Completed 1-year Follow-up Research Articles

Recreational drugs use as prognostic factor of major adverse cardiovascular and cerebrovascular events in patients hospitalised for acute cardiovascular events

Abstract Background Among patients admitted to the intensive cardiac care unit (ICCU), systematic screening for recreational drugs evidenced a significant prevalence of recent use and was associated with a higher rate in-hospital outcomes. However, long-term cardiovascular consequences of recreational drug use remain uncertain. Purpose We aimed to evaluate the prognostic impact of recreational drugs use at 1-year follow-up to predict major adverse cardiovascular and cerebrovascular events (MACCE) in consecutive patients admitted to ICCUs for acute cardiovascular events from the Addiction in Intensive Cardiac Care Units (ADDICT-ICCU) study. Methods In this prospective multicentric study, all consecutive patients admitted to ICCUs over two weeks in April 2021 at 39 centres across France were included. Screening for recreational drugs use was performed by systematic urinary testing. One-year follow-up consisted of a clinical visit or direct contact with the patient and the referring cardiologist. The primary composite outcome was the occurrence of one of the combined MACCE defined as cardiovascular death, nonfatal myocardial infarction (MI) or stroke. Subgroup analysis was performed in patients hospitalised at baseline for acute coronary syndrome. Results Of the 1499 consecutive patients screened, 1392 (93%) patients (63±15 years, 70% males) had a complete 1-year follow-up. Among them, 157 (11%) had an initial positive test for recreational drug use (cannabis, opioids, cocaine, amphetamines, 3,4-methylenedioxymethamphetamine [MDMA]). After 1-year of follow, 94 (7%) patients experimented MACCE. Patients with positive testing exhibited a higher rate of MACCE than non-users (13% vs 6%, respectively, p=0.002). After adjustment for traditional prognosticators, recreational drug use was independently associated with the occurrence of MACCE (HR=2.99; 95% CI: 1.73-5.16, p<0.001). In the subgroup analysis of 713 patients hospitalised at baseline for acute coronary syndrome, 96 (14%) had a positive recreational drug test and 50 (7%) experienced MACCE. Using a multivariable Cox analysis in this population, recreational drug use was still independently associated with MACCE after adjustment for traditional prognosticators (HR=2.98; 95% CI: 1.43-6.21, p=0.004). Conclusions In a large cohort of consecutive patients admitted to ICCUs for acute cardiovascular events, the prevalence of recreational drug use was 11%. Recreational drug use was strongly associated with the occurrence of 1-year MACCE even after adjustment for traditional prognosticators.Central illustrationPrognostic impact of drug use

Impact of dapagliflozin on supraventricular and ventricular arrhythmias, assessed by Holter ECG, in patients with heart failure with reduced ejection fraction

Abstract Background & Introduction Dapagliflozin has significantly reduced morbidity & mortality in patients with heart failure with reduced ejection fraction (HFrEF) (1). Some studies reported supraventricular & ventricular arrhythmia suppression, but Holter ECG was underused, hindering precise assessment of arrhythmia burden. Purpose We aim to assess the impact of dapagliflozin on reduction of arrhythmia in HFrEF at 1 year follow-up (FU) by Holter ECG. Methods This is a single center, prospective study. We have screened 219 HFrEF patients, but only 156 patients were enrolled with LVEF <40% in sinus rhythm from December 2021 to July 2023. All patients had dapagliflozin 10 mg once/day tablet with the standard HF therapy. Clinical evaluation, NYHA evaluation, 6-minute walking test (6MWT), echocardiogram, 24-hours Holter ECG and laboratory work-up were done at baseline, and FU at 6 months and 12 months. Results Males constituted 61.5% of study population; mean± SD participants’ age was 56.8 ± 8.6 years. The most common comorbidities were: ischemic etiology (63.3%), dilated cardiomyopathy (28.1%), hypertension (27.3%), smokers (14.7%), and type II diabetes (31.4%). LVEF was ≤ 35% in 85.9% of patients. We have reported (7.69%) deaths during 1-year FU, and 4 patients (2.56%) didn't complete 1-year FU. Main clinical and echocardiographic findings (baseline vs. 1-year FU): NYHA FC III& ambulant IV dropped from (42.9 to 32.9%), P value<0.05. Distance walked in 6MWT improved from 191.52 ± 75.37 to 219.35 ± 71.51 mean± SD meters, P value<0.05. E/e improved (9.4 to 8.3 cm/s, P value <0.01), LVEF improved (31.3 to 36.4%, P value<0.05). HF emergency: [HF visits dropped (23.7 to 19.2%) and HF hospitalization dropped (11.1 to 7.8%)], P value<0.05. Holter ECG (baseline vs. 1-year FU): Supraventricular Arrhythmia: [Paroxysmal AF reduced (56.2 to 47.6%), frequent PACs (≥ 10%) dropped (3.8 to 1.4%) & Intermittent 1st degree heart block dropped (12.5 to 7.3%)] P value <0.01. Ventricular Arrhythmia: [PVCs >5%-<10% dropped (16% to 9.3%), Frequent PVCs >10% dropped (3.2 to 1.4%), and NSVT dropped (7.8 to 3.1%)], P value <0.01. Stepwise logistic regression multivariable model aiming to predict the occurrence of ventricular and supraventricular arrhythmias has indicated a direct linear correlation with male gender, smoking, body mass index, left atrial volume, and a history of myocardial infarction. Conversely, there is an inverse relationship with systolic blood pressure, 6MWT distance, LVEF, and the administration of dapagliflozin (OR 0.72 [0.61 - 1.07], P value <0.01) concerning the likelihood of supraventricular and ventricular arrhythmias. Conclusions Dapagliflozin has demonstrated significant improvement in functional and echocardiographic parameters in HFrEF patients. Furthermore, it has effectively decreased the incidence of supraventricular and ventricular arrhythmias, identified through 24-hour Holter ECG monitoring during 1-year follow-up.

