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Does Intravitreal Bevacizumab Injection for Retinopathy of Prematurity Treatment Arrest Anterior Segment Development?-Juniper Publishers

Does Intravitreal Bevacizumab Injection for Retinopathy of Prematurity Treatment Arrest Anterior Segment Development?-Juniper Publishers

Juniper Publishers-Journal of Ophthalmology
Abstract
Purpose: To determine intravitreal bevacizumab (IVB) effect on ocular development by comparing refractive and biometric outcomes of intravitreal bevacizumab (IVB) and laser photocoagulation for treatment of retinopathy of prematurity (ROP).
Methods: A prospective nonrandomized interventional comparative study was conducted in a referral hospital for ROP management. All patients who received either single IVB or diode laser photocoagulation were enrolled. Cycloplegic refraction and biometry was performed before treatment and at the corrected age of 9 months.
Results: The IVB group included 17 patients (28 eyes; gestational age (GA): 28.54 ±2.2 weeks) and the laser group included 17 patients (34 eyes; GA: 28.53 ± 1.6 w). GA, BW and corrected age at the end of follow-up was statistically similar between the two groups. Eyes in IVB group had significantly longer axial lengths and thinner lenses at final visit (p=.037 and p=.002).
Conclusions: Following IVB treatment of ROP, eye development in general and crystalline lens in particular are less affected compared to laser treatment. This supports the idea that anterior segment arrest which was first described for laser therapy of ROP occurs minimally with IVB if at all.
Keywords: Retinopathy of Prematurity; Intravitreal Bevacizumab; Diode Laser photocoagulation; Refraction; Biometry Abbreviations: IVB: Intravitreal Bevacizumab; ROP: Retinopathy of Prematurity; GA: Gestational Age; ETROP: Early Treatment of ROP study; VEGF: Vascular Endothelial Growth Factor; AL= Axial Length; ACD= Anterior Camber Depth; LT= Lens Thickness; V= Vitreous Cavity

Introduction

Retinopathy of prematurity (ROP) is a vasoproliferative disease of preterm neonates which may result in severe complications if left untreated in high risk patients. In 2001 Early Treatment of ROP study (ETROP) showed significant benefit of laser photocoagulation in eyes with type 1 prethreshold ROP [1]. Since then, laser photocoagulation of the avascular retina using either transpupillary or transscleral approach is the standard of care for type 1 ROP [2-6]. In recent years, the use of anti-vascular endothelial growth factor (VEGF) agents mainly bevacizumab, has been increasingly popularized for the treatment of various ocular neovascular diseases including ROP [7-11] Promising results have been reported for IVB injection in ROP especially in patients with severe or aggressive posterior ROP [12].
Previous studies have shown that ROP patients show significant myopia (55.2 to 80.04% in age group under 3 years old) after laser photocoagulation [13-15]. It is well established that myopia associated with prematurity and conventionally treated (cryo- or laser therapy) ROP is not fully explainable by axial length changes. In fact, it may be a result of a disruption of emmetropization called anterior segment arrest consisting of corneal steepening, anterior chamber depth reduction, and lens thickening [16-19]. Recently, a few studies have reported less myopia after intravitreal bevacizumab (IVB) injection in ROP patients in comparison to laser photocoagulation or combination treatments [20-25]. Geloneck et al. [25] speculated that IVB minimally disrupts anterior segment development, hence less myopia. However biometric effects of anti-VEGF agents on ocular growth have not been fully evaluated in a pre- and post-treatment model. Current study was conducted to compare the refractive errors and biometric indices before and after single IVB injection and conventional laser therapy for ROP.

