Outcomes Registry Research Articles

Standards for Quality Improvement Registries on Abdominal Aortic Aneurysm Repair: A Delphi Consensus Report From VASCUNET and International Consortium of Vascular Registries

Outcome registries in vascular surgery are increasingly used to drive quality improvement by vascular societies. The VASCUNET collaboration, within the European Society for Vascular Surgery (ESVS), and the International Consortium of Vascular Registries (ICVR) developed a set of variables for quality improvement registries on abdominal aortic aneurysm (AAA) repair as a registry standard. Representatives from international vascular registries within VASCUNET, ICVR, and other nations with established registries were invited to provide the variables. The final variables were developed through a two stage modified Delphi process. Variables from the established registries with at least 60% consensus among all the registries were included for round 1. A five point Likert scale (strongly disagree to fully agree) was used. If the limit of consensual agreement was not reached in round 1, the variable was discussed again in round 2. For round 2, an array question method (yes, no to unsure) was used. Agreement of at least 70% resulted in the variable being included in the final dataset. A total of 88 out of 371 variables extracted from all AAA registries were circulated in the modified Delphi process as they reached the 60% consensus threshold. The questionnaire was circulated to 55 participants (round 1: 49; 89%; round 2: 43; 78%). After two rounds, 70 variables were recommended on consensual agreement. These variables comprised demographics (n = 4), pre-operative information (n = 28), intra-operative variables (n = 18), post-operative variables (n = 5), and follow up (n = 13). Based on this modified Delphi process, an international panel of vascular surgeons representing quality improvement registries recommended 70 core variables as standard in registries on AAA repair. The inclusion of a core set of variables in AAA vascular registries may help to further harmonise observational research and quality of AAA repair among global healthcare systems.

Endoscopic Iliopsoas Fractional Lengthening as a Treatment for Refractory Iliopsoas Impingement After Total Hip Arthroplasty Shows Favorable Functional Outcomes With No Impact In Range of Motion

To report the minimum 2-year clinical outcomes of endoscopic iliopsoas fractional lengthening (IFL) in patients with recalcitrant iliopsoas tendonitis after Total hip arthroplasty (THA). Data was prospectively collected from 2014 to 2020 for patients who underwent IFL following primary THA as part of the institutional hip outcomes registry. Patients were included if they had completed preoperative and minimum 2-year follow-up the following patients reported outcomes (PROs): modified Harris Hip Score (mHHS) and, visual analog scale (VAS). Preoperative and postoperative data was available for the International Hip Outcomes Tool (iHOT-12), and patient satisfaction was also analyzed. Patients included in the study reported irritation of the iliopsoas tendon following cementless THA, refractory to conservative treatment methods. IFL was recommended after workup which included ruling out infection and aseptic loosening, and a positive iliopsoas diagnostic injection. Seventeen patients were included in the study . The mean age at IFL was 56.42 (30.17-81.29). The mean interval between THA and IFL was 2.72 (0.25-8.34) years. There was a significant improvement in all evaluated PROs, and a high percentage of patients meeting MCID (14 (82.35%) for mHHS, 11 (92.00%) for iHOT-12, and 16 (94.12%) for VAS (p < 0.05). Furthermore 15 (88.2%) of patients reported a positive response to the PASS anchor question. No impact was observed from pre-to postoperative active range of motion and no patient reported weakness at the latest follow up (p > 0.05). Preoperative flexion was 106.33° (85.0°-120.0°) and post-operative flexion was 106° (900°-120.00). Endoscopic IFL yielded significant improvements in functional outcomes with a high patient satisfaction at minimum 2-year follow-up, with no reported complications. This procedure did not have a significant negative impact on hip range of motion. Retrospective Case Series; Level IV.

Assessment of Maternal and Infant Health Status in Durham Region

I completed my practicum as a Student Epidemiologist at the Durham Region Health Department with the Health Analytics and Research Team (HART). HART is tasked with conducting population health assessments in the Durham Region. As a member of HART, I played a critical role in assessing the maternal and infant health status of the local population using data from the Better Outcome Registry and Network (BORN) information system (BIS), a database that contains critical reproductive and child health data in Ontario. Specifically, my primary responsibilities included data extraction and data coding, which encompassed a series of tasks, spanning from data cleaning to data analysis in STATA. By analyzing BORN data, I was able to refine my statistical and programming skills. Moreover, I collaborated with public health program staff to develop infographics that disseminated critical maternal and infant health information to various communities. The infographics I assisted with covered a wide range of maternal and infant health topics, including issues such as gestational diabetes and maternal mental health concerns. From here, I was able to effectively communicate health information in a concise and understandable manner. In addition, I had the opportunity to attend various public health workshops and group meetings during my practicum. These experiences not only expanded my knowledge of diverse public health topics but also afforded me greater familiarity with public health practice. In summary, my time at the Durham Region provided me with an exceptional opportunity to apply the knowledge I gained in school to real-world practice. It was a valuable and enriching experience that significantly contributed to my professional development in the field of public health.

