CLINICAL ASSOCIATIONS AND PROGNOSTIC IMPLICATIONS OF REPAIR TISSUE PROLIFERATION IN EYES WITH RETINAL PIGMENT EPITHELIUM TEARS.

PURPOSE: To investigate demographic and clinical factors influencing the longitudinal changes of retinal pigment epithelium (RPE) dehiscence area after RPE tears, including the presence of RPE tear-associated repair proliferation (TARP), and identify factors associated with TARP development over follow-up. METHODS: Retrospective, single-center, observational cohort study of patients with a history of macular neovascularization and RPE tear. The area of RPE dehiscence was measured on repeated short-wavelength fundus autofluorescence imaging. Associations between covariates and RPE dehiscence areas were tested with multivariable linear mixed models. Associations between TARP development and clinical variables were investigated with Cox regression models. Factors associated with visual acuity changing rates were explored with linear mixed models. RESULTS: Thirty-seven eyes of 36 patients were included in this study and followed for a median time of 18 months. Tear-associated repair proliferation was identified in 27 eyes (73%). The median time for TARP detection was 112 days; none of the investigated factors was significantly associated with TARP occurrence. The presence of TARP (estimate: -0.042 mm2/month; P = 0.001) and female gender (estimate: -0.035 mm2/month; P = 0.006) were associated with slower rates of RPE dehiscence enlargement over time. Faster rates of visual improvement were observed in eyes with TARP compared with those without TARP (estimate = -0.010 logarithm of the minimum angle of resolution/month if TARP was present; P = 0.008). CONCLUSION: Retinal pigment epithelium tear repair with TARP and female gender were associated with slower RPE degeneration after RPE tears. The presence of TARP was associated better visual prognosis. Additional research on factors promoting TARP development may have therapeutic and prognostic implications.

QUANTITATIVE OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY PARAMETER VARIATIONS AFTER TREATMENT OF MACULAR NEOVASCULARIZATION SECONDARY TO AGE-RELATED MACULAR DEGENERATION.

PURPOSE: Macular neovascularization (MNV) secondary to age-related macular degeneration can be characterized by quantitative optical coherence tomography angiography. The aim of the study was to assess the evolution of quantitative optical coherence tomography angiography parameters after 1 year of antivascular endothelial growth factor injections. METHODS: Naive age-related macular degeneration-related MNV eyes were prospectively recruited to analyze optical coherence tomography and optical coherence tomography angiography parameters, including MNV vessel tortuosity (VT) and reflectivity, at baseline and at the end of the follow-up. Macular neovascularization eyes were categorized by a MNV VT cutoff, and quantitative parameter variations were documented after 1 year of treatment. We divided MNV eyes into Group 1 (MNV VT < 8.40) and Group 2 (MNV VT > 8.40). RESULTS: Thrity naive age-related macular degeneration-related MNV eyes (30 patients) were included. Our cohort included 18 Type 1 MNV and 12 Type 2 MNV lesions. Baseline central macular thickness (411 ± 85 µm) improved to 323 ± 54 µm at 1 year (P < 0.01). Only Group 1 MNV displayed significant visual improvement. Macular neovascularization VT values remained stable over the follow-up in both subgroups. Group 2 MNV eyes showed increased MNV reflectivity and increased MNV area at the end of the follow-up. Quantitative retinal capillary plexa parameters were found to be worse in Group 2 MNV. Outer retinal atrophy occurred in 2 of the 18 eyes in MNV Group 1 (11%) and in 6 of the 12 eyes in MNV Group 2 (50%) after 1 year. Vessel density proved to be always worse in Group 2 than in Group 1. CONCLUSION: Macular neovascularization VT provides information on the blood flow and identifies two subgroups with different final anatomical and visual outcomes, regardless of the treatment effect.

Acute changes in mitral valve geometry after percutaneous valve repair with MitraClip XTR by three-dimensional echocardiography.

