Development of a micro-mechanical valve in a novel glaucoma implant.

PubMed

Siewert, Stefan; Schultze, Christine; Schmidt, Wolfram; Hinze, Ulf; Chichkov, Boris; Wree, Andreas; Sternberg, Katrin; Allemann, Reto; Guthoff, Rudolf; Schmitz, Klaus-Peter

2012-10-01

This paper describes methods for design, manufacturing and characterization of a micro-mechanical valve for a novel glaucoma implant. The implant is designed to drain aqueous humour from the anterior chamber of the eye into the suprachoroidal space in case of an elevated intraocular pressure (IOP). In contrast to any existing glaucoma drainage device (GDD), the valve mechanism is located in the anterior chamber and there, surrounded by aqueous humour, immune to fibrosis induced failure. For the prevention of hypotony the micro-mechanical valve is designed to open if the physiological pressure difference between the anterior chamber and the suprachoroidal space in the range of 0.8 mmHg to 3.7 mmHg is exceeded. In particular the work includes: (i) manufacturing and morphological characterization of polymer tubing, (ii) mechanical material testing as basis for (iii) the design of micro-mechanical valves using finite element analysis (FEA), (iv) manufacturing of microstent prototypes including micro-mechanical valves by femtosecond laser micromachining and (v) the experimental fluid-mechanical characterization of the manufactured microstent prototypes with regard to valve opening pressure. The considered materials polyurethane (PUR) and silicone (SIL) exhibit low elastic modulus and high extensibility. The unique valve design enables a low opening pressure of micro-mechanical valves. An ideal valve design for PUR and SIL with an experimentally determined opening pressure of 2 mmHg and 3.7 mmHg is identified. The presented valve approach is suitable for the inhibition of hypotony as a major limitation of today's GDD and will potentially improve the minimally invasive treatment of glaucoma.

Managing high risk glaucoma with the Ahmed valve implant: 20 years of experience

PubMed Central

Rotsos, Tryfon; Tsioga, Anastasia; Andreanos, Konstantinos; Diagourtas, Andreas; Petrou, Petros; Georgalas, Ilias; Papaconstantinou, Dimitrios

2018-01-01

AIM To estimate the efficacy and safety of the Ahmed implant in patients with high risk for failure after glaucoma surgery. METHODS In 342 eyes of 342 patients with refractory glaucoma, even with application of medical treatment, the Ahmed valve was introduced for intraocular pressure (IOP) control, in the period of the last 20y. The nature of glaucoma was neovascular in 162 eyes, pseudophakic or aphakic in 49 eyes, inflammatory in 29 eyes and non working previous antiglaucomatic surgical interventions in 102 eyes. RESULTS Follow-up ranged from 18 to 120mo with a mean follow-up of 63.2mo. IOP before the operation decreased from 31.6±10.4 mm Hg to 18.3±5.4 mm Hg (no systemic treatment) at the end of follow up period. When we compared the IOP values before the operation using ANOVA showed statistically significant difference (P<0.001). The success rate was 85.2% during the first semester, 76.8% at 12mo and 50.3% at the end of follow up period (18 to 120mo after implantation). Success rate was 25.7% in neovascular glaucoma, 63.2% in aphakic glaucoma and 73.8% in non working previous antiglaucomatic surgical interventions. Complications due to the implant were: serous choroidal detachment in 14.8%, blockage of the tube in 2.8%, malposition of the tube in 4.9%, suprachoroidal hemorrhage in 2.1%, cataract progression in 39.6% (phakic eyes), shallow anterior chamber in 9.2%, hyphaema in 28.9%, exposure of valve in 2.6%, exposure of tube in 9.3%, hypotony in 4.9% and conjunctival fibrosis in 41.5%. CONCLUSION Despite the fact that Ahmed valve implant had suchlike results as other implants concerning the IOP control, complications rate due to hypotony or over filtration in the first days after the intervention are not that frequent as with other valve implants. PMID:29487813

Managing high risk glaucoma with the Ahmed valve implant: 20 years of experience.

PubMed

Rotsos, Tryfon; Tsioga, Anastasia; Andreanos, Konstantinos; Diagourtas, Andreas; Petrou, Petros; Georgalas, Ilias; Papaconstantinou, Dimitrios

2018-01-01

To estimate the efficacy and safety of the Ahmed implant in patients with high risk for failure after glaucoma surgery. In 342 eyes of 342 patients with refractory glaucoma, even with application of medical treatment, the Ahmed valve was introduced for intraocular pressure (IOP) control, in the period of the last 20y. The nature of glaucoma was neovascular in 162 eyes, pseudophakic or aphakic in 49 eyes, inflammatory in 29 eyes and non working previous antiglaucomatic surgical interventions in 102 eyes. Follow-up ranged from 18 to 120mo with a mean follow-up of 63.2mo. IOP before the operation decreased from 31.6±10.4 mm Hg to 18.3±5.4 mm Hg (no systemic treatment) at the end of follow up period. When we compared the IOP values before the operation using ANOVA showed statistically significant difference ( P <0.001). The success rate was 85.2% during the first semester, 76.8% at 12mo and 50.3% at the end of follow up period (18 to 120mo after implantation). Success rate was 25.7% in neovascular glaucoma, 63.2% in aphakic glaucoma and 73.8% in non working previous antiglaucomatic surgical interventions. Complications due to the implant were: serous choroidal detachment in 14.8%, blockage of the tube in 2.8%, malposition of the tube in 4.9%, suprachoroidal hemorrhage in 2.1%, cataract progression in 39.6% (phakic eyes), shallow anterior chamber in 9.2%, hyphaema in 28.9%, exposure of valve in 2.6%, exposure of tube in 9.3%, hypotony in 4.9% and conjunctival fibrosis in 41.5%. Despite the fact that Ahmed valve implant had suchlike results as other implants concerning the IOP control, complications rate due to hypotony or over filtration in the first days after the intervention are not that frequent as with other valve implants.

Ahmed Glaucoma Valve Implantation for Uveitic Glaucoma Secondary to Behçet Disease.

PubMed

Satana, Banu; Yalvac, Ilgaz S; Sungur, Gulten; Eksioglu, Umit; Basarir, Berna; Altan, Cigdem; Duman, Sunay

2015-01-01

To evaluate outcomes of patients with uveitic glaucoma secondary to Behçet disease (BD) who underwent Ahmed glaucoma valve (AGV) implantation. A retrospective chart review of 14 eyes of 10 patients with uveitic glaucoma associated with BD who underwent AGV implantation at a tertiary referral center. Treatment success was defined as intraocular pressure (IOP) between 6 and 21 mm Hg with or without antiglaucoma medication, without further additional glaucoma surgery or loss of light perception. The main outcome measures were IOP, best-corrected visual acuity measured with Snellen charts, and number of glaucoma medications. Mean duration of postoperative follow-up was 18.2±6.6 months (range, 6 to 31 mo). Of the 14 eyes, 10 (71.4%) were pseudophakic and 5 (35.7%) had primary AGV implantation without a history of previous glaucoma surgery. At the most recent follow-up visit, 13 of the 14 eyes had an IOP between 6 and 21 mm Hg. Mean IOP was significantly reduced during follow-up, as compared with preoperative values (P≤0.005). The cumulative probability of surgical success rate was 90.9% at 18 months based on Kaplan-Meier survival analysis. The mean number of antiglaucoma medications required to achieve the desired IOP decreased from 3.4±0.5 preoperatively to 1.0±1.1 postoperatively (P≤0.05). Visual acuity loss of >2 lines occurred in 4 eyes (28.5%) due to optic atrophy associated with retinal vasculitis. Temporary hypotony developed during follow-up in 4 eyes (28.5%) at first postoperative week. For the management of uveitic glaucoma associated with BD, AGV implantation is a successful method for glaucoma control but requires additional surgical interventions for high early hypotony rates.

Bilateral Ocular Decompression Retinopathy after Ahmed Valve Implantation for Uveitic Glaucoma.

PubMed

Flores-Preciado, Javier; Ancona-Lezama, David Arturo; Valdés-Lara, Carlos Andrés; Díez-Cattini, Gian Franco; Coloma-González, Itziar

2016-01-01

We report the case of a 29-year-old man who underwent Ahmed valve implantation in both eyes as treatment for uveitic glaucoma, subsequently presenting with bilateral ocular decompression retinopathy in the postoperative period. Ocular decompression retinopathy is a rare complication of filtering surgery in patients with glaucoma; however, the course is benign in most cases, with spontaneous resolution of bleedings and improvement of visual acuity.

Bilateral Ocular Decompression Retinopathy after Ahmed Valve Implantation for Uveitic Glaucoma

PubMed Central

Flores-Preciado, Javier; Ancona-Lezama, David Arturo; Valdés-Lara, Carlos Andrés; Díez-Cattini, Gian Franco; Coloma-González, Itziar

2016-01-01

Case Report We report the case of a 29-year-old man who underwent Ahmed valve implantation in both eyes as treatment for uveitic glaucoma, subsequently presenting with bilateral ocular decompression retinopathy in the postoperative period. Discussion Ocular decompression retinopathy is a rare complication of filtering surgery in patients with glaucoma; however, the course is benign in most cases, with spontaneous resolution of bleedings and improvement of visual acuity. PMID:27920718

Ahmed Glaucoma Valve Implantation in Vitrectomized Eyes.

PubMed

Erçalık, Nimet Yeşim; İmamoğlu, Serhat

2018-01-01

To evaluate the outcomes of Ahmed glaucoma valve (AGV) implantation in vitrectomized eyes. The medical records of 13 eyes that developed glaucoma due to emulsified silicon oil or neovascularization following pars plana vitrectomy and underwent AGV implantation were retrospectively reviewed. The main outcome measures were intraocular pressure (IOP), best-corrected visual acuity (BCVA), number of antiglaucoma medications, and postoperative complications. Surgical success was defined as last IOP ≤21 mmHg or ≥6 mmHg and without loss of light perception. The mean follow-up duration was 11.7 ± 5.5 (range, 6-23) months. The mean IOP before the AGV implantation was 37.9 ± 6.7 mmHg with an average of 3.5 ± 1.2 drugs. At the final visit, the mean IOP was 15.9 ± 4.6 mmHg ( p =0.001) and the mean number of glaucoma medications decreased to 2.3 ± 1.3 ( p =0.021). At the last visit, 11 eyes (84.4%) had stable or improved VA and one eye (7.7%) had a final VA of no light perception. Surgical success was achieved in 11 of the 13 eyes (84.4%). Postoperative complications were bleb encapsulation (69.2%), early hypotony (38.5%), hyphema (23.1%), decompression retinopathy (23.1%), choroidal detachment (15.4%), intraocular hemorrhage (7.7%), and late endophthalmitis (7.7%). One eye (7.7%) was enucleated because of late endophthalmitis. Despite complications necessitating medical and surgical interventions, vitrectomized eyes were effectively managed with AGV implantation.

Ahmed Glaucoma Valve Implantation in Vitrectomized Eyes

PubMed Central

İmamoğlu, Serhat

2018-01-01

Purpose To evaluate the outcomes of Ahmed glaucoma valve (AGV) implantation in vitrectomized eyes. Materials and Methods The medical records of 13 eyes that developed glaucoma due to emulsified silicon oil or neovascularization following pars plana vitrectomy and underwent AGV implantation were retrospectively reviewed. The main outcome measures were intraocular pressure (IOP), best-corrected visual acuity (BCVA), number of antiglaucoma medications, and postoperative complications. Surgical success was defined as last IOP ≤21 mmHg or ≥6 mmHg and without loss of light perception. Results The mean follow-up duration was 11.7 ± 5.5 (range, 6–23) months. The mean IOP before the AGV implantation was 37.9 ± 6.7 mmHg with an average of 3.5 ± 1.2 drugs. At the final visit, the mean IOP was 15.9 ± 4.6 mmHg (p=0.001) and the mean number of glaucoma medications decreased to 2.3 ± 1.3 (p=0.021). At the last visit, 11 eyes (84.4%) had stable or improved VA and one eye (7.7%) had a final VA of no light perception. Surgical success was achieved in 11 of the 13 eyes (84.4%). Postoperative complications were bleb encapsulation (69.2%), early hypotony (38.5%), hyphema (23.1%), decompression retinopathy (23.1%), choroidal detachment (15.4%), intraocular hemorrhage (7.7%), and late endophthalmitis (7.7%). One eye (7.7%) was enucleated because of late endophthalmitis. Conclusions Despite complications necessitating medical and surgical interventions, vitrectomized eyes were effectively managed with AGV implantation. PMID:29862068

The Ahmed Glaucoma Valve in Refractory Glaucoma: Experiences in Southwest Ethiopia.

PubMed

Gessesse, Girum W

2015-07-01

The management of refractory glaucoma is a challenging task for any glaucoma surgeon. This study is aimed to evaluate the efficacy of Ahmed Glaucoma Valve implantation in refractory glaucomas in South-West Ethiopia. A retrospective review was conducted on the charts of consecutive patients treated with Ahmed glaucoma valve implantation at Jimma University Specialized Hospital between August 2012 and August 2014. Success was defined as Intraocular Pressure (IOP) less than 22 mm Hg and greater than 5mm Hg at 6 months, with at least 30% reduction from baseline, without medical therapy (complete success) or either with or without medication (qualified successes). A total of 12 eyes of 11 patients were included. The mean age of patients was 40.7 (SD= 19.0) years; 63.6% of them were males. The main types of glaucoma were pseudoexfoliative (3 eyes), uveitic (2 eyes), chronic angle closure (2 eyes) and Juvenile Open Angle (JOAG) (2 eyes). The mean IOP was reduced from preoperative level (32.75±7.14 mmHg) to (15.75 ±4.35 mmHg) at six postoperative months, (P<0.001); 66.7% eyes had complete successes while 83.3% had qualified success. Intra-operative complications were encountered in 2(16.7%) eyes, while 5/12 (41.7%) eyes had post-operative complications-hypotony (one with choroidal effusion) and progression of cataract in 2 eyes each. Hypertensive phase was diagnosed in 2(16.7%) eyes. The Ahmed glaucoma valve implant appears to be effective and relatively safe for treating complicated glaucomas with success rate comparable with those reported from other studies. Ahmed glaucoma valve, refractory glaucoma, complications, Ethiopia.

Outcomes of Ahmed glaucoma valve implantation in advanced primary congenital glaucoma with previous surgical failure.

PubMed

Huang, Jingjing; Lin, Jialiu; Wu, Ziqiang; Xu, Hongzhi; Zuo, Chengguo; Ge, Jian

2015-01-01

The purpose of this study was to evaluate the intermediate surgical results of Ahmed glaucoma valve (AGV) implantation in patients less than 7 years of age, with advanced primary congenital glaucoma who have failed previous surgeries. Consecutive patients with advanced primary congenital glaucoma that failed previous operations and had undergone subsequent AGV implantation were evaluated retrospectively. Surgical success was defined as 1) intraocular pressure (IOP) ≥6 and ≤21 mmHg; 2) IOP reduction of at least 30% relative to preoperative values; and 3) without the need for additional surgical intervention for IOP control, loss of light perception, or serious complications. Fourteen eyes of eleven patients were studied. Preoperatively, the average axial length was 27.71±1.52 (25.56-30.80) mm, corneal diameter was 14.71±1.07 (13.0-16.0) mm, cup-to-disc ratio was 0.95±0.04 (0.9-1.0), and IOP was 39.5±5.7 (30-55) mmHg. The mean follow-up time was 18.29±10.96 (5-44, median 18) months. There were significant reductions in IOPs and the number of glaucoma medications (P<0.001) postoperatively. The IOPs after operation were 11.3±3.4, 13.6±5.1, 16.3±2.7, and 16.1±2.6 mmHg at 1 month, 6 months, 12 months, and 18 months, respectively. Kaplan-Meier estimates of the cumulative probability of valve success were 85.7%, 71.4%, and 71.4% at 6, 12, and 18 months, respectively. Severe surgical complications, including erosion of tube, endophthalmitis, retinal detachment, choroidal detachment, and delayed suprachoroidal hemorrhage, occurred in 28.6% cases. AGV implantation remains a viable option for patients with advanced primary congenital glaucoma unresponsive to previous surgical intervention, despite a relatively high incidence of severe surgical complications.

Initial Clinical Experience with Ahmed Valve Implantation in Refractory Pediatric Glaucoma

PubMed

Novak-Lauš, Katia; Škunca Herman, Jelena; Šimić Prskalo, Marija; Jurišić, Darija; Mandić, Zdravko

2016-12-01

The purpose is to report on the safety and efficacy of Ahmed Glaucoma Valve (AGV, New World Medical, Inc., Rancho Cucamonga, CA, USA) implantation for the management of refractory pediatric glaucoma observed during one-year follow up period. A retrospective chart review was conducted on 10 eyes, all younger than 11 years, with pediatric glaucoma that underwent AGV implantation for medicamentously uncontrolled intraocular pressure (IOP) between 2010 and 2014. Outcome measures were control of IOP below 23 mm Hg (with or without antiglaucoma medications) and changes in visual acuity. Complications were recorded. After AGV implantation, IOP values ranged from 18 mm Hg to 23 mm Hg (except for one eye with postoperative hypotonia due to suprachoroid hemorrhage, where the postoperative IOP value was 4 mm Hg). The number of antiglaucoma medications was reduced, i.e. four patients had two medications, one patient had one medication, and the others did not need antiglaucoma medication on the last follow-up visit. One eye had suprachoroid hemorrhage, one eye had long-term persistent uveitic membrane, and two eyes had tube-cornea touch. In conclusion, AGV implantation appears to be a viable option for the management of refractory pediatric glaucoma and shows success in IOP control. However, there was a relatively high complication rate limiting the overall success rate.

Supra-Tenon Capsule Implantation of the Ahmed Glaucoma Valve in Refractory Pediatric Glaucoma.

PubMed

Elhefney, Eman M; Al-Sharkawy, Hossam T; Kishk, Hanem M

2016-09-01

To evaluate the efficacy of supra-Tenon capsule implantation of an Ahmed glaucoma valve (AGV) as a measure to decrease the fibrotic potential of the Tenon capsule on bleb formation and its subsequent effect on intraocular pressure (IOP) control in children with refractory glaucoma. Mansoura Ophthalmic Centre, Faculty of Medicine, Mansoura University, Egypt. A prospective interventional study. Twenty-two eyes of 12 children with refractory glaucoma underwent supra-Tenon capsule implantation of AGV. Ophthalmic examinations under general anesthesia including measurement of the corneal diameter and the IOP with Perkin's tonometer were performed preoperatively, on the first postoperative day, the first postoperative week, weekly for the first month, 2-weekly for the following 3 months, and monthly for at least 18 months. Postoperative complications and the number of glaucoma medications used preoperatively and postoperatively were recorded. The paired Student t test was used to compare preoperative and postoperative data. There were 12 eyes (54.6%) with refractory congenital glaucoma, 7 eyes (31.8%) with refractory pseudophakic glaucoma, and 3 eyes (13.6%) with refractory aphakic glaucoma. Patients included 10 male (83.3%) and 2 female (16.7%) children with a mean age of 16.3±9.7 months. The mean follow-up duration was 24.1±4.3 months. There was a statistically significant difference between the mean preoperative IOP (30.7±2.88 mm Hg) and the mean postoperative IOP (16.1±3.60 mm Hg) (t=16.22 and P=0.000, with a mean decrease in the IOP by 47.6%). The difference between the mean number of antiglaucoma medications before surgery (1.86±0.4) and after surgery (1.0±0.9) was also statistically significant (t=4.31 and P=0.000). Total success was achieved in 18 eyes (81.9%). Postoperative complications included tube exposure and slippage (10%), hypotony (10%), and hyphema (5%). Supra-Tenon capsule implantation of the AGV was successful in controlling the IOP with few

Propionibacterium acnes endophthalmitis in Ahmed glaucoma valve.

PubMed

Gutiérrez-Díaz, E; Montero-Rodríguez, M; Mencía-Gutiérrez, E; Fernández-González, M C; Pérez-Blázquez, E

2001-01-01

To report a case of Propionibacterium acnes endophthalmitis in a patient with an Ahmed glaucoma valve. A nine-year-old boy with bilateral congenital glaucoma, with an Ahmed glaucoma valve implanted in the left eye, had recurrent conjunctival dehiscence and endophthalmitis. Vitreous cultures demonstrated the presence of Propionibacterium acnes. This is the first reported case of Propionibacterium acnes endophthalmitis in an Ahmed glaucoma valve and the second one in a glaucoma drainage device. We strongly recommend using a patch graft to prevent and treat tube exposure. Conjunctival grafts may be useful to close the conjunctiva when there is marked scarring to prevent patch exposure and melting or extrusion.

Outcomes of Ahmed glaucoma valve implantation in advanced primary congenital glaucoma with previous surgical failure

PubMed Central

Huang, Jingjing; Lin, Jialiu; Wu, Ziqiang; Xu, Hongzhi; Zuo, Chengguo; Ge, Jian

2015-01-01

Purpose The purpose of this study was to evaluate the intermediate surgical results of Ahmed glaucoma valve (AGV) implantation in patients less than 7 years of age, with advanced primary congenital glaucoma who have failed previous surgeries. Patients and methods Consecutive patients with advanced primary congenital glaucoma that failed previous operations and had undergone subsequent AGV implantation were evaluated retrospectively. Surgical success was defined as 1) intraocular pressure (IOP) ≥6 and ≤21 mmHg; 2) IOP reduction of at least 30% relative to preoperative values; and 3) without the need for additional surgical intervention for IOP control, loss of light perception, or serious complications. Results Fourteen eyes of eleven patients were studied. Preoperatively, the average axial length was 27.71±1.52 (25.56–30.80) mm, corneal diameter was 14.71±1.07 (13.0–16.0) mm, cup-to-disc ratio was 0.95±0.04 (0.9–1.0), and IOP was 39.5±5.7 (30–55) mmHg. The mean follow-up time was 18.29±10.96 (5–44, median 18) months. There were significant reductions in IOPs and the number of glaucoma medications (P<0.001) postoperatively. The IOPs after operation were 11.3±3.4, 13.6±5.1, 16.3±2.7, and 16.1±2.6 mmHg at 1 month, 6 months, 12 months, and 18 months, respectively. Kaplan–Meier estimates of the cumulative probability of valve success were 85.7%, 71.4%, and 71.4% at 6, 12, and 18 months, respectively. Severe surgical complications, including erosion of tube, endophthalmitis, retinal detachment, choroidal detachment, and delayed suprachoroidal hemorrhage, occurred in 28.6% cases. Conclusion AGV implantation remains a viable option for patients with advanced primary congenital glaucoma unresponsive to previous surgical intervention, despite a relatively high incidence of severe surgical complications. PMID:26082610

Effect of mitomycin c and 5-flurouracil adjuvant therapy on the outcomes of Ahmed glaucoma valve implantation.

PubMed

Cui, Qi N; Hsia, Yen C; Lin, Shan C; Stamper, Robert L; Rose-Nussbaumer, Jennifer; Mehta, Nitisha; Porco, Travis C; Naseri, Ayman; Han, Ying

2017-03-01

To examine the effect of mitomycin c and 5-flurouracil on treatment outcomes following Ahmed glaucoma valve implantation. Retrospective consecutive case series. Fifty patients who received Ahmed glaucoma valve implantation from 1999 to 2013 in the San Francisco Veterans Administration Hospital. The +INJECTION group received intraoperative mitomycin c followed by postoperative mitomycin c and/or 5-flurouracil, whereas the -INJECTION group did not. Primary outcome was treatment success at 1 year post-implantation. Intraocular pressure, hypertensive phase, and the number of glaucoma medications were also examined. Twenty-six patients/eyes in the +INJECTION group and 24 patients/eyes in the -INJECTION group were included. Treatment success was higher in the +INJECTION compared with the -INJECTION group (86 vs. 58%; P = 0.04). Intraocular pressure was lower in the +INJECTION compared with the -INJECTION group at 1, 3, 6 and 12 months (P ≪ 0.00001, P = 0.00003, 0.0008 and 0.024). Hypertensive phase occurred less often in the +INJECTION compared with the -INJECTION group (3.8 vs. 54%; P = 0.021). The +INJECTION group required fewer medications compared with the -INJECTION group (P = 0.02, 0.002, 0.003 and 0.008 at 1, 3, 6 and 12 months). Complication rates were comparable between groups (46.2 and 54.2%; P = 0.63). Adjuvant treatment with antifibrotics following Ahmed glaucoma valve implantation decreased the hypertensive phase and improved surgical outcomes without impacting complication rates at 1 year. This study postulates a role for antifibrotics in the postoperative management of Ahmed glaucoma valves. © 2016 Royal Australian and New Zealand College of Ophthalmologists.

The use of Ahmed glaucoma valve in the management of pediatric glaucoma.

PubMed

Balekudaru, Shantha; Vadalkar, Juhie; George, Ronnie; Vijaya, Lingam

2014-08-01

To assess the intraocular pressure control (IOP), changes in visual acuity, complications, reoperation rates and risk factors for failure following Ahmed glaucoma valve implantation in pediatric eyes with glaucoma. The medical records of consecutive patients with glaucoma who underwent Ahmed glaucoma valve implantation from January 2000 to December 2009) were retrospectively reviewed. Only one eye of each patient was included. Subgroup analysis was performed in three groups; group 1 included phakic eyes with primary congenital glaucoma, juvenile open-angle glaucoma, or glaucoma associated with ocular anomalies; group 2 included eyes with glaucoma in aphakia or pseudophakia; group 3 included eyes with other diagnoses. A successful outcome was defined as final IOP between 6 mm Hg and 18 mm Hg without loss of light perception or reoperation for glaucoma. A total of 71 eyes in 71 patients: 15 (21%) in group 1, 47 (66%) in group 2, and 9 (13%) in group 3 were included Successful IOP control was achieved in 44 eyes of 44 patients (62%). Cumulative probabilities of success by Kaplan-Meier analysis at 12 and 24 months was 97% and 80% for the entire group, 100% and 82% for group 1, 95% and 86% for group 2, and 90% and 42% for group 3. Reoperation was necessary for 18 patients (25%), either for tube-related complications or for IOP control. The only significant risk factor for failure was the category of diagnosis (P = 0.029). Ahmed glaucoma valve implantation is an option in the management of pediatric glaucoma; however, reoperations for tube related complications or for persistent elevated IOP is frequently needed. Copyright © 2014 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

Ahmed glaucoma valve in uveitic patients with fluocinolone acetonide implant-induced glaucoma: 3-year follow-up.

PubMed

Kubaisi, Buraa; Maleki, Arash; Ahmed, Aseef; Lamba, Neel; Sahawneh, Haitham; Stephenson, Andrew; Montieth, Alyssa; Topgi, Shobha; Foster, C Stephen

2018-01-01

To evaluate the efficacy and safety of Ahmed glaucoma valve (AGV) in eyes with noninfectious uveitis that had fluocinolone acetonide intravitreal implant (Retisert™)-induced glaucoma. This retrospective study reviewed the safety and efficacy of AGV implantation in patients with persistently elevated intraocular pressure (IOP) after implantation of a fluocinolone acetonide intravitreal implant at the Massachusetts Eye Research and Surgery Institution between August 2006 and November 2015. Nine patients with 10 uveitic eyes were included in this study, none of which had preexisting glaucoma in the study eye. Mean patient age was 42 years; 6 patients were female and 3 were male. Baseline mean IOP was 30.6 mmHg prior to AGV placement while mean IOP-lowering medications were 2.9. In the treatment groups, there was a statistically significant reduction in post-AGV IOP. IOP was lowest at 1-week after AGV implantation (9.0 mmHg). Nine out of 10 eyes achieved an IOP below target value of 22 mmHg and/or a 20% reduction in IOP from baseline 1 month and 1 year following AGV placement. All other postoperative time points showed all 10 eyes reaching this goal. A statistically significant decrease in IOP-lowering medication was seen at the 1-week, 1-month, and 3-year time points compared to baseline, while a statistically significant increase was seen at the 3-month, 6-month, and 2-year post-AGV time points. No significant change in retinal nerve thickness or visual field analysis was found. AGV is an effective and safe method of treatment in fluocinolone acetonide intravitreal implant-induced glaucoma. High survival rate is expected for at least 3 years.

Application of 5-Fluorouracil-Polycaprolactone Sustained-Release Film in Ahmed Glaucoma Valve Implantation Inhibits Postoperative Bleb Scarring in Rabbit Eyes.

PubMed

Bi, Xiu-Zeng; Pan, Wei-Hua; Yu, Xin-Ping; Song, Zong-Ming; Ren, Zeng-Jin; Sun, Min; Li, Cong-Hui; Nan, Kai-Hui

2015-01-01

This study was designed to investigate whether 5-fluorouracil (5-Fu)-polycaprolactone sustained-release film in Ahmed glaucoma valve implantation inhibits postoperative bleb scarring in rabbit eyes. Eighteen New Zealand white rabbits were randomly divided into three groups (A, B and C; n = 6 per group). Group A received combined 5-Fu-polycaprolactone sustained-release film application and Ahmed glaucoma valve implantation, group B received local infiltration of 5-Fu and Ahmed glaucoma valve implantation, and group C received Ahmed glaucoma valve implantation. Postoperative observations were made of the anterior segment, intraocular pressure, central anterior chamber depth, blebs, drainage tube, and accompanying ciliary body detachment. The pathology of the blebs and surrounding tissues were observed at month 3 postoperatively. We revealed that the 5-Fu-polycaprolactone sustained-release film maintained a release concentration range of 13.7 ± 0.12 to 37.41 ± 0.47 μg/ml over three months in vitro. Postoperatively, diffuse blebs with ridges were found in all eyes in group A, two blebs were observed in group B, and no bleb formation was present in group C. The postoperative central anterior chamber depth in group A was significantly less than that of the other two groups. The postoperative intraocular pressure of group A stabilized at 6.33-8.67 mmHg, whereas that of group C gradually remained at 7.55-10.02 mmHg. The histopathology showed that the fibrous tissue thickness of the blebs in group A was significantly thinner than that of the other groups. We conclude that the 5-Fu-polycaprolactone sustained-release film had a sustained drug release effect, which promoted the inhibition of bleb scarring after Ahmed glaucoma valve implantation.

Intracameral air injection during Ahmed glaucoma valve implantation in neovascular glaucoma for the prevention of tube obstruction with blood clot: Case Report.

PubMed

Hwang, Sung Ha; Yoo, Chungkwon; Kim, Yong Yeon; Lee, Dae Young; Nam, Dong Heun; Lee, Jong Yeon

2017-12-01

Glaucoma drainage implant surgery is a treatment option for the management of neovascular glaucoma. However, tube obstruction by blood clot after Ahmed glaucoma valve (AGV) implantation is an unpredictable clinically challenging situation. We report 4 cases using intracameral air injection for the prevention of the tube obstruction of AGV by blood clot. The first case was a 57-year-old female suffering from ocular pain because of a tube obstruction with blood clot after AGV implantation in neovascular glaucoma. Surgical blood clot removal was performed. However, intractable bleeding was noted during the removal of the blood clot, and so intracameral air injection was performed to prevent a recurrent tube obstruction. After the procedure, although blood clots formed around the tube, the tube opening where air could touch remained patent. In 3 cases of neovascular glaucoma with preoperative severe intraocular hemorrhages, intracameral air injection and AGV implantation were performed simultaneously. In all 3 cases, tube openings were patent. It appears that air impeded the blood clots formation in front of the tube opening. Intracameral air injection could be a feasible option to prevent tube obstruction of AGV implant with a blood clot in neovascular glaucoma with high risk of tube obstruction. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

Endophthalmitis associated with the Ahmed glaucoma valve implant

PubMed Central

Al-Torbak, A A; Al-Shahwan, S; Al-Jadaan, I; Al-Hommadi, A; Edward, D P

2005-01-01

Aim: To investigate the rate, risk factors, clinical course, and treatment outcomes of endophthalmitis following glaucoma drainage implant (GDI) surgery. Methods: A computerised relational database search was conducted to identify all patients who were implanted with Ahmed glaucoma valve (AGV) and developed endophthalmitis following surgery at the King Khaled Eye Specialist Hospital in Riyadh, Saudi Arabia, between 1 January 1994 and 30 November 2003. Only medical records of the patients who developed endophthalmitis were retrospectively reviewed. Results: 542 eyes of 505 patients who were on active follow up were included in the study. Endophthalmitis developed in nine (1.7%) eyes; the rate was five times higher in children than in adults. Delayed endophthalmitis (developed 6 weeks after surgery) occurred in eight of nine eyes. Conjunctival erosion overlying the AGV tube was present in six of nine eyes. Common organisms isolated in the vitreous included Haemophilus influenzae and Streptococcus species. Multiple regression analysis revealed that younger age and conjunctival erosion over the tube were significant risk factors associated with endophthalmitis. Conclusion: Endophthalmitis is a rare complication of GDI surgery that appears to be more common in children. Conjunctival dehiscence over the GDI tube seems to represent a major risk factor for endophthalmitis. Prompt surgical revision of an exposed GDI tube is highly recommended. PMID:15774923

Endophthalmitis associated with the Ahmed glaucoma valve implant.

PubMed

Al-Torbak, A A; Al-Shahwan, S; Al-Jadaan, I; Al-Hommadi, A; Edward, D P

2005-04-01

To investigate the rate, risk factors, clinical course, and treatment outcomes of endophthalmitis following glaucoma drainage implant (GDI) surgery. A computerised relational database search was conducted to identify all patients who were implanted with Ahmed glaucoma valve (AGV) and developed endophthalmitis following surgery at the King Khaled Eye Specialist Hospital in Riyadh, Saudi Arabia, between 1 January 1994 and 30 November 2003. Only medical records of the patients who developed endophthalmitis were retrospectively reviewed. 542 eyes of 505 patients who were on active follow up were included in the study. Endophthalmitis developed in nine (1.7%) eyes; the rate was five times higher in children than in adults. Delayed endophthalmitis (developed 6 weeks after surgery) occurred in eight of nine eyes. Conjunctival erosion overlying the AGV tube was present in six of nine eyes. Common organisms isolated in the vitreous included Haemophilus influenzae and Streptococcus species. Multiple regression analysis revealed that younger age and conjunctival erosion over the tube were significant risk factors associated with endophthalmitis. Endophthalmitis is a rare complication of GDI surgery that appears to be more common in children. Conjunctival dehiscence over the GDI tube seems to represent a major risk factor for endophthalmitis. Prompt surgical revision of an exposed GDI tube is highly recommended.

Trabeculectomy with Ex-PRESS implant versus Ahmed glaucoma valve implantation-a comparative study

PubMed Central

Waisbourd, Michael; Fischer, Naomi; Shalev, Hadas; Spierer, Oriel; Ben Artsi, Elad; Rachmiel, Rony; Shemesh, Gabi; Kurtz, Shimon

2016-01-01

AIM To compare the surgical outcomes of trabeculectomy with Ex-PRESS implant and Ahmed glaucoma valve (AGV) implantation. METHODS Patients who underwent trabeculectomy with Ex-PRESS implants or AGV implantation separately were included in this retrospective chart review. Main outcome measures were surgical failure and complications. Failure was defined as intraocular pressure (IOP) >21 mm Hg or <5 mm Hg on two consecutive visits after 3mo, reoperation for glaucoma, or loss of light perception. Eyes that had not failed were considered as complete success if they did not required supplemental medical therapy. RESULTS A total of 64 eyes from 57 patients were included: 31 eyes in the Ex-PRESS group and 33 eyes in the AGV group. The mean follow-up time was 2.6±1.1y and 3.3±1.6y, respectively. Patients in the AGV group had significantly higher baseline mean IOP (P=0.005), lower baseline mean visual acuity (VA) (P=0.02), and higher proportion of patients with history of previous trabeculectomy (P<0.0001). Crude failure rates were 16.1%, n=5/31 in the Ex-PRESS group and 24.2%, n=8/33 in the AGV group. The cumulative proportion of failure was similar between the groups, P=0.696. The proportion of eyes that experienced postoperative complications was 32.3% in the Ex-PRESS group and 60.1% in the AGV group (P=0.0229). CONCLUSION Trabeculectomy with Ex-PRESS implant and AGV implantation had comparable failure rates. The AGV group had more post-operative complications, but also included more complex cases with higher baseline mean IOP, worse baseline mean VA, and more previous glaucoma surgeries. Therefore, the results are limited to the cohort included in this study. PMID:27803857

[Ahmed valve in glaucoma surgery].

PubMed

Bikbov, M M; Khusnitdinov, I I

This is a review on Ahmed valve application in glaucoma surgery. It contains, in particular, data on the Ahmed valve efficiency, results of experimental and histological studies of filtering bleb encapsulation, examines the use of antimetabolites and anti-VEGF agents, and discusses implantation techniques. The current appraisal of antimetabolites delivery systems integrated into the Ahmed valve is presented. Various complications encountered in practice and preventive measures are also covered.

Ahmed glaucoma valve in uveitic patients with fluocinolone acetonide implant-induced glaucoma: 3-year follow-up

PubMed Central

Kubaisi, Buraa; Maleki, Arash; Ahmed, Aseef; Lamba, Neel; Sahawneh, Haitham; Stephenson, Andrew; Montieth, Alyssa; Topgi, Shobha; Foster, C Stephen

2018-01-01

Purpose To evaluate the efficacy and safety of Ahmed glaucoma valve (AGV) in eyes with noninfectious uveitis that had fluocinolone acetonide intravitreal implant (Retisert™)-induced glaucoma. Methods This retrospective study reviewed the safety and efficacy of AGV implantation in patients with persistently elevated intraocular pressure (IOP) after implantation of a fluocinolone acetonide intravitreal implant at the Massachusetts Eye Research and Surgery Institution between August 2006 and November 2015. Results Nine patients with 10 uveitic eyes were included in this study, none of which had preexisting glaucoma in the study eye. Mean patient age was 42 years; 6 patients were female and 3 were male. Baseline mean IOP was 30.6 mmHg prior to AGV placement while mean IOP-lowering medications were 2.9. In the treatment groups, there was a statistically significant reduction in post-AGV IOP. IOP was lowest at 1-week after AGV implantation (9.0 mmHg). Nine out of 10 eyes achieved an IOP below target value of 22 mmHg and/or a 20% reduction in IOP from baseline 1 month and 1 year following AGV placement. All other postoperative time points showed all 10 eyes reaching this goal. A statistically significant decrease in IOP-lowering medication was seen at the 1-week, 1-month, and 3-year time points compared to baseline, while a statistically significant increase was seen at the 3-month, 6-month, and 2-year post-AGV time points. No significant change in retinal nerve thickness or visual field analysis was found. Conclusion AGV is an effective and safe method of treatment in fluocinolone acetonide intravitreal implant-induced glaucoma. High survival rate is expected for at least 3 years. PMID:29750012

Long-term Outcomes of Ahmed Glaucoma Valve Implantation in Refractory Glaucoma at Farabi Eye Hospital, Tehran, Iran

PubMed Central

Zarei, Reza; Amini, Heidar; Daneshvar, Ramin; Nabi, Fahimeh Naderi; Moghimi, Sasan; Fakhraee, Ghasem; Eslami, Yadollah; Mohammadi, Masoud; Amini, Nima

2016-01-01

Purpose: To describe long-term outcomes and complications of Ahmed glaucoma valve (AGV) implantation in subjects with refractory glaucoma at Farabi Eye Hospital, Tehran, Iran. Materials and Methods: This retrospective cohort study evaluated patient records of all subjects with refractory glaucoma who had undergone AGV implantation up to January 2013. The main outcome measure was the surgical success rate. Complete success was defined as intraocular pressure (IOP) <22 mmHg, without anti-glaucoma medications or additional surgery. Qualified success was IOP <22 mmHg regardless of number of anti-glaucoma medications. In all cases, loss of vision (no light perception) was considered an independent indicator of failure. Data were also collected on intraoperative and postoperative complications. Results: Twenty-eight eyes were included in the study. With a mean follow-up of 48.2 ± 31.7 months (median: 40.50 months; range: 3–124 months), the IOP decreased from a mean preoperative value of 30.8 ± 5.6 mmHg to 20.0 ± 6.4 mmHg at last visit. The number of medications decreased from 3.7 ± 0.4 preoperatively to 2.5 ± 1.1 postoperatively. Cumulative qualified success was achieved in 69% of eyes. Mean time to failure according to qualified success criteria was 92.3 ± 9.4 months. Postoperative complications were recorded in 16 (57.1%) eyes. The most common complication was focal endothelial corneal decompensation at the site of tube-cornea touch. Conclusion: AGV implantation with adjunctive topical anti-glaucoma drops controlled IOP in approximately 70% of eyes with refractory glaucoma with a median of 40.5 months of follow-up. However, complication rates were higher. PMID:26957848

Long-term Outcomes of Ahmed Glaucoma Valve Implantation in Refractory Glaucoma at Farabi Eye Hospital, Tehran, Iran.

PubMed

Zarei, Reza; Amini, Heidar; Daneshvar, Ramin; Nabi, Fahimeh Naderi; Moghimi, Sasan; Fakhraee, Ghasem; Eslami, Yadollah; Mohammadi, Masoud; Amini, Nima

2016-01-01

To describe long-term outcomes and complications of Ahmed glaucoma valve (AGV) implantation in subjects with refractory glaucoma at Farabi Eye Hospital, Tehran, Iran. This retrospective cohort study evaluated patient records of all subjects with refractory glaucoma who had undergone AGV implantation up to January 2013. The main outcome measure was the surgical success rate. Complete success was defined as intraocular pressure (IOP) <22 mmHg, without anti-glaucoma medications or additional surgery. Qualified success was IOP <22 mmHg regardless of number of anti-glaucoma medications. In all cases, loss of vision (no light perception) was considered an independent indicator of failure. Data were also collected on intraoperative and postoperative complications. Twenty-eight eyes were included in the study. With a mean follow-up of 48.2 ± 31.7 months (median: 40.50 months; range: 3-124 months), the IOP decreased from a mean preoperative value of 30.8 ± 5.6 mmHg to 20.0 ± 6.4 mmHg at last visit. The number of medications decreased from 3.7 ± 0.4 preoperatively to 2.5 ± 1.1 postoperatively. Cumulative qualified success was achieved in 69% of eyes. Mean time to failure according to qualified success criteria was 92.3 ± 9.4 months. Postoperative complications were recorded in 16 (57.1%) eyes. The most common complication was focal endothelial corneal decompensation at the site of tube-cornea touch. AGV implantation with adjunctive topical anti-glaucoma drops controlled IOP in approximately 70% of eyes with refractory glaucoma with a median of 40.5 months of follow-up. However, complication rates were higher.

Wound Dehiscence and Device Migration after Subconjunctival Bevacizumab Injection with Ahmed Glaucoma Valve Implantation.

PubMed

Miraftabi, Arezoo; Nilforushan, Naveed

2016-01-01

To report a complication pertaining to subconjunctival bevacizumab injection as an adjunct to Ahmed Glaucoma Valve (AGV) implantation. A 54-year-old woman with history of complicated cataract surgery was referred for advanced intractable glaucoma. AGV implantation with adjunctive subconjunctival bevacizumab (1.25 mg) was performed with satisfactory results during the first postoperative week. However, 10 days after surgery, she developed wound dehiscence and tube exposure. The second case was a 33-year-old man with history of congenital glaucoma and uncontrolled IOP who developed AGV exposure and wound dehiscence after surgery. In both cases, for prevention of endophthalmitis and corneal damage by the unstable tube, the shunt was removed and the conjunctiva was re-sutured. The potential adverse effect of subconjunctival bevacizumab injection on wound healing should be considered in AGV surgery.

Long-term results of Ahmed glaucoma valve implantation in Egyptian population

PubMed Central

Elhefney, Eman; Mokbel, Tharwat; Abou Samra, Waleed; Kishk, Hanem; Mohsen, Tarek; El-Kannishy, Amr

2018-01-01

AIM To evaluate the long-term results and complications of Ahmed glaucoma valve (AGV) implantation in a cohort of Egyptian patients. METHODS A retrospective study of 124 eyes of 99 patients with refractory glaucoma who underwent AGV implantation and had a minimum follow-up of 5y was performed. All patients underwent complete ophthalmic examination and intraocular pressure (IOP) measurement before surgery and at 1d, weekly for the 1st month, 3, 6mo, and 1y after surgery and yearly afterward for 5y. IOP was measured by Goldmann applanation tonometry and/or Tono-Pen. Complications and the number of anti-glaucoma medications needed were recorded. Success was defined as IOP less than 21 mm Hg with or without anti-glaucoma medication and without additional glaucoma surgery. RESULTS Mean age was 23.1±19.9y. All eyes had at least one prior glaucoma surgery. IOP was reduced from a mean of 37.2±6.8 to 19.2±5.2 mm Hg after 5y follow-up with a reduced number of medications from 2.64±0.59 to 1.81±0.4. Complete and qualified success rates were 31.5% and 46.0% respectively at the end of follow-up. The most common complications were encapsulated cyst formation in 51 eyes (41.1%), complicated cataract in 9 eyes (7.25%), recessed tube in 8 eyes (6.45%), tube exposure in 6 eyes (4.8%) and corneal touch in 6 eyes (4.8%). Other complications included extruded AGV, endophthalmitis and persistent hypotony. Each of them was recorded in only 2 eyes (1.6%). CONCLUSION Although refractory glaucoma is a difficult problem to manage, AGV is effective and relatively safe procedure in treating refractory glaucoma in Egyptian patients with long-term follow-up. Encapsulated cyst formation was the most common complication, which limits successful IOP control after AGV implantation. However, effective complications management can improve the rate of success. PMID:29600175

Long-term results of Ahmed glaucoma valve implantation in Egyptian population.

PubMed

Elhefney, Eman; Mokbel, Tharwat; Abou Samra, Waleed; Kishk, Hanem; Mohsen, Tarek; El-Kannishy, Amr

2018-01-01

To evaluate the long-term results and complications of Ahmed glaucoma valve (AGV) implantation in a cohort of Egyptian patients. A retrospective study of 124 eyes of 99 patients with refractory glaucoma who underwent AGV implantation and had a minimum follow-up of 5y was performed. All patients underwent complete ophthalmic examination and intraocular pressure (IOP) measurement before surgery and at 1d, weekly for the 1 st month, 3, 6mo, and 1y after surgery and yearly afterward for 5y. IOP was measured by Goldmann applanation tonometry and/or Tono-Pen. Complications and the number of anti-glaucoma medications needed were recorded. Success was defined as IOP less than 21 mm Hg with or without anti-glaucoma medication and without additional glaucoma surgery. Mean age was 23.1±19.9y. All eyes had at least one prior glaucoma surgery. IOP was reduced from a mean of 37.2±6.8 to 19.2±5.2 mm Hg after 5y follow-up with a reduced number of medications from 2.64±0.59 to 1.81±0.4. Complete and qualified success rates were 31.5% and 46.0% respectively at the end of follow-up. The most common complications were encapsulated cyst formation in 51 eyes (41.1%), complicated cataract in 9 eyes (7.25%), recessed tube in 8 eyes (6.45%), tube exposure in 6 eyes (4.8%) and corneal touch in 6 eyes (4.8%). Other complications included extruded AGV, endophthalmitis and persistent hypotony. Each of them was recorded in only 2 eyes (1.6%). Although refractory glaucoma is a difficult problem to manage, AGV is effective and relatively safe procedure in treating refractory glaucoma in Egyptian patients with long-term follow-up. Encapsulated cyst formation was the most common complication, which limits successful IOP control after AGV implantation. However, effective complications management can improve the rate of success.

Evaluation of the tightness of contact between 
limbal sclera tunnel and tube following Ahmed 
glaucoma valve implantation.

PubMed

Holló, Gábor; Naghizadeh, Farzaneh

2013-01-01

To investigate whether the tightness of contact between the tube and the limbal sclera tunnel can be evaluated with high-magnification anterior segment optical coherence tomography (OCT) imaging following Ahmed glaucoma valve implantation. Tightness between the tube and the limbal sclera tunnel was investigated with the CAM-L cornea lens adapter of the Optovue Fourier-domain OCT (RTVue-OCT) for 21 uncomplicated Ahmed glaucoma valves implanted in 20 eyes of 19 patients with glaucoma. Nineteen valves were implanted 4 to 124 months earlier (late postoperative cases) and 2 valves 1 day prior to the imaging (early postoperative cases). All valves were introduced into the anterior chamber via a limbal sclera tunnel. The limbal intratunnel part of the tube was successfully imaged in all but 2 cases where an additional full-thickness sclera patch was used. In 14 cases, the contact was tight without tube compression. In 
5 cases, the tube was partially compressed but remained open in the limbal sclera tunnel, and redilated behind the limbus. No case with loose contact or peritubular filtration was seen. The posterior run of the tube was successfully imaged in all 19 cases without a full-thickness sclera patch. High-magnification imaging with the CAM- L anterior segment adapter of the RTVue-OCT allows detailed examination of the limbal insertion area of tubes in both the early and late postoperative periods. Therefore this method may potentially be applied for detection of complications related to tube insertion after glaucoma drainage device surgery.

Evaluation of success after second Ahmed glaucoma valve implantation

PubMed Central

Nilforushan, Naveed; Yadgari, Maryam; Jazayeri, Anis Alsadat; Karimi, Nasser

2016-01-01

Purpose: To evaluate the outcome of the second Ahmed glaucoma valve (AGV) surgery in eyes with failed previous AGV surgery. Design: Retrospective case series. Patients and Methods: Following chart review, 36 eyes of 34 patients with second AGV implantation were enrolled in this study. The primary outcome measure was surgical success defined in terms of intraocular pressure (IOP) control using two criteria: Success was defined as IOP ≤21 mmHg (criterion 1) and IOP ≤16 mmHg (criterion 2), with at least 20% reduction in IOP, either with no medication (complete success) or with no more than two medications (qualified success). Kaplan–Meier survival analysis was used to determine the probability of surgical success. Results: The average age of the patients was 32.7 years (range 4–65), and the mean duration of follow-up was 21.4 months (range 6–96). Preoperatively, the mean IOP was 26.94 mmHg (standard deviation [SD] 7.03), and the patients were using 2.8 glaucoma medications on average (SD 0.9). The mean IOP decreased significantly to 13.28 mmHg (SD 3.59) at the last postoperative visit (P = 0.00) while the patients needed even fewer glaucoma medications on average (1.4 ± 1.1, P = 0.00). Surgical success of second glaucoma drainage devices (Kaplan–Meier analysis), according to criterion 1, at 6, 12, 18, and 42 months was 94%, 85%, 80%, and 53% respectively, and according to criterion 2, was 94%, 85%, 75%, and 45%, respectively. Conclusion: Repeated AGV implantation seems to be a safe modality of treatment with acceptable success rate in cases with failed previous AGV surgery. PMID:27146930

Evaluation of success after second Ahmed glaucoma valve implantation.

PubMed

Nilforushan, Naveed; Yadgari, Maryam; Jazayeri, Anis Alsadat; Karimi, Nasser

2016-03-01

To evaluate the outcome of the second Ahmed glaucoma valve (AGV) surgery in eyes with failed previous AGV surgery. Retrospective case series. Following chart review, 36 eyes of 34 patients with second AGV implantation were enrolled in this study. The primary outcome measure was surgical success defined in terms of intraocular pressure (IOP) control using two criteria: Success was defined as IOP ≤21 mmHg (criterion 1) and IOP ≤16 mmHg (criterion 2), with at least 20% reduction in IOP, either with no medication (complete success) or with no more than two medications (qualified success). Kaplan-Meier survival analysis was used to determine the probability of surgical success. The average age of the patients was 32.7 years (range 4-65), and the mean duration of follow-up was 21.4 months (range 6-96). Preoperatively, the mean IOP was 26.94 mmHg (standard deviation [SD] 7.03), and the patients were using 2.8 glaucoma medications on average (SD 0.9). The mean IOP decreased significantly to 13.28 mmHg (SD 3.59) at the last postoperative visit (P = 0.00) while the patients needed even fewer glaucoma medications on average (1.4 ± 1.1, P = 0.00). Surgical success of second glaucoma drainage devices (Kaplan-Meier analysis), according to criterion 1, at 6, 12, 18, and 42 months was 94%, 85%, 80%, and 53% respectively, and according to criterion 2, was 94%, 85%, 75%, and 45%, respectively. Repeated AGV implantation seems to be a safe modality of treatment with acceptable success rate in cases with failed previous AGV surgery.

Wound Dehiscence and Device Migration after Subconjunctival Bevacizumab Injection with Ahmed Glaucoma Valve Implantation

PubMed Central

Miraftabi, Arezoo; Nilforushan, Naveed

2016-01-01

Purpose: To report a complication pertaining to subconjunctival bevacizumab injection as an adjunct to Ahmed Glaucoma Valve (AGV) implantation. Case Report: A 54-year-old woman with history of complicated cataract surgery was referred for advanced intractable glaucoma. AGV implantation with adjunctive subconjunctival bevacizumab (1.25 mg) was performed with satisfactory results during the first postoperative week. However, 10 days after surgery, she developed wound dehiscence and tube exposure. The second case was a 33-year-old man with history of congenital glaucoma and uncontrolled IOP who developed AGV exposure and wound dehiscence after surgery. In both cases, for prevention of endophthalmitis and corneal damage by the unstable tube, the shunt was removed and the conjunctiva was re-sutured. Conclusion: The potential adverse effect of subconjunctival bevacizumab injection on wound healing should be considered in AGV surgery. PMID:27195095

[Management of corneal endothelial decompensation with Descemet's membrane endothelial keratoplasty in a patient with Ahmed glaucoma valve implant].

PubMed

Röck, T; Bartz-Schmidt, K-U; Röck, D; Yoeruek, E

2014-05-01

Currently, the main causes for developing bullous keratopathy are from problems related to intraocular surgery, trauma, infection, Fuchs' endothelial dystrophy and chronically elevated intraocular pressure. In the 1990s penetrating keratoplasty was once considered the therapy of choice for treatment of bullous keratopathy but in recent years it has been replaced by posterior lamellar keratoplasty. The Descemet membrane endothelial keratoplasty (DMEK) procedure represents the final development of posterior lamellar keratoplasty. The question now arises whether DMEK can be used in patients with bullous keratopathy and Ahmed glaucoma valve implant. A 72-year-old man was referred to our hospital for further evaluation with the diagnosis of bullous keratopathy and pseudoexfoliative glaucoma. The bullous keratopathy was caused by a variety of previous operations as well as decompensation of intraocular pressure. This article describes the therapy of bullous keratopathy by DMEK with existing Ahmed glaucoma valve implant. After surgery the cornea became clear and the best-corrected visual acuity improved from hand movement to 0.2. The intraocular pressure remained normal (10-14 mmHg) without antiglaucoma medication and the endothelial cell count decreased only slightly over a follow-up of 13 months. No complications were encountered. The DMEK surgical procedure seems to be possible in patients with Ahmed glaucoma valve implant and endothelial decompensation. However, further studies with a larger number of patients should follow to validate the replacement of penetrating keratoplasty and other posterior lamellar procedures by DMEK.

Early Ahmed Glaucoma Valve Implantation after Penetrating Keratoplasty Leads to Better Outcomes in an Asian Population with Preexisting Glaucoma

PubMed Central

Tai, Ming-Cheng; Chen, Yi-Hao; Cheng, Jen-Hao; Liang, Chang-Min; Chen, Jiann-Torng; Chen, Ching-Long; Lu, Da-Wen

2012-01-01

Background To evaluate the efficacy of Ahmed Glaucoma Valve (AGV) surgery and the optimal interval between penetrating keratoplasty (PKP) and AGV implantation in a population of Asian patients with preexisting glaucoma who underwent PKP. Methodology/Principal Findings In total, 45 eyes of 45 patients were included in this retrospective chart review. The final intraocular pressures (IOPs), graft survival rate, and changes in visual acuity were assessed to evaluate the outcomes of AGV implantations in eyes in which AGV implantation occurred within 1 month of post-PKP IOP elevation (Group 1) and in eyes in which AGV implantation took place more than 1 month after the post-PKP IOP evaluation (Group 2). Factors that were associated with graft failure were analyzed, and the overall patterns of complications were reviewed. By their final follow-up visits, 58% of the patients had been successfully treated for glaucoma. After the operation, there were no statistically significant differences between the groups with respect to graft survival (p = 0.98), but significant differences for IOP control (p = 0.049) and the maintenance of visual acuity (VA) (p<0.05) were observed. One year after surgery, the success rates of IOP control in Group 1 and Group 2 were 80% and 46.7%, respectively, and these rates fell to 70% and 37.3%, respectively, by 2 years. Factors that were associated with a high risk of AGV failure were a diagnosis of preexisting angle-closure glaucoma, a history of previous PKP, and a preoperative IOP that was >21 mm Hg. The most common surgical complication, aside from graft failure, was hyphema. Conclusions/Significance Early AGV implantation results in a higher probability of AGV survival and a better VA outcome without increasing the risk of corneal graft failure as a result of post-PKP glaucoma drainage tube implantation. PMID:22629464

Long-term clinical outcomes of Ahmed valve implantation in patients with refractory glaucoma.

PubMed

Lee, Chang Kyu; Ma, Kyoung Tak; Hong, Young Jae; Kim, Chan Yun

2017-01-01

To evaluate the long-term efficacy of intraocular pressure (IOP) reduction and complications of Ahmed Glaucoma Valve (AGV) implantation in patients with refractory glaucoma. Retrospective study. The study involved 302 refractory glaucoma patients who underwent AGV implantation and had a minimum follow-up of 6 months between March 1995 and December 2013. An operation was defined as successful when (1) the postoperative IOP remained between 5 and 21 mmHg and was reduced 30% compared to the baseline IOP with or without medication, (2) there was no loss of light perception or vision-threatening severe complications, and (3) no additional filtering or aqueous drainage surgery was required. Clinical records were reviewed. IOP, anti-glaucoma medications, and complications. The mean follow-up period was 62.25 months (range, 6 to 190 months). The cumulative probability of success was 89% at 6 months, 81% at 1 year, 66% at 3 years, 44% at 10 years, and 26% at 15 years. IOP was reduced from a mean of 32.2 ± 10.5 mmHg to 18.6 ± 9.1 mmHg at 1 month, 15.2 ± 7.0 mmHg at 6 months, and 14.2 ± 3.5 mmHg at 15 years. Surgical failures were significantly increased when preoperative IOP was high, and when severe complications occurred after AGV implantation (P < 0.05). AGV implantation was successful for IOP control in patients with refractive glaucoma in the long term. However, the success rate of surgery decreased over time. Preoperative high IOP and severe complications related to the operation were significant risk factors for failure.

Long-term clinical outcomes of Ahmed valve implantation in patients with refractory glaucoma

PubMed Central

Lee, Chang Kyu; Ma, Kyoung Tak; Hong, Young Jae

2017-01-01

Purpose To evaluate the long-term efficacy of intraocular pressure (IOP) reduction and complications of Ahmed Glaucoma Valve (AGV) implantation in patients with refractory glaucoma. Design Retrospective study. Subjects The study involved 302 refractory glaucoma patients who underwent AGV implantation and had a minimum follow-up of 6 months between March 1995 and December 2013. Methods An operation was defined as successful when (1) the postoperative IOP remained between 5 and 21 mmHg and was reduced 30% compared to the baseline IOP with or without medication, (2) there was no loss of light perception or vision-threatening severe complications, and (3) no additional filtering or aqueous drainage surgery was required. Clinical records were reviewed. Main outcome measures IOP, anti-glaucoma medications, and complications Results The mean follow-up period was 62.25 months (range, 6 to 190 months). The cumulative probability of success was 89% at 6 months, 81% at 1 year, 66% at 3 years, 44% at 10 years, and 26% at 15 years. IOP was reduced from a mean of 32.2 ± 10.5 mmHg to 18.6 ± 9.1 mmHg at 1 month, 15.2 ± 7.0 mmHg at 6 months, and 14.2 ± 3.5 mmHg at 15 years. Surgical failures were significantly increased when preoperative IOP was high, and when severe complications occurred after AGV implantation (P < 0.05). Conclusion AGV implantation was successful for IOP control in patients with refractive glaucoma in the long term. However, the success rate of surgery decreased over time. Preoperative high IOP and severe complications related to the operation were significant risk factors for failure. PMID:29095931

The Results of the Use of Ahmed Valve in Refractory Glaucoma Surgery

PubMed Central

Bikbov, Mukharram Mukhtaramovich

2015-01-01

ABSTRACT The treatment of refractory glaucoma (RG) is challenging. The commonly adopted strategy in RG treatment is a glaucoma drainage device (GDD) implantation, which despite its radical nature may not always provide the desired intraocular pressure (IOP) levels for a long term. This review is based on the scientific literature on Ahmed glaucoma valve (AGV) implantation for refractory glaucoma. The technique of AGV implantation is described and data for both the types, FP7 and FP8 performance are presented. The outcome with adjunct antimetabolite and anti-VEGF drugs are also highlighted. An insight is given about experimental and histological examinations of the filtering bleb encapsulation. The article also describes various complications and measures to prevent them. How to cite this article: Bikbov MM, Khusnitdinov II. The Results of the Use of Ahmed Valve in Refractory Glaucoma Surgery. J Curr Glaucoma Pract 2015;9(3):86-91. PMID:26997843

Expanded polytetrafluoroethylene membrane alters tissue response to implanted Ahmed glaucoma valve.

PubMed

DeCroos, Francis Char; Ahmad, Sameer; Kondo, Yuji; Chow, Jessica; Mordes, Daniel; Lee, Maria Regina; Asrani, Sanjay; Allingham, R Rand; Olbrich, Kevin C; Klitzman, Bruce

2009-07-01

Long-term intraocular pressure control by glaucoma drainage implants is compromised by the formation of an avascular fibrous capsule that surrounds the glaucoma implant and increases aqueous outflow resistance. It is possible to alter this fibrotic tissue reaction and produce a more vascularized and potentially more permeable capsule around implanted devices by enclosing them in a porous membrane. Ahmed glaucoma implants modified with an outer 5-microm pore size membrane (termed porous retrofitted implant with modified enclosure or PRIME-Ahmed) and unmodified glaucoma implants were implanted into paired rabbit eyes. After 6 weeks, the devices were explanted and subject to histological analysis. A tissue response containing minimal vascularization, negligible immune response, and a thick fibrous capsule surrounded the unmodified Ahmed glaucoma implant. In comparison, the tissue response around the PRIME-Ahmed demonstrated a thinner fibrous capsule (46.4 +/- 10.8 microm for PRIME-Ahmed versus 94.9 +/- 21.2 microm for control, p < 0.001) and was highly vascularized near the tissue-material interface. A prominent chronic inflammatory response was noted as well. Encapsulating the aqueous outflow pathway with a porous membrane produces a more vascular tissue response and thinner fibrous capsule compared with a standard glaucoma implant plate. Enhanced vascularity and a thinner fibrous capsule may reduce aqueous outflow resistance and improve long-term glaucoma implant performance.

