Years Of Prospective Follow-up Research Articles

Incident cardiovascular events and imaging phenotypes in UK Biobank participants with past cancer

ObjectivesTo evaluate incident cardiovascular outcomes and imaging phenotypes in UK Biobank participants with previous cancer.MethodsCancer and cardiovascular disease (CVD) diagnoses were ascertained using health record linkage. Participants with cancer history...

Subtalar Arthroereisis as a Surgical Option in the Reconstruction of Progressive Collapsing Foot Deformity: A Prospective 3-year Follow-up Study on Patient Satisfaction and Causes for Implant Removal in 40 Cases Treated with the HyProCure Implant

Subtalar Arthroereisis as a Surgical Option in the Reconstruction of Progressive Collapsing Foot Deformity: A Prospective 3-year Follow-up Study on Patient Satisfaction and Causes for Implant Removal in 40 Cases Treated with the HyProCure Implant

Real world validation of activity recognition algorithm and development of novel behavioral biomarkers of falls in aged control and movement disorder patients.

The use of wearable sensors in movement disorder patients such as Parkinson's disease (PD) and normal pressure hydrocephalus (NPH) is becoming more widespread, but most studies are limited to characterizing general aspects of mobility using smartphones. There is a need to accurately identify specific activities at home in order to properly evaluate gait and balance at home, where most falls occur. We developed an activity recognition algorithm to classify multiple daily living activities including high fall risk activities such as sit to stand transfers, turns and near-falls using data from 5 inertial sensors placed on the chest, upper-legs and lower-legs of the subjects. The algorithm is then verified with ground truth by collecting video footage of our patients wearing the sensors at home. Our activity recognition algorithm showed >95% sensitivity in detection of activities. Extracted features from our home monitoring system showed significantly better correlation (~69%) with prospectively measured fall frequency of our subjects compared to the standard clinical tests (~30%) or other quantitative gait metrics used in past studies when attempting to predict future falls over 1 year of prospective follow-up. Although detecting near-falls at home is difficult, our proposed model suggests that near-fall frequency is the most predictive criterion in fall detection through correlation analysis and fitting regression models.

Directionality of change in obsessive compulsive disorder and depression over six years of prospective follow-up

Major Depressive Disorder (MDD) is often comorbid with obsessive-compulsive disorder (OCD) yet little is known about the directionality of the association between OCD and depression symptoms. We aim to investigate the effect OCD symptoms has on depression symptoms and vice versa over an extended period of time. This is one of the first longitudinal studies to evaluate the relationship between OCD and depression in a large clinical sample. Participants (n = 324) were treatment-seeking adults with a primary diagnosis of OCD. OCD and depression symptoms were assessed annually over the six-year follow-up period. Random intercepts cross-lagged panel models (RI-CLPM) were conducted to compare unidirectional and bidirectional models over time. The best-fitting and most parsimonious model included paths with OCD symptoms predicting depression symptoms, but not vice versa. OCD symptom severity in a given year predicted next year depression severity. However, depression severity did not predict next-year OCD symptom severity in this sample. Our results suggest that depression severity may be secondary to OCD symptoms and treating OCD should be prioritized over treating depression.

Test–retest precision and longitudinal cartilage thickness loss in the IMI-APPROACH cohort

