Reduction In Adverse Outcomes Research Articles

Determining sample size in a personalized randomized controlled (PRACTical) trial.

In clinical settings with no commonly accepted standard-of-care, multiple treatment regimens are potentially useful, but some treatments may not be appropriate for some patients. A personalized randomized controlled trial (PRACTical) design has been proposed for this setting. For a network of treatments, each patient is randomized only among treatments which are appropriate for them. The aim is to produce treatment rankings that can inform clinical decisions about treatment choices for individual patients. Here we propose methods for determining sample size in a PRACTical design, since standard power-based methods are not applicable. We derive a sample size by evaluating information gained from trials of varying sizes. For a binary outcome, we quantify how many adverse outcomes would be prevented by choosing the top-ranked treatment for each patient based on trial results rather than choosing a random treatment from the appropriate personalized randomization list. In simulations, we evaluate three performance measures: mean reduction in adverse outcomes using sample information, proportion of simulated patients for whom the top-ranked treatment performed as well or almost as well as the best appropriate treatment, and proportion of simulated trials in which the top-ranked treatment performed better than a randomly chosen treatment. We apply the methods to a trial evaluating eight different combination antibiotic regimens for neonatal sepsis (NeoSep1), in which a PRACTical design addresses varying patterns of antibiotic choice based on disease characteristics and resistance. Our proposed approach produces results that are more relevant to complex decision making by clinicians and policy makers.

Oral versus intravenous iron for anemia in pregnancy: a cost-effectiveness analysis.

Our findings suggest that treating antepartum anemia with currently available iron therapies would result in significant cost-savings and reductions in adverse outcomes associated with anemia in this context. Ferric carboxymaltose likely confers the greatest overall benefit among competing options. This conclusion is robust to uncertainty, even when the cost these therapies is significantly higher than is demonstrated in the literature.

Personalized Predictive Hemodynamic Management for Gynecologic Oncologic Surgery: Feasibility of Cost-Benefit Derivatives of Digital Medical Devices.

Intraoperative hypotension is associated with increased perioperative complications, hospital length of stay (LOS) and healthcare expenditure in gynecologic surgery. We tested the hypothesis that the adoption of a machine learning-based warning algorithm (hypotension prediction index-HPI) might yield an economic advantage, with a reduction in adverse outcomes that outweighs the costs for its implementation as a medical device. A retrospective-matched cohort cost-benefit Italian study in gynecologic surgery was conducted. Sixty-six female patients treated with standard goal-directed therapy (GDT) were matched in a 2:1 ratio with thirty-three patients treated with HPI based on ASA status, diagnosis, procedure, surgical duration and age. The most relevant contributor to medical costs was operating room occupation (46%), followed by hospital stay (30%) and medical devices (15%). Patients in the HPI group had EURO 300 greater outlay for medical devices without major differences in total costs (GDT 5425 (3505, 8127), HPI 5227 (4201, 7023) p = 0.697). A pre-specified subgroup analysis of 50% of patients undergoing laparotomic surgery showed similar medical device costs and total costs, with a non-significant saving of EUR 1000 in the HPI group (GDT 8005 (5961, 9679), HPI 7023 (5227, 11,438), p = 0.945). The hospital LOS and intensive care unit stay were similar in the cohorts and subgroups. Implementation of HPI is associated with a scenario of cost neutrality, with possible economic advantage in high-risk settings.

The impact of the affordable care act on access to bariatric surgery in Maryland

IntroductionThis study aims to investigate the influence of the Affordable Care Act (ACA) on the utilization of Roux-en-Y gastric bypass (RYGB) procedures in Maryland. MethodsUsing the Maryland State Inpatient Database, this retrospective study compared all patients undergoing RYGB during the pre-ACA (2007–2009) and post-ACA (2018–2020) periods, including patient demographic factors, pre-existing conditions, and socioeconomic factors. ResultsA total of 16,494 RYGB procedures were performed during the study period, of which 12,089 (73.3 ​%) were post-ACA. This was a 179.2 ​% increase in patients undergoing RYGB post-ACA; nearly triple that of the pre-ACA period. There was a significant decrease in uninsured patients (5.6 ​%–1.5 ​%, p ​< ​0.01) an increase in Black patients (32.1 ​%–46.8 ​%, p ​< ​0.01) and Medicaid beneficiaries (6.0 ​% pre-ACA to 17.8 ​% post-ACA, p ​< ​0.01). There were significant reductions in adverse outcomes (long hospital stays, hemorrhage, GIT leaks, and mortality) across all insurance types (all p ​< ​0.01). ConclusionThe ACA increased access to RYGB procedures, especially in Black and Medicaid recipients in Maryland, enhancing healthcare across all insurance types.

