Circulation-Cardiovascular Quality and Outcomes最新文献

{"title":"Classifying Race in Out-of-Hospital Cardiac Arrest and Potential Disparities: A Retrospective Cohort Study.","authors":"Jenny Shin, Jennifer Liu, Megin Parayil, Catherine R Counts, Christopher J Drucker, Jason Coult, Jennifer Blackwood, Sally Guan, Peter J Kudenchuk, Michael R Sayre, Thomas Rea","doi":"10.1161/CIRCOUTCOMES.124.011446","DOIUrl":"10.1161/CIRCOUTCOMES.124.011446","url":null,"abstract":"<p><strong>Background: </strong>Although racial disparities have been described in resuscitation, little is known about potential bias in race classification of out-of-hospital cardiac arrest (OHCA).</p><p><strong>Methods: </strong>We conducted a retrospective cohort study of adults treated by emergency medical services (EMS) for nontraumatic OHCA in King County, WA between January 1, 2018, and December 31, 2021. We assessed agreement using κ and evaluated patterns of missingness between EMS-assessed race versus comprehensive race classification from hospital and death records. Using multivariable logistic regression adjusting for Utstein data elements, we analyzed the association between race and OHCA survival across different sources.</p><p><strong>Results: </strong>Among 5909 eligible OHCA patients, the average age was 64.0 years, 35.4% were female, and 16.1% survived to hospital discharge. Based on comprehensive race classification, 68.7% were White, 12.8% Black, 12.1% Asian, 2.5% multiracial, 2.3% Native Hawaiian/other Pacific Islander, and 1.6% American Indian/Alaska Native. EMS did not classify race in 43.7%. The κ coefficient between EMS and comprehensive race classification was 0.88 (95% CI, 0.86-0.90), though agreement varied substantially by specific race and was lowest among American Indian/Alaska Native (39.5%). Missingness in EMS records varied according to race and was greater among those classified as American Indian/Alaska Native (60.8%), Native Hawaiian/other Pacific Islander (58.8%), Asian (57.8%), or multiracial (54.1%) compared with White (40.6%) or Black (40.4%). In multivariable models using EMS-classified race, the odds ratio (OR) of survival was not significantly different for any race group compared with the White race, that is, OR. However, when using comprehensive race classification, OR of survival was significantly lower among Native Hawaiian/other Pacific Islander (OR, 0.57 [95% CI, 0.33-0.97]) and among multiracial (OR, 0.40 [95% CI, 0.20-0.75]) compared with White race.</p><p><strong>Conclusions: </strong>In adult OHCA, race misclassification and missingness influenced its association with survival. Efforts should continue to evaluate best practices to classify race correctly and comprehensively.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011446"},"PeriodicalIF":6.2,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143025308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hospital Variability in the Use of Vasoactive Agents in Patients Hospitalized for Acute Decompensated Heart Failure for Clinical Phenotypes.","authors":"Yasuyuki Shiraishi, Nozomi Niimi, Shun Kohsaka, Kazumasa Harada, Takashi Kohno, Makoto Takei, Takahiro Jimba, Hiroki Nakano, Junya Matsuda, Akito Shindo, Daisuke Kitano, Shigeto Tsukamoto, Shinji Koba, Takeshi Yamamoto, Morimasa Takayama","doi":"10.1161/CIRCOUTCOMES.124.011270","DOIUrl":"10.1161/CIRCOUTCOMES.124.011270","url":null,"abstract":"<p><strong>Background: </strong>The absence of practice standards in vasoactive agent usage for acute decompensated heart failure has resulted in significant treatment variability across hospitals, potentially affecting patient outcomes. This study aimed to assess temporal trends and institutional differences in vasodilator and inotrope/vasopressor utilization among patients with acute decompensated heart failure, considering their clinical phenotypes.</p><p><strong>Methods: </strong>Data were extracted from a government-funded multicenter registry covering the Tokyo metropolitan area, comprising consecutive patients hospitalized in intensive/cardiovascular care units with a primary diagnosis of acute decompensated heart failure between January 2013 and December 2021. Clinical phenotypes, that is, pulmonary congestion or tissue hypoperfusion, were defined through a comprehensive assessment of clinical signs and symptoms, vital signs, and laboratory findings. We assessed the frequency and temporal trends in phenotype-based drug utilization of vasoactive agents and investigated institutional characteristics associated with adopting the phenotype-based approach using generalized linear mixed-effects models, with random intercepts to account for hospital-level variability.