Circulation-Cardiovascular Quality and Outcomes最新文献

{"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}

{"title":"Assessing the Relevance of the Kansas City Cardiomyopathy Questionnaire in Patients With Tricuspid Regurgitation: The Tri-QOL Qualitative Study.","authors":"Danielle M Olds, Jamie L Smith, John A Spertus, Shannon M Dunlay, Fraser D Bocell, Changfu Wu, David J Cohen, Suzanne V Arnold","doi":"10.1161/CIRCOUTCOMES.124.011245","DOIUrl":"https://doi.org/10.1161/CIRCOUTCOMES.124.011245","url":null,"abstract":"<p><strong>Background: </strong>Validly measuring disease-specific health status is critical in patients with severe tricuspid regurgitation (TR) to quantify the benefit of different interventions. The Kansas City Cardiomyopathy Questionnaire (KCCQ) has been used to assess health status in patients with severe TR, but its content validity in this patient population is unknown, including whether additional questions are needed to supplement the KCCQ.</p><p><strong>Methods: </strong>Twenty participants with symptomatic severe TR from 2 midwestern clinical sites were interviewed in 2023 using a semistructured guide. The interview guide addressed symptoms, physical and social functioning, and quality of life concepts of the KCCQ, as well as other potential TR symptoms not represented in the KCCQ. Interview transcripts were analyzed using inductive and deductive coding and content analysis, with additional participants recruited until thematic saturation occurred.</p><p><strong>Results: </strong>Mean age of the participants was 80 (41-89), and 75% were female. Shortness of breath and fatigue were reported by virtually all participants (n=20 and n=19, respectively) and had a marked negative impact on their physical and social functioning and quality of life. Lower limb edema was also reported by 10 participants. Although these concepts are captured by the KCCQ, other symptoms were also reported, including appetite loss (n=8) and upper body edema (n=4), but did not seem to markedly affect participants' function or quality of life. In addition, all participants who experienced these other symptoms reported symptoms that were already captured by the KCCQ.</p><p><strong>Conclusions: </strong>All participants experienced symptoms captured by the KCCQ, and these symptoms had a substantial impact on their physical and social functioning and quality of life. Although some participants reported additional symptoms not assessed by the KCCQ, their incorporation would only marginally improve content validity. Thus, the current KCCQ appears to be appropriate for capturing the disease-specific health status of patients with severe TR.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011245"},"PeriodicalIF":6.2,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081810","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":"Equitable Stroke Care for a Growing Population: The Need for Cultural Sensitivity.","authors":"Patricia R Rodriguez-Lozano, Cristiane C Singulane","doi":"10.1161/CIRCOUTCOMES.124.011737","DOIUrl":"10.1161/CIRCOUTCOMES.124.011737","url":null,"abstract":"","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011737"},"PeriodicalIF":6.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143014819","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":"Food Insecurity and Poor Health: Unraveling the Mechanisms, Informing Better Solutions.","authors":"Dariush Mozaffarian","doi":"10.1161/CIRCOUTCOMES.124.011743","DOIUrl":"10.1161/CIRCOUTCOMES.124.011743","url":null,"abstract":"","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011743"},"PeriodicalIF":6.