In-hospital stroke after transcatheter aortic valve implantation: A UK observational cohort analysis.

OBJECTIVES: We sought to identify baseline demographics and procedural factors that might independently predict in-hospital stroke following transcatheter aortic valve implantation (TAVI). BACKGROUND: Stroke is a recognized, albeit infrequent, complication of TAVI. Established predictors of procedure-related in-hospital stroke; however, remain poorly defined. METHODS: We conducted an observational cohort analysis of the multicenter UK TAVI registry. The primary outcome measure was the incidence of in-hospital stroke. RESULTS: A total of 8,652 TAVI procedures were performed from 2007 to 2015. There were 205 in-hospital strokes reported by participating centers equivalent to an overall stroke incidence of 2.4%. Univariate analysis showed that the implantation of balloon-expandable valves caused significantly fewer strokes (balloon-expandable 96/4,613 [2.08%] vs. self-expandable 95/3,272 [2.90%]; p = .020). After multivariable analysis, prior cerebrovascular disease (CVD) (odds ratio [OR] 1.51, 95% confidence interval [CI 1.05-2.17]; p = .03), advanced age at time of operation (OR 1.02 [0.10-1.04]; p = .05), bailout coronary stenting (OR 5.94 [2.03-17.39]; p = .008), and earlier year of procedure (OR 0.93 [0.87-1.00]; p = .04) were associated with an increased in-hospital stroke risk. There was a reduced stroke risk in those who had prior cardiac surgery (OR 0.62 [0.41-0.93]; p = .01) and a first-generation balloon-expandable valve implanted (OR 0.72 [0.53-0.97]; p = .03). In-hospital stroke significantly increased 30-day (OR 5.22 [3.49-7.81]; p < .001) and 1-year mortality (OR 3.21 [2.15-4.78]; p < .001). CONCLUSIONS: In-hospital stroke after TAVI is associated with substantially increased early and late mortality. Factors independently associated with in-hospital stroke were previous CVD, advanced age, no prior cardiac surgery, and deployment of a predominantly first-generation self-expandable transcatheter heart valve.

Transapical valve-in-ring mitral valve implantation through the anterior mitral valve leaflet.

Transcatheter mitral valve implantation (TMVI) is a relatively novel intervention used to replace the mitral valve of individuals deemed too high risk or unsuitable for surgery. It is associated with a number of specific risks, including left ventricular outflow tract obstruction (LVOTO).  In this video tutorial we present the case of a 75-year-old man who was unable to undergo redo surgical repair and had a number of risk factors for LVOTO. To minimize these risks, we deployed the TMVI within the anterior mitral valve leaflet. The postoperative result was mild mitral valve regurgitation and no LVOTO.  The long-term outcome of this approach is yet to be determined but we believe this technique offers a novel method to manage a select group of patients suffering with mitral valve disease and at risk of LVOTO.

Transapical valve-in-ring mitral valve implantation through the anterior mitral valve leaflet.

Transcatheter mitral valve implantation is a relatively novel intervention that replaces the mitral valve of individuals deemed too high-risk or unsuitable for surgery. It is associated with a number of specific risks, including left ventricular outflow tract obstruction. In this report, we present the case of a 75-year-old man who was unable to undergo redo surgical repair and had a number of risk factors for left ventricular outflow tract obstruction. To minimize this risk, we deployed transcatheter mitral valve implantation within the anterior mitral valve leaflet resulting in mild mitral valve regurgitation postoperatively and no left ventricular outflow tract obstruction. Long-term durability of this approach is yet to be determined, but we believe that this intervention adds to the armamentarium of the heart team.

Tibial intraneural ganglia at the ankle and knee: incorporating the unified (articular) theory in adults and children.