BACKGROUND: Mitral valve (MV) repair with MitraClip system is a safe treatment option for high-risk patients with significant mitral regurgitation (MR). We aimed to characterize, by three-dimensional echocardiography (3D-E), changes occurring in MV after implantation of third generation MitraClip XTR device, with specific reference to the underlying MR mechanism (functional vs degenerative, FMR vs DMR). METHODS: We prospectively enrolled 59 patients, who underwent intra-procedural 3D-E before and after device deployment. Three-D datasets were analyzed off-line, using a dedicated semiautomatic software, to obtain parametric quantification of mitral anatomy. RESULTS: Post-procedural MR of mild or lesser degree was achieved in 40 patients (68%), with no differences between FMR and DMR (p 0.9). After MitraClip XTR implantation, the FMR group experienced an immediate annular resizing, with reduction of antero-posterior diameter (p 0.024) and sphericity index (p 0.017), next to a recovery of physiological saddle-shape, defined by lower non-planar angle (p ≤0.001) and higher annulus height to commissural width ratio (p ≤0.001). On the opposite, the DMR group revealed a significant decrease of maximum annular velocity (p 0.027), addressing a mechanic effect of the device deployment. Finally, baseline anterior mitral leaflet angle was found as an independent predictor of acute procedural result (OR 6.7, [CI 1.01-44.33], p 0.049). CONCLUSIONS: MitraClip XTR implantation acts in restoring the original mitral geometry, with distinctive effects according to MR mechanism. Three-D parametric quantification of MV sheds new light on changes occurring in the valvular apparatus, and helps identifying possible new predictors of acute procedural success.

Why Do We Need Anatomical Implants? the Science and Rationale for Maintaining Their Availability and Use in Breast Surgery.

The choice between anatomical and round implants is an important decision in breast augmentation surgery; however, both have their place and the decision between them that should be made on a patient-by-patient basis, taking into account the patient's desires, anatomy, and surgical history. In some individuals, there are clear indications for using either anatomical or round devices, and there is good evidence that aesthetic outcomes are better with anatomical implants in some instances. When both types are an option, anatomical devices may offer increased flexibility and, despite a longer learning curve needed to properly manage them, they are associated with positive long-term outcomes and high levels of patient satisfaction. Concerns about implant rotation can be minimized with proper patient selection and surgical technique, and the overall complication rate may favor anatomical over round devices in appropriate patients. Breast implant-associated anaplastic large-cell lymphoma is an important issue, and while rare, it must be considered in the context of the entire patient risk profile. Both anatomical and round implants remain key elements of a complete surgical toolbox in breast augmentation. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Different types of implants for reconstructive breast surgery.