Methods

In this prospective comparative study, from March to September 2013, all premature infants who were scheduled to undergo either diode laser photocoagulation or IVB injection for the treatment of type 1 ROP in Rassoul Akram Hospital, Iran, Tehran were eligible for this study. Informed consent was obtained from the parents of all infants enrolled in the study, fully describing the treatment modalities and ultrasonography technique. Iran University Eye Research Center Ethics Committee approved the study. Screening and management of all patients were performed by retinal specialists (MMP and AS) in accordance to the guidelines of the American Association for Pediatric Ophthalmology and Strabismus [26] and the revised guidelines of the International Committee for the Classification of Retinopathy of Prematurity [27]. For prethreshold disease in zone I or posterior zone II, an intravitreous injection of 0.625 mg bevacizumab (Avastin; Genentech Inc, San Francisco, California, USA) was performed [10]. Infants with prethreshold disease in anterior zone II, received transscleral diode laser photocoagulation of avascular retina [28]. Patients who did not respond to primary monotherapy and needed further intervention were excluded. Also, eyes with media opacity including cataract, corneal opacity and vitreous hemorrhage, and those with other ocular diseases including glaucoma, and congenital vitreoretinal diseases were excluded.
Refractive errors and biometry indices were obtained under cycloplegic condition approximately 30 minutes after instillation of topical Tropicamide (Mydrax; Sina Darou, Tehran, Iran), 3 times with an interval of 5 minutes. Measurements were performed immediately before treatment, and at the age of 9 month.
Handheld retinoscopy was performed by two of the three expert examiners (RA, JK and MSS), masked to the planed treatment. If their results disagreed by more than 0.5 Diopters (D), refractions were repeated and the discrepancy was resolved. Spherical equivalent (SE) ≤ − 0.5 and ≤ − 5.00 D was considered as myopia and high myopia, respectively [29, 30].
Biometry was performed in supine position with the lid speculum in situ via A-scan contact mode ultrasonography (OcuScanRxP; Alcon Lab, Dallas, TX, USA). Measured indices included axial length (AL), anterior chamber depth (ACD), lens thickness (LT), and vitreous cavity length (V). All scans were performed by a single investigator (JK). After instillation of topical Tetracaine 0.5% (Anestocaine; Sina Darou, Tehran, Iran), 10 subsequent scans were recorded in Auto-save mode. Scans were repeated until standard deviation of less than 0.1 was achieved. Care was taken to apply minimum pressure on the cornea during ultrasonography.
Data analysis was done using SPSS software (version 16, SPSS, Inc., Chicago, IL, USA). T tests (paired t test when applicable) and Chi square test were used for analysis of continuous and categorical variables, respectively. P values less than 0.05 were considered statistically significant.

Results

A total of 34 neonates including 17 patients (28 eyes) in the IVB group and 17 patients (34 eyes) in the laser groups were studied. Table 1 shows demographics of the patients. Birth age, birth weight, follow up duration and corrected age at the end of follow-up were similar between the two groups; however, patients in IVB group received therapy significantly earlier (p< 0.001). All patients in the study responded to treatment in terms of resolution of ROP, no recurrence of ROP and no detachment/hemorrhage after treatment.
Results of refractive error measurements are summarized in Table 2. At baseline examination, a marginally significant difference was found in the mean SE between the 2 groups (-3.37 ± 4.68 Diopters [D] in the IVB group and -1.5± 3.97 D in the laser group, p: 0.08) and prevalence of myopia was significantly higher in IVB group (71.04% vs. 35.55%; P= 0.004). At final exam, refractive error in the IVB group and laser therapy group was -1.02 ± 2.96 D vs. -0.12 ± 2.28 D (P = 0. 18) and the rate of myopia in IVB group decreased to 50%, while no significant change was observed in the laser group (38.24%, P=0.36). Finally the absolute change in SE was not significantly different between the 2 groups (P=0.3).
Table 3 shows the biometric measurements. At baseline, no significant difference was found between the two groups in any of the biometric measurements. At final exam, eyes in the IVB group had significantly higher AL and V measurements and shallower ACD and shorter LT measurements compared to the laser group (p=.037, p=.017, p=.002 and p=.002). The biometric changes after treatment were significantly different between the two groups in AL, LT and V measurements (P=0.002, P=0.007 and P< 0.000).
In bivariate correlation analysis, SE change in the laser group correlated significantly to axial and vitreous cavity length changes (p=0.005 and p=0.006). No significant correlation between SE and biometric changes were found in IVB group.
In multivariate analysis, no significant association was found between SE changes and the treatment modality (p=0.46), AL changes (p=0.56), ACD changes (p=0.49), LT changes (p=0.08), V changes (p=0.49), GA (p=0.56) and BW (p=0.74).