The prevalence of threatened miscarriage in Malta

A retrospective cohort study was conducted in Malta to assess the prevalence of threatened miscarriage. The study focuses on cases managed at a local state hospital over a 12-month period. Currently, data on pregnancies prior to 22 weeks’ gestation are not publicly available, which hampers understanding of the frequency and impact of threatened miscarriage. This research provides the basis for a potential prospective study which analysis the epidemiology and outcomes of threatened miscarriage and advocates for early intervention and appropriate patient counselling. The study included females who visited the Accident and Emergency Department in a local state hospital in 2019 with first trimester vaginal bleeding. It excluded patients with incomplete medical records. Data from various hospital departments were collected, anonymised and analysed to track outcomes such as miscarriage, ongoing pregnancy, ectopic or molar pregnancy. The research aimed to create a comprehensive local registry of pregnancy outcomes following threatened miscarriage, reflecting the national situation. In 2019, 711 pregnant women in Malta experienced first-trimester vaginal bleeding. Of these, 241 had successful births beyond 22 weeks’ gestation, while 412 experienced miscarriages, with other outcomes including ectopic and molar pregnancies and 58 women had an unknown pregnancy outcome. A significant association was found between maternal age and risk of miscarriage, particularly higher for women aged 35–46 and those under 19. Birthweight data revealed that threatened miscarriage complications likely led to low birthweights in a significant proportion of newborns. This study analysed pregnancy outcomes which were preceded by first trimester vaginal bleeding in pregnant women in Malta. Establishing a local register of pregnancy outcomes following first trimester vaginal bleeding provides clinicians with enhanced insights into the current local context. This resource may improve patient counselling and informed policy decisions and lay the groundwork for future research in the field.

Abstract 4114497: Shape Variations in Right Ventricular 3D Geometry are associated with adverse outcomes in Hypoplastic Left Heart Syndrome Patients: A Fontan Outcomes Registry using CMR Examination (FORCE) Study

Introduction: Right ventricular (RV) function is critical to the long-term health of patients with hypoplastic left heart syndrome (HLHS). However, conventional measurements do not consider the range of RV morphology that may impact RV function and lead to adverse outcomes. In this study, we determined associations between RV shape and clinical outcomes of HLHS using statistical shape modeling (SSM) and a large cardiac magnetic resonance (CMR) multicenter registry. Methods: Three hundred and twenty-eight studies from unique HLHS patients in the F ontan O utcomes R egistry using C MR E xaminations (FORCE) were post-processed by a core lab at one institution, including volumetry and strain analysis. 3D end-diastolic models of RV were reconstructed using Mimics (Materialise). SSM was performed via Shapeworks Studio (NIH/NIGMS CIBC) to derive mean template and quantified shape variations (shape mode) representing deviation from the mean. RV shape relationship with mortality/heart transplant was assessed using bivariable/multivariable analyses with stepwise model selection. Results: The mean template from all 328 patients resembled a circumferentially dilated RV with loss of concavity in septal wall (Fig A). Several generalized variants were identified (Fig B), particularly p1 – a sigmoidal / “apical bulge” variant where the RV apex dilates and "wraps” around the hypoplastic left ventricle (Fig C). Twenty-eight patients (8.5%) experienced mortality/heart transplant at 2.5±2.4 years after CMR. On bivariable analysis, p1 was associated with mortality/heart transplant, along with larger indexed RV end-diastolic volume/mass and reduced global circumferential strain. On multivariable analysis, p1 and indexed RV mass were associated with mortality/heart transplant (Table). Conclusions: Statistical Shape Modeling can define the “usual” RV shape of HLHS. A sigmoidal shape variant is associated with adverse outcomes. SSM may provide patient-specific metrics to define RV dysfunction in HLHS.

