ABSTRACT
BACKGROUND AND AIMS: Contrast-induced nephropathy (CIN), also known as contrast-associated acute kidney injury (CA-AKI) underlies a significant proportion of the morbidity and mortality following coronary angiographic procedures in high-risk patients and remains a significant unmet need. In pre-clinical studies inorganic nitrate, which is chemically reduced in vivo to nitric oxide, is renoprotective but this observation is yet to be translated clinically. In this study, the efficacy of inorganic nitrate in the prevention of CIN in high-risk patients presenting with acute coronary syndromes (ACS) is reported. METHODS: NITRATE-CIN is a double-blind, randomized, single-centre, placebo-controlled trial assessing efficacy of inorganic nitrate in CIN prevention in at-risk patients presenting with ACS. Patients were randomized 1:1 to once daily potassium nitrate (12 mmol) or placebo (potassium chloride) capsules for 5 days. The primary endpoint was CIN (KDIGO criteria). Secondary outcomes included kidney function [estimated glomerular filtration rate (eGFR)] at 3 months, rates of procedural myocardial infarction, and major adverse cardiac events (MACE) at 12 months. This study is registered with ClinicalTrials.gov: NCT03627130. RESULTS: Over 3 years, 640 patients were randomized with a median follow-up of 1.0 years, 319 received inorganic nitrate with 321 received placebo. The mean age of trial participants was 71.0 years, with 73.3% male and 75.2% Caucasian; 45.9% had diabetes, 56.0% had chronic kidney disease (eGFR <60 mL/min) and the mean Mehran score of the population was 10. Inorganic nitrate treatment significantly reduced CIN rates (9.1%) vs. placebo (30.5%, P < .001). This difference persisted after adjustment for baseline creatinine and diabetes status (odds ratio 0.21, 95% confidence interval 0.13-0.34). Secondary outcomes were improved with inorganic nitrate, with lower rates of procedural myocardial infarction (2.7% vs. 12.5%, P = .003), improved 3-month renal function (between-group change in eGFR 5.17, 95% CI 2.94-7.39) and reduced 1-year MACE (9.1% vs. 18.1%, P = .001) vs. placebo. CONCLUSIONS: In patients at risk of renal injury undergoing coronary angiography for ACS, a short (5 day) course of once-daily inorganic nitrate reduced CIN, improved kidney outcomes at 3 months, and MACE events at 1 year compared to placebo.
Subject(s)
Acute Coronary Syndrome , Acute Kidney Injury , Contrast Media , Coronary Angiography , Nitrates , Humans , Coronary Angiography/adverse effects , Coronary Angiography/methods , Contrast Media/adverse effects , Male , Female , Double-Blind Method , Nitrates/administration & dosage , Nitrates/therapeutic use , Acute Kidney Injury/chemically induced , Acute Kidney Injury/prevention & control , Aged , Middle Aged , Glomerular Filtration Rate/drug effects , Potassium Compounds/administration & dosage , Potassium Compounds/therapeutic useABSTRACT
BACKGROUND: Patients with previous coronary artery bypass grafting often require invasive coronary angiography (ICA). However, for these patients, the procedure is technically more challenging and has a higher risk of complications. Observational studies suggest that computed tomography cardiac angiography (CTCA) may facilitate ICA in this group, but this has not been tested in a randomized controlled trial. METHODS: This study was a single-center, open-label randomized controlled trial assessing the benefit of adjunctive CTCA in patients with previous coronary artery bypass grafting referred for ICA. Patients were randomized 1:1 to undergo CTCA before ICA or ICA alone. The co-primary end points were procedural duration of the ICA (defined as the interval between local anesthesia administration for obtaining vascular access and removal of the last catheter), patient satisfaction after ICA using a validated questionnaire, and the incidence of contrast-induced nephropathy. Linear regression was used for procedural duration and patient satisfaction score; contrast-induced nephropathy was analyzed using logistic regression. We applied the Bonferroni correction, with P<0.017 considered significant and 98.33% CIs presented. Secondary end points included incidence of procedural complications and 1-year major adverse cardiac events. RESULTS: Over 3 years, 688 patients were randomized with a median follow-up of 1.0 years. The mean age was 69.8±10.4 years, 108 (15.7%) were women, 402 (58.4%) were White, and there was a high burden of comorbidity (85.3% hypertension and 53.8% diabetes). The median time from coronary artery bypass grafting to angiography was 12.0 years, and there were a median of 3 (interquartile range, 2 to 3) grafts per participant. Procedure duration of the ICA was significantly shorter in the CTCA+ICA group (CTCA+ICA, 18.6±9.5 minutes versus ICA alone, 39.5±16.9 minutes [98.33% CI, -23.5 to -18.4]; P<0.001), alongside improved mean ICA satisfaction scores (1=very good to 5=very poor; -1.1 difference [98.33% CI, -1.2 to -0.9]; P<0.001), and reduced incidence of contrast-induced nephropathy (3.4% versus 27.9%; odds ratio, 0.09 [98.33% CI, 0.04-0.2]; P<0.001). Procedural complications (2.3% versus 10.8%; odds ratio, 0.2 [95% CI, 0.1-0.4]; P<0.001) and 1-year major adverse cardiac events (16.0% versus 29.4%; hazard ratio, 0.4 [95% CI, 0.3-0.6]; P<0.001) were also lower in the CTCA+ICA group. CONCLUSIONS: For patients with previous coronary artery bypass grafting, CTCA before ICA leads to reductions in procedure time and contrast-induced nephropathy, with improved patient satisfaction. CTCA before ICA should be considered in this group of patients. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03736018.