Improved uptake and adherence to risk reducing medication with use of low dose Tamoxifen in patients at high risk for breast cancer.

Women at increased risk for breast cancer (BC) may benefit from taking risk reducing medication (RRM) with tamoxifen (tam). Historical uptake to tam for women who qualify has been low. Recent studies have shown low dose tam to have similar efficacy to standard dosing lower risk for adverse events. Herein, we aimed to evaluate uptake, adherence, and tolerability of low dose tam in women at increased risk for BC and those with DCIS. In this two-site prospective study, women who qualified for BC RRM were offered participation and received consultation with a breast specialist for discussion of RRM rationale, benefits, side effects, and risks. Patients received baseline and 1 year follow-up surveys. 41 patients consented for participation and 31 completed 1-year follow-up. After initial consultation, 90% (n=37) reported good/complete understanding of BC risk. Of patients included in 1 year follow-up, 5 had DCIS, 13 had high-risk intraepithelial lesion, and 13 qualified based on BCRAT/IBIS calculation. 74% (n= 23) of patients reported they took low dose tam after consultation with 78.2% (n=18) of those still taking medication at 1 year. Patients who continued medication had higher estimated BC risk compared to those who discontinued (IBIS 10-yr risk 12.7% vs 7.6%, p = 0.027). All patients with DCIS initiated low dose tam and only 1 patient with DCIS had discontinued at 1 year. Uptake to low dose tam after informed discussion is high. Adherence and tolerability at 1 year follow-up is improved compared with traditional dosing of tam.

Preoperative Osteoporosis Is Associated With Increased Health Care Utilization and Compromised Pain and Function Improvement After Primary Total Hip Arthroplasty: A Prospective Cohort Analysis

BackgroundOsteoporosis (OP) has been linked to complications after total hip arthroplasty (THA), but its impact on health care utilization and patient-reported outcomes remains unclear. This study aimed to evaluate the association between: 1) pre-THA OP and health care utilization as well as patient-reported pain and function outcome measures; and 2) dual energy X-ray absorptiometry (DEXA) scan-based T-scores and the aforementioned outcomes. MethodsA retrospective analysis of prospectively collected data of primary THA (2015 to 2018) was performed (n = 5,321) from a validated academic institutional database of a large North American tertiary health care system; of which 4,074 (76.6%) completed 1-year follow-up. Outcomes included prolonged length of stay [LOS] > three days, discharge disposition, 90-day readmission, and 1-year reoperation, as well as Hip Disability and Osteoarthritis Outcome Score (HOOS]) Pain, HOOS-function (PS), and minimal clinically important difference thresholds (MCID), and satisfaction. ResultsThe prevalence of OP pre-THA was 56.9%, of which 39.8% were not prescribed OP medications and 15.3% had a DEXA scan. Compared to those who did not have OP, those who had OP were independently associated with higher odds of prolonged LOS, nonhome discharge, 90-day readmission, and 1-year reoperation (P < 0.005). Furthermore, they had significantly higher odds of failing to achieve MCID (odds ratio: 1.41 (95% confidence interval: 1.06 to 1.89)) for HOOS-PS and satisfaction (odds ratio: 1.5 (95% confidence interval: 1.16 to 1.93)) at one year. Higher T-scores were associated with lower odds of prolonged LOS, nonhome discharge, failure to achieve MCID in HOOS-Pain, and HOOS-PS. ConclusionsOver half of patients had OP; however, only 15.3% of patients had a DEXA scan before THA. Patients who had OP were at higher risk of prolonged LOS, nonhome discharge, 90-day readmission, and 1-year reoperation in addition to poor pain/function improvement and dissatisfaction one year after THA.

