Friday, January 26, 2018

The World Pediatric Projects winter fundraiser called "Treasures in Paradise" happened last week, Friday January 26th,

The keynote speaker was Erickson Hernandez, a wonderful young man who Drs. Manke and Goldfarb, and myself treated at our Shriner's Hospital.

Check out the web address (copy and paste in your browser) below for a video of Erickson's speech.

Thursday, January 25, 2018

Vertebral Body Tethering (Part 4)

Primum non nocere or “do no harm” is a basic tenet of medicine.  This is why for surgical procedures, such as Vertebral Body Tethering or VBT, safety is the pre-eminent concern, even more so than its efficacy or how well it works.  If a surgical procedure is safe (infrequent, minor complications, with no significant long-term problems) but only demonstrates mild to moderate efficacy then it may be viewed as a reasonable treatment.  However if the procedure cannot be demonstrated to have reasonable safety it is unlikely any level of efficacy will be able to make this a reasonable treatment.  This is especially the case for diseases which are not life-threatening, such as scoliosis. 

As patients and caregiver potentially contemplate if VBT as a possible treatment (as detailed in an earlier post) it is important that the potential complications or adverse outcomes are detailed and well-understood as to their likelihood, severity and long-term implications.  The list of complications which may occur with VBT are:

Anesthetic problem (such as allergic reaction or airway problem)
Injury to the great vessels, heart, lungs
Uncontrolled bleeding
Neurologic deficit
Postoperative pneumothorax
Surgical site infection
Screw pullout or symptomatic migration
Tether breakage
Failure of VBT modulate growth
Over-correction of spinal deformity
Pleural scarring secondary to surgical approach and presence of screw heads/tether in chest
Irritation of the diaphragm or psoas due to screws
Back or chest pain

In the next blog post the long-term issues of VBT will be presented.

Tuesday, January 16, 2018

Vertebral Body Tethering for Scoliosis (Part 3)

In Medicine, and in particular the area of spine deformity, the development of new treatments and technologies which can demonstrate improved outcomes, lower frequencies of complications, and/or faster recovery can create a “buzz” and enthusiasm depending on its potential of improvement.  Physicians typically see these innovations earlier than the general public at medical meetings and read about them in peer-reviewed medical journals.  Slightly later the medical media, followed by mainstream media, begin to report on the new medical technologies, especially if these treatments have developed some traction amongst physicians.  One such technology is Vertebral Body Tethering (VBT) for scoliosis in the growing spine. 

As detailed in previous postings on this blog there is significant potential for this technology, but little scientific evidence of its efficacy in humans.  At present there are no approved implant systems in the U.S. which are FDA-approved for scoliosis. Spine implants used for VBT are being used in an off-label or unlabeled manner in the U.S.  It is important to understand that innovations, especially in area of surgical spine deformity treatment, advances typically occur faster than does FDA approval.  So innovations without FDA approval does not categorically mean they are unsafe or do not work, rather there is an absence of sufficient high-level of medical evidence to prove these devices are safe and efficacious to the FDA, who demands very high level of scientific proof.  Prior to FDA approval implant systems, such as VBT, exist in a “grey” area.  This can be frustrating to patients and caregivers who are anxious for advances in medicine, yet there is scant medical literature to help them navigate treatment options. 

In the next blog post the complications of VBT will be presented.