CANCARE RESEARCH
Explore previously published research highlights by topic, study type or publication date.
An automated research-discovery feed. Summaries are based on published abstracts and are not clinical recommendations.
Safety and Efficacy of Acute Normovolemic Hemodilution in Female Patients: A Secondary Analysis of the ANH Trial.
Clinical takeaway This exploratory analysis found no clear transfusion benefit in women, alongside signals of more hypotension and longer ICU and hospital stays with ANH. Confirmation in adequately powered studies is needed.
Summary & abstract
Study summary
This post hoc analysis included 405 women undergoing elective cardiac surgery with cardiopulmonary bypass, comparing acute normovolemic hemodilution (ANH) with usual care. Index-hospitalization red-cell transfusion occurred in 38.8% versus 44.6% (RR 0.87; 95% CI 0.69-1.10), without a statistically significant difference. Intraoperative hypotension was more frequent with ANH (16.0% versus 4.8%; RR 3.30; 95% CI 1.62-6.74). ANH was also associated with longer ICU stays (mean difference 21.13 hours; 95% CI 1.89-40.38) and hospital stays (1.92 days; 95% CI 0.14-3.70), while mortality and other postoperative complications did not differ significantly.
Study limitation: This post hoc female subgroup analysis is exploratory and requires confirmation in studies specifically powered for this population.
Published abstract
IMPORTANCE: Female patients undergoing cardiac surgery have a higher transfusion burden, yet they remain underrepresented in randomized clinical trials. Although the ANH trial showed no significant reduction in the proportion of patients receiving allogeneic blood transfusions with acute normovolemic hemodilution, evidence regarding its efficacy and safety specifically in female patients remains limited. OBJECTIVE: To evaluate the efficacy and safety of acute normovolemic hemodilution (ANH) compared with usual care in female patients undergoing elective cardiac surgery with cardiopulmonary bypass. DESIGN, SETTING, AND PARTICIPANTS: This was a post hoc secondary analysis of the multicenter, randomized ANH trial, which was conducted at 32 centers in 11 countries from April 2019 to December 2024. Of 2010 patients in the original ANH trial, 405 were women and were included in this analysis; 219 had been randomized to receive ANH and 186 to usual care. This secondary analysis was conducted from August 2025 to January 2026. INTERVENTION: Withdrawal of at least 650 mL whole blood with crystalloids replacement and reinfusion after cardiopulmonary bypass. MAIN OUTCOMES AND MEASURES: The primary outcome was the occurrence of at least 1 allogeneic packed red blood cell (pRBC) transfusion during the index hospitalization. Safety outcomes included intraoperative hypotension, intensive care unit (ICU) length of stay, hospital length of stay, mortality, and other perioperative complications. RESULTS: The median (IQR) age of the participants was 62 (54-69) years. The occurrence of allogeneic pRBC transfusion was similar in the ANH and usual care groups (38.8% vs 44.6%, respectively; relative risk [RR], 0.87; 95% CI, 0.69-1.10; P = .24). Intraoperative hypotension occurred more frequently with ANH (16.0% vs 4.8% in usual care; RR, 3.30; 95% CI, 1.62-6.74; P = .02). Patients receiving ANH also had longer ICU stays (mean difference, 21.13 hours; 95% CI, 1.89-40.38; P = .03) and hospital stays (mean difference, 1.92 days; 95% CI, 0.14-3.70; P = .04). No significant differences were observed in mortality or other postoperative complications. CONCLUSIONS AND RELEVANCE: In this post hoc secondary analysis of a randomized clinical trial, ANH was not associated with a reduction in allogeneic pRBC transfusion among women undergoing cardiac surgery and was associated with more frequent intraoperative hypotension and longer ICU and hospital stay. These exploratory findings warrant confirmation in adequately powered studies specifically designed to evaluate female patients undergoing cardiac surgery. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03913481.
AI summary and clinical bottom line, with automated source checks. Consult the original paper before applying findings.