Reduction of adverse outcomes from cesarean section by surgical-site infection prevention care bundles in maternity.

To reduce average surgical-site infection (SSI) rates to less than 7.5%, as well as other complications by incrementally implementing an SSI prevention care bundle in maternity: (1) ChloraPrep; (2) PICO dressings, performing elective cesarean sections in a main theater rather than a labor ward and warming blankets; (3) vaginal cleansing; and (4) Hibiscrub. In this prospective cohort study, the association between categorical variables was assessed by χ2 tests, temporal trends in the monthly percentage change of SSI were measured using the Joinpoint Regression Program v4.7.0.0. In all, 1682 women (mean age 33.1± 5.2 years) underwent either elective (53.9%) or emergency (46.1%) cesarean section. After a small initial increase (10.0%-11.8%), SSI progressively declined to 4.4% (χ2 = 22.1, P< 0.001), as did sepsis, reoperation or readmission for SSI: from 12.5% to 0.5% (χ2 = 90.1, P< 0.001). The rates of SSI fell progressively with the cumulative introduction care bundle components. The average monthly percentage change was -14.0% (95% confidence interval -21.8% to -5.4%, P= 0.004), and the average SSI rate was kept below 7.5% for the last 12 months of the study. The maternal SSI prevention care bundle is simple and inexpensive; it effectively reduces SSI after a cesarean section and should be offered routinely to women undergoing cesarean section.

Effectiveness of a disease management program in heart failure is influenced by patient's prior hospitalisation

Abstract Background Hospitalization due to heart failure (HF) is a strong predictor of adverse outcomes. This study sought to what extent previous HF admissions may affect the success of a disease management program (DMP). Methods We prospectively enrolled 1363 consecutive HF patients, who were followed for 3 months post-discharge. Of these, 431 (31%) received a DMP (1-month duration, including post-discharge home visits, medication reconciliation, exercise guidance and early clinical review). Study outcomes were all-cause readmission or death at 30- and 90-day post-discharge. Previous HF admissions were collected from medical records. Results Of 1363 HF patients, death or readmission occurred in 386 (28%) at 30-day and 556 (41%) at 90-day post-discharge. Compared to 765 patients without any previous admission, the 143 patients with a previous HF admission in &amp;gt;12 months had similar risks of readmission or death at 30-day and 23% higher risks at 90-day. The 420 patients who had a previous HF admission in ≤12 months had higher risks of the composite outcome both at 30-day (RR=1.47 [1.23–1.76]) and 90-day (RR=1.49 [1.30–1.69]). DMP was not associated with any reductions in adverse outcomes at 30-day and 90-day among patients with a previous HF admission in ≤12 months, but was significantly associated with up to a 75% reduction in risks at 30-day and a 50% reduction in risks at 90-day among those without an admission in ≤12 months. These findings were independent of all other factors. Conclusion Higher levels of attention should be focused on HF patients with a recent prior HF admission who have higher risks of post-discharge adverse outcomes and appear to be non-responsive to a DMP to reduce readmission. Funding Acknowledgement Type of funding sources: None.

The influence of regulation of medically assisted reproduction on the risk of hospitalization in the first 2years of life.

