Discharge Information About Adverse Drug Reactions Indicates Lower Self-Reported Adverse Drug Reactions and Fewer Concerns in Patients After Percutaneous Coronary Intervention.

AIM: There are discrepancies between the information patients desire about adverse drug reactions (ADRs) and the information they receive from healthcare providers; this is an impediment to shared decision-making. This study aimed to establish whether patients received information about ADRs resulting from prescribed pharmacotherapy, before hospital discharge, after percutaneous coronary intervention (PCI) and to determine whether receiving information about ADRs was associated with incidence of self-reported ADRs or concerns related to prescribed pharmacotherapy. METHODS: CONCARDPCI, a prospective multicentre cohort study including 3,417 consecutive patients after PCI, was conducted at seven high-volume referral PCI centres in two Nordic countries. Clinical data were collected from patients' medical records and national quality registries. Patient-reported outcome measures were registered 2 months (T1), 6 months (T2), and 12 months (T3) after discharge. Covariate-adjusted logistic regression yielded adjusted odds ratios (aORs) with 95% confidence intervals (CIs). RESULTS: At discharge, 38% of participants had been informed about potential ADRs. For these patients, the incidence of self-reported ADRs was significantly lower at T1 (aOR 0.61, 95% CI 0.50-0.74; p<0.001), T2 (aOR 0.60, 95% CI 0.49-0.74; p<0.001), and T3 (aOR 0.57, 95% CI 0.46-0.71; p<0.001). Those who were not informed reported higher levels of concern about prescribed pharmacotherapy at all measuring points (p<0.001 for all comparisons). Those living alone (aOR 0.73, 95% CI 0.57-0.92; p=0.008), who were female (aOR 0.57, 95% CI 0.44-0.72; p<0.001), and with three or more versus no comorbidities (aOR 0.61, 95% CI 0.44-0.84; p=0.002) were less likely to receive information. CONCLUSION: A substantial proportion of patients were not informed about potential ADRs from prescribed pharmacotherapy after PCI. Patients informed about ADRs had lower incidences of self-reported ADRs and fewer concerns about prescribed pharmacotherapy.

Use of health services and perceived need for information and follow-up after percutaneous coronary intervention.

OBJECTIVE: Few patients achieve full control of their coronary artery disease (CAD) risk factors. Follow-up, such as cardiac rehabilitation, is important to increase adherence to lifestyle changes and treatment, to improve the patient's risk profile, and to treat established complications of CAD clinical events. However, the type of follow-up patients receive varies. Therefore, the aim of this research note was to describe and compare patients' self-reported use of health services, the type of follow-up patients reported to prefer, and the type of information patients reported to be important, in two countries with different follow-up practices after PCI. RESULTS: We included 3417 patients in Norway and Denmark, countries with different follow-up strategies after PCI. The results showed large differences between the countries regarding health services used. In Denmark the most frequently used health services were consultations at outpatient clinics followed by visits to the general practitioner and visits to the fitness centre, whereas in Norway visits to the general practitioner were most common, followed by rehospitalisation and no follow-up used. However, patients found the same type of follow-up and information important in both countries. Patients' perceived need for follow-up and information decreased over time, suggesting a need for early follow-up when the patients are motivated. TRIAL REGISTRATION: NCT03810612 (18/01/2019).

'When age is not a barrier': an explorative study of nonagenarian patients' experiences of undergoing percutaneous coronary intervention.

AIMS: The recent rise in the number of nonagenarians (age ≥ 90 years) undergoing percutaneous coronary intervention (PCI) has revealed gaps in research, in particular on patients' experiences. Therefore, the aim of the study was to explore and describe nonagenarians' internal resources and their experiences of the in-hospital pathway. METHODS AND RESULTS: Nineteen nonagenarian patients (women n = 9), mean age 91 years, 9 acutely, and 10 electively treated, were consecutively enrolled from a tertiary university hospital from June 2021 to February 2023. In-depth interviews were conducted during hospitalization, audiotaped and transcribed. The interviews were analysed using qualitative content analysis. Three sub-themes emerged from the nonagenarians' experiences with the PCI treatment trajectory: (i) Taking lifelong responsibility for own physical and mental health describes a population striving to live a healthy life and to stay independent. Physical and mental activities including healthy food choices had been an integral aspect of their lives from early childhood. (ii) Individual internal resources influenced the PCI pathway describes how their internal resources were used, from actively engaging in the decision-making process to withstanding discomfort during the PCI procedure. (iii) The post-PCI pathway was multifaceted describes a short stay at the cardiac ward with individual post-procedural experiences, close monitoring, and preparation for discharge including cardiac rehabilitation. CONCLUSION: Nonagenarians undergoing PCI demonstrated a personal incentive to stay healthy and independent. Their internal resources of independence, stoicism, and resilience were used during their in-hospital stay contributing to a successful PCI procedure. Individual cardiac rehabilitation strategies were highlighted after discharge from hospital.

