Scandinavian Cardiovascular Journal最新文献

{"title":"A comparison of risk scores’ long-term predictive abilities for patients diagnosed with ST elevation myocardial infarction who underwent early percutaneous coronary intervention","authors":"A. Aldujeli, A. Haq, A. Hamadeh, Auguste Stalmokaite, Laurynas Maciulevicius, Egle Labanauskaite, I. Navickaitė, Z. Kurnickaite, G. Jaruševičius, R. Unikas, D. Zaliaduonytė, K. Tecson","doi":"10.1080/14017431.2022.2066718","DOIUrl":"https://doi.org/10.1080/14017431.2022.2066718","url":null,"abstract":"Abstract Objective. To compare the long-term (5 year) prognostic values of commonly used risk scores on major adverse cardiovascular events (MACE) in a cohort of patients who underwent primary PCI for STEMI. Design. We created a composite endpoint of MACE, defined as the occurrence of any of the following events within 5 years: ischemic or hemorrhagic stroke, target vessel revascularization, nonfatal myocardial infarction, cardiovascular death. We dichotomized risk scores into high risk and not high risk according to the literature’s pre-existing cutoffs as follows: GRACE score >127 = high risk, SYNTAX I score ≥33 = high risk, SYNTAX II ≥32 high risk, TIMI >8 = high risk. We utilized the area under the receiver operating characteristic curve (AUC) as the metric for predictive ability. Results. There were 768 patients in this study and 416 (54.2%), 209 (27.2%), 511 (66.5%), and 74 (9.6%) were at high risk according to the GRACE, SYNTAX I, SYNTAX II, and TIMI scores, respectively. The AUCs for 5-year MACE were 0.54 (95% confidence interval (CI): 0.49–0.59, p = .0947), 0.79 (95% CI: 0.75–0.83, p < .0001), 0.58 (95% CI: 0.54–0.62, p = .0004), and 0.5 (95% CI: 0.48–0.53, p = .7259), respectively. Conclusion. SYNTAX I score was superior in predicting MACE in patients with STEMI and a high burden of CAD. Utilizing the basal SYNTAX I score in STEMI patients with significant non-culprit CAD may improve risk stratification, decision-making, and outcomes.","PeriodicalId":21383,"journal":{"name":"Scandinavian Cardiovascular Journal","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44095993","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prediction of postoperative atrial fibrillation with postoperative epicardial electrograms.","authors":"Louise Feilberg Rasmussen,&nbsp;Jan Jesper Andreasen,&nbsp;Sam Riahi,&nbsp;Gregory Y H Lip,&nbsp;Søren Lundbye-Christensen,&nbsp;Jacob Melgaard,&nbsp;Claus Graff","doi":"10.1080/14017431.2022.2130421","DOIUrl":"https://doi.org/10.1080/14017431.2022.2130421","url":null,"abstract":"<p><p><i>Objectives.</i> New-onset postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery. The arrhythmia often entails a longer hospital stay, greater risk of other complications, and higher mortality both short- and long-term. An investigation of the use of early atrial electrograms in predicting POAF in cardiac surgery was performed. <i>Design.</i> In this prospective observational study, a total of 99 consecutive adult patients undergoing coronary artery bypass grafting, valve surgery or both were included. On the first postoperative morning, standard 12-lead electrograms (ECG), unipolar atrial electrograms (aEG), and vital values were recorded. The outcome was new-onset POAF within one month postoperatively. <i>Results.</i> Three multivariable prediction models for POAF were formed using measurements derived from the ECG, aEG, and patient characteristics. Age, body mass index, and two unipolar electrogram measurements quantifying local activation time and fractionation were strongly associated with the outcome POAF. The performance of the POAF prediction models was assessed through receiver operating curve characteristics with cross-validation, and discrimination using the leave-one-out-method to internally validate the models. The cross-validated area under the receiver operating characteristic curve (AUC) was improved in a prediction model using atrial-derived electrogram variables (AUC 0.796, 95% CI 0.698-0.894), compared with previous ECG and clinical models (AUC 0.716, 95% CI 0.606-0.826 and AUC 0.718, 95% CI 0.613-0.822, respectively). <i>Conclusions.</i> This study found that easily obtainable measurements from atrial electrograms may be helpful in identifying patients at risk of POAF in cardiac surgery.</p>","PeriodicalId":21383,"journal":{"name":"Scandinavian Cardiovascular Journal","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10412104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Echocardiographic diagnosis of heart failure with preserved ejection fraction in elderly patients with hypertension.","authors":"Magnus C Johansson,&nbsp;Annika Rosengren,&nbsp;Michael Fu","doi":"10.1080/14017431.2022.2129777","DOIUrl":"https://doi.org/10.1080/14017431.2022.2129777","url":null,"abstract":"<p><p><i>Objectives</i>. The aim of this study is to evaluate the diagnostic performance of echocardiography for the diagnosis of heart failure with preserved ejection fraction (HFpEF) in the elderly and to validate the Heart Failure Association diagnostic algorithm (HFA-PEFF). <i>Design.