Nationwide prevalence and geographic variation of idiopathic intracranial hypertension among women in the United States

The prevalence of idiopathic intracranial hypertension (IIH) is increasing, but this has not been examined on a nationwide scale. Our objective was to determine the nationwide prevalence and geographic distribution of IIH among women in the U.S. Retrospective cross-sectional study using Medicaid claims and electronic health record data from the IRIS® Registry (Intelligent Research in Sight) and Sight Outcomes Research Collaborative (SOURCE). Female Medicaid beneficiaries aged 18-55 with IIH diagnoses and prescriptions for acetazolamide or methazolamide in 2018, excluding those with other causes of intracranial hypertension. We also calculated the proportion of female IIH patients in the U.S. who were insured by Medicaid by combining analyses from the IRIS® Registry and SOURCE. To calculate the total number of IIH patients in the U.S. and by state, we divided the number of Medicaid beneficiaries with IIH by the proportion of IIH patients insured by Medicaid. We then used census data from the 2018 American Community Survey to calculate prevalence. We compared the geographic distribution of IIH to obesity prevalence data from the 2018 Behavioral Risk Factor Surveillance System, using the Moran's I statistic to test for spatial variation. In a validation study, we compared the calculated prevalence of IIH in Minnesota to similar data from the Rochester Epidemiology Project. Of 13,959 female Medicaid beneficiaries with IIH, 6,828 had a prescription for acetazolamide or methazolamide. In the IRIS® Registry and SOURCE, 25% of IIH patients were insured by Medicaid (95 % CI: 16-33%), suggesting that there were 27,312 women aged 18-55 with IIH taking acetazolamide or methazolamide in 2018 (6,828 / 0.25 = 27,312). Prevalence was 3.44 per 10,000 (95% CI: 2.61-5.39), and there was significant geographic variation (Moran's I statistic 0.20, P = 0.03) with higher prevalence in states where obesity was more common. The calculated prevalence of IIH in Minnesota was statistically equivalent to Rochester Epidemiology Project data (P < 0.05 for equivalence test). IIH affects 3.44 per 10,000 women aged 18-55 in the U.S., and there is significant geographic variation, some of which is explained by variation in obesity prevalence.

Predictors of Cardiac Rehabilitation Attendance and Completion: Analysis of 33,055 Patients from the Queensland Cardiac Outcomes Registry (2020–2022)

Cardiac rehabilitation (CR) under-attendance presents a global challenge. The Queensland Cardiac Outcomes Registry is a comprehensive clinical registry that routinely collects point-of-care CR data. We aimed to determine whether demographic, clinical, psychosocial, and behavioural characteristics of the population vary between those who (i) declined, (ii) commenced but did not complete, and (iii) completed CR. The cohort comprised 33,055 patients referred to one of 56 Queensland CR services extracted from the Queensland Cardiac Outcomes Registry (2020-2022). Bivariate and multivariable logistic regression analyses were used to identify factors associated with CR non-attendance and non-completion. Over the study period, 12,152 patients (37%) declined CR, 11,621 (35%) initiated but did not complete CR, and 9,282 (28%) completed CR. Significant predictors of CR non-attendance were aged ≥75 years (adjusted odds ratio [aOR] 1.51; 95% confidence interval [CI] 1.42-1.61), Indigenous status (aOR 1.65; 95% CI 1.50-1.81), living regionally (aOR 1.76; 95% CI 1.65-1.87) or remotely (aOR 2.33; 95% CI 1.92-2.82), and having arrhythmia (aOR 2.38; 95% CI 2.07-2.73), heart failure (aOR 1.54; 95% CI 1.37-1.74), non-ST-elevation myocardial infarction (aOR 1.30; 95% CI 1.21-1.40) or unstable angina (aOR 1.24; 95% CI 1.1.13-1.37). Significant predictors of CR non-completion were age <55 years (aOR 1.55; 95% CI 1.37-1.75), Indigenous status (aOR 1.60; 95% CI 1.29-1.98), living regionally (aOR 1.29; 95% CI 1.12-1.48), obesity (aOR 1.14; 95% CI 1.01-1.28), being a current (aOR 1.97; 95% CI 1.70-2.27) or former smoker (aOR:1.22, 95% CI 1.11-1.33) and having low social support (aOR 1.58; 95% CI 1.24-2.02). As one of the largest studies of CR participation to date, these findings can now be applied to develop targeted, co-designed initiatives to enhance CR participation, especially among First Nations populations, smokers, those with limited social support, people living regionally/remotely, patients with arrhythmia and heart failure, and those in varying age groups.