Do publicly funded fertility treatment and single embryo transfer (SET) result in lower hospitalization rates of children of parents with infertility? Following the 2010 Quebec law introducing free fertility treatment and SET, neonatal intensive care unit (NICU) admissions decreased among all children born to parents with infertility, but not among singletons, whose risk remained slightly higher than that of children of parents without infertility, even accounting for treatment and maternal age. Previous studies reported lower NICU admission rates among children conceived with ART after the 2010 law; however, children conceived without ART by parents with infertility were not considered. Cohort study of children born in 1997-2017 to patients evaluated for infertility ('exposed') at an academic fertility center in Montreal (Canada) in 1996-2015. A random sample of births to Montreal residents served as comparison. Outcomes were identified from Quebec administrative databases. We compared children's healthcare utilization before and after the 2010 law in 6273 exposed and 12583 randomly sampled births (6846 and 12775 children, respectively). We repeated the analysis among children conceived in the 63 months before and after the law ('restricted period'), and examined whether differences in twinning, fertility treatment, and maternal age explained the higher risk of NICU admission among children of parents with infertility. In the exposed cohort, the proportion of twin births and of several adverse outcomes declined after the law. NICU admission and duration of NICU stay decreased overall, but not in singletons. Both measures remained higher in exposed children. Except for NICU admission, hospitalization rates were similar in exposed and random sample children. After accounting for fertility treatment and maternal age, exposed singletons were 17% more likely to be admitted to the NICU than children of parents with no medical history of infertility. Sample size was relatively small; infertile patients were from a single center and the random sample from one city. Despite some limitations, administrative databases are likely to accurately reflect healthcare utilization. Universal access to treatment and, particularly, SET results in an overall reduction of adverse outcomes among children conceived with treatment; however, children of parents with infertility are at a slightly higher risk, regardless of treatment. This study was funded by the Canadian Institutes for Health Research (CIHR, grant no. 123362). No competing interests. N/A.

O-144 Adverse pregnancy and neonatal outcomes in an oocyte donation program. Expanded Carrier Screening can substantially decrease the risk of recessive conditions

Abstract Study question How frequent are adverse outcomes in oocyte donation (OD) programs and how many recessive conditions can be prevented with the implementation of expanded carrier screening(ECS)? Summary answer Adverse outcomes were reported only in 1.55% of cases. ECS prevented 2.66% autosomal recessive and X-linked-conditions, interpreted in a 63% decrease in adverse outcomes. What is known already Nowadays, oocyte donors undergo a rigorous selection process, including the evaluation of genetic risks. ECS has been widely implemented in the screening of gamete donors. Nevertheless, pregnancies conceived after OD cycles are still at risk for genetic adverse outcomes. There are very few reports in the literature regarding children born with an inherited genetic condition from a gamete donor, and they are reported in sperm donation-conceived offspring. To our knowledge, there is no published review of genetic adverse outcomes in oocyte donation offspring so far. Study design, size, duration This is a retrospective observational study that analyses the adverse events reported in 4573 OD cycles carried out between January 2014 and December 2021 in the Reproductive Medicine Unit of Dexeus University Hospital. The study also reviews the number of high-risk assignations that has been identified in the OD program where ECS was applied to the oocyte donors and the recipient’s male partner to avoid high-risk assignations. Participants/materials, setting, methods The study includes patients who underwent OD cycles and reported an adverse outcome with a potential genetic aetiology from 2014 to 2021. Moreover, genetic matchings were revised in the OD program and high-risk assignations were defined as matchings where oocyte donors and recipients’ male partners were carriers of the same autosomal recessive condition or as matchings where oocyte donor candidates were found to be carriers of X-linked conditions. Main results and the role of chance A total of 4.573 OD cycles were performed, including 1696 oocyte donors. Seventy-one recipients (1.55%) reported an adverse outcome of the pregnancy or children born from the OD. A confirmed genetic aetiology was reported in 23 (32.4%) cases including chromosomal abnormalities, microduplications and monogenic disorders. The reported remaining cases were due to congenital malformations, stillbirth, neurodevelopmental disorders, and other conditions for which a genetic aetiology has not been established to our knowledge. Moreover, we identified 211 (4.6%) high-risk assignations due to oocyte donors and recipient’s male partners being carriers of the same autosomal recessive condition when initially assigned, which would have led to an additional 1,15% of children born with an autosomal recessive conditions (25% of 4.6% high-risk assignations). Additionally, we rejected 52 (3.07%) oocyte donor candidates that were carriers of X-linked conditions, which would have led to an additional 1.5% of children born with an X-linked disorder. Based on our results, implementation of ECS, resulted in 63% risk reduction in adverse outcomes observed in our oocyte donation program from a potential adverse event rate of 4.2% to an actual 1.55% incidence of adverse outcomes. Limitations, reasons for caution The actual number of adverse outcomes and high-risk assignations in an OD program could be underestimated given that not all patients report the adverse outcome or in some cases adverse events have not yet developed. Additionally, the number of rejected/avoided high-risk assignations in ECS is not always collected. Wider implications of the findings This study provides evidence that ECS reduces the probability that children born from OD could inherit some autosomal recessive or X-linked conditions. However, there are still several genetic adverse events that cannot be avoided by implementing ECS, mostly caused by de novo monogenic changes, chromosomal abnormalities, or congenital malformations. Trial registration number Not applicable

Impact of Integrated Care Management on Clinical Outcomes in Atrial Fibrillation Patients: A Report From the FANTASIIA Registry.