OBJECT: The etiology of intraneural ganglia has been debated for centuries, and only recently a unifying theory has been proposed. The incidence of tibial nerve intraneural ganglia is restricted to the occasional case report, and there are no reported cases of these lesions in children. While evidence of the unifying theory for intraneural ganglia of the common peroneal nerve is strong, there are only a few reports describing the application of the theory in the tibial nerve. In this report the authors examine tibial nerve intraneural ganglia at the ankle and knee in an adult and a child, respectively, and describe the clinical utility of incorporating the unifying (articular) theory in the management of tibial intraneural ganglia in adults and children. METHODS: Cases of tibial intraneural ganglion cysts were examined clinically, radiologically, operatively, and histologically to demonstrate the application of the unified (articular) theory for the development of these cysts in adults and children. RESULTS: Two patients with intraneural ganglion cysts of the tibial nerve were identified: an adult with an intraneural ganglion cyst of the tibial nerve at the tarsal tunnel and a child with an intraneural ganglion cyst of the tibial nerve at the knee. In each case, preoperative MR imaging demonstrated the intraneural cyst and its connection to the adjacent joint via the articular branch to the subtalar joint and superior tibiofibular joint. At surgery the articular branch was identified and resected, thus disconnecting the tibial nerve intraneural cyst from the joint of origin. CONCLUSIONS: These cases detail the important features of intraneural ganglion cysts of the tibial nerve and document the clinical utility of incorporating the unifying (articular) theory for the surgical management of tibial intraneural ganglia in adults and children.

Efficacy of an aspheric treatment algorithm in decreasing induced spherical aberration after laser in situ keratomileusis.

PURPOSE: To determine the effectiveness of an aspheric laser in situ keratomileusis (LASIK) algorithm for myopia with and without astigmatism in minimizing postoperative induction of spherical aberration. SETTING: Four sites in Asia. METHODS: Patients with -1.00 to -10.00 diopters (D) of spherical myopia with -4.00 D or less of astigmatism were recruited. Patients randomly had bilateral Zyoptix aspheric algorithm (aspheric group) or bilateral conventional Zyoptix Tissue Saving algorithm (control group). A Technolas 217z100 excimer system was used for LASIK ablation. Visual effectiveness, safety, higher-order aberrations, and corneal asphericity (Q value) were evaluated postoperatively. RESULTS: The aspheric group comprised 86 eyes and the control group, 84 eyes. At 3 months, the high-contrast uncorrected distance visual acuity was 20/20 or better in 78% of eyes in the aspheric group and 83% of eyes in the control group. The control treatment induced 0.22 microm of spherical aberration, which was significantly higher than the 0.04 microm induced with the aspheric treatment (6.0 mm pupil) (P<.0001). The aspheric treatment induced significantly less vertical coma and trefoil (P = .02). Eyes in the aspheric group had significantly lower Q values (P<.0001). There was no statistically significant difference in the manifest refraction spherical equivalent between the 2 groups (P >.05). Although high- and low-contrast corrected distance visual acuity (CDVA) was similar between the groups, the aspheric group gained more lines of low-contrast CDVA. CONCLUSION: The aspheric algorithm was more effective than the conventional algorithm in reducing induced spherical aberration and maintaining corneal asphericity after myopic LASIK.

Photorefractive keratectomy in the cat eye: biological and optical outcomes.

PURPOSE: To quantify optical and biomechanical properties of the feline cornea before and after photorefractive keratectomy (PRK) and assess the relative contribution of different biological factors to refractive outcome. SETTING: Department of Ophthalmology, University of Rochester, Rochester, New York, USA. METHODS: Adult cats had 6.0 diopter (D) myopic or 4.0 D hyperopic PRK over 6.0 or 8.0 mm optical zones (OZ). Preoperative and postoperative wavefront aberrations were measured, as were intraocular pressure (IOP), corneal hysteresis, the corneal resistance factor, axial length, corneal thickness, and radii of curvature. Finally, postmortem immunohistochemistry for vimentin and alpha-smooth muscle actin was performed. RESULTS: Photorefractive keratectomy changed ocular defocus, increased higher-order aberrations, and induced myofibroblast differentiation in cats. However, the intended defocus corrections were only achieved with 8.0 mm OZs. Long-term flattening of the epithelial and stromal surfaces was noted after myopic, but not after hyperopic, PRK. The IOP was unaltered by PRK; however, corneal hysteresis and the corneal resistance factor decreased. Over the ensuing 6 months, ocular aberrations and the IOP remained stable, while central corneal thickness, corneal hysteresis, and the corneal resistance factor increased toward normal levels. CONCLUSIONS: Cat corneas exhibited optical, histological, and biomechanical reactions to PRK that resembled those previously described in humans, especially when the OZ size was normalized to the total corneal area. However, cats exhibited significant stromal regeneration, causing a return to preoperative corneal thickness, corneal hysteresis and the corneal resistance factor without significant regression of optical changes induced by the surgery. Thus, the principal effects of laser refractive surgery on ocular wavefront aberrations can be achieved despite clear interspecies differences in corneal biology.