Outcomes after hospital discharge in children requiring post-cardiotomy extracorporeal membrane oxygenation: a binational retrospective cohort study

ObjectivesTo describe longer-term survival and morbidity outcomes after hospital discharge in a binational cohort of children who required extracorporeal membrane oxygenation after cardiac surgery. MethodsRetrospective cohort study from the Australia and New Zealand Congenital Outcomes Registry for Surgery database. All patients younger than 18 years of age (n=12,290) undergoing paediatric cardiac surgical procedures between 1 January 2013 and 31 December 2021 who required post-cardiotomy extracorporeal membrane oxygenation in the same admission were included. ResultsAmong 376 (3%) patients who required post-cardiotomy extracorporeal membrane oxygenation, 242 (64.4%) survived to hospital discharge. Median follow-up in survivors post-hospital discharge was 4.2 years (IQR 2.6 – 8 years). Kaplan-Meier survival at 1, 3, 5 and 8 years was 62%, 58.5%, 55.8%, and 52.6%. Post-discharge survival was 95.5%, 90.7%%, 87.1% and 81.9% at 1, 3, 5, and 8 years respectively. Survival was significantly poorer in patients with single ventricle physiology. 43.3% (n=105) of hospital survivors had at least one major morbidity at the last follow-up. The most common major morbidities were developmental delay, permanent neurological deficits, and growth restriction. Conclusions38% of children who required ECMO after cardiac surgery did not survive beyond 1 year. However, of patients who survived to hospital discharge, 95% were alive at one year. Approximately 80% of patients were alive at 5 years after hospital discharge. Outcomes were poorer in patients with single ventricle physiology. 40% of patients had significant morbidity after hospital discharge.

Conversion from minimally invasive surgery to open surgery among endometrial cancer patients in the SGO clinical outcomes registry

Conversion from minimally invasive surgery to open surgery among endometrial cancer patients in the SGO clinical outcomes registry

Performance and safety of complex percutaneous coronary intervention in centres without on-site cardiac surgery: a multi-centre australian registry study.

Abstract Background Performing complex percutaneous coronary intervention (PCI) procedures in hospitals with no on-site cardiac surgery (NOSCS) remains controversial due to a lack of contemporary data and guideline support. Methods Victorian Cardiac Outcomes Registry data was analysed including all PCI cases in the state of Victoria, Australia, from 2014 to 2022. Patients were stratified by PCI at sites with on-site cardiac surgery (OSCS) or NOSCS. Complex PCI was defined as PCI to unprotected left main, bifurcation lesions, rotational atherectomy or intravascular lithotripsy use, severe left ventricular systolic dysfunction, chronic total occlusion, or vein graft PCI. The primary outcome was composite MACCE comprising all-cause mortality, stroke, non-fatal MI, emergency CABG, unplanned revascularisation, definite stent thrombosis and major bleeding (BARC 3 &amp; 5) at 30-days. Risk ratio for average treatment effect in the NOSCS cohort was estimated using inverse probability treatment weighting. Results 94,268 total PCI procedures (32.6% NOSCS) were analysed, including 12,459 complex PCI cases (28.7% NOSCS). Patients from NOSCS were younger (65.0 vs 67.4, p&amp;lt;0.001), less likely to have had previous PCI (29.5% vs 34.5%, p&amp;lt;0.001) or CABG (4.6% vs 8.0% p&amp;lt;0.001) and presented more frequently with acute coronary syndromes (NSTEMI [32.0% vs 28.0%, p&amp;lt;0.001; STEMI [23.3% vs 15.2%], p&amp;lt;0.001). A propensity weighted sample of 30,850 OSCS patients and 30,692 NOSCS patients demonstrated no difference in adjusted 30-day MACCE (risk ratio 0.93, 95% CI 0.87-1.01, p=0.051) for all PCI procedures. In a propensity-weighted subgroup of 3,638 OSCS and 3,576 NOSCS patients who underwent complex PCI, there was also no difference in adjusted 30-day MACCE (risk ratio 0.97, 95%CI 0.86-1.09, p=0.60). Unadjusted rates of CABG at 30-days were very low (0.1 vs 0.1%, p=1.00). Conclusion Patients undergoing PCI and complex PCI at NOSCS centres had comparable 30-day outcomes to those treated at OSCS centres. Newer percutaneous therapies such as intravascular lithotripsy and percutaneous left ventricular assist devices may further improve safety and efficacy of high-risk PCI in NOSCS centres as operator experience increases. Increasing PCI and complex PCI capabilities at NOSCS is likely to increase equitable treatment access for more patients.

