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Comparison of Materials Used in Frontalis Suspension
Barry N. Wasserman, MD;
Derek T. Sprunger, MD;
Eugene M. Helveston, MD
Arch Ophthalmol. 2001;119:687-691.
ABSTRACT
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Objective To compare various materials used in frontalis suspension surgery for
incidence of infection and/or granuloma formation and incidence of recurrent
ptosis.
Design and Methods A retrospective medical record analysis was performed for 102 frontalis
suspension operations performed on 43 patients between January 1, 1991, and
December 31, 1996, at Indiana University Medical Center, Indianapolis. Materials
used for surgery were compared for incidence of infection and/or granuloma
formation and incidence of recurrent ptosis. Materials included autogenous
fascia lata, banked fascia lata, monofilament nylon, braided polyester, expanded
polytetrafluoroethylene, and polypropylene.
Results Infection and/or granuloma formation occurred in 10.8% of all frontalis
suspensions and in less than 10.0% for each material used except expanded
polytetrafluoroethylene. Five (45.5%) of the 11 frontalis suspensions using
expanded polytetrafluoroethylene required removal of the material because
of suspected infection. Ptosis recurred in 32 cases (31.4%). Low incidence
of recurrence was found with autogenous fascia lata and expanded polytetrafluoroethylene.
Conclusions Of the materials compared in this study, autogenous fascia lata may
be the material of choice for frontalis suspension surgery in congenital ptosis.
Other materials are useful for temporary eyelid elevation. All materials carry
the risk of potential infection and/or granuloma formation.
INTRODUCTION
FRONTALIS suspension is the operative procedure often used for treatment
of severe blepharoptosis with poor or absent levator muscle function. Poor
levator function has been broadly defined as levator muscle movement of 2
mm or less and no more than 6 mm by various authors.1-5
Frontalis suspension is most commonly used for congenital ptosis but is also
used to treat blepharophimosis syndrome, Marcus Gunn jaw-wink phenomenon,
congenital fibrosis syndrome, cranial nerve III palsy, and double elevator
palsy. Treatment is most important when an eyelid blocks the visual axis causing
amblyopia, or when an anomalous head posture is apparent. Complications of
frontalis suspensions include recurrent ptosis, postoperative infection, and
granuloma formation.
Autogenous fascia lata has long been considered the material of choice
for frontalis suspension.3-4,6
It was first described in the treatment of congenital ptosis by Payr in 19093, 5-7 and again
by Wright in 1922.8 However, difficulty harvesting
the material, insufficient amounts of material, and scarring in children younger
than 3 years compelled surgeons to find alternative materials.5, 9
Banked fascia lata, a popular option, has been compared with autogenous fascia
lata for efficacy and long-term viability of the material.4-6
Autogenous fascia lata is generally more effective, with a lower rate of infection
and granuloma formation.4 Recurrent ptosis
rates have been reported to be as low as 5% with the use of autogenous fascia
lata, and 8% with the use of banked fascia lata.3, 6
Synthetic materials also have been investigated for use in frontalis
suspension surgery. These are more readily available and do not carry the
risk of transmitting infectious diseases.10
A study using 4-0 woven polyester suture reported a recurrent ptosis rate
of 43%.11 The use of polyfilament nylon cable
suture was evaluated in 2 separate studies that suggested that nylon was useful
as a temporary measure for young children with severe ptosis.1, 3
In the mid-1980s, oculoplastic researchers began investigating the use
of expanded polytetrafluoroethylene (ePTFE). This synthetic material, used
previously in vascular and abdominal surgery, is inert, extremely biocompatible,
and resistant to infection. It is easily suturable and biointegrates by means
of fibroblastic ingrowth.2, 10
Our study retrospectively evaluated the experience of surgeons at Indiana
University Medical Center, Indianapolis, who used various materials for frontalis
suspension procedures. Autogenous fascia lata, banked fascia lata, monofilament
nylon, braided polyester, ePTFE, and polypropylene were compared for incidence
of infection, granuloma formation, and recurrent ptosis.
