Correlates of poor clinical outcomes related to COVID-19 among older people with psychiatric illness - a mixed methods study.

OBJECTIVE: COVID-19 may lead to a range of clinical outcomes among older people with psychiatric and medical conditions. Evidence guiding management of future outbreaks among this vulnerable population in psychiatric hospital settings are sparse. In this study, we examined the correlates of poor clinical outcomes related to COVID-19 and explored the perspectives of COVID-19 survivors hospitalized in psychiatry settings. METHOD: The correlates of poor clinical outcomes related to COVID-19 were examined using a retrospective chart review of 81 older people hospitalized in psychiatry settings. Correlates of clinical outcomes related to COVID-19 were assessed by multiple logistic regression models. In addition, the perspectives of 10 COVID-19 survivors were explored by qualitative interviews. The qualitative data was subject to thematic analysis. RESULTS: Although 25.9% (n = 21) participants were asymptomatic, there was high COVID-19 related mortality (14.8%; n = 12). Vitamin-D deficiency, anticholinergic burden, and isolation policies within psychiatric wards were significantly (p < 0.05) related to COVID-19 related deaths. In qualitative interviews, participants emphasized the importance of strengthening local support networks and making vaccination centers more accessible. CONCLUSIONS: Reducing anticholinergic prescriptions and improving isolation policies may help to mitigate poor clinical outcomes. Future research investigating the impact of vitamin-D supplementation on COVID-19 related outcomes is warranted.

A prospective multi-site registry of real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation (Real-AF): design and objectives.

PURPOSE: Catheter ablation has become a mainstay therapy for atrial fibrillation (AF) with rapid innovation over the past decade. Variability in ablation techniques may impact efficiency, safety, and efficacy; and the ideal strategy is unknown. Real-world evidence assessing the impact of procedural variations across multiple operators may provide insight into these questions. The Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation registry (Real-AF) is a multicenter prospective registry that will enroll patients at high volume centers, including academic institutions and private practices, with operators performing ablations primarily with low fluoroscopy when possible. The study will also evaluate the contribution of advent in technologies and workflows to real-world clinical outcomes. METHODS: Patients presenting at participating centers are screened for enrollment. Data are collected at the time of procedure, 10-12 weeks, and 12 months post procedure and include patient and detailed procedural characteristics, with short and long-term outcomes. Arrhythmia recurrences are monitored through standard of care practice which includes continuous rhythm monitoring at 6 and 12 months, event monitors as needed for routine care or symptoms suggestive of recurrence, EKG performed at every visit, and interrogation of implanted device or ILR when applicable. RESULTS: Enrollment began in January 2018 with a single site. Additional sites began enrollment in October 2019. Through May 2021, 1,243 patients underwent 1,269 procedures at 13 institutions. Our goal is to enroll 4000 patients. DISCUSSION: Real-AF's multiple data sources and detailed procedural information, emphasis on high volume operators, inclusion of low fluoroscopy operators, and use of rigorous standardized follow-up methodology allow systematic documentation of clinical outcomes associated with changes in ablation workflow and technologies over time. Timely data sharing may enable real-time quality improvements in patient care and delivery. Trial registration Clinicaltrials.gov: NCT04088071 (registration date: September 12, 2019).

Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker.

BACKGROUND: The feasibility and outcomes of concomitant atrioventricular node ablation (AVNA) and leadless pacemaker implant are not well studied. We report outcomes in patients undergoing Micra implant with concomitant AVNA. METHODS: Patients undergoing AVNA at the time of Micra implant from the Micra Transcatheter Pacing (IDE) Study, Continued Access (CA) study, and Post-Approval Registry (PAR) were included in the analysis and compared to Micra patients without AVNA. Baseline characteristics, acute and follow-up outcomes, and electrical performance were compared between patients with and without AVNA during the follow-up period. RESULTS: A total of 192 patients (mean age 77.4 ± 8.9 years, 72% female) underwent AVNA at the time of Micra implant and were followed for 20.4 ± 15.6 months. AVNA patients were older, more frequently female, and tended to have more co-morbid conditions compared with non-AVNA patients (N = 2616). Implant was successful in 191 of 192 patients (99.5%). The mean pacing threshold at implant was 0.58 ± 0.35 V and remained stable during follow-up. Major complications within 30 days occurred more frequently in AVNA patients than non-AVNA patients (7.3% vs. 2.0%, p < .001). The risk of major complications through 36-months was higher in AVNA patients (hazard ratio: 3.81, 95% confidence interval: 2.33-6.23, p < .001). Intermittent loss of capture occurred in three AVNA patients (1.6%), all were within 30 days of implant and required system revision. There were no device macrodislodgements or unexpected device malfunctions. CONCLUSION: Concomitant AVN ablation and leadless pacemaker implant is feasible. Pacing thresholds are stable over time. However, patient comorbidities and the risk of major complications are higher in patients undergoing AVNA.

Lithium Neurotoxicity Due to Second-Generation Antipsychotics Combined With Lithium: A Systematic Review.

