Objective Cardiac rehabilitation (CR) is pivotal in preventing recurring events of myocardial infarction (MI). This study aims to investigate the effect of a smartphone-based home service delivery ...(Care Assessment Platform) of CR (CAP-CR) on CR use and health outcomes compared with a traditional, centre-based programme (TCR) in post-MI patients. Methods In this unblinded randomised controlled trial, post-MI patients were randomised to TCR (n=60; 55.7±10.4 years) and CAP-CR (n=60; 55.5±9.6 years) for a 6-week CR and 6-month self-maintenance period. CAP-CR, delivered in participants’ homes, included health and exercise monitoring, motivational and educational material delivery, and weekly mentoring consultations. CAP-CR uptake, adherence and completion rates were compared with TCR using intention-to-treat analyses. Changes in clinical outcomes (modifiable lifestyle factors, biomedical risk factors and health-related quality of life) across baseline, 6 weeks and 6 months were compared within, and between, groups using linear mixed model regression. Results CAP-CR had significantly higher uptake (80% vs 62%), adherence (94% vs 68%) and completion (80% vs 47%) rates than TCR (p<0.05). Both groups showed significant improvements in 6-minute walk test from baseline to 6 weeks (TCR: 537±86–584±99 m; CAP-CR: 510±77–570±80 m), which was maintained at 6 months. CAP-CR showed slight weight reduction (89±20–88±21 kg) and also demonstrated significant improvements in emotional state (K10: median (IQR) 14.6 (13.4–16.0) to 12.6 (11.5–13.8)), and quality of life (EQ5D-Index: median (IQR) 0.84 (0.8–0.9) to 0.92 (0.9–1.0)) at 6 weeks. Conclusions This smartphone-based home care CR programme improved post-MI CR uptake, adherence and completion. The home-based CR programme was as effective in improving physiological and psychological health outcomes as traditional CR. CAP-CR is a viable option towards optimising use of CR services. Trial registration number ANZCTR12609000251224.
Abstract Aims Survivors of out-of-hospital cardiac arrest (OHCA) have a high rate of morbidity and mortality. Invasive cardiac assessment with coronary angiography offers the potential for improving ...outcomes by facilitating early revascularization. The aim of the present study was to review the published data on early coronary angiography for survivors of OHCA, and its impact on survival and neurological outcomes. Methods Medline, Embase and PubMed were searched with a structured search query. The primary outcome was in-hospital (or if not available, 30 day or 6 month) survival. Rates of survival with good neurological outcome were a secondary endpoint. The time period of the search was from 1 January 1980 to 1 January 2014. Data was pooled with means and 95% CI interval calculated. Meta-analysis of the main outcomes was performed using a weighted random effects model. Results Following review of all identified records, 105 relevant full text articles were retrieved. Fifty had adequate outcome information stratified by the use of coronary angiography for analysis. In studies where a control group was available for comparison, the overall survival in the acute angiography group was 58.8% versus 30.9% in the control group (Odds ratio 2.77, 95% CI 2.06–3.72). Survival with good neurological outcome (as per the Utstein framework) in the early angiography group was 58% versus 35.8% in the control group (Odds ratio 2.20, 95% CI 1.46–3.32). Conclusions Early coronary angiography in patients following OHCA is associated with improved outcome and better survival.
To examine whether there are sex differences in the characteristics, management, and clinical outcomes of patients with an ST-elevation myocardial infarction (STEMI). Design, setting: Cohort study; ...analysis of data collected prospectively by the CONCORDANCE acute coronary syndrome registry from 41 Australian hospitals between February 2009 and May 2016.
2898 patients (2183 men, 715 women) with STEMI.
Rates of revascularisation (percutaneous coronary intervention PCI, thrombolysis, coronary artery bypass grafting CABG), adjusted for GRACE risk score quartile.
timely vascularisation rates; major adverse cardiac event rates; clinical outcomes and preventive treatments at discharge.
The mean age of women with STEMI at presentation was 66.6 years (SD, 14.5 years), of men, 60.5 years (SD, 12.5 years). The proportions of women with hypertension, diabetes, prior stroke, chronic kidney disease, chronic heart failure, or dementia were larger than those of men; fewer women had histories of previous coronary artery disease or myocardial infarction, or of prior PCI or CABG. Women were less likely to have undergone coronary angiography (odds ratio, adjusted for GRACE score quartile aOR, 0.53; 95% CI, 0.41-0.69) or revascularisation (aOR, 0.42; 95% CI, 0.34-0.52); they were less likely to have received timely revascularisation (aOR, 0.72; 95% CI, 0.63-0.83) or primary PCI (aOR, 0.76; 95% CI, 0.61-0.95). Six months after admission, the rates of major adverse cardiovascular events (aOR, 2.68; 95% CI, 1.76-4.09) and mortality (aOR, 2.17; 95% CI, 1.24-3.80) were higher for women. At discharge, significantly fewer women than men received β-blockers, statins, and referrals to cardiac rehabilitation.