Phenotyping Self-Reported Health Profiles in Octogenarians and Nonagenarians After Percutaneous Coronary Intervention: A Latent Profile Analysis.

BACKGROUND: Little is known about self-reported health in octogenarians (≥80 years) and nonagenarians (≥90 years) following percutaneous coronary intervention (PCI), including characteristics of different health outcomes. This study aimed to phenotype latent health profiles of self-reported health in older adults 2 months post-PCI. METHODS: A prospective, multicentre, real-world study (CONCARDPCI) of 270 octogenarians and nonagenarians was performed with five validated and standardised measures of self-reported health at 2 months post-PCI. Latent profile analysis was used to identify health profiles, and multinomial logistic regression analyses were used to investigate the associations between patient characteristics and health profiles. RESULTS: Three latent health profiles were identified: The Poor health profile included 29%, the Moderate health profile included 39%, and the Good health profile included 32% of the participants. Older adults who were frail (OR 2.50, 95% CI 1.17-5.33), had a low exercise level (OR 0.49, 95% CI 0.39-0.95), and low alcohol intake (OR 0.61, 95% CI 0.39-0.95) were more likely to belong to the Poor health profile relative to the Good health profile. Furthermore, older age (OR 1.19, 95% CI 1.03-1.37) and lower exercise level (OR 0.64, 95% CI 0.43-0.97) were associated with belonging to the Moderate health profile relative to the Good health profile. CONCLUSION: Two months after PCI, most participants displayed having Moderate to Good health profiles. Those with a Poor health profile were more likely to be frail and less active. These findings highlight that follow-up care has to be patient-centred and tailored to improve the health status of older adults.

Effectiveness, safety, and patient reported outcomes of a planned investment procedure in higher-risk chronic total occlusion percutaneous coronary intervention: Rationale and design of the invest-CTO study.

BACKGROUND: The anatomical complexity of a chronic total occlusion (CTO) correlates with procedural failure and complication rates. CTO modification after unsuccessful crossing has been associated with subsequent higher technical success rates, but complication rates remain high with this approach. While successful CTO percutaneous coronary intervention (PCI) has been associated with improved angina and quality of life (QOL) this has not been demonstrated in anatomically high-risk CTOs. Whether a planned CTO modification procedure, hereafter named Investment procedure, could improve patient outcomes has never been investigated. STUDY DESIGN: Invest-CTO is a prospective, single-arm, international, multicenter study, evaluating the effectiveness and safety of a planned investment procedure, with a subsequent completion CTO PCI (at 8-12 weeks), in anatomically high-risk CTOs. We will enroll 200 patients with CTOs defined as high-risk according to our Invest CTO criteria at centers in Norway and United Kingdom. Patients with aorto-ostial lesions, occlusion within a previous stent, or a prior attempt at target vessel CTO PCI within 6 months will be excluded. The co-primary endpoints are cumulative procedural success (%) after both procedures, and a composite safety endpoint at 30 days after completion CTO PCI. Patient reported outcomes (PROs), treatment satisfaction, and clinical endpoints will be reported. CONCLUSION: This study will prospectively evaluate the effectiveness and safety of a planned two staged PCI procedure in the treatment of high-risk CTOs and may have the potential to change current clinical practice.

Coronary calcium score in the initial evaluation of suspected coronary artery disease.

