Ambulatory Patients Research Articles

Prognostic value of the diagnosis of anemia in patients with heart failure: an analysis based on the Colombian heart failure registry (RECOLFACA).

Anemia represents a commonly reported comorbidity in patients diagnosed with heart failure (HF), related with a higher risk of unfavorable outcomes such as recurrent hospitalizations and mortality. There is a lack of evidence in Latin America regarding this topic. Our aim was to evaluate the prognostic value of the diagnosis of anemia in patients from the Colombian Heart Failure Registry (RECOLFACA). RECOLFACA registry included adult ambulatory patients with HF in 60 medical centers in Colombia during 2017-2019. Baseline characteristics of patients diagnosed with anemia and those without anemia were compared. The main outcome was all-cause mortality. A Cox proportional hazards regression model was used to evaluate the factors linked to the main outcome in patients with anemia. A statistically significant p-value was < 0.05. From the 2528 patients included in RECOLFACA, 2409 had at least one available hemoglobin value, and 726 (30.1%) corresponded to a diagnosis of anemia. Patients with anemia were significantly older, and had a higher prevalence of comorbidities, especially hypertension, type 2 diabetes, and chronic kidney disease (CKD). Patients without anemia had significantly lower mortality rate of 0.30 per 1000 person-years (95% CI 0.26-0.35), compared to patients diagnosed with anemia who had a mortality rate of 0.42 per 1000 person-years (95% CI 0.26-0.98) (p < 0.001). Lastly, the multivariate model results showed that the presence of an anemia diagnosis was associated with a significantly greater risk of mortality (HR 1.48; 95% CI 1.06, 2.05, p < 0.001). Anemia represents a highly prevalent comorbidity in patients with HF in Colombia and is also related with higher mortality in ambulatory patients during follow-up period. Our results highlight the relevance of anemia in the pathophysiology of HF. Nevertheless, due to its observational nature, out study results must be validated and further explored in future studies to elucidate the potential underlying mechanisms of this association.

EGS SO05 - Improving the Flow of Patients Attending Surgical Assessment Unit: Introduction of Ambulatory USS Slots - Closed Loop Audit

Abstract Background Modern emergency surgical service recognises that a significant proportion of patients presenting with acute abdomen can be diagnosed and treated in the ambulatory fashion. However, this approach requires multidisciplinary cooperation between the general surgery team and radiology department. We aimed to assess and improve the flow of patients presenting to Surgical Assessment Unit (SAU) with complaints of right iliac fossa (RIF) and right upper quadrant (RUQ) pain. Method We performed a retrospective analysis of all ambulatory patients returning to SAU of a District General Hospital with RUQ and RIF pain in January 2023. We measured the waiting time between the arrival to SAU and the time of USS. We presented the results in a local meeting and negotiated the introduction of two daily USS slots for SAU patients. We re-assessed the impact of the USS slots on waiting times in July 2023. Results In January 2023, 13 patients returned to SAU for USS. The minimum waiting time for this cohort was 59 minutes and the maximum waiting time was 3 hours and 39 minutes. The median was 2 hours and 15 minutes. In July 2023, 18 patients returned to SAU for USS. The minimum waiting time for this cohort was 4 minutes and the maximum waiting time was 2 hours and 20 minutes. The median was 1 hour and 5 minutes. There was an average reduction of 1 hour and 10 minutes in waiting time for USS. Conclusion The introduction of two USS slots per day for patients returning to SAU with RUQ and RIF pain resulted in a 48% reduction in waiting times. This improved the flow of patients, sped up the diagnosis and timely access to treatment, as well as significantly improved patients experience and satisfaction. We would recommend close co-operation between general surgery and radiology to allow timely access to imaging for patients presenting with acute abdomen to SAU.

Abstract 4135289: Renal Blood Perfusion is Closely Related to Right Ventricular Volume Overload in Congestive Heart Failure

Background: Cardiorenal syndrome (CRS) involves a bidirectional relationship where dysfunction in one organ exacerbates the other. A key factor in this interaction is the impact of right ventricular (RV) volume overload on renal blood flow, which is vital for the progression and management of heart failure (HF). Objective: This study aims to explore and quantify the relationship between right ventricular volume overload, i.e, echocardiographic assessments of right ventricular diameter (RVD), and the time-to-peak (TTP) of renal blood flow in patients with HF measured by 99mTc-DTPA renal scintigraphy. Methods: This single-center study included 304 stable, ambulatory HF patients admitted between October 2017 and August 2022. HF was diagnosed based on the 2016 ESC guidelines. Echocardiographic parameters, including RVD, and TTP of renal blood flow measured by 99mTc-DTPA renal scintigraphy, were collected. Statistical analysis was conducted using SPSS and R software, with Spearman correlation analysis used to assess the relationship between echocardiographic parameters and TTP. Results: The study showed there was a significant correlation between RVD and TTP (rs=0.535, P &lt;0.001), indicating that RV volume overload is closely related to impaired renal perfusion. The median TTP among the study population was 27.25 seconds (IQR: 21-39 seconds). Corrected for body surface area (BSA), RVD was found to be significantly higher in patients with heart failure with reduced ejection fraction (HFrEF) compared to heart failure with preserved ejection fraction (HFpEF) and heart failure with mid-range ejection fraction (HFmrEF) (HFrEF: 20.62 mm/m 2 , HFmrEF: 18.72 mm/m 2 , HFpEF: 18.09 mm/m 2 ; p &lt; 0.001). Furthermore, right atrial diameter (RAD) corrected for BSA (RAD/BSA) demonstrated the strongest correlation with TTP in the HFrEF subgroup (rs=0.602, p&lt;0.001). Conclusions: Our findings highlight the significant impact of right ventricular volume overload on renal perfusion, providing valuable insights into the pathophysiology of CRS. These results suggest that therapeutic strategies aimed at reducing RV overload could enhance renal perfusion and improve overall outcomes in HF patients.