Trends and predictors of cardiac rehabilitation referrals and participation in patients undergoing elective percutaneous coronary intervention

Abstract Background Research evidence shows that greater cardiac rehabilitation (CR) referrals and participation can reduce cardiovascular mortality and morbidity, which leads to social and economic benefits (1). It remains unknown, however, what the CR referrals and participation are for patients following elective percutaneous coronary intervention (PCI). Aim Our aim was to identify the prevalence, trends, and predictors of CR referrals and participation in patients undergoing elective PCI between July 2017 and December 2021 among six public hospitals in one of the Australian states. Methods A retrospective observational study was conducted. Data were extracted from a state-wide Cardiac Outcomes Registry for patients who underwent elective PCI. Patients were identified if they were referred to CR following hospital discharge. CR participation has two assessments. The initial assessment focuses on a comprehensive cardiovascular risk factor review that occurs before attending a CR program, whereas the final assessment represents CR completion. We conducted descriptive and inferential statistical analyses. Results Out of 3081 patients who underwent elective PCI, 1845 (59.9%) had CR referrals. Of the 1845 patients who had CR referred, 1022 (55.4%) completed an initial assessment, and 400 (21.7%) completed both an initial and final assessment. The rate of CR referrals increased from 12.0% in 2017 to 23.5% in 2018 before decreasing slightly in 2019 and 2020 (21.0% and 22.8%, respectively). There was a decline in the proportion of patients who had an initial assessment from 44.0% in 2017 to 29.0% in 2021. The rate of the final assessment showed a slight increase from 32% in 2017 to 41% in 2021. Multivariate logistic regression showed that of those patients undergoing PCI, patients who stayed overnight were 9.9 times more likely to receive a CR referral than those with same-day discharge. However, for those who had CR referrals, overnight stay was not a predictor in completing the initial assessment. Similarly, of those who completed an initial assessment, overnight stay was also not a predictor in completing the final assessment; rather, those with a positive family history were more likely to complete the final assessment. Conclusion Our findings reveal a low CR referral rate in patients undergoing elective PCI, and overnight stay is a strong predictor for CR referrals. As a referral is a gateway to CR participation (2), more work is needed to explore the options to increase CR referrals, particularly for patients discharged on the same day as their procedure. Following referrals, overnight stay did not predict completion of initial and final assessments, indicating that other strategies are required to promote CR participation.

Short-term neurologic outcomes in pediatric extracorporeal membrane oxygenation are proportional to bleeding severity graded by a novel bleeding scale.

This study aimed to characterize the severity of bleeding and its association with short-term neurologic outcomes in pediatric ECMO. Multicenter retrospective cohort study of pediatric ECMO patients at 10 centers utilizing the Pediatric ECMO Outcomes Registry (PEDECOR) database from December 2013-February 2019. Subjects excluded were post-cardiac surgery patients and those with neonatal pathologies. A novel ECMO bleeding scale was utilized to categorize daily bleeding events. Poor short-term neurologic outcome was defined as an unfavorable Pediatric Cerebral Performance Category (PCPC) or Pediatric Overall Performance Category (POPC) (score of >3) at hospital discharge. This study included 283 pediatric ECMO patients with a median (interquartile range [IQR]) age of 1.3years [0.1, 9.0], ECMO duration of 5days [3.0, 9.5], and 44.1% mortality. Unfavorable PCPC and POPC were observed in 48.4% and 51.3% of patients at discharge, respectively. Multivariable logistic regression analysis included patient's age, cannulation type, duration of ECMO, need for cardiopulmonary resuscitation, acute kidney injury, new infection, and vasoactive-inotropic score. As the severity of bleeding increased, there was a corresponding increase in the likelihood of poor neurologic recovery, shown by increasing odds of unfavorable neurologic outcome (PCPC), with an adjusted odds ratio (aOR) of 0.77 (confidence interval [CI] 0.36-1.62), 1.87 (0.54-6.45), 2.97 (1.32-6.69), and 5.56 (0.59-52.25) for increasing bleeding severity (grade 1 to 4 events, respectively). Similarly, unfavorable POPC aOR (CI) was 1.02 (0.48-2.17), 2.05 (0.63-6.70), 5.29 (2.12-13.23), and 5.11 (0.66-39.64) for bleeding grade 1 to 4 events. Short-term neurologic outcomes in pediatric ECMO are proportional to the severity of bleeding events. Strategies to mitigate bleeding events could improve neurologic recovery in pediatric ECMO.