BackgroundAn integrated and holistic approach is increasingly advocated in patients with atrial fibrillation (AF), based on the “Atrial fibrillation Better Care (ABC) pathway: A, Avoid stroke with anticoagulation; B, better symptom management; C, cardiovascular and comorbidity risk management.” The aim of this study was to examine the prevalence of adherence to each component of the ABC pathway and to analyze its impact on long-term prognosis in the “real-world” cohort of AF patients from the FANTASIIA registry.MethodsThis prospective study included consecutive AF outpatients anticoagulated with direct oral anticoagulants (DOAC) or vitamin K antagonists (VKA) from June 2013 to October 2014. From the ABC pathway, adherence to the “A criterion” was defined by a time in the therapeutic range (TTR) ≥ 70% or correct dose with DOAC; “B criterion” adherence was defined by a European Heart Rhythm Association (EHRA) Symptom Scale I-II; and “C criterion” adherence was defined as optimized risk factors and comorbidity management. Baseline features and embolic events, severe bleeding, and all-cause and cardiovascular mortality rates up to 3 years of follow-up were analyzed, and a Cox multivariate analysis was performed to investigate the role of each component of the ABC pathway in predicting major events.ResultsA total of 1,955 AF patients (age: 74.4 ± 9.4 years; 43.2% female patients) were included in this study: adherence to A criterion was observed in 920 (47.1%) patients; adherence to B criterion was observed in 1,791 (91.6%) patients; and adherence to C criterion was observed in 682 (34.8%) patients. Only 394 (20.2%) of the whole population had good control of AF according to the ABC pathway. After a median follow-up of 1,078 days (IQR: 766–1,113), adherence to A criterion was independently associated with reduced cardiovascular mortality [HR: 0.67, 95%CI (0.45–0.99); p = 0.048] compared with non-adherence. Adherence to the B criterion was independently associated with reduced stroke [HR: 0.28, 95%CI (0.14–0.59); p < 0.001], all-cause mortality [HR: 0.49, 95%CI (0.35–0.69); p < 0.001], cardiovascular mortality [HR: 0.39, 95%CI (0.25–0.62); p < 0.001], and major adverse cardiovascular events (MACE) [HR: 0.41, 95%CI (0.28–0.62); p < 0.001] compared with non-adherence. AF patients with C criterion adherence had a significantly lower risk of myocardial infarction [HR: 0.31, 95%CI (0.15–0.66); p < 0.001]. Fully adherent ABC patients had a significant reduction in MACE [HR: 0.64, 95%CI (0.42–0.99); p = 0.042].ConclusionIn real-world anticoagulated AF patients from FANTASIIA registry, we observed a lack of adherence to integrated care management of AF following the ABC pathway. AF managed according to the ABC pathway was associated with a significant reduction in adverse outcomes during long follow-up, suggesting the benefit of a holistic and integrated approach to AF management.

Cardiovascular disease prevention: Risk factor modification at the heart of the matter

Cardiovascular disease prevention: Risk factor modification at the heart of the matter

Integrated Care Systems and the Aortovascular Hub.

Aortovascular medicine and surgery in relation to vascular health of the population requires input from a broad range of specialists and institutions throughout a patient life as well as integration with allied health care providers. This paper presents the essence of the novel clinical concept of the 'Aortovascular Hub' .

Evaluation of Vaccination Strategies to Compare Efficient and Equitable Vaccine Allocation by Race and Ethnicity Across Time