Subject(s)
Computed Tomography Angiography , Coronary Angiography , Coronary Artery Disease , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Coronary Angiography/adverse effects , Coronary Angiography/methods , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/surgery , Coronary Artery BypassABSTRACT
AIMS: The public reporting of healthcare outcomes has a number of potential benefits; however, unintended consequences may limit its effectiveness as a quality improvement process. We aimed to assess whether the introduction of individual operator specific outcome reporting after percutaneous coronary intervention (PCI) in the UK was associated with a change in patient risk factor profiles, procedural management, or 30-day mortality outcomes in a large cohort of consecutive patients. METHODS AND RESULTS: This was an observational cohort study of 123 780 consecutive PCI procedures from the Pan-London (UK) PCI registry, from January 2005 to December 2015. Outcomes were compared pre- (2005-11) and post- (2011-15) public reporting including the use of an interrupted time series analysis. Patients treated after public reporting was introduced were older and had more complex medical problems. Despite this, reported in-hospital major adverse cardiovascular and cerebrovascular events rates were significantly lower after the introduction of public reporting (2.3 vs. 2.7%, P < 0.0001). Interrupted time series analysis demonstrated evidence of a reduction in 30-day mortality rates after the introduction of public reporting, which was over and above the existing trend in mortality before the introduction of public outcome reporting (35% decrease relative risk 0.64, 95% confidence interval 0.55-0.77; P < 0.0001). CONCLUSION: The introduction of public reporting has been associated with an improvement in outcomes after PCI in this data set, without evidence of risk-averse behaviour. However, the lower reported complication rates might suggest a change in operator behaviour and decision-making confirming the need for continued surveillance of the impact of public reporting on outcomes and operator behaviour.
Subject(s)
Acute Coronary Syndrome/surgery , Angina, Stable/surgery , Cardiologists/psychology , Interrupted Time Series Analysis/methods , Patient Care Management/statistics & numerical data , Acute Coronary Syndrome/diagnosis , Aged , Angina, Stable/diagnosis , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/mortality , Case-Control Studies , Cerebrovascular Disorders/epidemiology , Cerebrovascular Disorders/mortality , Clinical Decision-Making/ethics , Female , Hospital Mortality/trends , Humans , Male , Mandatory Reporting/ethics , Middle Aged , Patient Care Management/ethics , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Percutaneous Coronary Intervention/statistics & numerical data , Professional Misconduct/statistics & numerical data , Prospective Studies , Quality Improvement/standards , Registries , Risk Factors , Treatment Outcome , United Kingdom/epidemiologyABSTRACT
Transradial access is increasingly used for coronary angiography and percutaneous coronary intervention, however, femoral access remains necessary for numerous procedures, including complex high-risk interventions, structural procedures, and procedures involving mechanical circulatory support. Optimising the safety of this approach is crucial to minimize costly and potentially life-threatening complications. We initiated a quality improvement project recommending routine fluoroscopic guidance (femoral head), and upfront femoral angiography should be performed to assess for location and immediate complications. We assessed the effect of these measures on the rate of vascular complications. Data were collected prospectively on 4534 consecutive patients undergoing femoral coronary angiographic procedures from 2015 to 2017. The primary end-point was any access complication. Outcomes were compared pre and post introduction including the use of an Interrupted Time-Series (ITS) analysis. 1890 patients underwent angiography prior to the introduction of routine fluoroscopy and upfront femoral angiography and 2644 post. All operators adopted these approaches. Baseline characteristics, including large sheath use, anticoagulant use and PCI rates were similar between the 2 groups. Fluoroscopy-enabled punctures were made in the 'safe zone' in over 91% of cases and upfront femoral angiography resulted in management changes i.e. procedural abandonment prior to heparin administration in 21 patients (1.1%). ITS analysis demonstrated evidence of a reduction in femoral complication rates after the introduction of the intervention, which was over and above the existing trend before the introduction (40% decrease RR 0.58; 95% CI: 0.25-0.87; P < 0.01). Overall these quality improvement measures were associated with a significantly lower incidence of access site complications (0.9% vs. 2.0%, P < 0.001). Routine fluoroscopy guided vascular access and upfront femoral angiography prior to anticoagulation leads to lower vascular complication rates. Thus, study shows that femoral intervention can be performed safely with very low access-related complication rates when fluoroscopic guidance and upfront angiography is used to obtain femoral arterial access.