Association Between Relative Plasma Hyperosmolality and Postoperative Delirium Following Cardiac Surgery: A Post Hoc Analysis.
Clinical takeaway These exploratory findings link postoperative hyperosmolality and accumulated perioperative factors with delirium after cardiac surgery. They do not establish causality or demonstrate that modifying osmolality prevents delirium.
Summary & abstract
Study summary
This post hoc analysis of a randomized trial included 195 cardiac-surgery patients aged 65 years or older at one Swedish tertiary hospital. Postoperative delirium occurred in 36% (70/195), with postoperative assessments on days 1 and 3. Relative plasma hyperosmolality on postoperative day 3 was identified as a potentially independent correlate of delirium in multivariable analysis. More than two concurrent perioperative factors were reported to be associated with an eightfold greater likelihood of delirium, although the abstract provided neither confidence intervals nor a numerical effect estimate for hyperosmolality.
Study limitation: Single-centre post hoc associations, without reported confidence intervals or clear temporal ordering, limit causal interpretation and precision.
Published abstract
PURPOSE: To determine whether relative plasma hyperosmolality is independently associated with postoperative delirium (POD) and to explore the relationship between the cumulative number of concurrent perioperative variables and POD in patients aged greater than or equal to 65 years undergoing cardiac surgery. DESIGN: Post hoc analysis. METHODS: This post hoc analysis of a randomized controlled trial included 195 consecutive patients enrolled between March 2019 and June 2020 at a tertiary hospital in Sweden. The incidence of POD was 36% (70/195). POD was assessed preoperatively and postoperatively on days 1 and 3, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Plasma osmolality was measured on five occasions and coordinated with POD assessments. Potential perioperative variables associated with POD were analyzed using a multivariable logistic regression model. FINDINGS: The main findings indicate that relative hyperosmolality on the third postoperative day may represent a biochemical factor independently associated with the development of POD, and the presence of more than two concurrent perioperative factors, which may increase the likelihood of POD eightfold. CONCLUSIONS: Relative plasma hyperosmolality may be associated with POD after cardiac surgery. The accumulation of concurrent perioperative variables also appears important and supports further investigation of multicomponent prevention strategies. Multicenter studies are needed to confirm these findings.
AI summary and clinical bottom line, with automated source checks. Consult the original paper before applying findings.
Mechanical Thrombectomy Versus Anticoagulation Alone in Intermediate-High Risk PE: Improved Functional 90-Day Outcomes in STORM-PE RCT.
Clinical takeaway Thrombectomy was associated with better measured functional recovery at 90 days in this randomized trial. Incomplete testing and secondary-endpoint status temper interpretation; mortality benefit and equivalent safety were not established.
Summary & abstract
Study summary
STORM-PE randomized 100 patients with acute intermediate-high risk pulmonary embolism to computer-assisted vacuum thrombectomy plus anticoagulation or anticoagulation alone; this report evaluates 90-day secondary outcomes. Six-minute walk distance was greater with thrombectomy (478.7 ± 159.5 versus 368.0 ± 127.8 m; P = 0.003), although only approximately two-thirds completed testing. NYHA class I was more frequent with thrombectomy (97.4% versus 75.6%; P = 0.005). Dyspnea and quality-of-life scores were comparable, and no between-group differences were reported in all-cause mortality, PE-related mortality, or symptomatic PE recurrence through 90 days.
Study limitation: Functional outcomes were secondary endpoints, and only approximately two-thirds completed walk testing, creating potential follow-up bias.