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11835523/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142957129","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Relative Effectiveness of High-Dose Versus Standard-Dose Quadrivalent Influenza Vaccine in Older Adults With Cardiovascular Disease: A Prespecified Analysis of the DANFLU-1 Randomized Clinical Trial.","authors":"Jacob Christensen, Niklas Dyrby Johansen, Daniel Modin, Kira Hyldekær Janstrup, Joshua Nealon, Sandrine Samson, Matthew Loiacono, Rebecca Harris, Carsten Schade Larsen, Anne Marie Reimer Jensen, Nino Emanuel Landler, Brian L Claggett, Scott D Solomon, Gunnar H Gislason, Lars Køber, Martin J Landray, Pradeesh Sivapalan, Jens Ulrik Stæhr Jensen, Tor Biering-Sørensen","doi":"10.1161/CIRCOUTCOMES.124.011496","DOIUrl":"10.1161/CIRCOUTCOMES.124.011496","url":null,"abstract":"<p><strong>Background: </strong>Influenza vaccination reduces the risk of adverse outcomes in patients with cardiovascular disease (CVD). We sought to evaluate whether the presence of CVD modified the relative effectiveness of the high-dose quadrivalent influenza vaccine (QIV-HD) versus standard-dose quadrivalent influenza vaccine (QIV-SD) in this prespecified analysis of the DANFLU-1 trial (Feasibility of Randomizing Danish Citizens Aged 65-79 Years to High-Dose Quadrivalent Influenza Vaccine Versus Standard-Dose Quadrivalent Influenza Vaccine in a Pragmatic Registry-Based Setting).</p><p><strong>Methods: </strong>DANFLU-1 was a pragmatic, open-label, randomized feasibility trial of QIV-HD versus QIV-SD in adults aged 65 to 79 years during the 2021/2022 influenza season in Denmark. Vaccines were allocated in a 1:1 ratio. Baseline and follow-up data regarding diagnoses and mortality were obtained from Danish national registers. The trial is registered at Clinicaltrials.gov: NCT05048589. The CVDs assessed included heart failure, ischemic heart disease, atrial fibrillation, and a combined group denoted chronic CVD consisting of the aforementioned diseases, among others. Prespecified outcomes included hospitalizations for pneumonia or influenza, respiratory disease, CVD, cardiorespiratory disease, all-cause hospitalizations, and mortality. Effect modification was tested using interaction terms.</p><p><strong>Results: </strong>The final study population included 12 477 participants (mean age of 71.7±3.9 years and 5877 [47.1%] were female), of whom 2540 (20.4%) had chronic CVD. QIV-HD versus QIV-SD was associated with a lower incidence of hospitalizations for pneumonia or influenza (incidence rate ratio [IRR], 0.30 [95% CI, 0.14-0.64]) and all-cause mortality (IRR, 0.51 [95% CI, 0.30-0.86]) regardless of chronic CVD (<i>P</i>_interaction=0.57 and 0.49, respectively). The relative effectiveness of QIV-HD versus QIV-SD against all-cause hospitalizations was modified in participants with chronic CVD (overall: IRR, 0.87 [95% CI, 0.76-0.99]; no chronic CVD: IRR, 0.79 [95% CI, 0.67-0.92]; chronic CVD: IRR, 1.11 [95% CI, 0.88-1.39]; <i>P</i>_interaction=0.026). No other effect modification was observed by the presence of chronic CVD, heart failure, ischemic heart disease, or atrial fibrillation.</p><p><strong>Conclusions: </strong>The relative effectiveness of QIV-HD versus QIV-SD was consistent against hospitalizations for pneumonia or influenza and all-cause mortality regardless of chronic CVD. However, the relative effectiveness against all-cause hospitalizations was modified by the presence of chronic CVD. These results should be considered hypothesis generating.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT05048589.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011496"},"PeriodicalIF":6.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142113975","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":"Medicare Coverage and Patient Out-of-Pocket Costs for Mavacamten.","authors":"Kannu Bansal, Christopher V Chien, Ahmad Masri, Ralph J Riello, Tariq Ahmad, Nihar R Desai, Sourbha S Dani","doi":"10.1161/CIRCOUTCOMES.124.011331","DOIUrl":"10.1161/CIRCOUTCOMES.124.011331","url":null,"abstract":"","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011331"},"PeriodicalIF":6.