Abstract 4117927: Prevalence of Obstructive Sleep Apnea Among Consecutive Patients with Atrial Fibrillation Using WatchPAT Home Sleep Testing: A Prospective Cohort Study

Background: Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice and is associated with significant morbidity, mortality, and health system costs. Obstructive sleep apnea (OSA) is a highly prevalent condition affecting more than one third of the global adult population and, among patients with comorbid AF, contributes to poor AF related quality of life. However, the prevalence of undiagnosed OSA in the general AF population is unknown. Methods: In this pragmatic, phase IV prospective cohort study, we performed sleep testing on consecutively enrolled ambulatory AF patients for OSA using a cloud-based disposable home sleep test (the WatchPAT system). The primary outcome of our study was the prevalence of undiagnosed mild (5≤AHI&lt;15) or moderate/severe (AHI≥15) OSA in the general AF population. A prespecified power analysis supports 80% power to detect a &lt;5% difference in OSA prevalence compared to the general population (defined by AHI cut-offs of ≥5 or ≥15). Results: We performed sleep testing in 180 AF patients. Enrollment concluded early after a prespecified interim power analysis showed a larger than predicted difference of OSA prevalence between AF patients and the general population. Among the patients tested, 126 (70.4%) had paroxysmal AF, and 53 (29.6%) had persistent/long standing persistent AF. None had previous sleep testing. Our results show that the prevalence of OSA was 83.3% by AHI≥5 and 47.2% had moderate/severe OSA (AHI≥15). Patients with persistent or long standing persistent AF demonstrated even higher rates of OSA with 51 (96.3%) testing positive for OSA (AHI≥5) and 35 (64.2%) with moderate/severe OSA (AHI≥15). Conversely, standardized OSA screening instruments (Stop-BANG questionnaire or Epworth Sleepiness Scale) were poorly predictive of OSA in AF patients (AUC 0.66 and AUC 0.44, respectively). Conclusions: Undiagnosed OSA is highly prevalent in the general AF population. Our results demonstrate that OSA prevalence in AF patients exceeds that in the general population with a high degree of confidence. Widely used clinical prediction instruments cannot effectively be used to guide sleep testing decisions in AF patients. Our results suggest routine OSA testing should be performed in the comprehensive evaluation of all AF patients.

Final diagnoses and mortality rates in ambulance patients administered nebulized β2-agonists bronchodilators.

To assess final diagnoses and mortality rates (30day and 1year) in patients treated with the inhaled bronchodilator salbutamol by ambulance personnel, and to establish its role as an identifier of moderate to severe respiratory distress in the prehospital phase of treatment. In a descriptive retrospective observational study, patients experiencing respiratory distress and treated with inhaled bronchodilators, specifically salbutamol, in the prehospital setting within the Central Denmark Region during 2018-2019 were included. The study included 6318 ambulance transports, comprising 3686 cases of acute exacerbation of chronic obstructive pulmonary disease (AECOPD), 234 with community-acquired pneumonia (CAP), 320 with heart disease (HD), 233 adults with asthma, 1674 with various other primary ICD-10 diagnoses (other ≥ 18years), and 171 patients under 18years. The 30day mortality rate for all patients was 10.7% (95% CI 9.8-11.6), with zero deaths within 30days among adults with asthma and those under 18. Excluding low mortality groups, AECOPD patients had the lowest 30day mortality at 10.2% (95% CI 9.1-11.3), and HD patients the highest at 15.3% (95% CI 10.6-19.9). The 1-year overall mortality rate increased to 32.1% (95% CI 30.2-34.0), with mortality staying low for asthma and under-18 groups, while differences between other groups lessened and became insignificant. Patients requiring inhaled bronchodilator treatment in ambulances exhibit notably high mortality rates at 30days and 1year, except for those with asthma or under 18. The need for prehospital bronchodilators could serve as a clear and unmistakable marker for moderate to severe respiratory distress, enabling early intervention.