Subject(s)
Coronary Angiography/methods , Coronary Artery Disease/surgery , Fluoroscopy/methods , Percutaneous Coronary Intervention/methods , Surgery, Computer-Assisted/methods , Vascular System Injuries/prevention & control , Aged , Coronary Artery Disease/diagnosis , Female , Femoral Artery , Follow-Up Studies , Humans , Incidence , Male , Prospective Studies , Risk Factors , Time Factors , United Kingdom/epidemiology , Vascular System Injuries/epidemiologyABSTRACT
Importance: Microvascular obstruction commonly affects patients with acute ST-segment elevation myocardial infarction (STEMI) and is associated with adverse outcomes. Objective: To determine whether a therapeutic strategy involving low-dose intracoronary fibrinolytic therapy with alteplase infused early after coronary reperfusion will reduce microvascular obstruction. Design, Setting, and Participants: Between March 17, 2016, and December 21, 2017, 440 patients presenting at 11 hospitals in the United Kingdom within 6 hours of STEMI due to a proximal-mid-vessel occlusion of a major coronary artery were randomized in a 1:1:1 dose-ranging trial design. Patient follow-up to 3 months was completed on April 12, 2018. Interventions: Participants were randomly assigned to treatment with placebo (n = 151), alteplase 10 mg (n = 144), or alteplase 20 mg (n = 145) by manual infusion over 5 to 10 minutes. The intervention was scheduled to occur early during the primary PCI procedure, after reperfusion of the infarct-related coronary artery and before stent implant. Main Outcomes and Measures: The primary outcome was the amount of microvascular obstruction (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI) conducted from days 2 through 7 after enrollment. The primary comparison was the alteplase 20-mg group vs the placebo group; if not significant, the alteplase 10-mg group vs the placebo group was considered a secondary analysis. Results: Recruitment stopped on December 21, 2017, because conditional power for the primary outcome based on a prespecified analysis of the first 267 randomized participants was less than 30% in both treatment groups (futility criterion). Among the 440 patients randomized (mean age, 60.5 years; 15% women), the primary end point was achieved in 396 patients (90%), 17 (3.9%) withdrew, and all others were followed up to 3 months. In the primary analysis, the mean microvascular obstruction did not differ between the 20-mg alteplase and placebo groups (3.5% vs 2.3%; estimated difference, 1.16%; 95% CI, -0.08% to 2.41%; P = .32) nor in the analysis of 10-mg alteplase vs placebo groups (2.6% vs 2.3%; estimated difference, 0.29%; 95% CI, -0.76% to 1.35%; P = .74). Major adverse cardiac events (cardiac death, nonfatal MI, unplanned hospitalization for heart failure) occurred in 15 patients (10.1%) in the placebo group, 18 (12.9%) in the 10-mg alteplase group, and 12 (8.2%) in the 20-mg alteplase group. Conclusions and Relevance: Among patients with acute STEMI presenting within 6 hours of symptoms, adjunctive low-dose intracoronary alteplase given during the primary percutaneous intervention did not reduce microvascular obstruction. The study findings do not support this treatment. Trial Registration: ClinicalTrials.gov Identifier: NCT02257294.
Subject(s)
Coronary Occlusion/drug therapy , ST Elevation Myocardial Infarction/drug therapy , Tissue Plasminogen Activator/administration & dosage , Aged , Area Under Curve , Cardiac Catheters , Combined Modality Therapy , Coronary Angiography , Coronary Occlusion/surgery , Coronary Vessels , Dose-Response Relationship, Drug , Female , Humans , Infusions, Intra-Arterial , Magnetic Resonance Imaging , Male , Middle Aged , Percutaneous Coronary Intervention , Quality of Life , ST Elevation Myocardial Infarction/surgery , Tissue Plasminogen Activator/adverse effects , Treatment Failure , Troponin T/bloodABSTRACT
BACKGROUND: The association between intraoperative cardiovascular changes and perioperative myocardial injury has chiefly focused on hypotension during noncardiac surgery. However, the relative influence of blood pressure and heart rate (HR) remains unclear. We investigated both individual and codependent relationships among intraoperative HR, systolic blood pressure (SBP), and myocardial injury after noncardiac surgery (MINS). METHODS: Secondary analysis of the Vascular Events in Noncardiac Surgery Cohort Evaluation (VISION) study, a prospective international cohort study of noncardiac surgical patients. Multivariable logistic regression analysis tested for associations between intraoperative HR and/or SBP and MINS, defined by an elevated serum troponin T adjudicated as due to an ischemic etiology, within 30 days after surgery. Predefined thresholds for intraoperative HR and SBP were: maximum HR >100 beats or minimum HR <55 beats per minute (bpm); maximum SBP >160 mm Hg or minimum SBP <100 mm Hg. Secondary outcomes were myocardial infarction and mortality within 30 days after surgery. RESULTS: After excluding missing data, 1197 of 15,109 patients (7.9%) sustained MINS, 454 of 16,031 (2.8%) sustained myocardial infarction, and 315 of 16,061 patients (2.0%) died within 30 days after surgery. Maximum intraoperative HR >100 bpm was associated with MINS (odds ratio [OR], 1.27 [1.07-1.50]; P < .01), myocardial infarction (OR, 1.34 [1.05-1.70]; P = .02), and mortality (OR, 2.65 [2.06-3.41]; P < .01). Minimum SBP <100 mm Hg was associated with MINS (OR, 1.21 [1.05-1.39]; P = .01) and mortality (OR, 1.81 [1.39-2.37]; P < .01), but not myocardial infarction (OR, 1.21 [0.98-1.49]; P = .07). Maximum SBP >160 mm Hg was associated with MINS (OR, 1.16 [1.01-1.34]; P = .04) and myocardial infarction (OR, 1.34 [1.09-1.64]; P = .01) but, paradoxically, reduced mortality (OR, 0.76 [0.58-0.99]; P = .04). Minimum HR <55 bpm was associated with reduced MINS (OR, 0.70 [0.59-0.82]; P < .01), myocardial infarction (OR, 0.75 [0.58-0.97]; P = .03), and mortality (OR, 0.58 [0.41-0.81]; P < .01). Minimum SBP <100 mm Hg with maximum HR >100 bpm was more strongly associated with MINS (OR, 1.42 [1.15-1.76]; P < .01) compared with minimum SBP <100 mm Hg alone (OR, 1.20 [1.03-1.40]; P = .02). CONCLUSIONS: Intraoperative tachycardia and hypotension are associated with MINS. Further interventional research targeting HR/blood pressure is needed to define the optimum strategy to reduce MINS.