Corneal light backscatter measured by optical coherence tomography after LASIK.

PURPOSE: To objectively quantify corneal light backscatter after LASIK using optical coherence tomography (OCT). METHODS: Twenty-eight eyes of 14 patients (mean age: 39.9 +/- 8.6 years) underwent LASIK surgery. Corneal images were taken with a custom built anterior segment OCT at 1310 nm before and 1 day, 1 week, and 1 month after surgery. Backscattered light from the epithelium and 10 equally divided corneal stromal layers of the central cornea were analyzed using custom software. Light scattering of the interface area (defined as seven image pixels [46.2 microm] in depth centered by the peak corresponding to the interface between the corneal flap and bed) was also calculated and compared to the light backscatter at an equivalent depth of the respective preoperative cornea. RESULTS: There were significant differences of light backscatter in different layers (analysis of variance [ANOVA]: F(10, 130) = 44.89, P = .0001), but no significant differences between right and left eyes preoperatively (ANOVA: F(10, 130) = 1.16, P = .32). After surgery, there were significant differences in light backscatter profiles of the central cornea (repeated measures ANOVA: F(30, 810) = 7.70, P = .0001) with significant increases at approximately 140 to 190 microm in depth from the corneal front surface at 1 day (post hoc test: P = .004) and 1 week (post hoc test: P = .001) postoperatively, compared to the baseline. One month after surgery, light backscatter increased significantly in the epithelium (post hoc test: P = .0001) and decreased significantly (post hoc test: P = .0001) at approximately 100 to 140 microm in depth. Light backscatter results of these interface areas (repeated measures ANOVA: F(3, 81) = 21.29, P = .0001) showed significant increases at 1 day and 1 week postoperatively (post hoc tests: P = .0001) compared to baseline results and 1-month postoperative results. CONCLUSIONS: Objective and quantitative analysis of corneal light backscatter from OCT demonstrated increasing comeal light scattering at the interface and subsequent recovery.

Aberrations induced in wavefront-guided laser refractive surgery due to shifts between natural and dilated pupil center locations.

PURPOSE: To determine the aberrations induced in wavefront-guided laser refractive surgery due to shifts in pupil center location from when aberrations are measured preoperatively (over a dilated pupil) to when they are corrected surgically (over a natural pupil). SETTING: Center for Visual Science and Department of Ophthalmology, University of Rochester, Rochester, New York, USA. METHODS: Shifts in pupil center were measured between dilated phenylephrine hydrochloride (Neo-Synephrine [2.5%]) and nonpharmacological mesopic conditions in 65 myopic eyes treated with wavefront-guided laser in situ keratomileusis (Technolas 217z, Bausch & Lomb). Each patient's preoperative and 6-month postoperative wave aberrations were measured over the dilated pupil. Aberrations theoretically induced by decentration of a wavefront-guided ablation were calculated and compared with those measured 6 months postoperatively (6.0 mm pupil). RESULTS: The mean magnitude of pupil center shift was 0.29 mm +/- 0.141 (SD) and usually occurred in the inferonasal direction as the pupil dilated. Depending on the magnitude of shift, the fraction of the higher-order postoperative root-mean-square wavefront error that could be due theoretically to pupil center decentrations was highly variable (mean 0.26 +/- 0.20 mm). There was little correlation between the calculated and 6-month postoperative wavefronts, most likely because pupil center decentrations are only 1 of several potential sources of postoperative aberrations. CONCLUSIONS: Measuring aberrations over a Neo-Synephrine-dilated pupil and treating them over an undilated pupil typically resulted in a shift of the wavefront-guided ablation in the superotemporal direction and an induction of higher-order aberrations. Methods referencing the aberration measurement and treatment with respect to a fixed feature on the eye will reduce the potential for inducing aberrations due to shifts in pupil center.

