ORIGINAL STUDY
Ahmed Valve, Suture-less Implantation: A New Approach to an Easier Technique Salvador Garcı´a-Delpech, MD,*w Empar Sanz-Marco, MD,* Sebastian Martinez-Castillo, MD,* Maria Jesus Lo´pez-Prats, MD,* Patricia Udaondo, MD,*wz David Salom, MD,*zy and Manuel Dı´az-Llopis, MD*zy
Purpose: Tissue adhesives have been used in ophthalmology instead of sutures to minimize the operating time. This case series investigated the effectiveness and safety of use of cyanoacrylate in Ahmed valve implantation through pars plana for refractory glaucoma. Patients and Methods: Seventeen eyes of 17 patients with refractory glaucoma underwent Ahmed valve scleral suture-less implantation through pars plana with a cyanoacrylate suture of the plate. Refractory glaucoma was defined as intraocular pressure (IOP) Z21 mm Hg with antiglaucoma eye drops, good adherence to treatment, and no previous glaucoma surgery. IOP control and development of complications were evaluated during the follow-up (mean follow-up, 13.23 mo, 6 to 28 mo). Results: IOP control, defined as IOPr21 mm Hg with or without antiglaucoma eye drops, was achieved in 82.2% of patients, and 58.8% were able to eliminate antiglaucoma eye drops. Mean surgical time was 9.76 ± 2.60 and 6 ± 0.81 minutes in patients with previous vitrectomy (4 cases). Postoperative complications included transiently increased IOP, transient hyphema, early postoperative hypotony (4 cases), and tube block by the vitreous (2 cases): 1 resolved by Nd:YAG and the other by second vitrectomy. No cases of tube or plate extrusion, plate migration, choroidal or retinal detachment, or vitreous hemorrhage were observed. Conclusions: These results are promising and demonstrate a safe and effective alternative to the traditional scleral suture. Our data suggest that Ahmed valve implantation through pars plana with cyanoacrylate is a safe and effective method for refractory glaucoma. Further studies are needed to confirm our observation. Key Words: Ahmed valve, cyanoacrylate, suture less, glaucoma, scleral tunnel
(J Glaucoma 2013;22:750–756)
T
he Ahmed glaucoma valve (New World Medical Inc.; Rancho Cucamonga, CA) and the Kuprin valve are commonly used valved drainage devices. The first experience with an Ahmed valve was reported in 1995, and demonstrated the efficacy and safety of its use and
Received for publication May 19, 2011; accepted June 12, 2012. From the *Ophthalmology Department, La Fe University Hospital; wOphthalmology Department, Medicine Faculty, Catholic University of Valencia; yOphthalmology Department, Medicine Faculty, University of Valencia; and zResearch Center for Rare Diseases (CIBERER), Valencia, Spain. Disclosure: The authors declare no conflict of interest. Reprints: Empar Sanz-Marco, MD, Ophthalmology Department, La Fe University Hospital, 21 Campanar Av., 46015 Valencia, Spain (e-mail: [email protected]). Copyright r 2013 by Lippincott Williams & Wilkins DOI: 10.1097/IJG.0b013e318264ba4d
750 | www.glaucomajournal.com
effectiveness to prevent hypotony and other complications usually associated with no-valved drainage devices in glaucoma disease 1. Since the 1990s, its use in ophthalmology has significantly increased, especially in glaucoma cases with poor surgical prognosis, such as neovascular and postkeratoplasty glaucoma. Previous studies have shown that valved drainage shunts lower the rate of hypotony, flat anterior chamber,1,2 with appropriate intraocular pressure (IOP) control during the early postoperative period. Traditionally, the tube has been implanted in the anterior chamber, but the anterior chamber may not be an appropriate site for tube implantation in selected cases such as secondary angle closure, anatomic abnormalities of the anterior segment, patients with low endothelial density, or patients who have previously undergone keratoplasty. Therefore, some authors have reported the insertion of the drainage tube through pars plana into the vitreous cavity2–5 with a success rate comparable with the anterior chamber approach,1,2 including less risk of endothelial damage. In contrast, many materials have been used to cover the tube such as cadaveric sclera, cadaveric dura mater, fascia lata, bovine pericardium, or amniotic membrane. These biological materials imply a potential risk of contagious diseases; especially infections, such as prion infection,6 viremias, or neoplastic processes which, in addition, are not detected during the donation protocol.7 In addition, scleral sutures can prove to be difficult in certain situations, like high hyperopic eyes (because of small eye size) and scleromalacia and myopia (because of the presence of thin sclera). Furthermore, there are some theoretical complications secondary to scleral sutures which we can prevent using cyanoacrylate instead of classic scleral sutures. Therefore, we initiated a pilot study using a new suture-less Ahmed valve implantation technique through pars plana with a scleral tunnel in patients with refractory glaucoma.