Season-dependent characteristics of shock-related injuries in the Arctic zone of the Arkhangelsk region

Relevance. Studying the dynamics of injury rates, injury types and severity, as well as the treatment quality across various country regions, in particular the Arctic, is a prerequisite for managerial, healthcare, and strategic efficiency prior to and during hospital stay, taking into account the climate, geography, social and economic characteristics of every Russian Federation constituent.The objective is to analyse shock-related injuries in the Arctic zone of the Arkhangelsk region to understand season-related injury dynamics.Methods. Retrospective case series description parameters were used to study 140 patients with traumatic shock admitted to the Arkhangelsk Regional Clinical Hospital (ARCH) - a tier 1 trauma center. The analysed medical registration records included patient ambulance record and token (form 114/u), inpatient medical record (form 003/u), surgery logbook (form 008/u), patient radiographs, CT and nuclear MRI reports, as well as laboratory results. The study was conducted in accordance with ethical standards of the Declaration of Helsinki and European Community Directives (8/906 EC) and was approved by the local ethics committee of the Northern State Medical University of the Russian Ministry of Healthcare, Arkhangelsk (protocol no. 02/4-15 dated 04/08/2015). Statistical application package STATA ver.12 was used for statistical data processing.Results and discussion. The research demonstrated that the incidence of shock trauma is 4 times higher in men than in women. The vast majority of the injured are of working age. Seasonal distribution analysis per type of injuries and shock severity, including due to alcohol abuse, was carried out. The number of shock injuries is highest in winter, mainly due to road accidents which constitute 75.6 % of all injuries in winter. Throughout the year, over 50 % of shock injuries are combined injuries, that outperform isolated and multiple injuries in number. In particular, numerous combined injuries occur in winter with a responsible for almost 60 % among all other injuries. The majority the injured with shock-related trauma presented with stage 2 shock (49.3 %), whereas stage 1 and stage 3 shock was diagnosed in 27.9 % and in 21.4 % respectively. In winter, one in four patients with a shock-related injury presented with stage 3 shock. Alcohol-associated shock injuries are more numerous in summer (35.3 %), showing almost the same incidence as road traffic, domestic, and street injuries.Conclusion. The analysis of various types of injuries and season-related incidence of shock injuries in the Arctic territory of the Arkhangelsk region provides evidence to justify preventive measures to reduce the injury rates. Intensified efforts are required to minimise road traffic accidents in winter and combat alcohol abuse responsible for most injuries in summer. Since the vast majority of shock injuries occur in winter, in cold months ambulances must be equipped with local heating facilities, such as evacuation thermal bags with autonomous electric heating, thermal blankets, infusion warmers for blood transfusion and infusion sets.

Racing against time: Emergency ambulance dispatches and response times, a register-based study in Region Zealand, Denmark, 2013-2022.

The global strain on Emergency Medical Services (EMS) is reflected in the increasing number of emergency ambulance dispatches. Shorter EMS response times have demonstrated some effect on very specific and rare conditions. It is unknown if the increased number of ambulance dispatches compromises response times. This study aimed to describe trends in emergency ambulance dispatches and response times from 2013 to 2022 in Region Zealand, Denmark. Additionally, it aimed to outline the demographic profile of emergency ambulance patients, including age and comorbidities. Using administrative data from the Region Zealand emergency medical dispatch center, a register-based study spanning from January 1, 2013, to December 31, 2022, was conducted. Data were linked with nationwide registries and priority A (emergency), or B (urgent) ambulance dispatches were included. Trends were examined overall and stratified by catchment areas corresponding to the hospitals with emergency departments in the region. Poisson and ordinal logistic regressions were used to analyze data. The study encompassed 678,789 emergency ambulance dispatches, with 55.0% priority A and 45.0% priority B. Among these, 667,788 had a valid personal identification number allowing for further analysis. Within the study population, females comprised 48.5%, while 49.1% of patients were 65years or more. Overall, 47.5% of patients had no comorbidities, while 7.7% and 44.8% had mild and severe comorbidities, respectively. Emergency ambulance dispatches increased from 56,867 in 2013 to 81,080 in 2022 (143%). Correspondingly, the dispatch incidence rate per 1,000 residents per year increased from 69.2 to 95.5. Stratification by catchment areas revealed significant disparities. The median response time for priority A dispatches increased from 7min:14s in 2013 to 8min:20s in 2022 and for priority B dispatches from 12min:23s to 15min:6s. From 2013 to 2022, emergency ambulance dispatches both priorities A and B increased in absolute numbers and per 1000 residents per year. Ambulance response times also increased for both priorities during the study period. The study shows regional disparities regarding to the rate of emergency ambulance dispatches and response times indicating challenges in resource distribution in the future for maintaining emergency care standards.

A Real-world, prospective, observational, Investigator Initiated Trial to evaluate early discharge following Angio-Seal™ vascular closure device in patients undergoing percutaneous coronary intervention.

