Early Clinical Experience With The Baerveldt Implant in Complicated Glaucomas
Early Clinical Experience With The Baerveldt Implant in Complicated Glaucomas
Early Clinical Experience With The Baerveldt Implant in Complicated Glaucomas
• PURPOSE: To evaluate our early experience with with hypotony in 13 (26%) patients and corneal
the Baerveldt implant in patients with complicated graft failure in six of 13 (46%) corneal transplant
glaucoma. patients, respectively.
• METHODS: We reviewed the charts of all pa- • CONCLUSION: Within the study follow-up time,
tients with more than six months of follow-up the Baerveldt implant appeared to be safe and
after placement of a Baerveldt implant at LSU Eye effective, with success rates for intraocular pres-
Center. Surgery was considered a success if intra- sure control similar to those reported in a recent
ocular pressure was 21 mm Hg or less (with or retrospective study of the Molteno implant.
without antiglaucoma medications) at the last
postoperative visit, except when further glaucoma MPLANTATION OF A SETON, DEFINED AS A FOREIGN
surgery had been performed or when loss of light implantable material applied to an organ system to
perception occurred. create a fistulous pathway, is an effective surgical
• RESULTS: Fifty eyes (50 patients) were divided option to control recalcitrant glaucoma. Decreased
into six diagnostic groups, with mean follow-up intraocular pressure is attained by the shunting of
times of 16.1 to 19.2 months. Success was aqueous from the anterior chamber to a conjunctival
achieved in 36 of 50 patients (72%): 26 of 35 bleb overlying the implant. Commonly used setons
(74%) patients with aphakia or pseudophakia, include the single- and double-plate Molteno im-
nine of 12 (75%) patients with previously failed plant, anterior chamber tube shunt to encircling band
filtering surgery, three of seven patients with (Schocket procedure), and the valved Krupin-Denver
neovascular glaucoma, all three patients under the shunt.
age of 13 years, nine of 13 (69%) patients who
underwent penetrating keratoplasty, and four of
See also p. 23.
five phakic patients. Overall, visual acuity im-
proved or remained within one line of the preoper-
ative acuity in 32 (64%) patients. The most In February 1990, the Baerveldt implant (Iovision,
frequently observed short- and long-term compli- Inc., Irvine, California), which consists of a non-
cations were serous choroidal effusion associated valved silicone tube (internal and external diameters
of 0.30 and 0.64 mm, respectively) connected to a
Accepted for publication Jan. 12, 1995. large-surface-area (200, 350, or 500 mm2) silicone
From the LSU Eye Center, Louisiana State University Medical plate, was introduced. The implant is placed in a
Center School of Medicine, New Orleans, Louisiana. This study was
supported in part by United States Public Health Service grants single quadrant, usually superotemporally, by tucking
EY02580 and EY02377 from the National Eye Institute, National the ends of the flexible plate beneath adjacent recti
Institutes of Health, Bethesda, Maryland, and by a Career Develop-
ment Award (Dr. Burgoyne) from Research to Prevent Blindness, Inc., muscles (Fig. 1). The large filtration surface area
New York, New York.
Reprint requests to Claude F. Burgoyne, M.D., LSU Eye Center,
combined with ease of insertion is a presumed
2020 Gravier St., Suite B, New Orleans, LA 70112. advantage over other setons.1 Recently, Lloyd and
TABLE 1
Aphakia or pseudophakia — 11 0 0 13 0
Failed filters 11 — 0 0 1 1
Neovascular 0 0 — 0 0 0
Under age 13 years 0 0 0 — 0 0
Keratoplasty 13 1 0 0 — 0
Phakic 0 1 0 0 0 —
"One patient was included in three categories: aphakia or pseudophakia, keratoplasty, and failed filters
CATEGORY NO. (%) NO. (%) NO. pi) NO. <%) NO. (%) NO. (%)
Age (yrs)
Range 34.9-97.8 34.9-82.2 51.7-90.2 0.6-7.3 57.6-87.8 39.3-57.4
Mean ± S.D. 68.4 ± 12.1 62.6 ± 15.4 70.4 ± 15.5 3.2 ± 3.6 71,1 ± 8.6 47.9 ± 8.5
Race
Black 11 (31) 5(42) 2(29) 1(33) 4(31) —
White 24 (69) 7(58) 5(71) 2(67) 9(69) 5 (100)
Lens status
Phakic — 1(8) 2(29) 3 (100) — 5(100)
Aphakic 8(23) 2(17) 3(43) — 3(23) —
Pseudophakic 27 (77) 9(75) 2(29) — 10 (77) —
Anterior chamber intraocular lens 6(17) 2(17) 1(14) — 2(15) —
Posterior chamber intraocular lens 21 (60) 7(58) 1 (14) — 8(62) —
Diagnosis
Open-angle glaucoma 21 (60) 5(42) — — 10 (77) 2(40)
