Current approaches to diagnosis and management of ocular lesions in human immunodeficiency virus positive patients

Human immunovirus infection in India is rapidly increasing. Ocular lesions due to highly active antiretroviral therapy have been well recognized. Acquired immunodeficiency syndrome can affect all parts of the eye. However, posterior segment lesions are the most common and of these, Human immunodeficiency virus retinopathy and cytomegalovirus retinitis predominate. Often clinical examination can establish the diagnosis of many ocular lesions in acquired immunodeficiency syndrome; therefore, ophthalmologists need to be aware of the more common ones. Various drugs in different routes can used to treat cytomegalovirus retinitis. Highly active antiretroviral therapy has remarkably reduced systemic and ocular morbidity among acquired immunodeficiency syndrome patients. To facilitate care of these patients aseptic precautions for ophthalmic care personnel are now well established and therefore ophthalmologist should not hesitate to provide ophthalmic care to acquired immunodeficiency syndrome patients

136-37: Health-related quality-of-life in patients with leadless pacemaker

Purpose: Leadless pacemakers (LPs) are miniaturized, fully self-contained devices percutaneously implanted in the right ventricle using a femoral vein approach. The multicenter LEADLESS II clinical trial has demonstrated that both pre-specified safety and effectiveness endpoints for the NanostimTM LP were met. This study assessed the health-related quality-of-life (HRQoL) in these LP patients and its corresponding changes over time. Method: Patients\u27 HRQoL were assessed using the EuroQol EQ-5D, a preference-based instrument from which utility values could be generated on the basis of item responses and an established EuroQol algorithm. EQ-5D utilities were measured on a cardinal scale of 0–1, where 0 indicates death and 1 indicates full health; with higher utilities representing better HRQoL. We included the 468 patients from the LP IDE Study who had complete EQ-5D item responses at 4 time points including: pre-discharge, weeks 2, 6 and 12, respectively. Patients\u27 baseline EQ-5D utilities (before the LP implant) were not collected; hence, a systematic review of US single-chamber pacemaker studies was conducted to obtain the mean baseline utility value to be used as the reference point for comparison. Proportional changes in EQ-5D utilities at different time points, compared with the baseline utility, were estimated and tested using Analysis of Variance. Effect sizes were calculated to evaluate the magnitude of these changes, independent of sample size effects. Summary: Mean patient age was 75 (±12) years, 37% were female and 91% were white. As shown in Table 1, mean baseline EQ-5D utility, based on literature review, was 0.73. Mean EQ-5D utility at pre-discharge was 0.81, and increased to 0.84, 0.85 and 0.84 at weeks 2, 6, and 12, respectively (p \u3c 0.01). Compared with the baseline utility, the EQ-5D utility increased by 10.3% at pre-discharge, then by 14.7%, 16.7% and 14.7% at weeks 2, 6 and 12, respectively (p \u3c 0.01). A moderate to high effect size of 0.55 was achieved at week 2, followed by a sustained improvement over the 12-week period (Table 1). Table 1. EQ-5D utility values and changes over time Mean SD Utility Change(%, compared with baseline) Effect Size¥(compared with baseline) Baseline* 0.7300 Pre-discharge 0.8053 0.2219 10.31%§ 0.3393 Week 2 0.8375 0.1964 14.73%§ 0.5476 Week 6 0.8522 0.1833 16.73%§ 0.6666 Week 12 0.8375 0.1781 14.73%§ 0.6038 * Baseline utility was obtained from a systematic review of single-chamber pacemaker studies in the US, which was 0.73. ¥ Effect size (ES) measures the magnitude of the utility changes, independent of sample size effect, where: ES ≥ 0.8: large effect; 0.8 ≥ ES ≥ 0.5: moderate to high effect; 0.5 ≥ ES ≥ 0.2: low to moderate effect; ES ≤ 0.2: low effect. § All % utility changes were statistically significant, compared with baseline utility. Conclusions: These data indicate that implantation of the NanostimTM LP is accompanied with improved HRQoL immediately after implant and the improvement was sustained over time

In vivo porcine characterization of atrial lesion safety and efficacy utilizing a circular pulsed-field ablation catheter including assessment of collateral damage to adjacent tissue in supratherapeutic ablation applications.

IntroductionPulsed-field ablation (PFA), an ablative method that causes cell death by irreversible electroporation, has potential safety advantages over radiofrequency ablation and cryoablation. Pulmonary vein (PV) isolation was performed in a porcine model to characterize safety and performance of a novel, fully-integrated biphasic PFA system comprising a multi-channel generator, variable loop circular catheter, and integrated PFA mapping software module.MethodsEight healthy porcine subjects were included. To evaluate safety, multiple ablations were performed, including sites not generally targeted for therapeutic ablation, such as the right inferior PV lumen, right superior PV ostium, and adjacent to the esophagus and phrenic nerve. To evaluate the efficacy, animals were recovered, followed for 30(±3) days, then re-mapped. Gross pathological and histopathological examinations assessed procedural injuries, chronic thrombosis, tissue ablation, penetration depth, healing, and inflammatory response.ResultsAll eight animals survived follow-up. PV narrowing was not observed acutely nor at follow-up, even when ablation was performed deep to the PV ostium. No injury was seen grossly or histologically in adjacent structures. All PVs were durably isolated, confirmed by bidirectional block at re-map procedure. Histological examination showed complete, transmural necrosis around the circumference of the ablated section of right PVs.ConclusionThis preclinical evaluation of a fully-integrated PFA system demonstrated effective and durable ablation of cardiac tissue and PV isolation without collateral damage to adjacent structures, even when ablation was performed in more extreme settings than those used therapeutically. Histological staining confirmed complete transmural cell necrosis around the circumference of the PV ostium at 30 days

