In the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) trial, the SYNTAX score was useful in risk stratifying patients with complex coronary artery disease. ...The reproducibility of this score may affect its clinical utility. We therefore assessed SYNTAX score interobserver and intraobserver variability among a group of interventional cardiologists (ICs) and an experienced group of angiographic core laboratory (ACL) technicians.
After basic training from the SYNTAX score website, 3 ICs and 4 ACL technicians, each working independently, assessed the SYNTAX score of 30 multivessel disease angiograms. The ICs then underwent an intensive training session with ACL technicians, after which the SYNTAX score from 50 additional angiograms were assessed independently by both groups. Interobserver Fleiss κ statistic values were determined. A third assessment was performed using quantitative coronary angiography (QCA). The ACL technician interobserver strength of agreement from both periods was substantial or greater (k=0.82; 95% CI 0.72, 1.00 and 0.84 0.76, 1.00) and not different than QCA. The IC interobserver agreement was initially estimated to be at least slight (k=0.33 0.18, 0.44), improving to substantial or greater after advanced training (k=0.76 0.64, 1.00). Despite advanced training, ICs underscored the number of lesions, bifurcations, and small-vessel disease (P<0.001), resulting in a lower score than ACL technicians (mean difference=7.5, P<0.001).
Highly reproducible SYNTAX score measurements were quickly achieved by experienced ACL technicians. In contrast, agreement among ICs after the basic tutorial was initially poor but improved considerably after further training with the ACL, although differences still remained in interpretation of several lesion types. These findings have important implications for adoption of SYNTAX score methodology in routine practice and future clinical trials.
Understanding of the needs of people with stroke at hospital discharge and in the first six-months is limited. This study aim was to profile and document the needs of people with stroke at hospital ...discharge to home and thereafter.
A prospective cohort study recruiting individuals with stroke, from three hospitals, who transitioned home, either directly, through rehabilitation, or with early supported discharge teams. Their outcomes (global-health, cognition, function, quality of life, needs) were described using validated questionnaires and a needs survey, at 7-10 days, and at 3-, and 6-months, post-discharge.
72 patients were available at hospital discharge; mean age 70 (SD 13); 61% female; median NIHSS score of 4 (IQR 0-20). 62 (86%), 54 (75%), and 45 (63%) individuals were available respectively at each data collection time-point. Perceived disability was considerable at hospital discharge (51% with mRS ≥ 3), and while it improved at 3-months, it increased thereafter (35% with mRS ≥ 3 at 6-months). Mean physical health and social functioning were "fair" at hospital discharge and ongoing; while HR-QOL, although improved over time, remained impaired at 6-months (0.69+/-0.28). At 6-months cognitive impairment was present in 40%. Unmet needs included involvement in transition planning and care decisions, with ongoing rehabilitation, information, and support needs. The median number of unmet needs at discharge to home was four (range:1-9), and three (range:1-7) at 6-months.
Stroke community reintegration is challenging for people with stroke and their families, with high levels of unmet need. Profiling outcomes and unmet needs for people with stroke at hospital-to-home transition and onwards are crucial for shaping the development of effective support interventions to be delivered at this juncture.
02/08/2022; ISRCTN44633579.
Background Prior retrospective studies have identified a relationship between bleeding after cardiac surgery and subsequent mortality. Whether this is attributable to bleeding, anemia, or ...transfusions is undetermined. Methods ACUITY was an international prospective trial of patients with acute coronary syndromes. Coronary artery bypass grafting (CABG) before hospital discharge was performed in 1,491 patients. Major bleeding was adjudicated as CABG- or non-CABG related. The relationship between CABG-related bleeding and 1-year mortality was determined using a time-updated covariate-adjusted Cox model. Results Coronary artery bypass grafting–related major bleeding after surgery occurred in 789 patients (52.9%); allogeneic blood product transfusions were administered in 612 patients (41.0%), including red blood cell (RBC) transfusions in 570 (38.2%, range 1-53 U), platelet transfusions in 180 (12.1%), and fresh-frozen plasma in 195 (13.1%). One-year mortality occurred in 95 patients (6.4%). Red blood cell transfusion (but not transfusion of platelets or fresh-frozen plasma, CABG-related major bleeding per se, or nadir hemoglobin) was an independent predictor of 1-year mortality, but only after transfusion of ≥4 U (adjusted hazard ratio for death after transfusion of 1-3, 4-6, and ≥7 RBC units = 0.74, 2.01, and 5.22, respectively). Of the 95 deaths after CABG, 23 (24.2%) were attributable to CABG-related RBC transfusions. Conclusions In patients with acute coronary syndromes, RBC transfusion of ≥4 U after CABG is strongly associated with subsequent mortality. Future strategies should focus on reducing major hemorrhagic complications and RBC transfusions after CABG.