To investigate the test-retest precision and to report the longitudinal change in cartilage thickness, the percentage of knees with progression and the predictive value of the machine-learning-estimated structural progression score (s-score) for cartilage thickness loss in the IMI-APPROACH cohort - an exploratory, 5-center, 2-year prospective follow-up cohort. Quantitative cartilage morphology at baseline and at least one follow-up visit was available for 270 of the 297 IMI-APPROACH participants (78% females, age: 66.4±7.1 years, body mass index (BMI): 28.1±5.3kg/m2, 55% with radiographic knee osteoarthritis (OA)) from 1.5T or 3T MRI. Test-retest precision (root mean square coefficient of variation) was assessed from 34 participants. To define progressor knees, smallest detectable change (SDC) thresholds were computed from 11 participants with longitudinal test-retest scans. Binary logistic regression was used to evaluate the odds of progression in femorotibial cartilage thickness (threshold:-211μm) for the quartile with the highest vs the quartile with the lowest s-scores. The test-retest precision was 69μm for the entire femorotibial joint. Over 24 months, mean cartilage thickness loss in the entire femorotibial joint reached-174μm (95% CI: [-207,-141]μm, 32.7% with progression). The s-score was not associated with 24-month progression rates by MRI (OR: 1.30, 95% CI: [0.52, 3.28]). IMI-APPROACH successfully enrolled participants with substantial cartilage thickness loss, although the machine-learning-estimated s-score was not observed to be predictive of cartilage thickness loss. IMI-APPROACH data will be used in subsequent analyses to evaluate the impact of clinical, imaging, biomechanical and biochemical biomarkers on cartilage thickness loss and to refine the machine-learning-based s-score. NCT03883568.

Menstrual Cycle Regularity and Length Across the Reproductive Lifespan and Risk of Cardiovascular Disease

Menstrual cycle characteristics may be associated with an increased risk of cardiovascular disease (CVD). However, existing studies are limited, and few have explored the mediating role of established CVD risk factors. To explore the associations of menstrual cycle characteristics across the reproductive lifespan with the risk of CVD and to what extent these associations were mediated by hypercholesterolemia, chronic hypertension, and type 2 diabetes. This cohort study prospectively followed Nurses' Health Study II participants between 1993 and 2017 who reported menstrual cycle regularity and length for ages 14 to 17 years and 18 to 22 years at enrollment in 1989 and updated current cycle characteristics in 1993 (at ages 29 to 46 years). Data analysis was performed from October 1, 2019, to January 1, 2022. Menstrual cycle regularity and length across the reproductive lifespan. Incident CVD events of interest, including fatal and nonfatal coronary heart disease (CHD; myocardial infarction [MI] or coronary revascularization) and stroke. A total of 80 630 Nurses' Health Study II participants were included in the analysis, with a mean (SD) age of 37.7 (4.6) years and body mass index of 25.1 (5.6) at baseline. Over 24 years of prospective follow-up, 1816 women developed their first CVD event. Multivariable Cox proportional hazards models showed that, compared with women reporting very regular cycles at the same ages, women who had irregular cycles or no periods at ages 14 to 17, 18 to 22, or 29 to 46 years had hazard ratios for CVD of 1.15 (95% CI, 0.99-1.34), 1.36 (95% CI, 1.06-1.75), and 1.40 (95% CI, 1.14-1.71), respectively. Similarly, compared with women reporting a cycle length of 26 to 31 days, women reporting a cycle length 40 days or more or a cycle too irregular to estimate from ages 18 to 22 or 29 to 46 years had hazard ratios for CVD of 1.44 (95% CI, 1.13-1.84) and 1.30 (95% CI, 1.09-1.57), respectively. Mediation analyses showed that subsequent development of hypercholesteremia, chronic hypertension, and type 2 diabetes only explained 5.4% to 13.5% of the observed associations. In this cohort study, both irregular and long menstrual cycles were associated with increased rates of CVD, which persisted even after accounting for subsequently established CVD risk factors.

Incident Clinical and Mortality Associations of Myocardial Native T1 in the UK Biobank