BACKGROUND: Breast cancer is the most common cancer in women worldwide, and is a leading cause of cancer death among women. Prophylactic or curative mastectomy is often followed by breast reconstruction for which there are several surgical approaches that use breast implants with which surgeons can restore the natural feel, size and shape of the breast. OBJECTIVES: To assess the effects of different types of breast implants on capsular contracture, surgical short- and long-term complications, postoperative satisfaction level and quality of life in women who have undergone reconstructive breast surgery after mastectomy. SEARCH METHODS: We searched the Cochrane Breast Cancer Group's Specialised Register on 20 July 2015, MEDLINE (1985 to 20 July 2015), EMBASE (1985 to 20 July 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2015). We also searched the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov on 16 July 2015. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that compared different types of breast implants for reconstructive surgery. We considered the following types of intervention: implant envelope surfaces - texturised versus smooth; implant filler material - silicone versus saline, PVP-Hydrogel versus saline; implant shape - anatomical versus round; implant volume - variable versus fixed; brands - different implant manufacturing companies and implant generation (fifth versus previous generations). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed methodological quality and extracted data. We used standard Cochrane methodological procedures. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. MAIN RESULTS: Five RCTs with 202 participants met the inclusion criteria. The women participants were typically in their 50s, and the majority of them (about 82%) received reconstructive surgery following breast cancer, while the others had reconstructive surgery after prophylactic mastectomy. The studies were heterogenous in terms of implant comparisons, which prevented us from pooling the data.The studies were judged as being at an unclear risk of bias for most risk of bias items owing to poor quality of reporting in the trial publications. Three of the five RCTs were judged to be at high risk of attrition bias, and one at high risk of detection bias.Textured silicone versus smooth silicone implants: textured implants were associated with worse outcomes when compared to smooth implants (capsular contracture: risk ratio (RR) 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence; reintervention: RR 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence). No results in this comparison were statistically significant.Silicone versus saline implants: saline-filled implants performed better than silicone-filled implants for some outcomes; specifically, they produced less severe capsular contracture (RR 3.25, 95% CI 1.24 to 8.51; 1 study, 60 participants; very low quality evidence) and increased patient satisfaction (RR 0.60, 95% CI 0.41 to 0.88; 1 study, 58 participants; very low quality evidence). However reintervention was significantly more frequent in the saline-filled implant group than in the silicone-filled group (OR 0.08, 95% CI 0.01 to 0.43; 1 study, 60 participants; very low quality evidence).Poly(N-vinyl-2-pyrrolidone) hydrogel-filled (PVP-hydrogel) versus saline-filled implants: PVP-hydrogel-filled implants were associated with worse outcomes when compared to saline-filled implants (capsular contracture: RR 3.50, 95% CI 0.83 to 14.83; 1 study, 40 participants; very low quality evidence; short-term complications: RR 2.10, 95% CI 0.21 to 21.39; 1 study, 41 participants; very low quality evidence).Anatomical versus round implants: anatomical implants were associated with worse outcomes than round implants (capsular contracture: RR 2.00, 95% CI 0.20 to 20.15; 1 study, 36 participants; very low quality evidence; short-term complications: RR 2.00, 95% CI 0.42 to 9.58; 1 study, 36 participants; very low quality evidence; reintervention: RR 1.50, 95% CI 0.51 to 4.43; 1 study, 36 participants; very low quality evidence). No results in this comparison were statistically significant.Variable-volume versus fixed-volume implants: data about one-stage reconstruction using variable-volume implants were compared with data about fixed-volume implants positioned during the second surgical procedure of two-stage reconstructions. Fixed-volume implant reconstructions were possibly associated with a greater number of women reporting that their reconstruction corresponded with expected results (RR 0.25, 95% CI 0.10 to 0.62; 1 study, 40 participants; very low quality evidence) and fewer reinterventions (RR 7.00, 95% CI 1.82 to 26.89; 1 study, 40 participants; very low quality evidence) when compared to variable-volume implants. A higher patient satisfaction level (rated from 1 to 6, with 1 being very bad and 6 being very good) was found with the fixed-volume implants for overall aesthetic result (mean difference (MD) -1.10, 95% CI -1.59 to -0.61; 1 study, 40 participants; very low quality evidence).There were no studies that examined the effects of recent (fifth) generation silicone implants versus previous generations or different implant manufacturing companies. AUTHORS' CONCLUSIONS: Despite the central role of breast reconstruction in women with breast cancer, the best implants to use in reconstructive surgery have been studied rarely in the context of RCTs. Furthermore the quality of these studies and the overall evidence they provide is largely unsatisfactory. Some of our results can be interpreted as early evidence of potentially large differences between different surgical approaches, which should be confirmed in new high-quality RCTs that include a larger number of women. These days - even after a few million women have had breasts reconstructed - surgeons cannot inform women about the risks and complications of different implant-based breast reconstructive options on the basis of results derived from RCTs.

Laser treatment of drusen to prevent progression to advanced age-related macular degeneration.

