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10 result(s) for "Keeble, TR"
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A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina
In a randomized trial of PCI in patients with stable angina who were receiving little or no antianginal medication and had documented ischemia, PCI resulted in a better health status with respect to angina than placebo at 12 weeks.
Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial
The coronary sinus reducer (CSR) is proposed to reduce angina in patients with stable coronary artery disease by improving myocardial perfusion. We aimed to measure its efficacy, compared with placebo, on myocardial ischaemia reduction and symptom improvement. ORBITA-COSMIC was a double-blind, randomised, placebo-controlled trial conducted at six UK hospitals. Patients aged 18 years or older with angina, stable coronary artery disease, ischaemia, and no further options for treatment were eligible. All patients completed a quantitative adenosine-stress perfusion cardiac magnetic resonance scan, symptom and quality-of-life questionnaires, and a treadmill exercise test before entering a 2-week symptom assessment phase, in which patients reported their angina symptoms using a smartphone application (ORBITA-app). Patients were randomly assigned (1:1) to receive either CSR or placebo. Both participants and investigators were masked to study assignment. After the CSR implantation or placebo procedure, patients entered a 6-month blinded follow-up phase in which they reported their daily symptoms in the ORBITA-app. At 6 months, all assessments were repeated. The primary outcome was myocardial blood flow in segments designated ischaemic at enrolment during the adenosine-stress perfusion cardiac magnetic resonance scan. The primary symptom outcome was the number of daily angina episodes. Analysis was done by intention-to-treat and followed Bayesian methodology. The study is registered with ClinicalTrials.gov, NCT04892537, and completed. Between May 26, 2021, and June 28, 2023, 61 patients were enrolled, of whom 51 (44 [86%] male; seven [14%] female) were randomly assigned to either the CSR group (n=25) or the placebo group (n=26). Of these, 50 patients were included in the intention-to-treat analysis (24 in the CSR group and 26 in the placebo group). 454 (57%) of 800 imaged cardiac segments were ischaemic at enrolment, with a median stress myocardial blood flow of 1·08 mL/min per g (IQR 0·77–1·41). Myocardial blood flow in ischaemic segments did not improve with CSR compared with placebo (difference 0·06 mL/min per g [95% CrI –0·09 to 0·20]; Pr(Benefit)=78·8%). The number of daily angina episodes was reduced with CSR compared with placebo (OR 1·40 [95% CrI 1·08 to 1·83]; Pr(Benefit)=99·4%). There were two CSR embolisation events in the CSR group, and no acute coronary syndrome events or deaths in either group. ORBITA-COSMIC found no evidence that the CSR improved transmural myocardial perfusion, but the CSR did improve angina compared with placebo. These findings provide evidence for the use of CSR as a further antianginal option for patients with stable coronary artery disease. Medical Research Council, Imperial College Healthcare Charity, National Institute for Health and Care Research Imperial Biomedical Research Centre, St Mary's Coronary Flow Trust, British Heart Foundation.