Subject(s)
Blood Pressure/physiology , Heart Rate/physiology , Internationality , Monitoring, Intraoperative/methods , Myocardial Ischemia/physiopathology , Postoperative Complications/physiopathology , Aged , Aged, 80 and over , Cohort Studies , Female , Humans , Male , Middle Aged , Myocardial Ischemia/diagnosis , Myocardial Ischemia/etiology , Postoperative Complications/diagnosis , Postoperative Complications/etiology , Prospective StudiesABSTRACT
BACKGROUND: The clinical assessment of patients with chest pain of recent onset remains difficult. This study presents a critical review of clinical predictive tools for the assessment of patients with chest pain. METHODS: Systematic review of observational studies and estimation of probabilities of coronary artery disease (CAD) in patients with chest pain. Searches were conducted in PubMed, Embase, Scopus, and Web of Science to identify studies reporting tools, with at least three variables from clinical history, physical examination or ECG, produced with multivariate analysis, to estimate probabilities of CAD in patients with chest pain of recent onset, published from inception of the database to the 31st July 2015. The references of previous relevant reviews were hand searched. The methodological quality was assessed with standard criteria. Since the incidence of CAD has changed in the past few decades, the date of publication was acknowledged to be relevant in order to use the tool in clinical practice, and more recent papers were considered more relevant. Probabilities of CAD according to the studies of highest quality were estimated and the evidence provided was graded. RESULTS: Twelve papers were included out of the 19126 references initially identified. The methodological quality of all of them was high. The clinical characteristics of the chest pain, age, past medical history of cardiovascular disease, gender, and abnormalities in the ECG were the predictors of CAD most commonly reported across the studies. The most recent papers, with highest methodological quality, and most practical for use in clinical settings, reported prediction or exclusion of CAD with area under the curve 0.90 in Primary Care, 0.91 in Emergency department, and 0.79 in Cardiology. These papers provide evidence of high level (1B) and the recommendation to use their results in the management of patients with chest pain is strong (A). CONCLUSIONS: The risk of CAD can be estimated on clinical grounds in patients with chest pain in different clinical settings with high accuracy. The estimation of probabilities of CAD presented in these studies could be used for a better management of patients with chest pain and also in the development of future predictive tools.
Subject(s)
Chest Pain/diagnosis , Coronary Artery Disease/diagnosis , Decision Support Techniques , Myocardial Ischemia/diagnosis , Primary Health Care , Age Factors , Area Under Curve , Cardiology , Chest Pain/etiology , Coronary Artery Disease/complications , Electrocardiography , Emergency Service, Hospital , Humans , Myocardial Ischemia/complications , Observational Studies as Topic , Sex FactorsABSTRACT
Acute kidney injury (AKI) is a frequent complication of cardiac surgery and usually occurs in patients with preexisting chronic kidney disease (CKD). Remote ischemic preconditioning (RIPC) may mitigate the renal ischemia-reperfusion injury associated with cardiac surgery and may be a preventive strategy for postsurgical AKI. We undertook a randomized controlled trial of RIPC to prevent AKI in 86 patients with CKD (estimated glomerular filtration rate under 60 ml/min per 1.73 m(2)) undergoing coronary artery bypass graft (CABG) surgery. Forty-three patients each were randomized to receive standard care with or without RIPC consisting of three 5-minute cycles of forearm ischemia followed by reperfusion. The primary end point was the development of AKI defined as an increase in serum creatinine concentration over 0.3 mg/dl within 48 h of surgery. Secondary end points included a comparison between the study and control groups of several serum biomarkers of renal injury including cystatin-C, neutrophil gelatinase-associated lipocalin (NGAL), and interleukin-18 (IL-18), and urinary biomarkers including NGAL, IL-18, and kidney injury molecule-1 measured at 6, 12, and 24 h after CABG, and the 72-h serum troponin T concentration area under the curve as a marker of myocardial injury. Clinical and operative characteristics were similar between the preconditioned and control groups. AKI developed in 12 patients in both groups within 48 h of CABG. There were no significant differences between the two groups in the concentrations of any of the serum or urinary biomarkers of renal or cardiac injury after CABG. Thus, RIPC induced by forearm ischemia-reperfusion had no effect on the frequency of AKI after CABG in patients with CKD.
Subject(s)
Acute Kidney Injury/etiology , Acute Kidney Injury/prevention & control , Coronary Artery Bypass/adverse effects , Ischemic Preconditioning/methods , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Reperfusion Injury/etiology , Reperfusion Injury/prevention & control , Acute Kidney Injury/metabolism , Aged , Aged, 80 and over , Biomarkers/blood , Biomarkers/urine , Creatinine/blood , Female , Forearm/blood supply , Humans , Male , Middle Aged , Postoperative Complications/metabolism , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/surgery , Reperfusion Injury/metabolism , Troponin T/bloodABSTRACT
AIMS: Myocardial revascularization by either coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) carries the risk of serious complications. Observational data suggest that outcomes may be improved by experienced operators, but there are few studies that have analysed the relationship between mortality and primary operator grade. The aim of this study was to investigate the effect of operator grade (trainee vs. consultant) upon outcomes of revascularization procedures. METHODS AND RESULTS: This was an observational study at a tertiary cardiology centre with accredited training programmes, between 2003 and 2011. A total of 22 697 consecutive patients undergoing either CABG or PCI were included. Associations between operator grade and mortality were assessed by hazard ratios, estimated by Cox regression analyses; 6689 patients underwent CABG, whereas 16 008 underwent PCI. Trainees performed 1968 (29.4%) CABG procedures and 8502 (53.1%) PCI procedures. The proportion of procedures performed by trainees declined over time for both CABG (30.2% in 2003 vs. 26.0% in 2010) and for PCI (58.1% in 2003 vs. 44.5% in 2010). In the unadjusted Cox analysis, consultant operator grade was associated with an increased 5-year mortality after both CABG [HR: 1.26 (95% CI: 1.07-1.47)] and PCI procedures [HR: 1.34 (95% CI: 1.22-1.47)] compared with a trainee operator. However, following multiple adjustment, consultant grade was no longer associated with mortality after either procedure [CABG: HR: 1.02 (95% CI: 0.87-1.20), PCI: HR: 1.08 (95% CI: 0.98-1.20)]. CONCLUSION: There was no observed detrimental effect on patient outcomes arising from procedures undertaken by trainees working in a structured training environment compared with consultants.