</p><p><strong>Results: </strong>Among 37 293 patients (median age, 80 years; 43.7% female), 88.6% and 21.2% had pulmonary congestion and tissue hypoperfusion status, respectively. Throughout the study period, both overall and phenotype-based vasodilator utilizations showed significant declines, with overall usage dropping from 61.4% in 2013 to 48.6% in 2021 (<i>P</i>_trend<0.001). Conversely, no temporal changes were observed in overall inotrope/vasopressor utilization from 24.6% in 2013 to 25.8% in 2021 or the proportion of phenotype-based utilization. Notably, there was considerable variability in phenotype-based drug utilization among hospitals, with a median ranging from 48.3% to 77.8%. In multivariable-adjusted models, a higher number of board-certified cardiologists were significantly associated with lower rates of phenotype-based vasodilator utilization and reduced inappropriate inotrope/vasopressor utilization, while tertiary care hospitals were linked to more appropriate inotrope/vasopressor utilization.</p><p><strong>Conclusions: </strong>Substantial variability existed among hospitals in phenotype-based drug utilization of vasoactive agents for patients with acute decompensated heart failure, highlighting the need for standardized treatment protocols.</p><p><strong>Registration: </strong>URL: https://www.umin.ac.jp/ctr/index.htm; Unique identifier: UMIN000013128.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011270"},"PeriodicalIF":6.2,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143048441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Direct Oral Anticoagulants Versus Warfarin for Atrial Fibrillation in Relation to Time in Therapeutic Range: An Analysis of US Food and Drug Administration Regulatory Data.","authors":"Kim Boesen, Luis Carlos Saiz, Peter C Gøtzsche, Juan Erviti","doi":"10.1161/CIRCOUTCOMES.124.011321","DOIUrl":"10.1161/CIRCOUTCOMES.124.011321","url":null,"abstract":"","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011321"},"PeriodicalIF":6.2,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143191098","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing Health Equity in the Cardiovascular Device Life Cycle.","authors":"Andre M Small, Nathan W Watson, Rishi K Wadhera, Eric A Secemsky, Robert W Yeh","doi":"10.1161/CIRCOUTCOMES.124.011310","DOIUrl":"10.1161/CIRCOUTCOMES.124.011310","url":null,"abstract":"<p><p>Despite advancements in diagnostics and therapeutics for cardiovascular disease, significant health disparities persist among patients from historically marginalized racial and ethnic groups, women, individuals who are socioeconomically under-resourced or underinsured, and those living in rural communities. While transcatheter interventions have revolutionized the treatment landscape in cardiology, populations bearing the greatest burden of disease continue to face inequitable access and poorer outcomes. A notable gap in the literature concerns the role of modern approaches to cardiovascular device innovation in shaping and perpetuating health disparities. Health equity has been declared one of the top strategic initiatives for 2022 to 2025 by the Food and Drug Administration Center for Devices and Radiological Health, underscoring the need for greater attention, dialogue, and targeted interventions in this space. This narrative review uses the cardiovascular device life cycle as a conceptual framework to enhance understanding and guide future efforts to mitigate disparities in the field of interventional cardiology. Drawing on illustrative examples from interventional cardiology, we examine current practices in cardiovascular device regulation and approval, clinical trial evaluation, adoption patterns, and postprocedural outcomes with the aim of uncovering potential mechanisms of disparities and identifying opportunities for targeted interventions.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011310"},"PeriodicalIF":6.2,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of an Innovative Decision-Aid to Better Align Patients' Implantable Cardioverter Defibrillator Shock Status With Goals of Care.","authors":"Christine L Chen, Sarah Godfrey, Kelley Newcomer, Kristin Alvarez, Brenden Garrett, Jingwen Zhang, Nakul Patel, Christopher Viamontes, Nainesh Shah, Nimesh S Patel, Megan M Kelly, Melanie S Sulistio","doi":"10.1161/CIRCOUTCOMES.124.011544","DOIUrl":"10.1161/CIRCOUTCOMES.124.011544","url":null,"abstract":"","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011544"},"PeriodicalIF":6.2,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143014817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the Appropriate Use Criteria for Coronary Revascularization in Stable Ischemic Heart Disease Using Randomized Data From the ISCHEMIA Trial.","authors":"James Slater, David J Maron, Philip G Jones, Sripal Bangalore, Harmony R Reynolds, Zhuxuan Fu, Gregg W Stone, Ruth Kirby, Judith S Hochman, John A Spertus","doi":"10.1161/CIRCOUTCOMES.124.010849","DOIUrl":"10.1161/CIRCOUTCOMES.124.010849","url":null,"abstract":"<p><strong>Background: </strong>The appropriate use criteria for revascularization of stable ischemic heart disease have not been evaluated using randomized data. Using data from the randomized ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches; July 2012 to January 2018, 37 countries), the health status benefits of an invasive strategy over a conservative one were examined within appropriate use criteria scenarios.