The European Registry of Quality Outcomes for Cataract and Refractive Surgery: Benefits and Lessons of a Multinational Registry

Cataract surgery is the most commonly performed surgery worldwide. However, there is significant variation in practice both within and among countries. The European Registry of Quality Outcomes for Cataract and Refractive Surgery was established in 2007 to address this variation and improve the quality of care. Based on registry data from more than 500,000 surgeries, the registry developed the first European guidelines for cataract surgery, with plans to improve those guidelines continuously with registry-based studies. At this point, the registry has collected data from more than 4 million surgeries, creating opportunities for establishing guidelines, conducting research, and benchmarking. This article describes how the registry was developed, its achievements, planned refinements, efforts to expand participation, the challenges encountered, and future potential.

Jehovah's Witnesses: Challenges in liver disease management and in liver transplantation.

Patients of Jehovah's Witnesses faith who are in need of liver transplantation pose unique challenges. These patients should be seen at transplant centers with experience in caring for Jehovah's Witnesses to formulate careful preoperative, intraoperative, and postoperative strategies on an individualized basis with multidisciplinary input to mitigate the risk of bleeding complications and to prepare for potentially catastrophic scenarios. In-depth and individualized conversations about what constitutes acceptable bloodless transfusion strategies both for the patient and for the transplant center should begin as early as possible with an experienced coordinator or church liaison. A therapeutic physician-patient relationship is vital to formulating a safe care plan and to understanding the spectrum of beliefs among Jehovah's Witnesses. There remains a paucity of data on disparities in liver care and outcomes in patients of the Jehovah's Witnesses faith. Future research on liver diseases and liver transplantation in Jehovah's Witnesses should focus on creating registries of patient outcomes and centers with experience.

Pediatric Extracorporeal Membrane Oxygenation in Restrictive and Hypertrophic Cardiomyopathy: A Single Center Experience

Patients with restrictive cardiomyopathy (RCM) and hypertrophic cardiomyopathy (HCM) were previously considered poor candidates for mechanical circulatory support due to technical limitations related to restrictive ventricular physiology and small ventricular size, limiting the ability to provide adequate flows and decompress the heart. Literature examining use of extracorporeal membrane oxygenation (ECMO) in this population consists of a single case series reporting no survivors. We report our experience providing ECMO in children with RCM or HCM at a large pediatric quaternary cardiac center. Between 2012 and 2022, five patients (four RCM, one HCM) were supported with seven ECMO runs. All patients were cannulated to ECMO with ongoing cardiopulmonary resuscitation. Four patients survived decannulation from ECMO (median support time 209 hr, interquartile range [IQR]: 48–265), of which three (60%) survived to hospital discharge after transitioning to a ventricular assist device (VAD) and undergoing orthotopic heart transplant (OHT). Two remain alive at long-term follow-up with normal or mildly impaired functional status. These findings suggest that while RCM and HCM have traditionally been considered contraindications to ECMO due to adverse outcomes, this population may be successfully supported with ECMO with survival comparable to international registry outcomes in select centers where VAD as a bridge to OHT is available.

Timeliness of reperfusion in ST-segment elevation myocardial infarction and outcomes in Kerala, India: results of the TRUST outcomes registry.

Transatlantic guidelines endorse quality metrics for timely reperfusion in patients with ST-elevation myocardial infarction (STEMI). Compliance in low- and middle-income countries (LMICs) is largely unknown. We prospectively evaluated 2928 STEMI patients in Kerala, India, across 16 PCI-capable hospitals who received reperfusion with either primary percutaneous coronary intervention (PPCI) or fibrinolysis. Primary endpoint was a major adverse cardiovascular event (MACE) composite of death, non-fatal myocardial infarction, stroke or readmission for heart failure at 1-year. Among reperfused STEMI patients, 320 (10.9%) received timely reperfusion with either PPCI or fibrinolysis, 1985 (67.8%) received delayed PPCI, and 623 (21.3%) received delayed fibrinolysis. Timely reperfusion had lower unadjusted MACE rates than delayed PCI or fibrinolysis (timely reperfusion: 11.9%, delayed PPCI: 13.6%, delayed fibrinolysis: 23.9%, P < 0.001). Mortality was lowest in the timely reperfusion group (timely reperfusion: 6.3%, delayed PPCI: 7.8%, delayed fibrinolysis 18.8%, P < 0.001). After multivariate analysis, delayed fibrinolysis had a higher MACE rate (HR 1.52 95% CI 1.04-2.21) and mortality (HR 1.97, 95% CI 1.18-3.25) compared to timely reperfusion. Total ischemic time > 3h and delayed first medical contact-to-needle time predicted MACE at 1 year. Among STEMI patients in Kerala, India, only one in 10 eligible patients received timely reperfusion. Longer total ischemic times and delayed fibrinolysis were associated with 1-year MACE. Improving timely reperfusion is critical to enhancing STEMI outcomes in LMICs. What is already known on this topic Given the established link between delay to reperfusion and worse major adverse cardiac events (MACE), global efforts have concentrated on minimizing different components of the total ischemic time to improve ST-elevation myocardial infarction (STEMI) outcomes. Compliance in low- and middle-income countries (LMICs) is largely unknown. What this study adds In this cohort of STEMI patients in Kerala, India, total ischemic time and first medical contact-to-needle time correlated with long-term MACE rates, whereas other timeliness indicators did not. How this study might affect research, practice or policy Our study highlights the significant barriers to accessing STEMI care that are prevalent in LMICs despite incremental growth in the number of PCI-capable hospitals. The pre-hospital phase within total ischemic time is the most important quality improvement metric of STEMI care in LMICs, especially for patients chosen for fibrinolysis.