BackgroundCardiac magnetic resonance native T1-mapping provides noninvasive, quantitative, and contrast-free myocardial characterization. However, its predictive value in population cohorts has not been studied. ObjectivesThe associations of native T1 with incident events were evaluated in 42,308 UK Biobank participants over 3.17 ± 1.53 years of prospective follow-up. MethodsNative T1-mapping was performed in 1 midventricular short-axis slice using the Shortened Modified Look-Locker Inversion recovery technique (WIP780B) in 1.5-T scanners (Siemens Healthcare). Global myocardial T1 was calculated using an automated tool. Associations of T1 with: 1) prevalent risk factors (eg, diabetes, hypertension, and high cholesterol); 2) prevalent and incident diseases (eg, any cardiovascular disease [CVD], any brain disease, valvular heart disease, heart failure, nonischemic cardiomyopathies, cardiac arrhythmias, atrial fibrillation [AF], myocardial infarction, ischemic heart disease [IHD], and stroke); and 3) mortality (eg, all-cause, CVD, and IHD) were examined. Results are reported as odds ratios (ORs) or HRs per SD increment of T1 value with 95% CIs and corrected P values, from logistic and Cox proportional hazards regression models. ResultsHigher myocardial T1 was associated with greater odds of a range of prevalent conditions (eg, any CVD, brain disease, heart failure, nonischemic cardiomyopathies, AF, stroke, and diabetes). The strongest relationships were with heart failure (OR: 1.41 [95% CI: 1.26-1.57]; P = 1.60 × 10-9) and nonischemic cardiomyopathies (OR: 1.40 [95% CI: 1.16-1.66]; P = 2.42 × 10-4). Native T1 was positively associated with incident AF (HR: 1.25 [95% CI: 1.10-1.43]; P = 9.19 × 10-4), incident heart failure (HR: 1.47 [95% CI: 1.31-1.65]; P = 4.79 × 10-11), all-cause mortality (HR: 1.24 [95% CI: 1.12-1.36]; P = 1.51 × 10-5), CVD mortality (HR: 1.40 [95% CI: 1.14-1.73]; P = 0.0014), and IHD mortality (HR: 1.36 [95% CI: 1.03-1.80]; P = 0.0310). ConclusionsThis large population study demonstrates the utility of myocardial native T1-mapping for disease discrimination and outcome prediction.

Subendocardial and Transmural Myocardial Ischemia: Clinical Characteristics, Prevalence, and Outcomes With and Without Revascularization

BackgroundSubendocardial ischemia is commonly diagnosed but not quantified by imaging. ObjectivesThis study sought to define size and severity of subendocardial and transmural stress perfusion deficits, clinical associations, and outcomes. MethodsRegional rest-stress perfusion in mL/min/g, coronary flow reserve, coronary flow capacity (CFC), relative stress flow, subendocardial stress-to-rest ratio and stress subendocardial-to-subepicardial ratio as percentage of left ventricle were measured by positron emission tomography (PET) with rubidium Rb 82 and dipyridamole stress in serial 6,331 diagnostic PETs with prospective 10-year follow-up for major adverse cardiac events with and without revascularization. ResultsOf 6,331 diagnostic PETs, 1,316 (20.7%) had severely reduced CFC with 41.4% having angina or ST-segment depression (STΔ) >1 mm during hyperemic stress, increasing with size. For 5,015 PETs with no severe CFC abnormality, 402 (8%) had angina or STΔ during stress, and 82% had abnormal subendocardial perfusion with 8.7% having angina or STΔ >1 mm during dipyridamole stress. Of 947 cases with stress-induced angina or STΔ >1 mm, 945 (99.8%) had reduced transmural or subendocardial perfusion reflecting sufficient microvascular function to increase coronary blood flow and reduce intracoronary pressure, causing reduced subendocardial perfusion; only 2 (0.2%) had normal subendocardial perfusion, suggesting microvascular disease as the cause of the angina. Over 10-year follow-up (mean 5 years), severely reduced CFC associated with major adverse cardiac events of 44.4% compared to 8.8% for no severe CFC (unadjusted P < 0.00001) and mortality of 15.2% without and 6.9% with revascularization (P < 0.00002) confirmed by multivariable Cox regression modeling. For no severe CFC, mortality was 3% with and without revascularization (P = 0.90). ConclusionsReduced subendocardial perfusion on dipyridamole PET without regional stress perfusion defects is common without angina, has low risk of major adverse cardiac events, reflecting asymptomatic nonobstructive diffuse coronary artery disease, or angina without stenosis. Severely reduced CFC causes angina in fewer than one-half of cases but incurs high mortality risk that is significantly reduced after revascularization.