Clinical outcomes after combined Ahmed glaucoma valve implantation and penetrating keratoplasty or pars plana vitrectomy.

PubMed

Lee, Jin Young; Sung, Kyung Rim; Tchah, Hung Won; Yoon, Young Hee; Kim, June Gone; Kim, Myoung Joon; Kim, Jae Yong; Yun, Sung-Cheol; Lee, Joo Yong

2012-12-01

To evaluate whether a combination of penetrating keratoplasty (PKP) or pars plana vitrectomy (PPV) and Ahmed glaucoma valve (AGV) implantation affords a level of success similar to that of AGV implantation alone. Eighteen eyes underwent simultaneous PPV and AGV, 14 eyes with PKP and AGV and 30 eyes with AGV implantation alone were evaluated. Success was defined as attainment of an intraocular pressure (IOP) >5 and <22 mmHg, with or without use of anti-glaucoma medication. Kaplan-Meier survival analysis was performed to compare cumulative survival between the combined surgery groups and the AGV implantation-alone group. Cox proportional hazard regression analysis was conducted to identify factors predictive of success in each of the three groups. Mean (±standard deviation) preoperative IOP was 30.2 ± 10.2 mmHg in the PKP + AGV, 35.2 ± 9.8 mmHg in the PPV + AGV, and 36.2 ± 10.1 mmHg in the AGV implantation-alone group. The cumulative success rate at 18 months was 66.9%, 73.2%, and 70.8% in the three groups, respectively. Neither combined surgery group differed significantly in terms of cumulative success rate compared with the AGV implantation-alone group (p = 0.556, p = 0.487, respectively). The mean number of preoperative anti-glaucoma medications prescribed was significantly associated with success in the PKP + AGV implantation group (hazard ratio, 2.942; p = 0.024). Either PKP or PPV performed in conjunction with AGV implantation afforded similar success rates compared to patients treated with AGV implantation alone. Therefore, in patients with refractory glaucoma who have underlying corneal or retinal pathology requiring treatment with PKP or PPV, AGV implantation can be performed simultaneously.

[Results of fistulizing and Ahmed valve surgery for treatment of refractory glaucoma].

PubMed

Bikbov, M M; Babushkin, A E; Chaĭka, O V; Orenburkina, O I; Matiukhina, E N

2014-01-01

Surgical results of 76 patients (76 eyes) aged 25-79 years with secondary refractory glaucoma were analyzed. The best hypotensive effect and visual functions integrity were achieved with Ahmed valve implantation (86.7% and 83.3% of cases respectively); after conventional fistulizing surgery the hypotensive effect was observed in 45.5%, noncompromised vision--in 54.5% of cases. Tunnel trabeculectomy with iridocycloretraction led to normalization of intraocular pressure and stabilization of visual functions in 81.3% and 68.8% of cases respectively and thus can be considered as an alternative to fistulizing surgery in patients with secondary refractory glaucoma. Uveal glaucoma is a relative contraindication to Ahmed valve implantation, while neovascular glaucoma is that to tunnel trabeculectomy with iridocycloretraction.

Use of Mitomycin C to reduce the incidence of encapsulated cysts following ahmed glaucoma valve implantation in refractory glaucoma patients: a new technique.

PubMed

Zhou, Minwen; Wang, Wei; Huang, Wenbin; Zhang, Xiulan

2014-09-06

To evaluate the surgical outcome of Ahmed glaucoma valve (AGV) implantation with a new technique of mitomycin C (MMC) application. This is a retrospective study. All patients with refractory glaucoma underwent FP-7 AGV implantation. Two methods of MMC application were used. In the traditional technique, 6 × 4 mm cotton soaked with MMC (0.25-0.33 mg/ml) was placed in the implantation area for 2-5mins; in the new technique, the valve plate first was encompassed with a thin layer of cotton soaked with MMC, then inserted into the same area. A 200 ml balanced salt solution was applied for irrigation of MMC. The surgical success rate, intraocular pressure (IOP), number of anti-glaucoma medications used, and postoperative complications were analyzed between the groups. The surgical outcomes of two MMC applied techniques were compared. The new technique group had only one case (2.6%) of encapsulated cyst formation out of 38 eyes, while there were eight (19.5%) cases out of 41 eyes the in traditional group. The difference was statistically significant (P = 0.030). According to the definition of success rate, there was 89.5% in the new technique group and 70.7% in the traditional group at the follow-up end point. There was a significant difference between the two groups (P = 0.035). Mean IOP in the new technique group were significantly lower than those of the traditional group at 3 and 6 months (P < 0.05). By using a thin layer of cotton soaked with MMC to encompass the valve plate, the new MMC application technique could greatly decrease the incidence of encapsulated cyst and increase the success rate following AGV implantation.

Evaluation of Ahmed glaucoma valve implantation through a needle-generated scleral tunnel in Mexican children with glaucoma.

PubMed

Albis-Donado, Oscar; Gil-Carrasco, Félix; Romero-Quijada, Rafael; Thomas, Ravi

2010-01-01

To evaluate the results and extrusion rates of the Ahmed glaucoma valve (AGV) implantation through a needle-generated scleral tunnel, without a tube-covering patch, in children. A retrospective review of the charts of 106 Mexican children implanted with 128 AGVs operated between 1994 and 2002, with the needle track technique, at our institution, with at least six months follow up was done. Main outcome measures were intraocular pressure (IOP) control, tube extrusions or exposure and other complications. Kaplan-Meier analysis demonstrated a 96.9% survival rate at six months, 82.4% at one year, 78.7% at two years, 70% at three years and 41.6% at four years. Total success at the last follow-up (IOP between 6 and 21 mm Hg without medications) was achieved in 30 eyes (23.5%), 58 eyes (45.3%) had qualified success (only topical hypotensive drugs) and 40 eyes (31.3%) were failures. The mean pre- and post-operative IOP at the last follow up was 28.4 mmHg (SD 9.3) and 14.5 mmHg (SD 6.3), respectively. No tube extrusions or exposures were observed. Tube-related complications included five retractions, a lens touch and a transitory endothelial touch. The risk of failure increased if the eye had any complication or previous glaucoma surgeries. Medium-term IOP control in Mexican children with glaucoma can be achieved with AGV implantation using a needle-generated tunnel, without constructing a scleral flap or using a patch to cover the tube. There were no tube extrusions, nor any tube exposures with this technique.

Evaluation of Ahmed glaucoma valve implantation through a needle-generated scleral tunnel in Mexican children with glaucoma

PubMed Central

Albis-Donado, Oscar; Gil-Carrasco, Félix; Romero-Quijada, Rafael; Thomas, Ravi

2010-01-01

Purpose: To evaluate the results and extrusion rates of the Ahmed glaucoma valve (AGV) implantation through a needle-generated scleral tunnel, without a tube-covering patch, in children. Materials and Methods: A retrospective review of the charts of 106 Mexican children implanted with 128 AGVs operated between 1994 and 2002, with the needle track technique, at our institution, with at least six months follow up was done. Main outcome measures were intraocular pressure (IOP) control, tube extrusions or exposure and other complications. Results: Kaplan-Meier analysis demonstrated a 96.9% survival rate at six months, 82.4% at one year, 78.7% at two years, 70% at three years and 41.6% at four years. Total success at the last follow-up (IOP between 6 and 21 mm Hg without medications) was achieved in 30 eyes (23.5%), 58 eyes (45.3%) had qualified success (only topical hypotensive drugs) and 40 eyes (31.3%) were failures. The mean pre- and post-operative IOP at the last follow up was 28.4 mmHg (SD 9.3) and 14.5 mmHg (SD 6.3), respectively. No tube extrusions or exposures were observed. Tube-related complications included five retractions, a lens touch and a transitory endothelial touch. The risk of failure increased if the eye had any complication or previous glaucoma surgeries. Conclusion: Medium-term IOP control in Mexican children with glaucoma can be achieved with AGV implantation using a needle-generated tunnel, without constructing a scleral flap or using a patch to cover the tube. There were no tube extrusions, nor any tube exposures with this technique. PMID:20689189

A prospective comparative study on neovascular glaucoma and non-neovascular refractory glaucoma following Ahmed glaucoma valve implantation.

PubMed

Li, Zheng; Zhou, Minwen; Wang, Wei; Huang, Wenbin; Chen, Shida; Li, Xingyi; Gao, Xinbo; Zhang, Xiulan

2014-01-01

Neovascular glaucoma is a refractory disease, and difficult to manage. The aim of this study was to evaluate the clinical outcomes of Ahmed glaucoma valve implantation (AGVI) in neovascular glaucoma (NVG) and non-NVG patients. This prospective, non-randomized study included 55 eyes of 55 patients with refractory glaucoma; 27 had NVG (NVG group) and 28 had non-NVG (non-NVG group). All of the patients underwent AGVI. The NVG group was adjunctively injected with intravitreal ranibizumab/bevacizumab (IVR/IVB) before AGVI. Intraocular pressure (IOP) was the primary outcome measure in this study. Surgical success rate, number of antiglaucoma medications used, best corrected visual acuity (BCVA), and postoperative complications were analyzed between the groups. All of the patients completed the study (follow-up of 12 months). Kaplan-Meier survival curve analysis indicated that the qualified success rates in the NVG and non-NVG groups at 12 months were 70.5% and 92.9%, respectively; this difference was significant (P = 0.036). The complete success rates in the NVG and non-NVG groups at 12 months were 66.7% and 89.3%, respectively (P = 0.049). Compared with preoperative examinations, the postoperative mean IOP and use of medications were significantly lower at all follow-up time points in both groups (all P < 0.05). There were significant differences in BCVA between the two groups at the 12-month follow-up (χ(2) = 9.86, P = 0.020). Cox proportional hazards regression showed NVG as a risk factor for surgical failure (RR = 15.08, P = 0.033). Postoperative complications were similar between the two groups. AGVI is a safe and effective procedure in refractory glaucoma, but the success rate of surgery was related to the type of refractory glaucoma. The complete and qualified success rates of NVG patient adjunctive anti-vascular endothelial growth factor treatment are still lower than those of non-NVG patients.

Comparison of polypropylene and silicone Ahmed Glaucoma Valves.

PubMed

Ishida, Kyoko; Netland, Peter A; Costa, Vital P; Shiroma, Lineu; Khan, Baseer; Ahmed, Iqbal Ike K

2006-08-01

To evaluate and compare the clinical outcomes after implantation of the silicone plate and the polypropylene plate Ahmed Glaucoma Valves. Prospective, multicenter, comparative series. A total of 132 patients with uncontrolled glaucoma were treated with either the silicone or polypropylene Ahmed Glaucoma Valve implant. Success was defined according to 2 criteria: (1) intraocular pressure (IOP) of 6 mmHg or more or 21 mmHg or less, and (2) IOP reduction of at least 30% relative to preoperative values. Eyes requiring further glaucoma surgery, including cyclophotocoagulation, or showing loss of light perception were classified as failures. Average follow-up was 12.8 months (range, 6-30 months) for the silicone plate group and 14.5 months (range, 6-30 months) for the polypropylene plate group (P = 0.063). At the last follow-up examination, the mean IOP was 13.8+/-3.9 mmHg and 17.3+/-6.5 mmHg (P<0.0001) and the mean number of antiglaucoma medications was 1.9+/-1.3 and 2.1+/-1.4 (P = 0.48) in the silicone plate and polypropylene plate groups, respectively. The life-table success rates for the silicone plate and polypropylene plate groups were 94.2% and 83.2% at 12 months and 82.4% and 56.7% at 24 months by definition 1, respectively (P = 0.035). When an IOP reduction of at least 30% was used for success criterion (definition 2), probabilities of success were 89.5% and 71.7% at 12 months and 78.3% and 68.5% at 24 months in the silicone and the polypropylene plate groups, respectively (P = 0.012). Visual outcomes were comparable between the 2 groups. However, complications including Tenon's cyst were observed more frequently in the polypropylene plate than in the silicone plate group (P<0.05). The silicone Ahmed Glaucoma Valve (model FP7) showed improved IOP reduction compared with the polypropylene (model S2) implant. Differences observed in mean IOP, success rate, and complications suggest that plate material may influence clinical outcome.

Clinical efficacy analysis of Ahmed glaucoma valve implantation in neovascular glaucoma and influencing factors

PubMed Central

He, Ye; Tian, Ying; Song, Weitao; Su, Ting; Jiang, Haibo; Xia, Xiaobo

2017-01-01

Abstract This study aimed to evaluate the efficacy of Ahmed glaucoma valve (AGV) implantation in treating neovascular glaucoma (NVG) and to analyze the factors influencing the surgical success rate. This is a retrospective review of 40 eyes of 40 NVG patients who underwent AGV implantation at Xiangya Hospital of Central South University, China, between January 2014 and December 2016. Pre- and postoperative intraocular pressure (IOP), visual acuity, surgical success rate, medications, and complications were observed. Surgical success criteria were defined as IOP ≤21 and >6 mm Hg with or without additional medications. Kaplan–Meier survival curves and Multivariate cox regression analysis were used to examine success rates and risk factors for surgical outcomes. The mean follow-up period was 8.88 ± 3.12 months (range: 3–17). IOP declined at each visit postoperatively and it was statistically significant (P < .001). An average of 3.55 ± 0.86 drugs was applied preoperatively, while an average of 0.64 ± 0.90 drugs was used postoperatively, with the difference being of statistical significance (P < .05). The complete surgical success rate of 3, 6, and 12 months after the operation was 85%, 75%, and 65%, respectively. Meanwhile, the qualified success rate of 3, 6, and 12 months after the operation was 85%, 80%, and 77.5%, respectively. The multivariate cox regression analysis showed that age (hazard ratio: 3.717, 7.246; 95% confidence interval: 1.149–12.048, 1.349–38.461; P = .028, .021) was influencing factors for complete success rate and qualified success rate among all NVG patients. Gender, previous operation history, primary disease, and preoperative IOP were found to be not significant. AGV implantation is an effective and safe surgical method to treat NVG. Age is an important factor influencing the surgical success rate. PMID:29049253

Comparison of the Ahmed glaucoma valve with the Baerveldt glaucoma implant: a meta-analysis.

PubMed

Wang, Yi-Wen; Wang, Ping-Bao; Zeng, Chao; Xia, Xiao-Bo

2015-10-13

This study aims to compare the efficacy and safety of the Ahmed glaucoma valve (AGV) with the Baerveldt glaucoma implant (BGI) in glaucoma patients. Databases were searched to identify studies that met pre-stated inclusion criteria, involving randomized controlled clinical trials (RCTs) and non-randomized controlled clinical trials. Treatment effect was analyzed using a random-effect model. Ten controlled clinical trials (1048 eyes) were analyzed, involving two RCTs and eight retrospective comparative studies. Short-term results (6-18 months) and long-term results (>18 months) were analyzed separately. There was no significant difference in the success rate for short-term follow-up between the AGV and BGI groups (5 studies, 714 eyes, odds ratio [OR]: 0.97; 95 % confidence interval [CI]: 0.56, 1.66; P = 0.90). For long-term pooled results (7 studies, 835 eyes), the success rate of AGVs was lower than that of BGIs (OR: 0.73; 95 % CI: 0.54, 0.99, P = 0.04), However, subgroup and sensitivity analyses did not show a significant difference in the success rate between the two groups (P ≥0.05). The AGV group had a higher mean intraocular pressure than the BGI group in short-term (6 studies, 685 eyes, weighted mean difference [WMD]: 2.12 mmHg; 95 % CI: 0.72-3.52; P <0.05) and long-term pooled results (7 studies, 659 eyes, WMD: 1.85 mmHg; 95 % CI: 0.43, 3.28; P = 0.01). The BGI group required fewer glaucoma medications after implantation than the AGV group in two follow-up periods (all P <0.05). The AGV was found to be associated with a significantly lower frequency of total complications (8 studies, 971 eyes, OR: 0.67; 95 % CI: 0.50-0.90; P = 0.007) and severe complications (8 studies, 971 eyes, OR: 0.57; 95 % CI: 0.36-0.91; P = 0.02) than the BGI. The study showed no significant difference in success rate between the two groups. The BGI was more effective for control of intraocular pressure and required fewer medications than the AGV, but the AGV had lower incidence of

Comparison of polypropylene and silicone Ahmed® glaucoma valves in the treatment of neovascular glaucoma: A 2-year follow-up.

PubMed

Lubiński, Wojciech; Krzystolik, Karol; Gosławski, Wojciech; Kuprjanowicz, Leszek; Mularczyk, Maciej

2018-01-01

Inflammation associated with biomaterials of Ahmed® glaucoma drainage devices may cause the formation of a capsule around the device and can thus have a significant influence on the level of intraocular pressure reduction. The objective of this study was to compare the clinical outcomes after the implantation of a polypropylene or silicone Ahmed® glaucoma valve in patients with neovascular glaucoma. In the study, 27 eyes with neovascular glaucoma (group 1) received silicon Ahmed® valves and 23 eyes (group 2) received polypropylene valves. The best corrected distance visual acuity (BCDVA), intraocular pressure (IOP) and number of anti-glaucomatous drugs were recorded preoperatively and during a follow-up period of 24 months after surgery. Success was defined by the following criteria: 1) intraocular pressure in the rage of 6-21 mm Hg; 2) IOP reduction of at least 30% relative to preoperative values. All complications were registered. One month postoperatively, the mean BCDVA increased significantly in both groups compared to preoperative values (p < 0.001). These values did not change during the 24 months of follow-up examinations. The probability of success defined by criterion 1 at 24 months of observation was 66.7% for silicone and 27.3% for propylene valves group (p < 0.007). According to criterion 2, the difference in success between the groups was not statistically significant. The total number of complications that occurred in both groups during the 24 months of follow-up examinations was similar, except for a higher occurrence of Tenon's cyst formation in the group with a polypropylene valve (18% vs 35%; p < 0.04). In patients with neovascular glaucoma, the implantation of a silicone valve is associated with a significantly higher probability of long-term reduction of IOP below 21 mm Hg and with a lower risk of valve encapsulation in comparison to polypropylene valves. The obtained results suggest that silicone Ahmed® valves are more effective in the

Short term outcome of Ahmed glaucoma valve implantation in management of refractory glaucoma in a tertiary hospital in Oman

PubMed Central

Shah, Manali R.; Khandekar, Rajiv B.; Zutshi, Rajiv; Mahrooqi, Rahima

2013-01-01

Background: We present outcomes of Ahmed Glaucoma Valve (AGV) implantation in treating refractory glaucoma in a tertiary hospital in Oman. Refractory glaucoma was defined as previously failed conventional glaucoma surgery and an uncontrolled intraocular pressure (IOP) of more than 21 mm Hg despite treatment with three topical and/or oral therapy. Materials and Methods: This historical cohort study was conducted in 2010. Details of medical and surgical treatment were recorded. Ophthalmologists examined eyes and performed glaucoma surgeries using AGV. The best corrected distant vision, IOP, and glaucoma medications were prospectively reviewed on 1st day, 1st, 6th, 12th week postoperatively, and at the last follow up. Result: Glaucoma specialists examined and treated 40 eyes with refractory glaucoma of 39 patients (20 males + 19 females). Neo-vascular glaucoma was present in 23 eyes. Vision before surgery was <3/60 in 21 eyes. At 12 weeks, one eye had vision better than 6/12, seven eyes had vision 6/18 to 6/60, and eight eyes had vision 6/60 to 3/60. Mean IOP was reduced from 42.9 (SD 16) to 14.2 (SD 8) and 19.1 (SD 7.8) mmHg at one and 12 weeks after surgery, respectively. At 12 weeks, five (12.5%) eyes had IOP controlled without medication. In 33 (77.5%) eyes, pressure was controlled by using one or two eye drops. The mean number of preoperative anti-glaucoma medications (2.38; SD 1.1) was reduced compared to the mean number of postoperative medications (1.92; SD 0.9) at 12 weeks. Conclusion: We succeeded in reducing visual disabilities and the number of anti-glaucoma medications used to treat refractory glaucoma by AGV surgery. PMID:23772122

A retrospective study on the outcomes of Ahmed valve versus Ahmed valve combined with fluocinolone implant in uveitic glaucoma

PubMed Central

Sevgi, Duriye D.; Davoudi, Samaneh; Talcott, Katherine E.; Cho, Heeyoon; Guo, Rong; Lobo, Ann-Marie; Papaliodis, George N.; Turalba, Angela; Sobrin, Lucia; Shen, Lucy Q.

2017-01-01

Purpose To compare the intraocular pressure (IOP) outcomes of Ahmed glaucoma valve (AGV) surgery alone versus AGV with fluocinolone implant in uveitic glaucoma patients. Methods We identified uveitic glaucoma patients with AGV surgery alone and AGV surgery combined with fluocinolone implant from the Massachusetts Eye and Ear Ocular Inflammation Database. Demographic information, visual acuity, and IOP were recorded at preoperative visits and 1, 6, and 12 months after surgery. Incidence of hypertensive phase, defined as an IOP of >21 mm Hg or use of additional treatment to lower IOP occurring any time between 7 days to 6 months postoperatively, was investigated. Multilevel mixed effects models were performed to compare the outcomes between groups. Results Eighteen eyes of 13 uveitic glaucoma patients with 1-year follow-up data were included. There were 11 eyes of 9 patients (mean age, 56.5 years; 63.6% male) in the AGV group and 7 eyes of 4 patients (mean age, 61.3 years; 71.4% male) in the AGV + fluocinolone group. There was no significant difference in visual acuity change at 1 year after surgery between groups (P = 0.25), although visual acuity improvement was significant in the AGV group (P = 0.01). The hypertensive phase occurred in 91% of AGV patients and 43% of AGV + fluocinolone patients (P = 0.30), with onset of 8-40 days (mean, 18 days) after surgery. IOP and number of glaucoma medications decreased at the 1-year postoperative visits in both the AGV group (P < 0.0001, P < 0.0001) and the AGV + fluocinolone group (P = 0.001, P < 0.0001). Compared to the AGV group, the AGV + fluocinolone group used fewer glaucoma medications (0.28 vs 1.30 [P = 0.01]) and had better inflammation control (P = 0.02). The surgical complication rates were similar between groups. Conclusions In uveitic glaucoma, AGV with fluocinolone achieves a similar, desired IOP control but with fewer glaucoma medications than AGV alone. PMID:29162989

A retrospective study on the outcomes of Ahmed valve versus Ahmed valve combined with fluocinolone implant in uveitic glaucoma.

PubMed

Sevgi, Duriye D; Davoudi, Samaneh; Talcott, Katherine E; Cho, Heeyoon; Guo, Rong; Lobo, Ann-Marie; Papaliodis, George N; Turalba, Angela; Sobrin, Lucia; Shen, Lucy Q

2017-01-01

To compare the intraocular pressure (IOP) outcomes of Ahmed glaucoma valve (AGV) surgery alone versus AGV with fluocinolone implant in uveitic glaucoma patients. We identified uveitic glaucoma patients with AGV surgery alone and AGV surgery combined with fluocinolone implant from the Massachusetts Eye and Ear Ocular Inflammation Database. Demographic information, visual acuity, and IOP were recorded at preoperative visits and 1, 6, and 12 months after surgery. Incidence of hypertensive phase, defined as an IOP of >21 mm Hg or use of additional treatment to lower IOP occurring any time between 7 days to 6 months postoperatively, was investigated. Multilevel mixed effects models were performed to compare the outcomes between groups. Eighteen eyes of 13 uveitic glaucoma patients with 1-year follow-up data were included. There were 11 eyes of 9 patients (mean age, 56.5 years; 63.6% male) in the AGV group and 7 eyes of 4 patients (mean age, 61.3 years; 71.4% male) in the AGV + fluocinolone group. There was no significant difference in visual acuity change at 1 year after surgery between groups ( P = 0.25), although visual acuity improvement was significant in the AGV group ( P = 0.01). The hypertensive phase occurred in 91% of AGV patients and 43% of AGV + fluocinolone patients ( P = 0.30), with onset of 8-40 days (mean, 18 days) after surgery. IOP and number of glaucoma medications decreased at the 1-year postoperative visits in both the AGV group ( P < 0.0001, P < 0.0001) and the AGV + fluocinolone group ( P = 0.001, P < 0.0001). Compared to the AGV group, the AGV + fluocinolone group used fewer glaucoma medications (0.28 vs 1.30 [ P = 0.01]) and had better inflammation control ( P = 0.02). The surgical complication rates were similar between groups. In uveitic glaucoma, AGV with fluocinolone achieves a similar, desired IOP control but with fewer glaucoma medications than AGV alone.

Combined Ahmed Glaucoma Valve Placement, Intravitreal Fluocinolone Acetonide Implantation and Cataract Extraction for Chronic Uveitis.

PubMed

Chang, Ingrid T; Gupta, Divakar; Slabaugh, Mark A; Vemulakonda, Gurunadh A; Chen, Philip P

2016-10-01

To report the outcomes of combined Ahmed glaucoma valve (AGV) placement, intravitreal fluocinolone acetonide implant, and cataract extraction procedure in the treatment of chronic noninfectious uveitis. Retrospective case series of patients with chronic noninfectious uveitis who underwent AGV placement, intravitreal fluocinolone acetonide implantation, and cataract extraction in a single surgical session performed at 1 institution from January 2009 to November 2014. Outcome measures included intraocular pressure (IOP) and glaucoma medication use. Secondary outcome measures included visual acuity, systemic anti-inflammatory medications, number of uveitis flares, and complications. Fifteen eyes of 10 patients were studied, with a mean age of 40.3±15.7 and mean follow-up duration of 26 months (range, 13 to 39 mo). Before surgery, the IOP was 18.5±7.3 mm Hg and patients were using 1.5±1.5 topical glaucoma medications. At the 12-month follow-up, IOP was 12.8±3.2 mm Hg (P=0.01) and patients were using 0.5±0.8 (P=0.03) topical glaucoma medications. At 36 months of follow-up, late, nonsustained hypotony had occurred in 3 eyes (20%), and 1 eye (6%) had received a second AGV for IOP control. Before treatment, patients had 2.7±1.5 uveitis flares in the year before surgery while on an average of 2.1±0.6 systemic anti-inflammatory medications, which decreased to an average of 0.1±0.3 (P<0.01) flares the year after surgery while on an average of 0.4±1.1 (P<0.01) systemic medications. Combined AGV, intravitreal fluocinolone acetonide implant, and cataract extraction is effective in controlling IOP and reducing the number of glaucoma medications at 12 months after treatment in patients with chronic uveitis.

Clinical outcomes of trabeculectomy vs. Ahmed glaucoma valve implantation in patients with penetrating keratoplasty : (Trabeculectomy vs. Ahmed galucoma valve in patients with penetrating keratoplasty).

PubMed

Akdemir, Mehmet Orcun; Acar, Banu Torun; Kokturk, Furuzan; Acar, Suphi

2016-08-01

The aim of this study was to compare the visual outcomes, intraocular pressure (IOP), and endothelial cell loss caused by trabeculectomy (TRAB) and Ahmed glaucoma valve (AGV) implantation in patients who had previously undergone penetrating keratoplasty (PKP). The data from all patients who underwent surgical treatment of glaucoma after PKP were reviewed at the Cornea Department of Haydarpasa Numune Education and Research Hospital. Eighteen patients who had undergone surgical treatment of glaucoma after PKP were included in this retrospective study. Time between PKP and glaucoma surgeries, visual acuity results, IOP results, endothelial cell counts (ECC) before the surgery, at 1st, 6th, and 12th month of surgery were recorded. Differences between two groups were evaluated. Mean loss of ECC was 315 cells/mm(2) in the AGV group and 197 cells/mm(2) in TRAB group at 12th month of glaucoma surgery. The difference between endothelial cell loss at 12th month of surgery was statistically significant and higher in AGV group (p < 0.001). The decrease in IOP was 64.2 % in AGV group and 46.9 % in TRAB group at 12th month of surgery. Both differences were statistically significant between 2 groups (p = 0.001, 0.001). TRAB successfully decreased both the IOP and endothelial cell loss in patients with post-PKP glaucoma. Ahmed glaucoma valve had a significantly better IOP lowering but higher endothelial cell loss effect.

Ahmed glaucoma valve in children: A review☆

PubMed Central

Nassiri, Nariman; Nouri-Mahdavi, Kouros; Coleman, Anne L.

2011-01-01

Pediatric glaucoma is potentially a blinding disease. Although goniotomy and trabeculotomy are associated with good early success rates, eventually 20% of these procedures fail and many children will require additional surgery to control the IOP in the long-term. In this review, we reported that adequate IOP control can be achieved with the placement of Ahmed glaucoma valve and can last 5 or more years. However, most patients will need one or more glaucoma medications at some point after surgery. In addition, the implants may be associated with pupillary irregularities, lenticular opacification as well as tube-related complications, particularly in the first year of life, as the globe is enlarging with age. PMID:23960945

Hypertensive phase and early complications after Ahmed glaucoma valve implantation with intraoperative subtenon triamcinolone acetonide.

PubMed

Turalba, Angela V; Pasquale, Louis R

2014-01-01

To evaluate intraoperative subtenon triamcinolone acetonide (TA) as an adjunct to Ahmed glaucoma valve (AGV) implantation. Retrospective comparative case series. Forty-two consecutive cases of uncontrolled glaucoma undergoing AGV implantation: 19 eyes receiving intraoperative subtenon TA and 23 eyes that did not receive TA. A retrospective chart review was performed on consecutive pseudophakic adult patients with uncontrolled glaucoma undergoing AGV with and without intraoperative subtenon TA injection by a single surgeon. Clinical data were collected from 42 eyes and analyzed for the first 6 months after surgery. Primary outcomes included intraocular pressure (IOP) and number of glaucoma medications prior to and after AGV implantation. The hypertensive phase (HP) was defined as an IOP measurement of greater than 21 mmHg (with or without medications) during the 6-month postoperative period that was not a result of tube obstruction, retraction, or malfunction. Postoperative complications and visual acuity were analyzed as secondary outcome measures. Five out of 19 (26%) TA cases and 12 out of 23 (52%) non-TA cases developed the HP (P=0.027). Mean IOP (14.2±4.6 in TA cases versus [vs] 14.7±5.0 mmHg in non-TA cases; P=0.78), and number of glaucoma medications needed (1.8±1.3 in TA cases vs 1.6±1.1 in the comparison group; P=0.65) were similar between both groups at 6 months. Although rates of serious complications did not differ between the groups (13% in the TA group vs 16% in the non-TA group), early tube erosion (n=1) and bacterial endophthalmitis (n=1) were noted with TA but not in the non-TA group. Subtenon TA injection during AGV implantation may decrease the occurrence of the HP but does not alter the ultimate IOP outcome and may pose increased risk of serious complications within the first 6 months of surgery.

Hypertensive phase and early complications after Ahmed glaucoma valve implantation with intraoperative subtenon triamcinolone acetonide

PubMed Central

Turalba, Angela V; Pasquale, Louis R

2014-01-01

Objective To evaluate intraoperative subtenon triamcinolone acetonide (TA) as an adjunct to Ahmed glaucoma valve (AGV) implantation. Design Retrospective comparative case series. Participants Forty-two consecutive cases of uncontrolled glaucoma undergoing AGV implantation: 19 eyes receiving intraoperative subtenon TA and 23 eyes that did not receive TA. Methods A retrospective chart review was performed on consecutive pseudophakic adult patients with uncontrolled glaucoma undergoing AGV with and without intraoperative subtenon TA injection by a single surgeon. Clinical data were collected from 42 eyes and analyzed for the first 6 months after surgery. Main outcome measures Primary outcomes included intraocular pressure (IOP) and number of glaucoma medications prior to and after AGV implantation. The hypertensive phase (HP) was defined as an IOP measurement of greater than 21 mmHg (with or without medications) during the 6-month postoperative period that was not a result of tube obstruction, retraction, or malfunction. Postoperative complications and visual acuity were analyzed as secondary outcome measures. Results Five out of 19 (26%) TA cases and 12 out of 23 (52%) non-TA cases developed the HP (P=0.027). Mean IOP (14.2±4.6 in TA cases versus [vs] 14.7±5.0 mmHg in non-TA cases; P=0.78), and number of glaucoma medications needed (1.8±1.3 in TA cases vs 1.6±1.1 in the comparison group; P=0.65) were similar between both groups at 6 months. Although rates of serious complications did not differ between the groups (13% in the TA group vs 16% in the non-TA group), early tube erosion (n=1) and bacterial endophthalmitis (n=1) were noted with TA but not in the non-TA group. Conclusions Subtenon TA injection during AGV implantation may decrease the occurrence of the HP but does not alter the ultimate IOP outcome and may pose increased risk of serious complications within the first 6 months of surgery. PMID:25050061

Short-term to Long-term Results of Ahmed Glaucoma Valve Implantation for Uveitic Glaucoma Secondary to Behçet Disease.

PubMed

Yakin, Mehmet; Eksioglu, Umit; Sungur, Gulten; Satana, Banu; Demirok, Gulizar; Ornek, Firdevs

2017-01-01

To evaluate short-term to long-term outcomes of Ahmed glaucoma valve (AGV) implantation in the management of uveitic glaucoma (UG) secondary to Behçet disease (BD). A retrospective chart review of 47 eyes of 35 patients with UG secondary to BD who underwent AGV implantation was conducted. Success was defined as having an intraocular pressure (IOP) between 6 and 21 mm Hg with (qualified success) or without (complete success) antiglaucomatous medications and without need for further glaucoma surgery. Mean postoperative follow-up was 57.72±26.13 months. Mean preoperative IOP was 35.40±8.33 mm Hg versus 12.28±2.90 mm Hg at the last follow-up visit (P<0.001). Mean number of preoperative topical antiglaucomatous medications was 2.96±0.29 versus 0.68±1.12 at the last follow-up visit (P<0.001). In all eyes, IOP could be maintained between 6 and 21 mm Hg with or without antiglaucomatous medications during follow-up. The cumulative probability of complete success was 46.8% at 6 months, 40.4% at 12 months, and 35.9% at 36 months, and the cumulative probability of eyes without complication was 53.2% at 6 months, 46.5% at 12 months, and 39.6% at 24 months postoperatively based on Kaplan-Meier survival analysis. No persistent or irreparable complications were observed. This study includes one of the largest series of AGV implantation in the management of UG with the longest follow-up reported. AGV implantation can be considered as a primary surgical option in the management of UG secondary to BD with 100% total success rate (with or without medications).

Coupling of HRT II and AS-OCT to evaluate corneal endothelial cell loss and in vivo visualization of the Ahmed glaucoma valve implant.

PubMed

Mendrinos, E; Dosso, A; Sommerhalder, J; Shaarawy, T

2009-09-01

To report corneal endothelial cell loss and in vivo visualization of the Ahmed glaucoma valve implant in eyes with refractory glaucoma. Ten eyes underwent Ahmed valve implant surgery and were followed-up for 12 months. Data collected included intraocular pressure (IOP), number of antiglaucoma medications and surgery-related complications. At 6 and 12 months postoperatively, the intracameral length of the drainage tube (ICL) and the distance between the tube and the cornea (T-C distance), and the iris (T-I distance) were assessed using anterior segment optical coherence tomography (AS-OCT). Heidelberg cornea tomograph II (HRT II) was used to measure the corneal endothelial cell density. Mean (+/-SEM) preoperative IOP was 29.5+/-4 mmHg. Mean postoperative IOP was 11.6+/-2 at 12 months (P<0.01). Over a 6-month period, mean corneal endothelial loss was 7.9%+/-2.5 in the central and 7.5%+/-2.4 in the peripheral cornea (P<0.01). There was no correlation between central or peripheral corneal endothelial cell loss and the T-C, T-I distance or the ICL of the tube. Corneal endothelial cell loss occurs following Ahmed valve implant surgery, this appears to be multifactorial. AS-OCT and HRT II are promising methods for the follow-up of patients with a glaucoma drainage device.

[New concepts for pressure-controlled glaucoma implants].

PubMed

Allemann, R; Stachs, O; Falke, K; Schmidt, W; Siewert, S; Sternberg, K; Chichkov, B; Wree, A; Schmitz, K-P; Guthoff, R F

2013-08-01

In industrialized countries glaucoma is one of the most common causes that leads to blindness. It is also the most common cause of irreversible blindness worldwide. In addition to local treatment of intraocular pressure and filtering glaucoma surgery, alloplastic implants are increasingly being used in glaucoma therapy. As long-term results published in the literature of commonly used implants are unsatisfactory, it seems useful to search for new concepts. In order to avoid the well-known short-term and long-term postoperative complications a pressure-controlled microstent with antiproliferative surface modifications was developed. Additionally, the functionality of such a microstent should be investigated using an animal glaucoma model. This paper describes the concept of a microstent which drains aquous humour from the anterior chamber into the suprachoroidal space. In addition, the glaucoma models described in the literature are discussed. Unfortunately, none of the methods could be reproduced permanently. First results show a correct implantation of a coated microstent with valve where the anti-proliferative effect could be demonstrated histologically. The promising results should lead to further investigations and the final goal will be the testing of the stent in the human eye.

Bleb Analysis and Short-Term Results of Biodegradable Collagen Matrix-Augmented Ahmed Glaucoma Valve Implantation: 6-Month Follow-up.

PubMed

Rho, Seungsoo; Sung, Youngje; Ma, Kyoung Tak; Rho, Sae Heun; Kim, Chan Yun

2015-09-01

To evaluate the short-term efficacy of a biodegradable collagen matrix (BCM) as an adjuvant for Ahmed valve implantation surgery to prevent the hypertensive phase. This prospective study included 43 refractory glaucoma eyes, all followed for 6 months. Refractory glaucoma was defined as an IOP higher than 20 mm Hg with antiglaucoma eye drops without previous glaucoma surgery. Conventional method was performed in 21 eyes and BCM-augmented Ahmed valve implantation (BAAVI) in 22 eyes. In the BAAVI group, a 10 × 10 × 2-mm BCM was sutured on an Ahmed glaucoma valve FP7 model. Complete success was defined as an IOP of 21 mm Hg or lower (target IOP 1) or 17 mm Hg or lower (target IOP 2) without antiglaucoma medications and qualified success as an IOP of 21 mm Hg or lower with or without medications. Maximal bleb thickness was measured using anterior segment optical coherence tomography images. The preoperative IOPs and numbers of preoperative antiglaucoma medications were similar for both groups. Complete target IOP 1 success rates were 38.1% and 86.4%, complete target IOP 2 success rates were 19.0% and 59.1%, and qualified success rates were 52.4% and 90.9% in the conventional and BAAVI groups, respectively (P < 0.05). The hypertensive phase rate was lower in the BAAVI group (4.5% vs. 47.6%, P = 0.002). Maximal bleb thickness was increased in the BAAVI group on postoperative days 30 and 180 (P < 0.05). Success rates were higher in the BAAVI group than in the conventional group with the change of bleb morphology. Furthermore, use of BCM significantly decreased the need for antiglaucoma medications for at least 6 months postoperatively.

Clinical Outcomes of Ahmed Glaucoma Valve Implantation Using Tube Ligation and Removable External Stents

PubMed Central

Lee, Jong Joo; Kim, Dong Myung; Kim, Tae Woo

2009-01-01

Purpose To investigate the immediate and long-term outcomes of Ahmed glaucoma valve (AGV) implantation with silicone tube ligation and removable external stents. Methods This retrospective non-comparative study investigated the outcomes of AGV implantation with silicone tube ligation and removable external stents in 95 eyes (90 patients) with at least 12 months of postoperative follow-up. Qualified success was defined as an intraocular pressure (IOP) of ≤21 mmHg and ≥6 mmHg regardless of anti-glaucoma medication. Those who required additional glaucoma surgery, implant removal or who had phthisis bulbi were considered failures. Hypotony was defined as an IOP of <6 mmHg. Results Mean IOP reduced from 37.1±9.7 mmHg preoperatively to 15.2±5.6 mmHg at 12 months postoperatively (p<0.001). Qualified success was achieved in 84.2% at 1 year. Hypotony with an IOP of <6 mmHg was seen in 8.4% and an IOP of <5 mmHg in 3.2% on the first postoperative day. No case of hypotony required surgical intervention. Suprachoroidal hemorrhage did not occur in this study. When stents were removed on the first postoperative day because of an insufficient IOP decrease, the mean IOP decreased significantly from 42.0 mmHg to 14.1 mmHg (p<0.001) after 1 hour. The most common complication was hyphema, which occurred in 17.9%. Conclusions Hypotony-related early complications requiring surgical intervention were reduced by ligation and external stents in the tube. In addition, early postoperative high IOPs were managed by removing external stents. The described method can prevent postoperative hypotony after AGV implantation and showed long-term success rates comparable to those reported previously. PMID:19568356

Clinical outcomes of Ahmed glaucoma valve implantation using tube ligation and removable external stents.

PubMed

Lee, Jong Joo; Park, Ki Ho; Kim, Dong Myung; Kim, Tae Woo

2009-06-01

To investigate the immediate and long-term outcomes of Ahmed glaucoma valve (AGV) implantation with silicone tube ligation and removable external stents. This retrospective non-comparative study investigated the outcomes of AGV implantation with silicone tube ligation and removable external stents in 95 eyes (90 patients) with at least 12 months of postoperative follow-up. Qualified success was defined as an intraocular pressure (IOP) of or=6 mmHg regardless of anti-glaucoma medication. Those who required additional glaucoma surgery, implant removal or who had phthisis bulbi were considered failures. Hypotony was defined as an IOP of <6 mmHg. Mean IOP reduced from 37.1+/-9.7 mmHg preoperatively to 15.2+/-5.6 mmHg at 12 months postoperatively (p<0.001). Qualified success was achieved in 84.2% at 1 year. Hypotony with an IOP of <6 mmHg was seen in 8.4% and an IOP of <5 mmHg in 3.2% on the first postoperative day. No case of hypotony required surgical intervention. Suprachoroidal hemorrhage did not occur in this study. When stents were removed on the first postoperative day because of an insufficient IOP decrease, the mean IOP decreased significantly from 42.0 mmHg to 14.1 mmHg (p<0.001) after 1 hour. The most common complication was hyphema, which occurred in 17.9%. Hypotony-related early complications requiring surgical intervention were reduced by ligation and external stents in the tube. In addition, early postoperative high IOPs were managed by removing external stents. The described method can prevent postoperative hypotony after AGV implantation and showed long-term success rates comparable to those reported previously.

Comparison of Ahmed glaucoma valve implantation and trabeculectomy for glaucoma: a systematic review and meta-analysis.

PubMed

HaiBo, Tan; Xin, Kang; ShiHeng, Lu; Lin, Liu

2015-01-01

To compare the efficacy and safety of Ahmed glaucoma valve implantation (AGV) with trabeculectomy in the management of glaucoma patients. A comprehensive literature search (PubMed, Embase, Google, and the Cochrane library) was performed, including a systematic review with meta-analysis of controlled clinical trials comparing AGV versus trabeculectomy. Efficacy estimates were the weighted mean differences (WMDs) for the percentage intraocular pressure reduction (IOPR %) from baseline to end-point, the reduction in glaucoma medications, and the odds ratios (ORs) for complete and qualified success rates. Safety estimates were the relative risks (RRs) for adverse events. All outcomes were reported with a 95% confidence interval (CI). Statistical analysis was performed using the RevMan 5.0 software. Six controlled clinical trials were included in this meta-analysis. There was no significant difference between the AGV and trabeculectomy in the IOPR% (WMD = -3.04, 95% CI: -8.36- 2.26; P = 0.26). The pooled ORs comparing AGV with trabeculectomy were 0.46 (0.22, 0.99) for the complete success rate (P = 0.05) and 0.97 (0.78-1.20) for the quantified success rate (P = 0.76). No significant difference in the reduction in glaucoma medicines was observed (WMD = 0.24; 95% CI: -0.27-0.76; P = 0.35). AGV was found to be associated with a significantly lower frequency of all adverse events (RR = 0.71; 95%CI: 1.14-0.97; p = 0.001) than trabeculectomy, while the most common complications did not differ significantly (all p> 0.05). AGV was equivalent to trabeculectomy in reducing the IOP, the number of glaucoma medications, success rates, and rates of the most common complications. However, AGV was associated with a significantly lower frequency of overall adverse events.

Dynamic tube movement after reimplantation of Ahmed glaucoma valve in a child with glaucoma in aphakia

PubMed Central

Senthil, Sirisha; Badakare, Akshay

2014-01-01

A 10-year-old girl underwent an Ahmed glaucoma valve (AGV) implantation as a primary procedure for glaucoma in aphakia due to congenital cataract surgery. Following an unintended accidental excision of AGV tube during bleb revision for hypertensive phase, AGV was explanted and a second AGV was implanted in the same quadrant after 2 weeks. This resulted in a rare complication of dynamic tube movement in the anterior chamber with tube corneal touch and localised corneal oedema. Excision of the offending unstable tube and placement of a paediatric AGV in a different quadrant led to resolution of this complication, stable vision and well-controlled intraocular pressure. This case highlights the possible causes of dynamic tube, related complications and its management. This case also highlights the importance of understanding the various physiological phases after glaucoma drainage device implantation and their appropriate management. PMID:24695662

Long-term outcomes of uveitic glaucoma treated with Ahmed valve implant in a series of Chinese patients.

PubMed

Bao, Ning; Jiang, Zheng-Xuan; Coh, Paul; Tao, Li-Ming

2018-01-01

To report long-term outcomes of secondary glaucoma due to uveitis treated with Ahmed glaucoma valve (AGV) implantation in a series of Chinese patients. The retrospective study included 67 eyes from 56 patients with uveitic glaucoma who underwent AGV implantation. Success of the treatment was defined as patients achieving intraocular pressure (IOP) levels between 6 and 21 mm Hg with or without additional anti-glaucoma medications and/or a minimum of 20% reduction from baseline IOP. The main outcome measurements included IOP, the number of glaucoma medications at 1, 3, 6, 12, 24, 36, 48 and 60mo after surgery, surgical complications, final best-corrected vision acuity (BCVA), visual field (VF) and retinal nerve fiber layer (RNFL). The mean follow-up was 53.3±8.5 (range 48 to 60)mo. The cumulative probability of success rate was 98.5%, 95.5%, 89.6%, 83.6%, 76.1%, 70.1%, 65.7% and 61.2% at 1, 3, 6, 12, 24, 36, 48 and 60mo, respectively. IOP was reduced from a baseline of 30.8±6.8 to 9.9±4.1, 10.1±4.2, 10.9±3.7, 12.9±4.6, 13.8±3.9, 13.2±4.6, 12.3±3.5 and 13.1±3.7 mm Hg at 1, 3, 6, 12, 24, 36, 48 and 60mo, respectively ( P <0.01). The number of postoperative glaucoma medications was significantly decreased compared with baseline at all time points during the study period ( P <0.05). There was no significant difference between preoperative and postoperative BCVA. Remarkable surgical complications were not found after surgery. The VF and RNFL of the patients were stable after the surgery. AGV implantation is safe and effect in terms of reducing IOP, decreasing the number of glaucoma medications, and preserving vision for patients with uveitic glaucoma.

Ahmed glaucoma valve in post-penetrating-keratoplasty glaucoma: A critically evaluated prospective clinical study

PubMed Central

Panda, Anita; Prakash, Vadivelu Jaya; Dada, Tanuj; Gupta, Anoop Kishore; Khokhar, Sudarshan; Vanathi, Murugesan

2011-01-01

Aim: The aim was to evaluate the outcome of Ahmed glaucoma valve (AGV) in post-penetrating-keratoplasty glaucoma (PKPG). Materials and Methods: In this prospective study, 20 eyes of 20 adult patients with post-PKPG with intraocular pressure (IOP) >21 mmHg, on two or more antiglaucoma medications, underwent AG (model FP7) implantation and were followed up for a minimum of 6 months. Absolute success was defined as 5 implantation. The absolute success was achieved in 11 eyes and qualified success in 9. There was no significant change in best corrected visual acuity, graft clarity, or graft thickness. Six device-related complications occurred after AGV implantations which were successfully managed with medical or minor surgical therapy. Conclusions: Postkeratoplasty refractory glaucoma managed by AGV implantation revealed a satisfactory outcome up to 6 months of follow-up. PMID:21586837

Effect of glaucoma tube shunt parameters on cornea endothelial cells in patients with Ahmed valve implants.

PubMed

Koo, Euna B; Hou, Jing; Han, Ying; Keenan, Jeremy D; Stamper, Robert L; Jeng, Bennie H

2015-01-01

The aim of this study was to assess the effect of various tube parameters on corneal endothelial cell density (ECD) after insertion of Ahmed valves. Thirty-nine eyes of 33 patients with previous superotemporal (ST) Ahmed valve implantation and 20 eyes of 13 participants with previous uncomplicated phacoemulsification and intraocular lens implantation but no history of glaucoma surgery were evaluated. Various tube parameters were measured with anterior segment optical coherence tomography. ST, central, and inferonasal (IN) ECD and pachymetry were measured. Endothelial cell loss and corneal thickness in the ST cornea was compared with those in the IN cornea. The mean age of the operated patients was 58 ± 22 years, and the mean time since glaucoma surgery was 2.5 ± 2.6 years. Thirty-two of the 39 study eyes were pseudophakic. The ECD was significantly lower in the ST endothelium than in the IN endothelium in eyes with glaucoma tube surgery (P < 0.001), although this relative reduction in ST ECD was not greater than that seen in pseudophakic control eyes (P = 0.16). In univariate analysis, tube angle relative to the cornea and distance from the tip of the tube to the cornea were significant risk factors for decreased ST endothelial cell loss when assessed relative to the IN ECD (P = 0.01 and P = 0.02, respectively). In multivariate analysis, only the distance of the tube tip to the cornea remained significantly associated with ST endothelial cell loss. Although this was a retrospective study with inherent limitations, tubes that are closer to the cornea seem to lead to increased loss of adjacent endothelial cells.

Intraocular pressure control after the implantation of a second Ahmed glaucoma valve.

PubMed

Jiménez-Román, Jesús; Gil-Carrasco, Félix; Costa, Vital Paulino; Schimiti, Rui Barroso; Lerner, Fabián; Santana, Priscila Rezende; Vascocellos, Jose Paulo Cabral; Castillejos-Chévez, Armando; Turati, Mauricio; Fabre-Miranda, Karina

2016-06-01

The objective of this study is to evaluate the efficacy and safety of a second Ahmed glaucoma valve (AGV) in eyes with refractory glaucoma that had undergone prior Ahmed device implantation. This multicenter, retrospective study evaluated 58 eyes (58 patients) that underwent a second AGV (model S2-n = 50, model FP7-n = 8) due to uncontrolled IOP under maximal medical therapy. Outcome measures included IOP, visual acuity, number of glaucoma medications, and postoperative complications. Success was defined as IOP <21 mmHg (criterion 1) or 30 % reduction of IOP (criterion 2) with or without hypotensive medications. Persistent hypotony (IOP <5 mmHg after 3 months of follow-up), loss of light perception, and reintervention for IOP control were defined as failure. Mean preoperative IOP and mean IOPs at 12 and 30 months were 27.55 ± 1.16 mmHg (n = 58), 14.45 ± 0.83 mmHg (n = 42), and 14.81 ± 0.87 mmHg (n = 16), respectively. The mean numbers of glaucoma medications preoperatively at 12 and 30 months were 3.17 ± 0.16 (n = 58), 1.81 ± 0.2 (n = 42), and 1.83 ± 0.35 (n = 18), respectively. The reductions in mean IOP and number of medications were statistically significant at all time intervals (P < 0.001). According to criterion 1, Kaplan-Meier survival curves disclosed success rates of 62.9 % at 12 months and 56.6 % at 30 months. According to criterion 2, Kaplan-Meier survival curves disclosed success rates of 43.9 % at 12 months and 32.9 % at 30 months. The most frequent early complication was hypertensive phase (10.3 %) and the most frequent late complication was corneal edema (17.2 %). Second AGV implantation may effectively reduce IOP in eyes with uncontrolled glaucoma, and is associated with relatively few complications.

Comparison of Outcomes of Resident-performed Ahmed Valve Implantation vs Trabeculectomy

PubMed Central

Kammerdiener, Leah L; Wannamaker, Kendall W; Fan, Jie; Sharpe, Elizabeth D

2016-01-01

ABSTRACT Aims: To compare outcomes of resident-performed Ahmed valve surgery vs trabeculectomy in a Veteran Affairs medical facility. Materials and methods: A retrospective cohort of 103 eyes in 91 patients receiving Ahmed valve (valve) or trabeculectomy (trab) performed at a Veterans Administration Medical Center by residents in their third year of training. The primary outcomes included intraocular pressure (IOP), treatment failure, and complications over 1 year. Results: Of 103 eyes, 44 received valve and 59 received trab. Primary open-angle glaucoma was primary diagnosis more often in trab, while neovascular glaucoma predominated in the valve group (p < 0.001). Preoperative mean IOP was 35.1 ± 11.8 and 24.5 ± 7.1 mm Hg for valve and trabeculectomy respectively (p < 0.001), but at 1 year the IOP difference between groups was not statistically significant (p = 0.064). Overall, 11 (25.0%) and 11 (18.6%) eyes met any criteria for failure for valve and trab respectively. At 1 year, 22.5% of valves had IOP > 21 mm Hg vs only 4.3% of trab (p = 0.02). Complications were infrequent. There were no intraoperative complications for valve, whereas five for trab. Most common immediate complication for valve was hyphema. Both groups had low rates of choroidal effusions and reoperation. Conclusion: Ahmed valve implantation and trabeculectomy produce significant reductions in IOP when performed by residents-in-training. Valves tend to be used more frequently in patients with secondary glaucoma. Although complication profiles differ between procedures, both are safe and well tolerated when performed by resident physicians. Clinical significance: This study provides support for evidence-based patient counseling that supervised, resident-performed Ahmed valve implantation and trabeculectomy are indeed safe and effective. How to cite this article: Sharpe RA, Kammerdiener LL, Wannamaker KW, Fan J, Sharpe ED. Comparison of Outcomes of Resident-performed Ahmed Valve Implantation vs

Tenon advancement and duplication technique to prevent postoperative Ahmed valve tube exposure in patients with refractory glaucoma.

PubMed

Tamcelik, Nevbahar; Ozkok, Ahmet; Sarıcı, Ahmet Murat; Atalay, Eray; Yetik, Huseyin; Gungor, Kivanc

2013-07-01

To present and compare the long-term results of Dr. Tamcelik's previously described technique of Tenon advancement and duplication with the conventional Ahmed glaucoma valve (AGV) implantation technique in patients with refractory glaucoma. This study was a multicenter, retrospective case series that included 303 eyes of 276 patients with refractory glaucoma who underwent glaucoma valve implantation surgery. The patients were divided into three groups according to the surgical technique applied and the outcomes compared. In group 1, 96 eyes of 86 patients underwent AGV implant surgery without patch graft; in group 2, 78 eyes of 72 patients underwent AGV implant surgery with donor scleral patch; in group 3, 129 eyes of 118 patients underwent Ahmed valve implant surgery with "combined short scleral tunnel with Tenon advancement and duplication technique". The endpoint assessed was tube exposure through the conjunctiva. In group 1, conjunctival tube exposure was seen in 11 eyes (12.9 %) after a mean 9.2 ± 3.7 years of follow-up. In group 2, conjunctival tube exposure was seen in six eyes (2.2 %) after a mean 8.9 ± 3.3 years of follow-up. In group 3, there was no conjunctival exposure after a mean 7.8 ± 2.8 years of follow-up. The difference between the groups was statistically significant. (P = 0.0001, Chi-square test). This novel surgical technique combining a short scleral tunnel with Tenon advancement and duplication was found to be effective and safe to prevent conjunctival tube exposure after AGV implantation surgery in patients with refractory glaucoma.

Late-onset endophthalmitis secondary to exposed glaucoma tube implant in a rare case of paediatric glaucoma.

PubMed

Ranganath, Akshatha; Hashim, Adnan

2011-01-01

Glaucoma drainage implants (GDIs) are used to treat paediatric glaucoma resistant to conventional medical and surgical treatment, achieving good intraocular pressure (IOP) control and long-term success. Late endophthalmitis is a rare complication that may develop following GDI surgery. A 17-year-old male presented with acute endophthalmitis 2 years after Ahmed glaucoma valve implantation with pericardial patch graft for management of refractory glaucoma secondary to congenital ectropion uveae. The glaucoma tube was exposed due to erosion of the overlying conjunctiva with no visible pericardial graft. After control of active infection, he underwent tube revision surgery whereby the exposed tube was retained and repatched with a double-thickness pericardial patch graft. He did well following surgery with good control of IOP and restoration of vision. Conjunctival dehiscence with graft melting over the GDI tube presented a major risk factor for endophthalmitis. Prompt surgical revision of an exposed tube is highly recommended to avoid ocular morbidity.

The efficacy of Ahmed glaucoma valve drainage devices in cases of adult refractory glaucoma in Indian eyes

PubMed Central

Parihar, Jitendra K S; Vats, Devendra P; Maggon, Rakesh; Mathur, Vijay; Singh, Anirudh; Mishra, Sanjay K

2009-01-01

Aim: To evaluate the efficacy of Ahmed glaucoma valve (AGV) drainage devices in cases of adult refractory glaucoma in Indian eyes. Settings and Design: Retrospective interventional case series study. Materials and Methods: Fifty two eyes of 32 patients of refractory glaucoma in the age group of 35 to 60 years who underwent AGV implantation with or without concomitant procedures from January 2003 to Jan 2007 were studied. Of these, 46 eyes (88%) had undergone filtering surgery earlier whereas remaining eyes underwent primary AGV implantation following failure of maximal medical therapy. The follow up ranged between 12 months to 48 months Results: Eighteen eyes (35%) had undergone phacoemulsification with AGV implantation, penetrating keratoplasty (PK) with AGV and intraocular lens (IOL) implantation in 13 eyes (25%), AGV over preexisting IOL in eight eyes (15%). AGV implantation alone was done in six (11%) eyes. Anterior chamber (AC) reconstruction with secondary IOL and AGV was performed in the remaining eyes. The mean intra ocular pressure (IOP) decreased from 36.3 ± 15.7 mm Hg to 19.6 ± 9.2 mm Hg. Complete success as per criteria was achieved in 46 eyes (88%). None of the eyes had failure to maintain IOP control following AGV. Conclusion: The AGV resulted in effective and sustained control of IOP in cases of adult refractory glaucoma in intermediate follow up. PMID:19700871

Comparison of 1-year outcomes after Ahmed glaucoma valve implantation with and without Ologen adjuvant.

PubMed

Kim, Tai Jun; Kang, Sohyun; Jeoung, Jin Wook; Kim, Young Kook; Park, Ki Ho

2018-02-14

Many studies have investigated the clinical benefits of Ologen for trabeculectomy. However, its benefits for Ahmed glaucoma valve (AGV) implantation have not been investigated as extensively. The aim of this study was to compare the 1-year outcomes of AGV implantation with and without Ologen adjuvant for the treatment of refractory glaucoma. This retrospective study included a total of 20 eyes of 20 glaucoma patients, who were followed for at least 1-year after undergoing AGV implantation. In 12 eyes of 12 patients, conventional AGV (CAGV) surgery was performed, while in 8 eyes of 8 patients, Ologen-augmented AGV (OAGV) implantation was performed. The outcomes were evaluated according to intraocular pressure (IOP) and the number of IOP-lowering medications. Complete success was defined as IOP ≤ 21 mmHg without medications throughout the 1-year follow-up period, and qualified success was defined as IOP ≤ 21 mmHg with or without medications throughout the 1-year follow-up period. The rate of complete success was significantly higher in the OAGV group (50.0%) than in the CAGV group (8.3%) (p = 0.035). There were no significant differences between the two groups in terms of qualified success or incidence of the early hypertensive phase. The IOP changes were similar between the groups within 1-year postoperatively, though the number of IOP-lowering medications was significantly lower in the OAGV group during the early hypertensive phase (p = 0.031, 0.031, and 0.025 at postoperative months 1, 2, and 3, respectively). When subjects were divided into groups according to the occurrence of the early hypertensive phase, the group with early hypertensive phase was more likely to use IOP-lowering medications at postoperative 6 months and 1 year (p = 0.002 and 0.005, respectively). OAGV surgery shows encouraging results for patients with refractory glaucoma, specifically with respect to the achievement of complete success and the reduction of the

Outcomes of Ahmed Valve Implant Following a Failed Initial Trabeculotomy and Trabeculectomy in Refractory Primary Congenital Glaucoma

PubMed Central

Dave, Paaraj; Senthil, Sirisha; Choudhari, Nikhil; Sekhar, Garudadri Chandra

2015-01-01

Purpose: The aim was to report the outcome of Ahmed glaucoma valve (AGV) (New World Medical, Inc., Rancho Cucamonga, CA, USA) implantation as a surgical intervention following an initial failed combined trabeculotomy + trabeculectomy (trab + trab) in refractory primary congenital glaucoma (RPCG). Materials and Methods: Retrospective chart review of 11 eyes of 8 patients who underwent implantation of AGV (model FP8) for RPCG between 2009 and 2011. Prior trab + trab had failed in all the eyes. Success was defined as an intraocular pressure (IOP) >5 and ≤ 18 mmHg during examination under anesthesia with or without medications and without serious complications or additional glaucoma surgery. Results: The mean age at AGV implantation was 15.4 ± 4.9 months. The mean preoperative IOP was 28 ± 5.7 mmHg which reduced to 13.6 ± 3.4 mmHg postoperatively at the last follow-up (P < 0.0001). The number of topical antiglaucoma medications reduced from a mean of 2.6 ± 0.5 to 1.6 ± 0.9 postoperatively (P = 0.009). The definition of qualified success was met in 10 (90%) eyes. One eye developed a shallow anterior chamber with choroidal detachment at 1-week, which resolved spontaneously with medications. None of the eyes developed a hypertensive phase. One eye had a long tube resulting in tube corneal touch that required trimming of the tube. One eye developed tube retraction, which was treated with a tube extender. The mean follow-up was 17.9 ± 9.3 (6.2-35.4) months. Conclusion: Managing RPCG remains a challenge. AGV implant was successful in a significant proportion of cases. PMID:25624676

Assessment of conditions affecting surgical success of Ahmed glaucoma valve implants in glaucoma secondary to different uveitis etiologies in adults.