OBJECTIVE: To study cases of lithium neurotoxicity (LN), both reversible (RLN) and irreversible (ILN), due to second-generation antipsychotics (SGAs) combined with lithium. DATA SOURCES: A comprehensive search was conducted in MEDLINE, PsycINFO, EMBASE, and the Cochrane Library from their inception to July 31, 2017. STUDY SELECTION: Free terms and MeSH headings were combined as follows: [(lithium) AND (adverse events OR safety OR side effects OR neurotoxicity OR neurologic manifestations OR central nervous system) AND (risperidone OR paliperidone OR olanzapine OR aripiprazole OR clozapine OR quetiapine OR ziprasidone OR amisulpride OR asenapine OR lurasidone OR iloperidone)]. Only English-language articles reporting about LN due to SGAs combined with lithium were selected. DATA EXTRACTION: The age, sex, diagnostic categories, clinical features, lithium doses, serum lithium levels, antipsychotic dosages, causative factors, and preventive measures of 11 cases of LN (8 RLN and 3 ILN) due to the lithium and SGA combination were extracted. DATA SYNTHESIS: Forty-five percent of patients were aged > 60 years. The diagnostic categories were schizoaffective disorders, bipolar disorders, and schizophrenia. Cases of RLN presented as an acute brain syndrome, which recovered completely. Cases of ILN presented as a chronic brain syndrome and only partially recovered. The lithium doses in 9 cases were < 1,200 mg/d. The serum lithium levels in 2 cases in each of the groups were > 1.7 mEq/L. The SGAs implicated were clozapine, risperidone, aripiprazole, and quetiapine. One patient with RLN received 2 different first-generation antipsychotics and 1 patient with ILN received 2 different SGAs with lithium. Both groups had patients with medical comorbidities who were taking prescription medication. CONCLUSION: LN, both reversible and irreversible, due to SGAs combined with lithium presents with certain causative factors and a clinical profile. Early detection and prompt management will help prevent LN.

To retrieve, or not to retrieve: System revisions with the Micra transcatheter pacemaker.

BACKGROUND: Early experience with leadless pacemakers has shown a low rate of complications. However, little is known about system revision in patients with these devices. OBJECTIVE: The purpose of this study was to describe the system revision experience with the Micra Transcatheter Pacing System (TPS). METHODS: Patients with implants from the Pre-market Micra Transcatheter Pacing Study and the Micra Transcatheter Pacing System Continued Access Study (N = 989) were analyzed and compared with 2667 patients with transvenous pacemakers (TVPs). Revisions included TPS retrieval/explant, repositioning, replacement, or electrical deactivation (with or without prior attempt at retrieval, generally followed by TVP implant) for any reason. Kaplan-Meier revision rates were calculated to account for varying follow-up duration and were compared using a Fine-Gray competing risk model. RESULTS: The actuarial rate for revision at 24 months postimplant was 1.4% for the TPS group (11 revisions in 10 patients), 75% (95% confidence interval 53%-87%; P < .001) lower than the 5.3% for the TVP group (123 revisions in 117 patients). TPS revisions occurred 5-430 days postimplant for elevated pacing thresholds, need for alternate therapy, pacemaker syndrome, and prosthetic valve endocarditis; none were due to device dislodgment or device-related infection. TPS was disabled and left in situ in 7 cases, 3 were retrieved percutaneously (range 9-406 days postimplant), and 1 was surgically removed during aortic valve surgery. CONCLUSION: The overall system revision rate for patients with TPS at 24 months was 1.4%, 75% lower than that for patients with TVPs. TPS was disabled and left in situ in 64% of revisions, and percutaneous retrieval was successful as late as 14 months postimplant.

The efficacy of sirolimus- and paclitaxel-eluting stents: a meta-analysis of randomized controlled trials.

BACKGROUND: Drug-eluting stents prevent in-stent restenosis after percutaneous coronary intervention, and differences between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) may exist in the rates of target lesion revascularization, death, myocardial infarction and stent thrombosis. OBJECTIVE: To compare the efficacy of SES and PES with the efficacy of bare-metal stents for de novo coronary lesions in patients with stable or unstable angina. METHODS: A meta-analysis of randomized trials from MEDLINE, EMBASE and other electronic databases and conference proceedings was conducted. The efficacy of SES, PES with a polymer carrier (PPOL) and PES without a polymer carrier (PNPOL) was compared using random-effects models. RESULTS: Ten trials comprising 5041 patients were included in the meta-analysis. There was an absolute decrease in target lesion revascularization of 17% (95% CI 14% to 20%), 9% (95% CI 6% to 11%) and 3% (95% CI 0% to 6%) with SES, PPOL and PNPOL, respectively, with significant differences between SES and PPOL and between PPOL and PNPOL (P < 0.01 for both comparisons). However, sensitivity analysis using the OR of target lesion revascularization showed no difference between SES (OR 0.18 [95% CI 0.12 to 0.26]) and PPOL (OR 0.25 [95% CI 0.16 to 0.37]) (P = 0.26). There were no differences in the incidence of death, myocardial infarction or stent thrombosis, although the small number of events limited the power of these analyses. CONCLUSIONS: SES show a greater absolute reduction in target lesion revascularization than do PES, likely due to differences in the bare-metal stents used for comparison in the trials. Head-to-head comparisons are needed to directly address the differential efficacy of SES and PES.