Clinical and Radiological Outcomes After Isolated Double-Bundle Medial Patellofemoral Ligament Reconstruction: A 5-Year Analysis.

There are few studies that have examined clinical and radiological outcomes at 5 years after isolated medial patellofemoral ligament (MPFL) reconstruction. To date, midterm outcomes after isolated double-bundle (DB) MPFL reconstruction are not well known. Isolated DB MPFL reconstruction using a patellar suture anchor technique would lead to improved functional scores and radiological findings, and these improvements would remain stable over the 5-year postoperative period. Case series; Level of evidence, 4. Isolated MPFL reconstruction was performed in patients with recurrent patellar instability between March 2013 and February 2017. Clinical and functional evaluations were performed via an interview using the Kujala, Lysholm, and Tegner scores preoperatively and at 6, 12, 24, and 60 months postoperatively. Radiographs were taken preoperatively, immediately postoperatively, and at 24 and 60 months after surgery. Radiographic assessments included measuring the modified Insall-Salvati ratio, congruence angle, and lateral patellofemoral angle. A total of 31 patients (31 knees) underwent isolated MPFL reconstruction; 4 patients did not complete 5-year follow-up, and thus, 27 patients (27 knees) were enrolled in the study. The mean age at the time of surgery was 22.0 ± 6.4 years (range, 14-32 years). All clinical and functional scores significantly improved in the first 2 years (P < .001), with the mean Kujala, Lysholm, and Tegner scores improving from 52.7 to 90.7, 49.6 to 92.7, and 2.9 to 5.1, respectively. There was no significant difference in scores between 2- and 5-year follow-up. All radiographic parameters significantly improved between preoperatively and immediately postoperatively (P < .001), with mean values for the modified Insall-Salvati ratio, congruence angle, and lateral patellofemoral angle improving from 1.7° to 1.6°, 5.7° to -6.6°, and 3.0° to 5.9°, respectively. No significant differences were observed in radiographic measurements between the postoperative time points. No patients experienced a patellar redislocation or fracture. The prospective analysis of isolated DB MPFL reconstruction at 5-year follow-up showed that clinical and radiological outcomes significantly improved postoperatively and were maintained to 5 years. These midterm results suggest that isolated DB MPFL reconstruction is an effective treatment option for patients with patellar instability.

Radiofrequency catheter ablation of persistent atrial fibrillation by pulmonary vein isolation with or without left atrial posterior wall isolation: long-term outcomes of the CAPLA trial.

Posterior wall isolation (PWI) is commonly incorporated into catheter ablation (CA) strategies for persistent atrial fibrillation (AF) in an attempt to improve outcomes. In the CAPLA randomized study, adjunctive PWI did not improve freedom from atrial arrhythmia at 12 months compared with pulmonary vein isolation (PVI) alone. Whether additional PWI reduces arrhythmia recurrence over the longer term remains unknown. In this multicenter, international, randomized study patients with persistent AF undergoing index CA using radiofrequency (RF) were randomized to PVI+PWI versus PVI alone. Patients underwent regular follow-up including rhythm monitoring for a minimum of 3 years post CA. AF burden at 3 years post-ablation was evaluated with either 28-day continuous ambulatory ECG monitoring, twice daily single-lead ECG or from cardiac implanted device. Evaluated endpoints included freedom from any documented atrial arrhythmia recurrence after a single procedure, AF burden, need for redo catheter ablation, rhythm at last clinical follow-up, healthcare utilisation metrics and AF-related quality of life. 333 of 338 (98.5%) patients (mean age 64.3±9.4 years, 23% female) completed 3-year follow-up, with 169 patients randomized to PVI+PWI and 164 patients to PVI alone. At a median of 3.62 years post-index ablation, freedom from recurrent atrial arrhythmia occurred in 59 patients (35.5%) randomized to PVI+PWI vs 68 patients (42.1%) randomized to PVI alone (HR 1.15, 95% CI 0.88-1.51, p=0.55). Median time to recurrent atrial arrhythmia was 0.53 years (IQR 0.34-1.01 years). Redo ablation was performed in 54 patients (32.0%) in the PVI+PWI group vs 49 patients (29.9%, p=0.68) in the PVI alone group. Pulmonary vein reconnection was present in 54.5% (mean number of reconnected PVs 2.2±0.9) and posterior wall reconnection in 75%. Median AF burden at 3 years was 0% in both groups (IQR 0-0.85% PVI+PWI vs 0-1.43% PVI alone, p=0.49). Sinus rhythm at final clinical follow-up was present in 85.1% with PVI+PWI vs 87.1% with PVI alone (p=0.60). Mean AF Effect On Quality-Of-Life (AFEQT) score at 3 years post-ablation was 88.0±14.8 with PVI+PWI vs 88.9±15.4 with PVI alone (p=0.63). In patients with persistent AF, the addition of PWI to PVI alone at index RF catheter ablation did not significantly improve freedom from atrial arrhythmia recurrence at long-term follow-up. Median AF burden remains low and AF quality of life high at 3 years with either ablation strategy.