Baseline characteristics and predictors for early implantation of vagus nerve stimulation therapy in people with drug-resistant epilepsy: Observations from an international prospective outcomes registry (CORE-VNS).

Vagus nerve stimulation (VNS) Therapy is routinely indicated for people with drug-resistant epilepsy (DRE). We analyzed the baseline characteristics of individuals receiving the recently released VNS models and identified factors associated with early or late implantation. The Comprehensive Outcomes Registry of subjects with Epilepsy (CORE-VNS), a prospective observational study evaluating the clinical and psychosocial outcomes of VNS Therapy®, is following participants for up to 60 months after VNS implantation. In this analysis, we used Cox proportional hazards model to identify baseline characteristics associated with the time from diagnosis to first implantation. Of the 819 enrolled, 792 (96.7%) participants implanted with a VNS device were evaluated. 529 (64.6%) underwent the first implantation and 263 (32.1%) a re-implantation. Participants' median age at first implant was 24 years; 492 (62.1%) were ≥18 years old and 166 (20.3%) were < 12 years old. The average number of failed ASMs prior to VNS implantation was 7.1, and 145 (17.7%) had undergone previous epilepsy-related surgery. Epilepsy was classified as focal in 47.7% of participants, generalized in 16.1% and combined focal and generalized in 34.2%. Many of the participants (40.9%) had epilepsy of unknown etiology. The median time from diagnosis to first implantation was 10.33 years and was significantly shorter in participants with combined focal and generalized epilepsy compared to those with focal epilepsy alone, and in participants with genetic and immune epilepsy compared to those with unknown etiologies. In people with DRE, VNS Therapy is provided after multiple failures of ASMs and after failure of epilepsy surgery in one in six individuals. Time from diagnosis to first implantation is associated with epilepsy type and etiology, likely reflecting variable treatment pathways. Clearer guidelines on when and how non-drug therapies should be deployed in people with DRE related to different epilepsy factors are needed. Neuromodulation can be a very helpful treatment in people who have seizures that do not respond to medications. The most widely utilized neuromodulation therapy is vagus nerve stimulation (VNS). We present data from a large, global study to show that people use an average of seven anti-seizure medications before attempting VNS Therapy and that it takes about 10 years for people to get their first VNS implant. We advocate for clearer treatment guidelines on how and when to consider VNS Therapy in people with seizures that are resistant to medication.

Cardiac MRI Predictors of Arrhythmic Sudden Cardiac Events in Patients With Fontan Circulation