OBJECTIVE: We evaluated coronary artery calcium (CAC) scoring as an initial diagnostic tool in outpatients and in patients presenting at the emergency department due to suspected coronary artery disease (CAD). METHODS: 10 857 patients underwent CAC scoring and coronary CT angiography (CCTA) at Haukeland University Hospital in Norway during 2013-2020. Based on CCTA, obstructive CAD was defined as at least one coronary stenosis ≥50%. High-risk CAD included obstructive stenoses of the left main stem, the proximal left ascending artery or affecting all three major vascular territories with at least one proximal segment involved. RESULTS: Median age was 58 years and 49.5% were women. The overall prevalence of CAC=0 was 45.0%. Among those with CAC=0, 1.8% had obstructive CAD and 0.6% had high-risk CAD on CCTA. Overall, the sensitivity, specificity, positive predictive value and negative predictive value (NPV) of CAC=0 for obstructive CAD were 95.3%, 53.4%, 30.0% and 98.2%, respectively. However, among patients <45 years of age, although the NPV was high at 98.9%, the sensitivity of CAC=0 for obstructive CAD was only 82.3%. CONCLUSIONS: In symptomatic patients, CAC=0 correctly ruled out obstructive CAD and high-risk CAD in 98.2% and 99.4% of cases. This large registry-based cross-sectional study supports the incorporation of CAC testing in the early triage of patients with chest pain and as a gatekeeper to further cardiac testing. However, a full CCTA may be needed for safely ruling out obstructive CAD in the youngest patients (<45 years of age).

Guideline-Recommended Time Less Than 90 Minutes From ECG to Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction Is Associated with Major Survival Benefits, Especially in Octogenarians: A Contemporary Report in 11 226 Patients from NORIC.

Background Using contemporary data from NORIC (Norwegian Registry of Invasive Cardiology) we investigated the predictive value of patient age and time from ECG diagnosis to sheath insertion (ECG-2-sheath) in primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction (STEMI). Methods and Results Data from 11 226 patients collected from all centers offering 24/7/365 primary percutaneous coronary intervention service were explored. For patients aged <80 years the mortality rates were 5.6% and 7.6% at 30 days and 1 year, respectively. For octogenarians the corresponding rates were 15.0% and 24.2%. The Cox hazard ratio was 2.02 (1.93-2.11, P value <0.0001) per 10 years of patient age. Time from ECG-2-sheath was significantly associated with mortality with a 3.6% increase per 30 minutes of time. Using achievement of time goal <90 minutes in patients aged >80 years and mortality at 30 days, mortality was 10.5% and 17.7% for <90 or ≥90 minutes, respectively. The number needed to prevent 1 death was 39 in the whole population and 14 in the elderly. Restricted mean survival gains during median 938 days of follow-up in patients with ECG-2-sheath time <90 minutes were 24 and 76 days for patients aged <80 and ≥80 years, respectively. Conclusions Time from ECG-diagnosis to sheath insertion is strongly correlated with mortality. This applies especially to octogenarians who derive the most in terms of absolute mortality reduction. Registration URL: https://helsedata.no/en/forvaltere/norwegian-institute-of-public-health/norwegian-registry-of-invasive-cardiology/.

Perceptions of generic medicines and medication adherence after percutaneous coronary intervention: a prospective multicentre cohort study.

OBJECTIVE: To determine patient perceptions of generic medicines 2 and 6 months after percutaneous coronary intervention (PCI), and to determine whether these perceptions moderate medication adherence. DESIGN: Prospective multicentre cohort study with repeated measures of perceptions of generic medicines and medication adherence. SETTING: The CONCARDPCI study conducted at seven large referral PCI centres in Norway and Denmark between June 2017 and May 2020. PARTICIPANTS: A total of 3417 adults (78% men), using both generic and brand name medicines, with a mean age of 66 years (SD 11) who underwent PCI were followed up 2 and 6 months after discharge from hospital. MAIN OUTCOME MEASURES: Perceptions of generic medicines were the main outcome. The secondary outcome was medication adherence. RESULTS: Perceptions of generic medicines were significantly more negative at 2 than at 6 months (1.10, 95% CI 0.41 to 1.79, p=0.002). Female sex (-4.21, 95% CI -6.75 to -1.71, p=0.001), older age (-0.12, 95% CI -0.23 to -0.02, p=0.020), lower education level (overall p<0.001), ethnicity (overall p=0.002), Norwegian nationality (10.27, 95% CI 8.19 to 12.40, p<0.001) and reduced self-reported health status (0.19, 95% CI 0.09 to 0.41, p=0.003) were significantly associated with negative perceptions of generic medicines. There was no evidence to suggest that perceptions of generic medicines moderate the association between sociodemographic and clinical variables and medication adherence (p≥0.077 for all covariates). Moreover, self-reported medication adherence was high, with 99% scoring at or above the Medication Adherence Report Scale midpoint at both time points. There were no substantial correlations between negative perceptions of generic medicines and medication non-adherence at 2 months (r=0.041, 95% CI 0.002 to 0.081, p=0.037) or 6 months (r=0.038, 95% CI -0.005 to 0.081, p=0.057). CONCLUSIONS: Mistrust and uncertainty about the safety and efficacy of generic medicines remains in a sizeable proportion of patients after PCI. This applies especially to those of lower socioeconomic status, older age, female sex, immigrants and those with poorer mental health. However, this study demonstrated a shift towards more positive perceptions of generic medicines in the longer term.