Development, Progression, and Mortality of Suspected Interstitial Lung Disease in COPDGene.

Some with interstitial lung abnormalities (ILA) have suspected interstitial lung disease (ILD), a subgroup with adverse outcomes. Rates of development and progression of suspected ILD and their effect on mortality are unknown. To determine rates of development and progression of suspected ILD and assess effects of individual ILD and progression criteria on mortality. Participants from COPDGene were included. ILD was defined as ILA and fibrosis and/or FVC <80% predicted. Prevalent ILD was assessed at enrollment, incident ILD and progression at 5-year follow-up. CT progression was assessed visually and FVC decline as relative change. Multivariable Cox regression tested associations between mortality and ILD groups. Of 9,588 participants at enrollment, 267 (2.8%) had prevalent ILD. Those with prevalent ILD had 52% mortality after median 10.6 years, which was higher than ILA (33%; HR=2.0; p<0.001). The subgroup of prevalent ILD with fibrosis only had worse mortality (59%) than ILA (HR=2.2; p<0.001). 97 participants with prevalent ILD completed 5-year follow-up: 32% had stable CT and relative FVC decline <10%, 6% FVC decline ≥10% only, 39% CT progression only, and 22% both CT progression and FVC decline ≥10%. Mortality rates were 32%, 50%, 45%, and 46% respectively; those with CT progression only had worse mortality than ILA (HR=2.6; p=0.005). At 5-year follow-up, incident ILD occurred in 168/4,843 participants without prevalent ILD and had worse mortality than ILA (HR=2.5; p<0.001). Rates of mortality and progression are high among those with suspected ILD in COPDGene; fibrosis and radiologic progression are important predictors of mortality.

Medial-pivot design does not provide superior clinical results compared to posterior-stabilized total knee arthroplasty despite kinematic differences during step-up and lunge activities: A prospective randomized controlled trial under medial tight soft tissue balance.

This study aimed to compare in vivo kinematics during weight-bearing daily activities and determine the relationship with clinical outcomes in patients undergoing total knee arthroplasty (TKA) with a medial-pivot (MP, Evolution™) versus a posterior-stabilized (PS, Persona®) design under constant conditions of intraoperative soft tissue balance. Forty patients undergoing MP or PS-TKA under similar conditions of soft tissue balance were enrolled in this prospective randomized controlled trial. Outcome measures included clinical knee society scores (KSS) and knee injury and osteoarthritis outcome scores (KOOS). A kinematic assessment was conducted while the participants performed lunge and step-up activities under fluoroscopic guidance. Eighteen patients in each arm completed 1-year follow-up and were included in the analysis. All patients experienced pain relief and satisfactory knee function postoperatively. In kinematics, in the MP arm, the medial femoral condyle remained consistent, whereas the lateral femoral condyle gradually shifted posteriorly with increasing knee flexion. Conversely, in the PS arm, paradoxical anterior movement of the medial femoral condyle accompanied the lateral pivot motion. During lunge and step-up activities, a medial-pivot motion was observed in 83% and 72% of knees in the MP arm, respectively, compared with 22% and 11% in the PS arm. Despite these differences in kinematics, there were no statistically significant differences in the KSS and KOOS between the two groups. Under weight-bearing conditions during flexion, knees that underwent Evolution™ MP-TKA did not show superior clinical results compared to Persona® PS-TKA, despite exhibiting in vivo kinematics closely resembling the normal in vivo pattern. Therapeutic studies-Level I.

Nonoperative Versus Operative Treatment of Z-Type Comminuted Clavicle Fractures in Adolescents: A Prospective Substratified Cohort Analysis.