PubMed

Sungur, G; Yakin, M; Eksioglu, U; Satana, B; Ornek, F

2017-10-01

PurposeThere is little known about the long-term efficacy and safety of Ahmed glaucoma valve (AGV) implant and about the conditions affecting surgical success in uveitic glaucoma (UG).Patients and methodsThe charts of adult patients with UG who underwent AGV implantation from 2006 to 2015 were reviewed retrospectively.ResultsData of 46 eyes of 39 patients were evaluated. Mean follow-up was 51.93±23.08 months. Mean preoperative IOP was 37.05±9.62 mm Hg and mean number of preoperative topical anti-glaucomatous medications was 2.98±0.27. One eye (2%) was defined as failure because of implant extraction surgery. In the rest of the eyes, intraocular pressure (IOP) was under control with or without anti-glaucomatous medications during follow-up. The cumulative probability of complete success (IOP control without medications) was 78% at 6 months, 76% at 1 year, 71% at 2 years, 66% at 3 years, and 63% at 4 years (95% confidence interval, 61.24-87.81). The cumulative probability of eyes without complication was 64% at 6 months, 48% at 12 months, 44% at 24 months, 41% at 36 months, and 38% at 48 months (95% confidence interval, 34.64-62.85). Complete success was lower in eyes with previous ocular surgery than the eyes without (P=0.061) and it was lower in eyes with active inflammation at the time of surgery than the eyes without (P=0.011).ConclusionAGV implantation is an effective and safe alternative method in the management of UG, especially when it is performed as a primary surgical option and when no inflammation is present preoperatively.

Partial Tenon’s capsule resection with adjunctive mitomycin C in Ahmed glaucoma valve implant surgery

PubMed Central

Susanna, R

2003-01-01

Aim: To verify if partial intraoperative Tenon’s capsule resection (PTCR) with adjunctive mitomycin C is effective in developing thin, avascular blebs in eyes undergoing Ahmed glaucoma valve insertion, and to assess the efficacy and safety of this procedure. Methods: A multicentre, prospective, alternating case assignment, investigator unmasked, parallel group, comparative interventional study was conducted in four Latin American countries (Argentina, Brazil, Colombia, and Peru). Ahmed glaucoma valve implant insertion with PTCR (group A) and without PCTR (group B) was performed in neovascular glaucomatous eyes without previous surgery. Adjunctive mitomycin C (MMC) was used in both groups. Patients were examined 1 day, 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year following the surgery. Intraocular pressure (IOP) and the appearance of the bleb were evaluated at each examination. Appearance of the bleb was classified at both the 1 month mark and last examinations into one of three groups: flat and vascularised; elevated avascular; or elevated and not avascular. Results: 92 eyes from 92 patients were included in the study. The preoperative mean IOP was 50.0 (SD 10.5) mm Hg in group A and 48.4 (11.7) in group B (p>0.05). Statistically significant IOP reductions were observed at all periods of follow up. 12 months after surgery, the mean IOP was 17.2 (5.0) mm Hg in group A and 18.3 (8.7) mm Hg in group B (p>0.05). A hypertensive phase occurred in 40.0% in group A and in 46.8% in group B (p>0.05). At the 1 month and the final follow up, the blebs in all eyes were considered elevated and not avascular. The success rate (IOP⩽21 mm Hg) at 1 year after surgery was 70.4% in group A and 77.7% in group B (p>0.05). Overall, 74.2% of the patients achieved an IOP ⩽21 mm Hg and 55.2% an IOP⩽17 mm Hg, with or without additional medication administered to lower IOP. The incidence of complications was similar in both groups. Conclusions: In eyes undergoing Ahmed

Fluid Dynamics of a Novel Micro-Fistula Implant for the Surgical Treatment of Glaucoma.

PubMed

Sheybani, Arsham; Reitsamer, Herbert; Ahmed, Iqbal Ike K

2015-07-01

The purpose of this study was to describe the fluidics of a novel non-valved glaucoma implant designed to prevent hypotony and compare the fluidics of this device with two commonly used non-valved glaucoma devices. The XEN 45 micro-fistula implant was designed to limit hypotony by virtue of its length and width according to the Hagen-Poiseuille equation. Flow testing was performed using a syringe pump and pressure transducer at multiple flow rates. The pressure differentials across the XEN implant, the Ex-Press implant, and 10 mm of silicone tubing from a Baerveldt implant at a physiologic flow rate (2.5 μL/min) were extrapolated. The XEN 45 achieved a steady-state pressure calculated at 7.56 mm Hg at 2.5 μL/min. At the same flow rate, the Ex-Press device and Baerveldt tubing reached steady-state pressures of 0.09 and 0.01 mm Hg, respectively. Under flow testing, the XEN micro-fistula implant was able to maintain backpressure above numerical hypotony levels without the use of complex valve systems. This is due to the XEN implant's design, derived from the principles that dictate Newtonian fluids.

Clinical Experience with the M4 Ahmed Glaucoma Drainage Implant.

PubMed

Sluch, Ilya; Gudgel, Brett; Dvorak, Justin; Anne Ahluwalia, Mary; Ding, Kai; Vold, Steve; Sarkisian, Steven

2017-01-01

To evaluate the safety and efficacy of the M4 (porous polyethylene plate) Ahmed Glaucoma Valve (AGV) drainage implant in a multicenter retrospective study. A retrospective chart review of medical records of patients who had undergone the M4 Ahmed valve was performed from January 2013 to April 2015. The primary outcome measure was surgical failure defined as: Less than a 20% reduction in baseline intraocular pressure (IOP) to last follow-up visit, final IOP less than 5 mm Hg or greater than 18 mm Hg, reoperation for glaucoma, or loss of light perception vision. All eyes not meeting the above criteria were defined as success. A total of 291 eyes met all study inclusion criteria. The average follow-up in the study was 6 months (±7.6 months) with 112 patients achieving 12-month follow-up (38.5%). 208 eyes (71.5%) met the study success criteria at final follow-up. No statistically significant spikes in postoperative IOP at 1 and 4 months were detected. The average preoperative IOP was 26.0 on an average of 2.8 medications. At 6 months, the average IOP dropped to 16.7 on 0.9 medications and stayed relatively stable at 15.8 on 1.2 medications at 12-month follow-up. The M4 valve appears to have less of a hypertensive phase compared with the other Ahmed class valves with a similar safety profile. While 71.5% success rate was achieved at final follow-up, the failure rate steadily increased over time. While the M4 production has been discontinued, the porous design of the M4 may avoid a pressure spike in the Ahmed valve class and warrants future investigation for valve design. How to cite this article: Sluch I, Gudgel B, Dvorak J, Ahluwalia MA, Ding K, Vold S, Sarkisian S. Clinical Experience with the M4 Ahmed Glaucoma Drainage Implant. J Curr Glaucoma Pract 2017;11(3):92-96.

Adjunctive triamcinolone acetonide for Ahmed glaucoma valve implantation: a randomized clinical trial.

PubMed

Yazdani, Shahin; Doozandeh, Azadeh; Pakravan, Mohammad; Ownagh, Vahid; Yaseri, Mehdi

2017-06-26

To evaluate the effect of intraoperative sub-Tenon injection of triamcinolone acetonide (TA) as an adjunct to Ahmed glaucoma valve (AGV) implantation. In this triple-blind randomized clinical trial, 104 eyes with refractory glaucoma were randomly assigned to conventional AGV (non-TA group) or AGV with adjunctive triamcinolone (TA group). In the TA group, 10 mg TA was injected in the sub-Tenon space around the AGV plate intraoperatively. Patients were followed for 1 year. The main outcome measure was intraocular pressure (IOP). Other outcome measures included best-corrected visual acuity (BCVA), occurrence of hypertensive phase (HP), peak IOP, number of antiglaucoma medications, and complications. A total of 90 patients were included in the final analysis. Mean IOP was lower in the TA group at most follow-up visits; however, the difference was statistically significant only at the first month (p = 0.004). Linear mixed model showed that mean IOP was 1.5 mm Hg lower in the TA group throughout the study period (p = 0.006). Peak postoperative IOP was significantly lower in the TA group (19.3 ± 4.8 mm Hg versus 29 ± 9.2 mm Hg, p = 0.032). Rates of success (defined as 6 < IOP <21 mm Hg) were similar in both groups at 12 months. There was no difference in the occurrence of the HP between the 2 groups (p = 0.123). Loss of BCVA >2 lines was more common in the non-TA group (p = 0.032). Adjunctive intraoperative TA injection during AGV implantation can blunt peak IOP levels and reduce mean IOP up to 1 year. Visual outcomes also seem to be superior to standard surgery.

A Novel Surgical Technique for Ahmed Valves in Refractory Glaucoma With Silicone Oil Endotamponade.

PubMed

Davo-Cabrera, Juan Maria; Lanzagorta-Aresti, Aitor; Alcocer Yuste, Pablo

2017-10-01

The purpose of the study is to describe a novel technique to implant Ahmed valves in patients with refractory glaucoma because of silicone oil (SO) endotamponade PATIENTS:: Three patients with glaucoma without SO removal were used as an example for this technique. Technique report. We introduce a standard technique modification for Ahmed valves in patients with SO. This modification consists on locating the Ahmed valve more tangential to the limbus curvature instead of the usual perpendicular position and inserting the tube in the posterior chamber. The tube can be longer and run parallel to pupil. This technique allows use superotemporal quadrant (fewer complications), avoid corneal touch and decrease SO loss through the tube to subconjunctival space.

Complications and 2-year valve survival following Ahmed valve implantation during the first 2 years of life.

PubMed

Almobarak, F; Al-Mobarak, F; Khan, A O

2009-06-01

To report complications and 2-year valve survival following Ahmed valve implantation during the first 2 years of life. Retrospective institutional case series. Forty-two eyes of 36 patients with Ahmed valve implantation (without prior drainage device surgery) during the first 2 years of life and 2 years' postsurgical follow-up were identified. Most eyes had primary congenital glaucoma (28/42, 66.7%), aphakic glaucoma (5/42, 11.9%) or Peters anomaly (5/42, 11.9%). All but three eyes had prior ocular surgery. Surgery was at a mean age of 11.83 months (m) (SD 5.63). The most common significant postoperative complications were tube malpositioning requiring intervention (11/42, 26.2%), endophthalmitis (3/42, 7.1%; one with tube exposure) and retinal detachment (3/42, 7.1%). Thirty-six eyes (85.8%) required resumption of antiglaucoma medications to maintain intraocular pressure (IOP) < or =22 mm Hg a mean of 7.2 m (SD 6.8) postoperatively. Cumulative probabilities of valve survival (IOP< or =22 mm Hg with or without medication) by Kaplan-Meier analysis were 73.8% and 63.3% at 12 months and 24 months, respectively. Postoperative tube malpositioning that required surgical revision was common in this age group. Infectious endophthalmitis and retinal detachment are known potential complications following any incisional surgery for advanced buphthalmos; however, tube exposure is a unique potential problem following aqueous shunt implantation that can lead to intraocular infection. Cumulative valve survival 2 years following implantation was 63.3%.

Sutureless human sclera donor patch graft for Ahmed glaucoma valve.

PubMed

Zeppa, Lucio; Romano, Mario R; Capasso, Luigi; Tortori, Achille; Majorana, Mara A; Costagliola, Ciro

2010-01-01

To report the safety and effectiveness of a sutureless human sclera donor patch graft covering the subconjunctival portion of glaucoma drainage implant tube to prevent its erosion throughout the overlying conjunctiva. This was a prospective pilot study. Fifteen eyes of 15 consecutive patients not responsive to medical and to not-implant surgical glaucoma treatment underwent Ahmed glaucoma valve (AGV) implant surgery with sutureless human sclera donor patch graft. The surgical procedure included AVG implant placed 8 mm behind the corneal limbus and fixed to the sclera with two 9-0 black nylon sutures. The tube was passed through the scleral tunnel, parallel to the corneal limbus, and shortened at the desired length. The anterior part of the tube was covered with human donor scleral graft and kept in place with fibrin glue (Tissue Coll) under the conjunctiva. Examinations were scheduled at baseline and then at 1 week and 1, 3, 6, and 12 months after surgery. At 12-month follow-up, the best-corrected visual acuity did not significantly improve from baseline 0.78+/-1.2 logMAR, whereas mean intraocular pressure significantly decreased from preoperative values of 29.8 (SD 8.4) mmHg. In all cases, the scleral patch was found in place at each check during the follow-up period. No conjunctival erosion over the AGV tube nor sign of endophthalmitis was recorded at any time during the follow-up period. AVG implant surgery with sutureless human sclera donor patch graft represents an effective and relatively safe surgical procedure for complicated glaucomas, avoiding conjunctival erosions over the AGV tube.

Outcomes of using a sutureless bovine pericardial patch graft for Ahmed glaucoma valve implantation.

PubMed

Quaranta, Luciano; Riva, Ivano; Floriani, Irene C

2013-01-01

To evaluate the long-term outcomes of a surgical technique using a sutureless bovine pericardial patch graft for the implantation of an Ahmed glaucoma valve (AGV). 
 This was a pilot study on patients with primary open-angle glaucoma refractory to repeated surgical filtering procedures. All patients underwent AGV implant technique using a sutureless bovine pericardial patch graft. The pericardial membrane was cut using an ordinary corneal trephine with a diameter of 9.0 or 10.0 mm. The anterior part of the tube was covered with the graft and kept in place with fibrin glue. Subsequently, the cap was stitched all around the tube and the dissected conjunctiva was laid over it. Intraocular pressure (IOP) and complications were evaluated 1 week and 1, 3, 6, 12, and 24 months after surgery.
 The procedure was used to treat 20 eyes of 20 consecutive patients (12 men and 8 women: mean age [SD] 64.8 [7.8] years). Mean IOP was 28.1 mm Hg (SD 4.9) at baseline and decreased to 14.9 mm Hg (SD 1.5) 24 months after surgery (p<0.001). The overall mean number of topical medications was 3.1 (SD 0.5) at baseline and decreased to 1.4 (SD 0.8) after 24 months (p<0.001). During follow-up, there was no conjunctival erosion, thinning of pericardial patch graft over the tube, or tube exposure; no signs of endophthalmitis were recorded.
 The results suggest that the sutureless technique using a bovine pericardial graft patch is a safe and rapid procedure for AGV implantation.

Clinical Outcomes of FP-7/8 Ahmed Glaucoma Valves in the Management of Refractory Glaucoma in the Mainland Chinese Population.

PubMed

Zhu, Yingting; Wei, Yantao; Yang, Xuejiao; Deng, Shuifeng; Li, Zuohong; Li, Fei; Zhuo, Yehong

2015-01-01

To evaluate the efficacy and safety of the Ahmed glaucoma valve (AGV) and the risk factors associated with AGV implantation failure in a population of Chinese patients with refractory glaucoma. In total, 79 eyes with refractory glaucoma from 79 patients treated in our institution from November 2007 to November 2010 were enrolled in this retrospective study. The demographic data, preoperative and postoperative intraocular pressures (IOPs), best corrected visual acuity (BCVA), number of anti-glaucoma medications used, completed and qualified surgery success rates and postoperative complications were recorded to evaluate the outcomes of AGV implantation. Factors that were associated with implant failure were determined using Cox proportional hazard regression model analysis and multiple linear regression analysis. The average follow-up time was 12.7±5.8 months (mean±SD). We observed a significant reduction in the mean IOP from 39.9±12.6 mm Hg before surgery to 19.3±9.6 mm Hg at the final follow-up. The complete success rate was 59.5%, and the qualified success rate was 83.5%. The number of previous surgeries was negatively correlated with qualified success rate (P<0.05, OR=0.736, 95% CI 0.547-0.99). Patients with previous trabeculectomy were more likely to use multiple anti-glaucoma drugs to control IOP (P<0.01). The primary complication was determined to be a flat anterior chamber (AC). AGV implantation was safe and effective for the management of refractory glaucoma. Patients with a greater number of previous surgeries were more likely to experience surgical failure, and patients with previous trabeculectomy were more likely to use multiple anti-glaucoma drugs to control postoperative IOP.

Excisional Bleb Revision for Management of Failed Ahmed Glaucoma Valve.

PubMed

Eslami, Yadollah; Fakhraie, Ghasem; Moghimi, Sasan; Zarei, Reza; Mohammadi, Masoud; Nabavi, Amin; Yaseri, Mehdi; Izadi, Ali

2017-12-01

To evaluate the outcome of excisonal bleb revision in patients with failed Ahmed glaucoma valve (AGV). In total, 29 patients with uncontrolled intraocular pressure (IOP) despite of maximal tolerated medical therapy at least 6 months after AGV implantation were enrolled in this prospective interventional case series. Excision of fibrotic tissue around the reservoir with application of mitomycin C 0.02% was performed. IOP, number of glaucoma medications were evaluated at baseline and 1 week and 1, 3, 6, and 12 months postoperatively. Complete and qualified success was defined as IOP≤21 mm Hg with or without glaucoma medications, respectively. Intraoperative and postopervative complications were also recorded. Mean IOP was reduced from 30±4.2 mm Hg at baseline to 19.2±3.1 mm Hg at 12-month follow-up visit (P<0.001). Average number of glaucoma medications was decrease from 3.2±0.5 at baseline to 1.9±0.7 at 12-month follow-up (P<0.001). Qualified and complete success rates at 12-month follow-up were 65.5% and 6.9%, respectively. Younger age and higher number of previous glaucoma surgeries were significantly associated with the failure of excisonal bleb revision. Excisional bleb revision could be considered as a relatively effective alternative option for management of inadequate IOP control after AGV implantation.

Impact of same-session trabectome surgery on Ahmed glaucoma valve outcomes.

PubMed

Esfandiari, Hamed; Shazly, Tarek; Shah, Priyal; Hassanpour, Kiana; Torkian, Pooya; Yaseri, Mehdi; Loewen, Nils A

2018-03-30

To evaluate the efficacy and survival rates of same session ab interno trabeculectomy with the trabectome and Ahmed glaucoma valve implant (AT) in comparison to the Ahmed glaucoma valve alone (A). A total of 107 eyes undergoing primary glaucoma surgery were enrolled in this retrospective comparative case series, including 48 eyes which underwent AT and 59 eyes which received A alone. Participants were identified using the procedural terminology codes, and their medical records were reviewed. The primary outcome measure was success defined as IOP > 5 mmHg, ≤ 21 mmHg and ≥ 20% reduction of IOP from baseline at two consecutive visits after 3 months, and no need for glaucoma reoperation. Secondary outcome measures were IOP, the number of glaucoma medications, incidence of a hypertensive phase, and best corrected visual acuity (BCVA). The cumulative probability of success at 1 year was 70% in AT, and 65% in A (p = 0.85). IOP decreased significantly from 26.6 ± 10.1 mmHg at baseline to 14.7 ± 3.3 mmHg at the final follow-up in AT (p = 0.001). The corresponding numbers for A were 27.8 ± 10.2 and 16.7 ± 4.9, respectively (p = 0.001). The final IOP was significantly lower in AT (p = 0.022). The number of medications at baseline was comparable in both groups (2.6 ± 1.2 in AT and 2.5 ± 1.3 in A, p = 0.851). Corresponding number at 1 year visit was 1.2 ± 2 in AT and 2.8 ± 1.8 in A (p = 0.001). The incidence of a hypertensive phase was 18.7% in AT and 35.5% in A (p = 0.05). HP resolved in only 30% of eyes. The criteria for HP resolution were fulfilled in 9 eyes (30%). There was no difference in the rate of resolution of the hypertensive phase between AT and A (33.3 and 28.5%, respectively, p = 0.67). Ahmed glaucoma valve implant with same session trabectome surgery significantly decreased the rate of the hypertensive phase and postoperative IOP as well as the number of glaucoma

Clinical Outcomes of FP-7/8 Ahmed Glaucoma Valves in the Management of Refractory Glaucoma in the Mainland Chinese Population

PubMed Central

Yang, Xuejiao; Deng, Shuifeng; Li, Zuohong; Li, Fei; Zhuo, Yehong

2015-01-01

Background To evaluate the efficacy and safety of the Ahmed glaucoma valve (AGV) and the risk factors associated with AGV implantation failure in a population of Chinese patients with refractory glaucoma. Method In total, 79 eyes with refractory glaucoma from 79 patients treated in our institution from November 2007 to November 2010 were enrolled in this retrospective study. The demographic data, preoperative and postoperative intraocular pressures (IOPs), best corrected visual acuity (BCVA), number of anti-glaucoma medications used, completed and qualified surgery success rates and postoperative complications were recorded to evaluate the outcomes of AGV implantation. Factors that were associated with implant failure were determined using Cox proportional hazard regression model analysis and multiple linear regression analysis. Principle Findings The average follow-up time was 12.7±5.8 months (mean±SD). We observed a significant reduction in the mean IOP from 39.9±12.6 mm Hg before surgery to 19.3±9.6 mm Hg at the final follow-up. The complete success rate was 59.5%, and the qualified success rate was 83.5%. The number of previous surgeries was negatively correlated with qualified success rate (P<0.05, OR=0.736, 95% CI 0.547-0.99). Patients with previous trabeculectomy were more likely to use multiple anti-glaucoma drugs to control IOP (P<0.01). The primary complication was determined to be a flat anterior chamber (AC). Conclusion AGV implantation was safe and effective for the management of refractory glaucoma. Patients with a greater number of previous surgeries were more likely to experience surgical failure, and patients with previous trabeculectomy were more likely to use multiple anti-glaucoma drugs to control postoperative IOP. PMID:25996991

Adjunctive Mitomycin C or Amniotic Membrane Transplantation for Ahmed Glaucoma Valve Implantation: A Randomized Clinical Trial.

PubMed

Yazdani, Shahin; Mahboobipour, Hassan; Pakravan, Mohammad; Doozandeh, Azadeh; Ghahari, Elham

2016-05-01

To determine whether adjunctive mitomycin C (MMC) or amniotic membrane transplantation (AMT) improve the outcomes of Ahmed glaucoma valve (AGV) implantation. This double-blind, stratified, 3-armed randomized clinical trial includes 75 eyes of 75 patients aged 7 to 75 years with refractory glaucoma. Eligible subjects underwent stratified block randomization; eyes were first stratified to surgery in the superior or inferior quadrants based on feasibility; in each subgroup, eyes were randomly assigned to the study arms using random blocks: conventional AGV implantation (group A, 25 eyes), AGV with MMC (group B, 25 eyes), and AGV with AMT (group C, 25 eyes). The 3 study groups were comparable regarding baseline characteristics and mean follow-up (P=0.288). A total of 68 patients including 23 eyes in group A, 25 eyes in group B, and 20 eyes group C completed the follow-up period and were analyzed. Intraocular pressure was lower in the MMC group only 3 weeks postoperatively (P=0.04) but comparable at other time intervals. Overall success rate was comparable in the 3 groups at 12 months (P=0.217). The number of eyes requiring medications (P=0.30), time to initiation of medications (P=0.13), and number of medications (P=0.22) were comparable. Hypertensive phase was slightly but insignificantly more common with standard surgery (82%) as compared with MMC-augmented (60%) and AMT-augmented (70%) procedures (P=0.23). Complications were comparable over 1 year (P=0.28). Although adjunctive MMC and AMT were safe during AGV implantation, they did not influence success rates or intraocular pressure outcomes. Complications, including hypertensive phase, were also comparable.

Ahmed glaucoma valve in eyes with preexisting episcleral encircling element

PubMed Central

Choudhari, Nikhil Shreeram; George, Ronnie; Shantha, Balekudaru; Neog, Aditya; Tripathi, Shweta; Srinivasan, Bhaskar; Vijaya, Lingam

2014-01-01

Background: To describe the use of Ahmed glaucoma valve (AGV) in the management of intractable glaucoma in eyes with a preexisting episcleral encircling element. Materials and Methods: This is a retrospective, consecutive, noncomparative study. The study included 12 eyes of 12 patients with a preexisting episcleral encircling element that underwent implantation of silicone AGV to treat intractable glaucoma during January 2009 to September 2010. Results: The mean patient age was 25.6 (standard deviation 17.1) years. Five (41.6%) patients were monocular. The indications for AGV were varied. The mean duration between placement of episcleral encircling element and implantation of AGV was 30.5 (33.8) months. The mean follow-up was 37.4 (22.9) weeks. Preoperatively, the mean intraocular pressure (IOP) was 31.4 (7.9) mmHg and the mean antiglaucoma medications were 2.8. At the final postoperative follow-up, the mean IOP was 12.5 (3.5) mmHg and the mean number of antiglaucoma medications was 0.8 (P < 0.001). The complications observed over the follow-up period did include corneal graft failure in three eyes, tube erosion in two eyes and rhegmatogenous retinal detachment in one eye. Conclusion: AGV is an effective option in the management of intractable glaucoma in eyes with a preexisting episcleral encircling element keeping in mind the possibility of significant postoperative complications. PMID:24881603

Ahmed glaucoma valve in eyes with preexisting episcleral encircling element.

PubMed

Choudhari, Nikhil Shreeram; George, Ronnie; Shantha, Balekudaru; Neog, Aditya; Tripathi, Shweta; Srinivasan, Bhaskar; Vijaya, Lingam

2014-05-01

To describe the use of Ahmed glaucoma valve (AGV) in the management of intractable glaucoma in eyes with a preexisting episcleral encircling element. This is a retrospective, consecutive, noncomparative study. The study included 12 eyes of 12 patients with a preexisting episcleral encircling element that underwent implantation of silicone AGV to treat intractable glaucoma during January 2009 to September 2010. The mean patient age was 25.6 (standard deviation 17.1) years. Five (41.6%) patients were monocular. The indications for AGV were varied. The mean duration between placement of episcleral encircling element and implantation of AGV was 30.5 (33.8) months. The mean follow-up was 37.4 (22.9) weeks. Preoperatively, the mean intraocular pressure (IOP) was 31.4 (7.9) mmHg and the mean antiglaucoma medications were 2.8. At the final postoperative follow-up, the mean IOP was 12.5 (3.5) mmHg and the mean number of antiglaucoma medications was 0.8 (P < 0.001). The complications observed over the follow-up period did include corneal graft failure in three eyes, tube erosion in two eyes and rhegmatogenous retinal detachment in one eye. AGV is an effective option in the management of intractable glaucoma in eyes with a preexisting episcleral encircling element keeping in mind the possibility of significant postoperative complications.

Combined trabeculotomy-trabeculectomy versus Ahmed valve implantation for refractory primary congenital glaucoma in Egyptian patients: a long-term follow-up

PubMed Central

Helmy, Hazem

2016-01-01

Introduction Primary congenital glaucoma (PCG) is the most common type of glaucoma in pediatric patients. The aim of this study was to compare the effectiveness of combined trabeculotomy-trabeculectomy versus Ahmed valve implantation for cases of PCG refractory to traditional incisional angle surgery (goniotomy and trabeculotomy) in the Egyptian population. Methods The study was conducted in the Glaucoma Clinic of the Research Institute of Ophthalmology (Egypt). The study included 66 eyes of 66 patients (in two groups) with advanced PCG who had previous failed goniotomy, trabeculotomy, or both. Group 1 included 33 patients who underwent trabeculotomy-trabeculectomy procedures; group 2 included 33 patients who underwent FP 8 Ahmed valve implantation. The main outcome measures were intraocular pressure (IOP) reduction, corneal diameter, and axial length stability in both groups. Secondary outcome measures included detection of complications in both groups. Results The average ages of the patients were 13.5 ± 3.9 months and 15.3 ± 5.8 months in groups 1 and 2, respectively. Ten patients (30.3%) in group 1 and 9 patients (27.3%) in group 2 had family histories of PCG. Positive consanguinity was present in 26 patients (78.8%) in group 1 and in 27 patients (81.8%) in group 2. In group 1, the mean intraocular pressure (IOP) value decreased from 33.6 ± 3.4 mmHg preoperatively to 13.8 ± 0.6, 16.9 ± 1.5, 18.2 ± 2.5, 19.8 ± 3.6, and 20.2 ± 3.1 mmHg in the first postoperative month and after years 1, 2, 3, and 4, respectively (p < 0.001). In group 2, the mean IOP value decreased from 33.4 ± 4.5 mmHg preoperatively to 13.3 ± 1.1, 16.3 ± 1.6, 18.1 ± 1.0, 19.1 ± 3.5, and 19.9 ± 3.7 mmHg in the first postoperative month and after years 1, 2, 3, and 4, respectively (p < 0.001). The average number of medications decreased from 2.2 ± 0.4 preoperatively to 1.8 ± 0.4 postoperatively in group 1, while it decreased from 2.1 ± 0.4 preoperatively to 1.9 ± 0

Comparison of the Outcome of Silicone Ahmed Glaucoma Valve Implantation with a Surface Area between 96 and 184 mm2 in Adult Eyes

PubMed Central

Koh, Kyung Min; Hwang, Young Hoon; Jung, Jong Jin; Sohn, Yong Ho

2013-01-01

Purpose To compare the success rates, complications, and visual outcomes between silicone Ahmed glaucoma valve (AGV) implantation with 96 mm2 (FP8) or 184 mm2 (FP7) surface areas. Methods This study is a retrospective review of the records from 132 adult patients (134 eyes) that underwent silicone AGV implant surgery. Among them, the outcomes of 24 eyes from 24 patients with refractory glaucoma who underwent FP8 AGV implantation were compared with 76 eyes from 76 patients who underwent FP7 AGV implantation. Preoperative and postoperative data, including intraocular pressure (IOP), visual acuity, number of medications, and complications were compared between the 2 groups. Results There were no significant differences in baseline characteristics between the 2 groups (p > 0.05). The postoperative visual acuity of the patients in the FP8 group was better than that of the patients in the FP7 group in some early postoperative periods (p < 0.05); however, after 10 postoperative months, visual acuity was not significantly different through the 3-year follow-up period (p > 0.05). Postoperative IOP was not significantly different between the 2 groups (p > 0.05) except for IOP on postoperative day 1 (11.42 mmHg for the FP7 group and 7.42 mmHg for the FP8 group; p = 0.031). There was no statistical difference in success rates, final IOP, number of medications, or complication rates between the 2 groups (p > 0.05). Conclusions The FP7 and FP8 AGV implants showed no difference in terms of vision preservation, IOP reduction, and number of glaucoma medications required. PMID:24082774

Ahmed glaucoma valve implantation with tube insertion through the ciliary sulcus in pseudophakic/aphakic eyes.

PubMed

Eslami, Yadolla; Mohammadi, Massood; Fakhraie, Ghasem; Zarei, Reza; Moghimi, Sasan

2014-02-01

To report the efficacy and safety of Ahmed glaucoma valve (AGV) insertion into the ciliary sulcus in pseudophakic/aphakic patients. A chart review was done on patients with uncontrolled glaucoma, who underwent AGV implantation with tube inserted into the ciliary sulcus. Baseline intraocular pressure (IOP) and number of medications were compared with that of postoperative follow-up visits. Surgical success was defined as last IOP <21 mm Hg and 20% reduction in IOP, without further surgery for complications or glaucoma control, and without loss of light perception. Postoperative complications were recorded. Twenty-three eyes of 23 patients were recruited with the mean follow-up of 9 months (range, 3 to 24 mo). The mean (SD) age of patients was 49.9 (16.9) years (range, 22 to 80 years). The mean (SD) IOP (mm Hg) was reduced from 37.9 (12.4) before surgery to 16.2 (3.6) at the last follow-up visit (P<0.001). The mean (SD) number of medications was reduced from 3.3 (0.9) preoperatively to 1 (1.1) at the last follow-up (P<0.001). Success rate was 18/23 (78.6%). Complications included endophthalmitis in 1 eye, tube exposure in 1 diabetic patient, and vitreous tube occlusion in 1 eye. No case of corneal decompensation or graft failure was seen during follow-up. Ciliary sulcus placement of the tube of AGV effectively reduces IOP and medication use in short term. It has the potential to lower corneal complications of anterior chamber tube insertion and avoids the need for pars plana vitrectomy and tube insertion in patients at higher risk of corneal decompensation.

Changes in Corneal Endothelial Cell after Ahmed Glaucoma Valve Implantation and Trabeculectomy: 1-Year Follow-up.

PubMed

Kim, Min Su; Kim, Kyoung Nam; Kim, Chang-Sik

2016-12-01

To compare changes in corneal endothelial cell density (CECD) after Ahmed glaucoma valve (AGV) implantation and trabeculectomy. Changes in corneal endothelium in patients that underwent AGV implantation or trabeculectomy were prospectively evaluated. Corneal specular microscopy was performed at the central cornea using a non-contact specular microscope before surgery and 6 months and 12 months after surgery. The CECD, hexagonality of the endothelial cells, and the coefficient of variation of the cell areas were compared between the two groups. Forty eyes of 40 patients with AGV implantation and 28 eyes of 28 patients with trabeculectomy were studied. Intraocular pressure in the AGV implantation group was significantly higher than that in the trabeculectomy group ( p < 0.001), but there was no significant difference in other clinical variables between the two groups. In the AGV implantation group, the mean CECD significantly decreased by 9.4% at 6 months and 12.3% at 12 months compared with baseline values (both, p < 0.001), while it decreased by 1.9% at 6 months and 3.2% at 12 months in the trabeculectomy group ( p = 0.027 and p = 0.015, respectively). The changes at 6 months and 12 months in the AGV implantation group were significantly higher than those in the trabeculectomy group ( p = 0.030 and p = 0.027, respectively). In the AGV implantation group, there was a significant decrease in the CECD between baseline and 6 months and between 6 months and 12 months ( p < 0.001 and p = 0.005, respectively). However, in the trabeculectomy group, a significant decrease was observed only between baseline and 6 months ( p = 0.027). Both the AGV implantation group and the trabeculectomy group showed statistically significant decreases in the CECD 1 year after surgery. The decrease in CECD in the AVG implantation group was greater and persisted longer than that in the trabeculectomy group.

Changes in corneal endothelial cell density and the cumulative risk of corneal decompensation after Ahmed glaucoma valve implantation.

PubMed

Kim, Kyoung Nam; Lee, Sung Bok; Lee, Yeon Hee; Lee, Jong Joo; Lim, Hyung Bin; Kim, Chang-Sik

2016-07-01

To evaluate changes in the corneal endothelial cell density (ECD) and corneal decompensation following Ahmed glaucoma valve (AGV) implantation. This study was retrospective and observational case series. Patients with refractory glaucoma who underwent AGV implantation and were followed >5 years were consecutively enrolled. We reviewed the medical records, including the results of central corneal specular microscopy. Of the 127 enrolled patients, the annual change in ECD (%) was determined using linear regression for 72 eyes evaluated at least four times using serial specular microscopic examination and compared with 31 control eyes (fellow glaucomatous eyes under medical treatment). The main outcome measures were cumulative risk of corneal decompensation and differences in the ECD loss rates between subjects and controls. The mean follow-up after AGV implantation was 43.1 months. There were no cases of postoperative tube-corneal touch. The cumulative risk of corneal decompensation was 3.3%, 5 years after AGV implantation. There was a more rapid loss of ECD in the 72 subject eyes compared with the 31 controls (-7.0% and -0.1%/year, respectively; p<0.001). However, the rate of loss decreased over time and statistical significance compared with control eyes disappeared after 2 years postoperatively: -10.7% from baseline to 1 year (p<0.01), -7.0% from 1 year to 2 years (p=0.037), -4.2% from 2 years to 3 years (p=0.230) and -2.7% from 3 years to the final follow-up (p=0.111). In case of uncomplicated AGV implantation, the cumulative risk of corneal decompensation was 3.3%, 5 years after the operation. The ECD loss was statistically greater in eyes with AGV than in control eyes without AGV, but the difference was significant only up to 2 years post surgery. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Glaucoma Drainage Device Erosion Following Ptosis Surgery.

PubMed

Bae, Steven S; Campbell, Robert J

2017-09-01

To highlight the potential risk of glaucoma drainage device erosion following ptosis surgery. Case report. A 71-year-old man underwent uncomplicated superotemporal Ahmed glaucoma valve implantation in the left eye in 2008. Approximately 8 years later, the patient underwent bilateral ptosis repair, which successfully raised the upper eyelid position. Three months postoperatively, the patient's glaucoma drainage implant tube eroded through the corneal graft tissue and overlying conjunctiva to become exposed. A graft revision surgery was successfully performed with no further complications. Caution and conservative lid elevation may be warranted when performing ptosis repair in patients with a glaucoma drainage implant, and patients with a glaucoma implant undergoing ptosis surgery should be followed closely for signs of tube erosion.

Composite fibrous glaucoma drainage implant

NASA Astrophysics Data System (ADS)

Klapstova, A.; Horakova, J.; Shynkarenko, A.; Lukas, D.

2017-10-01

Glaucoma is a frequent reason of loss vision. It is usually caused by increased intraocular pressure leading to damage of optic nerve head. This work deals with the development of fibrous structure suitable for glaucoma drainage implants (GDI). Commercially produced metallic glaucoma implants are very effective in lowering intraocular pressure. However, these implants may cause adverse events such as damage to adjacent tissue, fibrosis, hypotony or many others [1]. The aim of this study is to reduce undesirable properties of currently produced drains and improve their properties by creating of the composite fibrous drain for achieve a normal intraocular pressure. Two types of electrospinning technologies were used for the production of very small tubular implants. First type was focused for production of outer part of tubular drain and the second type of electrospinning method made the inner part of shape follows the connections of both parts. Complete implant had a special properties suitable for drainage of fluid. Morphological parameters, liquid transport tests and in-vitro cell adhesion tests were detected.

Serial intracameral visualization of the Ahmed glaucoma valve tube by anterior segment optical coherence tomography.

PubMed

Lopilly Park, H-Y; Jung, K I; Park, C K

2012-09-01

To investigate serial changes of the Ahmed glaucoma valve (AGV) implant tube in the anterior chamber by anterior segment optical coherence tomography (AS-OCT). Patients who had received AGV implantation without complications (n=48) were included in this study. Each patient received follow-up examinations including AS-OCT at days 1 and 2, week 1, and months 1, 3, 6, and 12. Tube parameters were defined to measure its length and position. The intracameral length of the tube was from the tip of the bevel-edged tube to the sclerolimbal junction. The distance between the extremity of the tube and the anterior iris surface (T-I distance), and the angle between the tube and the posterior endothelial surface of the cornea (T-C angle) were defined. Factors that were related to tube parameters were analysed by multiple regression analysis. The mean change in tube length was -0.20 ± 0.17 mm, indicating that the tube length shortened from the initial inserted length. The mean T-I distance change was 0.11 ± 0.07 mm and the mean T-C angle change was -6.7 ± 5.6°. Uveitic glaucoma and glaucoma following penetrating keratoplasty showed the most changes in tube parameters. By multiple regression analysis, diagnosis of glaucoma including uveitic glaucoma (P=0.049) and glaucoma following penetrating keratoplasty (P=0.008) were related to the change of intracameral tube length. These results suggest that the length and position of the AGV tube changes after surgery. The change was prominent in uveitic glaucoma and glaucoma following penetrating keratoplasty.

Surgical Outcomes of Ahmed or Baerveldt Tube Shunt Implantation for medically Uncontrolled Traumatic Glaucoma.

PubMed

Yadgarov, Arkadiy; Liu, Dan; Crane, Elliot S; Khouri, Albert S

2017-01-01

To describe postoperative surgical success of either Ahmed or Baerveldt tube shunt implantation for eyes with medically uncontrolled traumatic glaucoma. A review was carried out to identify patients with traumatic glaucoma that required tube shunt implantation between 2009 and 2015 at Rutgers University in Newark, New Jersey, USA. Seventeen eyes from 17 patients met inclusion criteria, including at least 3-month postoperative follow-up. The main outcome measure was surgical success at 1-year follow-up after tube implantation. Mean preoperative intraocular pressure (IOP) was 34.1 ± 8.2 mm Hg on 3.1 ± 1.6 ocular hypotensive medications. Nine eyes (53%) sustained closed globe injury. Ten eyes (59%) received an Ahmed valve shunt and seven eyes (41%) received a Baerveldt tube shunt. Surgical success rate at 1 year postoperatively was 83%. Compared to preoperative, the mean postoperative IOP was significantly lower (16.1 ± 3.5 mm Hg, p < 0.001) on significantly fewer ocular hypertensive medications (1.3 ± 1.6, p = 0.001) at a mean follow-up of 10 months. Mean IOP reduction at last follow-up was 49%. There were three cases of surgical failures: One case of hypotony, one case of tube extrusion with subsequent explan-tation, and one case requiring second tube insertion for IOP control. Implantation of an Ahmed or Baerveldt tube shunt provided successful control of IOP in patients with medically uncontrollable traumatic glaucoma. Yadgarov A, Liu D, Crane ES, Khouri AS. Surgical Outcomes of Ahmed or Baerveldt Tube Shunt Implantation for medically Uncontrolled Traumatic Glaucoma. J Curr Glaucoma Pract 2017;11(1):16-21.

Flow Test to Predict Early Hypotony and Hypertensive Phase After Ahmed Glaucoma Valve (AGV) Surgical Implantation.

PubMed

Cheng, Jason; Beltran-Agullo, Laura; Buys, Yvonne M; Moss, Edward B; Gonzalez, Johanna; Trope, Graham E

2016-06-01

To assess the validity of a preimplantation flow test to predict early hypotony [intraocular pressure (IOP)≤5 mm Hg on 2 consecutive visits and hypertensive phase (HP) (IOP>21 mm Hg) after Ahmed Glaucoma Valve (AGV) implantation. Prospective interventional study on patients receiving an AGV. A preimplantation flow test using a gravity-driven reservoir and an open manometer was performed on all AGVs. Opening pressure (OP) and closing pressure (CP) were defined as the pressure at which fluid was seen to flow or stop flowing through the AGV, respectively. OP and CP were measured twice per AGV. Patients were followed for 12 weeks. In total, 20 eyes from 19 patients were enrolled. At 12 weeks the mean IOP decreased from 29.2±9.1 to 16.8±5.2 mm Hg (P<0.01). The mean AGV OP was 17.5±5.4 mm Hg and the mean CP was 6.7±2.3 mm Hg. Early (within 2 wk postoperative) HP occurred in 37% and hypotony in 16% of cases. An 18 mm Hg cutoff for the OP gave a sensitivity of 0.71, specificity of 0.83, positive predictive value of 0.71, and negative predictive value of 0.83 for predicting an early HP. A 7 mm Hg cutoff for the CP yielded a sensitivity of 1.0, specificity of 0.38, positive predictive value of 0.23, and negative predictive value of 1.0 for predicting hypotony. Preoperative OP and CP may predict early hypotony or HP and may be used as a guide as to which AGV valves to discard before implantation surgery.

Pericardium Plug in the Repair of the Corneoscleral Fistula After Ahmed Glaucoma Valve Explantation

PubMed Central

Yoo, Chungkwon; Kwon, Sung Wook

2008-01-01

We report four cases in which a pericardium (Tutoplast®) plug was used to repair a corneoscleral fistula after Ahmed Glaucoma Valve (AGV) explantation. In four cases in which the AGV tube had been exposed, AGV explantation was performed using a pericardium (Tutoplast®) plug to seal the defect previously occupied by the tube. After debridement of the fistula, a piece of processed pericardium (Tutoplast®), measured 1 mm in width, was plugged into the fistula and secured with two interrupted 10-0 nylon sutures. To control intraocular pressure, a new AGV was implanted elsewhere in case 1, phaco-trabeculectomy was performed concurrently in case 2, cyclophotocoagulation was performed postoperatively in case 3 and anti-glaucomatous medication was added in case 4. No complication related to the fistula developed at the latest follow-up (range: 12~26 months). The pericardium (Tutoplast®) plug seems to be an effective method in the repair of corneoscleral fistulas resulting from explantation of glaucoma drainage implants. PMID:19096247

Combined Glaucoma Tube Shunt (Ahmed) and Fluocinolone Acetonide (Retisert™) Implantation Compared to Ahmed Alone in Uveitic Glaucoma.

PubMed

Zivney, Mark; Lin, Phoebe; Edmunds, Beth; Parikh, Mansi; Takusagawa, Hana; Tehrani, Shandiz

2016-12-01

Glaucoma is a known complication of uveitis, and may require glaucoma tube shunt implantation for intraocular pressure (IOP) control. The success of glaucoma tube shunt implantation in the setting of a local ocular steroid depot in uveitic glaucoma remains unknown. The purpose of this study was to determine whether patients who underwent combined glaucoma tube shunt (Ahmed) and fluocinolone acetonide (Retisert™, Bausch + Lomb, Bridgewater, NJ, USA) implantation have superior outcomes compared to patients with Ahmed implants only in the setting of uveitic glaucoma. All participants were studied retrospectively and underwent Ahmed implantation alone or with existing/concurrent Retisert implantation (combined group) at a single academic institution. The main outcome measures were IOP, visual acuity (VA), number of IOP-lowering medications, and adverse events at 6 months after Ahmed implantation. Secondary outcome measures included adverse events and surgical success at 6 months after Ahmed implantation. Mean IOP at 6 months after Ahmed implantation was 15.3 ± 4.8 and 15.1 ± 4.9 mm Hg in the Ahmed only group (n = 17) and the combined group (n = 17), respectively (p = 0.89). The mean number of IOP-lowering medications at 6 months after Ahmed implantation was 1.7 ± 1.0 and 1.8 ± 1.0 in the Ahmed only group and the combined group, respectively (p = 0.86). Mean VA at 6 months after Ahmed implantation was 0.35 ± 0.29 and 0.42 ± 0.33 log mean angle of resolution in the Ahmed only group and the combined group, respectively (p = 0.50). No significant differences in surgical success or adverse events were noted between the two groups. At 6 months, no significant differences in mean IOP, mean number of IOP-lowering medications, VA, surgical success, or adverse events were noted between Ahmed implantation alone or combined Ahmed and Retisert implantation in patients with uveitic glaucoma.

The Ex-PRESS Glaucoma Filtration Device Implantation in Uveitic Glaucoma.

PubMed

Dhanireddy, Swetha; Kombo, Ninani C; Payal, Abhishek R; Freitas-Neto, Clovis Arcoverde; Preble, Janine; Foster, C Stephen

2017-12-01

To evaluate the outcomes of the Ex-PRESS Filtration Device in patients with uveitic glaucoma. We reviewed 23 eyes, comparing control simple glaucoma patients (n = 11) to uveitic glaucoma patients (n = 12). Intraocular pressure (IOP) and glaucoma medications at the preoperative examination were compared with those at the 6-month and 10-14-month postoperative examination. Surgical success was defined as ≥25% decrease in intraocular pressure without hypotony, and/or decrease in glaucoma medications at 6 months follow-up. Statistically significant reduction in mean IOP from preoperative levels occurred in both groups at 6 months follow-up (p<0.0001) and 10-14 months follow-up (p = 0.0007) and in the mean number of medications in the uveitic glaucoma (UG) group (p = 0.0313). Surgical success was seen in 10 eyes in the control group (90.9%) and nine eyes (75%) in the UG group (p = 0.314). Ex-PRESS implantation is an effective surgical intervention for the management of uveitic glaucoma.

Starflo glaucoma implant: early experience in Hungary

PubMed Central

István, Cseke; Péter, Vámosi; Mária, Bausz

2016-01-01

Aim: To present the early experience with the implantation technique, safety and efficiency of STARflo™ device for open angle glaucoma (OAG). Methods: referring intra- and postoperative clinical experience with a series of seven cases in three glaucoma centers in Hungary. Results: No intraoperative complications were observed. Postoperative inflammatory signs disappeared rapidly. The mean IOP reduction was from 27,6 ± 5,0 mmHg to 18,9±3,4 mmHg (32% reduction/ patient) at six months postoperatively. Conclusion: STARflo™ implant was safe and (except for one case with neovascular glaucoma) effective in our cases. The learning curve for experienced anterior segment surgeons was short. PMID:27220226

Pirfenidone inhibits fibrosis in foreign body reaction after glaucoma drainage device implantation

PubMed Central

Jung, Kyoung In; Park, Chan Kee

2016-01-01

Background The aim of this study was to investigate the antiscarring effects of pirfenidone on foreign body reaction in a rabbit model of glaucoma drainage implant surgery. Methods Adult New Zealand White rabbits had glaucoma drainage device implantation using Model FP8 Ahmed glaucoma valves. One eye was randomly assigned to receive postoperative intrableb injection of pirfenidone followed by topical treatment. The other eye underwent the same procedure but without the addition of pirfenidone. Histochemical staining and immunohistochemistry for blebs were performed. Results The degree of cellularity was smaller in the pirfenidone group than in the control group at 2 weeks post operation (P=0.005). A few foreign body giant cells were detected in the inner border of the capsule, and their numbers were similar in the control and pirfenidone groups (P>0.05). Using Masson’s trichrome stain, the inner collagen-rich layer was found to be thinner in the pirfenidone group than the control group at 4 weeks (P=0.031) and 8 weeks (P=0.022) post operation. The percentage of proliferating cell nuclear antigen-positive cells was lower in the pirfenidone group than in the control group at 2 weeks post operation (total bleb, P=0.022; inner bleb, P=0.036). Pirfenidone treatment decreased the immunoreactivity of connective tissue growth factor at 2 weeks post operation (total bleb, P=0.029; inner bleb, P=0.018). The height and area of α-smooth muscle actin expression were lower in the pirfenidone group than the control group at 2 weeks, 4 weeks, and 8 weeks post operation (all P<0.05). Conclusion Postoperative intrableb injection of pirfenidone followed by topical administration reduced fibrosis following glaucoma drainage device implantation. These findings suggest that pirfenidone may function as an antiscarring treatment in foreign body reaction after tube-shunt surgery. PMID:27143855

Pirfenidone inhibits fibrosis in foreign body reaction after glaucoma drainage device implantation.

PubMed

Jung, Kyoung In; Park, Chan Kee

2016-01-01

The aim of this study was to investigate the antiscarring effects of pirfenidone on foreign body reaction in a rabbit model of glaucoma drainage implant surgery. Adult New Zealand White rabbits had glaucoma drainage device implantation using Model FP8 Ahmed glaucoma valves. One eye was randomly assigned to receive postoperative intrableb injection of pirfenidone followed by topical treatment. The other eye underwent the same procedure but without the addition of pirfenidone. Histochemical staining and immunohistochemistry for blebs were performed. The degree of cellularity was smaller in the pirfenidone group than in the control group at 2 weeks post operation (P=0.005). A few foreign body giant cells were detected in the inner border of the capsule, and their numbers were similar in the control and pirfenidone groups (P>0.05). Using Masson's trichrome stain, the inner collagen-rich layer was found to be thinner in the pirfenidone group than the control group at 4 weeks (P=0.031) and 8 weeks (P=0.022) post operation. The percentage of proliferating cell nuclear antigen-positive cells was lower in the pirfenidone group than in the control group at 2 weeks post operation (total bleb, P=0.022; inner bleb, P=0.036). Pirfenidone treatment decreased the immunoreactivity of connective tissue growth factor at 2 weeks post operation (total bleb, P=0.029; inner bleb, P=0.018). The height and area of α-smooth muscle actin expression were lower in the pirfenidone group than the control group at 2 weeks, 4 weeks, and 8 weeks post operation (all P<0.05). Postoperative intrableb injection of pirfenidone followed by topical administration reduced fibrosis following glaucoma drainage device implantation. These findings suggest that pirfenidone may function as an antiscarring treatment in foreign body reaction after tube-shunt surgery.

XEN Gel Implant: a new surgical approach in glaucoma.

PubMed

Chaudhary, Ankita; Salinas, Lauriane; Guidotti, Jacopo; Mermoud, André; Mansouri, Kaweh

2018-01-01

Glaucoma is a leading cause of blindness worldwide. Intraocular pressure (IOP) lowering is the only effective treatment strategy. Traditional glaucoma surgeries are generally considered to be unpredictable and associated with a high rate of complications. This has led to the development of a novel XEN Gel Implant, a type of minimally invasive glaucoma surgery (MIGS), lowering the IOP without extensive surgical dissection. Areas covered: A literature search was undertaken on PubMed using the terms XEN glaucoma, gelatin microstent, and MIGS. All the articles and case reports on XEN Gel Implant and selected articles on MIGS were studied and reviewed. We have discussed the results of most studies on XEN Gel Implant related to its efficacy, safety and success. Expert commentary: The XEN Gel Implant effectively lowers IOP and medication use, with a favorable safety profile. Long-term data on its success and cost-effectiveness are lacking. The studies have shown it to be without any serious adverse events and to have good safety profile encouraging future research on this novel implant. There is a need to correctly identify selection criteria for patients, who would benefit the most from the XEN Gel Implant.

Glaucoma Mini-Shunt Implantation After Keratoplasty.

PubMed

Ledesma-Gil, Jasbeth; García-Rodríguez, María de Los Ángeles; Gurria, Lulu U; Graue-Hernández, Enrique O; Navas, Alejandro

2017-04-01

To report the outcomes of patients who underwent miniature glaucoma shunt implantation after secondary glaucoma due to keratoplasty. Prospective study of consecutive clinical cases who underwent mini-glaucoma shunt implantation following keratoplasty. In brief, a fornix-based conjunctival flap was performed, approximately 50% thickness scleral flap. Mitomycin C 0.025% placed under Tenon's capsule. A 25-G needle created entry for mini-shunt. Ex-PRESS model P-50 was inserted. Scleral flap and conjunctiva were closed with 10-0 Nylon. STATA 8.0 and SPSS software were used for statistical analysis. Seventeen eyes of 17 patients with a mean age of 39.70 years (SD=18.33, range: 18 to 76). A total of 64.70% were male and 35.30% female. Eleven cases after penetrating keratoplasty, 3 cases after triple procedure, 2 after deep anterior lamellar keratoplasty, and 1 following endothelial keratoplasty. Most of the indications for keratoplasty were keratoconus in 9 cases (52.94%), 4 due to endothelial failure (23.52%), 3 cases of herpetic keratitis (17.64%), and 1 case of post-LASIK ectasia (5.88%). Mean preoperative intraocular pressure was 35.94 mm Hg with maximal medical therapy (SD=9.65, range: 18 to 55). Decreasing intraocular pressure to 12.76 mm Hg postoperatively (SD=2.51, range 10 to 18) (P=0.001). Mean follow-up after mini-glaucoma shunt implantation was 23.76 months (SD=8.73, range: 10 to 35 mo). Preoperative mean uncorrected distance visual acuity (UDVA) was 1.31±0.63 (20/408 Snellen) and postoperative mean UDVA was 0.85±0.40 (20/141 Snellen) (P=0.001). Preoperative mean corrected distance visual acuity (CDVA) was 0.83±0.76 (20/135 Snellen) and postoperative mean CDVA was 0.56±0.44 (20/72 Snellen) (P=0.032). Ex-PRESS miniature glaucoma shunt could be an alternative treatment in postkeratoplasty glaucoma resistant to medical treatment. This technique may be helpful, in trying to avoid corneal damage produced by conventional glaucoma procedures.

Implants for draining neovascular glaucoma.

PubMed Central

Molteno, A C; Van Rooyen, M M; Bartholomew, R S

1977-01-01

The implant design, surgical technique, and pharmacological methods of controlling bleb fibrosis, used to treat neovascular glaucoma, are described, together with the results of 14 operations performed on 12 eyes. Images PMID:843508

Sequential transcatheter aortic valve implantation due to valve dislodgement - a Portico valve implanted over a CoreValve bioprosthesis.

PubMed

Campante Teles, Rui; Costa, Cátia; Almeida, Manuel; Brito, João; Sondergaard, Lars; Neves, José P; Abecasis, João; M Gabriel, Henrique

2017-03-01

Transcatheter aortic valve implantation (TAVI) has become an important treatment in high surgical risk patients with severe aortic stenosis (AS), whose complications need to be managed promptly. The authors report the case of an 86-year-old woman presenting with severe symptomatic AS, rejected for surgery due to advanced age and comorbidities. The patient underwent a first TAVI, with implantation of a Medtronic CoreValve ® , which became dislodged and migrated to the ascending aorta. Due to the previous balloon valvuloplasty, the patient's AS became moderate, and her symptoms improved. After several months, she required another intervention, performed with a St. Jude Portico ® repositionable self-expanding transcatheter aortic valve. There was a good clinical response that was maintained at one-year follow-up. The use of a self-expanding transcatheter bioprosthesis with repositioning features is a solution in cases of valve dislocation to avoid suboptimal positioning of a second implant, especially when the two valves have to be positioned overlapping or partially overlapping each other. Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

Valve thrombosis following transcatheter aortic valve implantation: a systematic review.

PubMed

Córdoba-Soriano, Juan G; Puri, Rishi; Amat-Santos, Ignacio; Ribeiro, Henrique B; Abdul-Jawad Altisent, Omar; del Trigo, María; Paradis, Jean-Michel; Dumont, Eric; Urena, Marina; Rodés-Cabau, Josep

2015-03-01

Despite the rapid global uptake of transcatheter aortic valve implantation, valve trombosis has yet to be systematically evaluated in this field. The aim of this study was to determine the clinical characteristics, diagnostic criteria, and treatment outcomes of patients diagnosed with valve thrombosis following transcatheter aortic valve implantation through a systematic review of published data. Literature published between 2002 and 2012 on valve thrombosis as a complication of transcatheter aortic valve implantation was identified through a systematic electronic search. A total of 11 publications were identified, describing 16 patients (mean age, 80 [5] years, 65% men). All but 1 patient (94%) received a balloon-expandable valve. All patients received dual antiplatelet therapy immediately following the procedure and continued to take either mono- or dual antiplatelet therapy at the time of valve thrombosis diagnosis. Valve thrombosis was diagnosed at a median of 6 months post-procedure, with progressive dyspnea being the most common symptom. A significant increase in transvalvular gradient (from 10 [4] to 40 [12] mmHg) was the most common echocardiographic feature, in addition to leaflet thickening. Thrombus was not directly visualized with echocardiography. Three patients underwent valve explantation, and the remaining received warfarin, which effectively restored the mean transvalvular gradient to baseline within 2 months. Systemic embolism was not a feature of valve thrombosis post-transcatheter aortic valve implantation. Although a rare, yet likely under-reported complication of post-transcatheter aortic valve implantation, progressive dyspnea coupled with an increasing transvalvular gradient on echocardiography within the months following the intervention likely signifies valve thrombosis. While direct thrombus visualization appears difficult, prompt initiation of oral anticoagulation therapy effectively restores baseline valve function. Copyright © 2014

Clinical outcomes of Ahmed glaucoma valve in anterior chamber versus ciliary sulcus.

PubMed

Bayer, A; Önol, M

2017-04-01

PurposeTo evaluate the outcomes of Ahmed glaucoma valve (AGV) tube insertion through the anterior chamber angle (ACA) or through the ciliary sulcus (CS).Patients and methodsIn this case-control study, we retrospectively reviewed the charts of consecutive glaucoma patients who had undergone AGV implantation either through the ACA or the CS between March 2009 and December 2014. The main outcome measures were intraocular pressure (IOP), number of glaucoma medications prescribed, best corrected visual acuity (BCVA), glaucoma type, success rate, complications, and survival ratios. Statistical analysis was carried out using SPSS.ResultsThere were 68 eyes in the ACA group and 35 eyes in the CS group. There were no significant differences between the groups for age, sex, laterality, IOP, preoperative glaucoma medication number, BCVA or glaucoma type (P>0.05). The postoperative follow-up period was 27.2±16.5 months and 30.2±17.7 months for the ACA and the CS groups (P=0.28); IOP values were significantly reduced at the last visit to 16.4±7.2 mm Hg and 14.4±6.8 mm Hg. The difference in the last-visit IOP between the groups was not significant (P=0.06), but the IOP reduction ratio was higher in the CS group (P=0.03). There was no significant difference in the number of postoperative medications (P=0.18). Postoperative complications were similar, but the incidence of flat anterior chamber was higher in the ACA group (P=0.05).ConclusionsThe use of an AGV can control IOP in the majority of cases whether placed in the ACA or the CS. The IOP reduction ratio seemed to be higher in the CS group.

Clinical outcomes of Ahmed glaucoma valve in anterior chamber versus ciliary sulcus

PubMed Central

Bayer, A; Önol, M

2017-01-01

Purpose To evaluate the outcomes of Ahmed glaucoma valve (AGV) tube insertion through the anterior chamber angle (ACA) or through the ciliary sulcus (CS). Patients and methods In this case-control study, we retrospectively reviewed the charts of consecutive glaucoma patients who had undergone AGV implantation either through the ACA or the CS between March 2009 and December 2014. The main outcome measures were intraocular pressure (IOP), number of glaucoma medications prescribed, best corrected visual acuity (BCVA), glaucoma type, success rate, complications, and survival ratios. Statistical analysis was carried out using SPSS. Results There were 68 eyes in the ACA group and 35 eyes in the CS group. There were no significant differences between the groups for age, sex, laterality, IOP, preoperative glaucoma medication number, BCVA or glaucoma type (P>0.05). The postoperative follow-up period was 27.2±16.5 months and 30.2±17.7 months for the ACA and the CS groups (P=0.28); IOP values were significantly reduced at the last visit to 16.4±7.2 mm Hg and 14.4±6.8 mm Hg. The difference in the last-visit IOP between the groups was not significant (P=0.06), but the IOP reduction ratio was higher in the CS group (P=0.03). There was no significant difference in the number of postoperative medications (P=0.18). Postoperative complications were similar, but the incidence of flat anterior chamber was higher in the ACA group (P=0.05). Conclusions The use of an AGV can control IOP in the majority of cases whether placed in the ACA or the CS. The IOP reduction ratio seemed to be higher in the CS group. PMID:27983734

Pars plana Ahmed valve and vitrectomy in patients with glaucoma associated with posterior segment disease.

PubMed

Wallsh, Josh O; Gallemore, Ron P; Taban, Mehran; Hu, Charles; Sharareh, Behnam

2013-01-01

To assess the safety and efficacy of a modified technique for pars plana placement of the Ahmed valve in combination with pars plana vitrectomy in the treatment of glaucoma associated with posterior segment disease. Thirty-nine eyes with glaucoma associated with posterior segment disease underwent pars plana vitrectomy combined with Ahmed valve placement. All valves were placed in the pars plana using a modified technique, without the pars plana clip, and using a scleral patch graft. The 24 eyes diagnosed with neovascular glaucoma had an improvement in intraocular pressure from 37.6 mmHg to 13.8 mmHg and best-corrected visual acuity from 2.13 logarithm of minimum angle of resolution to 1.40 logarithm of minimum angle of resolution. Fifteen eyes diagnosed with steroid-induced glaucoma had an improvement in intraocular pressure from 27.9 mmHg to 14.1 mmHg and best-corrected visual acuity from 1.38 logarithm of minimum angle of resolution to 1.13 logarithm of minimum angle of resolution. Complications included four cases of cystic bleb formation and one case of choroidal detachment and explantation for hypotony. Ahmed valve placement through the pars plana during vitrectomy is an effective option for managing complex cases of glaucoma without the use of the pars plana clip.