Secondary angle-closure glaucoma 10 (29) — — — 3(23) —
Combined mechanism 1(3) 3(25) — — — —
Anterior cleavage syndrome 2(6) 2(17) — — — 1(20)
Uveitis-glaucoma-hyphema syndrome 1(3) 1(8) — — — —
Angle recession — 1(8) — — — —
Neovascular glaucoma — — 7 (100)T — — —
Congenital glaucoma — — — 2(67) — —
Glaucoma associated with Sturge-Weber syncIrome — — — 1(33) — —
Iridocorneal endothelial syndrome — — — — — 2(40)
Surgical outcome
Success 26 (74) 9(75) 3(43) 3(100) 9(69) 4(80)
Complete success 13(37) 1(8) 2(29) 2(67) 5(38) 1(20)
Qualified success 13(37) 8(67) 1(14) 1(33) 4(31) 3(60)
Failure 9(26) 3(25) 4(57) — 4(31) 1(20)
Qualified failure 3(9) 1(8) 3(43) — KB) —
Complete failure 6(17) 2(17) 1(14) — 3(23) 1(20)
Further glaucoma surgery 5(14) 2(17) — — 3(23) 1(20)
Follow-up (mos)
Range 6.1-26.1 7.1-26.1 10.6-24.7 17.0-20.4 8.2-24.0 9.3-18.4
Mean ± S.D. 16.3 ± 6 . 1 16.1 ± 6.5 18.3 ± 5.6 19.2 ± 1.9 15.2 ± 5.7 13.7 ± 3.6
Visual outcome
Improved (gain of two or more lines) 6(17) 1(8) — — 4(31) —
No change (± one line) 16 (46) 5(42) 3(43) 1(33) 7(54) 2(40)
Worse (loss of two or more lines) 13 (37)* 7(58) 4(57) 2(67) 2(15) 3 (60)'
*Eight patients (67%) had one failed filtering procedure, and four patients (33%) had two failed filtering procedures.
♦Associated diagnoses were diabetes, two (29%); central retinal vein occlusion, two (29%); siderosis, one (14%); and unknown, two
(29%).
'Attributable to fibrous membrane covering intraocular lens in one patient and uncorrected aphakic visual acuity in one patient.
'Attributable to decompensated cornea in one patient.
TABLE 3
COMPLICATION NO. (%) NO. (%) NO. (%) NO. (%) NO. (%) NO. (%)
*ln two patients (15%), failure was related to Baerveldt-tube touch, with postoperative times to failure of 2,3 and 2.5 months. In four
patients (31%), failure was not directly Baerveldt related, with postoperative times to failure ranging from 0.9 to 22.4 months.
κ
h 1 (mean time to failure, 10.0 months) were thought not
1
0.8
to be directly related to the presence of the Baerveldt
0.6
L= implant. Overall, the 69% success rate that we
obtained for intraocular pressure control with the
I 0.4
Baerveldt implant after penetrating keratoplasty is
comparable to the 7 1 % to 96% range of success rates
reported for various studies of Molteno and Schocket
implants.7'10
Recently, studies of restrictive strabismus after
Baerveldt implantation have been published.1,11'12 Pro-
posed explanations include an increase in the length-
tension curve of the muscle(s) induced by the under-
Fig. 3 (Hodkin and associates). Kaplan-Meier analysis
for implants in all patients in all groups after Baerveldt lying Baerveldt implant plate, its fibrous cocoon, or
implantation. Median (50th percentile) time to failure both; incorporation of the rectus muscle(s) into the
was 721 days. fibrous cocoon surrounding the plate; or possibly a
posterior fixation effect caused by scarring posterior to
the implant. 11112 Smith and associates1 studied 30
by Minckler and associates4 were advanced enough to eyes examined retrospectively for strabismus after
be labeled "kissing choroidals," whereas we recorded placement of a 350-mm 2 Baerveldt implant; 23 (77%)
choroidal effusions of any size as a complication. were found to have a marked heterotropia in primary
In our study, five of the 13 postoperative serous gaze and restriction of gaze into the quadrant of the
choroidal effusions with hypotony (intraocular pres- implant. As a result, 11 (65%) of 17 functionally
sure less than 5 mm Hg) were observed to occur 12.4 binocular patients had diplopia in primary gaze. Most
± 1 1 . 6 (mean ± S.D.) days after stent removal, and commonly, supratemporal Baerveldt placement re-
one was seen five days after lysis of the ligature suture sulted in a hypertropia with exotropia, whereas supra-
with a laser. Three cases occurred spontaneously 4-7
± 2.6 days after Baerveldt implantation, despite
ligature placement during surgery. The remaining 50
four cases were not related closely in time (greater
than one month) either to Baerveldt implantation or 40
to stent removal. After long-term follow-up, four of
the 13 patients with choroidal effusions (31%) were 30
eventually classified as having graft failures. Two of E
E_
the failures were caused by high final intraocular 20
pressure, and the remaining two required choroidal o
drainage surgery and removal of an exposed Baerveldt 10
implant.