MATERIALS AND METHODS
A retrospective medical record analysis was performed on all patients
who underwent frontalis suspension surgery in the Department of Pediatric
Ophthalmology, Indiana University Medical Center, between January 1, 1991,
and December 31, 1996. All patients had severe ptosis with poor levator muscle
function. Indications for surgery were ptosis either obscuring the visual
axis or with anomalous head position. One hundred two procedures were performed
on 43 patients. The median age at surgery for the group was 18 months (range,
1-25 years). Sixty-five of these were primary procedures and 37 were secondary
or tertiary procedures. Autogenous fascia lata was not used for any child
younger than 3 years. Of the 65 primary procedures, 22 were bilateral (44
eyelids) and 21 were unilateral (11 on the right upper eyelid and 10 on the
left). Congenital ptosis was the initial diagnosis in 29 patients; blepharophimosis
syndrome in 8; cranial nerve III palsy in 2; and Marcus Gunn jaw-wink phenomenon,
chronic progressive external ophthalmoplegia, double elevator palsy, and congenital
fibrosis syndrome in 1 each. No patients had diagnoses that might limit surgical
success, such as atopic disease or immune suppression.
All operations were performed by the attending surgeon (including D.T.S.
and E.M.H.) using the technique described by Helveston and Ellis12
(Figure 1). After the eyelids were
compared for contour and crease, a corneoscleral protector was placed under
the eyelid. Incisions were performed through skin and orbicularis muscle.
A Wright fascia needle (Katena Products Inc, Denville, NJ) was used to bring
the sling material under the orbicularis muscle from one incision out through
another. In cases in which fascia lata or ePTFE was used, a nonabsorbable
suture was placed through the sling material. In procedures using ePTFE, strips
were fashioned intraoperatively from ePFTE sheets. Materials were prepared
with isotonic sodium chloride solution only; none were soaked in antibiotics.
Only the skin of the superior central incision was sutured closed with a 6-0
absorbable suture. Antibiotic ointment was then placed over each incision
and into the palpebral fissure, and such treatment was continued for 2 weeks.
Postoperative systemic antibiotics were not used.
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Figure 1. The frontalis suspension surgical
technique as described by Helveston and Ellis.12
Five incisions are placed, and the material is carried between the incisions
under the orbicularis muscle to form a pentagon. The material is then tied
under the apical incision and the skin is sutured. Reproduced with permission
from Helveston and Ellis.12
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Twenty-four eyelids had ptosis surgery using autogenous fascia lata.
In 35 eyelids, banked irradiated allogenic fascia lata (from the Hospital
for Sick Children, Toronto, Ontario) was the suspensory material used. Of
the remaining eyelids, 13 were repaired with monofilament nylon suture (Ethilon;
Ethicon, Somerville, NJ), 11 with braided polyester (Ticron; United States
Surgical, Norwalk, Conn), 11 with ePFTE (Gore-Tex; W. L. Gore & Assoc,
Flagstaff, Ariz), and 8 with polypropylene (Prolene; Ethicon).
Outcomes were based on clinical examination findings. Success depended
on eyelid height and symmetry, with particular regard to visual axis. Improvement
in head position was noted when applicable. The same factors were used to
define recurrent ptosis as for the primary cases, ie, ptosis that obscured
the visual axis and/or resulted in anomalous head position. Accurate eyelid
height measurements to define recurrent ptosis are often difficult to obtain
in young children, and specific measurements were not used for clinical judgments.
Postoperative infections and foreign body granulomas, often difficult
to differentiate clinically, may develop concomitantly in the postoperative
period. Both may develop with edema, erythema, and purulent exudate at the
incision sites. These cases are treated similarly with systemic antibiotics
and selected surgical drainage. Infections and/or granulomas are combined
in our analysis of surgical outcomes.
RESULTS
One hundred two frontalis suspension operations were performed on 43
patients (Table 1). Eleven eyelids
(10.8%) developed infections and/or granulomas. Eight (72.7%) of these required
incision and drainage and removal of the sling material, and 3 (27.3%) resolved
with administration of systemic antibiotics. Thirty-two eyelids (31.4%) required
further surgery for recurrent ptosis. Thirty-seven eyelids (36.3%) required
secondary or tertiary frontalis suspension surgery. (Five of the 11 eyelids
with infections and/or granuloma formation and all 32 eyelids with recurrent
ptosis had undergone subsequent operations at the time of this report.) None
of the patients had any lasting complications from exposure of the cornea
after frontalis suspension.
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Summary of Complications by Material*
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Follow-up time is defined as the duration from
the last procedure to the last available office visit or the duration between
the procedure and the recurrent ptosis or infection and/or granuloma formation
(Table 1). The median follow-up
from the last surgery was 24 months (range, 1 week to 9 years). Eyelid procedures
with less than 6 months of follow-up were included only when infection and/or
granuloma formation or recurrent ptosis occurred within that period. No procedure
using braided polyester or ePFTE had follow-up longer than 2 years.