BACKGROUND: Drusen are amorphous yellowish deposits beneath the sensory retina. People with drusen, particularly large drusen, are at higher risk of developing age-related macular degeneration (AMD). The most common complication in AMD is choroidal neovascularisation (CNV), the growth of new blood vessels in the centre of the macula. The risk of CNV is higher among people who are already affected by CNV in one eye.It has been observed clinically that laser photocoagulation of drusen leads to their disappearance and may prevent the occurrence of advanced disease (CNV or geographic atrophy) associated with visual loss. OBJECTIVES: To examine the effectiveness and adverse effects of laser photocoagulation of drusen in AMD. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2015, Issue 7), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to August 2015), EMBASE (January 1980 to August 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to August 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 3 August 2015. SELECTION CRITERIA: Randomised controlled trials (RCTs) of laser treatment of drusen in AMD in which laser treatment had been compared with no intervention or sham treatment. Two types of trials were included. Some trials studied one eye of each participant (unilateral studies); other studies recruited participants with bilateral drusen and randomised one eye to photocoagulation or control and the fellow eye to the other group. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and extracted data. We pooled data from unilateral and bilateral studies using a random-effects model. For the bilateral studies, we estimated the within-person correlation coefficient from one study and assumed it was valid for the others. MAIN RESULTS: The update of this review found two additional studies, totaling 11 studies that randomised 2159 participants (3580 eyes) and followed them up to two years, of which six studies (1454 participants) included people with one eye randomised to treatment and one to control. Studies were conducted in Australia, Europe and North America.Overall, the risk of bias in the included studies was low, particularly for the larger studies and for the primary outcome development of CNV. Photocoagulation did not reduce the development of CNV at two years' follow-up (odds ratio (OR) 1.07, 95% confidence interval (CI) 0.79 to 1.46, 11 studies, 2159 participants (3580 eyes), high quality evidence). This estimate means that, given an overall occurrence of CNV of 8.3% in the control group, we estimated an absolute risk reduction by no more than 1.4% in the laser group, according to the lower CI limit. Only two studies investigated the effect on the development of geographic atrophy and could not show a difference, but estimates were imprecise (OR 1.30, 95% CI 0.38 to 4.51, two studies, 148 participants (148 eyes), low quality evidence).Among secondary outcomes, photocoagulation led to drusen reduction (OR 9.16, 95% CI 6.28 to 13.4, three studies, 570 participants (944 eyes), high quality evidence) but was not shown to limit loss of 3 or more lines of visual acuity (OR 0.99, 95% CI 0.81 to 1.22, nine studies, 2002 participants (2386 eyes), moderate quality evidence).In a subgroup analysis, no difference could be shown for conventional visible (eight studies) versus subthreshold invisible (four studies) photocoagulation for the primary outcomes (P value = 0.29). The effect in the subthreshold group did not suggest a relevant benefit (OR 1.27, 95% CI 0.82 to 1.98). No study used micropulse subthreshold photocoagulation.No other adverse effects (apart from development of CNV, geographic atrophy or visual loss) were reported. AUTHORS' CONCLUSIONS: The trials included in this review confirm the clinical observation that laser photocoagulation of drusen leads to their disappearance. However, treatment does not result in a reduction in the risk of developing CNV, and was not shown to limit the occurrence of geographic atrophy or visual acuity loss.Ongoing studies are being conducted to assess whether the use of extremely short laser pulses (i.e. nanosecond laser treatment) cannot only lead to drusen regression but also prevent neovascular AMD.

DEXAMETHASONE IMPLANT FOR MACULAR EDEMA SECONDARY TO ISCHEMIC RETINAL VEIN OCCLUSIONS.

PURPOSE: To evaluate the effects of dexamethasone implant for the treatment of macular edema secondary to ischemic retinal vein occlusions (IRVO). METHODS: Consecutive patients affected by macular edema related to IRVO were prospectively recruited. After a comprehensive ophthalmological examination, including visual acuity, fluorescein angiography, and optical coherence tomography, each patient received a first implant. Further re-treatments were performed on the basis of macular edema detection from the fourth month on. The primary outcome measure was the change in Early Treatment Diabetic Retinopathy Study letter score at the 12-month examination. Secondary outcome measures included changes in central foveal thickness and number of implants over the follow-up. RESULTS: Fifteen patients with central IRVO and 14 patients with branch IRVO were recruited. The median ETDRS letter score at baseline was 10 (Snellen Equivalent 20/640) in the central IRVO subgroup, improving to 37 (Snellen Equivalent 20/200²âº) at the 12-month examination. The median ETDRS letter score in the branch retinal vein occlusion subgroup changed from 48 (Snellen equivalent 20/125³âº) at baseline to 62 (Snellen equivalent 20/63²âº) at the 12-month examination. The baseline median central foveal thickness was 749 µm in central IRVO, and 459 µm in branch IRVO, improving to 363 µm and 323 µm, respectively, at the 12-month examination. Mean number of implants was 2.8 in the central IRVO and 2 in the branch IRVO. CONCLUSION: Dexamethasone implant can reduce macular edema in eyes affected by IRVO, leading to a slight improvement in visual acuity.

Intravitreal ranibizumab for choroidal neovascularization with large submacular hemorrhage in age-related macular degeneration.

