Clinical governance of patients with acute coronary syndromes.

AIMS: Using the principles of clinical governance, a patient-centred approach intended to promote holistic quality improvement, we designed a prospective, multicentre study in patients with acute coronary syndrome (ACS). We aimed to verify and quantify consecutive inclusion and describe relative and absolute effects of indicators of quality for diagnosis and therapy. METHODS AND RESULTS: Administrative codes for invasive coronary angiography and acute myocardial infarction were used to estimate the ACS universe. The ratio between the number of patients included and the estimated ACS universe was the consecutive index. Co-primary quality indicators were timely reperfusion in patients admitted with ST-elevation ACS and optimal medical therapy at discharge. Cox-proportional hazard models for 1-year death with admission and discharge-specific covariates quantified relative risk reductions and adjusted number needed to treat (NNT) absolute risk reductions. Hospital codes tested had a 99.5% sensitivity to identify ACS universe. We estimated that 7344 (95% CI: 6852-7867) ACS patients were admitted and 5107 were enrolled-i.e. a consecutive index of 69.6% (95% CI 64.9-74.5%), which varied from 30.7 to 79.2% across sites. Timely reperfusion was achieved in 22.4% (95% CI: 20.7-24.1%) of patients, was associated with an adjusted hazard ratio (HR) for 1-year death of 0.60 (95% CI: 0.40-0.89) and an adjusted NNT of 65 (95% CI: 44-250). Corresponding values for optimal medical therapy were 70.1% (95% CI: 68.7-71.4%), HR of 0.50 (95% CI: 0.38-0.66), and NNT of 98 (95% CI: 79-145). CONCLUSION: A comprehensive approach to quality for patients with ACS may promote equitable access of care and inform implementation of health care delivery. REGISTRATION: ClinicalTrials.Gov ID NCT04255537.

Clinical governance programme in patients with acute coronary syndrome: design and methodology of a quality improvement initiative.

INTRODUCTION: Despite the availability of diverse evidence-based diagnostic and treatment options, many patients with acute coronary syndrome (ACS) still fail to receive effective, safe and timely diagnoses and therapies. The Association of Acute CardioVascular Care of the European Society of Cardiology has proposed and retrospectively validated a set of ACS-specific quality indicators. Combining these indicators with the principles of clinical governance-a holistic, patient-centred approach intended to promote continuous quality improvement-we designed the clinical governance programme in patients with ACS. METHODS AND ANALYSIS: This is a multicentre quality improvement initiative exploring multiple dimensions of care, including diagnosis, therapy, patient satisfaction, centre organisation and efficiency in all comers patients with ACS.The study will enrol ≈ 5000 patients prospectively (ie, at the time of the first objective qualifying ACS criterion) with a 1-year follow-up. Consecutive inclusion will be promoted by a simplified informed consent process and quantified by the concordance with corresponding hospital administrative records using diagnosis-related group codes of ACS.Coprimary outcome measures are (1) timely reperfusion in patients with ST-elevation ACS and (2) optimal medical therapy at discharge in patients with confirmed acute myocardial infarction. Secondary outcomes broadly include multiple indicators of the process of care. Clinical endpoints (ie, death, myocardial infarction, stroke and bleeding) will be adjudicated by a clinical event committee according to predefined criteria. ETHICS AND DISSEMINATION: The study has been approved by local ethics committee of all study sites. As a quality improvement initiative and to promote consecutive inclusion of the population of interest, a written informed consent will be requested only to patients who are discharged alive. Dissemination will be actively promoted by (1) the registration site (ClinicalTrials.Gov ID NCT04255537), (2) collaborations with investigators through open data access and sharing.

Periprocedural management of rivaroxaban-treated patients.