BackgroundCardiac catheterization procedures such as percutaneous coronary intervention (PCI) are widely used but with complications of access site bleeding. Manual compression (MC )is the well accepted technique to control bleeding but time consuming (15-20 mins); vascular closure devices (VCDs) are used increasingly as an alternative to MC and require <5 minutes for deployment.We aimed to document the real-world experience with a bioabsorbable collagen closure device (Angio-Seal™ ) with absorbable traction suture in patients undergoing PCI. ObjectiveThe primary objective was time (hours) to discharge from hospital after the procedure; to document the incidence of vascular access site complications, time to ambulation and time to hemostasis were the secondary objectives. MethodThis was a prospective, observational, investigator-initiated clinical trial wherein adult patients who underwent PCI procedure through femoral access route, with deployment of Angio-Seal™ femoral closure device were included. ResultsAmongst the 100 patients enrolled, 68% were males. systemic hypertension (63%), and type-2 diabetes mellitus (37%) were the major comorbidities reported. Mean overall time from the end of procedure to hemostasis was 2.32±0.99min. Time to ambulation was 156.08±36.81min and to hospital discharge was 25.21±4.49 hours, One subject experienced hematoma. No other complications particularly pertaining to vascular access site were observed. ConclusionAngio-Seal™ is an effective and safe VCD and results in early ambulation, rapid hemostasis, and discharge in patients undergoing PCI.

The use of pedometers to assess patient ambulation following gynecologic oncology surgery: A prospective observational study

The use of pedometers to assess patient ambulation following gynecologic oncology surgery: A prospective observational study

12362 The Use of Pedometers to Assess Patient Ambulation Following Gynecologic Oncology Surgery: A Prospective Observational Study

12362 The Use of Pedometers to Assess Patient Ambulation Following Gynecologic Oncology Surgery: A Prospective Observational Study

Characterization of patients with Duchenne muscular dystrophy across previously developed health states.

Project HERCULES has developed a natural history model (NHM) of disease progression in Duchenne muscular dystrophy (DMD) that comprises eight ordered health states (two ambulatory states, one transfer state indicating increased caregiver burden in which patients cannot walk/run 10m or rise from floor but can still support their own weight, and five non-ambulatory states). The current study used data from nine sources (clinical trial placebo arms, one real-world dataset, and three natural history datasets) to further characterize patients with DMD according to these health states. The study included 1,173 patients across 5,306‬ visits. Patients were on average older and exhibited worse ambulatory, pulmonary, upper limb, and cardiac functions with each successive health state. Mean±SE ages increased monotonically across health states, starting with 8.47±0.07 for early ambulatory, 10.86±0.13 for late ambulatory, 11.65±0.35 for transfer state, and ranging from 13.17±0.32 to 16.84±0.37 for the non-ambulatory states. North Star Ambulatory Assessment (NSAA) total score, which measures motor function and ranges from 34 (best) to 0 (worst), was 23.7 (interquartile range [IQR]: 20-30) for early ambulatory patients, 12.7 (IQR: 9-16) for late ambulatory patients, and 3.9 (IQR: 2-5) for transfer patients. Pulmonary function as measured by mean±SE of forced vital capacity percent predicted (FVC%p) was 94.5±0.8 for early ambulatory, 89.1±1.4 for late ambulatory, and 80.2±2.8 for transfer states, and decreased from 77.2±1.7 to 20.6±1.6 across the five non-ambulatory health states. In summary, these findings further characterize health states and their interpretation in economic modeling and decision-making in DMD management.

Venous Thromboembolism Risk Assessment in Inpatient and Ambulatory Otolaryngology Surgical Patients.

Venous thromboembolic events (VTEs) are a leading cause of postoperative morbidity, prolonged hospital stay, and increased cost. Recommendations for mechano- and chemoprophylaxis are currently based on the 2005 Caprini score, a screening tool developed to identify patients at risk for VTE. The Caprini risk assessment model (RAM) was designed for surgical impatients and has been tested in a number of surgical fields, including otolaryngology. However, the vast majority of otolaryngology cases are performed as ambulatory surgery. Simpler RAMs include the COBRA scoring system and Pannucci-NSQIP. Here, we evaluate risk stratification of otolaryngology surgical patients and correlate the findings of these three RAMs. Retrospective chart review. A retrospective chart review of 869 patients undergoing surgery by Weill Cornell faculty otolaryngologists between June and December 2022 was performed. Patient demographics, VTE risk factors, admission status, surgical subservice, and postoperative events were collected, and RAM scores were calculated for each patient. Wilcoxon and Kruskal-Wallis rank-sum tests were utilized to assess differences in VTE risk scores based on type of procedure and admission status, and Spearman's correlation was utilized to assess agreement between the three different scoring systems. Multivariate linear regressions were utilized to assess variables that impacted the Caprini, COBRA, and NSQIP RAMs. In total, two patients developed postoperative venous thromboembolism. Furthermore, there is a strong positive correlation between Caprini and COBRA RAMs (even when broken down by admission status, although it weakens in the inpatient population). There is a moderate positive correlation between Caprini and Pannucci-NSQIP in the full cohort, but that correlation is lost in the inpatient population. Otolaryngology surgical patients are at low risk of postoperative VTE. Caprini, Pannucci-NSQIP, and COBRA RAMs correlate well in determining ambulatory patients at risk for postoperative VTE and shorter, simpler RAMS such as COBRA and Pannucci-NSQIP can be used instead of Caprini RAM. 3 Laryngoscope, 2024.