Preclinical safety and electrical performance of novel atrial leadless pacemaker with dual-helix fixation

Background: Complications associated with transvenous pacemakers, specifically those involving the lead or subcutaneous pocket, may be avoided with leadless pacemakers (LPs). The safety and efficacy of single-chamber right ventricular LPs have been demonstrated, but their right atrium (RA) use poses new design constraints. Objectives: The purpose of this study was to evaluate the implant success, electrical performance, and safety of a novel RA LP design in benchtop and preclinical studies. Methods: A new LP was designed with a dual-helix fixation mechanism specific to the RA anatomy. A 12-week preclinical ovine study was conducted to evaluate implant success, electrical performance, mechanical stability, and safety in vivo, with supporting benchtop measurements to quantify the mechanical forces needed for device retrieval and dislodgment. Results: LPs were successfully implanted in all 10 ovine subjects with no complications. The pacing capture threshold improved significantly over time from implant to week 12 (1.1 ± 0.7 V vs 0.4 ± 0.2 V, P =.008). Sensing amplitudes and pacing impedances were stable from implant to week 12 (4.8 ± 1.8 mV vs 6.0 ± 1.9 mV, P =.160; and 393 ± 77 Ω vs 398 ± 65 Ω, P =.922, respectively). Gross pathology and microscopic histology revealed no adverse interactions and no evidence of device dislodgment or clinically significant myocardial perforation. Benchtop ex vivo porcine atrial tissue measurements revealed greater pull forces required to dislodge the LP vs transvenous active fixation lead (0.42 ± 0.18 lbf vs 0.29 ± 0.08 lbf, P =.020), and greater rotational forces required for deliberate extraction (0.28 ± 0.04 lbf vs 0.14 ± 0.07 lbf, P <.001). Conclusion: The novel atrial LP demonstrated successful implantation, with acceptable electrical performance, mechanical stability, and safety in a 12-week preclinical study

Comparative study of acute and mid-term complications with leadless and transvenous cardiac pacemakers

BACKGROUND: Leadless cardiac pacemakers (LCPs) aim to mitigate lead- and pocket-related complications seen with transvenous pacemakers (TVPs). OBJECTIVE: The purpose of this study was to compare complications between the LCP cohort from the LEADLESS Pacemaker IDE Study (Leadless II) trial and a propensity score-matched real-world TVP cohort. METHODS: The multicenter LEADLESS II trial evaluated the safety and efficacy of the Nanostim LCP (Abbott, Abbott Park, IL) using structured follow-up, with serious adverse device effects independently adjudicated. TVP data were obtained from Truven Health MarketScan claims databases for patients implanted with single-chamber TVPs between April 1, 2010 and March 31, 2014 and more than 1 year of preimplant enrollment data. Comorbidities and complications were identified via International Classification of Diseases, Ninth Revision and Current Procedural Terminology codes. Short-term (≤1 months) and mid-term (\u3e1-18 months) complications were compared between the LCP cohort and a propensity score-matched subset of the TVP cohort. RESULTS: Among 718 patients with LCPs (mean age 75.6 ± 11.9 years; 62% men) and 1436 patients with TVPs (mean age 76.1 ± 12.3 years; 63% men), patients with LCPs experienced fewer complications (hazard ratio 0.44; 95% confidence interval 0.32-0.60; P \u3c .001), including short-term (5.8% vs 9.4%; P = .01) and mid-term (0.56% vs 4.9%; P \u3c .001) events. In the short-term time frame, patients with LCPs had more pericardial effusions (1.53% vs 0.35%; P = .005); similar rates of vascular events (1.11% vs 0.42%; P = .085), dislodgments (0.97% vs 1.39%; P = .54), and generator complications (0.70% vs 0.28%; P = .17); and no thoracic trauma compared to patients with TVPs (rate of thoracic trauma 3.27%). In short- and mid-term time frames, TVP events absent from the LCP group included lead-related, pocket-related, and infectious complications. CONCLUSION: Patients with LCPs experienced fewer overall short- and mid-term complications, including infectious and lead- and pocket-related events, but more pericardial effusions, which were uncommon but serious

Evaluation of choroidal layer thickness in central serous chorioretinopathy

Purpose: To evaluate medium and large choroidal vessel layer thickness (MCVT and LCVT, respectively) in eyes with acute and chronic central serous chorioretinopathy (CSC) in comparison with age-matched controls. Methods: The study included 96 eyes of 96 patients with CSC, including 53 eyes with acute CSC, 43 eyes with chronic CSC, and 30 eyes of 30 age-matched normal subjects. Manual measurements of subfoveal choroidal thickness (SFCT), MCVT, and LCVT at subfoveal and 750 μm nasal and temporal to the fovea locations were made on enhanced depth imaging optical coherence tomography (EDI-OCT) of the macula in all subjects using ImageJ software (National Institutes of Health, Bethesda, MD, USA). Results: SFCT in acute CSC was significantly larger than that in healthy eyes (P = 0.0001). SFCT in acute CSC did not differ significantly from that in chronic CSC eyes. Subfoveal LCVT and MCVT in acute CSC eyes were greater than those in healthy eyes (P = 0.02 and P = 0.03, respectively). Mean SFCT and MCVT in chronic CSC eyes were significantly larger than those in control eyes (P = 0.01 and P = 0.04, respectively). No significant difference in LCVT was observed between chronic and control eyes. Conclusion: Choroidal vasculature is altered in both acute and chronic CSC. SFCT, MCVT, and LCVT are higher in eyes with acute CSC. The thickening of medium choroidal vessels is still detectable in chronic CSC compared to control eyes