Cut Points of Chair Stand Test for Poor Physical Function and Its Association With Adverse Health Outcomes in Community-Dwelling Older Adults: A Cross-Sectional and Longitudinal Study.

To identify the optimal cutoff points for poor physical function [measured by a 5-times sit-to-stand (5-STS) test] associated with slowness in community-dwelling older adults and to validate the 5-STS cut points by determining whether they predicted future slowness and clinically relevant health outcomes over a 2-year-follow-up period. Cross-sectional and longitudinal analyses of a cohort study. We conducted cross-sectional (n= 2977) and prospective 2-year follow-up analyses (n= 2515) among participants aged 70-84years enrolled in the nationwide Korean Frailty and Aging Cohort Study (KFACS). Classification and regression tree (CART) analysis was used to identify the 5-STS cut points for poor performance in terms of slowness (eg, gait speed ≥1.0m/s, gait speed >0.8m/s and <1.0m/s, gait speed ≤0.8m/s) at baseline. Multinomial logistic regression models were used to evaluate the prevalence and incidence of slowness and clinical outcomes according to the three 5-STS categories (normal, intermediate, and poor) in the cross-sectional and longitudinal analyses. The overall prevalence of slowness in our study sample was 9.0% for a gait speed of ≤0.8m/s and 32.1% for a gait speed of <1.0m/s. The CART model identified 5-STS cut points of 10.8seconds and 12.8seconds for intermediate and poor physical function, respectively. In the adjusted model, the cut point of 12.8seconds had a significantly increased likelihood of incident slowness and clinically relevant health outcomes (ie, mobility limitation, disability, frailty, sarcopenia risk, and falls) over the 2-year-follow-up period (all, P < .05). Our study established 5-STS test cutoff points for poor physical function. Thresholds of 10.8 and 12.8seconds (intermediate and poor physical function, respectively) for a 5-STS test might help identify individuals at risk of physical function impairments and, thus, help design preventive interventions in community health care settings.

The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study

ObjectiveEvaluate the safety and efficacy of a novel press-fit bone-anchored prosthesis in an FDA approved study. DesignSingle-center, prospective 1-year follow-up cohort study of a percutaneous bone anchored prosthesis. SettingVeterans Health Administration Hospital. ParticipantsTen male Veterans with unilateral transfemoral amputation that occurred at least 6 months prior to enrollment and was not the result of dysvascular disease (N=10). InterventionsAll participants received the novel press-fit Percutaneous Osseointegrated Prosthesis (POP) and a minimum of 10 days supervised rehabilitation therapy. Outcome MeasuresAdverse events and radiographs were collected to assess device safety. Temporal assessments of bone density, stomal skin, prosthetic don/doff, functional ambulation, and patient-reported outcome compared our POP to a socket suspension system. ResultsTen male participants mean age 48.8±12.1 years (range, 32-68 y) with mean time since amputation of 9.4± years (range 1-18 y) completed a two-staged implantation protocol and progressed to ambulation with an assistive device by post-operative day 14. Eight of 10 completed all study procedures. One implant loosened at 5 weeks, requiring removal. A second was removed after periprosthetic fracture from a non-device-related fall at 28 weeks. One patient required oral antibiotics for superficial infection. There were significant (P<.05) increases in bone density in the lumbar spine and adjacent to the distal porous coating with no radiographic evidence of bone resorption. Compared to the socket system, the use of POP significantly (P<.05) reduced prosthetic don and doff times and patient-reported prosthetic problem scores. Significant improvements (P<.05) in mean mobility, global health, and walking test scores were also observed. ConclusionsImprovements in bone density, function, and patient reported outcomes were observed with the POP device when compared to a socket suspension system. This Early Feasibility Study established initial safety and effectiveness of the POP device, supporting expanded investigation as an alternative to socket prostheses.

Women with polycystic ovary syndrome have poorer work ability and higher disability retirement rate at midlife: a Northern Finland Birth Cohort 1966 study.