Transcatheter aortic valve-in-valve implantation of a CoreValve in a JenaValve prosthesis: a case report.

PubMed

Lotfi, Shahram; Becker, Michael; Moza, Ajay; Autschbach, Rüdiger; Marx, Nikolaus; Schröder, Jörg

2017-09-10

Transcatheter aortic valve implantation has become an accepted treatment modality for inoperable or high-risk surgical patients with symptomatic severe aortic stenosis. We report the case of a 70-year-old white man who was treated for severe symptomatic aortic regurgitation using transcatheter aortic valve implantation from the apical approach. Because of recurrent cardiac decompensation 4 weeks after implantation he underwent the implantation of a left ventricular assist device system. A year later echocardiography showed a severe transvalvular central insufficiency. Our heart team decided to choose a valve-in-valve approach while reducing the flow rate of left ventricular assist device to minimum and pacing with a frequency of 140 beats/minute. There was an excellent result and our patient is doing well with no relevant insufficiency of the aortic valve at 12-month follow-up. This is the first report about a successful treatment of a stenotic JenaValve using a CoreValve Evolut R; the use of a CoreValve Evolut R prosthesis may be an optimal option for valve-in-valve procedures.

Remote actuated valve implant

DOE Office of Scientific and Technical Information (OSTI.GOV)

McKnight, Timothy E.; Johnson, Anthony; Moise, Kenneth J.

Valve implant systems positionable within a flow passage, the systems having an inlet, an outlet, and a remotely activatable valve between the inlet and outlet, with the valves being operable to provide intermittent occlusion of the flow path. A remote field is applied to provide thermal or magnetic activation of the valves.

Reversible Venting Stitch for Fenestrating Valve-less Glaucoma Shunts.

PubMed

Akil, Handan; Vu, Priscilla Q; Nguyen, Anhtuan H; Nugent, Alexander; Chopra, Vikas; Francis, Brian A; Tan, James C

2017-12-01

The purpose of this is to describe a venting stitch modification for valveless glaucoma aqueous shunts and characterize early postoperative intraocular pressure (IOP) and glaucoma medication use following the modification. Retrospective chart review of 61 sequential patients undergoing Baerveldt glaucoma implant (BGI)-350 implantation at the Doheny Eye Institute. Twenty-four patients received a glaucoma shunt with venting stitch modification (modified BGI) and 37 patients received an unmodified shunt (BGI-only). IOP, number of glaucoma medications, and number of hypotony cases (intraocular pressure ≤5 mm Hg) were compared between the groups. T-tests were used for statistical analysis. At postoperative-day 1, mean IOP was significantly lower compared with preoperatively in the modified BGI group (14 mm Hg; reduced by 51%; P<0.0001) but not the BGI-only group (27 mm Hg; P=0.06). IOP difference between groups persisted till immediately before tube opening (P=0.005) and fewer IOP-lowering medications needed in the modified BGI group (P<0.0001). One case (4.2%) of postoperative hypotony was encountered with BGI modification, which resolved after the stitch was removed in clinic. The venting stitch valveless shunt modification allows for effective, reliable, and safe control of early postoperative IOP.

[Postoperative Follow-Up of Glaucoma Drainage Devices].

PubMed

Dietlein, T S; Neugebauer, A; Fricke, J; Lappas, A; Rosentreter, A

2016-05-01

There is an increasing trend towards using glaucoma drainage implants. The postoperative management of such devices depends on their technical characteristics and specific complications. The Baerveldt glaucoma implant with its larger surface area has been shown to lower mean intraocular pressure more effectively than the Ahmed-FP7 implant. As a non-valve implant, however, it has been associated with a higher rate of severe complications, particularly ocular hypotension. Moreover, glaucoma implants may induce diplopia if they interfere with extraocular muscles. Topical treatment with antibiotics and steroids is necessary in cases of intraocular inflammation. In refractory cases, the tube may even have to be removed. Surgical reposition of the tube may be indicated when it is severely dislocated. Increased intraocular pressure is primarily treated by pressure-lowering medications during postoperative follow-up. If topical glaucoma medication is insufficient to control increases in intraocular pressure due to encapsulation, a second implant may be considered or the capsule surrounding the implant may be excised to reduce outflow resistance or additional cyclodestructive procedures can be performed. Chronic hypotension may be treated with tube ligation or occlusion. Severe corneal oedema may require lamellar keratoplasty. Conjunctival erosions with tube exposure or tube retractions also require surgical correction. Georg Thieme Verlag KG Stuttgart · New York.

Ahmed Versus Baerveldt Glaucoma Drainage Implantation in Patients With Markedly Elevated Intraocular Pressure (≥30 mm Hg).

PubMed

Resende, Arthur F; Moster, Marlene R; Patel, Neal S; Lee, Daniel; Dhami, Hermandeep; Pro, Michael J; Waisbourd, Michael

2016-09-01

Glaucoma patients with markedly elevated intraocular pressure (IOP) are at risk for developing severe hypotony-related complications. The goal of this study was to compare the surgical outcomes of the Ahmed Glaucoma Valve (AGV) and the Baerveldt Glaucoma Implant (BGI) in this patient population. Patients with preoperative IOP≥30 mm Hg were included. Outcome measures were: (1) surgical failure (IOP>21 mm Hg or <30% reduction from baseline or IOP≤5 mm Hg on 2 consecutive follow-up visits after 3 mo, or additional glaucoma surgery, or loss of light perception) and (2) surgical complications. A total of 75 patients were included: 37 in the AGV group and 38 in the BGI group. The mean±SD follow-up was 2.3±1.6 years for the AGV group and 2.4±1.7 years for the BGI group (P=0.643). Mean preoperative IOP was 38.7±6.5 mm Hg for the AGV group and 40.8±7.6 mm Hg for the BGI group. At the last follow-up, 10 (27.0%) patients failed in the AGV group compared with 6 (15.8%) patients in the BGI group (P=0.379). The BGI group had higher rate of flat or shallow anterior chamber (n=4, 10%) compared with the AGV group (n=0, 0%) (P=0.043). Failure rates of AGV and BGI in patients with IOP≥30 mm Hg were comparable. There were more early hypotony-related complications in the BGI group; however, none were vision threatening. Both glaucoma drainage implants were effective in treating patients with uncontrolled glaucoma in an emergency setting.

Implantation of a second glaucoma drainage device.

PubMed

Francis, Brian A; Fernandes, Rodrigo A B; Akil, Handan; Chopra, Vikas; Diniz, Bruno; Tan, James; Huang, Alex

2017-05-01

To evaluate success rates in controlling intraocular pressure (IOP) after implantation of a second glaucoma drainage device (GDD) with a Baerveldt glaucoma implant in patients with refractory glaucoma, with a secondary aim of reducing the need for postoperative glaucoma medications. This retrospective, noncomparative, interventional study included patients undergoing a second GDD for uncontrolled glaucoma from a tertiary care glaucoma service. Data were obtained from the medical records for the preoperative period and after the 1st, 15th, and 30th day, 3, 6, and 12 months, and then yearly until the last postoperative visit. Visual acuity, IOP, and number of glaucoma medications (NGM) from the follow-up visits were compared to baseline. Success and failure criteria were analyzed based on IOP level or need of glaucoma medications. Forty-nine patients were studied, with a mean follow-up time of 25 ± 21 months. The mean preoperative IOP was 23.7 ± 8.2 mmHg, and decreased to 14.8 ± 4.0 mmHg after 1 year, 14.4 ± 3.9 mmHg after 2 years, and 16.6 ± 8.5 mmHg after 3 years. The mean preoperative NGM was 3.4 ± 1.3, and decreased to 2.0 ± 1.8 after 1 year, 2.5 ± 1.6 after 2 years, and 2.8 ± 2.0 after 3 years. Absolute success was 9% after 1 year for a postoperative IOP between 5 and 18 mmHg, and 76% for a postoperative IOP between 5 and 21 mmHg. The qualified success was 88% at the first and second years and 83% at the third year. With up to 3 years of follow-up, a second glaucoma drainage device was successful in reducing IOP to below 21 mmHg, but not as successful below 18 mmHg. The success rate is improved with the use of glaucoma medications with up to 3 years of follow-up.

Spontaneous extrusion of a stainless steel glaucoma drainage implant (Ex-PRESS).

PubMed

Tavolato, M; Babighian, S; Galan, A

2006-01-01

To report a case of spontaneous extrusion of a stainless steel glaucoma drainage implant (Ex-PRESS). An Ex-PRESS was implanted under the conjunctiva in a 76-year-old man with primary open-angle glaucoma. Two years after implantation, the Ex-Press extruded spontaneously. Despite this adverse event, there was no increase in intraocular pressure. This is the first report of spontaneous extrusion of an Ex-PRESS device. Implanting the device under a scleral flap should be considered to avoid adverse events such as extrusion or conjunctival erosion.

Transfemoral aortic valve implantation in severe aortic stenosis patients with prior mitral valve prosthesis

PubMed Central

Sarı, Cenk; Baştuğ, Serdal; Kasapkara, Hacı Ahmet; Durmaz, Tahir; Keleş, Telat; Akçay, Murat; Aslan, Abdullah Nabi; Bayram, Nihal Akar; Bozkurt, Engin

2015-01-01

Introduction Transcatheter aortic valve implantation for severe symptomatic aortic stenosis in patients with a previous mitral valve prosthesis is technically challenging, and pre-procedural comprehensive assessment of these patients before transcatheter aortic valve implantation is vital for an uncomplicated and successful procedure. Aim We want to share our experience with transcatheter aortic valve implantation in patients with a preexisting functional mitral valve prosthesis and describe a series of important technical and pre-procedural details. Material and methods At our center, 135 patients with symptomatic severe aortic stenosis were treated with transcatheter aortic valve implantation. Six of them with a preexisting mitral valve prosthesis received an Edwards SAPIEN XT valve through the transfemoral route. Results Transcatheter aortic valve implantation was performed successfully in all 6 patients without any deformation of the cobalt-chromium/steel stents of the aortic valve bioprosthesis. Also no distortion or malfunction in the mitral valve prosthesis was observed after the procedure. There were no complications during the hospitalization period. Post-procedural echocardiography revealed no or mild aortic paravalvular regurgitation and normal valve function in all the patients. In addition, serial echocardiographic examination demonstrated that both the stability and function of the aortic and mitral prosthetic valves were normal without any deterioration in the gradients and the degree of the regurgitation at long-term follow-ups. Conclusions Our experience confirms that transcatheter aortic valve implantation is technically feasible in patients with previous mitral valve replacement but comprehensive evaluation of patients by multimodal imaging techniques such as transesophageal echocardiography and multislice computed tomography is mandatory for a successful and safe procedure. PMID:26677380

Schockmed Valve: A Novel Surgical Option for Uncontrolled Glaucoma in Eyes with Poor Conjunctiva and Encircling Bands.

PubMed

Fleischman, David; Kim, Bryan

2017-01-01

Surgical management of elevated intraocular pressure (IOP) in an eye with scarred conjunctiva, an encircling band, and silicone oil has limited options. By combining the flow restrictor of the Ahmed Glaucoma Valve (New World Medical, Rancho Cucamonga, California) and the capsule of the encircling band as a conduit for aqueous flow, immediate pressure reduction could theoretically be achieved in eyes with limited conjunctival mobilization. This is a description of a surgical technique in a case of a patient with multiple ocular surgeries with uncontrolled multimechanism glaucoma despite using all available topical and oral glaucoma medications. A combination of the Ahmed valve with a modification of the Schocket shunt technique was used in this case of an encircling band and poor conjunctiva. At 10-month follow-up, the patient maintains controlled pressures on dorzolamide-timolol drops. The combined Ahmed-Schocket (or Schockmed) technique may be another surgical option for management of uncontrolled IOP in cases of scarred conjunctiva and encircling bands needing immediate pressure reduction. A novel surgical option for uncontrolled glaucoma in eyes with poor conjunctiva and encircling bands. How to cite this article: Fleischman D, Kim B. Schockmed Valve: A Novel Surgical Option for Uncontrolled Glaucoma in Eyes with Poor Conjunctiva and Encircling Bands. J Curr Glaucoma Pract 2017;11(3):120-124.

Short- to long-term results of Ahmed glaucoma valve in the management of elevated intraocular pressure in patients with pediatric uveitis.

PubMed

Eksioglu, Umit; Yakin, Mehmet; Sungur, Gulten; Satana, Banu; Demirok, Gulizar; Balta, Ozgur; Ornek, Firdevs

2017-06-01

The aim of this study was to evaluate the long-term outcome of Ahmed glaucoma valve (AGV) implant for elevated intraocular pressure (IOP) in pediatric patients with uveitis. This was a retrospective chart review. The study included 16 eyes (11 children) with uveitis. Success was defined as having IOP between 6 and 21 mm Hg with (qualified success) or without (complete success) antiglaucoma medications and without the need for further glaucoma or tube extraction surgery. Mean age of patients at the time of AGV implantation was 14.19 ± 3.25 years. AGV implantation was the first glaucoma surgical procedure in 12 eyes (75%). Average postoperative follow-up period was 64.46 ± 33.56 months. Mean preoperative IOP was 33.50 ± 7.30 mm Hg versus 12.69 ± 3.20 mm Hg at the last follow-up visit (p < 0.001). Three eyes (18.7%) were determined as cases of "failure" because of tube removal in 2 eyes and a second AGV implantation in 1 eye. The cumulative probability of complete success was 68.8% at 6 months, 56.3% at 12 months, 49.2% at 36 months, 42.2% at 48 months, and 35.2% at 84 months, and the cumulative probability of eyes without complication was 75.0% at 6 months, 66.7% at 24 months, 58.3% at 36 months, 48.6% at 48 months and 24.3% at 108 months based on Kaplan-Meier survival analysis. Although AGV implant is an effective choice in the management of elevated IOP in pediatric uveitis, antiglaucoma medications are frequently needed for control of IOP. Tube exposure is an important complication in the long term. Differential diagnosis between relapse of uveitis and endophthalmitis is important in patients who received AGV implantation. Copyright © 2017 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Combined Phacoemulsification and Ahmed Glaucoma Drainage Implant Surgery for Patients With Refractory Glaucoma and Cataract.

PubMed

Valenzuela, Felipe; Browne, Andrew; Srur, Miguel; Nieme, Carlos; Zanolli, Mario; López-Solís, Remigio; Traipe, Leonidas

2016-02-01

To examine the indications, safety, efficacy, and complications of combined phacoemulsification and Ahmed glaucoma drainage implant surgery. A retrospective case review of 35 eyes (31 patients) subjected to combined phacoemulsification and Ahmed glaucoma drainage implant surgery. Demographic characteristics of the study population, indications for combined surgery, and operative and postoperative complications were recorded. Visual acuity, intraocular pressure (IOP), and number of glaucoma medications were evaluated preoperatively and postoperatively. Complete success was defined as IOP ≤ 21 mm Hg without medication, qualified success if IOP ≤ 21 mm Hg with ≥ 1 medications, and failure if IOP>21 mm Hg or ≤ 5 mm Hg on ≥ 2 consecutive visits. Mean follow-up was 29.5 months (range, 6 to 87 mo). The most common indication for combined surgery was a history of prior failed trabeculectomy (60%). Postoperative visual acuity improved in 30 of 35 eyes (85%) (P<0.01) regardless of the indication for combined surgery. IOP was reduced from a mean of 24.7 to 15.0 mm Hg at the last follow-up visit (P<0.01). The number of IOP-lowering medications was reduced from a median of 3.1 preoperatively to 1.7 at the last follow-up (P<0.01). Overall, there were 31 eyes (89%) classified as qualified success and 4 eyes (11%) as complete success. The most common postoperative complication was a hypertensive phase in 18 eyes (51%). Combined phacoemulsification and Ahmed glaucoma drainage implant surgery seems to be a safe and effective surgical option, providing good visual rehabilitation and control of IOP for patients with refractory glaucoma and cataract.

Polypropylene vs silicone Ahmed valve with adjunctive mitomycin C in paediatric age group: a prospective controlled study

PubMed Central

El Sayed, Y; Awadein, A

2013-01-01

Purpose To compare the results of silicone and polypropylene Ahmed glaucoma valves (AGV) implanted during the first 10 years of life. Methods A prospective study was performed on 50 eyes of 33 patients with paediatric glaucoma. Eyes were matched to either polypropylene or silicone AGV. In eyes with bilateral glaucoma, one eye was implanted with polypropylene and the other eye was implanted with silicone AGV. Results Fifty eyes of 33 children were reviewed. Twenty five eyes received a polypropylene valve, and 25 eyes received a silicone valve. Eyes implanted with silicone valves achieved a significantly lower intraocular pressure (IOP) compared with the polypropylene group at 6 months, 1 year, and 2 years postoperatively. The average survival time was significantly longer (P=0.001 by the log-rank test) for the silicone group than for the polypropylene group and the cumulative probability of survival by the log-rank test at the end of the second year was 80% (SE: 8.0, 95% confidence interval (CI): 64–96%) in the silicone group and 56% (SE: 9.8, 95% CI: 40–90%) in the polypropylene group. The difference in the number of postoperative interventions and complications between both groups was statistically insignificant. Conclusion Silicone AGVs can achieve better IOP control, and longer survival with less antiglaucoma drops compared with polypropylene valves in children younger than 10 years. PMID:23579403

[Late endophthalmitis following Ahmed valve].

PubMed

del-Hierro-Zarzuelo, A; Vico-Ruiz, E; Martínez-de-la-Casa, J M; García-Feijoó, J; Castillo-Martín, A; García-Sánchez, J

2005-11-01

A 71-year-old woman with a history of aphakic glaucoma underwent implantation of an Ahmed valve and scleral grafting in her right eye. Postoperative visual acuity was 0.5 and intraocular pressure was 12 mmHg during treatment with brimonidine tartrate (0.2%). Nine months after implantation she suffered a conjunctival infection which was treated with hygienic measures and topical antibiotic therapy. Four days later, she developed an endophthalmitis which was treated with topical, intravitreous and intravenous vancomycin and ceftazidime. The Ahmed drainage implant was replaced at 72 hours. Laboratory culture yielded Haemophilus influenzae. Four days later, the eye was enucleated. Endophthalmitis is an uncommon complication of glaucoma drainage implant surgery. Exposure of the drainage tube represents the greatest risk factor for this condition. Removal of the implant in the first 24 hours is recommended if a good visual prognosis is to be achieved.

A new one-step procedure for pulmonary valve implantation of the melody valve: Simultaneous prestenting and valve implantation.

PubMed

Boudjemline, Younes

2018-01-01

To describe a new modification, the one-step procedure, that allows interventionists to pre-stent and implant a Melody valve simultaneously. Percutaneous pulmonary valve implantation (PPVI) is the standard of care for managing patients with dysfunctional right ventricular outflow tract, and the approach is standardized. Patients undergoing PPVI using the one-step procedure were identified in our database. Procedural data and radiation exposure were compared to those in a matched group of patients who underwent PPVI using the conventional two-step procedure. Between January 2016 and January 2017, PPVI was performed in 27 patients (median age/range, 19.1/10-55 years) using the one-step procedure involving manual crimping of one to three bare metal stents over the Melody valve. The stent and Melody valve were delivered successfully using the Ensemble delivery system. No complications occurred. All patients had excellent hemodynamic results (median/range post-PPVI right ventricular to pulmonary artery gradient, 9/0-20 mmHg). Valve function was excellent. Median procedural and fluoroscopic times were 56 and 10.2 min, respectively, which significantly differed from those of the two-step procedure group. Similarly, the dose area product (DAP), and radiation time were statistically lower in the one-step group than in the two-step group (P < 0.001 for all variables). After a median follow-up of 8 months (range, 3-14.7), no patient underwent reintervention, and no device dysfunction was observed. The one-step procedure is a safe modification that allows interventionists to prestent and implants the Melody valve simultaneously. It significantly reduces procedural and fluoroscopic times, and radiation exposure. © 2017 Wiley Periodicals, Inc.

Simultaneous Implantation of an Ahmed and Baerveldt Glaucoma Drainage Device for Uncontrolled Intraocular Pressure in Advanced Glaucoma.

PubMed

Rao, Veena S; Christenbury, Joseph; Lee, Paul; Allingham, Rand; Herndon, Leon; Challa, Pratap

2017-02-01

To evaluate efficacy and safety of a novel technique, simultaneous implantation of Ahmed and Baerveldt shunts, for improved control of intraocular pressure (IOP) in advanced glaucoma with visual field defects threatening central fixation. Retrospective case series; all patients receiving simultaneous Ahmed and Baerveldt implantation at a single institution between October 2004 and October 2009 were included. Records were reviewed preoperatively and at postoperative day 1, week 1, month 1, month 3, month 6, year 1, and yearly until year 5. Outcome measures included IOP, best-corrected visual acuity, visual field mean deviation, cup to disc ratio, number of glaucoma medications, and complications. Fifty-nine eyes were identified; mean (±SD) follow-up was 26±23 months. Primary open-angle glaucoma was most common (n=37, 63%). Forty-six eyes (78%) had prior incisional surgery. Mean preoperative IOP was 25.5±9.8 mm Hg. IOP was reduced 50% day 1 (P<0.001, mean 12.7±7.0 mm Hg), which persisted throughout follow-up. At year 1, cup to disc ratio and mean deviation were stable with decreased best-corrected visual acuity from logMAR 0.72±0.72(20/100) to 1.06±1.13(20/200) (P=0.007). The Kaplan-Meier survival analysis showed median and mean survival of 1205 and 829±91 days, respectively. Complication rate was 47%. IOP is markedly reduced postoperative day 1 following double glaucoma tube implantation with effects persisting over postoperative year 1 and up to year 5. Complications were higher than that seen in reports of single shunt implantation, which may be explained by patient complexity in this cohort. This technique may prove a promising novel approach for management of uncontrolled IOP in advanced glaucoma.

Efficacy of long scleral tunnel technique in preventing Ahmed glaucoma valve tube exposure through conjunctiva.

PubMed

Kugu, Suleyman; Erdogan, Gurkan; Sevim, M Sahin; Ozerturk, Yusuf

2015-01-01

To evaluate the efficacy of long scleral tunnel technique used in Ahmed glaucoma valve (AGV) implantation in preventing tube exposure through conjunctiva. Patients of adult age, who were unresponsive to maximum medical treatment and underwent AGV implantation, were divided into two groups and investigated retrospectively. Group 1 consisted of 40 eyes of 38 patients that underwent surgery by long scleral tunnel technique and Group 2 consisted of 38 eyes of 35 patients that underwent implantation by processed pericardium patch graft method. The mean age was 54.8 ± 14.6 years (range 26-68 years) and the mean follow-up duration was 46.7 ± 19.4 months (range 18-76 months) for the patients in Group 1, whereas the mean age was 58.6 ± 16.7 years (range 32-74 years) and mean follow-up period was 43.6 ± 15.7 months (range 20-72 months) for the patients in Group 2 (p > 0.05). In the course of follow-up, tube exposure was detected in one (2.5%) eye in Group 1 and in three (7.9%) eyes in Group 2 (p = 0.042). Long scleral tunnel technique is beneficial in preventing conjunctival tube exposure in AGV implantation surgery.

Self-expandable CoreValve implantation without contrast media.

PubMed

Bruschi, Giuseppe; Colombo, Paola; De Marco, Federico; Barosi, Alberto; Mauri, Silvia; Klugmann, Silvio

2016-09-01

Transcatheter aortic valve implantation has been designed to treat high-risk surgical patients affected by severe aortic stenosis, many of whom are affected by chronic kidney disease. To perform transcatheter self-expandable valve implantation, multiple contrast injections are required to monitor the procedure, so these patients are at increased risk of acute kidney injury. We described self-expandable transcatheter aortic valve implantation without contrast media in an 80-year-old man affected by severe aortic stenosis and endstage chronic kidney disease. © The Author(s) 2015.

Assessment of Filtration Bleb and Endplate Positioning Using Magnetic Resonance Imaging in Eyes Implanted with Long-Tube Glaucoma Drainage Devices.

PubMed

Sano, Ichiya; Tanito, Masaki; Uchida, Koji; Katsube, Takashi; Kitagaki, Hajime; Ohira, Akihiro

2015-01-01

To evaluate ocular fluid filtration and endplate positioning in glaucomatous eyes with long-tube glaucoma drainage devices (GDDs) using magnetic resonance imaging (MRI) and the effects of various factors on postoperative intraocular pressure (IOP). This observational case series included 27 consecutive glaucomatous eyes (18 men, 7 women; mean age ± standard error, 63.0±2.0 years) who underwent GDD implantation (n = 8 Ahmed Glaucoma Valves [AGV] and n = 19 Baerveldt Glaucoma Implants [BGI]). Tubes were inserted into the pars plana in 23 eyes and anterior chamber in 4 eyes. Six months postoperatively, high-resolution orbital images were obtained using 3-Tesla MRI with head-array coils, and the filtering bleb volume, bleb height, and distances between the anterior endplate edge and corneal center or limbus or between the endplate and orbital wall were measured. In MR images obtained by three-dimensional fast imaging employing steady-state acquisition (3D-FIESTA) sequences, the shunt endplate was identified as low-intensity signal, and the filtering bleb was identified as high-intensity signals above and below the endplate in all eyes. The 6-month-postoperative IOP level was correlated negatively with bleb volume (r = -0.4510, P = 0.0182) and bleb height (r = -0.3954, P = 0.0412). The postoperative IOP was significantly (P = 0.0026) lower in BGI-implanted eyes (12.2±0.7 mmHg) than AGV-implanted eyes (16.7±1.2 mmHg); bleb volume was significantly (P = 0.0093) larger in BGI-implanted eyes (478.8±84.2 mm3) than AGV-implanted eyes (161.1±52.3 mm3). Other parameters did not differ. The presence of intraorbital/periocular accumulation of ocular fluid affects postoperative IOP levels in eyes implanted with long-tube GDDs. Larger filtering blebs after BGI than AGI implantations explain lower postoperative IOP levels achieved with BGI than AGV. The findings will contribute to better understanding of IOP reducing mechanism of long-tube GDDs.

Concomitant transcatheter aortic valve and left ventricular assist device implantation.

PubMed

Baum, Christina; Seiffert, Moritz; Treede, Hendrik; Reichenspurner, Hermann; Deuse, Tobias

2013-01-01

Relevant aortic regurgitation (AR) requires surgical repair at the time of left ventricular assist device (LVAD) implantation to reduce recirculation and ensure adequate forward flow. We report here on a patient with moderate AR in a noncalcified aortic valve and extensive calcification of the ascending aorta. The latter precluded aortic-crossclamping and, thus, surgical intervention on the aortic valve. Although there were no valvular or annular calcifications, a JenaValve transcatheter heart valve was successfully placed transapically with subsequent LVAD implantation in one operation. We believe concomitant transcatheter aortic valve implantation (TAVI) and LVAD implantation is a promising hybrid procedure, even in patients with pure AR.

Trans-catheter aortic valve implantation after previous aortic homograft surgery.

PubMed

Drews, Thorsten; Pasic, Miralem; Buz, Semih; Unbehaun, Axel

2011-12-01

In patients with previous heart surgery, the operative risk is elevated during conventional aortic valve re-operations. Trans-catheter aortic valve implantation is a new method for the treatment of high-risk patients. Nevertheless, this new procedure carries potential risks in patients with previous homograft implantation in aortic position. Between April 2008 and February 2011, 345 consecutive patients (mean EuroSCORE (European System for Cardiac Operative Risk Evaluation): 38 ± 20%; mean Society of Thoracic Surgeons (STS) Mortality Score: 19 ± 16%; mean age: 80 ± 8 years; 111 men and 234 women) underwent trans-apical aortic valve implantation. In three patients, previous aortic homograft implantation had been performed. Homograft degeneration causing combined valve stenosis and incompetence made re-operation necessary. In all three patients, the aortic valve could be implanted using the trans-apical approach, and the procedure was successful. In two patients, there was slight paravalvular leakage of the aortic prosthesis and the other patient had slight central leakage. Neither ostium obstruction nor mitral valve damage was observed. Trans-catheter valve implantation can be performed successfully after previous homograft implantation. Particular care should be taken to achieve optimal valve positioning, not to obstruct the ostium of the coronary vessels due to the changed anatomic situation and not to cause annulus rupture. Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Initial Experience With the New Ahmed Glaucoma Valve Model M4: Short-term Results.

PubMed

Cvintal, Victor; Moster, Marlene R; Shyu, Andrew P; McDermott, Katie; Ekici, Feyzahan; Pro, Michael J; Waisbourd, Michael

2016-05-01

To evaluate the clinical outcomes of the new Ahmed glaucoma valve (AGV) model M4. The device consists of a porous polyethylene shell designed for improved tissue integration and reduced encapsulation of the plate for better intraocular pressure (IOP) control. Medical records of patients with an AGV M4 implantation between December 1, 2012 and December 31, 2013 were reviewed. The main outcome measure was surgical failure, defined as either (1) IOP<5 mm Hg or >21 mm Hg and/or <20% reduction of IOP at last follow-up visit, (2) a reoperation for glaucoma, and/or (3) loss of light perception. Seventy-five eyes of 73 patients were included. Postoperative IOP at all follow-up visits significantly decreased from a baseline IOP of 31.2 mm Hg (P<0.01). However, IOP increased significantly at 3 months (20.4 mm Hg), 6 months (19.3 mm Hg), and 12 months (20.3 mm Hg) compared with 1 month (13.8 mm Hg) postoperatively (P<0.05). At 6 months and 1 year, the cumulative probability of failure was 32% and 72%, respectively. The AGV M4 effectively reduced IOP in the first postoperative month, but IOP steadily increased thereafter. Consequently, failure rates were high after 1 year of follow-up.

A planning system for transapical aortic valve implantation

NASA Astrophysics Data System (ADS)

Gessat, Michael; Merk, Denis R.; Falk, Volkmar; Walther, Thomas; Jacobs, Stefan; Nöttling, Alois; Burgert, Oliver

2009-02-01

Stenosis of the aortic valve is a common cardiac disease. It is usually corrected surgically by replacing the valve with a mechanical or biological prosthesis. Transapical aortic valve implantation is an experimental minimally invasive surgical technique that is applied to patients with high operative risk to avoid pulmonary arrest. A stented biological prosthesis is mounted on a catheter. Through small incisions in the fifth intercostal space and the apex of the heart, the catheter is positioned under flouroscopy in the aortic root. The stent is expanded and unfolds the valve which is thereby implanted into the aortic root. Exact targeting is crucial, since major complications can arise from a misplaced valve. Planning software for the perioperative use is presented that allows for selection of the best fitting implant and calculation of the safe target area for that implant. The software uses contrast enhanced perioperative DynaCT images acquired under rapid pacing. In a semiautomatic process, a surface segmentation of the aortic root is created. User selected anatomical landmarks are used to calculate the geometric constraints for the size and position of the implant. The software is integrated into a PACS network based on DICOM communication to query and receive the images and implants templates from a PACS server. The planning results can be exported to the same server and from there can be rertieved by an intraoperative catheter guidance device.

Transcatheter Aortic Valve Implantation: Experience with the CoreValve Device.

PubMed

Asgar, Anita W; Bonan, Raoul

2012-01-01

The field of transcatheter aortic valve implantation has been rapidly evolving. The Medtronic CoreValve first emerged on the landscape in 2004 with initial first human studies, and it is currently being studied in the Pivotal US trial. This article details the current experience with the self-expanding aortic valve with a focus on clinical results and ongoing challenges. Copyright © 2012 Elsevier Inc. All rights reserved.

Laser sclerectomy and 5-FU controlled-drug-release biodegradable implant for glaucoma therapy

NASA Astrophysics Data System (ADS)

Villain, Franck L.; Parel, Jean-Marie A.; Kiss, Katalin; Parrish, Richard K.; Kuhne, Francois; Takesue, Yoshiko; Hostyn, Patrick

1993-06-01

Laser sclerectomy, a simple filtering procedure performed to alleviate high intraocular pressure in glaucoma patients, was taught to offer longer lasting effect and therefore improve the patient's outcome when compared with the standard trabeculectomy procedure. Recent clinical trials have shown that this was not the case and pharmacologic wound healing modulation is also required with this new procedure. Five-Fluorouracil (5-FU) is useful as an adjunct treatment for glaucoma filtering surgery. However, efficacy depends upon maintaining sustained drug levels, currently achieved by repeated daily injection of the drug for several weeks. To overcome this limitation, we designed a biodegradable implant for the sustained release of 5-FU. After laser sclerectomy, the implant is inserted through the same 1 mm wide conjunctival snip incision and positioned below the open channel. Implantation takes less than a minute. The implant releases the drug for over 15 days and totally biodegrades in less than 100 days. The combined laser surgery and implantation procedure show great potentials for the treatment of glaucoma.

Using optical coherence tomography to evaluate glaucoma implant healing response in rabbit eyes

NASA Astrophysics Data System (ADS)

Gossage, Kirk W.; Tkaczyk, Tomasz S.; Barton, Jennifer K.

2002-06-01

Glaucoma is a set of diseases that cause optic nerve damage and visual field loss. The most important risk factor for the development of glaucoma is elevated intraocular pressure. One approach used to alleviate the pressure increase is to surgically install glaucoma implants. Two standard Ahmed and ten experimental ePTFE implants were evaluated in this study in rabbit eyes. The implants were imaged with optical coherence tomography (OCT) at 0, 7, 15, 30, and 90 days after implantation. Histology was collected at days 7, 15, 30, and 90 and compared to the OCT images. Preliminary analysis of images indicates that OCT can visualize the development of fibrous encapsulation of the implant, tissue erosion, fibrin accumulation in the implant tube, and tube position in the anterior chamber. A new OCT handheld probe was developed to facilitate in vivo imaging in rabbit eye studies. The OCT probe consists of a mechanical scaffold designed to allow the imaging fiber to be held in a fixed position with respect to the rabbit eye, with minimal anesthesia. A piezo electric lateral scanning device allows the imaging fiber to be scanned across the tissue so that 2D images may be acquired.

Concomitant Transapical Transcatheter Valve Implantations: Edwards Sapien Valve for Severe Mitral Regurgitation in a Patient with Failing Mitral Bioprostheses and JenaValve for the Treatment of Pure Aortic Regurgitation.

PubMed

Aydin, Unal; Gul, Mehmet; Aslan, Serkan; Akkaya, Emre; Yildirim, Aydin

2015-04-28

Transcatheter valve implantation is a novel interventional technique, which was developed as an  alternative therapy for surgical aortic valve replacement in inoperable patients with severe aortic stenosis. Despite limited experience in using transcatheter valve implantation for mitral and aortic regurgitation, transapical transcatheter aortic valve implantation and valve-in-valve implantation for degenerated mitral valve bioprosthesis can be performed in high-risk patients who are not candidates for conventional replacement surgery. In this case, we present the simultaneous transcatheter valve implantation via transapical approach for both degenerated bioprosthetic mitral valve with severe regurgitation and pure severe aortic regurgitation.

[Percutaneously implantable aortic valve: the JenaValve concept evolution].

PubMed

Figulla, Hans R; Ferrari, Markus

2006-10-01

Due to the increasing incidence of severe aortic stenosis in old and multimorbid patients, the percutaneous implantation of aortic valve-carrying stents has become an alternative to the surgical replacement of aortic valves. Starting in 1995, the authors developed a self-expanding stent which transferred the necessary forces for anchoring up to the aorta ascendens-a conception taken over from CoreValve. The further improvement of this idea over the past 11 years has led to a self-expanding, relatively short stent-valve system that is reliably positioned in the cusps of the old aortic valve and holds the old valve like a paper clip, thus transferring the holding forces physiologically. As compared to conventional systems, the sophisticated insertion catheter requires further chronic animal tests so as to represent a true alternative to the conventional surgical procedure.

Conjunctival erosion after glaucoma drainage device surgery: a feasible option.

PubMed

Dubey, Suneeta; Prasanth, Baswati; Acharya, Manisha C; Narula, Ritesh

2013-07-01

Glaucoma drainage devices (GDDs) have been used in the management of complicated glaucomas. GDDs are associated with various complications such as tube migration, tube or plate exposure or extrusion, ocular motility disturbance and infection. Erosion of conjunctiva and exposure of the GDD remains a risk factor for the development of endophthalmitis. A wide range of materials have been used for this purpose, including sclera, dura, pericardium, fascia lata and cornea. However, there is no evidence to prove that any of these methods is superior to another for providing tectonic durability in the long term. In this report, we present a case of neovascular glaucoma, who developed conjunctival melting over the tube of an Ahmed Glaucoma Valve implant and was successfully managed with Cap Doxycycline.

[Coupled Analysis of Fluid-Structure Interaction of a Micro-Mechanical Valve for Glaucoma Drainage Devices].

PubMed

Siewert, S; Sämann, M; Schmidt, W; Stiehm, M; Falke, K; Grabow, N; Guthoff, R; Schmitz, K-P

2015-12-01

Glaucoma is the leading cause of irreversible blindness worldwide. In therapeutically refractory cases, alloplastic glaucoma drainage devices (GDD) are being increasingly used to decrease intraocular pressure. Current devices are mainly limited by fibrotic encapsulation and postoperative hypotension. Preliminary studies have described the development of a glaucoma microstent to control aqueous humour drainage from the anterior chamber into the suprachoroidal space. One focus of these studies was on the design of a micro-mechanical valve placed in the anterior chamber to inhibit postoperative hypotension. The present report describes the coupled analysis of fluid-structure interaction (FSI) as basis for future improvements in the design micro-mechanical valves. FSI analysis was carried out with ANSYS 14.5 software. Solid and fluid geometry were combined in a model, and the corresponding material properties of silicone (Silastic Rx-50) and water at room temperature were assigned. The meshing of the solid and fluid domains was carried out in accordance with the results of a convergence study with tetrahedron elements. Structural and fluid mechanical boundary conditions completed the model. The FSI analysis takes into account geometric non-linearity and adaptive remeshing to consider changing geometry. A valve opening pressure of 3.26 mmHg was derived from the FSI analysis and correlates well with the results of preliminary experimental fluid mechanical studies. Flow resistance was calculated from non-linear pressure-flow characteristics as 8.5 × 10(-3) mmHg/µl  · min(-1) and 2.7 × 10(-3) mmHg/µl  · min(-1), respectively before and after valve opening pressure is exceeded. FSI analysis indicated leakage flow before valve opening, which is due to the simplified model geometry. The presented bidirectional coupled FSI analysis is a powerful tool for the development of new designs of micro-mechanical valves for GDD and may help to minimise the time and cost

Outcomes of Ahmed Glaucoma Valve Revision in Pediatric Glaucoma.

PubMed

Al-Omairi, Ahmed Mansour; Al Ameri, Aliah H; Al-Shahwan, Sami; Khan, Arif O; Al-Jadaan, Ibrahim; Mousa, Ahmed; Edward, Deepak P

2017-11-01

Encapsulation of the Ahmed glaucoma valve (AGV) plate is a common cause for postoperative elevation of intraocular pressure, especially in children. Many reports have described the outcomes of AGV revision in adults. However, the outcomes of AGV revision in children are poorly documented. The aim of this study was to determine the outcomes of AGV revision in children. Retrospective cross-sectional study. A retrospective chart review of patients less than 15 years of age who underwent AGV revision with a minimum postoperative follow-up of 6 months was conducted. Outcome measures included reduction in intraocular pressure from baseline, survival analysis, and reduction in the number of antiglaucoma medications. Postoperative complications were also noted. Complete success was defined as an IOP of 21 mm Hg or less without medications, while qualified success was defined as having an IOP of 21 mm Hg or less with medications. A total of 44 eyes met the inclusion criteria. Primary congenital glaucoma was present in 39 eyes (88.6%), aphakic glaucoma in 4 eyes (9.1%), and Peters anomaly-associated glaucoma in 1 eye (2.3%). The mean number of previous surgeries was 1.4, and the mean age was 6.7 years (range, 1.9-13 years) with a median follow-up of 12 months (range, 6-24 months). The IOP was reduced from a preoperative mean of 30.4 (± 10.3) to 24.9 (± 10.6) mm Hg at 6 months postoperatively. Kaplan-Meier analysis showed that the complete success rate at 1 month was 100% followed by a rapid decline at 6 months to 38.6%, 27.7% at 1 year, and 5.5% at 2 years. Qualified success rate was 100% at 1 month followed by a 6-month and 1-year survival rate of approximately 50% and a 2-year survival rate of approximately 16%. The median survival time was 14 months. No specific risk factors for failure were identified. Visual acuity remained unchanged following revision. The most common complication was recurrence of encapsulation with elevated IOP (15.9%). Other

The Ahmed shunt versus the Baerveldt shunt for refractory glaucoma: a meta-analysis.

PubMed

Wang, Shiming; Gao, Xiaoming; Qian, Nana

2016-06-08

The purpose of this study was to compare the efficacy and tolerability of the Ahmed glaucoma valve (AGV) implant and the Baerveldt implant for the treatment of refractory glaucoma. We comprehensively searched four databases, including PubMed, EMBASE, Web of Science, and the Cochrane Library databases, selecting the relevant studies. The continuous variables, namely, intraocular pressure reduction (IOPR) and a reduction in glaucoma medication, were pooled by the weighted mean differences (WMDs), and the dichotomous outcomes, including success rates and tolerability estimates, were pooled by the odds ratio (ORs). A total of 929 patients from six studies were included. The WMDs of the IOPR between the AGV implant and the Baerveldt implant were 1.58 [95 % confidence interval (CI): -2.99 to 6.15] at 6 months, -1.01 (95 % CI: -3.40 to 1.98) at 12 months, -0.54 (95 % CI: -4.89 to 3.82) at 24 months, and -0.47 (95 % CI: -3.29 to 2.35) at 36 months. No significant difference was detected between the two groups at any point in time. The pooled ORs comparing the AGV implant with the Baerveldt implant were 0.51 (95 % CI: 0.33 to 0.80) for the complete success rate and 0.67 (95 % CI: 0.50 to 0.91) for qualified success rate. The Baerveldt implant was associated with a reduction in glaucoma medication at -0.51 (95 % CI: -0.90 to -0.12). There were no significant differences between the AGV implant and the Baerveldt implant on the rates of adverse events. The Baerveldt implant is more effective in both its surgical success rate and reducing glaucoma medication, but it is comparable to the AGV implant in lowering IOP. Both implants may have comparable incidences of adverse events.

Infective endocarditis following Melody valve implantation: comparison with a surgical cohort.

PubMed

O'Donnell, Clare; Holloway, Rhonda; Tilton, Elizabeth; Stirling, John; Finucane, Kirsten; Wilson, Nigel

2017-03-01

Infective endocarditis has been reported post Melody percutaneous pulmonary valve implant; the incidence and risk factors, however, remain poorly defined. We identified four cases of endocarditis from our first 25 Melody implants. Our aim was to examine these cases in the context of postulated risk factors and directly compare endocarditis rates with local surgical valves. We conducted a retrospective review of patients post Melody percutaneous pulmonary valve implant in New Zealand (October, 2009-May, 2015) and also reviewed the incidence of endocarditis in New Zealand among patients who have undergone surgical pulmonary valve implants. In total, 25 patients underwent Melody implantation at a median age of 18 years. At a median follow-up of 2.9 years, most were well with low valve gradient (median 27 mmHg) and only mild regurgitation. Two patients presented with life-threatening endocarditis and obstructive vegetations at 14 and 26 months post implant, respectively. Two additional patients presented with subacute endocarditis at 5.5 years post implant. From 2009 to May, 2015, 178 surgical pulmonic bioprostheses, largely Hancock valves and homografts, were used at our institution. At a median follow-up of 2.9 years, four patients (2%) had developed endocarditis in this group compared with 4/25 (16%) in the Melody group (p=0.0089). Three surgical valves have been replaced. The Melody valve offers a good alternative to surgical conduit replacement in selected patients. Many patients have excellent outcomes in the medium term. Endocarditis, however, can occur and if associated with obstruction can be life threatening. The risk for endocarditis in the Melody group was higher in comparison with that in a contemporaneous surgical pulmonary implant cohort.

Transapical Mitral Valve Implantation for Native Mitral Valve Stenosis Using a Balloon-Expandable Prosthesis.

PubMed

Kiefer, Philipp; Noack, Thilo; Seeburger, Joerg; Hoyer, Alexandro; Linke, Axel; Mangner, Norman; Lehmkuhl, Lukas; Mohr, Friedrich Wilhelm; Holzhey, David

2017-12-01

Transcatheter mitral valve implantation (TMVI) is still in its infancy and is mainly limited to valve-in-valve or valve-in-ring implantations. We present the early experience with TMVI for severe calcified native MV stenosis. Between January 2014 and June 2015, 6 of 11 patients screened (mean age, 77.4 ± 6.3 years; 66% men) with severe native mitral valve (MV) stenosis (mean gradient [Pmean], 11.1 ± 2.1 mm Hg; mean effective orifice area [EOA], 0.9 ± 0.12 cm 2 ) underwent transcatheter MV replacement at our institution as a bailout procedure. Conventional surgical procedures were denied in all patients because of severe annular calcification and extensive comorbidities (mean logistic EuroScore, 31.4% ± 8.3%). The Edwards SAPIEN 3 (29 mm) (Edwards Lifesciences, Irvine, CA) was used in all cases. Procedural access was transapical in 5 cases and concomitant to aortic valve replacement through the left atrium through a sternotomy in 1 case. Initial implantation was successful in 100% of the cases. Because of early migration, 1 patient needed a valve-in-valve procedure. Postoperative echocardiography showed no residual mitral regurgitation in 4 cases (66%) and mild regurgitation in 2 cases (34%). Mean gradients were reduced to 4.2 ± 0.6 mm Hg (mean EOA, 2.8 ± 0.4 cm 2) . No patient had a stroke during hospitalization, and 30-day mortality was seen in 1 patient (17%) resulting from pneumonia. TMV implantation using the SAPIEN 3 aortic prosthesis in patients with heavy annular calcification is feasible and represents a reasonable bailout option for inoperable patients. However, several limitations need to be considered in this special patient population. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Iritis, glaucoma and corneal decompensation associated with BrightOcular cosmetic iris implant.

PubMed

Mansour, Ahmad M; Ahmed, Iqbal Ike K; Eadie, Brennan; Chelala, Elias; Saade, Joanna S; Slade, Stephen G; Mearza, Ali A; Parmar, Dipak; Ghabra, Marwan; Luk, Sheila; Kelly, Alla; Kaufman, Stephen C

2016-08-01

NewColorIris cosmetic iris implants have a record of high ocular morbidity and are no longer in use. Newer generation of iris implants, BrightOcular, have patented posterior grooves in order to decrease iris touch and facilitate aqueous flow around the implant. However, little is known about their safety despite their implantations in 10 countries. Collaborative case series of patients who had bilateral implantation of cosmetic iris implants solely for cosmetic reasons. 12 cases were collected being distributed as Caucasian (10) and Asian (2), women (11) and man (1) and with a mean age of 32 years. Ocular manifestations were present in 11 subjects and included anterior uveitis (10 of 12; 83.3%), glaucoma (7 of 12; 58.3%) and corneal decompensation (6 of 12; 50%). Visual acuity was normal in seven, decreased in five with two having visual recovery following explantation of the implant. Glaucoma could not be controlled medically in two patients. Cosmetic iris implants carry the risk of ocular damage when implanted in the anterior chamber of normal phakic eyes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Initial clinical experience of tube-shunt surgery in Ethiopian patients with refractory glaucoma.

PubMed

T/Giorgis, Abeba

2012-04-01

In Ethiopia, it is not uncommon to encounter refractory glaucoma cases that could be managed with tube-shunt surgery. Tube-shunt implant surgery has been a standard procedure option and widely used for various forms of refractory glaucoma. To described the initial experience and outcome of Ahmed Tube shunt implant for refractory adult Ethiopian glaucoma cases. Retrospective review of consecutive adult patients with refractory glaucoma who underwent Ahmed glaucoma valve implant at the Department of ophthalmology, Menelik II Hospital, Addis Ababa between April 2009 and December 2010. intraocular pressure (IOP), visual acuity, use of supplemental medical therapy and surgical complications. Success was defined as IOP greater than 5 and less than 22 mmHg with at least 30% reduction in IOP from preoperative levels with and without supplemental glaucoma medications, no additional surgeries to lower the IOP and without visual loss of light perception from devastating postoperative complications. Thirteen eyes of 12 patients (10 men, 2 women; mean age 52.4 +/- 15. 7) who underwent glaucoma tube-shunt drainage surgery with Ahmed-tube valve were included in this analysis. The mean preoperative IOP was 31.38 +/- 8.67 mmHg with 2.23 +/- 0.44 antiglaucoma medications. Postoperatively, the mean IOP reduced to 15.52 +/- 8.80 mmHg at 1 week, 14.77 +/- 6.39 mmHg at 1 month, 16.62 +/- 4.48 mmHg at 3 months, and 17.15 +/- 3.87 mmHg at 6 months. The reduction from the preoperative mean IOP at last follow up was 45.3% with 1.08 +/- 0.44 supplemental glaucoma medications. The success rate of IOP controlling according to the definition was 76.9%. The pressure remained below 18 mmHg with and without medication in 9/13 (69.2%) eyes, while three eyes required no medication at all till the last follow-up with sustained IOP < 15 mmHg. At the last follow-up the visual acuity reduced by > or = 2 lines in two eyes while one patient's vision worsened from counting finger of one meter to hand

Advanced pigment dispersion glaucoma secondary to phakic intraocular collamer lens implant.

PubMed

Ye, Clara; Patel, Cajal K; Momont, Anna C; Liu, Yao

2018-06-01

We report a case of pigment dispersion glaucoma secondary to uncomplicated phakic intraocular collamer lens (ICL) (Visian ICL™, Staar Inc., Monrovia, CA) implant that resulted in advanced visual field loss. A 50-year-old man presented for routine follow-up status post bilateral phakic intraocular collamer lens (ICL) placement 8 years earlier. He was incidentally found to have a decline in visual acuity from an anterior subcapsular cataract and elevated intraocular pressure (IOP) in the left eye. There were signs of pigment dispersion and no evidence of angle closure. Diffuse optic nerve thinning was consistent with advanced glaucomatous visual field defects. Pigment dispersion was also present in the patient's right eye, but without elevated IOP or visual field defects. The patient was treated with topical glaucoma medications and the phakic ICL in the left eye was removed concurrently with cataract surgery to prevent further visual field loss. Pigment dispersion glaucoma is a serious adverse outcome after phakic ICL implantation and regular post-operative monitoring may prevent advanced visual field loss.

Minimally Invasive Aortic Valve Replacement Following Root Enlargement on too Narrow Annulus to Perform Transcatheter Aortic Valve Implantation.

PubMed

Sakamoto, Kosuke; Totsugawa, Toshinori; Hiraoka, Arudo; Tamura, Kentaro; Yoshitaka, Hidenori; Sakaguchi, Taichi

2018-05-30

An 88-year-old woman was diagnosed with aortic stenosis and an aortic annulus that was too narrow to perform transcatheter aortic valve implantation. Surgery was performed through a 7-cm right mini-thoracotomy at the fourth intercostal space. A 19-mm aortic valve bioprosthesis was implanted after root enlargement. The fourth intercostal space was a suitable site for aortic root enlargement because of the shorter skin-to-root distance and the detailed exposure of the aortic valve after cutting the aortic wall. This study concluded that minimally-invasive aortic valve replacement following root enlargement can be an option for the treatment of elderly patients with aortic stenosis accompanied by an annulus that is too small to perform transcatheter aortic valve implantation.

Comparative study of the safety and efficacy of the Ahmed glaucoma valve model M4 (high density porous polyethylene) and the model S2 (polypropylene) in patients with neovascular glaucoma.

PubMed

Gil-Carrasco, F; Jiménez-Román, J; Turati-Acosta, M; Bello-López Portillo, H; Isida-Llerandi, C G

2016-09-01

To prospectively evaluate the safety and efficacy of the Ahmed glaucoma valve model M4 (High density porous polyethylene plate; Medpor) compared with the model S2 (polypropylene plate). Mexican patients with neovascular glaucoma were randomly included for each group (M4 and S2). They were operated on using conventional techniques and creating a sub-episcleral tunnel to place the valve tube in the anterior chamber. After one year of follow-up, the results were evaluated with respect to a post-operative reduction in pressure, changes in visual acuity, the need for drugs, and complications, as well as the demographic characteristics of each group. Each operation using the M4 valve was performed by a single surgeon (FGC). Those operated on using the S2 model had their surgery performed by the staff surgeons at the Glaucoma Department of the Mexican Association to Prevent Blindness (APEC). Each group (M4 and S2) contained 21 eyes of 21 Mexican patients with a diagnosis of neovascular glaucoma, leading to a total of 42 patients undergoing surgery. The mean preoperative intraocular pressure (IOP) was 43.5 (±11.8), and 42.24 (±12.84) mmHg for the M4 and S2 groups, respectively. After one year of follow-up, the IOP reported was 18.9 (±9.7) mmHg for the final 18 patients in the M4 group, and 16.38 (±9.76) mmHg for the 21 patients in the S2 group. The design of a drainage valve device such as that of Ahmed has characteristics such as moderate control of IOP, thanks to the valve component in the immediate post-operative period, which makes them safer than other non-valve devices. This avoids an excess of flat chambers and the presence of low IOPs, which can lead to bleeding in the early post-operative period due to the weak desmosomal junctions of the newly formed vessels, with the advantage of maintaining suitable control of IOP from the first day after surgery. Further studies with longer follow-up with a larger number of patients are needed to evaluate the effectiveness

Safety and efficacy of a low-cost glaucoma drainage device for refractory childhood glaucoma.

PubMed

Kaushik, Sushmita; Kataria, Pankaj; Raj, Srishti; Pandav, Surinder Singh; Ram, Jagat

2017-12-01

To evaluate the safety and efficacy of a low-cost glaucoma drainage device (GDD), Aurolab aqueous drainage implant (AADI), similar in design to the Baerveldt glaucoma implant (BGI), in refractory childhood glaucoma. This prospective interventional study was conducted in a tertiary care postgraduate teaching institute. Children aged <16 years with uncontrolled intraocular pressure (IOP) refractory to medical treatment and considered at high risk of failure following trabeculectomy were recruited. Eligible children were implanted with the AADI. Those completing minimum 6-month follow-up were included. Main outcome measures were IOP reduction from preoperative values and postoperative complications. 34 eyes of 31 patients were analysed. Average follow-up was 18.3±6.9 months. Mean IOP reduced from 27.4±7.5 mm Hg on maximum medication to 14.6±10.74 mm Hg, 13.8±7.5 mm Hg, 12.8±5.6 mm Hg and 14.7±5.8 mm Hg at 1 week, 6 months, 1 year (32 eyes of 29 children) and 2 years (25 eyes of 22 children) postoperatively, respectively (p<0.001). The cumulative probability of success was 91.18% at 6 months and 81.7% at 18-24 months. Mean number of topical medications decreased from 3.1±0.6 to 1.8±1.3 at 6 months and 1.6±1.1 at 24 months (p<0.001). Preoperatively, 25 patients required systemic acetazolamide, decreasing to three patients at 2 years. There was no tube erosion or infection. One eye developed retinal detachment. The AADI appears to be a viable low-cost GDD with effectiveness and safety profile comparable with published reports of the BGI and Ahmed glaucoma valve implant in children. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Perceval S aortic valve implantation in an achondroplastic Dwarf

PubMed Central

Baikoussis, Nikolaos G.; Argiriou, Michalis; Argiriou, Orestis; Dedeilias, Panagiotis

2016-01-01

Despite cardiovascular disease in patients with dwarfism is not rare; there is a lack of reports referring to cardiac interventions in such patients. Dwarfism may be due to achondroplasia or hormonal growth disorders. We present a 58-year-old woman with episodes of dyspnea for several months. She underwent on transthoracic echocardiography, and she diagnosed with severe aortic valve stenosis. She referred to our department for surgical treatment of this finding. In accordance of her anthropometric characteristics and her very small aortic annulus, we had the dilemma of prosthesis selection. We decided to implant a stentless valve to optimize her effective orifice area. Our aim is to present the successful Perceval S valve implantation and the descriptions of the problems coming across in operating on these special patients. To our knowledge, this is the first case patient in which a Perceval S valve is implanted according to the international bibliography. PMID:26750695

[Development of a glaucoma microstent with drainage into the suprachoroidal space: fluid mechanical model approach].

PubMed

Guthoff, R F; Schmidt, W; Buss, D; Schultze, C; Ruppin, U; Stachs, O; Sternberg, K; Klee, D; Chichkov, B; Schmitz, K-P

2009-09-01

The purpose of this study was to develop a microstent with valve function, which normalizes the intraocular pressure (IOP) and drains into the suprachoroidal space. In comparison to the subconjunctival space the suprachoroidal space is attributed with less fibroblast colonization and activity. Different glaucoma drainage devices were idealized as tubes and the flow rates were calculated according to Hagen-Poiseuille. The dimensions of the ideal glaucoma implant were modified with respect to an aqueous humor production of 2 microl/min and the different outflow pathways. Specific components of glaucoma drainage devices at the inlet and outlet were not included. The volume flow calculation of the tested glaucoma implants showed that the dimensions of all lumina were too large to prevent postoperative hypotension. A maximum inner tube diameter of 53 microm was calculated for drainage into the suprachoroidal space based on an intra-ocular pressure (IOP) of 20 mmHg. The glaucoma microstent has to guarantee an aqueous humor flow for physiological IOP. An increase of IOP has to be regulated to physiological pressure conditions by the microvalve.

Conjunctival inclusion cyst following repair of tube erosion in a child with aphakic glaucoma, leading to endophthalmitis.

PubMed

Roy, Avik Kumar; Senthil, Sirisha

2015-01-01

Glaucoma in aphakia is a major long term complication following congenital cataract surgery. Implantation of glaucoma drainage device provides an effective approach to manage refractory paediatric glaucoma. However implant surgery in young individuals is not free of complications. The prompt detection and management of tube erosion is of utmost importance to prevent devastating sequel of endophthalmitis. Implantation cyst following repair of tube erosion has not been reported so far. This case illustrates the rare occurrence of inclusion cyst following repair of tube erosion, the possible causes and its consequences. A 2-year-old child with aphakia developed intractable glaucoma. Following a failed glaucoma filtering surgery he underwent sequential Ahmed Glaucoma Valve implantation in both the eyes. Six weeks following right eye surgery, the child presented with conjunctival erosion overlying the tube, which was treated with scleral patch graft and conjunctival advancement. One month after the repair of tube erosion, the child presented with implantation cyst under the scleral patch graft, which was treated by drainage with a 29G needle. The child presented with endophthalmitis of his right eye following an episode of bilateral conjunctivitis. This was managed by an emergency pars plana vitrectomy, intraocular antibiotics and tube excision. At the last follow up visit, the IOP was 20 mmHg with 2 topical antiglaucoma medications in the right eye following a trans scleral photocoagulation. Lifelong careful follow-up of paediatric eyes with implant surgery is mandatory to look for complication such as tube erosion. It is important to place additional sutures to secure the patch graft during implantation of glaucoma drainage devices in children to prevent graft displacement and consequent tube erosion. During repair of tube erosion, it is crucial to remove all the conjunctival epithelium around the tube, thus not to incorporate epithelial tissue within the surgical

Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol.

PubMed

Krackhardt, Florian; Kherad, Behrouz; Krisper, Maximilian; Pieske, Burkert; Laule, Michael; Tschöpe, Carsten

2017-01-01

Conduction disturbances requiring permanent pacemaker implantation following transcatheter aortic valve replacement (TAVR) are a common problem. Pacemaker implantation rates after TAVR appear to be higher compared to conventional aortic valve replacement. The aim of this study was to analyze whether a high annulus implantation conveys the benefit of a decreased rate of permanent pacemaker implantation while being safe and successful according to Valve Academic Research Consortium 2 (VARC2)-criteria. A total of 23 patients with symptomatic severe aortic valve stenosis, an aortic annulus of 19-27 mm and at high risk for surgery were treated with the Lotus valve. In all patients the valve was implanted in a high annulus position via femoral access. The primary device performance endpoint was VARC2-defined device success after 30 days and the primary safety endpoint was the need for permanent pacemaker implantation. The mean age was 73.23 ± 7.65 years, 46% were female, 38% were New York Heart Association class III/IV at baseline. Thirty-day follow-up data were available for all patients. The VARC2-defined device success rate after 30 days was 22/23 (96%). 2/21 (10%) patients required a newly implanted pacemaker due to 3rd degree atrioventricular block. 25% of the patients developed a new left bundle branch block after valvuloplasty or device implantation. 21 of the 23 patients (96%) had no other signs of conduction disturbances after 30 days. The approach of the modified implantation technique of Lotus TAVR device was safe and effective. The incidence of need for a permanent pacemaker following TAVR could be significantly reduced due to adopted implantation protocol.

[LONG TERM FOLLOW-UP OF TRANSCATHETER SELF EXPANDABLE AORTIC VALVE IMPLANTATION].

PubMed

Chen, Shmuel; Zenios, Vicky; Gilon, Dan; Planer, David; Beeri, Ronen; Lotan, Chaim; Danenberg, Haim D

2018-03-01

Aortic stenosis is the most common significant valvular disease in the western world. These patients are treated operatively unless they are at high operative risk or inoperable. During the last decade an alternative approach has evolved - transcatheter aortic valve implantation (TAVI). This method was shown to be at least as effective and safe as the operative one. However, very little data exists on long term follow-up (5 years and above), especially regarding valve durability and patient survival. To present a long term follow-up on patients who underwent transcutaneous self-expandable aortic valve implantation in our department between the years 2008-2011. In September 2008 the first CoreValve implantation was performed in Israel at Hadassah Medical Center. All records of patients who were transplanted between 9.2008 and 10.2011 were reviewed. The function of the valve early after the procedure was compared to its function at the end of the follow-up period. A total of 38 patients (out of 71) survived at least 54 months, of them, 19 have an echocardiography examination at the end of the follow-up period. In all patients the implanted valve was found to function well at the end of the follow-up period, without significant stenosis or paravalvular leak. In fact, in approximately half of these patients, the degree of paravalvular leak decreased during the follow-up period. On long term (5 years) follow-up of patients who were implanted with the self-expandable aortic valve (CoreValve), no deterioration of the valve was observed. In fact, in approximately half of the patients, a decrease in the severity of the paravalvular leak was demonstrated.

Transcatheter aortic valve implantation for failing surgical aortic bioprosthetic valve: from concept to clinical application and evaluation (part 2).