Circulating secretoneurin concentrations predict cardiovascular death in ambulatory patients with heart failure

Abstract Background Secretoneurin (SN) is a novel biomarker, which predicts cardiovascular (CV)-related mortality in patients with acute dyspnea and sepsis. Higher SN concentrations have also been found associated with all-cause death in outpatients with heart failure (HF), but whether SN primarily reflects cardiovascular (CV)-related mortality in HF outpatients is not known. Objectives To evaluate the relation between SN concentrations and CV- &amp; non-CV death in ambulatory patients with HF. Methods We studied 184 consecutive patients who attended our HF clinic for routine follow up and had stored blood samples available for SN analysis. SN concentrations were measured with a CE-marked SN ELISA assay. We assessed the associations between SN concentrations and CV &amp; non-CV death. Mortality was ascertained using medical records, autopsy reports and death certificates, and CV deaths included sudden cardiac deaths or mortality due to myocardial infarction, HF or stroke. We assessed association with CV &amp; non-CV death by Kaplan-Meier curves and by Cox proportional hazard regression analysis. Results Median age was 76 years (range: 38-94 years) and two thirds were male. Sixty-three percent had HF with reduced ejection fraction, 22% had NYHA III/IV symptoms and median NT-proBNP was 1079 (interquartile range: 462-2347) ng/L. Median SN level was 60 (range: 21-134) pmol/L. In multivariable linear regression analysis, impaired renal function and lower body-mass index were significantly associated with increasing (log)SN concentration. During median follow up of 540 days, there were 18 CV deaths, including 15 HF deaths, and 7 non-CV deaths. A higher SN concentration was associated with higher risk of CV death, while we did not find statistically significant association between SN concentrations and non-CV deaths (Figure). Patients with SN concentration in the top tertile had 15-fold increased risk of CV death compared to patients with SN concentration in the lowest tertile. In multivariable Cox regression analysis that adjusted for age, NYHA functional class, frailty status, increasing SN concentrations were independently associated with CV death: hazard ratio per logSN (95% CI): 3.01 (1.02-8.90), p=0.04. Conclusion In ambulatory patients with HF, circulating SN concentrations were predictive of CV death. Higher SN concentrations in ambulatory HF patients seemed to be linked to impaired renal function and lower body-mass index. Figure: Kaplan Meier curves illustrating the relation between SN tertiles and (A) CV mortality (B) Non-CV mortality.

Hemodynamic profiles and survival in chronic advanced heart failure patients evaluated for heart replacement therapy

Abstract Background Advanced heart failure (HF) is associated with dismal prognosis despite optimal medical therapy. Invasive assessment with right heart catheterization (RHC) is a valuable tool to assess transplant candidates and hemodynamic profiling is crucial to stratify prognosis and select patients for advanced therapies. Purpose This study aims to examine the relationship between hemodynamic profiles based on cardiac index (CI) and filling pressures and survival in ambulatory patients with advanced HF evaluated for heart replacement therapy (HRT) such as heart transplantation (HT) and left ventricular assist device (LVAD) implant. Methods We analyzed adult ambulatory advanced HF patients evaluated for HRT with an available baseline RHC from 2003 to 2022. Hemodynamic data were classified using a CI &amp;lt; 2.2 l/min/m2 as marker of reduced cardiac output ("cold" profile opposed to the "warm" profile) and increased filling pressure, defined as right atrial pressure ≥ 10 mmHg and/or pulmonary capillary wedge pressure (PCWP) ≥ 15 mmHg as a marker for congestion ("wet" profile opposed to the "dry" profile). Study endpoint was death or urgent HT or LVAD implant at 5 years. Results Study population included 610 patients (mean age 53±10 years, 79% males). According to hemodynamic criteria, 332 patients (55%) exhibited a "wet cold" hemodynamic profile, 117 (19%) a "cold dry", 91 (15%) a "warm wet" and 66 (11%) a "warm dry" phenotype. The "wet" patients showed a significantly higher prevalence of pulmonary hypertension (96% wet cold, 94% wet warm vs 21% dry warm, 19% dry cold; p&amp;lt;0,001), a lower pulmonary artery pulsatility index (4,0 wet cold, 4,1 wet warm vs 7,4 dry warm, 6,9 dry cold; p&amp;lt;0,001). No differences were found in etiology of HF. Both reduced CI [OR 1,6 (1-2,4), p=0.003] and increased filling pressures [OR 1,9, (1,2-2,8) p=0.007] were associated with worse outcomes. Survival differed significantly among hemodynamic profiles, with a survival rate of 48% in the "cold wet" profile compared to 68% in the "cold dry" [OR 1,9 (1,2-3,1) p=0,007] and 65% in the "warm dry" [OR 2,2 (1,1-4,2), p=0.01]. The difference between "cold wet" and "warm wet" was borderline significant (p=0.07). Further stratification between right and left ventricular filling pressures showed that isolated right ventricular congestion was rare and associated with low event rate, while in patients with preserved CI, biventricular congestion was associated with borderline worse survival as compared to isolated left ventricular increased filling pressures (p=0.06). Conclusions Hemodynamic profiles assessed with RHC stratify prognosis in ambulatory patients with advanced HF referred for HRT. Evaluation of hemodynamic phenotype may help identify subgroups of patients at high risk and guide therapeutic decisions. Further studies are needed to confirm these findings and develop personalized management strategies to improve clinical outcomes in this population.Survival-hemodynamic phenotypeSurvival-filling pressures