Discussion

Although there are few reports of more hyperopic changes following laser treatment of ROP [31] most recent studies comparing IVB and laser monotherapy or combination therapies show a myopic preponderance in laser therapy (Table 4).
Whether the observed myopic shift is attributable to the allocated treatment or the severity of the disease has been a matter of controversy, however, the follow up of the BEAT- ROP clinical trial [10,25] the only large randomized prospective study in the field, demonstrated that the higher degree and frequency of myopia in laser treated eyes (compared to the eyes who received IVB) did occur in spite of no significant difference in myopia severity.
In a process called emmetropization a relatively wide distribution of refractive error in full term newborns, gets narrower toward hyperopia in the first few years of life [30,32]. In this process, vitreous cavity length elongation is balanced by reduction of corneal curvature (from 51 to 44 D), crystalline lens power (by getting thinner) [33]. Myopia associated with prematurity and conventionally (cryo- or laser therapy) treated ROP is not fully explained by axial length, but it is a result of an emmetropization disruption called anterior segment arrest consisting of corneal steepening, anterior chamber depth reduction, and lens thickening [16-19]. Although Geloneck et al. [25] speculated that IVB minimally disrupts anterior segment development; effect of anti-VEGF agents on ocular growth is not fully evaluated.
In the present study despite the initially higher prevalence of myopia among IVB group (71%) in comparison to laser therapy group (35.55%) before treatment, the frequency decreased to 50% at the age of 9 month in IVB group while no significant change was observed in laser therapy group (38.2%). On the other side, biometry results demonstrated that although the eyes in IVB group were initially marginally smaller than those in the laser group, they finally had significantly larger size. At a concordant trend lens thickness in IVB group significantly decreased leading to less frequency of myopia in this group. Such a significant reduction in lens thickness was not observed in the laser group. These observations support the idea that the crystalline lens development (the expected lens thinning) continues following IVB treatment of ROP while it is arrested by laser therapy. This is in consistence with a previous study which suggests that high myopia associated with ROP is primarily a reflection of inappropriately higher lens thickness and power [34]. To the best of our knowledge, it is for the first time that a study reports the refractive and biometric indices of eyes before and after undergoing treatment for ROP.
It has been proposed that anterior segment growth may be slowed by decreased levels of local growth factors as a result of delayed migration of vessels to oraserrata (in premature neonates) alongside photoreceptors maturation arrest [35,36]. It is also known that laser therapy stops retinal vessel development, while vessels continue to develop beyond neovascular ridges upto the oraserrata after IVB injection [10].This may partly explain the pathophysiology of the so-called anterior segment arrest following the laser therapy; however, further experimental investigation is needed.
The present study has several limitations. Although randomization would avoid analytical concerns inherent to the non-randomized design, investigators believed it would be unethical to randomize ROP patients, regardless of their stage of the disease, to the two treatment group. In the current ROP protocol applied in this reference hospital, ROPs in zone I and posterior zone II are treated with IVB and ROPs in anterior zone II are offered the laser treatment. Additionally enrolled infants in the present study have notably higher birth weight and gestational age compared to some studies which may also contribute to the smaller degree of myopia observed in the pretreatment examination in this study compared to other reports. Finally for the investigators a relatively short follow-up was considered an acceptable trade-off for the prospective design. Despite these limitations, current study is the first to report pre- and post-treatment biometric and refractive indices of eyes treated for ROP and its results further support the theory that IVB does not halt anterior segment development in ROP patients as laser therapy does.
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Thoracic Epidural Analgesia Lessens Inflammatory Response to Coronary Artery Bypass Grafting Surgery -Juniper Publishers