PubMed

Piazza, Nicolo; Bleiziffer, Sabine; Brockmann, Gernot; Hendrick, Ruge; Deutsch, Marcus-André; Opitz, Anke; Mazzitelli, Domenico; Tassani-Prell, Peter; Schreiber, Christian; Lange, Rüdiger

2011-07-01

This study sought to review the acute procedural outcomes of patients who underwent transcatheter aortic valve (TAV)-in-surgical aortic valve (SAV) implantation at the German Heart Center, Munich, and to summarize the existing literature on TAV-in-SAV implantation (n = 47). There are several case reports and small case series describing transcatheter aortic valve implantation for a failing surgical aortic valve bioprosthesis (TAV-in-SAV implantation). From January 2007 to March 2011, 20 out of 556 patients underwent a TAV-in-SAV implantation at the German Heart Center Munich. Baseline characteristics and clinical outcome data were prospectively entered into a dedicated database. The mean patient age was 75 ± 13 years, and the mean logistic European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons' Risk Model scores were 27 ± 13% and 7 ± 4%, respectively. Of the 20 patients, 14 had stented and 6 had stentless surgical bioprostheses. Most cases (12 of 20) were performed via the transapical route using a 23-mm Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, California). Successful implantation of a TAV in a SAV with the patient leaving the catheterization laboratory alive was achieved in 18 of 20 patients. The mean transaortic valve gradient was 20.0 ± 7.5 mm Hg. None-to-trivial, mild, and mild-to-moderate paravalvular aortic regurgitation was observed in 10, 6, and 2 patients, respectively. We experienced 1 intraprocedural death following pre-implant balloon aortic valvuloplasty ("stone heart") and 2 further in-hospital deaths due to myocardial infarction. TAV-in-SAV implantation is a safe and feasible treatment for high-risk patients with failing aortic bioprosthetic valves and should be considered as part of the armamentarium in the treatment of aortic bioprosthetic valve failure. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Surgically Induced Scleral Necrosis in a Patient With Rheumatoid Arthritis After AGV Implantation.

PubMed

Kumar, Suresh; Ichhpujani, Parul; Thakur, Sahil

2018-03-01

Surgically induced scleral necrosis (SINS) is a rare entity that has till date not been reported in a patient of glaucoma undergoing Ahmed glaucoma valve (AGV) implantation. We present a case of primary open-angle glaucoma who underwent AGV implantation followed by development of scleral necrosis, involving both the scleral patch graft and host sclera. After failure of surgical and medical management, AGV had to be explanted. The patient was diagnosed with rheumatoid arthritis and had to be treated with steroids and azathioprine for the same. SINS is a potentially disastrous complication of ocular surgery that can occur in patients with systemic diseases like rheumatoid arthritis and requires aggressive management to salvage the eye. SINS can occur with AGV implantation. Treatment may require aggressive medical and surgical intervention. It is imperative to evaluate patients for systemic illness before planning an AGV implant.

Valve in valve transcatheter aortic valve implantation (ViV-TAVI) versus redo-Surgical aortic valve replacement (redo-SAVR): A systematic review and meta-analysis.

PubMed

Nalluri, Nikhil; Atti, Varunsiri; Munir, Abdullah B; Karam, Boutros; Patel, Nileshkumar J; Kumar, Varun; Vemula, Praveen; Edla, Sushruth; Asti, Deepak; Paturu, Amrutha; Gayam, Sriramya; Spagnola, Jonathan; Barsoum, Emad; Maniatis, Gregory A; Tamburrino, Frank; Kandov, Ruben; Lafferty, James; Kliger, Chad

2018-05-20

Bioprosthetic (BP) valves have been increasingly used for aortic valve replacement over the last decade. Due to their limited durability, patients presenting with failed BP valves are rising. Valve in Valve - Transcatheter Aortic Valve Implantation (ViV-TAVI) emerged as an alternative to the gold standard redo-Surgical Aortic Valve Replacement (redo-SAVR). However, the utility of ViV-TAVI is poorly understood. A systematic electronic search of the scientific literature was done in PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov. Only studies which compared the safety and efficacy of ViV-TAVI and redo-SAVR head to head in failed BP valves were included. Six observational studies were eligible and included 594 patients, of whom 255 underwent ViV- TAVI and 339 underwent redo-SAVR. There was no significant difference between ViV-TAVI and redo- SAVR for procedural, 30 day and 1 year mortality rates. ViV-TAVI was associated with lower risk of permanent pacemaker implantation (PPI) (OR: 0.43, CI: 0.21-0.89; P = 0.02) and a trend toward increased risk of paravalvular leak (PVL) (OR: 5.45, CI: 0.94-31.58; P = 0.06). There was no significant difference for stroke, major bleeding, vascular complications and postprocedural aortic valvular gradients more than 20 mm-hg. Our results reiterate the safety and feasibility of ViV-TAVI for failed aortic BP valves in patients deemed to be at high risk for surgery. VIV-TAVI was associated with lower risk of permanent pacemaker implantation with a trend toward increased risk of paravalvular leak. © 2018, Wiley Periodicals, Inc.

[Transcatheter aortic valve implantation for aortic stenosis. Initial experience].

PubMed

Careaga-Reyna, Guillermo; Lázaro-Castillo, José Luis; Lezama-Urtecho, Carlos Alberto; Macías-Miranda, Enriqueta; Dosta-Herrera, Juan José; Galván Díaz, José

Aortic stenosis is a frequent disease in the elderly, and is associated with other systemic pathologies that may contraindicate the surgical procedure. Another option for these patients is percutaneous aortic valve implantation, which is less invasive. We present our initial experience with this procedure. Patients with aortic stenosis were included once selection criteria were accomplished. Under general anaesthesia and echocardiographic and fluosocopic control, a transcatheter aortic valve was implanted following s valvuloplasty. Once concluded the procedure, angiographic and pressure control was realized in order to confirm the valve function. Between November 2014 and May 2015, 6 patients were treated (4 males and 2 females), with a mean age of 78.83±5.66 years-old. The preoperative transvalvular gradient was 90.16±28.53mmHg and posterior to valve implant was 3.33±2.92mmHg (P<.05). Two patients had concomitant coronary artery disease which had been treated previously. One patient presented with acute right coronary artery occlusion which was immediately treated. However due to previous renal failure, postoperative sepsis and respiratory failure, the patient died one month later. It was concluded that our preliminary results showed that in selected patients percutaneous aortic valve implantation is a safe procedure with clinical improvement for treated patients. Copyright © 2016 Academia Mexicana de Cirugía A.C. Publicado por Masson Doyma México S.A. All rights reserved.

Outcomes of severe uveitic glaucoma treated with Baerveldt implant: can blindness be prevented?

PubMed

Tan, Annelie N; Cornelissen, Michiel F; Webers, Carroll A B; Erckens, Roel J; Berendschot, Tos T J M; Beckers, Henny J M

2018-02-01

To evaluate long-term outcomes on efficacy and safety of severe uveitic glaucoma treated with a Baerveldt glaucoma implant (BGI). A retrospective study of 47 eyes of 47 patients with uveitic glaucoma treated by a BGI between September 2002 and September 2015. Main outcome measures were intraocular pressure (IOP), number of glaucoma medications, course of the uveitis, visual acuity (VA) and complications. Mean IOP dropped from 30.6 ± 8.1 mmHg with 3.6 ± 1.1 glaucoma medications at baseline to 10.6 ± 4.3 mmHg with 1.0 ± 1.3 glaucoma medications after a mean follow-up of 63.6 ± 43.1 months. In the majority of cases, IOP remained stable during follow-up. However, especially in several patients with viral uveitis, episodes with IOP peaks were observed during a flare-up despite a functioning implant. These peaks remained below preoperative levels. During follow-up, 16 patients (34%) experienced a clinically significant VA loss, mainly because of late-stage glaucoma or hypotony maculopathy. Early postoperative complications were transient choroidal effusion (n = 5), shallow/flat anterior chamber (n = 4), hyphaema (n = 2) and suprachoroidal haemorrhage (n = 1). The most important late postoperative complication was hypotony maculopathy (n = 5), three of these in juvenile idiopathic arthritis (JIA) patients. The BGI is an effective and safe treatment for patients with refractive secondary glaucoma due to uveitis. In a majority of patients, VA remains stable and a low and stable IOP is maintained over time with an acceptable number of complications. In particular, patients with viral uveitis and glaucoma should be closely monitored for IOP peaks that may occur during episodes of a flare-up of uveitis, whereas at the other end of the spectrum, patients with JIA seem much more prone to hypotony maculopathy. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Surgical outcomes of trabeculectomy and glaucoma drainage implant for uveitic glaucoma and relationship with uveitis activity.

PubMed

Kwon, Hye Jin; Kong, Yu Xiang George; Tao, Lingwei William; Lim, Lyndell L; Martin, Keith R; Green, Catherine; Ruddle, Jonathan; Crowston, Jonathan G

2017-07-01

This study provides ophthalmologists who manage uveitic glaucoma with important information on factors that can affect the success of surgical management of this challenging disease. This study examines surgical outcomes of trabeculectomy and glaucoma device implant (GDI) surgery for uveitic glaucoma, in particular the effect of uveitis activity on surgical outcomes. Retrospective chart review at a tertiary institution. Eighty-two cases with uveitic glaucoma (54 trabeculectomies and 28 (GDI) surgeries) performed between 1 December 2006 and 30 November 2014. Associations of factors with surgical outcomes were examined using univariate and multivariate analysis. Surgical outcomes as defined in Guidelines from World Glaucoma Association. Average follow up was 26.4 ± 21.5 months. Overall qualified success rate of the trabeculectomies was not statistically different from GDI, being 67% and 75%, respectively (P = 0.60). Primary and secondary GDI operations showed similar success rates. The most common postoperative complication was hypotony (~30%). Active uveitis at the time of operation was higher in trabeculectomy compared with GDI group (35% vs. 14%). Active uveitis at the time of surgery did not significantly increase risk of failure for trabeculectomies. Recurrence of uveitis was significantly associated with surgical failure in trabeculectomy group (odds ratio 4.8, P = 0.02) but not in GDI group. Surgical success rate of GDI was not significantly different from trabeculectomy for uveitic glaucoma in this study. Regular monitoring, early and prolonged intensive treatment of ocular inflammation is important for surgical success particularly following trabeculectomy. © 2017 Royal Australian and New Zealand College of Ophthalmologists.

Percutaneous Transcatheter One-Step Mechanical Aortic Disc Valve Prosthesis Implantation: A Preliminary Feasibility Study in Swine

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sochman, Jan; Peregrin, Jan H.; Rocek, Miloslav

Purpose. To evaluate the feasibility of one-step implantation of a new type of stent-based mechanical aortic disc valve prosthesis (MADVP) above and across the native aortic valve and its short-term function in swine with both functional and dysfunctional native valves. Methods. The MADVP consisted of a folding disc valve made of silicone elastomer attached to either a nitinol Z-stent (Z model) or a nitinol cross-braided stent (SX model). Implantation of 10 MADVPs (6 Z and 4 SX models) was attempted in 10 swine: 4 (2 Z and 2 SX models) with a functional native valve and 6 (4 Z andmore » 2 SX models) with aortic regurgitation induced either by intentional valve injury or by MADVP placement across the native valve. MADVP function was observed for up to 3 hr after implantation. Results. MADVP implantation was successful in 9 swine. One animal died of induced massive regurgitation prior to implantation. Four MADVPs implanted above functioning native valves exhibited good function. In 5 swine with regurgitation, MADVP implantation corrected the induced native valve dysfunction and the device's continuous good function was observed in 4 animals. One MADVP (SX model) placed across native valve gradually migrated into the left ventricle. Conclusion. The tested MADVP can be implanted above and across the native valve in a one-step procedure and can replace the function of the regurgitating native valve. Further technical development and testing are warranted, preferably with a manufactured MADVP.« less

Percutaneous pulmonary and tricuspid valve implantations: An update

PubMed Central

Wagner, Robert; Daehnert, Ingo; Lurz, Philipp

2015-01-01

The field of percutaneous valvular interventions is one of the most exciting and rapidly developing within interventional cardiology. Percutaneous procedures focusing on aortic and mitral valve replacement or interventional treatment as well as techniques of percutaneous pulmonary valve implantation have already reached worldwide clinical acceptance and routine interventional procedure status. Although techniques of percutaneous pulmonary valve implantation have been described just a decade ago, two stent-mounted complementary devices were successfully introduced and more than 3000 of these procedures have been performed worldwide. In contrast, percutaneous treatment of tricuspid valve dysfunction is still evolving on a much earlier level and has so far not reached routine interventional procedure status. Taking into account that an “interdisciplinary challenging”, heterogeneous population of patients previously treated by corrective, semi-corrective or palliative surgical procedures is growing inexorably, there is a rapidly increasing need of treatment options besides redo-surgery. Therefore, the review intends to reflect on clinical expansion of percutaneous pulmonary and tricuspid valve procedures, to update on current devices, to discuss indications and patient selection criteria, to report on clinical results and finally to consider future directions. PMID:25914786

A novel flexible microfluidic meshwork to reduce fibrosis in glaucoma surgery.

PubMed

Amoozgar, Behzad; Wei, Xiaoling; Hui Lee, Jun; Bloomer, Michele; Zhao, Zhengtuo; Coh, Paul; He, Fei; Luan, Lan; Xie, Chong; Han, Ying

2017-01-01

Fibrosis and hence capsule formation around the glaucoma implants are the main reasons for glaucoma implant failure. To address these issues, we designed a microfluidic meshwork and tested its biocompatibility in a rabbit eye model. The amount of fibrosis elicited by the microfluidic meshwork was compared to the amount elicited by the plate of conventional glaucoma drainage device. Six eyes from 3 New Zealand albino rabbits were randomized to receive either the novel microfluidic meshwork or a plate of Ahmed glaucoma valve model PF7 (AGV PF7). The flexible microfluidic implant was made from negative photoresist SU-8 by using micro-fabrication techniques. The overall size of the meshwork was 7 mm × 7 mm with a grid period of 100 μm. Both implants were placed in the subtenon space at the supratemporal quadrant in a standard fashion. There was no communication between the implants and the anterior chamber via a tube. All animal eyes were examined for signs of infection and implant erosion on days 1, 3, 7, and 14 and then monthly. Exenterations were performed in which the entire orbital contents were removed at 3 months. Histology slides of the implant and the surrounding tissues were prepared and stained with hematoxylin-eosin. Thickness of the fibrous capsules beneath the implants were measured and compared with paired student's t-test between the two groups. The gross histological sections showed that nearly no capsule formed around the microfluidic meshwork in contrast to the thick capsule formed around the plate of AGV PF7. Thickness of the fibrotic capsules beneath the AGV PF7 plate from the 3 rabbit eyes was 90μm, 82μm, and 95 μm, respectively. The thickness at the bottom of fibrotic capsules around the new microfluidic implant were 1μm, 2μm, and 1μm, respectively. The difference in thickness of capsule between the two groups was significant (P = 0.002). No complications were noticed in the 6 eyes, and both implants were tolerated well by all rabbits

A model to measure fluid outflow in rabbit capsules post glaucoma implant surgery.

PubMed

Nguyen, Dan Q; Ross, Craig M; Li, Yu Qin; Pandav, Surinder; Gardiner, Bruce; Smith, David; How, Alicia C; Crowston, Jonathan G; Coote, Michael A

2012-10-05

Prior models of glaucoma filtration surgery assess bleb morphology, which does not always reflect function. Our aim is to establish a model that directly measures tissue hydraulic conductivity of postsurgical outflow in rabbit bleb capsules following experimental glaucoma filtration surgery. Nine rabbits underwent insertion of a single-plate pediatric Molteno implant into the anterior chamber of their left eye. Right eyes were used as controls. The rabbits were then allocated to one of two groups. Group one had outflow measurements performed at 1 week after surgery (n = 5), and group two had measurements performed at 4 weeks (n = 4). Measurements were performed by cannulating the drainage tube ostium in situ with a needle attached to a pressure transducer and a fluid column at 15 mm Hg. The drop in the fluid column was measured every minute for 5 minutes. For the control eyes (n = 6), the anterior chamber of the unoperated fellow eye was cannulated. Animals were euthanized with the implant and its surrounding capsule dissected and fixed in 4% paraformaldehyde, and embedded in paraffin before 6-μm sections were cut for histologic staining. By 7 days after surgery, tube outflow was 0.117 ± 0.036 μL/min/mm Hg at 15 mm Hg (mean ± SEM), whereas at 28 days, it was 0.009 ± 0.003 μL/min/mm Hg. Control eyes had an outflow of 0.136 ± 0.007 μL/min/mm Hg (P = 0.004, one-way ANOVA). Hematoxylin and eosin staining demonstrated a thinner and looser arrangement of collagenous tissue in the capsules at 1 week compared with that at 4 weeks, which had thicker and more densely arranged collagen. We describe a new model to directly measure hydraulic conductivity in a rabbit glaucoma surgery implant model. The principal physiologic endpoint of glaucoma surgery can be reliably quantified and consistently measured with this model. At 28 days post glaucoma filtration surgery, a rabbit bleb capsule has significantly reduced tissue hydraulic conductivity, in line with loss of implant

Trans-apical aortic valve implantation in patients with severe calcification of the ascending aorta.

PubMed

Buz, Semih; Pasic, Miralem; Unbehaun, Axel; Drews, Thorsten; Dreysse, Stephan; Kukucka, Marian; Mladenow, Alexander; Hetzer, Roland

2011-08-01

In patients with calcification of the ascending aorta, postoperative stroke and mortality rates remain high after conventional aortic valve replacement, but the results of trans-apical aortic valve implantation in these patients are not known. We evaluate the outcome of trans-apical aortic valve implantation in patients with severely calcified ascending aorta in a single center with expanded procedural experience. Between April 2008 and July 2010, 258 patients underwent trans-apical aortic valve implantation using Edwards Sapien valve. By computed tomography (CT) scan, we identified 46 (18%) patients with severe calcification of the ascending aorta (16 with porcelain aorta and 30 with severe, but not complete, calcification). Of 46 patients (mean age 77 ± 10 years, range 63-90 years; EuroSCORE (European System for Cardiac Operative Risk Evaluation) 45 ± 22%; STS (Society of Thoracic Surgeons) score 23 ± 13) with calcified aorta, 15 received 23-mm valves and 31 patients 26-mm valves. Primary valve implantation was successful in 44 patients and a second valve was implanted (valve-in-valve) in two. Six patients underwent concomitant interventions (three elective percutaneous coronary intervention (PCI), one off-pump coronary artery bypass (OPCAB), one tricuspid valve reconstruction, and one left-ventricular (LV) aneurysmectomy). The final procedural results showed valve incompetence (trace or grade 1) in 17 (37%) patients and paravalvular leak in 15 (32.6%) (trace in 10 and grade 1 in five). There was no 30-day mortality. Postoperatively, cranial CT showed new cerebral ischemia areas in three patients (6.2%), but only one patient (2.1%) experienced postoperative neurological deficit (temporary aphasia). Survival at 6 and 12 months was 88% and 85.2%, respectively. Trans-apical aortic valve implantation can be performed safely in patients with aortic valve stenosis and severe calcification of the ascending aorta. Copyright © 2010 European Association for Cardio

Intravalvular Implantation of Mitral Valve Prostheses

PubMed Central

Cooley, Denton A.; Ingram, Michael T.

1987-01-01

We describe a technique of intravalvular implantation of a low-profile prosthesis that has been used in nine patients with mitral valve lesions. This technique preserves the anterior and posterior chordae and papillary mechanisms, which may decrease the incidence of postoperative left ventricular dysfunction that has been noted following standard mitral valve replacement. The technique may also be useful in some patients with aortic and tricuspid regurgitation when the annulus and leaflets are relatively normal pathologically. (Texas Heart Institute Journal 1987;14:188-193) PMID:15229740

Successful treatment of pure aortic insufficiency with transapical implantation of the JenaValve.

PubMed

Bleiziffer, Sabine; Mazzitelli, Domenico; Nöbauer, Christian; Ried, Thomas; Lange, Rüdiger

2013-08-01

Transcatheter aortic valve implantation was predominantly developed for patients with severe calcified aortic stenosis, as most devices are designed to anchor within the native valve calcium. We report on a patient with pure insufficiency of a non-calcified aortic valve, in whom an anatomically oriented catheter valve was implanted successfully. The design of the prosthesis with position feelers engaging the native aortic valve leaflets proved to be suitable for the treatment of pure aortic insufficiency. Georg Thieme Verlag KG Stuttgart · New York.

Update on Minimally Invasive Glaucoma Surgery (MIGS) and New Implants

PubMed Central

Brandão, Lívia M.; Grieshaber, Matthias C.

2013-01-01

Traditional glaucoma surgery has been challenged by the advent of innovative techniques and new implants in the past few years. There is an increasing demand for safer glaucoma surgery offering patients a timely surgical solution in reducing intraocular pressure (IOP) and improving their quality of life. The new procedures and devices aim to lower IOP with a higher safety profile than fistulating surgery (trabeculectomy/drainage tubes) and are collectively termed “minimally invasive glaucoma surgery (MIGS).” The main advantage of MIGS is that they are nonpenetrating and/or bleb-independent procedures, thus avoiding the major complications of fistulating surgery related to blebs and hypotony. In this review, the clinical results of the latest techniques and devices are presented by their approach, ab interno (trabeculotomy, excimer laser trabeculotomy, trabecular microbypass, suprachoroidal shunt, and intracanalicular scaffold) and ab externo (canaloplasty, Stegmann Canal Expander, suprachoroidal Gold microshunt). The drawback of MIGS is that some of these procedures produce a limited IOP reduction compared to trabeculectomy. Currently, MIGS is performed in glaucoma patients with early to moderate disease and preferably in combination with cataract surgery. PMID:24369494

Transapical tricuspid valve-in-ring implantation: An alternative approach to a challenging clinical scenario.

PubMed

Girdauskas, Evaldas; Lauer, Bernward; Kuntze, Thomas

2018-04-01

We report on a transapical tricuspid valve-in-ring implantation performed via right ventricular apex using the Sapien-XT-prosthesis. A 57-year-old woman with recurrent episodes of right heart failure and three previous sternotomies, including tricuspid valve repair with a 32 mm Carpentier-Edwards-Classic annuloplasty ring was admitted due to recurrent severe tricuspid regurgitation. Given the excessive surgical risk, a 29 mm Sapien-XT-prosthesis was selected for valve-in-ring implantation. Transapical valve-in-ring implantation procedure was uneventful. Predischarge echocardiography showed only trace paravalvular tricuspid regurgitation in the septal region. Transapical approach via right ventricular apex is a viable alternative for tricuspid valve-in-ring implantation in selected high-risk patients. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

[Anesthetic management and experience in the transcatheter implantation of the CoreValve(®) self-expanding aortic valve].

PubMed

Fernández Suárez, F E; del Valle Fernández, R; González Alvarez, A; Sánchez Lasheras, J; Fernández Sánchez, L; Argüelles Tamargo, L

2013-10-01

To analyze the experience and anesthetic management in the transcatheter implantation of the CoreValve(®) self-expanding aortic valve, in a university tertiary hospital. Observational analytical review of data incorporated into a prospectively maintained database of 142 patients diagnosed with severe aortic stenosis who underwent implantation of a CoreValve(®) aortic self-expanding aortic valve between December 2007 and December 2012. The mean age of patients was 82.5±6.1 years and the logistic EuroSCORE was 14.9±11.2. General anesthesia was used in 107 patients (75.3%), with local anesthesia with sedation in 35 (24.6%). Local anesthesia and sedation was associated with a lower requirement of vasoactive drugs (P=.003) during implantation. No statistically significant differences were found between the 2 anesthetic techniques in the duration of the procedure, hospital stay, or morbimortality. The success rate was 97.1%. The most common complication was conduction disorders that required implantation of a permanent pacemaker in 46 patients (32.3%). There was no intraoperative mortality, and all-cause mortality at 30 days was 6.3%, with a one-year survival estimated by the Kaplan-Meier of 83.1%. This study confirms that in patients with severe aortic stenosis and high surgical risk, transcatheter implantation of aortic valve is a safe and effective alternative. Both, general anesthesia and local anesthesia with sedation are valid options, depending on the experience of the team. Copyright © 2013 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Published by Elsevier España. All rights reserved.

Transapical aortic valve implantation and minimally invasive off-pump bypass surgery

PubMed Central

Ahad, Samir; Baumbach, Hardy; Hill, Stephan; Franke, Ulrich F. W.

2014-01-01

Transcatheter aortic valve implantation (TAVI) has gained increasing popularity for high-risk patients with symptomatic aortic valve stenosis. A concomitant coronary artery disease leads to a complicated management and an increased perioperative risk. This case report describes the successful total arterial coronary revascularization of the left anterior descending and the left marginal branch of the circumflex artery utilizing the left internal mammary artery (LIMA) and left radial artery in off-pump technique in combination with the transapical transcatheter aortic valve implantation via minimally invasive anterolateral access in the fifth intercostal space. PMID:24221960

Long-Term Mortality Effect of Early Pacemaker Implantation After Surgical Aortic Valve Replacement.

PubMed

Greason, Kevin L; Lahr, Brian D; Stulak, John M; Cha, Yong-Mei; Rea, Robert F; Schaff, Hartzell V; Dearani, Joseph A

2017-10-01

The need for pacemaker implantation is a well-described complication of aortic valve replacement. Not so well described is the effect such an event has on long-term outcome. This study reviewed a 21-year experience at the Mayo Clinic (Rochester, Minnesota) with aortic valve replacement to understand the influence of early postoperative pacemaker implantation on long-term mortality rates more clearly. This study retrospectively reviewed the records of 5,842 patients without previous pacemaker implantation who underwent surgical aortic valve replacement from January 1993 through June 2014. The median age of these patients was 73 years (range, 65 to 79 years), the median ejection fraction was 62% (range, 53% to 68%), 3,853 patients were male (66%), and coronary artery bypass graft operation was performed in 2,553 (44%) of the patients studied. Early pacemaker implantation occurred in 146 patients (2.5%) within 30 days of surgical aortic valve replacement. The median follow-up of patients was 11.1 years (range, 5.8 to 16.5 years), and all-cause mortality rates were 2.4% at 30 days, 6.4% at 1 year, 23.1% at 5 years, 48.3% at 10 years, and 67.9% at 15 years postoperatively. Early pacemaker implantation was associated with an increased risk of death after multivariable adjustment for baseline patients' characteristics (hazard ratio, 1.49; 95% confidence interval, 1.20, 1.84; p < 0.001). Early pacemaker implantation as a complication of surgical aortic valve replacement is associated with an increased risk of long-term death. Valve replacement-related pacemaker implantation rates should be important considerations with respect to new valve replacement paradigms, especially in younger and lower-risk patients. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Transcatheter aortic valve implantation and cerebrovascular accidents.

PubMed

Stortecky, Stefan; Wenaweser, Peter; Windecker, Stephan

2012-09-01

Transcatheter aortic valve implantation (TAVI) is an evidence-based treatment alternative for selected high-risk patients with symptomatic severe aortic stenosis as acknowledged in the most recent edition of the ESC Guidelines on Valvular Heart Disease 2012. However, periprocedural complications and in particular cerebrovascular accidents remain a matter of concern. While transcatheter heart valve technology continuously improves and the development of novel and even less invasive implantation techniques is on-going, cerebrovascular events complicating TAVI may abrogate the usual improvement in terms of prognosis and quality of life. This article describes the incidence of cerebrovascular events after cardiovascular procedures, provides an overview of the pathophysiological mechanisms as well as the impact on outcomes and provides some insights into preventive strategies as well as the acute management of these events.

Dual infection by streptococcus and atypical mycobacteria following Ahmed glaucoma valve surgery.

PubMed

Rao, Aparna; Wallang, Batriti; Padhy, Tapas Ranjan; Mittal, Ruchi; Sharma, Savitri

2013-07-01

To report a case of late postoperative endophthalmitis caused by Streptococcus pneumoniae and conjunctival necrosis by Streptococcus pneumoniae and Mycobacterium fortuitum following Ahmed glaucoma valve (AGV) surgery in a young patient. Case report of a 13-year-old boy with purulent exudates and extensive conjunctival necrosis two months following amniotic membrane graft and conjunctival closure (for conjunctival retraction post AGV for secondary glaucoma). The conjunctiva showed extensive necrosis causing exposure of the tube and plate associated with frank exudates in the area adjoining the plate and anterior chamber mandating explantation of the plate along with intravitreal antibiotics. The vitreous aspirate grew Streptococcus pneumoniae while Streptococcus pneumoniae with Mycobacterium fortuitum was isolated from the explanted plate. Despite adequate control of infection following surgery, the final visual outcome was poor owing to disc pallor. Conjunctival necrosis and retraction post-AGV can cause late postoperative co-infections by fulminant and slow-growing organisms. A close follow-up is therefore essential in these cases to prevent sight-threatening complications.

Two-year survival of Ahmed valve implantation in the first 2 years of life with and without intraoperative mitomycin-C.

PubMed

Al-Mobarak, Faisal; Khan, Arif O

2009-10-01

To evaluate the effect of intraoperative mitomycin-C (MMC) on polypropylene Ahmed glaucoma valve (AGV) survival 2 years after implantation during the first 2 years of life. Retrospective institutional comparative series (1995-2005). Thirty-one eyes of 27 patients (23 unilateral, 4 bilateral; 16 boys, 11 girls) undergoing AGV implantation at a mean age of 11.1 months (standard deviation [SD], 5.46), all of which had 2 years of regular postoperative follow-up. MMC was applied intraoperatively in those cases in the area of AGV implantation in 16 (52%) and was not applied in 15 (48%). In some eyes, MMC was applied intraoperatively in cases done by the surgeons who routinely used MMC for all AGV implantation in young children. Failure was defined as intraocular pressure (IOP) > 22 mmHg with or without glaucoma medications, the need for an additional procedure for IOP control, or the occurrence of significant complications (e.g., endophthalmitis, retinal detachment, persistent hypotony [IOP < 5 mmHg]). Survival was the absence of failure. Failure or significant complications as defined. Mean survival for the non-MMC eyes (22.15 months; standard error [SE], 1.93) was significantly longer than survival for the MMC eyes (16.25 months; SE, 2.17) by the log-rank test (P = 0.025). The difference in cumulative survival at 2 years was also significantly different by log-rank test (P = 0.001): 80.0% (SE 10.3) and 31.3% (SE 11.6), respectively. Rather than improved survival, intraoperative use of MMC was associated with shorter survival 2 years after AGV implantation during the first 2 years of life. We speculate that MMC-induced tissue death can stimulate a reactive fibrosis around the AGV in very young eyes.

Transapical implantation of a second-generation transcatheter heart valve in patients with noncalcified aortic regurgitation.

PubMed

Seiffert, Moritz; Diemert, Patrick; Koschyk, Dietmar; Schirmer, Johannes; Conradi, Lenard; Schnabel, Renate; Blankenberg, Stefan; Reichenspurner, Hermann; Baldus, Stephan; Treede, Hendrik

2013-06-01

This study sought to report on the feasibility and early results of transcatheter aortic valve implantation employing a second-generation device in a series of patients with pure aortic regurgitation. Efficacy and safety of transcatheter aortic valve implantation in patients with calcific aortic stenosis and high surgical risk has been demonstrated. However, experience with implantation for severe noncalcified aortic regurgitation has been limited due to increased risk for valve dislocation or annular rupture. Five patients (mean age: 66.6 ± 7 years) underwent transapical implantation of a JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for moderate to severe, noncalcified aortic regurgitation. All patients were considered high risk for surgical aortic valve replacement after evaluation by an interdisciplinary heart team (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] range 3.1% to 38.9%). Procedural and acute clinical outcomes were analyzed. Implantation was successful in all cases without relevant remaining aortic regurgitation or signs of stenosis in any of the patients. No major device- or procedure-related adverse events occurred and all 5 patients were alive with improved exercise tolerance at 3-month follow-up. Noncalcified aortic regurgitation continues to be a challenging pathology for transcatheter aortic valve implantation due to the risk for insufficient anchoring of the valve stent within the aortic annulus. This report provides first evidence that the JenaValve prosthesis may be a reasonable option in these specific patients due to its unique stent design, clipping the native aortic valve leaflets, and offering promising early results. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Transapical aortic valve implantation without angiography: proof of concept.

PubMed

Ferrari, Enrico; Sulzer, Christopher; Marcucci, Carlo; Rizzo, Elena; Tozzi, Piergiorgio; von Segesser, Ludwig K

2010-06-01

Cardiac computed tomographic scans, coronary angiograms, and aortographies are routinely performed in transcatheter heart valve therapies. Consequently, all patients are exposed to multiple contrast injections with a following risk of nephrotoxicity and postoperative renal failure. The transapical aortic valve implantation without angiography can prevent contrast-related complications. Between November 2008 and November 2009, 30 consecutive high-risk patients (16 female, 53.3%) underwent transapical aortic valve implantation without angiography. The landmarks identification, the stent-valve positioning, and the postoperative control were routinely performed under transesophageal echocardiogram and fluoroscopic visualization without contrast injections. Mean age was 80.1 +/- 8.7 years. Mean valve gradient, aortic orifice area, and ejection fraction were 60.3 +/- 20.9 mm Hg, 0.7 +/- 0.16 cm(2), and 0.526 +/- 0.128, respectively. Risk factors were pulmonary hypertension (60%), peripheral vascular disease (70%), chronic pulmonary disease (50%), previous cardiac surgery (13.3%), and chronic renal insufficiency (40%) (mean blood creatinine and urea levels: 96.8 +/- 54 microg/dL and 8.45 +/- 5.15 mmol/L). Average European System for Cardiac Operative Risk Evaluation was 32.2 +/- 13.3%. Valve deployment in the ideal landing zone was 96.7% successful and valve embolization occurred once. Thirty-day mortality was 10% (3 patients). Causes of death were the following: intraoperative ventricular rupture (conversion to sternotomy), right ventricular failure, and bilateral pneumonia. Stroke occurred in one patient at postoperative day 9. Renal failure (postoperative mean blood creatinine and urea levels: 91.1 +/- 66.8 microg/dL and 7.27 +/- 3.45 mmol/L), myocardial infarction, and atrioventricular block were not detected. Transapical aortic valve implantation without angiography requires a short learning curve and can be performed routinely by experienced teams. Our report

Postoperative Complications in the Ahmed Baerveldt Comparison Study during Five Years of Follow-up

PubMed Central

Budenz, Donald L.; Feuer, William J.; Barton, Keith; Schiffman, Joyce; Costa, Vital P.; Godfrey, David G.; Buys, Yvonne M.

2016-01-01

PURPOSE To compare the late complications in the Ahmed Baerveldt Comparison Study during 5 years of follow-up. DESIGN Multicenter, prospective, randomized clinical trial. METHODS SETTINGS Sixteen international clinical centers. STUDY POPULATION Two hundred seventy six subjects aged 18 to 85 years with previous intraocular surgery or refractory glaucoma with intraocular pressure of > 18 mmHg. INTERVENTIONS Ahmed Glaucoma Valve FP7 or Baerveldt Glaucoma Implant BG 101-350. MAIN OUTCOME MEASURES Late postoperative complications (beyond 3 months), reoperations for complications, and decreased vision from complications. RESULTS Late complications developed in 56 subjects (46.8 ± 4.8 5 year cumulative % ± SE) in the Ahmed Glaucoma Valve group and 67 (56.3 ± 4.7 5 year cumulative % ± SE) in the Baerveldt Glaucoma Implant group (P = 0.082). The cumulative rates of serious complications were 15.9% and 24.7% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups respectively (P = 0.034) although this was largely driven by subjects who had tube occlusions in the two groups (0.8% in the Ahmed Glaucoma Valve group and 5.7% in the Baerveldt Glaucoma Implant group, P = 0.037). Both groups had a relatively high incidence of persistent diplopia (12%) and corneal edema (20%), although half of the corneal edema cases were likely due to pre-existing causes other than the aqueous shunt. The incidence of tube erosion was 1% and 3% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P = 0.04). CONCLUSIONS Long term rates of vision threatening complications and complications resulting in reoperation were higher in the Baerveldt Glaucoma Implant than the Ahmed Glaucoma Valve group over 5 years of follow-up. PMID:26596400

Redo aortic valve surgery versus transcatheter valve-in-valve implantation for failing surgical bioprosthetic valves: consecutive patients in a single-center setting

PubMed Central

Wottke, Michael; Deutsch, Marcus-André; Krane, Markus; Piazza, Nicolo; Lange, Ruediger; Bleiziffer, Sabine

2015-01-01

Background Due to a considerable rise in bioprosthetic as opposed to mechanical valve implantations, an increase of patients presenting with failing bioprosthetic surgical valves in need of a reoperation is to be expected. Redo surgery may pose a high-risk procedure. Transcatheter aortic valve-in-valve implantation is an innovative, less-invasive treatment alternative for these patients. However, a comprehensive evaluation of the outcome of consecutive patients after a valve-in-valve TAVI [transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV)] as compared to a standard reoperation [surgical aortic valve redo-operation (SAV-in-SAV)] has not yet been performed. The goal of this study was to compare postoperative outcomes after TAV-in-SAV and SAV-in-SAV in a single center setting. Methods All SAV-in-SAV and TAV-in-SAV patients from January 2001 to October 2014 were retrospectively reviewed. Patients with previous mechanical or transcatheter valves, active endocarditis and concomitant cardiac procedures were excluded. Patient characteristics, preoperative data, post-procedural complications, and 30-day mortality were collected from a designated database. Mean values ± SD were calculated for all continuous variables. Counts and percentages were calculated for categorical variables. The Chi-square and Fisher exact tests were used to compare categorical variables. Continuous variables were compared using the t-test for independent samples. A 2-sided P value <0.05 was considered statistically significant. Results A total of 102 patients fulfilled the inclusion criteria, 50 patients (49%) underwent a transcatheter valve-in-valve procedure, while 52 patients (51%) underwent redo-surgery. Patients in the TAV-in-SAV group were significantly older, had a higher mean logistic EuroSCORE and exhibited a lower mean left ventricular ejection fraction than patients in the SAV-in-SAV group (78.1±6.7 vs. 66.2±13.1, P<0.001; 27.4±18.7 vs. 14.4±10, P<0.001; and 49.8±13

Needle Revision With 5-fluorouracil for the Treatment of Ahmed Glaucoma Valve Filtering Blebs: 5-Fluoruracil Needling Revision can be a Useful and Safe Tool in the Management of Failing Ahmed Glaucoma Valve Filtering Blebs.

PubMed

Quaranta, Luciano; Floriani, Irene; Hollander, Lital; Poli, Davide; Katsanos, Andreas; Konstas, Anastasios G P

2016-04-01

To determine the outcome of needling with adjunctive 5-fluorouracil (5-FU) in patients with a failing Ahmed glaucoma valve (AGV) implant, and to identify predictors of long-term intraocular pressure (IOP) control. A prospective observational study was performed on consecutive patients with medically uncontrolled primary open-angle glaucoma (POAG) with AGV encapsulation or fibrosis and inadequate IOP control. Bleb needling with 5-FU injection (0.1 mL of 50 mg/mL) was performed at the slit-lamp. Patients were examined 1 week following the needling, and then at months 1, 3, and 6. Subsequent follow-up visits were scheduled at 6-month intervals for at least 2 years. Needling with 5-FU was repeated no more than twice during the first 3 months of the follow-up. Procedure outcome was determined on the basis of the recorded IOP levels. Thirty-six patients with an encapsulated or fibrotic AGV underwent 67procedures (mean 1.86 ± 0.83). Complete success, defined as IOP ≤ 18 mm Hg without medications, was obtained in 25% at 24 months of observation. The cumulative proportion of cases achieving either qualified (ie, IOP ≤ 18 mm Hg with medications) or complete success at 24 months of observation was 72.2%. In a univariate Cox proportional hazards model, age was the only variable that independently influenced the risk of failing 5-FU needling revision. Fourteen eyes (38.8%) had a documented complication. Needling over the plate of an AGV supplemented with 5-FU is an effective and safe choice in a significant proportion of POAG patients with elevated IOP due to encapsulation or fibrosis.

Trans-apical aortic valve implantation using a new self-expandable bioprosthesis: initial outcomes.

PubMed

Kempfert, Jörg; Rastan, Ardawan J; Beyersdorf, Friedhelm; Schönburg, Markus; Schuler, Gerhard; Sorg, Stefan; Mohr, Friedrich-W; Walther, Thomas

2011-11-01

Trans-apical aortic valve implantation (TA-AVI) has evolved into a standard approach for high-risk, elderly patients using the balloon-expandable Edwards SAPIEN™ prosthesis. As an alternative device, a self-expanding sub-coronary trans-apical bioprosthesis was evaluated. The Symetis Acurate™ trans-catheter heart valve is composed of a porcine biologic valve attached to a self-expandable nitinol stent. It allows for anatomical orientation, and facilitates intuitive implantation providing tactile feedback. Three valves sizes were available to treat patients with an annular diameter between 21 and 27mm. Since November 2009, a total of 40 patients have been treated at three sites. Patient age was 82.8±4 years, 60% were female, logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 21.5±10.9% and Society of Thoracic Surgeons (STS) Score was 9.0±4.6%. All implants were delivered successfully in the intra-annular and sub-coronary position off pump. One patient was converted to conventional surgery due to coronary impingement; post-dilatation was performed in 45% of patients; and two patients required the SAPIEN™ valve in valve implantation. Echocardiographic and angiographic control revealed no/trivial aortic incompetence (AI) in 59%, mild AI in 33.3%, and moderate AI in 7.7% of the patients. Three patients died within 30 days from a non-valve-related cause (respiratory), the patient converted did not recover from right-heart failure, and one patient died on day 19 due to unclear reasons. There was one incidence of new-onset atrioventricular (AV) block requiring pacemaker implantation. Two patients suffered a stroke (one secondary and the other intraprocedural). Transvalvular gradients were maximum 29.4±10.7mmHg and mean 14.3±6.8mmHg. The initial clinical results indicate a relatively straightforward implantation procedure and good functional results after trans-apical implantation of the Symetis Acurate™ device. Copyright © 2011

Transcatheter treatment of tricuspid regurgitation by caval valve implantation--experimental evaluation of decellularized tissue valves in central venous position.

PubMed

Lauten, Alexander; Laube, Adrian; Schubert, Harald; Bischoff, Sabine; Nietzsche, Sandor; Horstkötter, Kim; Poudel-Bochmann, Bhawana; Franz, Marcus; Lichtenberg, Artur; Figulla, Hans R; Akhyari, Payam

2015-01-01

Caval valve implantation has been suggested for transcatheter treatment of severe tricuspid regurgitation (TR). Combining the interventional technique with the promising surgical experience with decellularized valves, we sought to evaluate the functional and structural outcome of decellularized pericardial tissue valves (dTVs) in the low-pressure venous circulation in a chronic model of TR. Sixteen pericardial tissue valves were heterotopically implanted in the inferior and superior vena cava in a sheep model (54-98 kg; median 74.5 kg, n = 8) of severe TR. The devices were assembled using self-expanding nitinol stents and bovine pericardia decellularized by a detergent-based protocol (group dTV; n = 8). Glutaraldehyde-fixed pericardial tissue valves served as control (GaTV, n = 8). After 6 months, device function and structural maturation were analyzed using echocardiographic, histologic, immunohistologic, and electron microscopic approaches. After implantation, cardiac output increased significantly from 3.7 ± 1.1 l/min to 4.8 ± 1.1 l/min (P < 0.05) and competent valve function was verified by angiography. At 6 months, angiographic and echocardiographic evaluation revealed moderate to severe regurgitation in all GaTV. In contrast, five of the eight dTVs functioned well with only minor regurgitation. In these animals, autopsy revealed preserved valve structure with tender leaflets without signs of thrombosis or calcification. Conversely, GaTV showed severe degeneration with large calcification areas. Microscopic and histologic analysis confirmed endothelial repopulation in both valve types. However, additional interstitial reseeding was observed in decellularized valves. In the venous circulation in severe TR, decellularized valves show superior functional performance compared to Ga-fixed tissue valves. Macroscopic and microscopic analyses suggest preserved structural integrity and advanced endothelial and interstitial repopulation with

Endoscopic cyclophotocoagulation in refractory glaucoma after osteo-odonto-keratoprosthesis in Stevens-Johnson syndrome: a case report.

PubMed

Forlini, Matteo; Adabache-Guel, Tania; Bratu, Adriana; Rossini, Paolo; Mingaine, Mpekethu Sam; Cavallini, Gian Maria; Forlini, Cesare

2014-01-01

To report successful treatment of refractive glaucoma in a patient submitted to osteo-odonto-keratoprosthesis surgery for Stevens-Johnson syndrome. An interventional case report. The patient is a 62-year-old Indian man with known Stevens-Johnson syndrome since 1972 secondary to tetracycline therapy, with bilateral dry eye and corneal blindness. He underwent symblepharon release surgery with mucous membrane graft in both eyes. Osteo-odonto-keratoprosthesis surgery was later performed on the left eye. He was submitted to 2 Ahmed valve implants to control secondary glaucoma but visual fields continued to worsen; hence, he underwent endoscopic 140° cyclophotocoagulation with a good control of IOP. Endoscopic cyclophotocoagulation as alternative treatment provides good results in refractory glaucoma after osteo-odonto-keratoprosthesis surgery.

A novel antiproliferative drug coating for glaucoma drainage devices.

PubMed

Ponnusamy, Thiruselvam; Yu, Haini; John, Vijay T; Ayyala, Ramesh S; Blake, Diane A

2014-01-01

The implantation of a glaucoma drainage device (GDD) is often necessary for intractable cases of glaucoma. Currently, the success rate of GDD implants is relatively low because fibrosis that develops during the wound-healing process ultimately blocks fluid drainage. We describe herein a novel porous coating for Ahmed glaucoma valves based on biodegradable poly(lactic-co-glycolic acid) (PLGA). Thin films of PLGA were fabricated using a spin-coating technique. The procedure led to an asymmetric pore structure that was exploited to control the rate of dissolution. Double-layered porous films were constructed to achieve continuous drug release. A cell culture system was used to test the efficacy of these coatings. Double-layered films were manufactured to provide a burst of mitomycin C (MMC) release followed by a slow release of 5-fluorouracil (5-FU), which together prevented fibrosis over the most active period of postoperative wound healing (0 to 28 d). Double-layered films containing 5-FU only in the bottom layer showed a 3- to 5-day delay in drug release, followed by a sharp increase that continued for ~28 days. MMC was stable only when surface-loaded, and this drug was therefore surface-loaded onto the top PLGA layer to provide a continuous release of antifibrotics over the wound-healing period. The combined use of both MMC and 5-FU in a biodegradable device inhibits cell proliferation in a tissue culture model and has the potential to reduce fibrosis and increase the success rate of GDD implants. The design is simple and can be scaled for commercial production.

Trabecular micro-bypass stent implantation during small-incision cataract surgery for open-angle glaucoma or ocular hypertension: Long-term results.

PubMed

Neuhann, Tobias H

2015-12-01

To evaluate long-term safety and efficacy of iStent trabecular micro-bypass stent implantation during cataract surgery in patients with primary open-angle, pseudo-exfoliation glaucoma, ocular hypertension, or secondary or post-traumatic glaucoma. AaM Augenklinik am Marienplatz, Munich, Germany. Prospective, open-label, non-randomized study. Preoperative and postoperative evaluations included intra-ocular pressure (IOP), topical ocular hypotensive medication use, cup/disc ratio, corrected-distance visual acuity (CDVA), complications, and adverse events. A single trabecular micro-bypass stent was implanted through the same temporal, limbal incision used for cataract surgery via phacoemulsification in a consecutive series of 62 eyes of 43 patients. To date, a total of 41 eyes have been followed for 3 years postoperatively, whereas long-term postoperative follow-up on the remaining patients is ongoing. Mean preoperative IOP was 24.1 ± 6.9 mm Hg on a mean of 1.8 medications (±0.9). Analyses of eyes with no secondary surgical intervention showed mean IOP reduction to 14.8 ± 4.2 mm Hg at 12 months (n = 61), 14.5 ± 2.2 mm Hg at 24 months (n = 42), and 14.9 ± 2.3 mm Hg at 36 months (n = 39). Medications were eliminated in 74% of eyes at 36 months. Five eyes, 4 with previous glaucoma surgeries and 1 with pseudo-exfoliation syndrome, required additional glaucoma surgery after stent implantation. No intra-operative or postoperative complications typically seen with conventional glaucoma surgeries occurred after stent implantation. At 36 months, CDVA was 20/40 or better in 38 eyes (93%). Trabecular micro-bypass stent implantation during cataract surgery was safe and effective in patients with ocular hypertension or glaucoma as measured by a sustained reduction in IOP and medication use and an excellent safety profile through 3 years after surgery. Dr. Neuhann has no financial or proprietary interest in any material or method mentioned. Glaukos Corp. provided editorial

Transcatheter valve implantation can alter fluid flow fields in aortic sinuses and ascending aorta

NASA Astrophysics Data System (ADS)

Saikrishnan, Neelakantan; Yoganathan, Ajit

2012-11-01

Transcatheter aortic valves (TAVs) are valve replacements used to treat aortic stenosis. Currently, these have been used in elderly patients at high-risk for open-heart procedures. Since these devices are implanted under fluoroscopic guidance, the implantation position of the valve can vary with respect to the native aortic valve annulus. The current study characterizes the altered hemodynamics in the aortic sinus and ascending aorta under different implantation (high and low) and cardiac output (2.5 and 5.0 L/min) conditions. Two commonly used TAV designs are studied using 2-D Particle Image Velocimetry (PIV). 200 phase locked images are obtained at every 25ms in the cardiac cycle, and the resulting vector fields are ensemble averaged. High implantation of the TAV with respect to the annulus causes weaker sinus washout and weaker sinus vortex formation. Additionally, the longer TAV leaflets can also result in a weaker sinus vortex. The level of turbulent fluctuations in the ascending aorta did not appear to be affected by axial positioning of the valve, but varied with cardiac output. The results of this study indicates that TAV positioning is important to be considered clinically, since this can affect coronary perfusion and potential flow stagnation near the valve.

[Initial experience of transcatheter implantation with a new aortic valve in sheep].

PubMed

Wang, Jian-ming; Yang, Jian; Yang, Li-fang; Zhang, Xue-xin; Hu, Yun; Liu, Jin-cheng; Yu, Shi-qiang; Yi, Ding-hua

2011-11-01

To evaluate the feasibility and short-term results of transcatheter aortic valve implantation (TAVI) using a new transcatheter valve. Twenty healthy adult sheep received general anesthesia. Under the guidance of X-ray and transthoracic echocardiography (TTE), the new anti-calcification transcatheter valve was released from delivery system and implanted at the level of native aortic annulus via left common carotid artery. Position and function of the new anti-calcification transcatheter valve were evaluated by angiography and TTE immediately after intervention. Thirty day survival rate of animals was obtained. New transcatheter valves were implanted in all sheep. Fifteen sheep (75%) survived up to 30 days and post-operative examination showed that the transcatheter valve was in optimal position without migration and mitral valve impingement. The native coronary artery was patent in these animals. There was a slight paravalvular leak in 5 sheep. Postoperative echocardiography showed reflux percentage was significantly increased (P < 0.05) compared pre-intervention. Effective orifice area, aortic systolic pressure, diastolic aortic pressure, mean aortic pressure, left ventricular systolic pressure, left ventricular end diastolic pressure and heart rate were similar between post and pre-intervention (all P < 0.05). Five sheep died after TAVI within 30 days, including one fatal ventricular fibrillation occurred immediately after releasing the transcatheter valve and another sheep died of acute myocardial infarction due to left main coronary artery occlusion evidenced by angiography. Two sheep died of severe mitral regurgitation at 8 and 12 hours post-operation and one died of infective endocarditis at 26 days after intervention. Our favorable preliminary results showed that it was feasible to perform TAVI using the new transcatheter valve.

Transapical Transcatheter Aortic Valve Implantation Using the JenaValve: A One-Year Follow-up.

PubMed

Reuthebuch, Oliver; Koechlin, Luca; Kaufmann, Beat A; Kessel-Schaefer, Arnheid; Gahl, Brigitta; Eckstein, Friedrich S

2015-09-01

Since the first transcatheter aortic valve implantation (TAVI) in 2002, TAVI technique has gained an increasing popularity especially in high-risk patients. In this study, we present the first echocardiographic midterm outcome with the second-generation transapical JenaValve TAVI system (JenaValve Technology GmbH, Munich, Germany) in patients with aortic stenosis (AS). Between November 2011 and November 2012, a total of 28 patients received transapical TAVI using the JenaValve. Primary endpoint was a combined efficacy endpoint after 1 year, which included all-cause mortality after more than 30 days, failure of current therapy for AS requiring hospitalization for symptoms of valve-related cardiac decompensation or prosthetic heart valve dysfunction. Moreover, we analyzed secondary endpoints after 3 and 12 months including cardiovascular mortality; major stroke; and life-threatening, disabling, or major bleeding. Mean echocardiographic follow-up was 471.35 ± 102.72 days. Mean age was 80.43 ± 6.03 years and EuroSCORE II was 8.80 ± 7.21%. Successful implantation was accomplished in 100% (n = 28). Median transvalvular aortic mean pressure gradient was 44.5 mm Hg (interquartile range [IQR]: 34.5; 55.5) preoperatively, 12 mm Hg (IQR: 9; 16) postoperatively, and 11 mm Hg (IQR: 8; 16) after 1 year. After 12 months, no paravalvular leakage was seen in 52.38% of the patients and grade 1 paravalvular leakage was seen in 47.62% of the patients. There was no grade 2 or 3 leakage detected. Stroke, valve thrombosis or dislocation, myocardial infarction, or bleeding was also not observed. However, criteria for the combined efficacy endpoint after 1 year were met in five patients (17.86%). Thirty-day mortality was 14.29% (n = 4) and all-cause mortality after 1 year was 21.43% (n = 6). The JenaValve transapical TAVI system is a safe and feasible procedure with low peri- and postoperative complications and convincing midterm performance of the

Incidence of secondary glaucoma in behcet disease.

PubMed

Elgin, Ufuk; Berker, Nilufer; Batman, Aygen

2004-12-01

To determine the incidence of secondary glaucoma in Behcet disease. A total of 230 eyes of 129 patients with Behcet disease, were examined in uveitis and glaucoma clinics of Ankara Social Security Eye Hospital between January 1997 and September 2002. The data from all patients were investigated both retrospectively and prospectively. The mean age of 129 patients was 34.2 +/- 7.4 years (range, 18 to 55 years). In 22 patients (17%), the disease was diagnosed on the basis of the ocular findings, while in the remaining 107 patients (83%), the period between the diagnosis of Behcet disease and the onset of the ocular symptoms was 23.3 +/- 17 months (range, 1 month to 5.3 years); 122 eyes (53%) had the episodes of acute recurrent iridocyclitis, while 108 eyes (47%) developed chronic posterior uveitis, including vitreitis, retinitis, vasculitis, or optic nerve involvement. Secondary glaucoma was diagnosed in 25 eyes (10.9%); 11 eyes (44%) with steroid or inflammation induced open angle glaucoma, 6 eyes (24%) with partial angle-closure glaucoma and peripheral anterior synechiae, 5 eyes (20%) with angle closure glaucoma, peripheral anterior synechiae, and pupil block and 3 eyes (12%) with neovascular glaucoma. The treatments included YAG-laser iridotomy in 5 eyes, diode-laser cyclodestruction in 3 eyes, primary trabeculectomies with mitomycin-c in 4 eyes, secondary trabeculectomies with mitomycin-c in 2 eyes, Ahmed valve implantations in 2 eyes, and cyclocryotherapy in 3 eyes. We suggest that secondary glaucoma is a common and serious complication of Behcet disease. It develops as a result of multiple factors, generally triggered by recurrent intraocular inflammation. Early recognition and treatment of these factors have vital importance to avoid the visual morbidity.

Transcatheter aortic valve implantation in patients with bicuspid aortic valve stenosis.

PubMed

Wijesinghe, Namal; Ye, Jian; Rodés-Cabau, Josep; Cheung, Anson; Velianou, James L; Natarajan, Madhu K; Dumont, Eric; Nietlispach, Fabian; Gurvitch, Ronen; Wood, David A; Tay, Edgar; Webb, John G

2010-11-01

We evaluated transcatheter aortic valve implantation (TAVI) in high-risk patients with bicuspid aortic valve (BAV) stenosis. TAVI shows promise in the treatment of severe stenosis of triscupid aortic valves, especially in high-risk patients. However, BAV stenosis has been considered a contraindication to TAVI. Eleven patients (age 52 to 90 years) with symptomatic severe BAV stenosis underwent TAVI at 3 Canadian tertiary hospitals between May 2006 and April 2010. All patients were considered high risk for surgical aortic valve replacement. Edwards-SAPIEN transcatheter heart valves (Edwards Lifesciences, Inc., Irvine, California) were used. Transfemoral or transapical access was selected, depending on the adequacy of femoral access. Access was transfemoral in 7 patients and transapical in 4 patients. There were no intraprocedural complications. Significant symptomatic and hemodynamic improvement was observed in 10 of 11 patients. Baseline aortic valve area of 0.65 ± 0.17 cm(2) and mean transaortic pressure gradient of 41 ± 22.4 mm Hg were improved to 1.45 ± 0.3 cm(2) and 13.4 ± 5.7 mm Hg, respectively. Two patients had moderate perivalvular leaks. At the 30-day follow-up there were 2 deaths due to multisystem failure in 2 transapical patients. In 1 patient an undersized, suboptimally positioned, unstable valve required late conversion to open surgery. TAVI in selected high-risk patients with severe BAV stenosis can be successfully performed with acceptable clinical outcomes but will require further evaluation. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Patient-specific simulation of guidewire deformation during transcatheter aortic valve implantation.

PubMed

Vy, Phuoc; Auffret, Vincent; Castro, Miguel; Badel, Pierre; Rochette, Michel; Haigron, Pascal; Avril, Stéphane

2018-06-01

Transcatheter aortic valve implantation is a recent mini-invasive procedure to implant an aortic valve prosthesis. Prosthesis positioning in transcatheter aortic valve implantation appears as an important aspect for the success of the intervention. Accordingly, we developed a patient-specific finite element framework to predict the insertion of the stiff guidewire, used to position the aortic valve. We simulated the guidewire insertion for 2 patients based on their pre-operative CT scans. The model was designed to primarily predict the position and the angle of the guidewires in the aortic valve, and the results were successfully compared with intraoperative images. The present paper describes extensively the numerical model, which was solved by using the ANSYS software with an implicit resolution scheme, as well as the stabilization techniques which were used to overcome numerical instabilities. We performed sensitivity analysis on the properties of the guidewire (curvature angle, curvature radius, and stiffness) and the conditions of insertion (insertion force and orientation). We also explored the influence of the model parameters. The accuracy of the model was quantitatively evaluated as the distance and the angle difference between the simulated guidewires and the intraoperative ones. A good agreement was obtained between the model predictions and intraoperative views available for 2 patient cases. In conclusion, we showed that the shape of the guidewire in the aortic valve was mainly determined by the geometry of the patient's aorta and by the conditions of insertion (insertion force and orientation). Copyright © 2018 John Wiley & Sons, Ltd.

New-generation devices for transcatheter aortic valve implantation.

PubMed

Gatto, Laura; Biondi-Zoccai, Giuseppe; Romagnoli, Enrico; Frati, Giacomo; Prati, Francesco; Giordano, Arturo

2018-04-20

Transcatheter aortic valve implantation (TAVI) has overcome the pioneering phase and thanks to accrued clinical evidence has become a mainstay alternative to surgical aortic valve replacement (SAVR) in patients at high risk for post-operative complications. Despite these successes, TAVI remains a junior technology facing momentous developments in techniques and devices. Indeed, several new-generation devices for TAVI have become available in the last few years, including Acurate, Allegra, Evolut, Lotus, JenaValve, Portico, and SAPIEN3. Despite the inevitable setbacks, such as the one represented by DirectFlow, these new devices appear associated with comparative benefits, especially for minimal invasiveness, rates of permanent pacemaker implantation, and risk of residual aortic regurgitation. Indeed, no single device appears clearly better than the others, and a tailored and individualized approach should be sought in using these prostheses, taking into account operator and institutional expertise, on top of patient features. Few comparative effectiveness studies are available to date to guide decision making, and thus careful scrutiny is needed even in everyday clinical practice, especially if seeking to expand the current indications of TAVI. Further guidance will however come from long-term follow-up of completed studies and from results of ongoing trials.

Tissue-Engineered Heart Valve with a Tubular Leaflet Design for Minimally Invasive Transcatheter Implantation

PubMed Central

Moreira, Ricardo; Velz, Thaddaeus; Alves, Nuno; Gesche, Valentine N.; Malischewski, Axel; Schmitz-Rode, Thomas; Frese, Julia

2015-01-01

Transcatheter aortic valve implantation of (nonviable) bioprosthetic valves has been proven a valid alternative to conventional surgical implantation in patients at high or prohibitive mortality risk. In this study we present the in vitro proof-of-principle of a newly developed tissue-engineered heart valve for minimally invasive implantation, with the ultimate aim of adding the unique advantages of a living tissue with regeneration capabilities to the continuously developing transcatheter technologies. The tube-in-stent is a fibrin-based tissue-engineered valve with a tubular leaflet design. It consists of a tubular construct sewn into a self-expandable nitinol stent at three commissural attachment points and along a circumferential line so that it forms three coaptating leaflets by collapsing under diastolic back pressure. The tubular constructs were molded with fibrin and human umbilical vein cells. After 3 weeks of conditioning in a bioreactor, the valves were fully functional with unobstructed opening (systolic phase) and complete closure (diastolic phase). Tissue analysis showed a homogeneous cell distribution throughout the valve's thickness and deposition of collagen types I and III oriented along the longitudinal direction. Immunohistochemical staining against CD31 and scanning electron microscopy revealed a confluent endothelial cell layer on the surface of the valves. After harvesting, the valves underwent crimping for 20 min to simulate the catheter-based delivery. This procedure did not affect the valvular functionality in terms of orifice area during systole and complete closure during diastole. No influence on the extracellular matrix organization, as assessed by immunohistochemistry, nor on the mechanical properties was observed. These results show the potential of combining tissue engineering and minimally invasive implantation technology to obtain a living heart valve with a simple and robust tubular design for transcatheter delivery. The effect

INFECTIOUS ENDOPHTHALMITIS AFTER GLAUCOMA DRAINAGE IMPLANT SURGERY: Clinical Features, Microbial Spectrum, and Outcomes.