Left ventricular (LV) dysfunction and multivessel disease (MVD) have been associated with greater mortality after ST-segment elevation myocardial infarction. The aim of this study was to evaluate the ...impact of LV dysfunction and MVD in patients with ST-segment elevation myocardial infarctions treated with primary percutaneous coronary intervention (PCI). Patients from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial treated with primary PCI in whom baseline LV function was assessed using left ventriculography were included in this study. Early and late (3-year) outcomes were examined in groups of patients with reduced (<40%) and preserved (≥40%) LV ejection fractions (LVEFs), further stratified by the presence of MVD. A total of 2,430 patients were included. Patients with reduced LVEFs were older; were more likely to be women; were more likely to have histories of myocardial infarction, PCI, and heart failure; and were more likely to present in heart failure. Patients with reduced LVEFs had greater 30-day (8.9% vs 0.9%, hazard ratio 9.81, 95% confidence interval 5.23 to 18.42, p <0.0001) and 3-year (17.1% vs 3.7%, hazard ratio 5.03, 95% confidence interval 3.37 to 7.50, p <0.0001) mortality. Among patients with LVEFs <30% (n = 45), 30% to 40% (n = 157), 40% to 50% (n = 373), 50% to 60% (n = 659), and ≥60% (n = 1,196), 3-year mortality was 29.4%, 13.5%, 6.4%, 3.8%, and 2.9%, respectively (p for trend <0.0001). MVD was associated with greater mortality in patients with preserved but not reduced LVEFs. By multivariate analysis, LV dysfunction was the strongest predictor of 30-day and 3-year mortality. In conclusion, the presence of LV dysfunction as assessed on baseline left ventriculography in patients who undergo primary PCI in the contemporary era is a powerful predictor of early and late mortality, regardless of the extent of coronary artery disease.
Objectives This study sought to determine the clinical and angiographic variables that would identify patients with high-risk “vulnerable” coronary plaques. Background In the PROSPECT (Providing ...Regional Observations to Study Predictors of Events in the Coronary Tree) study, in patients successfully treated for acute coronary syndrome (ACS), plaque composition, plaque burden, and minimal luminal area as detected by 3-vessel radiofrequency intravascular ultrasound (IVUS) imaging were associated with an increased risk of developing future events from untreated atherosclerotic lesions (vulnerable plaques). Whether baseline demographic and angiographic findings can be used to identify patients most likely to have vulnerable coronary plaques has not been examined. Methods On the basis of 3-vessel radiofrequency IVUS imaging, patents in the PROSPECT trial were classified in 2 groups according to whether or not one or more untreated high-risk plaques were present, defined as having ≥2 high-risk features (a thin-cap fibroatheroma, plaque burden ≥70%, and/or minimal luminal area ≤4 mm2 ). Results The high-risk group (those with one or more high-risk lesions) had higher Framingham risk score (7.5 ± 3.4 vs. 6.9 ± 3.3; p = 0.04), more extensive coronary artery disease, and more nonculprit lesion–related cardiovascular events during the 3-year follow-up (hazard ratio: 2.63; 95% confidence interval: 1.62 to 3.66; p < 0.0001). However, demographic factors had poor discrimination in detecting high-risk patients (area under the curve 0.55), and discrimination was only slightly improved when angiographic variables were entered into the model (area under the curve 0.64). Conclusions Clinical and angiographic characteristics had poor predictive accuracy in identifying patients with untreated high-risk plaques related to future adverse events. This finding highlights the potential value of comprehensive 3-vessel imaging assessment (either invasive or noninvasive) to evaluate plaque phenotype for more accurate risk stratification of patients admitted with ACS.
The prognostic significance of postprocedure sustained ventricular tachycardia or ventricular fibrillation (VT/VF) in patients undergoing primary percutaneous coronary intervention (PPCI) for ...ST-segment elevation myocardial infarction (STEMI) has rarely been studied, although a previous study has suggested that its occurrence portends decreased survival. We examined outcomes from the prospective large-scale multicenter randomized HORIZONS-AMI trial to evaluate the incidence, clinical correlates, and outcomes of in-hospital sustained VT/VF after PPCI. Of 3,485 patients undergoing PPCI in whom VT/VF did not occur before or during the procedure, 181 patients (5.2%) developed VT/VF after PPCI. Most postprocedural VT/VF episodes (85%) occurred in the first 48 hours. Patients with postprocedural VT/VF were more likely men with Killip class >I on presentation but had a lower prevalence of hypertension and diabetes. Patients with postprocedural VT/VF were also less frequently taking β blockers and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers at admission. Mean door-to-balloon time was shorter and Thrombolysis In Myocardial Infarction grade 0 flow before PPCI was more common in patients with VT/VF, although Thrombolysis In Myocardial Infarction grade 3 flow rates after PPCI did not vary. There were no significant differences in adjusted 3-year rates of mortality (hazard ratio 0.73, 95% confidence interval 0.30 to 1.79) or composite major adverse clinical events (death, myocardial infarction, target vessel revascularization, or stroke; hazard ratio 0.71, 95% confidence interval 0.44 to 1.15) in patients with versus without postprocedural sustained VT/VF. In conclusion, sustained VT/VF after PPCI in the HORIZONS-AMI trial was not significantly associated with 3-year mortality or major adverse clinical events. Further studies are required to address the prognostic significance of VT/VF in patients with STEMI undergoing PPCI.