Efficacy and safety of ambulatory, weekly, high-intensity intravenous diuretic strategy for congestion-refractory heart failure patients: insights from the DEA-HF prospective randomized clinical trial

Abstract Background Congestion and volume overload are strongly associated with low quality of life and pose a significant risk for both rehospitalization and mortality in heart failure (HF) patients. Despite the widespread use of diuretics in HF, the use of weekly, intravenous (IV), high-intensity diuretic treatment has not been prospectively studied in the setting of ambulatory congestion-refractory patients. Purpose To assess the efficacy and safety of weekly high-intensity diuresis regimens in a practical setting of ambulatory day care for chronically congested HF patients. Methods We performed a sub-analysis on data from a prospective, randomized, cross-over controlled study (DEA-HF) originally designed to compare diuresis regimens in the setting of an HF ambulatory daycare unit who had signs of congestion or volume overload despite adherence to guideline-directed medical therapy. Each patient received three different IV diuretic regimens, in one of six randomized sequences: IV furosemide 250mg; IV furosemide 250mg + oral metolazone 5mg; and IV furosemide 250mg + IV acetazolamide 500mg. All regimens given on the same chronological week were pooled, and diuresis efficacy was assessed by measuring excreted urine volume and sodium weight 6 hours post treatment initiation. Additional assessment at one week post each treatment included serum levels of NT-ProBNP, body weight and creatinine as well as congestion score based on the presence of ascites, pleural effusion and pedal edema. Statistical analysis was based on linear mixed models while accounting for the random effect of patient identity. Results A total of 42 patients were recruited. The mean age was 72±9 years, twenty-one subjects (50%) had LVEF ≥ 50%. 74% of patients were NYHA III class. All patients were on contemporary guidelines-directed HF therapy. Analysis of excreted sodium weight and urine volume revealed values of 4202.1±180.1 mg (Mean±SEM) and 1.77±0.07 liter per visit, respectively. No significant differences in efficacy were detected among treatments given in consecutive weeks (P= 0.80 and 0.69 for differences in sodium weight and urine volume, respectively). After 4 weeks, log(NT-ProBNP) was significantly decreased (P=0.044), accompanied by a significant decrease of 2.4±0.62 kg in body weight (P=0.0004) and of 0.92±0.44 points in congestion score (P=0.037). Serum creatinine level was only slightly increased by 0.19±0.04 mg/dl (P=0.0001), demonstrating the overall safety of the high-intensity diuresis strategy. Conclusions In ambulatory, congestion refractory HF patients a strategy based on high-intensity, weekly diuresis therapy was safe and effective for three consecutive weeks. The natriuresis response to the treatments was maintained, NT-ProBNP levels and congestion score were decreased. The strategy may be instrumental for ambulatory HF patients that require diuretic therapy intensification and may allow to prevent hospitalization.

Cardiopulmonary exercise testing predicts risk of progressive heart failure and long term mortality in ambulatory patients awaiting isolated heart transplant