PURPOSE: To evaluate the effects of intravitreal ranibizumab injections in the treatment of choroidal neovascularization with large submacular hemorrhage secondary to age-related macular degeneration. METHODS: Prospective interventional case series. Patients presenting occult choroidal neovascularization with flat large submacular hemorrhage >50% of the entire lesion were considered. The protocol required 3 monthly consecutive injections, followed by repeat injections over the 12-month follow-up on the basis of optical coherence tomography parameters and angiographic features. RESULTS: Twenty-three patients were enrolled in the study and prospectively followed up. Mean best-corrected visual acuity and mean central macular thickness at the baseline were 0.82 ± 0.22 (logarithm of the minimum angle of resolution ± standard deviation) and 342 ± 56 µm, respectively. At 12-month examination, mean visual acuity improved significantly to 0.68 ± 0.41 (P = 0.04), and mean central macular thickness decreased to 236 ± 26 µm (P < 0.0001). A progressive resolution of macular bleeding was registered in 22 of 23 patients. No side effect or complication was registered. CONCLUSION: Intravitreal ranibizumab can be considered a beneficial approach for the management of choroidal neovascularization with flat large submacular hemorrhage secondary to age-related macular degeneration.

Intravitreal ranibizumab for naive extrafoveal choroidal neovascularization secondary to age-related macular degeneration.

PURPOSE: To investigate the effect of intravitreal ranibizumab on extrafoveal choroidal neovascularization secondary to age-related macular degeneration. METHODS: Eighteen eyes affected by extrafoveal choroidal neovascularization secondary to age-related macular degeneration were prospectively enrolled in this study. After an initial intravitreal ranibizumab, all patients were reevaluated monthly over 12 months of follow-up. Further retreatments were performed on a pro re nata basis, depending on detection of any type of fluid on optical coherence tomography and/or the presence of leakage on fluorescein angiography. Primary outcome measures were mean changes in best-corrected visual acuity and the proportion of eyes gaining at least 15 letters (3 Early Treatment Diabetic Retinopathy Study [ETDRS] lines) at the end of the follow-up. Secondary outcome measures were central macular thickness variations and changes in choroidal neovascularization size. RESULTS: Mean best-corrected visual acuity presented a significant improvement during the follow-up period, being 0.3 ± 0.2 logMAR at baseline and 0.2 ± 0.2 logMAR at the 12-month examination (P < 0.001). An improvement of at least 3 EDTRS lines was achieved by 6 eyes (33.3%), whereas 6 patients (33.3%) gained 1 to 2 lines. The mean central macular thickness at baseline was 314 ± 87 µm, changing to 268 ± 65 µm at the 12-month examination (P = 0.003). The mean lesion size was 1.4 ± 1.4 mm and remained stable throughout the follow-up, being 1.8 ± 2.9 mm at 12 months (P = 0.64). CONCLUSION: Intravitreal ranibizumab administered after a pro re nata regimen with monthly evaluation is a beneficial approach for the management of extrafoveal choroidal neovascularization secondary to age-related macular degeneration over 12 months of follow-up. Further studies are warranted to confirm our preliminary results.

Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness.

Implant texture is an important factor influencing implant selection for breast augmentation. Natrelle Biocell implants are characterized by macrotextured shell surfaces containing irregularly arranged concavities with large open-pore diameters and depths. These properties facilitate adhesion of the implant to the surrounding tissue, thereby promoting implant immobilization. Relative to implants with other surfaces, macrotextured implants offer low rates of capsular contracture; low rates of malposition, rotation, and rippling; and high rates of patient satisfaction. However, macrotextured implants are associated with a slightly higher risk of double capsule and late seroma. The surgeon can minimize these risks with straightforward techniques that encourage tissue adhesion. This report presents experience-based recommendations to optimize the effectiveness of Biocell anatomic implants. The authors discuss the application of best practices to all aspects of the breast implantation process, from implant selection and surgical planning to operative technique and postoperative management. LEVEL OF EVIDENCE 3.

Intravitreal bevacizumab for extrafoveal choroidal neovascularization secondary to pathologic myopia.