ObjectivePolycystic ovary syndrome (PCOS) presents with multiple comorbidities potentially affecting function. This was the first general population-based study to evaluate work ability, participation in working life, and disability retirement in middle-aged women with and without PCOS.DesignThis is a cohort study.MethodsWomen with PCOS (n = 280) and women without PCOS symptoms or diagnosis (n = 1573) were identified in the Northern Finland Birth Cohort in 1966 and were evaluated for self-rated work ability and potential confounders at age 46. Next, incidence rate ratios (IRRs) for disability and unemployment days were extracted from national registers during a prospective 2-year follow-up. Lastly, we assessed hazard ratios (HRs) for disability retirement between 16 and 52 years of age from national registers.ResultsThe women with PCOS reported poorer ability to work at age 46, especially due to poorer health. During the 2-year follow-up period, the affected women gained on average an additional month of disability and unemployment days, corresponding to an approximately 25% higher risk for both disability (IRR (95% CI): 1.25 (1.22–1.27)) and unemployment days (IRR (95% CI): 1.26 (1.23–1.28)) in models adjusted for health and socioeconomic factors. Lastly, we found a two-fold higher cumulative risk for disability retirement by age 52 compared to non-PCOS women (HR (95% CI): 1.98 (1.40–2.80)), which remained after adjusting for confounding factors (aHR (95% CI): 1.55 (1.01–2.38)).ConclusionsPCOS is associated with lower participation in working life already in midlife. Acknowledging PCOS-related multimorbidity, concerted efforts are needed to support sustainable careers for women with PCOS.

832-P: Five-Year Weight and Glycemic Outcomes following a Very-Low-Carbohydrate Intervention Including Nutritional Ketosis in Patients with Type 2 Diabetes

Objective: We previously reported long term effectiveness of a very low carbohydrate intervention including nutritional ketosis (VLCI) delivered via continuous remote care (CRC) for improving weight and glycemia at 2 years in people with type 2 diabetes (T2D) . We assessed 5-year changes to determine if the intervention is sustainable, durable, and effective over a longer period of time. Research Design and Methods: Patients with T2D who were initially enrolled in a 2 year non-randomized, controlled clinical trial received a CRC emphasizing a VLCI. These patients were offered to continue for an additional 3 years of prospective follow-up. Of the 200 patients completing 2 years, 169 (84.5%) patients consented to the extension and 122 (72.2%) were retained at 5 years. Among those who extended, baseline versus 5 year differences in weight and glycemic outcomes were assessed using linear mixed effects models in an intent-to-treat analysis. P-values were adjusted using Holm-Bonferroni correction. Results: At five years, there were persistent improvements in weight from 116.4 to 107.6 kg (-8.8 kg, 95%CI [-11.0, -6.6]) , fasting insulin from 25.8 to 24.5 mIU/L (-7.9 mIU/L, 95%CI [-10.0, -5.8]) , and HOMA-IR from 9.1 to 6.6 (-2.5, 95%CI [-3.5, -1.5]) (all adjusted p-values &amp;lt;0.05) . Total diabetes medications were reduced 46.6%, and 59.9% excluding metformin were deprescribed. The percent of patients prescribed diabetes medications significantly decreased at 5 years (from 85.2% to 71.3%; p&amp;lt;0.01) , including patients taking sulfonylureas (from 27.0% to 4.9%) , insulin (from 26.2% to 13.1%) , and SGLT2i (from 10.7% to 2.5%) . Despite less medication use, HbA1c improved from 7.5 to 7.2% (-0.3%, 95%CI [-0.6, 0.0], unadjusted p-value&amp;lt;0.05) . Conclusions: Over 5 years follow-up, the VLCI with CRC showed excellent retention, sustained clinically significant weight loss, and stable glycemic control with reduced dependency on antidiabetes medications. Disclosure S.J.Athinarayanan: Employee; Virta Health Corp. S.Phinney: Employee; Virta Health Corp. M.Vantieghem: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. A.L.Mckenzie: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. S.Hallberg: Advisory Panel; Atkins Nutritionals Inc., Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. C.G.P.Roberts: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. B.M.Volk: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. R.N.Adams: Employee; Virta Health Corp. R.E.Ratner: Employee; Virta Health Corp. J.Volek: Advisory Panel; Abbott Diagnostics, Simply Good Foods, Stock/Shareholder; Virta Health Corp.