Subject(s)
Cardiology/standards , Clinical Competence/standards , Coronary Artery Disease/surgery , Medical Staff, Hospital/standards , Myocardial Revascularization/mortality , Percutaneous Coronary Intervention/mortality , Cardiology/statistics & numerical data , Consultants/statistics & numerical data , Emergency Treatment/mortality , Epidemiologic Methods , Female , Hospital Mortality , Humans , Inservice Training , Male , Medical Staff, Hospital/statistics & numerical data , Middle Aged , Myocardial Infarction/etiology , Myocardial Infarction/mortality , Myocardial Revascularization/standards , Myocardial Revascularization/statistics & numerical data , Operative Time , Percutaneous Coronary Intervention/standards , Percutaneous Coronary Intervention/statistics & numerical data , Postoperative Complications/etiology , Renal Dialysis/mortality , Renal Dialysis/statistics & numerical data , Renal Insufficiency, Chronic/etiology , Renal Insufficiency, Chronic/mortality , Reoperation/mortality , Reoperation/statistics & numerical data , Stroke/etiology , Stroke/mortality , Treatment OutcomeABSTRACT
BACKGROUND: Computed tomography cardiac angiography (CTCA) is recommended for the evaluation of patients with prior coronary artery bypass graft (CABG) surgery. The BYPASS-CTCA study demonstrated that CTCA prior to invasive coronary angiography (ICA) in CABG patients leads to significant reductions in procedure time and contrast-induced nephropathy (CIN), alongside improved patient satisfaction. However, whether CTCA information was used to facilitate selective graft cannulation at ICA was not protocol mandated. In this post-hoc analysis we investigated the influence of CTCA facilitated selective graft assessment on angiographic parameters and study endpoints. METHODS: BYPASS-CTCA was a randomized controlled trial in which patients with previous CABG referred for ICA were randomized to undergo CTCA prior to ICA, or ICA alone. In this post-hoc analysis we assessed the impact of selective ICA (grafts not invasively cannulated based on the CTCA result) following CTCA versus non-selective ICA (imaging all grafts irrespective of CTCA findings). The primary endpoints were ICA procedural duration, incidence of CIN, and patient satisfaction post-ICA. Secondary endpoints included the incidence of procedural complications and 1-year major adverse cardiac events. RESULTS: In the CTCA cohort (n â= â343), 214 (62.4%) patients had selective coronary angiography performed, whereas 129 (37.6%) patients had non-selective ICA. Procedure times were significantly reduced in the selective CTCA â+ âICA group compared to the non-selective CTCA â+ âICA group (-5.82min, 95% CI -7.99 to -3.65, p â< â0.001) along with reduction of CIN (1.5% vs 5.8%, OR 0.26, 95% CI 0.10 to 0.98). No difference was seen in patient satisfaction with the ICA, however procedural complications (0.9% vs 4.7%, OR 0.21, 95% CI 0.09-0.87) and 1-year major adverse cardiac events (13.1% vs 20.9%, HR 0.55, 95% CI 0.32-0.96) were significantly lower in the selective group. CONCLUSIONS: In patients with prior CABG, CTCA guided selective angiographic assessment of bypass grafts is associated with improved procedural parameters, lower complication rates and better 12-month outcomes. Taken in addition to the main findings of the BYPASS-CTCA trial, these results suggest a synergistic approach between CTCA and ICA should be considered in this patient group. REGISTRATION: ClinicalTrials.gov, NCT03736018.
Subject(s)
Computed Tomography Angiography , Coronary Angiography , Coronary Artery Bypass , Coronary Artery Disease , Predictive Value of Tests , Humans , Female , Male , Middle Aged , Aged , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Artery Disease/surgery , Treatment Outcome , Coronary Artery Bypass/adverse effects , Time Factors , Risk Factors , Patient Satisfaction , Coronary Vessels/diagnostic imaging , Kidney Diseases/diagnostic imaging , Operative Time , Contrast Media/administration & dosage , Contrast Media/adverse effectsABSTRACT
BACKGROUND: Two advantages of transradial coronary procedures are an increased potential for same-day discharge and better resource management. This study assessed the impact of a dedicated "radial lounge" (1) on the rate of same-day discharge after elective percutaneous coronary intervention (PCI) and coronary angiography and (2) on bed utilization. METHODS: We compared our unit's rates of same-day discharge in patients who underwent elective PCI or coronary angiography in the year before and in the year after the opening of a dedicated radial lounge for elective patients. RESULTS: In its first year of operation, 439 patients who underwent PCI and 1,109 patients who underwent angiography were managed in the radial lounge. Among these patients, the rate of same-day discharge was 84.7% after PCI and 97.0% after angiography. Requirement for overnight admission was significantly more common after femoral access compared with radial access for both angiography (4.1% vs 2.8%, P < .05) and PCI (20.3% vs 14.2%, P < .01). The unit's overall rate of same-day discharge increased from 2.3% to 51.2% after elective PCI (P < .0005) and from 72.7% to 84.9% after elective angiography (P < .005). An estimated 595 bed days were saved through reduced overnight admissions in elective patients. CONCLUSIONS: Our unit's overall rates of same-day discharge after elective PCI and coronary angiography increased dramatically in the year after the opening of a dedicated radial lounge. This was directly attributable to the high rates of same-day discharge in radial lounge patients. The radial lounge impacted favorably on in-patient bed capacity.