Women with STEMI are less likely to receive invasive management, revascularisation, or preventive medication at discharge. The reasons for these persistent differences in care require investigation.
Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to ...improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR).
The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis.
Patients (n = 120; aortic annulus 19 to 27 mm) considered by a multidisciplinary heart team to be at high surgical risk received the valve transfemorally. The primary device performance endpoint, 30-day mean pressure gradient, was assessed by an independent echocardiographic core laboratory and compared with a pre-specified performance goal. The primary safety endpoint was 30-day mortality. Secondary endpoints included safety/effectiveness metrics per Valve Academic Research Consortium criteria.
Mean age was 84.4 years, 57% of the patients were female, and 76% were New York Heart Association functional class III/IV. Mean aortic valve area was 0.7 ± 0.2 cm(2). The valve was successfully implanted in all patients, with no cases of valve embolization, ectopic valve deployment, or additional valve implantation. All repositioning (n = 26) and retrieval (n = 6) attempts were successful; 34 patients (28.6%) received a permanent pacemaker. The primary device performance endpoint was met, because the mean gradient improved from 46.4 ± 15.0 mm Hg to 11.5 ± 5.2 mm Hg. At 30 days, the mortality rate was 4.2%, and the rate of disabling stroke was 1.7%; 1 (1.0%) patient had moderate PVR, whereas none had severe PVR.
REPRISE II demonstrates the safety and effectiveness of the Lotus valve in patients with severe aortic stenosis who are at high surgical risk. The valve could be positioned successfully with minimal PVR. (REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance; NCT01627691).
The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in ...the multicenter, prospective, single-arm CLASP study.
Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated.
Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days.
Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively.
The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349).
Lipid-rich plaque (LRP) is thought to be a precursor to cardiac events. However, its clinical significance in coronary arteries has never been systematically investigated.
This study investigated the ...prevalence and clinical significance of LRP in the nonculprit region of the target vessel in patients undergoing percutaneous coronary intervention (PCI).
The study included 1,474 patients from 20 sites across 6 countries undergoing PCI, who had optical coherence tomography (OCT) imaging of the target vessel. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, acute myocardial infarction, and ischemia-driven revascularization. Patients were followed for up to 4 years (median of 2 years).
Lipid-rich plaque was detected in nonculprit regions of the target vessel in 33.6% of patients. The cumulative rate of nonculprit lesion-related MACE (NC-MACE) over 48 months in patients with LRP was higher than in those without LRP (7.2% vs. 2.6%, respectively; p = 0.033). Acute coronary syndrome at index presentation (risk ratio: 2.538; 95% confidence interval CI: 1.246 to 5.173; p = 0.010), interruption of statin use ≥1 year (risk ratio: 4.517; 95% CI: 1.923 to 10.610; p = 0.001), and LRP in nonculprit regions (risk ratio: 2.061; 95% CI: 1.050 to 4.044; p = 0.036) were independently associated with increased NC-MACE. Optical coherence tomography findings revealed that LRP in patients with NC-MACE had longer lipid lengths (p < 0.001), wider maximal lipid arcs (p = 0.023), and smaller minimal lumen areas (p = 0.003) than LRPs in patients without MACE.
Presence of LRP in the nonculprit regions of the target vessel by OCT predicts increased risk for future NC-MACE, which is primarily driven by revascularization for recurrent ischemia. Lipid-rich plaque with longer lipid length, wider lipid arc, and higher degree of stenosis identified patients at higher risk of future cardiac events. (The Massachusetts General Hospital Optical Coherence Tomography Registry; NCT01110538).
Abstract Background Coronary CT angiography (CCTA) has high sensitivity, with 3 recent randomized trials favorably comparing CCTA to standard-of-care. Comparison to exercise stress ECG (ExECG), the ...most available and least expensive standard-of-care worldwide, has not been systematically tested. Methods CT-COMPARE was a randomized, single-center trial of low–intermediate risk chest pain subjects undergoing CCTA or ExECG after the first negative troponin. From March 2010 to April 2011, 562 patients randomized to either dual-source CCTA (n = 322) or ExECG (n = 240). Primary endpoints were diagnostic performance for ACS, and hospital cost at 30 days. Secondary endpoints were time-to-discharge, admission rates, and downstream resource utilization. Results ACS occurred in 24 (4%) patients. ExECG had 213 negative studies and 27 (26%) positive studies for ACS with sensitivity of 83% 95% CI: 36, 99.6%, specificity of 91% CI: 86, 94%, and ROC AUC of 0.87 CI: 0.70, 1. CCTA (> 50% stenosis considered positive) had 288 negative studies and 18/35 (51%) positive studies with a sensitivity of 100% CI: 81.5, 100, specificity of 94% CI: 91.2, 96.7%, and ROC of 0.97 CI: 0.92, 1.0; p = 0.2. Despite CCTA having higher odds of downstream testing (OR 2.0), 30 day per-patient cost was significantly lower for CCTA ($2193 vs $2704, p < 0.001). Length of stay for CCTA was significantly reduced (13.5 h 95% CI: 11.2–15.7, ExECG 19.7 h 95% CI: 17.4–22.1, p < 0.0005), which drove the reduction in cost. No patient had post-discharge cardiovascular events at 30 days. Conclusions CCTA had improved diagnostic performance compared to ExECG, combined with 35% relative reduction in length-of-stay, and 20% reduction in hospital costs. These data lend further evidence that CCTA is useful as a first line assessment in emergency department chest pain.