To compare the clinical, radiographic, and patient-reported outcomes of nonoperative and operative treatment of adolescents with comminuted "Z-type" midshaft clavicle fractures. Prospective observational cohort. Eight tertiary care pediatric centers. Patients aged 10-18 years who were treated either operatively or nonoperatively for a diaphyseal clavicle fracture between 2013 and 2017 were screened/enrolled at the time of injury. The current subcohort analysis was derived from a larger adolescent clavicle study population of 907 patients. Complications and validated patient-reported outcome measures (PROs):(ASES, QuickDASH, Marx Shoulder Activity Score, EQ-5D, EQ-VAS, and patient satisfaction score) were compared between operative and nonoperative cohorts. Eighty-one patients (69 male [85.2%], 12 female; average age 15 years [11.1-18.7]; 78 with sports participation [96.2%]) were followed through bony healing and return to sports, while 59 patients (73%) completed 2-year follow-up with PROs, 26 of whom were treated nonoperatively and 33 treated operatively. All demographic and fracture characteristics were similar (P > 0.05) between the 2-year follow-up cohorts except for fracture shortening, which was greater in the operative cohort (23 vs. 29 mm, P = 0.01). After controlling for this potential confounder through both regression and propensity matched subgroup analysis, nonoperative versus operative cohorts showed no difference in rates of nonunion (0%), delayed union (0% vs. 2.3%, P = 1.0), symptomatic malunion (2.7% vs. 0%, P = 0.4), refracture (2.7% vs. 2.2%, P = 1.0), unexpected subsequent surgery (5.4% vs. 11.4%, P = 0.45), or clinically significant complications (5.4% vs. 16%, P = 0.17). There were no differences in any PROs between cohorts, both before and after controlling for the difference in fracture shortening (all P-values >0.05). In this prospective comparison of complications and 2-year PROs in adolescents with comminuted Z-type clavicle fractures, nonoperative and operative treatment yielded similar outcomes. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Symptom subtype progression in obstructive sleep apnea over 5 years.

There is limited knowledge regarding the progression or consistency of symptoms in OSA over time. Our objective was to examine the changes in symptom subtypes and identify predictors over a span of 5 years. Data of 2,643 participants of the Sleep Heart Health Study with complete baseline and 5-year follow-up visits were analyzed. Latent Class Analysis on 14 symptoms at baseline and follow-up determined symptom subtypes. Individuals without OSA (AHI<5) were incorporated as a known class at each time point. Multinomial logistic regression assessed the effect of age, sex, body mass index (BMI) and AHI on specific class transitions. The sample consisted of 1,408 women (53.8%) and mean (SD) age 62.4 (10.5) years. We identified four OSA symptom subtypes at both baseline and follow-up visits: minimally symptomatic, disturbed sleep, moderately sleepy, and excessively sleepy. Nearly half (44.2%) of the sample transitioned to a different subtype; transitions to moderately sleepy were the most common (77% of all transitions). A five-year older age was associated with a 50% increase in odds to transit from excessively sleepy to moderately sleepy [OR (95% CI: 1.52 (1.17, 1.97)]. Women had 1.97 times higher odds (95% CI: 1.21, 3.18) to transition from moderately sleepy to minimal symptoms. A 5-unit increase in BMI was associated with 2.39 greater odds (95% CI: 1.30, 4.40) to transition from minimal symptoms to excessively sleepy. Changes in AHI did not significantly predict any transitions. The symptoms of OSA may fluctuate or remain stable over time. Knowledge of symptom progression in OSA may support clinicians with treatment decisions.

Coronary Artery Plaque Phenotype and 5-Year Clinical Outcomes in Older Patients with Non-ST Elevation Acute Coronary Syndrome.