Higher-order aberrations in eyes with irregular corneas after laser refractive surgery.

PURPOSE: To investigate the distribution of the eye's higher-order aberrations in postoperative laser refractive surgery patients with visual complaints and highly irregular corneal shapes. DESIGN: Retrospective case-control study. PARTICIPANTS: Thirty-three symptomatic postoperative LASIK and/or photorefractive keratectomy eyes with subjective visual complaints not corrected by spectacles more than 6 months after surgery are compared with 46 normal preoperative and 46 asymptomatic successful postoperative conventional LASIK eyes. METHODS: Postoperative wave aberrations were measured for each patient using a Shack-Hartmann wavefront sensor (Zywave, Bausch & Lomb, Rochester, NY) over a 6-mm pupil. These measurements were averaged across patients with similar corneal topographic diagnoses (central islands, decentered ablations, a new group termed baby bowties, and irregularly irregular corneas). MAIN OUTCOME MEASURES: Higher-order aberrations and corneal topography. RESULTS: The average (+/-1 standard deviation) higher-order root-mean-square (rms) wavefront error values (third, fourth, and fifth orders) for the symptomatic patients was 1.31+/-0.58 microm. This was an average of 3.46 times greater than the average magnitude of normal preoperative eyes (mean rms, 0.38+/-0.14 microm), and an average of 2.3 times greater than the average magnitude of asymptomatic successful postoperative conventional LASIK eyes (mean rms, 0.58+/-0.21 microm) over a 6-mm pupil. Higher-order rms wavefront error increased with pupil size, roughly doubling for every millimeter of increasing pupil diameter. On average, eyes with central islands (n = 6) had the most vertical coma (Z3(-1); mean, -1.35+/-0.43 microm). Eyes with central islands and decentered ablations (n = 2) also had elevated amounts of spherical aberration (Z4(0); means of 0.83+/-0.11 microm and 0.69+/-0.29 microm, respectively) compared with successful postoperative LASIK eyes (mean of 0.42+/-0.20 microm). Eyes with a topographic central baby bowtie demonstrated the most secondary astigmatism (Z4(2) and Z4(-2); mean rms, 0.56+/-0.17 microm; n = 3), despite the lowest average higher-order rms (mean, 0.84+/-0.05 microm) among symptomatic topographic subgroups. Eyes with irregularly irregular corneas had a mean higher-order rms of 1.10+/-0.39 mum. CONCLUSIONS: Symptomatic postoperative laser refractive surgery patients with irregular corneas have higher-order aberrations that are 2.3 to 3.5 times greater than asymptomatic postoperative LASIK and normal preoperative eyes, respectively. The higher-order aberrations seem to correlate with corneal topography.

Prediction of flap response.