Abstract Introduction Cardiopulmonary exercise testing (CPET) parameters such as peak VO2 ≤ 14ml/kg/min, percentage predicted peak VO2 (ppVO2) ≤ 50% and ventilation equivalent of carbon dioxide (Ve/VCO2) &amp;gt;35 l/min/l/min are recommended thresholds to list for isolated heart transplant. There is minimal data on clinical events after listing to guide clinical management or priority in organ allocation. Purpose To assess the effect of peak VO2, ppVO2, Ve/VCO2 on clinical events after listing for isolated heart transplant. Methods In a single centre retrospective study, we identified patients who were status 6 or status 2 prior to 2018 at time of listing for isolated heart transplant between 2007 and 2021. Clinical data were collected by chart review. Primary outcome of progressive heart failure was defined as death or upgrade in transplant priority status (new inotropes or mechanical circulatory support). Comparison was made between peak VO2 strata (&amp;gt; 14 vs ≤ 14 ml/kg/min), ppVO2 strata (&amp;gt; 50% vs 40-50% vs &amp;lt;40%) and Ve/VCO2 strata (&amp;lt;35 vs &amp;gt;35 l/min/l/min). Secondary outcome was time dependent survival after listing for heart transplant. Results We identified 141 patients of which 133 underwent CPET and follow up was available for 130 who were included in the analysis. Median age was 53 years (interquartile range 41-59 years), 29.1% of patients were female. Median peak VO2 was 14.0 ml/kg/min (11.2-15.7), ppVO2 was 44% (36-52), Ve/VCO2 slope was 34.0 (31.0-37.0) and RER was 1.1 (1.1-1.2). 87 patients had progressive heart failure consisting of 34 deaths and 83 patients having upgrade in priority status. There was a significant difference in risk of progressive heart failure comparing peak VO2 strata (Figure 1) (freedom from event at one year 71.4% with peak VO2 &amp;gt; 14 vs 46.5% with peak VO2 ≤ 14, p=0.00061) and ppVO2 strata (Figure 2) (freedom from event at one year 75.0% with ppVO2 &amp;gt;50% vs 61.2% with ppVO2 40-50% vs 42.6% with ppVO2 &amp;lt;40%, p=0.0015). There was no significant difference with Ve/VCO2 strata (freedom from event at one year 59.8% with Ve/VCO2 &amp;lt;34 vs 54.9% with Ve/VCO2 &amp;gt;34, p=0.52). There were 34 deaths before transplant and 23 deaths after transplant. 87 patients underwent transplant. In a time dependent survival analysis, age, gender and ppVO2&amp;lt;50% (HR 1.65 (0.87-3.12)) were not significant predictors of mortality. Both early transplant (defined as &amp;lt; 1 year after listing, HR 0.14 (0.06-0.34) and late transplant (defined as &amp;gt; 1 year after listing, HR 0.16 (0.08-0.32)) were significant predictors of lower mortality whilst Ve/VCO2&amp;gt;35 (HR 2.09 (1.19-3.68)) was a significant predictor of higher mortality. Conclusions Peak VO2 and ppVO2 stratify risk of progressive heart failure in ambulatory patients awaiting isolated heart transplant. However, Ve/VCO2 is a predictor of significantly higher mortality. These findings should affect clinical management and transplant priority status; and influence revision of future guidelines.Freedom from event by peak VO2 strataFreedom from event by ppVO2 strata

Population Pharmacokinetic Quantification of CYP2D6 Activity in Codeine Metabolism in Ambulatory Surgical Patients for Model-Informed Precision Dosing.

Codeine metabolism in humans is complex due to the involvement of multiple cytochrome P450 (CYP) enzymes, and has a strong genetic underpinning, which determines the levels of relevant CYP450 enzyme expression in vivo. Polymorphic CYP2D6 metabolises codeine to morphine via O-demethylation, while a strong correlation between CYP2D6 phenotype and opioidergic adverse effects of codeine is well documented. The aim of this study was to quantify the effect of CYP2D6 genotype on the biotransformation of codeine. We conducted a prospective clinical trial with 1000 patients, during which ambulatory patients were administered 60 mg of codeine preoperatively and the association between CYP2D6 activity and morphine exposure across various CYP2D6 genotypes was quantified using a population pharmacokinetic model. Plasma concentration data for codeine and its primary metabolites were obtained from 997 patients and CYP2D6 genotype was screened for study subjects, and respective sums of activity scores assigned for each CYP2D6 allele were used as covariates in model development. Our final model predicts the disposition of codeine and the formation of morphine, codeine-6-glucuronide and morphine-3-glucuronide adequately while accounting for variability in morphine exposure on the basis of CYP2D6 genotype. In agreement with previous results, patients with decreased function alleles (CYP2D6*10 and *41) showed varying levels of decrease in CYP2D6 activity that were inconsistent with increasing activity scores. Model simulations demonstrate that morphine concentrations in ultrarapid CYP2D6 metabolisers reach systemic concentrations that can potentially cause respiratory depression (over 9.1 ng/mL), and have 218% higher exposure (19 versus 8.7 µg · h/L, p < 0.001) to morphine than normal metabolisers. Similarly, poor and intermediate metabolisers had significantly reduced morphine exposure (1.0 and 3.7 versus 8.7 µg · h/L, p < 0.001) as compared with normal metabolisers. Our final model leads the way in implementing model-informed precision dosing in codeine therapy and identifies the use of genetic testing as an integral component in the effort to implement rational pharmacotherapy with codeine.

Effects of sarcopenia and nutritional status on surgical outcomes for metastatic spinal tumors: In the perspective of peri-operative complications and performance improvement.