1176-P: A Population Shift in Meeting Glycemic Targets Following Five Years of a Very-Low-Carbohydrate Intervention (VLCI) and Continuous Remote Care (CRC)

Background: We previously reported 1- and 2-year effectiveness of a VLCI via CRC. Here we assess the long term effectiveness of the treatment via achievement of A1c ≤6.5%, &amp;lt;7%, and &amp;lt;8% with and without antidiabetes medications at 5 years. Research Design and Methods: Patients with T2D who initially enrolled in a 2-year non-randomized, controlled clinical trial and received a VLCI via CRC were offered 3 additional years of prospective follow-up. Of the 200 patients completing 2 years, 169 (84.5%) consented to extend; 122 (72.2%) were retained at 5 years. Among those who extended, McNemar's test was used to assess the change in percent of patients meeting glycemic targets from baseline to 5 years among completers and on an intent-to-treat basis. Results: At 5 years, the percent of completing patients meeting glycemic goals improved across all defined targets (Table 1) . Of completing patients, 20% achieved diabetes remission, while 32.5% achieved an A1c &amp;lt;6.5% without the use of antidiabetes medications with the exception of metformin. Conclusions: One fifth of completing patients achieved the international consensus criteria for diabetes remission at 5 years, which is unique among lifestyle interventions. The proportion of people at A1c goal increased, suggesting the VLCI delivered via CRC may be an effective, long-term strategy to improve population health. Disclosure B.M.Volk: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. S.Hallberg: Advisory Panel; Atkins Nutritionals Inc., Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. A.L.Mckenzie: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. S.J.Athinarayanan: Employee; Virta Health Corp. M.Vantieghem: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. R.N.Adams: Employee; Virta Health Corp. C.G.P.Roberts: Employee; Virta Health Corp., Stock/Shareholder; Virta Health Corp. R.E.Ratner: Employee; Virta Health Corp. J.Volek: Advisory Panel; Abbott Diagnostics, Simply Good Foods, Stock/Shareholder; Virta Health Corp. S.Phinney: Employee; Virta Health Corp.

Cardiovascular risk factors in the elderly: a 10-year follow-up survival analysis.

Cardiovascular risk factors present a high prevalence and have an impact on the morbimortality of the elderly; however, studies evaluating the impact of cardiovascular risk factors in the elderly have had short follow-up times and have not allowed specific analyses of the effects of these factors in the aged population, including how they affect the survival of the elderly. This study aimed to analyse the survival of elderly individuals living in the community, considering the presence of cardiovascular risk factors. A prospective 10-year follow-up was initiated in 2008 with a cohort of 418 elderly people living in a community in Central Brazil. The Kaplan-Meier method and the Cox proportional hazards model were used to examine the association between survival and cardiovascular risk factors. The mean age of the participants was 70.6 (±7.1) years; most participants were hypertensive (81.6%) and participated in irregular physical activity (44%), and 43.3% smoked. After a mean follow-up of 8.38 (±2.82) years, 59.3% had survived and 34.1% had died; among the deaths, 14.1% were due to cardiovascular causes. Age [hazard ratio (HR) 1.067, 95% confidence interval (CI) 1.027-1.109], hypertension (HR 3.178, 95% CI 1.144-8.826), and smoking (HR 2.235, 95% CI 1.253-3.987) were confirmed as risk factors for reduced survival, whereas physical activity was a protective factor (HR 0.456, 95% CI 0.206-1.007). The results from this study highlight the need for educational policies towards hypertension and smoking prevention among elderly people, and participation in physical activity needs to be encouraged.