Abstract
Objectives: To evaluate the effects of preoperative thoracic epidural analgesia (TEA) on inflammatory response of patients undergoing on- pump coronary artery bypass graft (CABG) surgery under general anesthesia (GA).
Patients & Methods: Eighty-eight patients were divided into two groups; Group TEA received TEA and GA and Group GA received GA alone. Blood samples were collected preoperatively (T0), 4-hr (TJ, and one (T2) and two (T3) days after surgery for ELISA estimation of serum interleukin (IL)-1β, IL-6, IL-10 and tumor necrosis factor (TNF)-α. Intraoperative (IO) and postoperative (PO) data were collected.
Results: Patients of group E had significantly lower IO hemodynamic measures, shorter time for hemostasis and wound closure and less IO blood loss than patients of group G. Amount of 1st PO day wound drainage was significantly less, and durations of mechanical ventilation (MV), ICU stay and PO hospital stay were significantly shorter in group TEA. Patients of group E had significantly lower individual and collective pain scores. All patients showed significantly higher levels of estimated cytokines compared to preoperative levels. Patients of group E showed significantly lower serum IL-1β, IL-6 and TNF-α with significantly lower serum IL-10 levels compared to patients of group GA.
Conclusion: TEA provided significantly better control on inflammatory response during on-pump CABG in favor of anti-inflammatory arm. Continuous epidural analgesia during ICU stay significantly shortened duration of MV and ICU stay with reduction of need for opioid. Pain control provided by TEA allowed PO early ambulation, rehabilitation and short hospital stay.
Keywords: Thoracic epidural analgesia; Inflammatory response; CABG

Introduction

Coronary artery bypass grafting (CABG) surgery remains the preferred treatment in patients with complex coronary artery disease [1]. However, CABG has inherent impacts on multiple organ systems that could be attributed to altered inflammatory system functions [2]. Cardiopulmonary bypass (CPB) procedures are thought to activate systemic inflammatory reaction syndrome [3] and comparative studies found off-pump surgery could attenuate the CABG-associated inflammatory response [4,5].
Various drugs administered during anesthetic procedure were tried to reduce inflammatory response during on-pump CABG. Desflurane anesthesia induced lower concentrations of interleukin (IL)-8 and IL-6 [6], methyl-prednisolone [7] and dexamethasone [8] decrease levels of IL-6 and increase antiinflammatory activity through IL-10 [7]. Also, dexmedetomidine reduced circulating IL-1, IL-6, tumor necrosis factor-α (TNF-α), and interferon-γ levels after mini-CPB [9].
Epidural anesthesia is a central neuraxial block technique with many applications. It is a versatile anesthetic technique that can be used as an anesthetic, as an analgesic adjuvant to general anesthesia, and for postoperative analgesia [10].
The current prospective comparative study aimed to evaluate the effects of preoperative thoracic epidural analgesia (TEA) on inflammatory response of patients undergoing CABG surgery under general anesthesia (GA).

Patients & Methods

The current prospective study was conducted at Departments of Anesthesia and Cardiovascular Surgery at Nasser Institute. The study protocol was approved by Local Ethical Committee. Patients signed fully informed written consent were randomly; using sealed envelopes prepared by blinded assistant and chosen by patients, allocated into two equal groups: Group TEA included patients will receive TEA as adjuvant to inhalational GA and Group GA included patients will receive inhalational GA alone.

Anesthetic Technique

All patients were taken into the operating room unpremedicated and after standard non-invasive monitoring, Lactated Ringer's solution was started. In Group E epidural catheter was inserted before induction of anesthesia using the loss of resistance technique. A 20 gauge epidural catheter (Prefix 401, B. Braun, Melsungen AG) was inserted through an 18-gauge Tuohy needle that was placed at the T1-2 interspace and advanced 3 to 5 cm into the epidural space. An initial bolus of 10ml ropivacaine 0.75% was injected and followed by continuous infusion of ropivacaine 2% at rate of 10ml/hr. Sensory block was ascertained by sensory loss to needle prick.
For both groups, general anesthesia was induced with midazolam (0.05mg/kg) as a pre-anaesthetic medication, propofol (1-2mg/kg), fentanyl (1-2μg/kg), and atracurium (0.5mg/kg). After tracheal intubation, lungs were ventilated with 100% O2 using a semi-closed circle system, with a tidal volume of 6-8ml/kg, and the ventilatory rate was adjusted to maintain end tidal CO2 between 35-40mmHg. Anesthesia was maintained by sevoflurane 2% and atracurium injection was adapted to the patient's physiological reaction to surgical stimuli. Heart rate (HR), systolic, diastolic, mean arterial blood pressure (MAP) and oxygen saturation were invasively monitored throughout the surgery. Patients of group GA received fentanyl infusion (2μg/ kg/hr) as intraoperative analgesia. Postoperative (PO) pain was evaluated using the visual analogue score (1-10 points) and rescue analgesia for both groups was given at VAS of ≥4 as intramuscular mepridine (50-100mg).
Collected operative data included number of grafted vessels, aortic cross clamping (CCT), cardiopulmonary bypass (CPB) and total operative times. Duration of ICU stay, amount of chest tube drainage, and the frequency of PO events were recorded.

