Development of a percutaneous coronary intervention patient level composite measure for a clinical quality registry

© 2020 The Author(s). Background: Composite measures combine data to provide a comprehensive view of patient outcomes. Despite composite measures being a valuable tool to assess post-intervention outcomes, the patient perspective is often missing. The purpose of this study was to develop a composite measure for an established cardiac outcome registry, by combining clinical outcomes following percutaneous coronary interventions (PCI) with a patient-reported outcome measure (PROM) developed specifically for this population (MC-PROM). Methods: Two studies were undertaken. Study 1: Patients who had undergone a PCI at one of the three participating registry hospital sites completed the 5-item MC-PROM. Clinical outcome data for the patients (e.g. death, myocardial infarction, repeat vascularisation, new bleeding event) were collected 30 days post-intervention as part of routine data collection for the cardiac registry. Exploratory factor analysis of clinical outcomes and MC-PROM data was conducted to determine the minimum number of constructs to be included in a composite measure. Study 2: Clinical experts participated in a Delphi technique, consisting of three rounds of online surveys, to determine the clinical outcomes to be included and the weighting of the clinical outcomes and MC-PROM score for the composite measure. Results: Study 1: Routine clinical outcomes and the MC-PROM data were collected from 266 patients 30 days post PCI. The MC-PROM score was not significantly correlated with any clinical outcomes. Study 2: There was a relatively consistent approach to the weighting of the clinical outcomes and MC-PROM items by the expert panel (n = 18) across the three surveys with the exception of the clinical outcome of 'deceased at 30 days'. The final composite measure included five clinical outcomes within 30 days weighted at 90% (new heart failure, new myocardial infarction, new stent thrombosis, major bleeding event, new stroke, unplanned cardiac rehospitalisation) and the MC-PROM score (comprising 10% of the total weighting). Conclusions: A single patient level composite score, which incorporates weighted clinical outcomes and a PROM was developed. This composite score provides a more comprehensive reported measure of individual patient wellbeing at 30 days post their PCI-procedure, and may assist clinicians to further assess and address patient level factors that potentially impact on clinical recovery

Brain Tumor Segmentation from Multi-Spectral MR Image Data Using Random Forest Classifier

The development of brain tumor segmentation techniques based on multi-spectral MR image data has relevant impact on the clinical practice via better diagnosis, radiotherapy planning and follow-up studies. This task is also very challenging due to the great variety of tumor appearances, the presence of several noise effects, and the differences in scanner sensitivity. This paper proposes an automatic procedure trained to distinguish gliomas from normal brain tissues in multi-spectral MRI data. The procedure is based on a random forest (RF) classifier, which uses 80 computed features beside the four observed ones, including morphological ones, gradients, and Gabor wavelet features. The intermediary segmentation outcome provided by the RF is fed to a twofold post-processing, which regularizes the shape of detected tumors and enhances the segmentation accuracy. The performance of the procedure was evaluated using the 274 records of the BraTS 2015 train data set. The achieved overall Dice scores between 85-86% represent highly accurate segmentation

Symptoms and feelings valued by patients after a percutaneous coronary intervention: A discrete-choice experiment to inform development of a new patient-reported outcome

Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Objective To inform the development of a patient-reported outcome measure, the aim of this study was to identify which symptoms and feelings following percutaneous coronary intervention (PCI) are most important to patients. Design Discrete-choice experiment consisting of two hypothetical scenarios of 10 symptoms and feelings (pain or discomfort; shortness of breath; concern/worry about heart problems; tiredness; confidence to do usual activities; ability to do usual activities; happiness; sleep disturbance; dizziness or light-headedness and bruising) experienced after PCI, described by three levels (never, some of the time, most of the time). Preference weights were estimated using a conditional logit model. Setting Four Australian public hospitals that contribute to the Victorian Cardiac Outcomes Registry (VCOR) and a private insurer's claim database. Participants 138 people aged >18 years who had undergone a PCI in the previous 6 months. Main outcome measures Patient preferences via trade-offs between 10 feelings and symptoms. Results Of the 138 individuals recruited, 129 (93%) completed all 16 choice sets. Conditional logit parameter estimates were mostly monotonic (eg, moving to worse levels for each individual symptom and feeling made the option less attractive). When comparing the magnitude of the coefficients (based on the coefficient of the worst level relative to best level in each item), feeling unhappy was the symptom or feeling that most influenced perception of a least-preferred PCI outcome (OR 0.42, 95% CI 0.34 to 0.51, p<0.0001) and the least influential was bruising (OR 0.81, 95% CI 0.67 to 0.99, p=0.04). Conclusion This study provides new insights into how patients value symptoms and feelings they experience following a PCI

Association of Body Mass Index and Extreme Obesity With Long-Term Outcomes Following Percutaneous Coronary Intervention

Background: Previous studies have reported a protective effect of obesity compared with normal body mass index (BMI) in patients undergoing percutaneous coronary intervention (PCI). However, it is unclear whether this effect extends to the extremely obese. In this large multicenter registry‐based study, we sought to examine the relationship between BMI and long‐term clinical outcomes following PCI, and in particular to evaluate the association between extreme obesity and long‐term survival after PCI. Methods and Results: This cohort study included 25 413 patients who underwent PCI between January 1, 2005 and June 30, 2017, who were prospectively enrolled in the Melbourne Interventional Group registry. Patients were stratified by World Health Organization–defined BMI categories. The primary end point was National Death Index–linked mortality. The median length of follow‐up was 4.4 years (interquartile range 2.0‐7.6 years). Of the study cohort, 24.8% had normal BMI (18.5‐24.9 kg/m2), and 3.3% were extremely obese (BMI ≥40 kg/m2). Patients with greater degrees of obesity were younger and included a higher proportion of diabetics (P<0.001). After adjustment for age and comorbidities, a J‐shaped association was observed between different BMI categories and adjusted hazard ratio (HR) for long‐term mortality (normal BMI, HR 1.00 [ref]; overweight, HR 0.85, 95% CI 0.78‐0.93, P<0.001; mild obesity, HR 0.85, 95% CI 0.76‐0.94, P=0.002; moderate obesity, HR 0.95, 95% CI 0.80‐1.12, P=0.54; extreme obesity HR 1.33, 95% CI 1.07‐1.65, P=0.01). Conclusions: An obesity paradox is still apparent in contemporary practice, with elevated BMI up to 35 kg/m2 associated with reduced long‐term mortality after PCI. However, this protective effect appears not to extend to patients with extreme obesity

Prior Coronary Artery Bypass Graft Surgery Impacts 30-day Quality of Life after Percutaneous Coronary Intervention: Evidence from the Victorian Cardiac Outcomes Registry (VCOR): 30-day QoL after PCI in patients with prior CABG

Quality of life following percutaneous coronary intervention (PCI) in patients with coronary artery bypass graft surgery (CABG) has been reported as lower than non-CABG patients, however previous reports pre-date modern developments in PCI and cardiac surgery. This study aimed to examine the 30-day QoL after PCI between patients with and without prior CABG using a contemporary dataset. A retrospective analysis of the Victorian Cardiac Outcomes Registry was undertaken. This study included 36,799 patients who completed the EQ-5D questionnaire that was used to assess the 30-day QoL and was compared between groups with and without prior CABG at baseline. Most of the participants were older than 65 years, more than half were male and had PCI due to acute coronary symptoms (ACS) and nearly 90% of patients received drug eluting stents. Compared to the ‘no prior CABG’ group, the ‘CABG’ group had a significantly higher rate of reporting a health problem (OR 1.30, 95% CI 1.10–1.53), presence of a problem in mobility (OR 1.42, 95% CI 1.15–1.75), personal care (OR 1.49, 95%CI 1.13–1.97) and usual activities (OR 1.39, 95%CI 1.15–1.68), pain/discomfort (OR 1.31, 95%CI 1.11–1.54), and anxiety/depression (OR 1.20, 95%CI 1.02–1.42). Despite modern developments in both PCI and CABG, our study showed a consistent negative association between prior CABG status and 30-day QoL following PCI. There is a need for better targeted cardiac rehabilitation in patients with prior CABG to address their greater relative risk of experiencing poor health