Lesions with thin-cap fibroatheroma (TCFA), small luminal area and large plaque burden (PB) have been considered at high risk of cardiovascular events. Older patients were not represented in studies which demonstrated correlation between clinical outcome and plaque characteristics. This study aims to investigate the prognostic role of high-risk plaque characteristics and long-term outcome in older patients presenting with non-ST elevation acute coronary syndrome (NSTEACS). This study recruited older patients aged 75 years with NSTEACS undergoing virtual-histology intravascular ultrasound (VH-IVUS) imaging from the Improve Clinical Outcomes in high-risk patieNts with acute coronary syndrome (ICON-1). Primary endpoint was the composite of major adverse cardiovascular events (MACE) consisting of all-cause mortality, myocardial infarction (MI), and any revascularisation. Every component of MACE and target vessel failure (TVF) including MI and any revascularisation were considered as secondary endpoints. Eighty-six patients with 225 vessels undergoing VH-IVUS at baseline completed 5-year clinical follow-up. Patients with minimal lumen area (MLA) 4 demonstrated increased risk of MACE (hazard ratio [HR] 2.37, 95% confidence interval [CI] 1.00-5.59, p = 0.048) with a worse event-free survival (Log Rank 4.17, p = 0.041) than patients with MLA 4 . Patients with combination of TCFA, MLA 4 and PB 70% showed high risk of MI (HR 5.23, 95% CI 1.05-25.9, p = 0.043). Lesions with MLA 4 had 6-fold risk of TVF (HR 6.16, 95% CI 1.24-30.5, p = 0.026). Small luminal area appears as the major prognostic factor in older patients with NSTEACS at long-term follow-up. Combination of TCFA, MLA 4 and PB 70% was associated with high risk of MI. NCT01933581.

Cognitive impairment and treatment strategy for atrial fibrillation in older adults: The SAGE-AF study.

Cognitive impairment is strongly associated with atrial fibrillation (AF). Rate and rhythm control are the two treatment strategies for AF and the effect of treatment strategy on risk of cognitive decline and frailty is not well established. We sought to determine how treatment strategy affects geriatric-centered outcomes. The Systematic Assessment of Geriatric Elements-AF (SAGE-AF) was a prospective, observational, cohort study. Older adults with AF were prospectively enrolled between 2016 and 2018 and followed longitudinally for 2 years. In a non-randomized fashion, participants were grouped by rate or rhythm control treatment strategy based on clinical treatment at enrollment. Baseline characteristics were compared. Longitudinal binary mixed models were used to compare treatment strategy with respect to change in cognitive function and frailty status. Cognitive function and frailty status were assessed with the Montreal Cognitive Assessment Battery and Fried frailty phenotype tools. 972 participants (mean age = 75, SD = 6.8; 49% female, 87% non-Hispanic white) completed baseline examination and 2-year follow-up. 408 (42%) were treated with rate control and 564 (58%) with rhythm control. The patient characteristics of the two groups were different at baseline. Participants in the rate control group were older, more likely to have persistent AF, prior stroke, be treated with warfarin and have baseline cognitive impairment. After adjusting for baseline differences, participants treated with rate control were 1.5 times more likely to be cognitively impaired over 2 years (adjusted OR: 1.47, 95% CI:1.12, 1.98) and had a greater decline in cognitive function (adjusted estimate: -0.59 (0.23), p < 0.01) in comparison to rhythm control. Frailty did not vary between the treatment strategies. Among those who had 2-year follow-up in non-randomized observational cohort, the decision to rate control AF in older adults was associated with increased odds of decline in cognitive function but not frailty.

"WISER" intervention to reduce healthcare worker burnout - 1 year follow up.

Test sustainability of Web-based Implementation for the Science of Enhancing Resilience (WISER) intervention efficacy in reducing healthcare worker (HCW) emotional exhaustion (EE), a key component of burnout. One-year follow-up of WISER RCT using two cohorts (one waitlist control with shortened intervention period) of HCWs of four NICUs each, to improve HCW well-being (primary outcome: EE). In Cohorts 1 and 2, 194 and 312 WISER initiators were identified by 1-year, and 99 and 80 completed 1-year follow-up, respectively. Combined cohort results showed that relative to baseline, at 1-year WISER decreased EE (-7.07 (95%CI: -10.22, -3.92), p < 0.001), depression (-4.49 (-6.81, -2.16), p = <0.001), and improved work-life integration (6.08 (4.25, 7.90), p = <0.001). EE continued to decline between 6-month and 1-year follow-up (p = 0.022). The percentage of HCWs reporting concerning outcomes was significantly decreased for EE (-10.9% (95%CI: -17.9%, -4.9%); p < 0.001), and secondary outcomes depression and work-life integration. WISER improves HCW well-being for at least 1 year. NCT02603133; https://clinicaltrials.gov/ct2/show/NCT02603133.