PURPOSE: To assess the effects of intravitreal bevacizumab injections in the treatment of extrafoveal choroidal neovascularization (CNV) associated with pathologic myopia. METHODS: Patients diagnosed with pathologic myopia complicated by extrafoveal CNV were considered in this prospective, open-label interventional study. All patients underwent a complete ophthalmologic examination, including Early Treatment Early of Diabetic Retinopathy Study (ETDRS) visual acuity measurement, optical coherence tomography, and fluorescein angiography. The protocol treatment included a first injection, followed by repeated injections over a 24-month follow-up period on the basis of optical coherence tomography and angiographic features, monitored monthly. Primary outcomes were the mean changes in best-corrected visual acuity and the proportion of eyes gaining at least 15 letters at the 24-month examination. Secondary outcomes included central macular thickness, size of the CNV, and extension to the fovea. RESULTS: Fifteen patients were included in the study. Mean best-corrected visual acuity changed from 0.47 logarithm of the minimum angle of resolution (20/60 Snellen equivalent) at baseline to 0.22 logarithm of the minimum angle of resolution (20/30 Snellen equivalent) at the 24-month examination. An improvement of at least 3 ETDRS lines was achieved by 7 eyes (46.6%) at the 24-month examination. Mean central macular thickness changed from 313 µm to 254 µm at the 24-month examination (P = 0.008). Mean CNV size decreased from 348 µm2 to 251 µm2 at 24 months (P = 0.029). CONCLUSION: Intravitreal bevacizumab injection is a beneficial treatment for extrafoveal CNV associated with pathologic myopia.

Intravitreal bevacizumab for juxtafoveal choroidal neovascularization secondary to multifocal choroiditis.

PURPOSE: To assess the effects of intravitreal bevacizumab injections in the treatment of juxtafoveal choroidal neovascularization associated with multifocal choroiditis. METHODS: Prospective interventional case series. Fourteen patients (14 eyes) affected by juxtafoveal choroidal neovascularization secondary to multifocal choroiditis were examined. All patients underwent a complete ophthalmologic examination, including measurement of best-corrected visual acuity using Early Treatment Diabetic Retinopathy Study charts, optical coherence tomography, and fluorescein angiography. The protocol treatment included a first injection, followed by repeated intravitreal bevacizumab injections over a 12-month follow-up period on the basis of optical coherence tomography parameters and angiographic features. RESULTS: Mean best-corrected visual acuity changed from 0.41 logarithm of the minimum angle of resolution (approximately corresponding to 20/51 Snellen equivalent), at baseline, to 0.16 ± 0.13 logarithm of the minimum angle of resolution (approximately corresponding to 20/28 Snellen equivalent), at the 12-month examination (P < 0.002). A functional improvement of at least 3 Early Treatment Diabetic Retinopathy Study lines was achieved by 6 eyes (43%) at the 12-month examination. Mean central macular thickness at baseline was 318 µm, reducing to 239 µm at the 12-month examination (P < 0.001). No eye showed choroidal neovascularization extension to the fovea. CONCLUSION: Intravitreal bevacizumab is a beneficial treatment for juxtafoveal choroidal neovascularization associated with multifocal choroiditis. Further studies are warranted to confirm these preliminary results.

Oncologic surveillance of breast cancer patients after lipofilling.

BACKGROUND: The regenerative effects of fat injections are based on the same hormones, growth factors, and stem cells that stimulate neoplastic angiogenesis and cancer progression in basic research. Few studies have analyzed the oncologic risk. No report has covered 5 years of oncologic surveillance, and no long-term risk has been estimated. The in vivo relationship between lipofilling and breast cancer remains unclear and controversial. This observational study focused on locoregional recurrence (LR) risk after lipofilling. METHODS: The study enrolled 60 patients after breast cancer surgery (total mastectomy) from 2000 to 2007 treated by lipofilling (82 single-surgeon procedures with the same fat-decanting technique). The study ended when follow-up observation reached 10 years. RESULTS: The study included invasive carcinoma (55 cases), in situ carcinoma (five cases), T1 (71.6 %) and T2 (23.3 %) carcinoma, N+ carcinoma (45 %), and stages 1 (43.3 %) and 2 (45 %) carcinoma. The overall 12-year incidence of LR was 5 % (1.6 % before and 3.3 % after lipofilling). The incidence of local relapse per 100 person-years was 0.36 in the first observation period and 0.43 after lipofilling. All LRs were stage 2, and the same rate, limited to stage 2, was 1.04. The crude cumulative incidence after lipofilling was 7.25 % (95 % confidence interval [CI], 0-15.4 %) for LR and 7.6 % (95 % CI, 0.2-15 %) for distant metastases. DISCUSSION: Clinical data and recurrence incidences were compared with those of prior publications concerning lipofilling oncologic risk and discussed in relation to the inherent cancer literature. CONCLUSIONS: Lipofilling may be used safely to treat tumor node metastasis stage 1 subjects after mastectomy. The local risk is low. For stage 2 patients, local failure was not significantly higher. Compared with institutional data and prior publications, the risk still is reliable. Breast conservative treatment must be investigated further because of the high risk for local relapse. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Evaluation of Different Breast Implant Shapes in the Same Patient: Is There Really a Difference between Round and Anatomical Implants?

