Rhizotomy

Percutaneous Balloon Compression Rhizotomy
for the Treatment of Trigeminal Neuralgia:
Improvised Solution for an Unexpected
National Supply Shortage

Currently, the only balloon compression kit that is approved
by the US Food and Drug Administration for the treatment
of trigeminal neuralgia is the Mullan percutaneous trigeminal
ganglion microcompression set manufactured by Cook Medical,
Inc (Bloomington, Indiana). However, recently, the production
and sale of this kit was halted due to difficulties in the
manufacture of the balloon and it is not clear when, if ever, it
will resume. This has created a significant problem for neurosurgeons
who rely upon this kit for balloon compression rhizotomy.
At our institution, we have had to identify an alternative approach
for balloon compression rhizotomy.
Our replacement kit for this procedure includes a 15-G sharp
needle (manufacturer catalog number: 8881200029; Covidien,
LLC, Medtronic Inc, Dublin, Ireland), an 11-G Jamshidi biopsy
needle set (manufacturer catalog number: DJ4011X; CareFusion,
Inc, McGaw Park, Illinois), which included a needle, sharp
obturator, stylet, and luer lock adapter, a disposable Check-Flo
adapter (manufacturer catalog number: G16268; Cook Medical,
Inc), a 4-Fr Fogarty arterial embolectomy catheter of 80 cm,
with a 0.75-cc balloon (manufacturer catalog number: 120804F;
Edwards Lifesciences, LLC, Irvine, California), a Kyphon
Xpander inflation syringe (manufacturer catalog number: A08A;
Medtronic Sofamor Danek USA, Inc, Memphis, Tennessee), and
IsoVue-M 200 (manufacturer catalog number: 1411-11; Bracco
Diagnostics, Inc, Cranbury, New Jersey). Figure 1 shows the
improvised kit components.
Surgical technique is described as the following. The patient
is placed in the supine position on the operating table. After the
induction of general anesthesia, an external pacemaker is applied
to prevent possible bradycardia secondary to the trigeminocardiac
reflex during the compression of the trigeminal nerve root.1 The
head is kept in a neutral position with mild neck extension.
Portable fluoroscopy (ie, a mobile C-arm) is used to obtain a
lateral view of the patient’s skull. Both the operating table and
the portable fluoroscopy are adjusted to obtain a true lateral
image. A second portable fluoroscopy is used to obtain an oblique
submental view to visualize the foramen ovale on the side of
interest. The entry point on the cheek, which is 2.5 cm lateral
to the oral fissure, is prepared with sterile solution and then the
site is sterilely draped.
Prior to skin puncture, the Fogarty catheter is prepared by
carefully filling it with IsoVue-M 200. A 1-mL syringe filled with
IsoVue-M 200 is connected to the Fogarty catheter in a vertical
configuration. The balloon is then filled with IsoVue-M 200 and
FIGURE 1. Tray of improvised kit of components. 1: Jamshidi needle, 1A: Sharp
obturator. 1B: Stylet. 1C: Luer lock adapter. 2: Fogarty arterial embolectomy
catheter. 2A: Fogarty balloon. 3: Check-Flo adapter. 4: Kyphon Xpander inflation
syringe.
air bubbles are removed by repeatedly pulling back the syringe
plunger and then injecting more contrast. The inflation syringe is
also prepared by filling it with IsoVue-M 200. Careful handling
is emphasized to avoid bubbles within the syringe. The Check-
Flo adapter is then passed over the Fogarty catheter. The Fogarty
catheter is then passed through the Jamshidi needle, which is preassembled
with the luer lock adapter. The Check-Flo adapter is
then set to a depth that just exposes the Fogarty catheter balloon.
The stylet depth is also measured to match the depth of the
Fogarty catheter balloon. The Check-Flo valve is tightened to set
the appropriate depth on the Fogarty catheter. Figure 2 shows this
final setup orientation. The Fogarty catheter is then removed from
the Jamshidi needle.
The skin puncture is made using the 15-G sharp needle at
2.5 cm lateral to the oral fissure. The Jamshidi needle with the
obturator is passed toward the foramen ovale. Its location is
confirmed with both lateral and submental views of the X-ray.
Occasionally, an 11-G Jamshidi needle does not pass beyond
the foramen ovale, and only the stylet passes into Meckel’s cave.
The obturator is removed and the luer lock adapter is then
attached to the Jamshidi needle. The stylet is passed through
the needle to the preset length. The position is confirmed using
fluoroscopy. The stylet is withdrawn from the Jamshidi needle.
The balloon catheter is then passed through the Jamshidi needle
at the preset length, marked by the Check-Flo adapter. The
position is confirmed using fluoroscopy. The inflation syringe
OPERATIVE NEUROSURGERY VOLUME 13 | NUMBER 4 | AUGUST 2017 | E19
CORRESPONDENCE
FIGURE 2. Assembled components. 1: Jamshidi needle. 1A: Sharp obturator. 1B:
Stylet. 1C: Luer lock adapter. 2: Fogarty arterial embolectomy catheter. 2A: Fogarty
balloon. 3: Check-Flo adapter. 4: Kyphon Xpander inflation syringe.
is then connected to the Fogarty catheter. Figure 3 shows the
final positioning. The Fogarty catheter balloon is inflated with
the target intraluminal pressure of 1.4 atm for 90 s. The inflation
of the balloon needs to be performed with fluoroscopic control.
Pressure measurement is used to guide the appropriate degree
of compression delivered to the trigeminal nerve root. During
the compression of the trigeminal nerve root, patients may
experience the trigeminocardiac reflex. The external pacemaker
should automatically trigger when the heart rate drops to fewer
than 50 beats per minute, though this may vary depending on
the trigger set point. After 90 s, the balloon is deflated and its
deflation is confirmed fluoroscopically. The balloon catheter and
needle are removed together.
Two neurosurgeons at our institution did not find the new
technique to be inferior compared to their previous experiences
with theMullan kit. So far, they have effectively treated 3 patients
with trigeminal neuralgia without immediate complications.
Our initial experience suggests that the procedure is not
changed in any important way and therefore we do not believe
that the risk of the procedure is changed. After reviewing
294 patients, Lopez et al2 reported a 2% incidence of vascular
complications and associated them with the use of the sharp
obturator. Similarly, Natarajan reported carotid cavernous fistula
and external carotid fistula to be associated with use of the sharp
obturator.3 Lopez et al2 reported a 1.5% cranial nerve deficit
rate and a 2.6% rate of meningitis associated with the balloon
compression rhizotomy. None of these complications have been
observed in our cases.
Our improvised technique is not an FDA-approved procedure.
However, our experience demonstrates that the improvised
technique is a feasible alternate technique for balloon compression
rhizotomy. It helps to provide continuous care for those
patients with trigeminal neuralgia requiring