Identifying the most efficient COVID-19 vaccine allocation strategy may substantially reduce hospitalizations and save lives while ensuring an equitable vaccine distribution. To simulate the association of different vaccine allocation strategies with COVID-19-associated morbidity and mortality and their distribution across racial and ethnic groups. We developed and internally validated the risk of COVID-19 infection and risk of hospitalization models on randomly split training and validation data sets. These were used in a computer simulation study of vaccine prioritization among adult health plan members who were drawn from an integrated health care delivery system. The study was conducted from January 3, 2021, to June 1, 2021, in Oakland, California, and the data were analyzed during the same period. We simulated the association of different vaccine allocation strategies, including (1) random, (2) a US Centers for Disease Control and Prevention (CDC) proxy, (3) age based, and (4) combinations of models for the risk of adverse outcomes (CRS) and COVID-19 infection (PROVID), with COVID-19-related hospitalizations between May 1, 2020, and December 31, 2020, that were randomly permuted by month across 250 simulations and assessed vaccine allocation by race and ethnicity and the neighborhood deprivation index across time. The study included 3 202 679 adult patients (mean [SD] age, 48.2 [18.0] years; 1 677 637 women [52.4%]; 1 525 042 men [47.6%]; 611 154 Asian [19.1%], 206 363 Black [6.4%], 642 344 Hispanic [20.1%], and 1 390 638 White individuals [43.4%]), of whom 36 137 (1.1%) were positive for SARS-CoV-2. A risk-based strategy (CRS/PROVID) showed the largest avoidable hospitalization estimates (4954; 95% CI, 3452-5878) followed by age-based (4362; 95% CI, 2866-5175) and CDC proxy (4085; 95% CI, 2805-5109) strategies. Random vaccination showed substantially lower reductions in adverse outcomes. Risk-based strategies also showed the largest number of avoidable COVID-19 deaths (joint CRS/PROVID) and household transmissions. Risk-based (PROVID) and CDC proxy strategies were estimated to vaccinate the highest percentage of Hispanic and Black patients in 8 months (joint CRS/PROVID: 642 570 [100%] Hispanic, 185 530 [90%] Black; PROVID: 642 570 [100%] Hispanic, 198 480 [96%] Black; CDC proxy: 605 770 [95%] Hispanic and 151 772 [74%] Black) compared with an age-based approach (438 423 [68%] Hispanic, 154 714 [75%] Black). Overall, the PROVID and joint CRS/PROVID risk-based strategies were estimated to be followed by the most patients from areas with high neighborhood deprivation index being vaccinated early. In this simulation modeling study of adults from a large integrated health care delivery system, risk-based strategies were associated with the largest estimated reductions in COVID-19 hospitalizations, deaths, and household transmissions compared with the CDC proxy and age-based strategies, with a higher proportion of Hispanic and Black patients were estimated to be vaccinated early in the process compared with the CDC strategy.

One-step or 2-step testing for gestational diabetes: which is better?

In the United States, the common approach to detecting gestational diabetes mellitus is the 2-step protocol recommended by the American College of Obstetricians and Gynecologists. A 50 g, 1-hour glucose challenge at 24 to 28 weeks' gestation is followed by a 100 g, 3-hour oral glucose tolerance test when a screening test threshold is exceeded. Notably, 2 or more elevated values diagnose gestational diabetes mellitus. The 2-step screening test is administered without regard to the time of the last meal, providing convenience by eliminating the requirement for fasting. However, depending upon the cutoff used and population risk factors, approximately 15% to 20% of screened women require the 100 g, 3-hour oral glucose tolerance test. The International Association of Diabetes and Pregnancy Study Groups recommends a protocol of no screening test but rather a diagnostic 75 g, 2-hour oral glucose tolerance test. One or more values above threshold diagnose gestational diabetes mellitus. The 1-step approach requires that women be fasting for the test but does not require a second visit and lasts 2 hours rather than 3. Primarily because of needing only a single elevated value, the 1-step approach identifies 18% to 20% of pregnant women as having gestational diabetes mellitus, 2 to 3 times the rate with the 2-step procedure, but lower than the current United States prediabetes rate of 24% in reproductive aged women. The resources needed for the increase in gestational diabetes mellitus are parallel to the resources needed for the increased prediabetes and diabetes in the nonpregnant population. A recent randomized controlled trial sought to assess the relative population benefits of the above 2 approaches to gestational diabetes mellitus screening and diagnosis. The investigators concluded that there was no significant difference between the 2-step screening protocol and 1-step diagnostic testing protocol in their impact on population adverse short-term pregnancy outcomes. An accompanying editorial concluded that perinatal benefits of the 1-step approach to diagnosing gestational diabetes mellitus "appear to be insufficient to justify the associated patient and healthcare costs of broadening the diagnosis." We raise several concerns about this conclusion. The investigators posited that a 20% improvement in adverse outcomes among the entire pregnancy cohort would be necessary to demonstrate an advantage to the 1-step approach and estimated the sample size based on that presumption, which we believe to be unlikely given the number of cases that would be identified. In addition, 27% of the women randomized to the 1-step protocol underwent 2-step testing; 6% of the study cohort had no testing at all. A subset of women assigned to 2-step testing did not meet the criteria for gestational diabetes mellitus but were treated as such because of elevated fasting plasma glucose levels, presumably contributing to the reduction in adverse outcomes but not to the number of gestational diabetes mellitus identified, increasing the apparent efficacy of the 2-step approach. No consideration was given to long-term benefits for mothers and offspring. All these factors may have contributed to obscuring the benefits of 1-step testing; most importantly, the study was not powered to identify what we understand to be the likely impact of 1-step testing on population health.