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143014823","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":"Asking a More PRECISE Question?","authors":"Edward A Hulten, Marcelo F Di Carli","doi":"10.1161/CIRCOUTCOMES.124.011650","DOIUrl":"10.1161/CIRCOUTCOMES.124.011650","url":null,"abstract":"","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011650"},"PeriodicalIF":6.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081809","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":"Patient-Reported Outcomes in Heart Failure Clinical Trials: Trends, Utilization, and Implications.","authors":"Xichong Liu, Roy H Lan, Alexander T Sandhu","doi":"10.1161/CIRCOUTCOMES.124.011423","DOIUrl":"10.1161/CIRCOUTCOMES.124.011423","url":null,"abstract":"","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011423"},"PeriodicalIF":6.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972979","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":"Performance of the High-STEACS Early Rule Out Pathway Using hs-cTnT at 30 Days in a Multisite US Cohort.","authors":"Nicklaus P Ashburn, Anna C Snavely, Michael W Supples, Marissa J Millard, Brandon R Allen, Robert H Christenson, Troy Madsen, Bryn E Mumma, Tara Hashemian, R Gentry Wilkerson, Simon A Mahler","doi":"10.1161/CIRCOUTCOMES.124.011084","DOIUrl":"10.1161/CIRCOUTCOMES.124.011084","url":null,"abstract":"<p><strong>Background: </strong>The High-STEACS (High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome) pathway risk stratifies emergency department patients with possible acute coronary syndrome. This study aims to determine if the High-STEACS hs-cTnT (high-sensitivity cardiac troponin T) pathway can achieve the ≥99% negative predictive value (NPV) safety threshold for 30-day cardiac death or myocardial infarction (CDMI) in a multisite US cohort of patients with and without known coronary artery disease (CAD).</p><p><strong>Methods: </strong>A secondary analysis of the STOP-CP (High-Sensitivity Cardiac Troponin T [Gen 5 STAT Assay] to Optimize Chest Pain Risk Stratification) cohort, which enrolled adult emergency department patients with possible acute coronary syndrome at 8 US sites (January 25, 2017-September 6, 2018). Participants were classified into outpatient and admission dispositions using the High-STEACS hs-cTnT pathway. Known CAD was defined as prior MI, coronary revascularization, or ≥70% coronary stenosis. Outcomes included 30-day CDMI and efficacy, defined as the proportion identified for outpatient disposition. NPVs and negative likelihood ratios for 30-day CDMI were calculated. NPVs were compared between CAD subgroups using a Fisher exact test.</p><p><strong>Results: </strong>Among 1351 patients, 53.2% (719/1351) were male, 31.4% (424/1351) had known CAD, and the mean age was 57.4±12.8 years. At 30 days, CDMI occurred in 13.8% (187/1351). High-STEACS classified 63.4% (857/1351) to outpatient disposition, of which 2.0% (17/857) had 30-day CDMI, corresponding to an NPV of 98.0% (95% CI, 96.8-98.8) and negative likelihood ratio of 0.13 (95% CI, 0.08-0.20). In patients with CAD, 46.9% (199/424) were classified to outpatient disposition, of which 4.0% (8/199) had 30-day CDMI. Among patients without CAD, 71.0% (658/927) were classified to outpatient disposition with 1.4% (9/658) having 30-day CDMI. The NPV for 30-day CDMI was 96.0% (95% CI, 92.2-98.2) in patients with CAD versus 98.6% (95% CI, 97.4-99.4) among patients without CAD (<i>P</i>=0.04). The negative likelihood ratio for 30-day CDMI among patients with CAD was 0.16 (95% CI, 0.08-0.31) and 0.12 (95% CI, 0.06-0.22) among patients without CAD.</p><p><strong>Conclusions: </strong>The High-STEACS hs-cTnT pathway had high efficacy but was unable to achieve the ≥99% NPV safety threshold for 30-day CDMI.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02984436.</p>","PeriodicalId":49221,"journal":{"name":"Circulation-Cardiovascular Quality and Outcomes","volume":" ","pages":"e011084"},"PeriodicalIF":6.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11902900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142957130","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}