PATIENTS AND METHODS Participants, Outcomes, and Analysis Seventeen patients included in this prospective interventionist study were selected by the Ophthalmology Service of the University La Fe Hospital of Valencia, Spain. All the subjects were aged over 18 years. All the patients presented refractory glaucoma, defined as IOPZ21 mm Hg with antiglaucoma eye drops, with good adherence to treatment, and no previous glaucoma surgery. The study protocol complied with the provisions of the Declaration of Helsinki, and was reviewed and approved by the Ethics J Glaucoma
Volume 22, Number 9, December 2013
J Glaucoma
Volume 22, Number 9, December 2013
Committee of the La Fe University Hospital of Valencia, Spain. Informed consent was obtained from each subject. The mean follow-up was 13.23 months (6 to 28 mo). The following data were collected and analyzed: patients’ demographic characteristics (age, sex), type of glaucoma, and medical treatment. IOP was measured by Goldman tonometry. Our main study end-point was IOP reduction. Surgical success was based on the definitions by the World Glaucoma Association. Surgical success was defined as IOPZ5 mm Hg and IOPr21 mm Hg, with or without antiglaucoma medication, and surgical failure was defined as IOPZ21 mm Hg, phthisis, loss of light perception, enucleation, extrusion, mobilization or migration of the tube or the valve, or need for further glaucoma surgery. The paired t test was used to compare preoperative and postoperative IOP; the Wilcoxon test was employed to compare the number of antiglaucoma medications before and after surgery. Finally, Spearman r correlation coefficient was utilized to evaluate the association of age and final IOP control.
Surgical Technique and Postoperative Care All the surgery was performed by the same surgeon (S.G-.D.). All the patients received a model FP7 flexible
Suture-less Ahmed Valve
silicone Ahmed valve (New World Medical Inc.). This valve consists in a 16 13-mm episcleral drainage plate and a tube with an external diameter of 0.64 mm. Nine patients were at high risk of endothelial failure after Ahmed valve implantation in the anterior chamber (7 postkeratoplasty glaucoma patients and 2 chronic openangle glaucoma patients with low endothelial cell density). We decided to place the tube in the vitreous cavity, and pars plana vitrectomy (PPV) is mandatory for this purpose. The other 8 patients were previously vitrectomized. PPV was indicated in 7 patients to treat complications of diabetic retinopathy (5 patients), uveitis (1 patient), and central retinal vein occlusion (1 patient). PPV was indicated in 1 patient with traumatic angle recession because this patient presented a previous traumatic lens luxation. All the patients underwent PPV 23 G 3-port vitrectomy (1 port for IOP control, 1 port for vitreotome, and 1 port for direct optical control through the microscope) and Ahmed valve implantation. Anterior and central vitreous were thoroughly removed during surgery. Having finished the vitrectomy, the 2 ports used for vitreotome and direct optical control were removed. Afterward, a scleral tunnel was performed from 8.5 to 5.5 mm from the limbus in the