</i> A case-control study was conducted in patients with hypertension with or without HFpEF who were matched for age (<i>n</i> = 33; 78.4 ± 5.3 years) and sex. Participants underwent echocardiography including assessment of left atrial (LA) volume index (LAVI), early mitral filling to early diastolic mitral annulus velocity ratio (<i>E</i>/<i>e</i>'), LA reservoir strain (LASr), tissue Doppler LA contraction (<i>a</i>'), right ventricular isovolumic relaxation time (RVIVRT), and a 6-minute walk test (6-MWT). The filling pressure algorithm from the European association of cardiovascular imaging (EACVI) 2021 was applied. The HFA-PEFF score was also applied, using echocardiography parameters and the value of NT pro-BNP, without considering symptomatic status. <i>Results.</i> Echocardiographic parameters identified patients with HFpEF with an area under the curve (AUC) >0.9 for <i>E</i>/<i>e</i>', RVIVRT, LASr, <i>a</i>', and the ratio of LAVI/<i>a</i>'. LASr correlated with 6-MWT (<i>r</i> = 0.59, <i>p</i> = .0003). The EACVI algorithm classified all controls with normal filling pressure and 94% of patients with HFpEF with increased filling pressure. When the HFA-PEFF diagnostic algorithm was validated, a high score (≥5 points) had 100% sensitivity for HFpEF, while 88% of controls had intermediate scores (2-4 points). <i>Conclusion</i>. The EACVI filling pressure algorithm, RVIVRT, LASr, and the ratio LAVI/<i>a</i>' were accurate for diagnosing HFpEF in elderly patients with hypertension. The HFA-PEFF score had high sensitivity but limited ability to exclude HFpEF.</p>","PeriodicalId":21383,"journal":{"name":"Scandinavian Cardiovascular Journal","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10760646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hemodynamic changes during aortic valve surgery among patients with aortic stenosis.","authors":"Rasmus Carter-Storch,&nbsp;Søren Mose Hansen,&nbsp;Jordi S Dahl,&nbsp;Kasper Enevold,&nbsp;Nils Sofus Borg Mogensen,&nbsp;Henrik Berg,&nbsp;Marie-Annick Clavel,&nbsp;Jacob E Møller","doi":"10.1080/14017431.2022.2099008","DOIUrl":"https://doi.org/10.1080/14017431.2022.2099008","url":null,"abstract":"<p><p><i>Introduction.</i> Patients with severe aortic stenosis (AS) undergoing surgery are at increased risk of hypotension and hypoperfusion. Although treatable with inotropic agents or fluid, little is known about how these therapies affect central hemodynamics in AS patients under general anesthesia. We measured changes in central hemodynamics after dobutamine infusion and fluid bolus among patients with severe AS and associated these changes with preoperative echocardiography. <i>Methods.</i> We included 33 patients with severe AS undergoing surgical AVR. After induction of general anesthesia, hemodynamic measurements were obtained with a pulmonary artery catheter, including Cardiac index (CI), stroke volume index (SVi) and pulmonary capillary wedge pressure (PCWP). Measurements were repeated during dobutamine infusion, after fluid bolus and lastly after sternotomy. <i>Results.</i> General anesthesia resulted in a decrease in CI and SVi compared to preoperative values. During dobutamine infusion CI increased but mean SVi did not (38 ± 12 vs 37 ± 13 ml/m², <i>p</i> = .90). Higher EF and SVi before surgery and a larger decrease in SVi after induction of general anesthesia were associated with an increase in SVi during dobutamine infusion. After fluid bolus both CI, SVi (48 ± 12 vs 37 ± 13 ml/min/m², <i>p</i> < .0001) and PCWP increased. PCWP increased mostly among patients with a larger LA volume index. <i>Conclusion.</i> In patients with AS, CI can be increased with both dobutamine and fluid during surgery. Dobutamine's effect on SVI was highly variable and associated with baseline LVEF, and an increase in CI was mostly driven by an increase in heart rate. Fluid increased SVi at the cost of an increase in PCWP.