Sex differences in prehospital delays in patients with st-segment-elevation myocardial infarction undergoing percutaneous coronary intervention

BACKGROUND: Women with ST-segment-elevation myocardial infarction experience delays in reperfusion compared with men with little data on each time component from symptom onset to reperfusion. This study analyzed sex discrepancies in patient delays, prehospital system delays, and hospital delays. METHODS AND RESULTS: Consecutive patients with ST-segment-elevation myocardial infarction treated with percutaneous coronary intervention across 30 hospitals in the Victorian Cardiac Outcomes Registry (2013-2018) were analyzed. Data from the Ambulance Victoria Data warehouse were used to perform linkage to the Victorian Cardiac Outcomes Registry for all patients transported via emergency medical services (EMS). The primary end point was EMS call-to-door time (prehospital system delay). Secondary end points included symptom-to-EMS call time (patient delay), door-to-device time (hospital delay), 30-day mortality, major adverse cardiovascular events, and major bleeding. End points were analyzed according to sex and adjusted for age, comorbidities, cardiogenic shock, cardiac arrest, and symptom onset time. A total of 6330 (21% women) patients with ST-segment-elevation myocardial infarction were transported by EMS. Compared with men, women had longer adjusted geometric mean symptom-to-EMS call times (47.0 versus 44.0 minutes; P<0.001), EMS call-to-door times (58.1 versus 55.7 minutes; P<0.001), and door-to-device times (58.5 versus 54.9 minutes; P=0.006). Compared with men, women had higher 30-day mortality (odds ratio [OR], 1.38; 95% CI, 1.06-1.79; P=0.02) and major bleeding (OR, 1.54; 95% CI, 1.08-2.20; P=0.02). CONCLUSIONS: Female patients with ST-segment-elevation myocardial infarction experienced excess delays in patient delays, prehospital system delays, and hospital delays, even after adjustment for confounders. Prehospital system and hospital delays resulted in an adjusted excess delay of 10 minutes compared with men

Selective Light-Triggered Release of DNA from Gold Nanorods Switches Blood Clotting On and Off

Blood clotting is a precise cascade engineered to form a clot with temporal and spatial control. Current control of blood clotting is achieved predominantly by anticoagulants and thus inherently one-sided. Here we use a pair of nanorods (NRs) to provide a two-way switch for the blood clotting cascade by utilizing their ability to selectively release species on their surface under two different laser excitations. We selectively trigger release of a thrombin binding aptamer from one nanorod, inhibiting blood clotting and resulting in increased clotting time. We then release the complementary DNA as an antidote from the other NR, reversing the effect of the aptamer and restoring blood clotting. Thus, the nanorod pair acts as an on/off switch. One challenge for nanobiotechnology is the bio-nano interface, where coronas of weakly adsorbed proteins can obscure biomolecular function. We exploit these adsorbed proteins to increase aptamer and antidote loading on the nanorods.National Science Foundation (U.S.) (Grant DMR #0906838

Incidence of post myocardial infarction left ventricular thrombus formation in the era of primary percutaneous intervention and glycoprotein IIb/IIIa inhibitors. A prospective observational study