FIGURE 1. Surgical procedure. All the patients underwent pars plana vitrectomy 23-G 3-port and Ahmed valve implantation. Anterior and central vitreous were thoroughly removed during surgery (A). Once the vitrectomy had been finished, the 2 ports used for vitreotome and direct optical control were removed. Afterward, a scleral tunnel was performed from 8.5 to 5.5 mm from the limbus in the superotemporal quadrant just 2 mm behind the superotemporal sclerotomy used for vitrectomy (B). The valve was purged with saline serum and placed at the superotemporal quadrant (C). Then the port used for intraocular pressure control was removed and the drainage tube was inserted through the superotemporal sclerotomy at 3.5 to 4.0 mm from the corneal limbus (D). Next, the tube was introduced into the vitreous cavity, making sure it was visible through the dilated pupil (E). The plate was fixed at 15 mm from the corneal limbus with cyanoacrylate at the superotemporal quadrant. Having completed the surgery, the conjunctiva was closed with 2 drops of cyanoacrylate placed on the sclera (F). r
2013 Lippincott Williams & Wilkins
www.glaucomajournal.com |
751
F F F M F F
M F F M M F
F F M M M
Postkeratoplasty glaucoma Postkeratoplasty glaucoma Uveitic glaucoma Neovascular glaucoma OACG Postkeratoplasty glaucoma
Postkeratoplasty glaucoma OACG Postkeratoplasty glaucoma Neovascular glaucoma Neovascular glaucoma Neovascular glaucoma
752 | www.glaucomajournal.com
Postkeratoplasty glaucoma Neovascular glaucoma Neovascular glaucoma Traumatic glaucoma Postkeratoplasty glaucoma
20/200 CF LP 20/100 20/200
LP 20/20 20/200 20/60 CF 20/400
20/400 CF 20/50 HM 20/20 20/60
40 50 35 32 36
50 29 29 48 25 40
28 23 29 32 40 40
27 23 27 15 29
20 23 12 27 30 15
12 29 16 10 23 25
20 20 36 15 12
10 16 19 18 9 44
30 12 16 12 17 12
15 21 40 16 20
12 15 14 17 12 16
28 14 22 24 14 16
10 — — — 16
14 — — 16 — 16
28 16 7 12 — 17
— — — — —
12 — — — — —
— — 10 — — 16
Initial Preoperative IOP IOP IOP IOP IOP VA IOP 1 mo 3 mo 6 mo 12 mo 24 mo
Timolol + brimonidine
Timolol + brimonidine Timolol + bimatoprost
Timolol 0.5%
Timolol + brimonidine Timolol + brimonidine Timolol + bimatoprost
Antiglaucoma Eye Drops
20/200 CF LP 20/100 20/200
20/60 20/20 20/200 20/60 CF LP
20/400 HM 20/200 HM 20/20 20/60
Final VA
Vitreous obstruction of the tube treated with Nd:YAG
Vitreous obstruction of the tube treated with PPV
Complications
12 8 6 6 14
26 7 8 12 6 12
15 18 28 13 8 28
Yes Yes No Yes Yes
Yes Yes Yes Yes Yes Yes
No Yes Yes Yes Yes Yes
Followup Success
Data collected: 17 patients were enrolled, 10 women and 7 men. Mean preoperative IOP was 37.64 ± 8.41 mm Hg and mean postoperative IOP was 15.63 ± 5.44 mm Hg. Surgery failed in 11.76% patients, who presented vitreous obstruction of the tube and were treated with Nd:YAG (1 case) and vitrectomy (1 case). There was no case of mobilization or migration of the tube or the plate, and neither extrusion of the tube nor phthisis bulbi was reported during the follow-up. CF indicates count fingers; HM, hand movements; IOP, intraocular pressure; LP, light perception; OACG, open-angle chronic glaucoma; PPV, pars plana vitrectomy; VA, visual acuity.