With the advancement of cancer treatment, appropriate treatment for musculoskeletal problems is becoming more important as it extends the patient's lifespan and improves the quality of life. In surgical treatment for metastatic spine tumors (MST), various efforts are being considered to obtain a good prognosis. The purposes of this study are to analyze prognostic factors for postoperative ambulation and perioperative complications in patients surgically treated for MST with neurologic symptoms. Seventy five cases of patients who underwent surgery for MST with neurologic symptoms were enrolled between December 2016 and January 2023. Postoperative ambulatory function and medical complications were assessed for each patient in this study. The endpoint of ambulatory function was defined as the best function among entire periods of follow-up outpatient visits. We defined the improvement of ambulatory function as improvement in Eastern Cooperative Oncology Group (ECOG) scale. For complications, we applied complication classification system for orthopaedic surgery. Perioperative complications were defined as those requiring changes of treatment compared with routine postoperative treatment during patient's admission. Confirmed complications included expire, delirium, urinary tract infection (UTI), pneumonia, sepsis, bacteremia, acute kidney injury (AKI), chylothorax. Prognostic factors were collected and analyzed for relationship by logistic regression. Of the 75 cases, postoperatively 42 (56%) cases of patients were improved in Nurick grade, 36 (48%) cases of patients in ECOG performance. And 21 (28%) cases of patients were treated in intensive care unit (ICU) and 15 (20%) cases of patients suffered from major perioperative complications. Regression analysis showed that clinical factors such as ECOG, psoas muscle index (PMI) and prognostic nutritional index (PNI) were related to the improvement of ambulatory function and incidence of perioperative complications. On multivariate analysis, improvement of ambulatory function was associated with PMI (p = 0.014) and incidence of perioperative complications was associated with PNI (p = 0.045). Preoperative nutritional status and sarcopenia are related factors in the outcome of surgical treatment for MST, and preoperative efforts to improve these may be a way to obtain better clinical results.

Improving the Accuracy and Precision of Disease Identification When Utilizing Ehr Data for Research: the Case for Hepatocellular Carcinoma.

Objective We assessed the performance of ICD codes to identify patients with hepatocellular carcinoma (HCC) in a large academic health system and determined whether employing an algorithm using a combination of ICD codes could deliver higher accuracy and precision than single ICD codes in identifying HCC cases using electronic health record (EHR) data. Results The use of a single ICD code entry for HCC (ICD-9-CM 155.0 or ICD-10-CM C22.0) in our cohort of 1,007 established ambulatory care patients with potential HCC yielded 58% false positives (not true HCC cases) based on chart reviews. We developed an ICD code-based algorithm that prioritized positive predictive value (PPV), F-score, and accuracy to minimize false positives and negatives. The highest performing algorithm required at least 10 ICD code entries for HCC and the sum of ICD code entries for HCC to exceed the sum of ICD code entries for non-HCC malignancies. The algorithm demonstrated high performance (PPV 97.4%, F-score 0.92, accuracy 94%), which was internally validated (PPV 92.3%, F-score 0.90, accuracy 91%) using a separate sample of potential HCC cases. Our findings support the need to assess the accuracy and precision of ICD codes before using EHR data to study HCC more broadly.

Direct-Acting Oral Anticoagulants and Potential Inconsistencies with FDA-Approved Dosing for Non-Valvular Atrial Fibrillation: A Retrospective Real-World Analysis Across Nine US Healthcare Systems.

Direct-acting oral anticoagulants (DOACs) are recommended to reduce risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). However, DOAC dosing inconsistent with FDA-approved product labels is common and associated with poor clinical outcomes. Identify DOAC dosing inconsistent with FDA-approved product labels in ambulatory care patients with NVAF; identify variables associated with dosing lower and higher than label. Retrospective analysis using electronic health records from nine US healthcare systems. Adults with NVAF receiving DOAC therapy in 2022. Rates of label-inconsistent dosing; multivariable regression analysis to identify demographic and clinical variables associated with dosing lower and higher than label. Among 51,128 NVAF patients (56.1% male, 94.3% White, mean [SD] age 73.5 [10.5] years), 5008 (9.8%) were prescribed label-inconsistent doses of DOACs (6.8% lower and 3.0% higher than label). Age ≥ 75years, renal impairment, and hypertension were significantly associated with inconsistent dosing both higher and lower than label. Female sex and higher weight were significantly associated with dosing lower than label, as were heart failure, vascular or liver disease, and bleeding history. Dosing higher than label was significantly associated with male sex, race (African American/Black), weight < 60kg, and use of drugs with potential drug-drug interactions. When prescribed by primary care physicians, DOAC doses were 37% (95% CI, 27-49%) more likely to be lower than label and 30% (95% CI, 16-46%) more likely to be higher than label than when prescribed by cardiologists or electrophysiologists. Label-inconsistent dosing varied (6.7 to 15.8%) across participating systems. DOAC dosing inconsistent with label varied by demographics, clinical characteristics, prescriber specialty, and healthcare system, suggesting a need to monitor and assess dosing decisions in NVAF. Identification of variables associated with dosing inconsistencies may enable targeted interventions to ensure label-consistent dosing in vulnerable populations.