Glaucoma Drainage Implants



Fig. 5.1
Ahmed implant



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Fig. 5.2
Molteno implant (single plate)


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Fig. 5.3
Molteno implant (double plate )


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Fig. 5.4
Baelverdt implants


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Fig. 5.5
Eagle Vision implant



Table 5.1
Commercially-available glaucoma drainage implants





































 
Type of plate

Size range (mm2)

Type of material

Valved implants

Ahmed

Single, double, for pars plana, pediatric

96–364

Polypropylene or silicone

Non-valved implants

Baerveldt

Single, for pars plana

250–350

Silicone

Eagle vision

Single

365

Silicone

Molteno

Single, double, for microphthalmia

50–274

Polypropylene




Clinical Indications for the Use of Shunts


As mentioned previously, the GDDs were traditionally indicated for the treatment of refractory glaucoma, meaning cases in which filter surgery is associated with a high risk of failure (for example, neovascular or uveitic glaucoma), with a high rate of complications or in cases with previous failure of filter surgery for glaucoma. Moreover, the shunts appear to be effective in patients in which a previous intraocular surgery (vitreo-retinal or corneal) led to the formation of conjunctival scar tissues that reduce the amount of intact conjunctiva, precluding the trabeculectomy procedure or function. In recent years, the indications for these devices have expanded quite considerably, and now include congenital/juvenile glaucoma, traumatic glaucoma, glaucoma in the aphakic/pseudophakic eye, glaucoma post-keratoplasty, other secondary glaucomas (Irido-Corneal-Endothelial syndrome, Epithelial downgrowth). Moreover, in eyes with residual visual function, the shunts may be preferred over the cyclodestructive procedures that run a high risk of blindness and Phthisis bulbi (end-stage eye) (see Table 5.2). Lastly, in recent years these devices have been proposed as the elective procedure for cases of primary open-angle glaucoma: a number of authors have suggested their use in the primary surgical management of non-complicated glaucoma—the most precocious cases—thanks to their better result predictability compared to the trabeculectomy with MM-C and the lower incidence of complications (see results and complications below).


Table 5.2
Clinical indications for the glaucoma drainage implants



























• Previous failure of filtering surgery

• Patients in which filtering surgery is associated with a high risk of failure or complications

 – Neovascular glaucoma

 – Uveitic glaucoma

 – Previous intraocular surgery (vitreo-retinal or corneal surgery) with the formation of conjunctival scarring that preclude trabeculectomy

• Eyes with residual useful function, for which the cyclodestructive procedures have a high risk of blindness and Phthisis bulbi (end-stage eye)

• Post-traumatic glaucoma

• Congenital/juvenile glaucoma

• Glaucoma in the aphakic/pseudophakic eye

• Post-keratoplasty glaucoma

• Other secondary glaucomas (Irido-corneal-endothelial syndrome, epithelial downgrowth


Preoperative Evaluation


It is essential that the surgeon performs a meticulous pre-operative evaluation of the eye and devises an appropriate surgical plan to ensure the good outcome of the implant and minimize the risk of complications. First of all, the mobility of the conjunctiva must be examined to allow the surgeon to choose the best quadrant for the implant. In children affected by buphthalmos or in patients with vascular collagen disorders, the surgeon should attempt to identify thinned areas of the sclera where the implant should be avoided: under these clinical conditions, the surgeon must use certain techniques to anchor the plate of the device to the sclera to avoid possible perforations. The surgeon should examine the patient’s cornea for marked peripheral gerontoxons or leukomas that could obstruct the visualization of the tube and cause problems with its insertion and correct positioning in the AC. Moreover, in the event of damage to the corneal endothelium, the implant in pars plana is preferable to the implant in AC. If the endothelial damage is evident (corneal insufficiency), and a clinically important cataract is observed, a triple procedure may be considered (phaco + IOL + GDD). The iris should be examined under high magnification to identify new blood vessels that may be treated with a preoperative intravitreal injection of anti-VEGF drugs to reduce the risk of intra- and post-operative bleeding. The depth of the AC must be measured to avoid exclude lesions to the cornea or the iris induced by the tube in the AC. The condition of the lens must also be considered: the tube can be positioned in the ciliary sulcus of pseudophakic eyes or in pars plana in aphakic eyes. It is extremely important that gonioscopy is performed on patients who are candidates for the GDD implant; this will identify neovessels in the camerular angle (in neovascular glaucoma) and peripheral anterior synechias (frequently present in neovascular, uveitic and traumatic glaucoma). The surgeon must take note of the areas that are free from anterior peripheral synechias as this will allow him to correctly choose the site for the implant. In the event of anterior peripheral synechias of recent appearance, the tube can be positioned anterior to the synechias. If synechias are observed in an extremely anterior position, it may be necessary to perform an intraoperative iridectomy to facilitate the insertion of the tube. Alternately, the surgeon must plan the implant of the tube in the ciliary sulcus or in pars plana.