Subject(s)
Coronary Angiography/statistics & numerical data , Length of Stay/statistics & numerical data , Patient Discharge/statistics & numerical data , Percutaneous Coronary Intervention/statistics & numerical data , Aged , Female , Humans , Male , Middle Aged , Treatment OutcomeABSTRACT
BACKGROUND: Drug-eluting stents (DES) may be associated with an increased risk of late stent thrombosis (ST) compared with bare metal stents (BMS). We compared major adverse cardiac events (MACE) and long term all cause mortality in patients with isolated proximal LAD disease treated with DES or BMS. METHOD AND RESULTS: This study of 1653 patients with isolated proximal LAD disease, includes 643 treated with BMS and 1010 treated with DES. All patients received standard dual antiplatelet treatment. MACE after 5 years were less frequent in DES compared with BMS (12.1% 95% CI 9.3-14.2 versus 21.3% 95% CI: 16.9-25.1, P < 0.0001), driven largely by a decreased rate of both target vessel and lesion revascularization (TVR: 6.3%, 95% CI 4.0-7.5% versus 14.7%, 95% CI 11.0-17.3%, P < 0.0001, TLR: (5.3%, 95% CI 3.2-7.1% versus 13.2%, 95% CI 9.8.0-15.4%, P < 0.0001). There was no difference in the rate of death, myocardial infarction, or CVA. Incidence of stent thrombosis was also comparable (1.2% 95% CI: 0.6-2.6% versus 1.1% 95% CI: 0.6-2.5%, P = 0.8). Adjusted Cox analysis confirmed a decreased risk of MACE for DES compared with BMS 0.55 (95% confidence intervals 0.41-0.73) with no difference in the hazard of all cause mortality (HR: 1.04 95% CI: 0.67-1.61). CONCLUSION: When treating proximal LAD disease, use of DES was associated with a lower MACE rate than BMS, with no differences in the incidence of stent thrombosis, myocardial infarction or 5 year all cause mortality. Our data suggests that despite the adverse prognostic correlates of proximal LAD disease, DES deployment in this location is both safe and clinically more effective than BMS.
Subject(s)
Coronary Artery Disease/therapy , Coronary Thrombosis/etiology , Drug-Eluting Stents , Metals , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Stents , Aged , Cerebrovascular Disorders/etiology , Chi-Square Distribution , Coronary Artery Disease/mortality , Coronary Thrombosis/mortality , Drug Therapy, Combination , Female , Humans , Kaplan-Meier Estimate , Logistic Models , Male , Middle Aged , Multivariate Analysis , Myocardial Infarction/etiology , Percutaneous Coronary Intervention/mortality , Platelet Aggregation Inhibitors/therapeutic use , Propensity Score , Proportional Hazards Models , Prosthesis Design , Retrospective Studies , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: The incidence of infective endocarditis (IE) in dialysis patients is higher than the general population. Dialysis patients who develop endocarditis are thought to have a poorer prognosis than other patients with IE. AIM: To examine the risk profiles, clinical features, and outcomes of patients on dialysis who developed IE in a large cohort. DESIGN AND METHODS: A retrospective analysis of all patients developing IE on dialysis (using the modified Duke criteria) was undertaken between 1998 and 2011. Patients were identified from a prospectively collected clinical database. RESULTS: 42 patients developed IE out of a total incident dialysis population of 1,500 over 13 years. 95% of the patients (40/42) were on long-term haemodialysis (HD) and 5% (2/42) on peritoneal dialysis. Mean patient age was 55.2 years (IQR: 43-69), and mean duration of HD prior to IE was 57.4 months. Primary HD access at the time of diagnosis was an arteriovenous fistula in 35% (14/40), a dual-lumen tunnelled catheter in 55% (22/40), and a dual-lumen non-tunnelled catheter in 10% (4/40). Staphylococcus aureus (including methicillin-resistant S. aureus) was present in 57.1% (24/42). The aortic valve was affected in 42.8% of the patients (18/42), the mitral valve in 30.9% (13/42), and both valves in 9.5% (4/42). 33.3% of the patients had an abnormal valve before the episode of IE. In 21.4% (9/42), valve surgery was performed and mortality was lower in the surgical group compared to the group managed medically during hospitalisation (11.1 vs. 15.2%, p = 0.892), at 3 months (13.1 vs. 19.6%, p = 0.501), and during follow-up (p = 0.207), but this difference did not reach statistical significance. Age >60 years, septic emboli, and methicillin-resistant S. aureus were all adverse prognostic factors. Patients receiving surgery were younger (mean 47.1 ± 14.4 years vs. 57.4 ± 14.3, p = 0.049) and less likely to be infected with S. aureus (surgery 33.3% vs. antibiotics 63.6%, p = 0.046). CONCLUSION: This is one of the largest reported series of IE in dialysis patients. The incidence of IE remains high and the prognosis poor in dialysis patients, although patients selected for early valve surgery have good 1-year survival.