BACKGROUND: Before the widespread use of primary percutaneous coronary intervention (PCI) and glycoprotein IIb/IIIa inhibitors (GP IIb/IIIa) left ventricular (LV) thrombus formation had been reported to complicate up to 20% of acute myocardial infarctions (AMI). The incidence of LV thrombus formation with these treatment modalities is not well known. METHODS: 92 consecutive patients with ST-elevation AMI treated with PCI and GP IIb/IIIa inhibitors underwent 2-D echocardiograms, with and without echo contrast agent, within 24–72 hours. RESULTS: Only 4/92 (4.3%) had an LV thrombus, representing a significantly lower incidence than that reported in the pre-PCI era. Use of contrast agents did not improve detection of LV thrombi in our study. CONCLUSION: The incidence of LV thrombus formation after acute MI, in the current era of rapid reperfusion, is lower than what has been historically reported

Use of platelet glycoprotein IIb/IIIa inhibitors in diabetics undergoing PCI for non-ST-segment elevation acute coronary syndromes: impact of clinical status and procedural characteristics

Background: The most recent ESC guidelines for percutaneous coronary intervention (PCI) recommend the use of glycoprotein IIb/IIIa inhibitors (GPI) in high risk patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS), particularly in diabetics. Little is known about the adherence to these guidelines within Europe. Methods and results: Between May 2005 and April 2008 a total of 47,407 consecutive patients undergoing PCI were prospectively enrolled into the PCI-Registry of the Euro Heart Survey Programme. In the present analysis we examined the use of GPI in 2,922 diabetics who underwent PCI for NSTE-ACS. In this high risk population only 22.2% received a GPI; 8.9% upstream and 13.4% during PCI. The strategy of the individual institution had a major impact on the usage of GPI. In the multiple regression analysis clinical instability and complex lesion characteristics were strong independent determinants for the use of GPI, whereas renal insufficiency was negatively associated with its use. After adjustment for confounding variables no significant differences in hospital mortality could be observed between the cohorts, but a significantly higher rate of non-fatal postprocedural myocardial infarction was observed among patients receiving GPI upstream. Conclusions: Despite the recommendation for its use in the current ESC guidelines, only a minority of the diabetics in Europe undergoing PCI for NSTE-ACS received a GPI. The use of GPI was mainly triggered by high-risk interventional scenarios

Analysis of infectious virus clones from two HIV-1 superinfection cases suggests that the primary strains have lower fitness

<p>Abstract</p> <p>Background</p> <p>Two HIV-1 positive patients, L and P, participating in the Amsterdam Cohort studies acquired an HIV-1 superinfection within half a year from their primary HIV-1 infection (Jurriaans <it>et al</it>., <it>JAIDS </it>2008, <b>47:</b>69-73). The aim of this study was to compare the replicative fitness of the primary and superinfecting HIV-1 strains of both patients. The use of isolate-specific primer sets indicated that the primary and secondary strains co-exist in plasma at all time points after the moment of superinfection.</p> <p>Results</p> <p>Biological HIV-1 clones were derived from peripheral blood CD4 + T cells at different time point, and identified as the primary or secondary virus through sequence analysis. Replication competition assays were performed with selected virus pairs in PHA/IL-2 activated peripheral blood mononuclear cells (PBMC's) and analyzed with the Heteroduplex Tracking Assay (HTA) and isolate-specific PCR amplification. In both cases, we found a replicative advantage of the secondary HIV-1 strain over the primary virus. Full-length HIV-1 genomes were sequenced to find possible explanations for the difference in replication capacity. Mutations that could negatively affect viral replication were identified in the primary infecting strains. In patient L, the primary strain has two insertions in the LTR promoter, combined with a mutation in the <it>tat </it>gene that has been associated with decreased replication capacity. The primary HIV-1 strain isolated from patient P has two mutations in the LTR that have been associated with a reduced replication rate. In a luciferase assay, only the LTR from the primary virus of patient P had lower transcriptional activity compared with the superinfecting virus.</p> <p>Conclusions</p> <p>These preliminary findings suggest the interesting scenario that superinfection occurs preferentially in patients infected with a relatively attenuated HIV-1 isolate.</p