Smith S, and Vlahos A. Clinical Evaluation of Percutaneous Vertebral Augmentation Procedures using Radiofrequency Kyphoplasty in Treatment of 69 Vertebral Compression Fractures. ASBMR 2010.
  11. Pflugmacher R, Bornemann R, Randau T, and Wirtz DC. Comparison of clinical and radiological data in treatment of patients with osteoporotic vertebral compression fractures with radiofrequency kyphoplasty or balloon kyphoplasty. IOF 2010.
  12. Heck P and Bayer-Helms H. Case report: Treatment by radiofrequency kyphoplasty of an 85-year-old woman with traumatic osteoporotic fracture of the first lumbar vertebra. J Miner Stoffwechs. 2011;18 Suppl 1:S29-31.
  13. Schekelmann R. Radiofrequency kyphoplasty – a case report on multiple osteoporotic sintering of the lumbar spine. J Miner Stoffwechs. 2011;18 Suppl 1:S32-34.
  14. Licht AW and Kramer W. Radiofrequency kyphoplasty: a new method for the treatment of osteoporotic vertebral body compression fractures ¬– a case report. J Miner Stoffwechs. 2011;18 Suppl 1:S26-28.
  15. Drees P, Kafchitsas K, Mattyasovszky S, Juri S, and Breijawi N. Radiofrequency Kyphoplasty - An Innovative Method of Treating Osteoporotic Vertebral Body Compression Fractures. J Miner Stoffwechs. 2011;18 Suppl 1:S13-17.
  16. Licht, AW and Kramer W. One-year observation study upon a new augmentation procedure (Radiofrequency-Kyphoplasty) in the treatment of vertebral body compression fractures. Eurospine 2011.
  17. Erdem E, Akdol S, Amole A, Fryar K, and Eberle R. Initial Clinical Experience with Radio-Frequency Based Vertebral Augmentation in Treatment of Vertebral Compression Fractures As a Result of Multiple Myeloma. ASSR 2011.
  18. Pflugmacher, R, Bornemann, R, Randau, T, and Wirtz, DC. Comparison of clinical and radiological data in treatment of patients with osteoporotic vertebral compression fractures with radiofrequency kyphoplasty or balloon kyphoplasty. GRIBOI 2011 – The 21st Interdisciplinary Research Conference On Injectable Osteoarticular Biomaterials and Bone Augmentation Procedures.