PubMed

Zheng, Cindy X; Moster, Marlene R; Khan, M Ali; Chiang, Allen; Garg, Sunir J; Dai, Yang; Waisbourd, Michael

2017-06-01

To report the clinical features, microbial spectrum, and treatment outcomes of endophthalmitis after glaucoma drainage implant (GDI) surgery. Records of patients diagnosed with endophthalmitis after GDI surgery were reviewed. Data on clinical course, microbiological laboratory results, and treatment were analyzed. Of 1,891 eyes that underwent GDI surgery, 14 eyes (0.7%) developed endophthalmitis. The mean time interval between GDI surgery and diagnosis of endophthalmitis was 2.6 ± 3.2 years (median, 1.3 years; range, 11 days-11.4 years). For initial treatment, 13/14 eyes underwent vitreous tap and injection of intravitreal antibiotics and 1/14 eyes underwent primary pars plana vitrectomy. Three additional eyes underwent pars plana vitrectomy because of deteriorating clinical course. Glaucoma drainage implant erosion was present in 9/14 eyes. All 9 eroded GDIs were surgically removed within a mean of 9 ± 5 days (range 2-29 days) after diagnosis of endophthalmitis. Overall, mean logarithm of the minimum angle of resolution best-corrected visual acuity worsened from 0.7 ± 0.7 (Snellen equivalent 20/100) at baseline to 1.6 ± 1.1 (Snellen equivalent 20/800) at final follow-up (P = 0.005). Mean duration between the onset of symptoms and presentation was significantly longer in patients with decreased final best-corrected visual acuity (>2 Snellen lines) compared to patients with stable final best-corrected visual acuity (6.8 vs. 1.0 days; P = 0.005). Glaucoma drainage implant-related endophthalmitis is rare and often associated with GDI erosion. Patients who presented earlier after the onset of symptoms had better final visual outcomes. Prompt evaluation and treatment is required, often with removal of the eroded GDI.

Reliable experimental setup to test the pressure modulation of Baerveldt Implant tubes for reducing post-operative hypotony

NASA Astrophysics Data System (ADS)

Ramani, Ajay

Glaucoma encompasses a group of conditions that result in damage to the optic nerve and can cause loss of vision and blindness. The nerve is damaged due to an increase in the eye's internal (intraocular) pressure (IOP) above the nominal range of 15 -- 20 mm Hg. There are many treatments available for this group of diseases depending on the complexity and stage of nerve degradation. In extreme cases where drugs or laser surgery do not create better conditions for the patient, ophthalmologists use glaucoma drainage devices to help alleviate the IOP. Many drainage implants have been developed over the years and are in use; but two popular implants are the Baerveldt Glaucoma Implant and the Ahmed Glaucoma Valve Implant. Baerveldt Implants are non-valved and provide low initial resistance to outflow of fluid, resulting in post-operative complications such as hypotony, where the IOP drops below 5 mm of Hg. Ahmed Glaucoma Valve Implants are valved implants which initially restrict the amount of fluid flowing out of the eye. The long term success rates of Baerveldt Implants surpass those of Ahmed Valve Implants because of post-surgical issues; but Baerveldt Implants' initial effectiveness is poor without proper flow restriction. This drives the need to develop new ways to improve the initial effectiveness of Baerveldt Implants. A possible solution proposed by our research team is to place an insert in the Baerveldt Implant tube of inner diameter 305 microns. The insert must be designed to provide flow resistance for the early time frame [e.g., first 30 -- 60 post-operative days] until sufficient scar tissue has formed on the implant. After that initial stage with the insert, the scar tissue will provide the necessary flow resistance to maintain the IOP above 5 mm Hg. The main objective of this project was to develop and validate an experimental apparatus to measure pressure drop across a Baerveldt Implant tube, with and without inserts. This setup will be used in the

Comparison of the Ahmed and Baerveldt glaucoma shunts with combined cataract extraction.

PubMed

Rai, Amrit S; Shoham-Hazon, Nir; Christakis, Panos G; Rai, Amandeep S; Ahmed, Iqbal Ike K

2018-04-01

To compare the surgical outcomes of combined phacoemulsification with either Ahmed glaucoma valve (AGV) or Baerveldt glaucoma implant (BGI). Retrospective cohort study. A total of 104 eyes that underwent combined phacoemulsification with either AGV (PhacoAGV; n = 57) or BGI (PhacoBGI; n = 47) implantation. Failure was defined as uncontrolled intraocular pressure (IOP; <5 mm Hg, ≥18 mm Hg, or <20% reduction), additional glaucoma surgery, vision-threatening complications, or progression to no-light-perception vision. The PhacoAGV group was older (p = 0.03), had poorer baseline visual acuity (VA; p = 0.001), and had fewer previous glaucoma surgeries (p = 0.04). Both groups had similar baseline IOP (PhacoAGV: 26.4 ± 8.3 mm Hg; PhacoBGI: 25.7 ± 7.3; p = 0.66) and glaucoma medications (PhacoAGV: 3.8 ± 1.0; PhacoBGI: 3.6 ± 1.5; p = 0.54). At 2 years, failure rates were 44% in the PhacoAGV group and 23% in the PhacoBGI group (p = 0.02). Both groups had similar mean IOP reduction (PhacoAGV: 45%; PhacoBGI: 47%, p = 0.67) and medication use reduction (PhacoAGV: 47%; PhacoBGI: 58%, p = 0.38). The PhacoBGI group had higher IOP and medication use up to 1 month (p < 0.05). Both groups improved in VA from baseline (p < 0.05) and had similar overall complication rates (p = 0.31). The PhacoBGI group required more overall interventions (p < 0.0005). This comparative study found no difference in IOP, glaucoma medications, or complication rates between PhacoAGV and PhacoBGI at 2 years, despite BGIs being implanted in patients at higher risk for failure. The PhacoAGV group had higher failure rates at 2 years. Both groups had significant improvements in VA due to removal of their cataracts. The PhacoBGI group required more interventions, but most of these were minor slit-lamp procedures. Copyright © 2018. Published by Elsevier Inc.

Outcomes of fornix-based versus limbus-based conjunctival incisions for glaucoma drainage device implant.

PubMed

Suhr, Abraham W; Lim, Michele C; Brandt, James D; Izquierdo, Juan Carlos; Willits, Neil

2012-01-01

To determine the effect of conjunctival incision location on the long-term efficacy of nonvalved glaucoma drainage devices. We conducted a retrospective review of patients ≥18 years of age with uncontrolled glaucoma [intraocular pressure (IOP) ≥18 mm Hg] who underwent glaucoma drainage device implantation. A comparison was made of a limbal-based (LB-BGI) versus fornix-based (FB-BGI) conjunctival flap during placement of a 350-mm Baerveldt glaucoma implant (AMO, Santa Ana, CA) in subjects with at least 1 year of follow-up data. The primary outcome measure was IOP; secondary outcome measures were medication burden, visual acuity, and surgical complications. One hundred sixty eyes of 147 glaucoma patients were included. Two years after surgery, the IOP in the LB-BGI group was 14.3±5.3 mm Hg and in the FB-BGI group 13.1±4.7 mm Hg (P=0.47). Overall success of IOP control was achieved at the final visit (range 1 to 5 y) in 90% of the LB-BGI group and 87% of the FB-BGI group (P=0.63). The medication burden of the 2 groups at 1 and 2 years after surgery was not statistically significantly different. Worsening of visual acuity by more than 2 lines was not statistically different between the groups 2 years after the surgery and at the final visit (P=0.47, P=0.60, respectively). A greater number of eyes developed endophthalmitis and were more likely to undergo subsequent tube revision in the FB-BGI group, but the differences were not significant. Both incision techniques were equally effective in controlling IOP. Each surgical approach has its advantages and this study suggests that either technique may be used safely and effectively.

Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: feasibility and safety.

PubMed

Fiorina, Claudia; Maffeo, Diego; Curello, Salvatore; Lipartiti, Felicia; Chizzola, Giuliano; D'Aloia, Antonio; Adamo, Marianna; Mastropierro, Rosy; Gavazzi, Emanuele; Ciccarese, Camilla; Chiari, Ermanna; Ettori, Federica

2014-06-01

Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve. Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI. High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85%vs.64%,p=0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL≥2;9%vs.33%,p=0.02). Safety combined end point at 30 days was similar in both groups. Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups. Copyright © 2014 Elsevier Inc. All rights reserved.

Single-center experience and short-term outcome with the JenaValve: a second-generation transapical transcatheter aortic valve implantation device.

PubMed

Reuthebuch, Oliver; Inderbitzin, Devdas Thomas; Rüter, Florian; Jeger, Raban; Kaiser, Christoph; Buser, Peter; Fassl, Jens; Eckstein, Friedrich S

2014-01-01

We present the post-CE(Conformité Européenne)-mark single-center implantation experience and short-term outcome with the second-generation transapical JenaValve transcatheter aortic valve implantation system. Patients [N = 27; 9 women; mean (SD) age, 80.3 (5.5) years] were operated on between November 2011 and August 2012. Via a transapical approach, the valve was positioned, in some cases, repositioned, and finally implanted. All data were collected during the hospital stay. The implantation success rate was 100%; the mean (SD) operation time was 124.7 (43.2) minutes; and the size of the implanted prosthesis was 23 mm (n = 6), 25 mm (n = 14), and 27 mm (n = 7). The in-hospital major adverse cardiac and cerebrovascular events were as follows: intraoperative resuscitation with subsequent aortic rupture (n = 1), postoperative hemorrhage needing revision (n = 1), myocardial infarction (n = 1), atrioventricular block needing a definitive pacemaker (n = 1), new-onset renal failure needing hemodialysis (n = 1), and stroke (n = 1). The 30-day mortality was 11.1% (n = 3). The mean (SD) intensive care unit/total stay was 2.2 (1.7)/11.7 (7.9) days. Postoperative echocardiography [day 6.7 (4.8)] revealed residual paravalvular leakage of trace to grade 1 in 12 patients (44.5%) and no leakage in 15 patients, with a mean (SD) transvalvular pressure gradient of 11.6 (5.6) mm Hg with significant reduction by 36.0 (17.7) mm Hg (P = 0.0001, Wilcoxon signed rank test). This second-generation repositionable transcatheter aortic valve implantation device could safely and successfully be implanted with a fast learning curve, significant reduction in pressure gradients, overall clinical improvement at discharge, as well as an acceptable morbidity and mortality rate in this highest-risk patient cohort.

Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial.

PubMed

McElhinney, Doff B; Cheatham, John P; Jones, Thomas K; Lock, James E; Vincent, Julie A; Zahn, Evan M; Hellenbrand, William E

2011-12-01

Among patients undergoing transcatheter pulmonary valve (TPV) replacement with the Melody valve, risk factors for Melody stent fracture (MSF) and right ventricular outflow tract (RVOT) reintervention have not been well defined. From January 2007 to January 2010, 150 patients (median age, 19 years) underwent TPV implantation in the Melody valve Investigational Device Exemption trial. Existing conduit stents from a prior catheterization were present in 37 patients (25%, fractured in 12); 1 or more new prestents were placed at the TPV implant catheterization in 51 patients. During follow-up (median, 30 months), MSF was diagnosed in 39 patients. Freedom from a diagnosis of MSF was 77±4% at 14 months (after the 1-year evaluation window) and 60±9% at 39 months (3-year window). On multivariable analysis, implant within an existing stent, new prestent, or bioprosthetic valve (combined variable) was associated with longer freedom from MSF (P<0.001), whereas TPV compression (P=0.01) and apposition to the anterior chest wall (P=0.02) were associated with shorter freedom from MSF. Freedom from RVOT reintervention was 86±4% at 27 months. Among patients with a MSF, freedom from RVOT reintervention after MSF diagnosis was 49±10% at 2 years. Factors associated with reintervention were similar to those for MSF. MSF was common after TPV implant in this multicenter experience and was more likely in patients with severely obstructed RVOT conduits and when the TPV was directly behind the anterior chest wall and/or clearly compressed. A TPV implant site protected by a prestent or bioprosthetic valve was associated with lower risk of MSF and reintervention.

Incidence and predictors of permanent pacemaker implantation following treatment with the repositionable Lotus™ transcatheter aortic valve.

PubMed

Zaman, Sarah; McCormick, Liam; Gooley, Robert; Rashid, Hashrul; Ramkumar, Satish; Jackson, Damon; Hui, Samuel; Meredith, Ian T

2017-07-01

To determine the incidence and predictors of permanent pacemaker (PPM) requirement following transcatheter aortic valve replacement (TAVR) with the mechanically expanded Lotus TM Valve System (Boston Scientific). Pacemaker implantation is the most common complication following TAVR. Predictors of pacing following TAVR with the Lotus valve have not been systematically assessed. Consecutive patients with severe aortic stenosis who underwent Lotus valve implantation were prospectively recruited at a single-centre. Patients with a pre-existing PPM were excluded. Baseline ECG, echocardiographic and multiple detector computed tomography as well as procedural telemetry and depth of implantation were independently analyzed in a blinded manner. The primary endpoint was 30-day incidence of pacemaker requirement (PPM implantation or death while pacing-dependent). Multivariate analysis was performed to identify independent predictors of the primary endpoint. A total of 104 consecutive patients underwent TAVR with the Lotus valve with 9/104 (9%) with a pre-existing PPM excluded. New or worsened procedural LBBB occurred in 78%. Thirty-day incidence of the primary pacing endpoint was 28%. The most common indication for PPM implantation was complete heart block (CHB) (69%). Independent predictors of the primary endpoint included pre-existing RBBB (hazard ratio [HR] 2.8, 95% CI 1.1-7.0; P = 0.032) and depth of implantation below the noncoronary cusp (NCC) (HR 2.4, 95% CI 1.0-5.7; P = 0.045). Almost a third of Lotus valve recipients require pacemaker implantation within 30 days. The presence of pre-existing RBBB and the depth of prosthesis implantation below the NCC were significant pacing predictors. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Quarter-Shifted Microincisional Sutureless Vitrectomy in Patients with a Glaucoma Drainage Implant or Filtering Bleb.

PubMed

Song, Ji Hun; Jang, Seran; Cho, Eun Hyung; Ahn, Jaehong

2017-05-01

When vitrectomy is performed in eyes that have undergone glaucoma surgery, the site of sclerotomy often overlaps with the previous glaucoma operation site. It can lead to serious complications such as postoperative hypotony, leakage, and/or infection. Our technique involves modification of surgeon's position and two sclerotomy sites 45° away from the original position, with an infusion cannula inserted infranasally to avoid damage to the glaucoma drainage implant or filtering bleb. The modified approach was applied to seven eyes with various indications. Vitrectomy was successfully completed, and there were no sclerotomy site complications, leakage, or hypotony in any case. Good intraocular pressure control was maintained throughout the postoperative course in all cases. © Copyright: Yonsei University College of Medicine 2017.

Tricuspid Valve Dysfunction Following Pacemaker or Cardioverter-Defibrillator Implantation.

PubMed

Chang, James D; Manning, Warren J; Ebrille, Elisa; Zimetbaum, Peter J

2017-05-09

The potential for cardiac implantable electronic device leads to interfere with tricuspid valve (TV) function has gained increasing recognition as having hemodynamic and clinical consequences associated with incremental morbidity and death. The diagnosis and treatment of lead-related (as distinct from functional) tricuspid regurgitation pose unique challenges. Because of pitfalls in routine diagnostic imaging, a high level of clinical suspicion must be maintained to avoid overlooking the possibility that worsening heart failure is a consequence of mechanical interference with TV leaflet mobility or coaptation and is amenable to lead extraction or valve repair or replacement. The future of cardiac implantable electronic devices includes pacing and perhaps defibrillation without a lead traversing the TV. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Pacemaker dependency after transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System.

PubMed

van der Boon, Robert M A; Van Mieghem, Nicolas M; Theuns, Dominic A; Nuis, Rutger-Jan; Nauta, Sjoerd T; Serruys, Patrick W; Jordaens, Luc; van Domburg, Ron T; de Jaegere, Peter P T

2013-09-30

To determine pacemaker (PM) dependency at follow-up visit in patients who underwent new permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI). Single center prospective observational study including 167 patients without previous PM implantation who underwent TAVI with the self-expanding Medtronic CoreValve System (MCS) between November 2005 and February 2011. PM dependency was defined by the presence of a high degree atrioventricular block (HDAVB; second [AV2] and third degree [AV3B]), or a slow (<30 bpm) or absent ventricular escape rhythm during follow-up PM interrogation. A total of 36 patients (21.6%) received a new PM following TAVI. The indication for PM was AV2B (n=2, 5.6%), AV3B (n=28, 77.8%), postoperative symptomatic bradycardia (n=3, 8.3%), brady-tachy syndrome (n=1, 2.8%), atrial fibrilation with slow response (n=1, 2.8%) and left bundle branch block (n=1, 2.8%). Long term follow-up was complete for all patients and ranged from 1 to 40 months (median (IQR): 11.5 (5.0-18.0 months). Of those patients with a HDAVB, 16 out of the 30 patients (53.3%) were PM independent at follow-up visit (complete or partial resolution of the AV conduction abnormality). Overall, 20 out of the 36 patients (55.6%) who received a new PM following TAVI were PM independent at follow-up. Partial and even complete resolution of peri-operative AV conduction abnormalities after MCS valve implantation occurred in more than half of the patients. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Aortic annulus eccentricity before and after transcatheter aortic valve implantation: Comparison of balloon-expandable and self-expanding prostheses.

PubMed

Schuhbaeck, Annika; Weingartner, Christina; Arnold, Martin; Schmid, Jasmin; Pflederer, Tobias; Marwan, Mohamed; Rixe, Johannes; Nef, Holger; Schneider, Christian; Lell, Michael; Uder, Michael; Ensminger, Stephan; Feyrer, Richard; Weyand, Michael; Achenbach, Stephan

2015-07-01

The geometry of the aortic annulus and implanted transcatheter aortic valve prosthesis might influence valve function. We investigated the influence of valve type and aortic valve calcification on post-implant geometry of catheter-based aortic valve prostheses. Eighty consecutive patients with severe aortic valve stenosis (mean age 82 ± 6 years) underwent computed tomography before and after TAVI. Aortic annulus diameters were determined. Influence of prosthesis type and degree of aortic valve calcification on post-implant eccentricity were analysed. Aortic annulus eccentricity was reduced in patients after TAVI (0.21 ± 0.06 vs. 0.08 ± 0.06, p<0.0001). Post-TAVI eccentricity was significantly lower in 65 patients following implantation of a balloon-expandable prosthesis as compared to 15 patients who received a self-expanding prosthesis (0.06 ± 0.05 vs. 0.15 ± 0.07, p<0.0001), even though the extent of aortic valve calcification was not different. After TAVI, patients with a higher calcium amount retained a significantly higher eccentricity compared to patients with lower amounts of calcium. Patients undergoing TAVI with a balloon-expandable prosthesis show a more circular shape of the implanted prosthesis as compared to patients with a self-expanding prosthesis. Eccentricity of the deployed prosthesis is affected by the extent of aortic valve calcification. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Novel surgical procedures in glaucoma: advances in penetrating glaucoma surgery.

PubMed

Filippopoulos, Theodoros; Rhee, Douglas J

2008-03-01

Despite late modifications and enhancements, traditional penetrating glaucoma surgery is not without complications and is reserved for patients in whom pharmacologic treatment and/or laser trabeculoplasty do not suffice to control the intraocular pressure. This article critically reviews recent advances in penetrating glaucoma surgery with particular attention paid to two novel surgical approaches: ab interno trabeculectomy with the Trabectome and implantation of the Ex-PRESS shunt. Ab interno trabeculectomy (Trabectome) achieves a sustained 30% reduction in intraocular pressure by focally ablating and cauterizing the trabecular meshwork/inner wall of Schlemm's canal. It has a remarkable safety profile with respect to early hypotonous or infectious complications as it does not generate a bleb, but it can be associated with early postoperative intraocular pressure spikes that may necessitate additional glaucoma surgery. The Ex-PRESS shunt is more commonly implanted under a partial thickness scleral flap, and appears to have similar efficacy to standard trabeculectomy offering some advantages with respect to the rate of early complications related to hypotony. Penetrating glaucoma surgery will continue to evolve. As prospective randomized clinical trials become available, we will determine the exact role of these surgical techniques in the glaucoma surgical armamentarium.

Repeat transcatheter aortic valve implantation using a latest generation balloon-expandable device for treatment of failing transcatheter heart valves.

PubMed

Schaefer, Andreas; Treede, Hendrik; Seiffert, Moritz; Deuschl, Florian; Schofer, Niklas; Schneeberger, Yvonne; Blankenberg, Stefan; Reichenspurner, Hermann; Schaefer, Ulrich; Conradi, Lenard

2016-01-15

Paravalvular leakage (PVL) is a known complication of transcatheter aortic valve implantation (TAVI) and is associated with poor outcome. Besides balloon-post-dilatation, valve-in-valve (ViV) procedures can be taken into consideration to control this complication. Herein we present initial experience with use of the latest generation balloon-expandable Edwards Sapien 3® (S3) transcatheter heart valve (THV) for treatment of failing THVs. Between 01/2014 and 12/2014 three patients (two male, age: 71-80 y, log EUROScore I: 11.89 - 32.63) with failing THVs were refered to our institution for further treatment. THV approach with secondary implantation of an S3 was chosen after mutual agreement of the local interdisciplinary heart team at an interval of 533-1119 days from the index procedure. The performed procedures consisted of: S3 in Sapien XT, JenaValve and CoreValve. Successful transfemoral implantation with significant reduction of PVL was achieved in all cases. No intraprocedural complications occurred regarding placement of the S3 with a postprocedural effective orifice area (EOA) of 1.5-2.5 cm(2) and pressure gradients of max/mean 14/6-36/16 mmHg. 30-day mortality was 0%. At the latest follow-up of 90-530 days, all patients are alive and well with satisfactory THV function. Regarding VARC-2 criteria one major bleeding and one TIA was reported. In the instance of moderate or severe aortic regurgitation after TAVI, S3 ViV deployment is an excellent option to reduce residual regurgitation to none or mild. For further assertions concerning functional outcomes long-term results have to be awaited.

Thrombocytopenia following implantation of the stentless biological sorin freedom SOLO valve.

PubMed

Gersak, Borut; Gartner, Urska; Antonic, Miha

2011-07-01

Stentless biological valves have proven advantages in hemodynamic performance and left ventricular function compared to stented biological valves. Following a marked postoperative fall in the platelet count of patients after implantation of the Freedom SOLO valve, the study aim was to confirm clinical observations that this effect was more severe in patients receiving Freedom SOLO valves than in those receiving St. Jude Medical (SJM) mechanical aortic valves. Preoperative and postoperative platelet counts were compared in two groups of patients who underwent aortic valve replacement (AVR) without any concomitant procedures between January and December 2007. Patients received either a Freedom SOLO valve (n = 28) or a SJM mechanical valve (n = 41). Mean values of platelet counts were compared using three multiple linear regression models. Platelet counts were significantly lower in the Freedom SOLO group than in the SJM group from the first postoperative day (POD 1) up to POD 6 (p <0.001). In three patients of the Freedom SOLO group the platelet count fell below 30x10(9)/l, while the lowest level in the SJM group was 75x10(9)/l. Based on multiple linear regression models, the type of valve implanted had a statistically significant influence on postoperative platelet counts on POD 1, POD 3, and POD 5 (p <0.001). Whilst the reason for this phenomenon is unknown, the use of consistent monitoring should prevent severe falls in platelet count from becoming dangerous for the patient. Further studies are required to investigate the phenomenon since, despite a shorter cardiopulmonary bypass time, the fall in platelet count was more profound in the Freedom SOLO group.

Pros and cons of transcatheter aortic valve implantation (TAVI).

PubMed

Terré, Juan A; George, Isaac; Smith, Craig R

2017-09-01

Transcatheter aortic valve implantation (TAVI) or replacement (TAVR) was recently approved by the FDA for intermediate risk patients with severe aortic stenosis (AS). This technique was already worldwide adopted for inoperable and high-risk patients. Improved device technology, imaging analysis and operator expertise has reduced the initial worrisome higher complications rate associated with TAVR, making it comparable to surgical aortic valve replacement (SAVR). However, many answers need to be addressed before adoption in lower risk patients. This paper highlights the pros and cons of TAVI based mostly on randomized clinical trials involving the two device platforms approved in the United States. We focused our analysis on metrics that will play a key role in expanding TAVR indication in healthier individuals. We review the significance and gave a perspective on paravalvular leak (PVL), valve performance, valve durability, leaflet thrombosis, stroke and pacemaker requirement.

Transcatheter Heart Valve Selection and Permanent Pacemaker Implantation in Patients With Pre-Existent Right Bundle Branch Block.

PubMed

van Gils, Lennart; Tchetche, Didier; Lhermusier, Thibault; Abawi, Masieh; Dumonteil, Nicolas; Rodriguez Olivares, Ramón; Molina-Martin de Nicolas, Javier; Stella, Pieter R; Carrié, Didier; De Jaegere, Peter P; Van Mieghem, Nicolas M

2017-03-03

Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement related PPM implantations in patients with pre-existent right bundle branch block and categorize for different transcatheter heart valves. We pooled data on 306 transcatheter aortic valve replacement patients from 4 high-volume centers in Europe and selected those with right bundle branch block at baseline without a previously implanted PPM. Logistic regression was used to evaluate whether PPM rate differed among transcatheter heart valves after adjustment for confounders. Mean age was 83±7 years and 63% were male. Median Society of Thoracic Surgeons score was 6.3 (interquartile range, 4.1-10.2). The following transcatheter valve designs were used: Medtronic CoreValve (n=130; Medtronic, Minneapolis, MN); Edwards Sapien XT (ES-XT; n=124) and Edwards Sapien 3 (ES-3; n=32; Edwards Lifesciences, Irvine, CA); and Boston Scientific Lotus (n=20; Boston Scientific Corporation, Marlborough, MA). Overall permanent pacemaker implantation rate post-transcatheter aortic valve replacement was 41%, and per valve design: 75% with Lotus, 46% with CoreValve, 32% with ES-XT, and 34% with ES-3. The indication for PPM implantation was total atrioventricular block in 98% of the cases. Lotus was associated with a higher PPM rate than all other valves. PPM rate did not differ between ES-XT and ES-3. Ventricular paced rhythm at 30-day and 1-year follow-up was present in 81% at 89%, respectively. Right bundle branch block at baseline is associated with a high incidence of PPM implantation for all transcatheter heart valves. PPM rate was highest for Lotus and lowest for ES-XT and ES-3. Pacemaker dependency remained high during follow-up. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by

[Percutaneous stented pulmonary valve implantation].

PubMed

Ersbøll, Mads; Søndergaard, Lars

2010-03-29

A number of congenital cardiac malformations involve the right ventricular outflow tract and are often treated with a biological valved conduit. The longevity of these valves is limited due to graft degeneration, which causes progressive valvular dysfunction and subsequently right ventricular failure. Due to the young age of these patients, repeat surgery can be expected and this has motivated the invention of the percutaneous stented valve implantation (PPVR). We retrospectively examined 13 patients (mean age 26 +/- 10 years) treated with PPVR between 2006 and 2008 at our institution. Indications for PPVR were conduit dysfunction with severe stenosis and/or regurgitation, reduced exercise capacity and right ventricular dilatation. In all patients, immediate haemodynamic improvement occurred with full valvular competence after PPVR. The pressure gradient was reduced from 43 (+/- 15) mmHg to 12 (+/- 7) mmHg (p = 0,05) in patients with combined regurgitation and stenosis and 47 (+/- 14) mmHg to 12 (+/- 2) mmHg (p = 0,05) in patients with isolated stenosis. At mean follow-up after 141 (+/- 140) days, no reintervention had been required. Significant haemodynamic and clinical improvement occurred after PPVR in all patients and no major complications occurred. PPVR remains a safe and minimally invasive treatment modality, and our study demonstrates that PPVR can be safely performed in a low volume setting.

EX-PRESS Glaucoma Filtration Device: efficacy, safety, and predictability

PubMed Central

Chan, Jessica E; Netland, Peter A

2015-01-01

Trabeculectomy has been the traditional primary surgical therapy for open-angle glaucoma. While trabeculectomy is effective in lowering intraocular pressure, complications associated with the procedure have motivated the development of alternative techniques and devices, including the EX-PRESS Glaucoma Filtration Device. This review describes the efficacy, safety, complication rates, and potential advantages and disadvantages of the EX-PRESS Glaucoma Filtration Device. EX-PRESS implantation is technically simpler compared with that of trabeculectomy, with fewer surgical steps. Vision recovery has been more rapid after EX-PRESS implantation compared with trabeculectomy. Intraocular pressure variation is lower during the early postoperative period, indicating a more predictable procedure. While efficacy of the EX-PRESS implant has been comparable to trabeculectomy, postoperative complications appear less common after EX-PRESS implantation compared with trabeculectomy. The EX-PRESS Glaucoma Filtration Device appears to be safe and effective in the surgical management of open-angle glaucoma. PMID:26366105

Apical-access-related complications associated with trans-catheter aortic valve implantation.

PubMed

Bleiziffer, Sabine; Piazza, Nicolo; Mazzitelli, Domenico; Opitz, Anke; Bauernschmitt, Robert; Lange, Rüdiger

2011-08-01

The left-ventricular trans-apical access has become well established for trans-catheter aortic valve implantation, especially for patients in whom a retrograde trans-arterial implantation is contraindicated. We report on the short- and long-term implications of the apical-access-site-specific complications. Between June 2007 and August 2010, 143 patients were scheduled for trans-apical aortic valve implantation (mean age 80 ± 6 years, n=116 females, mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) 21 ± 13%). The patients are followed up at 30 days, 6 months, and then annually. Severe apical bleeding complications occurred in 10 patients (7%). In three of these patients, the procedure was terminated, and no valve was implanted. In the remaining, the bleeding was controlled with cardiopulmonary bypass support (n=3), via median sternotomy (n=1), or both (n=1) ± later re-exploration. Two additional patients required postprocedural re-exploration for apical bleeding. An apical pseudo-aneurysm developed in two patients (2%), one of whom was treated by surgical revision. Survival was significantly impaired when either apical bleeding, aneurysm, or re-exploration occurred (75% ± 0.082 survival at 30 days and 59% ± 0.122 at 1 year vs 94% ± 0.023 and 80% ± 0.043 in patients without apical complications, p=0.012). Twelve patients (8%) experienced secondary wound healing. An apical hypo- or akinesia was detected in 18/54 (33%) patients at 6 months' echocardiographic investigation, and in 11/30 (37%) 1 year after the procedure. The trans-apical access for trans-catheter aortic valve implantation might be challenging in elderly patients with fragile tissue. Severe bleeding complications or aneurysm formation significantly impairs survival. The clinical impact of subsequent apical hypo- or akinesia has to be further followed up. Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Transcatheter aortic valve implantation using anatomically oriented, marrow stromal cell-based, stented, tissue-engineered heart valves: technical considerations and implications for translational cell-based heart valve concepts.

PubMed

Emmert, Maximilian Y; Weber, Benedikt; Behr, Luc; Sammut, Sebastien; Frauenfelder, Thomas; Wolint, Petra; Scherman, Jacques; Bettex, Dominique; Grünenfelder, Jürg; Falk, Volkmar; Hoerstrup, Simon P

2014-01-01

While transcatheter aortic valve implantation (TAVI) has rapidly evolved for the treatment of aortic valve disease, the currently used bioprostheses are prone to continuous calcific degeneration. Thus, autologous, cell-based, living, tissue-engineered heart valves (TEHVs) with regeneration potential have been suggested to overcome these limitations. We investigate the technical feasibility of combining the concept of TEHV with transapical implantation technology using a state-of-the-art transcatheter delivery system facilitating the exact anatomical position in the systemic circulation. Trileaflet TEHVs fabricated from biodegradable synthetic scaffolds were sewn onto self-expanding Nitinol stents seeded with autologous marrow stromal cells, crimped and transapically delivered into the orthotopic aortic valve position of adult sheep (n = 4) using the JenaValve transapical TAVI System (JenaValve, Munich, Germany). Delivery, positioning and functionality were assessed by angiography and echocardiography before the TEHV underwent post-mortem gross examination. For three-dimensional reconstruction of the stent position of the anatomically oriented system, a computed tomography analysis was performed post-mortem. Anatomically oriented, transapical delivery of marrow stromal cell-based TEHV into the orthotopic aortic valve position was successful in all animals (n = 4), with a duration from cell harvest to TEHV implantation of 101 ± 6 min. Fluoroscopy and echocardiography displayed sufficient positioning, thereby entirely excluding the native leaflets. There were no signs of coronary obstruction. All TEHV tolerated the loading pressure of the systemic circulation and no acute ruptures occurred. Animals displayed intact and mobile leaflets with an adequate functionality. The mean transvalvular gradient was 7.8 ± 0.9 mmHg, and the mean effective orifice area was 1.73 ± 0.02 cm(2). Paravalvular leakage was present in two animals, and central aortic regurgitation due to a

[Pannus Formation Two Years after Bioprosthetic Aortic Valve Implantation;Report of a Case].

PubMed

Ono, Kimiyo; Kuroda, Hiroaki

2015-08-01

We report a case of early deterioration of the bioprosthetic aortic valve 23 months postoperatively. A 77-year-old man who had undergone aortic valve replacement with a 23-mm Epic valve( St. Jude Medical [SJM])presented to us after a syncopal episode. Echocardiography revealed severe aortic stenosis, and redo aortic valve replacement with a 21-mm SJM mechanical valve was performed. All 3 cusps of the tissue valve were thickened by fibrous pannus overgrowth. Neither calcification nor invasion of inflammatory cells was observed. The cause of pannus formation at such an early stage after implantation remains unknown.

Pros and cons of transcatheter aortic valve implantation (TAVI)

PubMed Central

Terré, Juan A.; George, Isaac

2017-01-01

Transcatheter aortic valve implantation (TAVI) or replacement (TAVR) was recently approved by the FDA for intermediate risk patients with severe aortic stenosis (AS). This technique was already worldwide adopted for inoperable and high-risk patients. Improved device technology, imaging analysis and operator expertise has reduced the initial worrisome higher complications rate associated with TAVR, making it comparable to surgical aortic valve replacement (SAVR). However, many answers need to be addressed before adoption in lower risk patients. This paper highlights the pros and cons of TAVI based mostly on randomized clinical trials involving the two device platforms approved in the United States. We focused our analysis on metrics that will play a key role in expanding TAVR indication in healthier individuals. We review the significance and gave a perspective on paravalvular leak (PVL), valve performance, valve durability, leaflet thrombosis, stroke and pacemaker requirement. PMID:29062739

Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk

PubMed Central

Mieres, Juan; Menéndez, Marcelo; Fernández-Pereira, Carlos; Rubio, Miguel; Rodríguez, Alfredo E.

2015-01-01

Transcatheter Aortic Valve Replacement (TAVR) is performed in patients who are poor surgical candidates. Many patients have inadequate femoral access, and alternative access sites have been used such as the transapical approach discussed in this paper. We present an elderly and fragile patient not suitable for surgery for unacceptable high risk, including poor ventricular function, previous myocardial infarction with percutaneous coronary intervention, pericardial effusion, and previous cardiac surgery with replacement of mechanical mitral valve. Transapical aortic valve replacement with a second-generation self-expanding JenaValve is performed. The JenaValve is a second-generation transapical TAVR valve consisting of a porcine root valve mounted on a low-profile nitinol stent. The valve is fully retrievable and repositionable. We discuss transapical access, implantation technique, and feasibility of valve implantation in this extremely high surgical risk patient. PMID:26346128

Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk.

PubMed

Mieres, Juan; Menéndez, Marcelo; Fernández-Pereira, Carlos; Rubio, Miguel; Rodríguez, Alfredo E

2015-01-01

Transcatheter Aortic Valve Replacement (TAVR) is performed in patients who are poor surgical candidates. Many patients have inadequate femoral access, and alternative access sites have been used such as the transapical approach discussed in this paper. We present an elderly and fragile patient not suitable for surgery for unacceptable high risk, including poor ventricular function, previous myocardial infarction with percutaneous coronary intervention, pericardial effusion, and previous cardiac surgery with replacement of mechanical mitral valve. Transapical aortic valve replacement with a second-generation self-expanding JenaValve is performed. The JenaValve is a second-generation transapical TAVR valve consisting of a porcine root valve mounted on a low-profile nitinol stent. The valve is fully retrievable and repositionable. We discuss transapical access, implantation technique, and feasibility of valve implantation in this extremely high surgical risk patient.

Structural valve deterioration in a starr-edwards mitral caged-disk valve prosthesis.

PubMed

Aoyagi, Shigeaki; Tayama, Kei-Ichiro; Okazaki, Teiji; Shintani, Yusuke; Kono, Michitaka; Wada, Kumiko; Kosuga, Ken-Ichi; Mori, Ryusuke; Tanaka, Hiroyuki

2013-01-01

The durability of the Starr-Edwards (SE) mitral caged-disk valve, model 6520, is not clearly known, and structural valve deterioration in the SE disk valve is very rare. Replacement of the SE mitral disk valve was performed in 7 patients 23-40 years after implantation. Macroscopic examination of the removed disk valves showed no structural abnormalities in 3 patients, in whom the disk valves were removed at <26 years after implantation. Localized disk wear was found at the sites where the disk abutted the struts of the cage, in disk valves excised >36 years after implantation in 4 patients. Disk fracture, a longitudinal split in the disk along its circumference at the site of incorporation of the titanium ring, was detected in the valves removed 36 and 40 years after implantation, respectively, and many cracks were also observed on the outflow aspect of the disk removed 40 years after implantation. Disk fracture and localized disk wear were found in the SE mitral disk valves implanted >36 years previously. The present results suggest that SE mitral caged-disk valves implanted >20 years previously should be carefully followed up, and that those implanted >30 years previously should be electively replaced with modern prosthetic valves

Outcomes and Complications of Ahmed Tube Implantation in Asian Eyes.

PubMed

Choo, Jessica Qian Hui; Chen, Ziyou David; Koh, Victor; Liang, Shen; Aquino, Cecilia Maria; Sng, Chelvin; Chew, Paul

2018-06-18

There is a lack of long-term Asian studies on the efficacy and safety of Ahmed glaucoma valve (AGV) implantation. This study seeks to determine the outcomes and complications of AGV implantation in Asians. Retrospective review of AGV surgeries performed at a single centre in Singapore was conducted. 76 patients with primary and secondary glaucoma who underwent their first AGV surgery from 1st January 2010 to 31st December 2012 were considered for our study. Primary outcomes evaluated were: failure, intra-ocular pressure, best-corrected visual acuity (BCVA), number of IOP-lowering medications and complications. Failure was defined by: IOP >21▒mm Hg on two consecutive visits after 3 months, IOP ≤5▒mm Hg on two consecutive visits after 3 months, reoperation for glaucoma, removal of implant or loss of light perception vision. Mean follow-up duration was 33.2±6.9 months. There was significant reduction in IOP (mean reduction 25.9%, P<0.001) and number of IOP-lowering medications (mean reduction 77.8%, P<0.001) at 3 years. Absolute failure rate was 23.9% at 3 years with no difference between eyes with or without previous trabeculectomy and between eyes with primary or secondary glaucoma. Occurrence of post-operative hyphema was a significant risk factor for failure. Commonest post-operative complications were hyphema and tube exposure. At 3 years after AGV surgery in Asian eyes, less than one-quarter of the eyes fulfilled the criteria for surgical failure.

[Long-term effects of permanent pacemaker implantation on tricuspid valve regurgitation].

PubMed

Ren, Chong-lei; Wang, Yao; Wang, Rong; Li, Bo-jun; Geng, Ren-yi; Gao, Chang-qing

2012-08-14

To explore the long-term effects of permanent pacemaker implantation (PPI) on tricuspid valve regurgitation (TR) in Chinese patients so as to determine the incidence and related factors, evaluate its effects on heart structure and function and ascertain the exact mechanism of TR after PPI. A total of 430 patients undergoing permanent pacemaker replacement at our hospital between January 2000 and June 2011 were recruited. The patients with isolated atrial lead implantation procedures, significant heart valve disease or chronic obstructive pulmonary disease were excluded. The data of 108 patients who had Doppler echocardiograms performed before the first pacemaker implantation procedure and this pacemaker replacement procedure were obtained and retrospectively analyzed. According to the post-implant grade of TR, the patients were divided into two groups: normal tricuspid (n = 79) and abnormal tricuspid (n = 29). Their clinical characteristics and echocardiographic data between two groups were analyzed and compared. The mean follow-up time (from the first pacemaker implantation) was (13 ± 6) years (range: 4 - 34). Among 108 patients with initially normal tricuspid post-implant, 29 patients (26.9%) developed significant TR during the follow-up. In comparison to those in normal tricuspid group, the patients in abnormal tricuspid group had a longer time from the first pacemaker implantation ((16 ± 7) vs (12 ± 5) years, P = 0.003), more transtricuspid leads (1.31 ± 0.66 vs 1.10 ± 0.30, P = 0.026), larger right atrial size ((38 ± 7) vs (35 ± 4) mm, P = 0.028) and higher prevalence of mild TR and mitral valve regurgitation (MR) pre-implantation (TR: 21% vs 4%, P = 0.015, MR: 28% vs 5%, P = 0.003). The size of right atrium, right ventricle and left atrium in abnormal tricuspid group were more than those in normal tricuspid group. The prevalence of significant MR post-implantation in abnormal tricuspid group was higher than that in normal tricuspid group. The ejection

The Suprachoroidal Route in Glaucoma Surgery

PubMed Central

Shaarawy, Tarek

2016-01-01

ABSTRACT Glaucoma surgeries targeting the uveoscleral drainage pathways have been drawing more attention lately. Among all the available techniques, procedures focusing on the supra-choroidal space seem particularly promising, by making use of a presumably efficient and secure outflow route and avoiding subconjunctival filtration blebs. The purpose of this review is to assess the efficacy and the security of the different suprachoroidal drainage implants, namely the CyPass Micro-Stent, the iStent Supra, the SOLX Gold Shunt, the Aquashunt, and the STARflo Glaucoma Implant. Most clinical studies seem to currently point toward the direction that there are actual benefits in suprachoroidal surgeries by avoiding bleb-related complications. Nevertheless, even suprachoroidal implants may be subject to scarring and failure. More data are still needed, especially concerning long-term effects, although the approach does seem appealing. How to cite this article: Gigon A, Shaarawy T. The Suprachoroidal Route in Glaucoma Surgery. J Curr Glaucoma Pract 2016;10(1): 13-20. PMID:27231415

Prevalence and Prognostic Significance of Right Ventricular Systolic Dysfunction in Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Lindsay, Alistair C; Harron, Katie; Jabbour, Richard J; Kanyal, Ritesh; Snow, Thomas M; Sawhney, Paramvir; Alpendurada, Francisco; Roughton, Michael; Pennell, Dudley J; Duncan, Alison; Di Mario, Carlo; Davies, Simon W; Mohiaddin, Raad H; Moat, Neil E

2016-07-01

Cardiovascular magnetic resonance (CMR) can provide important structural information in patients undergoing transcatheter aortic valve implantation. Although CMR is considered the standard of reference for measuring ventricular volumes and mass, the relationship between CMR findings of right ventricular (RV) function and outcomes after transcatheter aortic valve implantation has not previously been reported. A total of 190 patients underwent 1.5 Tesla CMR before transcatheter aortic valve implantation. Steady-state free precession sequences were used for aortic valve planimetry and to assess ventricular volumes and mass. Semiautomated image analysis was performed by 2 specialist reviewers blinded to patient treatment. Patient follow-up was obtained from the Office of National Statistics mortality database. The median age was 81.0 (interquartile range, 74.9-85.5) years; 50.0% were women. Impaired RV function (RV ejection fraction ≤50%) was present in 45 (23.7%) patients. Patients with RV dysfunction had poorer left ventricular ejection fractions (42% versus 69%), higher indexed left ventricular end-systolic volumes (96 versus 40 mL), and greater indexed left ventricular mass (101 versus 85 g/m(2); P<0.01 for all) than those with normal RV function. Median follow-up was 850 days; 21 of 45 (46.7%) patients with RV dysfunction died, compared with 43 of 145 (29.7%) patients with normal RV function (P=0.035). After adjustment for significant baseline variables, both RV ejection fraction ≤50% (hazard ratio, 2.12; P=0.017) and indexed aortic valve area (hazard ratio, 4.16; P=0.025) were independently associated with survival. RV function, measured on preprocedural CMR, is an independent predictor of mortality after transcatheter aortic valve implantation. CMR assessment of RV function may be important in the risk stratification of patients undergoing transcatheter aortic valve implantation. © 2016 American Heart Association, Inc.

Prosthetic valve endocarditis 7 months after transcatheter aortic valve implantation diagnosed with 3D TEE.

PubMed

Sarı, Cenk; Durmaz, Tahir; Karaduman, Bilge Duran; Keleş, Telat; Bayram, Hüseyin; Baştuğ, Serdal; Özen, Mehmet Burak; Bayram, Nihal Akar; Bilen, Emine; Ayhan, Hüseyin; Kasapkara, Hacı Ahmet; Bozkurt, Engin

2016-01-01

Transcatheter aortic valve implantation (TAVI) was introduced as an alternative treatment for patients with severe symptomatic aortic stenosis for whom surgery would be high-risk. Prosthetic aortic valve endocarditis is a serious complication of surgical AVR (SAVR) with high morbidity and mortality. According to recent cases, post-TAVI prosthetic valve endocarditis (PVE) seems to occur very rarely. We present the case of a 75-year-old woman who underwent TAVI (Edwards Saphien XT) with an uneventful postoperative stay. She was diagnosed with endocarditis using three dimensional (3D) echocardiography on the TAVI device 7 months later and she subsequently underwent surgical aortic valve replacement. Little experience of the interpretation of transoesophageal echocardiography (TEE) and the clinical course and effectiveness of treatment strategies in post-TAVI endocarditis exists. We report a case of PVE in a TAVI patient which was diagnosed with three-dimensional transoesophageal echocardiography (3DTEE). Copyright © 2016 Hellenic Cardiological Society. Published by Elsevier B.V. All rights reserved.

Association of CKD with Outcomes Among Patients Undergoing Transcatheter Aortic Valve Implantation

PubMed Central

Kaier, Klaus; Kaleschke, Gerrit; Gebauer, Katrin; Meyborg, Matthias; Malyar, Nasser M.; Freisinger, Eva; Baumgartner, Helmut; Reinecke, Holger; Reinöhl, Jochen

2017-01-01

Background and objectives Despitethe multiple depicted associations of CKD with reduced cardiovascular and overall prognoses, the association of CKD with outcome of patients undergoing transcatheter aortic valve implantation has still not been well described. Design, setting, participants, & measurements Data from all hospitalized patients who underwent transcatheter aortic valve implantation procedures between January 1, 2010 and December 31, 2013 in Germany were evaluated regarding influence of CKD, even in the earlier stages, on morbidity, in-hospital outcomes, and costs. Results A total of 28,716 patients were treated with transcatheter aortic valve implantation. A total of 11,189 (39.0%) suffered from CKD. Patients with CKD were predominantly women; had higher rates of comorbidities, such as coronary artery disease, heart failure at New York Heart Association 3/4, peripheral artery disease, and diabetes; and had a 1.3-fold higher estimated logistic European System for Cardiac Operative Risk Evaluation value. In-hospital mortality was independently associated with CKD stage ≥3 (up to odds ratio, 1.71; 95% confidence interval, 1.35 to 2.17; P<0.05), bleeding was independently associated with CKD stage ≥4 (up to odds ratio, 1.82; 95% confidence interval, 1.47 to 2.24; P<0.001), and AKI was independently associated with CKD stages 3 (odds ratio, 1.83; 95% confidence interval, 1.62 to 2.06) and 4 (odds ratio, 2.33; 95% confidence interval, 1.92 to 2.83 both P<0.001). The stroke risk, in contrast, was lower for patients with CKD stages 4 (odds ratio, 0.23; 95% confidence interval, 0.16 to 0.33) and 5 (odds ratio, 0.24; 95% confidence interval, 0.15 to 0.39; both P<0.001). Lengths of hospital stay were, on average, 1.2-fold longer, whereas reimbursements were, on average, only 1.03-fold higher in patients who suffered from CKD. Conclusions This analysis illustrates for the first time on a nationwide basis the association of CKD with adverse outcomes in patients

Association of CKD with Outcomes Among Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Lüders, Florian; Kaier, Klaus; Kaleschke, Gerrit; Gebauer, Katrin; Meyborg, Matthias; Malyar, Nasser M; Freisinger, Eva; Baumgartner, Helmut; Reinecke, Holger; Reinöhl, Jochen

2017-05-08

Despitethe multiple depicted associations of CKD with reduced cardiovascular and overall prognoses, the association of CKD with outcome of patients undergoing transcatheter aortic valve implantation has still not been well described. Data from all hospitalized patients who underwent transcatheter aortic valve implantation procedures between January 1, 2010 and December 31, 2013 in Germany were evaluated regarding influence of CKD, even in the earlier stages, on morbidity, in-hospital outcomes, and costs. A total of 28,716 patients were treated with transcatheter aortic valve implantation. A total of 11,189 (39.0%) suffered from CKD. Patients with CKD were predominantly women; had higher rates of comorbidities, such as coronary artery disease, heart failure at New York Heart Association 3/4, peripheral artery disease, and diabetes; and had a 1.3-fold higher estimated logistic European System for Cardiac Operative Risk Evaluation value. In-hospital mortality was independently associated with CKD stage ≥3 (up to odds ratio, 1.71; 95% confidence interval, 1.35 to 2.17; P <0.05), bleeding was independently associated with CKD stage ≥4 (up to odds ratio, 1.82; 95% confidence interval, 1.47 to 2.24; P <0.001), and AKI was independently associated with CKD stages 3 (odds ratio, 1.83; 95% confidence interval, 1.62 to 2.06) and 4 (odds ratio, 2.33; 95% confidence interval, 1.92 to 2.83 both P <0.001). The stroke risk, in contrast, was lower for patients with CKD stages 4 (odds ratio, 0.23; 95% confidence interval, 0.16 to 0.33) and 5 (odds ratio, 0.24; 95% confidence interval, 0.15 to 0.39; both P <0.001). Lengths of hospital stay were, on average, 1.2-fold longer, whereas reimbursements were, on average, only 1.03-fold higher in patients who suffered from CKD. This analysis illustrates for the first time on a nationwide basis the association of CKD with adverse outcomes in patients who underwent transcatheter aortic valve implantation. Thus, classification of CKD stages

Registry of transcatheter aortic-valve implantation in high-risk patients.

PubMed

Gilard, Martine; Eltchaninoff, Hélène; Iung, Bernard; Donzeau-Gouge, Patrick; Chevreul, Karine; Fajadet, Jean; Leprince, Pascal; Leguerrier, Alain; Lievre, Michel; Prat, Alain; Teiger, Emmanuel; Lefevre, Thierry; Himbert, Dominique; Tchetche, Didier; Carrié, Didier; Albat, Bernard; Cribier, Alain; Rioufol, Gilles; Sudre, Arnaud; Blanchard, Didier; Collet, Frederic; Dos Santos, Pierre; Meneveau, Nicolas; Tirouvanziam, Ashok; Caussin, Christophe; Guyon, Philippe; Boschat, Jacques; Le Breton, Herve; Collart, Frederic; Houel, Remi; Delpine, Stephane; Souteyrand, Geraud; Favereau, Xavier; Ohlmann, Patrick; Doisy, Vincent; Grollier, Gilles; Gommeaux, Antoine; Claudel, Jean-Philippe; Bourlon, Francois; Bertrand, Bernard; Van Belle, Eric; Laskar, Marc

2012-05-03

Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).

Minimally Invasive Implantation of HeartWare Assist Device and Simultaneous Tricuspid Valve Reconstruction Through Partial Upper Sternotomy.

PubMed

Hillebrand, Julia; Hoffmeier, Andreas; Djie Tiong Tjan, Tonny; Sindermann, Juergen R; Schmidt, Christoph; Martens, Sven; Scherer, Mirela

2017-05-01

Left ventricular assist device (LVAD) implantation is a well-established therapy to support patients with end-stage heart failure. However, the operative procedure is associated with severe trauma. Third generation LVADs like the HeartWare assist device (HeartWare, Inc., Framingham, MA, USA) are characterized by enhanced technology despite smaller size. These devices offer new minimally invasive surgical options. Tricuspid regurgitation requiring valve repair is frequent in patients with the need for mechanical circulatory support as it is strongly associated with ischemic and nonischemic cardiomyopathy. We report on HeartWare LVAD implantation and simultaneous tricuspid valve reconstruction through minimally invasive access by partial upper sternotomy to the fifth left intercostal space. Four male patients (mean age 51.72 ± 11.95 years) suffering from chronic heart failure due to dilative (three patients) and ischemic (one patient) cardiomyopathy and also exhibiting concomitant tricuspid valve insufficiency due to annular dilation underwent VAD implantation and tricuspid valve annuloplasty. Extracorporeal circulation was established via the ascending aorta, superior vena cava, and right atrium. In all four cases the LVAD implantation and tricuspid valve repair via partial median sternotomy was successful. During the operative procedure, no conversion to full sternotomy was necessary. One patient needed postoperative re-exploration because of pericardial effusion. No postoperative focal neurologic injury was observed. New generation VADs are advantageous because of the possibility of minimally invasive implantation procedure which can therefore minimize surgical trauma. Concomitant tricuspid valve reconstruction can also be performed simultaneously through partial upper sternotomy. Nevertheless, minimally invasive LVAD implantation is a challenging operative technique. © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals

Innovative approaches to glaucoma management of Boston keratoprosthesis type 1.

PubMed

Vajaranant, Thasarat S; Liu, Jessica; Wilensky, Jacob; Cortina, M Soledad; Aref, Ahmad A

2016-09-01

Glaucoma remains a prevalent disorder and visual limiting factor after Boston keratoprosthesis type 1 implantation. Patients with glaucoma have worse initial and late visual acuity outcomes after otherwise successful keratoprosthesis implantation. Management of glaucoma in the setting of a keratoprosthesis is challenging because of relatively rapid progression and an inability to accurately measure intraocular pressure (IOP). In addition, there are no standard guidelines for glaucoma surveillance and monitoring after keratoprosthesis surgery. This report provides a review of the current literature and offers innovative strategies that will overcome the challenges in managing glaucoma in the setting of a Boston keratoprosthesis type 1 implant. The topics that will be discussed in this section include alternative methods for IOP measurement, rationales and surgical techniques for a pars plana tube placement for glaucoma drainage device, effective medical and laser treatment, the risk for IOP elevations after YAG laser, and practical guides to glaucoma surveillance and monitoring.

A second prosthesis as a procedural rescue option in trans-apical aortic valve implantation.

PubMed

Kempfert, Jörg; Rastan, Ardawan J; Schuler, Gerhard; Linke, Axel; Holzhey, David; van Linden, Arnaud; Mohr, Friedrich-W; Walther, Thomas

2011-07-01

Trans-apical aortic valve implantation (TA-AVI) using the Edwards SAPIEN™ prosthesis has evolved to a routine procedure for selected high-risk elderly patients. In rare cases, misplacement of the SAPIEN™ valve (too low a position), dysfunction of the leaflets or perforation of the interventricular septum (ventricular septal defect, VSD) occurs and requires immediate implantation of a second prosthesis within the first one. Results of this 'bailout' maneuver have not been reported yet. Of 305 TA-AVI procedures, 15 patients required a second prosthesis due to dysfunctional leaflets (n = 6), low position (n = 7), or VSD (n = 2). Mean age was 82.5 ± 1.3 years, mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 45.5 ± 5.4, and Society of Thoracic Surgeons (STS) Score was 13.5 ± 1.5. All second SAPIEN™ valves could be implanted successfully within the first one. The second prosthesis solved leaflet dysfunction, sealed the VSD (lower position of the second prosthesis), or corrected the initial misplacement (higher position of the second prosthesis) in all patients. Within 30 days, four patients died (low cardiac output n = 3, all with preoperative ejection fraction (EF) <35%; intestinal ischemia n = 1). Intra-operative echocardiogram and angiogram revealed mild paravalvular leak in three and none/trace in 12 patients. Transvalvular gradients were low despite the implantation of the second valve (P(max)/mean 13.7 ± 4.3/6.4 ± 2.0). Placement of a second SAPIEN™ valve is a valuable 'bailout' technique in case of VSD, dysfunctional leaflets, or too low placement of the first prosthesis. The technique leads to an excellent functional result with low transvalvular gradients. The simple, straight, tubular stent design of the SAPIEN™ prosthesis may be the ideal design for such valve-in-valve procedures. Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Transhepatic implant of a trimmed Melody™ valved stent in tricuspid position in a 1-year-old infant.

PubMed

Cools, Bjorn; Rega, Filip; Gewillig, Marc

2017-02-15

Percutaneous valved stent implantation is precluded in small infants because large delivery sheaths and large devices. We describe a procedure in a 1-year-old boy in whom a 19 mm Epic™ valve in tricuspid position had become dysfunctional. As the internal diameter of the prosthetic valve was about 16 mm, the only available valve was the Melody™ valved stent. Technical modifications were required to address issues like venous access, the bulky delivery system, and the length of the valved stent. The Melody™ valved stent was surgically trimmed and mounted on a 16 mm Tyshak balloon, access was provided transhepatically through a short 18 Fr sheath. After deployment, the intrahepatic route was sealed with two vascular plugs (8 and 10 mm) in tandem. The procedure was uncomplicated with perfect valve function 18 months after implant. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Conduction Abnormalities and Pacemaker Implantations After SAPIEN 3 Vs SAPIEN XT Prosthesis Aortic Valve Implantation.

PubMed

Husser, Oliver; Kessler, Thorsten; Burgdorf, Christof; Templin, Christian; Pellegrini, Costanza; Schneider, Simon; Kasel, Albert Markus; Kastrati, Adnan; Schunkert, Heribert; Hengstenberg, Christian

2016-02-01

Transcatheter aortic valve implantation is increasingly used in patients with aortic stenosis. Post-procedural intraventricular conduction abnormalities and permanent pacemaker implantations remain a serious concern. Recently, the Edwards SAPIEN 3 prosthesis has replaced the SAPIEN XT. We sought to determine the incidences of new-onset intraventricular conduction abnormalities and permanent pacemaker implantations by comparing the 2 devices. We analyzed the last consecutive 103 patients undergoing transcatheter aortic valve implantation with SAPIEN XT before SAPIEN 3 was used in the next 105 patients. To analyze permanent pacemaker implantations and new-onset intraventricular conduction abnormalities, patients with these conditions at baseline were excluded. Electrocardiograms were recorded at baseline, after the procedure, and before discharge. SAPIEN 3 was associated with higher device success (100% vs 92%; P=.005) and less paravalvular leakage (0% vs 7%; P<.001). The incidence of permanent pacemaker implantations was 12.6% (23 of 183) with no difference between the 2 groups (SAPIEN 3: 12.5% [12 of 96] vs SAPIEN XT: 12.6% [11 of 87]; P=.99). SAPIEN 3 was associated with a higher rate of new-onset intraventricular conduction abnormalities (49% vs 27%; P=.007) due to a higher rate of fascicular blocks (17% vs 5%; P=.021). There was no statistically significant difference in transient (29% [20 of 69] vs persistent 19% [12 of 64]; P=.168) left bundle branch blocks (28% [19 of 69] vs 17% [11 of 64]; P=.154) when SAPIEN 3 was compared with SAPIEN XT. We found a trend toward a higher rate of new-onset intraventricular conduction abnormalities with SAPIEN 3 compared with SAPIEN XT, although this did not result in a higher permanent pacemaker implantation rate. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Bioprosthetic Valve Fracture to Facilitate Transcatheter Valve-in-Valve Implantation.

PubMed

Allen, Keith B; Chhatriwalla, Adnan K; Cohen, David J; Saxon, John T; Aggarwal, Sanjeev; Hart, Anthony; Baron, Suzanne; Davis, J Russell; Pak, Alex F; Dvir, Danny; Borkon, A Michael

2017-11-01

Valve-in-valve transcatheter aortic valve replacement is less effective in small surgical bioprostheses. We evaluated the feasibility of bioprosthetic valve fracture with a high-pressure balloon to facilitate valve-in-valve transcatheter aortic valve replacement. In vitro bench testing on aortic tissue valves was performed on 19-mm and 21-mm Mitroflow (Sorin, Milan, Italy), Magna and Magna Ease (Edwards Lifesciences, Irvine, CA), Trifecta and Biocor Epic (St. Jude Medical, Minneapolis, MN), and Hancock II and Mosaic (Medtronic, Minneapolis, MN). High-pressure balloons Tru Dilation, Atlas Gold, and Dorado (C.R. Bard, Murray Hill, NJ) were used to determine which valves could be fractured and at what pressure fracture occurred. Mitroflow, Magna, Magna Ease, Mosaic, and Biocor Epic surgical valves were successfully fractured using high-pressures balloon 1 mm larger than the labeled valve size whereas Trifecta and Hancock II surgical valves could not be fractured. Only the internal valve frame was fractured, and the sewing cuff was never disrupted. Manufacturer's rated burst pressures for balloons were exceeded, with fracture pressures ranging from 8 to 24 atmospheres depending on the surgical valve. Testing further demonstrated that fracture facilitated the expansion of previously constrained, underexpanded transcatheter valves (both balloon and self-expanding) to the manufacturer's recommended size. Bench testing demonstrates that the frame of most, but not all, bioprosthetic surgical aortic valves can be fractured using high-pressure balloons. The safety of bioprosthetic valve fracture to optimize valve-in-valve transcatheter aortic valve replacement in small surgical valves requires further clinical investigation. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Transcatheter aortic valve implantation transapical: step by step.

PubMed

Walther, Thomas; Möllmann, Helge; van Linden, Arnaud; Kempfert, Jörg

2011-01-01

Transcatheter aortic valve implantation (T-AVI) has been introduced into clinical practice to treat high-risk elderly patients with aortic stenosis. T-AVI can be performed by using a retrograde transfemoral (TF), transsubclavian, transaortic, and/or antegrade transapical (TA) approach. For TA-AVI, CE mark approval was granted in 2008 for the Edwards SAPIEN (Edwards Lifesciences, Irvine, CA) prosthesis with the Ascendra delivery system and in 2010 for the second-generation Edwards SAPIEN XT prosthesis and the Ascendra II delivery system, with 23-mm and 26-mm valves. In 2011, CE mark approval has been granted for TA-AVI by using the SAPIEN XT 29-mm prosthesis. Several other devices from different companies (Jenavalve, Jena Valve Inc, Munich, Germany; Embracer, Medtronic Inc, Guilford, CT; Accurate, Symetis Inc, Geneva, Switzerland) have passed "first in man trials" successfully and are being evaluated within multicenter pivotal studies. In this article we will focus on specific aspects of the TA technique for AVI. Copyright © 2011 Elsevier Inc. All rights reserved.