Subdorsal Z-flap: a modification of the Cottle technique in dorsal preservation rhinoplasty.

To present the novel technique of subdorsal Z-flap in dorsal preservation rhinoplasty and give an overview on current available dorsal preservation techniques in the literature. The subdorsal Z-flap combines the advantages of the high and low septal strip techniques in dorsal preservation rhinoplasty and ensures well tolerated treatment of the dorsal hump and structural stability. The technique and concept of Dorsal Preservation Rhinoplasty (DPR) has been used for more than a century but only recently gained significant popularity along with specific technical refinements. The advantage of DPR lies in the preservation of the delicate triangular cartilaginous unity of the septal and upper lateral cartilages with its functional and esthetic implications in contrast to all resecting techniques. A variety of modifications of DPR have been published in recent years, each with advantages and disadvantages. The issue of hump recurrence remains a major concern in DPR. We describe the 'subdorsal Z-flap' and related techniques of DPR in detail, present two clinical case studies and discuss alternative technical modifications. The 'subdorsal Z -flap' combines the advantages of the high septal strip procedure with the advantages of the traditional 'low septal strip' or Cottle technique. By starting the incision at a high level, final septal height can be adjusted precisely. By creating a triangular shape with a vertical cut below the K-Area, which is usually the highest point of the hump, significant leverage can be applied from below the hump and the septal overlap may be sutured securely for a stable correction. In combination with Piezo osteotomy and full open approach, great precision and predictability can be achieved. In a recent publication, we presented more than 100 consecutive cases of subdorsal Z-flap DPR with good functional and esthetic outcomes. The subdorsal Z-flap modification is a combination of two popular DPR techniques, fusing their advantages while minimizing risk profile. A slightly higher degree of technical difficulty and necessary tissue dissection provides the benefits of better predictability and reduction of adverse outcomes.

Impact of cardiovascular health status on the association between changes in physical activity and major cardiovascular events and mortality among 88,320 adults: outcomes of the Lifelines Cohort Study

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The Lifelines Biobank initiative received funding from the Dutch Ministry of Health, Welfare and Sport, the Dutch Ministry of Economic Affairs, the University Medical Center Groningen [UMCG], University Groningen and the Northern Provinces of the Netherlands. The work of T.M.H.E is supported by the Netherlands Heart Foundation [Senior E-Dekker grant #2017T051]. Background. Regular physical activity (PA) improves health. Many observational studies investigated the association between PA and health at a single time-point, but PA might change over time. Purpose. To examine the association between change in PA and major adverse cardiovascular events (MACE) and all-cause mortality, and to investigate the impact of cardiovascular health status at baseline on these outcomes. Methods. This study used data from the Lifelines Cohort Study (N = 88,320). Self-reported PA volumes were presented as Metabolic Equivalent of Task (MET) min/week. Change in PA was calculated by subtracting MET-min/week at the first assessment from the second assessment (median interval: 4 yrs), and 5 groups were created; large reduction (&amp;lt; -1500), moderate reduction (-1500 to -250), no change (-250 to 250), moderate improvement (-250 to 250) and large improvement (&amp;gt;1500). The outcome was a combination of MACE and all-cause mortality. Results. During a median follow-up of 7 years, 667 events occurred among healthy individuals (43 ± 12 yrs, 1% of 69,818) and 599 in individuals with CVRF (55 ± 11 yrs, 3% of 18,502). Adjusted for confounders and baseline PA, healthy individuals with a large reduction in PA had a greater risk of incident MACE and mortality (Table). In CVRF, moderate to large improvements in PA were associated with reductions in adverse outcomes. Risk estimates became stronger in individuals with lower baseline PA (&amp;lt;2000 MET-min/week), Table). Conclusions. Maintaining PA in healthy individuals and increasing PA in individuals with CVRF over time is important to prevent MACE and mortality. The impact of changes in PA was stronger for individuals with lower baseline PA. Table. Change of PA, MACE and mortality. Changes in PA Healthy CVRF Large reduction 1.40 [1.02;1.93] 1.27 [0.95;1.70] Moderate reduction 1.22 [0.89;1.68] 0.97 [0.72;1.30] No changes Ref Ref Moderate improvement 1.04 [0.74;1.44] 0.65 [0.47;0.91] Large improvement 0.96 [0.71;1.31] 0.69 [0.51; 0.94] Individuals with lower baseline PA Large reduction 2.24 [0.96;5.21] 2.85 [1.44;5.63] Moderate reduction 1.77 [1.10;2.84] 1.33 [0.89;1.98] No changes Ref Ref Moderate improvement 1.16 [0.73;1.83] 0.49 [0.31;0.76] Large improvement 0.77 [0.48;1.23] 0.58 [0.39;0.86]