81 67 57 40 41
69 59 77 51 51 67
46 70 48 55 59 43
Sex Age
Diagnosis
TABLE 1. Data Collected
Garcı´a-Delpech et al J Glaucoma
Volume 22, Number 9, December 2013
r
2013 Lippincott Williams & Wilkins
J Glaucoma
Volume 22, Number 9, December 2013
Suture-less Ahmed Valve
FIGURE 2. Kaplan-Meier survival analysis of surgical success in 17 glaucomatous patients, who underwent Ahmed valve suture-less implantation. Surgical success was defined as an intraocular pressure >5 and
Ahmed Valve, Suture-less Implantation: A New Approach to an Easier Technique Salvador Garcı´a-Delpech, MD,*w Empar Sanz-Marco, MD,* Sebastian Martinez-Castillo, MD,* Maria Jesus Lo´pez-Prats, MD,* Patricia Udaondo, MD,*wz David Salom, MD,*zy and Manuel Dı´az-Llopis, MD*zy
Purpose: Tissue adhesives have been used in ophthalmology instead of sutures to minimize the operating time. This case series investigated the effectiveness and safety of use of cyanoacrylate in Ahmed valve implantation through pars plana for refractory glaucoma. Patients and Methods: Seventeen eyes of 17 patients with refractory glaucoma underwent Ahmed valve scleral suture-less implantation through pars plana with a cyanoacrylate suture of the plate. Refractory glaucoma was defined as intraocular pressure (IOP) Z21 mm Hg with antiglaucoma eye drops, good adherence to treatment, and no previous glaucoma surgery. IOP control and development of complications were evaluated during the follow-up (mean follow-up, 13.23 mo, 6 to 28 mo). Results: IOP control, defined as IOPr21 mm Hg with or without antiglaucoma eye drops, was achieved in 82.2% of patients, and 58.8% were able to eliminate antiglaucoma eye drops. Mean surgical time was 9.76 ± 2.60 and 6 ± 0.81 minutes in patients with previous vitrectomy (4 cases). Postoperative complications included transiently increased IOP, transient hyphema, early postoperative hypotony (4 cases), and tube block by the vitreous (2 cases): 1 resolved by Nd:YAG and the other by second vitrectomy. No cases of tube or plate extrusion, plate migration, choroidal or retinal detachment, or vitreous hemorrhage were observed. Conclusions: These results are promising and demonstrate a safe and effective alternative to the traditional scleral suture. Our data suggest that Ahmed valve implantation through pars plana with cyanoacrylate is a safe and effective method for refractory glaucoma. Further studies are needed to confirm our observation. Key Words: Ahmed valve, cyanoacrylate, suture less, glaucoma, scleral tunnel
(J Glaucoma 2013;22:750–756)
T
he Ahmed glaucoma valve (New World Medical Inc.; Rancho Cucamonga, CA) and the Kuprin valve are commonly used valved drainage devices. The first experience with an Ahmed valve was reported in 1995, and demonstrated the efficacy and safety of its use and
Received for publication May 19, 2011; accepted June 12, 2012. From the *Ophthalmology Department, La Fe University Hospital; wOphthalmology Department, Medicine Faculty, Catholic University of Valencia; yOphthalmology Department, Medicine Faculty, University of Valencia; and zResearch Center for Rare Diseases (CIBERER), Valencia, Spain. Disclosure: The authors declare no conflict of interest. Reprints: Empar Sanz-Marco, MD, Ophthalmology Department, La Fe University Hospital, 21 Campanar Av., 46015 Valencia, Spain (e-mail: [email protected]). Copyright r 2013 by Lippincott Williams & Wilkins DOI: 10.1097/IJG.0b013e318264ba4d
750 | www.glaucomajournal.com
effectiveness to prevent hypotony and other complications usually associated with no-valved drainage devices in glaucoma disease 1. Since the 1990s, its use in ophthalmology has significantly increased, especially in glaucoma cases with poor surgical prognosis, such as neovascular and postkeratoplasty glaucoma. Previous studies have shown that valved drainage shunts lower the rate of hypotony, flat anterior chamber,1,2 with appropriate intraocular pressure (IOP) control during the early postoperative period. Traditionally, the tube has been implanted in the anterior chamber, but the anterior chamber may not be an appropriate site for tube implantation in selected cases such as secondary angle closure, anatomic abnormalities of the anterior segment, patients with low endothelial density, or patients who have previously undergone keratoplasty. Therefore, some authors have reported the insertion of the drainage tube through pars plana into the vitreous cavity2–5 with a success rate comparable with the anterior chamber approach,1,2 including less risk of endothelial damage. In contrast, many materials have been used to cover the tube such as cadaveric sclera, cadaveric dura mater, fascia lata, bovine pericardium, or amniotic membrane. These biological materials imply a potential risk of contagious diseases; especially infections, such as prion infection,6 viremias, or neoplastic processes which, in addition, are not detected during the donation protocol.7 In addition, scleral sutures can prove to be difficult in certain situations, like high hyperopic eyes (because of small eye size) and scleromalacia and myopia (because of the presence of thin sclera). Furthermore, there are some theoretical complications secondary to scleral sutures which we can prevent using cyanoacrylate instead of classic scleral sutures. Therefore, we initiated a pilot study using a new suture-less Ahmed valve implantation technique through pars plana with a scleral tunnel in patients with refractory glaucoma.