Use of funded multicenter prospective longitudinal databases to inform clinical trials in rare diseases-Examination of cholestatic liver disease in Alagille syndrome.

The conduct of long‐term conventional randomized clinical trials in rare diseases is very difficult, making evidenced‐based drug development problematic. As a result, real‐world data/evidence are being used more frequently to assess new therapeutic approaches in orphan diseases. In this investigation, inclusion and exclusion criteria from a published trial of maralixibat in Alagille syndrome (ALGS, ITCH NCT02057692) were applied to a prospective longitudinal cohort of children with cholestasis (LOGIC NCT00571272) to derive contextual comparator data for evolving clinical trials of intestinal bile acid transport inhibitors in ALGS. A natural history/clinical care cohort of 59 participants who met adapted inclusion and exclusion criteria of ITCH was identified from 252 LOGIC participants with ALGS with their native liver. Frequency weighting was used to match the age distribution of ITCH and yielded a cohort (Alagille Syndrome Natural History [ALGS NH]) that was very similar to the baseline status of ITCH participants. During a 2‐year prospective follow‐up there was a significant reduction in pruritus in the weighted ALGS NH cohort as assessed by the clinician scratch score (−1.43 [0.28] −1.99, −0.87; mean [SEM] 95% confidence interval). During the same time period, the total bilirubin, albumin, and alanine aminotransferase levels were unchanged, whereas platelet count dropped significantly (−65.2 [16.2] −98.3, −32.1). Weighted survival with native liver was 91% at 2 years in the ALGS NH. These investigations provide valuable real‐world data that can serve as contextual comparators to current clinical trials, especially those without control populations, and highlight the value and importance of funded multicenter, prospective, natural history studies.

Association Between Beta-Blocker or Statin Drug Use and the Risk of Hemorrhage From Cerebral Cavernous Malformations.

Background:We aimed to determine the association between beta-blocker or statin drug use and the future risk of symptomatic intracranial hemorrhage or persistent/progressive focal neurological deficit from cerebral cavernous malformations (CCM).Methods:The population-based Scottish Audit of Intracranial Vascular Malformations prospectively identified adults resident in Scotland first diagnosed with CCM during 1999 to 2003 or 2006 to 2010. We compared the association between beta-blocker or statin drug use after first presentation and the occurrence of new intracranial hemorrhage or persistent/progressive focal neurological deficit due to CCM for up to 15 years of prospective follow-up. We confirmed proportional hazards and used survival analysis with multivariable adjustment for age, intracranial hemorrhage at CCM presentation, and brain stem CCM location.Results:Sixty-three (21%) of 300 adults used beta-blockers (27/63 [43%] used propranolol), and 73 (24%) used statin drugs over 3634 person-years of follow-up. At baseline, the only statistically significant imbalances in prespecified potential confounders were age by statin use and intracranial hemorrhage at presentation by beta-blocker use. Beta-blocker use was associated with a lower risk of new intracranial hemorrhage or persistent/progressive focal neurological deficit (adjusted hazard ratio, 0.09 [95% CI, 0.01–0.66]; P=0.018). Statin use was associated with a nonsignificant lower risk of intracranial hemorrhage or persistent/progressive focal neurological deficit (adjusted hazard ratio, 0.37 [95% CI, 0.01–1.07]; P=0.067).Conclusions:Beta-blocker, but not statin, use was associated with a lower risk of intracranial hemorrhage or persistent/progressive focal neurological deficit in patients with CCM.