Outcomes after coronary angiography for unstable angina compared to stable angina, myocardial infarction and an asymptomatic general population.

Background: The outcomes of real-world unstable angina (UA) in the high-sensitivity troponin era are unclear. We aimed to investigate the outcomes of UA referred to coronary angiography compared to stable angina (SA), non-ST-segment elevation myocardial infarction (NSTEMI), STEMI and a general population. Methods: We included the 9,694 patients with no prior coronary artery disease (CAD) referred to invasive or CT coronary angiography from 2013 to 2018 in Northern Norway (51% SA, 12% UA, 23% NSTEMI and 14% STEMI), and 11,959 asymptomatic individuals recruited from the Tromsø Study. We used Cox models to estimate the hazard ratios (HR) for all-cause mortality and major adverse cardiovascular events (MACE), defined as cardiovascular death, MI or obstructive CAD. Results: The median follow-up time was 2.8 years. The incidence rate of death was 8.5 per 1000 person-years (95 % confidence interval [CI] 8.0-9.0) in the general population, 9.7 (95 % CI 8.3-11.5) in SA, 14.9 (95 % CI 11.4-19.6) in UA, 29.7 (95 % CI 25.6-34.3) in NSTEMI and 36.5 (95 % CI 30.9-43.2) in STEMI. In multivariable adjusted analyses, compared with UA, SA had a 38 % lower risk of death and a non-significant lower risk of MACE (HR 0.62, 95 % CI 0.44-0.89; HR 0.86, 95 % CI 0.66-1.11). NSTEMI had a 2.4-fold higher risk of death (HR 2.39, 95 % CI 1.38-4.14) and a 1.6-fold higher risk of MACE (HR 1.62, 95 % CI 1.11-2.38) compared tox UA during the first year after coronary angiography, but a similar risk thereafter. There was no difference in the risk of death for UA with non-obstructive CAD and obstructive CAD (HR 0.78, 95 % CI 0.39-1.57). Conclusion: UA had a higher risk of death but a similar risk of MACE compared to SA and a lower 1-year risk of death and MACE compared to NSTEMI.

Relationship between hypertension and non-obstructive coronary artery disease in chronic coronary syndrome (the NORIC registry).

BACKGROUND: The burden of non-obstructive coronary artery disease (CAD) in the society is high, and there is currently limited evidence-based recommendation for risk stratification and treatment. Previous studies have demonstrated an association between increasing extent of non-obstructive CAD and cardiovascular events. Whether hypertension, a modifiable cardiovascular risk factor, is associated with extensive non-obstructive CAD in patients with symptomatic chronic coronary syndrome (CCS) remains unclear. METHODS: We included 1138 patients (mean age 62±11 years, 48% women) with symptomatic CCS and non-obstructive CAD (1-49% lumen diameter reduction) by coronary computed tomography angiography (CCTA) from the Norwegian Registry for Invasive Cardiology (NORIC). The extent of non-obstructive CAD was assessed as coronary artery segment involvement score (SIS), and extensive non-obstructive CAD was adjudicated when SIS >4. Hypertension was defined as known hypertension or use of antihypertensive medication. RESULTS: Hypertension was found in 45% of patients. Hypertensive patients were older, with a higher SIS, calcium score, and prevalence of comorbidities and statin therapy compared to the normotensive (all p<0.05). There was no difference in the prevalence of hypertension between sexes. Univariable analysis revealed a significant association between hypertension and non-obstructive CAD. In multivariable analysis, hypertension remained associated with extensive non-obstructive CAD, independent of sex, age, smoking, diabetes, statin treatment, obesity and calcium score (OR 1.85, 95% CI [1.22-2.80], p = 0.004). CONCLUSION: In symptomatic CCS, hypertension was associated with extensive non-obstructive CAD by CCTA. Whether hypertension may be a new treatment target in symptomatic non-obstructive CAD needs to be explored in future studies. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: Identifier NCT04009421.