Surgical Technique


In most cases, the tube of the GDDs will be positioned in the AC. However, it can also be positioned in the ciliary sulcus of a pseudophakic patient or in pars plana in vitrectomized eyes. The implantation of GDDs in AC will be examined more in detail later. Each surgical step of this procedure requires maximum attention to achieve good results and reduce the post-operative complications. The first thing to do is to select the quadrant for the implant. Most of the GDDs are positioned in a single quadrant, with the exception of the implants with two plates. When possible (due to the conditions of the conjunctiva, sclera, etc), the implant with a single plate should be positioned in the supero-temporal quadrant: this site consents the easiest access to implant the plate and leads to a lower rate of disturbance of ocular motility (see the paragraph on the complications below). With a silicone oil tamponade added to the eye, the implant is positioned in the temporal-inferior quadrant to prevent oil escaping; it is lighter than aqueous humor and will tend to rise.

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Fig. 5.6
Conjunctival incision (limbus based flap ). Once the surgeon has selected the site for the implant, the first maneuver in this type of procedure is to perform the conjunctival incision (peritomy or peritectomy). Westcott scissors are generally used for this procedure. We prefer to perform a capsule-conjunctival incision with the hinge at the limbus (curved blue line in the drawing) rather that the fornix based flap (curved red line in the drawing). It must extend for 90–110° and be centered between the two rectus muscles (the distance is greater for the implant with two plates). The flap should include the conjunctiva and the Tenon because it should be a capsulo-conjunctival flap: this will ensure better closure and consequently a lower risk of exposing the implant. The advantages associated with the limbus based flap are the excellent posterior exposure (the implantation of the plate is easier), the reduced risk of leakage from the scar in the limbal position, lower conjunctival retraction and preservation of the stem cells of the limbus. The disadvantages are that the suture is more complex (compared to the incision when the hinge is at the fornix), and the scar will be positioned above the plate of the shunt, with the consequent risk of dehiscence of the wound, leakage and epithelial downgrowth


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Fig. 5.7
Exposure of the quadrant for the implant. To create good exposure of the quadrant for positioning the shunt it is recommended to place of a scleral or corneal suture in silk 6.0 or 7.0 and then to tension the thread. The conjunctiva and the Tenon are detached, with the formation of a pouch. The surgeon should avoid an excessively wide dissection as the space created should not be greater than the diameter of the plate: there is a risk of acute post-operative hypotonia, particularly when non-valved shunts are used


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Fig. 5.8
Anchoring of the plate of the shunt to the sclera. The conjunctiva and the Tenon are retracted using forceps (or a retractor) to expose the bare sclera below. Now the surgeon proceeds by positioning the implant in the capsule-conjunctival pouch, between the two rectus muscles, so that the anterior edge lies approximately 8–10 mm posterior to the limbus


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Fig. 5.9
Maneuvers to correctly position large shunts. The large implants (for example, the Baelverdt) should initially be inserted with the greater axis directed towards the apex of the eyeball and then rotated horizontally of approximately 90°, so that the tube is directed towards the AC, and the wings of the shunt slide under the rectus muscles (red arrow in the drawing). The surgeon should isolate the adjacent rectus muscles using a hook and mark the muscular insertion to allow correct positioning of the plate between or below the muscles


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Fig. 5.10
Correct positioning of shunts with two plates. When shunts with two plates are inserted, one of the plates is positioned in one quadrant and the second plate is positioned in another quadrant. The connecting tube of the two plates can be positioned below or above the rectus muscle that separates the two quadrants


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Fig. 5.11
Control of the patency of the tube of the valved shunts (priming). When valved shunts are inserted, prior to anchoring it on the sclera, it is advisable to irrigate the drainage tube (priming) using a syringe filled with BSS (Balanced Saline Solution) or sterile water with a 30G cannula; this can be used to control the correct movement of the internal valve (patency of the shunt); the valve can sometimes melt during the sterilization processes. The valve should not be touched with the forceps as it could be damaged producing a malfunction


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Fig. 5.12
Anchoring the shunt to the sclera. The plates of every type of shunt have small holes. Permanent/non-absorbable nylon 8.0, 9.0 or 10.0 sutures are passed through the holes and this consents firm anchoring to the sclera. As mentioned before, the surgeon should aim to anchor the anterior edge of the plate approximately 10 mm from the limbus. A spatulate needle is advisable as it reduces the risk of accidental scleral perforations. After passing the first suture, the surgeon must control that the GDD has been positioned correctly. Then, a second suture is passed through a second hole in the plate (there are normally two or three holes on each plate). It should be remembered that the knots must be recessed to avoid conjunctival erosion. It is also essential that the shunt is firmly anchored to the underlying sclera to prevent its postoperative migration in an anterior, posterior or lateral direction