Prospective 5-year follow-up of patients with acute coronary syndrome and percutaneous coronary intervention

Background. The study of predictors that negatively affect the long-term prognosis of patients with an increased risk of coronary syndrome can improve the effectiveness of measures for the secondary prevention of cardiovascular events.&#x0D; Aim. To determine the factors that have a negative impact on 5-year survival in patients with acute coronary syndrome and percutaneous coronary intervention.&#x0D; Material and methods. 135 patients with acute coronary syndrome enrolled in the Register of percutaneous coronary interventions in 20122013 at the Tyumen Cardiology Center, a branch of the Tomsk Research Institute of Cardiology of the Russian Academy of Sciences, were included in the study. After 12 and 60 months, the clinical status of patients and ongoing drug therapy were evaluated, and an examination including echocardiography with an ultrasound scanner, daily monitoring of the electrocardiogram and standard blood pressure measuring was performed. Laboratory studies included general and biochemical blood tests. To calculate the factors associated with poor prognosis, a Cox proportional hazards regression model with stepwise inclusion was used. Survival was assessed by the KaplanMeier method using the Log-rank test (logarithmic test).&#x0D; Results. After 1 year, only three-quarters of patients continued the recommended drug therapy, a similar trend continued after 5 years of follow-up. The number of patients without any antiplatelet therapy increased from 19.9% after 12 months to 29.7% after 60 months. Overall survival after 1 year was 97.1%, after 5 years 86.7%. The risk of death increased in the presence of chronic kidney disease (risk ratio 15.1; 95% confidence interval 4.3052.93; p=0.001); type 2 diabetes mellitus (risk ratio 3.67; 95% confidence interval 1.1811.43; p=0.025), history of stroke (risk ratio 9.07; 95% confidence interval 1.8544.60; p=0.007), in patients with a heart rate 80 beats per minute [risk ratio 4.3; (95% confidence interval 1.5112.26; p=0.006) and at pulse pressure 60 mm Hg (risk ratio 4.68; 95% confidence interval 1.6013.72; p=0.005)].&#x0D; Conclusion. The predictors that influenced the 5-year survival of patients after acute coronary syndrome and percutaneous coronary intervention were chronic kidney disease, diabetes mellitus, a history of stroke, high pulse pressure, and increased heart rate of more than 80 beats per minute.

No VTE Recurrence After 1-Year Follow-Up of Hospitalized Patients With COVID-19 and a VTE Event: A Prospective Study

No VTE Recurrence After 1-Year Follow-Up of Hospitalized Patients With COVID-19 and a VTE Event: A Prospective Study

Prediction of gastric cancer development based on mucosal atrophy and enlarged folds of the stomach, diagnosed by double-contrast upper gastrointestinal barium X-ray radiography: a prospective 10-year follow-up of 6,433 generally healthy subjects

Prediction of gastric cancer development based on mucosal atrophy and enlarged folds of the stomach, diagnosed by double-contrast upper gastrointestinal barium X-ray radiography: a prospective 10-year follow-up of 6,433 generally healthy subjects

Dual-Mobility Progressive Press-Fit Hemispherical Acetabular Cup in Primary Hip Arthroplasty: Safety and Efficacy. The SYMCOR-1 study [NCT04209374

Purpose: To Estimate the short-term clinical safety and efficacy of hemispherical with flattened pole chromium-cobalt metal back dual-mobility acetabular cup with porous outer coating (HFPC-DM-HA), in primary THA. Methods: Single-center retrospective observational cohort study of consecutive patients undergoing THA with a HFPC-DMHA cup 2 years prior to study start. Prospective 2-year follow-up with letter and phone questionnaires. Results: Sampling frame: 361 patients including 59 patients (16.3%) in the cohort. 6 patients (10%) lost to follow-up. Median age 77.5 years (67, 92), 32% female, median BMI 25.2 kg.m-2 (18.4 to 56.8). Primary osteoarthritis in 80%. Median follow-up 3.0 years (2.7 to 4.1) Primary Endpoint: 2-year implant survival rate: 97% [87, 99]. Prosthetic dislocation: 0%. Secondary Endpoint: Modified HHS (pain &amp; functional sub score) improved from baseline 39.7 [34.6, 44.7] to 75.8 [72.1, 79.6] at 1-year and to 86.7 [83.7, 89.7] at 2-year (p&lt;0.0001). Conclusions: The short-term benefit-risk balance was deemed satisfactory