Sedation and analgesia in post-cardiac arrest care: a post hoc analysis of the TTM2 trial
Background The routine use of sedation and analgesia during post-cardiac arrest care and its association with clinical outcomes remain unclear. This study aimed to describe the use of sedatives and analgesics in post-cardiac arrest care, and evaluate associations with good functional outcome, survival, clinical seizures, and late awakening. Methods This was a post hoc analysis of the TTM2-trial, which randomized 1900 out-of-hospital cardiac arrest patients to either normothermia or hypothermia. In both groups, deep sedation (Richmond Agitation and Sedation Scale ≤ -4) was mandatory during the 40-h intervention. Cumulative doses of sedatives and analgesic drugs were recorded within the first 72 h from randomization. Outcomes were functional outcome (modified Rankin Scale) and survival status at 6 months, occurrence of clinical seizures during the intensive care stay, and late awakening (Full outline of unresponsiveness motor score of four 96 h after randomization). Cumulative propofol doses were divided into quartiles (Q1-Q4). Logistic regression models were used to assess associations between sedative doses and functional outcome and survival, clinical seizures, and late awakening, adjusting for the severity of illness and other clinical factors influencing sedation. Results A total of 1861 patients were analyzed. In a multivariable logistic regression model, higher propofol doses (Q3, 100.7–153.6 mg/kg) were associated with good functional outcome (OR 1.62, 95%CI 1.12—2.34) and (Q2 and Q3, 43.9–153.6 mg/kg) with survival (OR 1.49, 95%CI 1.05—2.12 and OR 1.84, 95%CI 1.27—2.65, respectively). Receiving fentanyl and remifentanil were associated with good functional outcome (OR 1.69, 95%CI 1.27—2.26 and OR 1.50, 95%CI 1.11—2.02) and survival (OR 1.80, 95%CI 1.35—2.40 and OR 1.56, 95%CI 1.16—2.10). Receiving fentanyl (OR 0.64, 95%CI 0.48—0.86) and higher propofol doses (Q2-4 (43.9–669.4 mg/kg) were associated with the occurrence of clinical seizures. The highest quartile of propofol dose (153.7–669.4 mg/kg, OR 3.19, 95%CI 1.91—5.42) was associated with late awakening. Conclusions In this study, higher doses of propofol and the use of remifentanil and fentanyl were associated with good functional outcome and survival, occurrence of clinical seizures, and late awakening.
Hypothermia versus normothermia in patients with cardiac arrest and shockable rhythm: a secondary analysis of the TTM-2 study
Background The aim of this study was to assess whether hypothermia increased survival and improved functional outcome when compared with normothermia in out-of-hospital cardiac arrest (OHCA) patients with similar characteristics than in previous randomized studies showing benefits for hypothermia. Methods Post hoc analysis of a pragmatic, multicenter, randomized clinical trial (TTM-2, NCT02908308). In this analysis, the subset of patients included in the trial who had similar characteristics to patients included in one previous randomized trial and randomized to hypothermia at 33 °C or normothermia (i.e. target < 37.8 °C) were considered. The primary outcome was survival at 6 months; secondary outcomes included favorable functional outcome at 6 months, defined as a modified Rankin scale of 0–3. Time-to-death and the occurrence of adverse events were also reported. Results From a total of 1891 included in the TTM-2 study, 600 (31.7%) were included in the analysis, 294 in the hypothermia and 306 in the normothermia group. At 6 months, 207 of the 294 patients (70.4%) in the hypothermia group and 220 of the 306 patients (71.8%) in the normothermia group had survived (relative risk with hypothermia, 0.96; 95% confidence interval [CI], 0.81 to 1.15; P = 0.71). Also, 198 of the 294 (67.3%) in the hypothermia group and 202 of the 306 (66.0%) in the normothermia group had a favorable functional outcome (relative risk with hypothermia, 1.03; 95% CI, 0.87 to 1.23; P = 0.79). There was a significant increase in the occurrence of arrythmias in the hypothermia group (62/294, 21.2%) when compared to the normothermia group (43/306, 14.1%—OR 1.49, 95% CI 1.05–2.14; p = 0.026). Conclusions In this study, hypothermia at 33˚C did not improve survival or functional outcome in a subset of patients with similar cardiac arrest characteristics to patients in whom benefit from hypothermia was shown in prior studies.