Subject(s)
Endocarditis/etiology , Renal Dialysis/adverse effects , Adult , Aged , Echocardiography , Endocarditis/mortality , Female , Humans , Male , Middle Aged , Retrospective StudiesABSTRACT
Background: Coronary compromise is a serious potential complication following catheter ablation; however, procedural details in the literature are often lacking, preventing the identification of learning opportunities. Case summary: We report two cases of right coronary compromise following catheter ablation for symptomatic supraventricular tachycardia. After radiofrequency energy delivery at the coronary sinus ostium in both cases, inferior lead ST-elevation was observed. Diagnostic coronary angiography identified an occluded posterior left ventricular branch of the coronary artery, and optical coherence tomography demonstrated a high thrombus burden at this location. Electrocardiographic ST-segments settled with implantation of a drug-eluting stent. Discussion: Coronary compromise was likely secondary to energy delivery during catheter ablation. This case series highlights the need for electrophysiologist to understand coronary anatomy relative to anatomical landmarks, to anticipate the risk of vascular injury as physical distance from the site of ablation is likely important. Risk for coronary compromise, while a rare complication, needs to be discussed with patients during the consenting process. We also demonstrate the importance of an efficient multi-disciplinary team process for managing acute procedural complications.
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Background: Drug eluting balloons (DEB) are a feasible method of rapid delivery of drug to a coronary vessel wall. Their efficacy has been established for the treatment of in-stent restenosis and small vessel disease but there is limited data for their use in bifurcation lesions. Objective: The aim of this study was to assess the effectiveness of provisional upfront side-branch DEB use in bifurcation lesions compared to a simple balloon (POBA) or upfront 2 stent bifurcation strategy. Methods: We conducted an observational study of 625 patients undergoing PCI to bifurcation lesions. All the patients had a DES deployed in the main vessel (MV). Decision on revascularization option for the side branch (SB) was made by the operator. The primary endpoint was target vessel failure. Secondary endpoints were target vessel myocardial infarction and all-cause mortality. Results: 311 patients had upfront DEB to the SB whilst the remaining were treated with either DES (188) or POBA (126). Baseline characteristics were similar aside from history of previous MI, which were higher in patients treated with DES or POBA, p = 0.009 whereas patients with previous CABG were likely to undergo DEB treatment (p = 0.004). TVF was more likely to occur in the POBA group (7.5 %) compared to the DEB (3.3 %) and DES (3.3 %) groups (p = 0.0019). There was no significant difference in TV-MI (p = 0.62) or death (p = 0.98) between the groups. Conclusion: This study suggests that provisional bifurcation stenting with upfront Sirolimus DEB use in the SB is an effective treatment for non-LMS bifurcation PCI.
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BACKGROUND: It has been previously reported during the first COVID-19 outbreak that patients presenting with ST-segment elevation myocardial infarction (STEMI) and concurrent COVID-19 infection have increased thrombus burden and poorer outcomes. To date, there have been no reports comparing the outcomes of COVID-19-positive STEMI patients across all waves of the pandemic. OBJECTIVES: This study compared the baseline demographic, procedural, and angiographic characteristics alongside the clinical outcomes of patients presenting with STEMI and concurrent COVID-19 infection across the COVID-19 pandemic in the United Kingdom. METHODS: This was a single-center, observational study of 1,269 consecutive patients admitted with confirmed STEMI treated with percutaneous coronary intervention (between January 3, 2020 and October 3, 2022). COVID-19-positive patients were split into 3 groups based upon the time course of the pandemic, and a comparison was made between waves. RESULTS: A total of 154 COVID-19-positive patients with STEMI were included in the present analysis and were compared with 1,115 COVID-19-negative patients. Early during the pandemic (wave 1), STEMI patients presenting with concurrent COVID-19 infection had high rates of cardiac arrest, evidence of increased thrombus burden, bigger infarcts, and worse outcomes. However, by wave 3, no differences existed in outcomes between COVID-19-positive and -negative patients, with significant differences compared with earlier COVID-19-positive patients. Poor outcomes later in the study period were predominantly in unvaccinated individuals. CONCLUSIONS: Significant changes have occurred in the clinical characteristics, angiographic features, and outcomes of STEMI patients with COVID-19 infection treated by primary percutaneous coronary intervention during the course of the pandemic. Importantly, outcomes of recent waves and in vaccinated individuals are no different to a non-COVID-19 population.
Subject(s)
COVID-19 , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Thrombosis , Humans , COVID-19/epidemiology , ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/epidemiology , ST Elevation Myocardial Infarction/therapy , Pandemics , Thrombosis/diagnostic imaging , Thrombosis/epidemiology , Thrombosis/etiology , United Kingdom/epidemiology , Percutaneous Coronary Intervention/adverse effects , Treatment OutcomeABSTRACT
OBJECTIVE: To assess the safety and effectiveness of a novel pathway of deferrred invasive angiography in low-risk NSTEMI patients with concurrent COVID-19 infections; contrary to current UK guidelines recommending invasive coronary angiography in NSTEMI patients within 72 hours. METHODS: This was a single-centre, observational study of all NSTEMI patients referred for inpatient coronary angiography at Barts Heart Centre, between March 2020 and June 2022. Demographic, procedural and outcome data were collected as part of a national cardiac audit. RESULTS: 201 COVID positive NSTEMI patients were referred for angiography at Barts Heart Centre. 10 patients died from COVID related respiratory complications prior to angiography. Therefore, 191 patients underwent deferred angiography (median time 16 days from COVID diagnosis). The median GRACE score was 128 (IQR 86-153). Troponin levels were significantly elevated on initial COVID diagnosis compared to time of their procedure. 73% patients had a culprit lesion identified. 61.2% receiving PCI. Patients were followed-up for a median of 363 days (IQR 120-485 days) with MACE rates of 7.3%. This is comparable to the MACE event for NSTEMI patients (n=4529) without COVID at our institution treated during the same time-period (8.1%). CONCLUSION: This study demonstrates the safety and effectiveness of deferred coronary angiography on a COVID-Recovered pathway after a period of medical management for patients presenting with NSTEMI and concurrent COVID-19 infection. There was no adverse signal associated with the wait for angiography with similar MACE rates to the non-deferred NSTEMI cohort without COVID-19.