In patients with previous penetrating keratoplasty, pre post 1 wk 1 mo 6 mo 1 yr 2 yrs >2 yrs
a graft failure rate of 36% to 60% at a mean follow-up Time Interval After Aqueous Flow Initiated
of about one to two years has been observed in
previous studies of Molteno implantation and Fig. 4 (Hodkin and associates). Mean intraocular pres-
sure (± S.D.) for 19 patients with Baerveldt implants
Schocket procedures.7'10 We observed graft failure in
who were considered to be successes and who also had
six of 13 patients (46%) at a mean follow-up of 15.2
documented stent suture removal for control of intraocu-
months, a rate similar to that of the Molteno implant lar pressure (IOP) in the postoperative period. Pre
studies. Two of the graft failures (mean time to failure, indicates immediately before stent suture removal; post,
2.4 months) were attributed to Baerveldt-tube endo- immediately after stent suture removal.
COMPARABLE GROUPS IN CURRENT BAERVELDT STUDY AND A RETROSPECTIVE MOLTENO IMPLANT STUDY*
VISUAL OUTCOME
FOLLOW-UP (MOS) SUCCESS SAME OR BETTER
DIAGNOSTIC GROUP NO. OF PATIENTS RANGE MEAN ± S.D. NO. (%) NO. (%(
Aphakia or pseudophakia
Minckler and associates4 48 7-30 16.2 ± 5.9 26 (63) 31 (65)
Current study 35 6-26 16.3 ± 6.1 26 (74) 22 (63)
Failed filters
Minckler and associates' 10 6-25 12.3 ± 6.1 7 (70) 3 (30)
Current study 12 7-26 16.1 ± 6.5 9 (75) 6 (50)
Neovascular glaucomas
Minckler and associates4 18 7-39 20.2 ±12.1 7 (47) 10 (56)
Current study 7 11-25 18.3 ± 5.6 3 (43) 3 (43)
Under age 13 years
Minckler and associates' 14 12-34 22.8 ± 7.8 7 (54) 9 (64)
Current study 3 17-20 19.2 ± 1.9 3 (100). 1 (33)
nasal placement resulted in a hypotropia with exotro- based, rather than a limbal-based, conjunctival inci-
pia and restricted elevation in adduction, similar to sion for implantation. A limbal-based flap may pro-
Brown's syndrome. The latter manifestation was at- mote formation of scar tissue beneath the posterior
tributed to a taut superior oblique tendon.1 incision site, possibly leading to muscle scarring with
Our review of 50 patients disclosed only four cases motility restriction (Paul Palmberg, M.D., oral com-
of ocular motility disturbance. Three of them simulat- munication, April 1994). Fourth, since the study by
ed a superior oblique tendon syndrome. Notably, all Smith and associates1 was published, first two and
three were among a subset of seven patients with then four fenestrations were added to the design of
supranasal placement of the Baerveldt implant. The the plate to promote fibrous adhesions between the
fourth case involved vertical diplopia in a patient with sciera and the inner surface of the bleb (oral commu-
supratemporal implantation. Overall, this incidence nication, Iovision, Inc., Irvine, California, January
of strabismus was much lower than that reported by 1994). Theoretically, such adhesions might reduce
Smith and associates.1 At least four factors may bleb height by securing the inner surface of the bleb
account for this difference. First, in the present study, closer to the underlying sciera.112 In our study, 18 of
strabismus complications were not actively investigat- the 50 implants had the two-fenestration modifica-
ed during routine patient examinations. As a result, tion to the plate. None of the ocular motility distur-
strabismus may have been underreported, particularly bances occurred in the patients who received fenes-
in functionally monocular patients, who are much less trated plates.
likely to complain spontaneously of ocular muscle In general, we found that our results, in terms of
imbalance. Second, during implantation we tight- intraocular pressure control and visual outcome, were
ened the tube ligature to prevent any flow to the similar to those of a recent Molteno implant review4
Baerveldt implant plate in the early postoperative and not widely dissimilar to those of the recently
period, whereas Smith and associates1 allowed mini- published early studies by the Baerveldt group.2,3 Our
mal flow. As stated in their discussion, allowing early success rate (74%; 36 of 50 cases) was somewhat
flow before the development of the fibrous cocoon better than the 62% success rate (eight of 13 cases) in
may have been a factor in the development of their initial experience2 in which essentially the same
prominent heterotropia.1 Third, we used a fornix- criteria were used, but was somewhat worse than the