Drug-Eluting versus Bare-Metal Stents in Saphenous Vein Grafts Compared to Native Coronary Vessels: The Norwegian Coronary Stent Trial Study.

BACKGROUND: Drug-eluting stents (DES) reduce target lesion revascularization (TLR) with no effect on mortality or myocardial infarction (MI) compared to bare-metal stents (BMS) in native vessels. Randomized stent studies in saphenous vein grafts (SVG) are few and the reported effects are ambiguous. The Norwegian Coronary Stent Trial study is the first to randomize lesions to percutaneous coronary intervention in native vessels and SVG. AIMS: The aim of this study was to compare the rate of mortality, MI, and TLR across stent and vessel types. METHODS: In this substudy, 6,087 patients with a single lesion in native vessels and 164 in SVG were followed for 5 years. RESULTS: MI was more frequent in SVG (subdistributional hazard ratio [SHR] 4.95 (3.75-6.54, p < 0.001), but not affected by stent type. In the first 500 days, DES reduced TLR in native vessels (SHR 0.21 (0.15-0.30) p < 0.001) and SVG (SHR 0.18 (0.04-0.80) p = 0.02). Thereafter, DES and BMS were equivalent in native vessels, but DES had a higher TLR rate than BMS in SVG (SHR 3.31 (1.23-8.94) p = 0.02). After 5 years, the TLR rate was still significantly lower for DES in native vessels (3.2% vs. 7.8%, p < 0.001) but not in SVG (21.4% vs. 18. 4%). CONCLUSION: In SVG, no difference in TLR between DES and BMS was observed after 5 years in contrast to persistent benefit in native vessels. The high rate of TLR and MI in SVG makes treatment of native vessels a preference whenever feasible and better treatment options for SVG are warranted.

Low Pain Tolerance Is Associated With Coronary Angiography, Coronary Artery Disease, and Mortality: The Tromsø Study.

Background The initial presentation to coronary angiography and extent of coronary artery disease (CAD) vary greatly among patients, from ischemia with no obstructive CAD to myocardial infarction with 3-vessel disease. Pain tolerance has been suggested as a potential mechanism for the variation in presentation of CAD. We aimed to investigate the association between pain tolerance, coronary angiography, CAD, and death. Methods and Results We identified 9576 participants in the Tromsø Study (2007-2008) who completed the cold-pressor pain test, and had no prior history of CAD. The median follow-up time was 10.4 years. We applied Cox-regression models with age as time-scale to calculate hazard ratios (HR). More women than men aborted the cold pressor test (39% versus 23%). Participants with low pain tolerance had 19% increased risk of coronary angiography (HR, 1.19 [95% CI, 1.03-1.38]) and 22% increased risk of obstructive CAD (HR, 1.22 [95% CI, 1.01-1.47]) adjusted by age as time-scale and sex. Among women who underwent coronary angiography, low pain tolerance was associated with 54% increased risk of obstructive CAD (HR, 1.54 [95% CI, 1.09-2.18]) compared with high pain tolerance. There was no association between pain tolerance and nonobstructive CAD or clinical presentation to coronary angiography (ie, stable angina, unstable angina, and myocardial infarction). Participants with low pain tolerance had increased risk of mortality after adjustment for CAD and cardiovascular risk factors (HR, 1.40 [95% CI, 1.19-1.64]). Conclusions Low cold pressor pain tolerance is associated with a higher risk of coronary angiography and death.

Acute Myocardial Injury in a Patient with Attention Deficit Hyperactivity Disorder and History of Substance Abuse: A Multimodality Imaging Point of View.