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Fig. 5.13
Creation of a sclero-corneal opening . Now the surgeon makes a scleral incision, at about 1–1.5 mm from the limbus, with a 23G needle, that can be mounted on an insulin needle: the incision must be the right size to allow the insertion of the tube in the AC, it must be straight, positioned just above the iris and parallel to the iris itself. The needle is inserted immediately behind the limbus. It is important to stabilize the eye bulb with forceps when the surgical connection is being created and avoid lateral movements of the needle as this could induce hypotonia in the postoperative. Before the tube is insert in the AC, its distal portion must be cut with scissors to create a chamfered tip. It is extremely important to choose the incision site carefully: the tube must extend into the AC for approximately 2–3 mm, almost to the pupil margin. Its position should avoid the risk of any contact with the cornea or the iris, and the possible retraction that may cause the tube to exit the AC


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Fig. 5.14
Insertion of the chamfered tube in the AC. There will usually be no difficulty inserting a chamfered tube, with a 30°–45° bevel, into the AC. In order to facilitate the maneuver, the surgeon will normally use one or two toothless forceps


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Fig. 5.15
(ab) Correct positioning of the tube in the AC. Once the tube has been inserted, the surgeon must carefully control that it has been positioned correctly in the AC; contact with the cornea and the entrapment of the iris must be avoided. (a) Illustrates the correct position of the tube from above and (b) provides a side view of the tube in the correct position. The tube will now anchored to the sclera with a suture positioned just a few millimeters in front of the plate. The suture thread can be vicryl 8.0 or 10.0 (though some surgeons prefer nylon): the purpose of the suture is to stabilize the tube; it should not be excessively tight as this would obstruct the liquid flow in the valved shunts. If the tube is not positioned correctly, the surgeon should create a second paracentesis adjacent to the first and insert the tube through this second opening. The surgeon must pay attention to any leakage from the paracentesis: if leakage is observed, he must position a suture to maintain the intraoperative depth of the AC and reduce the dangerous risk of postoperative hyperfiltration and hypotonia


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Fig. 5.16
(ab) Covering the tube of the shunt. In recent years, many surgeons believe that the tube of the shunt must be covered with a patch or graft. This patch will reduce the incidence of conjunctival erosions, a dangerous and occasional occurrence. The patch is positioned to cover the extraocular portion of the tube of the shunt, from the plate to the insertion point in the AC. Single sutures in nylon 8.0 or 10.0 are used to anchor the patch to the bulb. Some surgeons prefer to use vicryl thread (see a). All sutures must be recessed in the scleral tissue to avoid late-onset erosion of the conjunctiva (see b). To avoid Dellen formation, the surgeon should thin the limbal edge of the patch prior to implanting it. Several materials can be used to cover the tube: scleral tissue, cornea, bovine pericardium, fascia lata and dura. However, the sclera and the cornea are the materials that are used more frequently and this can be sourced at the Eye Bank. Normally a patch measuring 6 × 6 mm or 4 × 6 mm will guarantee good cover. Some surgeons prefer corneal tissue (not suitable for keratoplasty) to the sclera. This is because the cornea is thinner than the sclera and will occupy a smaller volume. As an alternative, if the patch is not available, the surgeon can create a scleral flap that is not full depth: below this he can create the pass the tube with a 23G needle. The flap is then sutured with vicryl 10.0. However, this method would appear to be less secure than applying a patch


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Fig. 5.17
Suture of the conjunctiva and the Tenon capsule . Final stages of the procedure. After having positioned the patch correctly above the tube of the shunt and sutured it, the surgeon must suture the conjunctiva and the Tenon capsule to cover everything completely. These two tissues must be stretched to cover the plate, the tube and the patch. An 8.0 vicryl suture—continuous or single—is normally used (as shown in figure). Everything the surgeon has done during the procedure should be controlled at the end of surgery: he should examine the position of the plate and the patch, and the correct position of the tube in the AC. Fluorescein drops or strips are useful when checking for leakage of the conjunctiva. Any continuous solutions of the conjunctiva must be closed and sutured with vicryl. Finally, a subconjunctival injection of an antibiotic-steroid combination is recommended


Surgical Tips to Prevent Hypotonia with Non-valved Implants


When non-valved implants are used, two surgical maneuvers can be added to avoid hypotonia in the precocious post-operative period: both involve the use of suture thread that can be applied either inside or outside the tube of the implant.