INTRODUCTION: The increasing and widespread use of direct oral anticoagulants (DOACs) demands guidelines and experts' consensus for their rational and safe use, especially in certain situations for which there is no evidence-based consensus, such as the periprocedural setting. Rivaroxaban is an oral factor Xa inhibitor approved for stroke prevention in atrial fibrillation (AF) and for treatment and prevention of venous thromboembolism (VTE) in major orthopedic surgery. This article is addressed to all the clinicians involved in the periprocedural approach of patients treated with rivaroxaban, with the aim to give practical recommendations to improve patients' management during and after surgery. AREAS COVERED: This article is based on a consensus of specialists involved in anticoagulant treatment and in periprocedural setting, including experts in thrombosis, cardiologists, internists, clinical pathologists and anesthesiologists. The authors performed a review of the literature and expressed statements based on the results of the review as well as on personal experience. EXPERT OPINION: Rivaroxaban is a safe and effective drug that simplifies management of anticoagulation also in patients undergoing invasive procedures. However, periprocedural management could be challenging and physicians must carefully balance the risk of bleeding and the risk of thrombosis.

Off-hour primary percutaneous coronary angioplasty does not affect outcome of patients with ST-Segment elevation acute myocardial infarction treated within a regional network for reperfusion: The REAL (Registro Regionale Angioplastiche dell'Emilia-Romagna) registry.

OBJECTIVES: This study aims to evaluate whether results of "off-hours" and "regular-hours" primary angioplasty (primary percutaneous coronary intervention [pPCI]) are comparable in an unselected population of patients with ST-segment elevation acute myocardial infarction treated within a regional network organization. BACKGROUND: Conflicting results exist on the outcome of off-hours pPCI. METHODS: We analyzed in-hospital and 1-year cardiac mortality among 3,072 consecutive ST-segment elevation myocardial infarction (STEMI) patients treated with pPCI between January 1, 2004, and June 30, 2006, during regular-hours (weekdays 8:00 AM to 8:00 PM) and off-hours (weekdays 8:01 PM to 7:59 AM, weekends, and holidays) within the STEMI Network of the Italian Region Emilia-Romagna (28 hospitals: 19 spoke and 9 hub interventional centers). RESULTS: Fifty-three percent of patients were treated off-hours. Baseline findings were comparable, although regular-hours patients were older and had more incidences of multivessel disease. Median pain-to-balloon (195 min, interquartile range [IQR]: 140 to 285 vs. 186 min, IQR: 130 to 280 min; p = 0.03) and door-to-balloon time (88 min, IQR: 60 to 122 vs. 77 min, IQR: 48 to 116 min; p < 0.0001) were longer for off-hours pPCI. However, unadjusted in-hospital (5.8% off-hours vs. 7.2% regular-hours, p = 0.11) and 1-year cardiac mortality (8.4% off-hours vs. 10.3% regular-hours, p = 0.08) were comparable. At multivariate analysis, off-hours pPCI did not predict an adverse outcome either for the overall population (odds ratio [OR]: 0.70, 95% confidence interval [CI]: 0.49 to 1.01) or for patients directly admitted to the interventional center (OR: 0.79, 95% CI: 0.52 to 1.20). CONCLUSIONS: When pPCI is performed within an efficient STEMI network focused on reperfusion, the clinical effectiveness of either off-hours or regular-hours pPCI is comparable.

[Coronary care units: who to admit and how long]. / Le unità di terapia intensiva cardiologica: chi ricoverare, per quanto tempo.

Coronary care units (CCUs) should ensure the best intensive therapy for all critical cardiologic patients and not only for patients with acute coronary heart disease. Such structures apply the Hub & Spoke model, which consists of an integrated network of services allowing a health organization in which different realities interact and collaborate; this organization is composed of referral core centers (Hubs) and smaller structures (Spokes) referring to Hubs that are engaged in selection, channeling of patients in the acute phase, and for follow-up care of patients in the post-acute phase. The CCUs, based on the organizational reality in which they operate, must hospitalize and dismiss complex patients in a brief lapse of time. Criteria for CCU admission and length of stay are still ill-defined. Therefore, the following paper, summarizing the contents of the recent CCU convention at the ANMCO congress, attempts to define the priorities for hospitalization in the CCU, based on three different levels of evidence: level A indication (immediate mandatory admission); level B indication (immediate admission, the availability of beds allowing); level C indication (admission not indicated, but possible in the absence of other alternatives, e.g. limited bed availability in other intensive care units). Concerning the duration of stay within the CCU, clear-cut indications are difficult, but the concept is emphasized that the length of stay should be minimized, given the limited bed availability, in order to ensure the availability of intensive monitoring to all critical patients.