Both cannabis and amphetamine are the most commonly used illegal substances worldwide and are associated with a number of adverse cardiovascular effects including transient coronary vasospasm. Here, we present the case of a 39-year-old male admitted to our institution with a 6-h history of severe chest pain and ST-segment elevation on the ECG. Coronary angiography on admission showed normal coronary arteries. The patient had a 14-year history of substance abuse, primarily amphetamine and cannabis, and was prescribed lisdexamfetamin (Aduvanz®) for attention deficit hyperactivity disorder (ADHD) for the past 2 years. A cardiac magnetic resonance (CMR) the following day showed widely distributed focal lesions of late gadolinium enhancement in mid- and sub-epicardial myocardium in the anterior, lateral and inferior walls, suggestive of chronic fibrotic lesions. There was no sign of acute myocardial edema. No viral cause was identified during a thorough investigation, including negative SARS-COV-2 and endomyocardial biopsy. Substance-abuse-induced coronary vasospasm leading to ST-segment elevation, myocardial damage with a rise and fall of cardiac TnT, as well as a slightly reduced left ventricular ejection fraction (48%) and regional wall motion abnormalities on echocardiography, was the most likely diagnosis.

Patients' reflections on prehospital symptom recognition and timely treatment of myocardial infarction.

AIMS: Early treatment is crucial to successful therapy in patients with acute myocardial infarction (MI). Prehospital delay is associated with increased morbidity and mortality. There is little empirical evidence of patients' reflections on prehospital symptoms of MI and timely treatment at the time of discharge from hospital. To explore patients' reflections on prehospital symptoms of MI and their experiences of interaction with local hospitals, general practitioners, and laypersons. METHODS AND RESULTS: An inductive explorative design with a qualitative method approach was used to conduct in-depth interviews of patients after confirmed MI. Twenty patients were purposefully selected based on age and gender. Face-to-face, semi-structured interviews were conducted prior to hospital discharge. The interviews were organized around a set of predetermined, open-ended questions, transcribed verbatim and analysed using qualitative content analysis. There were patients who acted upon severe symptoms of MI by seeking medical assistance. Patients commonly experienced that the time from the onset of symptoms to treatment posed a transitional challenge. They did not take subtle signs of MI seriously; they underestimated symptoms of MI and delayed seeking medical assistance. Patients frequently experienced that healthcare professionals did not take them seriously, as they struggled to gain access to healthcare services. CONCLUSION: This study highlights patients' unique experiences of the pathway from symptom onset to confirmed MI. Severe chest pain is associated with MI and triggers an immediate need for care. However, patients often underestimated moderate chest pain or subtle signs and symptoms of MI. Existing knowledge gaps concerning the misinterpretation of symptoms in primary care need to be addressed in order to reduce this clinical challenge.

Impact of transcatheter aortic valve implantation on left ventricular function recovery, mass regression and outcome in patients with aortic stenosis: protocol of the TAVI-NOR prospective study.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is a widely used treatment option as an alternative to surgical aortic valve replacement in patients with severe aortic stenosis (AS) at high or intermediate surgical risk. TAVI improves symptoms, induces reverse left ventricular (LV) remodelling and increases overall survival. However, a careful patient selection is essential to achieve better outcome. Evidence on LV functional recovery and LV mass regression after TAVI based on contemporary registry data is scarce. The impact of TAVI on the arterial vasculature is also less explored. METHOD AND ANALYSES: This is a study of 600 consecutive patients with AS who underwent a TAVI at Haukeland University Hospital, Bergen, Norway. Demographics, clinical data, arterial haemodynamics and echocardiographic parameters were prospectively collected. In the present paper, we describe the design, major scientific objectives and echocardiography imaging protocol of the TAVI-NOR (TAVI in western NORway) study. The main objectives are: To explore the impact of TAVI on cardiac structure and function in patients with severe AS, identify the echocardiographic predictors of reverse LV remodelling, assess survival benefits according to baseline risk profile, evaluate long-term therapeutic success as reflected by reduction in valvular-arterial impedance and to investigate the impact of various types of blood pressure response immediately after TAVI on clinical outcome. ETHICS AND DISSEMINATION: The study was approved by the Regional Committees for Medical and Health Research Ethics (REK vest, ref. number 33814) and the Institutional Data Protection Services. Patients' consent was waived. The study findings will be disseminated via peer-reviewed publications and presentation in national and international scientific meetings and conferences. TRAIL REGISTRATION NUMBER: The study was registered in the international database: ClinicalTrials.gov, Identifier: NCT04417829.