Background: The choice of the right implant shape is one of the most frequent debates in cosmetic breast augmentation. In current literature, the question of whether there is a difference in the appearance of different implant shapes is still an argument of highly controversial discussion. The aim of the present work was, therefore, to analyze whether any difference exists in terms of aesthetic outcome between round and anatomical implants, and if they can be distinguished from each other in a like for like swap, making sure the evaluation was made in exactly similar conditions. Methods: Fourteen consecutive patients who underwent aesthetic breast augmentations received primarily an implant of a given volume, projection, and shape (round or anatomical) and then decided to undergo implant replacement to a different shape but maintaining the same volume and projection. At 12-months follow-up, standardized photographs were taken, blinded and randomized. They were evaluated by 10 plastic surgeons and 10 nurses. Results: All 20 observers could distinguish between round and anatomical shape in all 14 cases (100%), which was highly significant (P < 0.0001) for each observer. Conclusions: The present data indicate that there is a clear difference between anatomical and round-shaped implants in terms of aesthetic appearance, when a comparison is properly performed. With the use of both round and anatomical implant shapes, aesthetically appealing results can be achieved in cosmetic breast augmentation. The right implant choice must be made, based on patients' anatomy and desires.

Prediction of mortality and heart failure hospitalisations in patients undergoing M-TEER: external validation of the COAPT risk score.

BACKGROUND: A risk score was recently derived from the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial. However, external validation of this score is still lacking. AIMS: We aimed to validate the COAPT risk score in a large multicentre population undergoing mitral transcatheter edge-to-edge repair (M-TEER) for secondary mitral regurgitation (SMR). METHODS: The Italian Society of Interventional Cardiology (GIse) Registry of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) population was stratified according to COAPT score quartiles. The performance of the COAPT score for 2-year all-cause death or heart failure (HF) hospitalisation was evaluated in the overall population and in patients with or without a COAPT-like profile. RESULTS: Among the 1,659 patients included in the GIOTTO registry, 934 had SMR and complete data for a COAPT risk score calculation. The incidence of 2-year all-cause death or HF hospitalisation progressively increased through the COAPT score quartiles in the overall population (26.4% vs 44.5% vs 49.4% vs 59.7%; log-rank p<0.001) and COAPT-like patients (24.7% vs 32.4% vs 52.3% vs. 53.4%; log-rank p=0.004), but not in those with a non-COAPT-like profile. The COAPT risk score had poor discrimination and good calibration in the overall population, moderate discrimination and good calibration in COAPT-like patients and very poor discrimination and poor calibration in non-COAPT-like patients. CONCLUSIONS: The COAPT risk score has a poor performance in the prognostic stratification of real-world patients undergoing M-TEER. However, after application to patients with a COAPT-like profile, moderate discrimination and good calibration were observed.

Impact of extra-mitral valve cardiac involvement in patients with primary mitral regurgitation undergoing transcatheter edge-to-edge repair.

BACKGROUND: In the context of primary mitral regurgitation (PMR), the selection of patients for transcatheter edge-to-edge repair (TEER) does not include a systematic assessment of PMR-associated cardiac remodelling. AIMS: We aimed to investigate the epidemiology and prognostic significance of different phenotypes of extra-mitral valve (MV) cardiac involvement in a large series of patients with PMR referred for TEER. METHODS: The study included 654 patients from the multicentre Italian GIOTTO registry, stratified into groups according to extra-mitral valve (MV) cardiac involvement. The primary endpoint was all-cause death at 2-year follow-up. RESULTS: Patients with no cardiac involvement (NI; n=58), left heart involvement (LHI; n=343) and right heart involvement (RHI; n=253) were analysed. Acute technical success was achieved in 98% of patients. Kaplan-Meier curve analysis revealed significantly worse survival in patients with LHI and RHI (p=0.041). On multivariate Cox regression analysis, extra-MV cardiac involvement, haemoglobin level and technical success were independent predictors of the primary endpoint occurrence. CONCLUSIONS: Grading cardiac involvement may help refine risk stratification, since at least 1 group of extra-MV cardiac involvement represents in itself a negative predictor of midterm outcome.

Effects of the magnetic resonance field on breast tissue expanders.