HVAD Lavare Cycle Reduces Cerebrovascular Events and Improves Survival

<h3>Purpose</h3> The Lavare Cycle (LC) is a pre-programmed speed modulation algorithm in the HVAD device designed to automatically increase both ventricular and pump washing<b>.</b> The ReVOLVE trial suggested a reduction in adverse outcomes including stroke. We assessed the effect LC ON compared to LC OFF on HVAD implants. <h3>Methods</h3> We conducted a retrospective, single center study from 4/2017 to 6/2020 including all 46 patients who received a HVAD implant. The LC became available to our center on 06/2018. For the majority of patients LC was turned on at the time of implant admission. The primary endpoints were cerebrovascular events (CVE) by INTERMACS definition and survival between LC ON versus LC OFF. Secondary endpoints were GI bleeding and pump thrombosis rates. <h3>Results</h3> Fourty six patients (median age 57 years, 78% male, 58% non-ischemic cardiomyopathy) were implanted with HVAD device from 4/2017 to 6/2020. The median duration of HVAD support was 648 (245-902) days. The LC was activated in 33/46 patients. Median time to cycle activation in the LC ON group from implantation was, median (IQR): 4 (1-36) days. The LC ON group experienced less incidence of CVEs, with 6/33 (18%) in the ON vs. OFF 6/13 (46%), p=0.04 (Fig 1A). The median time of CVE from implant was for LC ON and OFF 223 and 104 days, respectively. Survival was significantly improved in the LC ON 31/33 (94%) vs OFF 7/13 (54%), p=0.003 (Fig 1B). There were however 7/33 GI bleeding events in the ON group while zero events in the OFF, p=0.08. Pump thrombosis events were equal rate in the ON 3/33 (9%) vs OFF 1/13 (8%), p=0.43. <h3>Conclusion</h3> LC ON was associated with a significant lower number of CVE (p =0.04) and better survival (p=0.003). The important impact of speed modulation on reducing neurologic events should be confirmed in a larger HVAD patient population.

Use of learning approaches to predict clinical deterioration in patients based on various variables: a review of the literature

Machine learning can be considered as the current gold standard for predicting deterioration in Intensive Care Unit patients and is in extensive use throughout the world in different fields. As confirmed by many studies, preventing the occurrence of the onset of deterioration in a sufficient time window is a priority in healthcare centers. Also, the significance of enhancing the quality of hospital care and the reduction of adverse outcomes is of great importance. Notably, it is hypothesized that by exploiting recent technologies, models built upon dynamic variables (e.g. vital signs, lab tests, and demographic variables) could reinforce the predictive ability of models aimed at detection of in clinical deterioration with high accuracy, sensitivity and specificity. This manuscript summarises the techniques and approaches proposed in the literature for predicting deterioration and compares the performance and limitations of various approaches grouped based on their application. While several approaches can attain promising results, there is still room for additional improvement, especially in pre-processing and modeling enhancement steps where most methods do not take the necessary steps for ensuring a high-performance result. In this manuscript, the most effective machine learning models, as well as deep learning models, for predicting deterioration of patients are discussed in hopes of assisting the readers with ascertaining the best possible solutions for this problem.