Transesophageal echocardiography operators (TEEOP) provide critical imaging support for percutaneous structural cardiac intervention procedures. They stand close to the patient and the associated ...scattered radiation.
This study sought to investigate TEEOP radiation dose during percutaneous structural cardiac intervention.
Key personnel (TEEOP, anesthetist, primary operator OP1, and secondary operator) wore instantly downloadable personal dosimeters during procedures requiring TEE support. TEEOP effective dose (E) and E per unit Kerma area product (E/KAP) were calculated. E/KAP was compared with C-arm projections. Additional shielding for TEEOP was implemented, and doses were measured for a further 50 procedures. Multivariate linear regression was performed to investigate independent predictors of radiation dose reduction.
In the initial 98 procedures, median TEEOP E was 2.62 μSv (interquartile range IQR: 0.95 to 4.76 μSv), similar to OP1 E: 1.91 μSv (IQR: 0.48 to 3.81 μSv) (p = 0.101), but significantly higher than secondary operator E: 0.48 μSv (IQR: 0.00 to 1.91 μSv) (p < 0.001) and anesthetist E: 0.48 μSv (IQR: 0.00 to 1.43 μSv) (p < 0.001). Procedures using predominantly right anterior oblique (RAO) and steep RAO projections were associated with high TEEOP E/KAP (p = 0.041). In a further 50 procedures, with additional TEEOP shielding, TEEOP E was reduced by 82% (2.62 μSv IQR: 0.95 to 4.76 to 0.48 μSv IQR: 0.00 to 1.43 μSv p < 0.001). Multivariate regression demonstrated shielding, procedure type, and KAP as independent predictors of TEEOP dose.
TEE operators are exposed to a radiation dose that is at least as high as that of OP1 during percutaneous cardiac intervention. Doses were higher with procedures using predominantly RAO projections. Radiation doses can be significantly reduced with the use of an additional ceiling-suspended lead shield.
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Transcatheter aortic valve implantation (TAVI) is an effective therapeutic option for severe symptomatic aortic valve stenosis (AS) with intermediate or high surgical risk. The purpose of this study ...was to examine the effects of TAVI on left ventricular (LV) mechanics using multilayer global longitudinal strain (GLS) by 2D speckle-tracking echocardiography. A total of 119 patients (mean age 83 ± 7.0 years, male 54%) with severe symptomatic AS and normal LV ejection fraction (LVEF) underwent echocardiography at baseline and 1 month after TAVI. Global longitudinal strain was measured from the endocardial layer (GLSendo), mid-ventricular layer (GLSmyo), epicardial layer (GLSepi) and full thickness of myocardium (GLSwhole). There was significant improvement in all 3 layers of GLS after TAVI compared with baseline, but there was no significant change in LVEF. The relative % increment in GLS in each layer strain were 11.2 ± 23.4% (GLSendo), 13.4 ± 33.0% (GLSmyo) and 18.0 ± 46.6% (GLSepi) with significant difference between GLSendo and GLSepi (p < 0.05). In conclusion, multilayer GLS is more sensitive than conventional LVEF to detect early improvement in LV systolic function after TAVI in patients with severe AS. There is a disproportional improvement in different layers with least improvement in the endocardium. Multilayer strain analysis may provide new insights into understanding mechanics of AS.
Continuous exposure to low-level scattered radiation to staff performing cardiac angiography and intervention is of concern. A novel shielding solution (NSS) (Rampart IC M1128) has the potential to ...provide greater shielding for staff present at the table-side. This study aimed to investigate the effectiveness of the NSS compared with a traditional shielding solution (TSS) in a randomized controlled trial that enrolled 100 patients who underwent cardiac angiography and/or intervention which were randomized to the NSS or TSS. Baseline patient characteristics and radiation dose data were collected. Staff who were scrubbed at the table-side wore 5 real-time dosimeters on the head, collar, waist, ankle, and under the apron. The median primary operator radiation dose was significantly lower (p <0.001) for all dosimeter locations with the NSS when compared with the TSS, being reduced by 86%, 80.0%, 100%, and 50.0% for the head, collar, waist, and leg respectively. Median under-apron dose was 0.0 µSv for both NSS and TSS. Median second operator dose was reduced by 100%, 100%, and 100% for the head, collar, and waist respectively (p <0.001). Median NSS and TSS dose at the ankle and under apron was 0.0 µSv. Median scrub nurse dose was reduced by 50% and 100% for the head and collar respectively (p <0.001). Median NSS and TSS dose at the waist, ankle, and under apron was 0.0 µSv. In conclusion, the NSS tested in this study demonstrates a significant decrease in radiation dose to operators and scrub nurses when compared with traditional radiation protection measures.
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