Low-dose warfarin with a novel mechanical aortic valve: Interim registry results at 5-year follow-up

ObjectivesTo evaluate whether warfarin targeted at an international normalized ratio of 1.8 (range, 1.5-2.0) after On-X mechanical aortic valve implant is safe for all patients. MethodsThis prospective, observational clinical registry assessed adverse event rates in adult patients receiving low-dose warfarin (target international normalized ratio, 1.8; range, 1.5-2.0) plus daily aspirin (75-100 mg) during a 5-year period after On-X aortic valve implant. The primary end point is the combined rate of major bleeding, valve thrombosis, and thromboembolism overall and in 4 subgroups. The comparator is the Prospective Randomized On-X Anticoagulation Trial control group patients on standard-dose warfarin (international normalized ratio, 2.0-3.0) plus aspirin 81 milligrams daily. ResultsA total of 510 patients were recruited at 23 centers in the United States, United Kingdom, and Canada between November 2015 and January 2022. This interim analysis includes 229 patients scheduled to complete 5-year follow-up by August 16, 2023. The linearized occurrence rate (in percent per patient-year) of the primary composite end point of major bleeding, valve thrombosis, and thromboembolism is 1.83% compared with 5.39% (95% confidence interval, 4.12%-6.93%) in the comparator group. Results are consistent in clinic-monitored and home-monitored patients and in those at high risk for thromboembolism. Major bleeding and total bleeding were reduced by 87% and 71%, respectively, versus the comparator group, without an increase in thromboembolic events. ConclusionsInterim results support the continued safety of the On-X aortic mechanical valve with a target international normalized ratio of 1.8 plus low-dose aspirin through 5 years after implant, with or without home monitoring.

Five percent weight loss is a significant 1-year predictor and an optimal 5-year cut-off for reducing the number of obesity-related cardiovascular disease risk components: the Japan Obesity and Metabolic Syndrome Study.

This study aimed to identify the amount of weight loss needed in patients with obesity to improve metabolic syndrome (MetS), a risk factor for cardiovascular disease (CVD), over a long period of time. A total of 576 patients with obesity were enrolled in this study. Effects of continuous physician-supervised weight loss on the cumulative MetS components excluding abdominal circumference (defined as obesity-related CVD risk score) were investigated during a 5-year follow-up period. The extent of weight loss required to reduce the obesity-related CVD risk components was assessed using receiver operating characteristic (ROC) curve analyses. Of the 576 participants, 266 completed 5-year follow-up, with 39.1% and 24.1% of them achieving ≥5.0% and ≥7.5% weight loss at the 5-year follow-up, respectively. The area under the ROC curve for reducing the obesity-related CVD risk components was 0.719 [0.662-0.777] at 1 year and 0.694 [0.613-0.775] at 5 years. The optimal cut-off value for weight loss was 5.0% (0.66 sensitivity and 0.69 specificity) and the value with 0.80 specificity was 7.5% (0.45 sensitivity) at 5 years. Greater reductions in weight were associated with greater improvements in the obesity-related CVD risk score at all follow-up periods (P-trend <0.001). Obesity-related CVD risk score was significantly improved by 5.0-7.5% and ≥7.5% weight loss at 1 year (P = 0.029 and P < 0.001, respectively) and ≥7.5% weight loss at 5 years (P = 0.034). A weight loss of ≥5.0% at 1 year and ≥7.5% at 5 years could reduce the number of obesity-related CVD risk components in patients with obesity.

Abstract P475: Adherence to the EAT-Lancet Planetary Health Diet and Cardiometabolic Risk Markers in the Mediators of Atherosclerosis in South Asians Living in America (MASALA) Study