PURPOSE: To find predictors of the induced biomechanical and optical effects of lamellar flap creation on the cornea. SETTING: Optimed Eye and Laser Clinic, Pretoria, South Africa, and the Department of Ophthalmology and Biomedical Engineering Center, The Ohio State University, Columbus, Ohio, and Bausch & Lomb Vision Research Laboratory, Rochester, New York, USA. METHODS: This prospective study monitored the refractive, wavefront aberration, and corneal topographic changes in 29 eyes of 15 patients for 3 months after the creation of a corneal lamellar flap. The main outcome measures for statistical analysis were refraction, total corneal thickness, residual corneal bed thickness, horizontal white-to-white corneal diameter, horizontal flap diameter, topography data, and wavefront data. RESULTS: Statistically significant changes were seen in the autorefraction mode. Wavefront data showed significant change in 4 Zernike modes-90/180-degree astigmatism, vertical coma, horizontal coma, and spherical aberration. The topography data indicated the corneal biomechanical response was significantly predicted by stromal bed thickness in the early follow-up period and by total corneal pachymetry and flap diameter in a 2-parameter statistical model in the late follow-up period. CONCLUSIONS: Uncomplicated lamellar flap creation is responsible for systematic changes in corneal topography and induction of higher-order optical aberrations. Predictors of this response include stromal bed thickness, flap diameter, and total corneal pachymetry.

Causes of spherical aberration induced by laser refractive surgery.

PURPOSE: To develop a corneal model to better explain how refractive surgery procedures induce spherical aberration. SETTING: Department of Ophthalmology and Center for Visual Science, University of Rochester, Rochester, New York, USA. METHODS: The preoperative cornea was modeled as a rotationally symmetric surface with various radii of curvature and asphericities. The postoperative cornea was defined as the difference between the preoperative cornea and an ablation thickness profile computed based on the Munnerlyn equation. A ray-tracing program and Zernike polynomial fitting were used to calculate the induced amount of spherical aberration assuming a fixed ablation depth per pulse or a variable ablation depth depending on the incidence angle of each pulse on the cornea. A biological eye model of the corneal surface change after laser refractive surgery was also developed to explain the induced spherical aberrations after myopic and hyperopic treatments. RESULTS: The clinical data showed that positive spherical aberration was induced after myopic correction and negative spherical aberration increased after hyperopic correction. In contrast, assuming a fixed ablation depth per pulse, the theoretical prediction was that negative spherical aberration with myopic treatment and positive spherical aberration with hyperopic treatment would increase. However, when assuming a variable ablation depth per pulse caused by non-normal incidence of laser spot on the cornea, the theoretically predicted induction of spherical aberration tends to fit better with the myopic and hyperopic clinical data. The effect of a variable ablation depth accounted for approximately half the clinically observed amount of spherical aberration. The biological model of the corneal surface change used to explain this remaining discrepancy showed the magnitude of the biological response in myopic correction is 3 times smaller than in hyperopic correction and that the direction of the biological response in hyperopic treatment is opposite that in myopic treatment. CONCLUSIONS: This nontoric eye model, which separates the effects of differences in ablation efficiency and biological corneal surface change quantitatively, explains how spherical aberration is induced after myopic and hyperopic laser refractive surgery. With the corneal topographic data, this model can be incorporated into the ablation algorithm to decrease induced spherical aberrations, improving the outcomes of conventional and customized treatments.

Surgeon offsets and dynamic eye movements in laser refractive surgery.

PURPOSE: To determine the amount of static and dynamic pupil decentrations that occur during laser refractive surgery. SETTING: The Center of Visual Science and the Department of Ophthalmology, University of Rochester, Rochester, New York, USA. METHODS: The surgeon's accuracy in aligning the pupil center with the laser center axis was measured when engaging the eye-tracker in 17 eyes receiving conventional laser in situ keratomileusis (LASIK) procedures (Technolas 217z; Bausch & Lomb). Eye movements were measured subsequently during the treatment in 10 eyes using a pupil camera operating at 50 Hz. Temporal power spectra were calculated from the eye movement measurements. RESULTS: The mean pupil misalignment by the surgeon at the beginning of the procedure was 206.1 microm +/- 80.99 (SD) (with respect to the laser center). The laser center was typically misaligned below (inferiorly) and to the left (nasally and temporally in left and right eyes, respectively) of the pupil [corrected] center. Small amounts of cyclotorsion were observed during the ablation (<2 degrees). The mean magnitude of dynamic pupil decentration from the laser center during treatment was 227.0 +/- 44.07 microm. The mean standard deviation of eye movements was 65.7 +/- 25.64 microm. Temporal power spectra calculated from the horizontal and vertical changes in eye position during the ablation were similar. Ninety-five percent of the total power of the eye movements was contained in temporal frequencies up to 1 Hz, on average, in both directions. CONCLUSIONS: Most eye movements during LASIK are slow drifts in fixation. An eye-tracker with a 1.4 Hz closed-loop bandwidth could compensate for most eye movements in conventional or customized ablations.