</p><p><strong>Methods: </strong>Among 1833 participants mapped to 36 appropriate use criteria scenarios, symptom status was assessed using the Seattle Angina Questionnaire-7 at 1 year for each scenario and for each of the 6 patient characteristics used to define the scenarios. Coronary anatomy and SYNTAX(Synergy between percutaneous coronary intervention with Taxus and cardiac surgery) scores were measured using coronary computed tomography angiography. Treatment effects are expressed as an odds ratio for a better health status outcome with an invasive versus conservative treatment strategy using Bayesian hierarchical proportional odds models. Differences in the primary clinical outcome were similarly examined.</p><p><strong>Results: </strong>The mean age was 63 years, 81% were male, and 71% were White. Diabetes was present in 28% and multivessel disease in 51%. Most clinical scenarios favored invasive for better 1-year health status. The benefit of an invasive strategy on Seattle Angina Questionnaire angina frequency scores was reduced for asymptomatic patients (odds ratio [95% credible interval], 1.16 [0.66-1.71] versus 2.26 [1.75-2.80]), as well as for those on no antianginal medications. Diabetes, number of diseased vessels, proximal left anterior descending coronary artery location, and SYNTAX score did not effectively identify patients with better health status after invasive treatment, and minimal differences in clinical events were observed.</p><p><strong>Conclusions: </strong>Applying the randomization scheme from the ISCHEMIA trial to appropriate clinical scenarios revealed baseline symptoms and antianginal therapy to be the primary drivers of health status benefits from invasive management. Consideration should be given to reducing the patient characteristics collected to generate appropriateness ratings to improve the feasibility of future data collection.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e010849"},"PeriodicalIF":6.2,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The First International Consortium for Health Outcomes Measurement (ICHOM) Standard Dataset for Reporting Outcomes in Heart Valve Disease: Moving From Device- to Patient-Centered Outcomes: Developed by a multisociety taskforce coordinated by the Heart Valve Society (HVS) including the American Heart Association (AHA), the American College of Cardiology (ACC), the European Association for Cardio-Thoracic Surgery (EACTS), the European Society of Cardiology (ESC), The Society of Thoracic Surgeons (STS), the Australian & New Zealand Society of Cardiac & Thoracic Surgeons (ANZSCTS), the International Society for Applied Cardiovascular Biology (ISACB), the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS), the South African Heart Association (SHA), Heart Valve Voice, and Global Heart Hub.","authors":"Emmanuel Lansac, Kevin M Veen, Andria Joseph, Paula Blancarte Jaber, Frieda Sossi, Zofia Das-Gupta, Suleman Aktaa, J Rafael Sádaba, Vinod H Thourani, Gry Dahle, Wilson Y Szeto, Faisal Bakaeen, Elena Aikawa, Frederick J Schoen, Evaldas Girdauskas, Aubrey Almeida, Andreas Zuckermann, Bart Meuris, John Stott, Jolanda Kluin, Ruchika Meel, Wil Woan, Daniel Colgan, Hani Jneid, Husam Balkhy, Molly Szerlip, Ourania Preventza, Pinak Shah, Vera H Rigolin, Silvana Medica, Philip Holmes, Marta Sitges, Philippe Pibarot, Erwan Donal, Rebecca T Hahn, Johanna J M Takkenberg","doi":"10.1161/HCQ.0000000000000128","DOIUrl":"10.1161/HCQ.0000000000000128","url":null,"abstract":"<p><strong>Background: </strong>Globally significant variation in treatment and course of heart valve disease (HVD) exists, and outcome measurement is procedure focused instead of patient focused. This article describes the development of a patient-related (International Consortium for Health Outcomes Measurement) standard set of outcomes and case mix to be measured in patients with HVD.</p><p><strong>Methods: </strong>A multisociety working group was formed that included patient representatives and representatives from scientific cardiology and cardiothoracic surgery societies that publish current guidelines for HVD. The standard set was developed to monitor the patient's journey from diagnosis to treatment with either a surgical or transcatheter procedure. Candidate clinical and patient-reported outcome measures (PROMs) and case mix were identified through benchmark analyses and systematic reviews. Using an online modified Delphi process, the working group voted on final outcomes/case mix and corresponding definition.