Published abstract
BACKGROUND: Up to 50% of pulmonary embolism (PE) survivors experience long-term functional limitations and reduced quality of life (QoL). Reperfusion strategies can rapidly relieve right-ventricular (RV) dysfunction and prevent clinical deterioration or hemodynamic collapse; however, these approaches have never been evaluated in a randomized trial against anticoagulation alone using patient-centered outcomes. OBJECTIVES: This study sought to evaluate whether mechanical thrombectomy with anticoagulation improves functional, QoL, and safety outcomes compared with anticoagulation alone in patients with acute intermediate-high risk PE over 90 days. METHODS: STORM-PE enrolled 100 PE patients randomized 1:1 to computer-assisted vacuum thrombectomy (CAVT) with anticoagulation or anticoagulation alone across 22 international sites, with RV-to-left-ventricular (RV/LV) ratio change at 48 hours as the primary endpoint. Secondary endpoints included major adverse events within 7 days, functional and QoL outcomes, mortality, and symptomatic PE recurrence through 90 days. RESULTS: For all patients, median time from randomization to last follow-up visit was 91.0 days [Q1-Q3: 80.5-100.0]. At 90 days, 66.0% (31/47) of CAVT and 64.2% (34/53) of anticoagulation patients completed the 6-min walk test. The CAVT arm exhibited a longer 6-min walk distance compared with anticoagulation alone (478.7 ± 159.5 m vs 368.0 ± 127.8 m, P = 0.003). More CAVT than anticoagulation patients were NYHA Functional Class I (97.4% [37/38] vs 75.6% [34/45], P = 0.005) at 90 days. Dyspnea and QoL scores were comparable between groups, with no differences between arms for all-cause mortality, PE-related mortality, and symptomatic PE recurrence within 90 days. CONCLUSIONS: In STORM-PE, CAVT with anticoagulation resulted in improved functional outcomes at 90 days compared with anticoagulation alone, with equivalent safety rates. This trial supports CAVT as an effective and safe reperfusion strategy for intermediate-high risk PE. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov Unique Identifier: NCT05684796.
AI summary and clinical bottom line, with automated source checks. Consult the original paper before applying findings.
Complexity of coronary artery disease in infarct-related cardiogenic shock and multivessel disease: a substudy of the DanGer Shock trial.
Clinical takeaway Coronary complexity provided prognostic information, but no significant pump-effect interaction was detected by baseline SYNTAX category. The isolated left main subgroup signal remains exploratory.
Summary & abstract
Study summary
This DanGer Shock secondary analysis examined coronary complexity and 180-day mortality in infarct-related cardiogenic shock; 256 patients had multivessel disease. High baseline SYNTAX scores were associated with greater mortality odds than low/intermediate scores (adjusted OR 3.12, 95% CI 1.17-8.69); residual scores independently predicted mortality. Baseline SYNTAX category did not significantly modify the microaxial pump effect (interaction p=0.31). Among 35 patients with isolated left main culprit lesions, pump support versus standard care was associated with lower mortality odds (adjusted OR 0.17, 95% CI 0.03-0.99), a hypothesis-generating finding.
Study limitation: Baseline SYNTAX scores were available for only 211 patients; the isolated left main analysis involved just 35 patients.
Published abstract
BACKGROUND: The prognostic impact of multivessel coronary anatomy and complexity in infarct-related cardiogenic shock (CS) is insufficiently characterised. AIMS: We sought to investigate the prognostic value of baseline and residual SYNTAX scores and their influence on the effect of microaxial flow pump (mAFP) support in multivessel disease (MVD) and infarct-related CS. METHODS: In this secondary analysis of the DanGer Shock trial, MVD was defined as ≥1 non-culprit stenosis ≥70% or an isolated left main (LM) culprit lesion. Baseline SYNTAX scores were categorised as low (≤22), intermediate (23-32), or high (>32). Patients with an isolated LM culprit lesion were analysed separately. The primary outcome was 180-day all-cause mortality. RESULTS: Of 355 patients included in DanGer Shock, 256 patients had MVD; 211 had an available baseline SYNTAX score, with 26% of these in the low, 47% in the intermediate, and 27% in the high baseline SYNTAX groups. In all, 35 patients had an isolated LM culprit lesion. A high baseline SYNTAX score was associated with higher odds of 180-day all-cause mortality compared with low and intermediate baseline SYNTAX scores (adjusted odds ratio [OR] 3.12, 95% confidence interval [CI]: 1.17-8.69). A higher baseline SYNTAX score was associated with a higher residual SYNTAX score (p<0.001). The residual SYNTAX score independently predicted 180-day all-cause mortality. The mAFP effect was not modified by the baseline SYNTAX group (p for interaction=0.31). In patients with an isolated LM culprit lesion, mAFP use was associated with lower odds of 180-day all-cause mortality compared with standard care alone (adjusted OR 0.17, 95% CI: 0.03-0.99). CONCLUSIONS: Baseline and residual SYNTAX scores independently predicted 180-day mortality. The mAFP effect was not modified by SYNTAX measures. In the isolated left main subgroup, a hypothesis-generating signal towards a clinical benefit with mAFP use was observed.