BACKGROUND: Tissue expansion for breast reconstruction after mastectomy is a safe and effective procedure. A magnetic resonance imaging (MRI) scan can be requested for patients with a breast expander to evaluate concurrent diseases. The electromagnetic field of the MR can interfere with biomedical devices, resulting in potential hazards, compromising the diagnosis, or creation of artifacts. METHODS: Four tissue expanders with an integrated magnetic valve were tested. The temperature increase was measured using an infrared camera in the MR scanner. The expanders were tested (half-full and full of saline solution) both free in air and immersed in a phantom. The ferromagnetic properties of the devices were assessed using the deflection angle method. To evidence artifacts due to the presence of the expander, MR images were acquired for expanders tested in air and in the phantom. A valve localization test was performed after MRI analysis. RESULTS: A slight increase in temperature was demonstrated, without any clinical significance. The deflection angle due to the magnetic field depends on the distance from the bore of the magnet. The angle is higher when the device is closer to the bore. The presence of the magnetic valve influences the MRI signal, creating artifacts on the acquired images, even far from the valve itself. The valve localization test allowed verification of correct valve functioning for all the expanders after the MRI analysis. CONCLUSIONS: Under selected conditions, MRI scans can be feasible. Heating is not expected to be a major concern, whereas valve displacement could happen in certain clinical conditions. The presence of artifacts is almost unavoidable. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

PARACENTRAL ACUTE MIDDLE MACULOPATHY IN CENTRAL RETINAL VEIN OCCLUSION COMPLICATING AMYLOID LIGHT-CHAIN AMYLOIDOSIS.

PURPOSE: To describe a case of paracentral acute middle maculopathy associated with central retinal vein occlusion in a patient affected by amyloid light-chain amyloidosis. METHODS: One patient with confirmed diagnosis of amyloid light-chain amyloidosis, displaying paracentral acute middle maculopathy and central retinal vein occlusion, was recruited. The patient underwent complete ophthalmologic examination and multimodal imaging, including: fundus autofluorescence, fluorescein angiography, indocyanine green angiography, spectral-domain optical coherence tomography, and optical coherence tomography angiography. RESULTS: Fundus autofluorescence showed a ferning pattern, corresponding to linear hypofluorescence in late-phase indocyanine green angiography and delayed venous filling, detected by fluorescein angiography. Structural optical coherence tomography revealed a hyper-reflective line located in the outer plexiform layer, corresponding to the prominent middle limiting membrane, along with several placoid lesions. Optical coherence tomography angiography found that the superficial capillary plexus was preserved, whereas vessel density was reduced in both the deep capillary plexus and the choriocapillaris. After 1 year of follow-up, the patient achieved an almost complete morphological recovery. CONCLUSION: Multimodal imaging described in depth the morphological features of a case of combined paracentral acute middle maculopathy and central retinal vein occlusion in a patient affected by amyloid light-chain amyloidosis.

The Clinical Characteristics of Unilateral Placoid Pigment Epitheliopathies.

Purpose: Placoid-pigment-epitheliopathies like Acute-Posterior-Multifocal-Placoid-Pigment Epitheliopathy (APMPPE) and Relentless-Placoid-Choroidopathy (RPC) usually show bilateral involvement. This retrospective case series describes the clinical features with unilateral disease onset.Methods: 21 patients from 9 tertiary referring institutions were collected and evaluated.Results: Seventeen patients were included: 11 (65%) had unilateral placoid-pigment-epitheliopathy consistent with APMPPE, 6 (35%) with RPC (mean age: 28.82 ± 9.1 years). Mean follow-up time was 45 ± 48 months. Forty-one percent fellow-eyes had initial inflammatory signs including vitreous-cells, vascular-sheathing, and ONH swelling. Thirty-five percent developed chorioretinal lesions during follow-up after 19.5 ± 16.9 months. Initial inflammation in fellow-eye was not associated with fellow-eye involvement (p = .5). However, subfoveal choroidal-thickness (SCT) at baseline was significantly thicker in fellow-eyes who developed chorioretinal lesion compared to fellow-eyes who did not (400 ± 70 µm versus 283 ± 127 µm,p = .047).Conclusion: Unaffected fellow-eyes may have inflammatory signs at initial disease-onset and may develop lesions over time. They should be carefully monitored, particularly if they present with an increased SCT.