</p>","PeriodicalId":21383,"journal":{"name":"Scandinavian Cardiovascular Journal","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40601832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnosis and treatment of the rare procedural complication of malpositioned pacing leads in the left heart: a single center experience.","authors":"Rasmus Borgquist,&nbsp;Maiwand Farouq,&nbsp;Hanna Markstad,&nbsp;Johan Brandt,&nbsp;David Mörtsell,&nbsp;Steen Jensen,&nbsp;Uzma Chaudhry,&nbsp;Lingwei Wang","doi":"10.1080/14017431.2022.2099013","DOIUrl":"https://doi.org/10.1080/14017431.2022.2099013","url":null,"abstract":"<p><p><i>Objectives</i>. This study assessed the management approach and outcome of the pacemaker or implantable cardioverter-defibrillator (ICD) leads malpositioned in the left heart. Malpositioned leads (MPLs) may have deleterious consequences, and appropriate management remains uncertain. <i>Methods</i>. The study population included all patients referred to a single institution for MPL in the left side of the heart after pacemaker or ICD implantation during the period from 2015 to 2021. The approach and outcome of lead management were retrospectively assessed. <i>Results</i>. During the study period, 6887 patients underwent device implantation. MPL was diagnosed in five patients (0.07%). In four cases, the pacing lead was placed in a coronary sinus (CS) branch, while the pacing lead was inside the left ventricle (LV) in one case. Symptoms suggestive of lead malposition were reported by 2 patients (40%). One of the patients presented with recurrent TIAs. Another presented with inappropriate ICD shocks. In one asymptomatic case, an ICD lead changed position from the right ventricle to the CS, suggesting idiopathic lead migration. In 4/5 patients, the leads were removed or repositioned by percutaneous approach, with no major periprocedural complications. <i>Conclusions</i>. In this series of MPL in the left heart, two patients presented with thromboembolic events or inappropriate ICD shocks. These serious complications highlight the critical need for early correct diagnosis and proper management of MPL.</p>","PeriodicalId":21383,"journal":{"name":"Scandinavian Cardiovascular Journal","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40635502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The relationship between six-minute walked distance and health-related quality of life in patients with chronic heart failure.","authors":"Charlotta Lans,&nbsp;Åsa Cider,&nbsp;Eva Nylander,&nbsp;Lars Brudin","doi":"10.1080/14017431.2022.2107234","DOIUrl":"https://doi.org/10.1080/14017431.2022.2107234","url":null,"abstract":"<p><p><i>Objectives</i>. To assess the relationship between the six-minute walk test (6MWT) and health-related quality of life (HRQL) in patients with chronic heart failure. <i>Methods</i>. Forty-six patients (37 men and 9 women) with chronic heart failure, mean age 68 (SD 9), NYHA II-III and EF 29 (9) % were included. They performed 6MWT and assessed HRQL using two tools, a Swedish version of the 36-item Short Form (SF-36) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). This was performed repeatedly during a study period of one year. <i>Results</i>. Patients with a walking distance lower than median experienced a lower HRQL than the higher performing half of the cohort, in four dimensions of the SF-36 and the summary of physical and mental components, but not in the dimensions of MLHFQ. <i>Conclusion</i>. Patients with heart failure with a short walking distance assessed their quality of life as inferior in half of the dimensions in the SF-36 but not in the dimensions measured with the MLHFQ. Thus, different aspects of the symptomatology are uncovered using the 6MWT and the different HRQL tools.</p>","PeriodicalId":21383,"journal":{"name":"Scandinavian Cardiovascular Journal","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40671826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term effects of cardiac rehabilitation after heart valve surgery - results from the randomised CopenHeart_VR trial.","authors":"Kirstine L Sibilitz,&nbsp;Lars Hermann Tang,&nbsp;Selina Kikkenborg Berg,&nbsp;Lau Caspar Thygesen,&nbsp;Signe Stelling Risom,&nbsp;Trine Bernholdt Rasmussen,&nbsp;Jean-Paul Schmid,&nbsp;Britt Borregaard,&nbsp;Christian Hassager,&nbsp;Lars Køber,&nbsp;Rod S Taylor,&nbsp;Ann-Dorthe Zwisler","doi":"10.1080/14017431.2022.2095432","DOIUrl":"https://doi.org/10.1080/14017431.2022.2095432","url":null,"abstract":"<p><p><b><i>Aims</i></b>. The CopenHeart_VR trial found positive effects of cardiac rehabilitation (CR) on physical capacity at 4 months. The long-term effects of CR following valve surgery remains unclear, especially regarding readmission and mortality. Using data from he CopenHeart_VR Trial we investigated long-term effects on physical capacity, mental and physical health and effect on mortality and readmission rates as prespecified in the original protocol. <b><i>Methods</i>.