Infection and/or granuloma formation occurred in 10.8% of all frontal
suspensions and in less than 10.0% for each material used except ePTFE (Figure 2). Five (45.5%) of the 11 procedures
using ePTFE required reoperations to remove the material because of suspected
infection. Six (54.5%) of the 11 infections and/or granulomas occurred within
1 month of the surgery, and the remaining 5 occurred 3 or more months after
surgery. Culture and sensitivity tests were performed in most cases, and systemic
antibiotics were adjusted based on sensitivity (Figure 3).
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Figure 2. Comparison of infection and/or
granuloma formation by material used in frontalis suspension. All materials
had less than 10.0% incidence of pyogenic granuloma formation, except expanded
polytetrafluoroethylene (ePTFE), which had 45.5%. AFL indicates autogenous
fascia lata; BFL, banked fascia lata.
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Figure 3. Postoperative infection in a patient
with expanded polytetrafluoroethylene (ePTFE) frontalis suspension. Note the
areas of edema and erythema at the incision sites. The patient underwent excision
of the infected material and received a course of systemic antibiotics. The
infection resolved, but the ptosis recurred.
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Ptosis recurred in 32 (31.4%) of the 102 procedures (Table 1). Median time to reoperation for recurrence was 24 months.
Reoperation for recurrence was necessary for each material used except ePFTE
(Figure 4). Although recurrence
was most frequent for monofilament nylon and banked fascia lata, patients
with these materials were followed up for longer periods (Table 1). For example, 10 (37.0%) of the 27 reoperations for recurrent
ptosis in the monofilament nylon and banked fascia lata groups occurred after
at least 3 years of follow-up. In contrast, in the group of patients with
ePFTE, none were followed up for more than 2 years.
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Figure 4. Recurrent ptosis by material.
AFL indicates autogenous fascia lata; BFL, banked fascia lata; and ePTFE,
expanded polytetrafluoroethylene.
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COMMENT
Although autogenous fascia lata has been considered the most desirable
material for frontalis suspension, physicians have continued to search for
alternatives.1-4,11, 13
This study evaluates the rate of infection and/or granuloma formation and
the rate of recurrent ptosis with the use of several materials. In our study,
the treatment outcomes for autogenous fascia lata compared favorably with
those of other materials. Of the 24 frontalis suspensions using autogenous
fascia lata, only 2 (8.3%) developed an infection and/or granuloma, and only
1 (4.2%) developed recurrent ptosis. The case of recurrent ptosis appeared
more than 5 years after the initial surgery. Of the materials compared, autogenous
fascia lata may be the material of choice when fascia can be harvested.
Banked fascia lata is a popular alternative for young children undergoing
frontalis suspension surgery. In his 20-year review of cases, Crawford4 reported an increased incidence of inflammatory reactions
with banked fascia lata compared with autogenous fascia lata. He suggested
that this may have more to do with the suture used to tie the material under
the frontalis muscle, and he suggested the use of 6-0 plain gut for that suture
when using autogenous fascia lata vs 6-0 polyglycolic acid (Dexon; United
States Surgical) when using banked fascia lata. Wagner et al3
found no incidence of infection or granuloma formation in their series with
banked fascia lata. They also reported a recurrent ptosis rate of 8.3% in
patients followed up for an average of 31.5 months. Broughton et al13 also found a low incidence of complications with
the use of lyophylized fascia lata, but average follow-up was limited to just
8.4 months. In that report, no conclusion could be drawn regarding the long-term
efficacy of the material.
Of our 35 eyelids using banked fascia lata, we found 2 cases (5.7%)
of infection and/or granuloma formation and 18 cases (51.4%) of recurrent
ptosis. Three cases of recurrent ptosis appeared within the first year after
surgery and 15 appeared later. This late recurrent ptosis may be related to
host reaborption of material.4-5
Crawford4 performed histologic studies on rabbits
and suggested that banked fascia lata acts as a bridge for host fibroblasts
that eventually replace the fascia lata. However, in biopsy specimens taken
from human patients up to 16 years after surgery, Beyer and Albert5 observed banked fascia lata that was histologically
intact without absorption.
Our patients' higher rates of recurrent ptosis were similar to those
reported by Wilson and Johnson,14 who found
increasing recurrent ptosis rates with each year beyond the first 9 years
of follow-up. They reported that 50.0% of frontalis suspensions using banked
fascia lata had failed at 9 years after surgery.14
Our study suggests that banked fascia lata is not as efficacious as autogenous
fascia lata, but it may be an acceptable alternative in selected cases.