Laboratory Investigations

Blood samples were collected from preoperatively (T0), 4-hr (T1), one (T2) and two (T3) days after surgery. Separated serum was stored at -80°C until assayed for ELISA estimation of serum IL-1β (Quantikine ELISA kit from R & D Systems, Inc., Minneapolis, MN, USA) [11], IL-10 (Milenia®, DPC Biermann, Bad Nauheim; Germany) [12], IL-6 [13] and TNF- α (Pelikine™ Inc., Concord, USA) [14].

Statistical Analysis

Sample size was calculated using the standard nomogram proposed by Kraemer & Thiemann [15] and a sample size of >40 patients was determined to be sufficient to detect a difference at the 5% significance level and give the trial 80% power (16). Obtained data were analyzed using One-way ANOVA with post- hoc Tukey HSD Test and Chi-square test (X2 test) using the SPSS (Version 15, 2006) for Windows statistical package. P value <0.05 was considered statistically significant.

Result

BMI: Body Mass Index; ASA grade: American Society of Anesthesiology; NYHA: New York Heart Association
The study included 88 patients assigned for isolated CABG (Table 1). Intraoperative hemodynamic measures were nonsignificantly (p>0.05) lower in group TEA till 30-min after induction of GA; then the difference became significantly (p<0.05) lower in group TEA till the end of surgery (Table 2 & Figure 1).
Data are presented as mean±SD; HR: Heart Rrate; SAP: Systolic Arterial Pressure; DAP: Diastolic Arterial Pressure; MAP: Mean Arterial Pressure; *: Significance Versus Control Levels
Operative data showed non-significant difference between both groups. Patients of group TEA showed significantly lower amount of 1st PO day wound drainage, and durations of mechanical ventilation and ICU stay. Pain scores, determined throughout 1st 36-hr afterward transfer, were significantly lower in patients of TEA group than those of group GA (Fig. 1) with significantly lower collective 36-hr pain score. Mean total duration of hospital stay was significantly shorter in group TEA compared to group GA (Table 3).
Data are presented as mean±SD, ratios & numbers; percentages are in parenthesis; *: significant difference versus group GA
Preoperative serum cytokine levels showed non-significant (p>0.05) difference between studied patients. All patients showed significantly (p<0.05) higher PO cytokines levels compared to preoperative levels with significantly higher serum IL-1β, IL-6 and TNF-α and significantly lower serum IL-10 levels in patients of group G compared to patients of group E. This significant difference persisted till 2-day PO (Table 4).
Postoperative serum levels of inflammatory cytokines were significantly higher, while levels of anti-inflammatory cytokine were with significantly lower compared to preoperative levels; a finding that illustrates the stress imposed by CABG surgery on immune system and supported that previously reported in literature [17-21]. However, thoracic epidural analgesia (TEA) significantly lessened this effect compared to general anesthesia (GA) alone. These findings illustrated the beneficial effects of epidural analgesia on surgery-induced activation of immune system and supported that previously reported by Bach et al.[22] and Palomero Rodriguez et al. [23] who reported that TEA as a part of a combined anesthesia attenuated the inflammatory response to cardiac surgery with CPB. Moreover, Caputo et al. [24] detected significantly lower IL-6 and IL-8 levels with significantly higher levels of IL-10 with combined GA and ETA than in GA alone in patients underwent off-pump CABG. Also, Zawar et al. [10] found combined TEA with GA decreased IL-6 at day 2, TNF-α at day 2 and 5 and concluded that TEA decreases inflammatory response to CABG.
Patients received TEA showed significantly lower pain score and rescue analgesia consumption for 36-hr after extubation. This allowed early ambulation and favorable outcome. Such outcome supported that previously documented that TEA provided better analgesia with significantly reduced pain intensity and analgesic consumption in early PO period after CABG (El-Morsy & El-Deeb [25], Gurses et al. [26], Onan et al. [27] and Porizka et al. [28].