V-CARE (Virtual Care After REsuscitation): Protocol for a Randomized Feasibility Study of a Virtual Psychoeducational Intervention After Cardiac Arrest—A STEPCARE Sub-Study
Background: Out-of-hospital cardiac arrest (OHCA) survivors and their relatives may face challenges following hospital discharge, relating to mood, cognition, and returning to normal day-to-day activities. Identified research gaps include a lack of knowledge around what type of intervention is needed to best navigate recovery. In this study, we investigate the feasibility and patient acceptability of a new virtual psychoeducational group intervention for OHCA survivors and their relatives and compare it to a control group receiving a digital information booklet. Methods: V-CARE is a comparative, single-blind randomized pilot trial including participants at selected sites of the STEPCARE trial, in the United Kingdom and Sweden. Inclusion criteria are a modified Rankin Scale (mRS) ≤ 3 at 30-day follow-up; no diagnosis of dementia; and not experiencing an acute psychiatric episode. One caregiver per patient is invited to participate optionally. The intervention group in V-CARE receives four semi-structured, one-hour-long, psychoeducational sessions delivered remotely via video call by a trained clinician once a week, 2–3 months after hospital discharge. The sessions cover understanding cardiac arrest; coping with fatigue and memory problems; managing low mood and anxiety; and returning to daily life. The control group receives an information booklet focused on fatigue, memory/cognitive problems, mental health, and practical coping strategies. Results: Primary: feasibility (number of patients consented) and acceptability (retention rate); secondary: satisfaction with care (Client Satisfaction Questionnaire 8 item), self-management skills (Self-Management Assessment Scale) and, where available, health-related outcomes assessed in the STEPCARE Extended Follow-up sub-study including cognition, fatigue, mood, quality of life, and return to work. Conclusions: If preliminary insights from the V-CARE trial suggest the intervention to be feasible and acceptable, the results will be used to design a larger trial aimed at informing future interventions to support OHCA recovery.
Coronary artery height differences and their effect on fractional flow reserve
Fractional flow reserve (FFR) uses pressure-based measurements to assess the severity of a coronary stenosis. Distal pressure (Pd) is often at a different vertical height to that of the proximal aortic pressure (Pa). The difference in pressure between Pd and Pa due to hydrostatic pressure, may impact FFR calculation. One hundred computed tomography coronary angiographies were used to measure height differences between the coronary ostia and points in the coronary tree. Mean heights were used to calculate the hydrostatic pressure effect in each artery, using a correction factor of 0.8 mmHg/cm. This was tested in a simulation of intermediate coronary stenosis to give the \"corrected FFR\" (cFFR) and percentage of values, which crossed a threshold of 0.8. The mean height from coronary ostium to distal left anterior descending (LAD) was +5.26 cm, distal circumflex (Cx) -3.35 cm, distal right coronary artery-posterior left ventricular artery (RCA-PLV) -5.74 cm and distal RCA-posterior descending artery (PDA) +1.83 cm. For LAD, correction resulted in a mean change in FFR of +0.042, -0.027 in the Cx, -0.046 in the PLV and +0.015 in the PDA. Using 200 random FFR values between 0.75 and 0.85, the resulting cFFR crossed the clinical treatment threshold of 0.8 in 43% of LAD, 27% of Cx, 47% of PLV and 15% of PDA cases. There are significant vertical height differences between the distal artery (Pd) and its point of normalization (Pa). This is likely to have a modest effect on FFR, and correcting for this results in a proportion of values crossing treatment thresholds. Operators should be mindful of this phenomenon when interpreting FFR values.