Patent ductus arteriosus shunt elimination results in a reduction in adverse outcomes: a post hoc analysis of the PDA RCT cohort.

A post hoc appraisal of the PDA RCT to assess the relationship between early patent ductus arteriosus (PDA) shunt elimination and chronic lung disease or death (CLD/Death). Infants <29 weeks were divided into four groups: intervention arm in whom PDA closure was achieved (n = 17); intervention arm in whom PDA closure was not achieved (n = 13); placebo arm (n = 30); low risk infants (n = 13). The main outcome measure was CLD/Death. The rates of CLD/Death were lower in the Intervention Success Group (29%) when compared to the Intervention Failure Group (85%) or the Placebo Group (60%, all p < 0.05). There was no difference in CLD/Death between the Intervention Success and Low Risk Groups (8%, p > 0.05). A persistent PDA beyond Day 8 was associated with CLD/Death (aOR 6.5 [1.7-25.5]). Early shunt elimination in preterm infants with a PDA may reduce respiratory morbidity when compared to infants with prolonged shunt exposure.

FIGO (international Federation of Gynecology and obstetrics) initiative on fetal growth: best practice advice for screening, diagnosis, and management of fetal growth restriction.

Fetal growth restriction (FGR) is defined as the failure of the fetus to meet its growth potential due to a pathological factor, most commonly placental dysfunction. Worldwide, FGR is a leading cause of stillbirth, neonatal mortality, and short- and long-term morbidity. Ongoing advances in clinical care, especially in definitions, diagnosis, and management of FGR, require efforts to effectively translate these changes to the wide range of obstetric care providers. This article highlights agreements based on current research in the diagnosis and management of FGR, and the areas that need more research to provide further clarification of recommendations. The purpose of this article is to provide a comprehensive summary of available evidence along with practical recommendations concerning the care of pregnancies at risk of or complicated by FGR, with the overall goal to decrease the risk of stillbirth and neonatal mortality and morbidity associated with this condition. To achieve these goals, FIGO (the International Federation of Gynecology and Obstetrics) brought together international experts to review and summarize current knowledge of FGR. This summary is directed at multiple stakeholders, including healthcare providers, healthcare delivery organizations and providers, FIGO member societies, and professional organizations. Recognizing the variation in the resources and expertise available for the management of FGR in different countries or regions, this article attempts to take into consideration the unique aspects of antenatal care in low-resource settings (labelled “LRS” in the recommendations). This was achieved by collaboration with authors and FIGO member societies from low-resource settings such as India, Sub-Saharan Africa, the Middle East, and Latin America.

103 Influence of medicaid expansion and access to immediate postpartum LARC on preterm birth

To assess the influence of Medicaid expansion and access to immediate postpartum LARC on preterm birth rates in the US. It is hypothesized that these programs prevent unintended pregnancy and short interpregnancy interval by providing wider access to contraception. We performed a population-based retrospective cohort study of all US live births in 2016 using birth certificate data. States were categorized into those that adopted Medicaid expansion (+ME) and states that provide access to immediate postpartum LARC (+LARC) through reimbursement. States that participated in Medicaid expansion after 1/1/2014 were excluded. Births from one state not participating in either program (n=3,876, <1%) were excluded given the small sample size. Multivariate logistic regression estimated the relative influence of ME and LARC on preterm birth <37 weeks, after adjusting for maternal race, age, marital status, and limited prenatal care. The study population consisted of 2,217,895 births to multiparous women among included states. The rate and risk of preterm birth was lowest in states with +ME/+LARC (10.3%, 95% CI 10.27-10.36%; adjusted RR 0.868, 95% CI 0.863-0.874). Preterm birth rates and adjusted risks were higher in states that only adopted one program: +ME/-LARC (11.6%, CI 11.5-11.7%; adjusted RR 1.04, CI 1.03-1.05) and -ME/+LARC (12.7%, CI 12.67-12.78%; adjusted RR 1.14, CI 1.14-1.15). These results demonstrate that women living in states with Medicaid expansion and access to immediate postpartum LARC through reimbursement have a decreased risk of preterm birth. More widespread implementation of programs that improve access to contraception may have a positive influence on reproductive outcomes in the U.S. through a reduction in adverse outcomes associated with preterm birth.View Large Image Figure ViewerDownload Hi-res image Download (PPT)