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Intradiscal
Electrothermal Annuloplasty
Presented at The Eleventh Annual
International Intradiscal Therapy Society Meeting
May 16, 1998
Richard Derby M.D.
Bjorn Eek M.D.
Deaglán P. Ryan M.S.
Introduction:
Intradiscal Electrothermal Annuloplasty (IEA) is a relatively
new procedure to heat the intervertebral disc for the purpose of relieving
discogenic pain. In May of 1997 the first author began treating patients
utilizing the IEA procedure. Investigation of procedural efficacy at 6
months is ongoing, patients data being included in the data set as they
reach 6 months post procedure. This abstract represents the ongoing 6-month
follow-up results for the first 33 patients undergoing the IEA procedure.
Methods
and Materials: The
IEA procedure utilizes an Oratec Interventions 30cm
SPINECath catheter, with a 6cm active tip. Utilizing
normal discographic technique, the catheter is inserted
anteriorly into the annulus or nucleus via a 17-gauge
introducer. The active tip is typically advanced anterior-laterally
inside the nuclear tissue, and is directed circuitously
to return posteriorally, ideally achieving full 360°
penetration. Following catheter positioning, electrothermal
heat is generated at the active tip, commencing at
65°C and increasing incrementally to (typically) 85°C,
for a mean duration of 14 minutes.
From 5/97 to 2/98 we enrolled
our first thirty two consecutive patients undergoing the IEA procedure
into a prospective outcome study. Prior to IEA all patients underwent
pressure-controlled discography to determine the number of symptomatic
discs, the location of annular tears, and to categorize the sensitivity
of the disc annulus to pressurization.
Results:
Outcome at 6 months was assessed by examining
changes between the baseline questionnaire (administered to each patient
just prior to their undergoing the IEA procedure) and a six month follow-up
questionnaire. Two primary comparative outcome instruments were utilized.
A mean 1.8 point decrease on a 10-point visual analogue pain scale was
found. An analysis of the 24-point Roland & Morris Disability questionnaire
returned a mean 4-point decrease in disability (p<0.05).
At follow-up, patients’
satisfaction with the procedure and its outcome were examined on a modified
4-point NASS Patient Satisfaction Index. 78.1% of the sample were satisfied
with their outcome, reporting that they would repeat the procedure for
the same outcome. 21.9% felt themselves to be the same or worse than before
undergoing the IEA procedure. At follow-up, five subjective improvement-in-activity
variables were also examined. 53.1% of the sample reported an improvement
in general overall activity levels, 40.6% in sitting, 40.6% in standing,
37.5% in walking and 40.6% reported an improvement in their sleeping.
Conclusions:
In the early stages of investigation, intradiscal
electrothermal annuloplasty appears promising as a technique to reduce
chronic pain of discogenic origin, and as a potential alternative to invasive
spine surgery. Further study is warranted, both to compare efficacy against
other intradiscal heating procedures and to assess the precise pathology
most successfully treated by the procedure. The current study is ongoing,
and outcome results at one year are pending.
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