8 The influence of collateral regression post coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) on donor vessel coronary pressure-derived measurements
BackgroundThere is strong evidence of FFR-guided treatment in multi-vessel disease. The presence of a concomitant CTO may influence the FFR measurement in donor vessel. We sought to investigate the influence of collateral regression after successful CTO recanalisation on donor vessel pressure-derived indices.Methods28 out of 34 consecutive patients underwent successful PCI to RCA CTOs and completed the follow up study (at 3 months post CTO-PCI). Resting Pd/Pa,iFR and FFR were measured pre and post successful CTO PCI and at follow-up in donor vessels.ResultsThe mean resting Pd/Pa, iFR and FFR pre and post-RCA CTO PCI and at follow-up procedures in major donor vessel were (0.893, 0.862, 0.764), (0.907, 0.886, 0.753) and (0.918, 0.901, 0.787) respectively. The mean resting Pd/Pa, iFR and FFR pre and post-RCA CTO PCI and at follow-up procedures in minor donor vessel were (0.979, 0.966, 0.890), (0.983, 0.979, 0.880) and (0.981, 0.974, 0.898) respectively. Changes in pressure-derived indices are summarised in table 1.Abstract 8 Table 1Changes in coronary pressure-derived measurements in donor vessel pre and post RCA CTO PCI and at fellow-up (FU: follow-up; PdPa: resting Pd/Pa; PCI: percutaneous coronary intervention; IFR: instantaneous wave-free ratio; FFR: fractional flow reserve; CTO: chronic total occlusion)ConclusionSuccessful recanalisation of a RCA CTO results in a significant increase in coronary pressure-derived indices of the major donor vessel at follow-up associated with a regression of collateral function. The expected change and the optimal timing to perform PCI in donor vessel should be considered when planning multi-vessel revascularisation in this setting.
20 The physiological impact of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) on donor vessel coronary pressure-derived measurements and the influence of collateral circulation
BackgroundThe presence of a concomitant CTO may influence the FFR measurement in donor vessel. We sought to investigate the immediate physiological impact of CTO recanalisation on donor vessel pressure-derived indices.Methods34 out of 40 consecutive patients underwent successful PCI to RCA CTOs. Resting Pd/Pa,iFR and FFR were measured pre and post-successful CTO PCI in donor vessels and collateral FFR in the CTO vessel.ResultsThe angiographic details are as outlined in table 1. The mean resting Pd/Pa, iFR and FFR pre and post CTO PCI in major donor vessel were (0.891,0.858, 0.759) and (0.903, 0.882, 0.746) (p=0.109, p=0.012, p=0.388) respectively. iFR in the major donor vessel increased from 0.858 to 0.882 (difference, 0.02412; p=0.012). The mean resting Pd/Pa, iFR and FFR pre and post CTO PCI in minor donor vessel were (0.982, 0.969, 0.894) and (0.985, 0.979, 0.885), (p=0.534, p=0.152, p=0.183) respectively. The mean collateral FFR was 0.310. The mean total ischaemic burden on baseline cardiac MRI in RCA territory was 12.6%.ConclusionSuccessful recanalisation of a RCA CTO results in a significant increase in the iFR of the major donor vessel but no significant difference was seen in resting Pd/Pa and FFR. Complete collateral regression was not observed in all patients immediately post RCA CTO PCI and this may account for the non-significant change in FFR values.Abstract 20 Table 1Angiographic characteristics (CTO: chronic total occlusion; RCA: right coronary artery; LAD: left anterior descending artery; LCX: left circumflex artery; PCI: percutaneous coronary intervention)
Short term prognosis of patients with acute coronary syndromes: the level of cardiac troponin T elevation corresponding to the “old” WHO definition of myocardial infarction
[...]future epidemiological studies will inevitably be skewed by the \"new\" definition with an increase in the numbers of patients diagnosed with MI, and an apparent improvement in overall prognosis likely to be related to a smaller proportion of patients with large transmural infarctions being exposed to the hazards of ventricular remodelling and heart failure. [...]our cTnT sample was taken 12 hours after onset of chest pain, as recommended for diagnostic purposes, whereas the studies which have correlated with infarct size and left ventricular ejection fraction have tended to sample either a peak result or cTnT at the plateau phase, usually 12-48 hours after onset of chest pain. 5 The two groups, CK [= or >, slanted] 400 IU/l and cTnT > 1.1 μg/l, contained different individual patients and of the 250 patients with CK [= or >, slanted] 400 IU/l, less than half (n = 115) also had a troponin concentration > 1.1 μg/l.
Massive pulmonary embolism without haemodynamic compromise caused by the presence of a patent foramen ovale
Intraoperative transoesophageal echocardiogram revealed the presence of a patent foramen ovale (PFO) with torrential right to left shunt which accounted for his haemodynamic stability throughout.