</b> A total of 147 participants were included after heart valve surgery and randomly allocated 1:1 to 12-weeks exercise-based CR including a psycho-educational programme (intervention group) or control. Physical capacity was assessed as peak oxygen uptake (VO₂ peak) measured by cardiopulmonary exercise testing, mental and physical health by Short Form-36 questionnaire, Hospital Anxiety and Depression Scale, and HeartQol. Mortality and readmission were obtained from hospital records and registers. Groups were compared using mixed regression model analysis and log rank test. <b><i>Results</i>.</b> No differences in VO₂ peak at 12 months or in self-assessed mental and physical health at 24 months (68% vs 75%, <i>p</i> = .120) was found. However, our data demonstrated reduction in readmissions in the intervention group at intermediate time points; after 3, 6 (43% vs 59%, <i>p</i> = .03), and 12 (53% vs 67%, <i>p</i> = .04) months, respectively, but no significant effect at 24 months. <b><i>Conclusions</i></b>. Exercise-based CR after heart valve surgery reduces combined readmissions and mortality up to 12 months despite lack of improvement in exercise capacity, physical and mental health long-term. Exercise-based CR can ensure short-term benefits in terms of physical capacity, and lower readmission within a year, but more research is needed to sustain these effects over a longer time period. These considerations should be included in the management of patients after heart valve surgery.</p>","PeriodicalId":21383,"journal":{"name":"Scandinavian Cardiovascular Journal","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40488472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Women with atrial fibrillation undergoing pulmonary vein isolation are more symptomatic but improve more in health-related quality of life and symptom burden than men.","authors":"Carina Carnlöf,&nbsp;Marie Iwarzon,&nbsp;Mats Jensen-Urstad,&nbsp;Fredrik Gadler,&nbsp;Per Insulander","doi":"10.1080/14017431.2022.2107235","DOIUrl":"https://doi.org/10.1080/14017431.2022.2107235","url":null,"abstract":"<p><p>Gender differences in symptoms and perceived health-related quality of life (HRQOL) in patients with atrial fibrillation (AF) referred to pulmonary vein isolation (PVI) have been reported previously. Women experience a lower HRQOL, faster heart rate, and more symptoms such as palpitation and dyspnea than men. Furthermore, they experience worse physical functioning independently of other heart diseases or age. This study evaluates referral patterns and symptoms, morbidity, functional impairment, and HRQOL from a gender perspective in patients with AF before and 6 months after PVI. The study includes 242 patients (121 men), mean age 62 ± 9 years, referred for PVI. Symptoms were assessed with the Symptom Checklist: Frequency and Severity (SCL), HRQOL with Short Form 36 (SF-36), and the functional impairment with Sickness Impact Profile (SIP). The patients' own experiences of the referral process and history of their disease were evaluated with a supplementary questionnaire. The results showed that women improved more than men in HRQOL, SIP, and SCL 6 months post PVI. There were no sex differences in proportion of paroxysmal and persistent AF or ablation outcome. At baseline, women scored higher than men in both scales of the SCL (<i>p</i> < 0.001), scored lower in all components in SF-36, and scored higher in five categories of the SIP. Women were not more reluctant to accept referral for ablation when offered. The conclusion is that women with AF undergoing PVI are more symptomatic but also improve more in HRQOL and in symptom burden than men.</p>","PeriodicalId":21383,"journal":{"name":"Scandinavian Cardiovascular Journal","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40595633","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fast acquisition of left and right ventricular function parameters applying cardiovascular magnetic resonance in clinical routine - validation of a 2-shot compressed sensing cine sequence.","authors":"Jan Gröschel,&nbsp;Clemens Ammann,&nbsp;Leonora Zange,&nbsp;Darian Viezzer,&nbsp;Christoph Forman,&nbsp;Michaela Schmidt,&nbsp;Edyta Blaszczyk,&nbsp;Jeanette Schulz-Menger","doi":"10.1080/14017431.2022.2099010","DOIUrl":"https://doi.org/10.1080/14017431.2022.2099010","url":null,"abstract":"<p><p><i>Objectives.</i> To evaluate if cine sequences accelerated by compressed sensing (CS) are feasible in clinical routine and yield equivalent cardiac morphology in less time. <i>Design.</i> We evaluated 155 consecutive patients with various cardiac diseases scanned during our clinical routine. LV and RV short axis (SAX) cine images were acquired by conventional and prototype 2-shot CS sequences on a 1.5 T CMR. The 2-shot prototype captures the entire heart over a period of 3 beats making the acquisition potentially even faster. Both scans were performed with identical slice parameters and positions. We compared LV and RV morphology with Bland-Altmann plots and weighted the results in relation to pre-defined tolerance intervals. Subjective and objective image quality was evaluated using a 4-point score and adapted standardized criteria. Scan times were evaluated for each sequence. <i>Results.