BackgroundAmong patients with congenital heart disease, those with single ventricles have the highest risk of early mortality. Sudden cardiac death is an important cause of death in this population. Understanding the risk factors for sudden cardiac events (SCE) in Fontan patients could improve prediction and prevention. ObjectivesThe goal of this study was to determine the prevalence of SCE and risk factors for SCE in the Fontan population. MethodsThe Fontan Outcomes Registry Using CMR Examinations (FORCE) is an international registry collecting clinical and imaging data on Fontan patients. SCE was defined as: 1) cardiac arrest from a shockable rhythm; 2) need for emergent cardioversion/defibrillation; or 3) documented sustained ventricular tachycardia. Univariate and multivariate Cox proportional hazards regression models estimated hazard ratios for predictors of SCE. ResultsOur sample included 3,132 patients (41% female). The median age at first cardiac magnetic resonance was 14.6 years. SCE was experienced by 3.5% (n = 109) over a median follow-up time of 4.00 years. Of the 109 patients with SCE, 39 (36%) died. On multivariable analysis, NYHA functional class >II (HR: 4.91; P < 0.0001), history of protein-losing enteropathy/plastic bronchitis (HR: 2.37; P = 0.0082), single-ventricle end-diastolic volume index >104 mL/m2 (HR: 3.15; P < 0.0001), and ejection fraction <50% (HR: 1.73; P = 0.0437) were associated with SCE. Kaplan-Meier analysis demonstrated that in patients with none of the above risk factors, the 4-year freedom from SCE was 99.5%. ConclusionsSCE occurred in 3.5% of the study population, and one-third of patients who experienced SCE died. Mild ventricular dysfunction and dilatation by cardiac magnetic resonance, NYHA functional class, and history of protein-losing enteropathy/plastic bronchitis were associated with SCE.

Outcomes following intensive allied health therapy in the acute hospital for trauma patients

The majority of patients hospitalised for trauma survive their injuries, with the quality of the survival potentially influenced by early acute hospital rehabilitation. The aim of this study was to review the outcomes of patients managed under an intensive Allied Health Model of Care (AHMOC) compared to a baseline cohort. MethodsThe AHMOC was commenced in February 2020 on the Trauma ward at Alfred Health for 12 months. The baseline group included patients admitted to the trauma ward in 2019. All patients who were registered by either the Victorian Orthopaedic Trauma Outcomes Registry (VOTOR) or the Victorian State Trauma Registry (VSTR). The association between the groups (AHMOC and baseline) and outcomes were assessed using logistic (discharge destination, 12-month return to work) and linear (length of stay (LOS)) regression. ResultsThere were 1644 in the baseline group and 1732 in the AHMOC group, of which 70 % and 76 % respectively were discharged directly home from the acute hospital (p value < 0.001). The trauma ward LOS was 4.0 days for each group (p value 0.77). After accounting for confounders, the adjusted odds of discharge home and RTW at 12 months were 53 % (AOR 1.53 95 % CI 1.29, 1.82) and 65 % (AOR 1.65 95% CI 1.24, 2.21) higher for the AHMOC group compared to baseline, respectively. There was also a 6 % reduction in the LOS in the AHMOC group compared to baseline (Adjusted mean difference 6 %; 95 % CI (0.881, 0.999) p value = 0.050). ConclusionThis study shows an association between an AHMOC for trauma patients with a focus on early and intensive therapy and improved odds of discharge directly home, as well as improved 12 month return to work outcomes.

Procedural Sedation and Analgesia in an Australian Emergency Department: Results of the First 3 Months of a Procedural Sedation Registry

Background: Procedural sedation and analgesia (PSA) is commonly performed in emergency departments (EDs) to reduce anxiety, discomfort, or pain during a procedure. The primary goal of PSA is to produce a state of relaxation and drowsiness without eliminating the patient’s protective reflexes. Despite the discovery of new techniques and medications to deliver PSA, there is a paucity of research evaluating PSA in EDs over the last decade. We aim to describe the current practice of PSA in an Australian tertiary mixed ED with 75,000 presentations per year. Methods: A retrospective study of the initial 3 months of a PSA registry, which was part of the Tasmanian Emergency Care Outcomes Registry, was analyzed; Results: All told, 80 consecutive cases were entered over a 3-month period, with pediatric patients (&lt;14 years old) making up 35% of all cases. Joint reductions (17, 39%) and fracture reductions (13, 29%) were the most common indications for the adult population, whilst fracture reductions (9, 36%), laceration repairs (7, 28%), and other distressing procedures (7, 28%) were the most common indications in the pediatric cohort. Pharmacological approaches also differed between groups, with ketamine (25, 92%) preferred in the pediatric cohort whilst the combination of propofol and fentanyl (22, 42%) was preferred in the adult cohort. No adverse events were recorded in the pediatric cohort whilst 6 (8%) minor events occurred in the adult population, with no severe events occurring for either cohort. PSA also occurred more frequently at 0900–1000 and the incidence was reduced between 0000 and 0800. Conclusions: PSA is commonly performed in our tertiary mixed ED and is both safe and effective, with non-severe complication rates similar to those in the reported literature. Severe complications are rare and therefore a larger cohort will be required to assess this aspect. The approach to ED PSA is also different between pediatric and adult populations and therefore research needs to differentiate both populations.