Patients received TEA enjoyed significantly better PO course with significantly shorter duration of MV and ICU stay. This could be attributed to the better control on inflammatory response in favor of anti-inflammatory direction and the perfect control of pain that allowed freer chest movement with subsequent better lung ventilation, thus reducing postoperative MV-induced complications. Additionally, TEA minimized the need for opioid with its sedative and possible respiratory inhibition effects thus allowed earlier weaning of MV and ICU discharge.
These data go in hand with El-Morsy & El-Deeb [25] who reported that in elderly CABG patients, TEA reduced severity of PO pulmonary dysfunction with faster restoration of normal function and significantly higher PaO2, lower PaCO2, thus resulting in earlier extubation and awakening. Moreover, Gurses et al. [26] found PO need for vasodilator, transfusion; analgesics, extubation time and duration of stay in ICU were significantly lower in TEA group of CABG patients compared to GA group. Also, Neskovic et al. [29] reported that combination of GA with TEA appears to be good choice during synchronous carotid endarterectomy and OPCAB due to advantages of early extubation and early neurological assessment. Recently, in 2016; Porizka et al. [28] and Barbosa et al. [30] reported significantly shorter time to extubation and lower ICU stay of CABG patients received TEA.
Furthermore, patients had combined GA and TEA showed significantly lower amount of mediastinal drainage on 1st PO day; mostly due to better intraoperative hemodynamic control secondary to significantly lower blood pressure so minimizing bleeding and subsequently decreased PO oozing and collection. Similarly, Gurses et al. [26] reported significantly lower intraoperative MAP, need for transfusion, whereas cardiac output and index, hematocrit values were significantly higher; and postoperative MAP, HR, hypertension development were significantly lower with TEA compared to GA.
In addition, patients received TEA showed non-significantly lower frequency of PO events, but had significantly shorter duration of hospital stay. In line with such outcome, Zawar et al. [10], Gurses et al. [26] and Porizka et al. [28] reported significantly shorter duration of hospital stay in TEA group compared to GA group. Also, Barbosa et al. [30], found combined TEA and GA showed lower incidence of arrhythmias and lower ICU and hospital stay and Stenger et al. [31] reported significantly lower frequency of PO dialysis and myocardial infarction and 6-m mortality rate of cardiac surgery patients received supplemental TEA to GA.
In line with outcomes of the current study and in support of the efficacy of TEA for patients undergoing CABG, multiple studies approved efficacy of combined TEA and GA for cardiac surgery in obese patients [32], chronic obstructive pulmonary disease patients [33] elderly cardiac surgery patients [34] and even in high risk cardiac surgery patients [35].
Multiple experimental studies tried to evaluate the beneficial effects of TEA for patients undergoing CABG; Bedirli et al. [36] using a rat model of mesenteric ischemia/reperfusion found TEA significantly decreased cytokine, malondialdehyde, and myeloperoxidase levels and increased antioxidant enzyme levels with significantly decreased intestinal injury score and percentage of apoptotic cells. Onan et al. [37] using immunocytochemistry showed that TEA increased internal thoracic artery free blood flow significantly via increased vascular endothelial growth factor and inducible nitric oxide synthase expressions and recommended the use of TEA as an adjunct to GA as an alternative to vasoactive agents for increasing internal thoracic artery blood flow during CABG surgery.

Conclusion

TEA provided significantly better control on inflammatory response during on-pump CABG in favor of anti-inflammatory arm. Continuous epidural analgesia during ICU stay significantly shortened duration of MV and ICU stay with reduction of need for opioid. Pain control provided by TEA allowed PO early ambulation, rehabilitation and short hospital stay.
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