</i> In total, no acquisitions were lost due to non-diagnostic image quality in the subjective image score. Objective image quality analysis showed no statistically significant differences. The scan time of the CS cines was significantly shorter (<i>p</i> < .001) with mean scan times of 178 ± 36 s compared to 313 ± 65 s for the conventional cine. All cardiac function parameters showed excellent correlation (<i>r</i> 0.978-0.996). Both sequences were considered equivalent for the assessment of LV and RV morphology. <i>Conclusions.</i> The 2-shot CS SAX cines can be used in clinical routine to acquire cardiac morphology in less time compared to the conventional method, with no total loss of acquisitions due to nondiagnostic quality.</p><p><strong>Trial registration: </strong>ISRCTN12344380. Registered 20 November 2020, retrospectively registered.</p>","PeriodicalId":21383,"journal":{"name":"Scandinavian Cardiovascular Journal","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40506686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Expanding the evidence base of new cardiovascular treatments by systematic registry-based evaluation of their implementation in clinical practice.","authors":"Björn Redfors,&nbsp;Elmir Omerovic","doi":"10.1080/14017431.2022.2100474","DOIUrl":"https://doi.org/10.1080/14017431.2022.2100474","url":null,"abstract":"Health care resources are limited. It is therefore important to distinguish cost-effective and life-saving new treatments from costly but ineffective treatments, or costly treatments that are no more effective than less expensive alternatives. Unfortunately, few new treatments are systematically evaluated after they are implemented in clinical practice. We advocate for systematic large-scale evaluation of the efficacy and safety of new treatments when they are introduced in clinical practice; by pragmatic, cluster-randomized implementation strategies followed up through health care registries. Randomized controlled trials (RCTs) represent robust and important tools for assuring that a new treatment is efficacious and safe prior to its implementation in clinical care, but even well-conducted RCTs rarely fully establish the efficacy and safety of treatment across different subsets of patients [1]. Furthermore, the RCTs that form the evidence base for the implementation of new treatments are often funded and conducted by profit-seeking organizations, a fact that arguably further justifies the continued evaluation of the performance of these treatments. Despite persisting uncertainties in their efficacy and safety at the time of their implementation in clinical practice, few treatments are systematically evaluated after their implementation [2]. Several treatments that were found to be inefficacious compared to less expensive alternatives many years after they were implemented could have been identified as ineffective earlier if they had been systematically evaluated when they were implemented [3]. Once a new treatment has been shown to be efficacious and safe in a traditional RCT, healthcare registries can be used as data capture systems to allow inexpensive further evaluation of the efficacy and safety of new treatments if the implementation of the treatment is done systematically using a cluster-randomized approach [4]. Cluster randomized designs represent flexible means of systematically implementing new treatments, by randomizing individual hospitals or health care regions (clusters of patients) to different treatments (parallel group design) or to the order in which they implement a new treatment (stepped wedge design) [5]. To reliably evaluate the implementation of a new treatment in a health care registry, the registry must be of sufficient detail and quality to allow for identification of the desired study population and reliable endpoint ascertainment. Some contemporary health care registries, such as the nationwide Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART), fulfill these criteria [4]. By systematically introducing new treatments using a cluster randomized approach and following up outcomes in already existing health registries, data can be acquired for a substantial number of patients at minimal cost. Clusterrandomized implementation ","PeriodicalId":21383,"journal":{"name":"Scandinavian Cardiovascular Journal","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40529886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}