Vision improvement by correcting higher-order aberrations with phase plates in normal eyes.

PURPOSE: To psychophysically demonstrate vision improvement when correcting higher-order aberrations with phase plates in normal eyes. METHODS: The wavefront aberrations of three nonsurgical normal eyes were measured with a Shack-Hartmann wavefront sensor. With these measured aberrations, phase plates were fabricated using a lathing technique. Theoretical improvement in retinal image quality was estimated by calculating the optical modulation transfer functions under the white light condition. Visual acuity measurements were also conducted to demonstrate improvement in visual performance after correcting higher-order aberrations with the phase plate. In this visual acuity measurement, a tumbling "E" with high (100%) and low (10%) contrast was used. RESULTS: The phase plate reduced the higher-order root mean square (RMS) wavefront error from 0.39 +/- 0.09 to 0.15 +/- 0.02 microm (mean +/- standard deviation from three eyes) for a 6-mm pupil. With the phase plate, retinal image quality based on the volume of modulation transfer function under 60 cycles per degree (c/deg) was improved by a factor of 1.8 +/- 0.4 over that of the eyes with spherocylindrical correction only. Average improvement in visual acuity achieved by correcting the higher-order aberration was 0.23 lines with high-contrast letters and 1.12 lines with low-contrast letters. All subjects reported subjective improvement in image quality of the letter with the phase plate. CONCLUSION: The phase plate effectively corrected the higher-order aberrations in normal eyes. As a result, both retinal image quality and visual acuity especially with the low-contrast letters were improved. This study demonstrated the feasibility of correcting higher-order aberrations and improving vision with customized optics.

Zyoptix: the Bausch & Lomb wavefront platform.

The Bausch & Lomb Zyoptix system provides a customized approach to corneal sculpting resulting in improvements in best-corrected visual acuity and contrast sensitivity over that achieved in conventional laser in situ keratomileusis surgery.

Noncontact measurements of central corneal epithelial and flap thickness after laser in situ keratomileusis.

PURPOSE: To investigate the changes in the epithelium and flap after laser in situ keratomileusis (LASIK), when measured with optical coherence tomography (OCT). METHODS: Twenty-eight eyes of 14 patients (age: 39.9 +/- 8.6 years) underwent LASIK. The central thickness of corneal epithelium and flap were measured with a real-time 1310 nm OCT 1 day, 1 week, and 1 month after surgery. A custom software program was used to process multiple images of each eye on each visit. RESULTS: After surgery, the corneal epithelium changed significantly (ANOVA: F((3, 81)) = 12.3, P = 0.000) with not statistically significant thinning at one day (mean +/- SD: 57.8 +/- 5.9 micro m, P = 0.26, compared with baseline: 59.9 +/- 5.9 micro m) and statistically significant thickening at 1 week (60.8 +/- 5.8 micro m, P = 0.04, compared with 1 day) and 1 month (64.6 +/- 6.1 micro m, P = 0.008 compared with all others). There were statistically significant changes in the corneal flap thickness (ANOVA: F((2, 54)) = 4.59, P = 0.01) with thickening in the intervals between 1 day (143.3 +/- 20.6 micro m) and 1 week (149.7 +/- 24.6 micro m, P = 0.12), and between 1 week and 1 month (152.7 +/- 19.3 micro m, P = 0.01). There was a strong correlation (r = 0.898) between the difference of corneal thickness before and after surgery and predicted laser ablation depth. CONCLUSIONS: OCT is a useful noncontact tool for thickness measurements of the epithelium, flap, and total cornea. After LASIK, the epithelium and flap showed thickening during the study period.