Transcatheter Aortic Valve-in-Valve Procedure in Patients with Bioprosthetic Structural Valve Deterioration

PubMed Central

Reul, Ross M.; Ramchandani, Mahesh K.; Reardon, Michael J.

2017-01-01

Surgical aortic valve replacement is the gold standard procedure to treat patients with severe, symptomatic aortic valve stenosis or insufficiency. Bioprosthetic valves are used for surgical aortic valve replacement with a much greater prevalence than mechanical valves. However, bioprosthetic valves may fail over time because of structural valve deterioration; this often requires intervention due to severe bioprosthetic valve stenosis or regurgitation or a combination of both. In select patients, transcatheter aortic valve replacement is an alternative to surgical aortic valve replacement. Transcatheter valve-in-valve (ViV) replacement is performed by implanting a transcatheter heart valve within a failing bioprosthetic valve. The transcatheter ViV operation is a less invasive procedure compared with reoperative surgical aortic valve replacement, but it has been associated with specific complications and requires extensive preoperative work-up and planning by the heart team. Data from experimental studies and analyses of results from clinical procedures have led to strategies to improve outcomes of these procedures. The type, size, and implant position of the transcatheter valve can be optimized for individual patients with knowledge of detailed dimensions of the surgical valve and radiographic and echocardiographic measurements of the patient's anatomy. Understanding the complexities of the ViV procedure can lead surgeons to make choices during the original surgical valve implantation that can make a future ViV operation more technically feasible years before it is required. PMID:29743998

Oculoplastic technique of connecting a glaucoma valve shunt to extraorbital locations in cases of severe glaucoma.

PubMed

Rubin, Peter A D; Chang, Eli; Bernardino, Carlo Roberto; Hatton, Mark P; Dohlman, Claes H

2004-09-01

To describe a technique for inserting glaucoma shunts to the sinuses or the lacrimal sac as a means of lowering intraocular pressure in patients with refractory glaucoma associated with severe ocular surface disease. Nineteen patients with severe ocular surface disease necessitating a keratoprosthesis and with intractable glaucoma underwent placement of a modified Ahmed shunt to direct aqueous in the maxillary or ethmoid sinus or lacrimal sac. Intraocular pressure is presently well controlled without glaucoma medications in two thirds of patients. None of the patients had endophthalmitis. Established oculoplastic surgery techniques may be used to redirect aqueous to extraorbital locations and effectively lower intraocular pressure in patients with severe ocular surface disease and refractory glaucoma. This procedure has not been associated with endophthalmitis.

Biomedical Impact in Implantable Devices-The Transcatheter Aortic Valve as an example

NASA Astrophysics Data System (ADS)

Anastasiou, Alexandros; Saatsakis, George

2015-09-01

Objective: To update of the scientific community about the biomedical engineering involvement in the implantable devices chain. Moreover the transcatheter Aortic Valve (TAV) replacement, in the field of cardiac surgery, will be analyzed as an example of contemporary implantable technology. Methods: A detailed literature review regarding biomedical engineers participating in the implantable medical product chain, starting from the design of the product till the final implantation technique. Results: The scientific role of biomedical engineers has clearly been established. Certain parts of the product chain are implemented almost exclusively by experienced biomedical engineers such as the transcatheter aortic valve device. The successful professional should have a multidisciplinary knowledge, including medicine, in order to pursue the challenges for such intuitive technology. This clearly indicates that biomedical engineers are among the most appropriate scientists to accomplish such tasks. Conclusions: The biomedical engineering involvement in medical implantable devices has been widely accepted by the scientific community, worldwide. Its important contribution, starting from the design and extended to the development, clinical trials, scientific support, education of other scientists (surgeons, cardiologists, technicians etc.), and even to sales, makes biomedical engineers a valuable player in the scientific arena. Notably, the sector of implantable devices is constantly raising, as emerging technologies continuously set up new targets.

Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation.

PubMed

Seiffert, Moritz; Bader, Ralf; Kappert, Utz; Rastan, Ardawan; Krapf, Stephan; Bleiziffer, Sabine; Hofmann, Steffen; Arnold, Martin; Kallenbach, Klaus; Conradi, Lenard; Schlingloff, Friederike; Wilbring, Manuel; Schäfer, Ulrich; Diemert, Patrick; Treede, Hendrik

2014-10-01

This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation. Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus. Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed. Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI. Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Transfemoral implantation of an Edwards SAPIEN valve in a tricuspid bioprosthesis without fluoroscopic landmarks.

PubMed

Calvert, Patrick A; Himbert, Dominique; Brochet, Eric; Radu, Costin; Iung, Bernard; Hvass, Ulrik; Darondel, Jean-Marc; Depoix, Jean-Pol; Nataf, Patrick; Vahanian, Alec

2012-03-01

We describe the first report of an Edwards SAPIEN valve implanted in a tricuspid bioprosthesis from the femoral vein. We highlight the feasibility of this previously avoided approach and the techniques involved. A 61-year-old woman with multiple valve replacements for rheumatic heart disease presented with NHYA IV dyspnoea secondary to a severely stenosed tricuspid bioprosthesis. After failed aggressive medical therapy and surgical turn down, an Edwards SAPIEN XT valve was deployed in the tricuspid bioprosthesis via the right femoral vein. Adaptations to the standard transfemoral transcatheter aortic valve implantation (TAVI) technique included: (1) crossing the tricuspid bioprosthesis with a balloon floatation catheter; (2) temporary pacing wire in the coronary sinus rather than the right ventricle; (3) mounting of the SAPIEN XT valve in the reverse orientation to transfemoral TAVI; and (4) fine positioning of the final valve position pre-deployment by 3D transoesophageal echocardiography (3D TOE) alone due to complete radiolucency of the tricuspid bioprosthesis. The procedure was completed without complication and resulted in significant symptomatic improvement. Deployment of an Edwards SAPIEN valve in a tricuspid bioprosthesis via the femoral vein is feasible and, with careful adaptations to established TAVI techniques, can be performed without complications and with good clinical response.

Use of the ex-press miniature glaucoma implant in a child with Sturge-Weber syndrome.

PubMed

Elgin, Ufuk; Simsek, Tulay; Batman, Aygen

2007-01-01

A two-stage antiglaucoma operation was planned for the left eye of an 11-year-old boy with bilateral Sturge-Weber syndrome to avoid intraoperative and postoperative choroidal and retinal effusion as with previous trabeculectomy. The Ex-Press miniature glaucoma implant was placed 10 days before trabeculectomy with mitomycin C. There were no complications with either procedure.

Percutaneous implantation of the CoreValve® self-expanding valve prosthesis in patients with severe aortic stenosis and porcelain aorta: medium-term follow-up.

PubMed

Pascual, Isaac; Avanzas, Pablo; Muñoz-García, Antonio J; López-Otero, Diego; Jimenez-Navarro, Manuel F; Cid-Alvarez, Belén; del Valle, Raquel; Alonso-Briales, Juan H; Ocaranza-Sanchez, Raimundo; Alfonso, Fernando; Hernández, José M; Trillo-Nouche, Ramiro; Morís, César

2013-10-01

There is little information on the use of transcatheter aortic valve implantation in patients with severe aortic stenosis and porcelain aorta. The primary aim of this study was to analyze death from any cause after CoreValve(®) implantation in patients with severe aortic stenosis, with and without porcelain aorta. In this multicenter, observational prospective study, carried out in 3 hospitals, percutaneous aortic valves were implanted in 449 patients with severely calcified aortic stenosis. Of these, 36 (8%) met the criteria for porcelain aorta. The primary end-point was death from any cause at 2 years. Patients with porcelain aorta more frequently had extracardiac vascular disease (11 [30.6%] vs 49 [11.9%]; P=.002), prior coronary revascularization (15 [41.7%] vs 98 [23.7%]; P=.017), and dyslipidemia (26 [72.2%] vs 186 [45%]; P=.02). In these patients, there was greater use of general anesthesia (15 [41.7%] vs 111 [16.9%]; P=.058) and axillary access (9 [25%] vs 34 [8.2%]; P=.004). The success rate of the procedure (94.4 vs 97.3%; P=.28) and the incidence of complications (7 [19.4%] vs 48 [11.6%]; P=.20) were similar in both groups. There were no statistically significant differences in the primary end point at 24 months of follow-up (8 [22.2%] vs 66 [16%]; P=.33). The only predictive variable for the primary end point was the presence of complications during implantation (hazard ratio=2.6; 95% confidence interval, 1.5-4.5; P=.001). In patients with aortic stenosis and porcelain aorta unsuitable for surgery, percutaneous implantation of the CoreValve(®) self-expanding valve prosthesis is safe and feasible. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

The challenge of valve-in-valve procedures in degenerated Mitroflow bioprostheses and the advantage of using the JenaValve transcatheter heart valve.

PubMed

Conradi, Lenard; Kloth, Benjamin; Seiffert, Moritz; Schirmer, Johannes; Koschyk, Dietmar; Blankenberg, Stefan; Reichenspurner, Hermann; Diemert, Patrick; Treede, Hendrik

2014-12-01

Recently, the feasibility of valve-in-valve procedures using current first-generation transcatheter heart valves (THV) in cases of structural valve degeneration has been reported as an alternative to conventional open repeat valve replacement. By design, certain biological valve xenografts carry a high risk of coronary ostia occlusion due to lateral displacement of leaflets after valve-in-valve procedures. In the present report we aimed to prove feasibility and safety of transapical valve-in-valve implantation of the JenaValve THV in two cases of degenerated Mitroflow bioprostheses. We herein report two cases of successful transapical valve-in-valve procedures using a JenaValve THV implanted in Sorin Mitroflow bioprostheses for structural valve degeneration. Both patients were alive and in good clinical condition at 30 days from the procedure. However, increased transvalvular gradients were noted in both cases. Transcatheter valve-in-valve implantation of a JenaValve THV is a valid alternative for patients with degenerated Mitroflow bioprostheses of sufficient size and in the presence of short distances to the coronary ostia who are too ill for conventional repeat open heart surgery. Increased pressure gradients have to be expected and weighed against the disadvantages of other treatment options when planning such a procedure.

"Ring pledget": a new concept for secure apex closure during transapical aortic valve implantation.

PubMed

Astarci, Parla; Glineur, David; Kefer, Joelle; Renkin, Jean; Vanoverschelde, Jean-Louis; El Khoury, Gebrine

2010-03-01

Transapical aortic valve implantation requires puncture of the left ventricle apex and insertion of a 32-French delivery sheath. A critical step in the procedure consists of secure closure of the ventricular apex. We describe 2 cases of apical rupture of 42 transapical aortic valve implantations. Furthermore, we describe the use of a newly designed single circular Teflon pledget that can help to avoid this complication. This pledget provides a more secure and uniform shrinkage of the entire apex to close the defect left by the delivery sheath.

Polymeric check valve with an elevated pedestal for precise cracking pressure in a glaucoma drainage device.

PubMed

Park, Chang-Ju; Yang, Dong-Seong; Cha, Jung-Joon; Lee, Jong-Hyun

2016-02-01

This paper presents the design, fabrication, and characterization of a polymeric micro check valve for a glaucoma drainage device (GDD) featuring the precise regulation of intraocular pressure (IOP) and effective aqueous humor turnover (AHT). The pedestal, slightly elevated by selective coating of a parylene C film, induces pre-stress in the thin valve membrane, which enhances the predictability of the cracking pressure of the GDD. The proposed GDD comprises a cannula and a normally closed polymeric micro check valve, which are made of PDMS, a biocompatible polymer, with three layers: top (cover), intermediate (thin valve membrane), and bottom (base plate). A feedback channel, located between the top and intermediate layers, prevents reverse flow by feeding the pressure of the outlet channel back to the thin valve membrane. To achieve a precise cracking pressure and sufficient drainage of humor for humans, the thicknesses of the valve membrane and parylene C film are designed to be 58 μm and 1 μm, respectively, which are confirmed using a COMSOL simulation. The experimental results show that the cracking pressure of the fabricated GDD lies within the range of normal IOP (1.33-2.67 kPa). The forward flow rate (drainage rate), 4.3 ± 0.9 μL/min at 2.5 kPa, is adequate to accommodate the rate of AHT in a normal human eye (2.4 ± 0.6 μL/min). The reverse flow was not observed when a hydrostatic pressure of up to 4 kPa was applied to the outlet and the feedback channel.

[Selection of patients for transcatheter aortic valve implantation].

PubMed

Tron, Christophe; Godin, Matthieu; Litzler, Pierre-Yves; Bauer, Fabrice; Caudron, Jérome; Dacher, Jean-Nicolas; Borz, Bogdan; Canville, Alexandre; Kurtz, Baptiste; Bessou, Jean-Paul; Cribier, Alain; Eltchaninoff, Hélène

2012-06-01

A good selection of patients is a crucial step before transcatheter aortic valve implantation (TAVI) in order to select the good indications and choose the access route. TAVI should be considered only in patients with symptomatic severe aortic stenosis and either contraindication or high surgical risk. Indication for TAVI should be discussed in a multidisciplinary team meeting. Echocardiography and/or CT scan are mandatory to evaluate the aortic annulus size and select the good prosthesis size. The possibility of transfemoral implantation is evaluated by angiography and CT scan, and based on the arterial diameters, but also on the presence of tortuosities and arterial calcifications. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis.

PubMed

Silaschi, Miriam; Treede, Hendrik; Rastan, Ardawan J; Baumbach, Hardy; Beyersdorf, Friedhelm; Kappert, Utz; Eichinger, Walter; Rüter, Florian; de Kroon, Thomas L; Lange, Rüdiger; Ensminger, Stephan; Wendler, Olaf

2016-11-01

Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR. The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions. The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation. In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia

The power of disruptive technological innovation: Transcatheter aortic valve implantation.

PubMed

Berlin, David B; Davidson, Michael J; Schoen, Frederick J

2015-11-01

We sought to evaluate the principles of disruptive innovation, defined as technology innovation that fundamentally shifts performance and utility metrics, as applied to transcatheter aortic valve implantation (TAVI). In particular, we considered implantation procedure, device design, cost, and patient population. Generally cheaper and lower performing, classical disruptive innovations are first commercialized in insignificant markets, promise lower margins, and often parasitize existing usage, representing unattractive investments for established market participants. However, despite presently high unit cost, TAVI is less invasive, treats a "new," generally high risk, patient population, and is generally done by a multidisciplinary integrated heart team. Moreover, at least in the short-term TAVI has not been lower-performing than open surgical aortic valve replacement in high-risk patients. We conclude that TAVI extends the paradigm of disruptive innovation and represents an attractive commercial opportunity space. Moreover, should the long-term performance and durability of TAVI approach that of conventional prostheses, TAVI will be an increasingly attractive commercial opportunity. © 2014 Wiley Periodicals, Inc.

The Role of Minimally Invasive Glaucoma Surgery Devices in the Management of Glaucoma

PubMed Central

Fingeret, Murray; Dickerson, Jaime E.

2018-01-01

SIGNIFICANCE Noncompliance is a problem affecting glaucoma patients. Approaches to improve adherence include the use of drug-delivery systems and safer forms of surgery. Minimally invasive glaucoma surgery (MIGS) has reduced complications, particularly in combination with cataract surgery, and with its good intraocular pressure (IOP) reduction may reduce or eliminate glaucoma medications. Glaucoma is a progressive disease and a leading cause of irreversible blindness. Elevated IOP is the most important risk factor, but effective medical management is dependent on patient adherence. This review summarizes the adherence problem in glaucoma and the efforts, including MIGS, to provide effective IOP control that is not dependent on patient compliance. The current understanding of patient adherence to pharmacological treatment of glaucoma is discussed including the challenges facing glaucoma patients. Historical approaches to providing IOP control in a sustained and reliable way are presented culminating in a review of the burgeoning use of MIGS devices. It is estimated that, in the United States, 27% of prescriptions written, across all medications, are not filled or are filled but not taken. For ocular hypotensive medications, even when filled, a large percentage (which varies widely by study) are not instilled as prescribed. To address this problem, methods for sustained drug delivery have been and continue to be developed, as well as surgical and laser approaches. Most recently, MIGS devices have gained popularity because of the ease of implantation during cataract surgery, favorable safety profile, and the possibility for effective and long-lasting IOP lowering, as well as the reduction or elimination of need for IOP-lowering medication. Poor adherence to treatment is relatively common among glaucoma patients and is associated with progression of disease. Recommending MIGS implantation during cataract surgery may offer optometrists a valuable treatment option in

Thrombogenic potential of transcatheter aortic valve implantation with trivial paravalvular leakage

PubMed Central

Siegel, Rolland

2014-01-01

Background Significant paravalvular leakage after transcatheter aortic valve implantation (TAVI) correlates with increased morbidity and mortality, but adverse consequences of trivial paravalvular leakage have stimulated few investigations. Using a unique method distinctly different from other diagnostic approaches, we previously reported elevated backflow velocities of short duration (transients) in mechanical valve closure. In this study, similar transients were found in a transcatheter valve paravalvular leakage avatar. Methods Paravalvular leakage rate (zero to 58 mL/second) and aortic valve incompetence (volumetric back flow/forward flow; zero to 32%) were made adjustable using a mock transcatheter aortic valve device and tested in quasi-steady and pulsatile flow test systems. Projected dynamic valve area (PDVA) from the back illuminated mock transcatheter aortic valve device was measured and regional backflow velocities were derived by dividing volumetric flow rate by the PDVA over the open and closing valve phase and the total closed valve area derived from backflow leakage. Results Aortic incompetence from 1-32% generated negative backflow transients from 8 to 267 meters/second, a range not dissimilar to that measured in mechanical valves with zero paravalvular leakage. Optimal paravalvular leakage was identified; not too small generating high backflow transients, not too large considering volume overload and cardiac energy loss caused by defective valve behavior and fluid motion. Conclusions Thrombogenic potential of transcatheter aortic valves with trivial aortic incompetence and high magnitude regional backflow velocity transients was comparable to mechanical valves. This may have relevance to stroke rate, asymptomatic microembolic episodes and indications for anticoagulation therapy after transcatheter valve insertion. PMID:25333018

[Percutaneous catheter-based implantation of artificial pulmonary valves in patients with congenital heart defects].

PubMed

Wyller, Vegard Bruun; Aaberge, Lars; Thaulow, Erik; Døhlen, Gaute

2011-07-01

Percutaneous catheter-based implantation of artificial heart valves is a new technique that may supplement surgery and which may be used more in the future. We here report our first experience with implantation of artificial pulmonary valves in children with congenital heart defects. Eligible patients were those with symptoms of heart failure combined with stenosis and/or insufficiency in an established artificial right ventricular outflow tract. The valve was inserted through a catheter from a vein in the groin or neck. Symptoms, echocardiography, invasive measurements and angiography were assessed for evaluation of treatment effect. Our treatment results are reported for the period April 2007-September 2009. Ten patients (seven men and three women, median age 17 years) were assessed. The procedure reduced pressure in the right ventricle (p = 0.008) and resolved the pulmonary insufficiency in all patients. The median time in hospital was two days. No patients had complications that were directly associated with the implantation procedure. One patient developed a pseudoaneurysm in the femoral artery, another had a short-lasting fever two days after the procedure and one patient experienced a stent fracture that required surgery 9 months after the implantation. After 6 months all patients had a reduced pressure gradient in the right ventricular outflow tract (p = 0.008), the pulmonary insufficiency had improved (p = 0.006) and they all reported improval of symptoms. These results persisted for at least 24 months for the four patients who were monitored until then. Percutaneous catheter-based implantation of artificial pulmonary valves improves hemodynamics in the right ventricle of selected patients with congenital heart defects. A randomized controlled study should be undertaken to provide a stronger evidence-base for usefulness of this procedure.

Secondary glaucoma after pediatric cataract surgery

PubMed Central

Şahin, Alparslan; Çaça, Ihsan; Cingü, Abdullah Kürşat; Türkcü, Fatih Mehmet; Yüksel, Harun; Şahin, Muhammed; Çinar, Yasin; Ari, Şeyhmus

2013-01-01

AIM To determine the incidence and risk factors of secondary glaucoma after pediatric cataract surgery. METHODS Two hundred and forty nine eyes of 148 patients underwent cataract surgery without intraocular lens (IOL) implantation (group 1), and 220 eyes of 129 patients underwent cataract surgery with IOL implantation (group 2) retrospectively, were evaluated between 2000 and 2011. The outcome measure was the presence or absence of post-cataract surgery glaucoma, defined as an intraocular pressure (IOP) ≥26mmHg, as measured on at least two occasions along with corneal or optic nerve changes. RESULTS The mean follow-up periods of group 1 and 2 were (60.86±30.95) months (12-123 months) and (62.11±31.29) months (14-115 months) respectively. In group 1, 12 eyes of 8 patients (4.8%) developed glaucoma. None of the patients developed glaucoma after surgery in group 2. The mean age of the patients at the cataract surgery was (2.58±0.90) months (1 month-4 months) and the average period for glaucoma development after surgery was (9.50±4.33) months (4-16 months) in group 1. Three of the 12 glaucomatous eyes were controlled with antiglaucomatous medication and 9 eyes underwent trabeculectomy+mitomycin C surgery. One patient underwent a second trabeculectomy + mitomycin C operation for both of his eyes. CONCLUSION The incidence of glaucoma after pediatric cataract surgery is very low in patients in whom IOL is implanted. The aphakic eyes after pediatric cataract surgery are at an increased risk for glaucoma development particularly if they underwent surgery before 4 months of age. PMID:23638427

Successful non-surgical treatment of endocarditis caused by Staphylococcus haemolyticus following transcatheter aortic valve implantation (TAVI).

PubMed

Loverix, L; Timmermans, P; Benit, E

2013-01-01

We describe a case of a 79-year-old male patient with severe aortic stenosis who underwent transcatheter aortic valve implantation (TAVI) at our institution. He presented at the emergency department with dyspnea and fatigue 7 months after implantation. The diagnosis of early prosthetic valve endocarditis (PVE) caused by Staphylococcus haemolyticus was made by transesophageal echocardiography (TEE) and multiple positive blood cultures. Since our patient was considered inoperable due to a history of coronary artery bypass graft (CABG) surgery with patent bypasses, high peri-operative mortality including renal failure and a poor general prognosis, surgical removal of the valve was not an option. The patient was successfully treated with antibiotic therapy.

Left Ventricular Assist Device Implantation with Concomitant Aortic Valve and Ascending Aortic Replacement.

PubMed

Huenges, Katharina; Panholzer, Bernd; Cremer, Jochen; Haneya, Assad

2018-01-01

Left ventricular assist device (LVAD) is nowadays a routine therapy for patients with advanced heart failure. We present the case of a 74-year-old male patient who was admitted to our center with terminal heart failure in dilated cardiomyopathy and ascending aortic aneurysm with aortic valve regurgitation. The LVAD implantation with simultaneous aortic valve and supracoronary ascending aortic replacement was successfully performed.

Relationship of aortic annular eccentricity and paravalvular regurgitation post transcatheter aortic valve implantation with CoreValve.

PubMed

Wong, Dennis T L; Bertaso, Angela G; Liew, Gary Y H; Thomson, Viji S; Cunnington, Michael S; Richardson, James D; Gooley, Robert; Lockwood, Siobhan; Meredith, Ian T; Worthley, Matthew I; Worthley, Stephen G

2013-04-01

Significant paravalvular aortic regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) is associated with negative clinical consequences. We hypothesize that increased eccentricity of the aortic annulus is associated with greater PAR. Patients with severe aortic stenosis underwent multidetector computed tomography (MDCT) before successful TAVI with the Medtronic CoreValve bioprosthesis. The smallest (D(min)) and largest (D(max)) orthogonal diameters in the basal ring of the aortic annulus were determined. We defined circularity of aortic annulus using the eccentricity index (1 - D(min)/D(max)). The primary endpoint was early occurrence of significant PAR, defined as > grade II PAR by postprocedural aortography. Eighty-four patients, mean age 83 ± 4 years with a mean aortic valve area of 0.7 ± 0.2 cm² were included. Twenty patients had postprocedural PAR > grade II. Using a receiver operating characteristic (ROC) analysis, eccentricity index correlated with significant PAR (AUC = 0.834; P=.034). A retrospectively determined eccentricity index cut-off of >0.25 was related to significant PAR with a sensitivity of 80%, specificity of 86%, and negative predictive value of 95% (P<.001). On univariate logistic regression, eccentricity index of >0.25 (P<.001) and device implantation depth (P=.015) correlated with significant PAR, while other parameters such as annular calcification and cover index did not. On multivariate analysis including only parameters with P<.1 on univariate analysis, eccentricity index >0.25 was the sole independent predictor of significant PAR. Eccentricity index is related to significant PAR after TAVI with Medtronic CoreValve. Further larger studies are required to determine the utility of this novel index in screening suitable patients for this procedure.

Association of aortic valve calcification severity with the degree of aortic regurgitation after transcatheter aortic valve implantation.

PubMed

Koos, Ralf; Mahnken, Andreas Horst; Dohmen, Guido; Brehmer, Kathrin; Günther, Rolf W; Autschbach, Rüdiger; Marx, Nikolaus; Hoffmann, Rainer

2011-07-15

This study sought to examine a possible relationship between the severity of aortic valve calcification (AVC), the distribution of AVC and the degree of aortic valve regurgitation (AR) after transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS). 57 patients (22 men, 81 ± 5 years) with symptomatic AS and with a logistic EuroSCORE of 24 ± 12 were included. 38 patients (67%) received a third (18F)-generation CoreValve® aortic valve prosthesis, in 19 patients (33%) an Edwards SAPIEN™ prosthesis was implanted. Prior to TAVI dual-source computed tomography for assessment of AVC was performed. To determine the distribution of AVC the percentage of the calcium load of the most severely calcified cusp was calculated. After TAVI the degree of AR was determined by angiography and echocardiography. The severity of AR after TAVI was related to the severity and distribution of AVC. There was no association between the distribution of AVC and the degree of paravalvular AR after TAVI as assessed by angiography (r = -0.02, p = 0.88). Agatston AVC scores were significantly higher in patients with AR grade ≥ 3 (5055 ± 1753, n = 3) than in patients with AR grade < 3 (1723 ± 967, p = 0.03, n = 54). Agatston AVC scores > 3000 were associated with a relevant paravalvular AR and showed a trend for increased need for second manoeuvres. There was a significant correlation between the severity of AVC and the degree of AR after AVR (r = 0.50, p < 0.001). Patients with severe AVC have an increased risk for a relevant AR after TAVI as well as a trend for increased need for additional procedures. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Case Series: Keratolimbal Allograft as a Patch Graft for Glaucoma Drainage Devices.

PubMed

Ahmed, Sarah F; Schmutz, Mason; Mosaed, Sameh

2017-09-01

Tube exposure remains one of the most common complications after glaucoma drainage device (GDD) implantation, despite various types of patch grafts available today. We present a 4 patient case series following the effectivity of the keratolimbal allograft (KLAL) as a patch graft for cases of tube exposure. Given its inherent population of stem cells, our hypothesis was that this highly replicative, biological tissue would provide an adequate means of glaucoma tube coverage. The subset of patients chosen for the KLAL patch graft all had a history of abnormally scarred conjunctiva or thin sclera. The aim of utilizing the KLAL patch with its associated donor conjunctival and scleral ring was also to provide additional reinforcement and adequate tube coverage in the setting of compromised native tissue. Four patients comprised of 2 males and 2 females with a minimum postoperative period of 12 months. All GDDs were initially implanted with a limbal-based incision using either Ahmed glaucoma valve or Baerveldt drainage implant. Three of the 4 patients received the KLAL patch graft after tube exposure with scleral patch graft and 1 patient received KLAL as the primary graft during initial tube placement. Two of the 4 eyes experienced tube re-exposure postoperatively at 2 and 3 months, respectively. Both of these cases had a history of prior tube exposure after scleral patch graft and both were tubes placed in the pars plana. Interestingly, the patients with failed grafts were younger with a history of more ocular surgeries as compared with the patients with graft viable eyes. Through our case series, we found that the KLAL utilized as a patch graft over GDD tubes has the potential for favorable outcomes in certain subtypes of eyes. Although further large scale investigation will be necessary to better define the risk factors associated with graft failure, proving the graft's viability is a crucial first step.

Percutaneous valved stent implantation in the ascending aorta for the treatment of very high-risk aortic regurgitation: an animal study.

PubMed

Zong, Gang-Jun; Jiang, Hai-Bin; Bai, Yuan; Wu, Gang-Yong; Ye, Guang-Ming; Chen, Jing-Kai; Qin, Yong-Wen; Zhao, Xian-xian

2013-12-01

We investigated the effects of percutaneous valved stent implantation in the ascending aorta as an alternative treatment for aortic regurgitation in a canine model. A total of 16 healthy dogs weighing an average of 18.3 ± 2.1 kg were used for the establishment of animal models of chronic aortic regurgitation by percutaneous aortic valve perforation and balloon dilation. At 2 mo after successful model establishment, all experimental animals underwent valved stent implantation in the ascending aorta and then were followed up for 3 mo. Experimental models of chronic aortic regurgitation were successfully established in 10 dogs. Surviving dogs underwent successful valved stent implantation in the ascending aorta and were subsequently followed up for 3 mo. The level of instantaneous aortic regurgitation at 3-mo follow-up was significantly reduced compared with that before valved stent implantation (2.4 ± 0.9 versus 10.6 ± 2.1 mL/s, P < 0.05). The left ventricular ejection fraction was significantly increased (53.8 ± 4.2% versus 37.8 ± 3.7%, P < 0.05), and the left ventricular end-diastolic volume was also significantly reduced (30.3 ± 2.2 versus 40.1 ± 3.6 mL, P < 0.05). No paravalvular leak, stroke, atrioventricular block, or other complications occurred in dogs undergoing valved stent implantation. Percutaneous valved stent implantation in the ascending aorta is feasible, effective, and safe as an alternative treatment for very high-risk aortic regurgitation in a canine model. Copyright © 2013 Elsevier Inc. All rights reserved.

Complete Transversal Disc Fracture in a Björk-Shiley Delrin Mitral Valve Prosthesis 43 Years After Implantation.

PubMed

González-Santos, Jose María; Arnáiz-García, María Elena; Dalmau-Sorlí, María José; Sastre-Rincón, Jose Alfonso; Hernández-Hernández, Jesús; Pérez-Losada, María Elena; Sagredo-Meneses, Víctor; López-Rodríguez, Javier

2016-10-01

A patient who underwent previous implantation of a mitral valve replacement with a Björk-Shiley Delrin (BSD) mitral valve prosthesis during infancy was admitted to our institution 43 years later after an episode of syncope and cardiac arrest. Under extreme hemodynamic instability, a mitral valve prosthetic dysfunction causing massive mitral regurgitation was identified. The patient underwent an emergent cardiac operation, and a complete disc fracture with partial disc migration was found. Exceptional cases of mechanical prosthetic heart valve fracture exist. We report the first case of complete transversal disc rupture of a BSD mitral valve prosthesis after the longest period of implantation ever reported in that position. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

A new design and application of bioelastomers for better control of intraocular pressure in a glaucoma drainage device.

PubMed

Luong, Quang Minh; Shang, Lei; Ang, Marcus; Kong, Jen Fong; Peng, Yan; Wong, Tina T; Venkatraman, Subbu S

2014-02-01

Glaucoma drainage device (GDD) implantation is an effective method of lowering the intraocular pressure (IOP). Commonly used GDDs can be classified into nonvalved and valved. Although a stable IOP is critical, currently available devices often cause extreme IOP fluctuations: nonvalved GDDs suffer from a risk of hypotony (IOP<5 mmHg), whereas valved GDDs have a higher risk ocular hypertensive (IOP>22 mmHg). It is hypothesized that a GDD with a valve designed to open around the time of onset of the hypertensive phase, would minimize IOP fluctuation. Accordingly, a valve fabricated from a biodegradable polymer poly(L-lactide-co-ϵ-caprolactone) (PLC 70/30) is evaluated in vitro and in vivo. The pressure response is compared with its non-degradable counterpart in in vitro studies of IOP. It is also established that in vitro, the biodegradability of the valve is programmed to occur over 12 weeks. In vivo, a steady and low IOP is achieved with the biodegradable valve and the hypertensive phase is significantly attenuated compared with the commercial device. Fibrotic encapsulation of the device is also minimized with the biodegradable valve in vivo. Copyright © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Transcatheter aortic-valve implantation with one single minimal contrast media injection.

PubMed

Arrigo, Mattia; Maisano, Francesco; Haueis, Sabine; Binder, Ronald K; Taramasso, Maurizio; Nietlispach, Fabian

2015-06-01

Performing transcatheter aortic valve implantation (TAVI) with the use of minimal contrast in patients at high-risk for acute kidney injury (AKI). Contrast-induced nephropathy (CIN) is a major cause of AKI following TAVI and is associated with increased morbidity and mortality. The amount of contrast media used increases the risk for CIN. Computed tomography was omitted during the screening process. For the procedure transfemoral access was default. The self-expanding CoreValve prosthesis was chosen in all patients to minimize the risk of annular rupture in case of oversizing. Valve sizing was based on echocardiography, aortography, calcification on fluoroscopy, as well as weight and height of the patient. A single contrast injection was performed to confirm correct position of the pigtail catheter at the level of the annulus. The pigtail then served as the marker for the device landing zone. Intraprocedural assessment of the implantation result relied on echocardiography and hemodynamics. Five patients with severe aortic stenosis and at high risk for developing CIN were included. Device success was achieved in all patients and no major complications occurred. The median dose of injected contrast media was 8 ml (4-9). All but one patient had improved renal function after the intervention compared to baseline. Our study shows feasibility of performing TAVI with a single minimal contrast media injection, using a self-expandable valve. This technique has the potential to reduce the incidence of CIN. © 2015 Wiley Periodicals, Inc.

Left Ventricular Assist Device Implantation with Concomitant Aortic Valve and Ascending Aortic Replacement

PubMed Central

Panholzer, Bernd; Cremer, Jochen; Haneya, Assad

2018-01-01

Left ventricular assist device (LVAD) is nowadays a routine therapy for patients with advanced heart failure. We present the case of a 74-year-old male patient who was admitted to our center with terminal heart failure in dilated cardiomyopathy and ascending aortic aneurysm with aortic valve regurgitation. The LVAD implantation with simultaneous aortic valve and supracoronary ascending aortic replacement was successfully performed. PMID:29552039

Single-centre experience with next-generation devices for transapical aortic valve implantation.

PubMed

Seiffert, Moritz; Conradi, Lenard; Kloth, Benjamin; Koschyk, Dietmar; Schirmer, Johannes; Schnabel, Renate B; Blankenberg, Stefan; Reichenspurner, Hermann; Diemert, Patrick; Treede, Hendrik

2015-01-01

Transcatheter aortic valve implantation (TAVI) has become an established procedure in patients with aortic stenosis and high surgical risk. Experience with first-generation transcatheter heart valves (THVs) is broad but limitations, e.g. paravalvular regurgitation, have been demonstrated. Much hope rests on the recently Conformité Européenne mark approved next-generation devices to improve results in these patients. However, apart from the initial approval studies, clinical data with these new devices are still scarce. We aimed to assess short-term outcomes of 200 consecutive patients who underwent transapical TAVI with next-generation THV at our institution. Transapical TAVI was performed in 200 consecutive patients 80.5±6.7 years old (38.5% female) at high surgical risk (log EuroSCORE 20.2±16.5%). Devices implanted were the Engager (Medtronic, Inc., Minneapolis, MN, USA; n=50), JenaValve (JenaValve Technology, Munich, Germany; n=88) and Symetis Acurate (Symetis SA, Ecublens, Switzerland; n=62) THV that were selected by the heart team on an individual basis. Data at baseline, during the procedure and follow-up were analysed according to standardized Valve Academic Research Consortium end points. Median follow-up was 219 days. Implantation was successful in 96.5% of cases. Valve function improved significantly with an increase in effective orifice area from 0.8±0.4 to 1.8±0.3 cm2 and a reduction in mean transvalvalvular gradients from 34.0±17.0 to 11.2±5.4 mmHg. Paravalvular regurgitation was none or trace in 70.3% of patients, Grade 1 in 26.1%, and Grade 2 in 3.5%. No patients developed aortic regurgitation>Grade 2. Major access site complications occurred in 6.5%, major stroke in 1.5% and stage-3 kidney injury in 2.5% of patients. A permanent pacemaker was implanted in 20.5% of patients overall and in 8.0% for a complete heart block. At 30-day follow-up 72.8% of patients were in New York Heart Association class I or II (10.5% at baseline). Overall

The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation.

PubMed

Silaschi, Miriam; Conradi, Lenard; Wendler, Olaf; Schlingloff, Friederike; Kappert, Utz; Rastan, Ardawan J; Baumbach, Hardy; Holzhey, David; Eichinger, Walter; Bader, Ralf; Treede, Hendrik

2018-06-01

We present 1-year outcomes of the post-market registry of a next-generation transcatheter heart valve used for aortic regurgitation (AR). Transcatheter aortic valve replacement (TAVR) is routine in high-risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism. The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012-2015, 30 patients with AR were enrolled. Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One-year Kaplan-Meier survival was 79.9%, one-year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow-up. The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication. © 2017 Wiley Periodicals, Inc.

Percutaneous transfemoral-transseptal implantation of a second-generation CardiAQ mitral valve bioprosthesis: first procedure description and 30-day follow-up.

PubMed

Ussia, Gian Paolo; Quadri, Arshad; Cammalleri, Valeria; De Vico, Pasquale; Muscoli, Saverio; Marchei, Massimo; Ruvolo, Giovanni; Sondergaard, Lars; Romeo, Francesco

2016-02-01

Transcatheter mitral valve implantation for mitral valve regurgitation is in the very early phase of development because of challenging anatomy and device dimensions. We describe the procedure of a transfemoral-transseptal implantation of the second-generation CardiAQ mitral valve bioprosthesis and 30-day follow-up. The procedure was performed percutaneously, without any left extracorporeal circulatory support. The patient had severe mitral regurgitation with severely depressed ventricular function and other comorbidities. The patient was deemed extreme high risk for conventional cardiac surgery by a multidisciplinary team. The main procedural steps were the creation of an arteriovenous loop with an exchange nitinol wire, and the use of a customised "steerable snare system" to facilitate the catheter delivery system into the mitral annulus. Transoesophageal echocardiography and fluoroscopy were utilised for device positioning and deployment. The mitral valve prosthesis was implanted with mild mitral regurgitation. The postoperative course was uneventful and at 30-day follow-up the patient is in NYHA Class I, with good function of the mitral valve bioprosthesis. This procedure shows that percutaneous transfemoral transcatheter mitral valve implantation is feasible, safe and successful. Further experience is needed to render this procedure clinically available.

In-Graft Endovascular Stenting Repair for Supravalvular Stenosis From Aortic Rupture After Balloon-Expanding Transcatheter Aortic Valve Implantation.

PubMed

Furukawa, Nobuyuki; Scholtz, Werner; Haas, Nikolaus; Ensminger, Stephan; Gummert, Jan; Börgermann, Jochen

2015-01-01

An 81-year-old man with high-grade aortic valve stenosis and status post-coronary artery bypass grafting and supracoronary replacement of the ascending aorta was referred for transcatheter aortic valve implantation. He was in New York Heart Association class III and had dyspnea. After appropriate screening, we implanted a 29-mm SAPIEN XT valve (Edwards Lifesciences, Irvine, CA USA) through a transapical approach because of severe peripheral arterial occlusive disease. Postinterventional aortography revealed correct positioning and function of the valve and free coronary ostia but contrast extravasation in the vicinity of the interposed vascular prosthesis, resulting in severe luminal narrowing. We chose to manage the stenosis with an endovascular stent. After stenting, extravascular compression was markedly reduced, and the pressure gradient disappeared. The patient was discharged home on the 20th postoperative day. Three months later, computed tomography depicted correct positioning of both grafts. The patient's general health is good, and he is now in New York Heart Association class II. This case illustrates a complication of transcatheter aortic valve implantation specific for patients with an ascending aortic graft. Although stenting may be a good solution, as depicted by this case, self-expanding transcatheter aortic valves should be preferred in patients with ascending aortic grafts to avoid the described complication.

The perceval S aortic valve implantation in patients with porcelain aorta; is this ideal option?

PubMed

Baikoussis, Nikolaos G; Dedeilias, Panagiotis; Prappa, Efstathia; Argiriou, Michalis

2017-01-01

We would like to present in this paper a patient with severe aortic valve stenosis referred to our department for surgical aortic valve replacement. In this patient, it was intraoperatively detected an unexpected heavily calcified porcelain ascending aorta. We present the treatment options in this situation, the difficulties affronted intraoperatively, the significance of the preoperative chest computed tomography scan and the use of the Perceval S aortic valve as ideal bioprosthesis implantation. This is a self-expanding, self-anchoring, and sutureless valve with a wide indication in all patients requiring aortic bioprosthesis.

Outcome after transvascular transcatheter aortic valve implantation in 2016.

PubMed

Gaede, Luise; Blumenstein, Johannes; Liebetrau, Christoph; Dörr, Oliver; Kim, Won-Keun; Nef, Holger; Husser, Oliver; Elsässer, Albrecht; Hamm, Christian W; Möllmann, Helge

2018-02-21

We analysed the number of procedures, complications, and in-hospital mortality rates of all patients undergoing transvascular transcatheter aortic valve implantation (TV-TAVI) in comparison to isolated surgical aortic valve replacement (iSAVR) from 2014 to 2016 in Germany. All aortic valve procedures performed in Germany are mandatorily registered in a quality control program. More than 15 000 TV-TAVI procedures were performed in 2016 in Germany. Especially the number of post-procedural complications declined within the last few years, including new pacemaker implantations (2015: 12.6% vs. 2016: 11.4%, P = 0.002) and vascular complications (2015: 8.5% vs. 2016: 7.1%; P < 0.001). Thus, in 2016 the overall in-hospital mortality rate after TV-TAVI was 2.6%, which is for the first time numerically below that of iSAVR, which was 2.9% (P = 0.19). A stratified analysis according to the German aortic valve score shows a lower observed than expected in-hospital mortality rate for TV-TAVI (O/E 0.68). Additionally, the in-hospital mortality was significantly lower after TV-TAVI than after iSAVR in the very high- (11.3% vs. 23.6%; P < 0.001), in the high- (4.1% vs. 9.2%; P < 0.001), and in the intermediate-risk group (3.0% vs. 4.6%; P = 0.016) and was similar to that of iSAVR in low-risk patients (1.6% vs. 1.4%; P = 0.4). The overall in-hospital mortality after TV-TAVI was numerically lower than after iSAVR in 2016 for the first time. In the low risk group in-hospital mortality was similar, whereas in all other risk groups in-hospital mortality after TV-TAVI was significantly lower than after SAVR. This is likely to contribute to a redefinition of the standard of care in the future. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Cardiology

Transcatheter aortic valve implantation: durability of clinical and hemodynamic outcomes beyond 3 years in a large patient cohort.

PubMed

Gurvitch, R; Wood, D A; Tay, E L; Leipsic, J; Ye, J; Lichtenstein, S V; Thompson, C R; Carere, R G; Wijesinghe, N; Nietlispach, F; Boone, R H; Lauck, S; Cheung, A; Webb, J G

2010-09-28

Although short- and medium-term outcomes after transcatheter aortic valve implantation are encouraging, long-term data on valve function and clinical outcomes are limited. Consecutive high-risk patients who had been declined as surgical candidates because of comorbidities but who underwent successful transcatheter aortic valve implantation with a balloon-expandable valve between January 2005 and December 2006 and survived past 30 days were assessed. Clinical, echocardiographic, and computed tomographic follow-up examinations were performed. Seventy patients who underwent successful procedures and survived longer than 30 days were evaluated at a minimum follow-up of 3 years. At a median follow-up of 3.7 years (interquartile range 3.4 to 4.3 years), survival was 57%. Survival at 1, 2, and 3 years was 81%, 74%, and 61%, respectively. Freedom from reoperation was 98.5% (1 patient with endocarditis). During this early procedural experience, 11 patients died within 30 days, and 8 procedures were unsuccessful. When these patients were included, overall survival was 51%. Transaortic pressure gradients increased from 10.0 mm Hg (interquartile range 8.0 to 12.0 mm Hg) immediately after the procedure to 12.1 mm Hg (interquartile range 8.6 to 16.0 mm Hg) after 3 years (P=0.03). Bioprosthetic valve area decreased from a mean of 1.7±0.4 cm(2) after the procedure to 1.4±0.3 cm(2) after 3 years (P<0.01). Aortic incompetence after implantation was trivial or mild in 84% of cases and remained unchanged or improved over time. There were no cases of structural valvular deterioration, stent fracture, deformation, or valve migration. Transcatheter aortic valve implantation demonstrates good medium- to long-term durability and preserved hemodynamic function, with no evidence of structural failure. The procedure appears to offer an adequate and lasting resolution of aortic stenosis in selected patients.

Percutaneous pulmonary valve implantation for free pulmonary regurgitation following conduit-free surgery of the right ventricular outflow tract.

PubMed

Cools, Bjorn; Brown, Stephen C; Heying, Ruth; Jansen, Katrijn; Boshoff, Derize E; Budts, Werner; Gewillig, Marc

2015-01-01

Pulmonary regurgitation (PR) following surgery of the right ventricular outflow tract (RVOT) is not innocent and leads to significant right heart dysfunction over time. Recent studies have demonstrated that percutaneous valves can be implanted in conduit free outflow tracts with good outcomes. To evaluate in patients with severe PR--anticipated to require future pulmonary valve replacement--the feasibility and safety of pre-stenting dilated non-stenotic patched conduit-free right ventricular outflow tracts before excessive dilation occurs, followed by percutaneous pulmonary valve implantation (PPVI). Twenty seven patients were evaluated, but only 23 were deemed suitable based on the presence of an adequate retention zone ≤ 24 mm defined by semi-compliant balloon interrogation of the RVOT. A 2 step procedure was performed: first the landing zone was prepared by deploying a bare stent, followed 2 months later by valve implantation. RVOT pre-stenting with an open cell bare metal stent (Andrastent XXL range) was performed at a median age of 13.0 years (range: 6.0-44.9) with a median weight of 44.3 kg (range: 20.0-88.0). Ninety six percent (22/23) of patients proceeded to PPVI a median of 2.4 months (range: 1.4-3.4) after initial pre-stent placement. Twenty one Melody valves and one 26 mm Edwards SAPIEN™ valve were implanted. Complications consisted of embolization of prestent (n = 1), scrunching (n = 4) and mild stent dislocation (n = 2). During follow-up, no stent fractures were observed and right ventricular dimensions decreased significantly. Post-surgical conduit-free non-stenotic RVOT with free pulmonary regurgitation can be treated percutaneously with a valved stent if anatomical (predominantly size) criteria are met. In experienced hands, the technique is feasible with low morbidity. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

JenaValve.

PubMed

Treede, Hendrik; Rastan, Ardawan; Ferrari, Markus; Ensminger, Stephan; Figulla, Hans-Reiner; Mohr, Friedrich-Wilhelm

2012-09-01

The JenaValve is a next-generation TAVI device which consists of a well-proven porcine root valve mounted on a low-profile nitinol stent. Feeler guided positioning and clip fixation on the diseased leaflets allow for anatomically correct implantation of the device without rapid pacing. Safety and efficacy of transapical aortic valve implantation using the JenaValve were evaluated in a multicentre prospective study that showed good short and midterm results. The valve was CE-mark released in Europe in September 2011. A post-market registry ensures on-going and prospective data collection in "real-world" patients. The transfemoral JenaValve delivery system will be evaluated in a first-in-man study in the near future.

Transcatheter aortic valve-in-valve implantation for severe bioprosthetic stenosis after Bentall operation using a homograft in a patient with Behçet's disease.

PubMed

Joo, Hyung Joon; Hong, Soon Jun; Yu, Cheol Woong

2015-03-01

A 43-year-old man presented with severe aortic stenosis. Eight years previously, he had undergone primary surgical aortic valve replacement (AVR) for severe aortic regurgitation, but one year later developed cardiac arrest and complete atrioventricular block as a result of non-bacterial thrombotic endocarditis with severe valvular dehiscence. Following the diagnosis of prosthetic valve failure caused by Behçet's disease, the patient underwent a Bentall operation using 23 mm aortic homograft with permanent pacemaker implantation and coronary artery bypass grafting. Subsequently, he was stable with steroid administration and azathioprine for seven years after the second operation, but recently suffered from severe dyspnea and chest pain. Echocardiography revealed the development of severe aortic stenosis. A preprocedural evaluation demonstrated a porcelain aorta with severe calcification in the previous homograft valve on computed tomography, and critical stenosis at the ostium of the left circumflex artery on coronary angiography. After percutaneous coronary intervention for the ostium of the left circumflex artery, a transcatheter AVR was successfully performed using a 26 mm Edwards SAPIEN XT valve. The patient recovered without any complications after the procedure. This is the first report of a successful transcatheter aortic valve-in valve implantation for severe homograft aortic stenosis after a Bentall operation, using a homograft, in a patient with Behçet's disease.

Cardiac Valve Noise Reduction by Non-Drug Interventions Improves the Sleep Quality of Patients after Mechanical Cardiac Valve Implantation.

PubMed

Lin, Yanjuan; Xu, Le; Huang, Xizhen; Jiang, Fei; Lin, Fen; Ye, Qingyang; Lin, Jianling

2016-01-01

To investigate the effects of non-drug interventions on the sleep quality of patients after mechanical cardiac valve implantation. In this prospective, randomized, controlled trial, 64 patients scheduled for mechanical mitral valve replacement were recruited. Patients underwent cognitive behavioral therapy and wore noise cancelling earplugs and eye mask. Sleep quality was evaluated on the 4th after admission and the 5th days after operation. The primary outcome was the total sleep quality score differences between the 4th day after admission and the 5th day after operation. All patients had been suffering from poor sleep quality for a month before admission. There was no difference between both groups on the 4th day after admission. Overall sleep quality in the intervention group was better than in the control group on the 5th day after operation. The subjective sleep quality of the patients in each group was significantly lower on the 5th day after the operation than on the 4th day after admission (P <0.05). Non-drug intervention could improve the sleep quality of patients after mechanical cardiac valve implantation and help the postoperative recovery of the patients. ( ChiCTR-TRC-14004405, 21 March 2014.).

Pseudomonas aeruginosa Infective Endocarditis Following Aortic Valve Implantation: A Note of Caution

PubMed Central

Dapás, Juan Ignacio; Rivero, Cynthia; Burgos, Pablo; Vila, Andrea

2016-01-01

Transcatheter aortic valve implantation (TAVI) is an alternative treatment for severe aortic valve stenosis (AS) in patients with prohibitive risk for surgical aortic valve replacement (SAVR). Prosthetic valve endocarditis (PVE) is a rare complication of this relatively novel procedure and current guidelines do not include specific recommendations for its treatment. We report a case of PVE due to Pseudomonas aeruginosa after TAVI that required SAVR, with successful outcome. PVE usually occurs during the first year after TAVI and entails a high mortality risk because patients eligible for this min-imally invasive procedure are fragile (i.e. advanced age and/or severe comorbidities). Additionally, clinical presentation may be atypical or subtle and transesophageal echocardiogram (TEE) may not be conclusive, which delays diagnosis and treatment worsening the prognosis. This case highlights that open SAVR might be ultimately indicated as part of treatment for TAVI-PVE despite a high-risk surgery score. PMID:27014375

Prognostic Impact of Calcium Score after Transcatheter Aortic Valve Implantation Performed With New Generation Prosthesis.

PubMed

Akodad, Mariama; Lattuca, Benoit; Agullo, Audrey; Macia, Jean-Christophe; Gandet, Thomas; Marin, Grégory; Iemmi, Anaïs; Vernhet, Hélène; Schmutz, Laurent; Nagot, Nicolas; Albat, Bernard; Cayla, Guillaume; Leclercq, Florence

2018-05-15

Calcium score (CS) is a well-known prognostic factor after transcatheter aortic valve implantation (TAVI) performed with first generation prosthesis but few data are available concerning new generation valves. The aim of this study was to evaluate if CS remains a prognostic factor after Sapien 3 and Evolut R valves implantation. Agatston CS was evaluated on multislice computed tomography before TAVI in 346 patients implanted with Sapien XT (n = 61), CoreValve (n = 57) devices, (group 1, n = 118), and with new generation Sapien 3 (n = 147), Evolut R (n = 81) prosthesis, (group 2, n = 228). Major adverse cardiovascular events and aortic regurgitation (AR) were evaluated at 1 month. The 2 groups were similar at baseline except for logistic Euroscore (20.1% in group 1 vs 15.0 % in group 2; p = 0.001), chronic renal failure (44.1% vs 37.2% respectively, p = 0.007) and preprocedural CS (4,092 ± 2,176 vs 3,682 ± 2,109 respectively, p = 0.022). In group 1, 28 patients (23.7%) had adverse clinical events vs 21 (9.2%) in group 2 (p <0.01). In multivariate analysis, a higher CS was predictive of adverse events in group 1 (5,785 ± 3,285 vs 3,565 ± 1,331 p <0.0001) but not in group 2 (p = 0.28). A higher CS was associated with AR in group 1 (6,234 ± 2711 vs 3,429 ± 1,505; p <0.001) and in patients implanted with an Evolut R device from group 2 (4,085 ± 3,645 vs 2,551 ± 1,356; p = 0.01). In conclusion, CS appears as an important prognostic factor of major events after TAVI with first generation valves but not with new generation devices. CS remains associated with AR only with new generation self-expandable Evolut R devices. Copyright © 2018 Elsevier Inc. All rights reserved.

How to Perform Transcaval Access and Closure for Transcatheter Aortic Valve Implantation

PubMed Central

Lederman, Robert J.; Babaliaros, Vasilis C.; Greenbaum, Adam B.

2016-01-01

Transcaval, or caval-aortic, access is a promising approach for fully percutaneous trans-catheter aortic valve implantation in patients without good conventional access options. This tutorial review provides step-by-step guidance to planning and executing the procedure, along with approaches to remedy complications. PMID:26356244

Percutaneous pulmonary valve implantation in patients with dysfunction of a "native" right ventricular outflow tract - Mid-term results.

PubMed

Georgiev, Stanimir; Tanase, Daniel; Ewert, Peter; Meierhofer, Christian; Hager, Alfred; von Ohain, Jelena Pabst; Eicken, Andreas

2018-05-01

To investigate the feasibility and mid-term results of percutaneous pulmonary valve implantation (PPVI) in patients with conduit free or "native" right ventricular outflow tracts (RVOT). We identified all 18 patients with conduit free or "native" right ventricular outflow tract, who were treated with percutaneous pulmonary valve implantation (PPVI) in our institution. They were divided into two groups - these in whom the central pulmonary artery was used as an anchoring point for the preparation of the landing zone (n=10) for PPVI and these, in whom a pulmonary artery branch was used for this purpose (n=8). PPVI was performed successfully in all patients with significant immediate RVOT gradient and pulmonary regurgitation grade reduction. Four patients had insignificant paravalvular regurgitation. In one patient the valve was explanted after 4months because of bacterial endocarditis. A follow-up of 19 (4-60) months showed sustained good function of the other implanted valves. The MRI indexed right ventricular end diastolic volume significantly decreased from 108(54-174) ml/m 2 before the procedure to 76(60-126) ml/m 2 six months after PPVI, p=0.01. PPVI is feasible with good mid-term results in selected patients with a "native" RVOT without a previously implanted conduit. Creating a stable landing zone with a diameter less than the largest available valve (currently 29mm) is crucial for the technical success of the procedure. Further studies and the development of new devices could widen the indications for this novel treatment. Copyright © 2017 Elsevier B.V. All rights reserved.

Four-year durability of clinical and haemodynamic outcomes of transcatheter aortic valve implantation with the self-expanding CoreValve.

PubMed

Gulino, Simona; Barbanti, Marco; Deste, Wanda; Immè, Sebastiano; Aruta, Patrizia; Bottari, Vera; Benvenuto, Emanuele; Tamburino, Claudia; Di Landro, Alessio; Liberto, Daria; Santonoceto, Letizia; Sicuso, Rita; Di Stefano, Daniele; Todaro, Denise; Di Simone, Emanuela; Indelicato, Antonino; Giannazzo, Daniela; Sgroi, Carmelo; Tamburino, Corrado

2016-10-10

Long-term data on the durability of currently available transcatheter heart valves are limited. We sought to assess four-year clinical and echocardiographic outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. Between June 2007 and February 2014, 450 consecutive patients with symptomatic severe aortic stenosis underwent TAVI in our institution. For the purposes of this study, we included only those patients undergoing successful TAVI with the CoreValve prosthesis who had a minimum follow-up of four years (n=125). Survival rates at one, two, three and four years were 83.2, 76.8, 73.6 and 66.3%, respectively. Aortic regurgitation was a common finding after the procedure, especially due to paravalvular regurgitation (PVR), which was observed in the majority of patients (71.5%), mostly mild (52.0%). Progression from mild acute PVR to moderate PVR at four-year follow-up was reported in three patients. No cases of severe PVR were observed. Prosthetic valve failure was reported in four patients (3.2%). Our study demonstrates that favourable outcomes after successful TAVI are associated with sustained clinical and functional cardiovascular benefits up to four-year follow-up. Signs of moderate prosthetic valve failure are present only in a small percentage of patients.

Latest evidence on transcatheter aortic valve implantation vs. surgical aortic valve replacement for the treatment of aortic stenosis in high and intermediate-risk patients.

PubMed

Praz, Fabien; Siontis, George C M; Verma, Subodh; Windecker, Stephan; Jüni, Peter

2017-03-01

The goal of this review is to summarize the current evidence supporting the use of transcatheter aortic valve implantation (TAVI) in high and intermediate-risk patients. The focus is on the five randomized controlled trials comparing TAVI with surgical aortic valve replacement (SAVR) published to date, as well as two recent meta-analyses. TAVI has profoundly transformed the treatment of elderly patients presenting with symptomatic severe aortic stenosis. In experienced hands, the procedure has become well tolerated and the results more predictable. So far, two trials using two different devices [Placement of Aortic Transcatheter Valve (PARTNER) 1A and US CoreValve High Risk] have shown that TAVI is able to compete in terms of mortality with SAVR in high-risk patients. These findings have been extended to the intermediate-risk population in two recently published randomized controlled trials [PARTNER 2 and Nordic Aortic Valve Intervention (NOTION)]. The two meta-analyses suggested improved survival in both high and intermediate-risk patients during the first 2 years following the intervention. The survival benefit was only found in patients treated via the transfemoral access, and appeared more pronounced in women. Individual randomized trials enrolling high and intermediate-risk patients have established the noninferiority of TAVI in comparison with SAVR, whereas subsequent meta-analyses suggest superiority of transfemoral TAVI in terms of a sustained survival benefit 2 years after valve implantation irrespective of the surgical risk category. The benefit of TAVI appears more pronounced in women than in men.

In vivo analysis of conjunctiva in gold micro shunt implantation for glaucoma.

PubMed

Mastropasqua, Leonardo; Agnifili, Luca; Ciancaglini, Marco; Nubile, Mario; Carpineto, Paolo; Fasanella, Vincenzo; Figus, Michele; Lazzeri, Stefano; Nardi, Marco

2010-12-01

To describe the conjunctival epithelial features seen with in vivo confocal microscopy (IVCM) after gold micro shunt (GMS) implantation in the suprachoroidal space, in patients with uncontrolled glaucoma. This was an observational case series study. Fourteen eyes of 14 consecutive glaucomatous patients with a history of multiple failed incisional surgeries followed by GMS implantation were evaluated with a digital confocal laser-scanning microscope (HRT II Rostock Cornea Module). Patients were divided into two groups: successful implantations (Group 1: eight patients, eight eyes), defined as a one-third reduction in preoperative intraocular pressure (IOP) with or without antiglaucoma medications and failed implantations (Group 2: six patients, six eyes) as a less than one-third reduction in preoperative IOP with maximal tolerated medical therapy. The examination was performed from 3 to 20 months (mean 15.4±5.4) postoperatively. Conjunctival mean microcyst density (MMD: cysts/mm(2)) and mean microcyst area (MMA: μm(2)) were the main outcome measurements. The mean postoperative IOP was statistically different between the two groups (p<0.05), with the values of 14.3±2.77 and 32.3±8.01 mm Hg in Groups 1 and 2, respectively. When comparing successful with failed implantation, the IVCM analysis showed a greater MMD (p<0.01) and MMA (p<0.01). Clinical evidence of filtering bleb was not found in any of the patients. Successful GMS implantation significantly increased conjunctival microcysts density and surface at the site of the device insertion. These findings suggest that the enhancement of the aqueous filtration across the sclera may be one of the possible outflow pathways exploited by the shunt.

Salvaging catastrophe in transcatheter aortic valve implantation: rehearsal, preassigned roles, and emergency preparedness.

PubMed

Tam, Derrick Y; Jones, Philip M; Kiaii, Bob; Diamantouros, Pantelis; Teefy, Patrick; Bainbridge, Daniel; Cleland, Andrew; Fernandes, Philip; Chu, Michael W A

2015-08-01

Emergency rescue plans for acute complications during transcatheter aortic valve implantation (TAVI) commonly include cardiopulmonary resuscitation, femoro-femoral cardiopulmonary bypass (CPB), and hemodynamic stabilization before definitive intervention is achieved. Nevertheless, most cases of emergency resuscitation remain chaotic and disorganized and often take longer than necessary, even in experienced centres. We sought to determine which factors and procedures may be associated with improved patient outcomes when emergencies arise during TAVI. MEDLINE(®) and EMBASE™ were searched with the following key words: "TAVI" or "TAVR" or "transcatheter valve implantation" or "transcatheter valve replacement" and "emergency cardiac surgery" or "conversion". Two hundred seventeen articles met the criteria and were reviewed. Utilization of a formal emergency checklist by a multidisciplinary TAVI team may reduce procedural errors, smooth the transition to CPB, and ultimately speed the delivery of corrective measures including emergency cardiac surgery. A well-organized regularly-rehearsed emergency rescue plan that preassigns resuscitative roles may shorten the duration of patient instability and resuscitation and improve patient outcomes when catastrophe occurs in TAVI. The anesthesia team plays a central role in preventing, detecting, and treating intraprocedural complications during TAVI.