Temporal Trends in X-Ray Exposure during Coronary Angiography and Percutaneous Coronary Intervention.

BACKGROUND: Percutaneous coronary intervention exposes patient and staff to ionizing radiation. Although staff only receive a small fraction of patient dose through scatter radiation, there are concerns about the potential health effects of repeated exposure. Minimizing both patient and occupational exposure is needed. OBJECTIVE: This article investigates patient and operator X-ray exposure over time in coronary intervention in relation to upgraded X-ray equipment, improved shielding, and enhanced operator awareness. MATERIALS AND METHODS: Data regarding irradiation time, patient dose, and patient characteristics were extracted from the Norwegian Registry for Invasive Cardiology (NORIC) for procedures performed from 2013 to mid-2019. Personal operator dosimetry records were provided by the Norwegian Radiation and Nuclear Safety Authority. Improved operator shielding and awareness measures were introduced in 2018. RESULTS: In the period 2013 through June 2019, 21499 procedures were recorded in our institution. Mean dose area product (DAP) for coronary angiography decreased 37% from 2981 µGy·m2 in 2013 to 1891 µGy·m2 in 2019 (p < 0.001). For coronary intervention, DAP decreased 39% from 8358 µGy·m2 to 5055 µGy·m2. Personal dosimetry data indicate a 70% reduction in operator dose per procedure in 2019 compared to 2013. The most pronounced reduction occurred after improved radiation protection measures were implemented in 2018 (-48%). CONCLUSIONS: This study shows a temporal trend towards considerable reduction in X-ray doses received by the patient and operator during cardiac catheterization. Upgraded X-ray equipment, improved shielding, and enhanced operator awareness are likely contributors to this development.

Rethinking rehabilitation after percutaneous coronary intervention: a protocol of a multicentre cohort study on continuity of care, health literacy, adherence and costs at all care levels (the CONCARDPCI).

INTRODUCTION: Percutaneous coronary intervention (PCI) aims to provide instant relief of symptoms, and improve functional capacity and prognosis in patients with coronary artery disease. Although patients may experience a quick recovery, continuity of care from hospital to home can be challenging. Within a short time span, patients must adjust their lifestyle, incorporate medications and acquire new support. Thus, CONCARDPCI will identify bottlenecks in the patient journey from a patient perspective to lay the groundwork for integrated, coherent pathways with innovative modes of healthcare delivery. The main objective of the CONCARDPCI is to investigate (1) continuity of care, (2) health literacy and self-management, (3) adherence to treatment, and (4) healthcare utilisation and costs, and to determine associations with future short and long-term health outcomes in patients after PCI. METHODS AND ANALYSIS: This prospective multicentre cohort study organised in four thematic projects plans to include 3000 patients. All patients undergoing PCI at seven large PCI centres based in two Nordic countries are prospectively screened for eligibility and included in a cohort with a 1-year follow-up period including data collection of patient-reported outcomes (PRO) and a further 10-year follow-up for adverse events. In addition to PROs, data are collected from patient medical records and national compulsory registries. ETHICS AND DISSEMINATION: Approval has been granted by the Norwegian Regional Committee for Ethics in Medical Research in Western Norway (REK 2015/57), and the Data Protection Agency in the Zealand region (REG-145-2017). Findings will be disseminated widely through peer-reviewed publications and to patients through patient organisations. TRIAL REGISTRATION NUMBER: NCT03810612.

Continuity of care and its associations with self-reported health, clinical characteristics and follow-up services after percutaneous coronary intervention.