PATIENTS AND METHODS Participants, Outcomes, and Analysis Seventeen patients included in this prospective interventionist study were selected by the Ophthalmology Service of the University La Fe Hospital of Valencia, Spain. All the subjects were aged over 18 years. All the patients presented refractory glaucoma, defined as IOPZ21 mm Hg with antiglaucoma eye drops, with good adherence to treatment, and no previous glaucoma surgery. The study protocol complied with the provisions of the Declaration of Helsinki, and was reviewed and approved by the Ethics J Glaucoma
Volume 22, Number 9, December 2013
J Glaucoma
Volume 22, Number 9, December 2013
Committee of the La Fe University Hospital of Valencia, Spain. Informed consent was obtained from each subject. The mean follow-up was 13.23 months (6 to 28 mo). The following data were collected and analyzed: patients’ demographic characteristics (age, sex), type of glaucoma, and medical treatment. IOP was measured by Goldman tonometry. Our main study end-point was IOP reduction. Surgical success was based on the definitions by the World Glaucoma Association. Surgical success was defined as IOPZ5 mm Hg and IOPr21 mm Hg, with or without antiglaucoma medication, and surgical failure was defined as IOPZ21 mm Hg, phthisis, loss of light perception, enucleation, extrusion, mobilization or migration of the tube or the valve, or need for further glaucoma surgery. The paired t test was used to compare preoperative and postoperative IOP; the Wilcoxon test was employed to compare the number of antiglaucoma medications before and after surgery. Finally, Spearman r correlation coefficient was utilized to evaluate the association of age and final IOP control.
Surgical Technique and Postoperative Care All the surgery was performed by the same surgeon (S.G-.D.). All the patients received a model FP7 flexible
Suture-less Ahmed Valve
silicone Ahmed valve (New World Medical Inc.). This valve consists in a 16 13-mm episcleral drainage plate and a tube with an external diameter of 0.64 mm. Nine patients were at high risk of endothelial failure after Ahmed valve implantation in the anterior chamber (7 postkeratoplasty glaucoma patients and 2 chronic openangle glaucoma patients with low endothelial cell density). We decided to place the tube in the vitreous cavity, and pars plana vitrectomy (PPV) is mandatory for this purpose. The other 8 patients were previously vitrectomized. PPV was indicated in 7 patients to treat complications of diabetic retinopathy (5 patients), uveitis (1 patient), and central retinal vein occlusion (1 patient). PPV was indicated in 1 patient with traumatic angle recession because this patient presented a previous traumatic lens luxation. All the patients underwent PPV 23 G 3-port vitrectomy (1 port for IOP control, 1 port for vitreotome, and 1 port for direct optical control through the microscope) and Ahmed valve implantation. Anterior and central vitreous were thoroughly removed during surgery. Having finished the vitrectomy, the 2 ports used for vitreotome and direct optical control were removed. Afterward, a scleral tunnel was performed from 8.5 to 5.5 mm from the limbus in the