AI summary and clinical bottom line, with automated source checks. Consult the original paper before applying findings.
Inflammation, Infarct Size and 10-Year Mortality in STEMI Patients Stratified by the ORBI Risk Score: A DANAMI-3 Sub-study.
Clinical takeaway ORBI-defined shock risk also marked higher long-term mortality and greater infarct burden in STEMI patients initially without shock. Its weaker discrimination than age alone limits its appeal as a stand-alone long-term prognostic tool.
Summary & abstract
Study summary
This DANAMI-3 secondary analysis classified 1,574 STEMI patients without cardiogenic shock as high or low risk using the ORBI score. High-risk patients had greater inflammation and larger final infarcts, involving 15.7% versus 10.1% of left ventricular mass. Ten-year all-cause mortality was 41% versus 20%, with an adjusted hazard ratio of 1.47 (95% confidence interval 1.16–1.85). The adjusted mortality association was strongest within 30 days, while the score discriminated 10-year mortality less well than age alone, with areas under the curve of 0.67 versus 0.79.
Study limitation: These nonrandomized risk-group comparisons cannot establish causality or whether targeting inflammation improves outcomes.
Published abstract
BACKGROUND: The ORBI Risk Score predicts in-hospital cardiogenic shock after primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). Whether high-risk patients also have more systemic inflammation, larger infarcts and higher long-term mortality is not known. METHODS: In a DANAMI-3 sub-study, 1,574 STEMI patients without cardiogenic shock were classified as high (ORBI ≥8, n = 273) or low risk (n = 1,301). Inflammation was assessed by routine C-reactive protein (CRP), leukocyte count and neutrophil-to-lymphocyte ratio (NLR) within 72 hours of PCI, and admission mid-regional pro-adrenomedullin (MR-proADM). Infarct size was measured by cardiac magnetic resonance. Ten-year all-cause mortality was obtained from the Danish Civil Registration System. Cox models were adjusted for age, sex, comorbidity, kidney function and randomised allocation. RESULTS: High-risk patients had higher peak CRP (72 vs. 11 mg/L), leukocyte count (12.8 vs. 10.4 × 109/L), NLR (6.2 vs. 3.5) and MR-proADM (0.73 vs. 0.62 nmol/L; all p < 0.001), and larger infarcts (final infarct size 15.7% vs. 10.1% of left ventricular mass). Ten-year mortality was 41% vs. 20% (hazard ratio 2.56, 95% CI 2.05-3.20; adjusted 1.47, 1.16-1.85). The adjusted hazard ratio was 4.79 within 30 days and 1.27 after the first year. The score discriminated 10-year mortality less well than age alone (area under the curve 0.67 vs. 0.79). CONCLUSIONS: The ORBI Risk Score identifies STEMI patients with more inflammation, larger infarcts and higher mortality, especially in the first year. Beyond the first year the association was largely explained by age. Whether anti-inflammatory treatment benefits these patients is a question for randomised trials.
AI summary and clinical bottom line, with automated source checks. Consult the original paper before applying findings.