Introduction: Poor diet is among the top risk factors for cardiometabolic disease, which disproportionately burdens South Asians. In 2019, the EAT-Lancet Commission proposed a Planetary Health Diet (PHD) designed to optimize human and global environmental health. Objective: We examined associations between a novel Planetary Health Diet Index (PHDI), that reflects adherence to the EAT-Lancet recommendations, and cardiometabolic risk in a prospective cohort of South Asians in the US. Methods: We included participants from the MASALA study with complete baseline (n=891) and 5-year follow-up (n=735) examinations. The PHDI was comprised of 15 food components with scoring based on the ranges prescribed by the EAT-Lancet commission for a total score range of 0–140. Higher scores indicate greater adherence to the PHDI. We used multivariable linear and logistic regression models to examine cross-sectional and prospective (5-years) associations between baseline PHDI and measures of glycemia, blood lipids, inflammation, and adiposity, adjusting for demographic, health, lifestyle, and baseline value of biomarker (for prospective models). Logistic regression was used to examine association between baseline PHDI and incident type 2 diabetes (among n=661 participants free from diabetes at baseline) Results: Among MASALA study participants (49% female, mean age 57 y), the mean PHDI score was 88.8 (SD 9.47). At baseline, each 10 unit increase in PHDI scores were associated with (β ± SE) lower fasting glucose (-0.5±0.24 mmol/L), HbA1c (-0.49±0.22%), LDL cholesterol (-0.015±0.007 mmol/L), CRP (-5.87±2.35 mg/L), higher adiponectin (4.71 ±2.01 mg/dL), lower body weight (-0.59 ±0.26 kg), BMI (-0.27±0.11 kg/m 2 ), waist circumference (-0.82±0.29 cm), visceral fat (-3.22±1.32 cm 2 ), and pericardial fat (-0.92±0.43 cm 3 ) ( p &lt;0.05 for all). Higher PHDI scores were associated lower odds of obesity [OR (95% CI): 0.80 (0.71-0.92] and overweight [0.77 (0.74-0.85)]. Prospectively, higher PHDI scores were associated with lower fasting glucose (-0.28 ± 0.14 mmol/L), lower HbA1c (-0.08±0.03%), higher HDL (0.38±0.17 mmol/L), lower body weight (-0.37±0.12 kg), BMI (-0.08±0.03 kg/m 2 ), waist circumference (-0.49±0.17 cm), and systolic blood pressure (-0.65 ± 0.30 mmHg) ( p &lt;0.05 for all). Each 10-unit higher PHDI was associated with a 20% lower risk of incident diabetes [OR (95%CI): 0.80 (0.54-0.86)]. Conclusions: In the MASALA study, we found that greater adherence to the PHDI was associated with better cardiometabolic risk factors and lower risk of incident type 2 diabetes. These observations support the planetary health diet as a feasible strategy to address planetary health while optimizing human health outcomes.

Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis

Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States. To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention. AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023. Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon. The primary end point of 1-year target lesion failure-defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death-was tested for superiority. Among 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P = .003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P = .001) and target vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P = .02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P = .38) in the coated vs uncoated balloon groups, respectively. Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis. ClinicalTrials.gov Identifier: NCT04647253.

Application of restorative neurostimulation for chronic mechanical low back pain in an older population with 2-year follow up

IntroductionData on the Medicare-aged population show that older patients are major consumers of low back pain (LBP) interventions. An effective approach for patients with mechanical LBP that has been refractory...

A prospective study of lumbar facet arthroplasty in the treatment of degenerative spondylolisthesis and stenosis: cost-effective assessment from the Total Posterior Spine system (TOPSTM) IDE Study: 2-year model revision and sensitivity analyses based on 305 subjects

BACKGROUND CONTEXTA previous cost-effectiveness analysis published in 2022 found that the Total Posterior Spine (TOPSTM) system was dominant over transforaminal lumbar interbody fusion (TLIF). This analysis required updating to reflect a more complete dataset and pricing considerations. PURPOSETo evaluate the cost-effectiveness of TOPSTM system as compared with TLIF based on an updated and complete FDA investigational device exemption (IDE) data set. STUDY DESIGN/SETTINGCost-utility analysis of the TOPSTM system compared to TLIF. PATIENT SAMPLEA multicenter, FDA IDE, randomized control trial (RCT) investigated the efficacy of TOPSTM compared to TLIF with a current population of n=305 enrolled and n=168 with complete 2-year follow-up. OUTCOME MEASURESCost and quality adjusted life years (QALYs) were calculated to determine our primary outcome measure, the incremental cost-effectiveness ratio. Secondary outcome measures included: net monetary benefit as well at willingness-to-pay (WTP) thresholds. METHODSThe primary outcome of cost-effectiveness is determined by incremental cost-effectiveness ratio. A Markov model was used to simulate the health outcomes and costs of patients undergoing TOPSTM or TLIF over a 2-year period. alternative scenario sensitivity analysis, one-way sensitivity analysis, and probabilistic sensitivity analysis were conducted to assess the robustness of the model results. RESULTSThe updated base case result demonstrated that TOPSTM was immediately and longitudinally dominant compared with the control with an incremental cost-effectiveness ratio of −9,637.37 $/QALY. The net monetary benefit was correspondingly $2,237, both from the health system's perspective and at a WTP threshold of 50,000 $/QALY at the 2-year time point. This remained true in all scenarios tested. The Alternative Scenario Sensitivity Analysis suggested cost-effectiveness irrespective of payer type and surgical setting. To remain cost-effective, the cost difference between TOPSTM and TLIF should be no greater than $1,875 and $3,750 at WTP thresholds of $50,000 and 100,000 $/QALY, respectively. CONCLUSIONSThis updated analysis confirms that the TOPSTM device is a cost-effective and economically dominant surgical treatment option for patients with lumbar stenosis and degenerative spondylolisthesis compared to TLIF in all scenarios examined.

One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.

Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking. We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice. Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology. Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10). One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.