</p><p><strong>Results: </strong>Patients with aortic/mitral/tricuspid valve disease or root/ascending aorta >40 mm were included in the standard set. Patients entered the dataset when the diagnosis of HVD was established, allowing outcome measurement in the preprocedural, periprocedural, and postprocedural phases of patients' lives. The working group defined 5 outcome domains: vital status, patient-reported outcomes, progression of disease, cardiac function and durability, and complications of treatment. Subsequently, 16 outcome measures, including 2 patient-reported outcomes, were selected to be tracked in patients with HVD. Case-mix variables included demographic factors, demographic variables, echocardiographic variables, heart catheterization variables, and specific details on aortic/mitral/tricuspid valves and their specific interventions.</p><p><strong>Conclusions: </strong>Through a unique collaborative effort between patients and cardiology and cardiothoracic surgery societies, a standard set of measures for HVD was developed. This dataset focuses on outcome measurement regardless of treatment, moving from procedure- to patient-centered outcomes. Implementation of this dataset will facilitate global standardization of outcome measurement, allow meaningful comparison between health care systems and evaluation of clinical practice guidelines, and eventually improve patient care for those experiencing HVD worldwide.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e000128"},"PeriodicalIF":6.2,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143434218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determinants of Racial and Ethnic Differences in Maternal Cardiovascular Health in Early Pregnancy.","authors":"Natalie A Cameron, Xiaoning Huang, Lucia C Petito, Hongyan Ning, Nilay S Shah, Lynn M Yee, Amanda M Perak, David M Haas, Brian M Mercer, Samuel Parry, George R Saade, Robert M Silver, Hyagriv N Simhan, Uma M Reddy, Jasmina Varagic, Ernesto Licon, Philip Greenland, Donald M Lloyd-Jones, Kiarri N Kershaw, William A Grobman, Sadiya S Khan","doi":"10.1161/CIRCOUTCOMES.124.011217","DOIUrl":"10.1161/CIRCOUTCOMES.124.011217","url":null,"abstract":"<p><strong>Background: </strong>Suboptimal cardiovascular health (CVH) in pregnancy is associated with adverse maternal and offspring outcomes. To guide public health efforts to reduce disparities in maternal CVH, we determined the contribution of individual- and neighborhood-level factors to racial and ethnic differences in early pregnancy CVH.</p><p><strong>Methods: </strong>We included nulliparous individuals with singleton pregnancies who self-identified as Hispanic, non-Hispanic Black (NHB), or non-Hispanic White (NHW) and participated in the nuMoM2b cohort study (Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be). First-trimester CVH was quantified using 6 routinely assessed factors in pregnancy included in the American Heart Association Life's Essential 8 score (0-100 points), in which higher scores indicate better CVH. Oaxaca-Blinder decomposition evaluated the extent to which racial and ethnic differences in CVH were explained by differences in individual- and neighborhood-level factors (age, socioeconomic characteristics, psychosocial factors, nativity, perceived racial discrimination, and area deprivation index).</p><p><strong>Results: </strong>Among 9104 participants, the mean age was 26.8 years, 18.7% identified as Hispanic, 15.6% identified as NHB, and 65.8% identified as NHW. Mean (SD) CVH scores were 76.7 (14.1), 69.8 (15.1), and 79.9 (14.3) in the Hispanic, NHB, and NHW groups, respectively (<i>P</i><0.01). The individual- and neighborhood-level factors evaluated explained all differences in CVH between Hispanic and NHW groups and 82% of differences between NHW and NHB groups. Racial and ethnic differences in educational attainment explained the greatest proportion of differences in CVH. If mean years of education among the Hispanic (14.0 [2.5]) and NHB (13.4 [2.4]) groups were the same as the NHW (15.8 [2.4]) group, mean CVH scores would be higher by 2.98 points (95% CI, 2.59-3.37) in the Hispanic and 4.28 points (95% CI, 3.77-4.80) in NHB groups.</p><p><strong>Conclusions: </strong>Racial and ethnic differences in early pregnancy CVH were largely explained by differences in individual- and neighborhood-level factors.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011217"},"PeriodicalIF":6.2,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142979596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating Percutaneous Coronary Intervention Safety, Quality, and Appropriateness Across Michigan Using Blinded Cross-Institutional Peer Review.","authors":"Stephanie M Spehar, Milan Seth, John F Collins, Simon R Dixon, Elizabeth Pielsticker, Daniel Lee, Mark Zainea, Thomas LaLonde, Dilip Arora, Devraj Sukul, Hitinder S Gurm","doi":"10.1161/CIRCOUTCOMES.124.011031","DOIUrl":"https://doi.org/10.1161/CIRCOUTCOMES.124.011031","url":null,"abstract":"<p><strong>Background: </strong>Several quality improvement initiatives have focused on the quality gap in percutaneous coronary intervention (PCI), yet significant variations in quality persist. Our objective was to use a novel blinded peer review system to evaluate PCI quality, safety, and appropriateness across Michigan.