FIGURE 1. Surgical procedure. All the patients underwent pars plana vitrectomy 23-G 3-port and Ahmed valve implantation. Anterior and central vitreous were thoroughly removed during surgery (A). Once the vitrectomy had been finished, the 2 ports used for vitreotome and direct optical control were removed. Afterward, a scleral tunnel was performed from 8.5 to 5.5 mm from the limbus in the superotemporal quadrant just 2 mm behind the superotemporal sclerotomy used for vitrectomy (B). The valve was purged with saline serum and placed at the superotemporal quadrant (C). Then the port used for intraocular pressure control was removed and the drainage tube was inserted through the superotemporal sclerotomy at 3.5 to 4.0 mm from the corneal limbus (D). Next, the tube was introduced into the vitreous cavity, making sure it was visible through the dilated pupil (E). The plate was fixed at 15 mm from the corneal limbus with cyanoacrylate at the superotemporal quadrant. Having completed the surgery, the conjunctiva was closed with 2 drops of cyanoacrylate placed on the sclera (F). r
2013 Lippincott Williams & Wilkins
www.glaucomajournal.com |
751
F F F M F F
M F F M M F
F F M M M
Postkeratoplasty glaucoma Postkeratoplasty glaucoma Uveitic glaucoma Neovascular glaucoma OACG Postkeratoplasty glaucoma
Postkeratoplasty glaucoma OACG Postkeratoplasty glaucoma Neovascular glaucoma Neovascular glaucoma Neovascular glaucoma
752 | www.glaucomajournal.com
Postkeratoplasty glaucoma Neovascular glaucoma Neovascular glaucoma Traumatic glaucoma Postkeratoplasty glaucoma
20/200 CF LP 20/100 20/200
LP 20/20 20/200 20/60 CF 20/400
20/400 CF 20/50 HM 20/20 20/60
40 50 35 32 36
50 29 29 48 25 40
28 23 29 32 40 40
27 23 27 15 29
20 23 12 27 30 15
12 29 16 10 23 25
20 20 36 15 12
10 16 19 18 9 44
30 12 16 12 17 12
15 21 40 16 20
12 15 14 17 12 16
28 14 22 24 14 16
10 — — — 16
14 — — 16 — 16
28 16 7 12 — 17
— — — — —
12 — — — — —
— — 10 — — 16
Initial Preoperative IOP IOP IOP IOP IOP VA IOP 1 mo 3 mo 6 mo 12 mo 24 mo
Timolol + brimonidine
Timolol + brimonidine Timolol + bimatoprost
Timolol 0.5%
Timolol + brimonidine Timolol + brimonidine Timolol + bimatoprost
Antiglaucoma Eye Drops
20/200 CF LP 20/100 20/200
20/60 20/20 20/200 20/60 CF LP
20/400 HM 20/200 HM 20/20 20/60
Final VA
Vitreous obstruction of the tube treated with Nd:YAG
Vitreous obstruction of the tube treated with PPV
Complications
12 8 6 6 14
26 7 8 12 6 12
15 18 28 13 8 28
Yes Yes No Yes Yes
Yes Yes Yes Yes Yes Yes
No Yes Yes Yes Yes Yes
Followup Success
Data collected: 17 patients were enrolled, 10 women and 7 men. Mean preoperative IOP was 37.64 ± 8.41 mm Hg and mean postoperative IOP was 15.63 ± 5.44 mm Hg. Surgery failed in 11.76% patients, who presented vitreous obstruction of the tube and were treated with Nd:YAG (1 case) and vitrectomy (1 case). There was no case of mobilization or migration of the tube or the plate, and neither extrusion of the tube nor phthisis bulbi was reported during the follow-up. CF indicates count fingers; HM, hand movements; IOP, intraocular pressure; LP, light perception; OACG, open-angle chronic glaucoma; PPV, pars plana vitrectomy; VA, visual acuity.
81 67 57 40 41
69 59 77 51 51 67
46 70 48 55 59 43
Sex Age
Diagnosis
TABLE 1. Data Collected
Garcı´a-Delpech et al J Glaucoma
Volume 22, Number 9, December 2013
r
2013 Lippincott Williams & Wilkins
J Glaucoma
Volume 22, Number 9, December 2013
Suture-less Ahmed Valve
FIGURE 2. Kaplan-Meier survival analysis of surgical success in 17 glaucomatous patients, who underwent Ahmed valve suture-less implantation. Surgical success was defined as an intraocular pressure >5 and