AIMS: Complexity of care in patients with coronary artery disease is increasing, due to ageing, improved treatment, and more specialised care. Patients receive care from various healthcare providers in many settings. Still, few studies have evaluated continuity of care across primary and secondary care levels for patients after percutaneous coronary intervention (PCI). This study aimed to determine multifaceted aspects of continuity of care and associations with socio-demographic characteristics, self-reported health, clinical characteristics and follow-up services for patients after PCI. METHODS: This multi-centre prospective cohort study collected data at baseline and two-month follow-up from medical records, national registries and patient self-reports. Univariable and hierarchical regressions were performed using the Heart Continuity of Care Questionnaire total score as the dependent variable. RESULTS: In total, 1695 patients were included at baseline, and 1318 (78%) completed the two-month follow-up. Patients stated not being adequately informed about lifestyle changes, medication and follow-up care. Those experiencing poorer health status after PCI scored significantly worse on continuity of care. Patients with ST-segment elevation myocardial infarction scored significantly better on informational and management continuity than those with other cardiac diagnoses. The regression analyses showed significantly better continuity (P ≤ 0.034) in patients who were male, received written information from hospital, were transferred to another hospital before discharge, received follow-up from their general practitioner or had sufficient consultation time after discharge from hospital. CONCLUSION: Risk factors for sub-optimal continuity were identified. These factors are important to patients, healthcare providers and policy makers. Action should be taken to educate patients, reconcile discharge plans and organise post-discharge services. Designing pathways with an interdisciplinary approach and shared responsibility between healthcare settings is recommended.

Impella use in acute myocardial infarction complicated by cardiogenic shock and cardiac arrest: Analysis of 10 years registry data.

AIMS: To assess characteristics and outcome of patients treated with Impella for acute myocardial infarction (AMI) complicated by severe cardiogenic shock (CS) or cardiac arrest (CA). METHODS AND RESULTS: From 2008 through 2017, 92 patients with AMI complicated by CS were treated with Impella. Survival varied according to clinical presentation. Patients in cardiogenic shock without CA had a 75% 30-day survival. Patients with CA and return of spontaneous circulation (ROSC) had a 43% survival and those with CA and ongoing cardio-pulmonary resuscitation (CPR) had a 6% 30-day survival. Age, pre-existing hypertension, coronary disease, ventilatory support and use of adrenergic agents were associated with worse prognosis. Complications were predominantly access site related. CONCLUSIONS: In this registry of patients with AMICS treated with Impella, hypertension and older age were found to be negatively predictive for survival. Patients without CA had the highest 30-day survival. In patients with ROSC, survival was strongly related to age and comorbidity. Patients with ongoing CPR had very high mortality.

Adaptation and psychometric properties of the Norwegian version of the heart continuity of care questionnaire (HCCQ).

BACKGROUND: Continuity of cardiac care after hospital discharge is a priority, especially as healthcare systems become increasingly complex and fragmented. There are few available instruments to measure continuity of cardiac care, especially from the patient perspective. The aim of this study was (1) to translate and adapt the Heart Continuity of Care Questionnaire (HCCQ) to conditions in Norway, and (2) to determine its psychometric properties in self-report format administered to patients after percutaneous coronary intervention (PCI). METHODS: The HCCQ was first translated into Norwegian from the original English version, following a widely used cross-cultural adaptation process. Data were collected before hospital discharge and in a follow-up after 2 months. To assess psychometric properties, a confirmatory factor analysis (CFA) was performed and three aspects of construct validity were evaluated: structural validity, hypotheses testing and cross-cultural validation. Internal consistency of the HCCQ subscales was calculated using Cronbach's alpha, while intra-class correlation (ICC) was used to assess test-retest reliability. Additionally, socio-demographic and patient-reported data were collected to correlate with HCCQ scores. RESULTS: Of those included at baseline, 436 (76%) completed the questionnaires after 2 months. CFA suggested that the fit of the HCCQ data to a 3-factor model was modest (RMSEA = 0.11, CFI = 0.90, TLI = 0.90). However, convergent validity was satisfactory, based on existing research. Internal consistency was good, as indicated by its Cronbach's alphas: total continuity of care (0.95); informational (0.93), relational (0.87), and management (0.89) continuity. The ICC for the total HCCQ score was 0.80 (95% CI [0.71, 0.87] p < 0.001). As indicated by negative care experiences (rated as 1 or 2 on the five-point scale), patients seemed to have limited knowledge about medical treatment, lifestyle modification and follow-up after PCI. Participation in cardiac rehabilitation and longer consultations with the general practitioner after hospital discharge were positively correlated with better continuity of care. CONCLUSIONS: Implementation of the HCCQ will likely support healthcare providers and researchers in identifying problem areas of continuity of cardiac care and in evaluating interventions aimed at improving continuity of care.