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Fig. 5.18
Prolene stent in the infero-temporal quadrant of an eye with a non-valved implant Another system that reduces the flow of aqueous humor through non-valved implants is external occlusion of the tube (binding): this consists of a suture that is applied around the tube to reduce the size of the lumen. A non-resorbable 7.0 nylon suture with a slipknot or resorbable vicryl are usually used. Like the stent, the release or the resorption of the suture thread occur 4–6 weeks from surgery, the period necessary for the fibrous capsule to form around the implant. This technique is not particularly indicated for eyes affected by important preoperative hypertonia due to the long period required to normalize the IOP


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Fig. 5.19
External binding of the tube of the non-valved shunt with suture thread. Another system that reduces the flow of aqueous humor through non-valved implants is external occlusion of the tube (binding): this consists of a suture that is applied around the tube to reduce the size of the lumen. A non-resorbable 7.0 nylon suture with a slipknot or resorbable vicryl are usually used. Like the stent, the release or the resorption of the suture thread occur 4–6 weeks from surgery, the period necessary for the fibrous capsule to form around the implant. This technique is not particularly indicated for eyes affected by important preoperative hypertonia due to the long period required to normalize the IOP

The first of these additional maneuvers involves positioning an obstruction inside the tube (stent): it consists of a prolene or 3.0, 4.0 or 5.0 nylon thread, positioned inside the tube’s lumen. This will reduce the patency and consequently decrease the drainage of the aqueous humor: the thread acts as a temporary valve. The piece of thread is approximately 15–20 mm long; it is inserted in the tube for 6–10 mm through an opening on the tube close to the plate. The free end of the prolene or nylon thread that exits the tube is positioned in the subconjunctival space of the quadrant adjacent to the implant, close to the limbus. Once the fibrous capsule has formed around the plate (4–6 weeks from surgery), the suture can be removed under the slit lamp and topical anesthesia. At this point, the aqueous humor can drain freely into the fibrous capsule around the plate, with the capsule providing resistance to the flow. However, even though this technique is efficacious for preventing precocious postoperative hypotonia, it may be necessary to remove the suture immediately in the event of precocious postoperative hypertonia caused by occlusion of the tube. So there is again a risk of hypotonia, a reduction in the depth of the AC and the associated complications.


Results


Most of the published studies report a mean percentage of success with the four types of implant of approximately 70% (range 50–80%), with an average postoperative reduction in the IOP of at least 50% over the preoperative values 2 years from surgery: the variation of the range depends on the type of glaucoma and the type of implant chosen. Unfortunately, failures account for 10% per year, with a consequent 50% function of the drainage implant after 5 years. One-year results of a comparative study for the Ahmed and Baerveldt implants did not clearly demonstrate any clear superiority of one over the other: even though the mean IOP was slightly higher in the eyes with the valved implant (Ahmed), this implant was associated with a lower incidence of precocious complications that are less severe than those observed with the Baerveldt implants. Recently an update with 5-year follow-up was published. It referred to an important study called ‘Treatment Outcomes in the Tube Versus Trabeculectomy” (TVT). It reported that 5 years from surgery, IOP was a slightly greater (though not significant) when shunts were used compared to trabeculectomy: in the postoperative, both types of procedure are associated with a fairly similar reduction in the IOP and comparable use of a topical pressure-reducing therapy. GDDs have a greater success rate compared to the trabeculectomy procedure associated with MM-C: the cumulative probability of failure during 5 years of follow-up has been reported as 29.8% for the GDDs and 46.9% for the trabeculectomy. By the same measure, the percentage of repeating surgery is greater for trabeculectomy. These important findings have driven numerous surgeons to increase the number of implant procedures performed and to propose this surgery in cases of simple, not complicated, chronic glaucoma. Barton et al concluded their study by stating that the Ahmed valves would appear to improve the predictability of the precocious postoperative control, and that the Baerveldt valves have a lower percentage of late encapsulation. The authors believe that the main obstruction to the diffusion of these devices in uncomplicated cases of glaucoma is the lack of data available on the long-term effects on the endothelium, an issue that has not been fully clarified. In conclusion, GDDs would appear to be associated with an efficacy that is comparable, and sometimes superior, to the trabeculectomy in the management of complicated glaucoma. Given that, traditionally, these devices were suggested for refractory cases of glaucoma, they have always been associated with poor results. Their use should be reviewed—something that is already happening to some degree—in the primary surgical management of uncomplicated glaucoma (the more precocious cases), even taking in consideration the greater predictability compared to the trabeculectomy with MM-C, combined with a lower incidence of complications.


Complications


There are numerous possible complications associated with GDDs; the surgeon must necessarily construct a precise preoperative plan and have learned a meticulous technique (for all phases of the procedure) to achieve a valid result.

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Dec 19, 2017 | Posted by in OPHTHALMOLOGY | Comments Off on Glaucoma Drainage Implants

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