Outflow resistance of the Baerveldt glaucoma drainage implant and modifications for early postoperative intraocular pressure control.

PubMed

Breckenridge, R Reid; Bartholomew, Luanna R; Crosson, Craig E; Kent, Alexander R

2004-10-01

To determine outflow resistance of the Baerveldt glaucoma implant using different tube configurations. Outflow resistance of 6 tube configurations (C1- C6) of Baerveldt implants was measured under conditions of constant pressure perfusion. Pressures ranged from 2 to 55 mm Hg. Venting slits were created using a 7-0 Vicryl, spatulated suture-needle. Seton tubes were occluded by threading a retrograde suture approximately 1.5 cm into the lumen. At pressures between 2 and 55 mm Hg, mean outflow resistance of the normally configured seton (ie, open tube; C1) was 0.41 (+/- 0.6) mm Hg/microL/min. Resistance was unchanged (mean 0.41 (+/- 0.4) mm Hg/microL/min) by the addition of 4 venting slits (C2) to the seton tube. Occlusion of the open seton tube with a 3-0 Supramid suture (C3) significantly increased (P < 0.001) mean outflow resistance to 14.99 (+/- 0.6) mm Hg/microL/min. Occlusion of the tube with a 4-0 Supramid suture (C4) significantly increased (P < 0.001) mean outflow resistance to 1.09 (+/- 0.5) mm Hg/microL/min. In implants where tubes were occluded with a 3-0 Supramid suture, the addition of venting slits (C5) significantly decreased (P = 0.038) mean outflow resistance to 8.98 (+/- 0.4) mm Hg/microL/min. In tubes occluded with a 4-0 Supramid suture, the addition of venting slits (C6) decreased mean outflow resistance to 0.98 (+/- 0.6) mm Hg/microL/min. Although these results cannot be directly correlated to the clinical setting, they do show that outflow resistance can be modified at the time of surgery by changing tube configuration of the Baerveldt glaucoma implant. Configuration C5 (3-0 Supramid with venting slits) closely approximates the outflow rate in the normal intraocular pressure range.

The third hand--a simple but useful tool for holding the sheath during transapical transcatheter aortic valve implantation.

PubMed

Wisser, Wilfried

2010-11-01

Transapical aortic valve implantation is an evolving technology for treating high-risk patients with symptomatic aortic stenosis. The transition to a catheter based implantation technique inherits one fundamental change: the native valve stays in place and is no longer removed. The selection of the correct plane of the aortic annulus, therefore, is mandatory. In addition, exact alignment of the sheath and catheters according to axis of the ascending aorta is imperative for correct implantation. That is why any additional movements have to be avoided. To aid in better workflow, we developed an easy-to-use cheap holder for the introduction sheath. By using a rigid table mount instrument holder the sheath can easily be fixed in the desired orientation, abolishing any movement and reducing the X-ray load to the implanting surgeon.

Glaucoma after corneal replacement.

PubMed

Baltaziak, Monika; Chew, Hall F; Podbielski, Dominik W; Ahmed, Iqbal Ike K

Glaucoma is a well-known complication after corneal transplantation surgery. Traditional corneal transplantation surgery, specifically penetrating keratoplasty, has been slowly replaced by the advent of new corneal transplantation procedures: primarily lamellar keratoplasties. There has also been an emergence of keratoprosthesis implants for eyes that are high risk of failure with penetrating keratoplasty. Consequently, there are different rates of glaucoma, pathogenesis, and potential treatment in the form of medical, laser, or surgical therapy. Copyright © 2017 Elsevier Inc. All rights reserved.

Inverse Relationship Between Membranous Septal Length and the Risk of Atrioventricular Block in Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Hamdan, Ashraf; Guetta, Victor; Klempfner, Robert; Konen, Eli; Raanani, Ehud; Glikson, Michael; Goitein, Orly; Segev, Amit; Barbash, Israel; Fefer, Paul; Spiegelstein, Dan; Goldenberg, Ilan; Schwammenthal, Ehud

2015-08-17

This study sought to examine whether imaging of the atrioventricular (AV) membranous septum (MS) by computed tomography (CT) can be used to identify patient-specific anatomic risk of high-degree AV block and permanent pacemaker (PPM) implantation before transcatheter aortic valve implantation (TAVI) with self-expandable valves. MS length represents an anatomic surrogate of the distance between the aortic annulus and the bundle of His and may therefore be inversely related to the risk of conduction system abnormalities after TAVI. Seventy-three consecutive patients with severe aortic stenosis underwent contrast-enhanced CT before TAVI. The aortic annulus, aortic valve, and AV junction were assessed, and MS length was measured in the coronal view. In 13 patients (18%), high-degree AV block developed, and 21 patients (29%) received a PPM. Multivariable logistic regression analysis revealed MS length as the most powerful pre-procedural independent predictor of high-degree AV block (odds ratio [OR]: 1.35, 95% confidence interval [CI]: 1.1 to 1.7, p = 0.01) and PPM implantation (OR: 1.43, 95% CI: 1.1 to 1.8, p = 0.002). When taking into account pre- and post-procedural parameters, the difference between MS length and implantation depth emerged as the most powerful independent predictor of high-degree AV block (OR: 1.4, 95% CI: 1.2 to 1.7, p < 0.001), whereas the difference between MS length and implantation depth and calcification in the basal septum were the most powerful independent predictors of PPM implantation (OR: 1.39, 95% CI: 1.2 to 1.7, p < 0.001 and OR: 4.9, 95% CI: 1.2 to 20.5, p = 0.03; respectively). Short MS, insufficient difference between MS length and implantation depth, and the presence of calcification in the basal septum, factors that may all facilitate mechanical compression of the conduction tissue by the implanted valve, predict conduction abnormalities after TAVI with self-expandable valves. CT assessment of membranous septal anatomy provides

An augmented magnetic navigation system for Transcatheter Aortic Valve Implantation.

PubMed

Luo, Zhe; Cai, Junfeng; Nie, Yuanyuan; Wang, Guotai; Gu, Lixu

2013-01-01

This research proposes an augmented magnetic navigation system for Transcatheter Aortic Valve Implantation (TAVI) employing a magnetic tracking system (MTS) combined with a dynamic aortic model and intra-operative ultrasound (US) images. The dynamic 3D aortic model is constructed based on the preoperative 4D computed tomography (CT), which is animated according to the real time electrocardiograph (ECG) input of patient. And a preoperative planning is performed to determine the target position of the aortic valve prosthesis. The temporal alignment is performed to synchronize the ECG signals, intra-operative US image and tracking information. Afterwards, with the assistance of synchronized ECG signals, the contour of aortic root automatic extracted from short axis US image is registered to the dynamic aortic model by a feature based registration intra-operatively. Then the augmented MTS guides the interventionist to confidently position and deploy the aortic valve prosthesis to target. The system was validated by animal studies on three porcine subjects, the deployment and tilting errors of which are 3.17 ± 0.91 mm and 7.40 ± 2.89° respectively.

Transcatheter JenaValve Implantation in a Stentless Prosthesis: A Challenging Case After 4 Previous Aortic Procedures.

PubMed

Sponga, Sandro; Mazzaro, Enzo; Bagur, Rodrigo; Livi, Ugolino

2017-04-01

A 40-year-old man underwent 4 aortic surgeries because of endocarditis and subsequent prosthesis dehiscence. At the last recurrence he presented with acute severe aortic regurgitation of a Pericarbon Freedom (LivaNova plc, London, UK) stentless bioprosthesis and a morphologically disarranged aortic root. He also presented with left ventricular dysfunction and a very low origin of the left coronary artery. Therefore, a fifth redo aortic valve replacement was considered at high surgical risk. Accordingly, before listing the patient for a heart transplantation, a transcatheter valve-in-valve implantation with the JenaValve (JenaValve Technology, GmbH, Munich, Germany) prosthesis was performed. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Transfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation.

PubMed

Schofer, Joachim; Nietlispach, Fabian; Bijuklic, Klaudija; Colombo, Antonio; Gatto, Fernando; De Marco, Federico; Mangieri, Antonio; Hansen, Lorenz; Bruschi, Giuseppe; Ruparelia, Neil; Rieß, Friedrich-Christian; Maisano, Franscesco; Latib, Azeem

2015-12-21

This study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure aortic regurgitation (AR). The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak. The study population consisted of patients treated for severe noncalcific pure AR with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers. The primary endpoint was the composite endpoint of device success and the secondary endpoint was the composite early safety endpoint (according to the VARC-2 criteria). Eleven high-risk (STS score 8.84 ± 8.9, Logistic EuroSCORE 19.9 ± 7.1) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, the initial valve prosthesis was retrieved after pull-through, and a second valve was successfully deployed. The early safety endpoint was reached in 91% of the patients, with 1 patient requiring surgical aortic valve replacement secondary to downward dislocation of the prosthesis that was successfully managed with surgical aortic valve replacement. DFM implantation resulted in excellent hemodynamics with none or trivial paravalvular regurgitation in 9 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients derived symptomatic benefit following the procedure, with 72% in New York Heart Association functional class I or II. This study reports the feasibility of treating severe noncalcific AR with the Direct Flow prosthesis via the transfemoral route. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Percutaneous management of vascular access in transfemoral transcatheter aortic valve implantation

PubMed Central

Dato, Ilaria; Burzotta, Francesco; Trani, Carlo; Crea, Filippo; Ussia, Gian Paolo

2014-01-01

Transcatheter aortic valve implantation (TAVI) using stent-based bioprostheses has recently emerged as a promising alternative to surgical valve replacement in selected patients. The main route for TAVI is retrograde access from the femoral artery using large sheaths (16-24 F). Vascular access complications are a clinically relevant issue in TAVI procedures since they are reported to occur in up to one fourth of patients and are strongly associated with adverse outcomes. In the present paper, we review the different types of vascular access site complications associated with transfemoral TAVI. Moreover, we discuss the possible optimal management strategies with particular attention to the relevance of early diagnosis and prompt treatment using endovascular techniques. PMID:25228962

Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium†

PubMed Central

Leon, Martin B.; Piazza, Nicolo; Nikolsky, Eugenia; Blackstone, Eugene H.; Cutlip, Donald E.; Kappetein, Arie Pieter; Krucoff, Mitchell W.; Mack, Michael; Mehran, Roxana; Miller, Craig; Morel, Marie-angèle; Petersen, John; Popma, Jeffrey J.; Takkenberg, Johanna J.M.; Vahanian, Alec; van Es, Gerrit-Anne; Vranckx, Pascal; Webb, John G.; Windecker, Stephan; Serruys, Patrick W.

2011-01-01

Objectives To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health. Background Transcatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials. Methods and results The Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the US Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included (i) respect for the historical legacy of surgical valve guidelines; (ii) identification of pathophysiological mechanisms associated with clinical events; (iii) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite

Conduction Abnormalities and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Device: The United Kingdom Experience.

PubMed

Rampat, Rajiv; Khawaja, M Zeeshan; Hilling-Smith, Roland; Byrne, Jonathan; MacCarthy, Philip; Blackman, Daniel J; Krishnamurthy, Arvindra; Gunarathne, Ashan; Kovac, Jan; Banning, Adrian; Kharbanda, Raj; Firoozi, Sami; Brecker, Stephen; Redwood, Simon; Bapat, Vinayak; Mullen, Michael; Aggarwal, Suneil; Manoharan, Ganesh; Spence, Mark S; Khogali, Saib; Dooley, Maureen; Cockburn, James; de Belder, Adam; Trivedi, Uday; Hildick-Smith, David

2017-06-26

The authors report the incidence of pacemaker implantation up to hospital discharge and the factors influencing pacing rate following implantation of the LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts) in the United Kingdom. Transcatheter aortic valve replacement (TAVR) is associated with a significant need for permanent pacemaker implantation. Pacing rates vary according to the device used. The REPRISE II (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System) trial reported a pacing rate of 29% at 30 days after implantation of the LOTUS device. Data were collected retrospectively on 228 patients who had the LOTUS device implanted between March 2013 and February 2015 across 10 centers in the United Kingdom. Twenty-seven patients (12%) had pacemakers implanted pre-procedure and were excluded from the analysis. Patients were aged 81.2 ± 7.7 years; 50.7% were male. The mean pre-procedural QRS duration was 101.7 ± 20.4 ms. More than one-half of the cohort (n = 111, 55%) developed new left bundle branch block (LBBB) following the procedure. Permanent pacemakers were implanted in 64 patients (32%) with a median time to insertion of 3.0 ± 3.4 days. Chief indications for pacing were atrioventricular (AV) block (n = 46, 72%), or LBBB with 1st degree AV block (n = 11, 17%). Amongst those who received a pacemaker following TAVR the pre-procedural electrocardiogram findings included: No conduction disturbance (n = 41, 64%); 1st degree AV block (n = 10, 16%); right bundle branch block (n = 6, 9%) and LBBB (n = 5, 8%). LBBB (but not permanent pacemaker) occurred more frequently in patients who had balloon aortic valvuloplasty before TAVR (odds ratio [OR]: 1.25; p = 0.03). Pre-procedural conduction abnormality (composite of 1st degree AV block, hemiblock, right bundle branch block, LBBB) was independently associated with the need for permanent pacemaker (OR: 2.54; p = 0.048). The absence of

Improvement in Outflow Facility by Two Novel Microinvasive Glaucoma Surgery Implants

PubMed Central

Hays, Cassandra L.; Gulati, Vikas; Fan, Shan; Samuelson, Thomas W.; Ahmed, Iqbal Ike K.; Toris, Carol B.

2014-01-01

Purpose. To determine improvement in outflow facility (C) in human anterior segments implanted with a novel Schlemm's canal scaffold or two trabecular micro-bypasses. Methods. Human anterior segments were isolated from 12 pairs of eyes from donors with no history of ocular disease and then perfused at 50, 40, 30, 20, and 10 mm Hg pressures for 10 minutes each. Baseline C was calculated from perfusion pressures and flow rates. The scaffold was implanted into Schlemm's canal of one anterior segment, and two micro-bypasses were implanted three clock-hours apart in the contralateral anterior segment. Outflow facility and resistance were compared at various standardized perfusion pressures and between each device. Results. Compared to baseline, C increased by 0.16 ± 0.12 μL/min/mm Hg (74%) with the scaffold, and 0.08 ± 0.12 μL/min/mm Hg (34%) with two micro-bypasses. The scaffold increased C at perfusion pressures of 50, 40, 30, and 20 mm Hg (P < 0.005). Two micro-bypasses increased C at a perfusion pressure of 40 mm Hg (P < 0.05). Conclusions. Both implants effectively increased C in human eyes ex vivo. The scaffold increased C by a greater percentage (73% vs. 34%) and at a greater range of perfusion pressures (20 to 50 mm Hg vs. 40 mm Hg) than the two micro-bypasses, suggesting that the 8-mm dilation of Schlemm's canal by the scaffold may have additional benefits in lowering the outflow resistance. The Hydrus Microstent scaffold may be an effective therapy for increasing outflow facility and thus reducing the IOP in patients with glaucoma. PMID:24550367

Use of Autologous Scleral Graft in Ahmed Glaucoma Valve Surgery.

PubMed

Wolf, Alvit; Hod, Yair; Buckman, Gila; Stein, Nili; Geyer, Orna

2016-04-01

To compare the efficacy of an autoscleral free-flap graft versus an autoscleral rotational flap graft in Ahmed glaucoma valve (AGV) surgery. Medical records (2005 to 2012) of 51 consecutive patients (51 eyes) who underwent AGV surgery with the use of either an autoscleral free-flap graft or an autoscleral rotational flap graft to cover the external tube at the limbus were retrieved for review. The main outcome measure was the incidence of tube exposure associated with each surgical approach. Twenty-seven consecutive patients (27 eyes) received a free-flap graft and 24 consecutive patients (24 eyes) received a rotational flap graft. The mean follow-up time was 55.6 ± 18.3 months for the former and 24.2± 5 .0 months for the latter (P<0.0001). Two patients in the free-flap group (8.9%) developed tube exposure at 24 and 55 months postoperatively compared with none of the patients in the rotational flap group. Graft thinning without evidence of conjunctival erosion was observed in 15 patients (55%) in the free-flap group and in 7 patients (29.1%) in the rotational flap group. The use of an autoscleral rotational flap graft is an efficacious technique for primary tube patch grafting in routine AGV surgery, and yielded better results than an autoscleral free-flap graft. Its main advantages over donor graft material are availability and lower cost.

Bioprosthetic Valve Fracture During Valve-in-valve TAVR: Bench to Bedside

PubMed Central

Saxon, John T; Allen, Keith B; Cohen, David J

2018-01-01

Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) has been established as a safe and effective means of treating failed surgical bioprosthetic valves (BPVs) in patients at high risk for complications related to reoperation. Patients who undergo VIV TAVR are at risk of patient–prosthesis mismatch, as the transcatheter heart valve (THV) is implanted within the ring of the existing BPV, limiting full expansion and reducing the maximum achievable effective orifice area of the THV. Importantly, patient–prosthesis mismatch and high residual transvalvular gradients are associated with reduced survival following VIV TAVR. Bioprosthetic valve fracture (BVF) is as a novel technique to address this problem. During BPV, a non-compliant valvuloplasty balloon is positioned within the BPV frame, and a highpressure balloon inflation is performed to fracture the surgical sewing ring of the BPV. This allows for further expansion of the BPV as well as the implanted THV, thus increasing the maximum effective orifice area that can be achieved after VIV TAVR. This review focuses on the current evidence base for BVF to facilitate VIV TAVR, including initial bench testing, procedural technique, clinical experience and future directions. PMID:29593832

Bioprosthetic Valve Fracture During Valve-in-valve TAVR: Bench to Bedside.

PubMed

Saxon, John T; Allen, Keith B; Cohen, David J; Chhatriwalla, Adnan K

2018-01-01

Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) has been established as a safe and effective means of treating failed surgical bioprosthetic valves (BPVs) in patients at high risk for complications related to reoperation. Patients who undergo VIV TAVR are at risk of patient-prosthesis mismatch, as the transcatheter heart valve (THV) is implanted within the ring of the existing BPV, limiting full expansion and reducing the maximum achievable effective orifice area of the THV. Importantly, patient-prosthesis mismatch and high residual transvalvular gradients are associated with reduced survival following VIV TAVR. Bioprosthetic valve fracture (BVF) is as a novel technique to address this problem. During BPV, a non-compliant valvuloplasty balloon is positioned within the BPV frame, and a highpressure balloon inflation is performed to fracture the surgical sewing ring of the BPV. This allows for further expansion of the BPV as well as the implanted THV, thus increasing the maximum effective orifice area that can be achieved after VIV TAVR. This review focuses on the current evidence base for BVF to facilitate VIV TAVR, including initial bench testing, procedural technique, clinical experience and future directions.

Successful Feasibility Human Trial of a New Self-Expandable Percutaneous Pulmonary Valve (Pulsta Valve) Implantation Using Knitted Nitinol Wire Backbone and Trileaflet α-Gal-Free Porcine Pericardial Valve in the Native Right Ventricular Outflow Tract.

PubMed

Kim, Gi Beom; Song, Mi Kyoung; Bae, Eun Jung; Park, Eun-Ah; Lee, Whal; Lim, Hong-Gook; Kim, Yong Jin

2018-06-01

Self-expandable percutaneous pulmonary valve implantation (PPVI) for native right ventricular outflow tract lesions is still in the clinical trial phase. The aim of this study is to present the result of feasibility study of a novel self-expandable knitted nitinol wire stent mounted with a treated trileaflet α-Gal-free porcine pericardial valve for PPVI. A feasibility study using Pulsta valve (TaeWoong Medical Co, Gyeonggi-do, South Korea) was designed for patients with severe pulmonary regurgitation in the native right ventricular outflow tract, and 6-month follow-up outcomes were reviewed. Ten tetralogy of Fallot patients were enrolled. Before PPVI, severe pulmonary regurgitation (mean pulmonary regurgitation fraction, 45.5%±7.2%; range, 34.9%-56%) and enlarged right ventricular volume (mean indexed right ventricular end-diastolic volume, 176.7±14.3 mL/m 2 ; range, 158.9-205.9 mL/m 2 ) were present. The median age at PPVI was 21.7±6.5 years (range, 13-36 years). Five patients were successfully implanted with 28 mm and the other 5 with 26 mm valves loaded on the 18F delivery cable. No significant periprocedural complications were noted in any patient. At the 6-month follow-up, indexed right ventricular end-diastolic volume was dramatically decreased to 126.3±20.3 mL/m 2 (range, 99-164.2 mL/m 2 ), and the mean value of peak instantaneous pressure gradient between the right ventricle and the pulmonary artery decreased from 6.8±3.5 mm Hg (range, 2-12 mm Hg) before PPVI to 5.7±6.7 mm Hg (range, 2-12 mm Hg) without significant pulmonary regurgitation. There was no adverse event associated with the valve. A feasibility study of the Pulsta valve for native right ventricular outflow tract lesions was completed successfully with planned Pulsta valve implantation and demonstrated good short-term effectiveness without serious adverse events. URL: https://www.clinicaltrials.gov. Unique identifier: NCT02555319. © 2018 American Heart Association, Inc.

Is valve choice a significant determinant of paravalular leak post-transcatheter aortic valve implantation? A systematic review and meta-analysis.

PubMed

O'Sullivan, Katie E; Gough, Aideen; Segurado, Ricardo; Barry, Mitchel; Sugrue, Declan; Hurley, John

2014-05-01

Paravalvular regurgitation (PVR) following transcatheter aortic valve implantation (TAVI) is associated with poor survival. The two main valve delivery systems used to date differ significantly in both structure and deployment technique. The primary objective of this study was to perform a systematic review and meta-analysis of studies identifying PVR in patients post-TAVI using Medtronic CoreValve (MCV) and Edward Sapien (ES) valves in order to identify whether a significant difference exists between valve types. The secondary objective was to identify additional factors predisposing to PVR to provide an overview of the other associated considerations. A systematic review and meta-analysis of the current literature to identify PVR rate in patients with MCV and ES valves was performed. We also sought to examine other factors predisposing to PVR. A total of 5910 patients were identified from 9 studies. PVR rates for MCV and ES were analysed. MCV was associated with a higher PVR rate of 15.75% [95% confidence interval (CI) 12.48-19.32] compared with ES 3.93% [95% CI 1.05-8.38]. We separately reviewed predisposing factors associated with PVR. A formal comparison of the MCV and ES valve leakage rates by mixed-effects meta-regression with a fixed-effect moderator variable for valve type (MCV or ES) suggested a statistically significant difference in leakage rate between the two valve types (P = 0.0002). Unfavourable anatomical and pathological factors as well as valve choice have an impact on rates of PVR. Additionally, certain anatomical features dictate valve choice. A direct comparison of all the predisposing factors at this time is not possible and will require prospective multivariate analysis. There is, however, a significant difference in the PVR rates between valves based on the published observational data available to date. The ES valve associated with a lower incidence of PVR overall; therefore, we conclude that valve choice is indeed a significant

Transcatheter Aortic Valve Implantation for Treatment of Aortic Valve Stenosis: A Health Technology Assessment

PubMed Central

Sehatzadeh, Shayan; Tu, Hong-Anh; Holubowich, Corinne; Higgins, Caroline

2016-01-01

Background Surgical aortic valve replacement (SAVR) is the gold standard for treating aortic valve stenosis. It is a major operation that requires sternotomy and the use of a heart-lung bypass machine, but in appropriately selected patients with symptomatic, severe aortic valve stenosis, the benefits of SAVR usually outweigh the harms. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure that allows an artificial valve to be implanted over the poorly functioning valve. Methods We identified and analyzed randomized controlled trials that evaluated the effectiveness and safety of TAVI compared with SAVR or balloon aortic valvuloplasty and were published before September 2015. The quality of the body of evidence for each outcome was examined according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. The overall quality was determined to be high, moderate, low, or very low using a step-wise, structural methodology. We also developed a Markov decision-analytic model to assess the cost-effectiveness of TAVI compared with SAVR over a 5-year time horizon, and we conducted a 5-year budget impact analysis. Results Rates of cardiovascular and all-cause mortality were similar for the TAVI and SAVR groups in all studies except one, which reported significantly lower all-cause mortality in the TAVI group and a higher rate of stroke in the SAVR group. Trials of high-risk patients who were not suitable candidates for SAVR showed significantly better survival with TAVI than with balloon aortic valvuloplasty. Median survival in the TAVI group was 31 months, compared with 11.7 months in the balloon aortic valvuloplasty group. Compared with SAVR, TAVI was associated with a significantly higher risk of stroke, major vascular complications, paravalvular aortic regurgitation, and the need for a permanent pacemaker. SAVR was associated with a higher risk of bleeding. Transapical TAVI was associated with higher

Transapical aortic valve implantation in Rouen: four years' experience with the Edwards transcatheter prosthesis.

PubMed

Litzler, Pierre-Yves; Borz, Bogdan; Smail, Hassiba; Baste, Jean-Marc; Nafeh-Bizet, Catherine; Gay, Arnaud; Tron, Christophe; Godin, Matthieu; Caudron, Jerome; Hauville, Camille; Dacher, Jean-Nicolas; Cribier, Alain; Eltchaninoff, Hélène; Bessou, Jean-Paul

2012-03-01

The first French transapical transcatheter aortic valve implantation (TAVI) was performed in July 2007 in our department. To report 4-year outcomes of transapical implantation with the Edwards transcatheter bioprosthesis. We prospectively evaluated consecutive patients who underwent transapical implantation with an Edwards transcatheter bioprosthesis between July 2007 and October 2011. Patients were not suitable for conventional surgery (due to severe comorbidities) or transfemoral implantation (due to poor femoral access). Among 61 patients (59.0% men), mean logistic EuroSCORE was 27.5 ± 14.9% and mean age was 81.0 ± 6.8 years. Successful valve implantation was achieved in 59/61 patients (96.7%) of patients. The other two patients required conversion to conventional surgery due to prosthesis embolization and died. Six additional patients died in the postoperative period. Causes of perioperative death were two septic shocks (one of peritonitis), two multi-organ failure, one ventricular fibrillation and one respiratory insufficiency. Intraprocedural stroke was not observed in any patient. The actuarial survival rates at 1, 2 and 4 years were 73.8%, 67.2% and 41.0%. During this 4-year period, four patients died of cardiovascular events, but no impairment of transprosthesis gradient was observed. Our series of 61 patients who underwent transapical implantation of the Edwards transcatheter bioprosthesis shows satisfactory results, similar to other reports, considering the high level of severity of patients referred for this method. Transapical access is a reliable alternative method for patients that cannot benefit from a transfemoral approach. Copyright © 2012. Published by Elsevier Masson SAS.

Pars Plana-Modified versus Conventional Ahmed Glaucoma Valve in Patients Undergoing Penetrating Keratoplasty: A Prospective Comparative Randomized Study.

PubMed

Parihar, Jitendra Kumar Singh; Jain, Vaibhav Kumar; Kaushik, Jaya; Mishra, Avinash

2017-03-01

To compare the outcome of pars-plana-modified Ahmed glaucoma valve (AGV) versus limbal-based conventional AGV into the anterior chamber, in patients undergoing penetrating keratoplasty (PK) for glaucoma with coexisting corneal diseases. In this prospective randomized clinical trial, 58 eyes of 58 patients with glaucoma and coexisting corneal disease were divided into two groups. Group 1 (29 eyes of 29 patients) included patients undergoing limbal-based conventional AGV into the anterior chamber (AC) along-with PK and group 2 (29 eyes of 29 patients) included those undergoing pars-plana-modified AGV along-with PK. Outcome measures included corneal graft clarity, intraocular pressure (IOP), number of antiglaucoma medications, and postoperative complications. Patients were followed up for a minimum period of 2 years. Out of 58 eyes (58 patients), 50 eyes (50 patients: 25 eyes of 25 patients each in group 1 and group 2) completed the study and were analyzed. Complete success rate for AGV (group 1: 76%; group 2: 72%; p = 0.842) and corneal graft clarity (group 1: 68%; group 2: 76%; p = 0.081) were comparable between the two groups at 2 years. Graft failure was more in conventional AGV (32%) as compared to pars plana-modified AGV (24%) but not statistically significant (p = 0.078) at 2 years. Though both procedures were comparable in various outcome measures, pars-plana-modified AGV is a viable option for patients undergoing PK, as it provides a relatively better corneal graft survival rate and lesser complications that were associated with conventional AGV.

[Glaucoma and retinal surgery].

PubMed

Müller, M; Geerling, G; Zierhut, M; Klink, T

2010-05-01

In the therapeutic approach to complex glaucomas different initial situations were considered: pre-existing glaucoma, induction of glaucoma after vitreoretinal surgery and antiglaucomatous procedures. In pre-existing glaucoma and after filtering surgery maintenance of the filtering bleb requires a vitreoretinal approach for conjunctiva preservation with techniques such as pneumatic retinopexy or small gauge vitrectomy. After vitreoretinal surgery an increase in intraocular pressure (IOP) is common. Secondary glaucoma may occur after scleral buckling and after vitrectomy with or without gas or silicone oil tamponade as well as after application of steroids. Angle closure glaucoma after scleral buckling develops because of congestion and anterior rotation of the ciliary body. Vitreous tamponades with expansive or saturated gases may cause angle-closure glaucoma with or without pupillary blockage and may critically shorten ocular perfusion. Postoperative checks, immediate action and a ban on boarding aircraft over the period of intraocular gas tamponade prevent permanent damage to the eye. The majority of secondary glaucomas can effectively be controlled by topical medication and adequate postoperative posture of the patient. Besides the temporary use of systemic antiglaucomatous medication or laser therapy, very rarely in cases of massive swelling or overfill, a direct intervention, such as partial gas or silicone oil removal is required. A prophylactic inferior peripheral iridectomy prevents pupillary blockage in aphakic eyes with intraocular tamponade. In cases of heavy silicone oil use, the peripheral iridectomy is placed in the superior position. Nd:YAG laser application will regulate IOP in cases of occlusion. Secondary glaucoma due to silicone oil emulsification overload is treated by trabecular meshwork aspiration and lavage. In refractory glaucoma repetitive cyclophotocoagulation and drainage implants represent an approved method for long-term IOP regulation

"Bail out" procedures for malpositioning of aortic valve prosthesis (CoreValve).

PubMed

Vavouranakis, Manolis; Vrachatis, Dimitrios A; Toutouzas, Konstantinos P; Chrysohoou, Christina; Stefanadis, Christodoulos

2010-11-05

Two techniques for correcting malpositioning occurring during percutaneous aortic valve replacement (PAVR) with the CoreValve ReValving™ System are described in this article. The "Removing and Reinserting Technique" was used in 2 patients, in whom the prosthesis was positioned too high. The "Snare Technique" was used in 1 patient, in whom the prosthesis was implanted too low. In all patients the aortic valve prosthesis was successfully re-implanted. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

Suprachoroidal drainage with collagen sheet implant- a novel technique for non-penetrating glaucoma surgery.

PubMed

Szurman, Peter; Januschowski, Kai; Boden, Karl Thomas; Seuthe, Anna-Maria

2018-02-01

Our purpose was both to introduce the new technique of suprachoroidal drainage with collagen sheet implantation as a novel technique of non-penetrating glaucoma surgery and to present first results of a prospective pilot study. A superficial rectangular sclera flap of half-scleral thickness sized 4 × 4.5 mm is dissected anteriorly until clear cornea. Then, a second scleral flap is created underneath the first one sized 3.5x4mm and is cut down full-thickness to the choroid exposing the suprachoroidal space. The flap is then bluntly prepared until the scleral spur is reached. Sharp dissection above the sclera spur exposes Schlemm's canal, which is located directly anteriorly. Schlemm's canal is unroofed, juxtacanalicular meshwork is peeled and the deep flap is cut off at its base. An absorbable collagen sheet (Ologen®, Dahlhausen, Cologne, Germany) is placed into the suprachoroidal space at the level of the ciliary body, and the superficial sclera flap is sutured tightly to prevent leakage. We prospectively analyzed 65 eyes that underwent suprachoroidal drainage with collagen sheet implantation. Mean reduction of intraocular pressure after 3 months was 35.1% (from 21.0 ± 4.3 mmHg to 13.5 ± 3.4 mmHg)(p < 0.01) and after 12 months 35.6% (from 21.0 ± 4.3 mmHg to 13.5 ± 3.0  mmHg)(p < 0.01). The number of topical IOP-reducing medication decreased significantly from 3.5 ± 0.7 to 0.6 ± 0.9 and to 0.9 ± 1.1 after 3 and 12 months, respectively (p < 0.01). No serious complications occurred. Suprachoroidal drainage with collagen sheet implantation seems to be a safe and effective surgical technique for non-penetrating glaucoma surgery that yields the opportunity of a sufficient IOP reduction for eyes unsuitable for canaloplasty.

Incidence and impact of prosthesis-patient mismatch after transcatheter aortic valve implantation.

PubMed

Bleiziffer, Sabine; Hettich, Ina; Hutter, Andrea; Wagner, Anke; Deutsch, Marcus-André; Piazza, Nicolo; Lange, Rüdiger

2013-05-01

The study aim was to investigate the incidence of patient-prosthesis mismatch (PPM) with new catheter valves, and its influence on the patients' clinical state. At present, few echocardiographic data are available on the incidence and impact of PPM with the CoreValve and Sapien prostheses for transcatheter aortic valve implantation (TAVI). The reliability of effective orifice area (EOA) measurements was assured by awaiting an interval of six months after TAVI. Of 256 survivors after TAVI, 149 complete echocardiographic data sets were available for the assessment of the indexed EOA (iEOA). In total, 106 CoreValve prostheses and 43 Sapien prostheses were implanted in this high-risk cohort (mean age 81 +/- 6 years, mean logistic EuroSCORE 20 +/- 13%). The overall incidence of PPM (iEOA < 0.85 cm2/m2) was 61%. Patients with a larger body surface area were more likely to develop PPM (p = 0.001), while the prosthesis type, native annulus diameter, preoperative EOA, gender and prosthesis size had no influence. The mean aortic gradient was significantly higher in patients with PPM. A reduction in the left ventricular end-diastolic diameter was seen in all patients, without significant differences between groups. There were no differences in postoperative NYHA class or self-assessed health state between patients with or without PPM. PPM was common after TAVI in the presented cohort, presumably because the native calcium masses narrow the outflow area available for blood flow. As expected for low gradients, there was no impairment of left ventricular dimension regression or clinical state of the patients, even if severe PPM was present. Based on the presented data, it is assumed that PPM might be less relevant in TAVI patients.

Angle closure glaucoma in congenital ectropion uvea.

PubMed

Wang, Grace M; Thuente, Daniel; Bohnsack, Brenda L

2018-06-01

Congenital ectropion uvea is a rare anomaly, which is associated with open, but dysplastic iridocorneal angles that cause childhood glaucoma. Herein, we present 3 cases of angle-closure glaucoma in children with congenital ectropion uvea. Three children were initially diagnosed with unilateral glaucoma secondary to congenital ectropion uvea at 7, 8 and 13 years of age. The three cases showed 360° of ectropion uvea and iris stromal atrophy in the affected eye. In one case, we have photographic documentation of progression to complete angle closure, which necessitated placement of a glaucoma drainage device 3 years after combined trabeculotomy and trabeculectomy. The 2 other cases, which presented as complete angle closure, also underwent glaucoma drainage device implantation. All three cases had early glaucoma drainage device encapsulation (within 4 months) and required additional surgery (cycloablation or trabeculectomy). Congenital ectropion uvea can be associated with angle-closure glaucoma, and placement of glaucoma drainage devices in all 3 of our cases showed early failure due to plate encapsulation. Glaucoma in congenital ectropion uvea requires attention to angle configuration and often requires multiple surgeries to obtain intraocular pressure control.

Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study).

PubMed

Barbanti, Marco; Schiltgen, Molly; Verdoliva, Sarah; Bosmans, Johan; Bleiziffer, Sabine; Gerckens, Ulrich; Wenaweser, Peter; Brecker, Stephen; Gulino, Simona; Tamburino, Corrado; Linke, Axel

2016-03-01

This study compared 3-year clinical outcomes of patients who underwent transcatheter aortic valve implantation with the Society of Thoracic Surgeons (STS) score ≤7% to those of patients with a score >7%. Data were drawn from the ADVANCE study, a multinational post-market clinical trial that enrolled real-world patients with severe aortic stenosis treated with the CoreValve bioprosthesis. Events were independently adjudicated using Valve Academic Research Consortium-1 definitions. A total of 996 patients were implanted: STS ≤7% (n = 697, median STS 4.3%, interquartile range 3.1% to 5.4%) and STS >7% (n = 298, median STS 9.7%, interquartile range 8.0% to 12.4%). At 3 years, the STS ≤7% group had lower rates of all-cause mortality (28.6 vs 45.9, p <0.01) and cardiovascular mortality (19.0 vs 30.2, p <0.01) than the STS >7% group. No differences were observed in cerebrovascular accidents, vascular complications, bleeding, or myocardial infarction. In patients with STS ≤7%, mortality at 3 years was higher in those with moderate or severe aortic regurgitation (AR) at discharge than in those with mild or less AR (39.9% vs 22.9%; hazard ratio 1.98; 95% confidence interval 1.37 to 2.86; p <0.01). Conversely, the severity of AR at discharge did not affect 3-year mortality in patients with STS >7% (42.9% vs 44.6%, moderate/severe vs mild/less; hazard ratio 1.04; 95% confidence interval, 0.62 to 1.75; p = 0.861; p for interaction = 0.047). In conclusion, patients with STS ≤7% had lower rates of all-cause and cardiovascular mortality at 3 years after transcatheter aortic valve implantation. Complication rates were low and stable in both groups, demonstrating the safety of this procedure for patients at various levels of surgical risk. Copyright © 2016 Elsevier Inc. All rights reserved.

Intravitreal ranibizumab injection combined trabeculectomy versus Ahmed valve surgery in the treatment of neovascular glaucoma: assessment of efficacy and complications.

PubMed

Liu, Lan; Xu, Yongfeng; Huang, Zhu; Wang, Xiaoyu

2016-05-26

Researches have shown anti-vascular endothelial growth factor (VEGF) agent is effective in treating neovascular eye diseases. The purpose of this study is to evaluate the efficacy and safety of intravitreal ranibizumab (IVR) injection combined trabeculectomy in the treatment of neovascular glaucoma (NVG), and compared it with Ahmed valve surgery. Thirty-six NVG patients (37 eyes) from the First Affiliated Hospital of Zhejiang medical college, between January 1, 2014 and January 31, 2015, were included in this prospective, interventional clinical study. Eighteen NVG eyes were given IVR injection one week before trabeculectomy. Ahmed valve implantation surgery was performed in nineteen eyes. Ocular pain, best corrected visual acuity (BCVA), intraocular pressure (IOP) and surgical complications were evaluated before and after the surgery. IOP was significantly decreased following IVR injection combined trabeculectomy treatment (baseline 57.1 ± 8.9 mmHg; week 1, 15.2 ± 4.3 mmHg p = 0.000; month 1, 16.9 ± 2.1 mmHg p = 0.000; month 3, 20.3 ± 7.7 mmHg p = 0.000; month 6, 19.7 ± 7.3 mmHg p = 0.000). There was a significant, though modest, BCVA improvement in sighted eyes of IVR group (baseline 2.42 ± 0.68, W1 1.80 ± 0.91, P = 0.013; M1 1.77 ± 0.93, p = 0.011). IVR injection combined trabeculectomy had less postoperative complications and lower failure ratio than Ahmed surgery (IVR 5.6 %, Ahmed 31.6 %). The study revealed that IVR injection combined trabeculectomy was an effective and safe treatment for NVG. Compared with Ahmed surgery, IVR injection combined trabeculectomy had less complications and higher success ratio. (Chinese Clinical Registry, TRN ChiCTR-OPN-16008147, 3/24/2016, retrospectively registered).

Impact of Mitral Regurgitation on Clinical Outcomes After Transcatheter Aortic Valve Implantation

PubMed Central

Tüller, David; Zbinden, Rainer; Eberli, Franz R

2016-01-01

Severe aortic stenosis (AS) and mitral regurgitation (MR) are the two most common valvular lesions referred for surgical intervention in Europe and frequently co-exist. In patients with both severe AS and significant MR referred for surgical aortic valve replacement (SAVR), a concomitant mitral valve intervention is typically performed if the MR is severe, despite the higher associated perioperative risk. The management of moderate MR among SAVR patients is controversial and depends on a number of factors including MR aetiology (i.e., organic versus functional MR), feasibility of repair and patient risk profile. Moderate or severe MR is present in up to one-third of patients undergoing transcatheter aortic valve implantation (TAVI), is mainly of functional aetiology and is typically left untreated. Although data are conflicting, a growing body of evidence suggests that significant MR exerts an adverse effect on both short- and long-term clinical outcomes after TAVI. Moderate or severe MR improves in just over half of patients following TAVI and recent data suggest MR is more likely to improve among patients receiving a balloon-expandable as compared with a self-expandable transcatheter heart valve. PMID:29588707

Risk factors for tube exposure as a late complication of glaucoma drainage implant surgery.

PubMed

Chaku, Meenakshi; Netland, Peter A; Ishida, Kyoko; Rhee, Douglas J

2016-01-01

The purpose of this study was to evaluate the risk factors for tube exposure after glaucoma drainage implant surgery. This was a retrospective case-controlled observational study of 64 eyes from 64 patients. Thirty-two eyes of 32 patients with tube erosion requiring surgical revision were compared with 32 matched control eyes of 32 patients. Univariate and multivariate risk factor analyses were performed. Mean age was significantly younger in the tube exposure group compared with the control group (48.2±28.1 years versus 67.3±18.0 years, respectively; P=0.003). The proportion of diabetic patients (12.5%) in the tube exposure group was significantly less (P=0.041) compared with the control group (37.5%). Comparisons of the type and position of the drainage implant were not significantly different between the two groups. The average time to tube exposure was 17.2±18.0 months after implantation of the drainage device. In both univariate and multivariate analyses, younger age (P=0.005 and P=0.027) and inflammation prior to tube exposure (P≤0.001 and P=0.004) were significant risk factors. Diabetes was a significant risk factor only in the univariate analysis (P=0.027). Younger age and inflammation were significant risk factors for tube exposure after drainage implant surgery.

Transcatheter Aortic Valve Implantation in an Extremely Tortuous S-Shaped Aorta

PubMed Central

Toleva, Olga; Pozeg, Zlatko; Menkis, Alan

2017-01-01

Transcatheter aortic valve implantation (TAVI) has emerged as an alternative technique to treating aortic stenosis in patients with high surgical risk. We present a case of a successful transfemoral TAVI in a high-risk patient with an extremely tortuous iliofemoral system and a significant S-type bend in the descending aorta. With careful preprocedure planning and using all the techniques available, TAVI can be performed in the most challenging patients. PMID:28352480

Evolution of Cognitive Function After Transcatheter Aortic Valve Implantation.

PubMed

Schoenenberger, Andreas W; Zuber, Chantal; Moser, André; Zwahlen, Marcel; Wenaweser, Peter; Windecker, Stephan; Carrel, Thierry; Stuck, Andreas E; Stortecky, Stefan

2016-10-01

This study aimed to assess the evolution of cognitive function after transcatheter aortic valve implantation (TAVI). Previous smaller studies reported conflicting results on the evolution of cognitive function after TAVI. In this prospective cohort, cognitive function was measured in 229 patients ≥70 years using the Mini Mental State Examination before and 6 months after TAVI. Cognitive deterioration or improvement was defined as change of ≥3 points decrease or increase in the Mini Mental State Examination score between baseline and follow-up. Cognitive deterioration was found in 29 patients (12.7%). Predictive analysis using logistic regression did not identify any statistically significant predictor of cognitive deterioration. A review of individual medical records in 8 patients with a major Mini Mental State Examination score decrease of ≥5 points revealed specific causes in 6 cases (postinterventional delirium in 2; postinterventional stroke, progressive renal failure, progressive heart failure, or combination of preexisting cerebrovascular disease and mild cognitive impairment in 1 each). Among 48 patients with impaired baseline cognition (Mini Mental State Examination score <26 points), 18 patients (37.5%) cognitively improved. The preinterventional aortic valve area was lower in patients who cognitively improved (median aortic valve area 0.60 cm 2 ) as compared with patients who did not improve (median aortic valve area 0.70 cm 2 ; P=0.01). This is the first study providing evidence that TAVI results in cognitive improvement among patients who had impaired preprocedural cognitive function, possibly related to hemodynamic improvement in patients with severe aortic stenosis. Our results confirm that some patients experience cognitive deterioration after TAVI. © 2016 American Heart Association, Inc.

Successful use of a left ventricular apical access and closure device for second-generation transapical aortic valve implantation.

PubMed

Conradi, Lenard; Seiffert, Moritz; Shimamura, Kazuo; Schirmer, Johannes; Blankenberg, Stefan; Reichenspurner, Hermann; Diemert, Patrick; Treede, Hendrik

2014-09-01

Transcatheter aortic valve implantation (TAVI) has become routine for the treatment of high-risk patients with aortic stenosis. We assessed safety and feasibility of a left ventricular apical access and closure device combined with second-generation transapical (TA) TAVI transcatheter heart valves (THV). Three elderly, comorbid patients (logEuroSCORE I 13.0-31.1%) received transapical aortic valve implantation (TA-AVI) via the Apica ASC device (Apica Cardiovascular Ltd., Galway, Ireland) using second-generation THV (Medtronic Engager [Medtronic 3F Therapeutics, Santa Ana, California, United States], JenaValve [JenaValve Technology GmbH, Munich, Germany], Symetis Acurate [Symetis S.A., Ecublens, Switzerland]). Access was gained using a non-rib-spreading technique and a novel access and closure device. THV deployment was successful with excellent hemodynamic outcome (no PVL, n = 2; trace PVL, n = 1; mean transvalvular gradients, 5-19 mm Hg) and complete apical hemostasis. No periprocedural major adverse events occurred and Valve Academic Research Consortium-2-defined composite end point of device success was met in all cases. Safety and feasibility of TA-AVI using the ASC device with second-generation THV was demonstrated. Combining latest available technology is a major step toward improved functional outcome and decreased surgical trauma in TA-AVI. Potentially, technical enhancements may eventually pave the way toward a fully percutaneous TA-AVI procedure. Georg Thieme Verlag KG Stuttgart · New York.

Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system.

PubMed

Haas, Nikolaus A; Carere, Ronald Giacomo; Kretschmar, Oliver; Horlick, Eric; Rodés-Cabau, Josep; de Wolf, Daniël; Gewillig, Marc; Mullen, Michael; Lehner, Anja; Deutsch, Cornelia; Bramlage, Peter; Ewert, Peter

2018-01-01

Patients with congenital or acquired heart defects affecting the pulmonary valve and right ventricular outflow tract (RVOT) commonly require multiple surgical interventions, resulting in significant morbidity. A less invasive alternative is percutaneous pulmonary valve implantation (PPVI). Though studies have previously reported the safety and efficacy of the early generation transcatheter heart valves (THVs), data on more recent devices are severely lacking. We performed a multinational, multicentre, retrospective, observational registry analysis of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46 patients that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis (58.7%), and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural success rate was high (93.5%), with a low frequency of periprocedural complications and adverse events (6.5% and 10.9%, respectively). At 30days post-procedure, NYHA class had improved significantly (90.6% were at NYHA I or II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1% at baseline to 5.0% at 30days, and the calculated peak systolic gradient had decreased from 45.2 (SD±21.3) mmHg to 16.4 (SD±8.0) mmHg, with these values remaining low up to 2years. The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common anatomies in patients with conduits, as well as those with native pulmonary valves or transannular patches. Continued data collection is necessary to verify long-term findings. CLINICALTRIALS. NCT02302131. Copyright © 2017 Elsevier B.V. All rights reserved.

Percutaneous pulmonary valve implantation: an update.

PubMed

Lurz, Philipp; Bonhoeffer, Philipp; Taylor, Andrew M

2009-07-01

The field of percutaneous valvular interventions is one of the most exciting and rapidly developing within interventional cardiology. Percutaneous pulmonary valve implantation (PPVI) represents the first in-human application of these techniques and is a nonsurgical option for treating right ventricular outflow tract/pulmonary trunk dysfunction. With the growing numbers of patients with right ventricle to pulmonary artery conduit dysfunction after repair of congenital heart disease, the importance of a technique with lower morbidity and mortality, good patient acceptance and efficacy, that is comparable to surgery, cannot be underestimated. Over the last 9 years, PPVI has become a feasible, safe and effective treatment for both conduit stenosis and regurgitation. Median follow-up data show good freedom from reoperation and recatheterization and demonstrate that PPVI can postpone open-heart surgery, thereby potentially reducing the number of operations that patients have to undergo within their lifetime. Complications seen after PPVI, in particular stent fractures, can require reintervention in some cases (second stent-in-stent PPVI); however, valve competency remains good, with significant regurgitation during follow-up only seen in the context of occasional endocarditis. Attempts are now being made to prolong the lifespan of the device by reducing the incidence of stent fractures. Further, meticulous patient selection must be maintained to ensure that hemodynamic results are optimized and the safety of the procedure remains high. Finally, new devices have to be developed that will allow for PPVI in dilated, distensible outflow tracts, to offer this nonsurgical treatment option to a larger patient population with congenital heart disease.

Embolic capture with updated intra-aortic filter during coronary artery bypass grafting and transaortic transcatheter aortic valve implantation: first-in-human experience.

PubMed

Ye, Jian; Webb, John G

2014-12-01

We report our first-in-human clinical experience in the use of the new version of the EMBOL-X intra-aortic filter (Edwards Lifesciences Corporation, Irvine, Calif) to capture embolic material during transaortic transcatheter aortic valve implantation and cardiac surgery. Five patients were enrolled into the first-in-human clinical assessment of the new version of the EMBOL-X intra-aortic filter. Three patients underwent coronary artery bypass grafting, and 2 patients underwent transaortic transcatheter aortic valve implantation. During coronary artery bypass grafting, the filter was deployed before clamping of the aorta and removal of the aortic clamp. In contrast, the filter was deployed before aortic puncture for transaortic transcatheter aortic valve implantation and kept in the aorta throughout the entire procedure. The filter introducer sheath and filter were easily placed and removed without difficulty. There were no complications related to the use of the filter. Postoperative examination of the retrieved filters revealed the presence of multiple microemboli in the filters from all 5 cases. Histologic study revealed various kinds of tissue and thrombus. This first-in-human clinical experience has demonstrated the safety and feasibility of using the new version of the EMBOL-X intra-aortic filter during either cardiac surgery or transaortic transcatheter aortic valve implantation. We believe that the combination of the transaortic approach without aortic arch manipulation and the use of the EMBOL-X filter with a high capture rate is a promising strategy to reduce the incidence of embolic complications during transcatheter aortic valve implantation. Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Advanced transcatheter aortic valve implantation (TAVI) planning from CT with ShapeForest.

PubMed

Swee, Joshua K Y; Grbić, Saša

2014-01-01

Transcatheter aortic valve implantation (TAVI) is becoming a standard treatment for non-operable and high-risk patients with symptomatic severe aortic valve stenosis. As there is no direct view or access to the affected anatomy, comprehensive preoperative planning is crucial for a successful outcome, with the most important decisions made during planning being the selection of the proper implant size, and determining the correct C-arm angulations. While geometric models extracted from 3D images are often used to derive these measurements, the complex shape variation of the AV anatomy found in these patients causes many of the shape representations used to estimate such geometric models to fail in capturing morphological characteristics in sufficient detail. In addition, most current approaches only model the aortic valve (AV), omitting modeling the left ventricle outflow tract (LVOT) entirely despite its high correlation with severe complications such as annulus ruptures, paravalvular leaks and myocardial infarction. We propose a fully automated method to extract patient specific models of the AV and the LVOT, and derive comprehensive biomarkers for accurate TAVI planning. We utilize a novel shape representation--the ShapeForest--which is able to model complex shape variation, preserves local shape information, and incorporates prior knowledge during shape space inference. Extensive quantitative and qualitative experiments performed on 630 volumetric data sets demonstrate an accuracy of 0.69 mm for the AV and 0.83 mm for the LVOT, an improvement of over 16% and 18% respectively when compared against state of the art methods.

iStent as a Solo Procedure for Glaucoma Patients: A Systematic Review and Meta-Analysis.

PubMed

Malvankar-Mehta, Monali S; Chen, Yufeng Nancy; Iordanous, Yiannis; Wang, Wan Wendy; Costella, John; Hutnik, Cindy M L

2015-01-01

Glaucoma is a leading cause of irreversible blindness. It is firmly entrenched in the traditional treatment paradigm to start with pharmacotherapy. However, pharmacotherapy is not benign and has been well documented to have a number of significant challenges. Minimally invasive glaucoma surgery (MIGS) that targets the outflow pathway with minimal to no scleral dissection has resulted in the need to reconsider the glaucoma treatment paradigm. To perform a systematic review and meta-analysis to evaluate and quantify the effect on post-operative intraocular pressure (IOP) and number of topical glaucoma medications, in patients receiving the iStent MIGS device as the solo procedure without concurrent cataract surgery. A systematic review was conducted by searching various databases between January 1, 2000, and June 30, 2014. Studies reporting up to a maximum follow-up period of 24 months were retrieved and screened using the EPPI-Reviewer 4 gateway. Percentage reduction in IOP (IOPR%), and mean reduction in topical glaucoma medications after surgery were computed. Meta-analysis was performed using STATA v. 13.0. The standardized mean difference (SMD) was calculated as the effect size for continuous scale outcomes. Heterogeneity was determined using the I2 statistics, Z-value, and χ2 statistics. Fixed-effect and random-effect models were developed based on heterogeneity. Sub-group analysis was performed based on the number of iStents implanted and the follow-up period. The outcome measures were changes in the IOP and number of glaucoma medications. The search strategy identified 105 records from published literature and 9 records from the grey literature. Five studies with 248 subjects were included for quantitative synthesis. A 22% IOP reduction (IOPR%) from baseline occurred at 18-months after one iStent implant, 30% at 6-months after two iStents implantations, and 40% at 6-months after implantation of three iStents. A mean reduction of 1.2 bottles per patient of

Graft failure: III. Glaucoma escalation after penetrating keratoplasty.

PubMed

Greenlee, Emily C; Kwon, Young H

2008-06-01

Glaucoma after penetrating keratoplasty is a frequently observed post-operative complication and is a risk factor for graft failure. Penetrating keratoplasty performed for aphakic and pseudophakic bullous keratopathy and inflammatory conditions are more likely to cause postoperative glaucoma compared with keratoconus and Fuchs' endothelial dystrophy. The intraocular pressure elevation may occur immediately after surgery or in the early to late postoperative period. Early postoperative causes of glaucoma include pre-existing glaucoma, retained viscoelastic, hyphema, inflammation, pupillary block, aqueous misdirection, or suprachoroidal hemorrhage. Late causes include pre-existing glaucoma, angle-closure glaucoma, ghost cell glaucoma, suprachoroidal hemorrhage, and steroid-induced glaucoma. Determining the cause of IOP elevation can help guide therapeutic intervention. Treatments for refractory glaucoma include topical anti-glaucoma medications such as beta-adrenergic blockers. Topical carbonic anhydrase inhibitors, miotic agents, adrenergic agonists, and prostaglandin analogs should be used with caution in the post-keratoplasty patient, because of the possibility of corneal decompensation, cystoid macular edema, or persistent inflammation. Various glaucoma surgical treatments have reported success in post-keratoplasty glaucoma. Trabeculectomy with mitomycin C can be successful in controlling IOP without the corneal toxicity noted with 5-fluorouracil. Glaucoma drainage devices have successfully controlled intraocular pressure in postkeratoplasty glaucoma; this is, however, associated with increased risk of graft failure. Placement of the tube through the pars plana may improve graft success compared with implantation within the anterior chamber. In addition, cyclophotocoagulation remains a useful procedure for eyes that have refractory glaucoma despite multiple surgical interventions.

Transapical JenaValve in a patient with mechanical mitral valve prosthesis.

PubMed

O' Sullivan, Katie E; Casserly, Ivan; Hurley, John

2015-04-01

We report the first case of transcatheter aortic valve replacement implantation using JenaValve™ in a patient with mechanical mitral valve prosthesis. We believe that the design features of this valve may be particularly suited for use in this setting. © 2014 Wiley Periodicals, Inc.

Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review.

PubMed

van Rosendael, Philippe J; Delgado, Victoria; Bax, Jeroen J

2018-06-01

The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with new-generation prostheses remains debated. This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical, anatomical, and procedural factors associated with PPI. In addition, the incidence of PPI after TAVI with early generation prostheses was reviewed for comparison. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist, this systematic review screened original articles published between October 2010 and October 2017, reporting on the incidence of PPI after implantation of early and new-generation TAVI prostheses. Of the 1406 original articles identified in the first search for new-generation TAVI devices, 348 articles were examined for full text, and finally, 40 studies (n = 17 139) were included. The incidence of a PPI after the use of a new-generation TAVI prosthesis ranged between 2.3% and 36.1%. For balloon-expandable prostheses, the PPI rate remained low when using an early generation SAPIEN device (ranging between 2.3% and 28.2%), and with the new-generation SAPIEN 3 device, the PPI rate was between 4.0% and 24.0%. For self-expandable prostheses, the PPI rates were higher with the early generation CoreValve device (16.3-37.7%), and despite a reduction in PPI rates with the new Evolut R, the rates remained relatively higher (14.7-26.7%). When dividing the studies according to the highest (>26.0%) and the lowest (<12.1%) quintile of PPI rate, patients within the highest quintile were more frequently women when compared with the lowest quintile group (50.9% vs. 46.3%, P < 0.001). Pre-existent conduction abnormalities (electrical factor), calcification of the left ventricular outflow tract (anatomical factor), and balloon valvuloplasty and depth of implantation (procedural factors) were associated

Three dimensional rotational angiography for assessment of coronary arteries during melody valve implantation: introducing a technique that may improve outcomes.

PubMed

Pockett, C R; Moore, J W; El-Said, H G

2017-02-01

Adverse events from Melody valve implantation may be catastrophic. To date a role for three dimensional rotational angiography of the aortic root (3DRAA) during Melody valve implantation has not been established. To describe the role of 3DRAA in the assessment of Melody valve candidacy and to demonstrate that it may improve outcomes. All patients who underwent cardiac catheterisation for Melody valve implantation and 3DRAA between August 2013 and February 2015 were reviewed. 31 patients had 3DRAA with balloon sizing. Ten were deemed not Melody candidates (5 coronary compression, 2 aortic root distortion with cusp flattening, 2 RVOT was too large, and 1 had complex branch stenosis and a short landing zone). Of the 21 patients who were Melody candidates, 12 had conduits, 6 prosthetic valves and 3 native RVOTs. In patients with conduits, the technique of stenting the conduit prior to dilation was used after measuring the distance between the conduit and the coronary arteries on 3DRAA. In the Melody patients, we had 100% procedural success and no serious adverse events (coronary compression, tears, stent fracture or endocarditis). As a tool for case selection, 3DRAA may facilitate higher procedural success and decreased risk of serious adverse events. Furthermore, 3D rotational angiography allows stenting of the conduit prior to dilation, which may prevent tears and possibly endocarditis.

Update of transcatheter valve treatment

PubMed Central

Liu, Xian-bao; Wang, Jian-an

2013-01-01

Transcatheter valve implantation or repair has been a very promising approach for the treatment of valvular heart diseases since transcatheter aortic valve implantation (TAVI) was successfully performed in 2002. Great achievements have been made in this field (especially TAVI and transcatheter mitral valve repair—MitraClip system) in recent years. Evidence from clinical trials or registry studies has proved that transcatheter valve treatment for valvular heart diseases is safe and effective in surgical high-risk or inoperable patients. As the evidence accumulates, transcatheter valve treatment might be an alterative surgery for younger patients with surgically low or intermediate risk valvular heart diseases in the near future. In this paper, the updates on transcatheter valve treatment are reviewed. PMID:23897785

Postoperative glaucoma following infantile cataract surgery: an individual patient data meta-analysis.

PubMed

Mataftsi, Asimina; Haidich, Anna-Bettina; Kokkali, Stamatia; Rabiah, Peter K; Birch, Eileen; Stager, David R; Cheong-Leen, Richard; Singh, Vineet; Egbert, James E; Astle, William F; Lambert, Scott R; Amitabh, Purohit; Khan, Arif O; Grigg, John; Arvanitidou, Malamatenia; Dimitrakos, Stavros A; Nischal, Ken K

2014-09-01

Infantile cataract surgery bears a significant risk for postoperative glaucoma, and no consensus exists on factors that may reduce this risk. To assess the effect of primary intraocular lens implantation and timing of surgery on the incidence of postoperative glaucoma. We searched multiple databases to July 14, 2013, to identify studies with eligible patients, including PubMed, MEDLINE, EMBASE, ISI Web of Science, Scopus, Central, Google Scholar, Intute, and Tripdata. We also searched abstracts of ophthalmology society meetings. We included studies reporting on postoperative glaucoma in infants undergoing cataract surgery with regular follow-up for at least 1 year. Infants with concurrent ocular anomalies were excluded. Authors of eligible studies were invited to contribute individual patient data on infants who met the inclusion criteria. We also performed an aggregate data meta-analysis of published studies that did not contribute to the individual patient data. Data were pooled using a random-effects model. Time to glaucoma with the effect of primary implantation, additional postoperative intraocular procedures, and age at surgery. Seven centers contributed individual patient data on 470 infants with a median age at surgery of 3.0 months and median follow-up of 6.0 years. Eighty patients (17.0%) developed glaucoma at a median follow-up of 4.3 years. Only 2 of these patients had a pseudophakic eye. The risk for postoperative glaucoma appeared to be lower after primary implantation (hazard ratio [HR], 0.10 [95% CI, 0.01-0.70]; P = .02; I(2) = 34%), higher after surgery at 4 weeks or younger (HR, 2.10 [95% CI, 1.14-3.84]; P = .02; I(2) = 0%), and higher after additional procedures (HR, 2.52 [95% CI, 1.11-5.72]; P = .03; I(2) = 32%). In multivariable analysis, additional procedures independently increased the risk for glaucoma (HR, 2.25 [95% CI, 1.20-4.21]; P = .01), and primary implantation independently reduced it (HR, 0.10 [95% CI, 0.01-0.76]; P =�

Evaluation of an injectable thermosensitive hydrogel as drug delivery implant for ocular glaucoma surgery.

PubMed

Xi, Lei; Wang, Tao; Zhao, Feng; Zheng, Qiongjuan; Li, Xiaoning; Luo, Jing; Liu, Ji; Quan, Daping; Ge, Jian

2014-01-01