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BACKGROUND: Mortality from alcohol-related liver disease has risen significantly for 3 decades. Transient elastography (TE) is a noninvasive test providing a numerical marker of liver disease. Preliminary evidence suggests that TE can reduce alcohol consumption. The KLIFAD (does knowledge of liver fibrosis affect high-risk drinking behavior?) study has developed a complex intervention wherein people receiving alcohol treatment are provided with access to TE, accompanied by scripted feedback tailored to their disease state, and access to video narratives describing alcohol misuse recovery after receiving TE. Recovery narratives are included due to preliminary evidence from mental health studies which suggest that access to digital narratives describing recovery from mental health problems can help people affected by mental health problems, including through mechanisms with the potential to be transferable to an alcohol treatment setting, for example, by increasing hope for the future, enabling learning from the experience of others, or promoting help-seeking behaviors. OBJECTIVE: We aimed to develop the KLIFAD intervention to the point that it could be delivered in a feasibility trial and to produce knowledge relevant to clinicians and researchers developing interventions making use of biomarkers of disease. METHODS: In research activity 1, standardized scripted feedback was developed by this study, and then iterated through focus groups with people who had experienced alcohol misuse and TE, and key alcohol workers with experience in delivering TE. We report critical design considerations identified through focus groups, in the form of sensitizing concepts. In research activity 2, a video production guide was coproduced to help produce impactful video-based recovery narratives, and a patient and public involvement (PPI) panel was consulted for recommendations on how best to integrate recovery narratives into an alcohol treatment setting. We report PPI recommendations and an overview of video form and content. RESULTS: Through research activity 1, we learnt that patient feedback has not been standardized in prior use of TE, that receiving a numeric marker can provide an objective target that motivates and rewards recovery, and that key alcohol workers regularly tailor information to their clients. Through research activity 2, we developed a video production guide asking narrators what recovery means to them, what helped their recovery, and what they have learned about recovery. We produced 10 recovery narratives and collected PPI recommendations on maximizing impact and safety. These led to the production of unplanned videos presenting caregiver and clinician perspectives, and a choice to limit narrative availability to alcohol treatment settings, where support is available around distressing content. These choices have been evaluated through a feasibility randomized controlled trial [ISRCTN16922410]. CONCLUSIONS: Providing an objective target that motivates and rewards recovery is a candidate change mechanism for complex interventions integrating biomarkers of disease. Recovery narratives can contain distressing content; intervention developers should attend to safe usage. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-054954.
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Background: Early identification followed by effective behaviour interventions is pivotal to changing the natural history of alcohol-related liver disease. We examined the feasibility of using transient elastography based advice and alcohol recovery video stories (ARVS) to change drinking behaviour in community alcohol services. Methods: A feasibility randomised control trial (RCT) was conducted in three community alcohol services. Adults 18+ years presenting with a primary alcohol problem were randomised (1:1) to receive either usual care (control group) or usual care and the KLIFAD Intervention, consisting of advice tailored to liver stiffness measure and access to ARVS (intervention group). Data were collected at baseline and six months. To establish definitive trial feasibility, recruitment and retention rates, study procedure safety and extent of effectiveness were measured (Start date: 02.10.2019, End date: 30.11.2022, ISRCTN.com: 16922410). Findings: 382 service users were screened, 184 were randomised (intervention: 93, control: 91), and baseline data were collected for 128 (intervention: 71, control: 59). Six months follow-up data were available in 87 (intervention: 53, control: 34). Intervention compared to the control group had a longer duration of engagement with services (mean difference 8.6 days SD = 18.4), was more likely to complete the allocated treatment program and reduced or stop drinking (54.9% vs 43.9%) and reduce AUDIT category (71.7% vs 61.8%). There were no reported serious adverse reactions, one intervention group participant reported an increase in AUDIT category. Interpretation: Integration of transient elastography in community alcohol services is feasible. It may improve engagement with services, retention in clinical trials and supplement the reduction in self-reported alcohol consumption. A definitive RCT is supported. Funding: National Institute for Health and Care Research (NIHR201146).
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Recently, there has been growing interest in the early discharge strategy for low-risk patients who have undergone primary percutaneous coronary intervention (PCI) to treat ST-segment elevation myocardial infarction (STEMI). So far findings have suggested there are multiple advantages of shorter hospital stays, including that it could be a safe way to be more cost- and resource-efficient, reduce cases of hospital-acquired infection and boost patient satisfaction. However, there are remaining concerns surrounding safety, patient education, adequate follow-up and the generalisability of the findings from current studies which are mostly small-scale. By assessing the current research, we describe the advantages, disadvantages and challenges of early hospital discharge for STEMI and discuss the factors that determine if a patient can be considered low risk. If it is feasible to safely employ a strategy like this, the implications for healthcare systems worldwide could be extremely beneficial, particularly in lower-income economies and when we consider the detrimental impacts of the recent COVID-19 pandemic on healthcare systems.