BiZact Tonsillectomy in the Pediatric Population
BiZact Tonsillectomy in the Pediatric Population
This study has been designed to evaluate how effective the Bizact tonsillectomy device is in
 reducing operating time and complications that occur after surgery. This device operates in a
 different way than the standard device that is used for most tonsillectomies. In 2019, a
 study was conducted in 186 children and adults using this device in tonsillectomies. Results
 showed lower blood loss and shortened time in surgery. However, the rate for bleeding as a
 complication after surgery was the same as other procedures that are used in tonsillectomy
Tonsillectomy is the second most common pediatric surgical procedure, with more than 280,000
 performed in children under the age of 15 in the United States in 2010. The most common
 indications for tonsillectomy in children include recurrent infections and obstructive sleep
 apnea. While tonsillectomy in the pediatric population is generally safe and well-tolerated,
 post-operative complications are not uncommon, with post-operative pain, respiratory
 compromise, and post-tonsillectomy hemorrhage being chief among them.

 Post-operative pain has been described as the main morbidity associated with tonsillectomy
 and is often ineffectively controlled. Pain beyond the initial 24-hour post-operative period
 has been noted to be worse with the use of electrocautery when compared to cold-knife
 dissection and snare tonsillectomy, perhaps attributable to the high levels of heat (400 °C
 to 600 °C) applied directly to the tonsillar area. Yet electrocautery remains one of the most
 frequently utilized tools due to its hemostatic effects through vessel coagulation at the
 time of dissection. Still, a recent large meta-analysis reported the rates of primary
 post-tonsillectomy hemorrhage (bleeding within the first 24 hours) at 2.4% and secondary
 post-tonsillectomy hemorrhage (beyond 24 hours) at 2.6%, suggesting that bleeding after
 tonsillectomy remains a relatively common occurrence. The search for a methodology that
 improves post-operative pain without increasing the risk of post-operative hemorrhage remains
 an active area of research.

 Coblation, which creates an ionized plasma layer by passing a bipolar radio-frequency current
 through a medium of saline, offers another approach. The saline irrigation results in much
 less heat when compared to monopolar cautery, measuring approximately 40°C to 70°C. Coblation
 can be used in both subcapsular and intracapsular fashion. Subcapsular tonsillectomy with
 coblation has demonstrated a minimal decrease in pain, and may result in slightly higher
 rates of post-operative hemorrhage.

 It has been pointed out that bipolar cautery could result in lower thermal injury and reduced
 blood loss, however tonsillectomy using traditional bipolar forceps leads to longer operative
 times. One group found that the use of BiClamp, a bipolar vascular sealing device originally
 designed for thyroidectomy, provided decreased operative times and less intraoperative
 bleeding compared to electrocautery. They noted, however, instances of posterior pillar
 perforation, which they attributed to curvature of the device that was designed for thyroid
 surgery, making dissection of the superior pole more difficult. Medtronic has now developed a
 similar device designed for use in tonsillectomy with a curved jaw meant to follow the
 contour of the tonsillar bed. In its marketing material for the recently developed BiZact ,
 Medtronic describes a bipolar device that continuously measures the impedance of clamped
 tissue, adjusting energy levels in real-time and automatically stopping energy delivery when
 a seal is established. Their literature suggests the device permanently seals vessels up to
 3mm with less thermal damage, resulting in less intraoperative blood loss, more efficient
 procedures, and possibly less pain.

 In a pilot study of 186 patients, intraoperative blood loss was shown to be <1ml of blood
 loss in 71 cases (38.2%) and between 1 and 10ml of blood loss in 81 cases (43.5%).
 Post-operative hemorrhage rate of 4.3% is similar to rates described by other studies. BiZact
 tonsillectomy allows for a shortened operative time with a median time of 5.1 minutes. Other
 studies have shown other techniques to have a time duration of 21.6 minutes (electrocautery),
 20.20 minutes (coblator), and 16.14 minutes (microdebrider).

 In off label use of the device at our institution, data from surgeons using the device showed
 that surgeons perceived a relative improvement in following compared to standard
 tonsillectomy:

 1. Less perceived thermal heat transfer to surrounding soft tissues

 2. Left perceived blood loss

 3. Superior ease of obtaining timely hemostasis

 4. Faster operative time
Inclusion Criteria:

 -  Tonsil hypertrophy with sleep disordered breathing

 -  Recurrent tonsillitis or pharyngitis

 -  Tonsil asymmetry or neoplasm

 -  Tonsil stones

 -  Must be able to take ibuprofen

 Exclusion Criteria:

 -  Bleeding disorders such as von Willebrand's disease or hemophilia

 -  Down's Syndrome or other craniofacial syndromes

 -  Revision tonsillectomy cases