Previous studies using polyfilament nylon cable for frontalis suspension
have reported recurrent ptosis in approximately 30.0% of eyelids.1, 3 Katowitz1
reported a 29.0% recurrence rate but an otherwise very low complication rate
after 55 eyelids followed for up to 10 years. Wagner et al3
found a recurrence rate of 28.1% and a rate of granuloma formation of 12.4%.
Our results with 13 eyelids using monofilament nylon found a recurrence rate
of 69.2%, including 4 eyelids with recurrent ptosis more than 3 years after
the initial surgery. Longer follow-up data in the other studies may have yielded
data more consistent with this report. We found only 1 case (7.7%) of infection
and/or granuloma formation after surgery using monofilament nylon. Others
have reported rates of less than 2.0% to 12.0%.1, 3
Although the recurrent ptosis rate is relatively high, monofilament nylon
is readily available and may be a reasonable option for temporary frontalis
suspension in young children.
We found that polypropylene and braided polyester had low rates of infection
and/or granuloma formation for our small number of cases (Figure 2). However, of the 3 eyelids with recurrent ptosis treated
with braided polyester, all occurred within 6 months (Table 1). Many of the remaining patients have less than 1 year of
follow-up. These materials may be alternatives for temporary frontalis suspension
in the young, but further study and additional cases are required to elucidate
their true long-term efficacy.
Expanded PTFE has shown great potential for long-term biocompatibility;
it is reportedly nonantigenic and both biologically and chemically inert.2, 10 In a series of 37 frontalis suspensions
using ePFTE that were followed up for an average of 3 years, Steinkogler et
al2 reported only 1 case of recurrent ptosis
requiring surgical repair and 1 "rejection" requiring surgical excision. They
stated that use of ePTFE would obviate the need for fascia lata in frontalis
suspension surgery. Our findings with 11 eyelids using ePTFE showed no recurrent
ptosis in patients observed for up to 18 months (Figure 4). However, we found a percentage of infection and/or granuloma
formation (45.5%) more than 4 times higher than that with any other material
used (Figure 2). The reason for
this finding is not clear. The highly porous nature may allow sequestration
of bacterial contaminants, with proliferation and abscess formation. We propose
altering the technique by adding suture closure of all incisions. Although
the data do not achieve statistical significance, the high incidence of infection
and/or granuloma formation warrants further study of ePTFE before recommending
it as an alternative in frontalis suspension surgery.
Our retrospective evaluation did not include other materials used in
frontalis suspension, such as silicone rods. These were not used at our institution
and therefore could not be included in the analysis. Most of the patients
in the study had congenital ptosis and relatively few had other diagnoses;
therefore, comparison by diagnosis was not possible. Our study population
did not have enough biostatistical power to yield statistically significant
differences between diagnoses or materials.
Synthetic materials were used in primary cases in children too young
to undergo harvesting of autogenous fascia lata. Perhaps the rapid growth
of these younger children, or simply their age, affected the recurrent ptosis.
Comparison is difficult, as the youngest patients did not receive autogenous
fascia lata. In addition, longer follow-up time for some materials may clarify
their true efficacy. Although determination of ptosis in children is generally
based on clinical judgment, quantitative measures, when feasible, would aid
in comparison of surgical outcomes within and between studies. Accurate measurements
are often difficult to obtain in children and were not used to determine surgical
cases at our institution. For children younger than 3 years, several reasonable
alternatives for temporary frontalis suspension are available. In addition
to recurrent ptosis, families should be counseled regarding the potential
for infections or granuloma formation.
AUTHOR INFORMATION
Accepted for publication November 6, 2000.
Supported in part by an unrestricted grant from Research to Prevent
Blindness, Inc, New York, NY.
Presented in part at the Annual American Academy of Ophthalmology Meeting,
San Francisco, Calif, October 29, 1997.
In addition to Drs Sprunger and Helveston, surgery was performed by
Forrest D. Ellis, MD; David A. Plager, MD; and Naval Sondhi, MD.
Corresponding author: Barry N. Wasserman, MD, Princeton Eye Laser Center, 100 Canal Pointe
Blvd, Suite 112, Princeton, NJ 08540
(e-mail: http://www.princetonlaser.com).
From the Princeton Eye Laser Center, Princeton, NJ (Dr Wasserman),
and the Department of Pediatric Ophthalmology, Indiana University Medical
Center, Indianapolis (Drs Sprunger and Helveston).
REFERENCES
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ABSTRACT
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