</p><p><strong>Methods: </strong>Single-vessel PCI cases were randomly selected from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry across Michigan (2018-2020), and anonymized angiograms and pertinent case records were uploaded to a secure server. Cases were reviewed by blinded interventional cardiologists internal and external to the institution, using a standardized peer review form and rated on procedural quality, safety, and appropriateness. We compared appropriateness ratings between reviewers and registry-based appropriateness criteria.</p><p><strong>Results: </strong>We conducted 1627 independent peer reviews of 961 cases; 23.7% of cases were for non-ST-segment-elevation myocardial infarction, and 36.4% were for ST-segment-elevation myocardial infarction. The majority (96.4%) of reviewers rated angiogram quality as excellent or adequate. Reviewers noted a complication or suboptimal result in 11.1% of reviews; 44.0% of these were deemed avoidable. Most PCI procedures were considered appropriate or may be appropriate, (87.1%) by all those reviewing. Reviewers were less likely to categorize PCI cases as appropriate compared with registry-based appropriate use criteria definitions (73.1% versus 93.3%). The percentage of cases rated as both appropriate/may be appropriate and technically competent ranged from 76.7% to 100% across sites.</p><p><strong>Conclusions: </strong>While the overall quality and appropriateness of PCI in Michigan are high, key opportunities to improve care were identified. Additional studies are needed to assess the utility of expanding this approach across the United States.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011031"},"PeriodicalIF":6.2,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Variations in the Medical Device Authorization and Reimbursement Landscape: A Case Study of 2 Cardiovascular Devices Across 4 Countries.","authors":"Marta M Williams, Nathan R Smith, Carin A Uyl-de Groot, Corstiaan A den Uil, Joseph S Ross, Mohamed O Mohamed, Mamas A Mamas, Amitava Banerjee, Dennis T Ko, Bruce Landon, Peter Cram","doi":"10.1161/CIRCOUTCOMES.124.011636","DOIUrl":"https://doi.org/10.1161/CIRCOUTCOMES.124.011636","url":null,"abstract":"<p><strong>Background: </strong>The authorization process and coverage/reimbursement mechanisms for medical devices play critical roles in device adoption and usage. However, international variation in these processes remains poorly characterized, especially with regard to data transparency and the effects of reimbursement on usage.</p><p><strong>Methods: </strong>This study examined publicly available databases, governmental agency recommendations and policies, and press releases from the United States, Canada, the United Kingdom, and the Netherlands to compare the regulatory approval processes and coverage/reimbursement mechanisms for 2 novel cardiovascular devices introduced in the early and late 2000's: the Watchman left atrial appendage occlusion device and the Impella percutaneous ventricular assist device. In addition to qualitative comparisons for each country, this study compared the date of the first regulatory review, time from submission to review completion, device approval date, agency approval requirements, number of review cycles, and necessity of postapproval studies as determined by the regulator, date of funding decision, final funding decision, and requirements for device reimbursement by relevant government payors.</p><p><strong>Results: </strong>Authorization data were easily accessible for the United States and Canada but extremely limited for the United Kingdom and the Netherlands. Chronologically, authorization occurred ≈10 years earlier in Europe (United Kingdom and the Netherlands) than in North America (United States and Canada) for both devices. The United States was the only country where the principal public payor (Medicare) explicitly reimbursed both procedures. The United States was similarly notable for more rapid adoption and higher utilization of both devices than the other countries, with the Watchman implanted at 3.4 devices per 100 000 adults annually and Impella used in 7 to 8 procedures per 100 000 people annually. In contrast, uptake was far lower in Canada and Europe.</p><p><strong>Conclusions: </strong>This research provides insights into how differences among countries in authorization and reimbursement mechanisms may impact the adoption and usage of medical devices, and may inform future policies on these processes.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011636"},"PeriodicalIF":6.2,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143469803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}