We sought to validate 4 angiographic measures as potential surrogates for clinical restenosis (target lesion revascularization TLR) after stent implantation.
Given the low revascularization rates ...with drug-eluting stents (DES), an angiographic surrogate of TLR is desirable to reduce the sample size required to demonstrate efficacy in future trials of antirestenosis devices.
We evaluated 4 potential angiographic measures (late loss LL and percent diameter stenosis %DS, both in-stent and in-segment) as a surrogate for TLR at 1 year. From 11 multicenter, prospective randomized stent trials, 9 comparing DES with bare-metal stents (BMS) and 2 comparing different DES, individual data on 5,381 patients with a single treated lesion and follow-up angiography at 6 to 9 months were analyzed.
By 4 well-defined criteria of surrogacy, LL and %DS strongly predicted the risk of TLR, with in-segment %DS being the most highly predictive (approximately 0.95). Differences in TLR risk were fully explained statistically by their differences in LL or %DS, although LL as a surrogate was dependent on vessel size whereas %DS was not. However, because of the curvilinearity of the logistic model, trials comparing 2 effective DES can have significant differences in mean LL and %DS but small expected differences in TLR risk, especially at the lower ranges of LL and %DS.
From in-stent and in-segment LL and %DS measures, logistic models can reliably estimate TLR rates for DES and BMS. These angiographic measures are thus suitable surrogate markers for clinical stent efficacy and can be used as primary end points in future DES trials to significantly reduce sample size.
Background
Catheter-based renal denervation (RDN) reduces blood pressure (BP) throughout the 24-h period, as reported in several randomized sham-controlled trials. Reduction of BP in the early ...morning hours is especially important due to increased cardiovascular risks during that time.
Objective
In this report, we examine the impact of RDN on systolic BP (SBP) and diastolic BP (DBP) during the critical morning surge period in a post-hoc analysis of patients in the SPYRAL HTN-ON MED trial.
Methods and results
Ambulatory BP measurements were collected at baseline and 6 months for treatment and control patient groups over 24-h periods. Average morning BP surge is the difference between average morning BP and average nighttime BP, and the morning surge slope reflects the rate of change of BP from nighttime to morning. Mean morning DBP surge slopes were significantly lower for RDN vs. control groups at 6 months (1.1 vs. 3.6 mmHg/h;
p
= 0.029). In the RDN group, morning DBP surge slopes were significantly lower at 6 months compared to baseline (1.1 vs. 4.1 mmHg/h;
p
= 0.006). Similar patterns were observed for mean morning SBP surge slope but did not reach statistical significance.
Conclusions
This decrease in the morning DBP surge slope, an index of the sympathetically-mediated morning BP surge, thus indicates a drop in late morning BP relative to early morning/nocturnal BP in the RDN group. Thus, RDN appears effective in attenuating the slope of morning surge in DBP that might indicate possible benefits in a high-risk hypertensive population.
Clinical trial registration
https://www.clinicaltrials.gov
(NCT02439775), registered May 12, 2015.
The clinical outcome of acute cardiovascular events may be more favorable in patients with a high body mass index (BMI), although obesity increases the risk for cardiovascular diseases. The authors ...sought to define the association between BMI and acute and long-term outcome of patients presenting within 12 hours of ST-segment myocardial infarction (STEMI) in a large multinational cohort. A total of 3,579 patients enrolled in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial were stratified according to BMI quartiles: <24.5, 24.5 to <27.1, 27.1 to 30.1, and >30.1 kg/m2 (quartiles 1, 2, 3, and 4, respectively). Death, myocardial reinfarction, ischemia-driven target vessel revascularization, stroke, and noncoronary artery bypass grafting-related major bleeding events were centrally adjudicated for the acute, 30 days, and yearly follow-up. Patients with a BMI in the highest quartile were younger than patients in the lower BMI quartiles and more frequently had hypertension, hyperlipidemia, and diabetes mellitus. Complete occlusions and noncalcified lesions were more common in patients with a high BMI. In-hospital mortality decreased with increasing BMI due to lower cardiac mortality (2.9%, 2.3%, 1.2%, and 1.0% for quartiles 1, 2, 3, and 4, respectively, p <0.05). Out-of-hospital 3-year mortality was also lower in higher-weight patients due to lower noncardiac mortality (4.2%, 2.6%, 2.3%, and 1.7% for quartiles 1 to 4, respectively, p = 0.01). After adjustment for covariates, BMI was no longer predictive of acute or long-term mortality after STEMI. In conclusion, as BMI increases, patients have a more extensive adjusted cardiovascular risk profile and disease burden and premature STEMI onset but similar adjusted acute and long-term outcomes.
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