Circulation-Cardiovascular Quality and Outcomes最新文献

Background: Previous observational studies showed left atrial appendage occlusions with the WATCHMAN device reduced 1-year mortality, which conflicted with evidence generated from randomized controlled trials. We proposed to use the high-dimensional propensity score (hdPS) to assist in nonactive comparator selection (prevalent user of medication) and compared 1-year mortality between patients with atrial fibrillation who received the WATCHMAN device (percutaneous left atrial appendage occlusion device [pLAAO]) and direct oral anticoagulants in 2 matched cohorts based on (1) traditional propensity score (PS) and (2) integrating traditional PS with information learned from hdPS.

Methods: Patients entered the cohort once diagnosed with atrial fibrillation in the 15% of Medicare fee-for-service claims database from 2011 to 2018. Patients could enter the study cohort upon receiving WATCHMAN or at an outpatient visit with an atrial fibrillation diagnosis, respectively. We used PS matching with a 1:3 ratio for patients in pLAAO and direct oral anticoagulant groups. In cohort 2, we implemented a multistep approach with information learned from hdPS. The Cox proportional hazards model was used to estimate hazard ratios of outcomes with 95% CIs.

Results: In cohort 1, we identified 1159 and 3477 patients in the pLAAO and direct oral anticoagulant groups with a mean age of 78.1 versus 77.5 years, 44.9% versus 40.8% of women, and a 1-year mortality rate of 8.02 versus 8.97/100 person-years (hazard ratio, 0.87 [95% CI, 0.69-1.09]). With the support of hdPS, in cohort 2, we excluded patients with malignant cancer and added frailty score in the PS model. We identified 953 and 2859 patients in the pLAAO and direct oral anticoagulant groups with a mean age of 78.1 versus 77.9 years, 47.2% versus 46.1% of women, and a 1-year mortality rate of 7.45 and 7.69/100 person-years (hazard ratio, 0.95 [95% CI, 0.73-1.24]).

Conclusions: No association was found between pLAAO and 1-year mortality, which is consistent with existing evidence from randomized controlled trials. The hdPS approach provides an opportunity to improve nonactive comparator selection in traditional PS analysis.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Peripheral artery disease (PAD) is an atherosclerotic condition that affects a growing number of individuals worldwide, with estimates exceeding 220 million. One of the central hallmarks of PAD is lower extremity pain, which may present as intermittent claudication and atypical leg pain, and, in more severe cases, ischemic rest pain, neuropathic pain, or phantom limb pain in those who underwent amputation. Although the majority of individuals with PAD may experience pain that is chronic in nature, the pathogenesis and phenomenology of pain may differ. Nociceptive, inflammatory, and neuropathic mechanisms all play a role in the generation of pain. Pain in PAD results in severe disability and can copresent with distress, sickness behaviors such as avoidance and further deconditioning, and concomitant depression, anxiety, and addiction secondary to opioid use. These factors potentially lead to chronic pain interacting with a multitude of domains of functioning, including physical, emotional, and behavioral. Whereas pain is a normal adaptive response, self-defeating behaviors and cognitions contribute to the persistence or worsening of the chronic pain experience, disability, and distress. Much remains unknown about the phenomenology of pain in PAD and its clinical subgroups and how it affects outcomes. Borrowing from other chronic pain syndromes, multimodal pain management strategies that emphasize a biopsychosocial model have generated a solid evidence base for the use of cognitive behavioral approaches to manage pain. Multimodal pain management in PAD is not the norm, but theoretical pathways and road maps for further research, assessment, and clinical implementation are presented in this scientific statement.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.